cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Fundoplicature of the Excluded Stomach Post Omega Bypass

The purpose of this study is to evaluate the efficacy of fundoplication with stomach excluded in the suppression of disabling gastroesophageal reflux requiring surgery in patients who have undergone one anastomosis gastric bypass, with complete objective evaluation of reflux.

The FEE\&amp; RGOIC trial is a single-center, ambispective, interventional, non-randomized pilot study to evaluate the efficacy of Fundoplicature with stomach excluded objectively and comprehensively in the treatment of disabling gastroesophageal reflux requiring gastric bypass after anastomosis.

The strategy under study is objective reflux suppression after fundoplication with the stomach excluded in the following specific context: treatment of disabling gastroesophageal reflux requiring post-bypass surgery in Omega.

The eligible study population will be any adult patient at the investigating center who has undergone one-anastomosis gastric bypass surgery followed by fundoplication of the excluded stomach as part of treatment for disabling post-bypass gastro-oesophageal reflux, resistant to medical treatment and requiring surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Patient operated for one anastomosis gastric bypass followed by Fundoplicature with stomach excluded for disabling gastroesophageal reflux requiring surgery within 2 years prior to inclusion;
* Patient in failure of medical treatment;
* Weight loss greater than 50% of excess weight;
* Patient with preoperative objective investigations (gastrojejunal fibroscopy, ph-impedancemetry, abdominal CT scan) of gastroesophageal reflux disease;
* Patient able to understand study-related information and to complete quality-of-life questionnaires in the opinion of the investigator;
* Patient willing to accept study evaluations;
* For women of childbearing age, effective contraception for the duration of the study or negative blood pregnancy test;
* Patient has been informed and has given free, informed and written consent.

Exclusion Criteria:

* Patient with conversion from one anastomosis gastric bypass to Y bypass for disabling gastroesophageal reflux requiring surgery;
* Patient with concomitant hiatal hernia correction for one anastomosis gastric bypass ;
* Patient with secondary one anastomosis gastric bypass ;
* Patient with a deregulated diet;
* Patient under legal protection, or deprived of liberty by judicial or administrative decision;
* Patient unable to understand study information for linguistic, psychological, cognitive or other reasons;
* Women who are or may become pregnant, of childbearing age, without effective contraception or who are breast-feeding;
* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial that could interfere with the results of the present study;
* Patient not covered by a social security scheme.
A Trial of Enteral Colostrum on Intestinal Permeability in Critically Ill Patients

The effects of colostrum on intestinal permeability in critical ill patients has not been investigated. In current trial, intensive care unit patients with enteral feeding will receive either enteral colostrum or maltodextrin as placebo.

A randomized, double blind, controlled trial will be conducted in general intensive care unit (ICU) in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. Intervention patients will be received 20 g/day of colostrum along with enteral formula and control patients will be received maltodextrin along with enteral formula. Patients will be evaluated for plasma endotoxin and plasma zonulin.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years old) admitted to ICU
* Start of study intervention within 48 hours after ICU admission
* Expected to require enteral nutrition for at least 72 hours aiming for full enteral nutrition and receive at least 80 percent of enteral formula during the first 48 hour
* Written informed consent of patient or written informed consent of legal representative

Exclusion Criteria:

* Enrollment in a related ICU interventional study
* Requiring other specific enteral nutrition for medical reason
* Death or Discharge before 5th day
* Having any contra-indication to receive enteral nutrition
* Pregnant patients or lactating with the intent to breastfeed
* BMI \<18 or \> 40.0 kg/m2
* Have life expectancy of \<6 mo
* Patients who are moribund
* History of allergy or intolerance to the study product components
* Receiving colostrum during two weeks before start study product
* Have other reasons
Bioequivalence Study Of Diltiazem In 60 Mg Tablets As Tilazem 60® Made by Pfizer, S.A. De C.V., Versus Angiotrofin® 60 Mg Made by Amstrong Laboratorios De Mexico, S.A. De C.V.

This study will research the existance of actual bioequivalence between Diltiazem in 60 Mg Tablets As Tilazem 60® Made by Pfizer, S.A. DE C.V., Versus Angiotrofin® 60 Mg Made by Amstrong Laboratorios De Mexico, S.A. DE C.V.

Bioequivalence of this particular drug

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Both genders
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 or ± 10% variation of the ideal weight; and a total body weight \>50 kg (110 lbs).

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
Integrating Early Stimulation and Play at Scale: "MAHAY Mikolo"

The overall objective of the study is to examine the effects of integrating early child development group sessions into the existing, at-scale, community health and nutrition programs administered by the government in Madagascar.

This research is a cluster-randomized trial that will assess the effects of integrating early child development activities on community health worker time use and caregiver time use and participation in the program. The evaluation will compare the addition of early child development sessions to the status quo health and nutrition program, with an additional intervention arm looking at the addition of toys to the program.

This study has four objectives, which will be measured at the community health worker level, and at the caregiver level for caregiver-child dyads (where children are between 6-30 months old at time of intervention launch):

1. Measure how the integration of ECD activities with standard nutrition programming affects the time and task allocation of the community health workers
2. Measure the extent, if any, that the addition of ECD activities crowds out community health worker health/nutrition tasks that are part of the standard community program
3. Measure how the integration of ECD activities affects rates of caregiver participation in nutrition and health activities over time (e.g., during changes in seasonal activities).
4. Measure the impact of enhanced availability and maintenance of age-appropriate play materials/activities on sustained caregiver participation rates in the program.

Eligibility Criteria:
Inclusion Criteria for communities:

1. No other ECD programs present in the community or neighboring communities;
2. At least 40 children monitored at the nutrition center in the target age range of 6-30 months (monitored is defined as attending at least one growth monitoring session between July 2019 to August 2020);
3. Stable supervisory presence. Local NGOs are contracted to monitor and supervise all community health workers and help to strengthen linkages with local structures such as the community health committees and primary care facilities. Each NGO supervisor is in charge to up to 9 communities, which they visit twice a month. The investigators defined stable presence as not having had NGO turnover within the last year.

Among the communities included, children 6-30 months were eligible to participate in the intervention. There was no inclusion criteria for community health workers.
Study of Normal Intestinal Development and Disease in Premature and Term Neonates

Current research on early intestinal development is primarily performed in mouse models. While useful in many other ways, mouse models are not ideal for studying human intestine development as the timing of this process differs between the two species. Further, prior research has demonstrated that some proteins and pathways that are critical in human development have no clear role in mice.

This study aims to improve the overall understanding of critical aspects of intestinal development in humans. In addition, this study will investigate the impact of intestinal diseases that are found in the early stages of life such as necrotizing enterocolitis (NEC).


Eligibility Criteria:
Inclusion Criteria:

* Any neonate or infant through 2 years of age having intestinal surgery or intestinal biopsies from an esophogastroduodenoscopy (EGD) or colonoscopy.

Exclusion Criteria:

* Children \> 2 years of age.
* Infants 0-2 years old not undergoing GI surgery or intestinal scope with biopsy procedure.
Use of Simulation-Based Mastery Learning for Thoracentesis to Improve Outcomes

The goal of the proposed research is to investigate the use a medical simulation and mastery learning (where all learners must reach a high standard before completion of training) curriculum to improve internal medicine residents' skills when performing thoracentesis procedures (remove fluid from around the lung) on patients. Additionally, we will evaluate how these skills affect patient outcomes by comparing thoracenteses performed by simulator-trained residents to those who have "traditional" training. This project will evaluate these overall hypotheses: simulation-based training using the mastery learning approach improves medicine resident's thoracentesis skills and improves patient outcomes and satisfaction.

Given medical procedures are the second most common cause of the complications that afflict 3% of hospitalized patients, simulation-based mastery learning should be applied to procedures done in all medical centers. In academic hospitals, bedside procedures such as thoracentesis procedures are often performed by unsupervised medical trainees. Traditionally, medical trainees learn procedures relying on the historic "see one, do one, teach one" mentality. Unfortunately, this approach subjects patients to procedures before trainees are competent.

Through the use of medical simulation, medical educators can increase the essential knowledge and skills of trainees while assuring procedural competence and reducing patient exposure to undue risk. Medical simulation training using the mastery learning model improves clinical skills and reduces the risk of procedure-associated injury. Our research group pioneered the use of this evidence-based approach for teaching medical trainees. Mastery learning requires that all trainees demonstrate a uniformly high level of skill before training completion. This ensures competence on a medical simulator before actual patient encounters.

Eligibility Criteria:
Inclusion Criteria:

* Patients:

  * undergoing a thoracentesis procedure
  * on internal medicine or hospitalist ward service
  * English or Spanish Speaking
* 2nd and 3rd year internal medicine residents

Exclusion Criteria:

* Cognitive impairment
Italian Version of the Oxford Elbow Score Score

Validation of the cross-cultural adapted Italian version of the Oxford Elbow Score, in order to have an instrument able to detect the functional state reported by patients after elbow surgery.

An Italian version of the Oxford Elbow Score has been created by an experts committee, according to the published guidelines for the cross-cultural adaptation of self-reported measures.

The new version of the questionnaire will be administered to a sample size of 120 patients, in addition to MEPS, Quick DASH and SF-36 questionnaires during the follow-up apointments at 2 and/or 6 months after elbow surgery in two Orthopaedic Clinic in North Italy.

Reliability, validity , reproducibility and responsiveness will be detected by questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Ability to speak and understand Italian,
* need for one-elbow surgical procedure any elbow disease.

Exclusion Criteria:

* Injury in more than one musculoskeletal district
European Registry of Transcatheter Repair for Tricuspid Regurgitation

To investigate clinical and survival outcomes following transcatheter tricuspid valve repair or replacement.

Background and Rationale:

Tricuspid regurgitation (TR) is a major health and economic burden due to high rates of heart failure hospitalizations, morbidity and mortality. Surcial treatment of TR is associated with high procedural and in-hospital mortality. Due to prohibitive surgical risk, a significant proportion of patients historically remained untreted beyond medical therapy. Transcatheter tricuspid valve (TV) repair and replacement techniques (TTVT) now offer a new treatment perspective for these patients. The EuroTR registry aims at optimizing patient selection prior to TTVT and thus treatment quality by collecting respective data in a real-world setting.

Objectives:

To investigate clinical and survival outcome following transcatheter tricuspid valve repair or replacement.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with one of the following transcatheter devices for TV repair or replacement: PASCAL, TriClip, TricValve, Evoque, LuX-Valve
* Age ≥ 18 years
Effects of Capoeira on the Physical and Psychological Performance of Adults

Regular physical activity (PA) promotes benefits for both physical and mental health. Among the numerous PA\&#39;s with a collective nature that can add to the existing recommendations, combat sports training interventions are viable alternatives since they integrate benefits in different aspects for health. In this way, capoeira can be a strategy for the prescription of exercise, aiming to serve participants collectively and maintaining the adherence of this practitioner to the intervention. However, little is known about this issue. So, the aim of the present study is to verify the effect of 12 weeks of capoeira training on the physical performance and psychological aspects of previously physically inactive adults.

The study will be conducted as a controlled, randomized, two-group parallel and superiority clinical trial with a 1:1 allocation ratio. The sample will be divided into two groups: 1) capoeira training group (n = 76; GCAP) and 2) control group (n = 76; GCONT). Participants aged between 18 and 59 years, classified as irregularly active A by the international physical activity questionnaire, who are not engaged in training programs and are not former athletes, will be eligible. Smokers and patients with respiratory or cardiovascular diseases will be excluded from the sample. Anamnesis and anthropometric evaluation will initially be performed. To evaluate the physical aspects, specific tests will be applied to determine aerobic and anaerobic fitness, strength and power of lower limbs, balance, motor coordination and questionnaires will be applied to verify the psychological aspects, such as emotional intelligence, motivation and quality of life. The descriptive analysis of the outcomes will be reported. The normality of the data will be checked by visual inspection of the Q-Q plot and statistically tested by the Shapiro-Wilk test. Two-way ANOVA for repeated measures will be employed to verify the time\*group interaction. The effect size (ES) of the intervention on dependent variables will be calculated and the difference between the ES and its respective 95% confidence interval will be calculated to estimate the magnitude of the response in the intervention. The alpha adopted will be 5% and the software used for data analysis will be Statistical Packages for the Social Sciences 25.0.

Eligibility Criteria:
Inclusion Criteria:

* Classified as "irregularly active A" by the International Physical Activity Questionnaire;
* Do not be engaged and/or have participated in the last two months of any physical training program;
* Do not be former athletes;
* Do not be a smoker or suffering from respiratory or cardiovascular diseases.

Exclusion Criteria:

* Do not have musculoskeletal problems during the program that make it impossible to participate;
* Do not participating in at least 80% of the training sessions during the intervention.
Efficacy of N-Acetylcysteine in Treatment of Overt Diabetic Nephropathy

Diabetic nephropathy has become the single most frequent cause of end-stage renal disease.

On a molecular level, at least five major pathways have been implicated in glucose-mediated vascular and renal damage and all of these could reflect a single hyperglycaemia-induced process of overproduction of reactive oxygen species.

Recent studies have shown that inflammation, and more specifically pro-inflammatory cytokines play a determinant role in the development of micro- vascular diabetic complications, most of the attention has been focused on the implications of TNF-α in the setting of diabetic nephropathy.

Glutathione is the most abundant low-molecular-weight thiol, and Glutathione/ glutathione disulfide is the major redox couple in animal cells.

N-acetylcysteine is effective precursors of cysteine for tissue Glutathione synthesis.

Not only does N-acetylcysteine exhibit antioxidant properties, but it may also counteract the glycation cascade through the inhibition of oxidation.

N-acetylcysteine can also reduce the apoptosis elicited by reactive oxygen species .

Indeed, N-acetylcysteine has been shown to inhibit reactive oxygen species induced mesangial apoptosis and to be able to protect cells from glucose-induced inhibition of proliferation.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients with more than 500 mg protein in 24 hours urine protein sample
* Males and post-menopausal non-lactating and non-pregnant females.
* Age greater than or equal to 30 years of age.
* Serum creatinine less than 3.0 mg/dL (265 micromoles per liter)
* Willing and able to give informed consent

Exclusion Criteria:

* Type 1 (insulin-dependent; juvenile onset) diabetes
* Patients with known non-diabetic renal disease
* Renal allograft
* Myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 3 months of study entry
* Cerebrovascular accident within 3 months of study entry
* New York Heart Association Functional Class III or IV
* Known allergies or intolerance to N-acetylcysteine
* Untreated urinary tract infection or other medical condition that may impact urine protein values.
A 6-Month Extension Study of VMDN-003-2 to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy

To evaluate the durability of efficacy and long-term safety of intramuscular administration of Engensis or Placebo that was administered in the double-blind, randomized, VMDN-003-2 Placebo-controlled Phase 3 Study.

The purpose of this 6-month extension study (VMDN-003-2b) is to evaluate the durability of efficacy and long-term safety of intramuscular administration of Engensis or Placebo that was administered in the double-blind, randomized, VMDN-003-2 Placebo-controlled Phase 3 Study. No treatments will be administered in this VMDN-003-2b extension study. The combined overall duration of the VMDN-003-2 and VMDN-003-2b studies will be 12 months.

Participants will be enrolled in the VMDN-003-2b study at completion of the Day 180 Visit of Study VMDN-003-2. Participants will continue to be identified by the same Participant number and the same treatment group (Engensis or Placebo) assigned by randomization in Study VMDN-003-2. No study drug or treatment will be administered in this VMDN-003-2b extension study. The double-blind treatment assignment from the prior study will be maintained for Investigators and Participants during this extension study.

This extension study will assess the durability of efficacy and long-term safety of Engensis compared to Placebo as measured by changes in Average Daily Pain Score of the full Brief Pain Inventory for Diabetic Peripheral Neuropathy, Bedside sensory testing, physical examinations, laboratory assessments, vital signs, treatment-emergent adverse events, treatment-emergent serious adverse events, and adverse events of special interest.

Eligibility Criteria:
Inclusion Criteria:

* Completed study VMDN-003-2 and consent to enroll in study VMDN-003-2b

Exclusion Criteria:

* None
Capturing Early Events in Human Parturition

This is a prospective observational study on normal singleton pregnant women who have no sign of labor at 40 weeks of gestation or pregnant women who admitted to hospital for any sign of labor at term, aiming to identify labor-associated markers.

The mechanisms that instigate human parturition have not been completely understood, though hypotheses such as 'functional progesterone withdrawal' and inflammatory signaling have been proposed. Researchers including our group have previously identified panels of genes which were differentially expressed between placentas obtained after spontaneous birth and those after elective cesarean delivery. However, such findings obtained after birth could only reflects the late changes in parturition. Similar findings in other gestational tissues, such as fetal membranes, amniotic fluids, myometrial biopsies are available, but these sample types cannot be readily collected until delivery.

Thus, we propose to explore biomarkers in maternal blood with a view to developing any useful analytes for predicting labor.

Eligibility Criteria:
Inclusion Criteria:

Healthy women who are carrying a healthy singleton pregnancy, but have not yet gone to labor at 40 weeks of gestation or who are at term and admitted to hospital for any sign of labor are invited to join the study.

Exclusion Criteria:

* Any obstetric contraindications for undergoing labor or vaginal delivery (e.g. placenta previa, cephalo-pelvic disproportion, macrosomia, previous classical cesarean section or uterine tear, etc).
* Any maternal or fetal complications that require immediate or early delivery (e.g. pre-eclampsia, abruption placenta, fetal distress, rupture of membranes, in utero death, etc).
* Any maternal or fetal complications that make vaginal birth an unfavorable choice (e.g. fetal growth restriction, fetal compromise or distress, etc).
* Any conditions that are known to affect the onset of labor (e.g. anencephaly).