cyrilzakka/clinical-trials huggingface dataset:
Energy Intake, Exercise and Energy Replacement

The aim of the present study is to compare the effect of an exercise alone versus. An exercise followed by the ingestion of an energy replacement snack on the following energy intake, food reward and appetite feelings in adolescents with obesity.

The present study will compare the nutritional response to the realisation of an acute exercise with and without an energy replacement snack on the following energy intake in adolescents with obesity. 18 adolescents with obesity will be asked to randomly complete three experimental sessions: i) one control session (rest); ii) one session with an acute exercise realized during the morning; iii) one session with the same exercise followed by a snack covering the exercise-induced energy expenditure. Their ad libitum energy intake will be assessed at the following meal as well as at dinner time. Appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* BMI percentile \> 97th percentile according to the french curves.
* ages 12-16 years old
* Signed consent form
* being registered in the national social security system
* no contraindication to physical activity

Exclusion Criteria:

* Previous surgical interventions that is considered as non-compatible with the study.
* Diabetes
* weight loss during the last 6 months
* cardiovascular disease or risks
Meal Timing on Glucose and Hyperandrogenism in PCOS Women

The objective of this study is to investigate the effects of two isocaloric maintenance diets with different meal timing distribution on insulin resistance hyperandrogenism and cytochrome P450c17 alpha activity in lean PCOS women.

The investigators hypothesis is that in lean PCOS women a Breakfast Diet (BD) which consist in high calorie breakfast and reduced dinner, vs Dinner Diet (DD) which consist in high calorie dinner with reduced breakfast; the BD will improve glucose and insulin response to OGTT and would decrease the hyperandrogenism and cytochrome P450c17 alpha activity.

Hyperinsulinemia plays a central role in the pathogenesis in obese as well as in lean PCOS women. These women are insulin resistant and have compensatory hyperinsulinemia that stimulates ovarian cytochrome P450c17 alpha activity that in turn stimulates ovarian androgen concentrations.

In obese PCOS women, weight loss improves insulin resistance and hyperandrogenism, resulting in improvement of clinical symptoms.

Since lean PCOS women do not have the option of weight loss, it is important to know if composition and meal timing distribution may influence glucose metabolism and hyperandrogenism and cytochrome P450c17 alpha activity. We hypothesized that a timing pattern of increased nutrient intake of protein and carbohydrates in the morning, with decreased caloric intake at night would improve insulin sensitivity and hyperandrogenism in lean women with PCOS

Eligibility Criteria:
Inclusion Criteria:

lean women with Polycystic Ovary BMI below 25 kg/m2 Testosterone above 1.0 ng/ml 17 Oh progesterone below 200 ng/ml US of Polycystic Ovaries

Exclusion Criteria:

Obesity BMI above 25 kg/m2 Diabetes Mellitus Other endocrine disease like hypothyroidism, late onset adrenal hyperplasia Pregnancy Contraceptive or other hormonal treatment
Pilot Study of the Entarik System With Advanced Functionality in Health Adults

In this single-site study, data will be recorded during nasogastric or orogastric placement (and post-pyloric placement) and removal of the Entarik Feeding Tube. Data will also be collected prior to, during, and following the delivery of a meal through the feeding tube.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old
2. Able to provide informed consent
3. Capable and willing to follow all study-related procedures
4. Confirmed fasted state for a minimum of 8 hours prior to study initiation

Exclusion Criteria:

1. Inability to receive a feeding tube
2. Known self-reported history of hiatal hernia, esophagitis, esophageal strictures or gastric ulcers
3. Has a basilar skull fracture
4. Self-reports pregnancy
5. Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination
Staff Experiences in Robotic Theatres

Studies have shown that team work impacts patients safety. This is particularly the case in surgical theatres where individuals from different backgrounds (surgeon, anaesthetists, nurses, ..etc) work together to achieve a common goal which is looking after the patient. The robotic theatre set up is different due to the physical separation of the surgeon from the patient and the rest of the team. This may represent a communication challenge. The Study investigators aim to study theatre staff experiences and practices of communication and teamwork in this special setup, investigating any challenges participants may be facing and possible ways of adapting to them. Staff opinions and suggestions for improvement will be explored for utmost surgical performance and patient safety.

The study will involve two parts:1) individual staff interviews and 2) teamwork observations during real life surgery. The two parts should complement each other giving an overall picture of the teamwork in the robotic theatre setup.


Eligibility Criteria:
Inclusion Criteria:

1. Robotic theatre staff as above.
2. Willing and able to participate.
3. Good command of the English language.

Exclusion Criteria:

1. Theatre staff not involved in robotic surgery.
2. Participants not willing / unable to participate.
3. Staff that have not worked in a conventional theatre setup before.
4. Inability to read/speak/understand English.
5. Lack of capacity for consent.
In-utero Death and Birth Mortality in Reunion Island

Infant mortality is still relevant despite the improvement and the accessibility of hospital care. Premature birth are two fold higher than in metropolitan France. Some factors has been suspected such as precariousness, alcoholism, congenital malformation, care accessibility, epidemic environment ... Nevertheless, the impact of these factors on foetal death or new-born death are not yet sufficiently quantified to provide appropriate care and prevention action in Reunion Island.

Through the analysis of interview of the mothers that have lost their infant during pregnancy or just after birth, the study aims to draw a picture of the pregnancy cares offer and pregnancy conditions in Reunion Island.

This study is an non interventional case-control study. Socio-economic conditions, pregnancy care and prevention are screened to identified the major cause of foetal or new-born death in Reunion Island. These data are still lacking and will be useful to identify which public health actions that should be organized.

Eligibility Criteria:
Inclusion Criteria:

* Case: foetal death (foetus weighing more than 500 g or more than 22-amenorrhea weeks old) or new-born death (premature: more than 23-amenorrhea weeks old or mature)
* Control: premature (more than 23-amenorrhea weeks old) or mature new-born, alive when the leave the hospital

Exclusion Criteria:

* medical abortion
* second pregnancy during the study period
* case under forensic expertise
Cetirizine and Famotidine for COVID-19

This study is a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of cetirizine and famotidine in reducing the duration of symptoms in patients with COVID-19. Secondary aims are to determine if cetirizine and famotidine decrease severity and duration of symptoms, incidence of hospitalizations, ICU admissions, and death.

COVID-19 is a disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Patients with COVID-19 may present with a myriad of symptoms ranging from fever and cough to more severe symptoms such as shortness of breath. Cetirizine and famotidine are commonly administered medications that can be found over-the-counter. They are well tolerated and have low potential for drug-drug interaction. With it's anti-inflammatory properties via modulation of proinflammatory cytokines, cetirizine may be an effective symptomatic therapeutic for COVID-19. With possible antiviral properties, famotidine may have a role in therapy as well.

After a positive COVID test has been confirmed, participants with be randomized to take cetirizine and famotidine or a placebo for 10 days and the study medication will be shipped to them. Participants will record their symptoms for 30 days and any serious adverse events will be followed for up to 60 days.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and above
* positive COVID-19 test (antigen or PCR)
* symptomatic from COVID-19
* symptoms less than or equal to 7 days

Exclusion Criteria:

* already enrolled in another COVID-19 drug study
* chronically taking a H1-receptor antagonist or H2-receptor antagonist
* have taken H1-receptor antagonist or H2-receptor antagonist less than 72 hours from expressed interest in the study.
* history of an adverse reaction to H1 or H2-receptor antagonists
* severe liver disease
* severe renal disease
* taking steroids
* taking hydroxychloroquine and/or azithromycin
* already participating in a COVID-19 vaccine trial
* already received a COVID-19 vaccine
* symptoms greater than 7 days
* have had COVID-19 more than once
Practicing Alternative Techniques to Heal From Depression: The PATH-D Study

This study is a randomized, controlled trial of Mindfulness-Based Cognitive Therapy (MBCT) versus Health-Enhancement Program (HEP) for patients with treatment-resistant major depressive disorder (MDD). Both arms of the study will continue to receive the standard medication management treatment as usual (TAU) throughout the study. MBCT is a new technique that has been found to be effective for prevention of relapse in individuals in complete recovery from depression. MBCT is a group-based, 8-week intervention that uses mindfulness meditation as its core therapeutic ingredient. It teaches people to have a different relationship to depressive thoughts and feelings. This study will use an active condition called the Health Enhancement Program (HEP) which was specifically developed to serve as a comparison condition for mindfulness interventions. HEP has been shown to decrease global stress levels and to increase perceived health. Stress has been considered a contributor to depression. One hundred and seventy four patients with MDD who have failed two or more adequate antidepressant trials will be identified and randomly assigned to one of two groups: MBCT+TAU or HEP+TAU. All patients who enroll in the study will undergo follow-up assessments at 3, 6, 9 and 12 months following the intervention. A supplemental portion of the study will enroll 88 patients to undergo functional magnetic resonance imagining (fMRI) scans immediately before and after treatment to better understand the neural pathways implicated in depression and those that may be affected through treatment.


Eligibility Criteria:
Inclusion Criteria:

DSM-IV TR Diagnosis of Major Depression receiving medication management.

Adequate trial of 2 or more antidepressants (ATHF) for a minimum of 6 weeks (one of which at UCSF).

Hamilton Depression Rating Scale 17 score ≥ 14

Any Ethnicity

English Speaking

Male or Female

No current psychotherapy (i.e. only medication management treatment) or plan to start new psychotherapy during MBCT or HEP

Exclusion Criteria:

Bipolar Disorder, Obsessive Compulsive Disorder, Schizophrenia, Schizoaffective Disorder, Antisocial and Borderline Personality Disorders, Current Eating Disorder, Pervasive Development Delay Major Depression with Psychotic Features

Active Suicidality (per HAM-D17 \> 1 on item 3)

Meditation Practice once or more per week; yoga more than twice per week at study entry

Substance Abuse Disorder within 6 months

Cognitive Disorder with Mini Mental Status Exam score \< 25

Medical illness rated 4 on Cumulative Illness Rating Scale
Brimonidine Tartrate for the Treatment of Injection Related Erythema

The primary objective of this study is to evaluate the Injection Related Erythema (IRE) mitigation effect of a single administration of brimonidine tartrate in comparison with a vehicle gel (placebo).

The secondary study objectives are to evaluate the IRE mitigation effect of a single administration of brimonidine tartrate in comparison with a vehicle gel on a more stringent definition scale, in accordance with the primary endpoint of the original brimonidine pivotal trials and participants' satisfaction with the overall appearance of their skin.

Participants naïve to treatment with subcutaneous (SC) interferons or oral Disease Modifying Therapy (DMT) who are about to start PLEGRIDY PEN therapy will be screened for participation in this Phase IV trial. Participants will remain on Plegridy therapy as prescribed by their physician. Plegridy will not be provided to participants by Biogen as a part of this study.

Eligibility Criteria:
Key Inclusion Criteria:

* RRMS patients naïve to treatment with SC interferon or oral and/or IV DMT for which PLEGRIDY is deemed necessary by the treating physician.
* Patient willing and able to complete PSA and PAA questionnaires with minimal assistance.

Key Exclusion Criteria:

* Known allergy to any interferon or any component of peginterferon beta-1a.
* Patients with hypersensitivity to Brimonidine topical gel.
* Patients with other skin disorders.
* History of previous treatment with Brimonidine tartrate.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension

To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to netarsudil (AR-13324) ophthalmic solution 0.02% and latanoprost ophthalmic solution 0.005%


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older (19 years of age or older in Canada)
2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension(OHT) in both eyes
3. Unmedicated intraocular pressure \>20mmHg and \<36mmHg in both eyes at 2 qualification visits
4. Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better
5. Able to give informed consent and follow study instructions

Exclusion Criteria:

Ophthalmic:

1. Clinically significant ocular disease
2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
3. Unmedicated intraocular pressure ≥36mmHg in either eye or use of more than 2 ocular hypotensive medications within 30 days of screening
4. Known hypersensitivity to any component of the formulation or latanoprost
5. Previous glaucoma surgery or refractive surgery
6. Ocular trauma within 6 months prior to screening
7. Any ocular surgery or non-refractive laser treatment within 3 months prior to screening
8. Recent or current ocular infection or inflammation in either eye
9. Use of ocular medication in either eye of any kind within 30 days of screening and throughout of the study
10. Mean central corneal thickness \>620µm at screening in either eye
11. Any abnormality preventing reliable applanation tonometry of either eye

    Systemic:
12. Clinically significant abnormalities in lab tests at screening
13. Clinically significant systemic disease
14. Participation in any investigational study within 60 days prior to screening
15. Systemic medication that could have had a substantial effect on IOP within 30 days prior to screening, or anticipated to be used during the study
16. Women of childbearing potential who were pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
Prehospital Ventilator-Associated Pneumonia Prevention Trial

Traumatic injury in rural America is a significant cause of morbidity and mortality, and the challenges of a rural trauma system can put patients at unique risk. Prolonged transport times to a trauma center, stopping for care at referring hospitals, and longer exposure to care-associated factors distinguish rural patients from their urban counterparts. Ventilator-associated pneumonia (VAP) is a significant risk in rural patients, increasing hospital stay, healthcare costs, and even mortality in the critically injured. The investigators propose a pilot study to test the hypothesis that a single dose of oral chlorhexidine gluconate (antiseptic) for trauma patients in the prehospital environment will decrease subsequent development of early VAP. Chlorhexidine is currently a standard therapy in intensive care units to prevent airway colonization and subsequent development of VAP. Demonstrating safety and effectiveness of prehospital infection control practices could significantly improve outcomes of traumatic injury in rural America.


Eligibility Criteria:
Inclusion Criteria:

* Adults (age \>= 18 years)
* Endotracheal intubation
* Transported by air ambulance
* Traumatic injury
* Interfacility transport (no flights from scene) en route to University of Iowa Hospitals and Clinics)

Exclusion Criteria:

* Known or suspected pregnancy
* Prisoners
* Patients diagnosed with pneumonia prior to transfer
* Known allergy to chlorhexidine gluconate
* Surgical airway (tracheostomy or cricothyroidotomy)
* Massive aspiration
* Anticipated nonsurvivable injury (survival projected \< 24 hours)
Food Survey, Curbside, Remote APPs SC

The proposed research will create accurate and standardized household FW measurement methodologies that foster serial and longitudinal assessments as well as confident and convenient one-time measurement by stakeholders. The investigators will have participants simutaneously deploy (1) retrospective surveys (2) curbside audits.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female, age 18 years and older
* Willing and able to store household food waste for curbside pickup by a third-party waste pickup company
* Internet or Wi-Fi availability to complete online surveys

Exclusion Criteria:

* Not willing to adhere to study procedures and study visit timelines
* Any condition or circumstance that in the judgement of the PI could interfere with study participation
Investigation of Acute Effects of Local Vibration and Whole-Body Vibration Applications

This study was designed as a single-blind, randomized and cross-over study to investigate and compare the acute effects of local vibration (LV) and whole-body vibration (WBV) applications on postural control in adult patients with ataxia.

The study will be included in patients aged 18-50 years, including ataxia diagnosed by the neurologist and able to walk independently. Patients with pregnancy status, epilepsy, spasticity, implant / endoprosthesis / pacemaker, benign paroxysmal positional vertigo, history of fracture in the last 6 months and other neurological diseases other than ataxia will not be included in the study. Between the applications, a washout period of one week will be given to each patient to apply both local and whole body vibrations. The order of application will be decided by the coin toss randomization method. Descriptive evaluations of the patients will be done with Mini-BESTest and Trunk Impairment Scale. Stability limits and postural sways (Bertec Balance Check ScreenerTM), gait time - distance characteristics (GAITRite), functional mobility skills (Timed Up and Go Test), and static balances (One Leg Stance Test) before, 1 minute after the application and 60 minutes after the application.


Eligibility Criteria:
Inclusion Criteria:

* Located in the 18-50 age range, diagnosed with ataxia by the neurologist, patients who can walk independently

Exclusion Criteria:

* Patients with pregnancy status, epilepsy, spasticity, implant / endoprosthesis / pacemaker, benign paroxysmal positional vertigo, history of fracture in the last 6 months, and other neurological disorders other than ataxia
Effect of Maraviroc on Endothelial Function in HIV-Infected Patients

The purpose of this study is to determine the potentially beneficial aspects of CCR5 inhibition on inflammation and endothelial function as measured by brachial artery reactivity in antiretroviral treated HIV patients with an undetectable viral load.


Eligibility Criteria:
Inclusion Criteria:

1. Stable antiretroviral therapy for at least 12 months
2. All plasma HIV RNA levels within the past year must be below level of detection (\< 50 copies RNA/mL), although isolated single values \> 50 but \< 200 copies will be allowed.
3. Screening plasma HIV RNA levels \< 50 copies RNA/mL
4. \>90% adherence to therapy within the preceding 30 days, as determined by self-report
5. Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.

Exclusion Criteria:

1. Ongoing or prior use of any integrase inhibitor or R5 inhibitor.
2. Patients who plan to modify existing antiretroviral therapy in the next 24 weeks for any reason
3. Serious illness requiring hospitalization or parental antibiotics within preceding 3 months
4. Concurrent or recent exposure to any immunomodulatory drugs
5. Advanced liver disease or active hepatitis B or C
6. Patients with systolic blood pressure \<100/70
7. Starting or stopping statin therapy during the trial
Personalized NFTs as a Trial Participation Incentive

NFTs are blockchain-based digital and physical assets traded on digital marketplaces. Current and exploratory NFT use cases include art, collectibles, in-game items, real estate, ticketing, events, fintech, licenses, IDs, and healthcare. NFT marketplaces, online games, virtual worlds, and open-source coding platforms use NFTs to incentivize participation. In trials, where the effectiveness of financial remuneration to increase trial participation is unclear, NFTs could encourage involvement. Considering the increasing opportunities for blockchain technology and NFT use in both the economy and society, we present a pilot study protocol to gauge the interest and feasibility of using NFTs as payment for trial participants, the first of its kind to our knowledge. Additionally, as the global population ages and chronic diseases become more prevalent, innovative solutions to sustain engagement in longevity-focused interventions are needed. Harnessing CURATE.AI, an indication-agnostic artificial intelligence (AI) platform that modulates the intensity of interventions to generate truly personalized profiles - or digital avatars, we will develop N-of-1 learning trajectory profiles for fifteen healthy volunteers trained on the CURATE.DTx, a digital therapeutic (DTx) platform. The profiles will be artistically modified and minted for the participants in the Ethereum blockchain, whereafter the recipient can choose to keep, display, or trade their NFT. Through interviews, we will evaluate the interest and acceptability of NFTs as an incentive for trial participation. This pioneering exploration connects AI-driven personalized medicine with inventive blockchain solutions. Our research aims to advance the field of digital therapeutics and pave the way for novel approaches to patient-centered care and incentivization strategies in clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Agree to audio-recording of the interview
* Meet the cognitive criteria for adequate mental capacity as determined by the MMSE.

Exclusion Criteria:

* Difficulty to understand and read English (the DTx text and audio are in English)
* Significant hearing impairment
* Evidence/diagnosis of severe cognitive impairment
* Inability to complete the study at the judgement of the investigators