cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Demonstrations to End Childhood Hunger - CN DietQual

The 2010 Child Nutrition Reauthorization provided funding to test innovative strategies to end childhood hunger and food insecurity. Demonstration projects were funded in Chickasaw Nation, Kentucky, Navajo Nation, Nevada, and Virginia. This study focuses on Chickasaw Nation and the diet quality of child participants.

School districts were matched, and then one was randomly assigned to either a treatment (n=20) or control group (n=20). Treatment households received one food box per eligible child, per month, delivered to the household, which contained (1) shelf-stable foods, including 6 protein-rich items, 2 dairy items, 4 grain foods, 4 cans of fruit, and 12 cans of vegetables; (2) a nutrition education handout (e.g., a recipe); and (3) a $15 Fresh Check for frozen or fresh fruits and vegetables that participants could redeem at any of 38 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)-authorized stores or farmers' markets in the study counties. Control households did not receive the treatment benefits but still could participate in other available nutrition assistance programs.

Objective: To reduce childhood food insecurity and hunger, increase families' consumption of nutritious foods, increase the diversity of foods in the home, and ultimately improve diet quality and well-being among children.

Target Population: 40 school districts (115 schools) in 12 counties within the Chickasaw Nation territory in Oklahoma. Within these districts, households with school-age children (both Native American and non-Native American) who were eligible for free school meals or attended a school that participated in the community eligibility provision were eligible to participate in the project.

Intervention School districts were matched, and then one was randomly assigned to either a treatment (n=20) or control group (n=20). Treatment households received one food box per eligible child, per month, delivered to the household, which contained (1) shelf-stable foods, including 6 protein-rich items, 2 dairy items, 4 grain foods, 4 cans of fruit, and 12 cans of vegetables; (2) a nutrition education handout (e.g., a recipe); and (3) a $15 Fresh Check for frozen or fresh fruits and vegetables that participants could redeem at any of 38 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)-authorized stores or farmers' markets in the study counties. Control households did not receive the treatment benefits but still could participate in other available nutrition assistance programs.

Eligibility Criteria:
Inclusion Criteria:

* 40 school districts (115 schools) in 12 counties within the Chickasaw Nation territory in Oklahoma.
* Within these districts, households with school-age children (both Native American and non-Native American) who were eligible for free National School Lunch Program meals or attended a school that participated in the community eligibility provision were eligible to participate in the project.
Telerehabilitation, Core Stability Exercises and Hereditary Ataxia (TRCore-ataxia)

Hereditary ataxias (HA) are a heterogeneous group of degenerative diseases of the cerebellum, brain stem and spinal cord. People who suffer from AH, among other symptoms, present deficiencies in the stability of the trunk, which leads to an alteration in postural control, with a strongly influential factor in the loss of balance and gait disorders. Improving the functionality of these physical aspects can help reduce the rate of falls, increase autonomy and quality of life for people with HA.

Evidence suggests that rehabilitation strategies based on core stability exercises (CSE) are effective in improving balance and postural control in several neurological diseases, such as stroke. However, there is little evidence with people with HA. In a previous study carried out by researchers of this project, in which an EEC exercise program was piloted at home, low adherence to treatment was perceived due to the little follow-up that was given to the participants. Therefore, including telerehabilitation in these programs would increase follow-up and could influence adherence.


Eligibility Criteria:
Inclusion Criteria:

* Suffer from degenerative HA at any stage of the disease (Spinocerebellar ataxia, Friedreich's ataxia, sporadic idiopathic cerebellar ataxia and neurodegenerative diseases where ataxia is the dominant symptom).
* Adults over 18 years of age.
* Be able to use a computer or mobile phone (It will be evaluated using the DILE scale)
* Have an internet connection.

Exclusion Criteria:

* Suffer from other neurological diseases and inability to follow simple instructions. -
* Suffering from a musculoskeletal injury that prevents you from performing the exercises.
* Being unable to maintain standing for more than 10 seconds without support (assessed with item 2 on the SARA scale).
Joint Effort Study

This pilot randomized controlled trial (RCT) will be conducted to evaluate the acceptability and feasibility of a digital tailored prevention tool (i.e., the Joint Effort mobile application) aimed at supporting university-level students into taking action on their cannabis use. The two main objectives of the proposed study are:

1. To assess the acceptability of the Joint Effort mobile application in terms of uptake, engagement and intervention appreciation.
2. To document the feasibility of the study processes in terms of online recruitment rate, adherence to online data collection methods, and attrition rate.


Eligibility Criteria:
Inclusion Criteria:

* active cannabis user (i.e., having used cannabis at least once in the past month)
* able to understand French
* own an iPhone (running on iOS 13 or higher).
I-Gel Versus Disposable Laryngeal Mask (LMA) for General Anesthesia (GA) With Controlled Ventilation

Randomized controlled trial comparing performance of the I-gel and disposable Laryngeal Mask Airways under controlled ventilation. 200 patients, 100 in each arm. Measurement of peak airway and sealing pressures. Postoperative questionnaires at 1 and 24hrs.

Hypothesis

There is no difference between the performance\* of the I-gel and disposable laryngeal mask airways for controlled ventilation under general anesthesia.

\*as defined by peak airway pressure and sealing pressures.


Eligibility Criteria:
Inclusion Criteria:

* Males and females.
* Age 18-89 inclusive.
* ASA grade 1-2.
* Elective surgery

Exclusion Criteria:

* Emergency surgery.
* Surgery within the peritoneum.
* Surgery requiring prone or steep head-down positioning.
* Patients at increased risk of aspiration
"Effects of Oral Citrulline on Protein Metabolism in Healthy Humans: a Prospective, Randomized, Double-blind , Cross-over Study" (Citrugrêle)

The specific aim of this study is to determine whether oral citrulline administration enhances whole body protein synthesis in healthy humans in the postabsorptive state. Protein metabolism will be assessed using an intravenous infusion of stable isotope labeled leucine. The investigators hypothesize that citrulline supplementation will decrease leucine oxidation without altering proteolysis, and consequently stimulate protein synthesis .


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult between 18 and 45 years of age
* Absence of any earlier supplementation with citrulline, glutamine, ornithine a-ketoglutarate, or stimol®
* Absence of any treatment with anabolic agents during the month prior to inclusion in the study- No current artificial feeding (enteral or parenteral)
* No renal, cardiac, respiratory or hepatic insufficiency
* No chronic inflammatory disease (intestinal or other
* No current corticotherapy
* Fasting blood glucose below 6mmol/L (126 mg/dL)
* Body mass index between 19 and 24.9
* Patient able to understand benefits and risks of protocol
* Not pregnant, taking oral contraceptive measure if able to procreate
* Subject affiliated to French health insurance (Sécurité Sociale)
* Informed consent form signed
* No concomitant participation to another clinical trial, and compliance with the exclusion period required by law

Exclusion Criteria:

* Subject not fulfilling inclusion criteria
* Subject mentioned in articles L1121-5 to L1121-8 of "code de la santé publique"
* Subject for whom the participation in this clinical trial would result, by cumulating stipends received for other clinical trials, in earning more than 4500 € within 12 consecutive months
Study of Safety and Efficacy of an Oral Contraceptive

This is a non-comparative study. The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Women
* Age 18-45
* At risk for pregnancy
* History of regular cycles

Exclusion Criteria:

* Contraindications for use of hormonal contraception
* Conditions which affect the absorption or metabolism of steroid hormones
* BMI \> 35
A Study to Evaluate the Efficacy of MK0719 in the Prevention of Postoperative Dental Pain (0719-002)

This study is being conducted to evaluate the safety and tolerability of the drug and to evaluate its efficacy compared to placebo and to ibuprofen in the prevention of postoperative dental pain in male patients.

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).


Eligibility Criteria:
Inclusion Criteria :

* Patients in generally good health who are scheduled to have 2 or more third molars removed, at least 1 of which is partially or completely embedded in bone and is a mandibular impaction

Exclusion Criteria :

* Patient has a history of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient
Breath Analysis of Patients Diagnosed With COVID-19 Using Infrared Spectroscopy

To analyze Volatile Organic Compounds (VOCs) in the breath of patients with SARS-CoV-2 and controls in SARS-CoV-2 breath specimens.

The study is a prospective cohort study, which enrol patients presenting to hospital and are tested for SARS-CoV-2. There will be two cohorts, COVID-19 positive and COVID-19 negative, who will have exhaled breath collection and analysis by infrared spectroscopy to characterize the composition of VOCs and identify differences in VOC profiles between the two groups.

Eligibility Criteria:
Inclusion Criteria for Covid-19 positive patients:

* Clinically tested for SARS-CoV-2 (as completed by standard laboratory testing e.g. RT-PCR) with a positive result
* Clinical features in keeping with COVID-19 illness.

Inclusion criteria for Covid-19 negative patients:

* Negative RT-PCR COVID-19 test
* Without any clinical features to suggest COVID-19 illness.
* No known or current features of respiratory infection, COPD, asthma, interstitial lung disease, other respiratory inflammatory conditions or lung cancer.
* Able to provide a breath sample (as based on clinical judgement).

Exclusion Criteria for Covid-19 positive and negative patients:

- Unable to provide a breath sample
Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed by central review CD30-positive nonlymphomatous malignancy
* Have failed, refused, or have been deemed ineligible for standard therapy
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 or a Karnofsky or Lansky Performance Status score greater than or equal to 70

Exclusion Criteria:

* Primary diagnosis of lymphoma or central nervous system (CNS) malignancy
* History of another primary invasive malignancy that has not been definitively treated or in remission for at least 3 years
* Evidence of active cerebral/meningeal disease
Pancreatic Exocrine Insufficiency After Bariatric Surgery

Main proposed benefit of sleeve gastrectomy is loss of ghrelin secreting tissue. Some studies express that ghrelin augment pancreatic regeneration. Therefore we hypothesized that with sleeve gastrectomy it may result with pancreatic insufficiency.

Mechanism of weight loss differs in bariatric surgery according to type of surgery.

With sleeve gastrectomy which has restrictive mechanism, ghrelin excretion decreases, and this condition is attributed as an additional mechanism in weight loss.

Ghrelin effects pancreatic regeneration, and loss of ghrelin may result with pancreatic insufficiency. Therefore we aimed to deteremine this association.

Eligibility Criteria:
Inclusion Criteria:

Patients underwent bariatric surgery (Sleeve gastrectomy) after concordonce with NIH criteria

Exclusion Criteria:

Additional operations to sleeve gastrectomy like duodenal switch. Other bariatric operations.
Chitosan Chewing Gum Study in Dialysis Patients

The purpose of the pilot study is to determine the impact of short-term administration of chitosan-containing chewing gum on phosphate levels in patients with elevated serum phosphate levels.

The impact of using salivary phosphate binders in ESRD patients is not fully known. The purpose of the pilot study is to determine the impact of short-term administration of chitosan-containing chewing gum on phosphate levels in patients with elevated serum phosphate levels.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-64 years old
* ESRD receiving hemodialysis
* serum phosphate \> 6.0 mg/dL

Exclusion Criteria:

* Unable to sign consent
Assessment of Cardiac Allograft Vasculopathy With Optical Coherence Tomography

Cardiac allograft vasculopathy (CAV) is a progressive disease of the coronary arteries in transplanted hearts which is a significant cause of morbidity and mortality. The broad objective of this research study is to advance our ability to diagnose as early as possible the presence of CAV and to non-invasively predict those patients at increased risk of CAV with novel techniques. Optical coherence tomography (OCT) is a novel intracoronary imaging technique using an optical analog of ultrasound with a resolution 10 times greater resolution than intravascular ultrasound (IVUS). Endothelial progenitor cells (EPCs) in peripheral blood have been shown to play a role in the pathogenesis of atherosclerosis and peripheral arterial tonometry is a clinical tool used to predict endothelial dysfunction (a precursor of atherosclerosis) which has been validated in non-transplant patients. Patients scheduled for routine cardiac catheterization with IVUS at the Mayo Clinic Rochester, Minnesota (MN) that reach inclusion and exclusion criteria for the study will be approached on the day to get informed consent to perform OCT, blood sampling and peripheral endothelial function testing. The investigators aim to 1) compare the frequency and plaque type of CAV as defined with OCT versus IVUS-Virtual Histology (IVUS-VH), 2) predict the presence and severity of CAV with absolute counts of EPCs and 3) with peripheral endothelial function scores.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 or older
* patients with cardiac transplant undergoing routine CAV surveillance

Exclusion Criteria:

* patients \< 18 years old
* patients with acute rejection
* patients with active infection
* patients with chronic renal insufficiency with a glomerular filtration rate (GFR) \< 30ml/min
* patients not able to give informed consent
Custom Pack in Spine Surgery

Recent evidence suggests the efficacy of "custom pack" procedure on the operators reduction time and on the contamination risk due to the opening of many sterile packs. Nevertheless ,the studies available are sponsored by the industry and their results are very few. The aim of this study is to evaluate the correlation and reliability of spine surgery "custom pack" efficacy in adult patients obtained in the reduction of surgery time, relative risks, and materials wasted compared with the standard surgical field procedure practice .


Eligibility Criteria:
Inclusion Criteria:

* Degenerative spinal disease from 2 to 4 levels,
* Oncologic spine disease with only decompression and stabilization.

Exclusion Criteria:

* Revision surgeries,
* Minimally invasive interventions,
* Interventions that provide a dual access, and
* Patients who refuse consent to experimentation.
Effects of Fast Acting Testosterone Nasal Spray on Anxiety

The proposed study will test the effects of a fast-acting testosterone nasal spray on the fear reactions of young men to two distinct anxiety challenges (social and nonsocial) using a double-blind randomized experimental design.

Aim 1: Test the hypothesis that men administered testosterone nasal spray will result in lower levels of anxiety (anticipatory and situational) and greater levels of approach behavior in response to two distinct (social and nonsocial) anxiety challenges relative to men administered placebo spray.

Aim 2: Test the hypothesis that anxiety challenge type (social versus nonsocial) will moderate the effects of testosterone administration on subjects' responses to challenge.

Aim 3: Test the hypothesis that rejection sensitivity - heightened sensitivity to evaluative threat - will moderate the effects of drug condition on response to the two anxiety challenge tests.

Eligibility Criteria:
Inclusion Criteria:

* Male, 18 years of age or older

Exclusion Criteria:

* Male breast cancer
* Obstructive sleep apnea
* Suspected or diagnosed prostate cancer
* Male breast cancer
* Obstructive sleep apnea
* Diabetes
* Heart Disease
* Liver disease (e.g., hepatitis)
* Kidney disease
* Thyroid disease
* Tuberculosis or history if positive TB test
* Infection or fever in the past 7 days
* Surgeries within the last 6 weeks
* Anemia
* Gastrointestinal disease
* Respiratory disease (e.g., asthma or chronic bronchitis)
* Other (Please list)
* Reynaud's Disease
* Type 2 diabetes
* Diagnosed hypersensitivity to cold
* Warfarin (Coumadin) for thinning blood
* Insulin or any oral drugs for diabetes
* Propranolol (Inderal)
* Oxyphenbutazone
* Imipramine
* Any kind of corticosteroid drug
* Insulin
* Steroids
* Statins (i.e.., cholesterol lowering drugs)
* Sleeping pills
* Drugs to treat hormone disorders
* Antibiotics in the past 7 days
* Gastrointestinal disease
* Pain Killers -
Physical Therapy to Prevent Osteopenia in Preterm Infants

To determine whether reflex locomotion therapy is effective for the prevention of osteopenia in preterm infants and compare its effectiveness over other physiotherapeutic methods like passive joint mobilizations and massage

Premature infants have smaller and low bone mineralization compared with term infants bones, since 80% of calcium uptake occurs at the end of pregnancy. Passive Physiotherapy has been effective in the treatment of osteopenia. Active mobilizations implemented by the baby itself, may be more effective than passive, as they cause muscle contraction from the Central Nervous System (CNS). Reflex locomotion therapy (RLT), stimulates CNS causing muscle contraction so it may be effective in the treatment of osteopenia in premature.

Objectives: To determine whether RLT is effective for the prevention of osteopenia in preterm infants and compare its effectiveness over other physiotherapeutic methods.

Methodology: Our study is a multicentre randomized clinical trial, with 90 children less than 34 weeks of gestational age, divided into three treatment groups, one will receive RLT, another will be treated with passive joint mobilizations with articular pressure; and last one will be done massage techniques. The treatment will last for one month, for the three groups. We intend to measure changes in mineralization, bone formation, and bone resorption, and anthropometry.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants
* 26 to 34 weeks of gestational age
* Admitted in neonates
* Hemodynamically stable
* Complete enteral nutrition
* Parents or guardians signed an informed consent authorizing the participation of the baby in this study.

Exclusion Criteria:

* Neurological disorders
* Mechanical ventilation

  * Bronchopulmonary dysplasia
* Congenital malformations
* Metabolic diseases
* Genetic diseases
* Intraventricular hemorrhage III-IV,
* Diuretic medication or corticosteroids
* Bone fractures at the time of inclusion.
CT Evaluation of Intimal Flap Mobility

Type A aortic dissection is an emergency condition, defined by the appearance of an intimal flap within the ascending aorta. Urgent treatment is required, with surgical replacement of - at minima - the tubular portion of the ascending aorta.

After surgery, a majority of patients will still have a residual aortic dissection involving the aortic arch and/or the descending aorta. Long-term survival in these patients can be hindered by the apparition of an aneurysmal progression of the dissected aorta, with risk of rupture, thrombose and/or embolism. Consequently, this condition requires frequent follow-up imaging examinations, usually by Computed Tomography Angiography (CTA), to monitor the extension of the dissection and the diameters of the dissected aorta. Patient management is therefore based on passive follow-up of the disease, as no definitive clinical or imaging features can predict the potential evolution (or the absence of) towards an aneurysmal evolution.

Therefore, one can understand the important need for accurate predictors of aneurysmal dilatation of post-operative residual dissection.

CTA has the ability to visualize the intimal flap motion, by averaging at least 3 or 4 cardiac cycles over a non-gated arterial acquisition.

This intimal flap mobility varies greatly between patients, between the localization and the extension of the dissection, and between acute and chronic dissections. It is thought that chronic dissections with immobile flap might be less prone to aneurysmal evolution.

The investigators hypothesize that this mobility could be a prognostic marker for the evolution towards aortic dilatation: flap that would remain highly mobile after initial surgery could be an additional marker towards an aneurysmal evolution, while immobile flap could be on the contrary a marker of stability.

Intimal flap motion can already be qualitatively and quantitatively assessed in CTA when ECG-synchronization is used. However, this technique has a limited availability and significantly increases the total radiation dose, therefore limiting its use in routine practice. Being able to quantify this marker using routine non ECG-gated CTA could be a significant addition to the literature, as it is currently unknown if this is feasible/relevant.


Eligibility Criteria:
Inclusion criteria:

* Major patient (≥18 years old)
* Ascending aorta replacement for aortic dissection, between 2010 and 2015 (timeframe established to allow for a significant follow-up period after surgery)
* Residual type B dissection after surgery availability of thin-slices good quality CT angiography before (at least one) and after (at least two) the surgery.

Exclusion criteria:

* Patient expressing opposition to participating in the study
* Patient under the protection of justice
* Patient under guardianship or curatorship