cyrilzakka/clinical-trials huggingface dataset:
High Protein Diet and Atherosclerosis

Atherosclerosis is the underlying cause of the majority of cardiovascular diseases, including myocardial infarction and strokes, and results in tremendous morbidity and mortality. A Western-type diet is a major risk factor for atherosclerosis because of the high saturated fat, cholesterol, and refined carbohydrate contents. Dietary strategies to reduce cardiovascular disease burden therefore focus on restriction of saturated fat, cholesterol, and refined carbohydrates whereas "lean" protein intake is recommended and has become popular. However, results from studies conducted in animal models suggest high dietary protein intake is also atherogenic. The investigators' extensive preliminary data in animal models show that dietary protein increases atherosclerotic plaque formation and size and promotes necrotic core formation, a characteristic of rupture-prone plaques. The goal of the current proposal is to provide deeper insights into the relationship between protein intake and the pathogenesis of atherosclerosis by studying the mechanisms involved in protein-mediated atherogenesis and formation of necrotic plaques. The overarching hypothesis is that high protein intake drives atherosclerosis via leucine-mediated mTORC1 signaling in macrophages, which inhibits macrophage mitophagy and aggrephagy and stimulates macrophage proliferation. Furthermore, the investigators hypothesize that proteins from animal sources are more atherogenic than proteins from plant sources, because animal proteins contain more leucine than plant proteins. The investigators will test these hypotheses by using a sophisticated array of experimental strategies, including assays in primary macrophages and human monocyte-derived macrophages and genetically engineered mouse models. In addition, they will begin to translate the results obtained in vitro and in animals to people, and explore approaches to pharmacologically target the pro-atherogenic pathways as novel cardiovascular therapeutics. This proposal represents a paradigm shift in how a Western-type diet affects vascular health which has important implications since many adults in Western societies consume excess protein and dietary protein is heavily marketed for its presumed beneficial health effects.


Eligibility Criteria:
Inclusion Criteria:

* \>=45 and \<=75 years of age
* body mass index \>=25.0 and \<40.0 kg/m2

Exclusion Criteria:

* \<45 and \>75 years of age
* body mass index \<25.0 or \>39.9 kg/m2
* plasma triglyceride \<125 mg/dl
* history of or current significant organ system dysfunction
* allergies or intolerances to meal ingredients
* use of medications or dietary supplements that could confound the study outcomes
* engaged in regular structured exercise \>150 min per week
* alcohol use disorder
* premenopausal women
* persons who smoke
* prisoners
* inability to grant voluntary informed consent
A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight

This study will look at how much weight participants will lose and how much blood sugar control they achieve from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide. In addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. Participants are more likely (4 out of 5) to get semaglutide than the "dummy" medicine. The study medicine will be injected briefly, under skin, with a thin needle, typically in the stomach, thighs, or upper arms. After receiving first dose, the dose of semaglutide will be gradually increased until reaching the target dose. The study will last for about 1.5 years.


Eligibility Criteria:
Inclusion Criteria:

* Male or female.
* Age above or equal to 18 years at the time of signing informed consent.
* BMI greater than or equal to 30.0 kilograms per square meter (kg/m\^2).
* Diagnosed with type 2 diabetes (T2D) greater than or equal to 180 days prior to the day of screening.
* History of at least one self-reported unsuccessful dietary effort to lose body weight.
* HbA1c 7.0-10.0 percent (53-86 millimoles per mole \[mmol/mol\]) (both inclusive) as measured by central laboratory at screening.

Exclusion Criteria:

* A self-reported change in body weight greater than 5 kilograms (kg) (11 pounds \[lbs\]) within 90 days before screening irrespective of medical records.
* Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
* Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square meter (30 mL/min/1.73 m\^2) (less than 45 mL/min/1.73 m\^2 in participants treated with Sodium-glucose Cotransporter-2 \[SGLT2i\]) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at screening.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception

To evaluate the contraceptive efficacy of an oral contraceptive containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen and to evaluate the safety compared to LNG 100 mg/EE 20 mg for 21 days followed by a 7-day hormone-free interval in a cyclic regimen.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women aged 18 to 49 years who are willing to rely upon a combination birth control pill as their only method of contraception.
* Women must be sexually active and at risk for becoming pregnant.
* Women must have had regular (21- to 35- day) menstrual cycles for the 3-month period preceding study visit 1.

Exclusion Criteria:

* High blood pressure
* Age greater then 34 and smoking more than 15 cigarettes per day.
* Depression requiring hospitalization or associated with suicidal ideation within the last 3 years.
Effectiveness of Dementia Nutrition Education

Nutritional problems can and do manifest themselves at various stages and with varying degrees of severity. Patients with dementia are at significant risk for weight loss and malnutrition due to the numerous issues that arise during the disease process. Caregivers of patients with dementia face significant challenges in providing nutritional care for their patients due to difficulties with nutrition for physical, emotional, cognitive, and behavioral reasons.

The following methods were used: This study employed a randomized controlled trial with a pretest-posttest design. The study was conducted with 89 patients and caregivers (45 in the intervention group and 44 in the control group). We collected data from the intervention and control groups before and after the intervention using the Descriptive Information Form, Edinburgh Nutrition Evaluation in Dementia (EdFED) Scale, Mini Nutritional Assessment, Dysphagia Assessment Scale in Multiple Sclerosis, and Sarcopenia Screening Test (SARC-F). The intervention group received a standardized educational program for three months. We evaluated the data using percentages, arithmetic means, standard deviations, medians, and interquartile ranges. We analyzed the data using chi-square tests, Mann-Whitney U tests, Wilcoxon signed-rank tests, and intention-to-treat analyses.


Eligibility Criteria:
Inclusion criteria for caregivers

* being a primary caregiver,
* aged\> 18,
* volunteering to participate in the study.

Exclusion criteria for caregivers -wanting to quit working, not attending training

Inclusion criteria for patients

* According to DSM-V criteria, they must have a nutritional disorder, metabolic disorder, or dementia that is not due to systematic diseases
* be fed orally
* have the caregiver/guardian of the patient with dementia voluntarily agree to participate in the research with him/herself and the patient

Exclusion criteria for patients

-Having a health condition that affects nutrition
Efficacy of Terlipressin Therapy in Acute Variceal Haemorrhage After EVL

Upper gastrointestinal (UGI) bleed of variceal origin is a common medical emergency. Prompt endoscopic variceal ligation (EVL) is therapeutic as well as diagnostic. Terlipressin, a vasopressin analog (intravenous, 2 mg q 4 hourly), is widely used promptly in any suspicious case of variceal haemorrhage (VH) before endoscopic procedure, along with volume and blood resuscitative measures. As per guideline, after EVL Terlipressin therapy (1 mg IV q 4 hourly) is continued for 2-5 day to prevent re-bleed. But the prolong use of Terlipressin is not completely safe as well as it is expensive also in resource constraint setting. At present there is no clinical trial available to prove the efficacy of post-EVL Terlipressin therapy in preventing re-bleed and mortality in cases of acute variceal haemorrhage. During the post marketing surveillance Terlipressin therapy has been found to be associated with life threatening complication like cardiac arrhythmia, myocardial ischemia, critical vasoconstriction of peripheral as well as internal organ leading to ischemia or gangrene, severe hyponatremia, hypertension, fluid overload and pulmonary oedema. So the justification of continuing Terlipressin therapy for 5 days after EVL is questionable, as haemostasis is primarily achieved by EVL and the risk versus benefit of Terlipressin therapy after EVL is still unknown. Continue IV Terlipressin therapy also prolongs in-hospital care causing further increase of health care burden. There is still lack of data of Terlipressin therapy, regarding its efficacy in preventing post-EVL re-bleed, mortality, adverse drug events and cost effectiveness. The investigator will study to evaluate the utility of Terlipressin therapy after EVL, in acute variceal haemorrhage.


Eligibility Criteria:
Inclusion Criteria:

* Irrespective of gender with age ≥ 18 years
* All the patients with endoscopy proven acute variceal haemorrhage (VH)
* Receiving Pre-EVL Terlipressin therapy
* EVL done within 24 hours of presentation
* Ready to give written informed consent

Exclusion Criteria:

* Patients with UGI bleed for more than 24 hours
* Not receiving pre-EVL Terlipressin therapy
* Pregnancy
* Past history of EVL
* Chronic kidney disease
* Patient's with EVL done beyond 24 hours of admission because of hemodynamic instability or encephalopathy
* Patients who are receiving blood thinners like anti-platelets, anti-coagulation agents within 4 weeks of presentation
The Effects of Increased Fructose Ingestion on FGF-21 Levels in Humans

The primary aim of this study is to examine the effect of fructose ingestion on serum FGF-21 levels in humans.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-60
* BMI 19-25 kg/m2; 19-23 for Asian subjects
* Stable weight (variation \< 3 kg within 6 months of screening visit)
* Ability to give informed consent in English
* Use of medically approved form of contraception

Exclusion Criteria:

* Fasting blood glucose \>100
* Hemoglobin A1C% \> 6.5%
* Fasting triglycerides \>150
* Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria
* Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure)
* Uncontrolled hypertension (BP \> 160/100 mmHg on or off antihypertensive medication) intravenous drug use
* Recent weight loss (\> 3 kg within 6 months of the screening visit)
* Gastroparesis
* Inflammatory or irritable bowel disease
* Malignancy treated with chemotherapy within the past 3 years
* Depression or psychosis requiring hospitalization
* Renal insufficiency (creatinine clearance \< 40 ml/min)
* Transaminases \> 2x above the normal range
* Known liver disease
* Pregnancy within 6 months of the screening visit
* Lactation
* Failure to use medically approved contraceptive methods
* History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling)
* Change in dose of thyroid hormone or antithyroidal medication within 3 months of screening visit
* History of alcohol abuse within the past 5 years
* Fructose intolerance

Exclusionary medications:

* Oral steroids
* Metformin
* Weight loss medications including nonprescription supplements
Time to Heal (Wound, Healing, Dialogue, Nutrition)

The objective of this study is to examine the feasibility, acceptability, fidelity, and outcome of a nurse-led nutritional intervention for patients with leg ulcers in a outpatient clinics. The intervention consists of a structured dialogue and patient information on key lifestyle behaviours to improve wound healing. Furthermore, the intervention includes protein supplement.

The study aims to address the following research questions:

Primary Research Questions:

1. Is the patient recruitment process feasible?
2. Is the delivery of the intervention feasible?
3. Is the intervention acceptable to the patients?
4. Is the intervention acceptable to the nurses?
5. Is the intervention consistently maintained during the study period?
6. Are the data collection procedures feasible?
7. Are the outcome measures feasible?
8. What are the reasons for any dropouts?

Secondary Research Questions:

1. What are the patients' and relatives' views on receiving the intervention?
2. Are there any longitudinal differences in outcomes for the patient group?
3. Are there any individual patient-specific differences in outcomes over time?

The feasibility study will recruit patients with a first-time referral to the outpatient clinic at the Department of Orthopaedic Surgery at Copenhagen University Hospital, Hvidovre, for leg ulcers caused by arterial or venous disease or neuropathy due to diabetes. The intervention will be administered by the clinic's nurses.

After inclusion, each patient will be contacted by telephone following their next two clinic visits. The initial follow-up will assess patient characteristics, information about their wound using the Wound-Qol Questionnaire, and their perspective on receiving the intervention. The second and final follow-up will consist of an interview exploring their perspective on receiving the intervention. Additionally, focus group interviews with the nurses will be conducted to investigate their capability, opportunity, and motivation (COM-B model) for implementing the intervention. Both patient and nurse interviews will be recorded and transcribed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with leg ulcers caused by arterial or venous disease or neuropathy caused by diabetes.
* Patient with an amputation wound.
* Speak and understand Danish.

Exclusion Criteria:

* Patients with wounds caused by high-intensity trauma.
* Patients in the end-of-life phase.
* Patients living in nursing homes.
* Patients with cognitive impairment.
Cognitive Consequences of an Activation of the Cortical Drive to Breath (VENTIPSY)

The purpose of the study is to measure the negative cognitive consequences of the ventilation under pathological or experimental cortical drive to breath.

Cognitive capacities are measured on healthy subject submitted to inspiratory threshold loading, patients treated by chronic mechanical ventilation due to suffering Ondine syndrome or amyotrophic lateral sclerosis. The spontaneous breathing is compared to NIV breathing or inspiratory threshold loading.

Eligibility Criteria:
Inclusion Criteria:

* Adults and non-vulnerable adults
* Fluent in French

Exclusion Criteria:

For patients:

* Total ventilatory dependency
* Coexistence of an other respiratory disease
* Alcohol and /or psychotropic consumption during the last 24 hours
* One or more episodes of acute respiratory failure during the past 6 months
* Serious cognitive deficiency or presence of fronto temporal dementia
* End-stage disease
* No affiliation to social security

For healthy volunteers:

* Existing respiratory disease
* Alcohol and /or psychotropes consumption during the last 24 hours
* Tobacco smoking more than 2 pack-years
* Sleep deprivation
* Serious cognitive deficiency
* No affiliation to social security
Reduction of Sperm DNA Fragmentation by Oral Ginger

This study is a randomized, double blind, controlled clinical trials assess the efficacy of the ginger oral treatment on sperm DNA fragmentation, sperm parameters and male hormones.

Sperm DNA fragmentation is known to affect male fertility. Previous findings have suggested the implication of oxidative stress in the etiology of this pathological condition. The present study was designed to find out DNA fragmentation in ejaculated spermatozoa can be reduced by oral treatment with Ginger extract. 71 men with unexplained or Idiopathic infertility were randomized between a Ginger treatment (500 milligram daily for 3months) group and a placebo group.

Sperm DNA fragmentation was evaluated by Terminal deoxyribonucleotidyltransferase-mediated dUTP nick-end labeling assay (TUNEL) before and after treatment. No differences in basic sperm parameters were found between the Ginger treatment and the placebo group before or after treatment. However, the percentage of DNA-fragmented spermatozoa was markedly reduced (P\< .005) in the Ginger treatment group after the treatment as compared with the pretreatment values). No difference in the pretreatment and post treatment incidence of sperm DNA fragmentation was observed in the placebo group. These data show that sperm DNA damage can be efficiently treated with oral Ginger extract administered during a relatively short time period.

Eligibility Criteria:
Inclusion Criteria:

* men with idiopathic infertility or unexplained

Exclusion Criteria:

* history of varicocele, genitourinary inflammation or infection
* history of cigarette smoking.
Interest of Ascorbic Acid in the Management of Pneumonia in Elderly People Hospitalized.

Pneumonia is the second common infection and its risk increases for elderly. In this population, it is the first cause of mortality by infections, and source of many complications. Geriatric studies had shown the high prevalence of ascorbic acid 's deficiency, especially in older hospitalized people. It is well known that vitamin C is one of the key of the immune system, it has a scavenger's role in case of aggression like sepsis. A Cochrane database published in 2013 analyzed the impact of vitamin C for preventing and treating pneumonia. Two randomized studies showed a benefit on respiratory symptoms for patients treated by vitamin C, and for one of those studies it was noted a significant reduction of mortality. The main objective of our study is first to determine the impact on respiratory symptoms of an adjuvant treatment by vitamin C for the management of pneumonia in older people hospitalized, and then evaluate its impact on functional status.

This study is French non-comparative phase II clinical trial, double-blind randomized, with placebo, single-center. One group would be treated the placebo group, and another would receive an adjuvant treatment by vitamin C : 500 mg twice a day by intra-venous way from the first day to the second included, and then 500 mg twice a day by oral way from the third day to the seventh. For each patient, the study's duration is 7 days, which is the mean stay of hospitalization. During those 7 days, we will make clinical exams and blood tests at d0, d2, d4 and d7. The vitamin C blood level will be measured at d0 and d7.

Eligibility Criteria:
Inclusion Criteria:

* people aged ≥ 75 years old
* pneumonia's symptoms according to the SPILF (Société de Pathologie Infectieuse de Langue Française) :

  * cough
  * at least one respiratory sign : dyspnea, chest pain, wheezing, and local signs at the auscultation
  * at least one general sign suggesting an infection : fever, sweat, headache, sore joints, common cold
* pneumonia's symptoms developed between the admission's date in the unit care and the seventh day included

Exclusion Criteria:

* palliative care's patients
* patients with deglutition's disorders
* patients who can't be on a drip
* antibiotherapy since more one day
* other concomitant infection(s)
* patients who can't make their own transfer 15 days ago
* patients who have a NYHA score at IV 15 days ago
* patients with contraindication to a vitamin C treatment : hemochromatosis, oxalo-calcic lithiasis antecedent, G6PD deficit (Glucose 6 Phosphate Dehydrogenase), and treatment by Deferoxamine
Allicin Bioavailability From Garlic Supplements and Garlic Foods

This study will measure the bioavailability of allicin, the main active compound of garlic, from garlic supplements and garlic foods (raw, cooked, processed) so that

* supplement manufacturers and clinical investigators know how supplements need to be made and consumed to obtain high bioavailability
* consumers can know how garlic can be prepared to obtain any established health benefits of garlic.

The bioavailability of allicin, the main active compound of garlic, from garlic supplements and garlic foods is highly questionable and unpredictable from in vitro tests, due to dependence upon alliinase activity under conditions that challenge alliinase activity (heat, gastric acid, intestinal proteases). It is likely that garlic supplement manufacturing procedures and coatings, meal conditions when supplements are consumed (high or low protein), and garlic food preparation conditions (temperature, surface area) will greatly affect allicin bioavailability. Such variability may account for some of the many conflicts seen in clinical trials on cardiovascular disease risk factors.

To resolve these issues, this study will determine the actual bioavailability of allicin from several types of garlic supplements and garlic foods under various conditions. Bioavailability will be determined by measuring the area under the 32-hour curve for breath concentrations of allyl methyl sulfide, the main metabolite allicin.

Eligibility Criteria:
Inclusion Criteria:

* in good health (self-judged)
* BMI (body mass index): 19-32 kg/m2
* not planning to move out of the area in the next year
* willing to abstain from consuming garlic and onion and foods that contain them for two days prior to and during each test (diet restrictions)
* able to deliver bags of breath to the research facility five times in two days
* willing to eat whole wheat tuna sandwiches

Exclusion Criteria:

* known serious health problems: diabetes, heart disease, active neoplasms, renal or liver disease, hyper- or hypothyroidism, breathing disorders, gastroesophageal reflux disease (GERD), gastrointestinal disease (absorption interference)
* known allergy to garlic or wheat
* tobacco user
* excessive alcohol intake (³2 drinks/day, self-reported)
* unable to speak English well