cyrilzakka/clinical-trials huggingface dataset:
Whole Body Vibration in Middle Aged Men

This study aims of this clinical trial is to evaluate the effect of an 8-week Whole Body Vibration (WBV) intervention on Bone Mineral Density (BMD), hand grip strength, and vitamin D levels in middle-aged men. Findings from this study will contribute to understanding whether WBV is a viable alternative to conventional exercise, especially for those with limitations in physical activity.

Study Objectives:

• Primary Objective: To assess the effectiveness of an 8-week WBV intervention in improving BMD, hand grip strength, and vitamin D levels compared to a placebo intervention.


Eligibility Criteria:
Inclusion Criteria:

* Male participants aged 50 years or older
* Participants with physical activity or exercise program involvement
* Participants with no history of serious medical conditions such as tumors, fractures, epilepsy, cardiac disease, or stroke within the past year.
* Participants must be non-smokers and not receiving hormone or calcium supplement therapy

Exclusion Criteria:

* Participants unable to stand on the WBV platform
* Participants with conditions contraindicating vibration therapy
* Participants participating in other clinical trials
Virtual Reality as a Digital Premed to Alleviate Pain and Anxiety Preoperatively in Patients Undergoing Spine Surgery

The aim of this research study is to evaluate the impact of immersive VR exposure on preoperative anxiety and pain. Additionally, to assess whether VR intervention would significantly alleviate pain and anxiety levels of patients undergoing complex spinal surgeries. Investigators hypothesize that the application of pre-operative VR-based intervention will alleviate anxiety and pain both pre- and post-operatively when it is used as treatment to complement standard care compared to standard routine care alone, and that it may lead to better outcomes and higher satisfaction in patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients between 25-70 years old, undergoing an elective spinal surgery.
* Patient's admission prior to surgery day (at least 1 day).
* Expected hospital stay - 2 days.
* Capable of providing informed consent and participate in the study follow-up questionnaire.
* Patients speak Polish.

Exclusion Criteria:

* Congestive heart failure, hypertension and anti-hypertensive medications
* Adrenal insufficiency
* Alcohol addiction (evaluated by CAGE/AUDIT) and substance addiction (evaluated by DUDIT)
* Cognitive impairment (evaluated by MMSE, MoCA)
* Cerebrovascular diseases, ophthalmological diseases (strabismus, diplopia, retina degeneration, glaucoma), neurological conditions (epilepsy or seizure, dementia, vertigo, dizziness, motion sickness) - evaluated by: history taking, examination, vision test (Ishihara test), Simulator Sickness Questionnaire
* Auditory impairment
* Psychiatric illness (schizophrenia, bipolar disorder, psychotic depression) - (evaluated by MINI questionnaire)
* Patients with neuropathic pain
* Use of sedative drugs, anti-depressants, anxiolytics, and anti-epileptic drugs
* Intracranial functional lesions (patients after TBI (Traumatic Brain Injury), cognitive or executive dysfunction)
* Patient with high risk due to major and emergency operations
* Claustrophobia
* GCS \< 15
Quality of Life Variations Among Adolescent Females Following Virtual Reality Games Approach

to compare the effects of virtual reality games, aerobic exercise, and dietary modifications on Quality of Life among adolescent females.

The study will assess whether virtual reality games, aerobic exercise, and dietary modifications lead to significant differences in Quality of Life scores, and perceived exertion as measured by the Borg scale. Additionally, the study will evaluate whether these interventions produce varying impacts on psychological factors such as depression, anxiety, and stress, and on physical measurements like waist circumference (WC) and body fat composition.

Eligibility Criteria:
Inclusion Criteria:

* Obese adolescent girls
* Class I Obesity (Body Mass Index from 30 to 34.99 kg/m2)
* Have regular menstruation
* Clinically and medically stable
* no impairment of sensation or other neurological or psychological problems

Exclusion Criteria:

* Visual and/or auditory defects
* Normal weight girls (Body Mass Index from 18 to 24.99 kg/m2) or below average weight (BMI less than 18 kg/m2) or Class II \&amp; III Obesity (BMI above 35 kg/m2)
* Girls with significant tightness and/or fixed deformity of lower limbs
* Participants with neurological disorders that affect balance or mentality (e.g. epilepsy).
* Girls with advanced radiographic changes include: Bone destruction, Bony ankylosis, Knee joint subluxation, and Epiphysial fracture)
* Congenital or acquired lower limb deformities in the lower limbs.
* Cardiopulmonary dysfunction.
* Girls under insulin therapy, uncontrolled bronchial asthma, anemia, and Pathological causes of obesity (endocrinal, genetic syndromes...etc.).
To Compare the Efficacy and Safety of a Therapy of Tacrolimus With Sirolimus or MMF in Kidney Transplantation.

Primary objective of this study is to compare the two therapy regimens with regard to renal function by using calculated creatinine clearance. The secondary objectives are to compare the efficacy and safety profiles of the two therapy regimens.

This phase III study shall provide detailed efficacy and safety information to compare this combination of sirolimus and tacrolimus with the current standard tacrolimus combination regimen (tacrolimus/MMF/steroids) which is widely used in European centres.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 60 years of age and having end stage kidney disease who will undergo primary renal transplantation or retransplantation are eligible for the study. Patients receiving a kidney transplant, from a cadaveric or living donor (not HLA identical) with compatible AB0 blood type can be included.

Exclusion Criteria:

* Patient has a high immunological risk
* Cold ischemia time greater than 30 hours
* Patient has significant liver disease
* Patient has severe hypercholesterolaemia
* Patient is allergic or intolerant to study medication
* Patient requires ongoing dosing with corticosteroids.
* Patient or donor is known to be HIV positive
* Patient with malignancy or history of malignancy
Safety and Efficacy of Perioperative Remodulin® in Orthotopic Liver Transplant Recipients

Patients undergoing orthotopic liver transplant will experience some degree of clinical and/or biochemical hepatic dysfunction. This early injury is known as primary graft dysfunction and varies from minor abnormalities to primary nonfunction. Prostaglandin-class drugs, including prostacyclin and its analogs, could represent an important advance toward the goal of reducing transplant related morbidity, mortality and associated costs by providing these benefits.

In vitro and in vivo research has consistently demonstrated an array of potential beneficial effects of prostanoids under both immune and non-immune circumstances relevant to liver allografts. (1-3) Recent reviews summarize the pharmacologic rationale and nonclinical and clinical experience supporting for the use of prostanoids, including prostacyclin and its analogs, in reducing early morbidity and mortality associated with liver transplantation. Prostaglandin-class drugs, including prostacyclin and its analogs, could represent an important advance toward the goal of reducing transplant related morbidity, mortality and associated costs by providing these benefits. Additionally, the reduction in serum creatinine and reduced need for post-operative dialysis observed in some studies has implications in protecting the kidneys from the nephrotoxic affects of the immunosuppressant agents, especially during the early post-operative period.

As a chemically stable analog of prostacyclin (PGI2), peri-operative intravenous administration of Remodulin is hypothesized to ameliorate or prevent reperfusion damage and thereby decrease hospitalization time and improve the clinical outcome of liver transplantation, compared to placebo control. Remodulin, as a prostanoid, is expected to facilitate restoration of the blood supply to the revascularized graft, and to provide the well-characterized protective effects of this class of compounds in liver transplant patients.

Eligibility Criteria:
Inclusion Criteria:

* Accepted as a liver transplant candidate at the University of Pittsburgh Medical Center
* Be receiving a cadaver donor liver transplant
* Treated in accordance with the standard of care protocol(s) in effect for liver transplant recipients at the University of Pittsburgh Medical Center.

Exclusion Criteria:

* Receiving a living done liver transplant
* Receiving a donor liver with a cold ischemia time less that 6 hours
* Receiving a donor liver with macrosteatosis greater than 30%
* Receiving any investigation drug with the except of alemtuzamab (Camphath)
* Failed liver transplant in previous 180 days
* Prior organ transplant or cell infusion
* Undergoing multi-organ transplant
* Pregnant or nursing female
Isocyanate Dermal Exposures in Autobody Shops

To characterize the skin route of exposure to the allergen hexamethylene diisocyanate (HDI) in the auto body industry.

BACKGROUND:

Isocyanates account for the highest number of reported cases of occupational asthma in the United States and developed countries. Prevention, however is limited by inadequate knowledge of isocyanate routes of exposure, exposure patterns, mechanisms of sensitization and other causal factors. The Survey of Painters and Repairers of Auto Bodies by Yale (SPRAY), a five-year cross-sectional epidemiologic survey of painters and repairers of autobodies at Yale was therefore initiated to address these questions. At the outset of Spray, it was not known how frequent skin contact among the painters might be. Moreover, there is new and exciting data from animal studies demonstrating that dermal rather than respiratory contact may be crucial to immune sensitization leading to asthma. Little is known, so far, about dermal exposure in autobody shops and its modifiers, especially the effectiveness of personal protective equipment (PPE) in preventing workers from skin contamination by isocyanates.

DESIGN NARRATIVE:

The study was ancillary to the SPRAY study and was integrated into it. The overall design was a cross-sectional investigation of 20 shops with 120 workers. This would allow a better understanding of the complex basis for asthma risk in these workers, and better recommendations to autobody shops and workers on protective measures for isocyanate dermal exposures.

Specific aims included: 1) Qualitatively and quantitatively assessing surface and skin contamination of HDI; 2) Identifying modifiers that affected surface and skin contamination, and specifically evaluating the effectiveness of personal protective equipment in protecting the skin from isocyanate contamination; 3) Exploring the relationships of dermal exposure with airborne exposure, biomarkers of systemic absorption and skin sensitization, and asthma-developing risk.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Comparison of Balance and Coordination Parameters of Visually Impaired and Healthy Individuals

The aim of this \[observational study\] is to examine balance in multiple aspects by comparing balance, coordination, and gait parameters between congenitally blind individuals and healthy individuals with multiple scales.

The main questions it aims to answer are:

Is there a difference in balance and coordination between congenitally blind individuals and healthy individuals? comparison group: Healthy sedated individuals Participants will be asked to complete balance scales.

Visually impaired, with all corrections, individuals who have one tenth of the usual visual acuity of the seeing eye, i.e. 20/200 visual acuity or less, or whose visual angle does not exceed 20 degrees are called blind. The meaning of 20/200 is that an individual affected by visual impairment can see from 60 cm, while an individual with normal vision can see from 6 m. Narrow angle of vision means that, despite normal visual acuity, vision is limited only to the centre, 20 degrees, and objects beyond 20 degrees cannot be seen.

Balance depends on the integration of information received from proprioceptive, vestibular and visual sensory systems. It has been observed that visually impaired individuals have problems in postural stability and balance due to insufficient information from the visual system. In this study, it was aimed to compare the balance, coordination and gait parameters of congenitally visually impaired individuals and healthy sedentary individuals.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Congenital visual impairment
* Not having any acute or chronic disease other than congenital blindness

Exclusion Criteria:

* Having musculoskeletal deformity
* Being involved in a professional sport
* Having received physiotherapy treatment for balance before
Health Disparities on the Labor Floor

The Agency for Healthcare Research and Quality (AHRQ) defines a disparity as a difference or a gap that exist between two groups, which is both statistically significant, larger than 10%, and indicates poor quality for the minority (non-referent) group. Despite advances in public health initiatives and medicine, disparities in healthcare are persistent. For example, in the United States, maternal mortality ratio has doubled since 1987 to 2009 where African American women were 4 times as likely to die from childbirth. Although there was no observed racial disparity in maternal deaths at University of Alabama Birmingham, there is anecdotal experience that may suggest health disparities do exist on the labor floor when examining neuraxial utilization and effectiveness. This retrospective study will seek to examine the successful extension of labor analgesia for cesarean section as it relates to insurance status.


Eligibility Criteria:
Inclusion Criteria:

* Pregnancy
* Age \>/= age 18 years

Exclusion Criteria:

* Women less than age 18 will be excluded.
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ACT-1004-1239 in Healthy Male Subjects

This Phase 1 study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of ACT-1004-1239 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
* Healthy male subjects aged between 18 and 55 years (inclusive) at Screening.
* No sperm donation from (first) study treatment administration up to at least 90 days after (last) study treatment administration.
* Sexual abstinence or use of condoms from (first) treatment administration up to at least 90 days after (last) study treatment administration. Moreover, the female partner of childbearing potential must use a highly effective method of contraception.

Exclusion Criteria:

* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
* Any previous and/or ongoing relevant immune-related disorder or any evidence for immune dysfunction based on medical history and laboratory tests at Screening
* Any cardiac condition or illness (including clinically relevant 12-lead ECG abnormalities) with a potential to increase the cardiac risk of the subject based on medical history and 12-lead ECG measured at Screening.
* QT interval corrected with Fridericia's formula (QTcF) \> 430 ms, respectively, QRS interval \> 110 ms, PR interval \> 200 ms, or heart rate (HR) \> 90 bpm on 12-lead ECG at Screening and Day 1 pre-dose (of the first period when applicable).
* Treatment with another investigational treatment within the 2 months prior to Screening or participation in more than 3 investigational treatment studies within the year prior to Screening.
* History or clinical evidence of any disease and/or existence of any surgical or medical condition that might interfere with the ADME of the study treatment (e.g., appendectomy and herniotomy allowed, cholecystectomy not allowed).
* Previous treatment with any prescribed medications (including vaccines and strong CYP3A4 inhibitors/inducers) or over-the-counter (OTC) medications (including homeopathic preparations, herbal medicines, vitamins, and minerals) within the 2 weeks or 5 terminal half-lives (t½; whichever is longer) prior to (first) study treatment administration.
Assessing Decision Maker Tools for Asthma: the Asthma APGAR

Asthma is a common problem among US adults and children. Unfortunately many people with asthma continue to suffer from asthma symptoms that could be control with better asthma care and more attention to details such as triggers, and adherence. To date the only tools available and recommended by groups such as the national asthma guideline group consider only asthma burden and do not include information on the most common factors that adversely affect asthma control. This study provides one half of the enrolled primary care offices with the Asthma APGAR which is a system of patient completed questions and a care flow sheet. The other half of the enrolled practices will continue to provide "usual" care without the support of the Asthma APGAR system. The research questions is whether or not asthma control and asthma related quality of life will be improved in people with asthma who are cared for in the intervention practices that use the Asthma APGAR system.

Since this is a practice intervention study, the practices are randomized and all patients enrolled within each practice receive either the intervention based care or the usual care.

The primary outcome is asthma related quality of life obtained from patient report. Other outcomes include asthma control, also a patient reported outcome, and number of exacerbations which is obtained from patient medical record review.

Eligibility Criteria:
Inclusion Criteria:

1. Have physician diagnosed asthma
2. Male or female between ages 5 through 60 years
3. Have persistent asthma as assessed by daily use of "controller" medication
4. Receive continuity care at practice where enrolled.
5. Not have been in ICU for asthma ever
6. Do not require daily or every other day oral steroids for asthma control

Exclusion Criteria:

1. Cannot read and speak English
2. Child refuses assent
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines - (DREAM) Probenecid vs Allopurinol

This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Eligibility Criteria:
Please see https://docs.google.com/spreadsheets/d/1N3IVoirGdWS7OiKiOWWgPHhgsSxX7SWDIhpeeZ-Ft7c/edit?usp=sharing or Appendix A for full code and algorithm definitions.

Medicare timeframe: 2007 to 2017 (end of data availability).

Inclusion Criteria:

* 1. No prior use of urate-lowering agents, including probenecid and allopurinol anytime prior to cohort entry date
* 2. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date

Exclusion Criteria:

* 1. Prior history of dementia measured anytime prior to cohort entry date
* 2. No prior history of gout recorded in the 365 days prior to cohort entry date
* 3. Prior history of nursing home admission in the 365 days prior to the cohort entry date
Refractive Error in Chinese Students

This cohort study aimed to assess the change of refractive status in Chinese school children.

A cohort study was conducted in 96 primary and secondary schools in 16 districts of Tianjin from 2018 to 2020, including about 36452 people totally. The changes in myopia rate in 3 years were compared by a generalized estimation equation. The distribution of average equivalent spherical mirror and different regions and grades was evaluated by linear regression analysis, and the correlation between the equivalent spherical mirror and different gender, nationality, and age was evaluated.

Eligibility Criteria:
Inclusion Criteria:

* no concurrent eye disease
* age from 6 to 18 years old

Exclusion Criteria:

* significant systemic illnesses
* ocular conditions
* congenital corneal diseases
* pterygium, keratoconus
* corneal degeneration or dystrophy
* media opacity, uveitis, glaucoma
* history of ocular surgery
* neurologic diseases
* retinal disease.
A 3 Year Follow-up Prospective Open Randomized Trial of TVT Versus Colposuspension for Primary Stress Incontinence

Objective: To compare TVT with COLPOSUSPENSION (CS) as primary treatment for stress incontinence (SUI).

Design: Randomised, open, comparative trial 3-years follow-up. Participants: 49 consecutive 35 to 70 years old women with urodynamic SUI. Setting: Urology department of a district general hospital at Leganés (Madrid), Spain.

Intervention: 24 patients randomised to TVT and 25 to CS.

Background: Evidence comparing effectiveness of tension-free vaginal tape (TVT) and Burch's colposuspension (CS) in the long term follow-up is weak.

Objective: To compare TVT with CS as primary treatment for stress incontinence (SUI).

Design: Randomised, open, comparative trial 3-years follow-up. Participants: 49 consecutive 35 to 70 years old women with urodynamic SUI. Setting: Urology department of a district general hospital at Leganés (Madrid), Spain.

Intervention: 24 patients randomised to TVT and 25 to CS. Measurements: Main outcome: Assessment before treatment and at 6-months, 1-year and 3-years postoperatively with the incontinence severity symptoms index (ISS) and the incontinence impact symptoms index (IIS) Secondary outcome: 3 groups to asses cure rates: cured, improved and failure.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 35 and 70 who had completed their family with a clinical (Booney test positive) and urodynamic diagnosis of Stress Urinary Incontinence
* Previous surgery for prolapse, incontinence or bladder disease, urodynamic diagnosis of detrusor overactivity, or voiding difficulty (defined as maximum flow less than 15 ml/second or voiding pressure greater than 50 cm H2O or residual volume greater than 100 ml)
* Cystocele over grade I
* Previous hysterectomy
* Body mass index (BMI) of 40 or more
* Uncontrolled diabetes
* Neurological disease
* Recurrent urinary tract infections
* Genital atrophy precluding vaginal surgery
* Known bleeding diathesis or current anticoagulant therapy