Kornimate/medical-research-clean huggingface dataset:
long term follow-up study of safety and efficacy of botulinum toxin type a for the treatment of patients with idiopathic overactive bladder with urinary incontinence

Conditions: Overactive Bladder; Urinary Incontinence

Summary: the purpose of this study is to assess the long term safety and effectiveness of botulinum toxin type a in treating patients with idiopathic overactive bladder with urinary incontinence.


Eligibility criteria:
inclusion criteria: * participation in preceding study 191622-095 (nct00910845) or 191622-520 (nct00910520) exclusion criteria: * females who are pregnant, nursing or planning a pregnancy * patient has any condition or situation which, in the investigators opinion, would put the patient at risk from continuing treatment with botulinum toxin type a
healthy weight at home: a pilot weight loss program for parents of children with a disability

Conditions: Overweight and Obesity

Summary: the objective of this study is to design, implement, and pilot a lifestyle-based, 12-week, weight loss program for parents of children with a disability. this weight loss program supports weight loss among parents. it is a first step towards a parent-only approach to promote healthier weight among children with a disability.


Eligibility criteria:
inclusion criteria: parent * age ≥18 * english speaking * completion of screening and baseline data collection * bmi ≥ 25 and weight \< 300lbs (weight limit due to scale limitations) * willing to lose weight through physical activity, weight tracking and decreased caloric intake * willing to make changes at home to facilitate a healthy weight * willing to complete 12 weekly weight loss video coaching sessions (20 minutes/session) * willing to use skype, facetime, zoom, or webex for regular intervention contact * internet/ cellular plan that is sufficient for weekly program video conferencing * willing to use the study scale with cellular technology to report weights at baseline, 12 weeks, and 24 weeks. * willing to use the study scale with cellular technology at least weekly during the study (12 weeks) * completion of screening and baseline data collection child * age 8-18 * has a disability * assent is required if the child is capable and willing to have height and weight taken by the parent at baseline, 12 weeks, and 24 weeks. exclusion criteria: * parent or child: previously diagnosed eating disorder, or treatment for an eating disorder * parent: currently pregnant or plan to get pregnant in the next 6 months * parent: planned weight loss surgery or procedure in the next 6 months
a trial exploring the opportune administration of nab-paclitaxel in the first line treatment, camrelizumab combined with nab-paclitaxel and famitinib, of tnbc.

Conditions: Triple-Negative Breast Cancer

Summary: the study is being conducted to evaluate the opportune administration of nab-paclitaxel in the first line treatment strategy, camrelizumab and famitinib with/without nab-paclitaxel, of patients with unresectable locally advanced or metastatic immunomodulatory triple negative breast cancer.


Eligibility criteria:
inclusion criteria: * ecog performance status of 0-1 * expected lifetime of not less than three months * metastatic or locally advanced, histologically documented tnbc (absence of her2, er, and pr expression) * cancer stage: recurrent or metastatic breast cancer; local recurrence be confirmed by the researchers could not be radical resection. * adequate hematologic and end-organ function, laboratory test results. * measurable disease according to response evaluation criteria in solid tumors v1.1 (recist v1.1) • patients had received no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer exclusion criteria: * previous received anti-vegfr small molecule tyrosine kinase inhibitors (e.g. famitinib, sorafenib, sunitinib, regorafenib, etc.) for treatment of the patients . * a history of bleeding, any serious bleeding events. * important blood vessels around tumors has been infringed and high risk of bleeding. * coagulant function abnormality * artery/venous thromboembolism event * history of autoimmune disease * positive test for human immunodeficiency virus * active hepatitis b or hepatitis c * uncontrolled pleural effusion and ascites • known central nervous system (cns) disease. * long-term unhealing wound or incomplete healing of fracture * urine protein ≥2+ and 24h urine protein quantitative \> 1 g. * pregnancy or lactation. * thyroid dysfunction. * peripheral neuropathy grade ≥2. * people with high blood pressure; * a history of unstable angina; * new diagnosis of angina pectoris. * myocardial infarction incident ;
implementation of a psychoeducational intervention in new mothers

Conditions: Depression, Postpartum; Anxiety

Summary: the goal of this clinical trial is to implement and examine the clinical effectiveness in a randomized study of the catalan and spanish versions of the culturally adapted "what were we thinking (wwwt)" psychoeducational intervention in primary care services, with the aim of preventing and reducing the prevalence of postpartum mental illness in new mothers. additionally, the trial will assess the acceptability and accessibility of the intervention by families and professionals. researchers will compare "usual care" (standard postnatal care provided by professionals from the sexual and reproductive health service) with "intervention group" (usual care plus two psychoeducative intervention wwwt sessions) to see if the "wwwt intervention" is better than "usual care" at preventing postpartum depression and anxiety disorders in new mothers. participants will: * take baseline questionnaires at 2-4 weeks postpartum * take usual care or usual care plus two psychoeducative intervention wwwt sessions within the first 6 weeks postpartum * take the same questionnaires used in baseline plus a semi-structured interview to diagnose major mental disorder (all participants) at 3 and 6 months follow-up * take a brief anonymous self-report survey (only those participants taking the wwwt intervention)


Eligibility criteria:
inclusion criteria: * primiparous women * given birth a healthy, full-term baby in the preceding 2 weeks * receiving postpartum healthcare at atenció a la salut sexual i reproductiva (assir) of àrea integral de salut barcelona esquerra (ais-be) * over 18 years of age * give consent to participate in the study exclusion criteria: * if are unable to complete the questionnaires due to language or literacy barriers

Keywords: postpartum period prevention preventive health care psychoeducation primiparity female
structured gym activities and aerobic activities in people with cardiac conditions

Conditions: Cardiac Disease

Summary: to compare the effect of structured gym activities and traditional aerobic activities on cardiorespiratory endurance in people with cardiac conditions to compare the effect of structured gym activities and traditional aerobic activities on quality of life in people with cardiac conditions


Eligibility criteria:
inclusion criteria: * individuals with cardiac conditions including post-first myocardial infarction, post valvular diseases, post-cabg patients. * individuals who can perform cardiorespiratory exercises with ease(who are able to complete 6 minute walk test). * individuals who have not performed regular physical activity in the past 6 months (pa-r) * no regular exercise or gym activity since last 6 months exclusion criteria: * individuals who are highly trained in gymnastic * already trained (any gym activity or regular exercise) * individuals with diabetes, hypertension, and kidney diseases. * any neurological complication * any musculoskeletal disorder

Keywords: gym activities aerobic exercises
left ventricular dysfunction in diabetes

Conditions: Diabetes Mellitus, Type 2; Heart Diseases; Left Ventricular Dysfunction

Summary: the purpose of this study is to evaluate the prevalence, during the enrolment, of left ventricular dysfunction diastolic and/or systolic in patients with diabetes mellitus type 2 without known or documented heart disease history and recognize its predictive clinical, biohumoral and with non-invasive techniques parameters.


Eligibility criteria:
inclusion criteria: * diabetes mellitus type 2 * absence of heart disease previously reported * age \>45 years * informed consent exclusion criteria: * presence of heart disease previously reported * diabetes type 1 * serious systemic disease, with an expected lifetime lower than 2 years * no willingness to participate to the screening * inadequate compliance to study procedure * participation to other study

Keywords: diabetes mellitus, type 2 heart diseases left ventricular dysfunction
study of safety and efficacy of ertugliflozin (pf-04971729, mk-8835) in participants with type 2 diabetes (mk-8835-016)

Conditions: Diabetes Mellitus, Type 2

Summary: mk-8835-016 (b1521006) is designed to evaluate the safety and efficacy of an investigational drug, ertugliflozin (mk-8835, pf-04971729) in participants with type 2 diabetes mellitus. participants in the study will receive 1 of 6 treatments for 12 weeks including 1 treatment with an approved drug (sitagliptin) for the treatment of type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * participants with type 2 diabetes on stable doses of background medicines for management of the diabetes; aged 18-70 years; body mass index between 23-45 kg/m\^2 exclusion criteria: * participants with type 1 diabetes, heart attack or stroke in last 6-months, uncontrolled blood pressure, significant kidney disease

Keywords: phase 2 safety and efficacy study with ertugliflozin (pf-04971729, mk-8835) type 2 diabetes mellitus
effect of medical hypnosis in virtual reality on insomnia disorders

Conditions: Insomnia Chronic

Summary: the prevalence of chronic insomnia is 13.3% in france in 2019 (8.9 million). the consequences for these people are multiple: drowsiness, memory problems, difficulty concentrating, anxiety. cognitive and behavioral therapy (cbt) is today the reference treatment recommended by the "haute autorité de santé" and the american college of physicians for chronic insomnia. today, however, few patients use cbt treatment due to the lack of trained practitioners, the cost of non-reimbursed sessions and the time and involvement that these sessions require. several clinical trials have shown beneficial effects of hypnotherapy on sleep disorders. the hypothesis of this work is that the use of hypnosis in virtual reality improves sleep time in patients suffering from insomnia disorders.


Eligibility criteria:
inclusion criteria: 1. patient suffering from insomnia as defined in the diagnostic and statistical manual of mental disorders v (dms-v) and the international classification of sleep disorders. exclusion criteria: 1. patient who, in the judgment of the investigator, has a disease that may preclude participation in study procedures. 2. minor subject 3. subject under judicial protection, guardianship or curatorship 4. inability to give informed information about the subject: demented patients, psychotic patients or follow-up for a psychiatric pathology 5. unbalanced epilepsy 6. hearing and/or visual disorders that contraindicate the use of virtual reality headphones 7. patient with a language barrier 8. pregnant or breastfeeding patient 9. subject in period of exclusion (determined by a previous or current study) 10. patient refusal 11. patient currently being treated for depression, alcoholism or drug addiction. 12. patient using drug treatment for insomnia not stabilized within 2 weeks prior to the start of the study. 13. patient starting psychological, complementary or alternative medicine treatment for insomnia within 2 weeks prior to the start of the study, or during the study. 14. patient receiving or having received cbt treatment for insomnia within the last 6 months. 15. patient diagnosed with sleep apnea, involuntary limb movement, restless legs syndrome. 16. patient with diagnosed medical conditions that cause insomnia: psychotic disorder, bipolar disorder, dementia, generalized anxiety disorder, panic disorder, manic disorder, schizophrenia, cancer.

Keywords: virtual reality hypnosis sleep
lean body mass as a determinant of docetaxel pharmacokinetics and toxicity

Conditions: Breast Cancer; Metastatic Castration-resistant Prostate Carcinoma

Summary: docetaxel is used as a first line anti-cancer drug in the treatment of several cancers, mainly breast- and metastatic castration-resistant prostate carcinoma. anti-cancer drugs are being dosed based on patients estimated body surface area in order to equalize total drug exposure. nevertheless, docetaxel treatment is characterized by highly interindividual pharmacokinetic variation leading to toxicity and under-treatment. the investigators will determine which anthropometric parameters, lbm, total body weight (tbw) or bsa correlate best to docetaxel exposure (auc) for both males and females.

docetaxel is used as a first line anti-cancer drug in the treatment of several cancers, mainly breast- and metastatic castration-resistant prostate carcinoma. anti-cancer drugs are being dosed based on patients estimated body surface area in order to equalize total drug exposure. nevertheless, docetaxel treatment is characterized by highly interindividual pharmacokinetic variation leading to toxicity and under-treatment. for most anti-cancer drugs, including docetaxel, other anthropometric parameters, such as lean body mass (lbm), have been suggested to be superior to body surface are (bsa) as a determinant for dosing but this has not been implemented in clinical practice. the investigators will determine which anthropometric parameters, lbm, total body weight (tbw) or bsa correlate best to docetaxel exposure (auc) for both males and females. the investigators will determine if occurrence of docetaxel toxicity can be related to dose/lbm. the investigators will determine which methods to measure lbm: dexa, bioelectrical impedance assessments (bia) or formula estimates are accurate enough for dosing calculations to be used for dosing docetaxel.

Eligibility criteria:
inclusion criteria: * subject is at least 18 * subject is able and willing to sign the informed consent form prior to screening evaluations * female subject diagnosed with breast carcinoma and will receive docetaxel treatment according to standard hospital protocol (tac regimen) or male subject diagnosed with metastatic castration-resistant prostate carcinoma and will receive docetaxel treatment according to standard hospital protocol (prodoc regimen) * subject has a live expectancy of 12 weeks or greater * absolute neutrophile count (anc) \> 1.5 x 10e9/l * platelet count \> 100 x 10e9/l * serum creatinine ≤ 2 x uln * total bilirubin level \< 1.5 x uln exclusion criteria: * docetaxel treatment within the last year * moderate or severe liver impairment; \[alat and/or asat ≥ 1.5 uln\] and \[af ≥ 2.5 uln\] * current therapy with any drug, dietary supplements, or other compounds, or have been used in the last 2 weeks prior to the first docetaxel administration, known to inhibit or induce cyp3a4. * inability to understand the nature and extent of the study and the procedures required

Keywords: breast cancer prostate carcinoma docetaxel lean body mass body surface area body weight dexascan
post-treatment follow-up study for liver disease subjects with or without cirrhosis after receiving emricasan or placebo

Conditions: Liver Diseases; Liver Fibrosis; Liver Cirrhosis; NASH Fibrosis; Decompensated Non-Alcoholic Steatohepatitis Cirrhosis; Orthotopic Liver Transplantation

Summary: a post-treatment follow-up observational study for liver disease subjects with or without liver cirrhosis after receiving emricasan or placebo. subjects must have been enrolled in a prior idn-6556 study to be eligible.

a multi-center, post-treatment follow-up observational study for liver disease subjects with or without liver cirrhosis after receiving emricasan or placebo. this phase 2 observational study will enroll subjects from study idn-6556-07 (post orthotropic liver transplantation - nct02138253), idn-6556-12 (nash fibrosis - nct02686762), idn-6556-14 (nash cirrhosis and severe portal hypertension - nct02960204) or idn-6556-17 (decompensated nash cirrhosis - nct03205345) who have received at least one dose of emricasan or placebo.

Eligibility criteria:
inclusion criteria: 1. subjects previously treated with at least 1 dose of emricasan or placebo from clinical studies idn-6556-07 (post orthotopic liver transplant due to hcv), idn-6556-12 (nash fibrosis), idn-6556-14 (nash cirrhosis), or idn-6556-17 (nash cirrhosis). 2. subjects able to provide written informed consent and able to understand and willing to comply with the requirements of the study. exclusion criteria: 1. use of controlled substances (including inhaled or injected drugs) or non-prescribed use of prescription drugs within 1 year of screening to the point of interfering with the subject's ability to comply, in the investigator's judgement, with study procedures. 2. treatment with an investigational drug following treatment with emricasan or placebo. 3. previous transplant unless subject was enrolled from idn-6556-07 (post orthotopic liver transplant due to hcv).
evaluation of the improvement of primary prevention in ischemic cardiomyopathy patients using new screening and referring system (advance-icm)

Conditions: Ischemic Cardiomyopathy

Summary: the patients who undergo icd(implantable cardioverter defibrillator) implantation for the primary prevention of sudden cardiac death with severe lv(left ventricle) dysfunction (ejection fraction ≤ 40%) by icm(idiopathic cardiomyopathy). indications for icd implantation for primary prevention in accordance with 2016 revised korean indication guideline on icd implantation * fu lvef(left ventricular ejection fraction) ≤ 30% (at least 40 days post-myocardial infarction) * fu lvef 31\~35%, nyha(the new york heart association) class ii, iii (at least 40 days post-myocardial infarction) * fu lvef ≤ 40%, nsvt(non-sustained ventricular tachycardia) (holter), inducible vf(ventricular flutter) or sustained vt(ventricular tachycardia) at electrophysiological study (at least 40 days post-myocardial infarction)


Eligibility criteria:
inclusion criteria: * age 18-80 years * patients eligible for the indications for icd implantation for primary prevention indication in accordance with 2016 revised korean indication guideline on icd implantation * patients should be managed by non-ep physician * patients who are willing to sign the informed consent * patients who are willing to receive the implantation and post-operative follow-up exclusion criteria: * malignant tumor * life expectancy \< 12 months * patients unable or unwilling to cooperate in the study procedures
investigating clinical efficacy of ofatumumab in adult rheumatoid arthritis (ra) patients who had an inadequate response to tnf-α antagonist therapy

Conditions: Arthritis, Rheumatoid

Summary: this is a phase iii, double-blind, randomized, multicenter, and parallel group trial with a duration of 24 weeks, followed by a 120 week open-label period. the primary purpose of the study is to demonstrate the efficacy and safety of ofatumumab in reducing clinical signs and symptoms in adult ra patients who had an inadequate response to tnf-α antagonist therapy.

this study consist of a double-blind, placebo controlled, and parallel group part with eligible patients enrolled into a 24 week double-blind period, and randomized in a 1:1 ratio to receive either ofatumumab or placebo in addition to their background methotrexate treatment. patients who complete the 24 week double-blind period without receiving rescue dmard treatment will then be eligible to proceed into the 120 week open-label period to receive repeat treatment courses with ofatumumab. in the open-label period ofatumumab treatment courses will be given at individualized time intervals only if a clinical response has been achieved following the previous treatment course, and followed by a subsequent worsening in disease activity. patients who have completed the open-label period or have been withdrawn will then enter a maximum 2 year follow-up period, or until there b-cells return to normal or to baseline levels, whichever occurs earlier

Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * active disease at the time of screening as defined by: ≥ 8 swollen joints (of 66 joints assessed) and ≥ 8 tender joints (of 68 joints assessed), c-reactive protein (crp) ≥ 1.0 mg/dl or erythrocyte sedimentation rate (esr) ≥ 22 mm/hour, das28≥3.2 (based on esr); * inadequate response to previous or current tnf-alpha antagonist treatment; * treatment with methotrexate (mtx), 7.5-25 mg/week, for at least 12 weeks and at a stable dose for at least 4 weeks. exclusion criteria: * patients with a history of a rheumatic autoimmune disease other than ra or with significant systemic involvement secondary to ra; * previous exposure to biologic anti-rheumatic therapies, including investigational compounds; * exposure to tnf-alpha antagonist treatment \< 12 weeks prior to visit 2; * chronic or ongoing active infectious disease requiring systemic treatment; * clinically significant cardiac disease; history of significant cerebrovascular disease; * significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral psychiatric disease, or evidence of demyelinating disease; * known hiv positive; serologic evidence of hepatitis b infection; positive test for hepatitis c; positive plasma / white cell jc virus pcr; * serum igg \< lower limit of normal; * breast feeding women or women with a positive pregnancy test at screening; * current participation in any other interventional clinical study; * patients known or suspected of not being able to comply with a study protocol.
omega-3 fatty acids and subconcussive head impacts

Conditions: Subconcussive Head Impact; Omega-3 Fatty Acids

Summary: the purpose of the proposed double-blind, randomized placebo-controlled trial is to understand how supplementation with fish oil \[docosahexaenoic acid (dha) and eicosapentaenoic acid (epa)\] promote brain health against soccer heading. the study involves taking dha+epa or placebo, questionnaires, blood draws, brain imaging, tests to evaluate heart function, and soccer headings.

the purpose of the proposed study is to determine whether, and to what extent, supplementation with omega-3 fatty acids \[docosahexaenoic acid (dha) and eicosapentaenoic acid (epa)\] can maintain or promote neural wellbeing against repetitive subconcussive head impacts. this study will also characterize what aspects of brain cellular and physiologic resiliencies are enhanced by supplementation in adult soccer players (aged 18-30 years old). a sub-cohort of participants who meet criteria for adhd diagnosis will be part of exploratory analysises.

Eligibility criteria:
inclusion criteria: * between age 18-30 * current or former soccer player * at least 5 years of soccer heading experience * have internet access * willing to commit to avoid any sport activity that purposefully uses one's head to maneuver during the study period (american football, ice-hockey, rugby, wrestling, and soccer heading). exclusion criteria: * any head or neck injury within 6 months before the study * implanted metal/magnetic devices (e.g., orthodontic braces * diagnosed autonomic or cardiovascular diseases (e.g., hypertension) * consuming oily fish (2 servings or more/month: salmon, bluefin, swordfish, anchovies) * allergy to fish or shellfish * consuming omega-3 fa supplements including plant-based (e.g., flaxseed) in the past 3 months. * pregnancy

Keywords: subconcussive brain injury tbi soccer heading omega-3 fatty acids