cyrilzakka/clinical-trials huggingface dataset:
Effects of Faba Bean Fractions as Ingredients in Novel Food Products on Glycemia, Appetite and Metabolic Control

The investigators hypothesized that consuming crackers or pasta enriched with faba bean fractions (faba bean protein concentrate, faba bean protein isolate, faba bean flour and faba bean starch), would reduce the blood glucose response to the meal compared to foods without faba bean components and reduce food intake at a meal


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking
* No metabolic disease
* BMI 20 - 25 kg/m\^2
* Male
* Age 18-30

Exclusion Criteria:

* Intolerance to treatments
* Currently taking appetite-modifying medications
* Restrictive eating
* Smoking
* Over- or underweight
* Breakfast-skipping
Correlating Probiotic Dietary Supplements During Pregnancy With Maternal Microbiome Profiles

The overarching goal of this project is to compare the microbiome profiles of healthy pregnant women, both before and after the introduction of a probiotic supplement into the maternal diet. Specifically, the investigators are performing a pilot randomized double-blinded placebo-controlled trial, comparing the microbiome profiles of 40 healthy pregnant women randomized to receive an oral probiotic containing a mixture of Lactobacillus and Bifidobacterium species (20 mothers) versus an oral placebo (20 mothers) during the first/second trimester of pregnancy. For each mother, the investigators will collect biospecimens from the vagina, rectum, and urine, both before intervention, and 4-6 weeks after intervention. These biospecimens will be analyzed to obtain their microbiome profiles using next-generation sequencing. The primary outcome of interest is the vaginal microbiome, with secondary outcomes including the microbiomes of the rectum and urine. Additionally, the investigators will collect clinical data from the mother's and infant's medical records to correlate our findings with pregnancy and postnatal outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients ≥ 18 years of age
* Singleton pregnancy
* Gestational age 6 weeks and 0 days through gestational age 13 weeks and 6 days

Exclusion Criteria:

* Pregnant patients \<18 years of age
* Multiple gestations
* Gestational age less than or equal to 5 weeks and 6 days
* Gestational age greater than or equal to 14 weeks and 0 days
* Institutionalization for psychiatric disorder, mental retardation, or criminal activity
* Inability to provide informed consent
* Major medical complication of pregnancy, including but not limited to: Diabetes, Chronic hypertension, Severe obesity with body mass index greater than or equal to 40 kg/m2
* Major surgical complications of pregnancy, including but not limited to: History of Bariatric surgery
* Major obstetrical complication of pregnancy, including but not limited to: History of spontaneous preterm birth
* Known maternal or fetal chromosomal abnormality
* Major fetal anomaly
* Intrauterine fetal demise
* Human immunodeficiency virus (HIV) or Hepatitis
* Chronic immunosuppressive medications or steroids
* Current use of probiotic supplementation
* Active urinary or vaginal infection
* Current use of antibiotics
* Current use of vaginal medication (e.g. vaginal progesterone)
* Cerclage in place
Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Teneligliptin)

The purpose of this study is to evaluate the efficacy and safety of co-administration of Canagliflozin (TA-7284) and Teneligliptin (MP-513) once daily for 24 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Canagliflozin and have inadequate glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* Men or women who are 20 - 75 years old
* HbA1c of ≥7.0% and \<10.5%
* FPG of ≤ 270 mg/dL
* Patients who are under dietary management and taking therapeutic exercise for diabetes over 8 weeks before run-in period

Exclusion Criteria:

* Patients with type I diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes
* Patients with serious diabetic complications
* Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
* Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
* Patients with severe hepatic disorder or severe renal disorder.
The Role of Ultrasonography in Predicting Outcomes of Fetal Nephropathy

Congenital anomalies of the kidneys and urinary tract are among the most frequently ultrasound-indentified malformations in the prenatal period.

Thanks to the introduction of fetal ultrasound in pregnancy screening programs, the diagnosis of these abnormalities in utero allows early manegement. In fact, prenatal diagnosis allows evolutionary control of the pathology and appropriate counseling, putting in place the best therapeutic strategies at birth. However, the predictive value of prenatal ultrasound findings is often difficult to establish.

Therefore, the investigators want to evaluate the postnatal outcomes in fetuses prenatally diagnosed with unilateral nephropathy, specifically the rate of live births, gestational age at delivery, neonatal weight, and the need for admission of the infant to the neonatal intensive care unit (NICU).

The data collected will allow investigators to assess postnatal outcomes in fetuses prenatally diagnosed with unilateral nephropathy, identifying the prenatal ultrasound findings most associated with poor postnatal prognosis to define the role of ultrasonography in predicting outcomes of fetal nephropathy.

Clinical data of single-pregnancy patients who were referred to the Pregnancy at Risk Outpatient Clinics of our center between 2007 and 2023 will be considered.

These patients were evaluated with serial ultrasound checks at the outpatient clinics for the presence of suspected unilateral nephropathy that emerged during morphologic ultrasound performed between the 19th and 21st weeks of gestation. Therefore, we will analyze the ultrasound data that emerged during serious outpatient checkups, the delivery data of patients who delivered at our center, and the postnatal data of newborns.

Information on the following will be collected for each patient:

* Age
* Type of suspected nephropathy (pyelectasis, hydronephrosis/hydroureteronephrosis, multicystic kidney, dysplasia)
* Gestational age at the time of suspected diagnosis
* Gestational age at the time of diagnosis
* Assessment of amniotic fluid
* Centile of affected kidney (\<5°, normal, \>95°)
* Centile of unaffected kidney (\<5°, normal, \>95°)
* Presence of associated abnormalities in the other anatomical districts
* Performance of invasive prenatal diagnostic methods (Karyotype analysis and CGH-array)
* Progression of nephropathy
* Involvement of contralateral kidney
* Gestational age at the time of delivery
* Mode of delivery (vaginal/caesarean section)
* Sex of the newborn at birth
* Infant's weight at birth
* Ph of newborn at birth
* APGAR index at 5 and 10 minutes
* Possible admission to neonatal intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

* Single pregnancy
* Age greater than or equal to 18 years
* Detection of Unilateral Renal Abnormalities during Confidential Ultrasound
* Delivery performed at the O.U. of Obstetrics and Prenatal Age Medicine
* Acquisition of informed consent form

Exclusion Criteria:

* Request for voluntary termination of pregnancy
Evaluation of a 6-month Intragastric Balloon

Post-market observational, adaptive, single-arm clinical study to evaluate the percentage of total weight loss after treatment with an intragastric balloon. Patients will be followed for 6 months after the device is installed.

Forty-six overweight patients over 18 years of age with a BMI of 27 kg/m2 or greater who are considered suitable for intragastric balloon placement will be included. The primary outcome will be the assessment of the percentage of total weight loss (%WL) at 6 months. Patients will be screened in an outpatient setting at the participating research center. All participants who meet the eligibility criteria will be invited to participate in the study, which includes a screening visit, standard intragastric balloon placement procedure, and follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form;
* Age 18 or older;
* Both sexes;
* Being overweight, with a Body Mass Index (BMI) of 27 kg/m2 or higher;
* Being able to follow the protocol monitoring requirements;
* Adhering to the diet recommended by the nutrition professional;
* Presenting reasonable expectations of weight loss, at least 10% of baseline weight.

Exclusion Criteria:

* Pregnant women or women during the breastfeeding period;
* People unable or unwilling to comply with restrictions regarding diet or medical monitoring and their respective guidelines during the program for use of the Intragastric Balloon;
* People with severe kidney and/or liver diseases;
* Patients who have undergone previous gastric surgery;
* Patients with inflammatory diseases of the gastrointestinal tract, gastric ulcer, duodenal ulcer or specific inflammations, such as Crohn\&amp;amp;#39;s disease, or with a propensity for gastrointestinal bleeding in the upper tract, such as esophageal or gastric varices, or acquired intestinal telangiectasia;
* People with severe cardiopulmonary or organic disorders;
* People with congenital or acquired anomalies of the gastrointestinal tract, such as atresia and stenosis; with large hiatal hernia;
* Drug addicts in general;
* Patients not committed to adhering to treatment and medical recommendations, including nutritional guidance.
Improving Care for Patients With Chronic Kidney Disease Using EMRALD

This pragmatic cluster randomized controlled trial will test the impact of feedback and a toolkit aimed at improving the management of chronic kidney disease (CKD) in the primary care setting. This trial will use family physicians in Ontario participating in the Electronic.

This trial will use family physicians in Ontario participating in the Electronic Medical Record Administrative data Linked Database (EMRALD) and receiving the System for Audit and Feedback to Improve caRE (SAFIRE) along with other decision support tools. Performance on CKD quality indicators for family physicians receiving the CKD feedback and tools will be compared to physicians not receiving the CKD feedback or tools.

Eligibility Criteria:
Inclusion Criteria:

* Family physicians participating in EMRALD, on the EMR for \>=2 years, roster size \>=100 patients
* Patient criteria, rostered and actively seeing an EMRALD physician, on the EMR for .=1 year

Exclusion Criteria:

* Updated data available at the time of study commencement
Effect of Real-fire Training on Vascular Function

Fire-fighters are at increased risk of death from heart attacks when compared to other emergency service professionals whose jobs involve similar components such as emergency call-outs and shift work. The unique risk to fire-fighters is likely to reflect a combination of factors including extreme physical exertion, mental stress, heat and pollutant exposure.

In the largest analysis of cause of death amongst on-duty fire-fighters, fire-fighter deaths were classified according to the duty performed during the onset of symptoms or immediately prior to any sudden death. The majority of deaths due to a cardiovascular cause (i.e. heart attack) occurred during fire-suppression whilst this activity represented a relatively small amount of a fire-fighters professional time. Fire simulation training centers offer a unique opportunity to assess the heart, blood and blood vessel response to fire suppression in a controlled environment.

In this study the investigators will assess healthy career fire-fighters on two occasions: following a fire-suppression training exercise in a purpose built real-fire training center, and following a sedentary period as a control. The investigators will take blood samples to measure platelet activity (platelets are the particles in blood that help blood clot) and will examine how blood clots outside of the body. The investigators will then perform studies placing small needles in the arm to assess blood vessel function following fire suppression. By undertaking this comprehensive assessment of blood, blood vessel and heart function we hope to understand the mechanisms whereby the risk of a heart attack is influenced by fire suppression. The investigators hypothesize that following the fire-suppression exercise firefighters blood will clot more readily and their blood vessels will not relax properly which are two of the main processes in the development of a heart attack.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking healthy firefighters

Exclusion Criteria:

* Current smoker
* History of lung or ischaemic heart disease
* Malignant arrhythmia
* Systolic blood pressure \>190mmHg or \<100mmHg
* Renal or hepatic dysfunction
* Previous history of blood dyscrasia
* Unable to tolerate the supine position
* Blood donation within the last 3 months
* Recent respiratory tract infection within the past 4 weeks
* Routine medication including aspirin and NSAIDs
Integrated Discovery and Development of Innovative TB Diagnostics

The long term goal of this project is to provide information critical to the development and use of a low-cost, point-of-care, rapid, simple, and highly accurate diagnostic tool that can help clinicians make a microbiological diagnosis in children who present with signs and symptoms suggestive of TB.

Specific aim 1: To identify the types of patient samples from which to best detect Mtb DNA in children with TB. We propose to obtain serial samples of sputum, blood, stool, and gastric and nasopharyngeal secretions from children with symptomatic TB and to use molecular methods to characterize the distribution of Mtb in these samples. The results of this study will allow us to identify the most promising sampling strategies for diagnosis of TB in children so that optimization of these easily-accessible samples for detection of Mtb nucleic acids can be addressed.

Specific aim 2: To determine whether cell free Mtb DNA can be detected in plasma and urine samples of children and adults with TB and to describe the host-related factors that alter the sensitivity of this assay. We propose to test serial urine and plasma samples for Mtb DNA fragments in two groups: (1) children with symptoms of TB and (2) adults with TB. Here, we will optimize sample volume sizes and of state-of-the-art sequencing tools to improve DNA recovery and detection. This study will help identify optimal samples and strategies for the non-invasive diagnosis of Mtb using urine.

Secondary aim: To create a bank of archived specimens for (1) optimization of Mtb DNA purification, extraction, and (2) use in future pediatric TB diagnostic research.


Eligibility Criteria:
Inclusion Criteria for aim 1:

Children must meet all of the following criteria at the time of enrollment to participate:

* Age \< 15 years;
* Presents to a participating health center;
* Meets the Criteria for Enrollment of Children Into TB Diagnostic Evaluation Studies
* Has a history of contact with an adult with TB disease; and
* A guardian provides informed consent for minor to participate and, if age 8 to 14 years, the minor also provides assent.

Inclusion criteria for aim 2:

Inclusion criteria for children who participate in Aim 2 will be the same as for those for Aim 1. Adults who participate in Aim 2 must meet all of the following criteria at the time of enrollment to participate.

* Age ≥ 18 years;
* Presents to a participating health center;
* Is diagnosed with incident pulmonary TB;
* Has sputum smear microscopy results;
* Has not yet initiated tuberculosis treatment; and
* Is willing to receive a rapid HIV test.

Exclusion Criteria:

-
The Effect of Video Education on Inhaler Use Technique

The investigators looked at the effect that video instruction located at www.useinhalers.com would have on improving inhaler technique at a hospital in Guayaquil, Ecuador. The investigators compared this video instruction to written Spanish inhaler education. The investigators video taped participants before and after the intervention, and graded their technique on a pre-defined rubric.


Eligibility Criteria:
Inclusion Criteria:

* Clinically-stable outpatient adults (≥18 years) with Asthma or Chronic Obstructive Pulmonary Disease (COPD) with history of at least one exacerbation in last 1 year
* Clinical diagnoses of asthma or COPD

Exclusion Criteria:

* Patients with language barrier (unable to understand and communicate in either English or Spanish)
* Cognitive or physical dysfunction that, in the investigator's opinion, would interfere with completion of the study
* Significant co-morbidity that can confound asthma symptoms - e.g. Congestive Heart Failure, current smoker, uncontrolled Gastroesophageal Reflux Disease, neuromuscular disease, chest wall deformity
Multistimulation Group Therapy for Alzheimer's Disease

Our previous findings support the notion that group activity program, based on cognitive stimulation, recreational-occupational activities and physical-psychomotor exercises, can lead to an improvement in behavioral aspects for people with Alzheimer's Disease (AD).

The purpose of this study is to clarify the efficacy of a rehabilitation program in outpatients affected by AD in mild to moderate stages.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of possible/probable AD
* mild to moderate stage of AD (MMSE score of 15 - 24)and CDR score of 1-2
* range years in age (65-85) and in school attendance (5-17)
* right handed

Exclusion Criteria:

* severe aphasia (Token test score \< 20)
* severe auditory and/or visual loss
* overt severe behavioral disturbances (delusions, hallucinations, agitation)
* recent (three month before the MST) introduction or dose modification of the following pharmacological treatments: cholinesterase inhibitor, memantine, antidepressant or antipsychotic drugs.
Pain Relief by Intra-Peritoneal Nebulization of Ropivacaine Under Remifentanil Anesthesia for Gynecological Laparoscopy

In our prospective, randomized, placebo controlled and double-blinded study we will study the efficacy of intraperitoneal ropivacaine nebulization on pain relief during gynecologic laparoscopic surgery. This is a second steady with protocol of general anesthesia used of Remifentanil.

Outcome Measures :

* VAS score
* Use of analgesics during operation and postoperative period

Eligibility Criteria:
Inclusion Criteria:

* Elective gynecological laparoscopic surgery including unilateral or bilateral salpingo-oophorectomy or ovarian cystectomy
* Patient not participating in other medical study at present or during the last 30 days
* Patient is capable of reading, understanding and signing on an informed consent
* Age 18 years and above
* ASA physical status grade 1-2

Exclusion Criteria:

* Allergy to ropivacaine or other local anesthetics or other medications listed in the protocol
* Acute pelvic inflammatory disease
* Coumadin or aspirin treatment
* Significant arrythmias
* Analgesic treatment for chronic pain
* BMI\>35
Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.

Prediabetes (PD) was defined as an state in which glucose levels are above normal but not enough to meet criteria for the diagnosis of type 2 diabetes (T2D). PD can be presented as impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and glycated hemoglobin A1c (A1C) altered. The International Diabetes Federation (IDF) reported that in 2013 the prevalence of IGT was 6.9% which is equivalent to approximately 316 million individuals with IGT, it is expected that by 2035 this number will increase to 417 million people affected. Many hypoglycemic effects attributed to Gymnema sylvestre have been reported, including: increase of insulin secretion, regeneration of pancreatic islet cells, increased glucose utilization in various ways and inhibition of glucose uptake in the intestine.

The target is to evaluate the effect of the administration of Gymnema Sylvestre on glycemic control, insulin secretion and insulin sensibility on patients with IGT. The investigators will conduct a double-blind trial, randomized, placebo control group, each group 12 female and male patients, between 30 and 59 years old with IGT (2-h values in the oral glucose tolerance test, OGTT) from 140 mg / dL to 199 mg / dL), Body Mass Index (BMI) from 25 to 34.9 kg / m2. Randomization will determine who will receive the intervention during the 9-week trial (Gymnema Sylvestre capsules, 300 mg 2 times daily with the first bite of breakfast and dinner or homologated placebo capsules). The clinical findings and laboratory tests include a metabolic profile and biosafety, which will be made at baseline and at week 9. Body weight, body fat, BMI and blood pressure will be determined during the initial and final visit. Adverse events and adherence to treatment will be documented. Statistical analysis: Mann-Whitney U test, Wilcoxon and Fisher exact test. It is considered with significance at p \<0.05.

Eligibility Criteria:
Inclusion Criteria:

* BMI: 25.0-34.99 kg / m2.
* Diagnosis of IGT (2h-OGTT Values between 140mg / dl and 199mg / dl.)
* Written informed consent.
* body weight stable over the last 3 months.
* Women in follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of laboratory tests.
* Women who are not contemplated get pregnant within the next 6 months.

Exclusion Criteria:

* Women pregnant or breastfeeding.
* Physical or mental disability that makes it impossible to perform the intervention.
* Diagnosis of hypertension or heart failure.
* Smokers.
* Untreated thyroid disease.
* Consumption of oral agents or other medications or supplements with proven properties that modify the behavior of glucose and lipids (oral hypoglycemic agents, insulin, lipid-lowering).
* Diagnosis of liver disease or elevation twice of the upper normal value of liver enzymes.
* Diagnosis of renal disease or creatinine \> 1.5 mg / dl.
* Diagnosis of Type 2 Diabetes Mellitus (T2DM) Fasting glucose ≥ 126 mg / dL and/or 2h-OGTT ≥ 200 mg / dL and/or A1C ≥ 6.5%.
* Total Cholesterol ≥ 280 mg/dL.
* Triglycerides ≥ 300 mg/dL.
* Known allergy to calcined magnesia or Gymnema sylvestre.