cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Posterior Component Separation Modified TAR Technique "Transversus Abdominids Release" in the Treatment of Parastomal Hernia

Aim of the work In this study, we will evaluate posterior Evaluation of posterior component separation modified TAR technique "Transversus Abdominids Release" in the treatment of parastomal hernia. The primary outcome will be recurrence while the secondary outcome will be infection, postoperative complications (bleeding and dehiscence), pain score, operative time, hospitalization, need for drain, time for drain removal and pulmonary function test before and after surgery


Eligibility Criteria:
Inclusion Criteria:

* Adult patient fit for general anesthesia with parastomal herniation.

Exclusion Criteria:

* Patients who are unfit for general anaesthesia.
* Poor pulmonary function tests.
* Pregnant females.
* Patient younger than 18 years.
* Immunodeficiency.
* Patient with psychiatric disease disabling surgical intervention.
Internet Technology Based Life-style and Care Intervention for Risk Factors of Non Communicable Diseases（NCD）

This study aims to control risk factors of non communicable diseases by life style and care intervention based on internet technology, looking forward to improve cardiovascular and cerebrovascular complications, diabetes and all-cause death.

Cardiovascular and cerebrovascular diseases, diabetes, chronic obstructive pulmonary disease and malignant tumors are the main chronic diseases, which have been the most important cause of human death, consuming most health resources. In China, patients with cardiovascular and cerebrovascular diseases account for more than 40% of all causes of death. After half a century of research, we have a thorough understanding of risk factors of cardiovascular disease, including genetics, aging, ethnicity, physical activity decreases, unbalanced nutrition and calorie intake, smoking, obesity, hypertension, dyslipidemia, and glucose abnormalities, etc. Many factors can be corrected through health education, indicating that the occurrence of chronic diseases can be prevented through lifestyle changes and the control of risk factors.

This project collects risk factors of cardiovascular disease and establishes a real and reliable health database by conducting a cross-sectional survey of chronic diseases among residents of Tian Tong Yuan District (there are hundreds of thousands of people).On this basis, community health management network was established with internet technology. Meanwhile, prospective, open, community randomized and controlled lifestyle intervention studies were carried out. Intervention was conducted on risk factors of cardiovascular and cerebrovascular diseases, such as smoking, obesity, hypertension, lipid metabolism disorder, and hyperglycemia. For patients with chronic diseases, lifestyle intervention and health education should be carried out to improve the diagnosis rate and control rate. The project focuses on the impact of lifestyle interventions and health education on risk factor control, cardiovascular and cerebrovascular complications, diabetes and all-cause death.

Eligibility Criteria:
Inclusion Criteria:

* Men and women older than 25 years of age with two or more risk factors as follows, BMI≥24 or BMI≤18.5 kg/m2, smoking, active exercise less than 30 minutes every day, blood pressure higher than 130/85 mmHg, dyslipidemia, fasting glucose higher than 6.1mmol/l, fatty liver.
* Patients with hypertension, diabetes and ASCVD

Exclusion Criteria:

* Patients had not signed the consent form
* Patients with severe heart failure, hepatic failure, renal failure and malignant tumor.
* Patients planing pregnancy
Effect of Home-Based Pulmonary Rehabilitation

This clinical trial aims to assess the effectiveness of home-based pulmonary rehabilitation in improving the clinical outcomes of patients with COPD.

Research questions :

RQ1: Is there a significant difference in the exacerbation rates before and after implementing the program? RQ2: Is there a significant improvement in the quality of life before and after implementing the program? RQ3: Is there a significant improvement in 6MWT before and after implementing the program? RQ4: Is there a significant improvement in COPD patients' modified Medical Research Council dyspnea scale before and after the implementation of the program?

Participants will receive pulmonary rehabilitation at home or any place they designated over eight consecutive weeks. Two sessions per week and continuous phone calls. Participants will also be given a structured manual to record their activities and follow instructions on days without supervision.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD, confirmed by spirometry and pulmonologist
* Age ≥40 years (to avoid recruiting participants with asthma rather than COPD)
* Current or previous smoker (≥10 packs per year)
* Confidence in using the proposed pulmonary rehabilitation (PR) system
* Kurdish language fluency
* Willingness to participate and sign an informed consent form.

Exclusion Criteria:

* patients with pulmonary hypertension
* patients with movement disorders and/or a history of falls
* patients with severe sensory or cognitive impairment
* patients with symptomatic ischemic heart disease
* patients with musculoskeletal degenerative disease
* Patients out site of the city or inability to be contacted
The Effects of Kinesio Tape Application With Different Verbal Input Given to With Patients With Rotator Cuff Tear

The aim of the study to investigate the effectiveness KT application with different verbal inputs on pain, function and range of motion (ROM) on patient with rotator cuff tear.

Rotator cuff tears are most common of shoulder pain and functional limitations. Kinesio tape (KT) are frequently used in the conservative treatment of shoulder pathology. Even if some studies showed that KT is effective on pain, we think that it is due to positive thoughts of the patients about KT. The aim of the study to investigate the effectiveness KT application with different verbal inputs on pain, function and range of motion (ROM) on patient with rotator cuff tear. 97 patients (Group 1, n=32; Group 2, n=33, Group 3, n=32) were randomized into 3 groups according to verbal input given to patients about the effectiveness of KT; Group 1 (it has been limited evidence of KT is effective), Group 2 (it has been not known that KT is effective or not), Group 3 (it has been known that KT has excellent result). The same standard KT was applied to 3 groups. The rest, night and pain in activity were assessed by Visual Analog Pain Scale (VAS) before, after 30 min and 24 hours after KT application. ROM assessed by goniometer and the function was evaluated by Disabilities of the Arm, Shoulder and Hand (DASH) and the American Shoulder and Elbow Surgery score (ASES) before and 24 hours of KT application. Minimal clinically important difference and effective were calculated for the assessments used in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients were included in the study if they had a partial rotator cuff tear diagnosed on clinical grounds
* No episodes of shoulder instability
* No radiographic signs of fracture of the glenoid or the greater or lesser tuberosity MRI evidence of cuff tear
* Duration of symptoms of at least 3 months,
* Inadequate response to nonoperative management (including nonsteroidal anti-inflammatory drugs, physical therapy, rest, and 1 local corticosteroid injection) Positive empty can test indicating possible supraspinatus involvement
* Positive Hawkins-Kennedy test indicating possible external impingement, -Subjective complaint of difficulty performing activities of daily living
* 20 to 50 years of age.

Exclusion Criteria:

* Patients were excluded from the study if they had inflammatory joint disease -Rheumatologic disease Osteoarthritis of humerus head
* Prior surgery on the affected shoulder
* Inability to complete questionnaires because of language problem or cognitive disorder
* Shoulder girdle fracture
* Glenohumeral dislocation/subluxation
* Acromioclavicular sprain
* Concomitant cervical spine symptoms
* A history of shoulder surgery
* Patients who did not accept to participate
* Patients who did not come to the second evaluation.
Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer

The primary objective of the study is to assess the progression-free survival (PFS) of oral veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and locally recurrent or metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed breast cancer that is either locally recurrent or metastatic.
* Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent.
* Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline mutation.
* If Human Epidermal Growth Factor Receptor (HER2) positive, subjects must have received and progressed on at least one prior standard HER2 directed therapy or the subject must be ineligible to receive anti-HER2 therapy.
* Measurable or non-measurable (but radiologically evaluable) disease by RECIST (Response Evaluation Criteria in Solid Tumors) criteria 1.1.
* Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
* Subject must have adequate bone marrow, renal and hepatic function.
* Subject must not be pregnant or plan to conceive a child.

Exclusion Criteria:

* Received anticancer agent(s) or an investigational agent within 21 days prior to C1D1, or radiotherapy within 28 days prior Cycle 1 Day 1.
* More than 2 prior lines of cytotoxic chemotherapy.
* Prior treatment of breast cancer with temozolomide, a platinum agent, or a Poly (ADP ribose) Polymerase (PARP) inhibitor.
* Prior taxane therapy for metastatic breast cancer.
* A history of or evidence of brain metastases or leptomeningeal disease.
* A history of uncontrolled seizure disorder.
* Pre-existing neuropathy from any cause in excess of Grade 1.
* Known history of allergic reaction to cremophor/paclitaxel.
* Clinical significant uncontrolled conditions, active infection, myocardial infarction, stroke, or transient ischemic attack, psychiatric illness/social situations that would limit compliance.
* Pregnant or breastfeeding.
A 12-week Intervention With Motivational Interviewing and Physical Activity Monitoring, to Enhance the Daily Amount of Physical Activity in Community Dwelling Older Adults - a Randomized Controlled Trial

To investigate if motivational-interviewing will enhance the expected effect from physical activity monitors, on physical activity in older adults, we will conduct a two-arm randomized controlled trial in 2019.

Both groups in the trial will receive a physical activity monitor for everyday use in the 12-week intervention period and a folder with information about the benefits of physical activity in older age. Participants in the intervention group will in addition to the use of the physical activity monitors receive a motivational feedback session by phone of about 20 minutes constructed from the theoretical framework of Motivational interviewing by Rollnick, Miller \& Butler and Social Cognitive Theory by Bandura. The content of the session focuses on investigating the most relevant possibilities and barriers for the participant to increase his or her levels of PA.

The primary outcome will be between group difference in average steps per day throughout the intervention period, measured objectively by the physical activity monitor (Garmin Vivofit 3). Secondary outcomes include participant reported outcome measures such as 'International Physical Activity Questionnaire', 'Nordic Physical Activity Questionnaire', 'EQ5D Quality of life questionnaire', 'UCLA Loneliness Scale', 'Self Efficacy for Exercise', and 'Outcome expectancy for Exercise'. To ensure 80% power with an alpha-level on 0.05, we will include 128 participants. The study will enroll in March 2019.


Eligibility Criteria:
Inclusion Criteria:

Participants must:

* Be minimum 70 years of age at the time of inclusion
* Own and use an Apple/Google/Microsoft smartphone device compatible with the Garmin Connect™ Mobile application.
* Own use an e-mail account
* Live in Denmark and have a Danish postal address and be able to receive the intervention content.
* Be able to walk independently with or without assistive devices.

Exclusion Criteria:

Participants cannot

* Receive active cancer treatment
* Have major cognitive impairment (e.g. dementia or alzheimers).
* Parkinson's or Multiple Sclerosis (or similar disease) affecting their mobility in such a way that the participants cannot walk on a daily basis.
Disaster Preparedness Among Families Caring for Children With Diabetes

The primary aim of the survey is to ascertain the emergency preparedness among our families with diabetes mellitus and to obtain a percentage of unprepared to the ones who are prepared. The secondary aim is to demonstrate the relationship between disaster preparedness and factors like socio-economic status, parent's marital status, ethnicity and those who had prior experience of a disaster to those who have not experienced a disaster.

This is a cross-sectional study. The subjects are the parent/parents/legal guardian, who will be coming to the clinic for their routine appointment for diabetes management. During the time in which the subject is waiting for the doctor or after their check-up, a research team member will approach the family and ask for their permission to administer the survey. The survey consists of a series of questions designed to ascertain the awareness towards emergency preparedness among families. After they have completed the questionnaire they would be given and/or mailed handouts to enhance their awareness towards disaster preparedness.

Potential Benefits:

This study will help to increase awareness regarding disaster preparedness among the surveyed families. Subjects and families will gain valuable information about caring for diabetes in the event of a disaster.

The potential benefit to the society is that through this study we can ascertain the primary caregiver's awareness of disaster preparedness in regard to a family member with a chronic illness. We will suggest measures to improve their competency towards dealing with disasters. We will be providing educational literature to the primary care givers in the form of handouts at the end of the survey.

Eligibility Criteria:
Inclusion Criteria:

* Subjects include families of children with type 1 and type 2 diabetes mellitus attending the Diabetes/ Endocrine Clinic at Texas Children Hospital.

Exclusion Criteria:

* Subjects excluded are families of Children with illnesses other than type 1 and type 2 diabetes mellitus attending the Diabetes/ Endocrine Clinic at Texas Children Hospital.
Using Focus Group to Explore Cultural Acceptability of Contraception

The purpose of this study is to learn what women of childbearing age think of Long Acting Reversible Contraception. A variety of myths regarding LARCs have been described in the literature. This study is designed to asses women's cultural belief's regarding LARCs. Investigators are looking to collect information from women in general, rather than solely who are seeking contraception. Investigators will be recruiting women ages 18-45 years from seven family health centers affiliated with UPMC. Participants will be asked to a attend a 60-90 minutes focus group session. During the session the facilitator will try to engage participants in a discussion about contraception in general. They will also be asked to complete a short demographic survey of 8-12 questions. Data from focus groups will be assessed for recurring themes which will be used to create a cultural survey instrument that will be used in the second phase of the study.

Following approval by the University of Pittsburgh institutional review board (IRB), female participants between 18 and 45 years of age seeking care for contraception or other women's health services were recruited from seven Family Health Centers (FHCs) partnered with the Department of Family Medicine. The participants agreed to participate in one 2 hour facilitated focus group session (recorded for later transcription) to discuss their perceptions about contraception.

Recordings were transcribed and de-identified. The resulting texts were coded by a team. Concepts and themes that arose from the coding were analyzed to inform the development of a survey on the topic of perspectives on contraception.

Qualitative analysis of the transcripts and coding was carried out and results were shared in pubic fora.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 18-45 years
* Not pregnant

Exclusion Criteria:

* Pregnancy
* Male
Remediation of Cognitive Dysfunction in Euthymic Bipolar Disorder Patients Using Transcranial Direct Current Stimulation (tDCS)

This study aims to investigate the potential for Transcranial Direct Current Stimulation (tDCS) to enhance cognitive functioning in euthymic bipolar patients through comparing the effect of active or sham tDCS (placebo control) during the performance of two cognitive tasks. The investigators hypothesize that task performance will be improved with active relative to sham tDCS.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be right-handed subjects aged 18-65 meeting DSM-IV diagnostic criteria for bipolar disorder, with no acute episodes of depression or mania within the previous 12 weeks
* A score of ≤ 20 on the MADRS, and a score of ≤ 6 on the YMRS, who have been on a stable dose of mood stabiliser medications for at least 1 month.

Exclusion Criteria:

* Patients with high suicide risk
* Co-morbid DSM-IV diagnosis of any psychotic disorder (current or within the last year), schizophrenia and schizoaffective disorder
* Mental retardation
* A history of drug or alcohol abuse or dependence within the last 3 months
* Co-morbid attention deficit hyperactivity disorder (ADHD), or any neurological disorder
* Recent stroke
* Head injury
* History of seizure, or who have had electroconvulsive therapy (ECT) within the 6 months preceding enrolment.
* Participants will also be excluded if currently taking medications known to be associated with frank cognitive impairment (e.g., benzodiazepines).
Vinblastine and Methotrexate in Treating Children With Desmoid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy with vinblastine and methotrexate in treating children who have desmoid tumors that are recurrent or untreatable with surgery or radiation therapy.

OBJECTIVES: I. Estimate the efficacy and toxicity of vinblastine and methotrexate for newly diagnosed or recurrent desmoid tumors in children who are not good candidates for treatment with surgery or radiation therapy.

OUTLINE: Patients receive vinblastine and methotrexate IV weekly for 26 weeks, then every 2 weeks for an additional 26 weeks. Treatment continues for a maximum of 1 year in the absence of unacceptable toxicity or disease progression. Patients with a complete response receive an additional 8 doses of chemotherapy. Patients are followed every 6 months for 4 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 13-25 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven, untreated, primary desmoid tumor (aggressive fibromatosis) for which surgery and/or radiation therapy is not thought to be feasible (prior attempted surgical resection allowed if gross residual disease remains) No other fibroblastic lesions or other fibromatoses allowed Recurrent desmoid tumor not previously treated with vinca alkaloids or methotrexate and no chemotherapy since recurrence Measurable disease by MRI

PATIENT CHARACTERISTICS: Age: Under 19 at time of diagnosis Performance status: Not specified Life expectancy: Not specified Hematopoietic: Hemoglobin normal for age WBC normal for age Platelet count normal for age Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) for age SGOT less than 1.5 times ULN for age Renal: Creatinine less than 1.5 times ULN for age

PRIOR CONCURRENT THERAPY: See Disease Characteristics
Lumbopelvic Manipulation Effects on Fatigue in Chronic Low Back Pain Patients

The aim of the study is determine the effects of lumbopelvic manipulation on fatigue, pain and disability in chronic low back pain patients. In this randomised clinical trial, lumbopelvic manipulation group was compared with conventional therapy group. Tools used in the study are numeric pain rating scale ,oswestry low back pain index and rating of fatigue scale.

Low back pain is an extremely common problem which causes morbidity in adults. It is more likely to occur in individuals around the age 20 to 60, this is partly due to the changes that occurs with aging. It can be acute (less than 12 weeks) or chronic (more than 12 weeks). There are many causes of low back pain one of the most common is the lumber disc herniation. Some of the most serious causes of low back pain include (infection, malignancy, vertebral fracture, cauda equina syndrome and inflammatory disorders such as axial spondyloarthritis). Mostly low backpain can be a result of injury such as muscle strain or sprains due to sudden movements or poor body mechanics while lifting heavy loads. Pain in low back can be the result of infection effecting the bony lumber spine, ligaments around the spine, the spinal cord, nerves and muscles of the spine, internal organs and skin around the spine.

Treatment for low back pain falls into three broad categories, multidisciplinary therapy is based on intensive exercises that improves physical function and has modest effects on pain physiotherapy treatment of low back pain includes laser, massage, multidisciplinary rehabilitation and spinal manipulation. Spinal manipulation is a high velocity thrust to a joint beyond its restricted range of movement. Spinal manipulation to lumber spine is a common intervention administered for patients with low back pain.

There is limited use of the technique in our society especially finding its effects on fatigue in chronic low back pain.

Eligibility Criteria:
Inclusion Criteria:

females patients having fatigue along with chronic low back pain low back pain for more than three months age 20-60

Exclusion Criteria:

* patients with conditions other than chronic low back pain having radiculopathy history of serious underlying pathology such as nerve root compromise, structural deformities, genetic spinal disorders and previous spinal surgery.