cyrilzakka/clinical-trials huggingface dataset:
Group B Streptococcal Carrier State Prevalence Among Arab Pregnant Women in Northern Israel District

The incidence of early neonatal GBS (group B Streptococcus) infection in the Nazareth Hospital through the years 2006-2013 has been higher compared to the national average. On reviewing all the cases of infants with early GBS infection, revealed that some of these infants were born to mothers who are not included in any of the high-risk groups that need to have prophylactic antibiotic treatment before delivery. Therefore, the question was whether pregnant Arab women in the North district of Israel have a higher GBS carrier state rate than the general rate in Israel?

Signs of early onset GBS infection of the newborn appear during the first week of life. Usually, the bacteria pass from a GBS carrier mother to the newborn during labor. The infection can cause multi-system problems such as pneumonia, meningitis and even death of the newborn. The prevention of the disease is best achieved by prophylactic antibiotics administered to the mother during labor.

In order to prevent early onset GBS infection of the newborn, pregnant women are treated with preventive antibiotics during labor based on either of two protocols:

A. Risk factors: Women with risk factors such as premature birth, prolonged premature rupture of membranes, intra-partum maternal fever or a previous child with GBS infection are treated.

B. Universal screening: Towards the end of pregnancy, at 35 - 37th week, a vaginal/anal swab for GBS is taken, and those found positive will be treated.

According to the Israeli Ministry of Health regulations' from July 2005 it is not accepted to routinely perform screening for GBS in pregnant women at 35-37th week of pregnancy. Therefore, the Israeli approach to prevent early neonatal GBS infection is based mainly on antibiotic prophylaxis treatment during labor of all pregnant women with risk factors.

In a study conducted at the Western Galilee Medical Center in the city of Nahariya and published in 2006, there was a significant increase in the GBS carrier state rate compared to previously published studies. It was also found that higher GBS carrier state rates prevail among Arab women compared to Jewish women.

The primary question of this study is to calculate GBS carrier state prevalence among pregnant Arab women attending the labor ward at the Nazareth Hospital at the 34 to 40th week of their pregnancy.

A vaginal / anal swab will be taken from all eligible participants to identify GBS carriers by PCR (polymerase chain reaction) test.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 to 40
2. Origin: Arab
3. Gestational age: 34 to 40

Exclusion Criteria:

1. Rupture of membranes
2. Women in active labor who has had one or more vaginal examinations.
Influence of Sugar on the Bioavailability of Cocoa Flavanols

The primary propose of this study is to determine the impact of ingredients and matrices on flavanol absorption and metabolism.

The investigators have conducted a randomized, triple-blind, cross-over study in 15 healthy human volunteers to investigate the absorption and metabolism of cocoa flavanols from a high-flavanol chocolate made with added sugar and a high-flavanol chocolate containing the sugar substitute maltitol; a nutrient-matched low flavanol control product was also fed. All products were matched for macro-nutrients, as well as for alkaloids (theobromine and caffeine), and were similar in taste and appearance. Both high-flavanol products contained \~259 mg cocoa flavanols, whilst the low-flavanol chocolate contained 48 mg of cocoa flavanols. On each study day, subjects were cannulated and baseline blood samples were collected prior to consumption of any of the test chocolates. Additional blood samples were collected at 1, 2 and 4 hours and plasma levels of flavanols were assessed using HPLC with fluorescence detection. All test products were well-tolerated by study participants.

Eligibility Criteria:
Inclusion Criteria:

* a signed consent form
* age of 18-50 years inclusive

Exclusion Criteria:

* did not suffer from any form of disease, including liver disease, diabetes mellitus or a myocardial infarction
* not on medications for the treatment of hypertension, elevated lipids or diabetes (type I and II).
* did not suffered gall bladder problems or abnormalities of fat metabolism
* weight reducing dietary regimen or taking any dietary supplements, including dietary fatty acids
* did not consume more than 15 units (120g) of alcohol per week
* did not have sensitivities to chocolate, reduced calorie sweeteners, dairy, nuts or gluten.
* Vegetarians and vegans
* taken antibiotics in the last 8 weeks
Vericiguat Drug-drug Interaction With Nitroglycerin in Stable Coronary Artery Disease Patients

This study is intended to investigate the effect of nitroglycerin on vericiguat in patients with stable coronary artery disease (CAD). Nitroglycerin is the standard therapy to treat acute crisis of angina. Thus there is a high likelihood of co-administration of both drugs in the target indication of vericiguat, worsening heart failure (HF). Therefore, it is important to investigate the safety and tolerability of vericiguat and nitroglycerin, which may be used as unprescribed on-demand treatment by patients with acute episodes of angina pectoris.


Eligibility Criteria:
Inclusion Criteria:

Patients with stable CAD defined by

* coronary artery stenosis in any of the 3 main coronary vessels \> 50% documented by coronary angiography within last 36 months or history of myocardial infarction
* Age: 30 to 80 years
* Body mass index (BMI): above/equal 18.0 and below/equal 36.0 kg / m²
* Female subjects must be of non-childbearing potential

Exclusion Criteria:

* Intervention e.g. revascularization by percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) during the last 3 months
* Progressive angina with symptoms of worsening of angina within the \< 3 months
* History of recent (\< 6 months prior to the first screening examination) myocardial infarction or unstable angina
* Symptomatic carotid stenosis, or transient ischemic attack or stroke within 3 months prior or patients with stroke at more than 3 months prior with significant residual neurologic involvement
* Insulin dependent diabetes mellitus
* Clinically relevant cardiac ischemia
* Clinical significant persistent ischemia
* Atrial fibrillation, pacemaker, defibrillator, atrial ventricular (AV)-block II and III
* Systolic blood pressure below 110 or above 160 mmHg
* Diastolic blood pressure above 100 mmHg
* Heart rate below 50 or above 100 beats / min
* Estimated glomerular filtration rate \< 30 mL/min/1.73m2
Homemade Yogurt Supplementation to Prevent Stunting

Stunting contributes substantially to child mortality and disease burden in low-income countries. In Bangladesh the prevalence of stunting among children \<5-years of age is high (36%) reaching 50% in slum areas. The pathogenesis of stunting is multifaceted, yet nutritional inadequacy and repeated infections are established risk factors of stunting.

A three-arm randomized controlled trial in Dhaka's slum area is proposed. The children will be recruited from vaccination clinics. Infants at risk of stunting (-1 SD length-for-age z-score, LAZ) aged around 5 months are eligible for the study. Eligible children will be randomized to receive: 1) nutrition education on dietary diversity; 2) a combination of similar education plus daily supplementation of homemade yogurt; 3) a 'usual care' (control) group. The investigators will recruit 120 children (40 per arm). Intervention will be initiated a month before starting of complementary feeding with an educational session and will last 7 months during which a monthly educational session will be delivered at participant's household. The homemade yogurt supplementation will start a week after beginning of 6 months of age once the child is introduced to solid foods of the mother's choice. The yogurt will be supplied to the mothers every day at time of feeding. Feeding behaviors will be self-monitored using a pictorial calendar. Primary outcome (LAZ) and secondary outcomes (fecal bio-markers, WAZ, head circumference, and food diversity scores), will be measured at baseline (6 months), 9 months and 12 months of child age. Supplementation with homemade yogurt is a novel approach with the potential to improve infant gut environment, improve food absorption and thus potentially prevent stunting.

Hypothesis:

The investigators hypothesize that, continued breastfeeding, adequate complimentary feeding and supplementation with homemade yogurt have the potential to reduce stunting.

Primary objective:

The present study is aimed to assess the impact of low-cost nutritional strategies to prevent childhood malnutrition in Bangladesh.

Specific objectives:

1. To compare differences in growth pattern (length-for-age z-score, weight-for age z-score, head circumference) of children at risk of stunting age 6-months between infants receiving educational program only, infants receiving education plus homemade yogurt supplementation and those receiving the "usual-care" (control).
2. To evaluate whether amount of gut microbiota necessary to improve gut health was associated with weight gain and growth in these children to support the casual mechanism behind this approach.

Eligibility Criteria:
Inclusion Criteria:

1. Infants at risk of developing stunting aged 5 months (-1SD LAZ)
2. All gender, religion, language and ethnicity
3. Infants born through normal delivery or cesarean section
4. Breastfeeding or non-breastfeeding

Exclusion Criteria:

1. Stunting or wasting (\<-2SD LAZ)
2. Infants with any major congenital abnormality or any chronic conditions (e.g., rheumatic heart disease)
Core Stability as a Prognostic Factor of Urinary Incontinence in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy

The study aims at investigating the possible correlation between core stability muscles and urinary incontinence following Robot-Assisted Laparoscopic Prostatectomy.

Sixty-two patients who are candidates for Robot-Assisted Laparoscopic Prostatectomy will be enrolled. All participants will be asked to be evaluated in their core stability functionality 30-40 days before Robot-Assisted Laparoscopic Prostatectomy intervention. The core stability functionality result will be correlated with the urinary incontinence 45-50 days after intervention.

The study aims at investigating the correlation between core stability muscles and urinary incontinence following Robot-Assisted Laparoscopic Prostatectomy.

All sixty-two participants will be asked to be evaluated in their core stability functionality 30-40 days before Robot-Assisted Laparoscopic Prostatectomy intervention. Core stability functionality will be evaluated through the Loumajoki Battery of tests, composed of 10 simple items in which the patients have to maintain core stability. In addition a Quality of Life questionnaire (WHO Quality of Life-BREF) will be administered. The core stability functionality result will be correlated with urinary incontinence measured by the 24h PAD test 45-50 days after intervention. At this point core stability will be evaluated again as done before.

Eligibility Criteria:
Inclusion Criteria:

* Patient who are candidates for Robot-Assisted Laparoscopic Prostatectomy
* Objectivity of core muscles recruitment through the Loumajoki Battery

Exclusion Criteria:

* Pre-surgery incontinence
* Pre-intervention radiotherapy treatment
* Previous urogenital surgery
* Concomitant presence of neurological, internal medicine or musculoskeletal system pathologies that may affect functional or motor recovery
* Subjects with cognitive deficits and/or psychiatric disorders
* Lumbar stabilization or abdominal interventions
* Acute low back pain
Bone Metabolism After Laparoscopic Gastric Bypass Surgery (BABS)

Bariatric surgery leads to rapid weight loss in female and male patients. Less data are available about its impact on bone metabolism.

The aim of this study is the investigation of changes in bone mineral density,bone histomorphometric changes, serum bone turnover markers and changes in body fat and muscle composition in patients after laparoscopic gastric bypass surgery.

Obese female and male adult patients eligible for laparoscopic gastric bypass surgery according to the national Austrian guidelines will be included in this study upon request and after patient approval.

Baseline data collection and quarterly follow up visits are planned to investigate the changes in bone mineral density and body composition measured by dual energy X-ray absorptiometry as well as the evaluation of serum bone turnover markers of bone formation and resorption.

After surgery subjects will be randomized into two groups:

Daily oral calcium (500mg) and weekly vitamin D3 supplementation (16.000 IU calciferol)or no supplementation of calcium and calciferol.

A sub-study (approximately 15% of study population) with transiliac bone biopsies will also be performed to investigate histomorphometric and histologic changes in bone (biopsy baseline and after 24 months).

The planned duration of the study is 24 months for each subject. Serum bone turnover markers will be collected every 3 months, dual energy X-ray absorptiometry measurements will be performed every 6 months.

Eligibility Criteria:
Inclusion Criteria:

* body mass index \>35
* female and male patients
* age 18 - 65 years
* eligible for laparoscopic gastric bypass surgery according to the Austrian national guidelines

Exclusion Criteria:

* any history of malignancy except basalioma
* any prior antiresorptive treatment
* any prior calcium or vitamin D supplementation
* any secondary disease affecting bone metabolism
BRAVE-DREAMS (BRAin VEnous DRainage Exploited Against Multiple Sclerosis)

To assess in a double blinded randomized control trial (RCT) study design safety and effectiveness of balloon angioplasty of the main extracranial and extravertebral veins in multiple sclerosis (MS) associated to chronic cerebrospinal venous insufficiency (CCSVI).

Mean follow-up 1 year. 5-8 Italian centres 360 relapsing remitting (RR) MS patients will be randomized, with expanded disability disease scale (EDSS) ranging 2-5.5, age 18-65.

Safety will be assessed by measuring serious and minor adverse effects related to treatment.

Effectiveness will be assessed by measuring 2 primary endpoints:

1. Clinical parameters will be expressed in an integrated functional measure leading to the score, respectively, of improved, stable, worsened. Functional assessment is performed by tools permitting a quantification and will be made by a team of independent assessors. Clinical instrumental evaluation will be performed at baseline, and subsequently on 3 months basis. The outcome parameters leading to the composite functional measure are instrumental parameters, less assessor dependent, singularly validated for measuring the disability in MS. They are the followings: A) Dynamic Balance Assessment: Balance Master Limits of Stability (LOS). In static platform, swinging to reach the set position of center of pressure. B) Walking Function: The subject walks spontaneously for 10 meters with chronometric measure of time counting the number of steps. The test calculates the walk ratio i.e. ratio between length and step frequency. C) Manual dexterity. Box \& Block test, moving wooden cubes. D) Sphincter control: Post-voiding residual by ultrasounds. F) Visual acuity: Low-contrast visual acuity Sloan Letter Chart.
2. Magnetic Resonance Imaging (MRI) outcome measures: T1Gad active lesion.T2 lesion volume MRI evaluation at baseline, 6, 12 months.

Secondary endpoints are: EDSS, chronic fatigue, cognitive function, rate of restenosis, annualized relapse rate.

Eligibility Criteria:
Inclusion Criteria:

* patients affected by CCSVI associated with MS
* relapsing-remitting and\\or secondary progressive
* 18-65 years old
* EDSS 2-5
* disease duration \< 10y
* No relapse in the 30 days preceding the procedure
* clinical stability in the last 6 months with disease mod. treatments
* Patients under the best available therapy

Exclusion Criteria:

* patients previously treated for CCSVI or inserted in other clinical trials in the last 3 months
* under treatment with natalizumab
* pregnant or refusing to adopt contraception
* presence of significant comorbidities
* alcool-drug abuse
* thrombophilia
* contraindication to MR
Dopamine and Insulin Resistance

Obese individuals have fewer striatal dopamine type 2 receptors (DRD2) than normal weight individuals. Lower DRD2 levels are associated with addiction and a decreased sense of pleasure.Obesity is also associated with insulin resistance (poor insulin action).We propose that insulin resistance and low DRD2 are associated. Using PET imaging,we aim to determine DRD2 binding potential (BP) in the brain is associated with insulin resistance and neuroendocrine hormone levels. Obese participants will be compared to lean, gender and age similar participants. We also aim to determine the effect of caloric restriction on DRD2 BP in obese subjects

In has been reported obese individuals have fewer striatal dopamine type 2 receptors (DRD2) compared to normal weight individuals congruent with diet induced obese rodent models and similar to models of addiction. Lower DRD2 levels are associated with addiction and a decreased sense of pleasure. Excessive weight gain also contributes to the onset of impaired insulin signaling (insulin resistance). In the brain insulin regulates monoamines and has trophic effects. We propose that the previous reports of low DRD2 in individuals with obesity will be associated with the degree of insulin resistance. Using PET imaging, we aim to determine DRD2 binding potential (BP) in the striatum and hypothesize these measurements will be associated with insulin resistance and potentially other neuroendocrine hormone levels. Obese participants will be compared to lean, sex and age similar participants. We also aim to determine the effect of caloric restriction on DRD2 BP in obese subjects. We hypothesize the caloric restriction will improve insulin resistance and that changes in DRD2 binding will be associated with changes in insulin signaling.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-60 yrs
* obese BMI \> 30kg/m2 and Weight less than 350 lbs
* lean control BMI 18-25kg/m2

Exclusion Criteria:

* Structured exercise \> equivalent to 30mins 5x week of walking times a week
* History of Substance Abuse, including but exclusive to alcohol, cocaine, marijuana, heroin, nicotine
* Current psychiatric disorder or significant h/o disorder
* Use or any antidepressants or antipsychotics for last 3-6months or depot antipsychotics in the last 12 months
* Any condition felt by PI or co-investigators to interfere with ability to complete the study
* Inability to abstain from alcohol, physical exercise or \> 1 cup of coffee or equivalent daily for 3 days prior to imaging studies
* Significant co-morbidities including atherosclerotic disease, metabolic disease, liver or renal insufficiency or abnormality found on MRI
* Any condition which would interfere with MRI or PET studies, e.g. claustrophobia, cochlear implant, metal fragments in eyes, cardiac pacemaker, neural stimulator, tattoos with iron pigment and metallic body inclusions or other metal implanted in the body which may interfere with MRI scanning
* Subjects on medications determined by PI, ex. sibutramine, frequent benzodiazepines or related drugs, which could affect quality of study for last 3 months.
Chronic Ankle Instability, Surgical Repair: Open Versus Closed

Rationale: Lateral ankle ligament injuries may be a result of ankle sprains. In 10-30% of patients with lateral ankle ligament injuries, chronic lateral ankle instability may be present. If conservative treatment fails, instability is treated surgically. Anatomic repair (also known as the Bröstrom procedure) is the current golden standard for surgical treatment of chronic ankle instability. The Bröstrom started out as an open technique and is now also performed arthroscopically. Both approaches are considered standard care and provide good results. Which approach is best, has not yet been researched. In this study it is hypothesized arthroscopic repair provides better functional outcome compared to open repair during short term follow-up.

Objective: The main objective of this study is to compare the functional outcome after arthroscopic and open anatomic repair in patients with chronic lateral ankle instability, and secondly to assess ankle stability and ankle Range of Motion (ROM) after arthroscopic and open ligament repair.

Study design: A Non-Blinded Prospective Randomized Controlled Trial Study population: All patients willing to participate, from an age of 18 years old, with persisting ankle instability for at least 6 months, eligible for anatomic repair.

Intervention: Both groups of patients are surgically treated with anatomic repair of the anterior talofibular ligament (ATFL). One group is treated arthroscopically and the other by the open approach.

Main study parameters/endpoints: The primary outcome measure is functional outcome 6 months after surgery measured using the Foot and Ankle Outcome Score. The main study parameter is a difference of ≥10 2 points per FAOS subscale between both treatment groups (Minimal Important Change = 10 points; 2 per subscale).


Eligibility Criteria:
Inclusion Criteria:

* Patients are 18 years or older;
* Experience pain and/or a sensation of instability during sports and/or daily activity;
* Isolated lateral ankle instability;
* Planned for surgical repair of the ATFL;
* At least one previous episode of an ankle inversion sprain;
* Complaints for at least 6 months;
* Failed previous conservative treatment.

Exclusion Criteria:

* Serious concomitant injury (like arthrosis, ruled out using an AP and lateral x-ray according to standard protocol);
* Foot or ankle fracture in past;
* Previous foot or ankle surgery;
* ROM restriction of \>10 degrees;
* Medial instability;
* Severe misalignment;
* Ankle/foot deformities (e.g. severe flat foot);
* Systemic comorbidity leading to delayed recovery (e.g. Diabetes Mellitus, Rheumatoid Arthritis)
* (general) Hyper laxity
* Inability or unwillingness to provide consent
* Present factors that may cause difficulty of follow-up
NIRS and Doppler to Predict NEC in Risk Neonates

The main objective is to evaluate the interest of cerebro-splanchnic oxygenation ratio (CSOR) for early diagnosis of necrotizing enterocolitis (NEC) in neonates with rectal bleeding and/or abdominal distension. CSOR will be determined using near infrared spectroscopy (NIRS).


Eligibility Criteria:
Inclusion Criteria:

* less than 28 days neonates hospitalised in neonatology care unit presenting rectal bledding and/or abdominal distension
* signed authorization by the parents (consent form)

Exclusion Criteria:

* - cutaneous lesions in the regions of monitoring
* emergency for NEC