cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Lanreotide Versus Placebo for Treatment of Patients With Digestive Fistulae

The purpose of the protocol, is to determine whether lanreotide 30 mg is effective in the treatment of patients with digestive fistulae.

The purpose of this study is to determine whether lanreotide 30mg compared to placebo is effective on the evolution of drainage volume of digestive fistulae in the 72 hours following the beginning of treatment and on the spontaneous closure time of digestive fistulae.

Eligibility Criteria:
Inclusion Criteria:

* Patient with pancreatic, duodenal, or small intestine fistula
* Patient with simple, externalised fistula
* Patient with fistula for which a medical conservative treatment is considered
* Patient with:
* for pancreatic fistulae: a mean drainage volume more than or equal to 100 ml/24h over 48 hours or more than or equal to 50 ml / 24h over 3 days and a concentration of amylase in the drainage fluid 3 times higher than in the serum over at least 2 or 3 consecutive days respectively,
* for duodenal and small intestine fistulae: a mean drainage volume more than or equal to 100ml/24h over 2 days

Exclusion Criteria:

* Patient expected to require a surgical treatment of the fistula during the study
* Patient having uncontrolled intra-abdominal sepsis; Crohn's disease; radiotherapy lesions of the small bowel; a mesenteric vascular insufficiency; a fistula localised in cancer-infiltrated areas; a distal obstruction; an exposed fistula of the small intestine; or intra-abdominal foreign bodies.
* Patient receiving long-term corticotherapy
* Patient having received any somatostatin analogue as curative treatment of the fistula or any PRF somatostatin analogue within the previous month.
* Patient having previously undergone a transplant
Tension-free Vaginal Tape (TVT) Versus Bulking Agent for the Treatment of Post Vulvectomy Urinary Incontinence

The surgical treatment of vulvar cancer is characterized by a radical approach as standard, often associated to an important rate of functional complications. This surgery often includes the partial excision of urethra, resulting in a reduction of urethral closure pressure. The radiotherapy-induced fibrosis in addiction leads to a reduction of urethral mobility. As consequence women treated for vulvar cancer may develop urinary incontinence. The incidence of this complication has been differently reported, but seems to reach the 100%. Poor data are available regarding the treatment of post vulvectomy urinary incontinence and no clear indication may be given at regards.

Based on these considerations the aim of this trial will be to compare tension free vaginal tape and bulking agent injection in women with urinary stress incontinence developed after radical surgery for vulvar cancer.

Women with urinary stress incontinence developed after radical vulvectomy will be enrolled and randomized in two groups (arm 1 and arm 2). Patients of group 1 will be treated with the tension free vaginal tape, whereas in patients of arm 2 will be used the bulking agent injection.

All eligible patients will undergo baseline assessment consisting of anthropometric, clinical, and urodynamic evaluations. During the study, the surgical outcomes, the clinical subjective and objective efficacy data, and the adverse experiences will be evaluated in each patient.

Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Stress urinary incontinence by self report, examination and test
* History of radical vulvectomy

Exclusion Criteria:

* Systemic disease and/or drugs known to affect bladder function
* Current chemotherapy or radiation therapy
* Detrusor instability
Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome

This study will evaluate the efficacy and safety of vibegron, a beta-3 adrenergic receptor (β3-AR) agonist, in the treatment of pain associated with irritable bowel syndrome (IBS) due to IBS with predominant diarrhea (IBS-D) or mixed episodes of diarrhea and constipation (IBS-M).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of irritable bowel syndrome (IBS) with predominantly diarrhea (IBS-D) or IBS with mixed episodes of diarrhea and constipation (IBS-M) according to the Rome IV criteria
* Has completed a colonoscopy according to the American Gastroenterological Association criteria, with no clinically significant findings in the last 5 years
* Has no clinically significant findings on a physical examination or clinical laboratory tests that could interfere with study participation or confound study assessments, in the opinion of the Investigator. Serum tissue transglutaminase antibody (IgA) must be negative. Fecal calprotectin testing is optional and should only be considered if there is a strong suspicion that the participant has inflammatory bowel disease (IBD) (eg, family history in a 1st degree relative, other genetic factors, etc.) or other organic disease, according to the clinical judgement of the investigator.

Exclusion Criteria:

* Diagnosis of IBS-C or IBS-U per Rome IV criteria
* History of chronic idiopathic constipation or functional constipation
* Structural abnormality of the gastrointestinal tract or a disease (e.g., known small intestine bacterial overgrowth) or condition that can affect gastrointestinal motility
* History of a gastrointestinal motility disorder other than IBS (e.g., gastroparesis, intestinal pseudo-obstruction, achalasia, Parkinsons disease, multiple sclerosis, spinal cord injury)
* Prior history of a gastrointestinal malignancy, inflammatory bowel disease, celiac disease
* Planned gastrointestinal or abdominal surgery within the next 6 months
* Co-existing gastroesophageal reflux disease or functional dyspepsia with symptoms predominant to IBS symptoms
* Symptoms or diagnosis of a medical condition other than IBS that may contribute to abdominal pain (e.g., interstitial cystitis; fibromyalgia currently being treated with pregabalin or gabapentin; and endometriosis with uncontrolled abdominal pain)
N-Terminal Pro-B-Type Natriuretic Peptide and Troponin Levels as Markers of Hemodynamic Stability in Very Low Birth Weight Infants During the First Days of Life

The primary objective is to test the hypothesis that there is an association between the hemodynamic status and the serum levels of NT-proBNP and cTnT in prematurely born infants. We would also evaluate the hypothesis that there is an association between the level of these proteins in the serum and the short and long term morbidity.

NT-proBNP is a member of the natriuretic hormone family which plays an important role in regulation of extracellular fluid volume and blood pressure.It is secreted from the cardiac ventricle myocytes in response to myocardial stress. This hormone serves as a marker of ventricular dysfunction in adults but its role in newborns and especially preterm infants has not been well studied yet. Following birth of a healthy infant there is a surge in NT-proBNP levels which is then followed by a rapid decrease. One explanation for this surge is the transition in hemodynamics from fetal circulation into postnatal one. Few studies conducted in this area have shown association between NT-proBNP level and patency of ductus arteriosus and with respiratory distress syndrome of the newborn. Cardiac troponin T (cTnT)is a specific cardiac protein which serves as a specific indicator of cardiac damage in adults, it is usually not detected at birth but following myocardial injury its serum levels will slowly rise and generally will not be detectable until at least 4 hours after onset of injury. There is no "gold standard" test for diagnosis of hemodynamic instability in very low birth weight infants. Myocardial dysfunction is thought to be the major cause for this condition in VLBW population. Since this condition is associated with severe short and long term morbidity early recognition and specific treatment may be detrimental. We hypothesized that NT-proBNP and cTnT levels may serve as a more accurate markers for diagnosis, monitoring, and outcome prediction in VLBW infants during the first days of life, than the methods we currently use (blood pressure, urine output etc.)

Eligibility Criteria:
Inclusion Criteria:

* VLBW infants born at Sheba medical Center

Exclusion Criteria:

* known cardiac or chromosomal anomaly
Risk Screening and Assessment of Shoulder, Neck and Lower Back Discomfort.

Identifying high-risk factors that may lead to shoulder, neck and lower back discomfort and contributing to the primary prevention of disease progression.

The purpose of this study is to design a self-assessment scheme for clinical assessment of shoulder, neck and lower back function and compare the consistency between clinical assessment and self-assessment. The body parameters (BMI, age, gender), daily activities (daily steps, sedentary), work and rest time (sleep time, quality) were collected through wearable devices, evaluating the risk factors of shoulder, neck and lower back discomfort.

Eligibility Criteria:
Inclusion Criteria

* 20-40 year of age with symptoms of shoulder
* Neck and lower back discomfort

Exclusion Criteria

* Red flag sign of the neck
Once Daily Given Alfuzosin in the Treatment of BPH

Collection of the data on the safety and efficacy of the once daily administration of the alfuzosin preparation /Alfetim Uno® l0 mg/ at patients with lower urinary tract symptoms/complaints rendering possible the presence of benign prostatic hyperplasia, in the course of everyday practice


Eligibility Criteria:
Inclusion Criteria:

* Sexually active male patient with lower urinary tract symptoms indicative of severe BPH, at whom disturbances of urinary retention and urination are present

Exclusion Criteria:

* Necessity of surgical intervention immediately or within 12 months because of BPH
* The patient has earlier /within 6 months/ obtained treatment because of BPH
* The patient did not improve on earlier alpha-1 blocker treatment
* Known hypersensitivity to alfuzosin
* Orthostatic hypotension in the history
* Concomitant application with another alpha-1 blocker
* Hepatic insufficiency /AST, ALT 3 fold of the upper limit of the normal value/
* Severe renal insufficiency /se creatinine greater than or equal to 150 umol/l/
* Intestinal obstruction /because of the castor oil content of the drug/
* Tumorous disease
* Severe, life threatening state

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Evaluation of the Effectiveness of the TOVERTAFEL System on Behavioral Disorders

The prevalence of behavioral disorders is high in patients living in an institutional environment or hospitalized in a long-term care unit. The consequences of these symptoms are not negligible with a faster cognitive decline and a significant impact on the life of the institution and of other patients when the disorders are pervasive and too difficult to manage for the healthcare teams.

Despite the daily attention paid to these disorders and their causes, especially the environmental ones, the teams are sometimes helpless, the teams are sometimes helpless today to fight against these symptoms, and their management thus constitutes a real challenge.

Non-drug interventions targeting this problem often require additional training, architectural installations (Snoezelen space) and / or are moderately effective. In order to offer a solution that can be used by everyone, that is transportable and based on new technologies, the TOVERTAFEL device was created.

These are interactive games projected onto a table using a ceiling projector. The light animations invite people to "play with the light" using arm or hand movements. These games stimulate residents' physical activity and encourage interactions between residents and with caregivers.

In this study, it is a question of evaluating the effectiveness of the TOVERTAFEL device on the frequent behavioral symptoms in dementia (agitation, ambulation, apathy, anxiety), the quality of life of the patients, as well as on psychotropic treatments.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman aged 60 to 106.
* Patient living in one of the USLD or UHR participating in the project.
* Score greater than or equal to 9 for at least one of the following items in the NPI-ES: apathy, agitation, anxiety, depression, aberrant motor behavior.
* Presence of TNC according to the standardization and calibration of the MMSE.
* The patients recruited must have given themselves, or through a trusted person provided for in article L. 1111-6 of the Public Health Code, failing this, by the family, or, failing that, by a person having close and stable ties with the person concerned; for adults under guardianship: the guardian or legal representative, for adults under guardianship: the curator, their informed consent to this study which must be approved by the Personal Protection Committee (PPC) prior to its completion.

Exclusion Criteria:

* Unstable pathology whose nature can interfere with the evaluation variables
* Deafness or blindness which could compromise the patient's assessment or his participation in the animation sessions.
Effect of Rimonabant on Weight Gain and Body Composition in Adults With Prader Willi Syndrome

The purpose of this study is to evaluate the effect of rimonabant, a cannabinoid receptor-1 blocking drug, on the appetite, body weight, body fat and growth hormone level of subjects with Prader-Willi Syndrome (PWS). This will be a double blind placebo controlled clinical trial involving a total of 18 young adults aged 18 to 35 years with PWS. Patients will be divided in to the two groups of control and intervention, and treated with either placebo (inactive drug), or rimonabant 20 mg once a day for a total duration of 6 months. Body weight, fat distribution, objective and subjective assessment of the hunger, fasting blood sample for measurement of ghrelin and leptin (two hormones regulating appetite), serum lipids , IGF-1(growth hormone related protein), insulin and glucose concentrations will be measured upon enrollment, at 3 months, and at the end of the study. The proportion of body fat to muscle will be determined using a radiological technique, whole body dual-energy x-ray absorptiometry (DEXA) scan, and also by measurement of skin fold thickness, waist and hip circumference at the enrollment prior to the intervention, and at the end of the study.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects will be selected if they have Prader Willi Syndrome previously confirmed by standard genetic testing (the DNA methylation test) or meet the clinical diagnostic criteria as follows :the presence of at least four of the six principal characteristics of PWS syndrome including 1) infantile hypotonia, 2) abnormal pubertal development, 3) obesity after early infancy, 4) dysfunctional central nervous system performance, 5) dysmorphic facial features, and 6) short stature. In addition, they must have one or more of the following characteristics commonly associated with PWS: 1) small hands and feet, 2) skin problems, 3) behavioral problems related to food, and 4) decreased pain sensitivity.
2. Subjects must be 18 to 35 years of age and fairly cooperative with the study protocol.
3. Subjects must have a BMI of at least 30 or more.

Exclusion Criteria:

1. Presence of pulmonary disease.
2. Presence of any other abnormal endocrine findings, including abnormal thyroid function.
3. Presence of significant behavioral problems or psychiatric illness including anxiety disorder and depression, interfering with the follow up of protocol. Any degree of depression and moderate to severe anxiety will be exclusion criteria for this study.
4. Subjects with Prader Willi Syndrome who are on other medications including growth hormone therapy, anti epileptic medications, or antipsychotic medications.
5. The presence of moderate to severe renal or liver disease. Mild elevations of liver enzymes are not exclusive.
6. Subjects who are on any other research or weight loss medication
Computerized Training for Individuals Diagnosed With Obsessive-Compulsive and Related Disorders

Obsessive-Compulsive Disorder (OCD) is a chronic and disabling disorder that costs the economy over $2 billion annually and represents a significant public health problem. This study aims to build on our understanding of aberrant emotional processing in OCD. The proposed project tests whether a computerized training aimed to alter emotional processes, can relieve repetitive thoughts and behaviors.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years old and older
* primary diagnosis of OCD
* sufficient severity of OCD symptoms
* Stable on psychotropic or other medication
* capacity to provide informed consent

Exclusion criteria:

* psychiatric or medical conditions that make participation unsafe
* concurrent use of any medications that might increase the risk of participation
* concurrent Cognitive-Behavioral therapy for OCD
Hemodynamic and Biological Evaluations During Reventilation Collapse in ICU

Prospective, observational clinical multicentric study in ICU; during the period surrounding the orotracheal intubation.

Main objective: to describe the characteristics of reventilation collapse: collapse rate, duration and treatment implemented

Secondary objectives:

* identify risk factors of reventilation collapse
* compare mortality, hemodynamic, respiratory, infectious and biological data between collapse group and no reventilation collapse group.

Eligibility Criteria:
Inclusion Criteria:

* Arterial line
* Consent of patients
* Adult patients
* Tracheal intubation in ICU

Exclusion Criteria:

* tracheal intubation for cardiac arrest
* pregnant woman
* major protected
The Effect of Thalidomide in Suppression of the Systemic Inflammatory Response Syndrome in Hemodialysis Patients

Both malnutrition and inflammation are associated with death in dialysis patients and also with cardiovascular disease. The researchers are testing the idea that inflammation causes malnutrition by using a drug to suppress inflammation in hemodialysis patients to find out whether that will increase blood tests that are associated with malnutrition. The researchers will give hemodialysis patients who have both inflammation and malnutrition either thalidomide or a placebo and compare the effects of treatment on the levels of two proteins in the blood, albumin and prealbumin, that are normally reduced in malnourished patients. Patients who have a serum albumin concentration \< 3.8 g/dl will be asked to sign consent to have blood drawn prior to dialysis for measurement of CRP (C-reactive protein). Those with CRP values ≥ 0.8 mg/dl will have a second measurement of CRP performed within 2 weeks. Those with two consecutive values of CRP ≥ 0.8 mg/dl will be eligible for enrollment

4.1 Pre-assignment measurements will include:

1. Patient is eligible for enrollment.
2. Complete physical examination.
3. Blood draw at initiation of hemodialysis session
4. Instruction on birth control methods required.
5. Subjects who are non-compliant with regard to medication compliance range or birth control requirements as outlined in the S.T.E.P.S.® program will be immediately discontinued from the study

4.2 Detailed description of treatment: Patients who completed the first 4 weeks will be randomized into Treatment group. A total of 24 subjects will be studied; 12 will receive no drug and 12 will receive thalidomide. Subjects randomized to "Active" Treatment arm will receive Placebo (no-drug/sugar pill) ,or thalidomide 100 mg (two 50 mg active capsules) to take at bedtime. Weekly, Subjects will have blood drawn; will undergo a capsule count to establish a compliance range of \> 85%; will have physical exam with special attention to skin and evaluation of peripheral nervous system for a change in or appearance of sensory neuropathy.

If somnolence is tolerable (subjects do not have residual somnolence in the morning) the dose will be increased to 200 mg (4 capsules).

Patients who completed 24 weeks of study will have final evaluation at week 28.

Eligibility Criteria:
Inclusion Criteria:

1. End stage renal disease (ESRD) patients on hemodialysis for at least 3 months.
2. Serum C reactive protein level of ≥ 0.8 mg/dl.
3. Serum albumin \< 3.8 g/dl (BCG).
4. Signing a written informed consent form.
5. Willingness and ability to comply with the FDA-mandated S.T.E.P.S ® program.
6. Age \> 18 years.

Exclusion Criteria:

1. Pregnant and/ or lactating female.
2. Active infection within the previous 8 weeks requiring administration of antibiotics.
3. Patients receiving systemic immunosuppressive therapy.
4. Patients with HIV.
A Comparative Study Between Honey and Alcohol as Topical Skin Disinfectant

Skin antisepsis is essential in every healthcare environment. Alcohol/chlorhexidine use might disrupt skin microbiota and lead to antibiotic resistance.

This study investigates honey (being natural product with many beneficial therapeutic effects) as topical skin anti-septic agent and compares it with alcohol, in terms of effectiveness and safety.

Recent years' investigations of the co-evolution and functional integration of the human body and its commensal microbiota have disclosed that the microbiome has a major impact on physiological functions including protection against infections.

Invasive procedures such as injections, punctures or surgeries penetrate the skin's natural protective barrier, which may allow pathogenic microorganisms to enter deeper skin layers and cavities and trigger infections there.

Alcohols usually in the form of 70% isopropyl alcohol or 60 to 80% ethyl alcohol, are commonly used topical disinfectants.

Despite being efficiently broad-spectrum antiseptic, Alcohol shows some local hazards affecting skin integrity and microbiome.

Honey has been used in wound care since ancient. It has many beneficial therapeutic effects, including anti-microbia, antioxidant, immune-modulator, wound healing and synbiotic effects .

Antimicrobial agents are important in reducing the burden of infectious diseases.

Eligibility Criteria:
Inclusion Criteria:

* - Children aged from 2 to 12 years, of both sexes, and with apparently healthy skin.
* Children, who did not receive any form of antimicrobial agent for at least one-week prior study.

Exclusion Criteria:

* - Immuno-compromised due to diseases or drugs.
* - Children having any skin disease as eczema or others