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270 | 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:
- Patients in good health as confirmed by medical history
- not pregnant as demonstrated by negative urine pregnancy test
- completed their last term pregnancy at least 42 days prior to Screening and at least
one normal menstrual period since last pregnancy
- not lactating
- post-menarcheal and pre-menopausal
Exclusion Criteria:
- History or presence of disorders commonly accepted as contraindications to steroid
hormonal therapy including but not limited to the following - active or history of
deep vein thrombophlebitis or thromboembolytic disorders or hypercoagulation
disorders, cerebral vascular or coronary artery disease, uncontrolled hypertension, or
migraines with focal aura, benign or malignant liver tumor which developed during the
use of oral contraceptives or estrogen-containing products
- treatment with continuous oral contraception within three months of study
- previous use of contraceptive patch including norelgestromin/ethinyl estradiol
- patients who are amenorrheic (abnormal suppression or absence of menstruation)
- recent history of alcohol or substance abuse
- skin conditions resulting in oily, irritated or damaged skin at potential sites of
application
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | An Open-Label Study to Compare the Bleeding Profile of Norelgestromin/Ethinyl Estradiol in an Extended Regimen to Norelgestromin/Ethinyl Estradiol Given in a Traditional Regimen | NCT00320580 | Contradiction |
3,404 | 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
You may be eligible for this study if you:
- Are HIV-negative.
- Are between the ages of 18 and 60.
- Agree to use a barrier method of birth control (e.g., a condom) during the study.
Exclusion Criteria
You will not be eligible for this study if you:
- Have a history of a chronic illness such as high blood pressure, heart disease,
arthritis, or diabetes.
- Are pregnant or breast-feeding.
- Are taking certain medications.
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 | A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood | NCT00000941 | Contradiction |
4,365 | 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:
- Subjects should have normal eyes and use no ocular medications. They may have worn
contact lenses previously, provided their eyes are shown to be normal at the start of
the investigation. A normal eye is defined as having the following characteristics:
1. No anterior segment infection, inflammation or abnormality.
2. No other active ocular or systemic disease that would contraindicate contact lens
wear; and
3. No medications that would contraindicate contact lens wear.
- VA correctable to 0.1 LogMAR or better, with spherical lenses ranging in power from
- 1.00 to -10.00 D myopia, astigmatism less than 2.00 D
- Willing to comply with all study procedures and be available for the duration of the
study.
- Provide signed and dated informed consent form.
Exclusion Criteria:
- Have history of allergies that would contraindicate "normal" contact lens wear.
- Have other active ocular or systemic disease such as, but not limited to: anterior
uveitis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus,
sclerodermas, keratoconus or type II diabetes, slip lamp findings greater than grade I
(such as cornea or interstitial edema).
- Have medications that would contraindicate contact lens wear.
- Have had any cornea surgery.
- Currently pregnant (to the best of the subject's knowledge), is lactating or is
planning a pregnancy within the next 1 month.
- Any active participation in another clinical trial within 30 days prior to this study.
- The presence of clinically significant (grade 3 or 4) anterior segment abnormalities;
inflammations such as iritis; or any infection of the eye, lids, or associated
structures.
- A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer,
corneal infiltrates or fungal infections.
- A history of papillary conjunctivitis that has interfered with contact lens wear.
- No monocular or monovision fits.
- Alcoholic or Drug Abused.
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.
| Clinical Performance of the OxyAqua Daily Disposable Silicone Hydrogel Soft Contact Lens | NCT03139201 | Entailment |
4,853 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
- Adrenal tumour with biochemical mild hypercortisolism defined as pathological
dexamethasone suppression test (cortisol > 50 nmol/L at 8.00 am after 1 mg
dexamethasone at 10 pm, plus one of the following criteria
- Low or suppressed adrenocorticotropic hormone (ACTH)
- Low or suppressed dehydroepiandrosterone (DHEA)
- No or pathological circadian rhythm of cortisol
Exclusion Criteria:
- Increased levels of 24 hours urinary excretion of cortisol
- Pregnancy or lactation
- Inability to understand information or to comply with scheduled follow-up
- Mild hypercortisolism with bilateral adrenal tumours, without a gradient
(lateralization on venous sampling)
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.
| Adrenalectomy Versus Follow-up in Patients With Subclinical Cushings Syndrome | NCT01246739 | Contradiction |
1,305 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
- Persons or legal guardian who have given their written informed consent
- Unclear molecular cause of the disease corresponding to the list of diseases selected
by the Solve-RD data interpretation force (principal investigator part of the team)
- Suspected genetic cause of the disease with negative exome reanalysis
- Healthy parents available for trio analysis
Exclusion Criteria:
- Person not affiliated to a national health insurance scheme
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Diagnostic Research in Patients With Rare Diseases -Solving the Unsolved Rare Diseases | NCT04024774 | Contradiction |
2,451 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
- Biopsy proven skin sarcoidosis
- Assessable target skin lesions
Exclusion Criteria:
- Rapidly evolving sarcoidosis
- Patients necessitating a corticosteroid regimen of more than 15mg per day.
- Women not willing to undertake a contraceptive method.
- Neurologic impairment
- Past treatment with Thalidomide
- Renal impairment
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.
| SARCOTHAL. Thalidomide in Skin Sarcoidosis | NCT00305552 | Entailment |
5,163 | 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:
- Female and at least 45 years of age.
- Must have undergone the onset of spontaneous or surgical menopause more than 5 years
prior to entry. Spontaneous menopause is defined as 12 months of spontaneous
amenorrhea. Surgical menopause is defined as ≥ 6 weeks postsurgical bilateral
oophorectomy with or without hysterectomy.
- Serum follicle-stimulating hormone (FSH) levels must be ≥ 30 mIU/mL.
- A body mass index (BMI) of not greater than 35 (BMI
=weight [kg]/height[m]2).
- Bone mineral density (BMD) T-score between -1.0 and - 2.5 at the total hip, femoral
neck, trochanter, or lumbar spine.
- Additional risk factors such that the 10 year risk of a major osteoporotic fracture or
hip fracture risk is at least as great as a 65-year-old woman of the same race and BMI
of 25 kg/m2 as determined by the FRAX algorithm .
- No clinically significant abnormal findings in the medical history or physical exam
that would preclude participation in the investigator's opinion.
- No clinically significant abnormal laboratory values at the screening assessment.
- Subjects must give written informed consent after reading the Subject Information and
Consent Form and having had the opportunity to discuss the study with the
investigator.
Exclusion Criteria:
- History of an osteoporotic fracture, defined as a fracture at the wrist, hip, or
humerus occurring from a fall at standing height or less.
- BMD T-Score at any site ≤ -2.5.
- Current treatment (or within 3 months prior to randomization) with hormone replacement
therapy.
- History of metabolic and other bone diseases, including osteogenesis imperfecta,
osteomalacia, and Paget's disease.
- Vitamin D insufficiency defined as a 25 hydroxyvitamin D level < 20 ng/mL (50 nmol/L).
- Prior use of calcitonin, ever.
- Prior use of any bisphosphonate, ever.
- Prior use of denosumab, fluoride, or strontium, ever.
- Prior use of parathyroid hormone analogs, ever.
- Any condition or disease that may interfere with the ability to have a dual energy
x-ray absorptiometry (DXA) scan or to evaluate a DXA scan, for example, severe
osteoarthritis of the spine, spinal fusion, pedicle screws, history of vertebroplasty,
or degenerative disease that results in insufficient number of evaluable lumbar
vertebrae, bilateral hip replacements.
- Use of anabolic steroids or androgens within 6 months preceding randomization.
- Use of vitamin D metabolites and analogs, (e.g., calcitriol) within 3 months preceding
randomization). Note: Vitamin D supplementation is not exclusionary.
- Use of estrogen or estrogen-related drugs (including selective estrogen receptor
molecules), for example, tamoxifen, tibolone, or raloxifene within 3 months preceding
randomization.
- Chronic systemic treatment with glucocorticoids.
- Clinically relevant abnormal history, physical findings, or laboratory values at the
pre-study screening assessment that could interfere with the objectives of the study
or the safety of the subject.
- Presence of acute or chronic illness or history of chronic illness which, in the
judgment of the investigator, makes participation in the study medically
inappropriate.
- Known acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV)
seropositivity.
- Uncontrolled hypertension, significant gastrointestinal abnormalities, uncontrolled
diabetes mellitus, significant coronary heart disease, any psychotic mental illness,
chronic allergic rhinitis, asthma, uncorrected endocrine dysfunction, or significantly
impaired hepatic, respiratory, or renal function.
- Participation in any other clinical study within the previous month.
- History of drug or alcohol abuse, or intake of more than 30 units of alcohol weekly.
- Possibility that the subject will not cooperate with the requirements of the protocol.
- Known sensitivity to sCT.
- Shift workers-individuals who are at work during overnight hours.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
| A Study of Oral Recombinant Salmon Calcitonin (rsCT) to Prevent Postmenopausal Osteoporosis | NCT01292187 | Contradiction |
4,565 | 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:
- Women diagnosed of adenomyosis by pathology, transvaginal ultrasound or MRI.
Exclusion Criteria:
- Refusal to join the study
Female
| Cooperative Adenomyosis Network | NCT03230994 | Contradiction |
1,268 | 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. | Inclusion Criteria:
- Histological confirmation of thoracic malignancies including non-small cell lung
cancer (NSCLC), small lung cancer (SCLC), esophageal cancer, hypopharyngeal and
laryngeal cancers (for which esophagitis symptoms can be relieved by doxepin swallow),
lymphoma, thyroid, thymoma, thymic carcinoma, mesothelioma, sarcoma, and spinal,
pulmonary or pleural-based metastases
- Planned RT (with or without chemotherapy) to a dose of >= 20 Gray (Gy) using 1.60 Gy
per daily fraction; if radiation is given twice daily, a cumulative planned dose of >=
15 Gy using at least 1.25 Gy per fraction is required; hypofractionated and
stereotactic body radiation therapy regimen are allowed
- At least 5 cm of the esophagus must be planned to receive radiotherapy, with a minimum
dose of at least 10 Gy
- >= 3 esophageal pain, either at rest or during swallowing, felt to be related to
esophagitis for which the patient wants relief, as measured by asking the following
question
- ?On a scale of 0 to 10 (0 = no pain; 10 = worst pain), what number best describes
your chest pain* (right now) due to your radiation treatment??
- Radiation can cause inflammation in your esophagus which can feel like a
chest pain, either at rest or during swallowing
- Able to swallow the study medication
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- Negative pregnancy test done =< 28 days prior to registration, for women of
childbearing potential only
- Ability to complete questionnaire(s) by themselves or with assistance
- Provide informed written consent
- Willingness to complete evaluation and questionnaires per protocol at the
participating institution for follow-up (during the active monitoring phase of the
study)
Exclusion Criteria:
- Known allergy to doxepin, tricyclic antidepressants, or any known component of the
drug formulation
- Histologic proof of and getting treatment for esophageal, stomach, spinal cord,
thyroid, breast, and head and neck cancers and vertebral metastases
- Use of a tricyclic antidepressant or monoamine oxidase inhibitor within the 2 weeks
prior to registration
- The presence or strong clinical suspicion of a tracheoesophageal fistula, or known
esophageal invasion by cancer
- Current untreated or unresolved esophageal candidiasis or herpes simplex virus (HSV)
infection
- Current untreated narrow angle glaucoma
- Current untreated urinary retention =< 6 weeks prior to registration
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
of the investigator, would make the patient inappropriate for entry into this study or
interfere significantly with the proper assessment of safety and toxicity of the
prescribed regimens
- Any of the following
- Pregnant women
- Nursing women
- Current use of doxepin or doxepin rinse as a swallow preparation
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.
| Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy | NCT02062632 | Entailment |
1,333 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
- Have completed 24 months of BMN 111 treatment in Study 111-202.
- Parent(s) or guardian(s) are willing and able to provide written, signed informed
consent. Subjects under the age of majority are willing and able to provide written
assent (if required). Subjects who reach the age of majority in their country will be
asked to provide their own written consent upon reaching the legal age of majority.
- If sexually active, willing to use a highly effective method of contraception while
participating in the study.
- Females >= 10 years old or who have started menses must have a negative pregnancy test
at baseline and be willing to have additional pregnancy tests during the study
- Willing and able to perform all study procedures as physically possible
- Parents/caregivers willing to administer daily injections to the subjects and complete
the required training.
Exclusion Criteria:
- Requires any investigational agent prior to completion of study period.
- Have a condition or circumstance that, in the view of the Investigator, places the
subject at high risk for poor treatment compliance or for not completing the study.
- Concurrent disease or condition that, in the view of the Investigator, would interfere
with study participation or safety evaluations for any reason.
- Permanently discontinued BMN 111 during the 111-202 study.
- Subject is pregnant at Baseline visit or planning to become pregnant (self or partner)
at any time during the study.
- Current chronic therapy with restricted medications.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 7 Years old.
| A Study to Evaluate Long-Term Safety, Tolerability, & Efficacy of BMN 111 in Children With Achondroplasia (ACH) | NCT02724228 | Contradiction |
5,459 | 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:
- Historically lowest VWF:Ag and/or VWF:RCo and/or VWF:CB < 0.50 IU/ml and/or FVIII:C <
0.50 IU/ml
- All types of VWD
- All ages
Exclusion Criteria:
- Patient without consent to participate
No condition on gender to be admitted to the trial.
| Latin-American Von Willebrand Disease Registry | NCT04279717 | Entailment |
488 | 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. | For participants with major depressive episode:
Inclusion criteria:
- female sex
- current diagnosis of a major depression episode
- minimum age of 18 years
- regular menstrual cycle.
Exclusion criteria:
- Pregnancy less than one year ago;
- women who are breastfeeding;
- bipolar disorder;
- acute suicidal tendencies;
- schizophrenic disorders (F20-29);
- substance use disorders
- psychotropic drugs in the last six months;
- chronic somatic diseases.
For participants without major depressive episode:
Inclusion criteria:
- female sex;
- minimum age of 18 years;
- regular menstrual cycle.
Exclusion criteria:
- current or lifetime mental disorder;
- pregnancy less than one year ago;
- women who are breastfeeding;
- psychotropic drugs in the last six months;
- chronic somatic diseases.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Depressive Symptoms and Subjective Stress in the Course of the Menstrual Cycle - an Ambulatory Assessment Study. | NCT04086316 | Contradiction |
3,898 | 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:
- Painful osteoarthritis
- Hydarthrosis (synovial effusion)
Exclusion Criteria:
- large effusion
- severe pathologies
- anti-osteoarthritic treatments
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 80 Years | Exploration of the Synovial Fluid Inflammation Mediators Under Diacerhein in Knee Osteoarthritis | NCT00440661 | Entailment |
554 | 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:
- male factor infertility
- normal female hormonal profile
- normal uterine cavity
Exclusion Criteria:
- previous ICSI failure
- endometriosis
- azoospermia
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 39 Years | Intra-uterine Injection of Human Chorionic Gonadotrophin (hCG) Before Embryo Transfer | NCT01030393 | Contradiction |
3,422 | 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:
- Woman aged 18 to 65, consultant in general medicine. (Any patient meeting the
inclusion criteria may choose to answer the questionnaire in the waiting room of
general practitioners selected by lot.)
Exclusion Criteria:
-
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Prevention of Cystitis. | NCT03744338 | Entailment |
1,273 | 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. | Inclusion Criteria:
1. Age: 18-75
2. Patients have confirmed lung cancer by histopathological methods (fiber, bronchoscopy,
lung biopsy, open chest biopsy, pleural effusion exfoliated cells, sputum exfoliated
cells)
3. After clinical assessment, patients who need chemotherapy (tumor stage III or IV of
lung cancer or others who are reluctant to receive pneumonectomy);
4. Patients have no previous history of chemotherapy
5. Patients with at least one clearly measurable lung lesion (lesion size larger than
10mm, by spiral CT, according to RECIST)
6. Health status scoring between 0-2 by Eastern Cooperative Oncology Group(ECOG) method
7. Patients voluntarily to join this study and signed informed consents.
Exclusion Criteria:
1. Any body metal implants (pacemaker implantation, nerve stimulator, vascular stent,
aneurysm clip, eye foreign body, the inner metal prosthesis) or artificial heart
valves
2. Patients with claustrophobia to MRI or CT examination
3. Patients who are reluctant to comply with follow-up and subsequent examination
4. The other condition that 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 18 Years old.
Subject must be at most 75 Years | Application of Diffusion Weighted MRI Versus CT in Evaluation of the Effect of Treating Lung Cancer | NCT02320617 | Entailment |
3,580 | 27 | A 31-year-old woman comes to the office due to 3 days of rash on her left arm. The lesion is mildly pruritic but not painful. She is otherwise healthy and occasionally takes ibuprofen during the first few days of her menstrual period. Temperature is 37 C, blood pressure is 110/75 mm Hg, and pulse is 95/min. The lesion is like a target sign known as erythema migrans. She recently went for an adventure trip in New Hampshire. The patient is diagnosed with Lyme disease. | I went to the clinic because I had a rash on my left arm for three days, and the lesion started to be putrid, but it was not painful. I'm a 31-year-old healthy woman and the only medication I use is ibuprofen when I get my periods. They took my temperature, which turned out to be 37°C and took my blood pressure which was 110/75 and my pulse 95. My lesion is round like a target sign. I just came back from a New Hampshire road trip with my friends. Unfortunately, the doctor diagnosed me with Lyme disease. | Inclusion Criteria:
- Adult (i.e., over 18 years old) men or women.
- Dry skin (i.e., Modified Kligman test >0)
- Accepts and signs the informed consent.
Exclusion Criteria
- Pregnant or breast-feeding women
- Subjects with a chronic disease that requires medication
- Subjects with known diagnosis of cancer
- Smoking habit or alcohol consumption habit (i.e., once a day or more)
- Recreational o medicinal cannabinoid use
- Skin diseases (i.e., diseases that require care of a dermatologist)
- Current medication uses such as: Immunomodulators, antibiotics, corticoids or
retinoids
- Hypersensitivity to any component of the research product
- Involvement in other clinical or cosmetic studies in the last 6 months
- Recent exposure to sun causing sun tanning (i.e., as reported by the subject causing
discomfort or change in the usual appearance of the skin)
- Permanent decoration of the skin in the test area
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 70 Years | Effect of an Emollient Cream Containing 0.5% Cannabidiol and 1% Hemp Oil in the Hydration and Erythema of the Skin | NCT04045314 | Entailment |
1,717 | 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 Smokers:
1. males and females 18-64 years old
2. smoking 1-10 cigarettes or > 10 cigarettes per day for the past 6 months
For Nonsmokers:
1. males and females 18-64 years old
EXCLUSION CRITERIA:
For Smokers:
1. current interest in reducing or quitting smoking
2. treatment for nicotine dependence in the past 3 months
3. use of nicotine replacement products, bupropion, or varenicline in the past 3 months
4. current use of tobacco products other than cigarettes
5. marijuana use greater than 5 times in past 14 days or use during 24 hours before
session
6. chronic pulmonary disease
7. study investigator or subordinate staff
For Nonsmokers:
1. use of any tobacco or nicotine products in the past 3 months
2. marijuana use greater than 5 times in past 14 days or use during 24 hours before
session
3. chronic pulmonary disease
4. study investigator or subordinate staff
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 64 Years | Breath Carbon Monoxide and Cotinine as Biomarkers to Distinguish Smokers From Nonsmokers | NCT01031121 | Entailment |
643 | 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:
- Healthy males or non-pregnant, non-lactating healthy females
- Age 18 to 55 years of age (both inclusive)
- Must, in the opinion of the investigator, be in good health based upon medical
history, physical examination (including vital signs and ECGs) and clinical laboratory
tests assessed at the time of screening
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 and a minimum body weight of 40 kg, or if
outside the range, considered not clinically significant by the investigator
- Ferritin levels not less than the lower limit of normal as defined by clinical
laboratory reference ranges for female and male subjects at screening only
- Transferrin Saturation (TSAT) not less than the lower limit of normal as defined by
clinical laboratory reference ranges for female and male subjects at screening only
- Hemoglobin levels not less than the lower limit of normal as defined by clinical
laboratory reference ranges for male and female subjects
- Must agree to use an adequate method of contraception:
- For male subjects: Subjects willing to follow approved birth control methods (a
double barrier method) for the duration of the study as judged by the
investigator(s), such as condom with spermicide, condom with diaphragm, or
abstinence. Subjects should also not donate sperm during this time.
- For female subjects: Female subjects of childbearing potential, defined as a
woman < 55 years of age who has not had a partial or full hysterectomy or
oophorectomy, must have a negative urine pregnancy test at screening and a
negative beta human chorionic gonadotropin (β-hCG) pregnancy test at admission.
Subjects of childbearing potential must use a medically acceptable means of
contraception during their participation in the study
- Non-smoker, defined as: Non-smoker for > 12 months (i.e., subject has not smoked or
used any tobacco product, e-cigarettes, and nicotine replacement products for the 12
months prior to the start of the study) based on subject report.
- Must be willing and able to comply with all study requirements
- Must be able to understand a written informed consent, which must be obtained prior to
initiation of study procedures
Exclusion Criteria:
- Hypersensitivity to iron sucrose or iron products
- Presence or history of clinically significant allergy requiring treatment, as judged
by the investigator. Hay fever is allowed unless it is active
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation
excipients
- Clinically significant abnormal biochemistry, hematology or urinalysis as judged by
the investigator
- History of iron deficiency within 6 months prior to screening
- History of anemia within 6 months prior to screening
- Suspicion of iron overload as evidenced by both elevated serum TSAT and serum ferritin
levels
- History of hemochromatosis
- Bleeding disorders, acute bleeding or recently documented hemorrhage
- Females with history of hypermenorrhea or menorrhagia
- History of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine,
immunological, dermatological, neurological or psychiatric disease or disorder, as
judged by the investigator
- Must not have significant serious skin disease, including rash, food allergy, eczema,
psoriasis, or urticaria
- Female subjects who are currently pregnant, lactating, or planning to become pregnant
during the study period
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or
human immunodeficiency virus (HIV) results
- Positive drugs of abuse test result or history of drug abuse in the past 6 months
based on subject report
- Positive urinalysis test for alcohol at screening or history of alcoholism in the past
6 months based on subject report
- Regular alcohol consumption in males >21 units per week and females >14 units per week
(1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of
wine, depending on type)
- Administration of an injectable drug within 14 days prior to drug administration in
this study
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other
than up to 4 g per day acetaminophen in the 14 days before IMP administration,
hormonal contraceptives, or hormone replacement therapy. Exceptions may apply on a
case by case basis, if considered not to interfere with the objectives of the study,
as agreed by the PI and sponsor's medical monitor
- Use of iron supplements (including iron-containing multivitamins) within 3 months of
the first dose IMP administration in the study
- Have poor venous access that limits phlebotomy
- Subjects who have donated blood (1 unit = 450 mL) within 3 months prior to the first
dose of the study drug and plasma within 7 days prior to the first dose of the study
drug.
- Subjects who have received any IMP in a clinical research study within 5 half-lives or
within 30 days prior to first dose. However, in no event, shall the time between last
receipt of IMP and first dose be less than 30 days
- Subjects who are study site employees, or immediate family members of a study site or
sponsor employee
- Subjects who have previously been enrolled in this study
- Failure to satisfy the investigator of fitness to participate for any other reason
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 | Bioequivalence Study Assessing Iron Sucrose or Venofer® in Healthy Adult Subjects | NCT04155814 | Contradiction |
4,186 | 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:
- Azoospermia in at least 2 prior semen analysis.
- Diagnosis of Non-Obstructive Azoospermia or Diagnosis of Cryptozoospermia
Exclusion Criteria:
- Obstructive Azospermia
- Anatomical abnormalities in the genital tract,
- Cancer,
- Hepatitis
- Patients with systemic medical problems
- Patients with chromosomal disorders
Male
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 65 Years | The Effects of Intratesticular PRP Injection in Men With Azoospermia or Cryptozoospermia | NCT04237779 | Contradiction |
5,682 | 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:
- overweight/obese adolescents in 8th grade
- BMI is over or equal to the 95th percentile (BMI>25 according to Cole's index)(height
and weight measured by the school nurse)
- school population
Exclusion criteria
- not have severe health problems as a result of their overweight
- not be in another treatment program
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 14 Years | Young, Fit and Happy. A Web-based Intervention to Prevent Obesity in Adolescents. | NCT01700309 | Contradiction |
15 | 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:
- 1. Voluntarily sign and date the study consent form(s) which have been approved by an
Institutional Review Board (IRB). Written consent must be obtained prior to the
initiation of any study procedures.
2. Male between 18 and 64 years of age, inclusive, with documented onset of
testosterone induced hypogonadism with impaired semen parameters who are attempting to
achieve a successful pregnancy.
3. Documented diagnosis of primary hypogonadism (congenital or acquired) or
hypogonadotropic hypogonadism (congenital or acquired).
4. Serum total testosterone < 350 ng/dL based on 2 consecutive blood samples obtained
1-4 weeks apart between 6 and 10 AM following an appropriate washout of current
androgen replacement therapy; with clinical symptoms of hypogonadism such as
diminished energy and sexual function; and/or a decreased sperm count (<20 million
sperm/mL semen).
5. Discontinued current testosterone replacement treatment and completed a washout of
4 weeks following androgen treatment (excluding Testopel TM). Washout must be
completed prior to collection of baseline serum testosterone samples to determine
study eligibility.
6. Judged to be in good general health as determined by the principal investigator
based upon the results of a medical history, physical examination, vital signs, and
laboratory profile.
Exclusion Criteria:
- 1. History of significant sensitivity or allergy to androgens, castor oil or product
excipients.
2. Clinically significant findings in the pre-study examinations including abnormal
breast examination requiring follow-up.
3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or I-PSS
score > 19 points.
4. Body mass index (BMI) ≥ 35 kg/m2.
5. History of vasectomy.
6. Clinically significant abnormal laboratory value, in the opinion of the
investigator, in serum chemistry, hematology, or urinalysis including but not limited
to:
1. Baseline hemoglobin > 16 g/dL
2. Hematocrit < 35% or > 50%
3. PSA > 4 ng/mL and age >40
7. History of seizures or convulsions, including febrile, alcohol or drug
withdrawal seizures.
8. History of any clinically significant illness, infection, or surgical
procedure within 4 weeks prior to study drug administration.
9. History of stroke or myocardial infarction within the past 5 years.
10. History of, or current or suspected, prostate or breast cancer.
11. History of diagnosed, severe, untreated, obstructive sleep apnea.
12. History of abuse of alcohol or any drug substance in the opinion of the
investigator within the previous 2 years.
13. History of nasal disorders such as nasal polyps; nasal septal perforation;
nasal surgery; nasal trauma resulting in nasal fracture within the previous 6
months or nasal fracture that caused a deviated anterior nasal septum; sinus
surgery or sinus disease
14. Donation or loss of 550 mL or more blood volume (including plasmapheresis) or
receipt of a transfusion of any blood product within 12 weeks prior to the start
of treatment.
15. Inadequate venous access for collection of serial blood samples required for
pharmacokinetic profiles.
16. Receipt of any investigational product within 4 weeks or within 5 half-lives
prior to the start of treatment.
17. Inability to understand and provide written informed consent for the study.
18. Considered by the investigator or the sponsor-designated physician, for any
reason, that the subject is an unsuitable candidate to receive Natesto.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years | The Effects of Natesto For Treatment Of Hypogonadism On Maintenance Of Spermatogensis. | NCT04717362 | Contradiction |
5,298 | 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:
- Postmenopausal (PMO) women between 45 and 89 years of age.
- Bone mineral density T score of -2.5 or less at femoral neck, total hip or lumbar
spine OR
- Bone mineral density T score of -2.0 or less at femoral neck, total hip or lumbar
spine with at least one documented osteoporotic vertebral fracture or a previously
documented history of an osteoporotic clinical non-vertebral fracture not due to
excessive trauma
Exclusion criteria:
- Any prior use of strontium
- Any past or active kidney disease or problems with kidney function
- Prior treatment with any intravenous (i.v.) or oral bisphosphonate (such as but not
limited to alendronate, risedronate and pamidronate) longer than 3 months
consecutively. If bisphosphonate exposure is less than or equal to 3 months , a
washout period of 1 year to randomization is required
- Calcium levels in blood within the normal range
- Normal liver function
- Non-osteoporotic forms of metabolic bone disease such as and not limited to Paget's
disease of bone, osteomalacia, osteogenesis imperfecta or multiple myeloma
- Less than 3 evaluable lumbar (L1-L4) vertebrae for dual energy x-ray absorptiometry
(DXA) measurement
- Treatment with osteoporotic therapies such as raloxifene, calcitonin or Hormone
Replacement Therapy within 3 months of randomization
- Allergy or previous exposure to teriparatide
Other protocol-defined inclusion/exclusion criteria may apply
Female
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 89 Years | Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis | NCT00439244 | Entailment |
2,742 | 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:
- informed consent
- age > 18 years
- inguinal hernia(primary, recurrence or bilateral)
- elective procedure
Exclusion Criteria:
- Scrotal hernia
- Prostatectomy, Pfannenstiehl-incision, pre-peritoneal surgery in history
- Participation in other trial
- Pregnancy
- Communicative or cognitive restrictions
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.
| LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein | NCT00788554 | Entailment |
756 | 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:
- 65 years old
- Diagnosed with knee osteoarthritis according to ACR diagnostic criteria
Exclusion Criteria:
Not having enough cooperation
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.
Subject must be at most 90 Years | Osteoarthritis, Balance, and Fear of Falling | NCT04660357 | Contradiction |
3,434 | 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:
- Signed informed consent.
- Subjects between 40 and 65 years old. Diagnosis of type 2 diabetes mellitus with more
than 5 years of evolution of disease.
- Metformin (alone or in combination with sulfonylurea and / or insulin and / or
thiazolidinediones) at a stable dose for at least the past 3 months.
- HbA1c ≥ 7,0 y ≤ 9,0 %.
- BMI between 30 and 40 kg / m2.
- No pulmonary disease (COPD, asthma, fibrosis, etc) known.
- Baseline FEV1 decline of equal or greater than 10% in the percentage of the
theoretical value.
- Chest radiography without significant changes in the lung parenchyma
Exclusion Criteria:
- Type 1 diabetes mellitus
- Treatment with inhibitors of dipeptidyl peptidase 4 glitazones and / or
- SGLT2 inhibitors.
- Active and former smokers for less than five years ago smoking.
- Chronic obstructive pulmonary disease.
- Respiratory sleep disorders that require treatment with continuous positive pressure
in the airway.
- Asthma treatment with bronchodilators.
- Previous bariatric surgery.
- Cardiovascular disease, heart failure and / or stroke.
- Pathology of the chest wall.
- Serum creatinine> 1.7 mg / dl.
- Abnormal results in liver function test (Alanine transaminase/ Aspartate
Aminotransferase greater than twice the upper limit of normal).
- History of acute or chronic pancreatitis.
- Personal or family history of medullary thyroid cancer or Multiple
- Endocrine Neoplasia (MEN ) type 2.
- Active neoplasms or neoplastic patients considered disease-free history from less than
5 years ago.
- Women of childbearing age who are pregnant (positive pregnancy test within 14 days
before the start of treatment) or intend to get pregnant.
- Lactating women.
- Women of childbearing potential not using adequate contraception (such as oral
contraceptives, intrauterine device or barrier method of birth control along with
spermicide or surgical sterilization) or unwilling to use during the study (as
required by local laws or practices).
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 65 Years | Study to Assess the Efficacy of Liraglutide in Patients With Type 2 Diabetes Mellitus | NCT02889510 | Entailment |
5,936 | 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 with grade N or M in the modified LA classification system confirmed by
endoscopy at initiation of the pre-observation period (VISIT 1).
2. Participants with repeated acid reflux symptoms (heartburn or regurgitation) for 2
days or more in one week in the 3 weeks before initiation of initiation of the
pre-observation period (VISIT 1).
3. Participants with severity* of moderate or higher for acid reflux symptoms (heartburn
or regurgitation) in the 3 weeks before initiation of the pre-observation period
(VISIT 1)
* Severity: No symptoms, very mild (symptoms present but often forgotten), mild (not
so painful), moderate (rather painful), severe (painful) and very severe (painful
enough to affect night time sleep or daily activities)
4. Outpatients (hospitalization for testing possible)
Exclusion Criteria:
1. Participants with an esophagus-related complication [Barrett's esophagus (3 cm or
more, LSBE), eosinophilic esophagitis, esophageal varices, scleroderma, viral or
fungal infections, esophageal stenosis, etc.], or a history of radiotherapy or
cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal
sclerotherapy, etc.). However, participants with Barrett's esophagus (less than 3 cm,
SSBE) or Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter)
are allowed to be included.
2. Participants who have received surgery or treatment affecting gastroesophageal reflux
(cardioplasty, dilation of esophageal stenosis [excluding Schatzki's ring], etc.), or
who have a history of surgery of stomach or duodenum (excluding removal of benign
polyp under endoscopy)
3. Participants who have acute upper gastrointestinal bleeding, gastric ulcers (mucosal
defects associated with white coating) or duodenal ulcers (mucosal defect with white
coating) within 30 days before initiation of the pre-observation period (VISIT 1)
However, participants with gastric or duodenal erosions are allowed to be included.
4. Participants with acute gastritis or acute exacerbation of chronic gastritis as a
complication
5. Participants with a previous or current history of the Zollinger-Ellison syndrome or
other gastric acid hypersecretion disorders
6. Participants with a history of chest pain due to heart disease or with chest pains
suspected of being caused by heart disease within one year before initiation of the
pre-observation period (VISIT 1)
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.
| Efficacy of TAK-438 Compared to Placebo in the Treatment of Non-Erosive Gastroesophageal Reflux Disease | NCT01474369 | Contradiction |
6,268 | 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:
- Diagnosis of Covid-19 test positive; hospitalized subjects; both sexes; given informed
consent.
Exclusion Criteria:
- no exclusion criteriae
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Functional Exhaustion of T Cells in COVID19 Patients | NCT04470323 | Contradiction |
6,835 | 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 diagnosed with hemophilia A and B.
- With or without joint involvement clinically diagnosed, and with or without a previous
history of hemarthrosis joint load legs.
- In prophylactic regimen with FVIII / FIX concentrates .
- Residents in the Autonomous Community of the Region of Murcia.
Exclusion Criteria:
- Patients without walking ability.
- Patients diagnosed with other congenital coagulopathy (von Willebrand disease, etc..).
- Patients with neurological or cognitive impairments that prevent understanding the
questionnaires and physical tests.
- Patients whose parents or guardians have not signed the informed consent document.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Bilateral Deficit Phenomenon in Patients With Haemophilic Arthropathy | NCT02165462 | Entailment |
3,165 | 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 male or female of any race, at least 18 years of age
- Have provided written informed consent
- Have a reported history of dry eye syndrome
- Have a history of use or desire to use eye drops for dry eye
Exclusion Criteria:
- Have any clinically significant eye findings that require therapeutic treatment or may
interfere with study parameters
- Have previously had LASIK surgery within the last 12 months
- Have used Restasis® within 30 days of Visit 1
- Be a woman who is pregnant, nursing or planning a pregnancy
- Be unwilling to submit a urine pregnancy test if of childbearing potential
- Have a known allergy and/or sensitivity to the test article or its components,
including the preservative benzalkonium chloride
- Be currently enrolled in an investigational drug or device study or have used an
investigational drug or device within 30 days of Visit 1
- 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.
| A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome (DES) | NCT02121301 | Contradiction |
6,692 | 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:
- Young Healthy Volunteers
- Participant is willing and able to give informed consent for participation in the
study.
- Male or Female, aged between 18 and 40 years old.
- Older Healthy Volunteers
- Participant is willing and able to give informed consent for participation in the
study.
- Male or Female, aged 70 years or above.
- Patients
- Participant is willing and able to give informed consent for participation in the
study.
- Male or Female, aged 18-70 years old.
- Participant has one of the following conditions:
- Atrial fibrillation
- A permanent pacemaker that is continuously active
- Reduced chest wall movement
Exclusion Criteria:
- Young Healthy Volunteers
- Any condition which might increase the risk of exercise testing
- Any history of ischaemic heart disease
- Any history of heart failure
- Any structural heart disease (eg: valvular lesions, hypertrophic obstructive
cardiomyopathy)
- Any abnormalities on a resting ECG
- Deep vein thrombosis diagnosed within the last 6 months or under active treatment
- Uncontrolled hypertension (systolic blood pressure >220 mm Hg, diastolic >120 mm
Hg)
- Aortic aneurysm
- Aortic or cardiovascular surgery within 6 months of recruitment
- A family history of sudden cardiac death, congenital arrhythmia syndromes or
cardiomyopathy
- Autonomic dysfunction, either previously diagnosed or upon testing by the
research team
- Any condition involving the brain or spinal cord
- Diabetes
- Alcohol consumption > 21 units/week for women and 28 units/week for men or a
history of previous alcohol dependence.
- Acute kidney injury
- Chronic kidney disease stage 4 or 5
- Any condition causing hepatic dysfunction
- Presence of a permanent pacemaker (these participants would be eligible for the
pacemaker group)
- Reduced chest wall movement (these participants would be eligible for the reduced
chest movement group)
- Any acute infection requiring antibiotic treatment within 3 months of recruitment
- Any other surgery or illness requiring hospitalisation within 3 months of
recruitment
- Currently taking any medication with the exception of analgesics or the oral
contraceptive pill.
- Any wound or skin condition affecting the torso which may be affected by the
application of adhesive ECG dots to the skin
- Pregnancy
- Inability to give informed consent
- Older Healthy Volunteers
- Any diagnosed condition primarily affecting the cardiovascular or respiratory
systems
- Symptomatic autonomic dysfunction
- Orthostatic hypotension
- Any condition involving the brain or spinal cord
- Diabetes
- Alcohol consumption > 21 units/week for women and 28 units/week for men or a
history of previous alcohol dependence.
- Acute kidney injury
- Chronic kidney disease stage 4 or 5
- Any condition causing hepatic dysfunction
- Presence of a permanent pacemaker
- Chronic Obstructive Pulmonary Disease (COPD).
- Any muscular dystrophy
- Kyphosis
- Scoliosis
- Pectus excavatum
- Any disease involving the lungs or pleura
- Any acute infection requiring antibiotic treatment within 3 months of recruitment
- Any other surgery or illness requiring hospitalisation within 3 months of
recruitment
- Currently taking any medication with the exception of analgesics or the oral
contraceptive pill.
- Any wound or skin condition affecting the torso which may be affected by the
application of adhesive ECG dots to the skin
- Pregnancy
- Inability to give informed consent
- Patients
- Any infection which would require isolation or barrier nursing according to the
hospital's infection control policy
- Any wound or skin condition affecting the torso which may be affected by the
application of adhesive ECG dots to the skin
- Requirement for any form of artificial ventilatory support, including oxygen
therapy
- More than one of the inclusion criteria. (ie: a patient may not have both atrial
fibrillation and reduced chest wall movement and be eligible for this study)
- Inability to give informed consent
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Months old.
| Validation of Respiration Rate Algorithms | NCT01472133 | Contradiction |
6,188 | 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:
- Confirmed COVID-19
Exclusion Criteria:
- N/A
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 Clinical Trial for Hospitalized Patients With COVID-19 in Ceará: ResCOVID Study | NCT04649827 | Contradiction |
1,203 | 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. | Inclusion Criteria:
- The participant is willing and able to give informed consent for participation in the
study.
- Adult male or female, aged 18 years or above.
- Diagnosed with a symptomatic pleural effusion requiring either diagnostic and/or
therapeutic pleural aspiration or drainage.
- Expectation by the clinician responsible for assessing the patient that more than
500mL of pleural fluid will be drained on this particular occasion.
Exclusion Criteria:
- Age less than 18 years
- Inability to provide informed consent
- Evidence of significant septation or loculation within the pleural effusion as
determined by the clinician responsible for assessing the patient.
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.
| Using Ultrasound to Predict the Results of Draining Pleural Effusions | NCT01973985 | Entailment |
6,408 | 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:
1. Adults 18 years of age or older;
2. Diagnosis of SARS-CoV-2 infection confirmed by RT-PCR or antigen test no more than 5
days ago;
3. Onset of clinical signs and symptoms of COVID-19 no more than 5 days manifested as:
1. Presenting sudden onset of anosmia and/or ageusia without any other reasonable
explanation and/or;
2. Thoracic image by radiography, tomography or ultrasonography compatible with
acute clinical symptoms findings of COVID-19 and/or;
3. Acute onset of cough accompanied by fever and/or
4. Acute onset of three or more of the following symptoms: fever, cough, fatigue or
general weakness, headache, myalgia, sore throat, runny nose, dyspnea, anorexia
or nausea or vomit, diarrhea and mental status change.
4. Oxygen saturation by pulse oximetry ≥92%
5. Agree to periodic contacts by phone, electronic means and home visits;
6. Demonstrate intention to participate in the study, documented by Informed Consent Form
signature on the part of the participant.
For the very high risk group:
7. Being on continuous drug immunosuppressant more than two weeks due to a basic medical
condition (e.g. transplant or cancer);
For the high risk group:
8. To present at least two risk factors for developing serious COVID-19 (Over 60 years of
age; diabetes mellitus; chronic obstructive pulmonary disease; kidney disease;
cardiovascular diseases and body mass index ≥ 35).
Exclusion Criteria:
1. Presenting COVID-9 in need of oxygen therapy on the moment of study inclusion, in
other words, score 5 or higher in WHO COVID-19 progression scale;
2. Behavioral, cognitive or psychiatric disease that, in principal investigator opinion
or his/her medical representative, affect the participant capacity in understanding
and collaborating with study protocol requirements;
3. Any use considered alcohol or drugs abuse in the last 12 months prior to study
inclusion that caused medical, professional or family problems, as indicated by
clinical history;
4. Severe allergic reaction history or anaphylaxis to heterologous serum or product
components of the study;
5. To have received heterologous serum or convalescent plasma in the last three months
before of study inclusion, or planned administration of hemoderivatives or
immunoglobulin on the next 28 days of study inclusion;
6. The participant is a team member who is conducting the study or is in a dependent
relationship with one of the study team members. Dependency relationships include
close relatives (in other words, sons, partner/spouse, brothers, parents), as well as
Researcher staff or staff from the location conducting the study;
7. Any other condition that, in the principal investigator opinion or his/her medical
representative, could threaten the safety or rights of a potential participant or
which prevents him from fulfilling with this protocol.
For female:
8. Pregnancy (confirmed by positive β-hCG test), breastfeeding and/or expressing an
intention to have sexual practices with reproductive potential without using a
contraceptive method within four weeks of the product administration;
For stages A and B:
9. Previous immunization with vaccine against COVID-19
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Clinical Trial for Assessment of Anti-SARS-CoV-2 Serum for Early Treatment of COVID-19 Cases | NCT04834089 | Entailment |
152 | 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:
1. Male aged 18 to 65 years, inclusive, at the time of providing informed consent to
participate in the study.
2. Hypogonadism defined as having 2 consecutive serum total T levels≤ 281 ng/dL based on
a blood sample, drawn at least 3 days apart, between 7 a.m. and 10 a.m.
3. At least 1 clinical feature consistent with male hypogonadism. If a subject is
receiving commercial TRT prior to Screening Visit 1, he must have a history of at
least 1 clinical feature consistent with male hypogonadism.
4. Must be naïve to androgen replacement therapy or washed out adequately of prior
androgen replacement therapies; willing to cease current T treatment; or currently not
taking any T treatment. Subjects must remain off all forms of T, except for dispensed
study drug, throughout the entire study.
5. No unstable ongoing concomitant medical conditions. Treated and well-controlled
conditions such as type 2 diabetes, hypertension, or dyslipidemia are acceptable with
stable medication in place for at least 3 months prior to study entry:
1. Hemoglobin A1c ≤ 8.0%
2. BP < 150/90 mm Hg
3. Low-density lipoprotein cholesterol < 190 mg/dL.
6. Subjects with an endocrine disorder requiring treatment other than hypogonadism must
be on a stable dose of replacement medication for at least 3 months prior to study
entry.
7. Adequate venous access to allow collection of a number of blood samples via a venous
cannula.
8. Written informed consent to participate in the study and ability to comply with all
study requirements.
Exclusion Criteria:
1. Serum PSA > 2.5 ng/ml and/or abnormal prostate gland on palpation, eg, palpable nodes,
at Screening Visit 2.
2. Received oral, topical, intranasal, or buccal T therapy within the previous 2 weeks,
intramuscular T injection of short-acting duration within the previous 4 weeks,
intramuscular T injection of long-acting duration within the previous 20 weeks, or T
implantable pellets within the previous 6 months.
3. Use of any drug that could interfere with measurement or assessment of serum androgen
levels, including 5 alpha-reductase inhibitors, anabolic steroids, and drugs with
antiandrogenic properties (eg, spironolactone, cimetidine, flutamide, bicalutamide,
and ketoconazole). These drugs must be stopped for at least 1 month prior to study
entry (6 months in the case of dutasteride). Patients taking potent, long-acting
opiate therapy on a daily basis are not eligible for the study. Conversely, ad hoc use
of potent, short-acting opiates for a period of less than 7 days may be permitted
after discussion with the Marius Pharmaceuticals medical monitor.
4. Use of over-the-counter products, including natural health products (eg, food
supplements and herbal supplements such as saw palmetto or phytoestrogens) that may
affect total T levels, within 7 days prior to study entry.
5. History of drug or alcohol abuse within the past 2 years that in the opinion of the
investigator could interfere with study participation and/or influence study efficacy
and safety endpoints assessments.
6. Unstable or chronic disease that could interfere with participation in the study or
patient safety, including psychiatric disorders.
7. Myocardial infarction, coronary artery surgery, heart failure, stroke, unstable
angina, or other unstable cardiovascular disease within the past 6 months.
8. Abnormal ECG considered clinically significant by investigator at Screening.
9. Diagnosis of any cancer within the previous 5 years other than basal or squamous cell
skin cancer with clear margins.
10. Any surgical or medical condition that might alter administration of the study drug or
comparator, including history of gastric surgery, cholecystectomy, vagotomy, bowel
resection, or any surgical procedure that might interfere with gastrointestinal
motility, pH, or absorption of TU.
11. Duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months
prior to screening.
12. Chronic skin conditions on the chest or upper arms that would prevent administration
of AndroGel in a manner designed to ensure reliable and consistent absorption thereof.
13. Human immunodeficiency virus (HIV) infection.
14. Chronic hepatitis B virus and/or hepatitis C virus (HCV) infection (as determined by
positive testing for hepatitis B virus surface antigen or HCV antibody with
confirmatory testing, ie, detectable serum HCV ribonucleic acid [RNA]).
15. Clinically significant abnormal laboratory values at screening including but not
limited to:
1. Elevated liver enzymes (aspartate aminotransferase [AST], alanine
aminotransferase [ALT] > 2x upper limit of normal)
2. Estimated glomerular filtration rate < 60 ml/min/1.73m2 as calculated by the
Modification of Diet in Renal Disease formula
3. Hemoglobin < 11.0 g/dL or > 16.0 g/dL. For a subject previously on testosterone
replacement therapy with less than 30 days washout prior to screening Visit 2,
hemoglobin < 11.0 g/dL or > 17.0 g/dL.
16. Severe and untreated obstructive sleep apnea syndrome.
17. Severe lower urinary tract symptoms (American Urological Association/ IPSS ≥ 19).
18. History of any clinically significant illness, infection, or surgical procedure within
1 month prior to study entry.
19. Past, current, or suspected prostate or breast cancer.
20. History of long QT syndrome or unexplained sudden death in a first-degree relative
(parent, sibling, or child).
21. Concurrent treatment with medications that may impact the absorption, distribution,
metabolism, or excretion of TU or place the subject at risk for treatment with T.
22. Subject has a partner who is currently pregnant or planning pregnancy during the
course of the study.
23. Treatment with any other investigational drug within 30 days of study entry or > 5
half-lives (whichever is longer) and at any time during the study.
24. History of noncompliance to medical regimens or potential unreliability in the opinion
of the investigator.
25. Unwilling or unable to comply to the dietary requirements for this study.
26. History of polycythemia, either idiopathic or associated with TRT.
27. Donated blood (≥ 500 mL) within the 12-week period prior to study entry.
28. History of an abnormal bleeding tendency or thrombophlebitis within the previous 2
years that is not linked to venipuncture or intravenous cannulation.
29. Onset of gynecomastia within the previous 6 months.
30. For adrenocorticotropic hormone (ACTH) stimulation substudy only: Primary or secondary
adrenal insufficiency.
31. For Bioanalytical Sample Stability Substudy only: subjects with a hemoglobin less than
13 g/dL at most recent assessment* [should be excluded].
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men | NCT03198728 | Entailment |
6,726 | 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 who are able to sign informed consent.
- Patients undergoing standard cardiac stress tests who are able to sign informed
consent.
- Patients with pulmonary disease who are being monitored in a routine manner who are
will ing to sign informed consent.
Exclusion Criteria:
- Children
- Patients unable or unwilling to give consent
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 | Ambulatory Measurements of Physiological Parameters | NCT01267513 | Contradiction |
3,223 | 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:
- Patients with SGSp according to revised American-European criteria
- Patients 18 years of age or older
- Patients affiliated to the French social security care system.
Exclusion Criteria:
- Patients under measure of maintenance of justice.
- Patients unable to understand or to participate to the study.
- Child and major patients making the object of a measure of lawful protection.
- Patients deprived of freedom.
- Concomitant interventional clinical 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.
| Evaluation of the Prevalence of Functional Digestive Disorders During Primary Sjögren Gougerot Syndrome | NCT03157011 | Entailment |
6,484 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
1. Healthy, male and non-pregnant female subjects, 18 years of age or older.
2. A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at
Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.
3. Subjects with the presence of telangiectasia at Baseline.
4. Subjects with an erythema score of at least 2 on the Investigator Assessment of
Erythema scale at Baseline.
5. Subjects with severe rosacea on the Investigators Global Assessment scale at Baseline.
Exclusion Criteria:
1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
2. Subjects with nodular rosacea.
3. Standard exclusion criteria.
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 Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle | NCT02576860 | Entailment |
5,201 | 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:
- Presents with severe osteoporosis based on the disease diagnostic criteria and upon
physician assessment
- Postmenopausal, nonpregnant, women older than 50 years of age, with previous fracture
history such as hip, spine, wrist, ribs, clavicle, humerus, tibia, and fibula or men
over 50 years of age with low impact fractures (fragility).
- Outpatients without concomitant diseases and with life expectancy of at least 3 years,
according to the medical criteria.
- Cannot be on medicines that can disturb bone metabolism.
- Patients should be capable of self-injection, to learn the use of Pen device and are
in agreement with its use.
Exclusion Criteria:
- Directly affiliated with the conduct of this study, or are the immediate family of
someone directly affiliated with the conduct of this study (that is, Lilly employees,
investigators, site personnel, or their immediate families). Immediate family is
defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- Received treatment within the last 30 days with a drug (not including study drug) that
has not received regulatory approval for any indication at the time of study entry.
- Previously completed or withdrawn from this study or any other study investigating
Teriparatide.
- Secondary osteoporosis or any disease that affects the bone metabolism, as renal
osteodystrophy, osteomalacia, hypoparathyroidism, and hyperparathyroidism, and
intestinal malabsorption.
- Cancer history in the 5 years prior to visit 1, with exemption of basocellular
carcinoma treated and cervix carcinoma definitively treated at least 1 year before to
visit 1
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.
| Bone Marker Changes With Teriparatide/Postmenopausal Osteoporosis | NCT00532545 | Entailment |
2,653 | 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:
- Male <60yrs with primary inguinal hernia
Exclusion Criteria:
- Recurrent hernia
- Bilateral hernia
- Non-reducible/obstructed hernia
- Previous lower abdominal surgery/radiotherapy
Male
No healthy subjects accepted to join the trial.
Subject must be at least 15 Years old.
Subject must be at most 60 Years | Laparoscopic vs Open Hernia Mesh Repair for Inguinal Hernia | NCT00311935 | Entailment |
4,987 | 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:
- Must be certified by a neurologist as having essential tremor or Parkinsonian tremor
that is insufficiently controlled by medication alone.
- Preference to receive radiation treatment for tremor treatment, rather than surgical
DBS implantation or surgical thalamotomy
- At least 18 years old
Exclusion Criteria:
- Contraindications to cranial radiation (such as prior radiation to the thalamus)
- Inability to have a MRI of the brain
- Prior surgical thalamotomy treatment (but contralateral deep brain stimulator [DBS] is
permitted)
- Estimated life expectancy less than 1 year
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.
| Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor | NCT01734122 | Entailment |
1,814 | 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:
- Age greater than or equal 18 years.
- Histologic or cytologic diagnosis of adenocarcinoma of stomach or gastric cardia
(Siewert Classification Type III)
- Preoperative Stage T3-4NxM0 by endoscopic ultrasound, CT of the abdomen/pelvis and
laparoscopy. (CT of the chest if it is a cardia lesion).
- Absence of malignant cells in peritoneal lavage fluid during laparoscopic examination.
- Patients must not have received any prior chemotherapy or hormonal therapy for the
treatment of gastric cancer.
- Karnofsky performance status of 70 or higher.
- Estimated life expectancy of at least 12 weeks.
- Adequate organ function including the following:
- Bone marrow:
- White blood cells (WBC) greater than or equal 3.5 x 109/L
- Absolute neutrophil (segmented and bands) count (ANC) greater than or equal 1.5 x
109/L
- Platelets greater than or equal 100 x 109/L
- Haemoglobin greater than or equal 9g/dL
- Hepatic:
- Bilirubin within upper limit of normal (ULN),
- ALT or AST less than or equal 2.5x ULN
- Alkaline phosphatase less than or equal 2.5x ULN.
- Renal:
- creatinine less than or equal 1.5x ULN
- Signed informed consent by patient or legal representative.
- Patients with reproductive potential must use an approved contraceptive method if
appropriate (eg, intrauterine device, birth control pills, or barrier device) during
and for three months after the study. Females with childbearing potential must have a
negative serum pregnancy test within 7 days prior to study enrollment.
Exclusion Criteria:
- Prior treatment for locally advanced or metastatic gastric cancer. Any metastatic
disease will render patient ineligible according to American Joint Committee on Cancer
(AJCC) staging manual. (See appendix 11.4).
- Treatment within the last 30 days with any investigational drug.
- Concurrent administration of any other cancer therapy, including cytotoxic
chemotherapy, hormonal therapy, and immunotherapy.
- Active infection that in the opinion of the investigator would compromise the
patient's ability to tolerate therapy.
- Pregnancy.
- Breast-feeding.
- Serious concomitant disorders that would compromise the safety of the patient or
compromise the patient's ability to complete the study, at the discretion of the
investigator.
- Poorly controlled diabetes mellitus with fasting blood sugar > 18 mmol/L(mM).
- Second primary malignancy that is clinically detectable at the time of consideration
for study enrollment.
- History of significant neurological or mental disorder, including seizures or
dementia.
- History of hypersensitivity to drugs formulated in Tween 80, the vehicle used for
commercial docetaxel formulations.
- History of hypersensitivity to 5-fluorouracil
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.
| Neo-adjuvant Chemotherapy in Locally Advanced Gastric Cancer | NCT00414271 | Entailment |
4,380 | 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:
- Patients attending routine genetic clinic/paediatric clinic appointments for diagnosis of
a multiple anomaly syndrome where distinctive facial features form part of their presenting
pattern.
OR:
- Biochemically or genetically confirmed diagnosis of inborn disorder of metabolism where
no well described dysmorphic facial features are known to be associated with disorder
Exclusion Criteria:
- Patients under 8 months of age where face-recognition technology has not been shown to
be effective.
- Patients who decline clinical photography as part of standard care.
- Patients who do not wish to consent to participation in the study even though they
consent to photos being taken for standard care.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 8 Months old.
| Evaluating Face-Recognition Technology in Syndrome Diagnosis | NCT04709965 | Entailment |
2,473 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
newly diagnosed sarcoidosis defined by presence of all of the following criteria:
1. Presence with clinical features of pulmonary (dyspnea, dry cough, chest pain, fever,
fatigue or crackles) or extra pulmonary organ (lymph nodes, liver, spleen, skin, eyes,
heart, etc.) involvement and consistent radiological involvement and
2. Compact non-caseating granulomas on trans-bronchial biopsy which are tissue AFB
smear-negative
Exclusion Criteria:
Patients who have received glucocorticoid treatment before initial evaluation by us, or
with presence of concomitant other cardio pulmonary disease will be excluded.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 15 Years old.
Subject must be at most 75 Years | Efficacy of Antituberculous Therapy in Management of Sarcoidosis | NCT01245036 | Entailment |
604 | 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:The inclusion criterion was the presence at transvaginal ultrasound of
an extraovarian adnexal mass in women with a suspected ectopic pregnancy (amenorrhea,
bleeding and pain) with positive test for beta-hCG.
-
Exclusion Criteria:The exclusion criterion was non-tubal ectopic pregnancy (cervical,
cesarean scar, ovarian, and abdominal).
-
Female
Subject must be at least 15 Years old.
Subject must be at most 40 Years | Are Serum Levels of Vascular Endothelial Growth Factor a Marker for the Early Diagnosis of Ectopic Pregnancy? | NCT01261026 | Entailment |
1,572 | 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. Voluntary, written, informed consent to participate in the study
2. Agreement to comply with the protocol and study restrictions
3. Healthy females and males of age 25 to 60 years (inclusive)
4. Self-declared, suspected or medically diagnosed lactose intolerance
5. Increase of more than 20 ppm in breath hydrogen within 3 h from the baseline fasting
breath hydrogen value
6. Participants who agree to maintain their usual dietary habits throughout the trial
period
7. Participants who agree not to consume probiotics, prebiotics, fermented milk, and/or
yogurt containing probiotics during the intervention period (Visits 3-5) and two weeks
before Visit 3 (2 weeks after screening visit)
8. Females of child-bearing potential who agree to use a medically approved method of
birth control
9. Ability of the participant (in the investigator's opinion) to comprehend the full
nature and purpose of the study including possible risks and side effects
10. Covered by Health Insurance System and / or in compliance with the recommendations of
National Law in force relating to biomedical research
Exclusion Criteria:
1. Gastrointestinal disorder or disease (e.g. Crohn's disease, ulcer, irritable bowel
syndrome (IBS), Celiac disease, small intestinal bacterial overgrowth (SIBO),
pancreatitis and disorders affecting gastrointestinal motility)
2. Diagnosed type 1 or type 2 diabetes
3. Prior abdominal surgery that, in the opinion of the investigator, may present a risk
for the participant or affect study results
4. Ongoing or recent (last 1 month) antibiotic treatment.
5. Use of laxatives or drugs known to affect gut motility 1 month preceding the screening
visit and during the study
6. Ongoing or recurrent use of proton pump inhibitors
7. Colonoscopy within 3 months before screening
8. History of recurrent colon cleansing and/or a colon cleansing within 3 months before
screening
9. Gastrointestinal infection within 1 month before screening or during the trial
10. Clinically significant underlying systemic illness that may preclude the participant's
ability to complete the trial or that may affect the study outcomes (e.g. bowel
cancer, prostate cancer, terminal illness)
11. History of diagnosed coronary heart disease/cardiovascular disease or artificial heart
valve
12. Any obstructive or restrictive respiratory syndrome/disease that may impact breath
test (e.g. asthma or chronic obstructive pulmonary disease (COPD))
13. Regular use of tobacco, snuff, nicotine and e-cigarette, and possible other inhaled
products. Light smokers (less than 5 cigarettes per day) who agree not to smoke during
the whole duration of the study may be included.
14. Self-declared history of alcohol abuse (for females: >3 drinks on any single day and
>7 drinks per week; for males: >4 drinks on any single day and >14 drinks per week)
15. Self-declared use of illicit drugs within 4 weeks preceding the screening visit
16. Pregnant or lactating female, or pregnancy planned during study period
17. Participants under administrative or legal supervision.
18. Participation in another study with any investigational product within 60 days of
screening
19. Clinically significant abnormal values in safety blood tests at screening
20. Other reasons that, in the opinion of the Investigator, make the participant
unsuitable for enrolment
21. Who would receive more than 4500€ as indemnities for his participation in biomedical
research within the last 12 months, including the indemnities for the present study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 25 Years old.
Subject must be at most 65 Years | Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Lactose Solution | NCT03814668 | Contradiction |
2,484 | 17 | A 67-year-old man comes to the clinic with slowly worsening vision in both eyes. He is not able to drive at night, as the symptoms are worse at night. His pupils are normal in diameter both in the light and darkness. Other medical history is unremarkable. Ocular examination shows loss of the red reflex and blurry vision. Acuity testing shows 50/100 vision in both eyes with normal visual field testing. His blood pressure is 130/70 and pulse is 68/min. the other physical examinations are normal. | I am a 67 years-old man, and I haven't been able to drive at night due to my vision getting worse. My vision is not the best in general, but night makes it even worse. The ophthalmologist told me that my pupils were normal. However, I have slow reflexes and blurry vision. My acuity test came back with 50/100 vision in both of my eyes. They also took my blood pressure, which was 130/70 with a 68 pulse. My other exams came back just fine. | Inclusion Criteria:
- Age 40 years or older at enrollment
- Presenting visual acuity better than 20/100 in both eyes
- Spherical equivalent refractive error within the range of 4.0 and -6.0 diopters in
both eyes
Exclusion Criteria:
- Ocular surgery in either eye within 3 months
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
| The Detection of Glaucoma Using Pupillography | NCT01462526 | Entailment |
5,372 | 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:
- Complaint of HMB, including women with fibroids
- Pre-menopausal
- Age 18 years and over
- Describing menstrual cycles every 21- 42 days
- Provide written informed consent prior to any study related procedures
- If of childbearing potential either agree to practice a non-hormonal method of
contraception for duration of study or have a partner with a vasectomy
- Workup (Study 1 or 2)- MBL for single screening period is >= 50mL
- Adaptive Trial (Study 3)- average MBL for two screening menstrual collections is >=
50mL
Exclusion Criteria:
- Currently breast-feeding
- History or current uterus, cervix, ovarian or breast cancer
- Known severe coagulation disorder
- Glucocorticoid treatment or sex steroid administration by any route in previous 1
month
- Taking prohibited medication -
- Thyroid, renal or liver dysfunction
- Diabetes mellitus
- Treated moderate/severe hypertension
- Psychotic depressive illness
- Rare hereditary galactose intolerance, lactase deficiency or glucose galactose
malabsorption (due to lactose content of trial medication)
- Has a problem with alcohol or drug abuse
- Has a mental condition rendering her unable to understand the nature and scope of the
study
- Participation in treatment phase in any earlier DexFEM study (1 or 2)
- Is currently enrolled in an investigational drug or device study or participated in
such a study within the previous 30 days and is still in exclusion period
- workup study 1, only, an additional exclusion criterion of any contra-indication to
MRI
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Dexamethasone for Excessive Menstruation | NCT01769820 | Contradiction |
5,758 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
- Healthy
- Speaks and understands English or Danish
- 18-60 years
Exclusion Criteria:
- Pregnancy or lactation
- Drug addiction
- Previous or current dermatological, neurological, musculoskeletal or mental illnesses
- Lack of ability to cooperate
- Current use of medications that may affect the 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 | Desensitization of Nociceptive Afferents by Application of Topical Capsaicin, Trans-cinnamaldehyde and L-menthol | NCT03132142 | Contradiction |
494 | 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:
- AMH (Anti-Müllerian hormone) > 6.28 pmol/L (Roche Elecsys assay)
- Female age 18 years to less than 40 years
- 1, 2 or 3 IVF/ICSI cycle with oocyte aspiration
- Regular menstrual cycle between 24 and 35 days
- BMI between 18 and 35
- Two ovaries
- Can and will sign informed consent
Exclusion Criteria:
- Women who do not fulfil the inclusion criteria
- Endometriosis stage III to IV
- Ovarian cysts with diameter > 30 mm at day of start of stimulation
- Submucosal fibroids
- Women with severe co-morbidity (IDDM, NIDDM, gastrointestinal, cardiovascular,
pulmonary, liver or kidney disease)
- Dysregulation of thyroid disease
- Not danish or English speaking women
- Contraindications or allergies to use of Gonadotrophins or GnRH antagonists
- TESA (testicular sperm aspiration)
- OD (oocyte donation)
- Previous inclusion in the study
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 39 Years | Study Comparing Outcomes Between Conventional IVF and a "Freeze-all"-Strategy in Assisted Reproductive Technology | NCT02746562 | Contradiction |
2,758 | 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:
Clinical diagnosis of symptomatic inguinal hernia Age 18-80
Exclusion Criteria:
Large scrotal hernia Bilateral hernia Symptom-free hernia Inguinal pain without clinical
evidence of hernia Asa class≥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.
Subject must be at most 80 Years | Postoperative Pain After Extraperitoneal Endoscopic Technique (TEP) vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair | NCT03566433 | Entailment |
2,206 | 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:
- 3 or more gout flares within last year
- Contraindication, intolerance or lack of efficacy for NSAIDs and/or colchicine
- Body mass index of less than or equal to 45 kg/m2
Exclusion criteria:
- Use of the following therapies (within varying protocol defined timeframes):
corticosteroids, narcotics, topical ice/cold packs, chronic opiate treatment, NSAIDs
(such as aspirin), colchicine.
- Hemodialysis
- Live vaccine within 3 months before first dose
- Donation or loss of 400 mL or more within 3 months before first dose
- Gout brought on by other factors such as chemotherapy, lead, transplant, etc.
- Presence of other acute inflammatory arthritis such as Rheumatoid Arthritis
- Any conditions or significant medical problems that puts the patient at an
unacceptable immunological risk to receive this type of therapy such as HIV,
Hepatitis, Tuberculosis and other infections/conditions
- Significant cardiovascular conditions such as uncontrolled hypertension
- Significant medical diseases such as uncontrolled diabetes, thyroid disease
- History of malignancy of any organ system within the past 5 years
- Women who are pregnant or nursing
- 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.
Subject must be at most 85 Years | Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients | NCT01356602 | Contradiction |
1,115 | 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:
- Patients aged 9-21 years
- Referred to the neurology POTS and Syncope clinic at Nationwide Children's Hospital
for clinical tilt table testing
- Has prior diagnosis or signs/symptoms of POTS (with or without syncope) or syncope
(without POTS)
Exclusion Criteria:
- Cognitive, somatic or psychiatric illness that precludes tilt table testing, prolonged
standing, or EEG lead placement
- Known seizure disorder
- Scalp or skull defect that could affect EEG amplitudes
- Pregnancy
- Non-English speaking
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 9 Years old.
Subject must be at most 21 Years | EEG Characteristics in Youth POTS and/or Syncope | NCT02167412 | Entailment |
279 | 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:
- Unexplained infertility ( 1ry & 2ndry infertility) : *
- Normal hormonal profile of infertile woman.
- Normal hystrosalpingogram.
- Normal laparoscopy.
- Normal investigation of the cervical factor
- Fertile semen analysis (according to world health organization criteria 2015).
Exclusion Criteria:
- • Infertile semen analysis.
- Abnormal HSG.
- Abnormal laparoscopic findings.
- Disturbed hormonal profile.
- Evidence of cervical factor.
- Known genetic disorder
- Known autoimmune disease
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 36 Years | Effect of Endometrial Injury in Couples With Unexplained Infertility | NCT03398993 | Contradiction |
233 | 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:
- Female with age between 18-40 years.
- Regular menstrual cycles
- Female diagnosed by ultrasound with unilateral ovarian endometrioma ≥4cm and ≤6cm.
Exclusion Criteria:
- Hormone, Gonadotropin-releasing hormone analogues or contraceptive therapy within 6
months before the current surgery and 6 months after surgery.
- Suspected or proven ovarian malignancy.
- Previous ovarian surgery.
- Evidence of polycystic ovary syndrome.
- Evidence of premature ovarian failure or premature menopause.
- Endocrinological diseases affecting ovarian reserve e.g. Diabetes mellitus,
hypothyroidism.
- Pregnancy test is positive.
- Lactation.
- Unable or unwilling to give written consent.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Assessment of Ovarian Reserve After Laparoscopic Cystectomy Versus Aspiration/Electrocoagulation in the Treatment of Ovarian Endometrioma | NCT04151173 | Contradiction |
5,590 | 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:
- Young girls with turner syndrome proved by karyotype
- Growth hormone secretion confirmed with ornithin stimulation test
- Normal glucidic metabolism confirmed by assessment of HbA1c
- None associated severe pathology which could have impact on growth (i.e. renal
insufficiency, decompensated heart failure)
- No previous or associated treatment with anabolic or sexual steroids
- Known parental height
Exclusion Criteria:
- Severe associated pathology with impact on growth
- Concomitant treatment with impact on growth
- Previous or associated treatment with anabolic steroids
- Associated growth hormone deficiency
Female
No healthy subjects accepted to join the trial.
Subject must be at most 4 Years | Growth Hormone Treatment for the Prevention of Short Stature in Young Girls With Turner Syndrome Before the Age of 4 Years | NCT01066052 | Contradiction |
3,847 | 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:
- Age: greater than 18 years
- Weight: less than 300 lbs.
- Diagnosis: osteoarthritis
- Type of Surgery: unilateral knee replacement
Exclusion Criteria:
- No pacemaker or defibrillator.
- No infection of the affected knee.
- No previous open surgery of the affected knee.
- No history of Rheumatoid Arthritis.
- No more than 2 narcotic pills per month in the last 6 months for 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.
| Use of Pulsed Electromagnetic Fields for Postoperative Knee Pain | NCT01415856 | Entailment |
6,767 | 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 ≥18 years of age
- Severe or moderately severe hemophilia A (FVIII activity ≤ 2 IU/dL) as evidenced by
- medical history
- Received FVIII prophylactic or on-demand replacement therapy for ≥ 150 accumulated
- days (exposure days)
- ≥12 bleeding episodes if receiving on-demand therapy over the preceding 12 months
- BMI ≤ 30
- Agree to use double-barrier contraceptive until at least 3 consecutive semen samples
are negative after ASC-618 infusion
Exclusion Criteria:
- Pre-existing immunity to AAV8 vector as defined by AAV8 total antibodies and
neutralizing antibodies qualified tests.
- Current inhibitors, or history of high titer FVIII inhibitors
- Presence of > Grade 2 liver fibrosis on elastography/Fibroscan or comparable imaging
methodology
- History of chronic renal disease
- Active infection or any immunosuppressive disorder
- History of cardiac surgery and need anticoagulant therapy
- Any cardiovascular / genetic risk factors for thromboembolic disorders
- Evidence of active Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV)-1/2 or
syphilis infection.
- Receipt of any vector or gene transfer agent
- Current antiviral therapy for hepatitis B or C
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| ASC618 Gene Therapy in Hemophilia A Patients | NCT04676048 | Entailment |
5,440 | 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:
- type 1 vWD patients
- healthy subjects with no known problem with bleeding or bruising were also recruited
Exclusion Criteria:
-
No condition on gender to be admitted to the trial.
| Evaluation of Bleeding Score in Egyptian Patients With vWD Type I and Correlate it With Laboratory Parameters | NCT03915873 | Entailment |
1,846 | 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:
- Pathological diagnosis of gastric adenocarcinoma
- Radical operation and adjuvant chemotherapy endurable
- Informed consent approved
Exclusion Criteria:
- Age <18 or >75 years old
- Pregnancy or lactating woman
- Any primary diagnosis other than gastric cancer
- Confirmed complement deficiency due to immunity dysfunction or other disease
- Required blood transfusion, plasmapheresis, or emergent operation
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 | The Predictive Value of Complement C3 in Patients With Advanced Gastric Cancer | NCT02425930 | Entailment |
4,536 | 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:
- Age: 35-49 years old.
- Normal gynecologic and breast examination
- Women who have sterilization or husband is sterilized or accepts to use a suitable
barrier contraception during the duration of the study.
- Heavy periods (were assessed by validated pictorial blood chart)
- Normal ultrasound, hysteroscopy and endometrial biopsy.
- Normal coagulation profile and thyroid function.
- No contraindication to tranexamic acid or Norethisterone acetate : allergy,History of
arterial or venous thromboembolic disease,Disturbance of liver function or Severe
renal impairment.
Exclusion Criteria:
- Women who are less than 35 years old or more than 49 years old.
- Women who had organic cause for heavy periods as uterine polypi,fibroids or
endometriosis.
- Women taking hormonal preparation the month before starting the trial.
- Women with abnormal findings in pelvic ultrasound,hysteroscopy or endometrial biopsy.
- Women who suffer from uncontrolled diabetes or uncontrolled hypertension.
- Women with history of breast cancer or precancerous conditions.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 49 Years | Effects of Tranexemic Acid Versus Norethisterone Acetate on Endometrial Vasculature . | NCT04290013 | Contradiction |
2,772 | 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 30-75 years
- Men
- Primary inguinal hernia
- ASA I-III
Exclusion Criteria:
- > 75 years
- Females
- ASA IV
- Previous ipsi-lateral hernia surgery
- Drug or alchol abuse
- Severe illness
Male
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 75 Years | PHS, Lichtenstein Mesh, and PerFixPlug for Primary Inguinal Hernia Repair - 3 Years Results | NCT00580177 | Entailment |
6,278 | 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:
1. Age from 18 to 65 years of age, inclusive, at the time of signing the informed
consent.
2. Willing and able to provide informed consent.
3. Women of reproductive potential must be using a highly effective method of
contraception for at least 28 days prior to enrolment and must be able and willing to
continue its use throughout the duration of the study.
4. Men must agree to use condoms when engaging in heterosexual sex during the study and
for the period up to 91 days after the last dose of study medication. Men who are not
randomized to a treatment arm including favipiravir (or another arm identified as
having teratogenic potential through semen) will no longer need to adhere to this
after randomization.
5. Laboratory confirmed SARS-CoV-2 infection, and any of the following self-reported
symptoms within 72 hours prior to randomization: fever or chills, cough, myalgia, sore
throat, shortness of breath, or new onset of anosmia or ageusia.
6. Body weight ≥45 kg.
7. Access to reliable video conference, telephone, direct/text messaging, or other device
permitting real-time, reliable information transfer.
Exclusion Criteria:
1. Pregnant or lactating women.
2. Known hypersensitivity or specific contraindications to the use of any of the active
drugs in the treatment arms, or similar compounds.
3. Signs of respiratory distress prior to randomization, including:
- respiratory rate >24 breaths/min
- SpO2 <95% in room air.
4. Resting pulse rate ≥120 beats/min.
5. High likelihood of hospitalization in the opinion of the attending clinician.
6. QTcF >470 msec for females, or >450 msec for males, at screening.
7. Serum potassium <3.5 mmol/L at screening.
8. History of clinically significant cardiovascular disease (including arrhythmias,
QT-interval prolongation, torsades de pointes (TdP), history of coronary artery
disease with graft or stent procedures/surgery, cardiac failure [class 2 or higher
using the New York Heart Association functional classification]).
9. Known chronic kidney disease (Stage IV or receiving dialysis).
10. Known cirrhosis (Child-Pugh Class B or greater).
11. Known macular degeneration, or other known retinal diseases, or
4-aminoquinolone-induced visual impairment.
12. Currently receiving, or recently received (within 60 days prior to randomization)
treatment with any of the drugs in the treatment arms.
13. Currently receiving, or recently received (within 30 days prior to randomization)
treatment with any antimalarial drugs.
14. Currently on treatment with drugs with known arrhythmogenic potential, or those known
to induce significant QT-interval prolongation or TdP, as detailed in Appendix 6.
15. Currently on treatment for tuberculosis (or on treatment with rifampicin for any other
indication), or on treatment with a protease inhibitor-based antiretroviral regimen,
or efavirenz, or carbamazepine.
16. Inability/unlikely to be in the study area for the duration of the 28 day follow-up
period.
17. Any surgical or medical condition which might significantly alter the absorption,
distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of
the volunteer or the objectives of the study. The Investigator should make this
determination in consideration of the volunteer's medical history.
18. Personnel (e.g. investigator, sub-investigator, research assistant, pharmacist, study
coordinator or anyone mentioned in the delegation log) directly involved in the
conduct of the study.
19. Participant is judged by the Investigator to be at significant risk of failing to
comply with the provisions of the protocol as to cause harm to self or seriously
interfere with the validity of the study results.
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 | COVID-19 Treatment in South Africa | NCT04532931 | Entailment |
2,184 | 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:
- Subjects with gout and at least one tophi.
Exclusion Criteria:
- Unable to undergo MRI.
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 | Magnetic Resonance Imaging in Subjects With Gouty Tophi | NCT00174954 | Contradiction |
3,474 | 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:
- On stable doses of atorvastatin (40 mg daily) for 45 days prior to Day 1.
- BMI 18.5 to 40 kg/m2 inclusive, and body weight equal or lower than 150 kg.
Exclusion Criteria:
- History of a cardiovascular event (e.g., MI ) during the past year.
- Poorly controlled Type 1 or Type 2 Diabetes mellitus (definition: uncontrolled
diabetes is defined as HBIAc >9%).
- Poorly controlled hypertension (uncontrolled hypertension is defined as a systolic
blood pressure greater than 140 mm Hg or a diastolic blood pressure greater than 90 mm
Hg, even with treatment). Subjects who have hypertension and are controlled on stable
dosages of anti-hypertensive medications can be included.
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 | Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination With Atorvastatin | NCT01163851 | Entailment |
1,849 | 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 must have histologic and radiographic proof of localized high-risk soft
tissue sarcoma (STS) required prior to registration.
- For the purpose of this study, high risk STS is defined by at least two of the
following risk factors:
- Tumor ≥ 5 cm in maximal diameter on MRI or CT
- Histology grade 3 or 4 (AJCC, 7th edition)
- Tumor deep to the investing fascia
- Locally recurrent sarcoma with no prior radiation therapy to the primary site
- Age >55 years old
- Tumor must be considered potentially resectable as defined by cross sectional imaging.
- At least 2 weeks must have elapsed from any prior surgery or hormonal therapy.
Patients must have ≤ grade 1 acute toxicities of any prior treatment with anti-cancer
modalities (returned to baseline status as noted before most recent treatment).
Patients with persisting, stable chronic toxicities from prior treatment ≤ grade 1 are
eligible.
- Age ≥18 years at time of consent.
- Physician documented life expectancy of greater than 3 months.
- Patients must have normal organ and marrow function within 4 weeks prior to study
treatment as defined below:
- hemoglobin ≥ 9 g/dL
- leukocytes ≥3,000/microliter (mcL)
- absolute neutrophil count ≥1,500/mcL
- platelets ≥100,000/mcL
- total bilirubin ≤ institutional upper limit of normal
- aspartate aminotransferase (AST/SGOT) and alanine aminotransferase(ALT/SGPT) <
2.5 x institutional upper limit of normal
- creatinine within 1.5 x upper limit of normal(ULN)
- Women of child-bearing potential must agree to use adequate contraception (hormonal or
barrier method of birth control; abstinence) prior to study entry and for the duration
of study participation and for 12 months after treatment. Patients must have a
negative serum pregnancy test within 14 days prior to beginning treatment on this
trial. Sexually active men must also use appropriate contraception method and should
not father a child while receiving therapy during this study.
- Ability to understand and the willingness to sign a written Institutional Review
Board(IRB) stamped, study specific informed consent document prior to any research
related procedures or study treatment.
Exclusion Criteria:
- Receiving any investigational agents.
- Treatment with cytotoxic agents and/or treatment with biologic agents within the 4
weeks prior to beginning treatment on this study.
- Evidence of metastatic disease.
- Previous radiotherapy to the affected site.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris,
uncontrolled cardiac arrhythmia, and/or psychiatric illness/social situations that
would limit compliance with study requirements.
- Pregnant women are excluded from this study because the investigational agents may
have the potential for teratogenic or abortifacient effects. Because there is an
unknown but potential risk for adverse events in nursing infants secondary to
treatment of the mother with these agents, breastfeeding should be discontinued if the
mother is treated.
- HIV-positive patients are ineligible because these patients are at increased risk of
lethal infections when treated with marrow-suppressive therapy and the potential
pharmacokinetic interaction between antiretroviral therapy and the investigational
agents.
- All herbal and/or alternative medications should be discontinued while on study, these
include but are not limited to: Hydrastis canadensis (goldenseal), Uncaria tomentosa
(cat's claw) or Echinacea angustifolia.
- Requirement for treatment with immunosuppressive agents or chronic steroids.
- A history of a hypersensitivity reaction to any of temozolomide's components or to
Dacarbazine(DTIC).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
| Proton Chemoradiotherapy for High-Risk Soft Tissue Sarcomas | NCT00881595 | Entailment |
3,663 | 29 | A 57-year-old man comes to the emergency department due to constipation. His last bowel movement was 2 days ago. He complains of spending about 30 minutes once attempting to defecate. He also has lower back pain. There is no history of trauma. The pain is not relieved with over-the-counter pain medications. His vital signs are within normal limits. Examination shows low back pain that is worse with back flexion and raising of the legs; it radiates into his left leg. Pinprick in the perianal area does not cause rapid contraction of the anal sphincter. The rest of the neurologic examination is normal. He is suspected of Cauda Equina syndrome and referred to a spinal MRI. | I'm a 57 year-old-man, and I had to go to the ER because I couldn't go defecate. My last trip to the toilet was 2 days ago, and I tried too many times, during 30 min, to get my poop to get out. I also have terrible lower back pain. The doctor did not notice any trauma. I tried to get the pain away using over-the-counter medications, but it simply did not work! Back in the ER my vitals were normal. My pain was even more intense with back flexion, and when I raised my legs, it radiated into my left leg. The doctor did an anus exam where he had to pinch it and it was not reacting! However the rest of my neurologic exam was normal. The doctor suspects a Cauda Equina syndrome and referred me to a spinal MRI. | Inclusion Criteria:
- Patients admitted to a Korean Medicine hospital for low back pain with or without
radiculopathy
- Age between 18 and 69
- NRS score of >6 on the day of the intervention
- Voluntary participation with written consent given to study consent form
Exclusion Criteria:
- Diagnosis of serious disease(s) which are possible causes of back pain such as
malignancy, vertebral fracture, spinal infection, inflammatory spondylitis, cauda
equina compression, etc.
- Prior diagnosis of other chronic disease(s) which could affect effectiveness or
interpretation of treatment results such as cardiovascular disease, diabetic
neuropathy, fibromyalgia, rheumatoid arthritis, Alzheimer's disease, epilepsy, etc.
- Progressive neurologic deficit(s) or concurrent severe neurological symptoms
- Unsuitable for or at risk of complications from acupuncture treatment such as patients
with clotting disorders, severe diabetes with risk of infection, serious
cardiovascular disease, or undergoing anticoagulant treatment, etc.
- Under prescription of corticosteroids, immuno-suppressant drugs, psychiatric medicine,
or other medication considered unsuitable for subjects by the researcher
- Experience of gastroenteric complications after taking NSAIDs or currently undergoing
treatment for digestive disorders
- During pregnancy or suspected pregnancy
- Subjects considered unsuitable for clinical trial by the researcher
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 69 Years | Immediate Pain Relieving Effects of Sinbaro-3 for Low Back Pain | NCT02196129 | Contradiction |
3,593 | 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:
1. Refractory menorrhagia with no definable organic cause
2. Female subject from age 25 to 50 years
3. Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus)
4. One of the following criteria:
A. Documented history of menorrhagia secondary to dysfunctional uterine bleeding
(DUB).
B. If a pictorial blood loss assessment chart (PBLAC) scoring systems is used; a
minimum PBLAC score of ≥150 for 3 months prior to study enrollment; OR, A minimum
PBLAC score ≥150 for one month for women who either i. had at least 3 prior months
documented failed medical therapy; or ii. had a contraindication to medical therapy;
or iii. refused medical therapy
5. Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml
6. Not pregnant and no desire to be pregnant in the future
7. Patient agrees not to use hormonal contraception or any other medical intervention for
bleeding during the study
8. Able to provide written informed consent using a form that has been approved by the
reviewing IRB/EC
9. Subject agrees to follow-up exams and data collection, including ability to accurately
use menstrual diaries
10. Subject who is literate or demonstrates an understanding on how to use menstrual
diaries or how to collect and provide used sanitary products
Exclusion Criteria:
1. Pregnancy or subject with a desire to conceive
2. Endometrial hyperplasia as confirmed by histology
3. Presence of active endometritis
4. Active pelvic inflammatory disease
5. Active sexually transmitted disease (STD), at the time of ablation. Note: Treatment of
STD documented in the chart serves as sufficient evidence of infection resolution.
Patient may be considered for study enrollment.
6. Presence of bacteremia, sepsis, or other active systemic infection
7. Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time
of the procedure
8. Known/suspected gynecological malignancy within the past 5 years
9. Known clotting defects or bleeding disorders
10. Untreated/unevaluated cervical dysplasia (except CIN I)
11. Known/suspected abdominal/pelvic cancer
12. Prior uterine surgery (except low segment cesarean section) that interrupts the
integrity of the uterine wall (e.g., myomectomy or classical cesarean section)
13. Previous endometrial ablation procedure
14. Currently on medications that could thin the myometrial muscle, such as long-term
steroid use (except inhaler or nasal therapy for asthma)
15. Currently on anticoagulants
16. Abnormal or obstructed cavity as confirmed by hysteroscopy or SIS, specifically:
1. Septate or bicornuate uterus or other congenital malformation of the uterine
cavity
2. Pedunculated or submucosal myomas distorting the uterine cavity
3. Polyps likely to be the cause of the subject's menorrhagia
4. Intramural or subserosal myomas that distort the uterine cavity
17. Presence of an intrauterine device (IUD) which the patient is unwilling to have
removed at the time of the operative visit
18. Presence of an implantable contraceptive device (e.g. Essure or Adiana).
19. Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal
birth control post-ablation (including a Mirena device).
20. Subject who is within 6-weeks post partum.
21. Any general health condition which, in the opinion of the Investigator, could
represent an increased risk for the subject
22. Any subject who is currently participating or considers future participation in any
other research of an investigational drug or device.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 50 Years | A Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System | NCT02023801 | Contradiction |
2,642 | 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 18 or older with unilateral or bilateral inguinal herna for laparoscopic repair
- American Society of Anesthesiology (ASA) Class I and II
Exclusion Criteria:
- Conversion from laparoscopic to open surgery
- History of Chronic pain or ongoing treatment for chronic pain
- Age less than 18 yrs
- Allergy to local anesthetics
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Effects of Local Anesthesia on Post-operative Pain During Laparoscopic Inguinal Hernia Repair | NCT02055053 | Entailment |
4,042 | 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:
- Any gender and age from 45 to 70 years
- Symptomatic osteoarthritis (OA) of the knee with mild joint discomfort for at least 6
months prior to enrollment, following ACR criteria with history and physical
examination(44). Subjects diagnosed with bilateral knee OA will be asked to specify
the most affected knee at baseline, and this knee will be evaluated throughout the
study period.
- Available confirmatory X-ray (performed within the previous 6 months) diagnosis
(Kellgren/Lawrence score 2) at the evaluated knee joint(45).
- Subjects experienced pain for at least 15 of the 30 days prior to the start of the
study.
Exclusion Criteria:
- Subjects who have any inflammatory arthritic condition (different from the OA of the
knee), fibromyalgia, multiple sclerosis or autoimmune disorder.
- Treatment with oral corticosteroids within 4 weeks before screening.
- Intra-articular injections of HA or corticosteroids in the target joint within 3
months before screening.
- Treatment with anti-inflammatory or chondroprotective drugs (chondroitin sulfate,
glucosamine, methylsulfonylmethane, HA, diacerein) 2 weeks before the selection.
- HA-containing nutritional supplements or cosmetics during the month before the study.
- Previous surgical treatment of knee joint(s) or its necessity necessity for
osteoarthritis (high tibial osteotomy, arthroplasty); complication(s) necessary for
hospitalization and surgical treatment.
- Significant injury to the target joint within the past 6 months prior to screening
(identified from medical history).
- Subjects following an energy-restricted diet for weight loss.
- Pregnant women, nursing mothers, or women (only if childbearing potential) not using
adequate methods of contraception.
- Subjects with cardiovascular, hepatic, renal, respiratory, or hematologic illness, or
other medical or psychiatric condition that, in the opinion of the investigator, would
compromise participation or be likely to lead to hospitalization during the course of
the study.
- Participation in an interventional clinical study in the previous 30 days.
- Presence of any clinically significant medical condition judged by the investigator to
preclude the patient's inclusion 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 45 Years old.
Subject must be at most 70 Years | Clinical Trial to Evaluate the Effects of a Nutraceutical in Patients Affected by Knee Osteoarthritis | NCT03612986 | Entailment |
2,701 | 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:
- planned laparoscopic inguinal or femoral herniorrhaphy
- ASA class I-II
- speak and read danish
Exclusion Criteria:
- converting to open operation
- low compliance (dementia, psychiatric disorder)
- use of morphine or similar drugs daily in the last month
- complications to the operation
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 | Pain and Convalescence After Laparoscopic Groin Hernia Repair | NCT00962338 | Entailment |
2,866 | 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:
- male or female
- age > 30 years
- definite or probable ALS according to the El Escorial criteria, bulbar or spinal form,
ALS diagnosis < 1 year and treatment by riluzole.
Exclusion Criteria:
- family history of ALS,
- oral, enteral or parenteral nutritional supply,
- vitamin or trace element supplementation
- confusing illness (cancer, diabetes, chronic infectious or inflammatory
disease,thyroid disorders, recent surgery...),
- current tobacco use,
- alcoholism
- treatment by corticosteroids,
- diuretics,
- anorectics
- NSAIDs
- cytotoxics
- anticoagulants...
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 30 Years old.
| Mitochondrial Functions and Oxidative Stress in ALS Patients | NCT00331812 | Entailment |
1,871 | 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:
- Age from over 18 to under 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or
poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT2-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the
American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- Expected to perform total gastrectomy with D2+No.19+No.20 lymph node dissction to
obtain R0 resection sugicall results.
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) class I to III
- Written informed consent
Exclusion Criteria:
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal
Dissection/Endoscopic Mucosal Resection )for gastric cancer)
- Gastric multiple primary carcinoma
- Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative
imaging
- History of other malignant disease within the past 5 years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within the past 6 months
- History of cerebrovascular accident within the past 6 months
- History of continuous systematic administration of corticosteroids within 1 month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by
gastric cancer
- FEV1<50% of the predicted values
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 | Clinical Outcomes of Robotic Versus Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III AEG | NCT04153058 | Entailment |
5,148 | 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:
1. Women or adult men (>18 years of age) with various medical diseases requiring
long-term prednisolone treatment. Pre-menopausal women should have no plan for
pregnancy within 2 years of study entry and agree to practice contraception during
this 2-year period.
2. A daily dose of prednisolone (or equivalent) of more than 2.5mg within 3 months of
study entry.
3. Having received oral bisphosphonate treatment for at least 2 years.
4. Suboptimal response to bisphosphonate treatment, defined as either one of the
following: (1) failure of lumbar spine, femoral neck or total hip BMD values to
increase; (2) values of lumbar spine, femoral neck or total hip BMD remain
osteoporotic, ie. T scores < -2.5 or Z scores < -2.0; or (3) development of new
fragility vertebral or non-vertebral fractures despite at least 2 years' treatment
with good compliance.
5. Informed consent from patients.
Exclusion Criteria:
1. Patients with previous use of denosumab or teriparatide.
2. Premenopausal women who plan for pregnancy within 2 years of study entry or who do not
agree for contraception within this 2-year period.
3. Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and
hyperparathyroidism.
4. Patients with unexplained hypocalcemia.
5. Patients with serum creatinine level of >=200umol/L.
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.
| Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis | NCT01465568 | Contradiction |
4,700 | 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:
- Age 18-50 years, inclusive
- General good health (by volunteer history and per investigator discretion)
- History of and currently regular menstrual cycles
- Willing to abstain from the use of vaginal products, other than the TFV gel and her
assigned study vaginal product for the duration of the study.
- Willing to abstain from sex and other vaginal activity during each crossover period
starting 72 hours prior to initiating product use, for the duration of use, and until
the sixth day following sample collection
- At low risk for pregnancy due to surgical sterilization of participant and/or her
sexual partner, use of copper IUD or male condom, abstinence, or same sex relationship
- Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to
easy genital tract sample collection
- History of Pap smears and follow-up consistent with ACOG practice guidelines
- Negative urine pregnancy test
- Willing to give voluntary consent, sign an informed consent form and comply with study
procedures as required by the protocol
Exclusion Criteria:
- History of hysterectomy
- Currently pregnant/within 2 calendar months from the last pregnancy outcome.
- Use of Depo-Provera in the last 120 days or any hormonal contraceptives in the last
month
- Currently breastfeeding or having breastfed an infant in the last 2 months, or
planning to breastfeed during the course of the study
- History of sensitivity/allergy to any component of:
- TFV 1% gel; or
- topical anesthetic, or allergy to both silver nitrate and Monsel's solution.
- Contraindication to any of 3 vaginal products (antifungal cream, antimicrobial gel, or
the combination contraceptive vaginal ring) to which participants may be randomized
- In the last 6 months, diagnosed with or treated for any STI or pelvic inflammatory
disease, by self report.
- Symptomatic BV
- Positive test for Trichomonas vaginalis at Visit 1
- Positive test for Neisseria gonorrhea or Chlamydia trachomatis
- Positive test for HIV
- Positive test for Hepatitis B surface antigen (HBsAg)
- Known bleeding disorder that could lead to prolonged or continuous bleeding with
biopsy
- Chronic or acute vulvar or vaginal symptoms
- Known current drug or alcohol abuse which could impact study compliance
- Grade 2 or higher laboratory abnormality, per the August 2009 update of the DAIDS
Table for Grading the Severity of Adverse Events
- Systemic use in the last 2 weeks or anticipated use during the study of any of the
following: corticosteroids, antibiotics, anticoagulants or other drugs known to
prolong bleeding and or clotting, antifungals, antivirals (e.g., acyclovir or
valacyclovir) or antiretrovirals (e.g., Viread®).
- Participation in any other drug or device interventional investigational trial
(device, drug, or vaginal trial) within 30 days of this study or planned participation
in any other investigational trial during the study
- History of gynecological procedures (including genital piercing) on the external
genitalia, vagina or cervix within the last 14 days
- Abnormal finding on laboratory or physical examination or a social or medical
condition which, in the opinion of the investigator, would make participation in the
study unsafe or would complicate interpretation of data
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | In Vivo Drug Interaction Pharmacokinetic Study of Tenofovir 1% Gel and Three Commonly Used Vaginal Products | NCT01813162 | Entailment |
333 | 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:
Increased levels of serum β-hCG and ultrasonography findings. The criteria for diagnosis by
ultrasonography was the presence of the following: (1) an empty uterine cavity and
endocervical canal; (2) detection of the placenta and/or a gestational sac embedded in the
hysterectomy scar; (3) the presence of the gestation sac with or without a fetal pole and
with or without fetal cardiac activity (depending on the gestational age) in the anterior
part of the uterine isthmus; and (4) a thin (1-3 mm) or absent myometrial layer between the
gestational sac and the bladder. All patients had taken Magnetic Resonance Imaging (MRI) to
clarify the diagnosis . Pregnancy tissues were identified by histopathology examinations of
the surgical tissues.
Exclusion Criteria:
All enrolled patients had no contraindications for transvaginal surgery or UAE, including
renal failure, active pelvic infection, clotting disorders, or known allergy to the
contrast material.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 45 Years | Outcome After MTX & Transvaginal Surgery or UAE & Uterine Curettage in Patients With Cesarean Scar Pregnancy | NCT03218059 | Contradiction |
1,859 | 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 or cytologically confirmed diagnosis of advanced gastric adenocarcinoma
2. Has a PTEN-deficient tumor as documented from archival or fresh (from biopsy) tumor
tissue or has shown genomic alterations in PI3K pathway genes (PIK3CB, PI3KR1, PTEN,
etc.) as assessed in a local laboratory.
3. Has had no prior taxane exposure (preferred) or at least 6 months since last taxane
exposure.
4. Eastern Cooperative Oncology Group performance status of 0 or 1
5. measurable or evaluable disease as determined by RECIST 1.1.
6. Is able to swallow and retain orally administered medication
7. adequate baseline organ function
Exclusion criteria
1. prior treatment with any AKT, mammalian target of rapamycin (mTOR) inhibitors or PI3K
pathway inhibitors
2. Has any unresolved Grade 2 (per CTCAE v4.0) toxicity from previous anti-cancer therapy
at the time of enrollment such as neuropathy, except alopecia or Grade 2 anemia (if
hemoglobin is ≥9.0 g/dL)
3. Has CNS metastases
4. Has a QTc interval >450 msec or QTc >480 msec for subjects with bundle branch block
(BBB)
5. Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to GSK2636771 or hypersensitivity to drug formulated in polyoxyl 35
castor oil, NF such as paclitaxel.
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.
| PI3Kβ Selective Inhibitor With Paclitaxel, Advanced Gastric Adenocarcinoma | NCT02615730 | Entailment |
5,339 | 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:
- Age 18-45 years, inclusive
- General good health (by volunteer history and per investigator discretion) without any
clinically significant systemic disease (including, but not limited to significant
liver disease/hepatitis, gastrointestinal disease, kidney disease, thyroid disease,
osteoporosis or bone disease, and diabetes)
- Currently having regular menstrual cycles of 26-35 days by participant report
- History of Pap smears and follow-up consistent with standard medical practice as
outlined in the study manual or willing to undergo a Pap smear
- Protected from pregnancy by one of the following: 1) Sterilization of either partner.
Note: Women protected from pregnancy by sterilization of either partner must abstain
from vaginal intercourse from 48 hours prior to Visit 3 until the sixth day after the
last study visit; or 2) Willing to abstain from vaginal intercourse from Visit 1 until
the sixth day after the last study visit.
- Willing to abstain from any other vaginal activity and the use of vaginal product
other than the study product including tampons, spermicides, lubricants, and douches
starting 48 hours before Visit 3 until the sixth day after the last study visit
- Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to
easy colposcopy and genital tract sample collection
- Negative urine pregnancy test
- P4 ≥3 ng/ml
- Willing to give voluntary consent, sign an informed consent form and comply with study
procedures as required by the protocol
Exclusion Criteria:
- History of hysterectomy
- Currently pregnant or within two calendar months from the last pregnancy outcome.
Note: If recently pregnant must have had at least two spontaneous menses since
pregnancy outcome.
- Use of any hormonal contraceptive method in the last 3 months (oral, transdermal,
transvaginal, implant, or hormonal intrauterine contraceptive device)
- Injection of Depo-Provera in the last 10 months
- Use of copper intrauterine device (IUD) after Visit 1
- Currently breastfeeding or having breastfed an infant in the last two months, or
planning to breastfeed during the course of the study
- History of sensitivity/allergy to any component of: TFV 1% gel, topical anesthetic, or
allergy to both silver nitrate and Monsel's solution.
- Contraindication to LNG
- In the last six months, diagnosed with or treated for any sexually transmitted
infection (STI) or pelvic inflammatory disease. Note: Women with a history of genital
herpes or condylomata who have been asymptomatic for at least six months may be
considered for eligibility.
- Nugent score greater than or equal to 7 or symptomatic bacterial vaginosis (BV) as
defined by Amsel's criteria
- Positive test for Trichomonas vaginalis, Neisseria gonorrhea (GC), Chlamydia
trachomatis (CT), HIV, or Hepatitis B surface antigen (HBsAg)
- Known bleeding disorder that could lead to prolonged or continuous bleeding with
biopsy
- Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting, etc.)
- Known current drug or alcohol abuse which could impact study compliance
- Grade 2 or higher laboratory abnormality, per the August 2009 update of the Division
of AIDS, National Institute of Allergy and Infectious Disease (DAIDS) Table for
Grading the Severity of Adverse Events, or clinically significant laboratory
abnormality as determined by the clinician
- Systemic use in the last two weeks or anticipated use during the study of any of the
following: corticosteroids, antibiotics, anticoagulants or other drugs known to
prolong bleeding and/or clotting, antifungals, antivirals (e.g., acyclovir or
valacyclovir) or antiretrovirals (e.g., Viread, Atripla®, Emtriva®, Complera®). Note:
Participants should avoid non-steroidal anti-inflammatory drugs (NSAIDs) except for
treatment of dysmenorrhea during menses. Participants may use Tylenol® on an as-needed
but not daily basis during the study
- Participation in any other investigational trial (device, drug, or vaginal trial)
within the last 30 days or planned participation in any other investigational trial
during the study
- History of gynecological procedures (including genital piercing) on the external
genitalia, vagina or cervix within the last 14 days
- Abnormal finding on laboratory or physical examination or a social or medical
condition which, in the opinion of the investigator, would make participation in the
study unsafe or would complicate interpretation of data
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Phase I One-month Safety, PK, PD, and Acceptability Study of IVR Releasing TFV and LNG or TFV Alone | NCT02235662 | Contradiction |
2,430 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
- Patient referred to bronchoscopy for tissue diagnosis of discrete enlarged (≥10mm
short axis diameter) mediastinal/hilar lymph nodes on CT scan that can be sampled by
E(B)US-NA.
Exclusion Criteria:
- Abnormal chest X-ray showing hilar/mediastinal lymph nodes
- Patients with suspected lung cancer
- Patients with previous malignancy diagnosed and definitely treated less than 5 years
previously or, if treated more than five years before but with subsequent evidence of
recurrence less than 5 years previously.
- Patient with concomitant (suspected or confirmed) bronchopulmonary infection or
treated with antibiotics within the 4 previous weeks
- Patients with a contraindication for bronchoscopy and tissue sampling
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.
| Linear Endosonography for the Assessment of Sarcoidosis Stage O | NCT01383226 | Contradiction |
6,117 | 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. | Recipient Inclusion Criteria:
- Patients with severe COVID-19 will be considered for randomization and will be transfused
convalescent plasma within 3 days of symptom onset (Severe COVID-19) Severe COVID -19
defined by WHO Interim Guidance and the Guideline of Diagnosis and Treatment of COVID-19 of
National Health Commission of China (version 5.0) along with confirmation by real-time
RT-PCR assay with severe disease i.e. meeting any 2 of the following criteria-
- Patients on ventilator (in last 24 hours)
- Respiratory distress, RR ≥30 beats/min
- Oxygen saturation level less than 90 % in resting state
- Partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) ≤ 300 mmHg
- Lung infiltrates > 50% within 24 to 48 hours
Recipient Exclusion Criteria:
- Patient/ family members who do not give consent to participate in the study.
- Patients with age less than 18 years
- Patients presenting with multi-organ failure
- Pregnancy
- Individuals with HIV and Viral Hepatitis and Cancer
- Extremely moribund patients with an expected life expectancy of less than 24 hours
- Hemodynamic instability requiring vasopressors
- Previous history of allergy to plasma
- Cirrhosis
- Severe renal impairment with GFR< 30ml/min or recipients of RRT, peritoneal dialysis
- Patients with uncontrolled diabetes mellitus, hypertension, arrhythmias and unstable
Angina
Donor Inclusion Criteria for Plasmapheresis
- Virologically documented (PCR positive by nasopharyngeal swab) who is recovered and
free of symptoms for 14 days.
- Has tested negative for SARS CoV 2 on two consecutive tests 24 hrs apart.
- Fulfill all criteria of donor eligibility for donor Plasmapheresis under the Drugs &
Cosmetics Act 1940 and Rules 1945, amended 11.03.2020
- Females who have been pregnant may be tested for anti-HLA antibodies and eligible if
negative for the same.
Donors Exclusion Criteria:
- Do not fulfill all criteria of donor eligibility for donor Plasmapheresis under
- the Drugs & Cosmetics Act 1940 and Rules 1945, amended 11.03.2020
- Females who have been pregnant and have not been tested for HLA antibodies or are HLA
antibody positive if tested and previously transfused donors (to prevent TRALI)
- Donors who have taken steroids during treatment for COVID-19
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 of Convalescent Plasma Therapy in Patients With COVID-19 | NCT04425915 | Contradiction |
1,647 | 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:
- Age 18-45 years, inclusive, of both genders
- Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy
- No history of episodic wheezing, chest tightness, or shortness of breath consistent
with asthma, or physician-diagnosed asthma.
- forced expiratory volume at one second (FEV1) of at least 80% of predicted and
FEV1/forced vital capacity (FVC) ratio of >0.70.
- Oxygen saturation of >93%
- Ability to provide an induced sputum sample.
- Subject must demonstrate a >10% increase in sputum %PMNs 6 hours following inhaled WSP
exposure, when compared to baseline sputum (to be completed in a separate protocol
IRB# 15-1775).
Exclusion Criteria:
- Clinical contraindications:
- Any chronic medical condition considered by the PI as a contraindication to the
exposure study including significant cardiovascular disease, diabetes, chronic renal
disease, chronic thyroid disease, history of chronic infections/immunodeficiency.
- Viral upper respiratory tract infection within 4 weeks of challenge.
- Any acute infection requiring antibiotics within 4 weeks of exposure or fever of
unknown origin within 4 weeks of challenge.
- Abnormal physical findings at the baseline visit, including but not limited to
abnormalities on auscultation, temperature of 37.8° C, Systolic BP > 150mm Hg or < 85
mm Hg; or Diastolic BP > 90 mm Hg or < 50 mm Hg, or pulse oximetry saturation reading
less than 93%.
- Physician diagnosis of asthma
- If there is a history of allergic rhinitis, subjects must be asymptomatic of allergic
rhinitis at the time of study enrollment.
- Mental illness or history of drug or alcohol abuse that, in the opinion of the
investigator, would interfere with the participant's ability to comply with study
requirements.
- Medications which may impact the results of the WSP exposure, interfere with any other
medications potentially used in the study (to include steroids, beta antagonists,
non-steroidal anti-inflammatory agents)
- Cigarette smoking > 1 pack per month
- Unwillingness to use reliable contraception if sexually active (IUD, birth control
pills/patch, condoms).
- Use of immunosuppressive or anticoagulant medications including routine use of NSAIDS.
Oral contraceptives are acceptable, as are antidepressants and other medications may
be permitted if, in the opinion of the investigator, the medication will not interfere
with the study procedures or compromise safety and if the dosage has been stable for 1
month.
- Orthopedic injuries or impediments that would preclude bicycle or treadmill exercise.
- Inability to avoid NSAIDS, Multivitamins, Vitamin C or E or herbal supplements.
- Allergy/sensitivity to study drugs or their formulations
- Pregnant/lactating women and children (< 18 years as this is age of majority in North
Carolina) will also be excluded since the risks associated with WSP exposure to the
fetus or child, respectively, are unknown and cannot be justified for this
non-therapeutic protocol. Individuals over 45 years of age will not be included due to
the increased possibility of co-morbidities and need for prohibited medications.
- Inability or unwillingness of a participant to give written informed consent
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 45 Years | Woodsmoke Particulate + Hypertonic Saline | NCT03851406 | Entailment |
3,157 | 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:
1. Subject must have dry eye.
2. Age: 18 years and older.
3. Males or females
4. Up to grade 3 conjunctival staining.
5. Score of no more than 4 on the Subjective Evaluation of Symptoms of Dryness (SESOD) at
screening.
6. Currently using Restasis to treat dry eye syndrome (at least for 3 months prior to
enrollment).
7. Willing and able to comply with scheduled visits and other study procedures.
Exclusion Criteria:
1. Prior unsuccessful use of topical cyclosporine (defined as patients taking it at least
3 months without improvement.
2. Known contraindications to any study medication or ingredients.
3. Planned use of contact lenses (unless discontinued use more than 30 days prior to
randomization.
4. Contact lens use during the active treatment portion of the trial.
5. Active ocular allergies.
6. Ocular surgery within the past 3 months.
7. Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
8. Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are
actively being treated or disease that is uncontrollable.
9. Pregnant or nursing mothers and females of childbearing potential not practicing a
reliable and medically acceptable method of birth control.
10. Participation in (or current participation) any investigational drug or device trial.
11. Conjuctival staining grade 4.
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.
| Evaluation of Blink Tears and Systane Concomitant With Restasis for the Treatment of Dry Eye Symptoms | NCT00565669 | Contradiction |
1,184 | 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. | Inclusion Criteria:
- The subject must meet all of the following inclusion criteria to participate in this
study.
1. Evidence of pleural disease on chest radiograph or bedside ultrasound or Computed
Tomography regardless of underlying aetiology
2. No age or gender restrictions
3. Ability to provide informed consent
Exclusion Criteria:
- Subjects who no radiographic evidence of pleural disease or who are unwilling/unable
to provide informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
Subject must be at most 100 Years | Pleural Disease: Phenotypes, Diagnostic Yield and Outcomes | NCT03922841 | Entailment |
1,226 | 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. | Inclusion Criteria:
- age 18 or older
- smokes at least five cigarettes daily for at least past 12 months
- wants to quit cigarette smoking in the next 30 days
- if concurrently using any other nicotine or tobacco products, wants to quit using them
within the next 30 days
- interested in learning skills to quit smoking
- willing to be randomly assigned to either condition
- resides in US
- has at least daily access to their own personal Apple iPhone, Android, or Windows
Phone
- knows how to login and download a smartphone application
- willing and able to read in English
- not using other smoking cessation interventions (including apps or our other
intervention studies).
- willing to complete all three follow-up surveys
- provide email, phone, and mailing address.
Exclusion Criteria:
- The exclusion criteria are opposite of the inclusion criteria listed above.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Trial of An Innovative Smartphone Intervention for Smoking Cessation | NCT02724462 | Entailment |
2,830 | 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:
- Clinical signs of weakness attributed to ALS.
- Familial ALS with a documented SOD1 gene mutation.
- Age 18 years or older.
- Capable of providing informed consent and willing to comply with trial procedures and
time commitments.
- Vital capacity (VC) at least 50% predicted value for gender, height and age at
screening and not using invasive respiratory support.
- If taking riluzole, patients must be on stable dosage for at least 30 days prior to
starting the study and expect to remain at that dosage until the end of the study.
- Medically able to undergo temporary insertion of intrathecal catheter.
- Normal test results for coagulation parameters.
Exclusion Criteria:
- Treatment with another investigational drug for ALS (e.g. pyrimethamine, ceftriaxone,
lithium, tamoxifen, arimoclomol, high dose creatine, biological agent, or device
within 1-month of Screening or 5 half-lives of study agent, whichever is longer. No
prior treatment with siRNA, cell transplant, or gene therapy is allowed.
- Dosing in ISIS 333611-CS1 in a previous dose cohort within 60 days of screening.
- Presence of any of the following clinical conditions:
1. Drug abuse or alcoholism within one year of the Screening visit.
2. Unstable cardiac, pulmonary, renal, hepatic, endocrine, hematologic function, or
active infectious disease.
3. Documented history of HIV infection.
4. Unstable psychiatric illness defined as psychosis or untreated major depression
within 90 days of the Screening Visit.
- Any condition that may impact intrathecal infusion including:
1. History of structural spinal disease including tumors and hyperplasia.
2. Presence of an implanted shunt for the drainage of CSF or an implanted CNS
catheter.
3. Clinically significant abnormalities in hematology or clinical chemistry
parameters as assessed by the Site Investigator during the Screening visit.
4. Ongoing medical condition that according to the Site Investigator would interfere
with the conduct and assessments of the study. Examples are medical disability
(e.g., severe degenerative arthritis, compromised nutritional state, peripheral
neuropathy) that would interfere with the assessment of safety and efficacy of
study material or device performance, or would compromise the ability of the
patient to undergo study procedures.
5. ALT or AST >/= 3 x ULN, unless discussed with and approved by the Medical
Monitor.
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, Tolerability, and Activity Study of ISIS SOD1Rx to Treat Familial Amyotrophic Lateral Sclerosis (ALS) Caused by SOD1 Gene Mutations | NCT01041222 | Entailment |
1,131 | 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:
- Adult patients (>= 16 years) with a complaint of TLoC
Exclusion Criteria:
- Patients needing immediate treatment, with trauma related or drug or alcohol related
TLoC were excluded, as well as patient with persistent altered level of consciousness,
simple fall and drop attack
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
| NICE Guideline 'Red Flags' to Predict Serious Outcome After Transient Loss of Consciousness | NCT01498471 | Entailment |
6,390 | 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:
- Patients presenting with clinical suspicion of COVID-19 infection, as per UHN case
definition at the time of presentation
- Age >18 years
- Ability to provide verbal informed consent
Exclusion Criteria:
- Patients who are not suspected of COVID-19 infection, as per UHN definition at the
time of presentation
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.
| Enhanced Triage for COVID-19 | NCT04750369 | Entailment |
4,131 | 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
1. Age of 18 to 40 years
2. Access to a participating HVTN CRS and willingness to be followed for the planned
duration of the study
3. Ability and willingness to provide informed consent
4. Assessment of understanding: volunteer demonstrates understanding of this study;
completes a questionnaire prior to first vaccination with verbal demonstration of
understanding of all questionnaire items answered incorrectly
5. Agrees not to enroll in another study of an investigational research agent
6. Good general health as shown by medical history, physical exam, and screening
laboratory tests
HIV-Related Criteria:
7. Willingness to receive HIV test results
8. Willingness to discuss HIV infection risks and amenable to HIV risk reduction
counseling.
9. 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)
10. Hemoglobin ≥ 11.0 g/dL for volunteers who were born female, ≥ 13.0 g/dL for volunteers
who were born male
11. White blood cell count = 3,300 to 12,000 cells/mm^3
12. Total lymphocyte count ≥ 800 cells/mm^3
13. Remaining differential either within institutional normal range or with site physician
approval
14. Platelets = 125,000 to 550,000/mm^3
Chemistry
15. Chemistry panel: ALT, AST, and ALP < 1.25 times the institutional upper limit of
normal; creatinine ≤ institutional upper limit of normal.
Virology
16. Negative HIV-1 and -2 blood test: Sites may use locally available assays that have
been approved by HVTN Laboratory Operations.
17. Negative Hepatitis B surface antigen (HBsAg)
18. Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase
chain reaction (PCR) if the anti-HCV is positive Urine
19. 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
20. 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.
21. Reproductive status: A volunteer who was born female must:
- Agree to consistently use effective contraception 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
condoms (male or female), or diaphragm or cervical cap, PLUS 1 of the following
methods: Intrauterine device (IUD), Hormonal contraception (in accordance with
Republic of South Africa: National Contraception Clinical 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 postvasectomy); or any other contraceptive method approved by the HVTN
107 Protocol Safety Review Team
- 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.
22. 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
23. Volunteers 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
1. Blood products received within 120 days before first vaccination
2. Investigational research agents received within 30 days before first vaccination
3. 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
4. Intent to participate in another study of an investigational research agent or any
other study that requires non-HVTN HIV antibody testing during the planned duration of
the HVTN 107 study
5. Pregnant or breastfeeding
Vaccines and other Injections
6. HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received
control/placebo in an HIV vaccine trial, the HVTN 107 PSRT will determine eligibility
on a case-by-case basis.
7. 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
in a volunteer's country of residence. For volunteers who have received
control/placebo in an experimental vaccine trial, the HVTN 107 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 107 PSRT on a case-by-case basis.
8. 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)
9. 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)
10. Allergy treatment with antigen injections within 30 days before first vaccination or
that are scheduled within 14 days after first vaccination
Immune System
11. Immunosuppressive medications received within 168 days before first vaccination. (Not
exclusionary: [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.)
12. 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 from
participation: a volunteer who had a nonanaphylactic adverse reaction to pertussis
vaccine as a child.)
13. Immunoglobulin received within 60 days before first vaccination
14. Autoimmune disease
15. Immunodeficiency
Clinically significant medical conditions
16. Untreated or incompletely treated syphilis infection
17. 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.
18. 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
19. 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.
20. Current anti-tuberculosis (TB) prophylaxis or therapy
21. 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.
22. Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not
excluded: history of isolated gestational diabetes.)
23. Thyroidectomy, or thyroid disease requiring medication during the last 12 months
24. 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.
25. Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or
platelet disorder requiring special precautions)
26. Malignancy (Not excluded from participation: 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)
27. 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.
28. Asplenia: any condition resulting in the absence of a functional spleen
29. 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 Immunogenicity of Clade C ALVAC and gp120 HIV Vaccine | NCT03284710 | Contradiction |
1,869 | 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:
- Age 18 or over
- Histological diagnosis of recurrent or metastatic gastric cancer
- Immunohistochemistry (IHC 0 or 1+) or FISH negative (if IHQ 2+) for HER2 on tissue
biopsy, according to institutional routine
- Candidates to initiate first-line palliative treatment; Previous adjuvant treatment is
allowed since its termination occurred at least 12 months ago
- ECOG performance range 0 to 2
- Informed consent form signed by patient or legal representative
Exclusion Criteria:
- Patients already on or previously using anti-HER2 therapy
- Left ventricular ejection fraction (LVEF) <55% baseline, as already evaluated in the
gastric cancer routine
- Pregnant or lactating women
- Patients participating in other experimental drug protocols
- Patients who received previous palliative chemotherapy
- Another synchronic neoplasia requiring systemic treatment
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.
| Trastuzumab to Patients With Advanced Gastric Cancer With HER2 Positive Expression in CTC | NCT04168931 | Entailment |
3,558 | 27 | A 31-year-old woman comes to the office due to 3 days of rash on her left arm. The lesion is mildly pruritic but not painful. She is otherwise healthy and occasionally takes ibuprofen during the first few days of her menstrual period. Temperature is 37 C, blood pressure is 110/75 mm Hg, and pulse is 95/min. The lesion is like a target sign known as erythema migrans. She recently went for an adventure trip in New Hampshire. The patient is diagnosed with Lyme disease. | I went to the clinic because I had a rash on my left arm for three days, and the lesion started to be putrid, but it was not painful. I'm a 31-year-old healthy woman and the only medication I use is ibuprofen when I get my periods. They took my temperature, which turned out to be 37°C and took my blood pressure which was 110/75 and my pulse 95. My lesion is round like a target sign. I just came back from a New Hampshire road trip with my friends. Unfortunately, the doctor diagnosed me with Lyme disease. | - INCLUSION CRITERIA:
Patients:
Age greater than or equal to 18 years
Diagnosis of EM - an expanding annular lesion, at least 5 cm in diameter on a person with a
history of exposure to the disease.
Exposure is defined as having been (less than or equal to 30 days before onset of EM) in
wooded, brushy, or grassy areas (i.e., potential tick habitats) in an area in which Lyme
disease is endemic.
A history of tick bite is not required.
The area of the erythema migrans lesion is suitable for biopsy. This excludes biopsies on
the face, neck, scalp, and over the tibia.
Not know to be positive for RPR, HIV, HBsAg or HCV
Able to give consent
Healthy Volunteers:
Age greater than or equal to 18 years
Not positive for RPR, HIV, HBsAg or HCV.
Able to give consent
EXCLUSION CRITERIA:
Patients:
Antibiotic therapy for the current episode of Lyme disease
Oral corticosteroids within the past 2 weeks
History of severe skin disease (such as psoriasis, atopic dermatitis) in the last year.
Diagnosis of diabetes, active cancer, or autoimmune diseases.
Investigational drugs in the past month
History of forming large thick scars after skin injuries or surgery
History of excessive bleeding after cuts or procedures or on anticoagulation.
Use of steroid cream/ointment at the rash.
Healthy Volunteers:
History of Lyme disease, or serological evidence for Lyme disease
No oral corticosteroids within the past 2 weeks
History of severe skin disease (such as psoriasis, atopic dermatitis) in the last year.
Diagnosis of diabetes, cancer, autoimmune diseases.
Investigational drugs in the past month
History of forming large thick scars after skin injuries or surgery
No history of excessive bleeding after cuts or procedures or on anticoagulation.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Analysis of Lyme Disease Lesions | NCT00132327 | Contradiction |
1,422 | 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
- No swallowing problems
Male
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 Oropharyngeal Dysphagia Screening Test for Patients and Professionals | NCT03907566 | Contradiction |
1,070 | 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:
- Over 18 years.
- Diagnosis of neurally mediated syncope with a tilting table test (Tilt test) that
demonstrates a mixed (type 1) or cardioinhibitory response (Type 2A and 2B).
- Negative impact on work and social life.
- Non-respondent to pharmacological therapy (Fludrocortisone 0.1mg / 24 hours for 3
months) and non-pharmacological (exercise, hydration and consumption of more than 3
months) is due to a cardiologist who has performed a strict stricture over time.
- At least 2 episodes of syncope in the last year.
Exclusion Criteria:
- Complete atrioventricular block.
- Second degree ventricular atrial block.
- Bradycardia syndrome - tachycardia.
- Disease of the sinus node.
- Arrhythmia (bradycardia or tachycardia that generate syncope and / or low cardiac
output).
- Syncope due to hypersensitivity of the carotid sinus.
- Syncope with Tilt Test that demonstrates depressant vasopressor response (type 3).
- Refusal of the patient, his relatives or the attending physician to participate 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.
| Pacemaker Effect With Closed Loop Sensor in Neuromodulated Syncope Refractory to Medical Therapy | NCT03876652 | Contradiction |
6,467 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
1. Male or non-pregnant, non-lactating female, 18 years of age or older.
2. Signed informed consent form that meets all criteria of current Food and Drug
Administration regulations.
3. Females of childbearing potential must not be pregnant or lactating.
4. Females of childbearing potential must agree to the use of a reliable method of
contraception throughout the study.
5. Have clinical diagnosis of rosacea with persistent (non-transient) facial erythema.
6. Have < 3 inflammatory lesions on the face.
7. Have an erythema score of 3 (moderate) or 4 (severe) for both the CEA and the PSA that
is reflective of the overall targeted areas.
8. Willing to minimize external factors that might trigger rosacea flare-ups (e.g., spicy
foods, hot drinks, hot environments, prolonged sun exposure, strong winds, emotional
stress and alcoholic beverages) during the study.
Exclusion Criteria:
1. Forms of rosacea that, in the opinion of the Investigator, would interfere with the
diagnosis or assessment of study endpoints
2. Patient has a skin condition that, in the opinion of the Investigator, would interfere
with the diagnosis or assessment of rosacea
3. Patients with active sunburn or excessive facial hair such as beards, sideburns,
moustaches, etc.
4. Patients with moderate to severe telangiectasial masses
5. History of blood dyscrasia.
6. Significant history or current evidence of any uncontrolled chronic or serious disease
or medical condition that would, in the judgment of the Investigator, would put the
subject at undue risk or compromise the study assessments.
7. History or current evidence of Raynaud's syndrome, severe, unstable or uncontrolled
cardiovascular disease, orthostatic hypotension, uncontrolled hypertension or
hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, renal or
hepatic or renal impairment, scleroderma, Sjögren's syndrome, depression, or
narrow-angle glaucoma to an extent that, in the opinion of the Investigator, would
place the subject at undue risk.
8. Female patients taking hormonal contraceptives or oral estrogen for less than one
month or those that plan to change the dosage regimen during the course of the study.
9. Previous participation in this study.
10. Employees of the Investigator or research center or their immediate family members.
11. Inability to understand the requirements of the study and the relative information and
are unable or not willing to comply with the study protocol.
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.
| An Evaluation of the Reduction in Erythema in Adult Patients With Moderate to Severe Persistent Facial Erythema Associated With Rosacea | NCT03352323 | Entailment |
349 | 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 between the ages of 18 and 38 inclusive
- Women with BMI up to 40
- Women able to freely give consent electronically, given COVID. For the purposes of
this study, this is defined as women who speak native or fluent English; and have a
high school degree or equivalent, and who are otherwise, in the professional judgement
of the PI, able to give informed consent
- N = 30 will be recruited from the general population, e.g., no known previous issues
- N = 15 will be positive controls with submucosal fibroids
- Women who are in driving distance from Boston (including Vermont and Connecticut);
these states are covered by the PI's medical license during the COVID emergency
- Women between cycle days 3 and 10 at the time of testing; or IUD users who do not have
a menses
Exclusion Criteria:
- Women with expert ultrasound experience, e.g., ultrasound technologists, radiologists,
OB/GYNs, Reproductive Endocrinologists
- Women with BMI over 40
- Women who do not speak English natively or fluently
- Women who have recently given birth, and have had fewer than 3 postpartum menstrual
cycles
- Women who have recently had a stillbirth or abortion more than 20 weeks (subject to
the 3 postpartum menstrual cycles above). Miscarriages or abortions less than 20 weeks
are subject to two wait cycles
- Women who are currently pregnant or may be pregnant
- Any woman the PI believes is not capable of giving independent, informed consent
- Turtle Health employees
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 38 Years | Sonograms Enable Looking Forward - Home Examinations Led by Providers Validation Study | NCT04687189 | Contradiction |
933 | 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 =>30 years
- Knee pain which appeared without any apparent cause, exacerbated by exertion and
subsided by rest.
- Presence of limited morning stiffness
- No history of infection, inflammation or trauma to rule out secondary OA
- Disability in sitting, climbing stairs or walking
Exclusion Criteria:
- Backache
- Leg pain (e.g. sciatica)
- Inability to lie supine (e.g. kyphosis)
- Inability to lie prone (e.g. central obesity)
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.
| An Attempt to Find Out Root Cause of a Pain Producing Knee Disease | NCT04496440 | Entailment |
4,199 | 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 Healthy Volunteers:
1. Healthy male volunteers between 18 and 50 years of age inclusive.
2. Able to communicate with site personnel and to understand and voluntarily sign the
Informed Consent Form.
3. Able and willing to comply with the Protocol, including availability for all scheduled
study visits.
4. Body Mass Index (BMI) of 20 to 30 kg/m2 inclusive, and weight between 60-90 kg
inclusive.
5. No clinically significant abnormalities at screening determined by medical history,
physical examination, blood chemistry, hematology, urinalysis, and 12-lead ECG.
Negative urine screen for drugs of abuse and negative alcohol breath test at Screening
and prior to dosing.
6. Negative human immunodeficiency virus (HIV) and Hepatitis B and Hepatitis C screening
test results.
7. Spirometry (forced expiratory volume in 1 second (FEV1)) value at screening greater
than 75% of predicted age-adjusted value.
Exclusion Criteria Healthy Volunteers:
1. A history of pulmonary or other disorder likely to influence drug absorption.
2. Evidence or suspicion of clinically significant respiratory, renal, hepatic, central
nervous system, cardiovascular or metabolic dysfunction.
3. A history of previous allergies or sensitivity to vancomycin, or other component(s) of
the study drug or reference drug.
4. Smokers (ex-smokers who quit smoking must have a one year period of not smoking prior
to the study drug administration).
5. Respiratory tract infection within the last two weeks prior to the first study drug
administration.
6. Treatment with any prescription medication and/or over-the-counter (OTC) products
including vitamins or mineral supplements within 48 hours before Investigational
Product administration.
7. Vaccination within one month before the study drug administration.
8. Systolic blood pressure <110 mmHg or >150 mmHg inclusive or diastolic blood pressure
<60 mmHg or >90 mmHg inclusive.
9. A history of drug or alcohol abuse.
10. Participation in a clinical study within three months on Investigational Product
administration.
11. Donation of blood or plasma within three months of Investigational Product
administration.
12. Any other condition which in the view of the Investigator is likely to interfere with
the study or put the subject at risk.
Inclusion Criteria CF Patients:
1. Able to communicate with site personnel and to understand and voluntarily sign the
Informed Consent Form.
2. Able and willing to comply with the protocol, including availability for all scheduled
study visits.
3. Have a confirmed diagnosis of cystic fibrosis (by two established methods, e.g.
positive sweat chloride value ≥ 60 mEq/L, nasal potential difference test, and/or
genotype with two identifiable mutations consistent with CF, accompanied by one or
more clinical features consistent with the CF phenotype).
4. Be aged ≥ 18 years old
5. Have FEV1 >40 % of predicted
6. Be able to perform all the techniques necessary to measure lung function
7. No liver enzymes increased by more than twice the upper limit of normal
8. Ability to spontaneously produce bronchial sputum daily
Inclusion Criteria CF Patients:
1. Administration of any investigational drug or device within 28 days of Screening and
within six half-lives of the investigational drug.
2. Oral corticosteroids in doses exceeding 10 mg per day or 16 mg every other day.
3. History of sputum culture or throat swab culture yielding B. cepacia in the previous
two years.
4. History of positive MRSA culture, or sputum culture positive for MRSA at screening.
5. Current daily continuous oxygen supplementation or requirement for more than 2 L/min
at night.
6. A history of previous allergies or sensitivity to vancomycin, or other component(s) of
the study drug.
7. Changes in antimicrobial, bronchodilator, anti-inflammatory or corticosteroid
medications within 7 days prior to Screening.
8. Changes in physiotherapy technique or schedule within 7 days prior to Screening.
9. History of lung transplantation.
10. A chest X-Ray at Screening or within the previous 90 days of Screening, with
abnormalities indicating a significant acute finding (e.g., lobar infiltrate and
atelectasis, pneumothorax, or pleural effusion).
11. Positive pregnancy test. All women of childbearing potential will be tested.
12. Female of childbearing potential who is lactating or is not practicing acceptable
method of birth control (e.g., hormonal or barrier methods, or intrauterine device).
13. Findings at Screening that, in the investigator's opinion, would compromise the safety
of the subject or the quality of the study data.
14. History of severe cough/bronchospasm upon inhalation of dry powder inhalation product.
15. Considered "terminally ill" or eligible for lung transplantation.
16. Have had a significant episode of hemoptysis (>60 mL) in the three months prior to
enrolment.
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 50 Years | Inhaled Vancomycin Tolerability, Safety and Pharmacokinetics | NCT01537666 | Contradiction |
1,483 | 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:
- All patients who presented to GI Motility Lab at IU University Hospital for esophageal
manometry-impedance and/or EndoFLIP
Exclusion Criteria:
- Age <18 yrs old
- Unable to communicate verbally with the staff
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 99 Years | Esophageal Impedance and Manometry Measurements and Dysphagia Symptom Scoring | NCT04503785 | Entailment |
2,862 | 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:
Medical Subjects:
- Be able to give consent themselves or via a legally authorized representative.
- Diagnosed with a neuromuscular disease and have limited ability to communicate.
- Be able to see visual cues such as targets or letters presented on the screen, and/or
ability to hear auditory cues such as tones or words presented through speakers or
earphones.
- Be able to understand and remember instructions concerning participation.
Healthy control subjects:
- Be able to consent to give consent themselves or via a legally authorized
representative.
- Be able to see visual cues such as targets or letters presented on the screen, and/or
ability to hear auditory cues such as tones or words presented through speakers or
earphones.
- Be able to understand and remember instructions concerning participation.
Exclusion Criteria:
- Individuals with cognitive impairments that would impact their ability to follow the
instructions
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 90 Years | EEG-Based Brain-Computer Interface Project for Individuals With Amyotrophic Lateral Sclerosis (ALS) | NCT00718458 | Entailment |
4,050 | 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:
- Referred to Sahlgrenska University hospital
- Primary osteoarthritis in the hip or knee
- Understanding and speaking Swedish
Exclusion Criteria:
- Prior assessment by and referral from an orthopedic surgeon for the current problem
- Secondary osteoarthritis (posttraumatic osteoarthritis, femoral head necrosis), when
stated on the referral
- Referred to a specific surgeon
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| PT-led Triage for Patients With Hip o Knee Osteoarthritis | NCT04665908 | Entailment |
1,531 | 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. Women aged 18-50 years, inclusive
2. General good health, by volunteer history and per investigator judgment
3. History of regular menstrual cycles of 24-35 days (inclusive), by volunteer report
4. History of Pap tests and follow-up consistent with standard medical practice or
willing to undergo a Pap test at Visit 1.
5. Protected from pregnancy by female tubal sterilization
6. Willing to abstain from or engage in intercourse with and without condoms and to
abstain from other vaginal activity as required in the protocol
7. In a mutually monogamous relationship for at least the last four months with a male
partner who:
1. Is at least 18 years old;
2. Has no known risk for STIs;
3. Is willing and able to comply with protocol requirements including sexual
activity/ abstinence and condom use requirements; and
4. Can engage in vaginal intercourse with the participant, with and without condoms,
as specified in protocol
8. Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to
easy colposcopy and genital tract sample collection
9. Willing to give voluntary consent, sign an informed consent form and comply with study
procedures as required by the protocol
Exclusion Criteria:
1. History of hysterectomy
2. Vasectomy in male partner
3. Sterility or known history of sperm dysfunction in male partner
4. Within two calendar months from the last pregnancy outcome. Note: If recently pregnant
must have had at least two spontaneous menses since pregnancy outcome.
5. Current use of any hormonal contraceptive or a copper IUD, or use of Depo-Provera
within the last 120 days
6. Currently breastfeeding or having breastfed an infant in the last two months, or
planning to breastfeed during the course of the study
7. Significant gynecological abnormalities (including abnormal vaginal bleeding or
excessive vaginal discharge)
8. Either device does not appropriately fit volunteer, as determined by clinician
9. Inability of the volunteer to insert, position, and/or remove either device, even with
assistance
10. History of sensitivity/allergy to nonoxynol-9 or to silicone or any other component of
Ovaprene™ or Caya, for either the volunteer or her male partner
11. In the last four months, either the volunteer or her male partner diagnosed with or
treated for any STI or pelvic inflammatory disease. Note: Women or male partners with
a history of genital herpes or condylomata who have been asymptomatic for at least six
months may be considered for eligibility
12. Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis,
or HIV
13. Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or
vesicles suspicious for a sexually transmitted infection
14. Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting, etc.)
15. Known current drug or alcohol abuse which could impact study compliance. (This is
defined as any illicit drug use or more than 15 alcoholic drinks per week)
16. Participation in any other investigational trial within the last 30 days or planned
participation in any other investigational trial during the study
17. History of gynecological procedures (including genital piercing) on the external
genitalia, vagina or cervix within the last 14 days
18. Abnormal finding on laboratory or physical examination or a social or medical
condition in either the volunteer or her male partner which, in the opinion of the
investigator, would make participation in the study unsafe or would complicate
interpretation of data
19. Nugent score greater than or equal to 7
20. Systemic use in the last two weeks or anticipated use during the study of antibiotics
(other than those used to treat UTI, vaginal candidiasis, or BV diagnosed at Visit 1,
or to treat UTI or vaginal candidiasis after Visit 1) or topical antivirals (e.g.,
acyclovir or valacyclovir). Note: Participants should avoid non-steroidal
anti-inflammatory drugs (NSAIDs) and Tylenol except for occasional use, as in
treatment of headaches or dysmenorrhea.
21. Grade 2 or higher abnormality per the March 2017 update of the Division of AIDS
(DAIDS), National Institute of Allergy and Infectious Disease (NIAID) Table for
Grading of the Severity of Adverse Events or clinically significant lab abnormalities
as determined by the investigator (see Section 13.5 for link to DAIDS table)
22. Inability to achieve adequate cervical mucus in two attempts at the baseline cycle
23. Inadequate sperm in endocervical aspirate during baseline testing without any device,
despite adequate mucus and presence of sperm in vaginal pool
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Safety and Acceptability Study of a Non-Hormonal Ring | NCT03598088 | Contradiction |
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