Kornimate/medical-research-clean huggingface dataset:
study of safety and efficacy of diractin® for the treatment of osteoarthritis (oa) of the knee

Conditions: Osteoarthritis of the Knee

Summary: the purpose of this study is to provide replicated evidence of safety and efficacy of 100 mg ketoprofen in diractin®.

the study will investigate safety and efficacy of diractin® at relieving signs and symptoms of knee oa, including the primary endpoint of patient assessment of pain.

Eligibility criteria:
inclusion criteria: * informed consent signed and dated * age \> 45 years * class i-iii oa of the knee and subject meets american college of rheumatology (acr) clinical classification criteria for osteoarthritis of the knee exclusion criteria: * skin lesions or dermatological diseases in the treatment area * directly or indirectly involved in the conduct and administration of this study * received any investigational medicinal product within 30 days prior to screening visit or participation in any previous clinical study with diractin® * pregnancy or lactation * residents of psychiatric wards, prisons or other state institutions * malignancy within the past 2 years * depressive disorders requiring treatment with tricyclics, treatment with other antidepressants must be stable for 3 months prior to screening and throughout the study * epilepsy * schizophrenia * neuropathic pain and any other pain condition requiring chronic use of pain medication * known hypersensitivity or allergy (including photoallergy) to nsaid´s including ketoprofen and to ingredients of the imp * preexisting asthma or bronchospasm after taking aspirin or other nsaids * unable to discontinue analgesic therapy including opioids, nsaid´s, tramadol, muscle relaxants, gabapentin, pregabalin, duloxetine, venlafaxine, capsaicine or other drugs approved or used for the treatment of pain for the duration of the study
multiple ascending dose of bms-911543

Conditions: Cancer

Summary: the purpose of this first in human study is to determine if bms-911543 is safe and tolerable in subjects with symptomatic intermediate-1, intermediate-2 or high risk myelofibrosis to permit clinical testing at the maximum tolerated dose or at a clinically active dose, and to determine if bms-911543 will demonstrate efficacy in symptomatic myelofibrosis.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * men and women at least 18 years old * a diagnosis of symptomatic, primary or secondary myelofibrosis (mf) \[world health organization (who) 2008 criteria\] with intermediate-1, intermediate-2 or high risk disease as assessed using the dynamic international prognostic scoring system international prognostic scoring system * last therapeutic or diagnostic treatment at least 28 days prior * any toxicity from prior therapies must have resolved to grade ≤1 * adequate liver and kidney function * serum amylase and lipase within normal institutional range * platelet count ≥50,000 cell mm³ * absolute neutrophil count (anc) ≥1,000 cells/mm3 * hemoglobin ≥8.0 g/dl exclusion criteria: * primary central nervous system tumors * subjects with currently active malignancy (other than mf) or with a prior history of malignancy with the exception of: (i) adequately treated basal cell carcinoma of the skin, (ii) curatively treated in situ carcinoma of the cervix, (iii) other malignancy that has undergone potentially curative therapy with no evidence of disease recurrence ≥3 years * any condition requiring chronic use of moderate/high dose steroids except inhalation or oral steroids for mild pulmonary disease * splenic irradiation ≤3 months prior to treatment with study drug * positive blood screen for hepatitis c antibody, hepatitis b surface antigen or human immunodeficiency virus-1 (hiv-1), or hiv-2 antibodies * abnormalities in serum electrolytes * significant cardiovascular disease * current or recent gastrointestinal disease * previous history of pancreatitis and/or significant risk factors for pancreatitis as judged by the treating physician * evidence of uncontrolled active infection or active graft vs. host disease * inability to tolerate oral medication

Keywords: advanced cancer, various, nos
comparative study on the effectiveness, comfort and compliance of hfnc and noninvasive mechanical ventilation bipap mode in the treatment of hypoxemia patients

Conditions: Hypoxemia

Summary: patients who met the inclusion criteria were included and signed an informed consent form, which complied with the requirements of the ethics committee of our unit. all subjects were inpatients. subjects were randomized into two groups. patients in group a were first treated with hfnc on top of conventional treatment, and after 24 hours, patients were treated with non-invasive ventilator-assisted ventilation bipap mode until discharge. patients in group b were treated with a non-invasive ventilator on top of conventional treatment, and after 24 hours of treatment, patients were treated with hfnc until discharge. patient information was collected during treatment.

patients who met the inclusion criteria were included and signed the informed consent, which met the requirements of the ethics committee of our unit. all subjects were hospitalized patients. subjects were randomly divided into two groups. patients in group a were treated with hfnc on the basis of conventional treatment. the initial parameters were: temperature:31-37℃, flow: 30-40l /min, spo2 \> 92% maintained, the oxygen concentration was adjusted according to the patient's oxygen saturation, and the treatment time was 24h. twenty-four hours later, the patients were treated with non-invasive ventilator-assisted ventilation bipap mode until discharge. on the basis of conventional treatment, patients in group b were given a non-invasive ventilator with the following initial parameters: bipap mode, initial inspiratory pressure (ipap) of 8-15cmh2o, initial expiratory pressure (epap) of 4-8cmh2o. the parameters were adjusted according to the specific conditions of the patients. after 24 hours of treatment, the patient was treated with hfnc until discharge. patient information was collected during treatment.

Eligibility criteria:
inclusion criteria: 1. . pao2 \< 60mmhg, spo2 \< 92%(without oxygen inhalation); 2. mild to moderate type i respiratory failure (100 mmhg \< pao/fi02≤300 mmhg); exclusion criteria: 1. missing primary outcome measures 2. terminal stage of various chronic diseases; 3. the patient or family members do not agree to niv or hfni treatment; 4. severe type i respiratory failure (pao2/fi02≤100 mmhg) 5. ventilation dysfunction (ph\<7.30) 6. contradictory breathing 7. the patient abandons or terminates treatment, automatically discharges or transfers to another hospital; 8. serious diseases, such as organ function damage and sepsis;

Keywords: hypoxemia, high-flow nasal cannula, mechanical ventilation
altretamine and etoposide in treating patients with hiv-related cancer

Conditions: Lymphoma; Sarcoma

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 i trial to study the effectiveness of altretamine plus etoposide in treating patients with hiv-related cancer.

objectives: i. determine toxic effects of repeated courses of altretamine plus etoposide at the maximum tolerated dose (mtd). ii. assess the response duration and time to progression at the mtd in the treatment of hiv malignancies. iii. assess the efficacy of the combination on the immune systems of these individuals. iv. assess the effect of the combination on the quality of life in these individuals. outline: patients are treated with altretamine (hmm) and etoposide for 2 weeks followed by 2 weeks of rest. this cycle is repeated for a minimum of 2 and a maximum of 6 cycles if there is no progression of disease. patients who are in complete remission receive an additional 2 cycles (total of 8 cycles). there are different cohorts consisting of 4 patients each in which toxic effects will be evaluated with escalating doses of this combination. the mtd is defined as the dose level immediately below that at which half of the patients experience dose-limiting toxicity. patients are followed for relapse and survival. projected accrual: 20 patients will be accrued in 2 years.

Eligibility criteria:
disease characteristics: documented hiv antibody positive histologically confirmed, by biopsy, non-hodgkin's lymphoma that is in complete remission or stable/partial remission for a minimal period of one month and/or histologically confirmed, by biopsy, kaposi's sarcoma without stable disease patient characteristics: age: 18 and over performance status: karnofsky 60-100% hematopoietic: absolute neutrophil count at least 500/mm3 platelet count greater than 25,000/mm3 (unless secondary to lymphoma) hepatic: transaminases less than 5 times upper limit of normal and bilirubin less than 2.0, unless secondary to lymphoma renal: creatinine less than 2.0 mg/dl or creatinine clearance at least 60 ml/min dose reduction of 21% if creatinine clearance 10-50 ml/min dose reduction of 50% if creatinine clearance less than 10 ml/min cardiovascular: no active cardiac arrhythmia or angina pulmonary: must exclude pneumocystis carinii pneumonia if there is any suspicion of infection other: no uncontrolled infections not pregnant or nursing adequate contraception for fertile patients prior concurrent therapy: biologic therapy: not specified chemotherapy: patients with concurrent antiretroviral therapy should be on a stable dose of that therapy for at least one month prior to entry no concurrent cytotoxic chemotherapy endocrine therapy: no concurrent hormone therapy radiotherapy: no concurrent radiotherapy surgery: not specified

Keywords: aids-related kaposi sarcoma recurrent kaposi sarcoma aids-related peripheral/systemic lymphoma
evaluation of a new nasal pillows mask for the treatment of obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: this clinical trial is designed to evaluate the performance, comfort, and usability of a new nasal pillows mask for the treatment of obstructive sleep apnea (osa) in a home environment.


Eligibility criteria:
inclusion criteria: * are ≥22 years of age * weigh ≥66 lbs * have been formally diagnosed with osa by a physician * have an ahi ≥5 on a diagnostic night * have been prescribed pap therapy to treat osa by a physician * are an existing nasal pillows mask user * have been using a nasal pillows mask for ≥3 months prior to enrolment into the study * are compliant with pap therapy for ≥4 hours per night for 70% of nights * are fluent in spoken and written english * possess the capacity to provide informed consent exclusion criteria: * are intolerant to pap therapy * possess, or suffer from, anatomical or physiological conditions which make pap therapy inappropriate * are currently diagnosed with respiratory disease or co2 retention * are pregnant or think they may be pregnant * have an ipap pressure of \>25 cmh2o * persons who use a pap therapy machine for the delivery of medicines, except o2 * use a pap therapy machine that does not possess data recording capabilities to capture ahi and leak information that is accessible to osmi
clinical and sociodemographic characterization of multiple myeloma participants with symptomatic relapse and/or refractory disease in spain (charismma study)

Conditions: Multiple Myeloma

Summary: the purpose of this study is to characterize the multiple myeloma (mm) participants with symptomatic relapse and/or refractory disease in spain.

adult participants with a diagnosis of mm who have received at least one previous treatment line and have experienced symptomatic relapse and/or refractory disease in the previous 6 months, who are still in follow-up at the time of the study visit will be observed in this study. the study will look into sociodemographic data, current clinical and therapeutic data, clinical data relative to the latest relapse and clinical data at diagnosis and previous relapses will be collected. the study will enroll approximately 350 patients. this multi-center trial will be conducted in a total of 30 public sites in spain. the overall time to collect data will be approximately 1 year from june 2017 to may 2018.

Eligibility criteria:
inclusion criteria: * have a diagnosis of mm and has received at least one previous treatment line. * have experienced symptomatic relapse and/or refractory disease in the 6 months before the study. * has continued in follow-up at the time of the study visit. * is currently treated in the site who have clinical records available. * is capable of understanding and completing the questions in the european organization for research and treatment of cancer quality of life questionnaire-core 30 (eortc qlq-c30), and eortc multiple myeloma module (qlq-my20) questionnaires. exclusion criteria: • participants who do not agree to participate in the study or who do not give written informed consent.
rct of meditation and health education on cimt and mace in black women and men

Conditions: Cardiovascular Disease

Summary: this was a randomized, single-blind, controlled, community-based trial comparing the clinical efficacy of the transcendental meditation program on carotid intima-media thickness and major adverse cardiovascular events in 197 african american men and women at risk for atherosclerotic cvd. after baseline testing, participants were randomly assigned to either a stress reduction program (transcendental meditation) or a standard health education program. follow up was conducted over one year and 12 years.

this was a randomized, single-blind, controlled, community-based trial comparing the clinical efficacy of the transcendental meditation (tm) program carotid intima-media thickness and major adverse cardiovascular events (mace) in 197 african american men and women at high risk for ascvd. this trial compared the efficacy of the tm program to health education over one year on cimt. eligible participants were randomly allocated to either the tm program or health education (he). the primary outcome was carotid intima-media thickness (imt) assessed by b-mode ultrasonography at baseline and 12 months. secondary outcomes were blood pressure, lipids, lifestyle, psychosocial stress and mace. fatal and nonfatal clinical events were assessed over one year, and mortality after 12 years.

Eligibility criteria:
inclusion criteria: race/ethnicity: african american, self-identified, age: no upper limit, gender: male or female, minimum carotid artery intima medial thickness (imt) of at least .72 mm for men and .65 mm for women or long-term history of diabetes, myocardial infarction, coronary artery revascularization or coronary angiography indicating at least one vessel with 50% stenosis. exclusion criteria: myocardial infarction, unstable angina, cabg, percutaneous transluminal coronary angioplasty (ptca), or stroke within the previous three months, carotid artery endarterectomy, arrhythmia - atrial fibrillation, second or third degree av block, congestive heart failure - class iii or iv or ejection fraction less than 30 %, clinically significant valvular heart disease, clinically significant hepatic or renal failure, major psychiatric disorders, current alcohol or other drug abuse dependency disorder, non-cardiac life-threatening illness, and participating in a formal stress management program -
lupus cohort--thrombotic events and coronary artery disease

Conditions: Cardiovascular Diseases; Coronary Disease; Thrombosis; Heart Diseases; Lupus Erythematosus, Systemic

Summary: to study longitudinally the incidence, pathogenesis, and risk factors for thrombotic events and coronary artery disease in a cohort of patients with systemic lupus erythematosus (sle).

background: the johns hopkins lupus cohort, begun by dr. petri in 1987, was a longitudinal study of the incidence and pathogenesis of thrombotic events and coronary artery disease in sle. the usual natural history of thrombotic events and coronary artery disease is telescoped in sle, so that patients present with these outcomes in their third and fourth decades. design narrative: risk factors addressed in the study included: 1) the hypercoagulable state secondary to antiphospholipid antibodies (the lupus anticoagulant and anticardiolipin antibody); 2) premature atherosclerosis, accelerated by prednisone and hypertension; 3) underlying vascular damage from lupus vasculopathy and vasculitis; 4) co-morbid factors, including obesity, smoking, hyperlipidemia, hypertension, sedentary life style, and family history of coronary artery disease, and 5) other factors, including sex, age, race, immunogenetics, compliance with medication, and socioeconomic status. the hopkins cohort study was uniquely able to focus on these issues, both because of its population, which reflected a broad racial, educational, and socioeconomic background, and because the four years of data accumulated showed promising preliminary results. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
electrogastrography (egc) in premature infants with feeding intolerance

Conditions: Infant, Newborn, Diseases

Summary: serial egc measurements in premature infants attempting to correlate egc measurements with signs of feeding intolerance and response to metoclopramide therapy.


Eligibility criteria:
inclusion: premature infants. absence of 1) infection, 2) congenital anomalies, 3) growth retardation

Keywords: feeding intolerance infant, premature
a bioequivalence study of ag-013736 tablets under fed conditions in healthy volunteers

Conditions: Healthy Volunteer

Summary: the purpose is to show that 5 mg form iv tablet of ag-013736 produces similar drug concentrations in plasma compared to 5 mg form xli tablet of ag-013736 after oral dosing under fed conditions.

to establish bioequivalence between form iv and form xli of ag-013736 tablets

Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 21 and 47 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram (ecg) and clinical laboratory tests) * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs) * an informed consent document signed and dated by the subject or a legally acceptable representative exclusion criteria: * evidence of significant disease of the blood, kidney, endocrine system, lungs, gastrointestinal, heart, liver, psychiatric, neurologic, or allergic (including drug allergies, but excluding season allergies) * use of tobacco- or nicotine- containing products (or a positive urine cotinine test). * pregnant or nursing females and females of childbearing potential including those with tubal ligation

Keywords: bioequivalence pharmacokinetics
atypical antipsychotics in the treatment of affective symptoms of schizophrenia in hungary

Conditions: Schizophrenia; Affective Symptoms

Summary: this is a noninterventional observational study lead amongst psychiatrists, to assess the the overall status of schizophrenic outpatients with affective symptoms treated with atypical antipsychotics.

atypical antipsychotics in the treatment of affective symptoms of schizophrenia in hungary

Eligibility criteria:
inclusion criteria: * schizophrenic outpatients diagnosis based on dsm -iv above 18 years of age with affective symptoms. * atypical antipsychotic treatment at least for a month before study inclusion. exclusion criteria: * pregnancy. * hepatic disease. * diabetes mellitus. * severe cerebro- or cardiovascular disease.

Keywords: schizophrenia atypical antipsychotics depressive symptoms
the diagnostic and prognostic value of two quantitative clinical tests in patients with lumbar disc herniation

Conditions: Pain; Lumbar Disc Herniation; Back Pain; Spinal Diseases; Surgery

Summary: this study will investigate whether two clinical tests can be used to diagnose and predict the outcome in patients with lumbar disc herniation undergoing surgery and non-surgery treatment. the two quantitative clinical tests include: electromyographic measurements using paraspinal mapping and pain responses using quantitative sensory pain testing.

150 patients will be included for the prospective cohort study. patients will be recruited from the region of southern denmark and capital region. participants will undergo mri scanning of the lumbar spine, fillout a questionnaire and undergo assessment with the two clinical tests. an 8-week follow-up will be made with patients completing a questionnaire. the two quantitative clinical tests include: electromyographic measurements using paraspinal mapping and pain responses using quantitative sensory pain testing.

Eligibility criteria:
inclusion criteria: * clinical and radiologically diagnosed lumbar disc herniation. * low back pain with pain below the knee or anterior thigh pain in one or both legs. * dermatomal leg pain. * average pain intensity of 3 or more on a numerical rating scale (0-10 nrs). exclusion criteria: * history of previous lumbar spine surgery. * surgery in general in the past 4 months. * current use of anticoagulants. * diagnoses which could confound with the diagnosis e.g. lumbar spinal stenosis, local muscle trauma, cancer metastases, fibromyalgia, neuropathy.

Keywords: electromyography paraspinal mapping quantitative clinical tests conditioned pain modulation temporal pain summation pain threshold pain tolerance
prevalence of attention deficit disorder among patients with constitutional growth delay

Conditions: Attention-deficit/Hyperactivity Disorder; Constitutional Growth Delay

Summary: the aim of the our study is to investigate whether there is an increased incidence of adhd ( based on self reports and questionnaires) among children with short stature due to constitutional growth delay (cgd) in comparison with children with familial short stature.

filling out the study questionnaire by adhd diagnosed and suspected children (have a positive dbdrs (disruptive behavior disorders rating scale questionnaire) result) who were referred to the pediatric endocrine clinic of our hospital for short statue evaluation. the study questionnaire will be filled by child's guardian. the study and the dbdrs questionnaires will be filled only after obtaining an informed consent. the required data including growth statistics, age at puberty, bone age and other relevant data will be collected from the child's medical records. the data on patients will be processed anonymously.

Eligibility criteria:
inclusion criteria: * undergo evaluation and follow-up due to short stature caused by either cgd or familial short stature exclusion criteria: * children with short stature due to other reasons such as hormonal disorders (thyroid disorders, growth hormone deficiency), genetic syndromes