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1,649 | 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:
Subjects must satisfy the following criteria to be enrolled in the study:
1. Subject is a male, or a non-pregnant and non-nursing female between 18 and 55 years,
inclusive, of age at the time of signing the Informed Consent Form (ICF).
2. Subject must understand and voluntarily sign an ICF prior to any study-related
assessments/procedures being conducted.
3. Subject is willing and able to adhere to the study visit schedule and other protocol
requirements.
4. Subject has a BMI ≥ 18 and ≤ 33 kg/m2 at screening.
5. Female subject
1. Must have a negative pregnancy test
2. If postmenopausal: must have follicular stimulating hormone (FSH) test result >40
IU/L and a negative pregnancy test
6. Contraception Requirements:
Must comply with the following acceptable forms of contraception. All females of
childbearing potential (FCBP) must use one of the approved contraceptive2 options
described below while taking CC-11050 and for at least 28 days after administration of
the CC-11050 dose. At the time of study entry, and at any time during the study when a
FCFP's contraceptive measures or ability to become pregnant changes, the Investigator
will educate the subject regarding contraception options and the correct and
consistent use of effective contraceptive methods in order to successfully prevent
pregnancy. A FCBP who engage in activity in which conception is possible must use one
of the approved contraceptive options described below: Option 1: One highly effective
method (eg, hormonal contraception [oral, injection, implant, transdermal patch,
vaginal ring]; intrauterine device; tubal ligation; or partner's vasectomy) and 1
additional form (latex condom or any nonlatex condom not made of natural [animal]
membrane [eg, polyurethane], diaphragm, sponge).
OR Option 2: Male or female condom (latex condom or non-latex condom NOT made out of
natural [animal] membrane [for example, polyurethane) PLUS one additional barrier
method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c)
contraceptive sponge with spermicide.
7. A male subject must:
a. Practice true abstinence3 (which must be reviewed on a monthly basis and source
documented) or agree to use a barrier method of birth control (condoms not made out of
natural [animal] membrane [latex condoms are recommended]) during sexual contact with
a pregnant female or female of FCBP while participating in the study, during dose
interruptions, and for at least 28 days after the dose of IP, even if he has undergone
a successful vasectomy.
8. Subject has clinical laboratory safety test results that are within normal limits
(WNL) or acceptable to the Investigator.
9. Subject is afebrile (febrile is defined as ≥ 38°C or ≥100.4°F), with supine systolic
blood pressure ≥ 90 and ≤ 150 mm Hg, supine diastolic blood pressure ≥ 50 and ≤ 90 mm
Hg, and pulse rate ≥ 40 and ≤ 100 beats per minute at screening
10. Subject is in good health as determined by past medical history, PE, vital signs,
12-lead ECG, and clinical laboratory safety tests. Clinical laboratory safety tests
(ie, hematology, chemistry, and urinalysis) and 12-lead ECGs must be WNL or clinically
acceptable as judged by the Investigator.
11. Subject has a normal or clinically acceptable 12-lead ECG at screening. In addition:
- If male, the subject has a QTcF value ≤ 450 msec at screening
- If female, the subject has a QTcF value ≤ 470 msec at screening
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
1. Subject has any significant medical condition, laboratory abnormality, or psychiatric
illness that would prevent the subject from participating in the study.
2. Subject has any condition including the presence of laboratory abnormalities, which
places the subject at unacceptable risk if he/she were to participate in the study.
3. Subject has any condition that confounds the ability to interpret data from the study.
4. Subject is pregnant or breastfeeding.
5. Subject was exposed to an investigational drug (new chemical entity) within 30 days
preceding the first dose administration, or 5 half-lives of that investigational drug,
if known (whichever was longer).
6. Subject has used moderate or strong CYP3A4/5 inducers and/or inhibitors (including St.
John's wort) within 30 days prior to dosing. The Indiana University P450 Drug
Interactions Flockhart Table™ may be consulted for a list of such medications.
7. Subject has any surgical or medical condition(s) possibly affecting drug absorption,
distribution, metabolism, and excretion, eg, bariatric procedure. A subject with an
appendectomy and/or cholecystectomy may be included.
8. Subject has donated blood or plasma within 8 weeks before dose administration to a
blood bank or blood donation center.
9. Subject has a history of drug abuse (as defined by the current version of the
Diagnostic and Statistical Manual) within 2 years before dose administration, or
positive drug screening test reflecting consumption of illicit drugs unless positive
drug screen is due to prescription drug use that is approved by the Investigator and
the Medical Monitor.
10. Subject has a history of alcohol abuse (as defined by the current version of the
Diagnostic and Statistical Manual) within 1 year before dose administration, or a
positive alcohol screen.
11. Subjects smokes more than 10 cigarettes per day, or the equivalent in order tobacco
products (self-reported).
12. Subject has had a positive result to the test for human immunodeficiency virus (HIV)
antibodies at Screening.
• Chronic or resolved Hepatitis B or Hepatitis C are acceptable only if sequelae are
limited to hepatic involvement and its consequent comorbidities. (ie, vasculitis,
clinically significant globulinemia, etc. are unacceptable).
13. Subject has received a live vaccination (excluding seasonal flu vaccination) within 30
days of dosing.
14. Used prescribed systemic or topic medication within 30 days of the first dose
administration
15. Used any non-prescribed systemic or topic medication (including vitamin/mineral
supplements, and herbal medicines, eg, St. John's Wort) within 14 days of the first
dose administration, unless Sponsor agreement is obtained.
16. History of significant multiple and/or severe allergies (e.g., food, drug, latex
allergy) or has had an anaphylactic reaction or significant intolerability to
prescription or nonprescription drugs or.
17. Subject is, for any reason, deemed by the Investigator to be inappropriate for this
study, including a subject who is unable to communicate or to cooperate with the
investigator or the clinical 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 55 Years | A Study to Evaluate the Safety, Tolerability Pharmacokinetics, and Pharmacodynamics of a New Spray Dried Dispersion (SDD) Formulation of CC-11050 After Single Dose of CC-11050 and to Evaluate the Pharmacokinetics of CC-11050 Under Fasted and Fed Conditions and After Coadministration With Omeprazole | NCT04139226 | Entailment |
1,435 | 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. | Patients (men and nonpregnant women) with systemic hypertension, patients with
hypercholesterolemia, and normal volunteers.
All blood pressure recordings must be consistently elevated.
No renovascular hypertension or other etiologies for elevated blood pressure.
No definite evidence of accelerated or malignant hypertension (diastolic pressures above
115 mmHg, with associated encephalopathic changes, papilledema, progressive renal failure,
or congestive heart failure), or serious intercurrent illness.
Patients in whom withdrawal of antihypertensive medications is considered hazardous are
ineligible.
Patients in whom the blood pressure remains at normal levels 2 weeks after withdrawal of
antihypertensive treatment will be closely monitored until they become hypertensive, at
which time they will undergo the study. Patients in whom blood pressure does not increase
after 2 months of discontinuation of therapy will be excluded from the study.
Patients with coexistent hypertension and hypercholesterolemia are ineligible.
Normal volunteers who are not taking any kind of medication are eligible.
No history of diabetes, peripheral vascular disease, coagulopathy, or any other disease
predisposing to vasculitis or Raynaud's phenomenon.
No history of keloid formation.
All patients must be capable of giving informed consent for all procedures.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Study of the Response of Human Small Blood Vessels | NCT00001622 | Contradiction |
3,575 | 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:
- erythema migrans
Exclusion Criteria:
- pregnancy or lactation
- immunocompromised
- taking antibiotic with antiborrelial activity within 10 days
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Patient's Pretreatment Expectations About Post-Lyme Symptoms | NCT03462329 | Entailment |
287 | 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:
We included nulliparous patients who were < 42 years of age with body mass index (BMI) < 30
kg/m2 and normal endometrial cavity, used fresh sperm or oocytes, had two or more embryos
available for transfer on day 3 post ovum pick-up (OPU), and no more than 3 previous
unsuccessful ART cycles
Exclusion Criteria:
Patients with uterine fibroids, uterine anomalies, intra-uterine adhesions, and uterine
polyps, patients with chronic diseases in the as uncontrolled diabetes or hypertension, or
if the patient had difficult mock ET . patients with severe male factors for infertility
requiring surgical retrieval of sperms were excluded from the study.
-
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 42 Years | Effect of Intrauterine Navigation Using Intrauterine Insemination Catheter for Mock Embryo Transfer Prior to Day 3 Embryo Transfer on Pregnancy Rate: A Pilot Study | NCT03358732 | Contradiction |
5,317 | 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:
- Patients suffering from constitutional von Willebrand disease for whom Desmopressin
treatment is deemed ineffective or contraindicated
- Patients suffering from von Willebrand disease and being treated or having been
treated with Voncento® for the treatment of surgical and non-surgical bleeding
episodes, the prophylaxis of surgical and non-surgical bleedings
- Patients with no history or suspicion of inhibitors (judged on previous efficacy)
Exclusion Criteria:
- Refusal of the patient or the patient's legal representative to take part in the
study;
- Existence of a contraindication to the use of Voncento® treatment
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Registry of Patients With Von WilLEbrand Disease Treated With Voncento® | NCT04657887 | Contradiction |
6,550 | 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:
- Clinical diagnosis of hemophilia type A or hemophilia type B.
- Knee, elbow or ankle arthropathy caused by hemophilia
- Pharmacological treatment based on using VIII or IX factor concentrates.
Exclusion Criteria:
- Presence of VIII FIX inhibitors.
- Having received anti-inflammatory treatment using Arcoxia (Etoricoxib)
- Having undergone a surgical intervention at the target joint.
- Patients enrolled in other research which implies doing physical exercise.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 45 Years | Therapeutic Exercise in Patients With Hemophilia | NCT04114448 | Contradiction |
429 | 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 who have a positive pregnancy test following IVF or frozen-thawed transfer
Exclusion Criteria:
- Women with renal failure are excluded due to assay interference with kisspeptin
measurement
Female
No healthy subjects accepted to join the trial.
| Serum Kisspeptin: a Predictive Marker of Miscarriage or Not? | NCT03940495 | Contradiction |
6,207 | 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:
- physicians working in endoscopy units worldwide
Exclusion Criteria:
- physicians not working in endoscopy units worldwide
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.
Subject must be at most 70 Years | COVID-19 Endoscopy Survey | NCT04342637 | Contradiction |
310 | 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:
- be healthy women, who are sexually active, at risk for pregnancy and desiring
contraception
- be within the age range of 18 through 40 years inclusive
- be at low-risk for human immunodeficiency virus (HIV) or sexually transmitted disease
(STD) infection, currently have (≥4 months) a single sexual partner who is also at
low-risk for HIV or STD infection and expect to have the same partner for the duration
of the study
- have a negative urine pregnancy test at the admission visit
- have normal cyclic menses with a usual length of 24 to 35 days over the last 2 months
- have a documented history of at least one spontaneous, normal menstrual cycle (two
menses) since delivery, abortion, or after discontinuing hormonal
contraception/hormonal therapy
- be willing to accept a risk of pregnancy
- be willing to engage in at least 4 acts of heterosexual vaginal intercourse per cycle
for a period of approximately seven months
- be willing to be randomized to either study treatment as applicable
- be willing to be fitted with a diaphragm and use the diaphragm with test product
during all acts of heterosexual vaginal intercourse for the duration of the study
- be willing to only use the test product with diaphragm as the primary method of
contraception over the course of the study [with the exception of emergency
contraception pills (ECPs), when indicated]
- be capable of using the product and diaphragm properly and agree to observe all study
directions and requirements
Exclusion Criteria:
- have a history of allergy or sensitivity to spermicides, products containing N-9,
and/or products containing latex
- have a history of toxic shock syndrome
- have had two or more UTIs in the past year or currently have a suspected or diagnosed
UTI or vaginitis by dipstick urinalysis or wet mount, unless treated and proof of cure
is documented
- be pregnant, have a suspected pregnancy or desire to become pregnant during the course
of the study
- have a history of infertility or conditions which may lead to infertility
- have contraindications to pregnancy (medical condition) or chronic use of class D or X
medications
- have been hospitalized for pelvic inflammatory disease without a subsequent
intrauterine pregnancy
- have had more than one sexual partner in the past 4 months
- have shared injection drug needles within the past 6 months
- have, or suspected to have, HIV infection
- have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence
(initial episode) within the 3 months prior to screening, or have clinical evidence of
HSV on exam
- have been diagnosed with any other STDs (including trichomonas) in the 6 months prior
to the screening visit
- be lactating or breastfeeding have had a Depo-Provera injection in the 10 months
prior to screening
- have a vaginal or cervical abnormality that would interfere with the proper placement
and retention of test product and diaphragm
In addition, in order to be eligible to participate in the trial, potential subjects must
state that, to her best knowledge, her sexual partner meets the following criteria:
- is not infertile
- has not been treated for Chlamydia trachomatis or N. gonorrhoeae in the past 6 months
- has not been previously diagnosed with, or suspected to have, HIV infection
- has not had more than one sexual partner in the past 4 months
- has not engaged in homosexual intercourse in the past 10 years
- has not shared injection drug needles in the past 10 years
- has no history of allergy or sensitivity to spermicides or products containing N-9
- has no history of allergy or sensitivity to products containing latex
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Open Label Study of the Safety and Contraceptive Efficacy of BufferGel® With Diaphragm | NCT00397670 | Contradiction |
5,530 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
1. Age more than 50 years
2. C-reactive protein (CRP)>15 mg/L or erythrocyte sedimentation rate (ESR)>40 mm/h
3. Either
1. cranial symptoms such as new-onset headache or scalp tenderness, jaw or tongue
claudication, visual disturbances
2. new-onset limb claudication
3. protracted constitutional symptoms, defined as weight loss>5 kilograms or
fever>38 degrees Celcius for >3 weeks
4. Bilateral shoulder pain and morning stiffness.
Exclusion Criteria:
1. oral glucocorticoid treatment within the past month;
2. subcutaneous, intramuscular, intra-articular or intravenous glucocorticoid within the
past 2 months;
3. DMARD treatment or other immunosuppressive therapy within the past 3 months;
4. ongoing treatment with interleukin2;
5. previous diagnosis of GCA or polymyalgia rheumatica;
6. any disease potentially causing large vessel inflammation, that is autoimmune
diseases; rheumatoid arthritis, Cogans syndrome, relapsing polychondritis, ankylosing
spondylitis, systemic lupus erythematosus, Buerger's disease, Bechet's disease,
inflammatory bowel disease, infections; syphilis, known active current or history of
recurrent tuberculosis, hepatitis or HIV, or other large vessel disease; sarcoidosis,
neurofibromatosis, congenital coarctation, Marfans syndrome, Ehlers-Danlos syndrome,
retroperitoneal fibrosis.
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.
| Evaluation of Ultrasound and PET/CT in the Diagnosis and Monitoring of Giant Cell Arteritis | NCT03765424 | Entailment |
1,576 | 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:
- wrist circumference: 14 cm-25 cm
Exclusion Criteria:
- none
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 23 Years old.
Subject must be at most 81 Years | Wrist-used Blood Pressure Monitor Clinical Test (Cuff Range: 14cm-25cm) | NCT00952965 | Contradiction |
3,059 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
1 Segment 1 :Boys at the age range of 8-13 years 2. Segment 2: Boys at the age range of
12-17 years 3. Tanner stage 1 (segment 1 only) 4. more than 2 SD's (standard deviation)
below the average height
Exclusion Criteria:
1. Mental retardation,
2. Psychiatric illness,
3. Lack of informed consent\assent.
4. Health status that required chronic treatment with steroids
Male
No healthy subjects accepted to join the trial.
Subject must be at least 8 Years old.
Subject must be at most 17 Years | Short Stature Related Distress | NCT01246219 | Entailment |
1,914 | 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, N0-3, M0 at preoperative evaluation according to the AJCC Cancer
Staging Manual Seventh Edition Expected curative resection through gastrectomy with D2
lymphadenectomy Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group)
scale ASA (American Society of Anesthesiology) score class I, II, or III Informed consent
obtained from patients or their appointed agent
Exclusion Criteria:
Patients treated with neoadjuvant chemotherapy or radiation therapy; Patients with history
of upper abdominal surgery; History with other severe comorbidities and cannot tolerate
laparoscopic surgery, such as severe heart and lung diseases, heart function below clinical
stage 2, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes
and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B
grade, and severe malnutrition, etc; Patients suffering from malignant diseases before the
study or with other gastric malignant diseases, such as lymphoma and stromal tumors, etc.;
Pregnant woman and woman during lactation; Patients with mental sickness; The patient
compliance is bad or the researcher expect there will not be good patient compliance;
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 | Study on Laparoscopic D2 Lymphadenectomy Plus Complete Mesogastrium Excision（D2+CME）for Advanced Gastric Cancer | NCT01978444 | Entailment |
2,363 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Age greater than 6 months and less than 14 years
- Confirmed duplication of exon 2 in the DMD gene using a clinically accepted technique
that completely defines the mutation
- Pre-ambulant (not yet walking) or ambulant (as defined by the ability to walk 10
meters without assistance)
- Males of any ethnic group will be eligible
- Ability to cooperate with muscle testing
- In subjects age 4 and above, stable dose and regimen of corticosteroid therapy
(prednisone, deflazacort, or their generic forms) for at least 12 weeks prior to gene
transfer.
Exclusion Criteria:
- Active viral infection based on clinical observations
- Symptoms or signs of cardiomyopathy, including:
1. Dyspnea on exertion, pedal edema, shortness of breath upon lying flat, or rales
at the base of the lungs
2. Echocardiogram with ejection fraction below 40%
- Serological evidence of HIV infection, or Hepatitis B or C infection
- Diagnosis of (or ongoing treatment for) an autoimmune disease
- Persistent leukopenia or leukocytosis (WBC ≤ 3.5 K/µL or ≥ 20.0 K/µL) or an absolute
neutrophil count < 1.5K/µL
- Concomitant illness or requirement for chronic drug treatment that in the opinion of
the SI creates unnecessary risks for gene transfer
- AAV9 binding antibody titers ≥ 1:400 as determined by ELISA immunoassay
- Abnormal laboratory values in the clinically significant range as listed in Table 7,
based upon normal values in the Nationwide Children's Hospital Laboratory.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
Subject must be at most 13 Years | AAV9 U7snRNA Gene Therapy to Treat Boys With DMD Exon 2 Duplications. | NCT04240314 | Entailment |
2,314 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Diagnosed with DMD, genotypically confirmed.
- Intact right and left biceps muscles or an alternative upper arm muscle group.
- Stable pulmonary and cardiac function.
- Minimum performance on 6MWT, North Star Ambulatory Assessment, and rise (Gowers) test
as specified in the study protocol.
- On a stable dose of corticosteroids for at least 6 months.
Exclusion Criteria:
- Previous treatment with the experimental agents BMN-195 (SMT C1100) or PRO053.
- Current or previous treatment with any other experimental treatments within 12 weeks
prior to study entry.
- Major surgery within the last 3 months.
- Presence of other clinically significant illness.
- Major change in physical therapy regime within the last 3 months.
Other inclusion and exclusion criteria may apply.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
Subject must be at most 15 Years | Phase I/II Study of SRP-4053 in DMD Patients | NCT02310906 | Entailment |
3,518 | 26 | A 33-year-old woman comes to clinic complaining of progressive fatigue, decreased appetite, and 11-lb weight loss in the past 2 months. She uses levothyroxine because of the previously diagnosed Hashimoto disease. She has no other medical conditions and does not use tobacco, alcohol, or illicit drugs. Physical examination shows a generalized increase in pigmentation of the skin. Measurement of serum cortisol before and after administration of exogenous adrenocorticotropic hormone (ACTH) shows no difference in the levels. Stable glucocorticoid replacement therapy starts for her with the diagnosis for primary adrenal insufficiency (Addison disease) | I went to the clinic because I was really suffering from fatigue and decreased appetite and I also lost 11 pounds over the past two months. I'm just 33 years old so that's not normal, especially for a woman. I take levothyroxine because I have been diagnosed with Hashimoto disease. I don't have any other medical condition, and I don't smoke I don't drink, and I don't do drugs. They also did my physical examination and they saw that I had an increase in pigmentation of my skin. They measured my cortisol level before and after giving me some ACTH hormone, and the results came back with no difference whatsoever. The doctor told me I have Addison disease and put me under glucocorticoid therapy. | Inclusion Criteria (1 of the following):
- Completed insulin tolerance testing (ITT) at University of Michigan from 2012 to
present.
- Are scheduled to complete ITT.
- Are clinically suspected to have adrenal insufficiency but have not undergone ITT.
Exclusion Criteria:
- Female patients who are of child-bearing potential (defined as a sexually mature woman
who has not undergone hysterectomy, bilateral oophorectomy bilateral salpingectomy or
bilateral tubal ligation/occlusion, at least 12 weeks prior to screening, or who has
not been naturally postmenopausal for at least 24 consecutive months prior to study
enrollment) and not using non-hormonal contraception.
- Female patients not willing to use non-hormonal contraception for one month following
treatment.
- Women who are pregnant or breast feeding.
- Patients with an existing diagnosis of adrenal insufficiency who are on any
glucocorticoid replacement other than oral hydrocortisone or prednisone.
- Patients on medications that are strong CYP3A
- Patients taking other medications metabolized by CYP3A
- Patients who have a history of QT prolongation and patients with any recent abnormal
electrocardiogram (ECG).
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.
| Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency | NCT04588688 | Contradiction |
5,369 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Healthy adult patients with one or more teeth to be extracted, from premolar to
premolar
Exclusion Criteria:
- Heavy smokers (more than 10 cig per day)
- Current Pregnant patients
- History of malignancy
- History of radiotherapy or chemiotherapy in the past 5 years
- Long term steroidal or antibiotic therapy
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 90 Years | Healing of Post-ext Sites Using Bovine Bone Mineral: a CBCT and Histologic RCCT | NCT01800149 | Contradiction |
1,276 | 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:
- Provide written informed consent to participate on the study
- Patients must have a pathologically confirmed diagnosis either at MSKCC or at the
participating site of stage I-III malignant pleural mesothelioma
- Epithelioid or biphasic histology subtype (Note: patients with biphasic histology can
have < 10% sarcomatoid)
- No evidence of metastatic disease.
- Patient age ≥ 18 years but ≤ 80 years at the time of consent.
- Karnofsky performance status ≥ 80%
- Pulmonary Function Tests:
1. For all patients: DLCO > 40% predicted (corrected for Hgb)
2. For patients enrolled post-P/D, only: FEV1 >/= 35% (corrected for Hgb) (Note:
patients enrolled prior to P/D will have PFTs repeated pre-IMRT. If this criteria
is not met, they will be removed from study)
- In cases of concern about decreased renal function and potential high radiation dose
to the kidneys, an optional nuclear medicine kidney function scan may be performed
prior to radiation therapy to determine the functional contribution of each kidney.
- Patient enrolled prior to chemotherapy must have adequate organ function as indicated
by the following laboratory values:
1. Absolute neutrophil count ≥1.5 K/mcL
2. Platelets ≥100 K/mcL
3. Serum total bilirubin ≤ 1.5 X ULN
4. AST (SGOT) or ALT (SGPT) ≤ 3.0 X ULN Note: patients enrolled after chemotherapy
do not have to meet the above criteria
Exclusion Criteria:
- > 10% Sarcomatoid or desmoplastic histology
- Continuous oxygen use
- Prior nephrectomy on the contralateral side of MPM
- Prior intrapleural therapy (except pleurodesis) or intrapleural therapy at the time of
P/D (i.e.: intrapleural chemotherapy, photodynamic therapy, intrapleural betadine)
- Prior thoracic radiation therapy preventing hemithoracic pleural IMRT
- Bulky disease in the fissure preventing lung-sparing pleural IMRT
- Patients undergoing extrapleural pneumonectomy
- Patients with an active infection that require systemic antibiotics, antiviral, or
antifungal treatments
- Patients with a concurrent active malignancy (except squamous or basal cell carcinoma
of the skin)
- Patients with serious unstable medical illness
- Presence of third space fluid that cannot be controlled by drainage
- For patients who develop or have baseline clinically significant pleural effusions
before or during initiation of pemetrexed therapy; consideration should be given to
drain the effusion prior to chemotherapy administration
- No acute congestive heart failure
- Pregnant or lactating women
- Men or women not using effective contraception
Reproductive risks Patients should not become pregnant or father a baby while on this study
because the drugs in this study can affect an unborn baby. Women should not breast-feed a
baby while on this study. Women of childbearing age will be counseled to use birth control
while on this 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.
Subject must be at most 80 Years | Pleurectomy/Decortication (Neo) Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma | NCT00715611 | Entailment |
6,410 | 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:
- Athletes (professional or recreational but aiming to compete at a national or
international level), performing mixed-type or endurance sports as defined by
Pelliccia et al. who:
1. have recovered from a proven (either by PCR (Polymerase Chain Reaction), serology
or chest Computed Tomography) COVID-19 infection
2. are more than 1-month post onset of symptoms or the first positive PCR and
3. are willing to start (or are) exercising again
Exclusion Criteria:
1. known prior cardiac fibrosis
2. known or newly diagnosed coronary artery disease
3. allergy or contraindications for gadolinium contrast.
4. unwillingness or impossibility to give informed consent
5. Presence of edema on the CMR
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.
| Effect of CoVid-19 (CoronaVirusDisease-19) and Exercise on Myocardial Fibrosis and Ventricular Arrhythmias | NCT04726150 | Entailment |
3,584 | 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:
Criteria for the diagnosis of Lyme disease can be found at The clinical assessment,
treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis:
clinical practice guidelines by the Infectious Diseases Society of America (4).
1. Patients With EM (N=35), Post Treatment
- Age 18 or older
- EM diagnosed by the study physician or, with a diagnosis of EM that is thought to
be highly likely by the study physician.
- Treatment with at least 1 course of antibiotics that fulfills the Infectious
Diseases Society of America guidelines for the recommended therapy for Lyme
disease. There must be at least 1 month and up to 4 months between the end of the
therapy and the study procedures.
2. High C6 Antibody Titer (N=35)
- Age 18 or older
- Diagnosed with confirmed or probable early or late Lyme disease as per Centers
for Disease Control and Prevention (CDC) case definition
(http://www.cdc.gov/ncphi/disss.nndss/caseded/lyme disease 2008.htm), have
received recommended antibiotic therapy and have a high C6 ELISA titer (index
above 3) at least 6 months after therapy.
3. Post Lyme disease syndrome (N=20)
- Age 18 or older
- Diagnosed with confirmed or probable early or late Lyme disease fulfilling the
case definition of Lyme disease by the CDC
(http://www.cdc.gov/ncphi/disss.nndss/caseded/lyme disease 2008.htm)
- Received recommended antibiotic therapy, with resolution or stabilization of the
objective manifestation(s) of Lyme disease.
- New complaints of fatigue, paresthesias or dysesthesias, widespread
musculoskeletal pain or cognitive difficulties within 6 months of the diagnosis
of Lyme disease
- Symptoms are persistent or relapsing for at least a 6-month period after
completion of antibiotic therapy, causing reduction in previous levels of
occupational, educational, social, or personal activities.
- No antibiotic therapy active against Lyme disease in the previous 3 months.
4. Patients With EM (N=20), On Treatment
- Age 18 or older
- EM diagnosed by the study physician and receiving antibiotic therapy for less
than 48 hours.
5. Lyme Arthritis (N=10)
- Age 18 or older
- Lyme arthritis and have not received therapy.
6. Healthy Volunteers (N=30)
- Age 18 or older
- No history of Lyme disease
- Negative whole-cell Borrelia ELISA or C6 ELISA
- Living in an endemic area for Lyme disease.
EXCLUSION CRITERIA:
- History of allergy to surgical tape or Nitex nylon mesh
- History of severe reactions to tick bites (granuloma or systemic reactions)
- Inability to maintain the dressing for any reason
- Currently receiving any antibiotic or having received antibiotics in the last month (3
months for patients with post Lyme disease syndrome and high C6 titer) (except
patients with EM on treatment)
- Pregnancy or lactation
- Unwillingness to use an effective method of birth control for 3 months after tick
placement (women of child-bearing potential only)
- Not able to understand all of the requirements of the study or unable to give informed
consent and/or comply with all aspects of the evaluation.
- Investigational therapy during the time of the study and/or in the month prior to
signing the informed consent.
- Active severe skin disease, uncontrolled diabetes, cancer other than non-melanoma skin
cancers, autoimmune disease requiring immunosuppressive therapy, or history of HIV,
chronic viral hepatitis, or syphilis.
- Oral steroids in the previous 2 weeks (nasal steroids and replacement doses of
steroids are not exclusions)
- Any other condition that, in the opinion of the investigator, would make the patient
unsuitable for enrollment or could interfere with the patient participating in and
completing the study.
EXCLUSION FROM SKIN BIOPSY PART OF THE PROTOCOL:
- History of forming large thick scars after skin injuries or surgery
- History of excessive bleeding after cuts or procedures
- Currently taking anticoagulants
- History of allergy to lidocaine
- Biopsies will not be done on face, neck, scalp, or over the tibia
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.
| Searching for Persistence of Infection in Lyme Disease | NCT01143558 | Entailment |
1,486 | 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:
- Subject is a female or male, 20-69 years of age, inclusive.
- Subject has a BMI of 18.5 to 39.9 kg/m2, inclusive.
- Subject has resting blood pressure measurements meeting the criteria for
pre-hypertension (SBP = 120 to 139 mm Hg and/or DBP = 80 to 89 mm Hg) or stage 1
hypertension (SBP = 140 to 159 mm Hg or DBP = 90 to 99 mm Hg)
- Subject reports history of consuming, on average, ≤2 servings/d of dairy foods as part
of their normal diet
- Subject is willing to consume ≤1 serving/d of dairy foods (other than the study
products provided) during each treatment phase.
- Subject is willing to maintain a stable body weight and habitual diet and physical
activity patterns throughout the trial, with the exception of specific study
instructions related to study product intake, alcohol intake, and physical activity.
Exclusion Criteria:
- Subject has known coronary heart disease (CHD) or a CHD risk equivalent
- Subject has a history of any major trauma or major surgical event
- Subject has digital deformities that would prevent EndoPAT measurements.
- Subject has used medications known to alter body weight
- Subject has used medications or dietary supplements that, in the opinion of the
Investigator, have strong potential to influence blood pressure or endothelial
function
- Subject has extreme dietary habits (e.g., Atkins diet, very high protein/low
carbohydrate).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 69 Years | Clinical Trial to Assess the Effects of Low-fat Dairy on Systolic Blood Pressure | NCT01463085 | Entailment |
6,713 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- patients with acquired haemophilia
- patients with congenital haemophilia A with inhibitor
Exclusion Criteria:
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Use of a TGA and TEM in the Assessment of the Efficacy of Treatment With APCC or rFVIIa | NCT01856751 | Contradiction |
1,580 | 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:
- Are males or females 18 years of age or older
- Have confirmed diagnosis of CTS in one or both wrists. For patients with bilateral
CTS, the most painful wrist will be identified as the "index" wrist, and will be the
wrist used for all efficacy evaluations.
- Have clinical symptoms of pain, paresthesia, numbness and/or tingling in the
distribution of the median nerve
- Have positive findings from electrodiagnostic tests using accepted criteria
- Have classification of the wrist(s) as "classic" or "probable" using the Katz Hand
Diagram (Katz and Stirrat, 1990)
- Have worst daily pain intensity greater than 5 (0-10 scale) on approximately 75% of
days over the previous 3 months; this criteria will be assessed at the screening visit
only
- Have a normal 12-lead electrocardiogram (ECG) without any clinically significant
abnormalities in heart rate, rhythm, or conduction
- Have been informed of the nature of the study and provided written informed consent
Exclusion Criteria:
- Have a positive serum pregnancy test (females of childbearing potential only)
- Have tumors or cysts in the wrist, muscle wasting in the forearm and/or hand,
peripheral neuropathy, mononeuropathy multiplex, or hand arthritis
- Have had previous CTS surgery
- Have severe CTS as defined by electrodiagnostic findings
- Have had steroid injections for CTS in the previous 3 months
- Have used diuretics (except a stable dose for hypertension) or Vitamin B6 or topical
treatments for CTS (e.g., ultrasound, iontophoresis, cold laser) in the past 2 weeks
- Require sleep medications
- Are using a lidocaine-containing product that cannot be discontinued during the study
- Have a known sensitivity or allergy to an amide-type local anesthetic agent
para-aminobenzoic (PABA) derivatives or local anesthetics
- Have previously participated in a Lidoderm study
- Have severe renal insufficiency (creatinine clearance of <30 mL/min)
- Have moderate or greater hepatic impairment, including a history of or active
hepatitis
- Have abnormal clinical laboratory test results unless deemed clinically insignificant
by the investigator
- Have current or planned litigation, or who are planning to acquire or are currently
receiving Worker's Compensation or Social Security benefits, or who, in the opinion of
the investigator, exhibit any evidence of secondary gain (monetary or non-monetary)
associated with carpal tunnel syndrome pain.
- Have a history of alcohol or substance abuse within the last 3 years
- Have received an investigational drug or product or participated in an investigational
drug study within a period of 30 days or 5 half-lives prior to receiving study drug
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Safety and Efficacy of Lidoderm (Lidocaine Patch 5%) in Treating Moderate to Severe Pain Associated With Carpal Tunnel Syndrome | NCT00266214 | Contradiction |
4,714 | 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 >40 years old, with no future childbearing plans
- Age >30 years old, who has tubal sterilization
- Significant symptoms related to adenomyosis, intractable to standard medical therapy,
or patient considering radiological intervention (uterine fibroid embolization) or
surgery.
- Clinical uterine size less than 20 weeks gestation
- Localized adenomyotic lesion or adenomyoma identified of less than 10 cm in diameter
as judged by contrast MRI, involving only anterior or posterior uterine wall and not
both.
- No laparotomy scars.
- Women should be able to give consent.
Exclusion Criteria:
- Other pelvic or uncontrolled systemic diseases
- Confirmed or suspected pregnancy
- Patients who are unable to communicate with researchers during the treatment
- Patients who are contraindicated for MRI examination
- Patients with thick abdominal wall (>5 cm, as measured by MRI)
- Presence or history of acute pelvic inflammatory disease or any pelvic malignancy
- History of lower abdominal surgery, known severe pelvic endometriosis and/ or
extensive pelvic adhesion
- Presence of significant sized fibroids which may interfere with the treatment or
affect the outcome measures
Female
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 60 Years | High-intensity Focused Ultrasound in Treatment of Uterine Adenomyosis | NCT02954757 | Entailment |
1,393 | 8 | A 7-month-old boy is brought to emergency by his parents due to irritability and inability to defecate for the past 3 days. The patient has had constipation and discomfort with bowel movements since birth. His symptoms worsened after eating semi-solid foods. Vital signs are normal. Abdominal examination shows distension and tenderness to palpation with presence of bowel sounds. Xray with barium shows a narrow rectum and rectosigmoid area. The rest of the colon proximal to this segment is dilated. Digital rectal exam revealed burst of feces out of the anus. The biopsy showed absence of submucosal ganglia in the last segment of the large intestine. | My baby boy just turned 7 months old but my wife and I cannot get a hold of him! He has not been able to poop for 3 days! My poor little thing has been having constipation and bowel problems since birth. But since he ate some semi-solid food it has just been worse! The doctor said his vitals are normal but his belly is tense and tender with his bowels making noise. They did an X-ray and found out that he had a narrow rectum. His colon is dilated. They also performed a touch rectal exam and he could finally poop! The biopsy revealed that there is no submucosal ganglia in his large intestine. | Inclusion Criteria:
1. Age from 6months to 3 years.
2. Both sexes.
3. Classic and long segment Hirshsprung.
4. Total a ganglionic colon.
5. Hirshsprung disease with leveling colostomy
Exclusion Criteria:
1. Patients <6 months and >3 years.
2. Short and Ultra-short Hirshsprung.
3. Recurrent cases of Hirshsprung.
4. Other contraindication of laparoscopy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
Subject must be at most 36 Months | Laparoscopic Assisted Pull-through Versus Other Surgical Procedures for Treatment of Hirschsprung Disease | NCT03269812 | Entailment |
3,827 | 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:
- osteoarthritis visible on knee radiograph
- patient opting for non-surgical treatment
- no corticosteroid knee injection for 90 days prior to consent
- no corticosteroid knee injection for 90 days following consent
Exclusion Criteria:
- bilateral symptomatic knee osteoarthritis
- prior surgery on the knee of interest
- hardware present on the knee of interest
- gross instability detected on physical exam
- malignancy in the knee of question
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 99 Years | Effects of Reparel™ Knee Sleeve on Knee Osteoarthritis | NCT04743921 | Entailment |
1,467 | 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:
- symptoms of gastroesophageal reflux
- presence of Zenker's diverticulum or cricopharyngeal hypertrophy
- undergoing surgery for Zenker's diverticulum or cricopharyngeal hypertrophy with
endoscopic laser cricopharyngeal myotomy
- at least 18 years old
Exclusion Criteria:
- pregnant women
- children
- prisoners
- adults lacking capacity to consent
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.
| Laryngopharyngeal Reflux Before and After Cricopharyngeal Myotomy | NCT01880892 | Entailment |
943 | 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:
Knee osteoarthritis participants only:
- Knee Osteoarthritis confirmed by a physician using the American College of
Rheumatology (ACR 1986) Criteria
- Have unilateral or bilateral knee osteoarthritis
- Aged 40 years or over.
Healthy control participants only:
- Have no history of unilateral/bilateral knee osteoarthritis
- Had no current chronic/stable knee pain in the past 3 months
- Aged 40 years or over.
Exclusion Criteria:
All participants are excluded if they:
- Have neuromuscular skeletal injury/illness (e.g.Multiple Sclerosis, Parkinson's
disease, Muscular Dystrophy, Cerebral Palsy)
- Have had knee surgery, knee arthroplastic surgery and arthroscopic debridement or
corrective surgery for knee osteoarthritis in the past 12 months
- Have had corticosteroid injections to or around the knee in the past 3 months.
- Have unstable heart disease
- Previously had a stroke
- Have insulin-dependent diabetes
- Have osteoporosis
- Have a history of falls and other motor deficits
- Are unable to walk up and down stairs
- Are unable to rise from a chair without the aid of another person
- Have an unstable medication schedule and medication that causes dizziness
- Have Dementia/Alzheimer's/ an inability to comprehend, follow instructions and give
informed consent
- Have an inability to lie flat for 60 minutes Have mental in their body.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
| Neuromuscular Control in Knee Osteoarthritis | NCT02314715 | Entailment |
949 | 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:
- Symptomatic knee osteoarthritis presenting to physician's office
- Radiographic evidence of knee osteoarthritis
- Age 18 years or older
- Failed minimum of 3 months of non-operative treatment, including, but not limited to,
Tylenol, anti-inflammatory medication, cortisone injection, physical therapy, bracing,
and/or heel wedge
- Symptoms for at least 3 months
Exclusion Criteria:
- Associated ligamentous instability
- History of deep knee infection
- Candidate for total knee arthroplasty or arthroscopy
- Peripheral neuropathy.
- X-rays that are completely negative and only MRI evidence or arthroscopic evidence
(from previous arthroscopy) of OA.
- Prior HA injections at any point in the past
- Chondrocalcinosis
- Patients with precautions or contraindications for viscosupplementation use
- Cortisone injection within past 3 months
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 | Prediction of Response to Intra-articular Injections of Hyaluronic Acid for Knee Osteoarthritis | NCT01557868 | Entailment |
694 | 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:
- Ages 10 years or older
- Known or suspected iron overload.
- Past serum ferritin > 500
Exclusion Criteria:
- Patients with contraindication to MRI (e.g. pacemaker, contraindicated metallic
implants, claustrophobia, etc)
- Pregnant or trying to become pregnant (as determined by self-report during MRI safety
screening)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 10 Years old.
| MRI QSM Imaging for Iron Overload | NCT04631718 | Entailment |
3,795 | 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:
1. ≥ 40 years of age
2. If female, subject is either not of childbearing potential, defined as postmenopausal
for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral
oophorectomy or hysterectomy), or is of childbearing potential and practicing methods
of birth control.
3. If female and of childbearing potential, serum pregnancy results must be negative at
Screening
4. Has a diagnosis of Osteoarthritis (OA) of the index knee according to American College
of Rheumatology (ACR) criteria, including radiological evidence of OA
(Kellgren-Lawrence grades 2 or 3).
5. Subject has had knee pain for at least 1 month prior to the Screening Visit.
6. Subject has had knee pain that has persisted despite conventional treatment, defined
as any one of the following medications taken for at least 1 month in the past:
- acetaminophen (2- 4 grams per day)
- therapeutic dose range of an NSAID
- acetaminophen/codeine combination (i.e. Tylenol No. 2, 3, 4) taken at least 3
times daily.
7. Has a pain score of ≥ 4 (0-10 NRS) in the index (more symptomatic) knee at Screening
and Baseline.
8. If the subject is taking Analgesic/NSAIDs, then the Analgesic/NSAIDs has been stable
for 14 days prior to the Baseline visit.
9. Has clinical evidence of a knee effusion in the index (more symptomatic) knee at
Screening and Baseline.
10. Able and willing to self-administer SC injections or has available qualified person(s)
to administer SC injections.
11. Has voluntarily signed and dated an approved informed consent form prior to any
study-specific procedures.
Exclusion Criteria:
1. Has a history of an allergic reaction or significant sensitivity to constituents of
adalimumab.
2. Has other bone and articular diseases (antecedents and/or current signs) such as
chondrocalcinosis, Paget's disease of the ipsilateral limb to the target knee,
rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis,
acromegaly, haemochromatosis, Wilson's disease, osteochondromatosis, seronegative
spondylo-arthropathy, mixed connective tissue disease, collagen vascular disease,
psoriasis, inflammatory bowel disease.
3. Subject has a BMI over 40.
4. Planned/anticipated surgery of the index knee during the study period.
5. Already scheduled for any surgery during the time of the study or within 70 days after
the end of treatment.
6. Prior arthroscopic or open surgery of the index knee within 12 months of Baseline.
7. Has a history of cancer or lymphoproliferative disease other than: Successfully and
completely treated cervical dysplasia, with no recurrence within the last five years,
Basal or Squamous Cell Carcinoma that has been adequately treated or excised.
8. Has had prior treatment with intravenous (IV) immunoglobulin or any investigational
agent within 30 days or 5 half-lives of the agent from Baseline, whichever is longer.
9. History of neurologic symptoms suggestive of central nervous system (CNS)
demyelinating disease (e.g. multiple sclerosis).
10. History of uncontrolled diabetes, unstable ischemic heart disease, active congestive
heart failure, New York Heart Association (NHYA) III, IV, inflammatory bowel disease,
active peptic ulcer disease, recent stroke (within 12 weeks of Screening), or any
other condition, which in the opinion of the investigator, would put the patient at
risk by participating in the study.
11. Has concurrent local or systemic infection that would preclude the use of adalimumab.
12. Has had a persistent or severe infection(s) requiring hospitalization or treatment
with IV antibiotics within 30 days, or oral antibiotics within 14 days, prior to
Baseline.
13. History of active tuberculosis or listeriosis, or other infections suggestive of
significant or profound immunosuppression, such as Pneumocystis carinii, aspergillosis
or other systemic protozoal or fungal infections.
14. Has latent TB (positive purified protein derivative (PPD) skin test, two-step PPD when
applicable, and chest X-ray indicative of TB) or has other risk factors for the
activation of latent TB, e.g. previous exposure to TB, and has not initiated TB
prophylaxis prior to the first adalimumab treatment.
15. Will be excluded if the Chest x-ray is found to have changes indicative of old healed
tuberculous lesion (e.g. calcified nodule, fibrotic scar, apical or basilar pleural
thickening etc.).
16. Has a positive serology for Hepatitis B or Hepatitis C that indicates active
infection.
17. Has a history of positive HIV status.
18. Currently taking or likely to begin anti-retroviral therapy at any time during the
course of the study.
19. Female subject is pregnant or breast-feeding.
20. Has a history of clinically significant drug or alcohol abuse in the last year, prior
to Screening.
21. Subject, in the opinion of the principal investigator, is unlikely to comply with the
study protocol or is unsuitable for any other reason.
Treatment-Related Exclusion Criteria
1. Subject has received intra-articular injections of steroid and/or hyaluronate
compounds into the index knee within 12 weeks prior to Baseline.
2. Subjects using injectable corticosteroids for any medical condition
(intra-articular/soft tissue injections are allowed, but not in the target knee).
3. Subjects using indomethacin or oral steroids.
4. Subjects taking glucosamine and/or chondroitin at screening must discontinue or remain
on a stable dose, unmodified if at all possible for the entire duration of the study.
5. If treatment for osteoarthritis (NSAID) or osteoporosis (bisphosphonates, selective
estrogen receptor modulators) is necessary, it will have to be continued, unmodified
if at all possible for the entire duration of the study. If the subject does not wish
to continue them during the study, they must be stopped 14 days prior to the Baseline
visit.
6. Subjects who have used compounds containing non-approved agents for arthritis or
agents claiming to possess disease/structure-modifying properties in the 14 days prior
to the Baseline visit (see exception above).
7. Subjects who require acetaminophen at daily doses > 4000 mg (4 g) on a regular basis.
8. Subjects who are taking lithium carbonate, phenytoin or anticoagulants (with the
exception of aspirin up to a maximum daily dose of 325 mg).
9. Subjects who use calcitonin.
10. Subjects who use immunosuppressive drugs. Subjects that are using methotrexate or
hydroxychloroquine must withdraw treatment 1 month prior to baseline, to be eligible
to enter the study.
11. Topical analgesics and NSAID's cannot be used on the target knee within the 48 hours
before each study visit.
12. No new physical modalities of treatment can be introduced and subject must maintain
normal activity during 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 40 Years old.
| Osteoarthritis of the Knee, Inflammation, and the Effect of Adalimumab (OKINADA) | NCT02471118 | Entailment |
3,666 | 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:
1. Age 18 to 75 years old (male or female).
2. Patients with posterior or posterolateral disc herniations at one or two levels
between L1 and S1 with radiographic confirmation of neural compression using CT and/or
MRI.
3. At least six (6) weeks of failed, conservative treatment prior to surgery, including
physical therapy, use of anti-inflammatory medications at maximum specified dosage
and/or administration of epidural/facet injections.;
4. Minimum posterior disc height of 3mm at the index level(s).
5. Lower back pain and/or sciatica with or without spinal claudication.
6. Oswestry Questionnaire score of at least 40/100 at baseline.
7. VAS leg pain of at least 40/100 at baseline.
Exclusion Criteria:
1. Spondylolisthesis Grade II or higher
2. Subject requires uni or bilateral facetectomy to treat leg/back pain
3. Subject has back or non-radicular leg pain of unknown etiology.
4. Prior fusion (with or without instrumentation), motion preservation, facetectomy or
IDET surgery at the index lumbar vertebral level
5. Subject's requiring a spine DEXA (i.e., patients with SCORE of ≥ 6) with a T Score
less than -2.0 at the index level.
6. Subject has clinically compromised vertebral bodies at the index level(s) due to any
traumatic, neoplastic, metabolic, or infectious pathology.
7. Subject has sustained pathologic fractures of the vertebra or multiple fractures of
the vertebra or hip.
8. Subject has scoliosis of greater than ten (10) degrees (both angular and rotational).
9. Any metabolic disease bone disease that has not been stabilized for at least three
months (e.g., Paget's disease, osteomalacia, osteogenesis imperfecta, thyroid and/or
parathyroid gland disorder, etc.).
10. Subject has an active infection either systemic or local.
11. Subject has cauda equine syndrome or neurogenic bowel/bladder dysfunction.
12. Subject has severe arterial insufficiency of the legs (Screening on physical
examination= patients with diminution or absence of dorsalis pedis or posterior
tibialis pulses. If diminished or absent by palpation, then an arterial ultrasound is
required with vascular plethysmography. If the absolute arterial pressure is below
50mm of Hg at the calf or ankle level, then the patient is to be excluded) or other
peripheral vascular disease).
13. Subject has significant peripheral neuropathy, patient defined as a patient with Type
I or Type II diabetes or similar systemic metabolic condition causing decreased
sensation in a stocking-like or non-radicular and non-dermatomal distribution in the
lower extremities.
14. Subject has insulin-dependent diabetes mellitus.
15. Subject is morbidly obese (defined as a body mass index >40, or weighs more than 100
lbs over ideal body weight).
16. Subject has been diagnosed with active hepatitis, AIDS, or HIV.
17. Subject has been diagnosed with rheumatoid arthritis or other autoimmune disease.
18. Subject has a known allergy to titanium, polyethylene or polyester materials.
19. Subject is pregnant or interested in becoming pregnant in the next three (3) years.
20. Subject has active tuberculosis or has had tuberculosis in the past three (3) years.
21. Subject has a history of active malignancy: A patient with a history of any invasive
malignancy (except non-melanoma skin cancer), unless he/she has been treated with
curative intent and there have been no signs or symptoms of the malignancy for at
least two (2) years.
22. Subject is immunologically suppressed, received steroids >1 month over the past year.
23. Currently taking anticoagulants, other than aspirin, unless the patient can be taken
off the anticoagulant for surgery
24. Subject has a current chemical/alcohol dependency or significant psychosocial
disturbance.
25. Subject has a life expectancy of less than three (3) years.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Barricaid EU Post Market Study for Primary Lumbar Disc Herniation | NCT01534065 | Contradiction |
4,492 | 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:
- adult premenopausal women (equal or greater than 18 years old)
- no symptoms of menopause
- undergoing robotic or laparoscopic total or supracervical hysterectomies or
myomectomies for the indication of symptomatic uterine fibroids
- not candidates for specimen removal via mini-laparotomy incision (as deemed by the
study surgeon) or who have refused mini-laparotomy
- endometrial biopsy with no suspicion for malignancy
Exclusion Criteria:
- known or suspected malignancy
- peri- or post-menopausal women
- specimen that can be removed without power morcellation (e.g., vaginally or through
laparoscopic trocars)
- adults unable to consent.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy | NCT02777203 | Contradiction |
5,504 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
- Patients who have a diagnosis of Giant Cell Arteritis (GCA)
- Patients who have a diagnosis of GCA of = 4 weeks' duration
- Patients who are receiving = 40 mg/day of prednisone/prednisolone Exclusion Criteria:
- Patients must not have a prior diagnosis of GCA > 4 weeks
- Patients must not have failed to respond to glucocorticosteroid therapy within 5 days
of initiation of therapy.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
| A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Giant Cell Arteritis | NCT00076726 | Entailment |
2,515 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | Inclusion Criteria:
- at least 19 years of age with a diagnosis of atopic dermatitis
- treated with protopic 0.1% ointment
Exclusion Criteria:
- treated with other medication or topical agent
- skin lesion on the scalp or hand and foot
- pregnant women/lactating women
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.
| Protopic Adherence and Efficacy in Korean Eczema Patient | NCT02126176 | Contradiction |
5,043 | 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:
- Age ≥18 years
- -normal cognitive functions (>24y)
- Normal clinical examination of ocular mobility, visualization of the target
- No drug potentially able to modify and to influence the data: anti-depressants,
neuroleptics, anti-emetics, amphetamines, anti myoclonic/dystonic drugs, alcohol,
dopaminergic drug, antiepileptic.
- Dystonia or essential tremor or Parkinson: diagnostic made by a neurologist
- For DYT11: mutation in SGCE gene.
- For dystonia: No secondary dystonia
- For Parkinson : UPDRS<28
- No other neurological disorder
For the patient having deep brain stimulation:
- Duration of stimulation> 6 months
- Cerebral imagery post operation made
- Stimulation parameter stable since 3 months at least.
- Usual stop of the stimulation during the night
Exclusion criteria:
- Uncontrollable medical problems not related to M-D
- Current active psychiatric disorder
- Intake during the last 3 days of drugs potentially able to modify and to influence the
data: anti-depressants, neuroleptics, anti-emetics, amphetamines, anti
myoclonic/dystonic drugs, alcohol, dopaminergic drug
- Subjects legally protected.
- Subjects who are not enrolled at social security.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Abnormal Movements, Cerebellum and Sensorimotor : Oculomotor Study | NCT01495897 | Entailment |
6,902 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
Participants will be classified as either normal controls, SMC, EMCI, LMCI or AD
participants. General Inclusion Criteria will apply to all groups, with specific criteria
for each group as described below:
General (applies to each category):
- Geriatric Depression Scale less than 6.
- Age between *55-90 (inclusive). *For normal controls and SMC participants, age must be
between 65-90.
- Study partner is available who has frequent contact with the participant (e.g. an
average of 10 hours per week or more), and can accompany the participant to all clinic
visits for the duration of the protocol.
- Visual and auditory acuity adequate for neuropsychological testing.
- Good general health with no diseases expected to interfere with the study.
- Participant is not pregnant, lactating, or of childbearing potential (i.e. women must
be two years post-menopausal or surgically sterile).
- Willing and able to participate in a longitudinal imaging study.
- Hachinski less than or equal to 4.
- Completed six grades of education or has a good work history (sufficient to exclude
mental retardation).
- Must speak English or Spanish fluently.
- Willing to undergo repeated MRIs (3Tesla) and at least two PET scans (one FDG and one
Amyloid imaging) and no medical contraindications to MRI.
- Agrees to collection of blood for Genome Wide Association Studies (GWAS), APOE testing
and DNA and RNA banking.
- Agrees to collection of blood for biomarker testing.
- Agrees to at least one lumbar puncture for the collection of CSF.
Specific Inclusion Criteria for normal controls:
- Participant must be free of memory complaints, verified by a study partner.
- Normal memory function score on Wechsler Memory Scale (adjusted for education)
- Mini-Mental State Exam (MMSE) score between 24 and 30 (inclusive)
- Clinical Dementia Rating (CDR) = 0; Memory Box score must be 0
- Cognitively normal, based on an absence of significant impairment in cognitive
functions or activities of daily living
- Stability of Permitted Medications for 4 weeks. In particular, participants may take:
- Antidepressants lacking significant anticholinergic side effects
- Estrogen replacement therapy is permissible
- Gingko biloba is permissible, but discouraged
- Washout from psychoactive medication (e.g., excluded antidepressants,
neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4
weeks prior to screening
Specific Inclusion Criteria for SMC participants:
- Subjects that are "self-referrals" that have a significant subjective memory concern
- Significant memory concern confirmed by a Cognitive Change Index score of more than or
equal to 16
- Normal memory function score on Wechsler Memory Scale (adjusted for education)
- Mini-Mental State Exam (MMSE) score between 24 and 30 (inclusive)
- Clinical Dementia Rating (CDR) = 0; Memory Box score must be 0
- Cognitively normal, based on the absence of significant memory impairment in cognitive
function or activities of daily living
- Stability of Permitted Medications for 4 weeks. In particular, subjects may take:
- Antidepressants lacking significant anticholinergic side effects
- Estrogen replacement therapy is permissible
- Gingko biloba is permissible, but discouraged
- Washout from psychoactive medication (e.g., excluded antidepressants,
neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4
weeks prior to screening
Specific Inclusion Criteria for EMCI and LMCI participants:
- Participant must have a subjective memory concern as reported by participant, study
partner, or clinician
- Abnormal memory function score on Wechsler Memory Scale (adjusted for education)
- Mini-Mental State Exam (MMSE) score between 24 and 30 (inclusive)
- Clinical Dementia Rating (CDR) = 0.5; Memory Box score must be at least 0.5
- General cognition and functional performance sufficiently preserved such that a
diagnosis of AD cannot be made by the site physician at the time of the screening
visit
- Stability of Permitted Medications for 4 weeks. In particular, participants may take:
- Antidepressants lacking significant anticholinergic side effects
- Estrogen replacement therapy
- Gingko biloba is permissible, but discouraged
- Washout from psychoactive medication (e.g., excluded antidepressants,
neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4
weeks prior to screening
- Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks
prior to screening
Specific Inclusion Criteria for AD participants:
- Participant must have a subjective memory concern as reported by participant, study
partner, or clinician
- Abnormal memory function score on Wechsler Memory Scale (adjusted for education)
- Mini-Mental State Exam (MMSE) score between 20 and 26 (inclusive)
- Clinical Dementia Rating (CDR) = 0.5 or 1.0
- National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's
Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD
- Stability of Permitted Medications for 4 weeks. In particular, participants may take:
- Antidepressants lacking significant anticholinergic side effects
- Estrogen replacement therapy
- Gingko biloba is permissible, but discouraged
- Washout from psychoactive medication (e.g., excluded antidepressants,
neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4
weeks prior to screening
- Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks
prior to screening
Specific Inclusion Criteria for follow-up participants from ADNI1 and ADNI GO:
- Must have been enrolled and followed in ADNI1 for at least one year or enrolled in
ADNI-GO with original diagnosis of Cognitively Normal (CN), Mild Cognitive Impairment
(MCI), or Early Mild Cognitive Impairment (EMCI) regardless of whether a diagnostic
conversion has occurred since initial enrollment in ADNI.
- Willing and able to continue to participate in an ongoing longitudinal study. A
reduced battery of tests is allowable if the participant is not able/willing to
complete the full battery.
- Study partner is available who has frequent contact with the participant (e.g. an
average of 10 hours per week or more), and can accompany the participant to all clinic
visits for the duration of the protocol.
Exclusion Criteria:
General (applies to each category):
- Screening/baseline MRI scan with evidence of infection, infarction, or other focal
lesions; Participants with multiple lacunes or lacunes in a critical memory structure
are excluded
- Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal
fragments or foreign objects in the eyes, skin or body
- Major depression, bipolar disorder as described in Diagnostic and Statistical Manual
of Mental Disorders, Fourth Edition (DSM-IV) within the past 1 year
- Currently treated with medication for obsessive-compulsive disorder or attention
deficit disorder
- History of schizophrenia
- History of alcohol or substance abuse or dependence within the past 2 years
- Any significant systemic illness or unstable medical condition which could lead to
difficulty complying with the protocol
- Clinically significant abnormalities in B12, or TFTs that might interfere with the
study
- Residence in skilled nursing facility
- Current use of specific psychoactive medications (e.g.,certain antidepressants,
neuroleptics, chronic anxiolytics or sedative hypnotics, etc.); Current use of
warfarin or dabigatran (exclusionary for lumbar puncture).
- Use of investigational agents one month prior to entry and for the duration of the
trial
- Participation in clinical studies involving neuropsychological measures being
collected more than one time per year
- Exclusion for FDG PET scan and amyloid imaging with Florbetapir F 18: Current or
recent participation in any procedures involving radioactive agents such that the
total radiation dose exposure to the participant in any given year would exceed the
limits of annual and total dose commitment set forth in the US Code of Federal
Regulations (CFR) Title 21 Section 361.1.
- Exceptions to these guidelines may be considered on a case-by-case basis at the
discretion of the protocol director
Specific Exclusion Criteria for normal controls and SMC participants:
- Any significant neurologic disease, such as Parkinson's disease, multi-infarct
dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor,
progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple
sclerosis, or history of significant head trauma followed by persistent neurologic
defaults or known structural brain abnormalities
Specific Exclusion Criteria for EMCI and LMCI participants:
- Any significant neurologic disease other than suspected incipient Alzheimer's disease,
such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal
pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder,
subdural hematoma, multiple sclerosis, or history of significant head trauma followed
by persistent neurologic defaults or known structural brain abnormalities.
Specific Exclusion Criteria for AD participants:
- Any significant neurologic disease other than Alzheimer's disease, such as Parkinson's
disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus,
brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma,
multiple sclerosis, or history of significant head trauma followed by persistent
neurologic defaults or known structural brain abnormalities.
Specific Exclusion Criteria for follow-up participants from ADNI1 and ADNI GO:
- Participants will not be able to participate in FDG PET scan and amyloid imaging with
Florbetapir F 18 if the following is true: Current or recent participation in any
procedures involving radioactive agents such that the total radiation dose exposure to
the participant in any given year would exceed the limits of annual and total dose
commitment set forth in the US Code of Federal Regulations (CFR) Title 21 Section
361.1.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 55 Years old.
Subject must be at most 90 Years | Alzheimer's Disease Neuroimaging Initiative 2 | NCT01231971 | Entailment |
5,839 | 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:
- Esophageal erosions
- Retrosternal pyrosis lasting ≥ 3 months
- Pyrosis and/or regurgitation with a frequency ≥ 3 nights per week
- GERD-associated sleep disturbance (insomnia, poor sleep quality) lasting ≥ 1 month
- GERD-associated sleep disturbance (insomnia, poor sleep quality) with a frequency ≥ 3
nights per week
Exclusion Criteria:
- Non-erosive gastroesophageal reflux disease (NERD)
- Peptic ulcer
- History of upper gastrointestinal surgery (except for cholecystectomy)
- Lactating or pregnant women
- Nighttime shift workers (12 am to 6 am)
- Obstructive sleep apnea hypopnea syndrome
- Chronic obstructive pulmonary disease
- Patients with nocturnal supplementary oxygen requirement
- Orthopnea
- Restless legs syndrome
- Patients consuming more than 3 cups of coffee per day
- Patients planning to travel beyond 3 time zones during study
- Patients being treated with sleep medication (e.g. anxiolytics, antihistamines,
benzodiazepines) for less than 3 months
- Patients being treated with sleep medication (e.g. anxiolytics, antihistamines,
benzodiazepines), when suspension or dose modification of this drugs is being planned
during the study course
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.
| Impact of Head of Bed Elevation in Symptoms of Patients With Gastroesophageal Reflux Disease | NCT02706938 | Contradiction |
3,282 | 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:
- willing to participate in this clinical study, and signed informed consent
- age from 18 to 70 years old,both genders are permitted
- diagnosed as the Sjögren syndrome
- have the symptoms and signs of dry eye disease as below:
1. have at least 2 symptoms such as dryness,foreign body sensation ,eye
strain,conjunctival congestion,secretion.The summed up score of symptoms greater
than 6.
2. the score of tear-film break up time less than 5 seconds or the score of Schirmer
test less than 5mm/5min.
3. the score of corneal fluorescein staining greater than 3.
Exclusion Criteria:
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | A Randomized, Parallel-Group Comparison Study of Topical Corticosteroids in Dry Eye Patients With Sjögren Syndrome | NCT02011776 | Entailment |
6,302 | 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. | Greater than 18 years of age. Cough present greater than one day and a history of fever and
chills or documented fever in the Emergency Department
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 Respiratory Specimens for Bacterial and Viral Pathogens by Real-Time PCR | NCT00275691 | Entailment |
5,344 | 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:
1. Healthy volunteers
Exclusion Criteria:
1. Any known platelet or coagulation disorder.
2. Pregnant or lactating women.
3. Known chronic liver or renal disease.
4. Coronary artery, carotid artery or peripheral artery disease
5. Recent history of taking antiplatelet drugs, anticoagulants or herbal preparations.
6. Smoker or alcohol user
7. Mentally incapable of providing informed consent
8. Students or junior staff members who had direct working relationship with the PI
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 | Desmopressin for Bleeding Related to Low Body Temperature | NCT00902057 | Contradiction |
4,883 | 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:
- Male and female patients with Cushing syndrome (CS) caused by ACTH-producing pituitary
adenoma or cortisol producing adrenal adenoma
- Age between 18 and 65 years
Exclusion criteria
- CS caused by ectopic ACTH producing tumours
- CS caused by adrenocortical carcinoma
- Pseudo CS
- Subclinical CS
- Exogenous CS
- Previous history of major psychiatric disorder (not related to CS)
- Neurological disorders affecting the central nervous system
- High alcohol consumption (more than 14 units of alcohol per week)
- Active malignancy or any treatment for malignancy during the last 2 years
- Heart failure (NYHC II-IV)
- Severe respiratory insufficiency
- Severely impaired hepatic function (alanine transaminase and/or aspartate transaminase
concentrations two times the upper limit of normal or above)
- Severely impaired renal function (serum- creatinine >150 µmol/L or glomerular
filtration rate <45 ml/min)
- Pregnancy or breast feeding
- Any other illness that significantly affects the patients cognitive function according
to the investigators opinion
- Contraindication for MRI (Presence of medical implants, metal in the body,
claustrophobia)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Quality of Life, Fatigue and Cognitive, Affective and Emotional Dysfunction in Patients With Cushing's Syndrome | NCT03211624 | Entailment |
1,027 | 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. | Key Inclusion Criteria (additional criteria may apply at screening):
1. A clinical diagnosis of osteoarthritis (OA) of the knee or hip based on the American
College of Rheumatology criteria with radiologic evidence of OA (K-L score ≥2 for the
index joint) at the screening visit.
2. Willing to discontinue current pain medications and to adhere to study requirements
for rescue treatments (acetaminophen/paracetamol to be taken as needed with a maximum
daily dose of 2500 mg [countries where 500 mg strength tablets/capsules are available]
or 2600 mg [countries where 325 mg strength tablets/capsules are available])
3. A history of at least 12 weeks of inadequate pain relief or intolerance to analgesics
used for pain due to OA of the knee or hip
4. Currently using a stable dose of NSAID
5. Willing to discontinue glucosamine sulfate and chondroitin sulfate treatments during
the 24 weeks of treatment
Key Exclusion Criteria (additional criteria may apply at screening):
1. Non-compliance with the numeric rating scale (NRS) recording during the
pre-randomization period
2. History or presence at the screening visit of non-OA inflammatory joint disease,
Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple
sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal
osteodystrophy
3. History or presence on imaging of arthropathy, hip or knee dislocation, extensive
subchondral cysts, evidence of severe structural damage, bone collapse, or primary
metastatic tumor with the exception of chondromas or pathologic fractures
4. Trauma to the index joint within 3 months prior to the screening visit
5. Signs or symptoms of carpal tunnel syndrome within 6 months of screening
6. Patient is not a candidate for magnetic resonance imaging (MRI)
7. Is scheduled for a JR surgery to be performed during the study period or who would be
unwilling or unable to undergo JR surgery if needed
8. History or presence at the screening visit of autonomic or diabetic neuropathy, or
other peripheral neuropathy, including reflex sympathetic dystrophy
9. Evidence of autonomic neuropathy as defined in the schedule of assessments (SoAs)
10. History or diagnosis of chronic autonomic failure syndrome including pure autonomic
failure, multiple system atrophy
11. Use of systemic corticosteroids within 30 days prior to the screening visit.
Intra-articular corticosteroids in the index joint within 12 weeks prior to the
screening visit, or to any other joint within 30 days prior to the screening visit
12. Exposure to an anti-NGF antibody prior to the screening visit or known sensitivity or
intolerance to anti-NGF antibodies
13. Women of childbearing potential who are unwilling to practice highly effective
contraception prior to the start of the first treatment, during the study, and for at
least 20 weeks after the last dose
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip | NCT03304379 | Entailment |
4,227 | 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:
- Male or Female, aged 16 years to 49 years inclusive.
- Presenting with a persistent cough of 2-8 weeks' duration without an established
diagnosis (e.g. asthma, gastro-oesophageal reflux).
- Able to complete cough diary and study questionnaires.
Exclusion Criteria:
- There is a contraindication to montelukast.
- Chronic severe disease which may cause persistent cough (eg cystic fibrosis,
bronchiectasis, cardiac failure).
- Immunodeficiency/immunocompromised state.
- Pregnancy.
- Breastfeeding.
- Current smoker (i.e. stopped smoking less than 6 months ago).
- Regular medication associated with persistent cough (ACE inhibitors).
- The individual is in another clinical research study.
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 49 Years | Montelukast for Persistent Cough in Young People and Adults | NCT01279668 | Contradiction |
5,723 | 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 included that the child must be:
1. Obese (BMI ≥ 95th percentile for age and gender) or at-risk for obesity (85th ≥ BMI >
95th percentile for age and gender);
2. African-American by parent report;
3. 7-11 years of age;
4. Without any medical or psychological condition that would make weight loss or physical
activity dangerous, or psychological disorders that would make adoption of health
behaviors difficult;
5. Without any complications of obesity that indicate prompt referral to a pediatric
obesity treatment center for more aggressive weight loss therapy;
6. Together with the parent/caregiver indicate that they are ready to make changes in
their eating and physical activity behaviors;
7. Have a parent/caregiver willing to participate.
Exclusion Criteria:
As noted above, to participate in this study the child must not have a medical or
psychological condition that would make weight loss or physical activity dangerous,
psychological disorders that would make adoption of health behaviors difficult, or
complications of obesity that necessitate prompt referral to a pediatric obesity treatment
center for more aggressive weight loss therapy. Examples of medical or psychological
conditions that would render the child ineligible for this study include uncontrolled or
poorly-controlled asthma or hypertension, bulimia, mental retardation or severe learning
disability, as well as pseudotumor cerebri, sleep apnea, obesity hypoventilation syndrome,
and slipped capital femoral epiphysis.
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.
Subject must be at most 11 Years | A Primary Care Behavioral Approach for Addressing Childhood Overweight | NCT00284557 | Entailment |
631 | 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:
- Chronic kidney disease stages G3-G5 (defined according to KDIGO criteria);
- Anemia (defined according to KDIGO criteria) and iron deficiency defined as serum
ferritin < 100 ng/mL and/or TSAT < 20% (KDIGO).
Exclusion Criteria:
- contraindications of intravenous iron therapy: iron allergy, active infection,
hemochromatosis, iron overload (serum ferritin > 500 ng/mL and/or transferrin
saturation > 50%);
- treatment with iron and erythropoiesis-stimulating agents (at the time of recruitment
and 6 months previously);
- active smoker status;
- antioxidant food supplements treatment in the last 3 months;
- clinically manifest bleeding;
- another cause of anemia (hemoglobinopathies, vitamin B12 and/or folic acid deficiency
suggested by the megaloblastic peripheral blood smears's appearance, multiple myeloma
and other paraproteinemias);
- severe anemia (Hb < 7 g/dl);
- baseline FMD < 7% (the existence of atherosclerosis which limits arterial reactivity);
- cancer (currently or in the past 6 months);
- hepatopathies (increased serum transaminases ≥ 3 x normal value) or hepatic impairment
≥ grade Child B;
- autoimmune disorders or significant inflammation (as defined by C-reactive protein > 5
mg/L);
- pregnancy or lactation;
- participation in other clinical trials over the upast 3 months;
- patient unwillingness.
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.
| Acute Effects of Intravenous Iron on Oxidative Stress and Endothelial Dysfunction in Non-dialysis CKD | NCT03388385 | Contradiction |
5,414 | 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:
1. Age between 18 and 45 years;
2. Ascertained diagnosis of one of the following inherited bleeding disorders:
1. Von Willebrand Disease type 1, 2, 3 severe and moderate (VWF:RCo < 30 %),as
diagnosed following Italian guidelines [4]
2. Glanzmann Thromboasthenia
3. Congenital Coagulation Factor VII, II or X deficiency
4. A and B Haemophilia Carriers (Factor VIII and IX <25%);
3. Bleeding Severity score > 2
4. Signing the consent form.
Exclusion Criteria:
1. Under continuous anti-hemorrhagic prophylaxis 2. Affected by an active cancer or
anti-phospholipid antibodies syndrome 3. History of liver, kidney or endocrine disorders 4.
Submucous uterine fibroids, uterine polyps or malignancy 5. Use of oral contraceptives or
intrauterine devices in the past three months 6. Treatment with non-steroidal
anti-inflammatory drugs
-
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Evaluation of Menses in Congenital Bleeding Disorders | NCT01261936 | Entailment |
6,716 | 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:
- 18 years old or older
- requiring one single tooth extraction and subsequently an implant-supported
restoration
- able to sign an informed consent form
Exclusion Criteria:
- history of systemic diseases that would contraindicate oral surgical treatment;
- long-term non-steroidal anti-inflammatory drug therapy;
- lack of opposite occluding dentition in the area intended for extraction and
subsequent implant placement;
- Oral biphosphonate therapy;
- absence of adjacent teeth;
- unwillingness to return for the follow-up examination;
- use of more than 10 cigarettes per day. Subjects smoking less than 10 cigarettes per
day were requested to stop smoking before and after surgery; however, their compliance
could not be monitored.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| mp3 vs Apatos in Post-extractive Sockets | NCT02644070 | Contradiction |
549 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1. Between 18-40 years of age at the time of study initiation; 1.1 Enrollment will be
targeted for 225 subjects aged 18-35 (for safety and effectiveness analyses) and an
additional 25 subjects aged 36-40 (for safety only) (note: all subjects will be
included in the analysis for device placement and tolerability);
2. Pre-menopausal, as determined by regular menstrual cycle (28 ± 5 days) for the last 3
months; 2.1 Based on patient history, when not on hormonal contraceptives;
3. Sexually active with a male partner who has not had a vasectomy;
4. Reasonably expect to have to coitus at least once monthly during the study period.
5. Married or in a steady relationship (e.g., 3-6 months);
6. Seeking to avoid pregnancy for the next 12 months;
7. Willing to use the study device as the sole form of contraception;
8. Willing to accept a risk of pregnancy;
9. Normal PAP or ASC-US with negative high risk HPV test result within the appropriate
screen timeframe, unless considered at risk;
10. Able and willing to comply with all study tests, procedures, assessment tools and
follow-up; and
11. Able and willing to provide and document informed consent and Authorization for
Release of Protected Health Information (PHI).
Exclusion Criteria:
1. Known or suspected pregnancy; or at risk for pregnancy from unprotected intercourse
earlier in current cycle
2. Subject who anticipates separation from her partner for more than 1 cycle within the
next 12 months;
3. A previously inserted IUD that has not been removed by the time VeraCept is
placed;History of previous IUD complications, such as perforation, expulsion,
infection (pelvic inflammatory disease) or pregnancy with IUD in place;
4. History of previous serious IUD complications;
5. Injection of hormonal contraceptive (e.g., Depo-Provera) within the last 10 months;
6.1 Must have had 2 normal menstrual cycles since the last injection;
6. Planned use of any non-contraceptive estrogen, progesterone or testosterone any time
during the 12 months of study participation;
7. Postpartum, prior to a minimum of 6 weeks or complete uterine involution;
8. Exclusively breastfeeding before return of menses; Lactating women will be excluded
unless they have had have had two normal menstrual periods.
8.1 Must have had 2 normal spontaneous menstrual cycles since delivery
9. Unexplained abnormal uterine bleeding (suspicious for serious condition), before
evaluation; Immediately post-septic abortion or puerperal sepsis;
10. Severely heavy or painful menstrual bleeding;
11. Suspected or known cervical, uterine or ovarian cancer, or unresolved clinically
significant abnormal pap smear requiring evaluation or treatment Any history of
gestational trophoblastic disease with or without detectable elevated ß-hCG levels, or
related malignant disease;
12. Known anatomical abnormalities of the uterine cavity that may complicate IUD
placement, such as:
12.1 Submucosal uterine leiomyoma 12.2 Asherman's syndrome 12.3 Pedunculated polyps
12.4 Bicornuate uterus 12.5 Didelphus or uterine septa
13. Known anatomical abnormalities of the cervix such as severe cervical stenosis, prior
trachelectomy or extensive conization that, in the opinion of the investigator would
prevent cervical dilation and study device placement;
14. Current or recent (within the last 3 months) pelvic infection (cervix, endometrium, or
fallopian tubes), or mucopurulent cervicitis;
15. High risk for STDs (e.g., multiple sexual partners);
16. Known or suspected AIDS;
17. Known intolerance or allergy to nickel or copper, including Wilson's Disease;
18. Currently participating or planning future participation in a research study of an
investigational drug or device during the course of this investigational study;
19. Subject had VeraCept placed previously or had 2 attempts at placement;
20. Known or suspected alcohol or drug abuse within 12 months prior to the screening
visit;
21. Any general health or behavioral condition that, in the opinion of the Investigator,
could represent an increased risk for the subject or would render the subject less
likely to provide the needed study information.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Evaluation of ContraMed VeraCept Intrauterine Copper Contraceptive for Long Acting Reversible Contraception | NCT02446821 | Contradiction |
381 | 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:
- between 5 and 12 completed weeks gestation
- 18 years or older
- hemodynamically stable
- confirmed diagnosis of intrauterine embryonic/fetal demise or anembryonic gestation
(ultrasound examination demonstrates a fetal pole without cardiac activity measuring
between 5.3 and 40 mm or an abnormal growth pattern diagnostic of early pregnancy
failure)
- willing and able to give informed consent
Exclusion Criteria:
- diagnosis of incomplete or inevitable abortion (absent gestational sac and/or active
bleeding, open cervical os)
- contraindication to mifepristone (chronic corticosteroid administration, adrenal
disease)
- contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, or
known allergy to prostaglandin)
- cardiovascular disease (angina, valvular disease, arrhythmia, or cardiac failure)
- most recent hemoglobin <9.5 g/dL
- diagnosis of porphyria
- known clotting defect or receiving anticoagulants
- pregnancy with an intrauterine device (IUD) in place
- breastfeeding during the first 7 days of study participation
- unwilling to comply with the study protocol and visit schedule
- any evidence of viable pregnancy
- possibility of ectopic pregnancy
- known or suspected pelvic infection
- concurrent participation in any other interventional trial
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Comparative Effectiveness of Pregnancy Failure Management Regimens | NCT02012491 | Contradiction |
5,423 | 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:
Patients who meet all of the following criteria are eligible for the study:
- Male or female patients aged ≥5.5 years at the time of enrolment
- VWD type 1 (baseline von Willebrand factor activity [VWF:RCo], <30 IU/dL), 2A, 2B, 2M,
or 3 according to medical history requiring substitution therapy with a VWF-containing
product to control bleeding
- Currently receiving frequent on-demand treatment with a VWF-containing product
- In female patients of child-bearing potential using hormonal contraception, the
medication class should remain unchanged for the duration of their study participation
- Voluntarily given, fully informed written and signed consent obtained before
collection of any patient data
Exclusion Criteria:
Patients who meet any of the following criteria are not eligible for the study:
- Patients currently on prophylaxis for VWD (except for perioperative prophylaxis) as
well as patients having received treatment once a month for menstrual bleeding, but
not for any other bleeds
- Patients whose VWD treatment is planned to be switched from on-demand to prophylactic
treatment in the next 6 months
- History, or current suspicion, of VWF or FVIII inhibitors
- Medical history of a thromboembolic event within 6 months before enrolment
- Severe liver or kidney diseases as described in the medical records
- Female patients with an existing or suspected pregnancy or who are breast-feeding at
the time of enrolment
- Change in hormonal contraception within 6 months before enrolment
- Cervical or uterine conditions causing abnormal uterine bleeding (including infection
or dysplasia)
- Other coagulation disorders or bleeding disorders due to anatomical reasons
- Participation in an interventional clinical study during the 6-month of study period
- Inability to complete the patient diary to reliably evaluate the type, frequency, and
treatment of BEs during the 6-month study period
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 66 Months old.
| Bleeding Incidence in VWD Patients Undergoing On-Demand Treatment | NCT04053699 | Entailment |
6,404 | 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. Provide written informed consent
2. Subjects age > 18 years at the time of signing the Informed Consent Form.
3. Male or Female
4. Must have a clinical diagnosis of COVID-19 by the qualitative reverse-transcription
polymerase chain reaction (RT-PCR), with at least one of mild or moderate COVID-19
clinical symptoms which are defined below in #5
5. Individuals with mild to moderately COVID-19 symptoms for outpatient and inpatient
population.
The main symptoms of mild illness are:
- low grade fever <38°C (37.5 to 37.9)
- a dry cough
- tiredness
- feeling slightly breathless
- muscle pain
- headache
- sore throat
- diarrhea
The main symptoms of moderate illness are:
In addition to the symptoms patients may get with a mild illness, they may also
experience:
- fever ≥38°
- a dry and more persistent cough several times an hour
- tiredness and a need to stay in bed
- feeling breathless when doing moderate exercise (such as walking upstairs)
- muscle pain and aches and need to stay in bed
- headache particularly if you are feeling hot
- sore throat, soreness from coughing, but no pain
- diarrhea
- a dry mouth
6. Adequate venous access
7. For Women of Child-Bearing Potential (WOCBP) only, willingness to use FDA-recommended
birth control until 6 months post treatment. The FDA-approved and cleared methods for
birth control are listed below:
- Permanent Sterilization
- Long-Acting Reversible Contraceptives (LARC)
- Contraceptive Injection
- Short-Acting Hormonal Methods
- Barrier Methods
- Emergency Contraception
https://www.fda.gov/consumers/free-publications-women/birth-control
8. Any male subject must agree to use contraceptives and not donate sperm during the
study.
9. Must agree to comply with all protocol requirements and be willing to complete all
study visits
Exclusion Criteria:
1. Patients who have moderate to severe respiratory distress syndrome due to COVID-19
2. Be a female who is pregnant, nursing, or of childbearing potential while not
practicing effective contraceptive methods. Female subjects must undergo a blood
pregnancy test at screening which will be within 72 hours of the IP infusion.
3. Inability to perform any of the assessments required.
4. Active listing (or expected future listing) for transplant of any organ.
5. Be a solid organ transplant recipient. This does not include prior cell-based therapy
(>12 months prior to enrollment), bone, skin, ligament, tendon or corneal grafting.
Have a history of organ or cell transplant rejection.
6. History of drug abuse (illegal "street" drugs except marijuana (If it is legal use in
states where patient resides), or prescription medications not being used
appropriately for a pre-existing medical condition or alcohol abuse (≥ 5 drinks/day
for ˃ 3 months), or documented medical, occupational, or legal problems arising from
the use of alcohol or drugs within the past 24 months
7. Patients with untreated HIV infection. However, patients can be enrolled if have been
treated for HIV and the test negative for HIV viral load but still test positive for
antibodies.
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| Expanded Access to ZofinTM (OrganicellTM Flow) for Patients With COVID-19 | NCT04657406 | Entailment |
1,941 | 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. WHO / ECOG /PS of 0 or 1 at enrollment
2. Must have a life expectancy of at least 12 weeks
3. Patients with histologically or cytologically confirmed advanced or metastatic
colorectal cancer who have disease progression after treatment with all available
therapies including fluoropyrimidine and oxaliplatin or irinotecan for metastatic
disease that are known to confer clinical benefit, or are intolerant to treatment, or
refuse standard treatment.
4. Histologically- or cytologically- confirmed, advanced or metastatic diffuse-type
adenocarcinoma of the stomach or gastroesophageal (GE) junction who have had disease
progression after at least two previous courses of chemotherapy for metastatic
disease, which should include fluoropyrimidine and platinum.
5. Confirmation of measurable disease based on RECIST 1.1
6. ICI-naïve patients
7. Adequate organ and marrow function as defined below: Bilirubin≤1.5 ×ULN ,AST (SGOT)
and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for patients with liver metastases) ,INR OR PT
≤1.5 × ULN , ANC ≥1500/µL , Platelets ≥100 000/µL, Hemoglobin ≥9.0 g/dL or ≥5.6
mmol/L1, Creatinine ≤1.5 × ULN
Exclusion Criteria:
1. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with
an agent directed to another stimulatory or co-inhibitory T-cell receptor
2. Has received prior radiotherapy within 2 weeks of start of study treatment.
3. Has received a live vaccine within 30 days prior to the first dose of study drug
4. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
5. Has a known additional malignancy that is progressing or has required active treatment
within the past 3 years.
6. Has known CNS metastases and/or leptomeningeal involvement
7. Judgement by the investigator that the patient should not 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 19 Years old.
| Vactosertib in Combination With Pembrolizumab in Metastatic Colorectal or Gastric Cancer | NCT03724851 | Entailment |
4,970 | 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
Tremor Subjects:
- Must be 18 years or older
- Fulfill the diagnostic criteria of essential tremor, pure dystonic tremor and tremor
associated dystonia, as defined by the Consensus Statement of the Movement Disorder
Society on Tremor, 1998. We will recruit patients displaying hand tremors in each
group as the follows:
- Hand tremor patients in ET group.
- Dystonic hand tremor patients in pDT group.
- Cervical dystonia (CD) patients or spasmodic dysphonia and hand tremor without
clinical evidence of hand dystonia in TAWD group.
- Ability to give informed consent.
- Ability to comply with all study procedures, based on the judgment by the
investigator(s).
- Agree to not drink caffeine or alcohol for 48 hours before participating in the
protocol.
Healthy Volunteers:
- Must be 18 years or older
- Absence of dystonia or other neurological disorder with any effect on the motor or
sensory systems.
- Ability to give informed consent.
- Ability to comply with all study procedures, based on the judgment by the
investigator(s).
- Agree to not drink caffeine or alcohol for 48 hours before participating in the
protocol.
EXCLUSION CRITERIA:
Patients:
- Botulinum toxin treatment < 3 months prior to visit.
- Employees and/or staff of NINDS
- Has used illegal drugs within the past 6 months based on history. The intent is to
exclude those with drug use that may affect study results. Participants who appear to
be intoxicated at the time of testing will be rescheduled.
- Has more than 7 alcoholic drinks a week in the case of a woman and 14 alcoholic drinks
a week in the case of a man.
- Abnormal findings on neurologic exam (other than tremor and dystonia in patient group)
- Has had a brain tumor, a stroke, head trauma, epilepsy or a history of seizures.
- Has major depression or any major mental disorders (axis I disorders)
- Has a neurologic disorder other than tremor or dystonia
- Has had a head injury where there was a loss of consciousness for more than a few
seconds.
- Currently taking primidone, anticholinergics or benzodiazepines.
Healthy Volunteers:
- Employees and/or staff of NINDS
- Has used illegal drugs within the past 6 months based on history. The intent is to
exclude those with drug use that may affect study results. Participants who appear to
be intoxicated at the time of testing will be rescheduled.
- Has more than 7 alcoholic drinks a week in the case of a woman and 14 alcoholic drinks
a week in the case of a man.
- Abnormal findings on neurologic exam.
- Has had a brain tumor, a stroke, head trauma, epilepsy or a history of seizures.
- Has a neurologic disorder other than tremor or dystonia
- Has major depression or any major mental disorders (axis I disorders)
- Has had a head injury where there was a loss of consciousness for more than a few
seconds.
Additional Exclusion Criteria for MRI:
- Has metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel,
surgical metal, clips in the brain, cochlear implants, or metal fragments in the eye
- Pregnancy
- Unable to lie flat on the back for the expect length of the study up to 3 hours.
- Feeling uncomfortable being in a small space for up to 3 hours.
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Additional Exclusion Criteria for TMS:
- Has metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel,
surgical metal, clips in the brain, cochlear implants, or metal fragments in the eye
- Pregnancy
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Neurophysiologic Study of Patient With Essential Tremor and Dystonic Tremor | NCT03041714 | Entailment |
6,625 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Male, aged 12 to 65 years
- Severe hemophilia A defined as < 1% FVIII:C
- >/= 150 days of previous treatment with FVIII in lifetime
- Currently receiving on-demand or any type of prophylaxis treatment regimen with any
FVIII product
- No history of or current FVIII inhibitors
Exclusion Criteria:
- Presence of another bleeding disease that is different from hemophilia A (e.g., von
Willebrand disease, hemophilia B)
- Low platelet count, abnormal kidney function, or liver disease
- Received treatment with immune suppressing drugs within the last 3 months prior or
requires treatment during the study. (Some drugs for hepatitis C, Human
immunodeficiency virus (HIV), and steroids are allowed)
- Receiving or has received other experimental drugs within 3 months prior to study
entry
- Allergy to Factor VIII or hamsters or mouse protein
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 65 Years | Trial to Evaluate the Efficacy and Safety of a New Full Length Recombinant Human FVIII for Hemophilia A | NCT01029340 | Contradiction |
2,501 | 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:
- at least 50 years of age
- has low-vision,
- deemed competent such as no language issues or communication barriers, no
self-reported or physician diagnosed mental health disorder besides having depressive
and anxiety symptoms,
- have sufficient hearing to be able to follow verbal instructions and able to sit
without physical discomfort for 30 minutes
- willing and able to attend 4 initial ASTM training sessions and at least 75% of
weekly, bi-weekly and monthly follow up sessions,
- willing to dedicate 20 minutes twice per day to ASTM practice at their own home.
Exclusion Criteria:
- actively suicidal as per self-report (scoring 2 or more on item 9 of the Patient
Health Questionnaire (PHQ-9) or on assessment by the physician,
- currently participating in other similar studies
- currently practicing any type of formal meditation regularly
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.
Subject must be at most 90 Years | Low-vision Rehabilitation Program for Low-vision Patients and Care Givers | NCT03166072 | Entailment |
1,655 | 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:
- Female
- Aged 15-19 years
- HIV-negative (willing to self-test onsite in the presence of the Research Assistant
who is also a trained HIV counselor)
- Has at least one current sexual partner she expects to meet at least twice in the next
3 months (not necessarily to have sex); this will provide opportunity for the
participant to suggest/offer testing.
- Resides in Siaya County and does not intend to relocate within 6 months from
enrollment, to allow follow up to be completed and to conduct IDI with those selected.
- Willing to be randomized into the partner self-testing or HTS referral groups.
- Reporting no incident of sexual, physical, emotional, or economic abuse in the last 12
months from the partner she intends to offer (Appendix 4) or refer for testing
(Appendix 3) in the next 3 months and does not believe the partner will abuse her if
she offers the self-test kits or HTS referral coupon.
- Has a male partner who has not tested for 6 months or whose HIV status is unknown to
her.
- Agrees to give consent to participate in the study.
Exclusion Criteria:
- Male
- HIV-positive
- Not willing to self-test onsite under in the presence of the Research Assistant
- Aged <15 years or >19 years
- Does not have a current sexual partner or does not expect to meet the partner at least
twice in the next 3 months
- Does not reside in Siaya County or intends to relocate within the next 6 months
- Not interested in obtaining HIV self-tests or HTS referral coupon for purposes of
suggesting testing to their sexual partners
- Reporting an incidence of sexual, physical, emotional or economic abuse in the last 12
months from the partner she would have offered self-test kit or referred for testing,
or believes the partner may subject her to sexual, physical, emotional, or economic
abuse if she offered them self-test kit or HTS coupon.
- Has a male partner who tested within the last 6 months.
- Does not give consent to participate in the study
Female
Accepts Healthy Volunteers
Subject must be at least 15 Years old.
Subject must be at most 19 Years | Acceptability, Feasibility and Impact of Oral HIV Self-testing for Partner Testing Among Kenyan Adolescent Girls Aged 15-19 Years: A Randomized Controlled Trial | NCT04805112 | Entailment |
3,356 | 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:
- Provide written informed consent
- Aged 45-65 years
- BMI < 35 kg/m2
Exclusion Criteria:
- Emotionally and intellectually not capable to decide about participation in the study
and the consequences of participation. Subjects who are not able to understand the
patient information
- Diabetes mellitus treated with oral antidiabetic medicine
- Type 1 diabetes mellitus
- Peripheral artery and/or coronary disease
- Untreated hypertension
- Alcohol use > 2 units/day
- Aberrations in kidney, liver and thyroid function
- Use of any experimental medication within 6 months of the study
- The use of immunosuppressive drugs
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 45 Years old.
Subject must be at most 65 Years | Inflammatory Aspects of Glucose in Hyperlipidemia and Diabetes | NCT02130505 | Contradiction |
1,116 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- All adult patients (age 18 or older) admitted with syncope or near-syncope
Exclusion Criteria:
- Patients who do not speak/read the language of the consent form
- Prisoners
- Patients who are of altered mental status or had head trauma
- Refusal or inability to sign consent
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 Syncope,Its Diagnosis, Treatment, Outcome and Prognosis | NCT00764985 | Entailment |
3,314 | 24 | A 4-year-old boy comes to the office for the follow up of his confirmed oculocutaneous albinism. The patient was born at 38 weeks gestation with no complications. Vital signs are normal. Weight and height are at the 50th percentile. On examination, iris transillumination is present, and there are no apparent foveae on funduscopic examination. Optic nerves are small and gray. All the hairs including eyebrows and lashes are white. | I brought my four-year-old son to his follow-up consultation for his albinism. All his hair is white, even lashes and eyebrows. My baby was born at 38 weeks pregnant with no complications whatsoever. During the consultations his vitals were normal and now his weight and height are at the 50th percentile. The doctor did an eye exam and it seems that his iris has a kind of transillumination, and there are no foveae. The doctor told me that his optic nerves are small and gray. | Inclusion Criteria:
-Oculocutaneous albinism (diagnosis validated by a clinician at the initial genetic
consultation and did not show mutations of the TYR, OCA2, TYRP1, SLC45A2 genes)
Exclusion Criteria:
None
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| New Strategies of Genetic Study of Patients With Oculocutaneous Albinism | NCT04068961 | Entailment |
187 | 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
Each patient must meet all of the following criteria at screening to participate in the
study:
1. The patient is 18 years of age or older;
2. The patient speaks, reads, and understands the English language at a sixth grade
reading level or higher;
3. The patient is willing to have photographs taken and/or be video recorded while he
completes study tasks, which will be de-identified prior to any potential use of the
image(s) for scientific or educational purposes;
4. The patient has sufficient availability to participate in the study and to comply with
the study schedule;
5. The patient has his own transportation to and from the study site;
6. The patient demonstrates the ability to understand and the willingness to follow all
study instructions; and
7. The patient has read, stated he understands, and has signed the Informed Consent Form
(ICF).
8. The patient has been diagnosed with hypogonadism;
9. The patient is a male;
10. The patient has a documented history of hypogonadism. Diagnosis must include
documentation of consistent signs and symptoms of androgen deficiency;
11. Patients in good health as determined by the Investigator and based on medical
history, physical examination, vital signs, electrocardiogram (ECG), and clinical
laboratory tests;
12. All male patients must practice effective contraception during the study and for 30
days after receiving the last dose of study drug. Acceptable methods of birth control
include condom with spermicide, vasectomy, or monogamous relations with a female
partner who is of non child-bearing potential (post-menopausal, surgical, or
congenital sterility) or is of child bearing potential and practicing a reliable
method of contraception (hormonal contraception, double barrier methods with
spermicide, or intrauterine device); and
13. Patients must have the ability to provide written informed consent and comply with all
study requirements and restrictions including the study visit schedule.
Exclusion Criteria
Patients will be excluded from participation in the study if any of the following criteria
apply:
1. Failure to meet 1 or more Inclusion Criterion;
2. The patient has participated in interviews, focus groups, or studies for any medical
products or therapies within the past 3 months or in a prior QST auto-injector
usability study, clinical trial, and/or has previous exposure to the investigational
device;
3. The patient or someone he lives with works or has worked for a Marketing/Market
Research Company, pharmaceutical or medical device company, a manufacturer,
distributor, or wholesaler of non-prescription drug products, or a government health
agency;
4. Individuals who have had an allergic reaction or idiosyncratic reaction to sesame
seeds, sesame products, and/or sesame oil;
5. History of food anaphylaxis;
6. History of intolerance, allergy, or idiosyncratic reaction to testosterone products;
7. Unstable psychiatric illnesses;
8. Lifetime history of psychosis, suicidal behavior, bipolar disorder, or personality
disorder; active suicidal ideation within 6 months prior to screening; or inadequately
treated depression. Note: Patients with depression who have been adequately treated
and with stable response for 3 months may be admitted into the study at the
Investigator's discretion;
9. Body mass index 40 kg/m2;
10. Hematocrit 52% at Initial Screening Visit;
11. Individual history or current evidence of breast or prostate cancer;
12. Other malignancy diagnosed or treated within 5 years of the date of Initial Screening
Visit with the exception of non-melanoma carcinoma of the skin;
13. Elevated prostate-specific antigen (PSA) for age. Prostate-specific antigen 2.5 ng/mL
in men 18 to 60 years old and 4 ng/mL in men 61 years and older is exclusionary;
14. Presence of prostate nodule or induration upon digital rectal exam;
15. Obstructive uropathy of prostatic origin and of a severity that, in the opinion of the
Investigator, contraindicates the use of testosterone;
16. Patients with poorly controlled diabetes. Patients on a stable dose and regimen of
anti diabetic medications for a minimum of 4 weeks, and who have a hemoglobin A1c
level of 7.5% may participate in the study;
17. Patients with New York Heart Association Class III or IV congestive heart failure;
18. Within 6 months of the Initial Screening Visit, have had myocardial infarction,
unstable angina leading to hospitalization, percutaneous coronary intervention,
coronary artery bypass graft, uncontrolled cardiac arrhythmia, stroke transient
ischemia attack, carotid revascularization, endovascular procedure, or surgical
intervention for peripheral vascular disease;
19. History of, or current treatment for, thromboembolic disease or current use of anti
thromboembolic medications. Use of low-dose aspirin is permitted for routine
cardioprophylaxis;
20. Patients intermittently taking adrenocorticotropic hormone, oral, or depot
corticosteroids (ongoing regimens required for panhypopituitarism or adrenal failure
are permitted);
21. Untreated sleep apnea;
22. Historical or current evidence of any clinically significant disease or disorder that,
in the judgment of the Investigator, may cause participation in this study to be
detrimental to the patient or which may influence the results of the study. This
includes cardiovascular, renal, hepatic, hematological, endocrine, gastrointestinal,
or pulmonary disease;
23. Positive serology for human immunodeficiency virus antibodies, hepatitis B surface
antigen, or hepatitis C virus antibody at the Initial Screening Visit;
24. Current evidence of alcohol or drug abuse. A positive drug screen is exclusionary
without documentation of a current prescription and medical condition requiring
treatment with the drug for which the screen is positive. Exception:
tetrahydrocannabinol is allowed in states where recreational use of marijuana is
legal;
25. Any skin condition that could confound injection site assessments (eg,
dermatographism, urticaria, or atopic dermatitis). Tattoos, scarring, or psoriasis of
the injection site is prohibited;
26. Administration of any other investigational compound within 1 month prior to Initial
Screening Visit or 5 half-lives of the investigational product (whichever is longer);
27. Patients considering or scheduled to undergo any major surgery or dental procedure
anticipated to be associated with significant blood loss (500 mL) during the study;
28. Systolic blood pressure (SBP) 140 mmHg and/or diastolic blood pressure (DBP) 90 mmHg
at the Initial Screening Visit. Patients with treated hypertension and SBP 140 and/or
DBP 90 mmHg at the Initial Screening Visit must be on a stable dose of
antihypertensive medication for at least 14 days at Day -1 (Baseline Visit) and plan
to remain on the same dose throughout the duration of the study; or
29. Unable to understand verbal or written English or any other language in which a
certified translation of the informed consent is available.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Safety of Subcutaneous Testosterone Enanthate in Adult Male Hypogonadism | NCT02777242 | Entailment |
4,684 | 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:
- absence of pregnancy at the time of presentation
- uterine volume between 12 and 18 weeks of gestation by pelvic examination
- appropriate medical status for laparoscopic surgery (American Society of
Anesthesiologists Physical Status classification 1 or 2)
Exclusion Criteria:
- any suggestion of malignant uterine or adnexal diseases
- any major medical comorbidities or psychiatric illnesses, which could affect follow-up
and/or compliance
- an inability to understand and provide written informed consent.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
Subject must be at most 70 Years | Retroperitoneal Ligation of Uterine Artery in Total Laparoscopic Hysterectomy for Enlarged Uterus | NCT03101098 | Entailment |
1,520 | 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:
- History of swallowing difficulties associated with aging and/or neurological diseases
including patients with: -neurodegenerative diseases. -non-progressive neurological
diseases including stroke. -older patients including nursing home patients.
- Age > 18 y
- Ability to give informed consent
Exclusion Criteria:
- Patients suffering idiosyncratic phenomena or who are allergic to any medication,
especially iodinated contrast media
- Patients suffering major respiratory disease or undergoing any type of surgery in the
three months prior to the study
- Patients with a background of alcohol dependence or other drug dependence
- Patient who cannot be expected to comply with treatment
- Patient currently participating or having participated in another clinical trial
during the last 4 weeks prior to the beginning of this study
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Bedside Screening Method for Patients With Potential Swallowing Impairment | NCT01158313 | Entailment |
6,982 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- ICH：
1. Age：above 20 years old.
2. Evidence of intraparenchymal hemorrhage on CT or MRI.
3. Patient agrees to participate in the study and receive neurophsychological
examinations, genetic and biochemical markers test, MRI and PET imaging.
- AD：
1. Age：above 20 years old.
2. Patients who fulfills the clinical criteria of possible or probable Alzheimer's
disease (AD).51
3. Patient agrees to participate in the study and receive neurophsychological
examinations, genetic and biochemical markers test, MRI and PET imaging.
- Control：
1. Age：above 20 years old.
2. Patient agrees to participate in the study and receive neurophsychological
examinations, genetic and biochemical markers test, MRI and PET imaging.
Exclusion Criteria:
- ICH：
1. patients with potential causes of hemorrhage including trauma, structural lesion,
brain tumor, or coagulopathy due to systemic disease or medication.
2. Patients could not receive the PET and MRI studies, including but not limited to
poor cooperative agitation impeding adequate study, allergy to contrast medium,
hemodynamic instability, implantation of cardiac pacemaker, past history of
receiving aneurysm clipping, panic mood to MRI study, impaired kidney function.
3. Patients with pregnancy or recently having a plan for pregnancy.
4. Patients with breast feeding or recently having a plan for breast feeding.
5. Patients with history of allergy to 11C-PiB and 18F-T807, or severe allergy
history.
6. Patient or family who does not agree to participate in the study.
7. patient with high risk by doctor evaluate.
- AD：
1. Patients could not receive the PET and MRI studies, including but not limited to
poor cooperative agitation impeding adequate study, allergy to contrast medium,
hemodynamic instability, implantation of cardiac pacemaker, past history of
receiving aneurysm clipping, panic mood to MRI study, impaired kidney function.
2. Patients with pregnancy or recently having a plan for pregnancy.
3. Patients with breast feeding or recently having a plan for breast feeding.
4. Patients with history of allergy to 11C-PiB and 18F-T807, or severe allergy
history.
5. Patient or family who does not agree to participate in the study.
6. patient with high risk by doctor evaluate.
- Control：
1. History of neurological or psychiatric disease, abnormal neurological
examination.
2. Patients could not receive the PET and MRI studies, including but not limited to
poor cooperative agitation impeding adequate study, allergy to contrast medium,
hemodynamic instability, implantation of cardiac pacemaker, past history of
receiving aneurysm clipping, panic mood to MRI study, impaired kidney function.
3. Patients with pregnancy or recently having a plan for pregnancy.
4. Patients with breast feeding or recently having a plan for breast feeding.
5. Patients with history of allergy to 11C-PiB and 18F-T807, or severe allergy
history.
6. Patient or family who does not agree to participate in the study.
7. patient with high risk by doctor evaluate.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
| Multimodal Biomarkers for Diagnosis and Prognosis in CAA | NCT03969732 | Entailment |
4,694 | 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 with adenomyosis
- at early- to mid-secretory phases
Exclusion Criteria:
- postmenopausal
- malignancy
Female
Accepts Healthy Volunteers
Subject must be at least 35 Years old.
Subject must be at most 50 Years | Proliferation of Endometrial Stromal Cells in Adenomyosis | NCT00173212 | Entailment |
5,407 | 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:
- Women between the ages of 18-45 (inclusive) not intending to become pregnant during
the next year
- Women complaining of heavy menstrual bleeding over several consecutive cycles
- Women without structural or histological abnormality of the uterus, or with fibroids
less than 3 cm in diameter which are causing no distortion of the uterine cavity
(eligible for pharmaceutical treatment according to the NICE guideline 2007)
- Informed consent (where required by laws or regulations)
Exclusion Criteria:
- The contraindications and warnings of the respective Summary of Product
Characteristics (Mirena®, combined oral contraceptives, oral/injectable progestogens,
non-steroidal anti-inflammatory drug, or anti-fibrinolytic agent) must be followed.
- Women taking hormone replacement therapy
- Women with symptoms such as intermenstrual or post-coital bleeding, unless an
endometrial biopsy has been performed and pathology excluded
- Women with fibroids that are palpable abdominally or who have intra-cavity fibroids
and/or whose uterine length as measured at ultrasound or hysteroscopy is greater than
12 cm (NICE guideline 2007)
- Women on anticoagulative therapy or other treatment (including e.g. Copper IUD use)
known to cause menorrhagia
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | MiCo - Mirena or Conventional Medical Treatment for Menorrhagia | NCT01085487 | Entailment |
3,996 | 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:
- Osteoarthritis of the knee or hip
- Adult (ages 18-80)
- Moderate pain (verbal score of ≥ 4 ≤ 7 on 0-10 scale for average pain intensity with
normal activity)
- American Society of Anesthesiologists physical status 1-3
- Healthy subjects without pain
Exclusion Criteria:
- Pregnancy;
- Currently taking gabapentin
- Currently taking a narcotic prescription medication that is > 50 mg morphine
equivalents/day
- Advanced or unstable cardiac, pulmonary, renal or hepatic dysfunction
- History of previous eye surgery
- Psychotic disorder or a recent psychiatric hospitalization
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 | Pain Expectations in Subjects With Osteoarthritis | NCT02155257 | Entailment |
1,129 | 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:
- 18 years and older presenting to the ED with acute syncope (defined as transient loss
of consciousness) or near syncope (sensation of impending but not actual loss of
consciousness) as a reason for ED visit.
Exclusion Criteria:
- persistent altered mental status
- alcohol or illicit drug-related loss of consciousness
- definite seizure, and transient loss of consciousness caused by head trauma.
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.
| Point-of-Care Ultrasound in the Emergency Department Evaluation of Syncope | NCT01671371 | Entailment |
2,487 | 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:
1. Patient must understand and sign the informed consent.
2. Patient must be at least 18 years of age.
3. Pupillary dilation to at least 6 mm must be possible.
4. Ocular media must be sufficiently clear to allow for quality images.
EXCLUSION CRITERIA:
1. Any condition such as corneal opacifiation that precludes adequate slit lamp examination
and photography of the fundus.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Optical Coherence Tomography Comparative Study | NCT00069199 | Entailment |
3,900 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Clinical diagnosis of knee or hip osteoarthritis with history of pain at the reference
joint for at least 3 months or clinical diagnosis of low back pain of benign origin
for at least 3 months
- Must be dissatisfied with their current analgesic therapy (e.g. Non-steroidal
anti-inflammatory drugs NSAIDS, COX-2 inhibitors, opioids, paracetamol/acetaminophen
- Have a pain intensity >4 on Numerical Rating Scale
Exclusion Criteria:
- Life-long history of seizure disorder or epilepsy
- Any of the following within one year: mild/moderate traumatic brain injury, stroke,
transient ischemic attack, and brain neoplasm
- Severe traumatic brain injury within 15 years (consisting of more than one of the
following: brain contusion (injuries resulting in hemorrhage), intracranial hematoma,
unconsciousness or post traumatic amnesia lasting for more than 24 hours) or residual
sequelae suggesting transient changes in consciousness
- History of malignancy within past 2 years, with exception of a successfully treated
basal cell carcinoma
- Presence of significant pain associated with conditions other than osteoarthritis or
low back pain that could confound the assessment or self-evaluation of 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.
| A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain | NCT00361504 | Entailment |
3,605 | 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:
- Anybody suitable for novasure ablation
Exclusion Criteria:
- Mirena IUS is indicated as treatment
Female
Accepts Healthy Volunteers
| RCT Novasure Versus Novasure + Mirena IUS in the Treatment of Menorrhagia | NCT01965587 | Entailment |
3,207 | 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:
- no participation in a similar study 2-weeks prior
- may be post-menopausal or have had a hysterectomy
- if sexually active, and of child bearing potential, subjects is using adequate
non-barrier method of birth control
- free from any vaginal disorders
- sexually active and in a monogamous, heterosexual relationship, and whose male partner
is willing and able to give informed consent and agrees to engage in sexual
intercourse at least twice each week during the two-week study or is not sexually
active
- personal lubricant user and agrees to replace her usual personal lubricant with the
investigational product
- can start regardless of where they are in their cycles
- agrees to use the provided investigational product at least four time weekly over the
two week study period
- exhibits no clinically significant evidence of vulvar or vaginal irritation, as
determined by a study doctor, and no reports of sensory irritation at the baseline
exam
- willing to refrain from introducing any new vaginal products, or using vaginal
medications or local contraceptives during study
- agrees to refrain from douching or using any medications, powder, lotions or personal
care products in the vulvar or perianal area
- willing to use a urine pregnancy test provided to them at baseline and on third visit
- standard medical history form on file
- signed informed consent
- completed HIPAA
- dependable and able to follow directions as outlined
- receives a score of 0 or 0.5 for erythema and edema; and 0 for sensorial irritation
(burning, stinging, itching and dryness) during the first examination.
Exclusion Criteria:
- pregnant, nursing or planning a pregnancy
- currently using or has used within two weeks prior to the study initiation, any
systemic or topical corticosteroids, vasoconstrictors, antibiotics,
anti-inflammatories or antihistamines
- known allergies to vaginal or any cosmetic products
- reports history of recurrent bladder, vaginal infections or incontinence
- exhibits or reports gynecologic abnormalities or has had vaginitis within 60 days
prior to study initiation
- uses a vaginal ring, diaphram or cervical/vault caps, condoms, or condoms with
spermicide as a means of contraception
- participated in a study involving the vaginal area or in an investigational systemic
drug study within two weeks of study initiation
- receives a score higher than 0/5 for erythema, edema or >0 for burning, stinging, or
itching, during first examination or shows any other sign of mucosal irregularities
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | A Clinical Study to Evaluate the Safety of a Personal Lubricant in Healthy Female Subjects | NCT02737592 | Entailment |
1,690 | 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:
- Born female
- Age 15 to 20 years
- HIV-negative
- No history of HPV vaccination
- Sexually active: history of 1-5 lifetime partners
- Resident within study area without plans to move away in the next 37 months
Exclusion Criteria:
- Allergies to vaccine components or latex,
- Pregnancy
- Hysterectomy
- Autoimmune, degenerative, and genetic diseases
- Investigator discretion
Female
Accepts Healthy Volunteers
Subject must be at least 15 Years old.
Subject must be at most 20 Years | The KEN SHE Study on HPV-vaccine Efficacy | NCT03675256 | Entailment |
3,911 | 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:
- symptomatic knee OA
Exclusion Criteria:
- Younger than 45 years of age or older than 85 years of age
- Prosthetic knee replacement or other clinically significant surgery to the arthritic
knee
- uncontrolled hypertension (>150/95)
- Heart disease including heart failure
- Peripheral neuropathy in which pain testing was contraindicated
- Systemic rheumatic disorders including rheumatoid arthritis, systemic lupus
erythematosus, gout, and fibromyalgia
- Neurological diseases such as Parkinson's, multiple sclerosis, stroke with loss of
sensory or motor function, or uncontrolled seizures
- Significantly greater pain in body sites other than in the knee
- Daily opioid use
- Hospitalization within the preceding year for psychiatric illness
- Currently pregnant or nursing/breastfeeding
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 85 Years | Study of Pain Catastrophizing | NCT03836586 | Entailment |
3,073 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Male or female subjects 12 to 40 years of age eventually expanding to 6 years of age
- Molecular documentation of the fragile X mutation.
- Clinical Global Impression - Severity (CGI-S) rating for problem behavior of moderate
or higher at screening and at Visit 1
- An Aberrant Behavior Checklist (ABC-C) Irritability Subscale score >12 and at least 3
items on the Irritability Subscale rated at least moderate or above.
- Current treatment with no more than three psychoactive medications, including
anti-epileptics.
- Current pharmacological treatment regimen has been stable for at least 4 weeks.
Exclusion Criteria:
- Subjects with a history of seizure disorder who are not currently receiving treatment
with antiepileptics.
- Subjects with any condition, including alcohol and drug abuse, which might interfere
with the conduct of the study, confound interpretation of the study results, or
endanger their own well-being. This includes, but is not limited to impairment of
renal function, evidence or history of malignancy or any significant hematological,
endocrine, cardiovascular, respiratory, hepatic, or gastrointestinal disease.
- Subjects who plan to initiate or change pharmacologic or non-pharmacologic
interventions during the course of the study.
- Subjects who are currently receiving treatment with racemic baclofen.
- Subjects currently treated with vigabatrin or tiagabine.
- Subjects taking another investigational drug currently or within the last 30 days.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
Subject must be at most 40 Years | Safety, Tolerability and Efficacy Study of STX209 in Subjects With Fragile X Syndrome | NCT00788073 | Entailment |
189 | 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. Man 18 to 65 years of age, inclusive, with hypogonadism as defined by 2 AM total T
values of <300 ng/dL drawn on 2 separate days ([approximately 7 days apart]).
2. Adequate venous access
3. Must be naïve to androgen-replacement therapy or washed out of prior androgen
replacement therapies; willing to cease current T treatment or currently not be taking
T treatment. Subjects must remain off all forms of T, except for dispensed study drug,
throughout the entire study.
4. Subjects on replacement therapy for hypopituitarism or multiple endocrine deficiencies
must be on stable doses of thyroid hormone and adrenal replacement hormones for at
least 14 days before Screen 1.
5. Voluntarily given written informed consent to participate in this study.
Exclusion Criteria:
1. 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.
2. Received oral TU in a previous Clarus-sponsored investigational study.
3. Significant intercurrent disease of any type; in particular, liver, kidney,
uncontrolled or poorly controlled heart disease, including hypertension, congestive
heart failure or coronary heart disease, or psychiatric-illness, including severe
depression.
4. Recent (within 2 years) history of stroke, transient ischemic attack, or acute
coronary event.
5. A mean of the triplicate assessment of systolic blood pressure (sBP) > 150 mm Hg
and/or diastolic blood pressure (dBP) > 90 mm Hg at screening.
6. Recent (within 2 years) history of angina or stent (coronary or carotid) placement.
7. Untreated, severe obstructive sleep apnea.
8. Clinically significant abnormal laboratory values (serum transaminases > 2 × ULN,
serum bilirubin > 1.5 × ULN and serum creatinine > 1.5 × ULN).
9. Hematocrit (HCT) value of < 35% or > 48%.
10. Has a history of polycythemia, either idiopathic or associated with testosterone
replacement therapy (TRT).
11. Glycosylated hemoglobin (A1C) > 8.5%.
12. BMI ≥ 38 kg/m2.
13. If receiving the following medications:
- Has been on stable doses of lipid-lowering medication for < 3 months;
- Has been on stable doses of oral medication for diabetes for < 2 months; or
- Has been on stable doses of antihypertensive medication for < 3 months.
14. Abnormal prostate digital rectal examination (palpable nodules), elevated Prostate
Specific Antigen (serum PSA > 4.0 ng/mL), International Prostate Symptom Score (I-PSS)
> 19 points at screening, and/or history of, or current or suspected, prostate cancer.
15. History of, or current or suspected, breast cancer.
16. History of abnormal bleeding tendencies or thrombophlebitis unrelated to venipuncture
or intravenous cannulation within the previous 2 years.
17. Use of dietary supplements such as saw palmetto or phytoestrogens and any dietary
supplements that may increase total T, such as androstenedione or
dehydroepiandrosterone within the previous 4 weeks.
18. Known malabsorption syndrome and/or current treatment with oral lipase inhibitors and
bile acid-binding resins.
19. Inability to refrain from smoking during the confinement periods as required by the
individual study center.
20. History of alcohol abuse or any drug substance within the previous 2 years.
21. Poor compliance or unlikely to keep clinic appointments.
22. Has received any drug as part of another research study within 30 days of initial dose
administration in this study.
23. Donated blood (≥ 500 mL) within the 12-week period before the initial study dose.
24. Currently uses antiandrogens, 5-alpha-reductase inhibitors, estrogens, potent oral
CYP3A4 inducers, potent CYP3A4 inhibitors, or long acting opioid analgesics.
25. Unwilling or unable to follow the dietary guidelines for this study, related to taking
oral TU with meals that contain approximately 20 to 40 g of fat
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men | NCT02722278 | Entailment |
6,642 | 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:
1. Male patients with congenital hemophilia A of any severity and any age.
2. History of high titer factor VIII inhibitor (Bethesda unit >5)
3. Currently prescribed bypassing agent therapy for bleed management.
4. Current treatment with emicizumab for a minimum of 2 months without interruption.
Exclusion Criteria:
1. Active bleed requiring factor therapy at screening.
2. Treatment with rFVIIa or aPCC 7 days prior to screening.
3. Surgical procedure 14 days prior to screening.
4. Current use of any medication other than emicizumab that could affect the coagulation
system e.g. aspirin, anticoagulants, etc.
Male
No healthy subjects accepted to join the trial.
| A Study to Evaluate the Safest Dose Range for FEIBA in Hemophilia A Patients With Inhibitors on Emicizumab | NCT04205175 | Contradiction |
3,828 | 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
- Idiopathic knee OA-I, II, &III
Exclusion Criteria:
- Post Traumatic OA Knees
- Ligament instability
- Condromalacia patellae
- Knee replacements
- Cognitive impairment
- Rheumatoid arthritis
- Meniscus injury
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.
Subject must be at most 70 Years | Patient Education Manual on Patients With Knee Osteoarthritis. | NCT04598126 | Entailment |
4,327 | 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:
- Healthy male subjects aged18 and 50 years inclusive; BMI between 18 and 28 kg/m2 and
body weight between 50 and 80 kg.
- Physical examinations and vital signs are normal or abnormal without clinical
significance.
- Abdominal color Doppler ultrasound, laboratory tests, etc. are normal or abnormal
without clinical significance.
Exclusion Criteria:
- Any current or history of severe allergic reaction to foods or drugs and History of
allergy to study products.
- Having severe injuries or surgery or fractures within 4 weeks before enrollment,or to
receive surgery during the study.
- Having clinically significantclinical history abnormalities or other clinically
indicated diseases (including but not limited to gastrointestinal, renal, liver,
neurological, hematological, endocrine, tumor, lung, immune, mental or cardiovascular
diseases).
- Having malignant tumor (excluding basal cell carcinoma who has undergone resection).
- Having clinically significant chronic or acute infections at screening/incorporation;
or active infections,Includes acute and chronic infections as well as local infections
(bacteria, viruses, parasites, fungi or other opportunities) Sexually infected
pathogen).
- Having a history of tuberculosis or latent tuberculosis or clinical manifestations
suspected of being tuberculosis(including But not limited to tuberculosis).
- Having been exposed to tuberculosis or/and suspected tuberculosis symptoms and/or
signs within 3 months before screening.
- Having used simponi,or any anti-tumor necrosis factor (TNF-α) biologic preparation or
any biological products within 6 months before enrollment or monoclonal antibodies
within a month.
- Having used drugs within 30 days before enrollment (including but not limited to
prescription drugs, Chinese medicine, non-prescription drugs).
- Having vaccinated active / attenuated vaccine within 12 weeks before screening or
planned to vaccinate active /attenuated vaccine the during the study.
- Having a history of hypertension or systolic blood pressure ≥ 140 mmHg, or diastolic
blood pressure ≥ at screening/inclusion90 mmHg, and it is judged abnormalities with
clinical significance.
- Electrocardiogram (ECG) examination abnormalities with clinical significance;
- Having positive detection of golimumab anti-drug antibody (ADA) during screening.
- Chest orthotopic examination abnormalities with clinical significance.
- Tuberculosis enzyme-linked immunospot assay (T-SPOT. TB) positive test,
- Having any alcoholic products within 24 hours prior to the use of the study drug.
- A drug abuse test positive or a history of drug abuse over the past five years.
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Comparative Study to Evaluate the Pharmacokinetics of BAT2506 vs Simponi® in Healthy Subjects | NCT04152759 | Contradiction |
5,353 | 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:
- Pre-menopausal adult women 30 years of age or older who have completed childbearing
- Heavy or prolonged menstrual bleeding
- Willing and able to complete all follow-up exams as required by protocol
Exclusion Criteria:
- Known or suspected endometrial cancer or pre-malignant change of the endometrium
- Untreated cervical dysplasia
- Hereditary malformations of the uterine cavity that would prevent insertion and/or
placement of the cryoprobe
- Uterine myomas > or = to 3 cm in diameter
- Past history of invasive treatment for abnormal uterine bleeding or uterine myomas
- History of classical (not low transverse incision) cesarean section
- Active genital or urinary tract infection or acute pelvic inflammatory disease (PID)
- Intrauterine device (IUD) in place
- Other medical conditions could be exclusionary upon evaluation for study treatment
Female
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 100 Years | Evaluation of Modified Treatment Regimens for Treatment of Heavy Menstrual Bleeding Using the HerOption® System | NCT00094536 | Contradiction |
2,677 | 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:
- primary inguinal hernia
- unilateral hernia
Exclusion Criteria:
- bilateral hernia
- recurrent hernia
- incarcerated hernia
- large scrotal hernia
- known femoral hernia
- need for associated procedures
- not able to understand the questionaire
- immunosuppression (including corticosteroids, radiotherapy, chemotherapy)
- chronic renal failure (hemodialysis)
- active infection
- pregnancy
- allergy to polypropylene or cyanoacrylate
- patient's refusal and/or absence of 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 18 Years old.
Subject must be at most 85 Years | Pain and Quality of Life After Inguinal Hernia Repair: Laparoscopic Versus Open Repair. | NCT04211142 | Entailment |
908 | 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:
1. Males or Females between the ages of 40 and 75 with a diagnosis of Osteoarthritis (OA)
of the knee consistent with the American College of Rheumatology (ACR) Clinical
Classification Criteria for Arthritis of the Knee (Altman, R. et al., 1986):
- Knee pain at study enrolment,
- Less than 30 minutes of morning stiffness with or without crepitus on active
motion.
- Confirmation either by arthroscopy or radiologist's report (X-rays showing
osteophytes, joint space narrowing or subchondral bone sclerosis {eburnation})
within 1 year prior to entry into the study.
2. ESR < 40 mm/h
3. Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Pain Subscales
total score equal to or more than 150 mm at baseline.
4. Oral and written language comprehension at a level sufficient to comply with the
protocol and complete study-related materials.
5. The Patient signed and dated the (IEC) approved, written, informed consent prior to
study participation
Exclusion Criteria:
1. Known rheumatoid arthritis or any other rheumatoid disease.
2. Secondary arthritis i.e. any of the following: septic arthritis; inflammatory joint
disease; gout; pseudogout; Paget's disease; joint fracture; acromegaly; fibromyalgia;
Wilson's disease; Ochronosis; Haemochromatosis; Osteochondromatosis; heritable
arthritic disorders; or collagen gene mutations.
3. Obesity Class II [body mass index (BMI) equal to or more than 35 kg/m2] (NIH, 2000)
4. Major illness that required hospitalisation during the 3 months before commencement of
the screening period.
5. Unwillingness to cease taking medication other than the study medication for arthritic
pain, any other concomitant pain, or OA medications.
6. Patients who had previously failed tramadol HCl therapy or those who discontinued
tramadol HCl due to AEs.
7. Patients who within the 3 weeks prior to study entry took the following medications:
monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds
(e.g. cyclobenzaprine, promethazine); neuroleptics; selective serotonin reuptake
inhibitors; or other drugs which reduce seizure threshold.
8. Patients who took another investigational agent within the 30 days prior to study
entry.
9. Patients with a history of seizure disorder other than Infantile Febrile Seizures.
10. Patients who were opioid dependent.
11. Patients with bowel disease causing malabsorption.
12. Patients who were pregnant or lactating or patients of child-bearing potential who
were unwilling to utilise a medically approved method of contraception during
participation in this clinical trial.
13. Patients with significant liver disease, defined as active hepatitis or elevated liver
enzymes >3 times the upper boundary of the normal range.
14. Patients with significant renal disease, defined as creatinine clearance <30 mL/min as
estimated by the method of Levey et al., 1999.
15. Current substance abuse or dependence, other than nicotine.
16. Allergy or adverse reaction to tramadol or any structurally similar drugs e.g.
opiates.
17. Any other condition that, in the opinion of the investigators, adversely affected the
patient's ability to complete the study or its measures.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 75 Years | A Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol HCl / Contramid® Tablets to Twice Daily Tramadol HCl (SR) for the Treatment of Osteoarthritis of the Knee | NCT00950651 | Entailment |
6,576 | 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:
1. Male or female subjects age ≥ 12 years at the time of informed consent
2. Body weight ≥ 35 kg
3. Diagnosed with severe hemophilia A. All subjects must have severe hemophilia A with
baseline FVIII <1% activity; <0.01 IU/mL
4. Have ≥ 150 previous exposure days to FVIII concentrates, as documented in the
subject's medical records
5. Subjects included in the on-demand treatment cohort must have a verifiable record of
at least three bleeding episodes per month on average in the last 6 months prior to
enrollment
6. Negative assays for FVIII inhibitor at inclusion (<0.6BU Nijmegen assay)
7. Negative assays for FVIII inhibitor in subject files (<0.6BU Nijmegen assay) No
history of positive inhibitor is allowed
8. Normal liver and kidney function.
9. Platelet count ≥ 100,000 μL
10. Normal prothrombin time or International Normalized Ratio (INR) < 1.5
11. Subjects receiving therapy for human immunodeficiency virus (HIV) or hepatitis must be
on a stable treatment regimen
12. Subjects must be able to withhold FVIII infusions for approximately 72 h prior to each
FVIII activity and inhibitor assay (96 h if participating in the PK sub study)
13. Absolute CD4 lymphocyte cell count ≥ 200 μL
14. Signed the written informed consent form or informed consent was obtained from the
subject's legal guardian
15. Females must not be lactating or pregnant at Screening or Baseline (as documented by a
negative beta-human chorionic gonadotropin [ß hCG] test with a minimum sensitivity of
25 IU/L or equivalent units of ß hCG). A separate baseline assessment is required if a
negative screening pregnancy test was obtained more than 72 hours before the first
dose of study drug
16. All females will be considered to be of childbearing potential unless they are
postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age
group and without other known or suspected cause) or have been sterilized surgically
(i.e. bilateral tubal ligation, total hysterectomy or bilateral oophorectomy, all with
surgery at least one month before dosing)
17. Willing and able to comply with all aspects of the protocol
Exclusion Criteria:
1. Presence at Screening of FVIII inhibitor ≥ 0.6 BU as tested with the Nijmegen
modification of the Bethesda assay in either central or local laboratory
2. History of FVIII inhibitor of ≥ 0.6 BU as measured using the Nijmegen modification of
the Bethesda assay
3. History of FVIII inhibitor ≥ 1.0 BU if the subject has been tested routinely using the
original Bethesda assay, or history of periods with low recovery and no response to
Factor VIII treatment
4. Demonstrated an inability to respond to conventional doses of FVIII therapy
5. History of incremental recovery of Factor VIII <1.35% per IU/kg infused
6. Hematological disorders or blood coagulation diseases (e.g., idiopathic
thrombocytopenic purpura, von Willebrand disease, etc.) other than hemophilia A
7. Laboratory or clinical evidence of portal vein hypertension including,(but not limited
to, an INR > 1.4, the presence of splenomegaly and/or spider angiomata on physical
examination and/or a history of esophageal hemorrhage or documented esophageal varices
8. Uncontrolled hypertension (diastolic blood pressure >100 mm Hg)
9. Hemoglobin < 10 g.dL
10. HIV disease symptoms regardless of presence of HIV antibodies
11. Routine administration (or planned routine administration during the course of the
study), of immunosuppressive or immunomodulating drugs other than antiretroviral
therapy (e.g., steroids, beta-interferon)
12. Severe renal dysfunction (creatinine > 2x upper limit of normal [ULN], total bilirubin
> 2x the ULN)
13. Liver disease (alanine aminotransferase [ALT], aspartate aminotransferase [ AST] > 3x
the ULN)
14. History of diabetes or other metabolic disease
15. History of hypersensitivity or serious adverse reaction to recombinant or
plasma-derived FVIII concentrate
16. History of pretreatment prior to the administration of FVIII products (e.g., of
antihistamines)
17. Regular use of antifibrinolytics or medications affecting platelet function
18. Hypersensitivity to hamster-or mouse derived proteins
19. Blood transfusions within 30 days of enrollment into the study
20. Current participation in another investigational drug or device study, or participated
in a clinical study involving an investigational drug or device within 30 days of
enrollment into the study
21. Unable or unwilling to cooperate with study procedures
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.
| Safety, Efficacy and Pharmacokinetics of GreenGene™ F to Previously Treated Patients With Severe Hemophilia A | NCT01619046 | Contradiction |
1,804 | 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:
- These subjects will include male or female aged between 18 and 60 years with
indications for upper-endoscopy ,but without serious gastritis and other serious
stomach lesions
Exclusion Criteria:
- Complications such as gastric and/or duodenal peptic ulcer, stenosis
- Esophageal, gastric or duodenal cancer or other malignancy
- History of stomach surgery
- A history of bronchial asthma, or known allergy to fluorescein.
- Pregnant or breast-feeding (for females)
- Below 18 or above 60 years of age
- Severe comorbidities ( e.g. such as renal failure, congestive cardiac failure, liver
cirrhosis).
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 | Evaluation of Image Quality Over Time After Injection of the fluorescein Sodium for Confocal Laser Endomicroscopy | NCT01042171 | Contradiction |
54 | 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
- Medically stable, ambulatory, surgically menopausal women, 21-60 years of age, who
have undergone bilateral salpingo-oophorectomy and hysterectomy at least 6 months
before study entry
- Serum total testosterone concentrations less than 31 ng/dL or free testosterone less
than 3.5 pg/ml (less than the median for healthy, young women
- Able to understand and give informed consent.
- The women will have been on a stable regimen of transdermal estrogen replacement for
at least three months. Those who are not on estrogen replacement or are taking a
different mode of estrogen replacement will be included only if they are willing to
switch to transdermal estradiol patch (see below).
- A normal PAP smear (if subject has a cervix) and mammogram in the preceding 12 months.
Exclusion Criteria:
- Significant depression, as assessed by Beck's Depression Scale.
- Any acute or chronic illness, malignant disease or fever of known or unknown origin
will be excluded.
- Poorly controlled diabetes mellitus (hemoglobin A1c greater than 8.5%)
- Uncontrolled hypertension defined as blood pressure of greater than 160/100
- Severe obesity defined as body mass index of greater than 40 kg/m2
- Current or recent (last 6 months) users of illicit drugs (which may affect appetite,
food intake, metabolism, and/or compliance with the protocol)
- Any one planning to initiate a weight-reduction diet in the subsequent six months
- Alcohol or drug dependence currently or in the preceding 6 month.
- Significant liver function abnormalities, defined as SGOT, SGPT or alkaline
phosphatase value of greater than three times the upper limit of normal in our
Clinical Pathology Laboratory or serum bilirubin levels of greater than 1.5 mg/dl will
be excluded.
- History of breast, ovarian, endometrial or cervical cancer
- History of hyperandrogenic disorders such as hirsutism, grade 2 or 3 acne, and
polycystic ovary disease. Testosterone administration to these patients may exacerbate
the underlying disorder.
- Intolerance to other transdermal formulations
- Women with abnormal PAP smears or mammograms will not be included unless they have
been evaluated by their gynecologists and breast and uterine/cervical cancers have
been excluded by appropriate tests.
- Women with dementia as assessed by the mini-mental state examination
- Women with depression, assessed by Beck's Depression Scale.
- Those with disabilities that would prevent them from participating in strength testing
(e.g., amputation of limbs, blindness, severe arthritis, neurologic disorders such as
Parkinson's disease, stroke, or myopathy).
- Women with any heart disease, including angina, congestive heart failure, or history
of myocardial infarction or coronary artery angioplasty or bypass surgery in the
previous year will be excluded.
- Subjects planning to initiate a weight-reduction diet in the subsequent six months
- Other Medications. Women who have received in the preceding three months drugs known
to affect testosterone production or metabolism such as ketoconazole, Megace, and/or
anabolic/androgenic steroids will be excluded. We will also exclude women who are
taking or have taken in the past three months medication that include sexual
dysfunction (e.g., spironolactone, SSRIs, GnRH agonists). Women who are using any
medication, device or dietary supplement known to enhance sexual function will not be
included. Women receiving thyroid hormone replacement therapy may participate in the
study only if they have been on a stable replacement dose of L-thyroxine for at least
three months.
- Intolerance to estrogen products or skin patches
- Undiagnosed vaginal or vulvar bleeding
- History of deep vein thrombosis, pulmonary embolism, or other thromboembolic disorder
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 60 Years | TDSM- Testosterone Dose Response in Surgically Menopausal Women | NCT00494208 | Contradiction |
294 | 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:
- Inclusion criteria included age younger than 37 years, having a regular and proven
ovulatory menstrual cycle with a length of 26-35 days and body mass index (BMI) of <35
kg/m2, and serum FSH and estradiol were within normal range. Indications for IVF were
tubal pathology, unexplained infertility, and male factor
Exclusion Criteria:
-
Female
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
Subject must be at most 37 Years | Multi-factorial Analysis of the Follicular Fluid Milieu to Explore the Discrepant Effect of Follicular Fluid Endometrial Flushing on Outcome of Assisted Reproduction Trial | NCT02468258 | Contradiction |
5,615 | 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:
- Patient with growth hormone deficiency
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 1 Year old.
Subject must be at most 81 Years | Molecular Basis of the Growth Axis in Short Stature | NCT00453245 | Contradiction |
749 | 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:
- OA symptoms lasting at least 1 month and managed with medications, activity
limitations, and/or physical therapy
- At least one symptom consistent with a torn meniscus. Symptoms may include clicking,
catching, popping, giving way, pain with pivot or torque, episodic pain, and/or pain
that is acute and localized to one joint line.
- Available knee X-ray (within 6 months) and MRI (within 3 years)
- Evidence of osteophyte formation or cartilage fissure, tear, or loss on a knee MRI OR
plain radiographic evidence of osteophyte formation or joint space narrowing
- Evidence of a meniscal tear (tear extending to surface of meniscus) on a knee MRI
- Willingness to undergo random assignment and sign an informed consent
Exclusion Criteria:
- Chronically locked knee
- Kellgren-Lawrence Grade IV status, indicating advanced OA and usually the need for
total knee replacement
- Contraindication to MRI
- Radiographic chondrocalcinosis (a condition in which there are deposits of calcium
pyrophosphate dihydrate [CPPD] crystals in one or more joints that eventually result
in damage to the affected joints) AND acute symptomatic pseudogout
- Inflammatory diseases (e.g., rheumatoid arthritis, psoriatic arthritis, systemic lupus
erythematosus, gout, pseudogout)
- Injection with viscosupplementation in the affected knee in the 4 weeks before study
entry
- Any medical contraindications to surgery or physical therapy
- Both knees are symptomatic for meniscal tears and a candidate for bilateral APMs
- Prior surgery on an affected knee
- Pregnancy or possible pregnancy
- Claim filed for worker's compensation
- Unable or unwilling to give informed consent
- Unable or unwilling to attend physical therapy sessions at designated locations or in
the community
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.
| Comparing Knee Cartilage Surgery Versus Standard Physical Therapy in Treating People With a Meniscal Tear and Osteoarthritis | NCT00597012 | Contradiction |
1,687 | 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:
- Healthy adult males and females, as assessed by a medical history, physical exam, and
laboratory tests;
- Age of at least 18 years of age on the day of screening and no greater than 40 years
on the day of first vaccination;
- Willing to comply with the requirements of the protocol and available for follow-up
for the planned duration of the study (screening plus 18 months);
- In the opinion of the principal investigator or designee has understood the
information provided. Written informed consent needs to be given before any
study-related procedures are performed;
- Willing to undergo HIV Testing and counseling, and receive HIV test results;
- If sexually active female, using an effective method of contraception from screening
until at least 4 months after last vaccination. All female volunteers must be willing
to undergo urine pregnancy tests.
- If sexually active male, willing to use an effective method of contraception from
screening until 4 months after the last vaccination and will be advised not to get his
partner pregnant.
Exclusion Criteria:
- Confirmed HIV-1 or HIV-2 infection;
- Reported high-risk behavior for HIV infection defined as:
Within 6 months before vaccination, the volunteer has:
- Had unprotected vaginal or anal sex with a known HIV infected person or with a casual
partner.
- Engaged in sex work for money or drugs
- Used injection drugs (illicit), or
- Acquired an STD;
- Any clinically significant abnormality on history or examination including history of
immunodeficiency or autoimmune disease; use of systemic corticosteroids,
immunosuppressive, antiviral, anticancer, or other medications considered significant
by the trial physician within the last 6 months;
- Any clinically significant acute or chronic medical condition requiring care of a
physician (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy,
substance abuse) that in the opinion of the investigator would preclude participation;
- Any of the following abnormal laboratory parameters listed below:
- Hemoglobin: <9.0 g/dL
- Absolute Neutrophil Count (ANL): ≤ 999/mm3
- Absolute Lymphocyte Count (ALC): ≤ 500/mm3
- Platelets: ≤ 90,000 ≥ 550,000/mm3
- Creatinine: > 1.4 x ULN
- AST: >3.0 x ULN
- ALT: >3.0 x ULN
- Urine dipstick: blood = 2+ or more (except in menstruating females); protein = 2+or
more
- Cardiac troponin I: > ULN;
- Confirmed diagnosis of hepatitis B (surface antigen, HbsAg); hepatitis C (HCV
antibodies) or active syphilis;
- If female, pregnant or planning a pregnancy within 4 months after last vaccination or
lactating;
- Receipt of a live attenuated vaccine (other than influenza) within 30 days or other
vaccine within 14 days of vaccination;
- Receipt of blood transfusion or blood products 6 months prior to vaccination;
- Participation in another clinical study of an investigational product currently or
within past 12 weeks or expected participation during this study;
- Receipt of another experimental HIV vaccine at any time;
- History of severe local or systemic reactogenicity to vaccination or history of severe
allergic reactions;
- Major psychiatric illness including any history of schizophrenia or severe psychosis,
bipolar disorder requiring therapy, suicidal attempt or ideation in the previous 3
years;
- In the opinion of the investigator, unlikely to comply with protocol;
- ECG with clinically significant findings or features that would interfere with the
assessment of myo/pericarditis including:
- conduction disturbance (atrioventricular or intraventricular condition, left or right
bundle branch block, AV block of any degree, or QTc prolongation)
- repolarization (ST segment or T wave) abnormality
- significant atrial or ventricular arrhythmia
- frequent atrial or ventricular ectopy (e.g. frequent premature atrial contractions, 2
premature ventricular contractions in a row)
- ST elevation consistent with ischemia
- evidence of past or evolving myocardial infarction;
History of, or known active cardiac disease including:
- previous myocardial infarction (heart attack)
- angina pectoris
- congestive heart failure
- valvular heart disease including mitral valve prolapse
- cardiomyopathy
- pericarditis
- stroke or transient ischemic attack
- chest pain or shortness of breath with activity (such as walking up stairs)
- other heart conditions under the care of a doctor;
Have 3 or more of the following risk factors:
- high blood pressure diagnosed by a doctor
- high blood cholesterol diagnosed by a doctor
- diabetes or high blood sugar diagnosed by a doctor
- a first degree relative (for example, mother, father, brother, sister) who had a heart
condition before the age of 50
- smoke cigarettes now.
- History of allergy to aminoglycosides (e.g. gentamycin)
- History of severe allergy to eggs or egg products e.g., "rash or breathing
difficulties"
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 a Modified Vaccinia Ankara (MVA) HIV Vaccine in HIV Uninfected Adults | NCT00252148 | Entailment |
4,238 | 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 subjects
- sporadic cigarette smoking (<9 cigarettes per month)
Exclusion Criteria:
- Any form of cardiovascular disease
- Any form of pulmonary disease like asthma or COPD
- Any form of systemic or chronic disorder like rheumatologic or metabolic diseases.
- Active allergy within 4 weeks of the study
- Symptoms of infection or inflammation within 4 weeks of the study
- Pregnancy
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 35 Years | Effects of E-smoke on Levels of Endothelial Progenitor Cells and Microparticles in Healthy Volunteers | NCT02532894 | Contradiction |
3,266 | 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
To enroll into the clinical trial, potential subjects must:
1. Be healthy women, who are sexually active, at risk for pregnancy and desiring
contraception.
2. Be within the age range of 18 through 40 years inclusive at enrollment.
3. Have a negative urine pregnancy test at the admission visit.
4. Have a history of regular cyclic menses with a usual length of 21 to 35 days when not
using hormonal contraception.
5. Have one menses after switching from oral contraceptives to using the Woman's Condom.
6. Have at least one spontaneous menstrual cycle (two menses) following a pregnancy that
ended at 14 or more weeks gestation.
7. Have at least one cycle (two menses) after an abortion at less than 14 weeks
gestation.
8. Be willing to accept a risk of pregnancy.
9. Be willing to engage in at least four acts of heterosexual vaginal intercourse per
month for a period of 6 months.
10. Be willing to only use the study product as the primary method of contraception over
the course of the study.
11. Be capable of using the study product properly and agree to observe all study
directions and requirements.
12. Be willing to keep a diary to record coital information, product use information,
information about the use of other vaginal products, and any symptoms, which occurred
in her or her partner over the course of study participation.
13. Be willing to state that, to her best knowledge, her sexual partner(s):
1. Has not had a vasectomy or been previously diagnosed as infertile.
2. Has not been previously diagnosed or suspected of HIV unless he has subsequently
had a negative HIV test.
3. Has not been known to have engaged in homosexual intercourse in the past 5 years
unless he has had negative HIV test results since then.
4. Has not shared injection drug needles in the past unless he has had a negative
HIV test at least 6 weeks since last use.
5. Has no known history of allergy or sensitivity to polyurethane (condom pouch),
polyvinyl alcohol (capsule), or other water-based lubricants such as Astroglide.
14. Agree not to participate in any other clinical trials during the course of this study.
15. Be willing to give written informed consent to participate in the trial.
Exclusion Criteria
To enroll into the clinical trial, potential subjects must not:
1. Have a history of allergy or sensitivity to polyurethane (condom pouch), polyvinyl
alcohol (capsule), or other water-based lubricants such as Astroglide.
2. Have current UTI or symptomatic vaginal infection as confirmed by dipstick urinalysis,
or if needed by a urine culture or wet mount (see Schedule of Assessments for
definitions), unless treated and proof of cure is documented by a negative test result
performed at least 2 weeks post-treatment.
3. Have evidence of Chlamydia trachomatis or Neisseria gonorrhea infection unless she and
her partner(s) complete treatment and proof of cure is documented for the subject only
by a negative test result performed at least 3 weeks post-treatment.
4. Be pregnant, have a suspected pregnancy or desire to become pregnant during the course
of the study.
5. Have a history of infertility or pelvic inflammatory disease without a subsequent
spontaneous intrauterine pregnancy.
6. Have been diagnosed with pelvic inflammatory disease (PID) without a subsequent
intrauterine pregnancy.
7. Be in a monogamous relationship of less than 4 months with their partner.
8. Have any contraindications to pregnancy (medical condition) or regularly use category
D or X or exclusionary medications listed in Appendix F.
9. Have shared injection drug needles in the past unless has a negative HIV test at least
6 weeks since last use.
10. Have known or suspected to have an HIV infection.
11. Have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence
(initial episode) within 3 months prior to screening or have clinical evidence of HSV
on exam.
12. Be lactating or breastfeeding.
13. Have any clinically significant abnormal vaginal bleeding or spotting within the month
prior to screening.
14. Have had vaginal or cervical biopsy or vaginal surgery within 3 months prior to
screening.
15. Have used vaginal or systemic antibiotics or antifungal agents within 14 days prior to
screening or enrollment.
16. Have received a Depo-Provera® injection in the 9 months prior to enrollment (this
exclusionary time period can be shortened to 6 months if the subject has also had 2
spontaneous menstrual cycles [requires minimum of 3 menses] that meet criteria for
normal menstrual cycles).
17. Have an abnormal Pap test based on the following criteria:
- Pap test in the past 15 months with ASC-US unless:
- less than 21 years of age;
- a repeat Pap test at least 6 months later was normal;
- reflex HPV testing was performed and was negative for high-risk HPV; or
- a colposcopy (with or without biopsy) found no evidence of dysplasia
requiring treatment or treatment was performed and follow-up at least 6
months after the treatment showed no evidence of disease;
- Pap test in the past 15 months with LSIL unless:
- less than 21 years of age;
- a colposcopy (with or without biopsy) found no evidence of dysplasia
requiring treatment or treatment was performed and follow-up at least 6
months after the treatment showed no evidence of disease;
- Pap test in the past 15 months with ASC-H, atypical glandular cells, or HSIL
unless colposcopy and/or treatment was performed and follow-up at least 6 months
after the colposcopy and/or treatment showed no evidence of disease;
- Pap test in the past 15 months with malignant cells.
18. Have a past (within 12 months) or current history of alcohol or drug [recreational,
prescription or over-the-counter (OTC)] abuse.
19. Have taken an investigational drug or used an investigational device within the past
30 days.
20. Have previously participated in or completed this study.
21. Have issues or concerns (in the judgment of the investigator) that may compromise the
safety of the subject or confound the reliability of compliance and information
acquired in this study. For example, if the subject is found to have Condyloma
Accuminata, the investigator can decide whether to exclude the subject or not,
depending on its location and if use of the condom may be painful for the subject.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | A Multicenter, Open-Label, Non-Comparative Study of the Safety and Contraceptive Efficacy of the Woman's Condom | NCT01223313 | Entailment |
2,641 | 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:
- 18 years of age or older
- Able to give informed consent
- Unilateral inguinal hernia
- Scheduled for elective inguinal hernia repair
- Eligible to tolerate general anesthesia
- Eligible to undergo minimally invasive inguinal hernia repair
- Willing to undergo mesh-based repair
Exclusion Criteria:
- Younger than 18 years old
- Unable to give informed consent
- Bilateral Inguinal hernias
- Emergent inguinal hernia repairs ( acute incarceration or strangulation)
- Recurrent inguinal hernia with prior preperitoneal mesh
- Unable to tolerate general anesthesia
- Not eligible for minimally invasive inguinal hernia repair
- Not willing to undergo mesh-based repair
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.
| Telescopic Dissection vs. Balloon Dissection During Laparoscopic TEP Inguinal Hernia Repair | NCT03276871 | Entailment |
5,809 | 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:
- Legally competent women and men
- Age 18 years or older
Exclusion Criteria
- Actual systemic or topical antifungal therapy
- Pregnant or lactating women
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Yeast Colonization and Infection in Patients With Inflammatory Skin Diseases | NCT04215458 | Entailment |
1,439 | 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:
- More than 70 years old.
- Oropharyngeal dysphagia with impaired safety of swallow (penetration aspiration score
higher or equal than 2).
- Patients able to comply with the study protocol.
- Signature or the written informed consent.
Exclusion Criteria:
- Previous history of severe gastrointestinal diseases.
- Epilepsy or previous convulsive crisis episodes.
- Pacemaker or implanted defibrillator carriers.
- Cardiopulmonary instability.
- Oropharyngeal dysphagia of structural cause.
- Previous history of head and neck surgery.
- Neurodegenerative disease.
- Advanced dementia (GDS higher than 5).
- Gastroesophageal reflux.
- Taking drugs with effects on dopamine.
- Neoplasia or active infection.
- Alcohol, tobacco or drugs dependence.
- Participate or have participated in another interventionist clinical trial in the 4
weeks prior to inclusion.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 70 Years old.
| Subacute Effect of Pharyngeal Pharmacological Sensory Stimulation in Elderly Patients With Oropharyngeal Dysphagia | NCT04741620 | Contradiction |
6,955 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion criteria for PWMC are as follows:
- English speaking
- a physician diagnosis of early-stage Alzheimer's disease or mild-to-moderate cognitive
impairment
- no history of serious mental illness (i.e., any major psychiatric disorder)
Inclusion criteria for care partners of PWMC are as follows:
- English speaking
- 21 years of age or over
- self-identifies as someone who provides assistance to the PWMC because of their memory
loss (these individuals are called ''care partners,'' as these individuals may or may
not provide the intensive hands-on care typical of ''caregivers'')
- plans to remain in the area for at least 6 months in order to reduce loss to follow-up
- indicates a willingness to use the smartwatch system
Exclusion Criteria for PWMC are as follows:
- non-English speaking
- no physician diagnosis of early-stage Alzheimer's disease or mild-to-moderate
cognitive impairment
- a history of serious mental illness (i.e., any major psychiatric disorder)
Exclusion criteria for care partners of PWMC are as follows:
- non-English speaking
- under 21 years of age
- does not identify as someone who provides assistance to the PWMC because of their
memory loss
- does not plan on remaining in the area for at least 6 months
- does not indicate a willingness to use the smartwatch system
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
| A Mobile Informatics Solution to Aid in Memory | NCT04700540 | Entailment |
1,662 | 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:
- Is the individual a healthy, normal adult man or woman who volunteers to participate?
- Is s/he within 18 to 45 years of age, inclusive?
- Is his/her BMI between 19 and 30 inclusive?
- Is she willing to avoid pregnancy by abstaining from sexual intercourse with a
non-sterile male partner, or by the use one of the following methods: diaphragm +
spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine
contraceptive device or hormonal contraceptives (at least 4 week prior to dosing) or
has she been surgically sterile or post-menopausal at least six months prior to
entering into the study?
- Is s/he considered reliable and capable of understanding his/her responsibility and
role in the study?
- Has s/he provided written informed consent?
Exclusion Criteria:
- Does the individual have a history or allergy or hypersensitivity to desloratadine?
- Does s/he have clinically significant laboratory abnormalities that would interfere
with the conduct or interpretation of the study or jeopardize his/her safety?
- Does s/he have significant history or clinical evidence of auto-immune,
cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological,
ongoing infection, pancreatic, or renal disease that would interfere with the conduct
or interpretation of the study or jeopardize his/her safety?
- Is she nursing?
- Does s/he have serious psychological illness?
- Does s/he have significant history (within the past year) or clinical evidence of
alcohol or drug abuse?
- Does s/he have a positive urine drug screen or a positive HIV-I, or hepatitis B or C
screen, or a positive pregnancy test?
- Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or
beverages during periods beginning 48 hours prior to study drug administration and
ending when the last blood sample has been taken in each study period?
- Has s/he used any prescription drug, other than hormonal contraceptives, during the 14
day period prior to study initiation, or any OTC drug during the 72 hour period
preceding study initiation?
- Is s/he unable to refrain from the use of all concomitant medications, other than
hormonal contraceptives, during the study?
- Has s/he donated or lost blood or participated in a clinical study which involved the
withdrawal of a large volume of blood (480 mL or more), during the six week period
preceding study initiation?
- Has s/he donated plasma during the two week period preceding study initiation?
- Has s/he received an investigational drug during the 30 day period preceding study
initiated?
- Has s/he used any tobacco products in the 3 months preceding drug administration?
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 | Bioequivalence Study for Desloratadine OD Tablets 5 mg Under Fasting Condition | NCT01506050 | Entailment |
5,253 | 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: Women over the age of 45 with regular menstruation should be included
in group 1, women over the age of 55 without menstruation for at least one year should be
included in groups 2 or 3 according to the results of the bone density test. If T-Score>
-2.5 will be included in group 2 and if T-Score <-2.5 they will be included in group 3.
-
Exclusion Criteria: Women with metabolic bone disease, thyroid or pre-thyroid disease,
diabetes, chronic steroid use, use of osteoporosis drugs, hormonal therapy, BMI below 20 or
over 27, pregnant women and tattooed women in the area under study will not be included in
the study.
-
Female
Accepts Healthy Volunteers
Subject must be at least 45 Years old.
Subject must be at most 65 Years | MRI Study of the Distal Radius Bone Marrow Fat Fraction in Osteoporotic and Healthy Women | NCT03742362 | Entailment |
776 | 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:
- Both males and females
- Patients with age 45-65 years
- Patients with knee OA of grade II or III according to Kellgren-Lawrence grade.
- Pain intensity ranging between> 5 measured by Numeric Pain Rating Scale.
- Patients who had minimum score of 25 on the Western Ontario McMaster Universities
Osteoarthritis Index (WOMAC) total score.
- Patients having knee pain for at least 3 months.
Exclusion Criteria:
- Patients with pain in other lower limb joints.
- Patients with symptomatic hip osteoarthritis.
- Patients with knee surgery in last 6 months.
- Patients with complaint of cancer, diabetes, neurological deficit or uncontrolled
hypertension
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 65 Years | Low Level Laser Therapy in Knee Osteoarthritis | NCT04682171 | Contradiction |
5,154 | 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:
- osteoporosis patients
Exclusion Criteria:
- not osteoporosis patients who are allergic to the drugs, refused to do this research,
or who are pregnant
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 120 Years | Examination of Efficacy and Safety of Other Anti-Resorption Drugs After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients | NCT03755193 | Contradiction |
6,086 | 45 | A 15-week-old infant brought to the clinic for the follow up. The infant has flat facies, small ears, a single palmar crease, and upward slanting eyes. He was born on 39th week to a 39-year-old woman who didn't have prenatal care. The medical record confirms the trisomy of chromosome 21 (Down syndrome). The infant is otherwise healthy. | My newborn, who is only 15 weeks old, had one of his follow-up appointments. The doctor pointed out that my baby had a flat face, small ears, only one palm line, and small eyes. He was born on his 39th week, while I was 39. What a coincidence! To be honest, I did not go to the doctor during my pregnancy. The doctor diagnosed my baby with Down syndrome. Apart from that he's healthy. | Potential eligible participants were directed to the study website (www.dsc2u.org) for the
eligibility screening questionnaire in English and Spanish and online consent. After
selecting a language preference (English or Spanish), in addition to questions about the
child's or dependent's biological sex, race and ethnicity, the eligibility screening
questions included:
1. Do you have a child or dependent with DS?
2. Is your child or dependent 1 year or older?
3. When is your child's next annual well visit ("PCP visit")?
4. Does your child or dependent currently receive care at a DS specialty clinic? (If the
child or dependent was actively followed in a DS specialty clinic, even one out of
state. For example, a family from Arizona who travels to Texas each year for their
child to be seen in a DS specialty clinic would be ineligible)
Inclusion Criteria:
- If you have a child or dependent with Down syndrome (DS)
- If your child or dependent is 1 year or older
- If your child or dependent is does not receive care at a DS specialty clinic
Exclusion Criteria:
- If your child or dependent does receive care at a DS specialty clinic
- If your child or dependent is under 1 year old
- If your child or dependent has a PCP that is already involved in the study
DS occurs naturally and proportionally in all races and ethnicities, so the study's
population estimates were proportional to the racial/ethnic distribution of the U.S.
population, as reported in the 2010 U.S. Census. To achieve commensurate representation in
the study, the investigators applied a quota system in offering enrollment using the race
and ethnicity of the individual with DS (not the caregiver).
The investigators' plan was to enroll participants such that there were: no more than 144
white individuals with DS, no fewer than 25 Hispanic or Latino/Latina individuals with DS,
and no fewer than 20 black individuals with DS. The team also planned to enroll no more
than 120 individuals with DS of one sex.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 1 Year old.
| Down Syndrome Clinic to You | NCT04227197 | Contradiction |
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