cyrilzakka/clinical-trials huggingface dataset:
Novel Alpha Glucan GI Tolerability Study (Loris Chronic)

This study aims to evaluate the gastrointestinal tolerance of chronic consumption (7 days) of a novel alpha glucan compared to a rapidly available carbohydrate (glucose syrup).

This study will be randomized, double blind, placebo-controlled, single-center, and 3x3 crossover in design.

Eligible participants will be randomized to receive the below products in single dose and in different random sequence, as determined by the randomization system:

1. novel alpha glucan (80 g/day)
2. novel alpha glucan (180 g/day)
3. glucose syrup (180 g/day)

Eligibility Criteria:
Inclusion Criteria:

1. Male or female participant,
2. Healthy status (based on anamnesis),
3. Age between 18 and 65 years,
4. Body mass index (BMI) between 18.5 and 29.9 kg/m2,
5. Able to understand and sign informed consent form,
6. Having a smartphone with Android or iOS version compatible with Patient Cloud application

Exclusion Criteria:

1. Fasting plasma glucose higher or equal to 6,1 mmol /L at screening,
2. Type I and type 2 diabetes,
3. Pregnant or lactating women,
4. Known food allergy or intolerance to test products,
5. Treatment with anorectic drugs, glucose-lowering drugs, steroids, medications known to affect glucose metabolism and/or gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption,
6. Colonoscopy, irrigoscopy or other bowel cleansing procedures four weeks prior the test,
7. Any concomitant medication potentially interfering with study procedures and assessment: such as antibiotics, antiacids, or other medications impacting transit time,
8. Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments,
9. Abnormal bowel transit, history of a gastrointestinal disorder (e.g., inflammatory bowel disease, diverticular diseases, colon cancer), or history of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average or chronic or recurrent diarrhea with spontaneous bowel movements more often than 3 times daily,
10. Recent episode of an acute gastrointestinal illness,
11. Habitual consumption of more than four servings per day of high-fiber foods or extreme dietary habits (e.g. very low carbohydrate diet),
12. Ongoing or recent weight loss interventions (e.g. dietary weight loss programs),
13. Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer,
14. Score of "severe" symptom for any of the symptoms included in the gastrointestinal symptom questionnaire,
15. Volunteer who cannot be expected to comply with the protocol,
16. Family or hierarchical relationships with Clinical Innovation Lab team.
COVID-19 Pandemic and Parents of Disabled Children

Pandemic period could affect the disabled children's rehabilitation and follow-up negatively because of preventive measures and this could create adverse results on their parents.

In this research, it is aimed to determine the positive and negative effects of pandemic on parents and disabled children and to provide an insight for future solutions.

To determine the effect of COVID-19 pandemic and the possible difficulties experienced by the parents of disabled children, a questionnaire was prepared. It takes approximately 10-15 minutes to complete the survey. Questionnaire is loaded to qualtrics program and sent to the families by e-mail or social media accounts.

Eligibility Criteria:
Inclusion Criteria:

* Having disabled child/children
* Having ability and facility to use internet
* Having ability to read and write
* Having enough cognitive capacity to answer the questionnaire
* To accept to participate the research

Exclusion Criteria:

* Not having disabled child/children
* Not having ability and facility to use internet
* Not having ability to read and write
* Not having enough cognitive capacity to answer the questionnaire
* Not to accept to participate the research
Mid-morning Gel Snacks on Subjective Appetite, Glycemic and Insulin Responses, and Food Intake

The purpose of this study was to determine the effect of mid-morning gel snacks on subjective appetite, glucose and insulin responses, and food intake in healthy weight young adults.

23 (14 male, 9 female) healthy, non-smoking human subjects aged 18-30 years with a body mass index (BMI) between 20 and 24.9 were recruited in the experiment. Five gel snacks including a control snack and four modified snacks containing whey protein, oats, coconut oil or maltodextrin were tested. On six separate mornings, at least 3 days apart and after a 12 hours overnight fast, each participant consumed a standardized breakfast of cereal, milk, and orange juice at home, then arrived in the lab 2 hours after breakfast to receive one of the five test snack treatments or skip snack. Subjective appetite by a 100 mm visual analogue scale (VAS) was measured at baseline (0 min) and after each treatment up to 2 h (15, 30, 60, 90, and 120 min). Blood glucose and insulin concentrations were measured via finger-prick at the same time VAS measurements were taken. Food intake was measured via ad libitum pizza lunch.

Eligibility Criteria:
Inclusion Criteria:

* be between 18 and 30 years of age
* be healthy, non-smoking and not be taking any medications, including birth control
* body mass index (BMI) between 20 and 24.9

Exclusion Criteria:

* fasting plasma glucose \>5.5 mmol/L
* health problems including previously diagnosed diabetes, known or uncertain pregnancy status at screening, gastrointestinal disease, liver or kidney disease
* major medical or surgical event within the past 6 months
* current or recent dieting
* breakfast skipping
* receiving any medications
* menstrual irregularities
* food sensitivities, allergies, intolerances, or dietary restrictions to foods including: cereal, orange juice, dairy, oat, coconut oil, honey, apple, pineapple, strawberry, and pear
* behavioural or emotional problems
* alcohol consumption \>7 beverages/week
A Study Based on Medical Records That Looks at the Characteristics of Idiopathic Pulmonary Fibrosis Patients Grouped by the Type of Medication They Are Taking

To understand differences in characteristics of Idiopathic Pulmonary Fibrosis (IPF) patients who are prescribed nintedanib compared to those who are prescribed pirfenidone.


Eligibility Criteria:
Inclusion Criteria:

* With ≥ 1 diagnosis for IPF (the International Classification of Diseases, Ninth Revision, Clinical Modification \[ICD-9-CM\] codes 516.3, 516.31, 515, or ICD-10-CM codes J84.112) in the EMR between October 1, 2013 to April 30, 2018
* With ≥ 1 prescription for nintedanib between October 1, 2014 and April 30, 2018 (the selection window)
* The date of the first prescription will be defined as the index date
* With ≥ 1 record in the EMR database during the 12 months prior to the index date (the pre-index period)
* With ≥ 1 diagnosis of IPF during the 12 months prior to the index date
* Age ≥ 40 on the index date
* IQVIA will explore also requiring ≥ 1 chest CT scan before first IPF diagnosis during the pre-index period

Exclusion Criteria:

* With ≥ 1 diagnosis of other known causes of interstitial lung disease (ILD) on the date of or after the first IPF diagnosis during the pre-index period
* Other known causes of ILD include conditions such as systemic sclerosis, rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, polymyositis, Sjögren disease, and hypersensitivity pneumonitis (ICD-9-CM codes 135, 237.7, 272.7, 277.3, 277.8, 446.21, 446.4, 495, 500-505, 506.4, 508.1, 508.8, 516.0, 516.1, 516.32-516.37, 516.2, 516.8, 516.9, 517.0, 517.2, 517.8, 518.3, 555, 710.0, 710.0-710.4, 714.0, 714.81, 720, and 759.5, or ICD-10-CM equivalent codes)
* With ≥ 1 prescription for nintedanib prior to the index date
* With ≥ 1 prescription for pirfenidone prior to or on the index date
The Wrist-Free Study - Comparing Traditional Above Elbow Casts to Ones That Free the Wrist

This randomized controlled trial compares clinical outcomes, patient comfort and satisfaction of freeing the wrist in casts for supracondylar humerus fractures in children.


Eligibility Criteria:
Inclusion Criteria:

* Type I and Type IIa Supracondylar Humerus Fracture

Exclusion Criteria:

* History of elbow injury
* Polytrauma
Antifungal Drugs in Pulmonary Mucormycosis

Pulmonary mucormycosis (PM) poses a substantial clinical challenge, particularly among immunocompromised patients. The aim of the study is to determine the effectiveness and safety of administering AmBisome at a dose of 5mg/kg/day combined with isavuconazole versus using AmBisome for the management of pulmonary mucormycosis


Eligibility Criteria:
Inclusion Criteria

* Patients aged 18 years or older diagnosed with pulmonary mucormycosis (PM).
* Individuals with Probable or proved PM, as indicated by clinical and radiological findings.

Exclusion Criteria:

* Patients with a history of pulmonary mucormycosis (PM) who have previously been treated with amphotericin B for a duration exceeding 5 days.
* Patients who have documented allergies to azoles or amphotericin B regimens
* Patients with serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, or bilirubin levels exceeding five times the upper limit of normal (ULN).
* Patients with irreversible heart or liver failure, or those experiencing massive, fatal hemoptysis.
* Patients who have experienced a myocardial infarction or cerebral infarction.
* Patients currently receiving extracorporeal membrane oxygenation (ECMO) treatment.
* Pregnant or breastfeeding individuals. 8.Patients with individual reasons that may prevent them from completing the treatment protocol.
Normal Saline Versus Betadine Use to Reduce the Incidence of Wound Infection in Cesarean Section

This is a prospective randomized controlled study to the difference between using normal saline or betadine irrigation of wound prior to skin closure in reducing the incidence of wound infection after Cesarean section.

This study will be conducted at the Department of Obstetrics \& Gynecology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University, from February to July 2018.

We include in our study 3oo pregnant women who will undergo Cesarean section. All participants will be divided into 3 groups with a 1:1:1 ratio with 100 patients in each group. Each participant will provide an informed written consent.

Consenting patients will be pre-operatively randomised using numerically ordered cards in sealed envelopes to either the group 1 (wound irrigation with 100 ml of normal saline before skin closure) or the group 2 (wound irrigation with 50 ml of 10% aqueous povidone iodine solution ̋ Betadinȅ ) or the control group (no wound irrigation with normal saline nor betadine).Subjects candidate for the study will be 37 weeks' gestation and require a cesarean section (elective or emergency). Patients with allergy to iodine, history of immunosuppressive drug use, gestationaldiabetes mellitus or preeclampsia, anemic patients, ruptured of membranes and feverish patients will be excluded from the study.

The primary outcome will be the incidence of wound infection. Wound infection is diagnosed when the wound drained purulent material or serosanguineous fluid in association with induration, warmth and tenderness. Suspected wound infections are opened for confirmation and wound cultures will be taken. Haematoma, seroma, or wound breakdown in the absence of the previouslydiscussed signs is not considered a wound infection.Wounds are examined twice daily during hospitalization for evidence of infection. After discharge, the women are instructed on the signs and symptoms of wound infection, and asked to contact one of the co-authors immediately if any of the listed symptoms appeared. All participants are examined at 2 and 6 weeks after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Subjects candidate for the study will be 37 weeks' gestation
* require a cesarean section (elective or emergency).

Exclusion Criteria:

* Patients with allergy to iodine
* history of immunosuppressive drug use,
* gestationaldiabetes mellitus
* preeclampsia
* anemic patients
* ruptured of membranes
* feverish patients
A Study to Evaluate the BrainPort® Vision Device in Subjects Who Are Blind

The purpose of this study is to assess the safety of the BrainPort vision device and to demonstrate improved object recognition and word identification and ambulation with use of the BrainPort vision device in subjects who are medically documented as blind, with acuity of 20/ 5000 or worse.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed written medical or low vision diagnosis of No Light Perception or Light Perception
* Performance on the FrACT acuity test of worse than 20/5000 or impossible to measure.
* Minimum post 6 months diagnosis blindness.
* Previously completed conventional rehabilitation such as orientation and mobility training with a cane or guide dog.
* Able to have read to him or her, understand, and sign the informed consent form.
* Daily access to an accessible computer with email for study communication, device- use logging and access to device user manual preferred.
* Willing and able to complete all testing, training, and follow- up evaluations required by the study protocol, after receiving a short orientation on the use of the device.

Exclusion Criteria:

* Current oral health problems as determined from the oral health exam which preclude enrollment in the study in the judgment of the Principal Investigator.
* Any medical condition that would interfere with performance on the assessments.
* Prior use of the BrainPort vision device.
* Known neuropathies of tongue or skin tactile system.
* Smoke or chew tobacco products less than 12 months prior to study enrollment
* Any allergies to nickel or stainless steel
* History of seizures or epilepsy.
* If female, pregnant. Women of child bearing potential must agree to use appropriate birth control to prevent pregnancy for the duration of the study.
* People with implanted electrical medical devices (i.e. pacemaker, deep brain stimulator, cochlear implant).
* Psychiatric disease including anxiety disorders and forms of depression (using provided Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI- II) as screening tools).
* Any disease or condition that prevents understanding or communication of informed consent, study demands and testing protocols including the following:
* Cognitive decline including forms of dementia and/or progressive neurological disease
* Deafness or selective frequency hearing loss that prevents hearing device alarms and alerts.
* Does not speak English
* Blindness occurring due to cortical injury (i.e. stroke, traumatic brain injury, etc)
* Principal Investigator, in his or her judgment, does not believe the subject is a good candidate for the trial.
The Adherence of Proactive Sleep Apnea Therapy

The goal of this clinical trial is to compare the adherence to Positive Airway Pressure (PAP) therapy for newly diagnosed Obstructive Sleep Apnea (OSA) patients. The main question(s) it aims to answer are:

1. To compare the adherence of proactive therapy and conventional Automatic-PAP (APAP) therapy short-term (3 months) and long-term (12 months) for newly diagnosed OSA patients.
2. To compare health outcomes (AHI, nightly usage, leak, and patient-reported outcomes) between proactive therapy and conventional APAP therapy.

This is a double-blind, randomized controlled superiority trial on newly diagnosed patients with obstructive sleep apnea. Each participant will be provided with a APAP device. The devices assigned to the test group will be modified to deliver the proactive therapy using Artificial Intelligence (AI). Devices assigned to the control group will deliver the conventional APAP therapy. A sleep technician will be in regular contact with participants and track the time spent interacting with each participant. At the conclusion of the first 3 months of the trial, participants who are acceptant to therapy will be asked if they would like to continue participating for an additional 9 months. Data will be collected by the PAP device and a series of self-reported questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Must have a new diagnosis of moderate or severe OSA (i.e., AHI \> 15 events/hour).
* Must be 18-70 years old.
* No history of self-reported, uncontrolled, severe cardiovascular or neurological issues.
* Must be able to comply with all study requirements as outlined in the consent form.
* Must be able to follow the directions of the study doctor and research team.
* Must be able to understand English and be willing to provide informed consent.

Exclusion Criteria:

* Prior use of PAP machines.
* Subjects actively using bi-level PAP or require oxygen therapy.
* Subjects who are medically complicated or who are medically unstable ( i.e., cancer, dementia, unstable cardiac or respiratory disease, or unstable psychiatric illness).
* Potential sleep apnea complications that, in the opinion of the clinician, may affect the health and safety of the participant.
* Inability or unwillingness to given written informed consent.
* Neuromuscular disease, hypoglossal-nerve palsy, severe restrictive or obstructive pulmonary disease, moderate-to-severe pulmonary arterial hypertension, severe valvular heart disease, New York Heart Association class III or IV heart failure, recent myocardial infarction or severe cardiac arrhythmias (within the past 6 months), persistent uncontrolled hypertension despite medication use, active psychiatric disease, and coexisting non-respiratory sleep disorders that would confound functional sleep assessment.
* Pregnancy, planning to attempt to become pregnant, or breastfeeding.
Evaluate Safety and Efficacy of Innovative Medical Devices for Colostomy Patients

The surgical ostomy process happens when it is necessary to open an organ (such as the intestine) in order to maintain a communication channel with the external environment. The need for ostomy surgery can happen as a result of illness, genetic factors, or trauma. Despite the extensive improvements in colorectal surgery, in case there is a need for total or partial extraction and exteriorization of the large intestine (colostomy), it is often necessary to perform a stoma that connects the end of the preserved intestine to the skin, in which cases it is necessary to place a a colostomy bag for stool collection. Thus, there is a substantial number of patients who need to live with a permanent abdominal stoma that significantly affects their quality of life, implying significant changes, both physical and social. It will then be necessary for patients to adjust their daily routines in order to deal with stoma care.

The primary objective of this study is to evaluate the Hydrustoma C3 medical devices (plate C3, capsule C3, night bag C3) in terms of its efficacy and safety as colostomy devices. It is also a primary objective of this study to compare the health-related quality of life in patients with colostomy when using a control and Hydrustoma C3 devices.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent;
* Male and Female patients;
* Adult aged ≥ 18;
* Descending and sigmoid colostomy created more than 3 months previously to the beginning of the study;
* Having formed stool and using a flat ostomy appliance;
* Able to understand the study procedures and fill questionaries;
* Able to apply and remove the ostomy device autonomously.

Exclusion Criteria:

* Repeated experiences of leakage with the usual ostomy device,
* Chronically liquid stools,
* Peristomal skin disorders,
* Known allergic reactions to components of the device,
* Receiving chemotherapy, radiation therapy or steroids in the previous month
The Effect of Metformin and DPP4 Inhibitors on Cognition and Cardiovascular Protection in Type 2 Diabetic Patients

The Impact of Metformin and Dipeptidyl Peptidase- 4 Inhibitors on Cognitive Function and cardiovascular protection in Type 2 Diabetic Patients

This study aims to investigate the effect of daily oral DPP4 inhibitors and oral metformin on neurodegeneration in type 2 diabetic patients.

This study aims to compare between the cardiovascular protective properties of DPP-4 inhibitors and Metformin in type 2 diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient should be diagnosed with Type 2 diabetes mellitus (T2DM) and guided with HA1c ≥7, age ≥40 years.
* moderate hypertension.

Exclusion Criteria:

* • Diabetic patients who have been currently receiving anti-diabetic agents other than metformin and/or insulin

  * Patients with type 1 DM, active liver disease, recent history of cardiovascular disease (acute coronary syndrome, coronary artery intervention, New York Heart Association Class III/IV heart failure, stroke, transient ischemic neurologic event, or new/worsening symptoms of coronary heart disease or cerebrovascular disease), severe peripheral vascular disease, triglyceride levels ≥ 600 mg/dL, history of HIV infection, pancreatitis, malignancy or clinically important hematologic disorder, and an estimated glomerular filtration rate (eGFR; calculated using the Modification of Diet in Renal Disease formula) less than 30 mL/min/1.73 m2.
  * Moreover, patients with dementia, AD, those were in delirium status during evaluation period, patients with psychotic disease (schizoaffective disorder, etc.)
  * Alcohol and substance addiction were not enrolled in the study.
  * Also, patients who have any hypersensitivity to metformin or to DPP4 inhibitors were also excluded.