cyrilzakka/clinical-trials huggingface dataset:
Long-term Effects of Blueberry Supplementation on Brain Health in Older Adults

This study will test whether consuming blueberry powder 20g/d for 24 weeks can improve memory and other cognitive function and alter serum biomarkers of brain injury among older adults.

In a randomized, double-blind placebo, controlled design, the investigators will test the effects of 20 g/d of blueberry powder for 24 weeks on cognitive function and serum biomarkers of brain injury among older adults.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 65-99 years
* Able to travel to Brigham and Women's Hospital for 4 clinic visits

Exclusion Criteria:

* Known allergies to blueberries
* Unable to abstain from blueberry consumption during the study period
* Inability to provide informed consent
* Planned major surgery during study period or recent major surgery up to 3 months before recruitment
* Organ transplant
* Plan to move out of greater Boston area during the study period
* Diagnosis of dementia, severe cognitive decline, end-stage renal disease, substance abuse, insulin-dependent diabetes mellitus, major cancer excluding non-melanoma skin cancer, and schizophrenia.
Magnetic Resonance Imaging Diffusion Tensor Tractography for Early Osteoarthritis Assessment

The aim of this study is the evaluation of new MRI tractography maps for early knee osteoarthritis assessment.

Knee osteoarthritis (OA) is a common and chronic degenerative disease of the articular cartilage. Despite recent progress in the field of cartilage imaging, no routinely used clinical imaging modality has the ability to evaluate and monitor changes in cartilage degeneration.

More and more studies report the benefits of Magnetic Resonance (MR) diffusion tensor imaging (DTI) in the study of early knee osteoarthritis and in particular the new MRI contrasts generating the Track Weighted Imaging (TWI) technique.

This observationnal, pilot, prospective, unrandomized and uncontrolled study aim to evaluate, for the first time, the new MRI tractography maps for the assessment of early knee osteoarthritis. This study doesn't modify the medical care of the patient.

Eligibility Criteria:
Inclusion Criteria:

Over 18 years of age Knee prosthetic surgery indication with cartilage excision

Exclusion Criteria:

Refusal to sign a non-objection form
Pediatric Vaccinations

As the Covid-19 pandemic hit New York City in the spring of 2020, many families were home-bound due to the city-wide lockdown. As a result, families in New York City were unable to attend their child's healthcare appointments and many young children did not receive their regularly-scheduled vaccinations. Parts of the city-wide lockdown did eventually lift in the summer of 2020 as positive Covid-19 virus rates declined in NYC. However, regularly scheduled vaccination rates (non-Covid-related) remain low. Yet, it is critical that young children receive their mandatory vaccines in a timely manner to decrease the chance of contracting preventable illnesses. Thus, the investigators seek to increase vaccination rates among children ages 0-2 years in Sunset Park Brooklyn.


Eligibility Criteria:
Inclusion Criteria:

* Children ages 0-2 years with delayed vaccinations (due for vaccine and due soon) in NYU Brooklyn Family Health Centers network.

Exclusion Criteria:

* Children above the age of 2 who do not attend NYU Brooklyn Family Health Centers network
Association Between Physical Activity Level ，Overall Muscle Strength and Pelvic Floor Muscle Function in Women.

In this study, it is assumed that grip strength is associated with pelvic floor muscle strength. And the outcome of pelvic floor function can be predicted by referring to the status of pelvic floor muscle strength through the value of grip strength, which is labor-saving, time-saving and more convenient for evaluating pelvic floor muscle function. Moderate physical activity and increase the overall strength can activate the potential mechanism of pelvic floor muscle contraction at the same time may be a "core muscles" overall effect, that core muscles mainly includes transverse abdominal muscle, pelvic floor muscles and the muscles around the back, these muscles in the body movement to spontaneous collaboration contract pelvic floor muscles, enhancing pelvic floor muscle function, thus reducing the incidence of pelvic floor dysfunction.

This study is a cross-sectional observational study, planned to enroll 942 participants from Gynecology Outpatient Clinic. Uniformly trained physicians as investigators to collect indicators from questionnaires and physical examinations.

Questionnaires may contain general information which include the patient's age, height, body weight before pregnancy and childbirth, weight gain during pregnancy, gestational age, pregnancy time, production time, high palace, delivery mode, neonatal birth weight, body length, blood sugar, blood fat, whether or not to use during pregnancy, childbirth, labor, perineal laceration, forceps midwifery, episiotomy and epidural data, pelvic floor cognition degree, physical activity levels, pelvic floor dysfunction score, pelvic floor functional impact score and sexual function score (including the prenatal and postnatal participants).

Physical examinations will be performed without the results of the questionnaire, including stress tests, pelvic floor POP-Q staging, pelvic floor muscle strength by palpation, vaginal relaxation degree, grip strength value, rectus abdominis separation, waist circumference, waist-hip ratio, etc.

Through univariate analysis of the general data of the patients, the related factors of female PFD were obtained, and the independent influencing factors of PFD were found by binary Logistic regression analysis (the dependent variable in this study was a dichotomous variable). The ROC curve was used to evaluate the predictive value of patients' overall strength level, physical activity level, body shape and other indicators on PFD outcome.

Eligibility Criteria:
Inclusion Criteria:

* Gynecological outpatient clinic patients
* In good condition and able to actively cooperate
* Agree to conduct the study.
* Age range: 18 to 80 years old

Exclusion Criteria:

* Patients who has a history of pelvic surgery or has had pelvic floor functional diseases
* Patients who do not have sex
* Pregnancy
* Patients who have serious medical diseases
* Patients with cardiac dysfunction or wear pacemakers
* Patients with neurological diseases and cognitive impairment who are difficult to cooperate with the study
Clinical Trial of Simvastatin to Treat Generalized Vitiligo

The investigators purpose is to initiate a phase II, randomized, placebo-controlled clinical trial to test simvastatin, an FDA-approved medication for hypercholesterolemia, as a new treatment for vitiligo. The aims of this placebo-controlled study seek to determine the safety and potential efficacy of simvastatin 80mg daily versus placebo in adult male patients with generalized vitiligo. Additionally, the investigators will collect blood to examine the effect of simvastatin on autoreactive CD8+ T cells in vitiligo patients.

Vitiligo is an autoimmune disease caused by autoreactive CD8+ T lymphocytes that target melanocytes, and interferon-γ-induced CXCL10 plays an important role.1 Simvastatin inhibits interferon-γ signaling by blocking activation of STAT12 and prevented and reversed disease in our mouse model.3 A case report described a patient with vitiligo who repigmented with simvastatin.4 We conducted a small, randomized, double-blind, placebo-controlled, phase II clinical trial to test simvastatin as a treatment for vitiligo. After obtaining informed consent, we enrolled men ages 18 to 64 years with vitiligo affecting 3% to 50% of their body surface area (BSA). We excluded patients with a segmental presentation; those already taking 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor; those with existing thyroid disease; and women, based on their increased risk of simvastatin-induced myopathy.

Eligibility Criteria:
Inclusion Criteria:

* male gender
* ages 18-64
* at least one vitiligo skin lesion measuring at least 2x2 cm in size
* willing and able to understand and sign informed consent
* able to complete study and comply with study procedures

Exclusion Criteria:

* history of segmental vitiligo
* allergy to statin medications
* use of statin medications due to cardiac risks.
* use of any medications contraindicated with use of simvastatin
* use of topical vitiligo treatments in past 4 weeks
* use of laser or light-based vitiligo treatments within the past 8 weeks
* treatment with immunomodulating oral medications in the past 4 weeks
* use of statin medications in the past 8 weeks
* evidence of hepatic dysfunction, personal or family history of non-alcoholic steatotic hepatitis, or personal history of hepatitis
* evidence of renal dysfunction
* history of myopathy or rhabdomyolysis, or elevated baseline creatinine kinase
* recent history of alcohol or drug abuse
* history of diabetes
* untreated hypothyroidism
* other conditions that require the use of interfering topical or systemic therapy
* other current conditions that might interfere with study assessments such as, but not limited to, atopic dermatitis and psoriasis
* clinically significant abnormal findings or conditions which might, in the opinion of the Principal Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
Evaluation of the Shape Up Rhode Island Campaign Study 5

Obesity is a major health problem that has reached epidemic levels. Efforts are needed to develop cost-effective public health approaches for weight loss and maintenance. One such approach is to develop team-based programs that may motivate people to lose weight and/or increase their physical activity. One such program is entitled Shape-up Rhode Island (SURI). The current trial is investigating whether adding both a behavioral intervention delivered online PLUS automated feedback to self-monitoring would enhance the outcomes of SURI participants.

Background: Given the epidemic of obesity, approaches to weight loss that can be applied on a community, state, or national level are needed. This project is an ongoing evaluation of Shape Up Rhode Island (SURI) program, a state-wide Internet based program involving team-based competition to increase physical activity and achieve weight loss.

Aim: To enhance the effectiveness of SURI utilizing a minimal contact intervention delivered online.

Design: SURI 2009 participants were invited to join a research study focusing on weight loss. Interested participants were randomized to two groups including a SURI Enhanced group (behavioral intervention presented in 12 weekly online presentations, daily self-monitoring, and weekly automated feedback) or a SURI Standard group (group given a list of previously existing online resources to aid with weight loss).

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obese
* Current participant in the Shape Up RI program weight loss competition

Exclusion Criteria:

* None
Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery

1. The investigators aim to examine the use of IV and oral ketorolac as an adjunctive agent to the standard of care pain protocol for postoperative pain control following ACL reconstruction surgery.
2. The investigators hypothesize that the use of IV and oral ketorolac in addition to the standard of care pain protocol will reduce postoperative opioid consumption following ACL reconstruction surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 89 years old
* Patients undergoing primary anterior cruciate ligament (ACL) reconstruction surgery

Exclusion Criteria:

* Patients below age 18 or above age 89
* Illiterate or non-English speaking individuals
* Patients with contraindications to Ketorolac
* History of chronic alcohol or drug abuse
* Chronic use of psychotropic or analgesic drugs
* Known peptic ulcer disease or bleeding diasthesis
* Renal dysfunction (estimated glomerular filtration rate \< 50 mL/min/1.73m2)
* Breastfeeding women
* Pregnant women
Selfcare MAnagement InteRvenTion in Heart Failure II (SMART HF II)

The purpose of the study is to evaluate if the digital support and communication platform for heart failure can provide patients with heart failure increased knowledge, compliance and quality of life and thus affect re-admissions and visit structure.

To evaluate whether a digital support and communication platform for heart failure patients after 6 months can provide:

1. Improved self-care
2. Improved quality of life and reduced number of patient-assessed symptoms
3. Reduction in the number of cardiovascular events, hospital nights, the number of hospitalizations or the number of deaths and out-patient visits


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed heart failure I.50 (newly discovered or existing) in NYHA Class I-IV in principle with ESC guidelines 2016.

  * Have completed the "consent form" or consent form, see §4.2 Exclusion criteria: \* Patient who refuses to participate in the trial.
  * It is assessed that they can handle the intervention themselves or with the help of personal or relatives.

Exclusion Criteria:

* Patient who declines to participate in the trial.

  * Impaired cognitive ability that is judged to affect the ability to conduct the study in the intended manner.
  * Life expectancy \<8 months
  * In other ways, by the treating physician, it is deemed inappropriate to participate in the study, e.g. due to participation in another study.
Patient Reported Outcome After Bariatric Surgery

Prospective association study to analyse patients' outcome after bariatric surgery.

Outcome comprises postoperative pain, analgesia, postoperative side-effects, long-lasting pain, patients' impairment in daily living.

Background

Bariatric surgery is a common procedure. Data on patient related outcome beyond loss of body weight are scarce. The question arises which patient is at specific risk for an unfavorable outcome after bariatric surgery.

Objective

The aim of this study is to investigate variables possibly associated with impaired outcome and increased patients' interference after bariatric surgery. Which patients are at risk for clinically meaningful impaired daily living?

Methods

Patients will be enrolled in a prospective observational study. Data will be collected in a registry with documentation of patient, surgery, anesthesia and analgesia related variables including preoperative status and postoperative patient reported outcome with a follow-up period up to 5 years after bariatric surgery.

Patients fill in standardized validated outcome questionnaires at predefined time points. The registry provides the basis for large scale analyses and benchmarks for several parameters.

Variables to be considered are pain scores after surgery, patient reported outcome, pain related interference after surgery (Brief Pain Inventory), quality of life (SF-12), long-term outcome, chronic (neuropathic) postsurgical pain, BMI, psychological questionnaires, surgery and patient related variables, including genetic variants.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Written informed consent
* Elective bariatric surgery
* Patients' ability to understand the purpose of the study

Exclusion Criteria

* No informed consent
* Cognitive impairment
Patellar Resurfacing Under Subvastus Approach in Total Knee Arthroplasty

This study aims to compare the clinical results of patella resurfacing or not under subvastus approach in total knee arthroplasty. Even though the excellent results of total knee arthroplasty(TKA), there is persistent controversy over whether or not to replace the patella. Anterior knee pain continued to be a unsolved problem of TKA patients. Some surgeons always performed patella resurfacing during total knee arthroplasty but the others didn't do that. It's up to surgeon's preference. There were several studies of patellar resurfacing or not in TKA. But previous studies almost have been done under other approach, not a subvastus approach.

This study prospectively randomized patients receiving bilateral TKA with patellar resurfacing or not in each knee. Patients preference and clinical results was investigated in both knee of same patients who received patellar resurfacing or not during minimum 2 year follow up.

The primary objective of this work was to compare pain, stiffness and function between groups at minimum 2 year postoperatively. Secondarily, we compared pain, patient preference at minimum 2 year postoperatively. The investigators hypothesized that there would be no difference between the two groups of subjects in the measured outcomes.

Patients receiving TKA were prospectively enrolled before surgery and randomized intraoperatively to either receive patella replacement or not in both knee of same patients. Subjects were assessed pre-operatively and at 6 months, 1, 2 years postoperatively for pain, function, and stiffness using a disease-specific (Western Ontario and McMaster Osteoarthritis Index \[WOMAC\]) . Other measurements like Knee Society score, Feller's score, Patient satisfaction (VAS) also checked pre-operatively and at 6 months, 1, 2 years postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients for total knee arthroplasty
* Having medicare insurance

Exclusion Criteria:

* Patients who are not able to cooperate
* Serious deformity (not suitable for a standard TKA prosthesis)
* Patellar thickness less than 18 mm
* Prior operation involving the extensor mechanism
* Rheumatoid arthritis
* Severe medical disability limiting the ability to walk
* Revision surgery
* Knees with predominantly patellofemoral arthrosis
Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US

This study aims to compare real-world effectiveness of BRAF/MEK inhibitors in BRAF-mutant metastatic melanoma patients in the United States by line of therapy.

The Flatiron Health electronic health record (EHR) data from US cancer clinics will be used for this retrospective database analysis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with melanoma based on International Classification of Disease 9th and 10th Revisions (ICD-9: 172.x; ICD-10: C43x, D03x) and ≥2 visits on different days in the Flatiron database on or after January 1, 2011.
* Clinically confirmed diagnosis of melanoma with pathologic stages III or IV at initial diagnosis or earlier stage disease with a first locoregional or distant recurrence on or after January 1, 2011.
* Age ≥18 years at the time of advanced melanoma diagnosis.
* Evidence of ≥1 BRAF positive test result at any time based on laboratory or genetic analysis results.

Exclusion Criteria:

-• Patients with prior BRAF- or MEK-inhibitor therapy

• Patients with ECOG performance status ≥ 2 (at the time of randomization for patients from COLUMBUS, during the baseline period for patients in Flatiron EHR)
The Effects of Creative Dance Therapy on Motor and Executive Functions in Children With Dyslexia

Although some benefits of dance have been described for motor and cognitive skills, the effects on individuals with dyslexia are unclear. The purpose of this study was to investigate the effects of creative dance training on the motor and executive skills of children with dyslexia.

Although some benefits of dance have been described for motor and cognitive skills, the effects on individuals with dyslexia are unclear. The purpose of this study was to investigate the effects of creative dance training on the motor and executive skills of children with dyslexia.

The randomized controlled trial was conducted between August 2019 and December 2020 in the Occupational Therapy Department of Hacettepe University. The sample consisted of 51 children with dyslexia aged 8-10 years. While 26 of the participants received routine literacy training, the other 25 also received creative dance training three times a week for 4 weeks. Motor functions were assessed using the "Bruininks-Oseretsky Motor Competence 2 Test- Short Form", and executive functions were assessedusing the "Executive Function and Occupational Routines Scale".

Eligibility Criteria:
Inclusion Criteria:

* an age between 6 and 10 years
* a diagnosis of dyslexia according to DSM-V criteria
* continued formal education in elementary school
* participation in routine literacy training in a special education and rehabilitation center
* voluntary participation in the study.

Exclusion Criteria:

* having additional physical or psychological problem accompanying the dyslexia
* using of psychotic drugs
* participating in sports regularly.
Service and Health Among Deployed Veterans

The purpose of the study is to better understand the health, including lung health, of Veterans who deployed in support of Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), or Operation New Dawn (OND) and other deployments following these Operations.

The aim of the study is to characterize the impact of deployment-related pollution exposures during the Post-9/11 Gulf War Era on current respiratory health using objectively ascertained and standardized physiologic and epidemiologic measures. The primary objective in support of this aim is to assess the association of cumulative exposure to PM2.5 during deployments to the U.S. bases and other locations in Central Asia (Afghanistan and Kyrgyzstan), Southwest Asia (Iraq, Kuwait, Qatar, and United Arab Emirates) and Africa (Djibouti) with current measures of pulmonary function. Secondary objectives in support of the aim will examine the association of cumulative exposure to PM2.5 during deployments with the clinical outcome of medically-treated asthma. The investigators will also explore the impact of deployment duration on both pulmonary function and asthma.

This study will execute 4 distinct efforts to meet the study objectives: (1) enroll a study cohort of up to 6,200 Veterans who live within the catchment area of 6 VA recruitment sites, conduct an in-person assessment of pulmonary function, and collect data on key covariates; (2) create a spatial-temporal exposure grid of environmental PM2.5 levels averaged per week per 1 square kilometer at locations where military personnel served; (3) link each individual's location and duration (spatial-temporal) history during deployed and non-deployed times with averaged PM exposures during each of these time periods; and (4) conduct association analyses to test hypotheses of deployment-related cumulative PM2.5 exposure and current respiratory health by combining exposure data with data collected from the cohort members and from their military records.

Eligibility Criteria:
Inclusion Criteria:

* Served during the Post-9/11 Gulf War Era in a service branch that had land-based deployments (Air Force, Army, and Marine Corps)
* Deployed to Afghanistan, Kyrgyzstan, Iraq, Kuwait, Qatar, United Arab Emirates, or Djibouti after October 1, 2001

Exclusion Criteria:

* Active duty at the time of recruitment
* Impaired decision making capacity
* No English language proficiency
* Prisoners