cyrilzakka/clinical-trials huggingface dataset:
Effects of Lifestyle Education Programs on Diabetes Control in Rwanda

Strategies to reduce the burden of diabetes in Rwanda, like in other resource poor settings, include involving diabetic patients in their own care and targeting modifiable risk factors through adopting appropriate dietary and lifestyle habits. According to previous research carried out in developed countries, lifestyle modifications may have effect on the development of diabetes and prevention of its complications.

However, direct evidence to show whether lifestyle intervention is beneficial for diabetic patients in resources limited countries like Rwanda is an open question. Though in these countries, access to healthy diet is claimed to be the barrier of implementation of therapeutic lifestyle based initiatives, we hypothesize that knowledge gaps are more important barriers than access to healthier diets and other lifestyle habits. We therefore would like to carry out this intervention to assess the effects of lifestyle education programs on glycemic control among people with diabetes followed up at CHUK.

The study is a randomized controlled trial with two groups (one interventional and one control) to be followed up for 12 months. It will be carried out in Kigali University Teaching Hospital, the main referral hospital in Rwanda.

Lifestyle intervention will consist in group counselling on dietary habits (meals composition, importance and ways to reduce unhealthy foods: salty (especially because hypertension is of concern among diabetic people and blood pressure will be one of the secondary outcome measures), sugar, unsaturated fats, smoking, alcohol abuse and adapt healthier regimens including fruits \& vegetables), effects of regular physical activity, importance of adherence to medications (including taking medications as directed, regular medical follow up,etc...), diabetes complications, actions to control blood sugar and ways of coping with stress.

Education \& counselling sessions will be provided by a team of registered dietitians, nurses and counselors who will have been trained for this purpose prior to the intervention and will be taking between 45 to 60 min.

After baseline data collection, subjects in the control group will continue to receive usual care delivered by attending physicians and nutritionists at CHUK. This includes usual monthly medical follow up and individual conselling on dietary habits and lifestyle change delivered by attending physicians and/or dietitians

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of diabetes known since three months at least,
* being currently on treatment (insulin or oral hypoglycemiants),
* able to follow up at CHUK

Exclusion Criteria:

* patients with advanced diabetic complications (advanced nephropathy \& CKD, proliferative retinopathy, recent history of myocardial infarction \& severe Heart Failure (LVEF\<35%), peripheral artery disease, stroke, severe diabetic foot disease,
* any other severe illness that may impede the patient's functional capacity,
* severe psychiatric disorders
* pregnancy
The Secretion of Incretin Hormones in Patients With Polycystic Ovary Syndrome

Polycystic ovary syndrome (PCOS) is an endocrine disease in reproductive women. It is characterized by anovulation and hyperandrogenism. Most patients with PCOS have metabolic abnormalities such as dyslipidemia, insulin resistance and glucose abnormalities. Almost 60-80﹪PCOS patients are obesity which exacerbates IR and hyperandrogenism. Obese PCOS patients tend to be overeating suggests that impaired appetite regulation might be contribute to the pathophysiology of PCOS. Our study is trying to observe difference of incretin between PCOS and normal control to figure out whether change of incretin is involved in the pathophysiology of PCOS.


Eligibility Criteria:
Inclusion Criteria:

* women at reproductive age
* women with PCOS and women without PCOS

Exclusion Criteria:

* young women who had their menarche less than 3 years
* women older than 45 years old, Amenorrhea of menopause, hyperglycemia, hyperthyroidism, hypothyroidism, heart failure, lung failure, renal failure, anemia, dystrophy, gonitis
VIR-7831 for the Early Treatment of COVID-19 in Outpatients

This is a phase 2/3 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 or placebo and will be assessed for safety, tolerability, efficacy, and pharmacokinetics.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be aged 18 years or older AND at high risk of progression of COVID-19 or ≥ 55 years old
* Participants must have a positive SARS-CoV-2 test result and oxygen saturation ≥94% on room air and have COVID-19 symptoms and be less than or equal to 5 days from onset of symptoms

Exclusion Criteria:

* Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours
* Symptoms consistent with severe COVID-19
* Participants who, in the judgement of the investigator are likely to die in the next 7 days
* Severely immunocompromised participants
Genetically Determined Response to Atenolol in Patients With Persistent Atrial Fibrillation

Atrial fibrillation (AF), the most common sustained heart rhythm disorder, is becoming increasingly prevalent in the Western world. The number of people with AF in the United States is projected to roughly double by the year 2050, to an estimated 6-12 million. For many patients with AF, rate control with atrioventricular (AV) node blockers is a widely accepted therapeutic strategy. These agents control heart rate, thus preventing symptoms and systolic heart failure associated with tachycardia due to a rapid ventricular response to AF. Beta-blockers are widely accepted as first line agents for rate control in AF, especially when patients have concomitant hypertension (HTN), coronary artery disease, cardiomyopathies, or heart failure (HF). As a class, beta-blockers are among the most commonly prescribed cardiovascular medications.

Among patients with AF treated with beta-blockers, the heart rate (HR) response varies substantially. Sometimes, adequate rate control can be achieved by titration of the beta-blocker dose; but frequently, additional AV nodal blockers and/or digoxin are necessary. In some cases, adequate rate control cannot be achieved even with the simultaneous use of multiple AV nodal blockers, necessitating mechanical ablation of the AV node and permanent pacemaker implantation.

Patient-specific variables that influence the response to beta-blockers include comorbid conditions, weight, age, and level of physical activity. Ethnic differences in the response to beta-blockers for the treatment of HTN and HF are well-described. However, the contribution of genetic variants to beta-blocker efficacy in AF is unknown. We propose to study whether the ADRB1 Gly389Asp SNP reduces response to beta-blockade in subjects with permanent AF.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be at least 18 years of age.
* Subjects must have a history of persistent AF currently treated with a rate control strategy.
* Subjects should be willing to give written, informed consent.
* Subjects must be willing and able to participate in the exercise protocol.

Exclusion Criteria:

* New York Heart Association Class III or IV heart failure.
* A history of heart failure induced by tachy-arrhythmia.
* A history of coronary artery disease and the presence of at least one of the following:

  * Canadian Class III or IV angina.
  * Recent myocardial infarction, coronary artery bypass grafting, or percutaneous coronary intervention within 6 months.
* Severe renal or hepatic impairment.
* Subjects who have a clinically significant allergy/intolerance to atenolol, including a history of beta-blocker induced bronchospasm.
* Females who are pregnant or nursing.
* History of severe AV node dysfunction/pacemaker dependence.
* Subjects who have a systolic blood pressure \< 90 mm Hg or resting Ventricular Rate \<50 or \>120 per minute on the day of the study.
* Patients currently taking Vaughan-Williams Class I or III anti-arrhythmic drugs.
The Use of Submucosal Dexamethasone After Periodontal Surgery

The aim of this study is to evaluate the effectiveness of submucosal 8 mg (2 mL) dexamethasone on postoperative pain, swelling, chewing efficiency, trismus, healing, and discomfort after periodontal flap surgery

Periodontitis is an oral inflamatuar disease caused by specific microorganisms, is characterized by attachment loss, alveolar bone resorption, pathological pocket formation. This disease causes deep periodontal pockets associated with deep intrabony defects as well as various clinical problems. For management overcome these problems, various approaches have been proposed in the treatment of periodontitis, including initial periodontal treatment such as scaling and root planing, followed by flap surgery, resective bone surgery and periodontal regeneration when applicable. However, periodontal flap surgery applied in these approaches causes undesirable side effects such as pain and swelling. To overcome these disorders, studies continue to investigate by using various medication regimens include pre, intra or post operative drugs.

Dexamethasone is a synthetic steroidal anti-inflammatory drug used to control pain, swelling, and inflammation occurring in third molar surgeries, periodontal therapy and periodontal surgeries, implant surgery, and endodontic treatment. In the literature, dexamethasone application is frequently used in oral surgery before or after third molar tooth extraction. There is limited research on dexamethasone applications in periodontal flap surgery. lt has been evaluated the effectiveness of oral use of etoricoxib and dexamethasone in preventing pain after open flap debridement surgery. Some authors used 4 mg dexamethasone tablets before mucoperiosteal flap surgery and reported that the pain level in the dexamethasone group was lower than placebo at the 3rd hour. It has been reported positive results where preferred its use intravenously in the postoperative management of periodontal surgery. However, to the investigators knowledge, there is no study in the literature in which dexamethasone is applied submucosally after periodontal flap surgery. Accordingly, the hypothesis of this study was that submucosal application of dexamethasone in periodontal flap surgery would have a positive effect on pain and patient comfort. In light of all these scientific data, this study aimed to evaluate the effect of submucosal dexamethasone application periodontal flap surgery on postoperative pain, swelling, chewing efficiency, trismus, healing and discomfort.

Eligibility Criteria:
Inclusion Criteria:

1. pocket depth ≥5mm;
2. systemically healthy;
3. without drug allergy;
4. without any blood disease;
5. not using medication (anti-platelet, anticoagulant, immunosuppressant medication);
6. received no any periodontal surgery in the last 6 months;

Exclusion Criteria:

1. poor oral hygiene;
2. smoking;
3. any systemic disease that would affect the surgical operation;
4. problem with the kidneys or adrenal glands;
5. connective tissue disease or immunodeficiency;
6. breastfeeding period or pregnancy.
7. high dental anxiety
The Effects of Red Wine and White Wine on Blood Estrogen and Progesterone Levels

Healthy pre-menopausal women will be recruited in order to test the effects of red wine and white wine on blood estrogen and progesterone levels. The women will be randomized and rotated through two different treatments (red wine, white wine). Estrone and estradiol are hormones in the category of estrogens. It is known that the bodies of both men and women may convert (or aromatize) a certain amount of naturally occurring testosterone into estrogen. Aromatase inhibitors have been used to prevent this conversion, or aromatization, of testosterone into estrogen, in the treatment of estrogen-dependent breast cancer in women. This inhibition leads to a marked decrease in estrogen (estradiol and estrone) levels. Naturally occurring aromatase inhibitors include grapes, grape juice, and red, but not white wine. The aromatase inhibitory effects are attributed to wine phytochemicals and not to alcohol. Based upon this information, the investigators will monitor the estrogen levels at various phases in the menstrual cycles of women since hormone levels naturally vary throughout the menstrual cycle. Several epidemiologic studies have found that there is a correlation with moderate to high levels of alcohol consumption and breast cancer. Therefore, study participants will be asked to drink only a eight ounces of wine which should have minimal or no risk for the development of breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. female
2. pre-menopausal with regular ovulatory cycles for 12 months prior to the study
3. willingness and ability to participate in study requiring alcohol consumption
4. in general good health
5. BMI of 18.5-35
6. on regular, unrestricted diet
7. not currently, or within the past 3 months, using oral contraceptives or other hormone replacement therapy

Exclusion Criteria:

1. male
2. irregular menstrual cycles or vasomotor symptoms within the last 12 months
3. pregnant (or breast feeding)
4. any hormone therapy including phytoestrogens, oral contraceptives, SERMs (selective estrogen receptor modulators), or androgens (or precursors) for three months prior to the study
5. history of alcohol abuse
6. history of any estrogen-dependent neoplasia
7. high intake of dietary soy products
8. Minors \< age 21 years
Enteroprotein Modified Fast ( EMF )

The purposes of the esperience is:

1. to verify the safety of protein sparing modified fast(PSMF) by enteral route ( EMF )performed in cycles of ten days/months for six months
2. to compare EMF with oral PSMF clinically ( appetite control, fat freemass mantainance, polmonary function tests and metabolic pattern)
3. to verify the weight mantainance after 6 months from the treatment suspension

Rationale A) primary endpoint

1. to verify the safety of protein sparing modified fast by enteral route ( EMF )in cycles of ten days/months repeated for six months,
2. To compare EMF with oral PSMF clinically ( appetite control, polmonary function tests and metabolic pattern) and on metabolic parameters (hypertension, glucose intolerance, dyslipidaemia) maintaining body composition (particularly fat free mass and muscular strength) in 15 patients with disease-causing obesity not responding to medical treatment and/or cognitive/behavioural therapy, who are candidates for invasive treatment such as the gastric balloon or surgery but do not intend to undergo them compared with 15 undergoing the same regimen without the naso-gastric tube. To verify the effects of treatment with regard to the enteral-hormonal structure during the acute phase (selected sub-group) and while undergoing treatment.

B) Secondary endpoints:

1. To verify the percentage of patients who maintain the weight reached 6 months after stopping treatment with the naso-gastric tube associated with a high-calorie normal-protein diet.
2. Verify clinical safety of EN in these patients.

Eligibility Criteria:
Inclusion Criteria:

* both genders, outpatients
* aged between 16 and 75
* with BMI 30 - 45 Kg/m2
* that are not in a restricted diet since at least 3 months
* with obesity related comorbidities (- type 2 diabetes
* mild or moderate OSAS
* orthopedic diseases (coxarthrosis, gonarthrosis)
* hypertension
* non alcoholic hepatic steatosis
* accepting to be enrolled in the study (signing informed consent)

Exclusion Criteria:

* Presence of gastrointestinal diseases
* Presence of cancer
* Patients treated with gastrolesive or anticoagulant drugs
* Hepatic failure, renal failure or multi-organ failure (cut off)
* Contraindications for enteral nutrition,Mechanical bowel complete, or partial chronic obstruction
* Severe mesenteric ischemia not caused by hypovolemia
* Digiunal or ileal fistula with high output (400 mL/die)
* Severe modifications of the intestinal function caused by enteropathies or insufficient absorbent surface, to the point that a normal nutritional state cannot be maintained
* Type 1 diabetes
* Type 2 diabetes treated with oral or injected drugs that may cause hypoglycemia
* ANBN: anorexia or bulimia nervosa, evaluation of other symptoms by specific tests
* Patients with major psychiatric disorders or not cooperative, or with alcohol or drug addiction disorders.
Eon® Flanks Safety Clinical Study Protocol

This study is designed to provide objective evidence regarding the safety of eon® treatment of the flanks.

This study is designed to provide objective evidence regarding the safety of eon® treatment of the flanks.

Eligibility Criteria:
Inclusion Criteria:

* Subject is a healthy male or female \> 18 years or older seeking treatment for unwanted fat in the flanks.

  * Subject must be able to read, understand and sign the Informed Consent Form (ICF) in English.
  * Subject has sufficient thickness (≥ 20 mm) of adipose tissue on the flanks area.
  * Subject must be willing and able to adhere to the treatment and follow-up visit schedule.
  * Subject is willing to have photographs and ultrasound measurements taken of the treated area.
  * Female subjects must be using medically acceptable form of birth control during the entire course of the study or may be post-menopausal, or surgically sterilized.

Exclusion Criteria:

* • Subject had an aesthetic fat reduction procedure in the treatment area within the previous year

  * Subject was pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in last 6 months
  * Subject has an infection, dermatitis or a rash in the treatment area.
  * Subject has tattoos or jewelry in the treatment area or within the treatment area site or photography frame.
  * Subject has a history of keloid scarring, hypertrophic scarring or of abnormal wound healing.
  * Subject has a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
  * Subject has a history of a known bleeding disorder.
  * Subject has a known photosensitivity to the study laser wavelength, history of ingesting medications known to induce photosensitivity, or history of seizure disorders due to light.
  * Subject has known collagen, vascular disease or scleroderma.
  * Subject has undergone a surgery or procedure in the treatment area within 6 months of treatment, which is still healing.
  * Subject suffers from significant concurrent illness, such as insulin-dependent diabetes, peripheral vascular disease or peripheral neuropathy.
  * Subject is undergoing systemic chemotherapy for the treatment of cancer.
  * Subject is using gold therapy for disorders such as rheumatologic disease or lupus.
  * Subject has participated in a study of another device or drug within three months prior to enrollment or during the study.
  * As per the investigator's discretion, the subject has any physical or mental condition which might make it unsafe for the subject to participate in this study.
  * Subject has ongoing use of steroids or secondary rheumatoid drugs.
  * Subject is actively taking psychotropic medications.
Evaluation of Probiotic (L.Reuteri) Survival in Presence of Prebiotic Galacto-oligosaccharides

This research study will compare the effect of test product #1 (containing a probiotic with the Galacto-OligoSaccharides fiber. GOS) and test product #2 (containing a probiotic without the GOS fiber) to understand how they can contribute to healthy digestion in toddlers between the age of 24 - 36 months. The hypothesis is that L. reuteri from TEST#1 will demonstrate an improved survival in the GIT of toddlers compared to that of TEST#2.

This study is a single-centre, randomized, double-blind, comparator-controlled, parallel group study. The study will be conducted at the Clinical Innovation Lab (CIL) at Nestlé Research.


Eligibility Criteria:
Inclusion Criteria:

1. Child is between 24 months to 36 months of age.
2. Singleton, full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
3. Healthy status based on medical history and physical examination
4. Weight- for-age and height-for-age within normal range on local childhood growth chart.
5. Written informed consent are obtained from both parents/legally authorized representative (LAR).
6. Parents/legally authorized representative must be able to provide evidence of the parental authority and identity.
7. Parents /legally authorized representative are of legal age of consent and must understand the informed consent and other study documents.
8. Parents/legally authorized representative are willing and able to fulfill the requirements of the study protocol.

Exclusion Criteria:

1. Known or suspected cows' milk protein intolerance / allergy, or lactose intolerance, or significant food allergies that impact a normal diet.
2. Prior to study participation, child has shown limited or no interest in drinking toddler milk.
3. Chronic infectious, gastrointestinal, metabolic, or genetic disease, including any disease/condition that impacts feeding or growth.
4. Use of systemic antibiotics or anti-mycotic medication in the 4 weeks preceding enrollment.
5. Child is currently consuming or has consumed any formulas or taking any supplement containing L. reuteri in the past 3 months.
6. Child is currently consuming or has consumed any formulas or taking any supplement containing GOS within the past 48 hrs prior to product in take, and who are not willing accept a temporary cessation of the consumption during the study period.
7. Child is currently participating in another investigational clinical trial.
8. Family or hierarchical relationships with the CIL team.
Here, My Voice 2 Voice Lessons Pilot

Active music engagement has been shown to provide unique benefits for both pediatric and adult cochlear implant (CI) users. Here, My Voice 2 (HMV 2) project will build upon the 2021 pilot program and provide personalized voice lessons to members of the hard-of-hearing (HOH) community in order to support the (re)discovery of their voice as a tool of self-expression. Over the course of 12 weeks, participants from the HOH community will partner with students from USC's Thornton School of Music to practice expressive vocal techniques in one-on-one individual lessons. At the conclusion of the lessons, HLAA will host a communal session with a recital in which each team will present what they have worked on. Data will be collected via self-assessment surveys, vocal assessment measures, and interviews at the beginning, middle, and end of the program, as well as a 3 month follow-up. This data will be quantified/coded using qualitative coding, as appropriate, and the findings will be published in relevant conferences and journals. The data will also be used to evaluate the merits of this program to improve the format in future iterations.


Eligibility Criteria:
Inclusion Criteria:

* Adults, English speaking, who experience profound hearing loss and use cochlear implants or/and hearing aids.
* Ability to use voice without discomfort and without causing any health issues.
* Ability to commit one hour a week over a 12-week period and an additional 10 min period of daily training.

Exclusion Criteria:

* People with medical conditions such as tracheostomy, which makes using voice difficult and potentially threatens their health
* People taking part in other training programs for vocal, musical or auditory skills in the same time period