cyrilzakka/clinical-trials huggingface dataset:
Milk Versus a Pea-based Beverage for Bone and Muscle Health in Young Athletes

Canada's Food Guide places an increased emphasis on plant-based proteins; however, Canadians who consume a plant-based diet may be compromised because of intake of lower-quality protein. Consumption of high-quality protein is important during growth and development, especially in highly active individuals. The study will compare milk (i.e. high quality protein) to a pea-based beverage (i.e. lower quality plant-based protein) in adolescent boys and girls who are engaged in resistance-training programs as part of their athletic training. One-hundred and fourteen adolescent boys and girls (12-17y of age) will be divided into groups that consume milk, a pea-beverage, or a carbohydrate (sugar) beverage after resistance training sessions performed three times per week for six months. It is predicted that the group consuming milk will have greater increases in muscle mass, strength, and bone density, and greater reductions in fat mass compared to the groups consuming a pea-based or carbohydrate beverages.

Milk protein is important especially for very active people and in the context of plant-based diets, which are lower in protein quality. The purpose of the study is to compare the effectiveness of milk supplementation to pea-beverage supplementation during resistance training programs for increasing lean tissue mass in adolescent boys and girls. Secondary and tertiary outcomes include fat mass, bone mineral density, and muscular strength. It is hypothesized that milk supplementation during resistance training will be more effective than plant-based proteins (i.e. pea-beverage) for increasing muscle mass, reducing fat mass, and improving bone mineral outcomes in adolescent boys and girls. One-hundred and fourteen boys and girls (aged 12-17y) who are currently enrolled in resistance training programs (3 times per week for 6 months) as part of their competitive athletic programs will be stratified by sex and maturity status before being randomized to three groups: 1) 1% chocolate milk supplementation; 2) pea-based beverage; 3) carbohydrate beverage (placebo control). Beverages will be consumed during recovery from each resistance training session (i.e. 250 ml immediately after training and 250 ml one hour later to optimize post-exercise protein synthesis) over the six-month intervention. It is anticipated that milk supplementation will be more effective than plant-based protein supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Currently participating in a resistance-training program 3 times per week
* Female participants must have reached menarche

Exclusion Criteria:

* Have taken any nutritional supplement (e.g., protein, creatine, amino acids) within the past month
* Currently taking anabolic steroids or oral corticosteroids
* Allergies to dairy, almonds, cashews, or peas
The Effect Of Using Sticky Bone With Coronally Advanced Flap In Management Of Type 1 Gingival Recession

the main goal of this clinical trial is to evaluate the effect of sticky bone with coronally advanced flap in management of gingival recession in comparison to coronally advanced flap alone


Eligibility Criteria:
Inclusion Criteria:

1. Selected patients of both sexes with age range 25-45 years old.
2. Patients are systemically healthy based on questionnaire dental modification of Cornell index.
3. O'Leary index (1972) is less than 10% (the surgical therapy is not initiated until the patient reaches the 10% level or less of plaque accumulation).
4. Buccal recession defects are classified RT1 according to Cairo's classification (2011).
5. Clinical indication and/or patient request for recession coverage.

Exclusion Criteria:

1. Pregnant female.
2. Smokers.
3. Patients with special needs or with any mental problems.
4. All patients are using any kind of medications that could interfere with healing of periodontal tissues. Such as chemotherapy and radiotherapy.
5. Teeth with carious lesions.
6. Rotated and extruded teeth.
7. Patient undergone any prior periodontal surgery in the relevant region within year.
A Study of YM155 Plus Rituximab in Subjects With Non-Hodgkin's Lymphoma Who Have Received Prior Treatment

The purpose of this study is to evaluate response rate, survival, safety and tolerability of YM155 given in combination with rituximab in subjects with Non-Hodgkin's Lymphoma.

This is an outpatient study. All subjects enrolled in this study will receive YM155 and rituximab given during 14 day cycles. Each subject will be assessed at the end of each cycle to determine if he or she may continue to the next cycle. Each subject will be eligible to continue receiving the combination regimen in this study until one of the discontinuation criteria is met.

If a subject discontinues treatment without progressive disease (PD) that subject will complete follow-up visits every 12 weeks for 1 year or until initiating another systemic anti-lymphoma treatment, exhibiting PD, or death.

Each subject will be contacted by the study site every 12 weeks for survival following the End of Treatment Visit. The contacts will continue until death or for no more than 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Any stage, histologically confirmed CD20-positive primary or transformed diffuse large B cell lymphoma (DLBCL)or grade 3 follicular lymphoma (FL)
* Ineligible for or have previously received an autologous stem cell transplant (ASCT)
* Relapsed following receipt of the last dose of systemic chemotherapy or ASCT
* At least one prior chemotherapy regimen. Prior chemotherapy regimen must have contained anthracycline (unless contraindicated)
* If the subject is female, she must be non-pregnant and non-lactating at the Baseline Visit. All sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the study period
* Eastern Cooperative Oncology Group (ECOG) performance status \</= 1

Exclusion Criteria:

* Use of any standard/experimental anti-lymphoma drug therapy within 21 days of the Baseline Visit
* Use of systemic steroids within 5 days of the Baseline Visit (except for the purposes of pre-medication prior to study regimen treatment)
* Prior allogeneic stem cell transplant (SCT)
* The subject has been previously treated with YM155
* The subject has known human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibody
* The subject has received other investigational therapy or procedures within 21 days prior to the first study drug administration
Intraocular Pressure Immediately Following Intravitreous Injection of Ranibizumab

This study will quantify the intraocular pressure elevation in the immediate time period following intravitreous injection. With more widespread use of intravitreous injections in patients that may require several injections per year, it is important to document the sudden increase in intraocular pressure, including the maximum intraocular pressure and the time required for the intraocular pressure to return to baseline. This data may be useful in stimulating additional studies to evaluate the long term ocular effects of repeated intravitreous injections.

We hypothesize that the intraocular pressure increases significantly following intravitreous injection and then returns to baseline during the initial thirty minutes following ranibizumab injection.

We will assess the trend of intraocular pressure immediately following intravitreal injection of ranibizumab 0.5 mg (0.05 mL) by taking serial intraocular pressure readings every five minutes for thirty minutes after injection. This study is a prospective descriptive data collection consisting of measuring intraocular pressure immediately following intraocular injection, and at 5, 10, 15, 20, 25, and 30 minutes following injection of ranibizumab 0.5 mg.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female Patients \>18 years of age
2. Patients will have documented choroidal neovascular membranes on fluorescein angiogram and/or optical coherence tomography
3. Requiring treatment or maintenance therapy for choroidal neovascular membrane
4. Able and willing to provide written informed consent

Exclusion Criteria:

1. History of arterial occlusive disease of the eye.
2. History of advanced glaucoma.
Augmentation of Treatment-Resistant Depression With An Analog of the Neuroactive Steroid Allopregnanolone

Major depressive disorder (MDD) is highly prevalent and nearly 70% of individuals with MDD do not respond to standard antidepressant therapies despite adequate dosing. An effective and well-tolerated antidepressant augmentation therapy would have important clinical and public health implications. Neuroactive steroid hormones are known to directly activate neurotransmitter receptors in the brain, and thus are potential candidates for augmentation therapies to enhance the effect of traditional antidepressants. The investigators hypothesize that administration of an allopregnanolone analog in women with treatment-resistant depression will improve depressive symptoms.

Major depressive disorder (MDD) is highly prevalent and can have profoundly negative consequences on one's health, well-being and productivity. Women are twice as likely as men to experience depression during their lifetimes. In fact, it is reported that twelve million women in the U.S. each year will experience depression, and that one in eight women will experience a clinical depressive episode during their lifetimes. Additionally, nearly 70% of individuals with MDD do not respond to standard antidepressant therapies despite adequate dosing. Therefore, the identification of an effective and well tolerated antidepressant augmentation therapy would have important clinical and public health implications. Neuroactive steroid hormones are known to directly activate neurotransmitter receptors in the brain, and thus are potential candidates for augmentation therapies to enhance the effect of traditional antidepressants. Specifically, allopregnanolone, a steroid hormone derived from progesterone, is a potent positive modulator of GABA action at GABA-A receptors, which are known to have positive effects on mood symptoms. Data suggest that depression, chronic stress and posttraumatic stress disorder may be associated with low central nervous system allopregnanolone levels. The investigators propose to administer an oral allopregnanolone analog to 10 postmenopausal women with treatment-resistant depression as an add-on therapy to their current treatment for a period of 8 weeks followed by a 2-week taper. The investigators hypothesize that administration of the oral allopregnanolone analog in women with treatment-resistant depression will improve depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. Female, age 50-75
2. Postmenopausal
3. Major Depressive Disorder
4. Currently treated with SSRI or SNRI at adequate dose

Exclusion Criteria:

1. Serious suicide or homicide risk
2. Unstable medical illness
3. Substance use disorder
4. Psychosis
5. Use of hormones (estrogens, androgens or related hormones)
6. History of hormone responsive cancer
7. Receiving strong CYP3A4 inducers or inhibitors or who intend to consume grapefruit products regularly during the study
8. Alanine aminotransferase (ALT) or creatinine \> 3x upper limit of normal
A Novel VIRTUAL Reality Intervention for CAREgivers of People With Dementia (VirtualCare)

This clinical trial aims to explore if a virtual reality experience increases the beneficial effect of psychoeducational programs in informal caregivers of people with mild-to-moderate Alzheimer's disease. This study will test changes in psychological distress and neural activity in brain systems that regulate stress and empathic care.

Participants will be randomized into two arms: the control group will participate in an online psychoeducational intervention, while the experimental group will participate in the psychoeducational intervention combined with virtual reality.


Eligibility Criteria:
Inclusion Criteria:

* Being an unpaid informal caregiver (CG; i.e., family members or friends) living with or caring for a person with Alzheimer's Disease (AD) for at least 4 hours a day for at least six months before enrolment;
* Caring for a person with a diagnosis of AD at prodromal or mild stage (i.e., Mini-Mental State Examination score:18-24) and still living at home.

Exclusion Criteria:

* Receiving daily assistance for more than 10 hours from formal CGs;
* Being formal CGs (i.e., nurse or another paid figure);
* Being informal CGs of i) persons with moderate-to-severe AD, or ii) persons with non-AD diseases;
* Not having or being able to use a device connected to internet (e.g., smartphones or PC).
* Having received psychotherapeutic o psychological support, or having already participated to psychoeducational programs.
* Only a family member for person with dementia is accepted.

Exclusion Criteria for experimental group (Psychoeducation + VR):

* Medical history of epilepsy.

Exclusion Criteria for subsample of caregivers assess with MRI:

* Metal implants, artificial prostheses, pace-makers, prosthetic heart valves;
* Claustrophobia;
* Pregnancy.
Effects of Cigar Flavors on Measures of Abuse Liability Among Young Adults

This study involves 25 current young adult combustible tobacco cigarette (CTC) smokers who will complete 5 Latin square ordered, within-subject, laboratory conditions that differ by the tobacco product smoked:

1. own-brand CTC (positive control),
2. original-flavored Black \& Mild (B\&M) cigar,
3. apple-flavored B\&M cigar,
4. cream-flavored B\&M cigar, and
5. wine-flavored B\&M cigar.


Eligibility Criteria:
Inclusion Criteria:

* To be included, participants must be healthy, as determined by self-report and heart rate/blood pressure (HR/BP) check, between the ages of 18-25, and willing to provide informed consent.
* They must agree to attend the lab and abstain from tobacco/nicotine as required, to use the designated products, and to follow the study protocol.
* Participants must also be regular CTC smokers (≥5 cigarettes/day for past 3 months) naïve to cigar products (smoked no more than 10 cigar products of any type in lifetime) who can provide a semi-quantitative urine cotinine result of ≥3 at screening (NicAlert test).

Exclusion Criteria:

* Individuals with a self-reported history of chronic diseases or psychiatric conditions will be excluded.
* Other exclusion criteria are: history of or active cardiovascular disease, current oral health problems or injuries, low/high BP, seizures, regular prescription medication use (other than vitamins or birth control), and past month use of cocaine, opioids, benzodiazepines, and methamphetamine (self-report).
* Individuals who report using marijuana or alcohol \>20 days in the past 30 or interest in quitting CTC use within the next 30 days will also be excluded.
* Women will be excluded if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
Postprandial Hypotension and Insulin Levels

The goal of this observational study is to learn about the relationship between postprandial hypotension and insulin levels in adults. The main question it aims to answer is:

Is the incidence of postprandial hypotension high in patients who undergo mixed meal test?

Is insulin level higher in individuals with postprandial hypotension compared to those without during a mixed meal test?

Patients with postprandial symptoms were scheduled for a mixed meal test, during which plasma glucose, insulin, C-peptide, blood pressure, and heart rate were measured at specific time points.


Eligibility Criteria:
Inclusion Criteria:

* Adults with postprandial symptoms

Exclusion Criteria:

* Individuals with prediabetes or diabetes,
* Those aged 65 and above,
* Patients using antihypertensive medications or with known hypertension,
* Those with active infections,
* Congestive heart failure,
* Peripheral artery disease,
* Advanced-stage dementia,
* Individuals who could not provide a history or were unable to cooperate,
* Patients using medications that could induce hypoglycemia (oral antidiabetics, insulin, beta-blockers, hydroxychloroquine, bromocriptine, etc.)
* Those with conditions that could cause hypoglycemia (uncontrolled hypothyroidism, adrenal insufficiency, growth hormone deficiency, etc.)
Clinical Characteristics of Metabolic Associated Fatty Liver Disease

Metabolic associated fatty liver disease (MAFLD), which can lead to liver fibrosis, cirrhosis, liver failure and even hepatocellular carcinoma, poses a significant burden on society. With the improvement of living standards and changes in dietary habits, MAFLD patients show a younger and increasing trend, but there is still no specific drug. The clinical features and prognosis of MAFLD may be different with different metabolic disorder phenotypes and treatment measures. Therefore, further systematic study of the clinical characteristics and prognosis of MAFLD patients will be of great significance for the formulation of corresponding clinical prevention and treatment strategies.

Metabolic associated fatty liver disease (MAFLD), which can lead to liver fibrosis, cirrhosis, liver failure and even hepatocellular carcinoma, poses a significant burden on society. With the improvement of living standards and changes in dietary habits, MAFLD patients show a younger and increasing trend, but there is still no specific drug. The clinical features and prognosis of MAFLD may be different with different metabolic disorder phenotypes and treatment measures. Therefore, further systematic study of the clinical characteristics and prognosis of MAFLD patients will be of great significance for the formulation of corresponding clinical prevention and treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older;
2. MAFLD patients

Exclusion Criteria:

1. malignant tumors;
2. mental illness, severe impairment of cardiopulmonary function, severe renal insufficiency, severe infections, and cerebrovascular accidents;
3. received liver or other organ transplants.
Trial Aiming at Assessing the Effect of Humidification on the Comfort of the Patient Receiving an Oxygen Therapy

In France, the most used humidifying system during oxygen therapy is a non heated device with weak efficiency and non-proven clinical benefits. This study aims to assess the lack of benefits of non-heated humidification compared to no humidification, as regards to the comfort of the patient receiving oxygen therapy.


Eligibility Criteria:
Inclusion Criteria:

* Admission in Intensive Care Unit
* Oxygen therapy started for less than two hours in ICU

Exclusion Criteria:

* Age under 18
* Pregnancy
* Participation in other trials with the same endpoints
* absence of registration in french health care system
* patient protected by law
* tracheotomised or intubated patient
* Patient with non invasive ventilation
* Oxygen therapy started for more than two hours in ICU
* moribund
Cryolipolysis Induced Gluteal Fat Change

There was no difference in efficacy in removal of local fat on thigh by cryolipolysis through Zeltiq machine.

Cryolipolysis was found to be safe for 12 week clinical trial.

this study is conducted to investigate the clinical efficacy and safety of cryolipolysis on fat removal of thigh through cryolipolysis.

Healthy premenopausal volunteered women had been conducted to assess their anthropometrical, social, and cardio-metabolic, and femoral fat amount by computer tomography, and adverse events at initial, 4 week, 12 week visit.

Eligibility Criteria:
Inclusion Criteria:

* pre-menopausal healthy women
* subjects with body mass index ≥ 18
* subjects with visible fat on both thigh
* subjects to understand and agree to this study protocol

Exclusion Criteria:

* subjects with cryoglobulinemia, cold urticaria, or paroxysmal cold hemogobulinemia
* subjects with pregnancy or lactation within 6 months or next 3 months
* subjects with any laboratory, or metabolic abnormalities
* uncooperative subjects to comply with the study protocol
* women taking any medication/ over the counter/herbal supplements to regulate weight or fat mass over 6 months
* subjects with menstrual irregularities
* subjects to change over 10% of the former weight within the past 6 months - any procedure such as liposuction, or another surgical procedure or mesotherapy to reduce fat within 6 months
* subjects with any dermatologic abnormalities on the target areas (thigh)
* subjects with any injection into the area of intended treatment (e.g. cortisone) within 6 months
Respiratory Events Among Premature Infants

Assess the burden of disease associated with RSV infection with premature children in an outpatient setting.

The primary objective of this prospective study is to assess the burden of disease associated with RSV infection, as measured/determined by rates of outpatient medically attended LRI, emergency room visits and hospitalization among preterm infants (32-≤36 wGA) during RSV season, and its medical/health consequences, as measured by wheezing events, the infant's first RSV season, up to May 2009.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from parent/guardian to participate in study
* Male or female preterm infants 32-≤36 wGA
* Infant is ≤ 6month old at the time of enrollment
* Parent/guardian has the ability and willingness to follow study protocol (during the first RSV season) as required by the protocol

Exclusion Criteria:

* Receipt of any RSV prophylactic agent: palivizumab, IGIV, or motavizumab at any time prior to enrollment
* Participation in trials of investigational RSV prophylaxis or RSV therapeutic agents
* Presence of BPD or CHD (other than surgically treated PDA, ASD or VSD)
* Condition that limits life span to 6 months or less from the date of enrollment
Visual and Functional Assessment in Low Vision Patients

Vision testing is a fundamental part of every optometry and ophthalmology assessment. Traditional vision testing charts are not able to measure vision below a certain level. Vision in this range is classified as counting fingers (CF), hand movements (HM) and light perception (LP). These measures are not very accurate or easily quantifiable. They are also poorly understood in terms of impact on quality of life. This study aims to assess new methods for measuring the vision of patients with very low vision.

Assessing very low vision accurately is becoming increasingly important with the increase in research in this area, such as using retinal implants to restore vision. Without being able to accurately measure the change in vision before and after treatment, it is not possible to fully assess the effect of treatment.

The Freiburg Vision Test (FrACT) is a computer based test developed to assess patients down to the LP level. It has been used in research in recent years. The FrACT is suitable for research but is not suitable for a clinical setting. The Berkeley Rudimentary Vision Test (BRVT) works on a similar principal as the FrACT but consists of hand held cards shown to the patient. Little work has been completed on how well the BRVT test works. Results from FrACT and BRVT will be compared in a group of patients with very low vision. This is important to establish how easily research results can be applied to a clinical setting.

Patients will also be asked to complete a daily living survey to better understand the impact of such poor vision on the ability to carry out day to day tasks. This understanding will help guide low vision services for patients as well as help direct low vision research to achieve a useful level of functional vision.

Eligibility Criteria:
Inclusion Criteria:

* Snellen VA or equivalent ≤ 6/60 in both eyes
* Patient has capacity to give consent and to undertake vision tests

Exclusion Criteria:

* Diagnosis of functional vision loss
* Unwilling and/or unable to sign informed consent and complete the vision tests