Kornimate/medical-research-clean huggingface dataset:
efficacy of fimasartan on arterial stiffness in patients with hypertension

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the effects of fimasartan on arterial stiffness in patients with hypertension


Eligibility criteria:
inclusion criteria: * subjects who agree to participate in this study and give written informed consent * subjects whose sitting diastolic blood pressure measured at placebo visit and baseline are more than 90 mmhg and/or systolic blood pressure are more than 140 mmhg * subjects who are naive to anti-hypertensive treatment * subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study exclusion criteria: * subjects who are hypersensitive to angiotensin type 1-receptor blockers * subjects with secondary hypertension * subjects with severe hypertension (systolic blood pressure \>= 180 mmhg or diastolic blood pressure \>= 110) * severe cardiac disease (heart failure, ischemic heart disease, peripheral vascular disease, moderate valvular disease, arrhythmia requiring treatment, cardiomyopathy, etc.) * subjects with chronic obstructive pulmonary disease or history * clinically significant renal dysfunction (creatinine 2.0 mg/dl) and liver dysfunction (alt, ast \> 2x unl) * subjects with life expectancy of less than 2 years due to non-cardiac disease * subjects with history or evidence of abuse of drugs or alcohol within 2 years * severe insulin-dependent diabetes mellitus or intractable diabetic patient (dose/regimen change of oral hypoglycemic agent, insulin use) * severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, within 6 months) * wasting diseases, autoimmune diseases (rheumatoid arthritis, systemic lupus anticoagulants, etc.), history of connective tissue disease or ongoing disease. * women with pregnancy and breast feeding * women planning to be pregnant or without admitted contraception despite of probability of pregnancy (women who underwent sterilization operation are excluded. fertile women without such surgery should undergo pregnancy test and can participate only with negative result. intermittent abstinence like basic body temperature method, natural period method are not considered admitted contraception and no hormonal contraception is allowed.). * subjects who are participating in other clinical trials for investigating agents or have taken other clinical trial medication within 4 weeks before screening visit. * subjects judged to be inappropriate by the investigator
a long-term, open-label, uncontrolled trial of ym443 (z-338) in patients with functional dyspepsia

Conditions: Dyspepsia; Functional Dyspepsia

Summary: to examine the safety and efficacy of z-338 (ym443) after long-term administration in patients with functional dyspepsia, and also to examine the pattern of long-term administration.


Eligibility criteria:
inclusion criteria: * patient showing at least one of the following 4 symptoms from more than 6 months before obtaining consent * postprandial fullness * early satiation * upper abdominal pain * upper abdominal discomfort * patient showing at least 2 of the 8 symptoms shown below repeatedly from 3 months before obtaining consent (at least one symptom of either postprandial fullness or early satiation should be included.) * patient showing either postprandial fullness, bloating in the upper abdomen, or early satiation as the major complaint among the 8 symptoms shown below at the time of obtaining consent * upper abdominal pain * upper abdominal discomfort * postprandial fullness * bloating in the upper abdomen * early satiation * nausea * vomiting * belching * outpatient exclusion criteria: * patient showing symptoms of organic disease (reflux esophagitis, erosion, ulceration, esophageal hiatal hernia, bleeding, malignant tumor, barrett's esophagus) when upper gastrointestinal endoscopy is performed within 24 weeks before obtaining consent * patient showing heartburn within 12 weeks before obtaining consent * patient complicated by irritable bowel syndrome * patient complicated by diabetes mellitus requiring medication * patient complicated by severe anxiety disorder with some problems in interpersonal relationships or social life * patient complicated by depression (including suspected cases) or sleep disturbance

Keywords: ym443 z-338 acotiamide rome iii signs and symptoms, digestive
a study evaluating the long-term safety and efficacy of vx-445 combination therapy

Conditions: Cystic Fibrosis

Summary: the study evaluates the long-term safety and tolerability of vx-445 in triple combination (tc) with tezacaftor (tez) and ivacaftor (iva) in subjects with cystic fibrosis (cf) who are homozygous or heterozygous for the f508del mutation


Eligibility criteria:
inclusion criteria: * completed study drug treatment in a parent study i.e.vx17-445-102 (nct03525444) and vx17-445-103 (nct03525548); or had study drug interruption(s) in a parent study but completed study visits up to the last scheduled visit of the treatment period in the parent study. exclusion criteria: * history of drug intolerance in a parent study that would pose an additional risk to the subject in the opinion of the investigator. * current participation in an investigational drug trial (other than a parent study) other protocol defined inclusion/exclusion criteria may apply.
a phase 2a study to evaluate the pharmacokinetics, safety, efficacy, tolerability, and pharmacodynamics of sotatercept (ace-011) for the correction of anemia in subjects with end-stage renal disease on hemodialysis.

Conditions: Anemia

Summary: this is the first study in hemodialysis subjects with anemia to evaluate the pharmacokinetics, safety, efficacy, tolerability, and pharmacodynamics of sotatercept (ace-011)

part 1: approximately 8 subjects will be randomized to receive either a single 0.1 mg/kg subcutaneous dose of sotatercept or matching placebo in a 3:1 ratio part 2: approximately 8 subjects will be randomized to each of the 3 sequential dose groups (0.3mg/kg or 0.5mg/kg or 0.7 mg/kg) with a 3:1 ratio of sotatercept or placebo (6 subjects in the sotatercept arm and 2 in the placebo arm). a total of 24-36 subjects may be randomized in the 3 dose groups.

Eligibility criteria:
inclusion criteria: * males or females ≥18 years of age. * subjects on hemodialysis for at least 12 weeks before screening * subjects on a stable dose of erythrocyte stimulating agents product to maintain hemoglobin (hb) for at least 6 weeks prior to screening. * 3 consecutive pre-dialysis hb concentrations with a mean ≥10 to ≤ 12 g/dl (≥100 to ≤120 g/l) at screening and one pre-dialysis hb concentration ≥8 to \< 10 g/dl (≥ 80 to \< 100 g/l) before randomization. * adequate iron status defined as serum transferrin saturation ≥ 20% before randomization. exclusion criteria: * non renal causes of anemia. * subjects on peritoneal dialysis. * systemic hematological disease * high sensitivity c-reactive protein \>50mg/l at screening. * alanine transaminase (alt) or aspartate transaminase (ast) laboratory values \> 2 times the upper limit of normal (uln) at screening. * uncontrolled diabetes mellitus (hba1c \> 9) at screening. * uncontrolled hypertension. * red blood count (rbc) transfusions within 8 weeks prior to screening. * active serious infection or history of recurrent serious infection likely to recur during the study * history of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational product or to the iron products needed to normalize iron levels for subjects. * subjects that received treatment with another investigational drug or device within 28 days prior to day 1 * pregnant or lactating females.

Keywords: end-stage renal disease anemia hemodialysis renal anemia esrd
registry for the improvement of postoperative outcomes in cardiac and thoracic surgery

Conditions: Heart Diseases; Death; Postoperative Complications; Cardiac Complication

Summary: the registry for the improvement of postoperative outcomes in cardiac and thoracic surgery aims to prospectively collect data in order to test the association between various preoperative and per-operative variables ; and several postoperative outcomes such as mortality, shock, redo surgery, sepsis and extracorporeal life-support.

cardiac and thoracic surgery is plagued by severe morbidity and mortality. understanding and being able to predict postoperative outcomes may allow to better fit peri-operative care of cardio-thoracic patients. riposte database aims to prospectively collect baseline characteristics and per-operative information in order to test associations with the incidence of postoperative outcomes. baseline characteristics include: age, euroscore 2 and its components (age, gender, new york heart association (nyha) functional class, angina symptoms, insulin-dependent diabetes mellitus, extracardiac arteriopathy, chronic pulmonary dysfunction, neurological or musculoskeletal dysfunction severely affecting mobility, previous cardiac surgery, renal function with creatinin clearance, active endocarditis, critical preoperative state, left ventricle ejection fraction, recent myocardial infarction, pulmonary artery systolic pressure, procedure urgency and weight of the procedure (coronary artery bypass graft, valve surgery and/or thoracic aorta)) weight, height, preoperative biology and preoperative echocardiography parameters when measured. peroperative information include: cardiac bypass duration, type of procedure, implanted device, valve size. postoperative outcomes include: death, postoperative shock, mediastinitis, length of stay in intensive care unit, overall length of stay, blood transfusion.

Eligibility criteria:
inclusion criteria: * all patients eligible for cardiac or thoracic surgery exclusion criteria: * non applicable

Keywords: cardiac surgery thoracic surgery
effects of vitamin d supplementation on strength, bone density, and injury risk in collegiate athletes

Conditions: Vitamin D Deficiency

Summary: the goal of this study is to determine whether vitamin d supplementation improves strength and bone density, and reduces the risk of injury in collegiate athletes.

vitamin d is a hormone that is important for bone and muscle health. as such, not having enough vitamin d in your body is associated with increased risk of injury and reduced health and athletic performance. it is often recommended that individuals who have low levels of vitamin d take vitamin d supplements. however, the effects of vitamin d supplementation on health and strength gains in collegiate athletes are not known. the goal of this study is to determine whether vitamin d supplementation increases strength and bone density, while reducing the risk of injury in collegiate athletes. fasting vitamin d concentrations will be measured and athletes will be supplemented daily with vitamin d for 8-12 weeks. the amount of supplementation will depend on whether the athlete is categorized as sufficient (\>30ng/ml), insufficient (20-35ng/ml), or deficient (\<20ng/ml). vitamin d concentrations, strength, bone density, and injury risk will be assessed before and after the intervention period.

Eligibility criteria:
inclusion criteria: * athlete for a sanctioned virginia tech sport exclusion criteria: * pregnant or trying to become pregnant, currently taking vitamin d (\>600iu/day), calcium (\>1000mg/dl), taking any performance enhancing supplements (example, creatine), or any other medication or nutritional supplements that might influence the study variables, cardiac or thyroid problems, have diabetes, or epilepsy
safety and efficacy of brimonidine tartrate posterior segment drug delivery system in improving visual function

Conditions: Rhegmatogenous Macula-off Retinal Detachment

Summary: this study will evaluate the efficacy and safety of the brimo ps dds® applicator system (200 μg and 400 μg brimonidine tartrate) on visual function in patients with previous rhegmatogenous macula-off retinal detachment.


Eligibility criteria:
inclusion criteria: * the macula-off retinal detachment must have been caused by a rupture (rhegmatogenous in etiology) * the repair of the macula-off retinal detachment must have occurred at least 6 months before the day 1 visit in the study eye * the repair must have been deemed an anatomic success and required no more than one macular re-attachment procedure * the visual acuity score must be between 20/50 and 20/320 in the study eye exclusion criteria: * any sight-threatening ocular condition in the study eye other than the ruptured retinal detachment * anticipated need for ocular surgery during the 12-month study period * any injectable, periocular, or intravitreal corticosteroid treatment to study eye within 6 months prior to screening (eg, triamcinolone acetonide) * any injectable, periocular, or intravitreal anti-vegf treatment to the study eye within 3 months prior to screening (eg, avastin or lucentis) * any infectious condition in the study eye
effects of taping & exercise therapy on lower back musculoskeletal conditions in pakistani patients

Conditions: Lower Back Pain; Musculoskeletal Diseases or Conditions

Summary: lower back pain has been one of the most frequently occurring musculoskeletal disorder among the females. this act as a global burden and is highly prevalent in our society. this pain can result in life long disability, loss of function and mobility among individuals. the female of the society suffers from lower back pain the most because of the under lying causes, prolong standing and stooping as well as because of hormonal changes in their bodies

after studying the prevalence of the lower back pain among the females of pakistan, the investogator find the need to assess the type of their pain and find out the best way to ease their pains. the motive was to develop a treatment protocol whose effects last longer and is inexpensive for the management of lower back pain. moreover, the investigator decided to study that which treatment protocol is better when compared to another and what is the role of sham treatment when given to the patients.

Eligibility criteria:
inclusion criteria: * females who were willing to participate. * participants with nonspecific lower back pain will only be included and screened through the screening questionnaire. exclusion criteria: * post-menopausal women * females with any diagnosed co-morbidity. * back pain progressive to any neurological deficit * sustained or increased back pain with loss of appetite and unexplained weight loss accompanied with fever, nausea and chills * with any known spinal or lower back pathology * tumor of the spine * any underlying diseases of spinal cord (i.e, ankylosing spondylosis, spondolisthesis) * with any steroid therapy for lower back pain in the past three months * any inflammatory rheumatic disease * sensitive skin or any skin allergy or dermatological condition * any rehabilitative services taken for the lower back pain in the past two months * rejection to manual conatct

Keywords: lower back pain non specific lower back pain
bioequivalence and food effect study in healthy volunteers

Conditions: Sleep Initiation and Maintenance Disorders

Summary: the purpose of this study is to select the formulation with the optimal pharmacokinetic profile for an hypnotic drug to further develop in the market.

a single-centre, open-label, randomized, single-dose, 6-way crossover study to investigate the pharmacokinetics, safety and tolerability of 6 different formulations of sb-649868 30 mg (part a) and the effect of food on the selected formulation of sb-649868 pharmacokinetic (part b) in healthy male volunteers

Eligibility criteria:
inclusion criteria: * healthy adult male subjects aged between 18 and 65 years of age inclusive. * body weight and bmi within the protocol ranges. * healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring. * circulating levels of lh, fsh and testosterone within the normal reference range. * signed and dated written informed consent. * the subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions. exclusion criteria: * positive pre-study urine drug screen and alcohol breath test. * positive pre-study hepatitis b surface antigen, hepatitis c antibody, or hiv ½ result. * abuse of alcohol as per protocol criteria. * consumption of prohibited food and drink as per protocol. * subject who is not prepared to eat the standard meals provided by the site. * use of prescription or non-prescription drugs 1 or 2 weeks before the first dose of study medication. * where participation in study would result in donation of blood in excess of 500ml within a 56 day period. * history or presence of allergy to the study drug or drugs of this class, or a history of other allergy. * smoking history in the last three months as per protocol. * an unwillingness of male subjects to follow contraception methods as per protocol. * history or presence of significant psychiatric, respiratory or gastrointestinal illnesses, hepatic or renal diseases or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs. * the subject is unable or unwilling to abstain from strenuous physical activity in the 48 hours before screening and in the 48 hours before and the 48 hours after the treatment period. * current or previous (within 6 months) participation in a clinical trial.

Keywords: bioequivalent pharmacodynamic reference formulation 5 new formulation food effect pharmacokinetics
validity and reliability of the french translation of the richards-campbell questionnaire

Conditions: Sleep Disorders Not Due to A Substance or Known Physiological Condition

Summary: the validation of a sleep questionnaire (translated into french from a source questionnaire in english) will provide a reliable and easily administered tool for assessing sleep quality in intensive care, enabling better identification of patients at risk of sleep disorders and other associated complications, in particular ventilatory weaning difficulties.

sleep disturbance in intensive care is influenced by a number of factors, such as environmental nuisances (noise, light, repeated interruptions), treatments (sedation, analgesia, mechanical ventilation) and the severity of the acute pathology that led to admission. consequences include alterations to the immune system, neuropsychiatric disorders and impaired functional recovery. current management of these disorders remains limited: * no pharmacological treatment has clearly demonstrated its efficacy on sleep quality in intensive care. * interventions aimed at modulating environmental nuisances (reducing noise, reducing light exposure, respecting day/night cycles) have shown limited effects. * according to the available data, individual devices (eye masks, earplugs) have not significantly improved sleep architecture. in this context, the richards-campbell questionnaire (rcsq) represents an interesting alternative for subjectively assessing sleep in intensive care patients. this questionnaire, specifically designed for these patients, provides a simple and rapid assessment of sleep disturbances. the validation of a french version of the rcsq meets a need to standardise assessment practices in france and to gain a better understanding of the factors influencing sleep quality in intensive care.

Eligibility criteria:
inclusion criteria: * patient aged ≥ 18 years * hospitalised in intensive care for at least 24 hours * able to understand and answer questionnaires * unsedated (discontinued for 24 hours) presenting a richmond sedation agitation scale score between ≥-2 and ≤ +1 * fluent in french * having given oral consent for participation in the study * person affiliated to a social security scheme. exclusion criteria: * patient refusal * person deprived of liberty by an administrative or judicial decision or protected adult subject (under guardianship or curatorship) * patient unable, for whatever reason, to read, understand or answer the questionnaires (visual problems, psychiatric or cognitive problems, etc.) * patient already included in the study or another study evaluating sleep

Keywords: sleep disorders in intensive care patients
breast vceus to evaluate early response to neoadjuvant chemotherapy

Conditions: Breast Cancer

Summary: 1. evaluate quantitative vceus imaging for determining early breast cancer response to neoadjuvant chemotherapy and compare results to co-temporal volume change on grayscale ultrasound and post-treatment mammography findings utilizing final surgical pathology and clinical outcome. 2. assess incremental benefit of quantitative vceus to planar ceus tumor perfusion measurements and enhancement patterns in predicting tumor response to adjuvant treatment in clinical studies. the contrast agent definity® is fda approved for use as a contrast agent during ultrasound (echocardiography) of the heart. definity® will be used "off-label" (during ultrasound of the breast) in this study. the administration of definity® during this study will follow total dose guidelines approved by the fda.


Eligibility criteria:
inclusion criteria: 1. adult patients (age 19 years or older). 2. patients with newly diagnosed and untreated stage ii and iii breast cancer scheduled to undergo neoadjuvant chemotherapy. 3. patients with signed informed consent. exclusion criteria: 1. any history of prior radiation or chemotherapy for breast cancer. 2. patients who only have non-measurable disease. 3. patients who are medically unstable. 4. patients with other primary cancers requiring systemic treatment. 5. patients with cardiac shunts. 6. patients with unstable cardiopulmonary conditions. 7. patients with known pulmonary hypertension. 8. patients with known hypersensitivity to any component of definity (r) microbubble contrast. 9. patients who are pregnant, breast-feeding or are planning to become pregnant during the study duration.

Keywords: breast cancer definity ultrasound