Kornimate/medical-research-clean huggingface dataset:
venous thromboembolism (vte) treatment study in japanese pulmonary embolism (pe) patients

Conditions: Pulmonary Embolism

Summary: the objective of this study is to evaluate the efficacy, safety, pharmacokinetics (pk) and pharmacodynamics (pd) of rivaroxaban in the treatment of pulmonary embolism (pe) and the prevention of the occurrence and the recurrence of deep vein thrombosis (dvt) or pe in japanese patients with acute symptomatic pe with or without symptomatic dvt.


Eligibility criteria:
inclusion criteria: * men and women \>/= 20 years of age in patients with confirmed acute symptomatic pulmonary embolism (pe) with or without symptomatic deep vein thrombosis (dvt) exclusion criteria: * thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of pe * more than 48 hours pre-randomization treatment with therapeutic dosages of anti-coagulant treatment or more than a single dose of warfarin from the onset of the current episode of pe to randomization * calculated creatinine clearance (clcr) \< 30 ml/min * subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk * active bleeding or high risk for bleeding contraindicating treatment with unfractioned heparin (ufh) or warfarin * systolic blood pressure \> 180 mmhg or diastolic blood pressure \> 110 mmhg

Keywords: acute symptomatic pulmonary embolism
the clonal hematopoiesis & inflammation in vasculature registry and biorepository

Conditions: Clonal Hematopoiesis

Summary: this study will investigate the association between clonal hematopoiesis and other conditions. clonal hematopoiesis (ch) refers to the mutations in a person's stem cells which commonly affect people as they get older. these mutations have notably been linked to increased risk of certain cancers as well as increased risk of heart disease.

objectives: * to develop the chive registry with ch patients or patients with elevated risk for ch in order to better characterize associated clinical outcomes and co-morbidities in these populations * to improve understanding of cardiovascular phenotypes and risk of patients with known clonal hematopoiesis of indeterminate potential (chip) or clonal cytopenias of undetermined significance (ccus) * to investigate prognostic significance of ch mutations for the development hematologic malignancies * to generate a chive biorepository to acquire patient samples to study the natural history of ch, and to make available to ch investigators.

Eligibility criteria:
inclusion criteria: * patient greater than or equal to 18 years old at time of consent * able to provide informed consent * idiopathic cytopenia (icus) or idiopathic cytoses (elevated blood counts without disease or explanation); clonal cytopenia of undetermined significance (ccus), clonal hematopoiesis of indeterminate potential (chip) or individuals at higher risk for clonal hematopoiesis (ex. patients with known diagnosis of solid tumors or cardiovascular disease) exclusion criteria: * unable to provide consent * diagnosis of active hematologic malignancy. for example, a diagnosis of cmml, aml, mds, mpn; history of hematologic malignancy is not exclusionary if in complete remission (e.g. previous myeloma or lymphoma)
combination chemotherapy plus radiation therapy in treating patients with early-stage hodgkin's disease

Conditions: Lymphoma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. radiation therapy uses high-energy x-rays to damage tumor cells. combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have early stage hodgkin's disease.

objectives: i. determine the progression-free and overall survival at 5 and 10 years after a short-term stanford v regimen comprising mechlorethamine, doxorubicin, vinblastine, prednisone, vincristine, bleomycin, and etoposide followed by modified involved-field radiotherapy in patients with favorable, early-stage hodgkin's disease. ii. determine whether the early and late toxic effects of treatment can be minimized by avoiding staging laparotomy, limiting cumulative doses of chemotherapeutic drugs, and reducing the dose and volume of radiotherapy in these patients. iii. determine the freedom from second disease progression at 5 and 10 years after treatment and treatment-related toxicity in these patients. iv. determine the quality of life of patients treated with this regimen. outline: patients receive the stanford v regimen comprising mechlorethamine iv on days 1 and 29; doxorubicin iv and vinblastine iv on days 1, 15, 29, and 43; oral prednisone every other day on days 1-36 followed by tapered doses; vincristine iv and bleomycin iv on days 8, 22, 36, and 50; and etoposide iv on days 15, 16, 43, and 44. beginning 2 weeks after completion of chemotherapy and when blood counts recover, patients undergo modified involved-field radiotherapy 5 days a week for 3-4 weeks. quality of life is assessed. patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. projected accrual: a total of 50 patients will be accrued for this study within 5 years.

Eligibility criteria:
disease characteristics: histologically proven stage i-iia hodgkin's disease no lymphocyte predominant disease no stage ia high neck presentation (above the top of the larynx) no mediastinal mass equal to or greater than one-third the maximum intrathoracic diameter on chest x-ray no constitutional (b) symptoms at diagnosis no more than 1 extranodal site of disease patient characteristics: age: 16 to 60 performance status: not specified hematopoietic: granulocyte count at least 2,000/mm3 platelet count at least 150,000/mm3 hepatic: bilirubin no greater than 2.5 mg/dl renal: creatinine no greater than 2 mg/dl other: no other medical condition that would preclude study therapy hiv negative no other prior malignancy except basal cell skin cancer not pregnant prior concurrent therapy: no prior therapy for hodgkin's disease no other concurrent antineoplastic therapy no other concurrent investigational drugs

Keywords: stage i adult hodgkin lymphoma stage ii adult hodgkin lymphoma
evaluation of purified poloxamer 188 in vaso-occlusive crisis of sickle cell disease (epic)

Conditions: Vaso-occlusive Crisis; Sickle Cell Disease

Summary: the purpose of this study is to evaluate whether mst-188 can reduce the duration of vaso-occlusive crisis (voc) in subjects with sickle cell disease. the study will also evaluate whether mst-188 can reduce the frequency of rehospitalization of subjects due to a recurrence of voc. additionally, this study will compare the development of acute chest syndrome during voc in subjects who receive mst-188 to those who do not receive mst-188.


Eligibility criteria:
inclusion criteria: * age 4 through 65 years * subject has a confirmed diagnosis of hbss, hbsc, hbsβ+thal, or hbsβ0thal * subject is experiencing acute pain typical of vaso-occlusive crisis requiring treatment with parenteral analgesia * subject requires hospitalization exclusion criteria: * subject has acute chest syndrome * subject's laboratory results indicate inadequate organ function * subject is pregnant or nursing an infant * subject had a painful crisis requiring hospitalization within the preceding 14 days or has experienced \> 5 hospitalizations for voc in the prior 6 months * subject has been transfused within the past 14 days * subject is hospitalized for a condition other than voc * subject has complications related to scd

Keywords: sickle cell disease vaso-occlusive crisis
lithium water in gun violence prevention

Conditions: Assault by Handgun Discharge; Violence; Homicide; Sexual Assault by Bodily Force; Substance Abuse Problem

Summary: the word lithium frequently conjures images of catatonic psychiatric patients and side effects so severe that premature death is commonplace. but naturally occurring lithium is a far cry from pharmaceutical grades. found in the soil, water and certain foods, it is an essential mineral for maintaining physical and mental health. when exposure is low, suicide rates, mental illness and violent crime increase

lithium has a long history of use in the treatment of mental disorders. however, it hasn't been until recently that scientists began exploring the psychiatric implications of naturally occurring lithium in the water supply. as stated in the article, foods rich in lithium and lithium supplements: "research suggests that locations with the highest concentration of lithium tend to have the lowest rates of depression and violent crime. these studies have been conducted across the globe in different climates with different natural habits and diets. researchers have therefore concluded that this phenomenon is fairly universal." a study in the united states agrees with these findings. according to everything addiction: "in a 1990 study of 27 texas counties, researchers found an "inverse association of tap water lithium content in areas of texas with the rates of mental hospital admissions, suicides, homicides, and certain other crimes." it was also discovered that young men incarcerated for violent crimes in some parts of texas had disproportionately low lithium levels. schrauzer and shrestha discovered that the negative correlation was confirmed," especially in the south-central region of the state where high suicide mortality rates correspond to low lithium concentrations."' another study published in the british journal of psychiatry had similar results. researchers at oita university examined the suicide rates in japan's oita prefecture. the team discovered that cities with higher levels of natural lithium in the public water supply had lower rates of suicide overall.

Eligibility criteria:
inclusion criteria: * men and women aged 14-60. * existence of alcoholism, substance abuse, violence antecedent, suicide history answered all questions in the pre-treatment safety questionnaire. gave their oral and written consent to participate in the trial. exclusion criteria: patients with renal failure, cardiovascular insufficiency, addison's disease and untreated hypothyroidism. pregnancy. patients who have vomiting or diarrhea or if fluid or salt (sodium) intake is increased or decreased. inadequate communication with examiner. participation in another clinical study, either concurrent with this trial or in the 3 months preceding it. inability to sign a consent form.
evaluation of the ronnie gardiner method in individuals with stroke in late phase of recovery

Conditions: Stroke

Summary: stroke is a common condition that often leads to long-term disabilities, significantly affecting individuals' quality of life and imposing substantial societal costs. there is growing evidence that physical rehabilitation can improve motor function, well-being, and quality of life even in the chronic phase after stroke. in recent years, rhythm- and music-based interventions have gained increasing attention as promising tools in neurorehabilitation. the ronnie gardiner method (rgm) is a structured, music-based training method that engages motor, sensory, cognitive, and emotional functions simultaneously. while preliminary studies have shown positive effects of rgm in individuals with parkinson's disease, there is limited research on its impact in stroke rehabilitation, particularly in the chronic phase. this randomized controlled multicenter study aims to evaluate the effects of rgm training in individuals aged 18 and older who are more than six months post-stroke. participants will be randomly assigned to either an intervention group receiving rgm training twice per week for 12 weeks, or to a passive control group. the primary outcome is balance, assessed by the mini-bestest. secondary outcomes include gait, upper limb function, cognitive abilities such as working memory and divided attention, and health-related quality of life. additionally, qualitative data will be collected to explore participants' and trainers' experiences regarding motivation, engagement, and perceived impact on daily participation. the study is expected to provide valuable evidence on the clinical usefulness of rgm in chronic stroke rehabilitation and its potential to be implemented as part of community-based, cost-effective rehabilitation programs.


Eligibility criteria:
inclusion criteria: * community-dwelling individuals with stroke that occurred \> 6 months ago * cognitive ability corresponding to at least 25 out of 30 points on the montreal cognitive assessment (moca) * functional disability corresponding to a modified rankin scale (mrs) score of 2-3 * no assistance required for daily activities during participation (e.g., can independently travel to measurement/training sites and use the restroom) * ability to stand for 2 minutes without support and walk 10 meters with or without assistive devices, but without supervision exclusion criteria: * severe visual and/or hearing impairments that would interfere with study participation * participation in regular sessions with rgm after august 2024 * previous experience playing a musical instrument (defined as practicing \>1 hour/week in the past 10 years) * a score of less than 25 on the montreal cognitive assessment (moca)

Keywords: music-based intervention stroke rehabilitation ronnie gardiner method
gae using embosphere microspheres vs corticosteroid injections for treatment of symptomatic knee oa (motion)

Conditions: Knee Osteoarthritis

Summary: this multicenter, prospective, interventional trial is designed to assess the outcome of subjects with symptomatic knee osteoarthritis (oa) that are randomized to treatment with either genicular artery embolization (gae) using embosphere microspheres or steroid injection over a period of 24 months.

this study is an ide study. it is an rct comparing gae to steroid injection in the knee to treat knee osteoarthritis.

Eligibility criteria:
key inclusion criteria: provides written informed consent age ≥21 years mild to severe knee pain, defined as a womac pain score of ≥8 out of 20 (in the target knee) pain refractory to conservative therapies for at least 90 days prior to enrollment/randomization. kellgren-lawrence grade 1, 2, 3 or 4 key exclusion criteria: planned major surgical or endovascular procedures ≤ 30 days after the index procedure. advanced atherosclerosis known history of rheumatoid or infectious arthritis. prior knee replacement surgery of the target knee.

Keywords: genicular artery embolization gae knee embolization knee oa
growth hormone in children under 2 years with prader-willi in hospital of sabadell

Conditions: Prader-Willi Syndrome

Summary: the pws is a genetic disease with intellectual disabilities associated with multiple manifestations in other body systems. it is characterized by hypothalamic-pituitary abnormalities with severe hypotonia during the early years of life, conditioning feeding difficulties. hyperphagia appears later, causing severe obesity in pre - school ages. other endocrine abnormalities associated produce short stature, gh deficiency and hypogonadotropic hypogonadism. these patients also have varying cognitive dysfunction associated as well as learning problems, compounded by the development of psychological-psychiatric and behavioral problems language. the aetiology of gh decreased secretion of the spw is controversial, it is known that igf -1 levels are reduced in children and adults with pws. the rational use of gh is derived from knowledge of comorbidities observed in pws, which seem to be related to gh deficiency: hypotonia, altered body composition, decreased growth, even obesity. • the gh is accepted since 2000 for the treatment of pws. following fatal episodes in our country, it was decided to start treatment at 2 years of age in an arbitrary manner, but not in the u.s. or france. subsequent studies have found that gh per se is not a risk factor for mortality. the currently published data supporting the benefits of gh treatment when started between 4 and 6 months of life, even some experts advocate starting at 3 months, but due to the lack of consensus on the age of onset treatment, despite the benefits of your home at an early age before the onset of obesity often starts around 2 years of life. hypothesis the use of gh is safe and effective in patients with pws children under 2 years old.


Eligibility criteria:
inclusion criteria: * children under 2 years exclusion criteria: -

Keywords: prader-willi syndrome growth hormone children
mitigating cardiovascular disease risk among rural diabetics

Conditions: Health Promotion

Summary: the study explored the effects of the cardiovascular disease risk reduction intervention on diabetes fatalism, self-care activities, social support, knowledge, perceived self-managment among a rural population.

an experimental pretest-posttest control group design was used to assess the effects of a diabetes health promotion intervention among participants recruited from rural churches located in the southern united states. the intervention, called project power, is a culturally relevant, church-based diabetes education program that was developed by the american diabetes association (ada). participating churches were randomized to experimental and control groups using random numbers tables having numerical parity no greater than 2. since an individual church is the unit of randomization, all of the participants in that church received the same treatment condition. churches randomized to the intervention group received the health promotion program, and those designated to the control group received an educational brochure. recruitment, data collection and intervention delivery, for the intervention group, occurred on the church grounds.

Eligibility criteria:
inclusion criteria: * self-identified african americans aged 22 years or older, who have been diagnosed with diabetes mellitus, type 1 or 2 exclusion criteria: * other than african american, younger than 22 years of age
second-generation self-expandable versus balloon-expandable valves and general versus local anesthesia in tavi

Conditions: Aortic Stenosis

Summary: aim of the study is to demonstrate equivalence of second-generation self-expandable valves (corevalve evolut r) in comparison to second-generation balloon-expandable valves (edwards sapien 3) and of local anesthesia with conscious sedation in comparison to general anesthesia with respect to safety and efficacy in high-risk patients with severe aortic stenosis undergoing transcatheter aortic valve implantation.


Eligibility criteria:
inclusion criteria: * severe symptomatic aortic valve stenosis defined as aortic valve area (ava) ≤ 1cm2 or 0.6 cm²/m² * age ≥75 years and/or logistic european system for cardiac operative risk evaluation (euroscore) ≥20% and/or society of thoracic surgeons (sts) risk score ≥10% and/or high risk/contraindication to conventional surgical aortic valve replacement * native aortic valve annulus measuring 18-29 mm * suitability for transfemoral vascular access * written informed consent exclusion criteria: * life expectancy \<12 months due to comorbidities * cardiogenic shock or hemodynamic instability * history of or active endocarditis * contraindications for transfemoral access * active peptic ulcer or upper gastro-intestinal bleeding \<3 months * hypersensitivity or contraindication to aspirin, heparin or clopidogrel * contraindication for a specific mode of anesthesia as judged by the cardiac anesthesia representative of the heart team * active infection requiring antibiotic treatment * participation in another trial
magnesium sulfate in addition to bupivacaine in ultrasound-guided transmuscular quadratus lumborum block for post-operative analgesia after total hip arthroplasty

Conditions: Pain Score Reduction

Summary: the aim of this clinical trial is to evaluate the efficacy of adding magnesium sulfate to bupivacaine in ultrasound-guided transmuscular quadratus lumborum block for postoperative analgesia in adult patients underdoing hip arthroplasty. the main questions it aims to answer are: * does magnesium sulphate lower pain score (vas) postoperatively. * does magnesium sulphate lowertotal opioid consumption postoperatively. and what side effects do participants have when taking magnesium sulphate? researchers will compare magnesium sulphate to a placebo (a look-alike substance that contains no drug) to see if magnesium sulphate works to lower pain score. participants will: * take with have ultrasound-guided transmuscular quadratus lumborum block after surgery using bupivacaine with magnesium sulphate or with placebo * followed up 48 hours postoperatively to monitor pain score or any reported side effect.

the quadratus lumborum block (qlb) is an abdominal wall fascial block plane block described for providing perioperative analgesia for abdominal, hip and lower limb surgeries . opioid-sparing analgesic treatments for hip arthroplasty such as lumbar plexus and femoral nerve blocks, are effective but they carry a high risk of undesirable lower limb motor or muscle weakness. fascia iliaca block, on the other hand, does not consistently provide adequate pain relief. quadratus lumborum (ql) block is a relatively new truncal regional block technique that provides effective pain control after upper and lower abdominal surgeries. ersalis fascia laterally. the anterior ql block was also classified as transmuscular approach (in between ql and pm muscles) in earlier studies . local anesthetic injected between the ql muscle and anterior layer of the thoracolumbar fascia can potentially spread to the thoracic paravertebral (pvb) space. magnesium plays an important role in the physiological function of the human body. a large number of studies have reported the safetyand effectiveness of adding magnesium sulfate in various regional anesthesia techniques . therefore, this prospective randomized controlled study to compare the analgesic efficacy of combining magnesium sulfate with bupivacaine in qlb.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * american society of anesthesiology (asa) class i-iii * undergoing hip arthroplasty . exclusion criteria: * patient refusal. * body mass index (bmi) \> 40 kg/m2. * allergy to local anesthetics or magnesium sulphate. * coexisting coagulopathy. * local infection at puncture site. * severe renal impairment ( egfr \< 30 ml/min)
angiotensin converting enzyme inhibitors during cardiopulmonary bypass in infants and children

Conditions: Congenital Heart Disease

Summary: the purpose of this study is to determine whether ace inhibitors alter the fibrinolytic, inflammatory, and hemodynamic response to cardiopulmonary bypass in infants and children with congenital heart disease.


Eligibility criteria:
inclusion criteria: * infants or children (newborn to 17 years of age) undergoing cardiopulmonary bypass for elective surgical correction of a congenital heart defect. * patients must be taking an ace inhibitor prior to their operation exclusion criteria: * patients in which discontinuing aceis is deemed unsafe by their primary cardiologist * any condition rendering the subjects legal guardian unable to understand the nature, scope, and possible consequences of the study. * pregnancy as ruled out by standard of care screening procedures. * individuals whose weight is less than 3.5 kg at the time of enrollment. * inability to comply with the protocol. ie. children in whom it is deemed unsafe to have the extra blood draws, and children who are thought to be noncompliant with their medications.

Keywords: cardiopulmonary bypass ace inhibitor pediatrics