cyrilzakka/clinical-trials huggingface dataset:
Dietary Calcium Supplementation, Gut Permeability and Microbiota in Type 2 Diabetics

Dietary calcium seems to act on glycemic control, favoring the prevention and treatment of type 2 diabetes mellitus (DM2). It is possible that calcium modulates gut microbiota and increase the integrity of the intestinal mucosa. This study aims to evaluate the effects of dietary calcium supplementation in permeability and intestinal microbiota in overweight type 2 diabetics. This is a single-blind, randomized, placebo-controlled, crossover study. Patients (n=20) with low habitual calcium intake will be allocated in control group (CONTROL) or test group (DAIRY). Hypocaloric diets (restriction of 500 kcal / day) will be prescribed containing 800 mg of calcium from dietary sources / day. During intervention period, a beverage (shake) (CONTROL - without the addition of calcium sources or DAIRY - 700 mg of calcium as milk powder) will be ingested in the laboratory. Food intake, body composition (total body fat and fat free mass) and anthropometric measures (waist circumference, waist-hip ratio, waist-height, neck circumference and sagittal abdominal diameter) will be evaluated at baseline and at the 6th and 12th weeks. Physical activity level, gut permeability, gut microbiota, and biochemical parameters (parathyroid hormone, 25-dihydroxy vitamin D, calcium, fasting glucose, fasting insulin, fructosamine, hemoglobin, HbA1c, uric acid, triglycerides, cholesterol total and partial, lipopolysaccharide, inflammatory markers) will be evaluated at baseline and after 12 weeks. The statistical analysis will be performed with the use of SPSS software (SPSS Inc., Chicago, IL, 2008, version 17.0). Parametric or non-parametric tests will be applied, according to the distribution of variables (level of statistical significance of 5%).


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus using oral hypoglycemic medication
* Overweight (body mass index between 25 and 34.9 kg / m2)
* Usual intake of calcium less than 600 mg / day
* Level of physical activity light to moderate
* HbA1c above 7% or fasting glucose above 130 mg / dl

Exclusion Criteria:

* Smoking
* Use of calcium, vitamin D, magnesium, zinc, chromium, copper supplements or medication affecting the metabolism of these micronutrients,
* Use of drugs, herbs or diets that reduce appetite and body weight
* Estrogen replacement
* Gain or loss of at least 5 kg in the last 3 months
* Recent change in the level of physical activity
* Aversion or intolerance to food provided in the study
* Alcohol consumption of more than 2 doses / day (more than 50g ethanol / day)
* Eating disorders
* Endocrine disease, renal disease, hepatic disease or malabsorption syndrome that alters calcium metabolism
* History of recurrent nephrolithiasis
* Caffeine consumption of\> 300 mg / day
* Pregnancy, lactation or postmenopausal
* Anemia
* Cardiovascular, infectious, inflammatory, thyroid, liver, kidney or intestinal disease
* Use of anti-inflammatory, antacids, antibiotics and laxatives drugs
* Major gastrointestinal surgery.
Validation of the Efficacy of the Tool GIMIAS® for the Assessment of Left Atrial Fibrosis in a Group of Healthy Volunteers (RESTORE-HV)

The purpose of this study is to validate the technique for the detection of left atrial fibrosis through segmentation of endocardial and epicardium landmarks of the images obtained with 3 Tgadobutrol-enhanced magnetic resonance with the software GIMIAS® in a cohort of healthy volunteers, without atrial fibrillation or known cardiovascular risk factors.

3D reconstructions obtained by GIMIAS® will be evaluated. Processing images will be carried out by two independent operators, and will calculate the kappa interobserver agreement .

Subsequently, the processed images are compared with images previously obtained in 10 patients with persistent atrial fibrillation adjusted for sex and age. A qualitative visual comparison will be made.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers capable of being subjected to the prespecified tests of the study.
* Healthy volunteers that sign the informed consent after being informed.

Exclusion Criteria:

* Healthy volunteers with:
* A medical history of atrial fibrillation, hypertension or diabetes mellitus.
* A medical history of heart disease, structural, ischemic or arrhythmic.
* A medical history of chronic obstructive pulmonary disease/obstructive sleep apnoea/hypopnoea syndrome
* Sport habits: intense sport activities during three or more hours in a week
* Any assumption that contraindicates the magnetic resonance and/or the use of gadolinium or other contrast mediums, including a medical history of previous allergic or not allergic reactions with the use of gadolinium or other contrast mediums, bronchial asthma or allergic diseases.
* Pregnancy or breast feeding.
A Phase 2 Study to Determine the Effects of BXT-51072 in Diabetic Patients Undergoing Angioplasty (PCI)

The purpose of this study is to determine the safety and feasibility of BXT-51072 as a cardioprotective agent in diabetics undergoing elective angioplasty / percutaneous intervention (PCI), a procedure to "open" coronary arteries.

BXT-51072 belongs to a class of drugs called "glutathione peroxidase mimics." BXT-51072 works by imitating a substance produced in various tissues in the body, which prevents damage of the heart and blood vessels.

Following screening, baseline measurements and informed consent, patients will receive BXT-51072 40 mg or placebo in a 2:1 ratio, 30 minutes before their scheduled PCI and then three times per day for 2 days. There will be 5 treatment visits and 3 follow-up visits.

Blood samples will be obtained for CK-MB, troponin and routine chemistry. A 24-hour continuous electrocardiogram will be obtained following the PCI and regular electrocardiograms will be obtained during the study and follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Scheduled for elective angioplasty with acute coronary syndrome within 72- hours or MI within 7 days

Exclusion Criteria:

* CK-MB above normal
* Elevated troponin not showing a decreasing value
* Congestive heart failure
* Atrial fibrillation or left bundle branch block
* Uncontrolled diabetes
The Effects of Lactobacillus Reuteri DSM 17938 on Immunomodulation and Gastric Motility in Preterm Newborns

The investigators propose a Phase II interventional trial to investigate the role of Lactobacillus reuteri DSM 17938 on the intestinal motility and immune response of premature infants and further evaluate safety of the use of this probiotic in a population of premature infants.

Hypothesis Administration of Lactobacillus reuteri to premature infants will improve their intestinal motility when compared with infants receiving placebo. Primary Objective Evaluate the effects of L. reuteri in the intestinal motility by measuring the gastric emptying rate in infants before and after 21 consecutive days of administration of L. reuteri.

Secondary Objectives 1. Mechanisms of action of L. reuteri - L.reuteri impact in the host immune response by determining fecal cytokines, sIgA and calprotectin before and after 21 days of administration - L.reuteri rate of colonization after its administration.

2. Efficacy and safety of L. reuteri to premature infants - Clinical beneficial effects secondary to the administration of L. reuteri to premature infants. The following clinical outcomes will be identified and compared between groups:

* Number of gastrointestinal symptoms (regurgitation, vomiting, stasis)
* Days to full feeds. Number of days to reach full feeds defined as \> 120cc/kg/day) x2 days or more.
* Days on parenteral nutrition
* Weight gain defined as the number of days needed to reach 150% of birth weight
* Length of hospital stay
* Any possible side effects and adverse events secondary to the administration of L. reuteri to premature infants.
* Incidence of late onset sepsis.
* Incidence and severity of necrotizing enterocolitis categorized by Bell's classification
* Use of antibiotics (number of days on antibiotics during the hospital stay)
* Mortality (at 28 days after birth and at hospital discharge).

Eligibility Criteria:
Inclusion Criteria:

* Gestational age 30 - 32 weeks. Gestational age will be defined by the best estimate based on prenatal ultrasound in the first trimester, DLM and/or Balard Score after birth.

Exclusion Criteria:

* Cardiovascular or (respiratory) instability after 48 hours of age - Chromosomal anomalies.
* Major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia)
* Congenital (e.g. jejunal atresia) and acquired (e.g. GI perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention
* Parental refusal
* Prior enrollment into a conflicting clinical trial. Conflicting clinical trial will be those in which the intervention could modify the outcome of the present study, for example studies that could alter the intestinal motility or the immune response of the premature infants.
Low-level Laser Therapy Versus Formocresol in Primary Molar Pulpotomies

This study aimed to assess and compare the clinical and radiographic success rates of LLLT and FC for pulpotomy in human primary teeth. One hundred and six primary molars from 36 children aging five to eight years were included and randomly assigned into two equal groups; LLLT group and FC group. Teeth were evaluated clinically and radiographically at 3, 6 and 12 months.

Background: Various agents are available to dress the remaining pulp tissue after pulpotomy procedure with the formocresol (FC) being the gold standard for the last 60 years. Nowadays, low-level laser therapy (LLLT) becomes a technique of interest, due to its many characteristics. However, the literature available on its success in pulpotomy is limited and reported conflicting results.

Aim of the study: To assess and compare the clinical and radiographic success rates of LLLT and FC for pulpotomy in human primary teeth.

Materials and methods: Utilizing split-mouth technique, the sample consisted of 106 primary molars from 36 children aging five to eight years. The teeth were selected based on specific clinical and radiographic inclusion criteria and randomly assigned into two equal groups; LLLT group and FC group. All the 106 primary molars were indicated for pulpotomy, where 53 teeth were treated using FC and 53 teeth were treated with LLLT. Teeth were evaluated clinically and radiographically at 3, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

Children inclusion criteria:

* Children aged 5-8 years with at least two bilateral deep carious primary molars indicated for pulpotomy.
* Children who are physically and mentally healthy without any known medical history of systemic conditions contraindicating pulp therapy.
* Children who had "positive" or "definitely positive" behavioral ratings according to the Frankl behavior classification scale (Frankl, 1962).
* Children whose parents signed an informed consent for the child's participation in the study.

Teeth inclusion criteria:

Teeth were selected according to clinical and radiographic criteria.

Clinically, the study included:

* Teeth with restorable crowns
* Teeth with pathologic carious exposure of vital pulps
* Teeth with no tenderness to percussion, physiologic or pathologic mobility or any clinical evidence of pulp inflammation or degeneration such as history of swelling, pain or presence of sinus tract.

Radiographically, the recruited teeth should have:

* Normal radiographic appearance with healthy supporting tissues
* No pulp calcification
* No internal or external root resorption
* No periapical or inter-radicular radiolucency
* At least two thirds of the root remaining (not more than one third of the root is physiologically resorbed)

Exclusion Criteria:

* Any child complained of clinical signs such as pain, swelling, abnormal mobility, vertical or lateral tenderness to percussion was excluded from the study.
* Radiographically, any child with signs of internal or external root resorption or periapical or inter-radicular pathology was omitted from the study.
Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor

Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation and who participated in Study 109 (NCT02514473) or Study 011B (NCT01897233). Study 110 is designed to evaluate the safety and efficacy of long term treatment of lumacaftor in combination with ivacaftor.


Eligibility Criteria:
Inclusion Criteria:

Subjects entering the Treatment Cohort must meet both of the following criteria:

* Completed study visits up to Week 24 of Study 109 or Week 26 of Study 011B and did not permanently discontinue treatment
* Willing to remain on a stable CF medication through the Safety Follow-up Visit.

Subjects entering the Observational Cohort must meet 1 of the following criteria:

* Completed 24 weeks of study drug treatment in Study 109 or completed 24 weeks of study drug treatment and the Week 26 Safety Follow up in Study 011B.
* Received at least 4 weeks of study drug and completed visits up to Week 24 of Study 109 or Week 26 of Study 011B.

Exclusion Criteria (Treatment Cohort Only):

* History of any comorbidity or laboratory abnormality that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject (e.g., cirrhosis with portal hypertension).
* Pregnant and nursing females.
* Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements.
* History of drug intolerance in the prior study that would pose an additional risk to the subject in the opinion of investigator
* History of poor compliance with study drug and/or procedure in the previous study as deemed by the investigator.
* Participation in an investigational drug trial (including studies investigating lumacaftor and/or ivacaftor).
Learning Through Play Plus for Psychosis

Evidence reports that parents with schizophrenia are particularly vulnerable to parenting difficulties and also experience problems in sensitively interacting with their children. This may cause insecure attachment in infants of mothers with psychosis. Children of parents with schizophrenia have poor developmental and clinical outcomes. However, there is no published trial, to the best of our knowledge, for children of parents with schizophrenia. Learning through Play (LTP) is a potentially low cost intervention to improve maternal mental health and child outcomes by promoting health child development. The proposed study will integrate LTP with existing culturally appropriate Cognitive Behaviour Theray (CBT) for psychosis (CaCBT-p) and test its feasibility and acceptability for parents with schizophrenia.

Objectives

* To determine whether the proposed intervention is acceptable to the parents with schizophrenia.
* To assess the feasibility of proposed intervention for target population (no of sessions attended, content, duration and location, uptake and retention).
* To determine most suitable outcome measures for future randomized controlled trial.
* To identify any barriers in recruitment of participants. Recruiting up to 75% of total sample will be a success criteria.

Methods Design: Mixed method feasibility Randomised Controlled Trial Study Sites The participants will be recruited from outpatient departments of psychiatry and community settings in 7 cities of Pakistan i.e. Karachi, Hyderabad, Lahore, Rawalpindi, Multan, Peshawar and Quetta.

Sample Size:

A total of 90 individuals (45 in each arm) meeting the eligibility criteria will be recruited to participate in the study from different psychiatric units.

Randomization Participants will be randomized into one of the two treatment conditions (LTP Plus or TAU) through computer generated algorithm.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic and Statistical Manual-V (DSM-V) diagnosed first episode psychosis, schizophrenia, schizoaffective disorder, psychosis not otherwise specified or schizophreniform disorder.
* Parents (Mother or Father), age 18 year and above
* Parents (Mother or Father) having a child from birth to 36 months
* Parents (Mother or Father) living within the catchment area of recruitment site.
* Competent and willing to give informed consent
* Parents (Mother or Father) are stable on medication for at least 3 months prior to the intervention.

Exclusion Criteria:

* Violation of any inclusion criteria
* Failure to perform screening or baseline examinations.
* Patients who will meet the criteria for a DSM-V diagnosis of alcohol or substance abuse (other than for nicotine) within the last month or the criteria for DSM-V alcohol or substance dependence (other than for nicotine) within the last 6 months
* Temporary resident unlikely to be available for follow up.
Risk Factors for Poor Outcome After Epigastric and Umbilical Hernia Repair

Umbilical and epigastric hernia repairs are common and performed by numerous surgical techniques. Considering that the hernia repairs in general are relatively small and simple procedures there are disproportionate poor results.

The aim of present study is to determine surgical risk factors for readmission after umbilical and epigastric hernia repair and to report risk factors for later reoperation for recurrence.

All elective umbilical or epigastric hernias registered in the Danish Ventral Hernia Database are included in the study. The included patients will be followed in up to 4 years in order to identify correlation between technical aspects of the hernia repair and postoperative morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Umbilical or epigastric hernia repair

Exclusion Criteria:

-
Temporal Changes in the Gut Microbiota Before and After Migrating to High Altitude

This prospective observational cohort study aims to learn about temporal changes in the gut microbiota before and after migrating to high altitudes in healthy participants. The main questions it aims to answer are:

* changes in the gut microbiome before and after migrating to high altitude.
* Do the migrants tend to share similar gut microbiota characteristics with the residents? Participants will detect 16S ribosomal RNA profiles from stool samples. Researchers will compare the residents with the migrants to see if gut microbiota characteristics are similar.

Changes in geographical environment can lead to alterations in the composition of the host's gut microbiota. However, the dynamic process and specific bacterial composition and patterns of change in the microbiota are not yet clear. In this study, the investigators conducted microbial analysis of the gut microbiota based on 16S rRNA amplicon sequencing in five healthy volunteers living in a plain area (Liaocheng City, Shandong Province) before and after their relocation to a high-altitude region (Gangcha County, Qinghai Province). Samples were collected at multiple time points, including 1 month, 3 months, 6 months, and 12 months after relocation, as well as 1 month, 3 months, 6 months, and 12 months after returning to Liaocheng City from Gangcha County. Additionally, a control group consisting of five local healthy individuals from Gangcha County (matched for age, gender, and ethnicity in a 1:1 ratio) was included. Dietary and lifestyle habits were investigated to determine the impact of environmental changes on the gut microbiota. The study aimed to analyze the diversity and abundance changes of the gut microbiota at different time points and identify specific bacterial compositions through clustering analysis.

Eligibility Criteria:
Inclusion criteria:

Volunteers in good health, without any diagnosed chronic diseases or gastrointestinal disorders.

Exclusion criteria:

recent antibiotic use; severe gastrointestinal infections; long-term use of immunosuppressive drugs or other medications that may impact the gut microbiota; history of gastrointestinal surgical interventions.
Effects of Developing a Mobile-based Interactive Simulation Scheme for Assisting the Personalized Hands-on Learning of Nasogastric Tube Insertion

A mobile-based interactive simulation scheme (MISS) was proposed and developed to investigate its effects on facilitating hands-on learning of nasogastric tube insertion in undergraduate medical students.


Eligibility Criteria:
Inclusion Criteria:

* fifth-year undergraduate medical students
* at least 20 years old
* without any practical clinical experience

Exclusion Criteria:
The Cognitive Ageing Nutrition and Neurogenesis (CANN) Trial

There is a dearth of research which takes a multi-compound approach to dietary interventions, in humans, aimed at improving outcome measures of cognition. Animal research in particular points towards fatty acids and flavonoids having a potentiating effect on each other, and possibly even being synergistic. Thus, study products will be administered in the present trial comprising both of these compounds, with a view to investigating their potential effects on cognition in older adults with mild cognitive impairment (MCI) or subjective memory impairment (SMI).

240 participants, aged 55 or above, will be recruited (120 Norwich, 120 Melbourne; to include both MCI and SCI participants).

Participants will be asked to take the study food each day for 12 months, and to come to the clinical assessment unit on 3 occasions, at baseline, 3 months and 12 months, to complete a cognitive task battery such that their performance may be investigated in the context of the intervention.

Urine, blood and faecal samples will be collected and magnetic resonance imaging (MRI) will be applicable to half of each population (i.e to 60 MCI and 60 SCI, 30 of each at Norwich and Melbourne).

Eligibility Criteria:
Inclusion Criteria:

* Male and female, aged ≥ 55 years
* Mild cognitive impairment (MCI) or subjective memory impairment (SMI) with no indication of clinical dementia or depression
* Willing and able to provide written informed consent.
* Understands and is willing and able to comply with all study procedures.
* Fluent in written and spoken English.
* In good general health including blood biochemical, haematological and urinalysis within the normal range at screening (as judged by the clinical advisor)
* Normal, or corrected to normal vision and hearing
* Right handed, for MRI
* Stable use of any prescribed medication for at least four weeks

Exclusion Criteria:

* Diagnosis of Alzheimer's disease (AD) or other form of dementia or significant neurological disorder
* Parent or sibling who developed premature dementia \<60y (suggestive of a familial monogenic form of cognitive decline)
* Past history or MRI evidence of brain damage including significant trauma, stroke, learning difficulties or serious neurological disorder, including loss of consciousness \> 24 hours
* History of alcohol or drug dependency within the last 2 years
* Other clinically diagnosed psychiatric disorder likely to affect the cognitive measures (as judged by clinical adviser)
* Existing diagnosed gastrointestinal disorders likely to impact on absorption of flavonoids and fatty acids (as judged by clinical adviser)
* Major cardiovascular event, e.g. myocardial infarction or stroke, in the last 12 months
* Carotid stents or severe stenosis
* Known allergy to fish or any other component in the intervention supplements
* Existing medical conditions likely to affect the study measures (as judged by clinical adviser)
* Uncontrolled hypertension (Systolic Blood Pressure (SBP) \>140mmHg, Diastolic Blood Pressure (DBP) \>90mmHg)
* BMI \>40kg/m2