cyrilzakka/clinical-trials huggingface dataset:
Impact of Vitamin D Supplementation on Fetomaternal Outcomes in LTBI Pregnant Females

The goal of this randomized controlled trial is to see the effect of vitamin D supplementation on fetomaternal outcomes in pregnant females with Latent Tuberculosis infection

The main question\[s\] it aims to answer are:

If Vitamin D supplementation has any impact on maternal outcomes. If Vitamin D supplementation has any impact on fetal outcomes.

This study aims to see the impact of vitamin D supplementation on fetomaternal outcomes in pregnant females with latent tuberculosis infection. A three-arm (parallel) randomized controlled trial (RCT) will be conducted in a high-burden setting. A calculated sample of 99 (33 in each group) pregnant females with LTBI will be enrolled based on predefined inclusion criteria. Vitamin D supplementation will be given as per study protocols. Group-A (No intervention), Group-B (2000IU/day), Group-C (4000IU/day). To maintain the safety measures throughout the study all the study participants will be monitored for hypervitaminosis D. Informed consent will be obtained from all participants. The study will be conducted after approval by the ethical review board(s). The final analysis will be based on the effect of vitamin D supplementation on pre-defined fetomaternal outcomes.

Eligibility Criteria:
Inclusion Criteria:

- Pregnant females aged 18-35 years, already enrolled for delivery in the specified setting coming regularly for prenatal checkups with positive tuberculin skin test

Exclusion Criteria:

* History of active T.B
* Use of any dietary supplement containing more than 400 IU/day (10 mcg/day) of vitamin D within the month before enrolment;
* Presence of any confounders;
Oral Supplementation With AM3, Hesperidin and Spermidine Supplementation on Immunity Response and Biological Age.

The goal of this interventional study is to know the immune status of healthy participants and to obtain their biological age before and after two months of ingesting a dietary supplement. These individuals are compared with others who will be given a product of similar appearance, but without containing active components, being the constituents of the placebo group.

The study has a duration of 8 weeks, with 2 interventional visits (complete blood samples will be collected) at baseline and at 8 weeks.

In order to be included in the trial, the patient must read the Patient Information Sheet and sign the informed consent form.

The dosage regimen is two capsules per day in a single dose.

Forty consenting volunteers will be included in this prospective, randomized, double-blind study and will be randomized by a statistician independent of the research team.

The study consists of two milestones, in which different parameters are evaluated to finally reach the main goal, to measure their immune status and their biological age after taking the supplement (whose active ingredients include AM3, polyamines and flavonoids):

- Complete blood samples are collected from participants at milestone 1. To determine immune functions; neutrophils, lymphocytes and NK cells are measured. The adherence and chemotaxis capacity of neutrophils and lymphocytes is determined, as well as neutrophil phagocytosis and lymphocyte proliferation. In addition, the release of pro-inflammatory and anti-inflammatory cytokines is assessed.

In parallel, each participant will be given a survey to assess their perception of stress, which they will have to complete before and after 2 months of ingestion of the product (experimental and placebo).

- In milestone 2, oxidative and inflammatory stress parameters are analyzed. Regarding oxidative stress: catalase activity, glutathione reductase activity and reduced glutathione concentration are measured. In terms of inflammatory stress: concentrations of both proinflammatory and anti-inflammatory cytokines released are measured.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers who give their consent for the study will be included after having read and understood the information provided in the informed consent document
* Between 29-65 years old
* Residents in the Community of Madrid

Exclusion Criteria:

* Volunteers with no allergies or intolerances to the product
* Patologies
* Excessive alcohol consumption
* Pregnant women
* Antioxidants intake from supplements
Evaluation of a Lifestyle Intervention for Employees With Prediabetes

The purpose of this study is to evaluate the impact of a worksite lifestyle intervention for diabetes prevention among employees with prediabetes.

The lifestyle intervention includes a 16-week group-based program which targets weight reduction through the adoption of a lower fat diet and greater physical activity.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* overweight or obese
* prediabetes with elevated glucose value

Exclusion Criteria:

* recent cardiovascular event
* use of corticosteroids
* concurrent participation in a structured weight loss program
* pregnant or lactating
Influence of High Vitamin C Dose on Lactate During and After Extracorporeal Circulation

The aim of our study is to find out whether high doses of vitamin C before cardiopulmonary bypass and during the first 24 hours after that have and impact of lowering the incidence of hyperlactatemia.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old patients with cardiac disease needing surgery (coronary bypass, valve replacement)

Exclusion Criteria:

* dementia
* kidney stones
* dialysis
* haemochromatosis
* thalassemias
* G-6-P deficiency
A Prospective, Multi-center, Randomized, Blinded Study to Evaluate Durasphere FI for the Treatment of Fecal Incontinence

The purpose of this study is to evaluate a new injectable bulking agent for the treatment of fecal incontinence in adult men and women. This study has been designed to assess the safety, effectiveness and performance of Durasphere in adults suffering from fecal incontinence under monitored clinical conditions.

The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score as the primary criteria by which success is evaluated.


Eligibility Criteria:
Inclusion Criteria:

* History of fecal incontinence;
* Incontinence episodes over a 14-day period;
* Eighteen years of age or older;

Exclusion Criteria:

* Abnormalities of the external sphincter greater than 10 mm;
* Fibrosis of the tissue at the likely injection sites;
* Has a condition that could lead to significant postoperative complications
* Rectal varices;
* Cancer of the rectum or colon, undergoing active treatment;
* Crohn's disease or ulcerative colitis;
* Chronic diarrhea unmanageable by drugs and/or diet;
* Rectal bleeding;
* Pregnant or within one year postpartum.
Safety and Tolerability Study of Single-dose Administration of Brexpiprazole in Adult Subjects With Schizophrenia

To determine the pharmacokinetics, safety and tolerability of brexpiprazole administered subcutaneously or intramuscularly in adults with schizophrenia.

This trial is designed to assess the pharmacokinetics, safety and tolerability of brexpiprazole in the treatment of subjects with schizophrenia. The trial will consist of two parts across 13-36 months. The trial population will include approximately 110 male \& female subjects between 18 and 64 years of age (inclusive) with a diagnosis of schizophrenia as defined by DSM-V criteria.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between 18 and 64 years of age, inclusive, at the screening visit with a diagnosis of schizophrenia as defined by DSM-V criteria.
* Body mass index between 18 and 35 kg/m\^2 at the screening visit.
* Good physical health as determined by no clinically significant deviation from normal.
* Ability to provide informed consent and/or consent obtained from a legally acceptable representative (as required by IRB), prior to the initiation of any protocol-required procedures.
* Male and female subjects who are surgically sterile, female subjects who have been postmenopausal for at least 12 consecutive months prior to the screening visit, or male subjects/female subjects (of childbearing potential) who agree to remain abstinent or to practice 2 of the approved birth control methods from the screening visit and for at least 150 days after the dose of IMP for a female subject or 180 days after the dose of IMP for a male subject.

Exclusion Criteria:

* Subjects who have:
* Met DSM-V criteria for substance use disorder within the past 180 days; including alcohol and benzodiazepines, excluding caffeine/nicotine.
* A positive drug screen for drugs of abuse (excluding stimulants, other prescribed medications, and marijuana \[if in investigator's documented opinion the subject does not meet DSM-V criteria for substance use disorder\]).
* Use of more than 1 psychotropic medication at the screening or baseline visit, except for oral brexpiprazole administered during the brexpiprazole tolerability testing (if applicable) and current oral antipsychotic medication.
* Use of varenicline beyond screening.
* Subjects who have participated in any clinical trial involving a psychotropic medication within 1 month prior to the administration of IMP or 5 half-lives from last IMP administration whichever is longer.
* Subjects who have a significant risk of committing suicide based on history, routine psychiatric status examination, investigator's judgment, or who have an answer of "yes" on questions 4 or 5 on the Baseline Version of the C-SSRS.
* Subjects currently in an acute relapse of schizophrenia as assessed by the investigator.
* Subjects with a current DSM-V diagnosis other than schizophrenia. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
Intravitreal Ranibizumab (Lucentis®) for Neovascular Glaucoma- a Randomized Controlled Study

Neovascular glaucoma is a potentially blinding condition characterized by the growth of newvessels at the anterior part of the eye. This growth is driven by the overexpression of a protein called Vascular Endothelial Growth Factor (VEGF). That happens in diseases such as diabetic retinopathy or venous retinal occlusion, and lead to a fast increase in intraocular pressure (IOP). Traditional treatment include laser photocoagulation of the retina in order to decrease VEGF formation. The investigators postulate that the use of anti-VEGF intravitreal injections may accelerate recovery and decrease the need of surgery in cases of neovascular glaucoma.

This is a prospective, randomized controlled study that aims to evaluate the efficacy of ranibizumab (Lucentis®) as an adjunct in the treatment of patients with neovascular glaucoma.

28 patients with neovascular glaucoma (14 in the study group and 14 in the control standard of care group) will be recruited at a single center- University of Sao Paulo Medical School General Hospital. A complete ophthalmologic exam will be carried out, including the obtention of an informed consent for eligible patients willing to participate on the study.

Patients will be randomly assigned to either standard of care- retinal laser photocoagulation and clinical management of intraocular pressure with drops, or standard of care plus intravitreal ranibizumab injections. Two injections will be performed 30 days apart. The patients will be followed for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* IOP greater than 24 mmHg
* Iris or anterior chamber neovascularization
* At least 120 degrees of opened anterior chamber angle

Exclusion Criteria:

* Visual acuity worse than counting fingers in the fellow eye
* No light perception in the treated eye
* Any ocular infectious disease
* Use of systemic steroids
* Lack of media transparency precluding laser photocoagulation
* Thromboembolic disease
* Known hypersensitivity to ranibizumab
* Female participants at childbearing age not using oral contraceptives
* Use of intravitreal anti-VEGF over the last 30 days.
Neoadjuvant Pegylated Liposomal Doxorubicin and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Breast Cancer

The purpose of this study is to determine the efficacy of neoadjuvant treatment with pegylated liposomal doxorubicin (Caelyx) and cyclophosphamide +/- trastuzumab followed by docetaxel in patients with locally advanced, inflammatory breast cancer or with a primary tumor \> 5 cm.

Patients with locally advanced or inflammatory breast cancer have a very bad prognosis. Several studies have shown that patients who receive a pathological complete response have the best prognosis. Neoadjuvant chemotherapy including anthracyclines and taxanes has become established as a standard option in the multidisciplinary management of this group of patients. In HER2 positive patients, chemotherapy in combination with trastuzumab is therapeutically attractive. Recent studies have also demonstrated that evaluation with PET-CT scan can be used to stratify treatment and monitor early response to neoadjuvant therapy.

Eligibility Criteria:
Inclusion Criteria:

* pathologically proven breast cancer
* inflammatory, locally advanced breast cancer or a tumor \> 5 cm
* ECOG performance status \< 2
* LVEF \> 50% measured by MUGA (HER2 positive patients)
* adequate bone marrow, liver and renal function
* written informed consent must be obtained

Exclusion Criteria:

* another malignancy within 5 years prior to study entry
* concurrent treatment with an investigational agent
* other disease or condition that contraindicates participation in the study
* pregnant or lactating females
Immuno Nutrition by L-citrulline for Critically Ill Patients

The main objective of this study is to demonstrate that the only administration of L-citrulline, can improve immune functions in critically ill patients at high risk of nosocomial infection.

This is a multicentric therapeutic trial, randomized and double blind: standard enteral nutrition plus L-citrulline (5 grams/12 Hours for 5 days from the admission in Intensive Care Unit (ICU)) versus standard enteral nutrition plus placebo.

Methods-Patients: Non-surgical patients admitted in medical intensive care unit, under mechanical ventilation for an expected duration \> 2 days, without severe sepsis or septic shock, will be enrolled. Symptoms leading for ICU admission ongoing for five days maximum. On admission (before treatment), the severity will be evaluated with the Sepsis-related Organ Failure Assessment (SOFA) score together with an assessment of plasmatic arginine, cytokines (InterLeukin-6 (IL6) ), and expression of Human Leukocyte Antigen - antigen D Related (HLA-DR) by monocytes. The same evaluation will be repeated on day 3 (during treatment) and on day 7 (after treatment).

The enrolment of 100 patients is statistically enough to demonstrate a decreased SOFA scores in the L-citrulline group as compared to the placebo group on day 7.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* medical patient (absence of recent surgery or trauma)
* initial aggression \< 5 days
* mechanically ventilated with expected duration of mechanical ventilation \> 2 days
* exclusive enteral nutrition
* absence of previous immunosuppression

Exclusion Criteria:

* severe sepsis
* septic shock
* obesity defined as BMI above 40
* pregnancy
Effect of Aquatic Therapy on Pulmonary Functions in Patients With Muscular Dystrophy

This study aimed to assess the efficacy of aquatic therapy on pulmonary functions in patients with muscular dystrophy.

Muscular dystrophy (MD) is a group of muscle diseases that results in increasing weakening and breakdown of skeletal muscles over time. The disorders differ in which muscles are primarily affected, the degree of weakness, how fast they worsen, and when symptoms begin. Many people will eventually become unable to walk. Some types are also associated with problems in other organs. The muscular dystrophy group contains thirty different genetic disorders that are usually classified into nine main categories or types.

The signs and symptoms consistent with muscular dystrophy are: progressive muscular wasting, poor balance, scoliosis (curvature of the spine and the back), progressive inability to walk, waddling gait, Calf deformation, Limited range of movement,respiratory difficulty, cardiomyopathy and muscle spasms

Eligibility Criteria:
Inclusion Criteria:

* Their age will ranging from four to forty years.
* Patients participated in this study will from both sexes.
* All patients will able to walk supported or unsupported by the therapist.
* All patients will able to follow the instructions during testing and training.
* All patients had no fixed contractures or deformities at the lower limb.

Exclusion Criteria:

* Patients with visual or auditory problems.
* Patients with structural joints deformities of the lower limbs.
* Patients with convulsions and fixed contractures.
* Uncooperative Patient.
The Effects of Rye Crisp Bread on Appetite and Metabolic Function

The aim of this study is to contribute to a better understanding of how dietary fibre in rye affects appetite and metabolic processes. We will evaluate how the intake of rye crisp breads affects appetite, insulin secretion and glucose levels in the blood in healthy humans. We will also investigate microstructural properties of the crisp breads with microscopy, as well as to characterize the food products with respect to the content of dietary fibre and certain bioactive compounds. The aim is also to try to elucidate how observed effects on appetite are related to changes in insulin and glucose levels, appetite related hormonal signals and microstructural properties to verify findings from previous studies.

The short-term effects (up to 4 hours after intake) of rye crisp breads on subjective appetite and metabolism will be evaluated using a randomized cross-over study design. Each participant will consume three different breakfasts consisting of two different rye crisp breads and one wheat crisp bread on three different occasions separated by a 1 week wash-out period. Participants will rate subjective appetite (satiety, hunger and desire to eat) by using a visual analogue scale (VAS) every 30 min during a 4-hour period, starting 30 min before breakfast. Blood samples will be collected before breakfast and at regular intervals throughout the day for analysis of glucose, insulin and hormone levels. Gastric emptying rate will also be evaluated using paracetamol as an indicator. Glucose and hormonal responses will be related to subjective appetite and to differences in composition of the breakfasts.

Eligibility Criteria:
Inclusion Criteria:

* Habitual breakfast eaters

Exclusion Criteria:

* Pregnancy, lactation or wishing to become pregnant during the study period
* Dieting
* Weightloss
* Eating disorder
* Hyperglycemic
* Hyperinsulinemic
* Thyroid disease
* Metabolic issues
* Diabetes
* Physical or psychological problems with eating
* Food intolerance/allergies to foods included in the study
* Intolerance/allergy to paracetamol
* Heavy smokers
* Recent or concurrent participation in a dietary intervention research study
Impact of a Double-reading Animated Film (Child, Parents) in Preoperative on the Anxiety of Children Upon Arrival at the Operating Room

Preoperative anxiety affects 40 to 60% of children. A literature review concluded that effective preparation strategies must involve parents, must be appropriate to their age and proposed upstream of the intervention.

A double-readinganimated film aimed at informative was created for the children and their parents/legal guardians in order to solve the problem of anxiety found at the arrival of children in the operating room.


Eligibility Criteria:
Inclusion Criteria:

* Child boy or girl.
* 3 to 7 years old.
* programmed for: removal of tonsils, vegetations, paracentesis or installation of trans-tympanic aerators, pre-heliceal fistula, otoplasty, myringoplasty
* Scheduled intervention in the outpatient department of specialized surgeries or hospitalization of a postoperative night.
* Accompanied by an adult, French-speaking, whose child lives at home.
* Of which the holders of the parental authority formulated their non-opposition to the participation of their child and gave their signed agreement for the realization of videos of their child.
* Assent of the child for children aged 6 to 7
* Parents affiliated to social security

For the group under study only:

- Support available at home that can watch the movie on the internet

Exclusion Criteria:

* Child having already had surgery.
* Presence of associated disability (blindness, profound deafness, autistic disorders).
* Child having anxiolytic treatment.
* Child to be operated within less than 2 days
Develop a Novel Occupational Training Program for Schizophrenia Patients Based on Virtual Reality Techniques

Establish a novel vocational training program and test its validity in a pilot study.

40 schizophrenia patients will be recruited to join the virtual reality based vocational training program, the training effect will be compared by interview skills and problem solving before and after the training.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders -5th version
* Aged between 20 and 55 years.
* Motivated to have a job.
* Having a full-scale IQ \> 70 on the Wechsler Adult Intelligence Scale-version IV.
* Having a PANSS positive scale \< 70, indicating a stable condition during the illness course.

Exclusion Criteria:

* Comorbid with other major psychiatric disorders (i.e., bipolar disorders) or neurological diseases.
* Substance abuse within one year.
* Visual impairment and/or hearing impairment that would preclude participation in the VR-based training program.