cyrilzakka/clinical-trials huggingface dataset:
Prevention of Relapse Study of SR58611A in Improved Patients With Generalized Anxiety Disorder

The purpose of the study is to evaluate the efficacy and safety of SR58611A (350 mg BID) compared to placebo in the prevention of relapse of anxiety, in patients with Generalized Anxiety Disorder improved after 12 weeks of treatment with SR58611A.

The primary objective is to evaluate the efficacy of SR58611A 350mg BID compared to placebo over a 24 to 52-week treatment period.

The secondary objective is to assess the safety and tolerability of SR58611A in patients with GAD.


Eligibility Criteria:
Inclusion Criteria:

For entry into the open phase:

* Patients suffering from generalized anxiety disorder, according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and assessed with the Mini International Neuropsychiatric Interview (MINI) plus Generalized Anxiety Disorder (GAD) module.
* With a total score on the 14-item Hamilton Anxiety Rating Scale (HAM-A) \> 20 at V1(D-4) and V2 (D-1).

For entry into the double-blind randomized phase:

* Improved patients with HAM-A score \< 11 at V7 (W12).

Exclusion Criteria:

* Inpatients.
* Patients with a diagnosis of Major Depressive Disorder (DSM IV-TR) within 6 months of screening.
* Patients with a MADRS total score \> 18 at screening or baseline.
* Patients at immediate risk for suicidal behaviour.
* Patients with other current (within 6 months) anxiety disorder according to the MINI
* Patients with a lifetime history according to the MINI of: Bipolar disorder, Psychotic disorder, Antisocial personality disorder.
* Patients with a current history according to the MINI of: Anorexia nervosa or bulimia nervosa in the past 6 months, Alcohol or substance dependence or abuse in the past 12 months, except nicotine or caffeine dependence.

The investigator will evaluate whether there are other reasons why a patient may not participate.
Inhibition of Aldosterone in Patients With Chronic Renal Disease

The purpose of this study is to examine whether the inhibition of aldosterone will result in lower excretion of protein via urine. The hypothesis is that if loss of protein is lowered, progression of renal disease with be slower than otherwise expected.

Patients with chronic renal disease are likely to progress to end stage renal disease with the need for renal replacement therapy. It is accepted that proteinuria is a surrogate measurement for progression. If proteinuria can be lowered we hope to prolong patients pre-dialysis phase. Our theory is that aldosterone inhibition will lead to this.

For a period of 8 weeks patients will be randomized to either aldosterone receptor inhibition with the drug eplerenone or control without. Blood pressures will be kept at the same level using other drugs.

Eligibility Criteria:
Inclusion Criteria:

* Proteinuria \> 500 mg/24 hours
* Hypertension or anti-hypertensive treatment

Exclusion Criteria:

* Diabetic nephropathy
* GFR\< 20 ml/min
* P-potassium between 3,5 mmol/l and 5,0 mmol/l
Powered Assist Hip Exoskeleton to Improve Ambulation in Severe Lung Disease

Chronic respiratory disease (CRD) is among the most prevalent and growing diseases worldwide with disabling consequences. Many with a compromised respiratory system cannot support the metabolic energy demands of walking causing them to walk slowly and stop often. Those with CRD could receive substantial benefit from a powered wearable exoskeleton device that assumes part of the energy of walking. Assisting the legs will lower the metabolic energy demands, and therefore the ventilation required for exercise, thereby allowing them to walk faster and further. Proposed is a series of single-case experiments comparing walking endurance with and without a powered hip exoskeleton assist. The aim of this study is to determine the efficacy of an exoskeleton on walking endurance in ventilatory limited patients with CRD. An exoskeleton could be a novel immediate and long term strategy to augment walking as part of the spectrum of pulmonary rehabilitation and community reintegration.


Eligibility Criteria:
Inclusion Criteria:

* stable chronic respiratory disease
* modified medical research council dyspnoea score (mMRC) ≥ 2

Exclusion Criteria:

* evidence of cardiac rhythm or circulatory compromise
* myocardial infarct within the previous three months
* moderate-severe aortic stenosis
* uncontrolled hypertension
* sustained cardiac arrhythmias
* untreated neoplasia
* lung surgery within the previous three months
* any other predominant co-morbidities or treatments that might influence walk testing
* body size outside of exoskeleton fit specifications
* skin sores or skin breakdown in the area where the device is worn
* a high risk of fracture
Physical Functioning Following Total Hip Arthroplasty

Adults suffer from Osteoarthrosis of hip joint that willing to participate in the study will be tested with well-established measuring techniques of Balance control using force plate before 3 month and 6 month after Total Knee Arthroplasty (THA) in the movement and Rehabilitation Laboratory at BGU. An automated algorithm will be used to extract standardized stabilogram-diffusion parameters from each of the COP data sets collected during quiet standing. These parameters include diffusion coefficients, critical displacement, critical time and scaling exponents for both lateral and anterior-posterior sway directions (Collins \& De Luca, 1993). Each of the Times (before 3 month and 6 month after the THA) in two task conditions (eyes closed and eyes close conditions). Participants will be required to stand on the platform 10 times for 30 s For each trial, they will be instructed to sway as little as possible. In addition step execution test and Late life function and disability questionnaires will be also examined.


Eligibility Criteria:
Inclusion Criteria:

* Able to stand safely for 30 seconds
* Able to walk independently
* Hip OA prior THA

Exclusion Criteria:

* Stroke or other neurological diseases
* Minimal score 24 or higher
* Blindness
Planning the Next Steps: Using an Implementation Intention Approach to Increase Daily Walking

The study goal is to design an intervention utilizing implementation intentions to help participants prospectively plan and visualize ways to increase activity for the next day among working adults who do not currently exercise or use an activity monitor. Investigators will assess the level of and changes in physical activity, and how this relates to various individual factors that are related to exercise and health, including self-efficacy, control beliefs, and cognition.

The 5-week study consists of a 1-week baseline, where participants are asked to wear a Fitbit to document the number of steps taken that day to establish an objective measurement of steps before the intervention began. In the intervention condition, after the baseline week, during weeks 2 to 5, this condition is prompted with an email each evening for four weeks to review their schedules for the following day and identify time slots where they could add activity. They are given instructions for providing a detailed calendar of appointments and open slots for the next day using a simple daily planner. The planning implementation intention manipulation involves recording specific information about when, where, and how they will add steps to their day. They are provided with maps near their home and work with specific information about distances, estimated time to walk between different points, and number of steps for specific routes to help them in planning for specific routes.The control condition is matched for how much contact they have with the research staff (called and emailed the same amount of times) and also wear the Fitbit daily. The only difference from the intervention group is that they do not get the daily planning instructions or maps for the implementation intention strategy treatment. All activity data from the Fitbit was deidentified and aggregated with an online platform called Fitabase.

Eligibility Criteria:
Inclusion Criteria:

* Currently working full time
* Not engaged in regular exercise
* 35 years of age or older

Exclusion Criteria:

* Not healthy enough to engage in a walking intervention
Multi-center Evaluation of the VERSANT® CT/GC DNA 1.0 Assay (kPCR)in Detecting C. Trachomatis and N. Gonorrhoeae

Multicenter clinical study to test a new qualitative in vitro nucleic acid amplification assay based on kPCR technology. The assay is intended for the diagnosis of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC).

The study was terminated

This clinical trial protocol outlines the analytical and clinical performance characteristics that will be evaluated to demonstrate equivalency of the VERSANT CT/GC DNA 1.0 (kPCR) Assay for product registration. The Gen-Probe APTIMA Combo 2 Assay will be used as the CE-marked comparative method. The studies conducted during the clinical trial are intended to provide data to support the safety and effectiveness, as well as the labeling claims for the VERSANT CT/GC Assay. The study objectives are as follows:

* To demonstrate concordance with the Gen-Probe APTIMA Combo 2 Assay;
* To estimate the positive and negative predictive values for each specimen type included in the study;
* To estimate the indeterminate rate for each specimen type included in the study;
* To estimate the equivocal rate for each specimen type; and
* To assess reproducibility of the VERSANT CT/CG DNA 1.0 Assay (kPCR) using the VERSANT kPCR Molecular System.

Two (2) studies will be conducted to validate the analytical and clinical performance characteristics of the CT/GC DNA 1.0 (kPCR) Assay. Table 1 provides an overview of these studies.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age or older.
* Subject signed an IRB approved informed consent form.
* Subject is able to follow verbal and written instructions.

Exclusion Criteria:

* Subject has been on antibiotic therapy within 21 days prior to study enrollment.
* Subject urinated within one hour prior to sample collection.
Retrospective Comparison Between AirSeal® and Standard Insufflation in Appendicular Peritonitis

The AirSeal System Valve-less Trocar is known to decrease postoperative pain, consumption of analgesics, operating time, and length of stay in adults during robotic and laparoscopic procedures. The investigators would like to know if these allegations also apply to children.

From January the 1st 2022 to December the 31st 2022, 100 children aged under 18 years old had an appendicular peritonitis treated by laparoscopic appendectomy. The pediatric surgeons either used the AirSeal System Valve-less Trocar or the standard insufflation. On one hand, only the surgeon, the anesthetist and the nurses of the operating room knew which type of insufflation was used. On the other hand, the patient, his parents and the nurses in the pediatric department did not know which type of insufflation was used. The participants were divided in two groups: the Airseal group (A) and the standard group (S). In each group, the investigators studied and compared the postoperative pain, the consumption of analgesics, the operating time, and the length of stay for each participant.

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 4 and 17 years old
* Who underwent laparoscopic appendectomy for appendicular peritonitis
* Between 2022/06/1st and 2022/12/31st

Exclusion Criteria:

* Children younger than 4 years old or older than 18 years old
* Who did not have appendicular peritonitis
* Between 2022/01/1st and 2022/12/31st
Plasma Citrulline: A Marker for Monitoring & Quantifying Radiation-Induced Small Bowel Toxicity

Small bowel irradiation results in epithelial cell loss and consequently impairs function and metabolism. A metabolic end product of small bowel enterocytes is plasma citrulline. The investigators evaluate the correlation between plasma citrulline level, dose-volume histogram of small bowel, and small bowel toxicity grade by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE ver.4.0) to investigate whether citrulline can be used as a biomarker for quantifying radiation-induced epithelial cell loss.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed cancer patients
* Appropriate liver, renal, and bone marrow function for radiotherapy
* Willing to provide informed written consent
* At least 20 years old

Exclusion Criteria:

* prior abdominopelvic radiation therapy or chemotherapy or abdominal surgery
* Any contraindication to radiotherapy (i.e. Severe connective tissue disorder, etc.)
* Prior or simultaneous history of other malignancy
* On medication for small bowel disease or CTCAE 4.0 Grade 1 or higher toxicity before radiation
* Any treatment delay more than 1 week during radiotherapy
* No radiotherapy due to any other reason except small bowel toxicity
Pelvic Floor Muscle Training With and Without Biofeedback in Women With Stress Urinary Incontinence

This study evaluates the action of the pelvic floor muscle training with and without EMG Biofeddback in the treatment of stress urinary incontinence in menopausal, peri and post menopausal women and their quality of life before and after the interventions.

The Pelvic floor muscle training has been the first line of choice in the treatment of Stress Urinary Incontinence. The goal of this technique is increasing the strength and function of the pelvic floor which aims to support the pelvic viscera, as well as part of their duties, such as locks sphincter muscles.

Risk factors such as advanced age, obesity, multiple pregnancy, can cause a woman to present urinary incontinence (SUI), where the main cause is the dysfunction of the pelvic floor muscles and the lack of awareness of these muscles as well as biomechanical problems.

Some studies describe the use of EMG biofeedback to assess and improve the function of the pelvic floor muscles, however, the studies are not yet conclusive about the action of adding this equipment in the treatment of SUI.

In this regard, the EMG Biofeedback has the ability to physiologically evaluate these disorders and perform a faster treatment for these patients, improving their quality of life. The EMG has the ability to monitor and measure the progression of activation of the pelvic floor muscles, giving feedback to the patient and therapist about the actual condition of muscle function.

Eligibility Criteria:
Inclusion Criteria:

Will be included in this study:

* all women,
* spontaneous free will,
* have knowledge of research and sign the Instrument of Consent -TCLE.
* Menopausal women,
* pre and post-menopause,
* urinary incontinence with the effort

Exclusion Criteria:

Will be excluded from the study:

* patients with neurological, cardiovascular, rheumatologic diseases,
* diabetes mellitus,
* chronic lung disease,
* rheumatoid arthritis,
* Enhlers-danlos,
* Sexually Transmitted Diseases (STDs),
* do not submit annual gynecological exams.
Evaluation in Healthy Volunteers of CARDIOSPACE II

The aim of this project is to test the CARDIOSPACE II system that integrates several medical devices. This system is dedicated to physiological studies in space environment.

* Electrocardiogram
* Vascular doppler
* Laser doppler with iontophoresis
* Continuous blood pressure recording at the finger level
* Brachial blood pressure
* Ultrasound
* Ambulatory Electrocardiogram and SAO2 (arterial oxygen saturation) recorder


Eligibility Criteria:
Inclusion Criteria:

* Height between 160 et 180 cm
* Body mass index between 18 et 24
* Normal blood pressure, heart rate and cardio-pulmonary auscultation at rest
* Normal electrocardiogram
* Possibility to perform transcranial doppler
* Able to understand aims and constraints of this study
* National health insurance
* Signature of the informed consent form

Exclusion Criteria:

* Pregnant woman (Beta HCG - human chorionic gonadotropin - with urinary test) or breastfeeding
* Participating at the time to another clinical trial investigating
* Reached or surpassed the annual amount of financial compensation allowed by clinical trials (according to French regulation)
* Taking any chronic treatment
* Any sign of cardiovascular or respiration disease
* Any sign of syncopal events by questioning (\>2 events per year)
* Contraindication to perform physical activity
Evaluate Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs

This study will evaluate long-term safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic NET patients, who who have not progressed during 12 months of combination therapy with pasireotide LAR and everolimus


Eligibility Criteria:
Inclusion and Exclusion Criteria:

Patients eligible for inclusion in this extension study have to meet all of the additional inclusion criteria:

* The patient must provide a signed Informed Consent Form (ICF) for the extension study prior to any study related procedures
* Completion of the whole treatment period of 15 months (3 months monotherapy with either pasireotide LAR or everolimus followed by a 12 months combination of pasireotide LAR/everolimus) in the CSOM230F2102 study
* No tumor progression during 12 months of combination therapy with pasireotide LAR and everolimus (checked via radiologically assessment).

No intolerable toxicity during combination therapy with pasireotide LAR and everolimus
Evaluation of Quality of Life and Psychosocial Status in Children With Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is a chronic condition that affects the psychosocial status and physical activities of children and their parents in many ways. Our study aimed to investigate the variability of disease-related quality of life and behavioral and emotional adjustment issues compared to a healthy control group among adolescents and their families diagnosed with IBD. Children with IBD and the healthy control group, as well as the parents of both groups, will administered the Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ). The PedsQL is a scale used to assess physical and psychosocial functioning based on the individual's own experiences, commonly employed in clinical trials and quality improvement initiatives. The scale evaluates physical activity status and psychosocial functioning through questions related to emotional, social, and school-related issues.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 8-17 years
* Diagnosed Inflammatory bowel disease
* Healthy adolescents aged between 8-17 years

Exclusion Criteria:

* Not obtaining informed consent
* Diagnosis of psychiatric disorder
Effects of Non-invasive Neuromodulation on Food Desire, Chewing Pattern, Executive Functions and Oxidative Stress.

From the change in self-regulation, memory is inhibited, allowing individuals to suppress or ignore unwanted or outdated associations and thus help to filter information relevant to dietary goals from irrelevant information. Provoking changes in neuroplasticity and cortical excitability contribute to the regulation of neural activity. Both could be modified by applying direct electrical current to the sensorimotor cortex, with polarity/current-dependent results, and their effect would last for hours after the end of stimulation. Transcranial Direct Current Stimulation (tDCS), translated into Portuguese as Estimulação Transcraniana por Corrente Contínua (ETCC) is a neuromodulating tool in which a low-intensity electrical current is applied to the scalp to modulate neuronal activity.


Eligibility Criteria:
Inclusion Criteria:

* being a health professional at the HU-UFPI (higher and technical levels);
* both sexes;
* Age between 20 and 59 years old.

Exclusion Criteria:

* Participants with communication disabilities (outbound or inbound);
* Type 1 and 2 diabetes
* low Body Mass Index (BMI; below 18.5),
* intracranial metal clip and/or prostheses;
* Abrupt change in weight (\> 5 kg) in the last six months;
* the use will be excluded recreational use of psychoactive drugs,
* Being a smoker or using nicotine (tablet / absorbent),
* Having had significant recent trauma or traumatic brain injury,
* Present history of epilepsy,
* to be pregnant or under suspicion
* Missing teeth;
* Medical diagnosis of eating disorder or any psychiatric disorder,
* Having or having had cancer,
* Diagnosis of heart disease.
Titanium-Sapphire Laser Trabeculoplasty in Glaucoma: A Randomized Study Comparing Titanium-Sapphire With Argon Laser Trabeculoplasty in Open-Angle Glaucoma Patients

Titanium Sapphire laser trabeculoplasty is effective in lowering intraocular pressure in glaucoma patients, and is comparable to argon laser trabeculoplasty

Objective: To compare the medium-term outcome of Titanium-Sapphire laser trabeculoplasty (TiSLT) vs. Argon Laser Trabeculoplasty (ALT) in uncontrolled Open-angle Glaucoma (OAG) patients.

Methods: Prospective, masked, randomized comparative clinical study. Thirty-seven OAG patients with uncontrolled IOP and no previous filtration surgery (22 females and 15 males, mean age of 68 years) participated. Eighteen were treated with TiSLT and 19 with ALT. All patients underwent a comprehensive eye examination including visual acuity, IOP, goniocscopy and slit-lamp biomicroscopy and visual field examinations. Patients were examined pre-operatively and then at 1 hour, 1 day, 1 week, 1, 3 and 6 months, 1 year and 18 months post-operatively.

Main outcome measures: Final IOP, delta IOP and number of anti-glaucoma medications.

Results: The 18 patients in the TiSLT arm had an average of 8.3(±2.7) mm Hg or 32% reduction from pre-operative IOP (P\<0.001). The 19 patients in the ALT arm had a mean IOP decrease of 6.5 (±4.3) mm Hg (P\<0.001) or a 25% IOP reduction. Patients in both groups achieved a similar decrease in IOP (P\>0.05). TiSLT patients had statistically significant fewer IOP spikes compared to the ALT group. (P=0.002). Two patients (1 in each arm) underwent trabeculectomy and were considered failures. Mean follow-up time was 15 months.

Conclusions: TiSLT provides similar efficacy to ALT in IOP reduction in OAG patients, and may offer better safety with fewer IOP spikes see post-operatively.

Application to clinical practice: If confirmed in additional studies, TiSLT may be used as an alternative to ALT in OAG patients.

Eligibility Criteria:
Inclusion Criteria:

* Uncontrolled open angle glaucoma patients