Kornimate/medical-research-clean huggingface dataset:
the effectiveness of a recovery program for people with mental illness: a multicenter study

Conditions: Mental Illness

Summary: recovery-oriented approach has been the main trend in mental health field. however, few recovery-oriented programs are available in taiwan, and many taiwanese people with mental illness don't understand the concepts of recovery. a program which provides recovery knowledge and assists in setting recovery goals is beneficial for taiwanese people with mental illness. hence, this study aimed to investigate the effectiveness of a recovery program for people with mental illness.

this is a randomized control trial. participants will be recruited from the psychiatric rehabilitation organizations in taiwan. they will be randomly assigned to the intervention group or control group. the recovery program has 2 phases and consists of 20 classes, 1.5 hour per class and one class per week. we will introduce concepts of recovery and personal strengths in phase 1. then, we will help participants to set goals and implement their plans in phase 2. participants will fill out five questionnaires during the recruitment meeting, including stages of recovery scale, medical outcomes study social support survey, the hope scale, rosenberg self-esteem scale and brief symptom rating scale-50. they will fill out the same questionnaires plus the course satisfaction survey in the end of phase 1 and 2. six months later, participants will receive a follow-up interview and fill out the questionnaires again. the control group will receive a spiritual book and complete the questionnaires at the same time as the intervention group.

Eligibility criteria:
inclusion criteria: * diagnosis of mental illness * lived in community exclusion criteria: -
study with nåva foot cream in patients with tinea pedis interdigitalis

Conditions: Tinea Pedis

Summary: a prospective, open post-market clinical investigation that will enroll male and female subjects diagnosed with foot fungus and at least one of the following conditions: heal cracks, calluses and/or dry feet. the investigation population will consist of 48 subjects fulfilling the eligibility criteria for the clinical investigation. the subjects will all be treated with the study product, nåva foot cream. the duration of the investigation is estimated to 6 months, including a 2-month recruitment period and 2-month follow up period.


Eligibility criteria:
inclusion criteria: 1. signed informed consent form 2. \> 18 years of age 3. tinea pedis (athlete's foot) confirmed with positive mycological culture for a dermatophyte 4. total score of 6-16 when grading the eight sign and symptoms of tinea pedis (erythema, erosions, macerations, pruritus, fissures, burning/stinging, hyperkeratosis, odour) using a 4-point severity scale (0=absent, 1= mild, 2= moderate, 3=severe) o score of 2 or higher required in at least one of the following: erythema, pruritus, macerations or odour 5. score of at least 2 (moderate) required in at least one of the following: heel cracks (rhagades), calluses and dry feet (hyperkeratosis) using a 5-point severity scale (0=absent, 1= mild, 2= moderate, 3= advanced, 4=severe) age exclusion criteria: 1. patients with negative mycological culture 2. severe tinea pedis interdigitalis (athlete's foot) total score of grading sign and symptoms \> 16 3. women pregnant or lactation at time of enrolment 4. patients using medicinal topical antifungal therapy within 4 weeks prior to study start 5. treatment with oral terbinafine, itraconazole or fluconazole within 6 months prior to start of study 6. treatment with other systemic antifungals within 12 weeks prior to start of study 7. treatment with systemic corticosteroids or immunosuppressants within 6 weeks prior to start of study 8. any other condition that as judged by the investigator may make follow-up or investigations inappropriate 9. any patient that according to the declaration of helsinki is unsuitable for enrollment
implementation of first-trimester screening and prevention of preeclampsia trial (forecast)

Conditions: Pre-Eclampsia

Summary: this implementation study aims to evaluate the efficacy, acceptability, and safety of first-trimester screening and prevention for preterm-preeclampsia. it is a multicenter stepped wedge cluster randomized trial including maternity / diagnostic units from ten regions in asia. the study involves a period where no intervention will take place at all recruiting units, and then at regular intervals, one cluster will be randomized to transit from non-intervention group to intervention group in which first-trimester screening for preterm-preeclampsia by the bayes based method followed by the commencement of low-dose aspirin in high-risk women.


Eligibility criteria:
inclusion criteria: * singleton pregnancy; * live fetus; exclusion criteria: * multiple pregnancy; * major fetal defects identified at 11-13 weeks of assessment; * non-viable fetus (missed spontaneous abortion or stillbirth).

Keywords: pre-eclampsia aspirin
internet based cognitive behavior therapy for concerned significant others of problem gamblers

Conditions: Gambling

Summary: background: about 2.3 % of the adult population in sweden is considered to be problem gamblers, and it is estimated that only 5 % of them seek treatment. problem gambling can have devastating effects on the economy, health and relationship, both for the problem gambler and their concerned significant other (cso). no empirically supported program exists for the csos of problem gamblers. consequently, the aim of this study is to develop and evaluate a program aimed at csos of treatment refusing problem gamblers. the program will be based on principles from cognitive behavioral therapy and motivational interviewing. in order to benefit as many csos as possible, the program will be delivered via the internet with therapist support via email and telephone. methods/design: this will be a randomized wait-list controlled internet-delivered trial. a cognitive behavioral-therapy program for the concerned significant others (csos) of problem gamblers (pgs) will be developed and evaluated. the participants will work through 8 modules over 10 weeks in a secure online environment, and receive support via text messages and over telephone. 150 csos over 18 years of age will be included. measures will be taken at baseline 3, 6 and 12 months. primary outcomes concern gambling-related harm and motivating the pg to seek treatment. secondary outcomes are cso's feelings of depression, anxiety, relationship satisfaction and quality of life. hypothesis: the investigators hypothesize: 1) that the cbt-cso group will lead to a reduction in gambling related harm experienced by the cso, 2) the cbt-cso program will reduce the cso's anxiety and depressive feelings, 3) the cbt-cso program will decrease the amount of time and money the problem gambler spend on gambling, 4) the cbt-cso program will increase the cso's relationship satisfaction with the problem gambler.


Eligibility criteria:
inclusion criteria: * the cso and the gambler are at least 18 years old, * the cso is a parent, child, sibling, friend or partner of the gambler. * the cso must have had a relationship with the gambler for at least 3 months. * neither the cso nor the gambler has had any treatment in the past 3 months (that is related to gambling). * the gambler is currently refusing help. * the cso is able to read and answer questions in swedish, and is willing to talk to a counselor each week. * the gambler is a problem gambler according to problem gambling severity index, as rated by the cso. * the cso must agree to have their telephone calls recorded. exclusion criteria: * presence of psychotic- or bipolar disorder in the cso or gambler. * cso meets pgsi criteria for ongoing problem gambling.

Keywords: concerned significant other internet-delivered cognitive-behavioral therapy, treatment-refusing problem gambler
saracatinib and alcohol drinking

Conditions: Alcohol Drinking

Summary: the purpose of this study is to evaluate the effects of the study medication, saracatinib/azd0530 (placebo or 125 mg/day) on alcohol drinking behavior in a laboratory setting in which participants are given an initial drink of alcohol followed by the choice to drink up to 12 more drinks over a three-hour period. the investigators hypothesize that saracatinib will reduce craving and number of drinks consumed prior to and after exposure to the initial drink of alcohol and during the three hour drinking period.


Eligibility criteria:
inclusion criteria: * ages 21-50 * able to read english at 6th grade level or higher and to complete study evaluations * regular alcohol drinker exclusion criteria: * individuals who are seeking alcohol treatment * medical conditions that would contraindicate the use of saracatinib * regular use of other substances
effects of activity on diabetes risk among breast cancer survivors on endocrine therapy (abide)

Conditions: Breast Cancer

Summary: the aim of this study is to learn more about how physical activity and cardiorespiratory fitness are related to diabetes risk among breast cancer patients prescribed an endocrine therapy.

80 women between the ages of 18-80 years will be recruited for this study. the study design consists of two separate in-person visits to university of colorado anschutz medical campus or colorado state university. the study consists of glucose testing, a body composition scan, exercise testing, and a two-week period of free living activity monitoring.

Eligibility criteria:
inclusion criteria: * female * diagnosed with breast cancer * age 18-80 years * completed surgery, chemo- and/or radiation therapy * prescribed aromatase inhibitor or serm for at least one year from the time of screening exclusion criteria: * age \ 80 * type 1 diabetes * type 2 diabetes * prescribed anti-hyperglycemic medication, insulin, or sulfonylurea. * pregnant, breastfeeding or planning to become pregnant in next 2 months * have absolute contraindications to exercise testing which are: 1. unstable angina 2. recent myocardial infarction, cardiac surgery, or vascular surgery (\<3 months) 3. uncontrolled high blood pressure 4. heart failure 5. peripheral artery disease (based on report of symptomatic claudication) 6. hepatic or renal disease 7. severe arthritis or mobility impairment that would interfere with exercise testing * suspected cognitive impairment that would prevent understanding or comprehension of study procedures.

Keywords: exercise breast cancer endocrine therapy insulin resistance body composition
treatment of hypertension with adalat® in combination with other drugs

Conditions: Hypertension

Summary: to investigate the therapeutic effectiveness of long acting nifedipine containing combination therapy in the treatment of hypertensive patients.


Eligibility criteria:
inclusion criteria: * previously untreated hypertensive patients starting with combination therapy containing nifedipine or * insufficiently controlled hypertensive pts. receiving nifedipine as an add-on to existing non-ccb (calcium-channel-blocker) containing antihypertensive therapy exclusion criteria: * none. exclusion criteria are defined by contraindications and precautions as stated in the local product information.

Keywords: hypertension drug therapy, combination
pilot study evaluating a perioperative e-follow-up protocol in patients with ambulatory surgery for breast cancer

Conditions: Breast Cancer

Summary: this is a monocentric, prospective cohort study evaluating the feasibility of a perioperative e-follow-up protocol in patients with ambulatory surgery for breast cancer. this protocol will be based on: * a coordinated ambulatory follow-up performed by a dedicated nurse * an electronic follow-up tool used in pre- and post-surgery patients will be followed 8 days before the surgery until 30 days after the surgery of breast cancer.


Eligibility criteria:
inclusion criteria: 1. patient eligible for an ambulatory surgery of breast cancer (partial mastectomy with or without lymph node sampling) 2. ambulatory surgery planned 10 days or more after inclusion date 3. age \> or = 18 years old 4. affiliated to the french social security system 5. patient must provide written informed consent prior to any study-specific procedure or assessment exclusion criteria: 1. surgery other than breast cancer surgery in ambulatory (benign breast surgery, other surgical specialities) 2. patient who cannot connect to the electronic tool at home (no computer, no tablet computer or no internet connection) 3. pregnant or breastfeeding women 4. any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure 5. patient protected by law

Keywords: breast cancer ambulatory surgery electronic tool e-follow-up
study to assess safety & immunogenicity of gsk biologicals' boostrix (dtpa) vaccine vs. chinese dt vaccine

Conditions: Diphtheria; Acellular Pertussis; Tetanus

Summary: this study will evaluate the safety and immunogenicity of a booster dose of gsk biologicals' reduced antigen content diphtheria, tetanus, acellular pertussis (dtpa) vaccine - boostrix in comparison with chinese dt vaccine, in children 6-8 years of age.


Eligibility criteria:
inclusion criteria: * a male or female between, and including, 6-8 years of age at the time of vaccination, * written informed consent obtained from the parent or guardian of the subject, exclusion criteria: * subjects who have received a total of 4 doses of dtp vaccine in the first 2 years of life, subjects who have received previous dtp booster vaccination since administration of the fourth dose of vaccine in second year of life can not participate. * subjects with history of diphtheria, pertussis or tetanus diseases can not participate.

Keywords: chinese dt vaccin
physical activity behavior change for older adults after dysvascular amputation

Conditions: Amputation; Diabetes Mellitus, Type 2; Peripheral Artery Disease

Summary: this pilot study will use mobile-health technology to deliver an intervention designed for lasting physical activity behavior change. the study will assess the feasibility of using the physical activity behavior change(pabc) intervention for veterans with lower limb amputation. this intervention will be delivered using wrist-worn wearable activity sensors and a home-based tablet computer to allow real-time physical activity feedback and video interface between the participants and the therapist.

this pilot study will assess the feasibility of using the physical activity behavior change(pabc) intervention for veterans with dysvascular lower limb amputation. in addition, preliminary efficacy of the pabc intervention will be assessed using a two-group randomized cross-over design. testing will occur at baseline (pre-intervention), three months (end of intervention), and six months. the primary aim is to determine feasibility of using the pabc intervention with veterans who have dysvascular amputation by measuring: 1. participant retention 2. dose goal attainment 3. participant acceptability 4. safety the secondary aim is to preliminary assess efficacy of the pabc intervention by measuring accelerometer-based physical activity and self-report disability effect sizes.

Eligibility criteria:
inclusion criteria: * lower limb amputation 1-5 years prior to enrollment * type 2 diabetes mellitus and/or * peripheral artery disease * ambulatory using a lower limb prosthesis * english speaking exclusion criteria: * traumatic or cancer-related etiology of the lower limb amputation * unstable heart condition, including: * unstable angina * uncontrolled cardiac dysrhythmia * acute myocarditis * acute pericarditis * uncontrolled hypertension * acute systemic infection * prisoner * decisionally challenged volunteers * cancer * recent cerebral vascular accident (within two years) * lower extremity wound or ulcer that limits ability to ambulate

Keywords: amputation physical activity rehabilitation
production of clinical-grade anti-cd19 chimeric antigen receptor t cells for refractory b-cell malignancies

Conditions: Leukemia

Summary: immunotherapy is a promising therapeutic approach for patients with cancers. patients with acute lymphoblastic leukemia (all) experiencing early relapse less than 18 months from diagnosis had very poor prognosis with 5-year survival rate of 21% (1). recent clinical trials demonstrated that infusions of autologous t cell modified with chimeric antigen receptors (cars) induced durable complete remissions in patients with relapse or refractory b-cell all (2-4). the editors of science journal announced cancer immunotherapy as the breakthrough of the year for 2013 (5). on jan 30, 2015, dr. steven m. altschuler, chief executive officer of the children's hospital of philadelphia and 9-year-old all patient emily whitehead with 3-year leukemia free after car-t cell infusion were invited to white house for president barack obama's announcement of the precision medicine initiative. the mit technology review announced that the top one breakthrough technology in 2016 is genetically engineered immune cells saving the lives of cancer patients. this project will focus on the manufacturing of clinical-grade anti-cd19 cars for b-cell malignancies in the future clinical trials.


Eligibility criteria:
1. at least 14 years of age (underage patients under the age of 20 only collect peripheral venous blood, do not perform double-lumen venous catheter and white blood cell separation). 2. there are no known serious systems or diseases with systemic immunodeficiency, but blood-related cancers are not. 3. systemic chemotherapy and target treatment were not received within 14 days. 4. the subject consent form has been signed prior to the program-related procedures.

Keywords: acute lymphoblastic leukemia,immunotherapy,chimeric antigen receptor,non-hodgkin's lymphoma
backpack weight impacts

Conditions: Exertion; Excess

Summary: backpacking is an increasingly popular outdoor recreational activity. the base pack weight (bpw) includes gear that is not consumed or worn on the body: shelter, sleep system, weather-proofing layers and personal gear to ensure a degree of comfort and safety. as such, reducing bpw is one of the most important tasks a backpacker manages when preparing for a trip. available recommendations for ideal bpw are currently inconsistent, lack clear parameters, and rely on anecdotal evidence. the study aims to collect field data on perceived exertion and heart rate (hr) in relation to bpw during a day-long interval of hiking. such findings can have implications on the cost and safety profiles extending from recreational backpacking to military and wilderness rescue operations.


Eligibility criteria:
inclusion criteria: * only adult (age 18-65) * have gone on at least two overnight backpacking trips in the past 5 years * have hiked at least 8 miles in a day on one of those trips exclusion criteria: * lower extremity injuries or surgeries in the past 6-months * daily smokers * chronic medical problems: * hypertension * high cholesterol * diabetes * heart attack * heart surgery, cardiac catheterization, or coronary angioplasty * pacemaker/implantable cardiac defibrillator/rhythm disturbance * heart valve disease * heart failure * heart transplantation * congenital heart disease * kidney disease * back pain
shorter duration radiotherapy to treat prostate cancer after removal of the prostate

Conditions: Prostate Cancer

Summary: radiation therapy is one of the standard treatments for men with prostate cancer who have detectable levels of prostate specific antigen (psa, a prostate cancer specific marker) after surgery. when radiation therapy is given to patients who have an increase in psa after surgery, it is called "salvage radiation therapy". currently the standard radiation therapy course length for this type of cancer is around 7 ½ -8 weeks. sometimes, radiation therapy after prostate removal causes unpleasant side effects. a shorter course of radiation therapy, known as a "hypofractionated" course, gives fewer but higher doses of radiation than standard radiation. the purpose of this study is to test the safety of a shorter course of radiation therapy at progressively lower dose levels and shorter lengths of treatment (hypofractionated) with patients who have had their prostate removed. the study will assess whether the hypofractionated course works better without causing additional side effects to the remaining cancer cells in the prostate bed.

primary objectives: to determine the shortest dose-fractionation schedule (dose schedule) with acceptable grade ¡ã 3 gu/gi toxicity rate for salvage hypofx rt to maintain a constant, high bed for prostate cancer response while reducing the bed for late gu and gi toxicity to assess health-related quality of life (hrqol) of the recommended dose schedule of salvage hypofx rt by demonstrating no significant change in 1-year disease specific qol, as compared to baseline secondary objectives: to evaluate and characterize the acute and late genitourinary (gu) and gastrointestinal (gi) adverse effects associated with postoperative, hypofractionated radiation therapy. to evaluate biochemical failure rate, defined separately as nadir plus 2 ng/ml and as three consecutive rises in psa, at 2 years after hypofractionated, post-prostatectomy radiation therapy. to evaluate health utilities at 1 year after hypofx salvage rt, as measured by the eq-5d instrument. to evaluate changes in sexual domain of epic quality of life instrument at 1 year after hypofx salvage rt. to evaluate the treatment burden for patients undergoing salvage hypofx rt, in order to examine whether hypofx rt results in less burdensome treatment for patients, as measured by patient-reported direct and indirect (i.e., transportation) health care costs and lost productivity due to treatment, as evaluated by the work productivity and activity impairment questionnaire¢-general health (wpai-gh).

Eligibility criteria:
inclusion criteria: * diagnosis of prostate adenocarcinoma and * have had a prostatectomy * have detectable psa * 18 years of age or older exclusion criteria: * are receiving chemotherapy or other agents intended for cancer treatment * history of rectal surgery or lower gastrointestinal bleed * history of bleeding diathesis or abnormal sensitivity to ionizing radiation * had prior pelvic irradiation or are scheduled to receive pelvic nodal irradiation

Keywords: radiotherapy, hypofractionated salvage therapy radiotherapy, adjuvant
comorbidity after gastric bypass

Conditions: Severe Obesity

Summary: to evaluate effect on comorbid disease and weight loss in the long-term (\>five years) after roux-en-y gastric bypass (rygb) surgery for severe obesity.

individuals with severe obesity frequently have comorbid diseases, e.g. diabetes, hypertension, hyperlipidemia, and sleep apnea. we will study the remission rate and weight loss in the long-term (10 years) after roux-en-y gastric bypass (rygb) surgery in a nationwide large group of patients.

Eligibility criteria:
inclusion criteria: * registered individuals in scandinavian obesity surgery registry (soreg) having had gastric bypass exclusion criteria: * all other operations
study investigating the effect of idalopirdine on cardiac repolarisation in healthy men

Conditions: Healthy Volunteers

Summary: to evaluate the effect of idalopirdine (120 and 360 mg) on cardiac repolarisation in healthy men.


Eligibility criteria:
inclusion criteria: * body weight at least 50 kg and body mass index \>18.5 and \< 30 kg/m2 * good general health ascertained by a detailed medical history, laboratory tests and physical examination * use of contraception. exclusion criteria: * the subject has evidence of cardiac conduction abnormalities as calculated by the ecg equipment and evaluated by the investigator, at the screening visit or at the baseline visit * the subject has a history of long qt syndrome, history of cardiac arrhythmia, or history of cardiac disease (eg, coronary artery disease, valvular disease, etc.). other protocol defined inclusion and exclusion criteria do apply