cyrilzakka/clinical-trials huggingface dataset:
Keep On Keep Up for Parkinson's

The goal of this mixed methods, user research study is to evaluate the Keep On Keep Up programme for people with Parkinson's (KOKU4PD).

The main aims of the study are to:

1. To explore the usability and acceptability of the PD specific KOKU programme from a user and health care professional perspective.
2. To produce a KOKU4PD digital program that is ready for National Health Service (NHS) approval and a future effectiveness evaluation.

Participants will use the KOKU4PD app at home for 4 weeks. They will be assessed at baseline and after the 4 weeks to measure aspects of their disease status, mobility, thinking, mood and quality of life. They will also be asked to complete some questionnaires about the usability of the app.

Keep on Keep Up (KOKU) is a digital program available on a tablet that has been designed to engage people in safe and effective falls prevention exercises. KOKU incorporates evidence-based exercise programmes for balance and function and has demonstrated high usability and acceptability in older adults. KOKU is approved by NHS Digital as compliant with regulatory data and safety standards.

Earlier work by the research team has shown that KOKU is effective in improving balance in older adults. However, the effectiveness of KOKU in PD is unknown. The purpose of this study is to explore if app-based exercise is feasible, acceptable and effective in PD, especially in harder-to-reach populations who may not exercise on a regular basis.

Through mixed methods approaches, the proposed study aims to: (i) explore the usability and acceptability of the PD specific KOKU programme from a user and health care professional perspective and (ii) produce a KOKU4PD digital program that is ready for NHS approval and a future effectiveness evaluation.

20 people with PD will be recruited to take part in the study where they will be asked to use the KOKU app independently at home for 4 weeks. A repeated measure design will be employed with assessments performed at the clinical gait lab during two separate sessions lasting between 2-3 hours. Participants will attend the lab for outcomes to be measured at the start and after 4 weeks of exercise with the KOKU app. During the second lab visit, participants will complete a questionnaire about the usability of the KOKU app and take part in an interview to explore their experiences of using it.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Parkinson's by a movement disorder specialist according to United Kingdom (UK) brain bank criteria (H\&Y stage I-III)
* Able to walk and stand without support or assistance from another person
* \>40 years
* Stable medication for the previous 1 month and anticipated over a period of 6 months.
* Adequate vision and hearing - to watch and use an iPad or Tablet.Aim: To define the study population/sample

Exclusion Criteria:

* Dementia (\<21 on Montreal Cognitive Assessment (MoCA) or as diagnosed according to the Movement Disorder Society guidelines
* Orthopaedic or cardiothoracic ailments that preclude safe walking
* Severe auditory or visual impairment,
* Diagnosis of clinical depression
Pediatric Post-operative Abdominal Wound Dehiscence in Association With Midline vs Other Incisions: A Prospective Cohort Study

This study is designed to see different abdominal incisions complication among neonates, infants and children and to find risk factors for developing wound dehiscence


Eligibility Criteria:
Inclusion Criteria:

-all abdominal surgeries patient under 18-year-old.

Exclusion Criteria:

* Umbilical hernia, redo laparatomy, laparoscopic surgery.
Family-centered Obesity Prevention: Communities for Healthy Living (CHL)

The Communities for Healthy Living (CHL) program is a family-focused intervention to promote healthy lifestyle behaviors including diet and physical activity among children (age 3-to 5-years) and their families, enrolled in Head Start.

This evaluation will test the effectiveness of a family-focused intervention, Communities for Healthy Living (CHL), implemented through Head Start. Over 20% of preschool-aged children in the US experience overweight or obese. Because obesity prevention depends heavily on the adoption of healthy lifestyle behaviors early in life, preventive efforts offer a higher promise for success if they are family-centered. Effective family-centered interventions for obesity prevention in preschool-aged children, however, remain elusive. While a number of interventions have shown positive effects on child Body Mass Index (BMI), results are inconsistent and short term effects are not maintained. What is more, because families at greatest risk of childhood obesity - including low-income, single-parent, and ethnic minority families - are the most difficult to recruit and retain, results are often limited in their applicability to high risk populations.

In response, the researchers have partnered with Head Start to develop and test a new approach to family-centered childhood obesity prevention that addresses family engagement upfront. The CHL program will be refined and rigorously tested for efficacy in collaboration with Head Start programs in the greater Boston area, which collectively serve over 2000 low-income children each year. Building on a previous pilot study, the investigators will broaden the parent-centered Community Based Participatory Research approach and include Head Start staff in the decision making and implementation process, refine intervention components, and expand technical assistance protocols to support Head Start ownership of CHL while ensuring implementation fidelity. In addition, consistent with the overarching theoretical framework (Family Ecological Model), neighborhood-level socioeconomic, food and physical activity environments around family homes and examine their impact on intervention outcomes will be measured to inform future scale up efforts.

Eligibility Criteria:
Primary Outcome Measures

Inclusion:

* Enrolled in a participating Head Start program
* Age 33 months to 5 years (i.e., meets Head Start age eligibility criteria)

Exclusion:

* Those not meeting inclusion criteria

Secondary Outcome Measures

Inclusion:

* Enrolled in a participating Head Start program
* Age 33 months to 5 years

Exclusion:

* Children not enrolled at a participating Head Start program
* Children less than 29 months or older than 59 months by Sept 1
Photographic Assessment of Eyebrow Position and Range of Motion

Forehead and eyebrow surgery is a frequently performed cosmetic surgical procedure in which the eyebrows are raised to a more aesthetically pleasing position. Typically, this position is judged by the surgeon pre-operatively based on traditional aesthetic concepts, some of which date to the Classical era. This study is designed to assess the variance of the eyebrow from the desired aesthetic position (as determined by the subject), as wel as to assess the distance of normal excursion of the brow from maximum voluntary depression to maximum voluntary elevation.

A set of 5 digital photographs will be taken of 100 (30 male, 70 female) adult study participants. Prior to photography, water soluble ink will be used to mark the inferior aspect of the superior orbital rim above the medial and lateral canthi and in the mid pupillary line. Photographs taken will image patients from crown to chin and will be taken with eyes open and closed, brows raised, maximally contracted and at rest. A final photograph will be taken with the subject manually holding both brows in the position he/she finds most aesthetically pleasing as seen in a mirror. During all photography, a ruler will be held against the face for later calibration, all photographs will be taken with a camera mounted flash and with the patient in a Frankfort horizontal plane. All photographs will be analyzed with proprietary computer software.

Eligibility Criteria:
Inclusion Criteria:

* adults,
* aged 18-85 years

Exclusion Criteria:

* prior forehead, eyebrow or eyelid surgery,
* neurotoxin treatment to the forehead or eyes within the past 6 months,
* injectable soft tissue filler used within the last 12 months,
* photosensitivity.
Trial to Assess Response to Oral Vitamin D3 Supplementation in Obese Individuals

This study is an extension of an earlier study of vitamin D supplementation conducted on normal weight individuals by Dr. John Aloia of the Bone Mineral Research Division at Winthrop University Hospital. The investigators plan to compare the response to vitamin D supplementation in obese individuals with the response already measured in normal weight individuals. The same dosing schedule of vitamin supplementation will be used as in the past. The doses used in the past have demonstrated safety in a number of trials, here at Winthrop as well as outside of Winthrop Hospital. Sixty study volunteers are planned for enrollment in the study. The study participants will mainly be recruited from a group of patients who have in the past been enrolled in the weight loss program at Winthrop Hospital. Each participant will be on vitamin D supplementation for a total of 8 weeks. Vitamin D blood levels will be measured before and at the end of the supplementation period. They will then be compared to see the change over time as a result of supplementation.


Eligibility Criteria:
Inclusion Criteria:

* obese adults aged 18-65 years and BMI\>35

Exclusion Criteria:

* chronic medical illness (diabetes, malignancy, uncontrolled hypertension, kidney disease)
* subjects who have undergone bariatric surgery or currently enrolled in a medically supervised weight loss program
* BMI \< 35
* pregnancy
* use of medication that influences vitamin D metabolism
* history of of hypercalcemia, hypercalciuria, nephrolithiasis
Apical Support During Hysterectomy for Pelvic Organ Prolapse

This is a retrospective chart review using TriHealth Electronic Privacy Identification Center (EPIC) to determine whether gynecologic surgeons at a large community hospital are already meeting the recently recommended best practice of supporting the vaginal apex.

The prevalence of pelvic organ prolapse (POP) in the United States is estimated to be between 40-50% with an anticipated increase over the next several decades. Approximately 300,000 women undergo surgeries to repair POP in the United States every year. Following pelvic reconstructive surgery, recurrence rates of symptomatic prolapse range between 6-30%. Our understanding of pelvic anatomy and its support has been significantly improved over recent decades, with many researchers reporting on details and mechanics previously not understood.

In November 2017, the American College of Obstetricians and Gynecologists released a new practice bulletin outlining the current standard of care for the treatment of women with pelvic organ prolapse. In this bulletin, they state that a hysterectomy alone is not adequate treatment for pelvic organ prolapse, and further that any woman having a hysterectomy for pelvic organ prolapse should undergo a concurrent apical suspension procedure as a standard of care.

The purpose of this study is to determine the proportion of patients already meeting the recently recommended best practice of supporting the vaginal apex at the time of hysterectomy for pelvic organ prolapse among the population who underwent the surgery performed at a TriHealth facility between October 2012 and October 2017.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or older
* Underwent hysterectomy for pelvic organ prolapse, performed at a TriHealth facility between October 2012 and October 2017

Exclusion Criteria:

* Age \< 18 years old
* Pelvic Organ Prolapse was not an indication for their surgery
* Surgery performed by a physician of Cincinnati Urogynecology Associates.
Tai Chi for Stroke Rehabilitation on Balance and Cognition

Tai Chi, an ancient Chinese martial art, is a low intense aerobic exercise characterized by continuous movements that embrace the mind, body, and spirit. Tai Chi addresses the integration and balance of mind and body using the fundamental principles of slow, smooth, and continuous movement control, and the transfer of body weight while maintaining an upright and relaxed posture. The present randomized clinical trial project aims to apply the suggested principles as the typical features of Tai Chi applied stroke rehabilitation, and to evaluate the effects on physical (balance), psychological, and cognitive function.

Cerebrovascular disease is a major global concern. The individuals with stroke would suffer from disease associated symptoms which influence their functioning in everyday life. These symptom clusters were usually known to be sharing similar underlying mechanisms. It is clear that the development of effective stroke rehabilitation involves interdisciplinary team approach to manage physical, social, cognitive, and psychological functioning in this population.

Tai Chi, an ancient Chinese martial art, is a low intense aerobic exercise characterized by continuous movements that embrace the mind, body, and spirit. Tai Chi addresses the integration and balance of mind and body using the fundamental principles of slow, smooth, and continuous movement control, and the transfer of body weight while maintaining an upright and relaxed posture. The newly developed style of Tai Chi for health programs is the seated Tai Chi, which shares the common Tai Chi principles while being modified to adjust the movements for patients with limited mobility.

The present randomized clinical trial project aims to apply the suggested principles as the typical features of Tai Chi applied stroke rehabilitation, and to evaluate the effects on physical (balance), psychological, and cognitive function. Only a few studies ever addressed the feasibility of Tai Chi for stroke rehabilitation, and the relationship between cognition and balance in this population is still very early stage of investigation. The main purpose of our collaborating project is to explore the direct relationship between cognition and balance in stroke patients during their rehabilitation process.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as stroke at least for 3 months upto 2 years
* eligible to participate rehabilitation therapy referred by primary physician

Exclusion Criteria:

* not able to understand questionnaires
* not able to stand alone for balance test
The Effect of Losartan and Losartan Plus Isosorbide Mononitrate on Central Blood Pressure Measurements (0954-317)

This study will qualify a functional model that can measure central blood pressure and vascular compliance effects through noninvasive means.


Eligibility Criteria:
Inclusion Criteria:

* Patient is in good health with the exception of mild to moderate hypertension
* Patient is willing to comply with the study restrictions
* Patient does not smoke

Exclusion Criteria:

* Patient has a history of any illness that might confound the results of the study or make participation in the study unsafe
* Patient is taking a prescription medication that is contraindicated for use with COZAAR® or IMDUR®
* Patient has a condition for which there is a warning, contraindication, or precaution against the use of COZAAR® or IMDUR®
A Post-marketing Surveillance to Assess Safety and Efficacy of Twotopsplus.

Post-marketing surveillance of Twotopsplus.

This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of MFDS for market authorization.

Eligibility Criteria:
Inclusion Criteria:

* The patient diagnosed with hypertension.
* The patient who is first prescribed and administered Twotopsplus Tab.

Exclusion Criteria:

* The patients who are overreacting to this drug or its components.
* The patients with severe renal impairment.
Oral SAR245408 (XL147) and Oral MSC1936369B in Patients With Locally Advanced or Metastatic Solid Tumors

Primary Objective:

- To determine the maximum tolerated dose(s) (MTD) and the recommended Phase 2 dose(s) (RP2D) of SAR245408 and MSC1936369B when combined in adult subjects with locally advanced or metastatic solid tumors.

Secondary Objective:

* To characterize the safety and tolerability of SAR245408 and MSC1936369B combination therapy administered orally to adult patients with locally advanced or metastatic solid tumors
* To evaluate the pharmacokinetic (PK) profile of SAR245408 and MSC1936369B when used in combination
* To evaluate the pharmacodynamic (PD) effect of the SAR245408/MSC1936369B combination by assessing target and pathway inhibition

The duration of the study will include a period for screening of up to a maximum of 28 days, a pretreatment evaluation period of up to 5 days, the on-treatment period, followed by a minimum of 30-day follow-up after the last study drug administration.

The patient may continue study treatment until disease progression, unacceptable toxicity, or consent withdrawal.

The study will have 2 parts:

* Part one - Dose Escalation
* Part Two - Expansion. At the defined maximum tolerated doses (MTD(s), additional patients will be enrolled to collect safety, Pharmacokinetic, and Pharmacodynamic data

Eligibility Criteria:
Inclusion criteria:

Patient with advanced solid tumors for which there is no approved or curative therapy:

* has any advanced solid tumor with diagnosed alteration in 1 or more genes of the PI3K, and mitogen-activated protein kinase (MAPK) pathways and/or
* has a histologically or cytologically confirmed diagnosis of 1 of the following solid tumors: pancreatic, thyroid, colorectal, non-small cell lung, endometrial, renal, breast, ovarian carcinoma and melanoma

Exclusion criteria:

The patient has previously been treated with a PI3K inhibitor or a Mitogen-activated protein extracellular signal-regulated kinase (MEK) inhibitor

The patient has received:

* Chemotherapy, immunotherapy, hormonal therapy, biologic therapy, or any other anticancer therapy within 28 days or 5 half lives for noncytotoxics (whichever is shorter) of Day 1 of trial drug treatment (6 weeks for nitrosureas or mitomycin C)
* Any investigational agent within 28 days of Day 1 of trial drug treatment The patient is currently receiving anticoagulation therapy with therapeutic doses of warfarin (low-dose warfarin ≤1 mg/day, heparin, and low-molecular weight heparins are permitted) History of central nervous system metastases The patient has had congestive heart failure, unstable angina, a myocardial infarction, cardiac conduction abnormality or pacemaker or a stroke within 3 months of entering the study. The patient has retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), history of uveitis, or history of retinal vein occlusion, or has medically relevant abnormalities identified on screening ophthalmologic examination.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Community Health Worker Diabetes Prevention Intervention

The primary goal of this study is to develop, implement, and test a community health worker (CHW) program designed to promote diabetes prevention among Korean and South Asian Americans in New York City.

In particular, the specific aims of this study are:

1. To utilize community based participatory research (CBPR) methods to expand upon an existing campus-community partnership to develop and implement a CHW program among Korean and South Asian Americans that promotes diabetes prevention;
2. To develop, implement, and assess the efficacy of a CHW intervention to promote diabetes prevention and access to care among NYC Koreans and South Asians.


Eligibility Criteria:
Inclusion Criteria:

* is a South Asian or Korean American immigrant;
* is identified as at-risk by a diabetes risk assessment
* is between 18-75 years of age; and
* is willing to be randomized to either treatment or control groups.

Exclusion Criteria:

* is a confirmed diabetic;
* is on renal dialysis;
* has an acute or terminal illness or serious mental illness;
* has a history of recent coronary event within the last 12 months;
* has a recent history of acute medical problem or admission to hospital;
* has any other severe medical conditions that might make it difficult to attend educational sessions;
* has poor short-term prognosis (expected death in \<2 years);
* is planning to travel for longer than 6 weeks during the 6-month intervention period; or
* is participating in another CVD study.
Comparison of Three Kinds of Postoperative Analgesia After Total Knee Arthroplasty

Postoperative pain after total knee arthroplasty (TKA) can be difficult to manage and may delay recovery. There are multimodal postoperative pain management after TKA, including intravenous opioids, epidural analgesia, peripheral nerve blocks or periarticular infiltration with local anesthetics. All of these treatments may lead to side effects such as nausea, headache, hypotension, urinary retention, partial motor block and infection of the knee. Therefore the investigators will compare three methods of postoperative analgesic after TKA by their efficiency and complication.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of American Association of anesthetists（ASA）Grade 1、2 or 3
2. Aged between 18 and 85 years
3. Undergoing elective total knee replacement

Exclusion Criteria:

1. Mental illness can not match
2. Nerve block, epidural anesthesia contraindicated
3. People who have Slow-type arrhythmias
4. History of chronic headaches and long-term use of analgesic drugs
5. People who were postoperative consciousness, language or hearing impaired
PREdiction of Chronic LUng Allograft Dysfunction

Chronic lung allograft dysfunction (CLAD) is the leading cause of long-term mortality after lung transplantation. Several risk factors for CLAD have been identified, but the exact pathophysiology and triggering molecular factors remain largely unknown. Moreover, in clinical practice, no integration of the different risk factors is achieved. CLAD is therefore diagnosed most often late with the persistent decline in respiratory function, revealing a profound and irreversible alteration of the pulmonary graft. Several blood biomarkers that can predict the occurrence of CLAD more than 6 months before clinical diagnosis have been identified and validated. From these preliminary results, a composite score is being developed from independent samples from the COLT (COhort in Lung Transplantation) cohort. The main objective of this project is to validate this robust and predictive composite score (biological and clinical) of CLAD.


Eligibility Criteria:
Inclusion Criteria:

* Patients to receive lung transplants awaiting registration on the transplant waiting list
* Patients affiliated to a social security system
* Patients who have given their informed consent
* Patients weighing more than 26 kg
* Patients over 16 years of age

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patients unable to follow the protocol
* Patients with concomitant inflammatory diseases, regardless of acute, chronic or infectious rejection.
* Patients with a history of cancer in remission for less than 5 years, with the exception of localized skin cancers, excluding melanoma.
Emergence of Generative Language

The purpose of this study is to investigate the effects of several applied behavior teaching procedures on the use of multi-word utterances by children with autism.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Autism Spectrum Disorder (ASD)
* Provide a diagnostic report confirming a diagnosis of ASD and/or obtain a total raw score of 15 or greater on the Social Questionnaire Lifetime Form (SCQ)
* Speaks primarily in one word utterances
* English as their primary language
* Follows simple 1-step instructions
* Transportation/availability to attend 3, 1-hour sessions each week for 12 weeks

Exclusion Criteria:

* Children with significant problem behavior that interferes with structured intervention