cyrilzakka/clinical-trials huggingface dataset:
Effect of Beta-alanine and Pelvic Floor Muscle Training on Urinary Incontinence After Radical Prostatectomy (BELA)

The purpose of this study is to evaluate the effectiveness of beta-alanine in combination with pelvic floor muscle training (PFMT) compared to PFMT plus placebo in men undergoing radical prostatectomy.

This study will assess efficacy of beta-alanine in combination with PFMT for the treatment of participants with urinary incontinence after radical prostatectomy. B-alanine is a component of L-carnosine (with L-histidine), which is needed for its synthesis. Βeta-alanine, thanks to its bioavailability) is a commonly used supplement that can improve exercise performance by increasing the amount of carnosine in striated muscle tissues. Supplementation of beta-alanine in elderly patients has resulted in an increase in physical activity, less fatigue and overall increase in L-carnosine concentration in muscles. PFMT utilization is considered a strong predictor of early return of urinary continence after radical prostatectomy (RP). We hypothesize, that combination of PFMT with beta-alanine could result in improved urinary continence after RP. The intervention will start 30 days before the surgery and will continue until primary outcome is met. Beta-alanine/placebo will be given daily. Efficacy, pharmacokinetics, biomarkers, tissue histology, participants reported outcomes and safety will be assessed. The total duration of study will be approximately 6 months.

Eligibility Criteria:
* Inclusion Criteria:

  * Age 40-80 years
  * Able to give informed consent
  * Histologically proven prostate cancer
  * BMI \<35
  * No other cancer treatment
  * Continent
  * Good physical and mental activity
  * On normal diet
  * Scheduled for radical prostatectomy (open or robotic)
* Exclusion Criteria:

  * Other malignant cancer (except for benign skin cancer)
  * Age \> 80 years
  * Diabetes mellitus (any type)
  * Chronic bowel inflammatory disease
  * Urinary incontinence
  * Impaired mental activity
  * Previous radiotherapy of hormonal therapy
  * Vegetarian/vegan/on macrobiotic diet
mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation

This study is designed to evaluate efficacity and safety of everolimus or (cyclosporine then everolimus) vs. cyclosporine as immunosuppressive treatment in renal transplantation for elderly (\>60 years old) recipients receiving graft from elderly donor(\>60 years old).


Eligibility Criteria:
Inclusion Criteria:

* Patient who has given written informed consent to participate in the study
* First or second single transplantation of a recipient (male or female) older than 60 years old
* Donor older than 60 years old
* PRA \< 30%

Exclusion Criteria:

* Living donor
* Third transplantation
* PRA \> 30%

Other protocol-defined inclusion/exclusion criteria may apply.

* Recipient of multi-organ transplant
* Active major infections (HBV, HCV, HIV)
* Loss of a first graft for immunologic issues
* Anemia (\<9g/l) or leucopenia (\<2500/mm3)
Impact of Bariatric Surgery on Epicardial Adipose Tissue and on Myocardial Function

Growing evidence suggests that bariatric surgery is a relevant treatment for severely obese patients, especially those with metabolic complications, as it significantly reduces weight, hypertension and ameliorates glycemic control. Its action on adipose tissue distribution and in particular on epicardial adipose tissue EAT remains unknown. Whether metabolic improvement is associated with EAT reduction is also unknown.

The researchers thus investigated the effect of bariatric surgery on EAT in severely obese patients. The primary endpoint of this study was the change in EAT amount 6 months after bariatric surgery.

The best of our knowledge, no study has really addressed whether this EAT was modulated by diet or therapeutics like bariatric surgery. The researchers were particularly interested in studying the impact of bariatric surgery and of weight loss on the amount of EAT and whether reduction in EAT could have a positive impact on myocardial function.

Eligibility Criteria:
Inclusion Criteria:

* men or women who have more than 18 years
* patients have been informed and have consented
* severely obese patients with surgery indication

Exclusion Criteria:

* contraindications at surgery, at MNR imagery
* History of infarct, of congenital cardiomyopathy
* Treatment modifying the distribution of the fat
* Pregnant or breast-feeding women
* patients less than 18 years
* Patient without consentment
A First in Human Study Using 89Zr-cRGDY Ultrasmall Silica Particle Tracers for Malignant Brain Tumors

The purpose of this study is to test if PET scans using 89Zr-DFO-cRGDY-PEG-Cy5-C' dot particles, can be used to take pictures of brain tumors. The investigators want to understand how the particles are distributed and removed from the body, which may help others be treated in the future. This will be the first time that 89Zr-DFO-cRGDY-PEG-Cy5-C' dot particles are being used in people. The amount of particles given in this study is very small compared to the amount that was used in mice animal studies.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Histologically confirmed diagnosis of malignant primary brain tumor clinical and radiographic findings consistent with a pituitary adenoma, or known metastatic cancer with brain lesion presumed to be metastatic.
* Normal baseline cardiac function based upon pre-operative evaluation at the physcian's discretion
* All patients of childbearing age must use an acceptable form of birth control
* Women who are pre-menopausal must have a negative serum pregnancy test

Exclusion Criteria:

* Known pregnancy or breast-feeding Medical illness unrelated to the tumor which in the opinion of the attending physician and principal investigator will preclude administration of the tracer

  °This includes patients with uncontrolled infection, chronic renal insufficiency, myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis, or New York Heart Association Classification III or IV heart disease
* More than one metastatic cancer active in the last 5 years
* Active metastatic cancer in addition to malignant primary brain tumor
* Weight greater than the 400-lb weight limit of the PET scanner
* Unmanageable claustrophobia
* Inability to lie in the scanner for 30 minutes
The Role of Minerelocorticoid Receptor on Modulating Aldosterone Production

The purpose of this research protocol is to determine if the same effects are observed in vivo in humans using a similar approach. Demonstrating that mineralocorticoid acts on zona glomerulosa cells to regulate aldosterone production in a short feedback loop would provide important insight into hormone regulation, and explain variability in pathophysiologic states such as hypertension and cardiovascular diseases.

In order to provide additional evidence indicating the presence of functional and in order to provide additional evidence indicating the presence of functional mineralocorticoid receptors (MR) on zona glomerulosa (ZG) cells, the investigators propose the following protocol in healthy volunteers. The investigators will evaluate aldosterone and cortisol production in response to an angiotensin II infusion after three separate test conditions: 1) placebo, 2) following a single dose of fludrocortisone, and 3) following a single dose of eplerenone (a MR antagonist).

Eligibility Criteria:
Inclusion Criteria:

* Participants must be healthy, with no prior history of hypertension, no family history of hypertension, diabetes, stroke or cardiac disease in first-degree relatives before the age of 70 years and have an average (two measurements) blood pressure of \<130/89 mm Hg and \>100/50 mmHg at the screening visit.
* All subjects will have body mass index 19-25 kg/m2.
* Subjects must have normal laboratory values for: Complete blood count; serum creatinine, sodium, potassium, glucose, liver enzymes; urinalysis; negative urine HCG in women; normal ECG

Exclusion Criteria:

* Alcohol intake \>12oz per week, as well as tobacco or recreational drug use.
* Any subject with a history of coronary disease, diabetes, hypertension, stroke, kidney disease, or illness requiring overnight hospitalization in the past 6 months will be excluded from the study.
* Subjects taking any prescription medications (with the exception of birth control pills) or herbal medications will be excluded.
* Because of the unknown risk of infused angiotensin II in pregnancy, women who are pregnant will be excluded from study and all women will be screened for pregnancy by quantitative serum hCG measurement on the day of each CCI admission.
* Women currently breastfeeding will also be excluded from the study.
A Serosurvey Study of Hand, Foot, and Mouth Disease in Indonesia

This study is a sero-survey study of infants aged 6 months to 71 months in Bandung City and West Bandung District. As initial data to find out how many children have been exposed to human enterovirus type 71 (HEV-71) which causes Hand, foot, and mouth disease (HFMD).

This study is a cross-sectional seroprevalence survey of EV-71, associated with HFMD, among children aged between 6 to 71 months in Bandung, sampled from urban and rural Primary Health Center in Bandung, Indonesia. This study was implemented by Department of Child Health Hasan Sadikin General Hospital/Medical Faculty Universitas Padjadjaran Bandung, West Java. Age-stratified sample of 600 children aged 6-71 months will be conducted from these sites. Samples testing includes routine blood counts, enzyme-linked immunosorbent assays (ELISAs) for enterovirus type 71 (EV71) IgG and ELISAs for other HFMD-associated enteroviruses.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 months to 71 months.
* The participant's parent/guardian receives an explanation and receives a Letter of Consent after the explanation (informed consent) and provided a documented informed consent by parents/legally accepted representative (LAR) participants prior to the study procedures.
* Domicile in Bandung and West Bandung District for at least 6 months.

Exclusion Criteria:

* Children with difficulty to withdraw the blood during blood collection
* Children with severe illness who require further treatment
Oxygen Consumption After Acute Whole Body Vibration Session

Noninvasive assessment of VO2 during a single session of whole body vibration and changes in blood flow caused by the acute activity.

A single whole body vibration session into two groups, a young adults groups and elderly group, booth healthy, will be held with concomitant collection of VO2 consumed during the session, by MetaMax cortex. Immediately after the session, it will be checked peripheral blood flow through US surface in color Doppler mode.

Eligibility Criteria:
Inclusion Criteria:

* healthy young adults (between 20 to 30 years) and healthy elderly (between 60 to 74 years), sedentary according International Physical Activity Questionnaire.

Exclusion Criteria:

* presence of thrombosis, labyrinthitis, osteoporosis and individuals who have difficulty adapting to the assessment or training protocol.
Study to Assess Adverse Events and Compare How Two Subcutaneous ABBV-154 Injection Formulations Move Through the Body of Adult Healthy Participants

This study will assess how safe ABBV-154 is and how ABBV-154 moves through the body of adult healthy participants. Adverse Events will be assessed.

ABBV-154 is an investigational drug being developed for potential treatment of immune-mediated inflammatory diseases. Participants are randomly assigned to one of the 2 treatment groups. Approximately 40 adult healthy volunteers will be enrolled in 2 sites in the United States.

All participants will receive ABBV-154 as subcutaneous injections with one of the 2 different formulations.

There may be higher burden for participants in this trial. Participants will be confined for 9 days. Adverse Events and blood tests will be performed.


Eligibility Criteria:
Inclusion Criteria:

- Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounding to the nearest tenth at screening and upon initial confinement.

Exclusion Criteria:

* Participant using any medications, vitamins and/or herbal supplements, within the 2 week period or 5 half-lives (whichever is longer) prior to study drug administration.
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease, glaucoma, psychiatric disease or disorder, or any uncontrolled medical illness.
* Prior exposure to similar biologic therapies.
The Cardiac Autonomic System Response to Activity and Cognitive Tasksinjury

18 children post acquired brain injury and 18 typically developed controls matched for age and gender.

All children aged 10-18 yrs who understand simple commands.

Tools:

1. Heart rate monitor
2. Six minute walk test
3. The behavior rating inventory

Method:

1. At the introductory visit the child will be asked to walk for six minutes, to sit and perform a cognitive test and then to walk on a treadmill for 5 seconds.
2. At the second visit the child will be asked to go on the treadmill for 5 minutes and at the same time to perform the cognitive assignment; After a rest the child will be asked to walk on the treadmill for 5 minutes and at the end to perform the cognitive assignment .


Eligibility Criteria:
Inclusion Criteria:

aged 10-18 understand simple commands walk independently

Exclusion Criteria:

Canot understand simple commands
Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)

This is a prospective, observational study designed to evaluate the long-term safety and tolerability of ADVM-022 in participants with diabetic macular edema (DME). Participants who previously participated in the INFINITY parent study and received a single unilateral intravitreal dose of ADVM-022 are eligible for enrollment upon completion of the end of study visit in the parent study.

This is a multi-center study to evaluate the long-term safety and tolerability of a single intravitreal (IVT) injection of ADVM-022 in a preceding "parent" study, ADVM-022-04 \[INFINITY\]. Participants will be followed for a total of 5 years post- ADVM-022 administration (inclusive of the parent study). There is no investigational treatment administered in this study.

Eligibility Criteria:
Inclusion Criteria:

* Must have participated in the ADVM-022-04 \[INFINITY\] (parent) study and received ADVM-022
* Must provide signed informed consent
* Must be willing and able to comply with all study procedures

Exclusion Criteria:

- None
Acclimatization Mechanisms During Ascent to 7500m

The trial evaluates the role of ascent protocol on acute mountain sickness and cardio-respiratory physiology during an ascent to Muztagh Ata (7546m). Two groups of mountaineers ascend with different acclimatization time to the summit. The prevalence and severity of symptoms of acute mountain sickness are evaluated along with physiologic variables.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, physically fit subject
* Mountaineering experience

Exclusion Criteria:

* Any type of cardiac or respiratory disease
* Regular intake of any medication
* History of high altitude pulmonary oedema
* Severe acute mountain sickness at altitudes below 3500m or high altitude cerebral oedema.
Safety and Preliminary Efficacy Study of GX-I7 in Patients With COVID-19

This study is a phase 1b clinical trial to investigate the safety and preliminary effects of a single dose of a test drug or placebo to the subjects who has diagnosed as COVID-19 infection.

This study is a phase 1b clinical trial to investigate the safety and preliminary effects of a single dose of a test drug or placebo to the subjects who has diagnosed as COVID-19 infection.

Study design: prospective, randomized, placebo-controlled, single-blind, single-center

Eligibility Criteria:
Key Inclusion Criteria:

1. Subjects who have been confirmed to be COVID-19 corresponding to mild cases of severity categorization classified by FDA through polymerase chain reaction (PCR) test or virus gene test (sequencing) and who can be available to be administered within seven days from the date of manifestation.
2. Subjects who are or will be inpatient.

Key Exclusion Criteria:

1. Patients with symptoms of moderate or higher in the severity classification presented by FDA have evidence of lower respiratory tract infection in their imaging findings or need supplemental oxygen therapy or mechanical respiration (ie, non-invasive ventilation, invasive mechanical ventilation, extracorporeal membrane oxygenation, etc)
2. Subjects with infectious diseases such as bacteremia or severe pneumonia requiring active treatment within four weeks prior to the IP administration
Melanocyte Transplantation for Patients With Stable Vitiligo.

Vitiligo is an acquired skin disease that significantly impacts the quality of life of patients. Medical treatment of vitiligo includes the use of melanocyte transplantation but the results are variable.

This single center, single blind clinical trial comparing another treatment and also no treatment was designed to assess the efficacy of autologous monocyte transplantation in monolayers on a substrate of amniotic membrane for the treatment of stable vitiligo. Patients will receive the two interventions, melanocyte suspension and monolayer on amniotic membrane and will provide an untreated area as a control.

Main Objective:

The main objective is to assess the efficacy of autologous transplantation of monocytes in monolayers grown on a biological substrate of amniotic membrane in the treatment of stable vitiligo. Using a system of digital imaging analysis the percentage of re-pigmentation obtained will be studied after 3, 6 and 9 months of treatment.

Secondary Objectives:

To demonstrate differences in efficacy (as measured by the percentage of re-pigmentation) of each of the 2 techniques used: pure melanocytes in suspension and amniotic membrane with melanocytes in monolayers.

To assess how rapidly epithelialization occurs and the cosmetic result in the short and long term of the areas treated with each of the techniques.

To assess if de-epidermization with CO2 laser may be by itself a stimulus for the reservoir of melanocytes in the adjacent epidermis or hair follicles or if the re-pigmentation obtained with this procedure is merely postinflammatory as a result of trauma to the epidermis.

Eligibility Criteria:
Inclusion criteria

* Patients must voluntarily provide informed consent before any of the tests included in the trial which do not form part of standard treatment can be performed.
* Mentally stable patients, suffering from piebaldism, vitiligo of metameric distribution, focal or generalized vitiligo which has remained stable for at least one year without de-pigmentation or spontaneous re-pigmentation after standard medical treatment.
* A minimum hypopigmented area to treat of 100 cm2 (at least 30 cm2 for each of the therapeutic options).
* For women of child-bearing age, a negative pregnancy test.

Exclusion criteria:

* Women who are pregnant or breast-feeding.
* Positive results in any of the blood tests given
* Concomitant serious illness.
* Patients who have received any agent currently the focus of research in the 30 days prior to their inclusion.
* Patients currently participating in another clinical trial or receiving any other agent currently the focus of research.
Cosmetics and Pregnancy

The use of cosmetics is an important source of exposure to many chemicals including endocrine disruptors. Recently, national and international scientific recommendations have been issued to limit exposure to chemicals during pregnancy. However, the perception and the use of cosmetics by pregnant women is still little studied. The objectives of the PERICOS study are to identify the risk perception and the attitudes regarding cosmetic's use by the pregnant women.

Understanding the risk perception, the knowledge, attitudes and expectations of women about the use of cosmetics during pregnancy will help to set up effective strategies to improve prevention of chemical exposure.

A qualitative study of 60 pregnant women using six focus groups (9-11 pregnant women per group) was implemented study in Auvergne Region, France. Six focus groups will be conducted until data saturation.

The women will be recruited from the Clermont-Ferrand University Hospital (maternity type III - 2 groups), the private clinic in Beaumont (maternity type II - 2 groups), the Saint-Flour hospital center (maternity type I - 1 group), and from liberal health professionals (1 group).

If a women is found to be eligible, she will be invited to participate in the study. The focus group discussions will be conducted in a private room in the maternity of the women. They will last approximately 2 hours and will be led by an interviewer using an interview grid.

All interviews will be audio-recorded, transcribed, coded and computerized for analysis with the NVIVO v11 software.

Eligibility Criteria:
Inclusion Criteria:

* - Pregnant women between 22 (≥ 22 weeks) et ≤ 39 weeks of gestation;
* Obstetric management in the Réseau de Santé en Périnatalité d'Auvergne (RSPA);
* At least 18 years;
* Understanding and speaking French;
* And giving their signed agreement of participation.

Exclusion Criteria:

* Refusal to participate or to be registered during the collective interview;
* Women with fetal death in utero or whose fetus or fetuses have a malformation;
* Women with psychiatric disorders, mental confusion or language disorders making impossible the interview;
* Women with chronic dermatological pathology requiring dermatological care (eczema, psoriasis, etc.).
Prescreening Protocol to Enroll in Food Allergy Clinical Studies at a Single Site

This is a protocol for prescreening of participants who would like to be in clinical studies in our Center at Stanford.


Eligibility Criteria:
Inclusion Criteria:

* Any individual with possible food allergy (as per their clinical history) who is interested in performing the gold standard food challenge for diagnosis.

Exclusion Criteria:

* Any individual who does not consent
* Any individual who is currently taking oral steroids
* Any individual with moderate to severe asthma (FEV1\<80%)