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4,345 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | Inclusion Criteria:
- Be able to understand and be willing to sign a written informed consent form
- Age ≥18 years
- Be willing and able to adhere to the instructions set forth in this protocol and able
to keep all specific appointments
- Have naturally occurring myopia up to -6.00 D or hyperopia up to +2.00 D (spectacle
plane) with or without corneal astigmatism up to 6.00 D
- Be in good general health, based on his/her knowledge, including normal healthy eyes
- Possess wearable and visually functional eyeglasses
- Have manifest refraction visual acuity equal to or better than 20/25 in each eye
Exclusion Criteria:
- Subject requires multifocal vision correction or is wearing lenses in a monovision
modality
- Subject has lenticular astigmatism uncorrectable by normal RGP tear layer optics
- Subject exhibits poor personal hygiene
- Subject is currently or within 30 days prior to enrollment in this study has been an
active participant in another clinical study (except SynergEyes Protocol # SI 08-05)
- Subject is currently pregnant (to the best of the subject's knowledge), is planning a
pregnancy within the next 9 months, or is lactating
- Subject has a known sensitivity to ingredients used in contact lens care products
- Subject has undergone refractive surgery or is currently receiving or has previously
received orthokeratology treatment
- Subject is aphakic or pseudophakic
- Subject has ocular or systemic disease such as, but not limited to, anterior uveitis
or iritis (past or present), glaucoma, Sjogren's Syndrome, lupus erythematosus,
scleroderma, keratoconus, post surgical corneal irregularity or type II diabetes
- Subject is using ocular medications for any reason or systemic medications which might
interfere with contact lens wear
- A known history of corneal hypoesthesia (reduced corneal sensitivity)
- Slit lamp findings that would contraindicate contact lens wear, including, but not
limited to:
- Evidence of corneal ulcer, corneal infiltrates or fungal infections
- Corneal scars within the visual axis
- Pterygium
- Dry eye symptoms with decrease tear levels and punctuate staining ≥ Grade 2
- Neovascularization or ghost vessels ≥1.5mm in from the limbus
- Seborrhoeic eczema or seborrhoeic conjunctivitis
- History of papillary conjunctivitis that has interfered with lens wear or a
current condition of Grade 2 or greater
- Clinically significant (Grade 3 or 4) anterior segment abnormalities or any infection
of the eye, lids or associated structures
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Study to Evaluate the Clinical Performance of SynergEyes A2 Hybrid Contact Lenses | NCT01058629 | Entailment |
5,438 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Patient with bleeding history sent to the Hemophilia Treatment Center in Dijon or
Nantes University Hospital with abnormal bleeding score (>3 in men and >5 in women
- Patient who has provided a signed consent to participate at this study and for blood
sampling
- Affiliation with French social security system
Non-Inclusion Criteria:
- Minors will not be included in the study.
- On-going pregnancy and postpartum period (3 months after delivery)
- Substitutive treatment with coagulation factor concentrates or desmopressin
administration within 10 days before sampling.
- Ongoing infectious or inflammatory disease that can modify VWF levels.
- Diagnosis of obvious hemostasis disorder
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Performance Evaluation of Von Willebrand:Collagen-Binding Assays to Diagnose Von Willebrand Factor Deficiency in Patients With Increased Risk of Bleeding | NCT02792205 | Entailment |
1,746 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- All subject
- Age 18-60
- Provision of written consent
Additional to FD patient
- Symptoms fulfilling Rome III criteria of functional dyspepsia
- Negative upper endoscopy (oesophagogastroduodenoscopy or OGD) finding
Exclusion Criteria:
- All subject
- History of cancer
- Diabetes mellitus
- History of gastric surgery
- Acid suppressants or medications that affect motility in past 4 weeks
- Organic disease as cause of dyspepsia (for subjects with dyspeptic symptom)
Additional to healthy volunteer
• Any gastrointestinal symptoms (including acid regurgitation, heartburn, epigastric pain,
bloating sensation, constipation, abdominal pain, diarrhea) in the past 4 weeks
Additional to FD patient
- Frequent (once or more per week) acid reflux or heartburn symptoms
- Helicobacter pylori (Hp) infection
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Effect of Genetic Association With Functional Dyspepsia and Mood Disorders | NCT02282995 | Contradiction |
5,283 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- To have Dual-energy X-ray absorptiometry (DXA) results and thoracolumbar lateral spine
X-Rays taken for any reason in the last 6 months.
- To have calcium, phosphorus, parathormone (PTH) and 25-hydroxyvitamin D level in the
last 3 months.
- To be independently ambulatory.
- To have a cognitive capacity to understand and complete the questionnaires.
Exclusion Criteria:
- To have malignancy.
- To have inflammatory diseases.
- To have a metabolic bone disease other than osteoporosis.
- To have neuromuscular diseases.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| Validation of the Turkish Version of QUALEFFO-31 | NCT04259099 | Entailment |
1,856 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- single lesion of adenocarcinoma in preoperative endoscopic biopsy
- clinical stage T1N0 in the preoperative evaluation of endoscopy and computed
tomography
- tumor size: less than 3cm in differentiated type, less than 2cm in undifferentiated
type
- location: 2cm far from the pylorus or cardia
- aged 20 to 80
- ECOG 0 or 1
- patient who signed the agreement
- patient who is suspected to underwent laparoscopy assisted gastrectomy
Exclusion Criteria:
- indication of endoscopic submucosal resection
- inoperable due to poor cardiac, pulmonary function
- pregnant
- having allergic reaction, previous upper abdominal surgery except laparoscopic
cholecystectomy, previous radiation therapy to upper abdomen
- diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and
thyroid cancer
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 80 Years | Pilot Study of Non-exposure Simple Suturing EFTR With Sentinel Lymph Node Navigation for EGC (Senorita3-pilot) | NCT03216174 | Entailment |
1,447 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- Willing to participate
- Having swallowing problems
Exclusion Criteria:
- Being under the age of 20 years, and above the age of 60 years
- Not willing to participate
- Having no swallowing problems
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 60 Years | The Turkish Deglutition Handicap Index | NCT04296409 | Contradiction |
4,372 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | Inclusion Criteria:
- Chinese male or female, aged 18-55 years (both inclusive) at the time of signing
informed consent.
- Body weight equal to or above 54.0 kg
- Body mass index (BMI) between 20.0 and 24.9 kg/m^2 (both inclusive)
- Considered to be generally healthy based on the medical history, physical examination,
and the results of vital signs, ECG and clinical laboratory tests performed during the
screening visit, as judged by the investigator.
Exclusion Criteria:
- Female who is pregnant, breast-feeding or intends to become pregnant or is of
child-bearing potential and not using highly effective contraceptive methods
- History of pancreatitis (acute or chronic) as declared by the subject.
- Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or medullary
thyroid carcinoma (MTC) as declared by the subject.
- History or presence of malignant neoplasms within the last 5 years (except basal and
squamous cell skin cancer and in-situ carcinomas) as declared by the subject.
- History of major surgical procedures involving the stomach potentially affecting
absorption of trial product (e.g., subtotal and total gastrectomy, sleeve gastrectomy,
gastric bypass surgery) as declared by the subject.
- Smoker (defined as a subject who is smoking equal to or more than 1 cigarette or the
equivalent per day).
- Unable or unwilling to refrain from smoking and use of nicotine substitute products
during the inpatient periods, as judged by the investigator.
- Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in
excess of 400 mL within the 3 months preceding screening.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | A Research Study of How Oral Semaglutide Tablets Work in Healthy People Who Are Chinese | NCT04016974 | Entailment |
4,219 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
General and Demographic Criteria
- Age of 18 to 40 years
- Access to a participating HVTN CRS and willingness to be followed for the planned
duration of the study
- Ability and willingness to provide informed consent
- Assessment of understanding: volunteer demonstrates understanding of this study;
provides answers to a questionnaire prior to first vaccination with verbal
demonstration of understanding of all questionnaire items answered incorrectly
- Agrees not to enroll in another study of an investigational research agent
- Good general health as shown by medical history, physical exam, and screening
laboratory tests
HIV-Related Criteria:
- Willingness to receive HIV test results
- Willingness to discuss HIV infection risks and amenable to HIV risk reduction
counseling.
- Assessed by the clinic staff as being at "low risk" for HIV infection and committed to
maintaining behavior consistent with low risk of HIV exposure through the last
required protocol clinic visit.
Laboratory Inclusion Values:
Hemogram/Complete blood count (CBC)
- Hemoglobin ≥ 11.0 g/dL for volunteers who were born female, ≥ 13.0 g/dL for volunteers
who were born male
- White blood cell count = 3,300 to 12,000 cells/mm^3
- Total lymphocyte count ≥ 800 cells/mm^3
- Remaining differential either within institutional normal range or with site physician
approval
- Platelets = 125,000 to 550,000/mm^3 Chemistry
- Chemistry panel: ALT, AST, and ALP < 1.25 times the institutional upper limit of
normal; creatinine ≤ institutional upper limit of normal.
Virology
- Negative HIV-1 and -2 blood test: Sites may use locally available assays that have
been approved by HVTN Laboratory Operations.
- Negative Hepatitis B surface antigen (HBsAg)
- Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase
chain reaction (PCR) if the anti-HCV is positive Urine
- Normal urine:
- Negative urine glucose, and
- Negative or trace urine protein, and
- Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a
microscopic urinalysis with red blood cells levels within institutional normal
range).
Reproductive Status
- Volunteers who were born female: negative serum or urine beta human chorionic
gonadotropin (β-HCG) pregnancy test performed prior to vaccination on the day of
initial vaccination. Persons who are NOT of reproductive potential due to having
undergone total hysterectomy or bilateral oophorectomy (verified by medical records),
are not required to undergo pregnancy testing.
Reproductive status: A volunteer who was born female must:
- Agree to consistently use effective contraception (Appendix B) for sexual activity
that could lead to pregnancy from at least 21 days prior to enrollment through the
last required protocol clinic visit.
- Effective contraception is defined as using 1 of the following methods:
- Condoms (male or female), or
- Diaphragm or cervical cap,
- PLUS 1 of the following methods:
- Intrauterine device (IUD),
- Hormonal contraception (in accordance with applicable national contraception
guidelines),
- Successful vasectomy in the male partner (considered successful if a volunteer
reports that a male partner has [1] documentation of azoospermia by microscopy,
or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite
sexual activity after vasectomy); or
- Any other contraceptive method approved by the HVTN 111 PSRT
- Or not be of reproductive potential, such as having reached menopause (no menses for 1
year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation;
- Or be sexually abstinent. Volunteers who were born female must also agree not to seek
pregnancy through alternative methods, such as artificial insemination or in vitro
fertilization until after the last required protocol clinic visit Other Volunteers 21
years of age and older who were born female consenting to provide cervical samples:
pap smear within the 3 years prior to enrollment, with the latest result reported as
normal or ASCUS (atypical squamous cells of undetermined significance); for those 21
years and older that have not had a pap smear within the last 3 years prior to
enrollment, must be willing to undergo a pap smear with the result reported as normal
or ASCUS prior to sample collection.
Exclusion Criteria:
General
- Blood products received within 120 days before first vaccination
- Investigational research agents received within 30 days before first vaccination
- Body mass index (BMI) ≥ 40; or BMI ≥ 35 with 2 or more of the following: systolic
blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg, current smoker, known
hyperlipidemia
- Intent to participate in another study of an investigational research agent during the
planned duration of the HVTN 111 study
- Pregnant or breastfeeding Vaccines and other Injections
- HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received
control/placebo in an HIV vaccine trial, the HVTN 111 PSRT will determine eligibility
on a case-by-case basis.
- Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine
trial. Exceptions may be made for vaccines that have subsequently undergone licensure
by the FDA. For volunteers who have received control/placebo in an experimental
vaccine trial, the HVTN 111 PSRT will determine eligibility on a case-by-case basis.
For volunteers who have received an experimental vaccine(s) greater than 5 years ago,
eligibility for enrollment will be determined by the HVTN 111 PSRT on a case-by-case
basis.
- Live attenuated vaccines other than influenza vaccine received within 30 days before
first vaccination or scheduled within 14 days after injection (eg, measles, mumps, and
rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)
- Influenza vaccine or any vaccines that are not live attenuated vaccines and were
received within 14 days prior to first vaccination (eg, tetanus, pneumococcal,
Hepatitis A or B)
- Allergy treatment with antigen injections within 30 days before first vaccination or
that are scheduled within 14 days after first vaccination Immune System
- Immunosuppressive medications received within 168 days before first vaccination. (Not
excluded from participation: [1] corticosteroid nasal spray; [2] inhaled
corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatitis; or
[4] a single course of oral/parenteral corticosteroids at doses < 2 mg/kg/day and
length of therapy < 11 days with completion at least 30 days prior to enrollment.
- Serious adverse reactions to vaccines or to vaccine components such as eggs, egg
products, or neomycin, including history of anaphylaxis and related symptoms such as
hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded: a
volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.)
- Immunoglobulin received within 60 days before first vaccination
- Autoimmune disease
- Immunodeficiency Clinically significant medical conditions
- Untreated or incompletely treated syphilis infection
- Clinically significant medical condition, physical examination findings, clinically
significant abnormal laboratory results, or past medical history with clinically
significant implications for current health. A clinically significant condition or
process includes but is not limited to:
- A process that would affect the immune response,
- A process that would require medication that affects the immune response,
- Any contraindication to repeated injections or blood draws,
- A condition that requires active medical intervention or monitoring to avert
grave danger to the volunteer's health or well-being during the study period,
- A condition or process for which signs or symptoms could be confused with
reactions to vaccine, or
- Any condition specifically listed among the exclusion criteria below.
- Any medical, psychiatric, occupational, or other condition that, in the judgment of
the investigator, would interfere with, or serve as a contraindication to, protocol
adherence, assessment of safety or reactogenicity, or a volunteer's ability to give
informed consent
- Psychiatric condition that precludes compliance with the protocol. Specifically
excluded are persons with psychoses within the past 3 years, ongoing risk for suicide,
or history of suicide attempt or gesture within the past 3 years.
- Current anti-tuberculosis (TB) prophylaxis or therapy
- Asthma other than mild, well-controlled asthma. (Symptoms of asthma severity as
defined in the most recent National Asthma Education and Prevention Program (NAEPP)
Expert Panel report). Exclude a volunteer who:
- Uses a short-acting rescue inhaler (typically a beta 2 agonist) daily, or
- Uses moderate/high dose inhaled corticosteroids, or
- In the past year has either of the following:
- Greater than 1 exacerbation of symptoms treated with oral/parenteral
corticosteroids;
- Needed emergency care, urgent care, hospitalization, or intubation for
asthma.
- Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not
excluded: history of isolated gestational diabetes.)
- Thyroidectomy, or thyroid disease requiring medication during the last 12 months
- Hypertension:
- If a person has been found to have elevated blood pressure or hypertension during
screening or previously, exclude for blood pressure that is not well controlled.
Well-controlled blood pressure is defined as consistently ≤ 140 mm Hg systolic
and ≤ 90 mm Hg diastolic, with or without medication, with only isolated, brief
instances of higher readings, which must be ≤ 150 mm Hg systolic and ≤ 100 mm Hg
diastolic. For these volunteers, blood pressure must be ≤ 140 mm Hg systolic and
≤ 90 mm Hg diastolic at enrollment.
- If a person has NOT been found to have elevated blood pressure or hypertension
during screening or previously, exclude for systolic blood pressure ≥ 150 mm Hg
at enrollment or diastolic blood pressure ≥ 100 mm Hg at enrollment.
- Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or
platelet disorder requiring special precautions)
- Malignancy (Not excluded: Volunteer who has had malignancy excised surgically and who,
in the investigator's estimation, has a reasonable assurance of sustained cure. or who
is unlikely to experience recurrence of malignancy during the period of the study)
- Seizure disorder: History of seizure(s) within past three years. Also exclude if
volunteer has used medications in order to prevent or treat seizure(s) at any time
within the past 3 years.
- Asplenia: any condition resulting in the absence of a functional spleen
- History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Safety and Immune Response to a Clade C DNA HIV Vaccine | NCT02997969 | Contradiction |
1,556 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- Normal spirometry at screening and in good general health as determined by a complete
medical history, physical examination, 12-lead ECG, blood chemistry profile,
hematology, and urinalysis,
- Smokers must have a history of smoking > 15 cigarettes/day currently and for at least
the last 2 years,
- Nonsmokers must have never smoked > 5 cigarettes/day and not smoking at all for at
least the last 2 years.
Exclusion Criteria:
- Any acute illness in the 5 days,
- Use of a bronchodilator for the treatment of wheezing within 12 months, OR
- Any other disease or condition, by history, physical examination, or laboratory
abnormalities that would present undue risk to the subject, or may confound the
interpretation of study results.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 50 Years | Staccato Loxapine PK in Smokers and Nonsmokers | NCT00873769 | Contradiction |
2,721 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
Age: 21- 80 yrs
- Informed consent
- Diagnosis of Hernia
- ASA I and II
- BMI<25.
Exclusion Criteria:
Bleeding disorders
- Age below 21
- Strangulated Hernia
- BMI > 30
- Incarcerated and obstructed hernia
- Recurrent hernia
- Bilateral hernia
- Previous LSCS
- Previous lower abdominal surgery
Male
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 80 Years | SIngle Port vs Standard TEP for Primary Inguinal Hernia Repair | NCT02302937 | Entailment |
6,313 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Key Inclusion Criteria:
1. Over 19 years of age
2. COVID-19 confirmed by a real-time RT-PCR tests 4 days prior to clinical trial
enrollment
3. Patients with peripheral capillary oxygen saturation (SPO2) greater than 94% at the
time of screening
4. Patients whose body temperature is measured according to the measured area without
taking a fever reducer during screening:
[armpit of greater than 37.0 °C or an oral of greater than 37.2 °C; Patients with
rectum greater than 37.6 °C or eardrum greater than 37.5 °C] (Notes: Although you take
a fever reducer, you can still be enrolled in after investigator's judgement whether
there is fever or not.)
5. Patients with evidence of lung invasions as a result of radiation tests
Exclusion Criteria:
1. Patients who need breathing device (for example, Invasive ventilation, Invasive
mechanical ventilation, Extra-corporeal membrane oxygenation).
2. Patients who participated in other clinical trials related to COVID-19.
3. Patients who were administered drugs directly to COVID-19 24 hours prior to the start
of the study.
4. Patients whose AST or ALT has increased by more than 5 times the normal lab value.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
| The Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Moderate COVID-19 | NCT04347915 | Entailment |
2,279 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- all Duchenne muscular dystrophy patients in our center
Exclusion Criteria:
- none
Male
Subject must be at least 15 Years old.
| Digestive Events in Duchenne Muscular Dystrophy Patients | NCT04384354 | Contradiction |
2,575 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- adult patients
- underwent uni-or bilateral groin hernia repair in the period 2015- 2019
- surgery through minimal invasive repair
Exclusion Criteria:
- open surgery or conversion from minimal-invasive to open surgery
- combined procedures
- age below 18 years
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Economic Assessment of STarting Endoscopic Robotic Groin Hernia Repair | NCT04431271 | Contradiction |
4,592 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:patients with regular menstrual cycles -
Exclusion Criteria:patients on contraceptive pills.patients after uterine surgery
-
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Computerized Evaluation of the Endometrial Myometrial Junction During a Natural Menstrual Cyle. | NCT02295917 | Contradiction |
3,811 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Must be 18-85 years old
- Have a clinical diagnosis of OA of the knee
- Be able to read and write English
Exclusion Criteria:
- Can't have rheumatoid arthritis, fibromyalgia, or other chronic pain condition.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Virtual Reality for Osteoarthritis Knee Pain Pilot | NCT01899508 | Entailment |
2,780 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Patients scheduled for elective inguinal hernia repair (out-patient treatment)
Exclusion Criteria:
- Previous lower abdominal surgery
- ASA-score 3 or above
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 85 Years | 3D HD Versus 2D HD in Laparoscopic Inguinal Hernia Repair: a Randomized Controlled Trial | NCT02396940 | Entailment |
1,824 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
1. Histologic and/or cytologic diagnosis of unresectable locally advanced or limited
metastatic adenocarcinoma of the stomach or esophagogastric junction.
2. Metastatic lesions are resectable or can be controlled by local ablative procedure.
3. Definition of limited metastatic status:
1. abdominal, retroperitoneallymphnodemetastases only (eg,para-aortic, intra
aortic-caval, peripancreatic, or mesenterial lymph nodes).
2. One incurable organ site with or without retroperitoneal lymph node metastases.
One incurable organ site metastases according to the following schema： -
Localized potentially operable peritoneal carcinomatosis or only cytology-
positive (Cy1) peritoneal lavage fluid without macroscopic peritoneal metastasis
.
- liver metastasis, and the number of liver metastasis ≤ 3 those are
potentially resetabl.
- unilateral or bilateral Krukenberg's tumors in the absence of macroscopic
peritoneal carcinomatosis.
- unilateral or bilateral adrenal metastases
- Extra-abdominal lymph node metastases such as supraclavicular or cervical
lymph node involvement.
4. Tumor HER-2 is negative.
5. Age 18-75, gender unlimited.
6. Survival expectation ≥12 weeks.
7. Eastern Cooperative Oncology Group (ECOG) 0 or 1.
8. Not previously treated with any systemic treatment (including HER2 inhibitors), or who
have metastasis 6 months after the end of adjuvant chemotherapy or neoadjuvant
chemotherapy. (Note: the use of oxaliplatin in previous adjuvant or neoadjuvant
therapy should not exceed 800 mg/m2, and the treatment-related toxicity must be
restored to common terminology criteria for adverse events (CTCAE) level 1 of the
National Cancer Institute [NCI] before randomization.).
9. According to the recist1.1 standard, there is at least one measurable objective tumor
focus. The maximum diameter of spiral CT must be ≥ 1cm, and the maximum diameter of
normal CT or MRI must be ≥ 2cm, and it should be carried out within 28 days before
enrollment.
10. All eligible patients have adequate organ function. According to the following
laboratory test results (no blood transfusion, G-CSF or other medical support
treatment within 14 days before the drug administration). The laboratory test results
within 1 week before the study drug administration meet the following conditions:
(HGB≥90 g/L , PLT ≥75 × 10⁹ /L, WBC ≥ 3.0× 10⁹ /L, ANC ≥1.5× 10⁹ / L, TBI ≤1.5 times
UNL, Cr≤1.5 times the UNL, ALT and AST ≤2.5 times UNL（5 times UNL )in case of liver
metastasis.
11. Subjects with active hepatitis B or active hepatitis C must receive antiviral
treatment for at least 14 days before the administration of the first study drug, and
pass the detection of hepatitis B virus (HBV) DNA titer (no more than 500 IU / ml or
2500 copies [CPS] / ml) and hepatitis C virus (HCV) RNA (no more than the detection
limit of the detection method), which can be included in the group test, and are
willing to continue to receive effective antiviral treatment during the study period.
12. Patients participate voluntarily and sign written informed consent
Exclusion Criteria:
1.Severe hepatorenal insufficiency or history of myocardial infarction (within 3 months).
2.5-year history of other malignancies(except skin basal cell carcinoma, cervical carcinoma
in situ).
3.Subjects with active or previous autoimmune diseases or risks that may recur(eg：requiring
immunosuppressive therapy for organ transplantation). However, subjects with type I
diabetes, hypothyroidism requiring hormone replacement therapy only, or skin diseases
without systemic treatment (such as vitiligo, psoriasis, or alopecia) were allowed to enter
the group.
4.Have had interstitial lung disease or noninfective pneumonia, etc. symptoms of the
disease or previous lung history may hinder the assessment or management of lung toxicity
related to the study drug.
5.Before the first administration of the study drug and who had a history of active
tuberculosis infection more than one year ago were considered suitable for inclusion if
they were judged by the investigator to have no evidence of active tuberculosis at present.
6.Severe uncontrolled medical disease or acute infection (fever above 38 ℃ caused by
infection).
7.The combination of serious internal and external diseases, affecting organ function, the
researchers think it is not suitable to participate in this clinical trial.
8.Pregnant or lactating women or fertile (men or women with menopause less than 1 year) are
unwilling to take contraceptive measures.
9.Patients with a long history of chronic diarrhea or complete intestinal obstruction.
10.Subjects requiring systemic treatment with corticosteroids (> 10 mg / day equivalent of
prednisone) or other immunosuppressive drugs within 14 days prior to administration of the
study drug. Note: if there is no active autoimmune disease, it is allowed to use inhaled or
local steroid hormone, or adrenaline replacement therapy with equivalent dose of prednisone
≤ 10 mg per day. Short term (< 7 days) use of glucocorticoids for prophylactic treatment
(e.g. contrast agent allergy) or for treatment of non autoimmune diseases (e.g. delayed
type hypersensitivity caused by contact allergens) is allowed.
11.Have interstitial lung disease or noninfective pneumonia, etc. symptoms of the disease
or previous lung history may hinder the assessment or management of lung toxicity related
to the study drug.
12.Subjects who have received any antibody / drug (such as anti-PD-1, anti-PD- L1,
anti-CTLA-4, anti OX-40, anti-CD137, anti Tim-3, anti LAG-3 antibody, etc.) targeting
T-cell co regulatory protein (immunocheckpoint).
13.Subjects with a history of hypersensitivity or hypersensitivity to study drug
components.
14.unable to take oral medicine.
15.Presence of immunodeficient disease or HIV infection.
16.Patients not suitable for this clinical trial determined by the investigator
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Conversion Therapy With Sintilimab Plus CAPOX in Patients With Unresectable Locally Advanced or Limited Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction | NCT04263870 | Entailment |
5,421 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Participant has been diagnosed with:
1. Type 1 (Von Willebrand factor: Ristocetin cofactor activity (VWF:RCo) < 20 IU/dL)
or,
2. Type 2A (VWF:RCo < 20 IU/dL), Type 2B (as diagnosed by genotype), Type 2N (Factor
VIII activity (FVIII:C) <10% and historically documented genetics), Type 2M or,
3. Type 3 ( Von Willebrand factor antigen (VWF:Ag) ≤ 3 IU/dL) or,
4. Severe Von Willebrand disease (VWD) with a history of requiring substitution
therapy with von Willebrand factor concentrate to control bleeding
- Participant, who participates in the treatment for bleeding episodes, has had a
minimum of 1 documented bleed (medical history) requiring VWF coagulation factor
replacement therapy during the previous 12 months prior to enrollment.
- Participant has a Karnofsky score ≥ 60%
- Participant is at least 18 and not older than 65 years of age at enrollment
- If female of childbearing potential, participant presents with a negative pregnancy
test
- Participant agrees to employ adequate birth control measures for the duration of the
study
- Participant is willing and able to comply with the requirements of the protocol
Exclusion Criteria:
- Participant has been diagnosed with pseudo VWD or another hereditary or acquired
coagulation disorder other than VWD (eg qualitative and quantitative platelet
disorders or elevated PT/international normalized ratio [INR] >1.4).
- Participant has a documented history of a VWF:RCo half-life of <6 hours.
- Participant has a history or presence of a VWF inhibitor at screening.
- Participant has a history or presence of a factor VIII (FVIII) inhibitor with a titer
≥0.4 BU (by Nijmegen assay) or ≥ 0.6 BU (by Bethesda assay).
- Participant has a known hypersensitivity to any of the components of the study drugs,
such as mouse or hamster proteins.
- Participant has a medical history of immunological disorders, excluding seasonal
allergic rhinitis/conjunctivitis, mild asthma, food allergies or animal allergies.
- Participant has a medical history of a thromboembolic event.
- Participant is HIV positive with an absolute CD4 count <200/mm3.
- Participant has been diagnosed with cardiovascular disease (New York Heart Association
[NYHA] classes 1-4.
- Participant has an acute illness (eg, influenza, flu-like syndrome, allergic
rhinitis/conjunctivitis, non-seasonal asthma) at screening.
- Participant has been diagnosed with significant liver disease as evidenced by any of
the following: serum alanine aminotransferase (ALT) 5 times the upper limit of normal;
hypoalbuminemia; portal vein hypertension (eg, presence of otherwise unexplained
splenomegaly, history of esophageal varices).
- Participant has been diagnosed with renal disease, with a serum creatinine level ≥2
mg/dL.
- In the judgment of the investigator, the participant has another clinically
significant concomitant disease (eg, uncontrolled hypertension) that may pose
additional risks for the participant.
- Participant has been treated with an immunomodulatory drug, excluding topical
treatment (eg, ointments, nasal sprays), within 30 days prior to enrollment
- Participant is pregnant or lactating at the time of enrollment.
- Participant has participated in another clinical study involving an IP or
investigational device within 30 days prior to enrollment or is scheduled to
participate in another clinical study involving an investigational product or
investigational device during the course of this study.
- Participant has a history of drug or alcohol abuse within the 2 years prior to
enrollment.
- Participant has a progressive fatal disease and/or life expectancy of less than 3
months.
- Participant is identified by the investigator as being unable or unwilling to
cooperate with study procedures.
- Participant suffers from a mental condition rendering him/her unable to understand the
nature, scope and possible consequences of the study and/or evidence of an
uncooperative attitude.
- Participant is in prison or compulsory detention by regulatory and/or juridical order
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor (rVWF) in the Treatment of Bleeding Episodes in Von Willebrand Disease (VWD) | NCT01410227 | Entailment |
6,791 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- All patients hemophiliac A or B, with or without inhibitors, included in the Nhemo (7
centres) and the Behrlingo database, treated with factor 8 or factor 9 products or
by-passing agents
- All Hemophilia A or B patients of any severity without inhibitors, included in the
NHEMO database and the BEHRLINGO database, without any treatment by clotting factors
- All Hemophilia A or B patients having given consent to be included in the study (2
times 12 months), during their usual follow-up (consultation…). For the other
patients, a derogation from the obligation to inform the patients will be made to the
CNIL.
Exclusion Criteria:
- patients under guardianship
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| MOTHIF II : THERAPEUTIC MANAGEMENT AND USE OF CLOTTING FACTORS IN HEMOPHILIA A & B IN FRANCE II | NCT03596814 | Entailment |
6,814 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Male, aged 18 to 75 years at the time of screening.
- Established severe hemophilia A (FVIII:C <1%, measured following >=5 days without
FVIII treatment) and/or documented intron 1 inversion or intron 22 inversion mutation
in the F8 gene, consistent with severe hemophilia A , and documented evidence of >=3
hemorrhages over the previous 12 months requiring treatment with exogenous FVIII or
use of FVIII prophylaxis because of history of frequent bleeding episodes.
- History of greater than (>) 150 exposure days to exogenously administered FVIII
concentrates or cryoprecipitate.
- Sexually active men must agree to use barrier contraception (combination of a condom
and spermicide) or limit sexual intercourse to post-menopausal, surgically sterilized,
or contraception-practicing partners for a minimum of 6 months after administration of
BAX 888, or until BAX 888 genomes are no longer detected in the semen, whichever is
sooner.
- Participant is willing and able to comply with the requirements of the protocol,
including provision of semen samples, maintenance of a diary of bleeding episodes and
FVIII protein use.
- Signed informed consent.
Exclusion Criteria:
- Bleeding disorder(s) other than hemophilia A.
- Personal laboratory evidence of having developed inhibitors to FVIII protein at any
time (>=0.6 Bethesda units [BU] on any single test).
- Documented prior allergic reaction to any FVIII product.
- Anti-Adeno-associated virus, serotype 8 (AAV8) neutralizing antibody titer >=1:5.
Participants whose laboratory assessments are less than or equal to (<=) 1:10 may be
re-tested within the same screening window and, if eligibility criterion is met on
retest, may be enrolled after confirmation by the Sponsor Medical Monitor.
- Known hypersensitivity to prednisolone or prednisone, or to any of the excipients.
- Having a disease in which treatment with prednisolone or prednisone is not tolerated
(including but not limited to osteoporosis with vertebral fractures, difficult to
control hypertension, and difficult to control diabetes).
- Evidence of markers of potential underlying risk for autoimmune mediated hepatic
disease:
- Anti-smooth muscle antibody assay results >=40 (Inova QUANTA LiteTM Actin IgG
enzyme-linked immunosorbent assay [ELISA]); values of 31 to 39 will be flagged as
possibly abnormal and the Investigator and Medical Monitor will evaluate the
participant for eligibility.
- Elevated anti-liver-kidney microsomal antibody type 1 (LKM1) titers.
- Total immunoglobulin G (IgG) >1.5*upper limit of normal (ULN).
- Antinuclear antibody (ANA) titer >1:320; OR ANA titer >1:80 if demonstrated
concurrently with alanine aminotransferase (ALT) that is >ULN.
- Active Hepatitis virus (Hepatitis C): As indicated by detectable hepatitis C virus
(HCV) ribonucleic acid (RNA) by polymerase chain reaction (PCR).
- Hepatitis B: If surface antigen is positive.
- Seropositive for Human Immunodeficiency Virus (HIV).
- Receiving systemic antiviral and/or interferon therapy within 4 weeks prior to
enrollment.
- Clinically significant infections (e.g. systemic fungal infections) requiring systemic
treatment.
- Known immune disorder (including myeloma and lymphoma).
- Concurrent chemotherapy or biological therapy for treatment of neoplastic disease or
other disorders.
- An absolute neutrophil count <1000 cells per cubic millimeter (cells/mm^3).
- Markers of hepatic inflammation or cirrhosis as evidenced by 1 or more of the
following:
- Platelet count of <150,000/microliter (mcL).
- Serum albumin level is below the central laboratory's lower limit of normal and
FibroSURE is >=0.48 (i.e., Metavir staging of F2 or greater). Of note, in
participants with a known history of Gilbert's syndrome, a Fibrotest cannot be
used for fibrosis testing.
- Total bilirubin >1.5*ULN and direct bilirubin >=0.5 milligram per deciliter
(mg/dL).
- ALT or aspartate aminotransferase (AST) >1.0*ULN.
- Alkaline phosphatase (AP) >2.0*ULN.
- History of liver biopsy indicating moderate or severe fibrosis (Metavir staging
of F2 or greater).
- History of ascites, varices, variceal hemorrhage, or hepatic encephalopathy.
- Any findings on screening ultrasound that would preclude the safe use of AAV gene
therapy.
- Prothrombin time (PT) international normalized ratio (INR) >=1.4.
- Serum creatinine >1.5 mg/dL.
- Urine protein >30 mg/dL or >0.5 gram per day (g/day).
- Body mass index >38.
- Major surgery or an orthopedic surgical procedure planned within 6 months after
enrollment.
- Acute or chronic disease that, in the opinion of the investigator, would adversely
affect participant safety or compliance or interpretation of study results.
- Received an AAV vector previously or any other gene transfer agent in the previous 12
months prior to Study Day 0.
- Received an investigational intervention or participated in another clinical trial
within 4 weeks prior to enrollment or within 5 half-lives of the investigational drug
administration, whichever is longer.
- Significant cardiovascular disease (such as New York Heart Association Class III or IV
cardiac disease, congestive heart failure, myocardial infarction within the previous 6
months, unstable arrhythmias, or unstable angina) or significant pulmonary disease
(including obstructive pulmonary disease).
- Recent history of psychiatric illness or cognitive dysfunction (including drug or
alcohol abuse) that in the opinion of the investigator, is likely to impair
participants ability to comply with protocol mandated procedures.
- Participant is a family member or employee of the investigator.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | A Study of BAX 888 in Male Adults With Severe Hemophilia A | NCT03370172 | Entailment |
1,938 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- With or without gastrointestinal complaints
- Scheduled to undergo a capsule endoscopy for both stomach and small bowel
- Signed the informed consents before joining this study
Exclusion Criteria:
- Suspected or known gastrointestinal stenosis
- Obstruction or other known risk factors for capsule retention
- Pregnancy or suspected pregnancy
- Pacemakers or electromedical devices implanted
- Any other contraindications determined by endoscopists
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 80 Years | MCE Direct Visualization of Drug Behavior in Upper-gastrointestinal Tract | NCT04327869 | Entailment |
88 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Males between 35 and 55, normal serum testosterone levels, normal gonadal function
Exclusion Criteria:
- History of prostate cancer, PSA>2.0, AUA BPH symptom score >10, History of
testosterone or anabolic steroid use, chronic medical illness or prostate disease,
active serious infection or immunosuppression, history of a bleeding disorder or need
for anticoagulation, abnormal digital rectal exam, abnormal prostate ultrasound, first
degree relative with history of prostate cancer
Male
Accepts Healthy Volunteers
Subject must be at least 35 Years old.
Subject must be at most 55 Years | The Effects of Testosterone on Prostate Tissue (ACYP-1) | NCT00161486 | Contradiction |
496 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- All women above 18 years of age
- Less than 12 weeks of gestation.
- Pregnancy is confirmed by pregnancy test or ultrasound scan.
- missed abortion
- Normal general and gynecological examination.
- The size of the uterus on pelvic examination was compatible with the estimated
duration of pregnancy
Exclusion Criteria:
- Hemodynamically unstable.
- Suspected sepsis with temperature 38 °C.
- Concurrent medical illness e.g. hematological, cardiovascular, thromboembolism,
respiratory illnesses, recent liver disease or pruritus of pregnancy.
- Presence of intrauterine contraceptive device (IUCD).
- Suspect or proven ectopic pregnancy.
- Failed medical or surgical evacuation before presentation.
- Known allergy to misoprostol.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage | NCT02686840 | Contradiction |
3,713 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Diagnosis of primary symptomatic KOA according to the criteria of the American College
of Rheumatology
- Women aged older than 65 years
- Pain predominantly over the last 3 months
- Kellgren and Lawrence score ≥2.
Exclusion Criteria:
- Ankle, hip or foot severe disorders
- Chronic back pain
- Alzheimer's disease, Parkinson's disease, motor neuron disorders.
- Diabetes mellitus
- Cardiac or respiratory insufficiency
- Inability to understand the procedure
Female
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
| Individualized Comprehensive Rehabilitation Program in Chronic Knee Osteoarthritis | NCT04138784 | Contradiction |
1,931 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | - INCLUSION CRITERIA:
- Patients with the following are eligible:
- Malignant or non-invasive, neoplastic lesions of the stomach confirmed by
histopathology or cytopathology in a CLIA-certified laboratory
OR
--Suspicious lesions not yet confirmed, but considered likely to be related to the stomach
pending further evaluation
OR
- Confirmed, deleterious germline mutation (including but not limited to HDGC, GAPPS)
known to predispose to gastric tumors;
- Confirmed or suspicious heritable gastric malignancy disorder;
- Clinically suspicious personal or family medical history of gastric cancer or gastric
cancer syndrome that warrants genetics evaluation.
- Patients with a family history of gastric cancer or suspicion of a heritable
gastric malignancy disorder
- Patients must have an ECOG performance score of 0-2.
- Age greater than or equal to 2 years. Note: Patients greater than or equal to 2
and less than or equal to 18 years of age may only participate in research sample
collection if the tissue acquisition is performed during a clinically indicated
surgical procedure, and the sampling of tissue, blood and urine does not add risk
to the clinically indicated procedures.
- The patient is a candidate for the clinically indicated medical evaluations that
are being offered
- Ability of subject, their parents/guardians or legally authorized representative
(LAR) to understand and must be willing to sign a written informed consent
document.
EXCLUSION CRITERIA:
Candidates who do not meet the inclusion criteria.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
| Prospective Evaluation and Molecular Profiling in People With Gastric Tumors | NCT03027427 | Entailment |
2,517 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | Inclusion Criteria:
- clinical diagnosis of Atopic Dermatitis
- older than 12 years old
Exclusion Criteria:
- other specific forms of eczema such as contact eczema, seborrheic eczema, nummular
eczema, occupational dermatitis, hand eczema
- systemic diseases that can be accompanied by immunological skin abnormalities as
psoriasis;
- clinically significant chronic infectious disease(s) (eg, HIV, hepatitis B or C);
- breastfeeding,pregnant/intending to become pregnant during study;
- participation in any other clinical study;
- part of the staff personnel involved with the study;
- family member of investigational/study staff.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
| Efficacy and Safety of a a Biofunctional Textile in the Management of Atopic Dermatitis | NCT01597817 | Contradiction |
2,545 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | Inclusion Criteria:
1. Able to comprehend and follow the requirements of the study (including availability on
scheduled visit dates)
2. Male or female of any race or ethnicity, 6 months to 47 months of age;
3. Diagnosed as having eczema
4. Willing to stop use of all non-assigned moisturizers and/or creams for the entire
duration of the study
5. Child must have bedtime/sleep issues due to their dry, itchy skin
Exclusion Criteria:
1. Use of a therapeutic (over-the-counter or prescription) body wash that contains an
active ingredient for eczema
2. Participation in any clinical study within 30 days of Visit 1
3. Active infection of any type at the start of the study
4. Diagnosed as having severe eczema
5. Atopic Dermatitis requiring systemic, super-potent (Class I) or potent (Class II or
III) topical corticosteroids
6. Child wakes up 3 or more times during the night
7. Child is awake more than 60 minutes during the night
8. Child sleeps for less than a total of 9 hours (during the day or night)
9. Child requires greater than 2.0 mg per day of inhaled or intranasal corticosteroids
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
Subject must be at most 47 Months | Test to Determine the Effectiveness of Moisturizing Balm Used on Babies With Dry, Itchy Skin | NCT02404493 | Entailment |
1,620 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- Volunteers of 20 healthy, right dominant hands
- 10 patients with tendon pathologies
- 10 patients with Dupuytren disease
- 10 patients with osteoarthritis of the wrist
- Patients older than 18 years
- Patient willing and able to give written informed consent to participate in the study
Exclusion Criteria:
- Inflammatory disease (e.g. rheumatoid arthritis)
- Pregnant women
- German language barrier to complete the questionnaires
- Any disease process that would preclude accurate evaluation (e.g. neuromuscular,
psychiatric or metabolic disorder)
- Legal incompetence
- Participation in any other medical device or medicinal product study within the
previous months that could influence the results of the present study
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Three-dimensional Kinematic Motion Analysis of Finger and Wrist During Daily Activities | NCT02890862 | Contradiction |
6,698 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Patient currently a patient at dental school or eligible for treatment at dental
school
- Patient resides within 50 mile radius of dental school
- A single rooted tooth that has been identified by dental faculty as requiring
extraction
- Have adequate restorative space for a dental implant-retained restoration
- Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus
or inferior alveolar canal.
- Have a dehiscence of the buccal or lingual bony plate of the tooth socket extending no
more than 50% of the total depth of the socket.
- Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and
non-pregnant women of child-bearing potential.
Exclusion Criteria:
- not meeting inclusion criteria above
- Active localized or systemic infection other than periodontitis.
- Inadequate bone dimensions or restorative space dimensions to place a dental implant
- Presence of a disease entity, medical condition or therapeutic regimen which decreases
probability of soft tissue and bony healing, e.g., poorly controlled diabetes,
chemotherapeutic and immunosuppressive agents, autoimmune diseases, history of
bisphosphonate use or long-term steroid therapy.
- Positive medical history of endocarditis following oral or dental surgery.
- Sensitivity or allergy to Bacitracin, Gentamicin, Polymyxin B Sulfate, alcohol and/or
surfactants (per package insert)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 89 Years | Effect of Healing Time on New Bone Formation Following Tooth Extraction and Ridge Preservation With Demineralized Freeze-Dried Bone Allograft | NCT02154386 | Contradiction |
5,678 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
- BMI >85th% for age and sex
- Weight gain over the last 6 months of >5% than expected on the growth curve
- 12-17 years of age
Exclusion Criteria:
- Subjects with intolerance to dairy products (e.g., lactose intolerance) will be
excluded from entering into the study.
- Subjects must not have a history of clinically significant cardiac disease, congenital
heart disease, any clinically significant abnormal cardiac condition, or be known to
have a clinically significantly abnormal ECG. Specifically excluded conditions include
coronary artery disease, clinically significant cardiac arrhythmias, and congestive
heart failure.
- Subjects must not have a history of anorexia nervosa, untreated hypothyroidism (TSH
greater than 4.0 mU/L for a second generation test), malignancy, pathophysiologic or
genetic syndromes associated with obesity (i.e., Cushing's syndrome, Turner's
syndrome, Prader Willi syndrome), major psychiatric illness such as bi-polar disorder,
ADD, major depression, bulimia, schizophrenia, or psychosis.
- Subjects may not participate in any weight management program, except for that in this
study, during this pilot. Subjects may not use prescription or over-the-counter (or
herbal) weight control medication during the trial.
- Subjects must not have a history of alcohol or drug addiction or substance abuse
within the previous 2 years.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 12 Years old.
Subject must be at most 18 Years | Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents | NCT00207519 | Contradiction |
2,945 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- possible, probable or definite ALS according to El Escorial revised criteria
Exclusion Criteria:
- Any other clinically significant cardiovascular, gastrointestinal, hepatic, renal,
neurological or psychiatric disorder or any other major concurrent illness that in the
opinion of the investigator could interfere with the interpretation of the study
results
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Italian Validation of the Beaumont Behavioural Inventory (BBI) | NCT04440644 | Entailment |
4,944 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
1. Men and women, aged 18 or older, with abnormal movements (including tremor, chorea,
dystonia, myoclonus, and tic) and normal controls (subjects without abnormal
movements).
2. Subjects must be willing and able to comply with study procedures.
3. Patients must be willing and able to give meaningful, written informed consent.
Exclusion Criteria:
1. Significant cognitive impairment which, in the opinion of the Investigator, would
interfere with the ability to complete all the tests required in the protocol.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| WiiMote Game Controller as a Device to Study Movement Disorders | NCT00802191 | Entailment |
1,568 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria for chronic periodontitis groups:
- Clinical attachment loss ≥ 5mm
- Probing depth ≥5mm
- Bone loss affecting >30% of the existing teeth on clinical and radiographic
examination
- gingival index (GI) score> 1
Inclusion criteria for control group:
- full-mouth PD was≤ 3mm,
- Gingival index <1
- there was no indication of Attachment Loss or no radiographic evidence of alveolar
bone loss in control group.
- Non-smokers.
Smoking criteria for groups:
- patients smoked more than 10 cigarettes in a day
- smoking for 3 or more years,
Exclusion Criteria:
- systemic condition (diabetes, cardiovascular disease, immunologic disorders,
hepatitis, e.g.)
- pregnancy, lactation or menopause term,
- antibiotic treatment or non-steroidal anti-inflammatory medications within the last 3
months before the study,
- non-surgical periodontal treatment during the last 6 months before the study,
- treatment with Vitamin D supplementation before the study
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 35 Years old.
Subject must be at most 50 Years | Effects of Smoking and Vitamin D3 on the Levels of Human Cathelicidin Peptide LL-37 | NCT03923218 | Contradiction |
5,214 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Patient groups
Inclusion Criteria:
- Verified osteoporosis (T-score -2.5 to -3.5) from previous Dual-energy X-ray
absorptiometry scanning (DXA)
- Receiving medical treatment for osteoporosis
Exclusion Criteria:
- Drug addiction defined as the use of cannabis, opioids or other drugs.
- Use of medical cannabis.
- Previous neurologic, musculoskeletal (besides osteoporosis) or mental illnesses
- Lack of ability to cooperate.
- Osteoporosis grade higher than moderate or severe (T-score < -3.5)
Healthy elderly groups
Inclusion Criteria:
• T-score higher than -2.5 from previous Dual-energy X-ray absorptiometry scanning (DXA)
Exclusion Criteria:
- Drug addiction defined as the use of cannabis, opioids or other drugs.
- Use of medical cannabis.
- Previous neurologic, musculoskeletal (besides osteoporosis) or mental illnesses
- Lack of ability to cooperate.
- Osteoporosis grade higher than mild, moderate or severe (T-score < -2.5)
- Receiving medical treatment for osteoporosis
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 65 Years old.
| Dancing Against Fall Fractures in Osteoporosis Patients and Healthy Elderly | NCT03683849 | Entailment |
5,451 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Healthy women of reproductive age (21-38 years)
- Not at risk for pregnancy based on subject has undergone sterilization or subject is
monogamous and her male partner has undergone sterilization
- Have regular menstrual cycles of 21-35 days duration
- Have an intact uterus and both ovaries
- Will be able to comply with the protocol
- Capable of giving informed consent
Exclusion Criteria:
- Women participating in another clinical trial within 30 days of initiation of this
clinical trial
- Women not living in the catchment area of the clinic
- Known hypersensitivity to progestins or antiprogestins
- Known hypersensitivity to copper
- Any known chronic disease including HIV/AIDS
- All contraindications to IUD use,
- Desire to get pregnant during the study Breastfeeding
- Undiagnosed vaginal discharge or vaginal lesions or abnormalities
- Women with a current abnormal Pap. In accordance with the Bethesda system of
classification: smear suggestive of high-grade pre-cancerous lesion(s), including
HGSIL, are excluded;
- Women with LGSIL or ASCUS/high-risk HPV positive may participate if further evaluated
with colposcopy and biopsy and no evidence of a lesion with a severity > CIN I is
present and/or endocervical curettage is negative.
- Women with a biopsy finding of CIN I should have follow up for this finding per
standard of care; women are excluded it treatment is indicated.
- Known benign or malignant liver tumors; known active liver disease
- Cancer (past history of any carcinoma or sarcoma)
- Medically diagnosed severe depression currently or in the past
- Known or suspected alcoholism or drug abuse
- Abnormal, clinically significant, serum fasting clinical chemistry values
- Women with known abnormal thyroid status
- Women with known impaired hypothalamic-pituitary-adrenal reserve
- Average diastolic BP > 85 mm or systolic BP >135 mm Hg after 5-10 minutes rest
- Body mass index (BMI) > 30.0 (or ≤18) Kg/m2
- Women with uterine anomalies
- Use within the past 2 months of any implanted hormonal contraceptives including
progestin-releasing intrauterine systems (IUS) or progestin-releasing subdermal
implants. NOTE: Removal of implanted hormonal contraceptives must have been for
personal reasons unrelated to the purpose of enrollment in this study.
- Current use of a non-hormone containing IUD. NOTE: Removal of an IUD must be for
personal reasons unrelated to the purpose of enrollment in this study.
- Use of injectable contraceptives during the previous 3 months (e.g. Cyclofem) or 6
months (e.g. DMPA).
- Women who do not have at least two progesterone measurements ≥10nmol/L during the
baseline cycle will be excluded from further participation in the study (See Section
13.4.1)
- Acute pelvic inflammatory disease or a history of pelvic inflammatory disease unless
there has been a subsequent intrauterine pregnancy. Postpartum endometritis or
infected abortion in the past 3 months.
- Genital bleeding of unknown etiology.
- Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower
genital tract infections until infection is controlled.
- Current behavior suggesting a high risk for pelvic inflammatory disease
- Mucopurulent cervicitis
- Wilson's disease
- Allergy to any component of the IUS
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 38 Years | A proof-of Concept, Randomized 3-month Study to Evaluate the Effects of Three Contraceptive Intrauterine Systems Delivering Copper and a Daily Dose of 5, 20 or 40 μg of Ulipristal Acetate (UPA) | NCT03230539 | Entailment |
3,481 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
- GAD65 antibody negative patients with T2D
- Duration of diabetes 6 months to 10 years
- No diabetic complications
- Treated with either diet alone or diet in combination with either metformin, oral
DPP-4 inhibitors or sulphonylureas
- Patients should be able and willing to discontinue all drugs for 1 weeks prior to the
studies
- Obese and lean controls should be healthy, glucose tolerant and drug naive
- Obese and lean controls should have no family history of diabetes
- All participants should be able to provide informed written consent
Exclusion Criteria:
- Any unknown disease or need for medication that occurs after inclusion
- Abnormal ECG, screening blood tests and/or severe hypertension
- Impaired glucose tolerance in non-diabetic subjects
Male
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 65 Years | Abnormalities in the Effects of Insulin and Exercise on Glucose- and Lipid Metabolism in Obesity and Type 2 Diabetes | NCT03500016 | Entailment |
1,850 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
1. Histologically confirmed, medically operable, resectable diffuse or mixed type (Lauren
classification) adenocarcinoma of the gastroesophageal junction (AEG II-III) or the
stomach (uT3, uT4a, any N category, M0), or any T N+ M0 patient
2. Patient has received 3 to 6 cycles of neoadjuvant FLOT (de-escalation or dose
modification allowed)
3. No preceding cytotoxic or targeted therapy other than neoadjuvant FLOT (including
de-escalated or dose reduced schema) therapy
4. No prior partial or complete tumor resection
5. Female and male patient ≥ 18 and ≤ 75 years. Female patient with childbearing
potential needs to have a negative pregnancy test within 7 days prior to study start.
Males and females of reproductive potential must agree to practice highly effective
contraceptive measures* during the study. Male patients must also agree to refrain
from father a child during treatment and additionally to use a condom during treatment
period. Their female partner of childbearing potential must also agree to use an
adequate contraceptive measure.
*highly effective (i.e. failure rate of <1% per year when used consistently and
correctly) methods: intravaginal and transdermal combined (estrogen and progestogen
containing) hormonal contraception; injectable and implantable progestogen-only
hormonal contraception; intrauterine device (IUD); intrauterine hormone-releasing
system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence
(complete abstinence is defined as refraining from heterosexual intercourse during the
entire period of risk associated with the study treatments).
6. ECOG ≤ 1
7. Exclusion of distant metastases by CT or MRI of abdomen, pelvis, and thorax, bone scan
or MRI (if bone metastases are suspected due to clinical signs). Exclusion of the
infiltration of any adjacent organs or structures by CT or MRI
8. Laparoscopic exclusion of peritoneal carcinomatosis at initial staging, before start
of FLOT chemotherapy
9. Adequate hematological, hepatic and renal function parameters:
1. Leukocytes ≥ 3000/mm³, platelets ≥ 100,000/mm³, neutrophil count (ANC) ≥1000/µL
2. Serum creatinine ≤ 1.5 x upper limit of normal
3. Bilirubin ≤ 1.5 x upper limit of normal, AST and ALT ≤ 3.0 x upper limit of
normal, alkaline phosphatase ≤ 6 x upper limit of normal
4. For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN;
for patients receiving therapeutic anticoagulation: stable anticoagulant regimen
10. Patient able and willing to provide written informed consent and to comply with the
study protocol and with the planned surgical procedures
Exclusion Criteria:
1. Patient without neoadjuvant therapy or those who received a neoadjuvant therapy other
than FLOT
2. Known hypersensitivity against 5-FU, leucovorin, oxaliplatin, or docetaxel
3. Other known contraindications against, 5-FU, leucovorin, oxaliplatin, or docetaxel
4. Clinically significant active coronary heart disease, cardiomyopathy or congestive
heart failure, NYHA III-IV
5. Clinically significant valvular defect
6. Past or current history of other malignancies not curatively treated and without
evidence of disease for more than 5 years, except for curatively treated basal cell
carcinoma of the skin and in situ carcinoma of the cervix
7. Criteria of primary unresectability, e.g.:
- Radiologically documented evidence of major blood vessel invasion or invasion of
adjacent organs (T4b).
- Patients with involved retroperitoneal (e.g. para-aortal, paracaval or
interaortocaval lymph nodes) or mesenterial lymph nodes (distant metastases!)
8. Other severe internal disease or acute infection
9. Peripheral polyneuropathy ≥ NCI Grade II
10. Patient has undergone major surgery within 28 days prior to enrollment except staging
laparoscopy.
11. Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a
history of hepatic encephalopathy or ascites.
12. On-treatment participation in another interventional clinical study in the period 30
days prior to inclusion and during the study
13. Patient pregnant or breast feeding, or planning to become pregnant
14. Patient in a closed institution according to an authority or court decision (AMG § 40,
Abs. 1 No. 4)
15. Any other concurrent antineoplastic treatment including irradiation
16. Known intraabdominal adhesion situs
17. Pre-existing peritoneal seeding
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | HIPEC + FLOT vs. FLOT Alone in Patients With Gastric Cancer and GEJ (PREVENT) | NCT04447352 | Entailment |
1,144 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- Age >= 18 years visiting the Emergency Department,
- history of syncope in the past 24 hours: loss of consciousness, rapid onset, short
duration (<1 min), transient, with spontaneous and rapid recovery without post event
confusion
- With or without prodromes
- Without any other obvious cause
- Informed written consent
- Affiliation to a social security system (AME Excepted)
Exclusion Criteria:
- Other criteria for PE suspicion : Acute onset of dyspnea Acute severe chest pain,
- Pregnancy
- Concurrent anticoagulation treatment
- Other obvious cause of syncope : Seizure, Stroke, Traumatic brain injury , toxic
intake , Atrioventricular block type 3
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Prevalence of PE in ED Patients With Isolated Syncope | NCT03487237 | Entailment |
5,999 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
1. Participants identifying their main symptom as a burning feeling in the mid-epigastric
area and/or chest area (that is, heartburn).
2. Must have a history of symptomatic GERD for 6 months or longer prior to Screening with
GERD symptoms that were responsive to acid-suppressive therapy.
3. Must have episodes of heartburn for 4 or more days during the 7 days prior to Day -1
as recorded in the eDiary.
Exclusion Criteria:
1. Has a history of cancer (except basal cell carcinoma of the skin), that has not been
in remission for at least 5 years prior to Screening.
2. Has a known history of Barrett's esophagus with dysplastic changes or any changes
suspicious Barrett's seen during screening endoscopy.
3. Participant developed acute upper gastrointestinal bleeding, gastric ulcer (a mucosal
defect with white coating) or duodenal ulcer (a mucosal defect with white coating),
within 30 days before the start of the Screening Visit (with the possible inclusion of
those with gastric or duodenal erosion). The participant requires chronic use (greater
than [>] 12 doses per month) of nonsteroidal anti-inflammatory drugs (NSAIDs)
including cyclooxygenase-2 (COX-2) NSAIDs within 30 days prior to the Screening Period
and throughout the study.
4. Has comorbidities that could affect the esophagus (eosinophilic esophagitis,
esophageal varices, scleroderma, viral or fungal infection, esophageal strictures); a
history of radiotherapy or cryotherapy of the esophagus; and a history of corrosive or
physiochemical injury (with the possible inclusion in the study of those with
Schatzki's ring).
5. Has a history of surgical procedures that may affect the esophagus (example,
fundoplication and mechanical dilatation for esophageal strictures) or a history of
gastric or duodenal surgery other than endoscopic removal of benign polyps.
6. Has erosive esophagitis (EE) as shown by endoscopy, during the Screening Period.
7. Is known to have acquired immunodeficiency syndrome (AIDS) or hepatitis, including
hepatitis virus carriers: (that is, hepatitis B surface antigen HBs-antigen (HBsAg)
positive or hepatitis C virus (HCV)-antibody positive).
8. Has current or historical evidence of Zollinger-Ellison syndrome or a history of
gastric acid hypersecretion.
9. Is scheduled for surgery that requires hospitalization or requires surgical treatment
during his/her participation in the study.
10. Has donated or lost >300 milliliter (mL) blood volume, undergone plasmapheresis, or
has had a transfusion of any blood product within 90 days prior to the first dose of
study drug.
11. Has a history of alcohol abuse (defined as any illicit drug use), or drug addiction in
the 12 months prior to Screening.
12. Participant with positive serology result of Helicobacter pylori (H. pylori) that
needs eradication therapy during the study participation period as anticipated by the
investigator.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Efficacy and Safety of Dexlansoprazole on Heartburn Relief in Chinese Patients | NCT02873689 | Entailment |
2,922 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- All subjects must have a verifiable diagnosis of ALS of 0.5 to 2 years' duration.
- The diagnosis must be supported by the Revised Criteria of the World Federation of
Neurology.
- The grades of diagnosis must be clinically definite ALS or clinically probable ALS.
- All subjects must be over age 18 and below 65.
- The ALS is mildly to moderate based on ALS Health State Scale.
- Electrophysiological features show CMAP amplitude of motor nerve normal or mild
declining.
- Serum creatine kinase is normal or mild upper, less than 500U/L.
Exclusion Criteria:
- If anyone of the above eligibility requirements is not met
- Use of any other investigational agent within 30 days beginning the treatment phase of
this study
- Severe cardiac, pulmonary, hepatic or/and hematic disease
- HIV positivity or signs and symptoms consistent with HIV infection
- Pregnant or nursing women
- History of cancer with less than 5 years documentation of a disease-free state
- History of anaphylactic reaction or hypersensitivity to G-CSF or proteins derived from
E.coli
- Alcohol or drug abuse in recent 1 year
- Can't understand or obey the rules of treatment
- Blood donor in recent 30 days
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Cistanche Total Glycosides for Amyotrophic Lateral Sclerosis: A Randomized Control Trial (RCT) Study Assessing Clinical Response | NCT00753571 | Entailment |
6,887 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- Males and females, from all racial and ethnic categories between the ages of 60-80
years of age, with English as their first language.
- Residents of the New York City metropolitan area.
- Minimum of 12 years of education.
- Participants will be grouped according to the following classifications: normal aging,
mild cognitive impairment (MCI), Alzheimer's disease (AD), or frontotemporal dementia
(FTD).
- Participants will agree to ApoE genotyping and DNA banking.
Exclusion Criteria:
- Past history or MRI evidence of brain damage including significant trauma, stroke,
hydrocephalus, lacunar infarcts, seizures, mental retardation or serious neurological
disorder.
- Significant history of alcoholism or drug abuse.
- History of psychiatric illness (e.g., schizophrenia, mania or depression).
- Any focal signs or significant neuropathology.
- A score of 4 or greater on the Modified Hachinski Ischemia Scale suggesting
cerebrovascular disease.
- A total score of 16 or more on the Hamilton Depression Scale to exclude possible cases
of primary depression.
- Evidence of clinically relevant and uncontrolled hypertensive, cardiac, pulmonary,
vascular, metabolic or hematologic conditions.
- Physical impairment of such severity as to adversely affect the validity of
psychological testing.
- Hostility or refusal to cooperate.
- Any prosthetic devices (e.g., pacemaker or surgical clips) that could be affected by
the magnetic field employed during MRI imaging.
- History of familial early onset dementia.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 60 Years old.
Subject must be at most 80 Years | Predictors of Cognitive Decline in Normal Aging | NCT00094939 | Entailment |
87 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Healthy males between the ages of 21 and 65 years of age
- All clinical laboratory tests within normal ranges (any clinically significant
deviation of laboratory results will require approval of sponsor)
- Previously or concurrently diagnosed as having secondary hypogonadism and confirmed
morning testosterone <250ng/dL (two assessments at least 10 days apart)
- Ability to complete the study in compliance with the protocol
- Ability to understand and provide written informed consent
- Agreement to use double barrier contraception if with a fertile female partner
- Agreement to provide a semen sample in the clinic
Exclusion Criteria:
- Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 6
months prior to study
- Use of spironolactone, cimetidine, Clomid, 5α-reductase inhibitors, hCG, androgen,
estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
- Use of Clomid in the past year
- Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment
at baseline. Subjects treated for Type II diabetes but exhibiting glycemic control
will be allowed into the study
- A hematocrit >50% or a hemoglobin >17 g/dL
- Clinically significant abnormal findings on screening examination
- Use of an investigational drug or product, or participation in a drug or medical
device research study within 30 days prior to receiving study medication
- Known hypersensitivity to Clomid
- Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade > 2 based
on 0-4 scale or any trace of posterior subcapsular cataract)
- Any condition which in the opinion of the investigator would interfere with the
participant's ability to provide informed consent, comply with study instructions,
possibly confound interpretation of study results, or endanger the participant if he
took part in the study
- Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome,
primary hypogonadism, vasectomy, or tumors of the pituitary)
- Current or history of breast cancer
- Current or history of prostate cancer or a suspicion of prostate disease unless ruled
out by prostate biopsy, or a PSA>3.6
- Presence or history of hyperprolactinemia with or without a tumor
- Chronic use of medications use such as glucocorticoids
- Subjects with cystic fibrosis (mutation of the CFTR gene)
- Subjects unable to provide a semen sample in the clinic
- Subject has a BMI >36 kg/m2
Male
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 65 Years | Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism | NCT01270841 | Contradiction |
6,068 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Experiencing heartburn at least 2 days per week during the nighttime period over the
past month.
- Having heartburn that responds to heartburn medication.
- Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion
in the study.
Exclusion Criteria:
- Having history of erosive esophagitis or gastroesophageal reflux disease diagnosed by
a physician and confirmed by testing (endoscopy).
- Be unwilling to take only the study medication, and antacid provided as a rescue
medication for relief of acute heartburn during the study.
"Other protocol-defined inclusion/exclusion criteria may apply"
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn | NCT00701259 | Entailment |
6,386 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Age ≥ 18
- Patient admitted in an emergency unit or hospitalized, infected with SARS-CoV2 or
suspected of being (the recruitment can occured during acute episode or during a
follow-up visit)
- Written informed consent or emergency procedure
- Affiliated to health insurance system
Exclusion Criteria:
- Refusal of participation
- Patient under justice protection measure except guardianship and trusteeship
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Cohort of Patients Infected With SARS-CoV2 (COVID-19) or Suspected of Being | NCT04352348 | Entailment |
1,197 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | DISEASE CHARACTERISTICS:
- Diagnosis of malignant pleural effusion requiring pleurodesis confirmed by 1 of the
following:
- Histologically proven pleural malignancy
- Typical features of pleural malignancy seen on direct vision during thoracoscopy
- Pleural effusion in the context of histologically proven cancer elsewhere
- No primary lymphoma or small cell lung carcinoma
- All patients undergoing thoracoscopy for suspected malignant pleural effusion are
eligible
PATIENT CHARACTERISTICS:
- Life expectancy > 1 month
- Not pregnant or nursing
- No history of GI bleeding or untreated peptic ulceration
- No known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), opiates, or
paracetamol
- No hypercapnic respiratory failure
- No known intravenous drug abuse
- No severe renal or liver disease
- No known bleeding diathesis
- Able to give informed consent
PRIOR CONCURRENT THERAPY:
- More than 2 weeks since prior and no concurrent corticosteroid therapy
- No concurrent warfarin therapy
- No other concurrent analgesics
- Analgesics used as a breakthrough regimen are allowed from trial entry to tube
withdrawal at day 3 post-pleurodesis (i.e., regular paracetamol, assigned study
analgesia, and breakthrough medication only, including opiate slow release
patches)
- No concurrent enrollment on another clinical study
- Patients may participate in other trials immediately after completion of current
trial, excluding those involving further pleural procedures or analgesia trials
in which patients must wait at least 3 months after completion of current trial
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Ibuprofen or Morphine in Treating Pain in Patients Undergoing Pleurodesis for Malignant Pleural Effusion | NCT00644319 | Entailment |
6,073 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Patients with reflux complaints
- 18 years of age
Exclusion Criteria:
- Restrictions as mentioned in the registration text
- H2RA or PPI use in the month prior to inclusion
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| The Effect of Lifestyle-Adjustments Prior to Medical Treatment on the Effect of Medical Treatment in Reflux Patients | NCT00524251 | Entailment |
2,572 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:1- 10 year- old who were scheduled to bilateral inguinal hernia surgery
-
Exclusion Criteria: Patients with neurological disoder, reoperation for inguinal hernia
surgery, coagulation disorder
-
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 1 Year old.
Subject must be at most 10 Years | Caudal Block Versus Ultrasound Guided Ilioinguinal/Iliohypogastric Block in Pediatric Patient | NCT03258736 | Contradiction |
6,311 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | - INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the
following criteria as per respective group:
1. Stated willingness to comply with all study procedures and availability for the
duration of the study
2. Male or female age greater than or equal to 15 years old with no upper age limit.
3. Ability of subject to understand and the willingness to sign a written informed
consent and/or assent document.
4. For Healthy Volunteers Group:
- Age greater than or equal to 15 with no upper age limit.
- No history of autoimmune diseases and in good general health as evidenced by
medical history.
5. For symptomatic COVID-19 group must have laboratory evidence (positive PCR for
SARSCOV-2 or other test developed after this proposal gets approved and is available
through the Clinical Center) and one of the signs and symptoms associated with
COVID-19 infection (e.g. fever or chills, cough, shortness of breath or difficulty
breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore
throat, congestion or runny nose, nausea or vomiting, diarrhea).
6. For post COVID-19 study visits must have laboratory evidence (e.g. positive PCR for
SARS- COV-2, antibody against SARS-COV-2 or other test developed after this proposal
gets approved) of current or prior exposure to COVID-19. Alternatively, patients
should have documented evidence of having received one of the SARS-COV-2 vaccines that
may become available during the study.
7. For subjects with known COVID exposure, they must fulfill one of the following
criteria:
- A minimum of 28 days has passed since the initial positive test date AND B.
Resolution of fever was greater than or equal to7 days ago (without the use of
fever-reducing medications) AND C. Resolution of respiratory symptoms was greater
than or equal to7 days ago, OR
- A minimum of 10 days has passed since the initial positive test AND B. A minimum
of 2 consecutive oropharyngeal swabs OR 2 consecutive nasopharyngeal swabs or 2
saliva testing collected greater than or equal to 24 hours apart that are
negative for SARS CoV-2 PCR A positive PCR requires restarting the series of
swabs (wait 5 days to retest)
8. Specific Inclusion Criteria for Systemic Autoimmunity Diseases Group:
- Age greater than or equal to 15 years with no upper age limit
- Systemic lupus erythematosus (SLE): Meets at least 4 of 11 modified American
College of Rheumatology (ACR) (1997) Revised Criteria for the Classification of
Systemic Lupus Erythematosus or Systemic Lupus International Collaborating
Clinics (SLICC) classification criteria for systemic lupus erythematosus.
- Anti-neutrophil cytoplasmic antibody associated vasculitis (AAV): Meet Revised
1990 ACR criteria for Granulomatosis with polyangiitis (GPA) or the 2012 Chapel
Hill Nomenclature for microscopic polyangiitis (MPA).
- Idiopathic inflammatory myopathies (IIM):Meets the 2017 EULAR/ACR Classification
Criteria for Adult and Juvenile idiopathic inflammatory myopathies and their
major subgroups.
- Primary Sjogren's syndrome (SS): Meets 2016 ACR criteria.
- Progressive systemic sclerosis (PSS): ACR/EULAR 2013 Classification criteria.
- Immunologically mediated kidney diseases (IKD): Based on results from kidney
biopsy consistent with immunologically mediated nephrotic syndrome and/or
glomerulonephritis
- Rheumatoid arthritis (RA): Meet the 2010 ACR/EULAR Classification Criteria.
- Systemic autoimmunity syndrome not otherwise specified (SA-NOS): Patients not
utoimmune disease but with evidence of autoantibodies and clinical features
suggestive of a systemic autoimmune disorder.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation
in this study:
1. Pregnant and lactating subjects will be excluded because pregnancy and lactation
modify immune responses and may interfere with correlations.
2. Concomitant medical problems which would confound the interpretation of studies
gathered by this protocol. Included in this is the presence of HIV in the blood,
active malignancies, or other significant medical conditions that may interferes with
interpretation of studies.
3. Concomitant medical, surgical or other conditions for which inadequate facilities are
available to support their care at NIH.
4. Inability or unwillingness to comply with follow up requirements (e.g. distance,
social, physical limitations).
5. Any comorbidity of medical or psychological/psychiatric condition or treatment, that
in the opinion of the Principal Investigator, would exclude the subjects from the
research studies (e.g. Patient requiring urgent and/or acute medical care, surgical or
other procedures)
6. Unwilling to participate in research studies or to provide research samples or data
7. Exclusion criteria for the (optional) vascular studies:
-Healthy volunteers with known history of coronary artery disease, peripheral vascular
disease or atherosclerosis.
8. Exclusion criteria for the (optional) FDGPET/CT scan:
-Individuals younger than 18 years old will be excluded given the radiation exposure
9. Subjects with SAD and Healthy volunteers younger than 18 years old will be excluded
from chest x-rays unless clinically indicated.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 15 Years old.
| Natural History of Coronavirus Disease (COVID-19) in Systemic Autoimmune Diseases | NCT04690816 | Entailment |
3,738 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion criteria:
- Patients with the diagnosis of Osteoarhtritis of the knee, graded according to
Kellgren as grade 1-4
Exclusion criteria:
- Patients that suffer from acute septic arthritis.
- Patients that treated with coumadin and/or other anti-coagulant drugs
- Patients that show mental or physical conditions, which preclude compliance with study
and/or device.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 90 Years | The Effect of Intraaricular Knee Injections of Hyaluronic Acid (HA) on Bone and Cartilaginous Debris, as a Therapeutic Indicator | NCT00422643 | Contradiction |
1,118 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- all cases of syncope.
Exclusion Criteria:
-
No condition on gender to be admitted to the trial.
Subject must be at least 1 Year old.
Subject must be at most 18 Years | Clinical Audit on Evaluation of Patient With Syncope at Asssiut University Children Hospital | NCT04575376 | Entailment |
1,065 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Key Inclusion Criteria:
- Diagnosed with nHCM (hypertrophied and non-dilated left ventricle in absence of
systemic or other known cause), with LV wall thickness ≥ 15mm at Screening or ≥ 13mm
with a positive family history of HCM.
- Age 18 and greater, Body weight ≥ 45kg
- Documented LVEF ≥ 55% at the Screening as determined by echo central lab
- LVOT gradient < 30 mmHg at rest AND during Valsalva AND post-exercise
- NYHA functional class II or III
- Elevated NT-proBNP at rest
Key Exclusion Criteria:
- History of syncope, sustained ventricular tachyarrhythmia with exercise, obstructive
coronary artery disease or myocardial infarction within the past 6 months
- History of resuscitated sudden cardiac arrest at any time or known appropriate
implantable cardioverter defibrillator (ICD) discharge within 6 months prior to
Screening
- Current treatment with disopyramide or ranolazine (within 14 days prior to Screening)
- Current or planned treatment during the study with a combination of beta-blockers and
calcium channel blockers
- Has been treated with invasive septal reduction (surgical myectomy or percutaneous
alcohol septal ablation [ASA]) within 6 months prior to Screening
- History of resting or post-exercise LVOT >30 mmHg unless subsequently treated by
septal reduction
- Has QTc Fridericia (QTcF) >480 ms or any other ECG abnormality considered by the
investigator to pose a risk to participant safety (eg, second-degree atrioventricular
block type II)
- Has persistent or permanent atrial fibrillation not on anticoagulation for at least 4
weeks prior to Screening and/or not adequately rate-controlled within 1 year of
Screening
- History of clinically significant malignant disease within 10 years such as
non-metastatic cutaneous squamous cell or basal cell carcinoma
- History or evidence of any other clinically significant disorder, condition, or
disease that, in the opinion of the investigator or MyoKardia physician, would pose a
risk to subject safety or interfere with the study evaluation, procedures, or
completion.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM) | NCT03442764 | Contradiction |
673 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
1. Age 18-75 years
2. Either gender
3. Patients with chronic liver disease with iron deficiency anemia with transferrin
saturation<20% and Hemoglobin in Non-pregnant women (15 years of age and above)
<12g/dl and in men <13g/dl -
Exclusion Criteria:
1. Those who do not consent to participate in the study
2. Inability to obtain informed consent from patient or relatives
3. Severe preexisting cardiopulmonary disease
4. Renal dysfunction (S. Creatinine ≥ 2mg/dL)
5. Pregnancy/Lactation
6. Post liver transplant patients
7. HIV infection
8. Patients who are on psychoactive drugs, like sedatives or antidepressants
9. Patients who are too sick to carry out the protocol
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Lactoferrin in Treatment of Fe Deficient Anemia In Cirrhosis | NCT04335058 | Contradiction |
1,062 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- Emergency Department patient
- Age 30 years or above
- Chief complaint of syncope
- Capacity to make medical decisions
- Speak and read English
- Working phone number and fixed address
Exclusion Criteria:
- Altered Mental Status
- Cognitive Impairment
- Serious acute diagnosis:
(e.g. clinically significant cardiac dysrhythmia, structural heart disease,
gastrointestinal hemorrhage, myocardial infarction, pulmonary embolism, pneumonia,
arterial dissection, serious infection, ectopic pregnancy, subarachnoid hemorrhage, or
stroke.)
- Hemodynamic instability
- Inability to read or speak English
- Major communication barrier
- Lack of phone number or fixed address
- Too high risk as per physician judgment
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
| Syncope Decision Aid for Emergency Care | NCT02971163 | Contradiction |
568 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1.Patients with thin endometrium (4mm≤ EMT <7mm )or scarred endometrium (scarred area≤70%)
which is nonresponsive to estrogen stimulation 2.Infertile patients with clear fertility
desires 3.20-42 years old 4.Normal ovarian function or with frozen embryos 5.Willing to
participate in follow-up
Exclusion Criteria:
1. Endometrial thickness <4mm or scarred endometrial area>70%
2. Uterine cavity out of shape and the cavity depth<6.5mm
3. Abnormal chromosome karyotype
4. Uterine diseases including large intramural myomas, severe endometriosis, severe
adenomyosis, severe congenital uterine malformations, endometrial tuberculosis,
vaginitis and endometritis
5. Systemic diseases: hypertension, diabetes, and so on
6. Contraindications to pregnancy
7. Contraindications to hormone replacement therapy
8. Medical history of pelvic tumors or receiving pelvic radiotherapy 9 .Involved in other
clinical studies
10. Unable to adhere to the follow-up
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 42 Years | Clinical Study of in Situ Regeneration of Endometrium | NCT04233892 | Entailment |
2,678 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Adult patients (18 years and older)
- Patients undergoing one of the following procedures: laparoscopic cholecystectomy,
laparoscopic appendectomy, minor hernia repair (including laparoscopic or open
inguinal, femoral, umbilical, and epigastric hernia repair), open and laparoscopic
ventral/incisional hernia repair, laparoscopic colectomy, open colectomy, vaginal
hysterectomy, laparoscopic hysterectomy, and open abdominal hysterectomy
- Patients who underwent surgery between January 1, 2013 and December 31, 2019
Exclusion Criteria:
- Patients who are not opioid-naive at the time of surgery, defined as filling 1 or more
opioid prescriptions between the 12 months to 31 days prior to surgery
- Patients without continuous insurance enrollment for at least 12 months before and at
least 6 months after the date of surgery
- Patients still in the hospital on postoperative day 30
- Patients not discharged home after surgery
- Patients who underwent another surgery within 6 months of their index operation
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| A Difference-In-Differences Analysis of New Persistent Opioid Use After Surgery | NCT04805229 | Entailment |
3,146 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- Be at least 18 years of age;
- Provide written informed consent;
- Have a reported history of dry eye;
- Have a history of use of eye drops for dry eye symptoms;
Symptoms of dry eye syndrome including:
- Ocular discomfort
- Conjunctival redness
- Tear film break up time
- Schirmer test score
Signs of dry eye syndrome including:
- Conjunctival staining score
Exclusion Criteria:
- Have any clinically significant slit lamp findings at entry visit ;
- Be diagnosed with an ongoing ocular infection;
- Have any significant ocular lesion that could interfere with assessment of safety or
efficacy or prevent study conduct in the opinion of the PI;
- Have any planned ocular and/or lid surgeries over the study period;
- Have an uncontrolled systemic disease;
- Be a woman who is pregnant, nursing or planning a pregnancy;
- Be a woman of childbearing potential who is not using an acceptable means of birth
control;
- Have a known allergy and/or sensitivity to the test article or its components;
- Have a condition or be in a situation which the investigator feels may put the subject
at significant risk, may confound the study results, or may interfere significantly
with the subject's participation in the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Study of TOP1630 for Dry Eye Syndrome | NCT03833388 | Contradiction |
3,842 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Clinical diagnosis of osteoarthritis
- Accept the intra-articular HA injection therapy
Exclusion Criteria:
-
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 75 Years | Identification and Characterization of the Biomarker in Synovial Fluid for Hyaluronic Acid Therapy in Osteoarthritis | NCT01813916 | Entailment |
1,787 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- GERD patients:
- typical symptoms of reflux, such as heartburn and/or regurgitation;
- gastro-esophageal reflux assessed by 24-h pH-impedance monitoring or a positive
symptom association or;
- esophagitis assessed by upper GI endoscopy with careful evaluation of the
presence and extent of a hiatal hernia (HH).
- GERD/FD overlap:
- FD symptoms according to the Rome III criteria. The symptoms of FD include one or
more of: bothersome postprandial fullness occurring after normal sized meals,
early satiation that prevents finishing a regular meal, epigastric pain, and
epigastric burning at least several times per week during the last 6 months.
Exclusion Criteria:
- Healthy volunteers:
- history of any upper gastrointestinal (GI) symptoms or GI surgery;
- psychological disorders;
- any drug history;
- use of medication altering GI motility;
- pregnant or nursing women.
- GERD patients:
- psychological disorders;
- any drug history;
- use of medication affecting GI motility;
- pregnant or nursing women;
- history of GI surgery.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Relationship Between Gastric Accommodation, TLESRs and Reflux in HV and in GERD With or Without Overlapping Dyspepsia | NCT03788109 | Contradiction |
967 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
The project will focus on patients with a diagnosis of a mild-moderate KOA (level 1-3
Kellgren and Lawrence and WOMAC in the lower two quartiles), in the target knee, (Frestedt
et al., 2008) and a BMI between 20 and 30 kg/m2.
Exclusion Criteria:
[1] rheumatoid arthritis [2] gout [3] pseudo gout [4] Paget's disease [5] seizure disorder
[6] insulin dependent diabetes mellitus [7] uncontrolled hypertension [8] unstable
cardiovascular disease [9] active hepatic or renal disease [10] active cancer and/or HIV
infection, involved in other clinical trial or experimental treatments in the past 3
months; pregnant, lactating, or at risk of becoming pregnant; intramuscular/systemic
corticosteroid injection within 4 weeks; intra-articular corticosteroid injection within 2
months; or inter-articular hyaluronic acid injection within 4 months prior to enrollment.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 55 Years old.
Subject must be at most 70 Years | The Marigot Osteoarthritis Nutritional Intervention (MOANi) Trial | NCT03106584 | Entailment |
4,563 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Sexually naïve and agree to abstain from sex during the study
- Moderate to severe menstrual-related pelvic pain
- Regular spontaneous menstrual cycles
Exclusion Criteria:
- Any contraindication to the use of oral contraceptives
- Treatment with an oral contraceptive within the previous 3 months
- Previous treatment failure with an extended oral contraceptive regimen
Female
No healthy subjects accepted to join the trial.
Subject must be at most 17 Years | A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain | NCT00196313 | Contradiction |
1,544 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:- Fitzpatrick Skin type I or II
- Nonpregnant Females, age 18-30 or 50-70
- Body Mass Index Normal or Overweight
- If age 18-30, must be non-smoker
- Willing to fast for 8 hours prior to a blood draw; Exclusion Criteria:- History of
cosmetic surgery
- Use of anti-aging medications within 3 months of enrollment
- Use of over-the-counter anti-aging creams (not sunscreens) more than once per week
within one month of enrollment
- Use of dietary supplements including vitamins within one month of enrollment
- Use of tanning beds or excessive UV exposure (greater than 2 hours per day) within one
month of enrollment
- Use of sunless tanners within one month of enrollment
- Uncontrolled or ongoing serious medical condition
- Participation in another clinical study involving use of an investigational drug or
product
- Medical condition which, at the discretion of the investigator, will have a
significant impact on ability to judge participant's skin characteristics, including
age.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Pilot Investigation of a Multinutrient Supplement on Skin Aging and Aging Metabolites in Healthy Women | NCT00541931 | Contradiction |
571 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1. Requests a medical abortion and fulfills standard eligibility criteria for M&M
abortion:
- Clear decision to have an abortion
- Valid Ontario Health card
- Willing to abstain for vaginal intercourse and alcohol for 14 days
- Ability to insert misoprostol vaginal tablets
- Emergency Contact number
- Stop folic acid vitamins on initial contact
- Good general health
- Single intrauterine gestation less than or equal to 49 days as determined by
transvaginal ultrasound
- Telephone access
- Access to emergency medical care within 30 minutes of home
- Agrees to undergo a surgical abortion in case of failure of the medical abortion
method
2. Ability to understand the protocol and consent
3. Willingness to comply with either the SFU or RFU follow-up schedule
Exclusion Criteria:
1. Factors that exclude women from eligibility for M&M abortion:
- Coagulopathy or hemoglobin less than 100, White Blood Cell count < 4.0 platelet
<140,000
- Allergy to methotrexate or misoprostol
- Presence of an intrauterine device
- Acute or chronic renal or hepatic disease
- Acute inflammatory bowel disease
- Uncontrolled seizure disorder
- Sickle cell anemia
- Breastfeeding
- Chronic oral corticosteroid therapy
- Any condition that in the opinion of the clinician investigator would compromise
the safety of medical abortion for this patient
2. Requires the support of an interpreter
Female
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
| Comparison of Telephone Follow-up With In-person Follow-up After Medical Abortion | NCT01943279 | Entailment |
6,772 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- At least 18 years of age
- Willing and able to provide informed consent
- In need of one implant to replace a missing tooth
- At least 20 teeth in good repair and occlusion
- Sufficient bone volume for dental implant placement without required bone augmentation
- Site development (soft and/or bone tissue) performed at least 5 months before implant
placement, when required
Exclusion Criteria:
- Current smoker
- Implant cannot be placed without bone graft
- Unable to pay for crown
- Untreated rampant caries and/or uncontrolled periodontitis
- Absence of adjacent (mesial and/or distal) natural tooth
- Uncontrolled diabetes
- Systemic or local disease or condition that would compromise post-operative healing
and/or osseointegration
- use of bisphosphonates
- History of radiation in the head and neck region
- Unable or unwilling to return for follow-up visits
- Unrealistic esthetic or functional demands
- Unlikely to be able to comply with study procedures
- Unwilling or unable to provide informed consent
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| CATER: Comprehensive Alveolar and Tooth Esthetic Replacement | NCT04082143 | Entailment |
5,646 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
- Chronological age ≥ 3 and chronological or bone age less than or equal to 11 years
inclusive in girls;
- Chronological age ≥ 3 and chronological or bone age less than or equal to 12 years
inclusive for boys
- Prepubertal
- Height SD score of < -2
- IGF-1 SD score of < -2
Exclusion Criteria:
- Prior treatment with rhGH, rhIGF-1, or other growth-influencing medications
- Growth failure associated with other identifiable causes (e.g., syndromes, chromosomal
abnormality)
- Chronic illness such as diabetes, cystic fibrosis, etc.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 12 Years | Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency | NCT00125164 | Contradiction |
4,470 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
1. Both bone forearm fractures in which the fracture of the radius and/or ulna is located
in the proximal one half of the bone
2. The fracture requires a reduction maneuver
3. All skeletally immature individuals under the age of 18
4. Patient aged greater than three years old
5. Patient or patient's consenting parent/guardian competent in English.
Exclusion Criteria:
1. Skeletally mature individuals
2. Both fractures are located in the distal one-half of the radius and ulna
3. Isolated fractures of the radius or ulna
4. The fracture does not require a reduction maneuver
5. Any nerve or arterial injury in the injured extremity
6. Humerus fracture on the ipsilateral side
7. Any open fracture requiring formal surgical debridement
8. Patient or patient's consenting parent/guardian not competent in English.
9. Patient or patient's consenting parent/guardian not present.
9. Severe problems with maintaining follow-up (e.g live in different state) 10.
Contractures in which applying an extended elbow cast is not possible or practical
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 18 Years | Extended vs Flexed Elbow Casting | NCT03935516 | Entailment |
570 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- women
- seeking pregnancy termination services at one of the study facilities
- self-report last menstrual period to be at least 10 weeks ago or not know her
gestational age
- 15 years old or older
- live in Nepal
Exclusion Criteria:
- under 15 years old
- not pregnant
- do not live in Nepal
Female
Accepts Healthy Volunteers
Subject must be at least 15 Years old.
| Consequences of Unwanted Pregnancy in Nepal | NCT03930576 | Entailment |
963 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- ≥40 years of age;
- having knee pain;
- having at least three of the following additional symptoms: a-morning stiffness ≤ 30
minutes, b-crepitation, c-bone margin tenderness, d-bony enlargement or e-no palpable
warmth;
- willing to provide informed consent
Exclusion Criteria:
- rheumatoid arthritis;
- serious pathological conditions (inflammatory arthritis and malignancy); total or
partial arthroplasty of the affected knee joint, or on waiting list for joint
replacement surgery;
- recent surgical procedure of the lower extremities in the previous 6 months;
- uncontrolled hypertension and unstable cardiovascular problems that could subject the
participant to increased risk with exercise and physical exertion;
- physical incapability to safely perform exercises, walking or stationary cycling, as
in: debilitating visual defects, neurological problems, exaggerated low back pain,
advanced osteoporosis, and inability to walk 10 meters without an assistive device;
- use of prescribed analgesics, corticosteroid or analgesic injection intervention for
knee pain within the previous 30 days;
- lack of clear comprehension of study procedures or inability to comply with
instructions;
- stated inability to attend or complete the proposed course of intervention and
follow-up schedule.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| The Distraction of Knee Joint to Alleviate osteoArthritic Pain (DiKAP) Trial | NCT04331990 | Entailment |
266 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Amenorrhoea for >= 12 months.
- Serum estradiol and FSH level within the postmenopausal range
- Baseline endometrial biopsy assessed by light microscopic histological evaluation
revealing: insufficient endometrial tissue for diagnosis because of insufficient
available (atrophic) endometrial tissue (not because of an inaccessible cervix) and
endometrial thickness < 5 mm (double layer) by transvaginal ultrasound, atrophic
endometrium, secretory endometrium, menstrual type endometrium, proliferative
endometrium
Exclusion Criteria:
- Previous systemic unopposed estrogen replacement therapy over 6 months or more.
- Any estrogen, progestogen, and/or androgen therapy in the last four weeks before
Screening Visit (Visit 1). The baseline endometrial biopsy should in all cases be
taken after cessation of the withdrawal bleeding due to previous hormone replacement
therapy.
- History or presence of an estrogen dependent neoplasia (including breast- cancer).
- History or presence of malignant neoplasms other than basal or spinal cell carcinoma
of the skin.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
| Endometrial Safety Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination | NCT00160316 | Contradiction |
2,794 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- All patients were recruited from a single Consultant's surgical clinic at the same
District General Hospital between August 2010 and February 2012. This study was
approved by the local ethics committee (National Research Ethics Service REC ref:
09/H0405/65) and informed consent was obtained from all patients after they had the
opportunity to study information leaflets that were also given to them. The trial was
designed as a prospectively randomized and double blind trial with a 1:1
(control:intervention) allocation.
The inclusion criteria was all adults with an American Society of Anesthesiologists (ASA)
physical status grade 1 or 2, who were undergoing elective laparoscopic cholecystectomy for
gallbladder disease or laparoscopic inguinal hernia repair performed as a transabdominal
preperitoneal procedure (TAP). All procedures and data collection occurred at a District
General Hospital.
Exclusion Criteria:
The pre-operative exclusion criteria included patients younger than 18 years, those who
refused to give consent, those that had an inability to understand the research
questionnaire and pregnancy. Patients who were found to require additional procedures, for
example a conversion to open surgery, were excluded from the study prior to randomization.
-
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Reduction of Pain Following Laparoscopic Surgery: A Double Blind Prospective Randomized Controlled Trial | NCT01720433 | Entailment |
5,198 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Ambulatory, postmenopausal women with osteoporosis (no vaginal bleeding for at least 2
years prior to trial entry)
- Free of severe or chronically disabling conditions other than osteoporosis that will
impair ability to complete the trial
- Bone mineral density (BMD) T-score of at least -2.5 at the femoral neck, total hip, or
lumbar spine (L1-L4, with at least 2 evaluable vertebrae), with or without atraumatic
fracture or,
- Bone mineral density (BMD) T-score of at least -1.5 at the femoral neck, or total hip,
or lumbar spine (L1-L4, with at least 2 evaluable vertebrae), and either 1 or more
atraumatic vertebral fracture(s) or an atraumatic nonvertebral fracture in the opinion
of the investigator. Nonvertebral fracture sites allowed are wrist, hip, pelvis, ribs,
humerus, clavicle, leg (femur, tibia, and fibula, excluding the ankle).
- Serum calcium, parathyroid hormone (PTH), alkaline phosphatase must be within normal
reference range
Exclusion Criteria:
- Have an increased risk of osteosarcoma (bone tumor); this includes Paget's disease of
bone, a previous bone tumor, or radiation involving the skeleton
- Are allergic or cannot tolerate teriparatide or zoledronic acid or any of their
ingredients or components
- Are allergic to tetracycline
- Have a history of exposure to tetracycline therapy in the 3 months prior to trial
entry
- Have participated in a prior PTH clinical trial or received prior treatment with
teriparatide, PTH, or other related medications
- Have a vitamin D level below 10 nanogram/milliliter (ng/mL)
- Have a condition that could possibly put one at risk for an adverse event due to the
bone biopsy procedure (e.g. bleeding disorder)
- Have undergone two previous iliac crest bone biopsies (one in each iliac crest)
- Have taken any intravenous (IV) osteoporosis medication
- Have taken other oral osteoporosis medications and have not been off of them for a
specific period of time before trial entry
- Have a history of certain cancers in the 5 years prior to trial entry
- Have active liver disease
- Have significantly impaired kidney function
- Currently have active or suspected diseases that affect the bones, other than
osteoporosis
- Have active or recent history of significant gastrointestinal (stomach or intestinal)
disorders
- Have been treated with certain glucocorticoids for more than 30 days in the past 1
year prior to trial entry
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 89 Years | Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women | NCT00927186 | Entailment |
1,667 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- men and women
- age: 18-60 years
- BMI between 19 and 25 kg/m²
- subject considered as healthy after clinical examination and medical questionnaire
- subject giving his/her written informed consent
- subject willing to comply with study procedures
- affiliated to National Health Insurance
Exclusion Criteria:
- biological results judged abnormal by investigator
- positive serologies to HIV or HCV
- respiratory failure or cardiovascular problem
- taking medicine : beta blockers, corticoids, anti-inflammatory drug, thyroid hormones,
insulin
- abnormal ECG
- more than 10% of weight or gain loss in the three last months
- tumoral, inflammatory, pulmonary, renal, digestive or liver diseases
- surgery made less than 6 months before the study beginning
- thyroid disease
- pregnant women and nursing mother
- insanity
- smoker
- claustrophobic
- no affiliated to national health insurance people
- refusal to sign informed consent
- refusal to be registered on the national volunteers data file
- currently participating or who having got 4500€ in this year before to have
participated in another clinical trial
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Modelling of Energy Expenditure From Heart Rate, Accelerometry and Other Physiological Parameters | NCT01209572 | Entailment |
6,773 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
· Patients with moderate or severe congenital hemophilia A, a current FVIII inhibitor, who
have taken at least two different FVIII products during their lifetime.
Exclusion Criteria:
- Patients who have had an inhibitor prior to their current inhibitor.
- Patients with immune disorders.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Study Evaluating Inhibitor Specificity in Hemophilia A | NCT00151385 | Entailment |
3,075 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Patients (children and adults) with intellectual deficiency (ID), whatever the degree
- Absence of a clear clinical diagnosis at the first consultation for the dysmorphology
assessment
- Patients who have never undergone genetic investigations
- Consent of the patient or his/her legal representative
- Patient with national health insurance cover
- Samples available from both parents
Exclusion Criteria:
- Pregnant or breast-feeding women
- Patients presenting learning disorders
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Medico-economic Evaluation of Different High-throughput Sequencing Strategies in the Diagnosis of Patients With Intellectual Deficiency | NCT03287206 | Entailment |
4,904 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- Healthy Control • Age 35-85
Parkinson Disease (PD) Age 35-85
Diagnosis of clinically definite PD made by a movement disorders specialist, with evidence
of the following features:
- Presence of bradykinesia and 1 or both of the following:
1. Rest tremor
2. Rigidity
- Asymmetric Onset
- Progressive motor symptoms
- Levodopa responsive
- Duration at least 1 but not more than 10 years
- Hoehn and Yahr Stage 1-2
Progressive Supranuclear Palsy (PSP) Age 40-85
Diagnosis of clinically definite PSP, with the following features:
- Gradually progressive disorder.
- Onset after age 39
- Supranuclear palsy* and postural instability with falls in the first year of disease
onset*.
- No evidence of other disease.
Parkinsonism of Other or Undetermined Cause (POC) Age 35-85
Diagnosis of parkinsonism of undetermined other other cause by a movement disorders
specialist, with the following features:
- Signs and symptoms of Parkinsonism including
1. Bradykinesia
2. Mixed or resting tremor
3. Rigidity
4. Characteristic deficits of gait and balance associated with Parkinsonism
Essential Tremor (ET) Age 35-85
Diagnosis of essential tremor, with the following features:
- A 2+ postural tremor of at least 1 arm (a head tremor may also be present, but is not
sufficient for diagnosis)
- On examination, there must be
1. a 2+ kinetic tremor during at least 4 tasks, or;
2. a 2+ kinetic tremor on 1 task and a 3+ kinetic tremor on a second task; tasks
include pouring water, using a spoon to drink water, drinking water,
finger-to-nose, and drawing a spiral
- If on examination, the tremor is present in the dominant hand, then by report, it must
interfere with at least 1 activity of daily living.
REM Behavior Disorder (RBD) Age 25 - 85
Documented diagnosis of REM sleep behavior disorder (RBD) by a sleep medicine specialist,
with the following clinical features:
- Presence of REM sleep without atonia on polysomnography
- At least one of the following conditions:
1. Sleep-related, behaviors by history (eg, dream enactment behavior)
2. Abnormal REM sleep behavior documented during PSG monitoring
Exclusion Criteria:
Healthy Control
- Pregnancy
- First-degree blood relative affected by PD
- Neurodegenerative disease
- History of repeated head injury, encephalitis, brain surgery, stroke, dementia,
neuroleptic exposure, or serious medical illness that may interfere with
participation.
Parkinson Disease (PD)
- Any exclusion criteria that would exclude a healthy control patient
- Atypical features indicative of a Parkinson-Plus disorder
Progressive Supranuclear Palsy (PSP)
- Any exclusion criteria that would exclude a healthy control patient
- Any finding atypical for PSP
- Neuroradiologic evidence of relevant structural abnormality unrelated to appropriate
changes known to be associated with PSP
Parkinsonism of Other or Undetermined Cause (POC)
- Any exclusion criteria that would exclude a healthy control patient
- Signs and symptoms suggestive of clear diagnosis of idiopathic Parkinson disease,
Progressive Supranuclear Palsy, or Essential Tremor
Essential Tremor (ET)
- Any exclusion criteria that would exclude a healthy control patient
- No other potential etiologic factors for the tremor
- Any first-degree blood relative affected by PD
- History of neurodegenerative disease
REM Behavior Disorder (RBD)
- Any exclusion criteria that would exclude a healthy control patient
- Sleep disorder not better explained by another sleep disorder, medical or neurological
disorder, mental disorder, medication use, or substance use disorder
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 19 Years old.
Subject must be at most 85 Years | MRI Study of Brain Activity in Healthy Adults and Individuals With Parkinsonism and Rapid Eye Movement Disorder. | NCT01547481 | Contradiction |
2,956 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
1. Have the ability to understand the requirements of the study, provide written informed
consent, understand and provide written authorization for the use and disclosure of
Protected Health Information (PHI) [per Health Insurance Portability and
Accountability Act (HIPAA) Privacy Ruling] and comply with the study procedures.
2. Subjects with sporadic or familial ALS diagnosed as laboratory-supported
probable,probable or definite according to the World Federation of Neurology El
Escorial Criteria (Appendix A), based on examination by the site PI.
3. Age 18 years or older.
4. Females must have a negative serum pregnancy test and practice an acceptable method of
contraception or be of non-childbearing potential (post-menopausal for at least 2
years or surgically sterile [hysterectomy, oophorectomy or surgical sterilization]).
5. Geographic accessibility to the study center and the ability to travel to the clinic
for study visits.
6. Presence of a willing and able caregiver.
7. Medically able to undergo lumbar or cervical laminectomy as determined by the
Investigator, surgeon and anesthesiologist.
8. Medically able to tolerate immunosuppression regimen consisting of basiliximab,
tacrolimus, mycophenolate mofetil, and methylprednisolone as determined by the site
Investigator.
9. Agrees to the visit schedule as outlined in the informed consent.
10. Not taking riluzole (Rilutek®) or on a stable dose for ≥30 days.
11. All required vaccinations current: tetanus/diptheria (TDAP), herpes
zoster/shingles(Vostavax®: within last 10 years and must be prior to surgery),
pneumonia (Pneumovax®),seasonal/H1N1 flu vaccines (as appropriate for season) for
Groups B-E.
Exclusion Criteria:
1. Etiology of paraplegia or weakness is due to causes other than ALS such as spinal
ischemia, traumatic spinal injury, traumatic brain injury, multiple sclerosis,
cerebral stroke, cerebral palsy, or infection.
2. VC < 60% predicted normal by standard nomogram at the time of screening and VC < 50%
predicted normal measured supine for age at the time of surgery.
3. Current or peak Panel Reactive Antibody (PRA) due to alloantibodies > 20% receiving
their first allograft.
4. Any known immunodeficiency syndrome.
5. Receipt of any investigational drug,device or biologic within 30 days of surgery.
6. Any concomitant medical disease or condition limiting the safety to participate:
- Coagulopathy
- Active uncontrolled infection
- Hypotension requiring vasopressor therapy
- Previous spinal surgery at the site of planned transplantation except for
anterior cervical dissection fusion (ACDF)
- Skin breakdown over the site of surgery
- Malignancy (except for non-melanoma skin cancer)
- Primary or secondary immune deficiency
- Spinal stenosis.
7. Creatinine >1.5, liver function tests (SGOT/SGPT, Bilirubin, Alk Phos) > 2x the upper
limit of normal, hematocrit/hemoglobin < 30/10, total WBC < 4000, uncontrolled
hypertension (defined as systolic >180 or diastolic >100) or uncontrolled
diabetes(defined as hemoglobin A1C >8), evidence of GI bleeding by hemoccult test,
positive tuberculosis (TB test: PPD/Mantoux), hepatitis B or C, or human
immunodeficiency virus (HIV).
8. Presence of any of the following conditions:
- Current drug abuse or alcoholism
- Unstable medical conditions
- Unstable psychiatric illness including psychosis and untreated major depression
within 90 days of screening
- Positive blood test for hepatitis B or C.
9. Any condition that the site PI feels may interfere with participation in the study.
10. Any condition that the surgeon feels may pose complications for the surgery.
11. Known hypersensitivity to basiliximab, tacrolimus, mycophenolate mofetil, or
methylprednisolone.
12. Inability to provide informed consent as determined by screening protocol.
13. Inadequate family or caregiver support as determined by the site PI.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Human Spinal Cord Derived Neural Stem Cell Transplantation for the Treatment of Amyotrophic Lateral Sclerosis | NCT01348451 | Entailment |
4,379 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | Inclusion Criteria:
- men and women, aged 18-55 years
- who are able to read and write
- who are able to give voluntary written informed consent
- have no current uncontrolled medical condition such as neurological, cardiovascular,
endocrine, renal, liver, or thyroid pathology
- have no history of a neurological or psychiatric disorder, e.g., no DSMIV Axis 1
diagnosis in 2 preceding years, except nicotine dependence in smokers)
- drink less than 21 drinks/week for women and less than 35 drinks per week for men
- have not used marijuana in the past 30 days and have not met criteria for dependence
in the past 2 years
- do not suffer from claustrophobia or any MRI contradictions
- nonsmokers (smoked < 40 cigarettes in lifetime with urinary cotinine levels 0-30 ng/mL
both at intake evaluation and on scan day)
- smokers (smoked at least 10 cigarettes/day for at least one year with an FTND>3, urine
cotinine >150 ng/mL and CO >12 ppm at intake)
Exclusion Criteria:
- psychosis
- presence of acute or unstable medical or neurological illness. Subjects will be
excluded from the study if they present with any history of serious medical or
neurological illness or if they show signs of a major medical or neurological illness
on examination or lab testing including history of seizures, head injury, brain tumor,
heart, liver or kidney disease, eating disorder, diabetes.
- regular use of any psychotropic drugs including anxiolytics and antidepressants and
other over-the-counter medications and herbal products within the last six months
- pregnancy/breast feeding (as documented by pregnancy testing at screening or on days
of the imaging studies),
- suicidal ideation or behavior
- pacemaker or other ferromagnetic material in body.
- use of medications which affect dopamine transmission within 2 weeks of the PET study
- participation in other research studies involving ionizing radiation within one year
of the PET scans that would cause the subject to exceed the yearly dose limits for
normal volunteers
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Test-retest Reproducibility of [11C]PHNO PET Using the Constant Infusion Paradigm | NCT01699607 | Entailment |
5,101 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Being a woman with postmenopausal osteoporosis
- Being between the ages of 45-85
- Using bisphosphonate therapy for at least two years
- Vertebral and/or Femur T score below -2.5
- Unresponsive to bisphosphonate therapy
- More than 2% decrease in BMD values despite using bisphosphonates and/or
- New major fracture development during treatment
Exclusion Criteria:
- Male gender
- Being extremely thin (BMI <15) or extremely obese (BMI> 45)
- Malignancy
- Severe chronic liver and kidney failure
- Chronic Steroid use
- Having an active rheumatic disease
- Having other secondary causes of osteoporosis (primary hyperparathyroidism etc.).
Female
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 85 Years | Efficacy of Denosumab Treatment in Bisphosphonate Unresponsive Patients | NCT04702204 | Contradiction |
3,272 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- Adult patients with a diagnosis of primary SS as per the 2002 American-European
Consensus Group (AECG) classification criteria, or
- Adult patients with a diagnosis of primary SS as per the 2016 American College of
Rheumatology/European League Against Rheumatism classification criteria
- Adults with the capacity to consent to their involvement in the study
- Willingness to participate in focus groups
- Fluency in the English language to allow participation in focus group discussion
- Willingness to complete the newly developed questionnaire on at least on occasion
Exclusion Criteria:
- Patients with SS who have developed lymphomatous chang
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 100 Years | SS-INQ Information Needs Questionnaire in Sjögren's Syndrome | NCT04798911 | Entailment |
558 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- over 18 years of age healthy no contraindication to medical treatment visible fetal
structures such as yolk sac or fetus
Exclusion Criteria:
- empty gestational sac more than sparse bleeding or dilated cervix mental instability
after diagnosis contraindication to medical treatment
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage | NCT01615224 | Contradiction |
1,641 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | -INCLUSION CRITERIA:
1. Must have the ability to understand and must personally sign a written informed
consent form, which must be obtained prior to initiation of study procedures.
2. Must be between 18 and 65 years of age, inclusive.
3. Must have discontinued use of nicotine and nicotine containing products including
vaping or juuling from 90 days prior to study drug dosing and throughout the study
duration.
4. Must be willing to abstain from any food or beverages containing alcohol 72 hours
prior to first dose and through follow-up visit.
5. Must be willing to abstain from cannabis 72 hours prior to first dose and through
follow-up visit.
6. Must be willing to abstain from caffeine (including tea, coffee, chocolate) or
grapefruit, Seville orange juice or other methyl xanthine containing foods (e.g.
theophylline, theobromine, tea leaves, yerba mate, kola nuts and guarana berries) 72
hours prior to the first dose and through follow- up visit.
7. Must have a body mass index (BMI) from 19 to 30 kg/m^2 (inclusive) at screening.
8. Must be human immunodeficiency virus type 1 (HIV-1) antibody negative at screening.
9. Must be hepatitis B (HBV) surface antigen negative at screening.
10. Must be hepatitis C (HCV) antibody or RNA negative at screening.
11. Male subjects must refrain from sperm donation from clinic admission, throughout the
study period, and continuing for at least 90 days following the last dose of study
drug.
12. Subjects must refrain from blood donation from clinic admission, throughout the study
period, and continuing for at least 30 days following the last dose of study drug.
13. Must be willing to comply with contraception guidelines below Contraception:
The fetal risks associated with ANS-6637 are not known, but pre- clinical animal data
demonstrate some risk. Subjects must agree not to become pregnant or impregnate a
female. Females of childbearing potential must have a reproductive risk assessment
done to determine the risk of undetectable pregnancy at study start [i.e. sexual and
contraceptive history for 30 days preceding screening] pregnancy test at screening and
baseline (Day 0). For the duration of the study, subject and their partners must
practice two non-hormonal methods of birth control, having begun no less than 30 days,
without interruption, prior to screening. They must continue to use both methods until
3 months after stopping the study drug. Two of the three methods of birth control
listed below MUST be used, or an alternative combination offering very high efficacy,
per the PI, in consultation with the Sponsor Medical Monitor may be considered:
- Male or female condoms [but not both] with a spermicide
- Diaphragm with a spermicide
- Intrauterine device (IUD)
If pregnancy is suspected or should occur, subjects must notify the study staff
immediately.
14. Must, in the opinion of the Investigator, be in good health based upon medical history
and physical examination, and screening laboratory evaluations.
15. Judged to be healthy based on medical history, physical examination, vital signs, and
clinical laboratory tests at screening and Day 0: liver function tests (AST, ALT,
Tbili) less than or equal to upper limit of normal [ULN], platelets (PLT) >150,000/
microliter, hemoglobin (Hgb) >13 g/dL (males); >12 g/dL (females), CK less than or
equal to 2x ULN, Amylase/lipase < ULN, thyroid function tests [TSH and T4] within
normal range, fasting total cholesterol <240 mg/dL, or fasting triglycerides <240
mg/dL, per DAIDS AE table and Toxicity Grading Scale for Healthy Adult and Adolescent
Volunteers Enrolled in Preventive Vaccine Trials AE table for total bilirubin [Tbili]
only.
16. Must be willing and able to comply with all study requirements.
EXCLUSION CRITERIA:
1. Therapy with any prescription, over-the-counter (OTC), herbal, or holistic
medications, including hormonal contraceptives by any route, within 5 half- lives of
the agent prior to receipt of any study medications will not be permitted with the
following exception: Intermittent or short-course therapy (<14 days) with prescription
or OTC medications, herbals, or holistic medications within the screening period prior
to starting study drugs may be permitted after review by the investigators on a
case-by-case basis for potential drug interactions. Receipt of influenza vaccination
will be allowed prior to, during, and/or after the study.
2. Have any serious or active medical, surgical, or psychiatric conditions which, in the
opinion of the Investigator, would interfere with subject treatment, assessment, or
compliance with the protocol.
3. Have previously participated in an investigational trial involving administration of
any investigational compound within 30 days prior to screening.
4. Have current, or a history of mild to severe alcohol use, cannabis or other substance
use disorder including any use of illicit drugs as defined by DSM-5 criteria, within
12 months of first study dose
5. Renal impairment (chronic renal insufficiency of any chronic kidney disease stage, or
acute renal failure not induced by drug therapy defined as eGFR <90 ml/min)
6. Have a positive urine drug test (ethanol, cannabis, barbiturates, cocaine, opiates, or
amphetamines) at Screening or Day 0.
7. History of flushing or intolerance related to alcohol consumption using the NIAAA
screening assessment questionnaire tool for alcohol flushing
8. Inability to obtain venous access for sample collection.
9. Have a history of significant drug sensitivity or drug allergy to any benzodiazepines.
10. Known hypersensitivity to formulation excipients: microcrystalline cellulose,
croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide,
polyethylene glycol, and talc.
11. Have been treated with systemic steroids, immunosuppressant therapies or
chemotherapeutic agents within 3 months of study screening or expected to receive
these agents during the study (e.g., corticosteroids, immunoglobulins, and other
immune- or cytokine-based therapies).
12. Presence or history of clinically significant cardiovascular disease, cardiomyopathy,
and/or cardiac conduction abnormalities.
13. Have clinically significant ECG abnormalities or any of the following ECG
abnormalities at Screening: PR >220 msec; QRS >120 msec; QTcF >450 msec; HR <40 beats
per minute; second or third degree heart block.
14. Have a history or family history of Long QT Syndrome, Brugada syndrome,
Wolfe-Parkinson-White Syndrome, or have a family history of sudden cardiac death or
unexplained death in an otherwise healthy individual between the ages of 1 and 30
years.
15. Have history of syncope, palpitations, unexplained dizziness or chronic nausea or
headaches.
16. Have an implanted defibrillator or pacemaker.
17. Have a history of liver disease, including Gilbert's Disease.
18. Any clinically significant electrolyte abnormality (outside of NIH normal reference
ranges) at screening (e.g., hypokalemia, hypocalcemia, hypomagnesemia) or any
condition that could lead to abnormal electrolyte disturbances (eg, eating disorder).
19. Have a history of taking dopamine antagonists/anti-psychotics.
20. Are unable to comply with study requirements.
21. Positive urine toxicology screen
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | The Influence of ANS-6637 on Midazolam Pharmacokinetics in Healthy Volunteers | NCT03831971 | Entailment |
244 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- pre-menopausal woman aged 18-40 years
- current symptomatic uncomplicated cystitis
- cystitis is treated with trimethoprim-sulfamethoxazole (TMP-SMX)
- completion of screening procedures
- negative screening monolayer Pap smear or hysterectomy
- history of at least two prior symptomatic UTI's treated within the past 12 months or
one pior symptomatic UTI treated in the past six months
- agree to return for the Randomization Visit (Visit 2)
- regular menstrual cycles or amenorrheic due to use of a long acting progestin,
continuous use of oral contraceptives or hysterectomy
- willing to insert vaginal capsules without an applicator
- capable of providing informed consent
- able to read and understand English
- agree to abstain from self-medication with antibiotics for UTI symptoms
- agree to abstain from antibiotic prophylaxis for recurrent UTI
- agree to abstain from the use of any other intra-vaginal product
- agree to abstain from sexual intercourse for 24 hours after capsule insertion
- agree to not use tampons for 24 hours after capsule insertion
- agree to use an adequate method of birth control
Exclusion Criteria:
- complicated cystitis or uncomplicated pyelonephritis.
- cystitis at Visit 1 not treated with TMP-SMX
- uropathogen resistant to TMP-SMX isolated at Visit 1 and persistent symptoms at Visit
2 or failure to achieve a significant reduction in urine wbc count at Visit 2
- vaginal or cervical infection, currently or within the past 21 days, with bacterial
vaginosis (treated, symptomatic infection), Trichomonas vaginalis, Neisseria
gonorrhoeae, Chlamydia trachomatis or Herpes Simplex
- symptomatic bacterial vaginosis at Visit 1
- high risk for sexually transmitted diseases and/or HIV, including:
1. diagnosis of N. gonorrhoeae, C. trachomatis or T. vaginalis on two or more
occasions during the previous six months;
2. sexual intercourse with a homosexual/bisexual male in the last 10 years;
3. sexual intercourse with an injection drug user or sex worker in the last 10
years; or
4. shared needles for injected drugs in the last 10 years.
- chronic vaginal, urinary or pelvic symptoms not attributable to UTI
- recurrent bacterial vaginosis (three or more symptomatic, treated infections in the
prior 12 months)
- pregnancy or within two months of last pregnancy
- lactation
- antibiotic therapy fewer than three days prior to Randomization Visit
- antifungal therapy fewer than seven days prior to the Randomization Visit
- Antibiotics planned within four months
- abnormal Pap smear requiring a procedure for diagnosis or treatment in the past 12
months
- use of CTV-05 within one year of the Randomization Visit
- menopause
- use of a NuvaRing planned during the course of the study
- any significant disease or acute illness that in the Investigator's assessment could
complicate the evaluation
- known HIV infection
- immunosuppressive drug within 60 days
- known allergy to any component of LACTIN-V or the placebo capsule
- unavailable for follow-up visits
- drug or alcohol abuse within past two years
- any social or medical condition that, in the opinion of the Investigator, would
preclude provision of informed consent, make participation in the study unsafe,
complicate interpretation of study outcome data, or otherwise interfere with achieving
the study objectives
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Intravaginal LACTIN-V for Prevention of Recurrent Urinary Tract Infection | NCT00305227 | Contradiction |
4,554 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
Inclusion Criteria for Primary Dysmenorrhea Group: All cases (n=70) will have pain in the
region between the umbilicus and the perineum, above the level of the inguinal ligament,
and rate their average pain greater than or equal to 6/10 (0 = no pain; 10 = worst
imaginable pain) during menses when not using NSAIDs. The investigators will use strict
inclusion criteria and verification with structural MRI to ensure patients with primary
dysmenorrhea most likely do not have endometriosis, leiomyoma, or adenomyosis as described
below. It is not possible to reliably evaluate superficial endometriosis with MRI
(Nisenblat et al., 2016), but suspicious cases for deep infiltrating endometriosis will be
confirmed by the radiologists who routinely evaluate MRIs for our gynecological surgical
service. Although it is impossible to rule out endometriosis without surgery, in select
cases The investigators will use clinical exams and criteria supported by decision trees
(Eskenazi et al., 2001; Chapron et al., 2005, 2011; Vercellini et al., 2007) that suggest
the detection of endometriosis stage 2 or higher would be unlikely (<15%) in this
population. Participants with dysmenorrhea that rate their bowel pain, dyspareunia, or
non-menstrual pelvic pain equal to or greater than 40 on 0-100 visual analog pain scale on
the McGill Pain Questionnaire will be given the option to participate in an additional
clinical exam visit. To reduce the likelihood of comorbid endometriosis, primary
dysmenorrhea participants with symptoms of endometriosis described above, will be required
to have a negative clinical exam and no immediate family history of endometriosis to
qualify for final analyses.
Inclusion Criteria for Leiomyomata Group: The investigators will also study participants
with leiomyomata (n=20) because it is a frequent cause of menstrual pain and will often be
identified in disqualified primary dysmenorrhea participants. Leiomyomata (nondegenerated)
will be diagnosed by foci homogeneously hypointense on T2, but isointense relative to
myometrium on T1 according to standard definitions (Kubik-Huch et al., 2018). To reduce
variability within this category, the investigators will restrict enrollment to small to
medium sized intramural leiomyomata (30 to 150 cm3 combined volume). The investigators
anticipate 10 participants with leiomyomata will be identified from incidental MRI during
this study, while 10 more will be recruited from advertisements and our clinic. A smaller
cohort is studied here because the main purpose of this group is to establish whether the
physiological basis for menstrual pain in women with leiomyomata is significantly different
than women with primary dysmenorrhea. Participants with leiomyomata, who are also
symptomatic with surgically diagnosed endometriosis will be excluded.
Inclusion Criteria for Endometriosis Group: Participants without leiomyomata, but
symptomatic for endometriosis (n=20) will be enrolled before planned surgical excision
(follow-up surgery from an earlier diagnosis). The investigators will confirm a diagnosis
of Stage 2, 3, or 4 endometriosis following surgery. For the patients without confirmed
abnormal surgical findings for endometriosis with dysmenorrhea will be considered as
primary dysmenorrhea cases. Dr. Tu's pelvic pain division performs over 100 laparoscopic
pain evaluations annually (many with deep infiltrating disease) enabling us to characterize
MRI signals in surgically confirmed endometriosis patients. A smaller cohort is studied
here because the main purpose of this group is to establish whether the physiological basis
for menstrual pain in women with endometriosis is significantly different than women with
primary dysmenorrhea.
Inclusion Criteria for Healthy Controls: Healthy control cases (n=20) must rate their
average menstrual pain < =2/10 over that past 6 months (without NSAID use) and have no
other concurrent pain diagnoses or leiomyomata. Their lack of concurrent pain diagnoses
will be confirmed with questionnaires (NIH PROMIS scales, Rome Foundation IBS criteria
(Palsson et al., 2016), AUA bladder pain syndrome criteria (Hanno et. al. 2012), and the
Complex Medical Symptom Inventory (Williams and Schilling, 2009) and a medical exam screen.
Healthy controls and participants with primary dysmenorrhea will be ratio-metrically
age-matched with comparable pregnancy history to ensure similar demographics between
groups.
Exclusion Criteria:
Age restrictions for all study participants: Regularly menstruating women (age 18-45) will
be identified using our well-tested community-wide recruitment strategy, including
approaching our division's busy gynecological disorders clinic, and the departments of
Ob/Gyn at NorthShore and the University of Chicago. Although women above the age of 45 can
have menstrual pain, irregularities in perimenopause could cause confounding effects on
uterine physiology and scheduling difficulty. Similarly, irregularities in menstruation,
ovulation, and pain levels in participants under age 18 could potentially detract from
meaningful interpretation of phenotypes (Seidman et al., 2018). Additionally, before age
18, the uterus is still developing and substantially increasing in size (Porcu et al.,
1989; Verguts et al., 2013). Thus, to limit potential confounding effects, participants
under the age of 18 will be investigated in a separate study.
Menstruation-related exclusion criteria for all study participants: The investigators will
exclude certain participants with conditions associated with the absence of regular menses
such as polycystic ovarian syndrome, pregnancy, current use of any continuous hormonal
medication or contraceptive, or Asherman's syndrome.
MRI-related or participation related exclusion criteria for all study participants:
The investigators will exclude participants with criteria that would affect our ability to
obtaining meaningful MRI data such as
1. presence of an intrauterine device (IUD). The use of an IUD potentially affects
interpretability of MRI because it creates an imaging artifact in the endometrium
extending to the myometrium.
2. inability to read or comprehend the informed consent written in English,
3. history of metallic implants,
4. history of metallic injury,
5. any diagnosed condition that would preclude investigation with MRI (e.g.,
claustrophobia),
6. BMI >40,
7. allergy or inability to tolerate naproxen
Exclusion criteria for known factors that affect the interpretability of the data for all
study participants:
1. thyroid dysfunction,
2. adrenal dysfunction,
3. renal disorders,
4. liver disorders,
5. coagulopathy,
6. prolactinoma,
7. von Willebrand disease,
8. platelet disorders,
9. diabetic neuropathy,
10. gastrointestinal conditions or surgeries that would affect naproxen absorption,
11. active genitourinary or sexually transmitted infection
Provisional exclusion for primary analyses for all study participants: Acute or chronic
conditions associated with pelvic pain with a defined anatomical cause other than
endometriosis or leiomyoma (e.g., pathological ovarian cysts, significant persistent
hydro/hematosalpinx, untreated pelvic inflammatory disease, active pelvic or abdominal
malignancies, Mullerian anomalies, or stage 3 uterine prolapse), and comorbid diagnosis of
significant leiomyoma and endometriosis.
Note: these exclusion criteria may be incidentally discovered after the MRI scan and
confirmed with a radiologist's or Dr. Tu's diagnosis.
Provisional exclusion for adenomyosis group: Because the frequency of adenomyosis is low or
unknown, and may consist of multiple subtypes resulting in heterogeneity and inadequate
statistical power, adenomyosis patients are not a planned study group and diagnosed cases
will be initially excluded from recruitment. Focal and diffuse adenomyosis will be excluded
by guidelines (Chapron et al., 2017) adapted from the Kishi criteria (Kishi et al., 2012):
maximal junctional zone thickness exceeding 12 mm, a ratio of junctional zone thickness to
myometrium exceeding 40%, or high-intensity foci within the myometrium. If a substantial
number of adenomyosis participants participate, as discovered after-the-fact with MRI,
results will be analyzed.
Intermediate levels of dysmenorrhea pain exclusion: Participants with mild menstrual pain
(between 3 and 5 on a 0-10 scale) will be excluded. Our prior experience with this cohort
(Westling et al., 2013) suggests that The investigators may encounter a floor effect when
studying the effectiveness of NSAIDs. Also, since this cohort is most likely to respond to
NSAIDs, it is imperative The investigators study the mechanisms of the most severe
sufferers of refractory menstrual pain.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Mechanistic Characterization of Uterine Pain | NCT04145518 | Contradiction |
3,924 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Males or females in generally good health at least 40 years of age
- Osteoarthritis (OA) of at least one knee, verified by a weight-bearing radiograph
- Subject has taken an oral NSAID or analgesic at least 3 days during the past 30 days
to treat knee OA pain
Exclusion Criteria:
- Females who are pregnant or lactating or who may become pregnant
- Hypersensitivity (exacerbations of asthma, rhinitis, or urticaria) to sulfonamides,
acetaminophen, diclofenac, celecoxib, aspirin, or any other NSAID
- History of myocardial infarction, congestive heart failure, stroke, coronary-artery
bypass graft surgery, or any other significant cardiovascular disease, or is on any
form of anticoagulation therapy other than low-dose aspirin (no more than 325 mg/day)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial I | NCT00546507 | Entailment |
3,592 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
- Agrees to protocol-defined use of effective contraception
- If a woman, must have a negative serum human chorionic gonadotropin (hCG) pregnancy
test at screening; and a negative urine pregnancy test on Day -1 of each treatment
period
- Body mass index (BMI) (weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive),
and body weight not less than 50 kg
- Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 mmHg
systolic, inclusive, and no higher than 90 mmHg diastolic
- A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and
function
Exclusion Criteria:
- Current or prior history of psychiatric disorder including but not limited to
psychotic, bipolar, major depressive, or anxiety disorder
- Clinically significant medical illness including cardiac arrhythmias or other cardiac
disease, hematologic disease, coagulation disorders , lipid abnormalities, significant
pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus,
renal or hepatic insufficiency, thyroid disease, neurologic disease, infection,
hypertension or vascular disorders, kidney or urinary tract disturbances, sleep apnea,
myasthenia gravis, or any other illness
- Clinically significant abnormal values for hematology, clinical chemistry, or
urinalysis at screening or at admission to the study center (Day -1) as deemed
appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs, or 12-lead ECG at
screening or at admission to the study center (Day -1 of each treatment period) as
deemed appropriate by the investigator
- Has an abnormal or deviated nasal septum with any 1 or more of the following symptoms:
blockage of 1 or both nostrils, nasal congestion (especially 1-sided), frequent
nosebleeds, frequent sinus infections, noisy breathing during sleep, facial pain,
headaches, and postnasal drip
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | A Study to Evaluate the Pharmacokinetics of Intranasal Esketamine Administered With and Without a Nasal Guide on the Intranasal Device | NCT02060929 | Contradiction |
832 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Age of 21 to 80 years
- Diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence
grading scale
Exclusion Criteria:
- Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren
Lawrence grading scale
- BMI greater than 40 kg/m2
- Subject has active infection at the injection site
- Symptomatic OA of the contralateral knee or of either hip that is not responsive to
acetaminophen (Tylenol) and requires other therapy.
- Subject has rheumatoid arthritis, psoriatic arthritis or has been diagnosed with any
other disorder that is the primary source of their knee pain, including but not
limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor or cancer
- Subject has documented history of gout or pseudo-gout
- Subject has an autoimmune disease or known history of having Acquired Immunodeficiency
Syndromes (AIDS) or HIV
- Subject has received any of the following to the target knee:
1. Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening
2. Intra-articular cortisone (steroid/corticosteroid) injection into the knee joint
within 12 weeks of treatment
3. Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to
screening
4. Has had or is planning to have major surgery or arthroscopy in the target knee
within 26 weeks of treatment
- History of partial or total knee arthroplasty
- Subject has used an investigational drug, device or biologic within 12 weeks prior to
treatment
- Subject has a history of immunosuppressive or chemotherapy in the last 5 years
- Subject has had prior radiation at the site
- Subject is currently taking narcotic medication for any reason.
- Subject is pregnant or plans to become pregnant within 365 days of treatment
- Subject has any significant medical condition that, in the opinion of the
Investigator, would interfere with protocol evaluation and participation
- Subject is a worker's compensation patient
- Subject is a prisoner
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 80 Years | An Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) in the Treatment of Osteoarthritis of the Knee | NCT04201743 | Entailment |
1,145 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- The patient is adult (> or = 18 years) and informed.
- He's agree for a 24-month follow-up.
- The patient must be member or beneficiary of a health insurance system.
- He must have a clear diagnosis of HCM defined by a left ventricular hypertrophy in
tranthoracic echocardiography (superior to 15mm or 13mm if there is a familial
history) without other causes of hypertrophy (severe hypertension, aortic stenosis,
amyloidosis or fabry disease, ..)
Exclusion Criteria:
- The patient is under safeguarding justice, tutorship or curatorship.
- The patient formalizes his opposition.
- It's impossible to give enlightened information.
- The patient doesn't read French.
- The patient is pregnant or breastfeeding.
- Contraindication to the realization of a MRI (defibrillator, no-MRI compatible PMK,
claustrophobia,..)
- Contraindication to the Persantine° injection (asthma, high degree block, ..)
- Contraindication or impossibility to realize a stress echocardiography.
- Comorbidity that can be responsible of the studied anomalies: coronaropathy,
myomectomy, multicomplicated diabetes, …
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Study of Hypertrophic Cardiomyopathy Under Stress Conditions. Concordance Between Two Complementary Tests: Stress MRI and Exercice Stress Echocardiography | NCT02500420 | Entailment |
1,289 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | DISEASE CHARACTERISTICS:
- Histologically confirmed malignant pleural mesothelioma
- All subtypes allowed
- T1-3, N0-1, M0 disease
- No N2 or N3 involvement confirmed by mediastinoscopy within 21 days before study
entry
- No clinical invasion of mediastinal structures (e.g., heart, aorta, spine, esophagus)
- No wide-spread chest wall invasion except focal chest wall lesions
- No clinical or radiological evidence of shrinking hemithorax
- No clinically significant third-space fluid (e.g., pleural effusions or ascites) that
cannot be managed with thoracentesis or pleurodesis
PATIENT CHARACTERISTICS:
Age
- Under 70
Performance status
- WHO 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC > 3,500/mm^3
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Hemoglobin ≥ 11 g/dL
Hepatic
- AST and ALT < 1.5 times upper limit of normal (ULN)
- Bilirubin < 1.5 times ULN
- Alkaline phosphatase < 1.5 times ULN
Renal
- Creatinine clearance ≥ 60 mL/min
- Acceptable (predicted) post-radiotherapy renal function by semiquantitative isotope
renography, with a relative contribution of the contralateral kidney of ≥ 40%
Pulmonary
- See Disease Characteristics
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after
completion of study treatment
- Deemed to be fit enough to undergo study treatment
- No preexisting sensory neurotoxicity > grade 1
- No uncontrolled infection
- No prior or concurrent melanoma, breast cancer, or hypernephroma
- No other malignancy within the past 5 years except carcinoma in situ of the cervix or
adequately treated basal cell skin cancer
- No psychological, familial, sociological, or geographical condition that would
preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
- No concurrent routine use of colony-stimulating factors during neoadjuvant
chemotherapy
- Concurrent secondary prophylactic use allowed during neoadjuvant chemotherapy
- No concurrent secondary prophylactic use of colony-stimulating factors during
post-operative radiotherapy
Chemotherapy
- No prior chemotherapy for mesothelioma
Endocrine therapy
- No concurrent hormonal cancer therapy
Radiotherapy
- No prior radiotherapy to the lower neck, thorax, or upper abdomen
Surgery
- See Disease Characteristics
Other
- No other concurrent anticancer therapy
- No other concurrent experimental medications
- No nonsteroidal anti-inflammatory drugs or salicylates for 2 days before, during, and
2 days after administration of neoadjuvant chemotherapy (5 days before and 2 days
after for drugs with a long half-life [e.g., naproxen, piroxicam, diflunisal, or
nabumetone])
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 69 Years | Pemetrexed Disodium and Cisplatin Followed By Surgery and Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma | NCT00227630 | Entailment |
3,837 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | All Cohorts:
To be eligible to participate in this study, a subject must meet all the following
criteria.
Inclusion Criteria-ALL Cohorts:
1. Men and women age 18 or older
2. Clinical and radiographic diagnosis of OA in one of the following areas: Ankle, Hip,
Knee, Shoulder, or Wrist
3. Continued OA pain in the targeted joint despite conservative measures (per treating
provider's discretion)
4. Average daily VAS Pain Score ≥3
5. Understand and provide written informed consent and Health Insurance Portability and
Accountability Act (HIPAA) authorization prior to initiation of any study-specific
procedures
6. Subject must also meet additional inclusion criteria specific to the targeted joint
cohort
Ankle Cohort:
1. Currently Kellgren-Lawrence Grade II, III or IV in the ankle based on X-ray
(weight-bearing mortise views with 20⁰ internal rotation)
2. Ankle pain for at least 6 months, despite conservative treatment or inability to
tolerate the side effects of medications
3. Normal activity level, not bedridden or confined to a wheelchair, able to walk 30
meters without the aid of a walker, crutches or cane
Hip Cohort:
1. Hip OA diagnosed on x-ray and/or Magnetic Resonance Imaging (MRI) (Tӧnnis grade 1, 2, or
3)
Knee Cohort:
1. Kellgren-Lawrence system of Grade II, III, or IV
2. Subject may have concomitant patellofemoral but they must have stage II or higher
generalized knee OA
Shoulder Cohort:
1. Grades 1, 2 or 3 OA in the index glenohumeral joint based on the Samilson-Prieto
classification system as confirmed by X-ray (axillary view and true anterior-posterior
view)
2. Subjects who have failed standard non-surgical management of their shoulder arthritis
who would benefit from a shoulder arthroplasty. Failed medical management will be
defined as persistent pain and disability despite adequate standard non-operative
management for 6 months. Medical management will be defined as:
1. The use of drugs including analgesics and non-steroidal anti-inflammatory drugs
2. Physiotherapy consisting of stretching, strengthening and local modalities
(ultrasound, cryotherapy, etc.)
3. Activity modification
4. Patients will present with a type of B2 glenoid deficiency, as defined by the
Walch classification system, with greater than 10 degrees of retroversion.
Wrist Cohort:
1. Clinical symptoms consistent with wrist OA
Exclusion Criteria- ALL Cohorts:
1. Subject cannot meet any of the exclusion criteria listed of the targeted joint cohort
2. Viscosupplementation within 6 months of screening in the targeted joint
3. Other Biologic Injection (Platelet Rich Plasma (PRP) or stem cell) within 6 months in
the targeted joint
4. Surgery in the targeted joint within the past 6 months (either open or scope)
5. Planned/anticipated surgery of the targeted joint during study participation
6. Systemic or intra-articular injection of corticosteroids in any joint within 3 months
before screening
7. Females of childbearing age who have not used or do not plan to use acceptable birth
control measures, for the duration of the study. Oral, injected or implanted hormonal
contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine
device, surgical sterilization, transdermal delivery, congenital sterility or sexual
abstinence are considered acceptable forms of birth control. If sexually active, the
subject must have been using one of the accepted birth control methods at least one
month prior to study entry.
8. Part of a vulnerable population per Office for Human Research Protections (OHRP)
definition (pregnant women and breast-feeding women, cognitively impaired, prisoners,
etc.)
9. Unwilling to discontinue the use of Non-Steroidal Anti-Inflammatory (NSAID)s for 7
calendar days prior to the procedure
10. Unwilling to discontinue NSAIDS for 5 calendar days after procedure
11. Insufficient amount of subcutaneous tissue to allow recovery of at least 100mL of
lipoaspirate
12. Diagnosed musculoskeletal cancer or any diagnosed cancer, other than musculoskeletal
if not on long term remission (e.g. at least 5 years or negative biopsy at last exam),
except basal cell carcinoma
13. Have received chronic (more than 7 consecutive days) treatment with systemic
corticosteroids at a dose equivalent to prednisone ≥ 10 mg/day within 14 days prior to
an injection procedure.
14. Subject is currently participating in another clinical trial that has not yet
completed its primary endpoint. (Nonintervention observational studies are not
exclusionary.)
15. History of, or ongoing, autoimmune disorder that requires treatment with an
immunosuppressive medication
16. Subjects who have a documented history or presence of inflammatory arthritis,
rheumatoid arthritis, and sepsis in the treatment site
17. Subjects who have active synovitis in the treatment site
18. History of bleeding disorders or inflammatory joint disease
19. Inability to hold anti-platelet therapy according to treating provider prior to
procedure
20. Any medical condition that could preclude participation in the study in the opinion of
the investigator
21. Active workers' compensation case in progress with the targeted joint
22. Daily opioid use for the 3 months prior to screening or anticipated daily use while
participating on study
23. Psychiatric disorder that may prevent participation in the study in the opinion of the
investigators
24. A positive screen for human immunodeficiency virus (HIV) by antibodies or nucleic acid
test
25. Allergy to sodium citrate of any "caine" type of local anesthetic
26. Hemoglobin less than 10g/dL at the time of screening
27. Leukocytes <3,000/µL; neutrophils <1,500/µL; lymphocytes <800/µL; platelets
<100,000/µL at the time of screening
28. Subjects with a known diagnosis of osteoporosis
29. Diagnosis of liver disease as defined by alanine aminotransferase (ALT) >2x the upper
limit of age-determined normal (ULN) or total bilirubin > 1.5x ULN
Ankle Cohort:
1. Lower leg trauma in a location other than within the ankle
2. Arthroscopy or open surgery of the ankle joint within 6 months of screening.
3. Extreme obesity, as defined by National Institutes of Health (NIH) Clinical Guidelines
Body Mass Index (BMI > 40)
4. Any condition other than OA of the ankle joint which, in the opinion of the
investigator, affects their ability to ambulate to a sufficient degree to interfere
with the assessment of the safety and treatment effects of the study injection.
Hip Cohort:
1. Evidence of hip dysplasia (centre edge angle less than 20⁰)
2. Previous trauma to the affected hip requiring medical or surgical treatment
3. Previous surgery on the affected hip or contralateral hip
4. Severe acetabular deformities (e.g. acetabular protrusion, coxa profunda,
circumferential labral ossification)
5. Infections or skin diseases at target hip joint
6. Significant medical co-morbidities (requiring daily assistance for activities of daily
living)
7. Any clinically significant or symptomatic vascular or neurologic disorder of the lower
extremities
8. Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI>40)
Knee Cohort:
1. Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI>40)
2. Clinically apparent tense effusion of the targeted knee
3. Significant valgus/varus deformities (+/- 10⁰)
Shoulder Cohort:
1. Walch B2 glenoid with less than 10⁰ of retroversion
2. Rotator cuff arthropathy
3. Significant muscle paralysis
4. Charcot's arthropathy
Wrist Cohort:
1. Subjects who have a documented history of chondrocalcinosis in the wrist
2. Subjects who have a documented diagnosis of active carpal tunnel syndrome
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Disease-based Treatment Study for Diagnosed Osteoarthritis Utilizing Adipose-derived Regenerative Cells | NCT04405297 | Entailment |
4,276 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- Have a complex, prolonged (neck shoulder pain or lower back pain
- Have been followed by a pain management specialist for at least 6 months
- Referred for Pain Medicine Consultation
- Be >18 years of age
- Be able to travel to and from the clinic
- Have a goal and motivation that is adequate in relation to the program offered
- Be medically prepared and not have any other medical examination or ongoing disease
that constitutes an obstacle as well as adequate pharmacological treatment
- Have no major change in pain management (e.g. medications)
- Own a smart phone, tablet or computer or have the knowledge to use one
Exclusion Criteria:
- Low back pain requiring surgical intervention in the next 3 months
- Severe or acute psychiatric illness, severe anxiety or depression
- Reported/acute psychiatric illness or acute crisis
- Ongoing abuse of alcohol, drugs and drug-based drugs. This also includes high doses of
prescribed drugs
- Pain related to malignancy
- Other areas of pain exceeding the level/intensity of low back or neck pain
- Currently involved in a lawsuit or pending litigation in relation to the low back or
neck pain
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Self-Management of Chronic Pain | NCT04837794 | Entailment |
4,234 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
1. Non-smoking healthy male volunteers, (18-55 years, extremes included).
2. Good health condition, as determined by medical history, physical examination and
clinical laboratory testing
3. Body mass index (BMI) within normal range: 18.0 ≤ BMI < 30.0 (kg/m2)
4. Haematology and chemistry parameters within normal range, or showing no clinically
relevant deviations (as judged by the Investigator)
5. Heart rate and/or blood pressure within normal range (as judged by the Investigator)
6. Electrocardiogram (ECG) within normal range, or showing no clinically relevant
deviations (as judged by the Investigator)
7. Negative urine test for selected drugs of abuse at screening
8. Negative alcohol breath test upon check-in at study unit
9. Negative hepatitis panel (including hepatitis B surface antigen (HBsAg) and
anti-hepatitis C virus antibodies (anti-HCV)), and negative human immunodeficiency
virus (HIV) antibody screens
10. Willingness to consent to using an effective contraceptive method (by using 2 methods
of contraception in combination with a female partner: at least 1 of the contraception
methods must be a barrier contraception method, e.g., condom) during the study and for
at least 3 months after last study drug administration
11. Ability to comprehend and willingness to sign an Informed Consent Form (ICF)
For oral inhalation only:
12. Lung function test which shows a Forced Expiratory Volume in 1 second (FEV1) ≥ 90% of
predicted value
13. Ability to retro-breathe with nebulizer
14. Height between 170 and 190 cm (extremes included)
15. Ability to produce a sufficient amount of induced sputum (at least 400 μL containing
visual sputum plugs) to assess immunogenicity
Exclusion Criteria:
1. Current smokers, or ex-smokers abstinent from tobacco for less than one year, or a
history of smoking more than 10 packs a year
2. Symptomatic viral infection, or suspicion thereof (including rhinitis) in the last 14
days prior to dosing
3. Signs of active pulmonary infection or other pulmonary inflammatory conditions, even
in the absence of febrile episodes, in the last 14 days prior to dosing
4. History or presence of disease in the kidneys and/or heart, lungs, liver,
gastrointestinal tract, endocrine organs or other conditions such as metabolic disease
known to interfere with the absorption, distribution, metabolism or excretion of drugs
5. Malignancy, or prior malignancy, with a disease-free interval of < 5 years after
diagnosis and intervention, except basal cell carcinoma (treated curatively)
6. Autoimmune disorders such as (but not limited to) lupus erythematosus, multiple
sclerosis, rheumatoid arthritis, or sarcoidosis.
7. History of hypersensitivity or allergies to any drug compound, including constituents
of ALX-0171
8. History of previous administration of ALX-0171, or any other inhaled biologic or drug
targeting the Respiratory Syncytial Virus (RSV) F protein. In any other case of use of
biologics: at least 6 months before administration of first study medication, or the
time of duration of the pharmacodynamic effect, or 10 times the half-life of the
respective drug, whatever is longer
9. Receipt of any investigational drug within 60 days prior to dosing
10. Intake of prescribed or over-the-counter medication within 14 days prior to dosing (≤
3 g/day paracetamol is allowed)
11. History or presence of alcohol or drug abuse
12. Blood donation (> 500 mL) or a comparable blood loss within three months prior to
dosing
13. Planned donation of germ cells, blood, organs, bone marrow during the course of the
study or within 6 months thereafter
14. Any other condition or prior therapy which, in the opinion of the Investigator, would
make the subject unsuitable for this study
15. Vulnerable subjects (e.g., persons kept in detention)
For oral inhalation only:
16. History or presence of atopy or any condition associated with airway
hyperresponsiveness (e.g., allergic or non-allergic asthma, chronic obstructive
pulmonary disease (COPD))
17. FEV1 drop of > 10% after inhalation of 4 mL of ALX-0171 placebo (measured at 5 min
after the end of inhalation)
18. Contra-indication for sputum induction, such as (but not limited to) recent eye
surgery, recent fractured ribs and recent (or history of) pneumothorax
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | ALX-0171 Phase I Pharmacokinetic Study in Healthy Male Volunteers | NCT01875926 | Contradiction |
2,962 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Main Inclusion criteria
- Patient is 18 years old and less than 76 years old
- Possible, Probable, Probable laboratory-supported or Definite ALS as defined by El
Escorial Revised ALS diagnostic criteria
- Disease duration <= 24 months
- Slow Vital capacity >= 70% of normal
- No prior or present riluzole treatment
- Lumbar punctures accepted by patient and done
Main Exclusion criteria
- Other neurodegenerative disease that could explain signs or symptoms
- Contra indication for lumbar puncture (history of allergy to xylocaine, presence of
contra-indicated treatment, or coagulation test abnormality, clinically significant
coagulopathy or thrombocytopenia)
- Non authorized treatment
- Other disease or disorders that could preclude functional assessment, or
life-threatening disorders
- Any documented, active, past or present, auto-immune disorders except asymptomatic
Hashimoto thyroiditis
- Using assisted ventilation
- Feeding through gastrostomy or nasogastric tube
- Women of child-bearing potential or sexually active man without contraception
- Pregnant or breast feeding woman
- Any clinically significant laboratory abnormality (excepting cholesterol,
triglyceride, glucose, CK, ferritin)
- History of documented symptomatic and treated asthma within the past 5 years
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | MIROCALS: Modifying Immune Response and OutComes in ALS | NCT03039673 | Entailment |
2,606 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- patients admitted to undergo elective unilateral inguinal hernia repair
- patients with ASA II, III or IV
Exclusion Criteria:
- bilateral inguinal hernia
- incarcerated hernia
- emergency cases
- known history of allergic reactions to local anesthesia
- bleeding disorders
- neurological disorders
- infection at site of injection
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
| Paravertebral Block for Inguinal Hernia Repair in Elderly | NCT02537860 | Contradiction |
2,799 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | 1. Inclusion Criteria:
- Patients older than 18 years old
- Laparoscopic inguinal hernioplasty as the pincipal surgery
2. Exclusion Criteria:
- Patients with, high anesthetic risk (decompensated ASA III and ASA IV)
- Morbid obesity (higher BMI 40),
- Sleep apnea with indication of use of CPAP (Continuous Positive Airway Pressure)
- Medicated psychiatric disease,
- Drug-dependent patient
- Patients with an inadequate social environment-
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Ambulatory Laparoscopic Inguinal Hernioplasty: Feasibility and Cost Analysis | NCT04504461 | Entailment |
3,232 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- SS was diagnosed according to the SS European Criteria
- chronic symptoms of burning, foreign body sensation, itching in both eyes
- daily need of artificial tears
- abnormal Schirmer (ST) I test < 5mm or rose Bengal staining (RBS) ≥ 4, or break up
time (BUT) < 5 seconds.
Exclusion Criteria:
- any structural abnormalities (lid scarring, entropion, trichiasis, etc.)
- any inflammation or active structural change in the iris or anterior chamber
- glaucoma
- previous eye surgery or punctual occlusion
- use of any other topical medication other than artificial tears
- any systemic or topical antibacterial or antiinflammatory drug treatment 90 days
before study entry
- contact lens wearer
- the presence of any corneal infection
- any corneal diseases (marginal ulcer, opacity, scar, bullous keratopathy,
conjunctivochalasis, symblepharon or tumor)
- pregnancy
- change in the immunosuppressive systemic therapy 90 days before study entry
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 60 Years | Treatment of Dry Eye Using 0.03% Tacrolimus Eye Drops | NCT01850979 | Entailment |
3,047 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Molecular documentation of the full FMR1 mutation
- Current pharmacological treatment regimen has been stable for at least 4 weeks prior
to Screening.
- Subjects with a history of seizure disorder must currently be receiving treatment with
antiepileptics and must have been seizure free for 6 months, or must be seizure free
for 3 years if not currently receiving antiepileptics.
- If the subject is already receiving stable non-pharmacologic educational, behavioral,
and/or dietary interventions, participation in these programs must have been
continuous during the 2 months prior to Screening
Exclusion Criteria:
- Subjects with any condition, including alcohol and drug abuse, which might interfere
with the conduct of the study, confound interpretation of the study results, or
endanger their own well-being.
- Subjects who plan to initiate or change pharmacologic or non-pharmacologic
interventions during the course of the study.
- Subjects who have taken another investigational drug within the last 30 days.
- Subjects who are not able to take oral medications.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 50 Years | Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome | NCT01282268 | Entailment |
884 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Clinical diagnosis of osteoarthritis
Exclusion Criteria:
- Must be able to speak and understand swedish
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Effect of an Education Programme for Patients With Osteoarthritis in Primary Care - a Randomized Controlled Trial | NCT00979914 | Entailment |
2,219 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
1. Outpatients of either gender, age 18 or older ( no upper age limit).
2. Patient is hyperuricemic: screening serum uric acid must be ≥8 mg/dL.
3. Patient has symptomatic gout (presence of at least 3 gout flares in the 18 months
prior to entry, or at least one gout tophus, or gouty arthritis).
4. Conventional therapy is contraindicated or has been ineffective in this patient, i.e.,
patient has a history (either by medical record or patient interview) of
hypersensitivity or of failure to normalize SUA with at least 3 months treatment with
allopurinol at the maximum labeled dose (800 mg/dL in the U.S.), or at a medically
appropriate lower dose based on dose-limiting toxicity or dose-limiting co-morbidity.
5. Patient is willing and able to give informed consent and adhere to visit/protocol
schedules (informed consent must be given before the first study procedure is
performed, including washout).
6. If the patient is a woman of childbearing potential, she must have had a negative
screening serum pregnancy test and must use a medically approved form of birth control
during her participation in the protocol. Such methods include oral, injectable or
implantable contraceptives; IUDs and barrier contraceptives in combination with
spermicide. (If male or surgically sterile, check N/A.)
Exclusion Criteria:
1. The patient has unstable angina.
2. The patient has uncontrolled arrhythmia.
3. The patient has non-compensated congestive heart failure.
4. The patient has uncontrolled hypertension (above 150/95).
5. The patient has a history of end stage renal disease requiring dialysis.
6. The patient has hemoglobin < 8 g/dL (males) or < 7 g/dL (females).
7. The patient is an organ transplant recipient
8. The patient has had prior treatment with PEG-uricase, or other recombinant uricase, or
any concomitant therapy with a PEG-conjugated drug.
9. The patient has had a gout flare at screening that is resolved for less than one week
prior to first treatment with study drug (exclusive of chronic synovitis/ arthritis).
10. The patient has glucose-6-phosphate dehydrogenase (G6PD) deficiency.
11. The patient has a history of anaphylactic reaction to a recombinant protein or porcine
product, or hypersensitivity to PEG.
12. The patient is pregnant or breast feeding.
13. The patient has taken an investigational drug within 4 weeks prior to study drug
administration or plans to take an investigational agent during the study.
14. The patient has a known allergy to urate oxidase or PEGylated products.
15. The patient has any other medical or psychological condition which, in the opinion of
the investigator, might create undue risk to the subject or interfere with the
subject's ability to comply with the protocol requirements, or to complete the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout | NCT00325195 | Contradiction |
2,062 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Inclusion Criteria:
- IPF is considered the most likely diagnosis by the Regional Interstitial Lung Disease
Multidisciplinary Team meeting (ILD-MDT).
- History of cough, with or without exertional dyspnoea.
- High resolution computed tomography (HRCT) scan features of honeycombing in a
predominantly basal subpleural distribution.
- Bibasal crackles on auscultation.
- Features of a restrictive ventilatory defect [vital capacity (VC) <90% predicted
and/or diffusion factor for carbon monoxide (Tco) <90% predicted].
- Aged 40-85 years.
- Patients taking short courses (eg. 2 months) of proton pump inhibitors (PPI) will be
eligible once the treatment has been discontinued for a minimum of 1 month.
Exclusion Criteria:
- Known allergy to Omeprazole or other proton pump inhibitor.
- Concomitant use of warfarin, diazepam, phenytoin, ketoconazole.
- Concomitant use of a regular PPI, antacid, prokinetic or raft alginate during the
trial period.
- History of upper respiratory tract infection, lower respiratory tract infection or
exacerbation of IPF in the 4 weeks before starting study drugs.
- Active trial of treatment for IPF 9eg. prednisolone, pirfenidone, N-acetylcysteine)
started in the 4 weeks before starting study drugs.
- Documented history of hepatic cirrhosis.
- Pregnancy or lactation.
- ILD-MDT considers the most likely cause of he patient's ILD to be a condition other
than IPF (eg. rheumatoid lung, systemic sclerosis ILD, asbestosis, chronic
hypersensitivity pneumonitis, sarcoidosis, etc.).
- Concurrent enrolment in a trial of a Clinical Trial of Investigational Medicinal
Product (CTIMP) for IPF.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 85 Years | Pilot Trial Of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF) | NCT02085018 | Entailment |
2,342 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Is male at birth, ambulatory and from 4 to under 8 years of age at time of
randomization.
- Definitive diagnosis of Duchenne Muscular Dystrophy based on documented clinical
findings and prior genetic testing
- Ability to cooperate with motor assessment testing.
- Stable dose equivalent of oral corticosteroids for at least 12 weeks.
- rAAVrh74 antibody titers are not elevated as per protocol-specified requirements.
Exclusion Criteria:
- Has a concomitant illness, autoimmune disease, chronic drug treatment, and/or
cognitive delay/impairment that in the opinion of the Investigator creates unnecessary
risks for gene transfer.
- Exposure to gene therapy, investigational medication, or any treatment designed to
increase dystrophin expression within protocol specified time limits.
- Abnormality in protocol-specified diagnostic evaluations or laboratory tests.
Other inclusion/exclusion criteria apply.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 7 Years | A Gene Delivery Study to Evaluate the Safety of and Expression From SRP-9001 in Duchenne Muscular Dystrophy (DMD) | NCT04626674 | Entailment |
2,853 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
1. Patients with ALS: Familial and Sporadic ALS, with symptom onset < or equal to 24
months.
2. At least 18 years of age
3. Subjects meet the El Escorial criteria of definite criteria for a diagnosis of ALS.
4. Subjects can be on a stable dose of riluzole for at least a month or not taking or
initiating riluzole for the duration of the trial.
5. Not on any experimental medication for the last 1 month or five times the half-life of
experimental medication.
6. At screening, must have a Forced Vital Capacity (FVC) ≥ 65% of predicted capacity for
age, height and gender.
7. Have fully completed informed consent form
8. Ability to comply with study procedures
9. Women of child-bearing age must be on birth control. Pregnancy test should be done in
women in child bearing age.
10. Medically safe to have lumbar puncture to collect CSF
Exclusion Criteria:
1. History of liver disease, severe renal failure, diabetes, coronary heart disease,
cancer
2. Clinically significant EKG abnormality at screening
3. Any comorbid condition which would make completion of the trial unlikely
4. FVC < 65%
5. Presence of a bleeding disorder
6. Allergy to local anesthetics
7. Problem with CSF pressure
8. Topical or other skin infection at the lumbar puncture site
9. BMI > 32 kg/m2
10. Medical or surgical conditions in which a lumbar puncture is contraindicated
11. Use of any anti-platelet or anticoagulant drugs, such as plavix, aggrenox, ticlid,
warfarin or coumadin
-
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| GM604 Phase 2A Randomized Double-blind Placebo Controlled Pilot Trial in Amyotrophic Lateral Disease (ALS) | NCT01854294 | Entailment |
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