Kornimate/medical-research-clean huggingface dataset:
a biomarker and mri study on troponin release after exercise in hypertrophic cardiomyopathy

Conditions: Hypertrophic Cardiomyopathy

Summary: study population: 1) mutation carriers without the hypertrophic phenotype (pre-clinical hypertrophic cardiomyopathy (hcm)) and in 2) patients with clinically overt hcm (clinical hcm). hypothesis: cardiac troponin release after exercise can be demonstrated in both clinical and pre-clinical hcm patients.


Eligibility criteria:
inclusion criteria: * patients with an echocardiographically proven hypertrophic cardiomyopathy according to the esc guidelines or individuals with a hcm associated mutation without the clinical characteristics of hypertrophic cardiomyopathy (pre-clinical hcm patients); * age ≥ 18 years; * able to comply with the protocol; * written informed consent. exclusion criteria: * known significant epicardial coronary artery disease; * patients with lvh in the clinical setting of other disorders that explain the myocardial hypertrophy (amyloidosis, melas, anderson-fabry, wpw etc.); * heart failure nyha class iii-iv; * patients with known hemodynamic instability or syncope during exercise due to left ventricular outflow gradient or occurrence of ventricular arrhythmia; * history of ptsma (percutaneous transluminal septal myocardial ablation) or morrow myectomy; * patients not able to complete a bicycle test; * any contraindication to mr imaging (mr imaging is not obligatory for assessment of the primary objective, therefore relative exclusion criterion); * recent (within 30 days) admittance to the hospital for any cardiac reason (myocardial infarction, heart failure, cardiac arrhythmia, etc.); * severe renal insufficiency (egfr \< 30 ml/min); * any other condition which, in the opinion of the investigator, may pose a significant hazard to the subject if he or she participates in the present study.

Keywords: troponin exercise mri
combination chemotherapy in treating patients with metastatic prostate cancer that has not responded to hormone therapy

Conditions: Prostate Cancer

Summary: 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 combination chemotherapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

objectives: * determine the efficacy of the combination of mitoxantrone and vinorelbine in terms of response rate, progression free survival, overall survival, and quality of life in patients with metastatic hormone refractory adenocarcinoma of the prostate. * determine the toxicities of this treatment regimen in these patients. outline: this is a multicenter study. patients receive vinorelbine iv on days 1 and 8 and mitoxantrone iv on day 8. treatment repeats every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity. quality of life is assessed prior to treatment, prior to each course, and then at 2 months after study completion. patients are followed every 3 months until disease progression. projected accrual: a total of 14-39 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed stage iv hormone refractory adenocarcinoma of the prostate * progressive disease despite hormonal therapy or orchiectomy * no brain metastases patient characteristics: age: * 18 to 80 performance status: * who 0-2 life expectancy: * at least 3 months hematopoietic: * absolute neutrophil count at least 2,000/mm\^3 * platelet count greater than 100,000/mm\^3 * hemoglobin greater than 9 g/dl hepatic: * alkaline phosphatase no greater than 2 times upper limit of normal (uln) (unless bone metastasis) * bilirubin less than 2 times uln renal: * creatinine less than 2 times uln cardiovascular: * adequate cardiac function other: * no other prior malignancy except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior chemotherapy endocrine therapy: * see disease characteristics * prior corticosteroids allowed if started at least 8 weeks prior to study radiotherapy: * at least 8 weeks since prior extensive radiotherapy surgery: * see disease characteristics

Keywords: adenocarcinoma of the prostate stage iv prostate cancer recurrent prostate cancer
a study to learn about the study medicine (called tofacitinib) in people with psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: the purpose of this study is to learn about the safety and effects of the study medicine for the potential treatment of psoriatic arthritis (psa). psoriatic arthritis is a joint swelling disease that can also affect the skin, nails and eyes. the study medicine is called tofacitinib. this study is seeking participants who: * started taking tofacitinib alone or with other approved medicines (eg. methotrexate, leflunomide, sulfasalazine, apremilast) for psa disease. we will only look at participants' who started tofacitinib after december 14, 2017. * have a 6-month follow-up visit (with a 3-month window) this is an observational study. participants receiving tofacitinib will be included to assess how well tofacitinib works. we will look at participants' demographic information and therapy history. we will also monitor participants' disease progression before and 6 months after treatment. we will examine the experiences of people receiving the study medicine. this will help us determine if the study medicine is safe and effective.

tofacitinib is an oral janus kinase (jak) inhibitor approved in 2017 by the us food and drug administration (fda) for the treatment of adult patients with active psa who have had an inadequate response or intolerance to methotrexate or other disease modifying antirheumatic drugs (dmards). as of december 3, 2021, tofacitinib is approved for use in patients who have had an inadequate response or intolerance to one or more tnf blockers. this is an observational retrospective cohort study that will be conducted using patients enrolled in the corevitas psa/spa registry, initiating tofacitinib on or after december 14th, 2017. patients receiving tofacitinib will be included to assess the effectiveness of tofacitinib overall and when stratified by key variables of interest. more specifically, the overall aim will be to describe baseline demographic, therapy history, and disease activity characteristics and assess change in disease activity measures six months after initiation of tofacitinib. there are two primary objectives for this study: 1. to describe the effectiveness of all tofacitinib initiators at 6 months in psa patients 2. to describe the effectiveness of all tofacitinib initiators at 6 months stratified by monotherapy and combination therapy of psa

Eligibility criteria:
inclusion criteria: * psa patients in corevitas initiating tofacitinib monotherapy or in combination with oral small molecules (eg methotrexate, leflunomide, sulfasalazine, apremilast) after 14 december 2017 (market approval of tofacitinib in the us) with no prior use of tofacitinib. only the patient's first initiation after december 14, 2017 will be included in the analysis * have a 6 month follow-up visit (with ±3 month window) exclusion criteria: * patients taking tofacitinib in combination with any other bdmard
contralateral acupuncture in the treatment of chronic shoulder pain

Conditions: Shoulder Pain

Summary: according to traditional chinese medical theories, a variety of acupuncture formulas can treat diseases such as pain. for example, stimulating acupoints either local or distal to the pain site has been proposed under some conditions. we hypothesize that stimulating acupoints contralateral to the pain site can successfully treat chronic shoulder pain.


Eligibility criteria:
inclusion criteria: * uni-lateral shoulder pain for 6 weeks to 2 years * vas score ≤ 50 * 25-65 years of age * positive neer's or hawkins' signs * accept the informed consent exclusion criteria: * shoulder pain of neurological origins * shoulder pain of neck origins * systematic arthritis * wrist problems * previous shoulder, arm, neck or chest fractures or surgeries * mental diseases * pregnancy * inability to work for more than 3 months before treatment * diabetes * coagulative dysfunction * corticosterone or physicotherapy experience on the affected shoulder in the last 6 months * failure to accept the informed consent

Keywords: shoulder pain acupuncture
assessment of the quality of life of patients with lymphomas treated with oral therapy

Conditions: Quality of Life

Summary: the emergence of new anti-cancer drugs orally administered has revolutionized the prognosis and modalities of management of several lymphomas over the past decade. today, half of patients receive oral therapy at home. ibrutinib, acalabrutinib, idelalisib, venetoclax and lenalidomide are oral therapies used in the treatment of chronic lymphoid leukemia, follicular lymphoma, waldenström's disease and mantle cell lymphoma, in relapsing but soon to be 1st line. nevertheless, clinical trials leading to marketing authorizations for these drugs were performed in a small number of patients and very little data is available on their use in real life conditions. their impact on the quality of life of patients also remains to be assessed. the aim of this clinical research is to evaluate quality of life of patients at the initiation of the first oral therapy and every year for 5 years. this study will also identify factors (biological and non-biological: quality of life, shared decision-making ...) associated with a good response of patients and follow-up for the occurrence of long-term adverse reactions (5 years).

prospective longitudinal cohort. this observational study is monocentric. for each patient, data will be collected during 5 years.

Eligibility criteria:
inclusion criteria: * patients included in the pk-e3i clinical study or * over the age of 18 * patients with hemopathies and starting treatment with oral therapy (idelalisib, ibrutinib, venetoclax, lenalidomide, acalabrutinib...) * be able to understand the objective and the constraints related to research * patient having read the information notice and the non-objection form * social security affiliation exclusion criteria: * pregnant women * persons under legal protection of adults * patients under judicial protection

Keywords: oral therapy lymphoma quality of life
study of long-acting acetaminophen in postoperative dental pain

Conditions: Dental Pain

Summary: the purpose of the study is to evaluate the efficacy and safety of acetaminophen er 1500 mg (two 750 mg tablets) over 10 to 12 hours in the dental pain model following third molar extraction(s) and to evaluate the pharmacokinetics of acetaminophen er 1500 mg (two 750 mg tablets) in a sub-group of subjects.


Eligibility criteria:
inclusion criteria: * must be at least 17 and less than 46 years of age * must weigh at least 100 lbs with a body mass index of at least 18 and less than 30 * scheduled to undergo surgical extraction of one impacted third molar from the lower jaw. the third molar from the upper jaw from the same side may also be removed. * experiencing moderate to severe pain after extraction of third molars. exclusion criteria: * cannot be allergic to acetaminophen (tylenol) or any non-steroidal anti-inflammatory drugs (e.g., motrin, advil, aleve, naproxen). * cannot be pregnant (or planning to be pregnant) or nursing a baby * unable to swallow whole large tablets or caplets. * cannot have any other medical conditions that the investigator feels may compromise your safety or the study results.

Keywords: acetaminophen paracetamol analgesics analgesics non-narcotic pain postoperative pain antipyretics dental surgery third molar extraction
patient controlled epidural analgesia versus continuous epidural infusion: obstetrical and neonatal outcomes

Conditions: Pain

Summary: the investigators intend to perform a large randomized trial using standardized obstetrical and anesthetic practice at a single institution to determine the effects of patient controlled epidural analgesia on obstetrical and neonatal outcomes.

women in their first pregnancy in spontaneous labor desiring epidural anesthesia will be randomized to one of three groups. each group will initially be given intrathecal bolus. before and 30 minutes after the initial bolus, the patient's verbal pain score will be recorded. the continuous epidural infusion group (group i) will be started immediately on a continuous pump infusion.they will also have the opportunity to give a pca bolus finally, the patient controlled epidural group (group iii) will be able to give a bolus every 20 minutes with no continuous infusion. each group will also be allowed 2 boluses,by the anesthesia staff in the event that their pain is not controlled by the indicated study medication. an hourly evaluation of verbal pain score and maternal mobility will be recorded. after delivery, obstetrical outcomes, neonatal outcomes, anesthesia interventions, and patient satisfaction questionnaires will then be collected.

Eligibility criteria:
inclusion criteria: * early labor * nulliparous exclusion criteria: * inductions * breech * contraindications to regional anesthesia

Keywords: patient controlled epidural anesthesia pain control in labor
effect of exercise on cardiometabolic profile in women with polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome (pcos) is a complex hormonal and metabolic disorder that has been shown to affect women's fertility. it can also share many symptoms with pre-diabetes, and women with pcos often have an increased risk for type 2 diabetes, heart attack and stroke. this study aims to assess the feasibility and acceptability of exercise intervention and increased lifestyle physical activity to improve cardiovascular disease risk factors in women with pcos.

this is a three arm feasibility study in which participants will be allocated to an exercise group, an increased lifestyle physical activity group, or a control group. we will determine the appropriateness of procedures for recruitment, allocation, measurement and retention for the intervention procedures in women with polycystic ovary syndrome. the investigators will also determine if we are able to detect changes in blood lipid profile, inflammation, and hormonal and metabolic profile as a result of the intervention(s) using blood biomarkers.

Eligibility criteria:
inclusion criteria: * women diagnosed with pcos according to the rotterdam criteria 2003, national institute of health (nih) 1990 criteria or androgen excess and polycystic ovary syndrome (ae-pcos) society 2006 criteria. * have experienced menarche (their first menstrual bleeding) and be at least 18 years of age. * are english speaking. * are physically able to perform exercise. exclusion criteria: * post-menopausal status. * are smokers. * are undertaking regular structured exercise defined as \>150min/week. * have been taking metformin for less than three months. * are taking the oral contraceptive pill (ocp) or have taken in the last month. * have any medical condition that may be responsible for the symptoms of pcos, such as congenital hyperplasia, androgen-secreting tumour, hyperprolactinemia, or cushing's syndrome. * have current cardiovascular disease or a history of cardiac events.

Keywords: polycystic ovary syndrome exercise physical activity cardiovascular disease low-density lipoprotein metabolism
the efficacy and safety of pregabalin release tablets for the treatment of fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of this study is to evaluate the efficacy and safety of pregabalin sustained release tablets versus placebo for fibromyalgia


Eligibility criteria:
inclusion criteria: * patients who met the 1990 american college of rheumatology (acr) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites). patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the visual analogue scale (vas) at screening and randomization . exclusion criteria: * patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia. patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders.
significance of duration of maintenance therapy with rituximab in non-hodgkin lymphomas

Conditions: Follicular Lymphomas; Immunocytomas; Marginal Zone Lymphomas; Mantle-Cell Lymphomas; Lymphocytic Lymphoma; Non-Hodgkin's Lymphoma

Summary: the purpose of this study is to determine if an extended maintenance therapy with rituximab in follicular and a maintenance therapy in other indolent and mantle cell lymphomas has advantages compared to a shorter or no maintenance therapy.

results from several randomised studies show a clinical benefit of a maintenance therapy with rituximab in follicular lymphomas. the advantage of a maintenance therapy in other indolent and mantle cell lymphomas is - due to the lower incidence of these diseases- not well investigated. this study tries to determine the significance of an extended maintenance therapy with rituximab in follicular lymphomas and the significance of a maintenance therapy other indolent and mantle cell lymphomas compared to observation.

Eligibility criteria:
inclusion criteria: * patients with histological verified cd20-positive b-cell-lymphoma of the following entities: * follicular lymphoma grade 1 and 2 * lymphoplasmocytic lymphoma / immunocytoma (morbus waldenström) and small cell lymphocytic lymphoma (cll without leukemic hemogram) * marginal zone lymphoma, nodal and extra nodal * mantle cell lymphoma * no prior therapy with cytotoxics, interferon or monoclonal antibodies * need for therapy, except mantle cell lymphomas * stadium iii or iv or stadium with ii bulky disease (\> 7 cm diameter, or 3 lesions \> 5 cm) * general condition who 0-2 * age min. 18 years, max. 80 years * negative pregnancy test, contraceptives mandatory for women of child-bearing age * actual histology, not older than 6 months required * written informed consent exclusion criteria: * patients not meeting the inclusion criteria above * possibility of a primary radiation therapy with curative intention * pretreatment, except a single, localized radiation therapy (radiation field not larger than 2 adjacent lymph node regions) * co-morbidities, excluding a therapy according to the protocol: * severe, medicinal not adjustable hypertension * severe limited capacity of the heart (nyha iii or iv), the lung (who-grade iii or iv), the liver and kidneys (creatinin \> 2 mg/dl, got and gpt or bilirubin 3 x uln), except if caused by lymphoma * severe, medicinal not adjustable diabetes mellitus * active autoimmune disease * active infection, requiring antibiotic therapy * patients with proven hiv-infection * active replicating hepatitis-infection * severe psychiatric diseases * lacking or anticipated non-compliance * known hypersensitivity against the active components or additives or mouse- proteins * pregnant or nursing women * patients with a secondary malignancy or malignant disease in his history if, curative surgery can not be doubtless assured .

Keywords: bendamustine rituximab significance of maintenance therapy efficacy and safety
durvalumab (medi4736) with cetuximab in previously treated recurrent or metastatic head and neck squamous cell carcinoma

Conditions: Recurrent Head and Neck Cancer; Head and Neck Cancer; Head and Neck Neoplasms; Metastatic Cancer

Summary: the purpose of this research study is to test the combination of the anti-cancer drugs durvalumab, the study drug, and cetuximab as a treatment for metastatic or recurrent head and neck cancer. participants will receive both durvalumab and cetuximab.

this research study is designed to see if the study drug, durvalumab, will work better with cetuximab than either medicine alone along with the evaluation of side effects of the drug combination.

Eligibility criteria:
inclusion criteria: * body weight \> 30 kg * histologically or cytologically confirmed recurrent or metastatic hnscc * not considered a candidate for other curative therapy (i.e. surgery/rt) * documented progression of disease after receiving platinum based regimen * ecog performance status 0-2 exclusion criteria: * nasopharyngeal and salivary gland tumors * prior exposure to both immunotherapy drugs and cetuximab. single exposure to either immunotherapy or cetuximab is allowed.
effect of hipec after radical surgery on long-term survival for locally advanced gastric cancer

Conditions: Gastric Cancer; Survival Rate

Summary: the study focuses on patients with locally advanced gastric adenocarcinoma (ct3n+m0 and ct4an+/-m0), assessing the feasibility, surgical safety, and oncological benefit of prophylactic hipec treatment following laparoscopic d2 radical surgery.

patients meeting the inclusion criteria will undergo laparoscopic d2 radical surgery. before closing the abdomen during surgery, heat perfusion tubes are inserted, typically placing four tubes in a cross arrangement. two drainage tubes at the pelvic floor exit through the upper abdomen, and two drainage tubes at the hepatorenal and splenorenal recesses exit through the lower abdomen, thus completing the tube placement. within 48 hours postoperative, the first infusion was performed with 3000-4000 ml of saline and 50 mg/m2 cisplatin at 43°c, with an infusion rate of 600 ml/min for a duration of 2 hours. during treatment, close attention is given to the patient's heart rate, blood pressure, oxygenation, and other vital signs. a total of 2 hipec treatments were conducted, each 48 hours apart. systemic chemotherapy is initiated 3-4 weeks postoperative for 6-8 cycles using sox: intravenous injection of oxaliplatin (130 mg/m2) on the first day and oral administration of tegafur (40-60 mg twice daily, with doses adjusted for body surface area: \ 1.5m2, 60 mg bid) from day 1 to 14. hipec is not performed postoperative. systemic chemotherapy is initiated 3-4 weeks postoperative for 6-8 cycles using sox: intravenous injection of oxaliplatin (130 mg/m2) on the first day and oral administration of tegafur (40-60 mg twice daily, with doses adjusted for body surface area: \ 1.5m2, 60 mg bid) from day 1 to 14.

Eligibility criteria:
inclusion criteria: 1. age \>18 and ≤70 years; 2. male or nonpregnant female; 3. gastric adenocarcinoma ct3n+m0 and ct4an+/-m0 (according to the 8th edition of the ajcc tnm staging system); 4. no distant metastasis, suitable for d2 lymph node dissection; 5. ecog (eastern cooperative oncology group) performance status of 0-2; 6. no prior cytotoxic chemotherapy, radiotherapy, or immunotherapy; 7. written informed consent given before any study-related procedures; exclusion criteria: 1. other cancers within the past 5 years; 2. distant metastasis (m1) found during surgery; 3. asa (american society of anesthesiologists) classification ≥iv and/or ecog performance status \>2; 4. severe liver, kidney, cardiac, pulmonary, or coagulation dysfunction, or severe underlying diseases that make the patient unable to tolerate surgery; 5. a history of severe mental illness; 6. history of taking steroid medications; 7. receiving other chemotherapy, radiotherapy, or immunotherapy; 8. lack of written informed consent;