Kornimate/medical-research-clean huggingface dataset:
a phase iii clinical trial evaluating the efficacy and safety of valsartan/levamlodipine (syh9056) tablets in hypertensive patients

Conditions: Mild-to-moderate Essential Hypertension

Summary: syh9056 tablets are a combination of valsartan and levamlodipine maleate. this is a multicenter, randomized, double-blind, parallel-controlled phase iii study, designed to validate the efficacy and safety of syh9056 tablets in patients with mild-to-moderate essential hypertension not controlled after 4 weeks of treatment with either levamlodipine maleate tablets or valsartan capsules, using either levamlodipine maleate tablets or valsartan capsules as a control. the study consisted of 4 phases: a screening period (2 weeks), an introduction period (4 weeks), a core treatment period (12 weeks), an extended treatment period (12 weeks), and a safety follow-up period (1 week), totaling approximately 31 weeks.


Eligibility criteria:
inclusion criteria: 1. 18-75 (inclusive) years old; 2. 18.0 kg/m\^2 ≤ bmi ≤ 35.0 kg/m\^2 and ≥ 50 kg for men and ≥ 45 kg for women at screening; 3. diagnosis of mild or moderate essential hypertension; 4. office blood pressure measurements meet any of the following at the time of screening: ① patients who have not used any antihypertensive medication for at least 4 weeks prior to screening, with an average office sitting blood pressure (average of 3 measurements) of 150 mmhg ≤ sbp \< 180 mmhg and dbp \< 110 mmhg; ② patients who have been using a stable dose of one or two component of antihypertensive medications (including single agents, two-drug combination or two-component combinations) for at least 4 weeks prior to screening, and who, in the judgment of the clinician, can be switched to levlevamlodipine maleate tablets (2.5 mg/day) or valacyclovir capsules (80 mg/day), and whose mean office sitting blood pressure meets 140 mmhg ≤ sbp \< 180 mmhg and dbp \< 110 mmhg; 5. prior to randomization, mean office sitting blood pressure meets 140 mmhg ≤ sbp \< 180 mmhg and dbp \< 110 mmhg; 6. medication adherence between 80% and 120% (including borderline values) during the introductory period. exclusion criteria: 1. rrefractory hypertension, hypertensive emergencies, hypertensive sub-emergencies and secondary hypertension; 2. allergy (≥ 3 drug or food allergies) or known hypersensitivity to levamlodipine, levlevamlodipine, valsartan and related drugs (dihydropyridine calcium channel blockers, angiotensin ii receptor blockers); 3. history of malignancy within the last 5 years (with the exception of cured basal cell carcinoma of the skin, limited squamous cell carcinoma of the skin, or cervical cancer in situ), or an underlying malignancy currently under evaluation; 4. known or suspected symptomatic upright/postural hypotension ; 5. uncontrolled diabetes mellitus; 6. abnormal thyroid function; 7. severe cardiovascular or cerebrovascular disease within 6 months prior to screening or randomization.
headless screws x bouquet in boxer's fracture

Conditions: Boxer's Fracture

Summary: despite the high prevalence (20% of the hand fractures) of unstable neck metacarpals fractures (boxer's fractures) there is still no consensus concerning the preferred method and ideal moment of treatment, especially in active patients where the time or type of management can have a strong psychological impact on the outcomes. the use of intramedullar technique (headless intramedular screws or bouquet technique fixation) as definitive treatment of unstable boxer's fractures in active patients at the first week, may be a good choice of treatment. this technique is fast, safe, minimally invasive and easily performed reproducible method, without address the extensor tendon to prevent tendon adhesion and joint stiffness, unable earlier functional recovery and shorten the working return time of these patients. choose a reproducible and effective method, which presents a cost / benefit compatible with our reality. the goal of the present study is to compare working return time, vas (visual analogue score), quick dash (disability arm, shoulder and hand) and radiographic outcomes of two methods of definitive internal fixation in active patients in boxer's fractures, operated in the first week.

a double center, parallel group, prospective, randomized clinical trial was conducted at the department of hand surgery, abc university hospital, santo andre, brazil and hospital mãe de deus, porto alegre, brazil. two implants used for fixation in closed reduction of boxer's fractures were compared: the headless cannulated screws (synthes®, davos) and the bouquet technique with k-wires (synthes®, davos). the protocol was approved by the local research ethics committee. all patients received, signed and are aware of what was recommended in the informed consent (ic). inclusion criteria were; presence of an acute (0 to 7 days), closed and simple fracture of the metacarpal neck, absence of an ipsilateral injury or deformity, start january 2017.

Eligibility criteria:
inclusion criteria: * presence of an acute (0 to 7 days), closed and simple fracture of the metacarpal neck, absence of an ipsilateral injury or deformity, presence of an angulation of over 40 degrees in oblique plane imaging, being 18 years of age or older, having acquired a master's degree or still being a student, and being an employee in a social-professional environment with mild physical activities. exclusion criteria: * elderly, children, mental ness

Keywords: boxer's fracture
regaining bladder control in postmenopausal women with osteoporosis

Conditions: Urinary Incontinence

Summary: conservative management for urinary incontinence has been shown to improve bladder control. we are conducting a study of the effectiveness of conservative management for urinary incontinence in women who also have osteoporosis. we hope to find that treatment for incontinence improves bladder control and thereby allows women to be more active and reduces their risk of falling and breaking bones.


Eligibility criteria:
inclusion criteria: postmenopausal women osteopenia or osteoporosis and stress urinary incontinence exclusion criteria: -

Keywords: randomized clinical trial osteoporosis urinary incontinence physiotherapy education
evaluation of lymphodepletion with allo-647 in adults with r/r large b cell lymphoma receiving allo-501a allogeneic car t cell therapy

Conditions: Relapsed/Refractory Large B Cell Lymphoma

Summary: the purpose of the expand study is to assess the safety and clinical efficacy of allo-647 combined with fludarabine and cyclophosphamide compared to fludarabine and cyclophosphamide alone in a lymphodepletion regimen prior to allo-501a car t therapy in adults with relapsed or refractory large b-cell lymphoma


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of relapsed/refractory large b-cell lymphoma at last relapse * relapsed or refractory disease after at least 2 lines of chemotherapy * ecog performance status 0 or 1 * absence of significant donor (product)-specific anti-hla antibodies (dsa) * adequate hematological, renal and liver function exclusion criteria: * active central nervous system involvement by malignancy * autologous or allogeneic hsct within last 6 months prior to lymphodepletion * hypocellular bone marrow for age

Keywords: car t cell therapy allogeneic cell therapy cellular immuno-therapy allocar t allo-501a allo-647 lbcl lymphoma large b-cell lymphoma
identifying predictors of response to antipsychotics using a treatment algorithm

Conditions: Schizophrenia or Schizoaffective Disorder

Summary: the objective of this study is to evaluate predictors of response to antipsychotic medication in subjects with schizophrenia. the investigators will evaluate psychopathology,brain mri, genetics and neuropsychological profile. two groups of treatment will be compared: first generation antipsychotics vs. second generation antipsychotics. participants will be randomized to one of the groups. trial duration: 12 weeks.


Eligibility criteria:
inclusion criteria: * schizophrenia or schizoaffective disorder * age: 18-45 years olde * less than 10 years of diagnosis * acute exacerbation of psychotic symptoms exclusion criteria: * use of clozapine * clinical unstable disease * delirium and cognitive disorders

Keywords: schizophrenia predictors of response antipsychotics 18-45 years old non-refractory
effects of mulligan bent leg raise with and without bowen therapy on hamstring tightness in asymptomatic adults

Conditions: Asymptomatic Condition

Summary: hamstring tightness is a common problem caused by a sedentary lifestyle and can have negative effects on posture and musculoskeletal function. it can lead to postural misalignment, increasing loading on the lumbar spine, increased pressure on inter-vertebral disc and potentially resulting in low back problems. bowen technique and mulligan bent leg raise is used to treat conditions including hamstring tightness. the goal of this clinical trial is to compare the effects of mulligan bent leg raise with and without bowen therapy on hamstring tightness in asymptomatic adults.

a randomized control trial will be conducted at riphah rehabilitation center and physiogic physiotherapy clinic on 50 asymptomatic adults who meet the inclusion criteria will be recruited using non probability purposive sampling and randomly allocated using random allocation software 2.0. informed consent will be obtained from all participants. they will be divided into two groups which will contain 25 participants in each group. group a will receive three alternate sessions of mulligan bent leg raise with bowen therapy and group b will receive three alternate sessions of mulligan bent leg raise. the mulligan bent leg raise technique will be performed with 3 repetition, 3-4 times with 20 sec hold and one minute rest between each repetition.

Eligibility criteria:
inclusion criteria: * male/female * age group between 18-40 years * unilateral limitation of slr less than 75 degrees * asymptomatic, active knee extension less than 160 degrees exclusion criteria: * fracture of lower limb * individuals with soft tissue injury * chronic back pain * prolapsed intervertebral disc * any surgery was done for back, pelvis hip or knee. * spinal deformity
problem solving for caregivers of persons with brain injury

Conditions: Traumatic Brain Injury

Summary: family caregivers of persons with traumatic brain injury (tbi) have long-term demands that tax their coping abilities and adversely affect their health and well-being. this project will test the effectiveness of a problem-solving training program tailored to the unique needs of family caregivers of persons with tbi. over a 3-year period, family caregivers and their care recipients will be recruited and randomly assigned to a problem-solving intervention group (n=40 dyads) or a control group (n=40 dyads). participants in the problem-solving intervention group will receive four face-to-face problem-solving training sessions and monthly telephone problem-solving sessions over the course of 1 year. control group participants will receive a handbook of educational materials and a staff member will contact each control group participant monthly by telephone to review these materials and other informational needs. no problem-solving training will be provided to control participants throughout the year. caregivers and care recipients will be assessed at four points during their participation: at the initial assessment, at 4 months, at 8 months, and at the completion of the 1-year participation period. all evaluations will be conducted in the participants' homes. measures of problem-solving ability, caregiver burden, and adjustment (depression, health, satisfaction with life) will be collected. structural equation modeling and other regression/inferential analyses will be used to determine the effects of problem solving on caregiver adjustment over time after taking into account care recipient adjustment and caregiver ethnicity. this project will: (1) demonstrate how specified physical and emotional outcomes of caregivers and care recipients are related to caregiver problem-solving abilities and how these relationships vary as a function of time; (2) evaluate the effectiveness of a community-based, problem-solving intervention that will be delivered to caregivers; and (3) identify caregivers and care recipients with tbi who are at risk for adverse emotional and health outcomes.


Eligibility criteria:
inclusion criteria: minimum age of 19 years brain injury diagnosis at least 6 mos in-house non-paid caregiver of person with brain injury functional literacy caregiver willing to discuss abuse issues exclusion criteria: -

Keywords: emotional outcomes health outcomes traumatic brain injury caregiving
comparison of exercise therapy vs mobilization with movement among patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: comparison of exercise therapy vs mobilization with movement among patients with knee osteoarthritis in household females

to determine the effect of exercise therapy and mulligan\*s mobilization with movement techniques on pain and difficulty in performing adls with knee oa in household females.

Eligibility criteria:
inclusion criteria: * subject with age group of 40-60 included in this study. * history of knee osteoarthritis, with grade i or ii. * no impairment in other body parts. * patients already diagnosed with osteoarthritis by orthopedic surgeon. exclusion criteria: * patients with communication problems * patients with a history of previous stroke or other neurological diseases or disorders. * patients with inflammation. * patients who had undergone any surgery. * infection or dermatological conditions. * cardiovascular problems (unstable angina, recent myocardial infarction within the last three months, congestive heart failure, significant heart valve dysfunction etc).
potential use of a poct for the direct transfer of stroke patients from the ambulance to the thrombectomy center

Conditions: Stroke, Acute Ischemic

Summary: stroke is the leading cause of long-term disability and the second most common cause of death worldwide. currently, the protocols require the imaging techniques at the hospitals to differ ischemic strokes with large vessel occlusion (lvo) from others. in this study, a duplex poc will be used in combination with an app to identify lvo ischemic strokes in a 800 patients'cohort with pre-hospital and in-hospital blood samples.

stroke is the leading cause of long-term disability and the second most common cause of death worldwide, accounting for around 6.7 million deaths each year. the burden of stroke due to illness, disability and early death is set to double within the next 15 years due to an ageing population. currently, imaging techniques are required to differentiate ischemic strokes with large vessel occlusion (lvo) from others. since those neuroimages cannot be easily done at a pre-hospital level, our objective is to develop a simple point-of-care test (poc) to differentiate between both ischemic strokes during the acute phase, which will allow in the future an earlier thrombectomy treatment and an improvement of the patient outcomes significantly. for that, the investigators will recruit a 800 patients' cohort with pre-hospital and in-hospital blood samples by a multiplex poc for the biomarker measurement using an app in combination with clinical data to identify lvo ischemic strokes. finally, an interim analysis is planned when 400 patients are recruited.

Eligibility criteria:
inclusion criteria: * i.1: patients \> 18 years old. * i.2: stroke code activated. * i.3: \< 6 hours from symptoms onset. in the case of stroke with uncertain chronology or wake-up stroke, the initial time will be considered as the last moment the patient was seen fine. exclusion criteria: * e.1: previous diagnosis different from stroke. * e.2: impossibility of getting a blood sample. * e.3: refusal to provide the informed consent by the patient/relative.

Keywords: large vessels occlusion (lvo) thrombectomy biomarkers point of care test (poct)
caring for the sexual health and wellbeing of cancer survivors and their intimate partners: an anonymous survey

Conditions: Cancer

Summary: the aim of this survey study is to provide broad information as reported by cancer survivors and their intimate partners about both their sexual health and their experiences of care from the united kingdom hospital cancer team, including their perspectives on factors that may hinder or help care. this information will be analysed and used to inform the questions asked in a separate, subsequent, qualitative study.


Eligibility criteria:
inclusion criteria: 1. cancer survivors diagnosed with any type of cancer at age 18 years or over 2. a partner of someone diagnosed with any type of cancer at age 18 years or over 3. cancer diagnosis must be no more than 10 years ago 4. cancer survivors or their partners who experienced treatment and follow up care in the united kingdom exclusion criteria: 1. cancer survivors who were diagnosed with cancer below the age of 18 years 2. partners of cancer survivors who were diagnosed with cancer below the age of 18 years 3. cancer diagnosis was more than 10 years ago 4. cancer survivors/partners of survivors where the cancer treatment and follow up was not in the united kingdom 5. previous completion of the survey

Keywords: cancer survivors neoplasms oncology sexual health sexual dysfunction, physiological sexual dysfunctions, psychological sexuality barrier facilitator professional-patient relations communication
intervention study to compare the natriuretic effects of enalapril on low and high salt diet

Conditions: Salt-sensitive Hypertension

Summary: the kidney plays a crucial role in maintaining salt balance by two opposing physiological mechanisms: the renal dopaminergic system which enhances salt excretion and the renin-angiotensin system (ras) which causes salt retention. salt-sensitive hypertension occurs when this balance is altered or abnormal. we hypothesized that this balance is influenced by salt intake: therefore dietary salt affects the natriuretic response to the renal dopaminergic agonist fenoldopam, and the angiotensin converting enzyme inhibitor, enalapril. in this trial we study normal salt balance mechanisms in salt resistant adults with normal blood pressure.

eight adults of both genders and all races were studied in this double blind placebo controlled cross over study with randomization of the order of interventions. after 5 days each on low salt (about 1 gram/day) and high salt (about 6 grams/day)diet, with a washout period of at least four weeks in between, every subject was treated with enalapril and placebo on two consecutive days, followed by a fenoldopam infusion for three hours, during which natriuresis and renal function testing were performed.

Eligibility criteria:
inclusion criteria: * volunteers * healthy * normal blood pressure exclusion criteria: * renal impairment * obesity * salt sensitive increase in blood pressure

Keywords: salt balance renin angiotensin system fenoldopam\blood pressure sodium
epigenetic safety of assisted reproductive technology

Conditions: Infertility

Summary: the primary purpose of the study is to investigate the relationship between different protocols of assisted reproductive technology and the epigenetic safety of the offspring. different interventions of assisted reproductive technology include controlled ovarian hyperstimulation (coh), in vitro embryo culture, in vitro fertilization(ivf), intracytoplasmic sperm injection(icsi), frozen-thawed embryo transfer(fet), preimplantation genetic testing(pgt). the investigators are also interested in the relationship between pregnancy outcomes in art or natural conception and environmental, nutritional and lifestyle factors.


Eligibility criteria:
inclusion criteria: 1. couples undergoing treatment for infertility or getting pregnant naturally and wanting to deliver their babies in women's hospital school of medicine zhejiang university, the international peace maternity \& child health hospital, and changhai hospital of shanghai. 2. men 22-55 years old 3. women 20 - 45 years old exclusion criteria: 1. any individual or couple who is outside of age range . 2. any couple who don't plan to complete their pregnancy check-up or deliver their babies in women's hospital school of medicine zhejiang university, the international peace maternity \& child health hospital, or changhai hospital of shanghai.
development of a cabozantinib (cabometyx) symptom management application for use in patients with renal cancer

Conditions: Metastatic Renal Cell Carcinoma Treated With Cabozantinib

Summary: the purpose of this study is to develop an on-line electronic symptom management application that can ultimately be used to improve clinical outcomes in patients with mrcc treated with cabozantinib.

this is a single-site, prospective technology-based, clinical trial. nine patients with mrcc initiating cabozantinib therapy who meet subject eligibility criteria will be enrolled in this study. subjects will be given an ipod touch with the symptom monitoring application installed, physical activity and blood pressure monitors. each patient will be kept on study for the first 12 weeks of therapy with cabozantinib. subjects on treatment for less than 12 weeks will not be replaced.the symptoms and other data (physical activity, blood pressure) recorded electronically by the patient will be compared to symptoms recorded in the medical record at interval clinic visits.

Eligibility criteria:
inclusion criteria: patients \> 18 years of age patients planning to start treatment with cabozantinib therapy for renal cancer. technology requirement: the patient will need to have home wireless internet access for use of the software and technology in this study. the patient will need to already have or be willing to set up a duke mychart account. exclusion criteria: non-english speaking. any patient who is not able to comprehend and operate the technology at the discretion of the enrolling provider.
prevention ventilator associated pneumonia

Conditions: Ventilator-associated Pneumonia

Summary: the objective of the investigators work was to evaluate the impact of 4 sequentially implemented measures for preventing vap in a major heart surgery icu. the measures were a specific training program, aspiration of subglottic secretions (ass), introduction of an inclinometer to improve the semirecumbent position, and reinforcement of oral care with chlorhexidine.


Eligibility criteria:
inclusion criteria: * all patients with heart surgery admitted in critical care unit during the study period exclusion criteria: * none

Keywords: bundle prevention disturbance; heart, functional, postoperative, cardiac surgery
limited compression ultrasound by emergency physicians to exclude deep vein thrombosis

Conditions: Deep Vein Thrombosis

Summary: deep vein thrombosis is a common condition seen in the emergency department. standard of care for diagnosis of dvt includes a combination of a clinical pre-test probability rule known as well's criteria, d-dimer blood testing, and radiology department ultrasound. the purpose of this study is to determine whether emergency physicians can safely rule out deep vein thrombosis using well's criteria and d-dimer blood testing combined with emergency department bedside ultrasound.


Eligibility criteria:
inclusion criteria: * age \> 16 years * clinically suspected lower extremity dvt exclusion criteria: * known chronic dvt * acute dvt confirmed by prior formal imaging * inability to assess common femoral or popliteal area (due to cast, above knee amputation, etc.) * anticoagulation \>48 hours prior to imaging (formal or lcu)

Keywords: deep vein thrombosis venous thromboembolic disorders diagnostic ultrasound