cyrilzakka/clinical-trials huggingface dataset:
New Moves - Obesity Prevention Among Adolescent Girls

The New Moves study will evaluate the impact of a school based program for inactive high school girls who are overweight or at risk for being overweight due to low levels of physical activity. The primary study hypothesis is that girls in the intervention schools will significantly decrease their percent body fat as compared to girls in the control schools. Secondary research hypotheses include that girls in the intervention condition will significantly increase their physical activity levels and improve the quality of their dietary intake.

The purpose of the New Moves study is to evaluate the effectiveness of a school-based all girls alternative to regular physical education class for inactive high school girls. New Moves uses a large-scale community randomized controlled study involving girls from six intervention schools and six control schools. The New Moves class includes physical activity, nutritional guidance, and social support within a supportive, non-competitive environment. In addition the program includes individual counseling sessions.

The primary research hypothesis is that girls in the intervention condition will significantly decrease their percent body fat as compared to girls in the control condition. Secondary research hypothesis to be tested are that girls in the intervention condition will significantly increase their level of physical activity and improve the quality of their dietary intake as compared to girls in the control condition. In addition a range of socioenvironmental, personal, and behavioral variables will be compared across conditions.

Eligibility Criteria:
Inclusion Criteria:

* High school girls
* Low levels of physical activity - defined as being in precontemplation, contemplation, or preparation stages of change for physical activity with activity levels at, or below, 30 minutes per day/three days per week outside of school physical education class
* Priority will be given to girls with a body mass index (BMI) greater than or equal to the 75th percentile for age and gender

Exclusion Criteria:

* BMI less than the 25th percentile for age and gender
Go Fish: Omega-3 Fatty Acid Supplementation in Diabetes-Related Kidney Disease

In this application the investigators describe plans for a randomized controlled cross-over trial to determine the effects of omega-3 fatty acid supplementation on urine protein excretion in 30 adults with diabetes (NIDDM) and kidney disease defined by the presence of proteinuria.

Diabetes is the most common cause of end-stage kidney disease in the United States. Half of patients with diabetes develop kidney disease. The benefits of omega-3 fatty acids have been shown in animal models of kidney injury. Mechanistic studies of omega-3 fatty acid supplements support biological plausibility: omega-3 supplements have been shown to improve vascular reactivity, lower oxidative stress, reduce inflammation, and have beneficial effects on the metabolism of eicosanoids favoring synthesis of vasodilatory prostaglandins and thromboxanes. However, in spite of overwhelming evidence for a potential benefit of dietary omega-3 fatty acids at preventing or slowing progression of kidney disease for adults with NIDDM, clinical trials providing evidence to support recommendations of supplementation are lacking.

The current recommendation for omega-3 intake for adults, one gram/day of DHA+EPA, is based on evidence for cardiovascular disease risk (CVD) reduction. Whether omega-3 fatty acid prevents or slows progression of diabetic kidney disease, whether the current recommended dose is adequate to modify disease, or whether a higher dose should be recommended, needs to be determined.

In this setting, we propose to conduct a randomized placebo-controlled cross-over clinical trial to determine the effects of a daily dose of omega-3 fatty acid supplementation (4.0 g/day) compared with placebo on urine protein excretion and biomarkers of kidney injury and function in adults with diabetes and proteinuria.

Eligibility Criteria:
Inclusion Criteria:

* Participants have a diagnosis of diabetes (either oral medication or diet controlled)
* Have an average systolic blood pressure (SBP) \<150 and diastolic blood pressure (DBP) \<90 mmHg
* Have quantified proteinuria -- urine albumin/creatinine ratio of \> 17 mg/g (men) and \>25 mg/g (women) (i.e. at least microalbuminuria).
* Participants must be on stable doses of antihypertensive, hypoglycemic, and lipid lowering medications for a minimum of two months prior to randomization. Participants must agree to stay on stable doses of diabetes, antihypertensive and lipid medication for the duration of the study.

Exclusion Criteria:

* Major exclusion criteria will be poorly controlled diabetes (Hemoglobin A1c \>9%)
* Use of insulin
* Use of fish oil supplements or are unwilling to stop fish oil supplements one month prior to randomization and refrain from the supplements during the study
* Stage 4 or stage 5 CKD or a screening urine protein/creatinine ratio of \>2.5.
A Phase 1 Clinical Study in Healthy Volunteers to Investigate the Drug-drug Interaction Between Multiple Doses of RO7033877 and Multiple Doses of Colistin Methanesulfonate Sodium (CMS)

This single center, open-label, randomized study will investigate the drug-drug interaction potential between multiple doses of RO7033877 and multiple doses of colistin methanesulfonate sodium (CMS).


Eligibility Criteria:
Inclusion Criteria:

* Adult male or female (of non childbearing potential) healthy volunteers between 18 to 55 years
* Body mass index (BMI) between 18 and 30 kg/m2
* Non smokers
* Use adequate contraception methods

Exclusion Criteria:

* Evidence of active of chronic disease
* Regular consumption of drugs of abuse
* Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
* History of significant allergic reactions
* Abnormal blood pressure
* Clinically significant abnormalities (e.g. cardiovascular, laboratory values)
Safety and Efficacy Study of Two Dose Regimens of Becocalcidiol in the Treatment of Plaque-Type Psoriasis

The purpose of this study is to evaluate the efficacy and safety of two dosing regimens of QRX-101 ointment (75 mcg/g QD and 75mcg/g BID) in the treatment of plaque-type psoriasis when applied topically twice daily for 8 weeks


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stable plaque-type psoriasis affecting 2% to 10% of the subject's body surface area
* Psoriasis of a severity that is appropriate for treatment with topical therapy; PGA of at least 3 (moderate) at baseline; PSS of at least 7, and with no individual symptom score (erythema, induration, or scaling) less than 2
* Subject must sign the IRB approved informed consent and agree to follow dosing instructions and complete required clinic visits.

Exclusion Criteria:

* Pregnant or nursing females
* Systemic corticosteroids, methotrexate, cyclosporine, systemic retinoids, prolonged sun exposure or ultraviolet light therapy within 4 weeks of dosing
* Topical corticosteroids, retinoids, calcipotriene, coal tar, anthralin, or any other treatment indicated for psoriasis within 2 weeks of dosing
* Untreated bacterial, tubercular, fungal or any viral lesion of the skin
* Biologic agents/monoclonal antibodies in the last 6 months
* Currently using lithium or plaquenil
* Currently using a beta-blocking medication or thiazide diuretic and the dose has not been stabilized for at least 6 months
* History of hypercalcemia or evidence of vitamin D toxicity
* Current or history of melanoma skin cancer in the past 5 years
Exercise Oxygen Kinetic and Cardiac Output in Hypertrophic Cardiomyopathy

Fatigue and dyspnea that reduce exercise performance are common symptoms in patients with hypertrophic cardiomyopathy. Since the cause of this functional limitation has not yet been described, this study aims to evaluate the cardiopulmonary parameters measured at cardiopulmonary exercise test in combination with those obtained by non-invasive measurement of cardiac output by impedance (Physioflow) and echocardiography. These results will help to better define the mechanisms underlying limitation in these patients, also in relation to the degree of LVOT obstruction.

The aim of the present study is to assess the cardiopulmonary response to exercise in patients with hypertrophic cardiomyopathy, based on the degree of LVOT obstruction, by adding non-invasive measurement of cardiac output by Physioflow and echocardiographic parameters to the cardiopulmonary exercise test parameters associated with stroke volume and cardiac output (ie. VO2/WR, O2pulse) Consecutive patients with a previous diagnosis of hypertrophic cardiomyopathy on optimised medical therapy will be enrolled to perform a cardiopulmonary exercise test with simultaneous measurement of cardiac output and an exercise echocardiogram for clinical routine.


Eligibility Criteria:
Inclusion Criteria:

* hypertrophic cardiomyopathy diagnosis

Exclusion Criteria:

* use of long-term oxygen therapy;
* presence of comorbidities affecting the ability to perform cardiopulmonary exercise test or interfering with exercise performance;
* concomitant at least moderate chronic obstructive pulmonary disease
The RELAX TO SLEEP Study

Sleep is a biological process essential for health. Being hospitalized can exacerbate common sleep difficulties in children. Factors that contribute to sleep disturbances during hospitalization include environmental, physiological, and psychological factors. Although sleep interventions exist for healthy children in the community, interventions aimed at hospitalized children need to be developed and piloted with rigorous evaluative methods. The primary purpose of this study is to examine the feasibility and acceptability of the RELAX TO SLEEP program on hospitalized children. Although this study is a pilot study, comparisons will be made to examine sleep outcomes between the intervention group and the control group including: total nocturnal (19h30-07h29), number of nighttime awakenings, longest stretch of nocturnal sleep, and total daytime (07h30-19h29) sleep. Other comparisons include anxiety levels and the development of post-hospital maladaptive behaviours.


Eligibility Criteria:
Inclusion Criteria:

1. Children between the ages of 4 and 10.
2. Children expected to stay for 3 nights.
3. Children must have a parent present that plans to stay overnight with the child and must understand English (parent must read English).
4. Child must be in a single private room.

Exclusion Criteria:

1. Children who are receiving palliative care only during their hospital admission.
2. Children diagnosed with a sleep disorder or a clinical anxiety disorder.
3. Children with limited or abnormal movements of both upper and lower extremities (e.g. paralysis, brain injury, cerebral palsy, use of drugs to induce paralysis, musculoskeletal impairments, use of restraints, under heavy sedation), thereby impairing sleep wake activity recording and the inability to use the relaxation breathing exercise.
4. Children who are too acutely ill to participate in the study.
5. Children who have major cognitive impairments that may impact their ability to understand and carry out the intervention.
6. Children who are heavily sedated or receiving benzodiazepines or chloral hydrate.
AI ENRICH - AI Detection of ICH

To evaluate the performance of the Viz RECRUIT software in subjects identified as symptomatic of a stroke event as determined by standard of care imaging assessments and interpretation.

This study will be a multicenter prospective feasibility trial to evaluate the performance of the Viz RECRUIT software. This study will enroll subjects evaluated at each center for stroke via CT imaging. The Viz RECRUIT software will review the CT and notify a specialist if an ICH is detected. It will also evaluate the ICH parameters per study specific guidelines related to the ENRICH Trial and notify a specialist if their ICH meets the study inclusion or exclusion criteria related to cerebral blood flow volume. If an enrolled subject is ultimately included in the ENRICH trial, they will be identified in a prospective cohort of subjects exposed to Viz (intervention arm) will be evaluated per the secondary endpoints to a cohort of subjects retrospectively from the ENRICH Trial (control arm) which were evaluated and enrolled prior to Viz use.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with stroke symptoms who undergo CT brain imaging.

Exclusion Criteria:

* Subjects with poor or incomplete CT brain imaging.
ALTO-100 in Bipolar Disorder with Depression (BD-D)

The purpose of this study is to assess antidepressant efficacy differences between ALTO-100 and placebo during the Double-Blind period in patients with bipolar disorder I or II with current major depressive episode, when used adjunctively to a mood stabilizer, related to patient characteristics. Additionally, safety, tolerability, and efficacy will be assessed in a subsequent open label treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of BD-I or BD-II as well as BD-D
* At baseline, taking a mood stabilizer, lithium (LI) or lamotrigine (LMG) or valproic acid (VPA, any form) or combination of Li + LMG or Li + VPA for at least 6 weeks with no dose modifications in the past 2 weeks
* Willing to comply with all study assessments and procedures
* Must not be pregnant or breastfeeding at time of enrollment or throughout study

Exclusion Criteria:

* Evidence of unstable medical condition
* Concurrent use of any prohibited medications or substance use disorder
* Diagnosed psychotic disorder (other than mania or depression)
* Current moderate or severe substance use disorder
* Has a history of hypersensitivity or allergic reaction to ALTO-100 or any of its components/excipients
* Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
Airway Manoeuvers - Implications for Airway Management?

In anesthesia, intubation is a technique used to secure an airway. This technique is not always straightforward. Sometimes it is difficult to place an endotracheal tube. There are two manners of giving pressure to the patients neck, to improve view and facilitate intubation.

The investigators hypothesize that by giving this pressure the effective work area is likely to be smaller. The investigators would like to quantify this effect by measuring the effective work area, using a specially designed computer program.

Cricoid pressure (CP) and the backward-upward-rightward pressure (BURP) manoeuver, are extralaryngeal manoeuvers which are widely applied during endotracheal intubation, respectively offering potential protection against passive gastric regurgitation and improved laryngeal view in emergency airway management.

Their validity in achieving an improvement of the laryngeal view has been questioned.

The objective of this study is to measure the change in mean anterior-posterior rima glottidis (APRIMA) distance and mean area under the vocal cords after backward upward rightward pressure (BURP) and cricoid pressure (CP).

The investigators will measure the APRIMA distances and areas under the vocal cords, using a specially created module in the program DeVIDE. The measurements assessed during BURP and CP will be expressed relative to the measurements when no external pressure is applied.

Eligibility Criteria:
Inclusion Criteria:

- 200 consecutive adult patients scheduled for elective surgery requiring endotracheal intubation

Exclusion Criteria:

* BMI \> 35 kg.m-2);
* chronic obstructive pulmonary disease;
* history of difficult intubation;
* mouth opening \< 3 cm;
* inadequate neck mobility;
* history of oropharyngeal pathology.
Strength Training Regimen for Normal Weight Diabetics

The Strength Training Regimen in Normal Weight Diabetics (STRONG-D) study will examine the effectiveness of different exercise regimen types in controlling diabetes for the normal weight type 2 diabetes population.

In the STRONG-D study, participants are randomly assigned to strength training, aerobic training or a combined strength and aerobic training group. Participants in the exercise group will attend exercise sessions over the course of 9 months at the YMCA. Participants will have opportunities to engage in other activities such as educational run-in visits that will allow for measurement of hemoglobin A1c and emphasize the importance of exercise in improving Type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Recent hemoglobin A1c result between 6.5%-13%
* Diagnosis of Type 2 Diabetes Mellitus
* BMI between 18.5 -25 kg/m2
* Blood pressure \< 160/100
* Sedentary lifestyle
* Able and willing to enroll and meet requirements of the study

Exclusion Criteria:

* Age less than 30 years or greater than 75 years
* Type 1 diabetes or use of insulin pump
* Triglycerides \>500 mg/dL
* Use of weight loss medication
* Bariatric surgery
* Consumes \>14 alcoholic drinks per week
* Pregnancy
* Plans to be away for more than four weeks
* Medical conditions which would prevent long-term participation or which would contraindicate physical activity
Does an Additional Antirotation U-Blade (RC) Lagscrew Improve Treatment of AO/OTA (Orthopaedic Trauma Association) 31 A1-3 Fractures With Gamma 3 Nail?

The purpose was to evaluate whether the additional use of the Gamma3 ® RC Lag Screw is associated with a reduced cutout rate in patients with OTA/AO 31A1-3 inter-trochanteric fractures.


Eligibility Criteria:
Inclusion Criteria:

* OTA/AO 31A1-3 fractures treated with Gamma 3® Nail (Stryker Trauma Germany) and either with standard lagscrews or with the Gamma3 ® RC Lag Screw (Stryker Trauma Germany)

Exclusion Criteria:

* Patients with pathological fractures
* Patients treated with a long gamma nail were excluded
TMS for Improving Response Inhibition in Adolescents With OCD

The study will examine whether inhibition of the pre-supplementary motor area (pSMA) using transcranial magnetic stimulation (TMS) normalizes activity in pSMA-connected circuits, improves response inhibition, and reduces compulsions in adolescents with OCD.


Eligibility Criteria:
Inclusion Criteria:

* Age 13-18 years
* Presence of OCD, as indicated by score on the Children's Yale-Brown Obsessive-Compulsive Scale
* Patient and one parent speak English fluently (to ensure comprehension of study measures and instructions
* Right-handed
* If taking psychotropic medications, these have been stable for \> 6 weeks and are expected to remain stable for the approximately 3-week study protocol
* If currently in psychotherapy, symptom improvement has plateaued (no improvement in the past 6 weeks and symptoms expected to remain stable for the approximately 3-week study protocol)

Exclusion Criteria:

* • Medical conditions contraindicated for TMS or EEG, including history of intracranial pathology, increased intracranial pressure, epilepsy or seizures, traumatic brain injury, brain tumor, stroke, implanted medical devices, possible pregnancy (female of childbearing age not using effective contraception), or any other serious medical condition (note that medical history will be reviewed by a study physician prior to TMS administration)

  * Metal in the head, except mouth (e.g., cochlear implant, implanted brain stimulators, aneurysm clips)
  * Active suicidality or psychosis
  * Existing diagnosis of Bipolar disorder, Autism Spectrum Disorder, mental retardation, or cognitive disability
  * Substance abuse or dependence
  * Taking a stimulant medication (and unwilling to forgo on study visit days)
  * Taking medication with the potential to lower seizure threshold (e.g., neuroleptics, antipsychotics)
  * Patient is a ward of the state
  * Family history of epilepsy
  * History of syncope
Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer

This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen.


Eligibility Criteria:
Inclusion Criteria:

* ErbB-2 positive locally recurrent or metastatic breast cancer
* Eastern Cooperative Oncology Group (ECOG) 0-2
* Measurable disease
* Availability of tumor tissue for HER2 status confirmation

Exclusion Criteria:

* Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent or metastatic disease
* Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or adjuvant setting
* Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant therapy
* History of heart disease
* History of gastrointestinal disease
To Evaluate the Safety and Efficacy of Inhaled CT-P63 and CT-P66 Combination Therapy in Symptomatic Patients With COVID-19 Not Requiring Supplemental Oxygen

This is a Phase 3 study to assess the efficacy about therapeutic effect of inhaled CT-P63 and CT-P66 combination therapy to symptomatic patiemts with COVID-19 and overall safety.

CT-P63 and CT-P66 are monoclonal antibodies targeted against SARS-CoV-2 spike receptor binding domain as a treatment for COVID-19 infection. CT-P63 and CT-P66 are currently being developed by the Sponsor as a potential treatment for COVID-19 infection. In this study, efficacy, safety, and virology of inhaled CT-P63 and CT-P66 will be evaluated in symptomatic patients with COVID-19 Infection.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female patient, aged 18 or above.
* Patient diagnosed with SARS-CoV-2 infection at Screening by using the sponsor-supplied rapid SARS-CoV-2 diagnostic test or RT-PCR.
* Patient with conditions meeting all of the following criteria:

  1. Oxygen saturation ≥ 94% on room air.
  2. Not requiring supplemental oxygen.
* Patient who has onset of one or more of the SARS-CoV-2 infection associated symptoms within 7 days prior to the study drug administration.

Exclusion Criteria:

* Patient with current serious condition meeting one of the following:

  1. Previously or currently hospitalized or requires hospitalization for treatment of serious SARS-CoV-2 related conditions.
  2. Respiratory distress with respiratory rate ≥30 breaths/min.
  3. Severe pneumonia
  4. Requires supplemental oxygen
  5. Experience shock
  6. Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.
* Patient who has received or has a plan to receive any of following prohibited medications or treatments:

  1. Drugs with actual or possible antiviral drugs and/or possible anti-SARS-CoV-2 activity including but not limited to nirmatrelvir and ritonavir, molnupiravir, remdesivir, chloroquine, hydroxychloroquine, dexamethasone (or alternative corticosteroids to dexamethasone), and other immunomodulatory agents and human immunodeficiency virus protease inhibitors for therapeutic purpose of SARS-CoV-2 infection prior to study drug administration
  2. Any SARS-CoV-2 human intravenous immunoglobulin, convalescent plasma for the treatment of COVID-19 infection prior to study drug administration
  3. Any approved monoclonal antibody (sotrovimab, casirivimab and imdevimab, bamlanivimab and etesevimab, etc), any other investigational device or medical product including but not limited to any monoclonal antibody(tocilizumab, sarilumab, etc.), fusion proteins or biologics for the treatment of COVID-19 infection prior to the first study drug administration.
  4. Any investigational vaccine for SARS-CoV-2.