cyrilzakka/clinical-trials huggingface dataset:
Improving the Mental Health and Well Being of Healthcare Providers Through the Transcendental Meditation Technique

The level of stress-related disorders experienced by Healthcare Providers (HCPs) has increased due to the recent COVID-19 Pandemic, impacting patient care and provider shortages. This trial aims to evaluate the use of the Transcendental Meditation Technique in improving burnout and wellbeing of HCPs over a 3-month trial period.

A total of 130 HCPs will be recruited from participating Miami hospitals, with 65 HCPs receiving training in the use of the Transcendental Meditation Technique. The remaining participants will be part of a matched control group and will not receive any training. Study outcomes will be assessed at baseline, 2 weeks, 1 month, and 3 months.

This parallel population study aims to optimize and evaluate Healthcare Provider (HCP) wellness and performance through an evidence-based stress reduction program, Transcendental Meditation.

Transcendental Meditation (TM) has been found to be effective in reducing adverse mental health outcomes, including burnout, emotional exhaustion, depression, anxiety, insomnia, and trauma symptom severity. It is a mind-body program that allows the practitioner to experience progressively quieter, less excited states of mental activity.

For this trail, 65 HCPs affiliated with three participating Miami hospitals (Baptist Health South Florida Hospital, Mercy Miami Hospital and Encompass Health Rehabilitation Hospital of Miami) will receive instructions in the Transcendental Meditation Technique. A control group of similar numbers of HCPs will be recruited to match, to the best extent possible, for gender, age, type of HCP (doctor, nurse, etc.), and work schedule (e.g., days, nights, etc.). The control group participants will not receive Transcendental Meditation Technique training and will continue with their usual lifestyle.

The total duration of the study period will be 3 months. Study outcomes will be assessed at baseline, 2 weeks, 1 month, and 3 months' posttest, with change in burnout, insomnia, symptom, and well-being, as measured by the corresponding indexes as the primary outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Fulltime healthcare providers, medical doctors, physician assistants, nurses or other HCPs involved in active patient care or administration of patient care (Hospital Administration).
2. 18 years or older.
3. Have treated COVID-19 patients or working at locations where COVID-19 patients are being treated.
4. Willing and able to complete both baseline and post-testing.
5. If being treated with psychoactive medications, the maintenance of a stable regimen for at least two months before enrollment.
6. In the non-control group, willing and able to dedicate the time to learning the Transcendental Meditation technique and practice it twice daily for approximately 20 minutes.

Exclusion Criteria:

1. Already instructed in the Transcendental Meditation technique.
2. Currently unstable psychiatric symptoms as demonstrated by self-report, medical chart, or psychiatric hospitalizations in the past six months.
Repetitive Transcranial Magnetic Stimulation in Irritable Bowel Syndrome

The purpose of this study is to evaluate the efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) on rectal hypersensitivity in patients with irritable bowel syndrome (IBS) in a prospective, randomized, double-blind study.

IBS patients frequently demonstrate a rectal hypersensitivity which could participate to the abdominal pain. rTMS is an effective treatment of neurogenic chronic pain. The aim of the study is to evaluate the efficacy of rTMS on rectal hypersensitivity in patients with IBS in a prospective, randomized, double-blind study.

Patients and method: 20 patients with rectal hypersensitivity secondary to IBS will have one active session of rTMS located on the cortical area of the abdominal muscles during 5 consecutive days and one session of simulated rTMS during 5 over consecutive days corresponding to the placebo session. The order of the two session will be randomized. The efficacy of rTMS will be assessed by a rectal barostat to determine the pain or discomfort threshold and by a RIII reflex. The barostat and RIII reflex will be performed at the beginning and at the end of each session.

The investigators hope to demonstrate an improvement of the rectal hypersensitivity during the active stimulations compared to the placebo one.

Eligibility Criteria:
Inclusion Criteria:

* more than 18 years old
* IBS defined by Rome III criteria
* Rectal hypersensitivity evaluated by barotat with a pain or inconfort volume less than 28 mmHg
* IBS for more than 3 months
* With an organic exploration for less than 6 months
* Without any knowledge concerning the rTMS

Exclusion Criteria:

* Pregnant women or women without any contraception
* Patients with pace-maker or other metallic implant
* Patients complaining of epilepsia or with past of epilepsia
* Patients with psychiatric disorders
* Patients treated by any drugs which could interfere with rTMS
* Patients having participate to another protocol within the month preceeding the inclusion
* Patients who could not stop the antalgic drugs within the week preceeding the onset of the study
* patients with a significant lesion on RMI.
Management of Pes Planovalgus With Talocalcaneal Coalition ,Osteotomy vs Arthroereisis

the investigators compare the corrective osteotomies vs arthroereisis in management of talcalcaneal coalition in adolescents as regard the outcome to provide the best intervention for the patient

In talocalcaneal coalition management is controversial so in this study the invstigators try to compare techniques other than coalition excision only or fusion only by using two types of intervention including first coalition excision and multiple corrective osteotomies according to deformity as evans ,medial displacement calcaneal osteotomy and cotton osteotomy vs coalition excision and arthroereisis the investigators compare functional and radiological outcomes and complication to provide the best management for these patients .

Eligibility Criteria:
Inclusion Criteria:

* flat foot due to talocalcaneal coalition Symptomatic patient Resectable coalition Age between 10 and 20

Exclusion Criteria:

* flat foot of other etiology Age more than 20 Concurrent knee deformity unless corrected before surgery Extensive coalition more than 50 %of posterior facet
Safety and Feasibility of Sutureless Pars-plana Vitrectomy in Sub-Tenon Anesthesia

The aim of this prospective study is to investigate the feasibility of performing minimally invasive vitrectomy under sub-tenon anesthesia in terms of intraoperative patients' tolerance and the surgeon's confidence. In particular, the tolerance and pain sensation during the operation as well as the possible perception of light and colour sensations are to be recorded with the help of questionnaires. In addition, the surgeon's impressions regarding eye motility, chemosis and general feasibility will be evaluated.

A prospective, one-center clinical trial to identify the safety and feasibility of sutureless pars-plana vitrectomy performed in sub-tenon anesthesia.

Background:

In Germany pars-plana vitrectomies are mostly performed in general anesthesia. This requires the immediate availability of a trained anesthesiology team, which is not always granted, especially in urgent eye disease (i.e. endophthalmitis, high risk retinal detachment). Furthermore, some patients are not suitable for general anesthesia due to systemic diseases (i.e. cardio-vascular diseases). There are several procedures of local ocular anesthesia (i.e. peribulbar, retrobulbar, sub-tenon anesthesia). The main advantage of sub-tenon anesthesia is the use of a blunt cannula limiting the risk of potential complications.

Purpose:

The purpose of this study is to investigate the safety of local sub-tenon anesthesia procedure for sutureless vitrectomy (anesthetic mixture: 2ml xylocaine and 2ml bupivacaine) in a prospective clinical study design.

Objectives:

Primary outcome: The evaluation of 1. sensation of pain, 2. patients' intraoperative discomfort and 3. visual sensations using the standardized questionnaires (WONG-BAKER Faces Scale, Visual Analog Scale and individual questions).

Secondary Outcome: The evaluation of 1. chemosis, 2. eye movement, 3. surgeon's general feeling of comfort during surgery (rating scale).

Eligibility Criteria:
Inclusion Criteria:

* Age over 40 years
* Presence of a clinical condition that requires surgical treatment with vitrectomy and does not necessarily require general anesthesia (retinal detachment, endophthalmitis, vitreous hemorrhage, after silicone oil surgery, vitreomacular traction, epiretinal gliosis, macular holes, subretinal bleeding, lens luxation).

  * The medical indication for vitrectomy is not linked to study participation. Not until the patient has consented to the vitrectomy (standardized information forms) potential study subjects will be approached to participate in the clinical trial.
* Willingness to participate in the clinical trial
* Understanding the objectives of the clinical trial and the study process
* Signed informed consent form

Exclusion Criteria:

* Concomitant diseases of the eye

  * State after filtering glaucoma operations
  * Distinct corneal opacities, which make the examination considerably more difficult
  * Complicated proliferative vitreoretinopathy
* Lack of understanding of the study, its objectives and study conduct
* Psychiatric diseases
* Pregnancy
* Simultaneous participation in another clinical trial
HIV Prevention Toolkit for HIV-negative Male Couples

Though technology is integrated into the lives of our target population, use of any particular technology will depend on the content delivered, aesthetic appeal, and overall design. Based on the completion and analysis of data from Phase 1, the investigators were able to obtain feedback on HIV-negative male couples' attitudes toward the original content in the prevention toolkit modules. The research team, along with the web-developers, used this feedback to specifically tailor the content of the modules to fit the unique needs of the intervention's target population: at risk HIV-negative male couples. For Phase 2, the investigators conducted focus groups at each site to help identify strengths and potential areas for improvement of the prevention toolkit, which will be incorporated before piloting it in the intervention for Phase 3 of this project. After assessing the acceptability of the prevention toolkit, including the content of modules, aesthetic appeal, and overall design with HIV-negative male couples target population, the research team will pilot test whether the RCT with the prevention toolkit will help reduce HIV risk through formation and adherence to a sexual agreement, reduction in occurrences of condomless anal sex with casual sex partners, and increase testing behaviors among at-risk HIV-negative male couples. The interactive website, herein referred to as the "HIV prevention toolkit" will contain unique modules about sexual agreements and effective HIV prevention strategies.


Eligibility Criteria:
Inclusion Criteria:

Eligible male couples:

1. are identified as two men (i.e., main partners) who had been in a sexual relationship together for \> 6 months;
2. are at least 18 years of age;
3. are self-reported as being HIV-negative;
4. had been practicing CAS in their relationship for \> 6 months;
5. report no recent history (\< 1 year) of intimate partner violence (IPV) or coercion;
6. have had no current sexual agreement; and
7. own a smartphone and have an alternate method to access the Internet (e.g., computer).

Exclusion Criteria:

1. Interested participants, including both men of a male couple, who did not meet the inclusion criteria above will be excluded from participating in Phase 3 of this study.
2. Individuals who participated in Phase 1 or 2 will be were excluded from participating in Phase 3 of this study.
3. Adults who are unable to consent;
4. Individuals who are not yet adults;
5. Pregnant and non-pregnant women, and prisoners.
Phase I Study of AZD2171 co-Administered With Fixed Multiple Oral Doses of ZD1839 in Patients With Advanced Cancer

Phase I AZD2171 in combination with ZD1839 study recruiting patients with advanced cancer


Eligibility Criteria:
Inclusion Criteria:

* tumor progressed on standard therapy or ineligible for standard therapy
* life expectancy of 12 weeks or more
* WHO performance status 0-2

Exclusion Criteria:

* History of active interstitial lung disease
A Pilot Study to Examine the Role of Nitazoxanide to Prevent Recurrence of Hepatitis C After Transplantation

Recurrence of Hepatitis C virus infection (HCV) is universal after orthotopic liver transplantation (LTx) and is associated with allograft failure, death and need for re-transplantation. Currently, there are no effective therapies to prevent HCV recurrence. Nitazoxanide (NTZ), an oral thiazolide anti-infectious agent, was safe, well tolerated and effective in achieving sustained viral response in patients with chronic HCV genotype 4. Its role in the prevention of HCV recurrence after liver transplantation has not been studied. The investigators propose to conduct an open label pilot study examining the role of NTZ in the prevention of HCV re-infection in eight patients undergoing LTx. First time transplant recipients for chronic HCV without history of renal failure or HIV/HBV co-infection, will receive NTZ immediately prior to LTx and for 3 days thereafter. The primary endpoint is the number of patients who remain HCV-RNA-negative at day 7 after LTx. If at least one patient remains negative, the study will be determined to be positive. Additionally, the investigators will examine the viral kinetics of HCV, tolerability and safety of NTZ.

Recurrence of Hepatitis C virus infection (HCV) is universal after orthotopic liver transplantation (LTx) and is associated with allograft failure, death and need for re-transplantation. Currently, there are no effective therapies to prevent HCV recurrence. Nitazoxanide (NTZ), an oral thiazolide anti-infectious agent, was safe, well tolerated and effective in achieving sustained viral response in patients with chronic HCV genotype 4. Its role in the prevention of HCV recurrence after liver transplantation has not been studied. We propose to conduct an open label pilot study examining the role of NTZ in the prevention of HCV re-infection in eight patients undergoing LTx. First time transplant recipients for chronic HCV without history of renal failure or HIV/HBV co-infection, will receive NTZ immediately prior to LTx and for 3 days thereafter. The primary endpoint is the number of patients who remain HCV-RNA-negative at day 7 after LTx. If at least one patient remains negative, the study will be determined to be positive. Additionally, we will examine the viral kinetics of HCV, tolerability and safety of NTZ.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female patients age 18-75
* HCV infection identified by positive, quantifiable HCV RNA prior to transplant

Exclusion Criteria:

* Scheduled recipient of living donor transplantation
* History of chronic hepatitis B or HIV infection
* Transplantation for fulminant hepatic failure
* Estimated glomerular filtration rate \<60ml/min
* Women who are pregnant or breast feeding and men or women that are sexually active but do not agree to use acceptable birth control
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02390 in participants with select advanced malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Participants with locally advanced or metastatic tumors who are not eligible for any available therapy likely to convey clinical benefit (locally advanced disease must not be amenable to resection with curative intent).
* Participants who have disease progression after treatment with available therapies that are known to confer clinical benefit or who are intolerant to treatment.
* Willingness and ability to safely undergo pretreatment and on-treatment tumor biopsies (core or excisional).
* Eastern Cooperative Oncology Group performance status 0 or 1.
* Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.

Exclusion Criteria:

* Laboratory values at screening outside the protocol-defined ranges.
* Administration of colony-stimulating factors within 14 days before Study Day 1.
* Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
* Receipt of a live vaccine within 30 days of planned start of study drug.

Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox/zoster, yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live-attenuated vaccines and are not allowed.

* Active autoimmune disease that required systemic treatment in the past (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
* Known active central nervous system metastases and/or carcinomatous meningitis.
* Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for \> 1 year, after treatment with curative intent.
* Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
* Active infection requiring systemic therapy.
* Evidence of active HBV or HCV infection.
* Known history of HIV (HIV 1/2 antibodies).
* Known allergy or reaction to any component of study drug or formulation components.
* Prior treatment with an anti-TIM-3 antibody for any indication.
Single Rising Dose Study of BI 207127 NA in Healthy Male Asian Volunteers and Single Dose Study of BI 207127 NA in Healthy Male Caucasian Volunteers

The aim of the study is to evaluate safety, tolerability and pharmacokinetics in Asian and Caucasian healthy male volunteers administered BI 207127 NA.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male volunteers
2. Chinese ethnicity or Japanese ethnicity or Caucasian
3. Body Mass Index (BMI) = 18.5 and BMI =25 kg/m2 for Japanese and Chinese, BMI =18.5 and BMI = 29.9 kg/m2 for Caucasians

Exclusion criteria:

1. Any finding of the medical examination (including Blood pressure(BP), Pulse rate (PR) and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease
3. Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
Fuel for Fun: Cooking With Kids Plus Parents and Play

Fuel for Fun: Cooking with Kids Plus Parents and Play (FFF), is an integrated research, extension, and education project targeting 4th grade students. Its long-term goal of reducing the risk of childhood obesity will be addressed by promoting healthful food and activity environments, policies and behaviors through: 1) building and testing the efficacy of a 4th grade comprehensive school- and family-based intervention, 2) applying it to an after-school setting to broaden its reach, and, 3) disseminating both versions through outreach.

Fuel for Fun: Cooking with Kids Plus Parents and Play (FFF) is based on existing, evidence-based components: the experiential Cooking with Kids curriculum, the SPARK Active Recreation program; principles of behavioral economics in school cafeterias and homes; the online About Eating 5-lesson module based on eating competence concepts, and a family-based FFF component specifically designed for this intervention.

Each component addresses policy and environment in addition to behavior change at school and home. The main research project - school-based FFF - will be implemented in 8 low-to-moderate income schools for two years using an asynchronous design that allows for assessment of the school-based program alone and in combination with both parent programs. Changes in fruit and vegetable intake (measured by self-report, cafeteria plate waste) and activity levels (measured by self-report and accelerometry) are primary outcomes, with measured BMI as a secondary outcome. Subsequent studies will involve the development of an after-school version and adoption of FFF by other districts.

University students will gain valuable research experience and school and Extension educators will receive important childhood obesity prevention training. The project's long term goal is consistent with the United States Department of Agriculture (USDA) goal of improving the nation's nutrition and health by promoting the development of healthy eating and activity habits in children.

Eligibility Criteria:
Inclusion Criteria:

* all students enrolled in participating classrooms are invited to participate

Exclusion Criteria:

* none
Study to Evaluate QLS-101 Compared to Timolol Maleate Eye Drops in Subjects With High Eye Pressure (Glaucoma or Ocular Hypertension).

Evaluating the safety and tolerability of QLS-101 versus timolol maleate ophthalmic solution in glaucoma or ocular hypertension.

Multi-site study to evaluate the safety and tolerability of 3 concentrations of QLS-101 versus timolol maleate Preservative Free (PF) 0.5% ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension

Eligibility Criteria:
Inclusion Criteria:

1. Visual acuity +1.0 logMAR or better
2. Willing to give informed consent
3. Ability to washout from current intraocular pressure lowering medications -

Exclusion Criteria:

1. Severe glaucomatous damage
2. Previous glaucoma intraocular or laser surgery
3. Refractive surgery
4. Ocular infection or inflammation