cyrilzakka/clinical-trials huggingface dataset:
Effect of Vitamin D Supplementation on Muscle Mass and Function

The study was designed to assess the effects of vitamin D supplementation during exercise training on body composition, muscle function, and glucose tolerance. The investigators hypothesis for these studies is that vitamin D supplementation enhances exercise-induced increases in strength and lean mass, potentially through enhancing insulin sensitivity and reducing inflammation.

The study was designed to assess the effects of vitamin D supplementation during exercise training on body composition, muscle function, and glucose tolerance. It was a double-blind, randomized, placebo-controlled, clinical trial with participants randomized into either a 4,000 IU/day vitamin D or placebo group and all participants completed 12 wks (3 d/wk) of exercise training.

Eligibility Criteria:
Inclusion Criteria:

* Physical activity scores in the "low" to "very low" category
* Fitness estimations in the "below average" or lower categories
* body mass index scores \>24.9 indicating overweight or obesity.

Exclusion Criteria:

* Use of tanning booths or other artificial UV light exposure
* High baseline vitamin D and calcium intake
* Plans to visit sunny/warm destinations during the winter months/study period
* History or presence of metabolic disease, type 2 diabetes, eating disorders, gastrointestinal disorders, pregnancy or lactation
* Use of drugs to treat obesity (last 12 weeks)
* Use of over the counter anti-obesity agents (last 12 weeks)
* Recent initiation of an exercise program (last four weeks).
A Study With Teduglutide (Revestive®) in Adults With Short Bowl Syndrome

The main aims of the study are to assess the safety profile of teduglutide (Revestive®) as well as how many people with Short Bowl Syndrome experience a reduction of parenteral support when treated with teduglutide (Revestive®).

This study is about collecting existing data only; participants will not receive teduglutide (Revestive®) as part of this study. No new information will be collected during this study. Only data already available in the hospital records will be reviewed and collected for this study.

Participants do not need to visit their doctor in addition to their normal visits.


Eligibility Criteria:
Inclusion Criteria:

* Participants \>= 18 years of age diagnosed with intestinal failure due to SBS as a result of intestinal resection.
* SBS-IF participants treated with teduglutide according to Summary of Product Characteristics (SmPC).
* Patients who receive or have received teduglutide for at least six months at the date of inclusion (from treatment initiation to inclusion date, date of discontinuation, death for any cause or loss of follow-up).
* When required by the ethics committee of the center: participants who have signed the informed consent form (ICF) to participate in the study.

Exclusion Criteria:

- Participants who do not meet the inclusion criteria.
Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea

The aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea.

Obstructive sleep apnea (OSA) affects millions of people in the U.S., and currently, there is not a well-established, general anesthetic technique that clearly decreases the risk of postoperative respiratory complications in these patients. If OSA patients have significantly decreased postoperative opioid requirements and improved recovery profiles in the PACU, the protocol could have significant implications in defining future standardized general anesthesia recommendations for patients with this disease. Ultimately, the aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea. The objective of this study is to compare the postoperative recovery profile of OSA patients receiving standard Sevoflurane inhaled anesthesia with normal saline infusion versus Sevoflurane combined with a low-dose ketamine infusion.

Eligibility Criteria:
Inclusion Criteria:

* aged 19-100
* scheduled to undergo general ENT or Orthopedic Surgery
* diagnosis of obstructive sleep apnea as confirmed by sleep study or deemed high risked for obstructive sleep apnea by clinical predictors (greater than 4 clinical predictors of obstructive sleep apnea as described by STOP BANG ).

Exclusion Criteria:

* positive pregnancy test
* ASA \> III
* history of alcohol or narcotic abuse in last 90 days
* significant cardiovascular or respiratory disease (baseline oxygen saturation below 92%)
* significant psychiatric or neurologic disease
* history of significant hepatic or renal disease (baseline creatinine\>1.5)
* history of allergy or contraindication to anesthetic agents or ketamine including patients with increased ICP
* increased IOP
* severe arrhythmias
* history of delirium
* history of hallucinations
* history of psychosis
* history of uncontrolled seizures
* potential risk for malignant hyperthermia (family history)
* history of difficult intubation that would preclude standard induction of anesthesia
* prisoners
* persons who are mentally impaired
* non-English speakers
Adventure: Teacher Delivered Personality-targeted Interventions for Substance Misuse

Several personality factors have been shown to be associated with risk for alcohol and substance misuse, and differentiate substance abusers based on clinical profile, treatment response and susceptibility to other forms of mental illness. Personality-targeted interventions have been found to have significant preventative effects on onset and growth of drinking, binge-drinking and drinking problems in adolescents attending mainstream schools (Conrod, Castellanos \& Mackie, 2008). The interventions concurrently reduced personality-specific emotional and behavioural problems (Castellanos \& Conrod, 2006), and prevented the onset and escalation of drug-use over a two-year period (Conrod, Castellanos-Ryan \& Strang, 2010). This cluster randomised controlled trial aims to examine whether these results can be replicated when interventions are delivered by trained educational professionals. In addition, the trial will evaluate the broader impact of the programme on cigarette smoking, school attendance, academic achievement and school-wide behaviours.

The Adventure study aims to examine whether educational professionals such as teachers, mentors or individuals in a pastoral role, who are trained in carrying out personality-targeted interventions will be effective in reducing problem behaviours in a group of adolescents.

20 schools in London, U.K. were recruited for the trial, and over 2000 adolescents (mean age 13.7 years) consented to participate in the survey and intervention phases of the trial. Schools were randomly assigned to control or intervention condition, and students in intervention schools who met the criteria for any of the 4 personality risk subscales of the Substance Use Risk Profile Scale (Negative Thinking, Anxiety Sensitivity, Sensation Seeking and Impulsivity) were invited to participate in a personality-targeted intervention by trained members of staff from their schools. All participants were invited to complete follow-up surveys at 6-month intervals for 2 years. The remaining 55% of low risk students in the grad were also followed to examine population-level effects of the intervention as well.

The main outcome measures of this RCT are alcohol and illicit drug outcomes. Secondary measures include mental health symptoms, risky behaviour, school attainment and attendance, and school-wide behaviours.

It is hypothesised that teacher-delivered personality-targeted interventions will have similar preventative effects on alcohol and drug use as reported by Conrod et al (2008, 2010), in addition to the personality-specific intervention effects reported by Castellanos \& Conrod (2006). In addition, broader effects of the intervention on academic achievement and school-wide behaviour will be examined in this trial, both at the individual level and at the population-level.

Eligibility Criteria:
Inclusion Criteria:

* Secondary school student

Exclusion Criteria:

* None
To Determine the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy

Phase 2 clinical study to evaluate of the efficacy and safety of DW1029M on microalbuminuria in Patients With Diabetic Nephropathy

A Phase Ⅱ, prospective, 24 weeks, double-blind, placebo-controlled, randomized, multi-center clinical trial for the evaluation of the efficacy and safety of DW1029M on microalbuminuria in Patients With Diabetic Nephropathy

Eligibility Criteria:
Inclusion Criteria:

* Has confirmed diabetic mellitus prior to 6years
* Has confirmed microalbuminuria 30 \~ 299㎍/㎎creatinine prior to 5months one time and microalbuminuria 30 \~ 299㎍/㎎creatinine during screening period
* Blood Pressure(BP) ≤ 150 / 90 mmHg
* estimated glomerular filtration rate(eGFR) ≥ 30 ml/min/1.73m2
* Hemoglobin A1c(HbA1c) ≤ 9%
* Low density lipoprotein(LDL-C) ≤ 130mg/dl

Exclusion Criteria:

* kidney or liver disease as follows i.Serum Creatinine \> 2.0mg/dl ii.Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) \> 2 x Upper Limit Normal(ULN) iii.Total Bilirubin \> 2 x ULN
* Organic gastrointestinal disorder or Chronic gastroenterologic disorders prior to 6 months as follows \[NOTE\] Active Crohn's disease, Active ulcerative colitis, Chronic peptic ulcer disease, etc.
* cardiovascular disease prior to 3 months as follows \[NOTE\] Unstable angina pectoris, Myocardial infarction, Coronary artery bypass surgery, Percutaneous Transluminal Coronary Angioplasty, transient ischemic attack, cerebrovascular accident etc.
Evaluation of the Effectiveness of Intraoperative Frozen Section on the Treatment of Suspected Gallbladder Cancer

Evaluate the effectiveness of intra-operative frozen section in the treatment of gallbladder cancer.

The study will be looking in to identify if intraoperative frozen section is a viable method to intraoperatively evaluate the presence of adenocarcinoma and the depth of its invasion and if the information given by frozen section is enough to modify the operative strategy.


Eligibility Criteria:
Inclusion Criteria:

- Patients with suspected GB cancer

Exclusion Criteria:

-
Estrogen for Treating Depression in Menopausal Women With Hot Flashes and Insomnia

This study will evaluate the effectiveness of estrogen replacement therapy in treating depression in menopausal women with hot flashes and insomnia.

Estrogen is a hormone that plays an important part in the development of the female reproductive system. During menopause, estrogen levels drop significantly. The drop in estrogen may cause physiologic and psychological changes in women; common symptoms include hot flashes, sweating, insomnia, and irritability. In addition, approximately 10% of menopausal women experience depression. Estrogen replacement therapy (ERT) is often prescribed to alleviate these symptoms. It is not known, however, exactly how ERT treats depression. It may indirectly decrease depression by alleviating insomnia associated with hot flashes, or it may directly improve mood and decrease depression by altering chemicals in the brain. The purpose of this study is to gain insight into how ERT treats depression and to develop strategies to reduce depression in menopausal women. In turn, these findings may help categorize populations of women whose depression should be treated with ERT versus nonhormonal therapies.

In this 9-week study, participants will be randomly assigned to receive ERT, a sleeping pill, or placebo. Study visits will occur at baseline and Weeks 2, 4, 6, and 9; at each study visit, blood pressure will be monitored, and standardized psychological tests and questionnaires will be used to assess the participant's level of depression and reported quality of life outcomes. Blood will be drawn at baseline and Week 9 to measure estrogen and follicle stimulating hormone levels.

Eligibility Criteria:
Inclusion Criteria:

* Perimenopausal or postmenopausal status
* Surgical menopause or hysterectomy with one or both ovaries preserved if serum follicle stimulating hormone is greater than 20 IU/L
* Diagnosed with mild to moderate clinical depression
* Currently experiencing moderate to severe hot flashes
* Currently experiencing insomnia caused by nocturnal hot flashes
* Normal mammogram within the 2 years prior to study entry
* Willing to use an effective form of contraception throughout the study if perimenopausal and sexually active

Exclusion Criteria:

* Current severe depression or history of severe depression within the 5 years prior to study entry
* Suicidal or homicidal ideation
* Psychotic symptoms
* History of any psychiatric disorder (e.g., psychosis, bipolar disorder, panic disorder, obsessive-compulsive disorder, or anorexia nervosa)
* History of any substance abuse (including alcohol abuse) within the 5 years prior to study entry
* Regular use of hormonal medications within the month prior to study entry
* Regular use of hypnotic drugs, antidepressants, or over-the-counter drugs known to influence hot flashes, sleep, or mood within the 2 weeks prior to study entry
* Intolerance to estrogen therapy or informed that estrogen therapy is medically inadvisable
tVNS in Children With Prader-Willi Syndrome

The purpose of the current project is to test the impact of transcutaneous vagus nerve stimulation (tVNS) on social ability in children with Prader-Willi Syndrome (PWS). Social ability and blood neuropeptides associated with social functioning will be measured before and after engagement in 12 weeks of tVNS therapy.


Eligibility Criteria:
Inclusion Criteria:

* (1) be between the ages of 8-14 years; (2) have a confirmed diagnosis of PWS by genetic testing; (3) be minimally verbal and able to sit at a table to complete cognitive and behavioral testing; (4) be willing to provide blood samples; and (5) be willing to engage in a 16-week study period (baseline to intervention follow-up).

Exclusion Criteria:

* (1) currently taking oxytocin and/or arginine vasopressin or related analogs and (2) have a DSM-5 diagnosis of any severe mental or behavioral disorder (e.g. schizophrenia, bipolar disorder, conduct or oppositional defiant disorder) that significantly impacts daily functioning.
Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)

To assess whether changes in quantitative tumor perfusion parameters after 3 weeks of treatment, as measured by power Doppler ultrasound, can predict initial objective response, defined by current standard-of-care, to therapy at 12 weeks after start of treatment


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Pathology-confirmed diagnosis of metastatic RCC
* At least one tumor lesion greater than 1 cm in diameter, amenable to ultrasound imaging
* Written informed consent.

Specific inclusion criteria:

* arm 1: planned to be treated with combination of VEGFR2 tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)
* arm 2: planned to be treated with non-ICI therapy

Exclusion Criteria:

-Any comorbid condition that, in the opinion of the treating provider or the Protocol Directors, compromises the participant's ability to participate in the study
Inhaled Nitric Oxide in Brain Injury

This study will evaluate the changes in respiratory mechanics following traumatic brain injury and determine the effect of inhaled nitric oxide on gas exchange.

Intubation and mechanical ventilation are common treatments in the care of patients with traumatic brain injury (TBI). Intubation allows for airway control and facilitates removal of respiratory secretions. Mechanical ventilation allows control of arterial carbon dioxide to aid in control of intracranial pressure. Recent evidence suggests that lung protective ventilation (tidal volumes of 6 ml/kg of predicted body weight and moderate positive end expiratory pressure) improves outcomes following brain injury and reduces brain-lung cross talk.

The treatment of respiratory failure in TBI must balance the need to improve lung function with the negative consequences of increased intrathoracic pressure on mean arterial pressure, intracranial pressure and venous return. Traditional treatment of increasing positive end expiratory (PEEP) and mean airway pressure then, represent competing interests. Methods for improving arterial oxygenation while avoiding negative hemodynamic effects are needed.

The impact of head injury on respiratory mechanics has been studied in just a few clinical investigations. (1-3) Of note, the earliest of these noted that the ventilation perfusion (V/Q) matching following TBI was not the result of lung collapse or parenchymal lung disease but secondary to alterations in perfusion. There are three possibilities for this finding:

1. redistribution in regional perfusion, which is partially mediated by the hypothalamus
2. pulmonary microembolism, leading to increased dead space
3. lung surfactant depletion due to excessive sympathetic stimulation and hyperventilation.

The introduction of inhaled pulmonary vasodilators such as inhaled nitric oxide or aerosolized epoprostenol offer an opportunity to improve oxygenation in patients with TBI without increasing airway pressures in the face of V/Q inequalities.

This study will evaluate the changes in respiratory mechanics following TBI and determine the effect of inhaled nitric oxide on gas exchange.

Eligibility Criteria:
Inclusion Criteria:

* Hospital admission with traumatic brain injury (penetrating or blunt)
* Requirement for mechanical ventilation
* Glasgow Coma Score \> 3

Exclusion Criteria:

* Brain death
* Expected survival \< 48 hours
* Air leak (bronchopleural fistula, tracheal injury)
* Current inspired oxygen concentration (FiO2) \> 0.65
* Hemodynamic instability (systolic blood pressure \< 100 mm Hg, cardiac arrhythmia)
* Uncontrolled intracranial pressure (\> 20 mm Hg)
* Spinal cord injury with hypotension
* Severe acute respiratory distress syndrome (ARDS) (PaO2/FiO2 \< 100)
* Chest abbreviated injury score (AIS) \> 3
* First rib fracture
* Flail chest
Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System

To validate an updated version of CapsoCam® SV-3 Endoscopy System brand name CapsoCam Plus™) with respect to the reproducibility of the system to capture and download small bowel images in a manner consistent with the predicate CapsoCam® SV-2 and SV-3 capsule endoscopy systems.

The purpose of the study is validate the an updated version of the CapsoCam® SV-3 Endoscopy System brand name CapsoCam Plus™) with respect to the reproducibility of the system to capture and download small bowel images in a manner consistent with the predicate CapsoCam® SV-2 and SV-3 capsule endoscopy systems.

The system to be validated consists of an updated version of the CapsoCam® SV-3 video capsule endoscope, the CapsoView® CVV Software, the CapsoAccess ® Capsule Data Access System (CDAS3) and the CapsoRetrieve® Capsule Retrieval Kit for the collection of the excreted CapsoCam capsule.

The captured CapsoCam® SV-3 capsule images of the small bowel will be downloaded via the CapsoAccess® Capsule Data Access System (CDAS3) to a computer and proprietary CapsoView® CVV Software is used to review capsule images. The CapsoView® software displays the video and employs a variety of image-enhancement, video playback, and image analysis features to facilitate physician review of the captured images. The software allows the physician to efficiently annotate individual frames from the video and compile a procedure report, which aids in diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Willing and able to provide written informed consent
* Completion of pre-study questionnaire
* Approval of study principal investigator

Exclusion Criteria:

* Subjects with abdominal pain of unknown origin
* Difficulty Swallowing
* Known or suspected gastrointestinal disease
* Diarrhea or constipation
* Anemia of unknown origin
* Rectal or other gastrointestinal bleeding
* Pregnancy
Free HIV Testing in Private Biological Laboratories: A New Offer to Encourage HIV Testing

The program " Au labo sans ordo " aims to increase HIV testing coverage, in order to improve the first stage of the HIV care cascade in Paris and the Alpes-Maritimes, areas facing a much higher HIV epidemic than the other regions in metropolitan France. Both departments are engaged in the Fast Track Cities Initiative.

The program relies on the hypothesis that the opportunity to get tested for HIV for free (called VihTest) in any Private Laboratory (PL), without prior appointment nor prescription, combined with an intense targeted promotion and communication strategy, will significantly increase the testing coverage. This offer might remove some of the multiple barriers to HIV testing and ease the move to action, in particular within key affected populations which contribute to the largest part of the epidemic dynamic.

This program offers a new access to HIV testing. It is developed jointly by local authorities, the health insurance and state regional health agencies, in response to the very low increase of HIV testing coverage despite a diversification of the testing supply and national recommendations for generalized and repeated HIV testing within key populations.

The experimentation will be implemented for 12 months in all Private Laboratories in Paris (164) and the Alpes-Maritimes (107), targeting a 15% increase in the total volume of tests performed outside of hospital settings.

The evaluation process will focus on:

Axis 1 : The number of tests performed and the number of new HIV diagnosis considering the potential substitution effect towards the current testing provision through CeGIDD (free Centers for Information, Diagnosis and Testing) and community-based outreach testing programs.

Axis 2 : The linkage to care following an HIV positive test will be organized and documented and the characteristic of HIV+ population diagnosed after VihTest will be describe (ALSO_PARCOURS) Axis 3: The characteristics of the program's users will be collected and compared 1) to those of PL attendants with a medical prescription for an HIV test and 2) to CeGIDD clients.

Axis 4: The feasibility and acceptability of the program by the PL's staff will be documented using detailed qualitative questionnaire; Axis 5: The cost-effectiveness of scaling-up such a testing strategy and its budgetary impact will be assessed through a microcoasting evalutation.

Eligibility Criteria:
Axis 2

Inclusion Criteria:

* Major
* being diagnosed HIV positive after a VihTest

Exclusion Criteria:

* Minor
Sun Protection Factor - Assay

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF
* Signed and dated Informed Consent Form
* Signed and dated HIPAA Form
* An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.