cyrilzakka/clinical-trials huggingface dataset:
Genetic Studies Spermatogenic Failure

The proposed study is designed to test the following hypotheses:

1. Mouse autosomal or X-linked genes which are exclusively expressed in mouse spermatogonia are also spermatogonia-specific in human.
2. Severe spermatogenic defect, especially hypospermatogenesis or SCOS, is caused by an intrinsic defect in germ line stem cell or speramtogenia.
3. Spermatogonia-specific genes are caudate genes for human spermatogenic defect, especially for hypospermatogenesis or SCOS.
4. For a significant fraction of cases with severe spermatogenic defect, the sterile genes are transmitted via multifactorial inheritance mode.
5. For some cases with severe spermatogenic defect, mutations of spermatogonia- specific genes may be transmitted in the X-linked recessive, autosomal recessive, or autosomal dominant mode.

Between 2% and 12% of couples worldwide are affected by reduced fertility. Men who have defects in sperm production (spermatogenic defect) account for about half of these cases. In Drosophila and mouse, targeted disruptions of numerous sterility- associated genes have been created. Physiological studies in the Drosophila and in mouse also indicate that spermatogenesis is subjected to complex regulation, and male infertility may result from aberrant regulatory events. In the human being, deletions of the Y chromosome account for only 10% of cases with spermatogenic defect, and etiologies of remaining 90% of cases are still unknown. It is evident that multiple genes are involved in male infertility. For cases with severe spermatogenic defect , testicular histology shows either decreased number of germ cells in all developmental stages (hypospermatogenesis) or complete absence of germ cells (Sertoli cell only syndrome or SCOS). It appears that there is an intrinsic defect which causes depletion of germ-line stem cells (spermatogonia) for cases with hypospermatogenesis or SCOS. Of 25 genes exclusively expressed in mouse spermatogonia, 3 are Y-linked, 10 are X-linked, and only 12 are distributed on autosomes.

Eligibility Criteria:
Inclusion Criteria:

* Men with oligozoospermia(\<2\*10\^7/ml) or azoospermia

Exclusion Criteria:

* Abnormal karyotypes
* Obvious genital trauma history
* Genital hernia
* Other recognizable causes of male infertility
A Study Comparing PF-05089771 TS Tablet to PF-05089771 TS Oral Dispersion In The Fasted State And To PF-05089771 TS Tablet In The Fasted And Fed State

The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-05089771 tablet.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or non-childbearing potential female subjects between the ages of 18 and 55 years

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal,endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
* Treatment with an investigational drug within 60 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
* Screening supine blood pressure ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest 7. Single 12-lead ECG demonstrating QTc \>450 msec or a QRS interval \>120 mseca at screening. If QTc exceeds 450 msec, or QRS exceeds \>120 mseca the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility.
E-lombactifs: Evaluation of the Impact a Smartphone Application on Adherence an Exercise Program in Chronic Low Back Pain

The main objective is to assess the impact of smartphone application on adherence to a physical exercise program in chronic low back pain patients.

Adherence to a physical exercise program will be assessed at the start of the protocol, at three weeks and six months.

A control group will benefit from conventional care in a rehabilitation center and an intervention group will benefit from a conventional care in a rehabilitation center accompanied by education in the use of a smartphone application including physical exercises and information about low back pain.

The hypothesis of the search is that adherence is better in intervention group than control group at 6 months due to education in the use of smartphone application.


Eligibility Criteria:
Inclusion Criteria:

* Adult People
* With nonspecific chronic low back pain (according to the definition of the HAS)
* Covered under the national health insurance
* Giving informed written consent to participate in the study

Exclusion Criteria:

* Patient who do not meet the diagnostic criteria according to the definition of HAS
* Behavioral disorders or comprehension difficulties making assessment impossible
* Patient with a contraindication to physical exercise for medical reasons
* Patient under guardianship, curatorship or safeguard of justice
A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease

The purpose of study is to test the effect of an experimental medication GED-0301(mongersen) and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease. The study will test GED-0301 compare to placebo for 12 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease. Adolescent patients will also be allowed treatment with stable doses of exclusive enteral nutrition and growth hormone.

All patients who complete the study will have the option to enter a long term active treatment study.


Eligibility Criteria:
Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

* Male or female ≥ 12 years
* Subject is able to swallow the IP tablets
* Active Crohn's disease (CD) disease as determined by the Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's Disease (SES-CD)
* Must meet a determined average minimum number of daily stools or rating of abdominal pain over a 7day period
* Subject must have failed or experienced intolerance to at least one of the following: budesonide; systemic corticosteroids; immunosuppressants (eg, azathiopurine, 6-mercaptopurine, or methotrexate); or biologics for the treatment of CD (ie, infliximab, adalimumab, certolizumab, or vedolizumab).

Exclusion Criteria:

• The presence of any of the following will exclude a subject from enrollment: Diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis, or colitis due to immunodeficiency

* Local manifestations of Crohn's Disease (CD) such as abscesses, short bowel syndrome; or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy
* Subject has strictures with prestenotic dilatation, requiring procedural intervention, or with obstructive symptoms. In addition, subjects with colonic strictures that are not passable with an age-appropriate colonoscope, or strictures in the ileum or ileocecal valve that are fibrotic in nature, will be excluded
* Intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the Screening Visit
* Ileostomy or a colostomy
* Subject has a history of any clinically significant medical condition that, in the investigator's opinion, would prevent the subject from participating in the study
* Adolescents with delayed growth or pubertal development who are on corticosteroids at baseline and who should not continue treatment with the same dose of corticosteroids until the Week 12 visit.
Comparison Study of 3 Ostomy Products

To purpose of the study is to evaluate and compare the efficacy of three ostomy accessory products.

The primary objective of this study was to evaluate and compare the efficacy of three ostomy accessory products in terms of leakage and wear time. Secondary objectives were to evaluate and compare the safety of three ostomy accessory products, and to assess and compare the performance of the three products in terms of use and overall impression.

Eligibility Criteria:
Inclusion Criteria:

* Has an ostomy
* Is at least 18 years of age
* Has a stoma for at least 3 months
* Other than thier ostomy is considered to have a healthy/stable health
* Is able to take care of their stoma

Exclusion Criteria:

* Known sensitivity to any of the ostomy devices or components
* Is undergoing chemotherapy or radiotherapy
* Has participated in a clinical study within the past 30 days
* Has a medical condition, in which in the opinion of the Investigator would not be a good candidate for the study and justifies exclusion
Platelets in Acute Wounds: A Pilot Study (PAWS)

Comparison of wound healing treatments; platelet gel vs. control

Comparison of autologous platelet gel to a control treatment in acute wounds, specifically punch biopsy wounds. Eight patients included in this pilot/feasibility study. Wound healing evaluated over 6 months for wound closure and long term outcome.

Eligibility Criteria:
Inclusion Criteria:

Healthy non-smokers, \>18 years of age, BMI\<30 -

Exclusion Criteria:

Smokers, obese, keloid formers, bleeding disorders, medications -
Measurement of Outcome of Surgical Treatment in Patients With Acromegaly

OBJECTIVES: I. Compare growth hormone (GH) levels at baseline and after glucose suppression measured with both a polyclonal radioimmunoassay and a highly sensitive immunoradiometric assay (IRMA) in patients with acromegaly and normal volunteers.

II. Measure the levels of IGF-I and its binding protein, IGFBP-3, in these cohorts.

III. Determine any correlation between levels of IGF-I and IGFBP-3 and GH suppressibility as assessed by sensitive IRMA.

IV. Determine if patients who demonstrate biochemical features of mild GH excess are at risk for progression to active disease.

PROTOCOL OUTLINE: Blood samples are collected and assessed for growth hormone and IGF-I by polyclonal radioimmunoassay (RIA) and immunoradiometric assay (IRMA). Growth hormone is measured at baseline and 60, 90, and 120 minutes after a 100 g glucose drink. Serum glucose is measured at baseline and at 2 hours post dextrose administration by the glucose hexokinase method.

Clinical scores are determined for headache, perspiration, fatigue, joint pain, and acne.

Exams and tests may be repeated every 6 months for 2 years.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of acromegaly and treated with transsphenoidal surgery

Biochemically and histologically confirmed growth hormone secreting tumor

OR

Healthy volunteers

--Prior/Concurrent Therapy--

Surgery:

* See Disease Characteristics
* Greater than 6 months since prior surgery

Other: At least 1 month since prior bromocriptine or octreotide

--Patient Characteristics--

Performance status: Ambulatory

Hepatic: No active hepatic disease

Renal: No active renal disease

Other:

* No diabetes mellitus
* No glucose intolerance
* Hypopituitarism allowed if on stable doses of replacement therapy
Multichannel EMG Diagnosing True Preterm Labor

We have designed new electromyography sensors for measuring uterine activity. These sensors are directional - they preferentially report uterine muscle contractions at specific locations, called regions. By measuring the synchronization of the regions of the uterus during contractions we intend to non-invasively determine if any patient is in-labor or not-in-labor. Accurately diagnosing true preterm labor allows timely intervention to avoid preterm birth; Accurately diagnosing false preterm labor avoids needlessly treating patients who would not benefit.

The legacy device for assessing uterine contractions is the tocodynamometer (Toco). The Toco is plunger-driven device that measures the uterine shape change that occurs with a contraction. Toco only reports the timing of contractions, not the contraction strength, and cannot distinguish between false and true labor.

Our overarching goal is to validate our method of determining if a patient experiencing contractions is in true labor or false labor. We will accomplish this by applying new knowledge to an old technology - uterine EMG.

This trial is based on our advanced understanding of how the uterus generates coordinated contractions without a pacemaker or dedicated electrical conduction pathways - mechanotransduction and intrauterine pressure - but also uses bioelectrical signaling for local tissue recruitment.

The uterus emits bioelectrical signals with each contraction that can be detected by electromyography (EMG). To observe uterine bioelectrical signals, we created a novel EMG sensor, we call the "area sensor". This sensor is directional - capable of preferentially reporting muscle contractions from immediately below the sensor location.

In this clinical trial we use multiple area sensors placed on the maternal abdomen to directly observe how well the regional contractions are synchronized. Our hypothesis to be tested is that highly synchronized contractions predicts true labor, unsynchronized predicts false labor.

Patients with unclear labor status, or those in early labor will be studied. We will correlate the results of the synchronization analysis against the patient's progress over the ensuing 24 hours. These data will validate the ability to identify false and true labor using multichannel EMG and area sensors.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* One living fetus
* Experiencing frequent uterine contractions

Exclusion Criteria:

* Cervical dilation \> 4 cm
* Ruptured membranes
* Maternal or fetal indications for immediate delivery
Laparoscopic Gynecologic Surgery With Robotic Assistance System Kymerax® : Pilot Study

Laparoscopic robotic surgery (LSM) seems to increase quality of surgery. Diffusion of LSM is limited by cots of the only available system today. Kymerax® is a cheaper new system of LSM.

Aim : To evaluate feasibility of laparoscopy with Kymerax® system in different laparoscopic procedures in gynecology.

Material and methods : Observational study. Inclusion criteria were : patient requiring laparoscopic procedure in gynecology who give informed consent. The investigators evaluate procedures routinely performed by laparoscopy in gynecology.

Hypothesis : Procedures performed routinely in gynecology were feasible with Kymerax® system.


Eligibility Criteria:
Inclusion Criteria:

* Patient requiring a following surgical procedure realized usually by coelioscopy:

Total hysterectomy or inter annexielle for mild or neoplastic pathology Promontofixation for genital prolapse Annexectomie or ovarian kystectomie for ovarian pathology Pelvic or lombo-aortic cleaning out for uterine cancer Tubaire Salpingectomie for pathology Rectovaginale partition Exérèse hurts of endometriosis

Exclusion Criteria:

* Patient refusing to participate in the study
* Patient understanding French.
* Minor waits
A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in Thailand

This study is conducted in Asia. The aim of this observational study is to evaluate current status of diabetes management, control, complications in diabetic subjects in Thailand.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients registered in the particular centre for more than 12 months.
* Patients should have visited the centre at least once in the last 3-6 months apart from the initial visit.
* Patients willing to sign informed consent form.

Exclusion Criteria:

* Repetition of any patient as patients should not be included twice for any reason.
* Unwilling to participate or unable to comply with protocol requirements.
A Phase I Study of ZD1839 and Palliative Thoracic Radiotherapy in Patients With Non-small-cell Lung Cancer

The purpose of this study is to characterize the safety profile of ZD1839 in combination with Palliative thoracic Radiotherapy in patients with non-small cell lung cancer


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Patients requiring low dose palliative thoracic irradiation to a field size of less than or equal to 150cm2
* Histologically or cytologically conformed non-small cell lung cancer
* Aged 18 or over

Exclusion Criteria:

* Previous thoracic radiotherapy
* Any condition that may pre-dispose the patient to suffer an individual drug-relaged DLT (dose limiting toxicity) event
* Known hypersensitivity to any component of study medication
Project SMART Automated Pillbox Study

The aim of this study is to examine the effect of mHealth tools on antiretroviral (ART) adherence and persistence among HIV-infected individuals with co-occurring cocaine use disorders (CUDs).

To conduct qualitative assessments using focus groups of people living with HIV (PLH) who use cocaine and healthcare providers that will assess the acceptability, feasibility, facilitators and barriers of implementing mHealth interventions; and will aid in developing the final design and content of both automated and clinician feedback in preparation for designing a pilot feasibility study.

To conduct a 12-week pilot feasibility RCT among PLH with co-occurring CUDs that will examine the impact of mHealth tools (cellular-enabled smart pill boxes and cell phones) and feedback (no feedback vs. automated feedback vs. automated + clinician feedback) on primary (ART adherence and persistence) and secondary outcomes (HIV viral suppression, cocaine use, retention in HIV care).

Eligibility Criteria:
Inclusion Criteria:

* Age equal to or greater than 18 years
* Clinic-confirmed HIV diagnosis
* Currently prescribed or eligible for ART
* Currently has insurance
* Self-reported cocaine use in the past 30 days
* Willing and able to use a cell phone and electronic pill box for the 12-week intervention

Exclusion Criteria:

* Unable to provide informed consent
* Verbally or physically threatening to research staff
* Unable to communicate in either English or Spanish
The Interaction Between Appetite Hormones

Glucagon Like Peptide (GLP) -1 affects metabolic response corrected for weight change

Many obese people have had several successful weight losses, however very few can maintain the weight loss over a longer period (e.g. one year) Therefore, we want to investigate the metabolic response and the importance for maintenance of weight loss in obese people, who lost at least 7, 5 % body weight by low calorie diet followed by 52 weeks of diet weight maintenance with or without supplement of GLP-1.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30 and \< 40 (kg/m2)
* Healthy

Exclusion Criteria:

* Other known illness
* Medicine that affects glucose- and lipid metabolism, appetite or food intake
* Pregnancy
* Breast feeding
The Effect of Dronabinol on the Acquisition and Consolidation of Trauma-Associated Memories

The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid dronabinol (delta-9-tetrahydrocannabinol) on the formation of intrusive memories after analog trauma.

A well-established stress-film paradigm will be used to induce intrusive symptoms in healthy participants. In a double-blind placebo-controlled study, the impact of exogenous dronabinol on intrusive symptoms during exposure to a trauma film will be examined. The primary hypothesis is that exogenous oral dronabinol will decrease the number of intrusive memories recorded in the four days following experimental trauma compared with placebo controls.

This project will contribute to the current understanding of intrusive memory formation in PTSD and may guide the development of future pharmacological preventions.

Recent data suggest that the cannabinoid-system is involved in stress regulation and posttraumatic stress disorder (PTSD) after traumatic events. In own of our own studies, we found reduced concentrations of the endocannabinoid arachidonylethanolamide (AEA) in BPD patients compared to healthy women (see Fig 1a). Furthermore, we found a correlation between hair concentrations of AEA and cortisol (p = .06; Fig 1b).

Low endocannabinoid signaling has been found in PTSD patients and might even present a precondition to develop PTSD after trauma. In consequence, increased endocannabinoid signaling during acquisition and consolidation of traumatic events might be a promising approach to prevent the development of PTSD. The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid dronabinol (delta-9-tetrahydrocannabinol) on the formation of intrusive memories after analog trauma.

A well-established stress-film paradigm will be used to induce intrusive symptoms in healthy participants. In a double-blind placebo-controlled study, the impact of exogenous dronabinol on intrusive symptoms during exposure to a trauma film will be examined. The primary hypothesis is that exogenous oral dronabinol will decrease the number of intrusive memories recorded in the four days following experimental trauma compared with placebo controls.

This project will contribute to the current understanding of intrusive memory formation in PTSD and may guide the development of future pharmacological preventions.

Eligibility Criteria:
Inclusion Criteria:

* healthy female volunteers
* German on a native level

Exclusion Criteria:

* former or present disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)
* any physical illnesses
* any medication intake (except oral contraceptive)
* history of traumatic experience, e.g. history of sexual abuse or rape
* pregnancy or lactation period
* follicular phase of menstrual cycle for all women not using oral contraceptives