Kornimate/medical-research-clean huggingface dataset:
efficacy of novoseven® in bleeding prophylaxis in hemophilia

Conditions: Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors

Summary: this trial is conducted in africa, asia, europe, south america, and the united states of america (usa). the purpose of this study is to evaluate the effectiveness of secondary prophylactic treatment with novoseven® in haemophilia a and b patients with inhibitors.


Eligibility criteria:
inclusion criteria: * diagnosis of congenital haemophilia a or b with inhibitors development against fviii or fix, respectively exclusion criteria: * prophylactic administration of any haemostatic drug within 3 last months prior to entering the trial.
the engineer-built system, video-game based kinect sensor in upper extremities problems in cerebral palsy children

Conditions: Cerebral Palsy

Summary: there are 3 phases of this project. first phase is to study the satisfaction in healthy children aged 10-15 years old when they are playing our computer games. the sample size of this phase was 10. in addition, we will ask the occupational therapist to play and comment our game for further development.


Eligibility criteria:
inclusion criteria: * normal children aged 10-15 years * sufficient cognitive/attention capacity * give the informed consent exclusion criteria: * inability to understand the instruction and follow the task * has severe visual or auditory impairment * has limb deformities that interfere with video game playing * got an epilepsy or convulsive condition * denied to give the informed consent

Keywords: video-game based kinect sensor upper extremities
application of improved baduanjin combined cross-theoretical model based on internet in family empowering elderly pci cardiac rehabilitation

Conditions: Coronary Heart Disease

Summary: this study explores the effect of internet based improved baduanjin combined cross-theoretical model in family empowering cardiac rehabilitation for elderly patients with coronary heart disease after pci, provides a scientific and reasonable case management plan for the rehabilitation of patients with coronary heart disease, and provides a reference for the development of scientific and refined cardiac rehabilitation case management suitable for elderly patients with pci.

in this study, a total of 120 elderly patients with coronary heart disease who underwent pci in our hospital from july 2024 to july 2025 were selected, and an improved baduanjin combined cross-theoretical model based on the internet was applied to empower family cardiac rehabilitation management. the effect of this method on cardiac rehabilitation of elderly patients with coronary heart disease after pci operation was evaluated by four indexes: cardiac function index, quality of life, medication compliance and satisfaction degree, and scientific guidance was provided for clinical cardiac rehabilitation practice.

Eligibility criteria:
inclusion criteria: * (1) all met the diagnostic criteria for coronary heart disease; * (2) pci was performed for the first time with clear indications of pci surgery; * (3) postoperative condition was stable; * (4) nyha cardiac function grade i-ii; * (5) age 60 \~75 years old; * (6) patients and their family members gave informed consent to this study and signed informed consent, which met the ethical standards of human trials and was approved by the ethics committee of the hospital. exclusion criteria: * (1) uncontrolled arrhythmias combined with hemodynamic abnormalities. * (2) copd, pulmonary embolism, deep vein thrombosis, stroke and other factors affecting motor function. * (3) physical disability affecting safety and full participation in the experiment. * (4) myocarditis, cardiomyopathy, liver and kidney insufficiency. * (5) aphasia, hearing impairment and other conditions affecting normal doctor-patient communication.

Keywords: coronary heart disease ba duan jin cross-theoretical model family empowerment
icg fluorescence imaging in lower extremity amputation patients

Conditions: Trauma Injury

Summary: this is a non-randomized prospective study of 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (icg) fluorescence imaging at several steps during surgical procedure.

this is a non-randomized prospective study of 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (icg) fluorescence imaging at several steps during surgical procedure. the data collected in this study will inform the development of methodology and thresholds around providing surgeons with objective data regarding critically injured bone in the setting of musculoskeletal trauma and/or bone infection. this will improve our management of and decrease variation associated with management of these disabling conditions.

Eligibility criteria:
inclusion criteria: 1. patients 18 years of age or older 2. scheduled for a lower extremity amputation (either below knee, through knee or above knee) 3. provision of informed consent exclusion criteria: 1. iodine allergy 2. pregnant women

Keywords: trauma amputation orthopaedic lower extremity
measurement-based care (mbc) implementation, effectiveness, and mechanisms of change

Conditions: Depressive Disorder; Anxiety Disorders

Summary: although measurement-based care (mbc) is an evidence-based practice with known benefits, it is not always systematically implemented with fidelity. questions remain regarding mbc's unique added value compared to usual care. thus, the goal of this clinical trial is to investigate the implementation outcome, effectiveness, and mechanisms of change of measurement-based care in adult behavioral health. this study implemented mbc in adult ambulatory behavioral health and will test outcomes using a pragmatic randomized control trial within the re-aim (reach, efficacy, adoption, implementation, and maintenance) framework. researchers will compare three groups: 1) the measurement-based care group, 2) the treatment-as-usual group, and 3) the waitlist control group. participants will participate in weekly individual psychotherapy sessions for 12 sessions in total.

measurement-based care (mbc) is an evidenced-based practice, involving routine completion of patient-reported outcome measures and collaborative discussions between clinician and client to inform clinical decision-making and facilitate improvement. despite its known benefits, such as reduced dropout rates and improved treatment outcomes, questions remain regarding mbc's unique effectiveness compared to standard care. furthermore, mechanisms of change on how mbc actually works in treatment have yet to be fully investigated. thus, the current study aims to conduct a randomized control trial to evaluate the added value of mbc, by comparing an mbc+psychotherapy group, a psychotherapy-only group, and a waitlist group with no interventions.

Eligibility criteria:
inclusion criteria: 1. primary concern and referral reason for seeking psychotherapy are either depressive- or anxiety-related symptoms and/or psychological distress, using minimum scores as follows: phq-9 (score \> 4), gad-7 (score \> 4), and base-6 (score \> 18), and 2. being 18 years old or older. exclusion criteria: 1. severe physical or psychiatric conditions that would hinder the treatment (e.g., clients with acute psychosis, intellectual disability, or neurocognitive disorders who do not have the capacity to undergo informed consent and participate in the study); 2. currently receiving psychotherapy through another source; 3. significant suicidal/homicidal risk that would need immediate intervention; 4. do not have ability complete patient-rated outcome measures (proms) either in person or remotely

Keywords: measurement-based care effectiveness rct implementation psychotherapy mechanisms of change
safety, tolerability and efficacy study of arct-032 in people with cystic fibrosis

Conditions: Cystic Fibrosis; CFTR Gene Mutation

Summary: arct-032-02 is a phase 2, open-label, multicenter, multiple-ascending dose study of arct-032 in adults with cf who are not eligible for cftr modulator therapy or are not taking cftr modulators due to drug intolerance, poor response, or lack of access to modulators.

this is an open-label, multiple-ascending dose study of arct-032 in adults with cf who are not on cftr modulator therapy. after successful screening, eligible participants will receive nebulized arct-032 daily for 4 weeks, and then followed for safety for a total of 12 weeks.

Eligibility criteria:
key inclusion criteria: 1. confirmed diagnosis of cystic fibrosis 2. not eligible for cftr modulator therapy, or not taking cftr modulators for at least 60 days prior to dosing (e.g. due to intolerance, poor response, or lack of access to modulators). 3. fev1 between 40% and 100% of predicted value exclusion criteria: 1. history of illness or medical condition that might pose an additional risk or may confound study results 2. recent moderate or severe hemoptysis 3. recent major surgery 4. solid organ or hematologic transplant 5. requirement of supplemental oxygen while awake or \> 2l per minute while sleeping. 6. chronic maintenance systemic corticosteroids exceeding equivalent of daily 15 mg oral prednisone or 30 mg every other day 7. adequate liver and kidney function as determined by lab tests

Keywords: cftr mrna
a multiple ascending dose study of bms-650032 in hcv infected subjects

Conditions: Chronic Hepatitis C

Summary: the primary purpose of this study is to assess the change in hcv rna during dosing with bms-650032 and during the follow-up period in subjects with chronic hepatitis c infection


Eligibility criteria:
inclusion criteria: * chronically infected with hcv genotype 1 * treatment naive * hcv rna viral load of ≥10\*5 iu/ml * bmi 18 to 35kg/m² exclusion criteria: * women of childbearing potential (wocbp) * any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with hcv infection * hcv infected subjects who are treatment non-responder (defined as subject who received at least 12 weeks of soc and continue to have a detectable hcv rna level or subjects who did not attain a 2-log decline in hcv rna levels at 12 weeks and stopped treatment * hcv infected subjects who are treatment intolerant (defined as subject who are unable to receive at least 12 weeks of soc due to toxicities associated with interferon and/or ribavirin * hiv and/or hbv positive * major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
efficacy of hipec in the treatment of advanced-stage epithelial ovarian cancer after cytoreductive surgery

Conditions: Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Summary: this project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of advanced-stage epithelial ovarian cancer after cytoreductive surgery. median recurrence-free survival is the primary end points of this project.

the current standard treatment for epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer is maximal cytoreductive surgery followed by intravenous chemotherapy with or without intraperitoneal chemotherapy (ip). recently, the organizations of sgo and asco recommended that women with fagotti score by laparoscopic exploration \< 6 would benefit from primary cytoreductive surgery followed by postoperative chemotherapy, and are likely to attain optimal cytoreduction (residual lesion ≤ 1 cm). hyperthermia promotes chemotherapy to penetrate deeper into the cancer tissue. therefore, hyperthermic intraperitoneal chemotherapy (hipec) as newly postoperative chemotherapy after primary cytoreductive surgery in the treatment of ovarian cancer could lead to higher response rate and better survival outcomes.

Eligibility criteria:
inclusion criteria: * disease status primary epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer (stage iii ) * fagotti score by laparoscopic exploration \< 6 * residual tumor \< 1cm after completion of cytoreductive surgery * 18 \< age \< 70 year old * expected survival \> 3 months * performance status: ecog 0-1 * adequate bone marrow function hb ≥8 g/dl (after correction in case of iron deficient anemia) wbc ≥ 3,000/mm3, platelet ≥ 100,000/mm3 * adequate renal function creatinine ≤ 1.5 mg/dl, and adequate hepatic function bilirubin ≤ 1.5 mg/dl and ast and alt ≤ 80 iu/l * voluntary participation after getting written informed consent. exclusion criteria: * fagotti score by laparoscopic exploration \>= 6 * suboptimal debulking (residual tumor \> 1cm) * extensive adhesion in peritoneal cavity * previous history of other malignancies (except excision of skin cancer, thyroid cancer) * poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction\<50% * receiving other chemotherapy, radiotherapy or immunotherapy * patients who are unsuitable candidates by doctor's decision * without given written informed consent

Keywords: hyperthermic intraperitoneal chemotherapy advanced-stage epithelial ovarian cancer cytoreductive surgery postoperative chemotherapy
study of ozanimod (rpc1063) in relapsing multiple sclerosis (ms)

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (rms).


Eligibility criteria:
inclusion criteria: * multiple sclerosis as diagnosed by the revised 2010 mcdonald criteria * edss score between 0 and 5.0 at baseline exclusion criteria: • primary progressive multiple sclerosis

Keywords: ms rms multiple sclerosis relapsing multiple sclerosis
myopia control using soft bifocal lenses

Conditions: Myopia

Summary: the purpose of this study is to evaluate whether bifocal soft contact lenses (cls) with low addition and nasally decentered optical zone are effective in controlling myopic progression in children. visual manipulations induced by multifocal soft cls with high addition have been shown to inhibit eye growth and myopia development in children by recent studies. several theories have been proposed including alteration in peripheral defocus, reduced accommodation demand, alterations in binocular vision status and increased ocular higher order aberrations. however, those theories remain to be proven and the optical properties and performance of multifocal soft cls have not been investigated in children.

visual manipulations induced by multifocal soft contact lenses (cls) with high addition (+2.00 d or above) have been shown to inhibit eye growth and myopia development in children with up to 25-50% efficacy by recent studies. several theories have been proposed including; alteration in peripheral defocus, reduced accommodation demand, alterations in binocular vision status and increased ocular higher order aberrations, which remain to be proven. however, the effect of controlling myopic progression by bifocal cls with low addition has not been studied. several studies have shown that multifocal soft cls can induce changes in ocular aberrations and degradation of image qualities in adults, whereas the optical properties and performance of multifocal soft cls have not been investigated in children. due to the differences in ocular structure and function, for instance, the pupil size and accommodation response, the performance of multifocal cls in children may vary compared with that in adults. as a result, it is essential to assess the optical quality of these lenses worn by children for myopia control, through coas (complete ophthalmic analysis system). the aim of this randomized clinical trial is to evaluate myopic progression in children wearing soft bifocal with low addition cls (menicon 2 week duo \*\*) used as daily disposable lenses, compared to control subjects wearing single-vision spectacles. myopia progression quantified by changes in axial length (al) and cycloplegic refractive error (rx) will be monitored for 2 years with single-masking. the optical performance of bifocal cls worn by children will also be investigated. (\*\*this lens is currently commercially available in japan only. the oxygen permeability (dk) is 34 with 72% water content, fda group ⅱ.)

Eligibility criteria:
inclusion criteria: * refractive sphere: -0.75 d to -4.50 d * refractive cylinder: not exceed 1.00 d * spherical equivalent: -0.75 d to -5.00 d * best corrected distance va (logmar): 0.14 or better in each eye and 0.10 or better in both eyes * difference in refractive error (spherical equivalent) in the two eyes: not exceed 1.00 d exclusion criteria: * prior history of myopia control treatment * contraindication to contact lens wear * binocular anomalies (e.g. strabismus)

Keywords: myopia control, bifocal soft contact lenses, children
validating the clinical effect of a knee orthosis

Conditions: Medial Gonarthrosis

Summary: the aging population is steadily increasing, partly due to increasing life expectancy. at the same time, chronic diseases, including those affecting the musculoskeletal system (e.g., osteoarthritis), whose prevalence increases with age, limit the daily activities of those affected and thus affect more and more people. arthrosis is the most common form of these diseases worldwide. according to the l'institut de la statistique du québec, nearly one in two quebecers aged 15 and over is affected by a chronic health problem. knee orthosis is one form of treatment that helps patients suffering from knee gonarthrosis. this treatment aims to compensate for certain biomechanical deficits in patients. a variety of joint configurations exists to target specific biomechanical deficits. a constant challenge for companies manufacturing orthoses is transmitting the orthosis's biomechanical effect to the patient. the desired effect requires a change in the forces applied inside the knee, but the orthosis cannot directly transmit forces to the patient's bones due to its external nature to the body. customization of orthoses is crucial to improve the transmission of the biomechanical effect as well as tolerance to it. o3d inc. aims to validate the effectiveness of its new custom orthosis for treating knee gonarthrosis symptoms.


Eligibility criteria:
inclusion criteria: * suffering from medial gonarthrosis * receiving a regular model of the o3d orthosis exclusion criteria: * suffering from tricompartmental gonarthosis * having completed the delivery appointment for a o3d orthosis

Keywords: knee orthosis knee brace validation womac knee pain knee stiffness daily activities knee function
the effect of short-term statins and nsaids on levels of beta-amyloid, a protein associated with alzheimer's disease

Conditions: Alzheimer Disease

Summary: the purpose of this study is to determine whether short-term use of the drugs ibuprofen and lovastatin affects levels of a protein called beta-amyloid in people who are at risk for developing alzheimer's disease (ad).

there is increasing evidence that nonsteroidal and cholesterol lowering medications may be associated with a delay in the onset of alzheimer's disease (ad). there is separate evidence that beta-amyloid(1-42) is involved in the pathophysiology of ad and levels of beta-amyloid(1-42) in the cerebrospinal fluid (csf) of ad patients are significantly lower than that found in controls. it has been suggested that these standard medications may have indirect effects that alter the normal course of ad, but there is no data to directly support this contention in humans. based on previous work, it is our hypothesis that csf beta-amyloid(1-42) levels may serve as an early biomarker of ad. any pharmacological induced change in csf beta-amyloid(1-42) might have profound implications for the eventual onset of illness. therefore, the purpose of this study is to evaluate the short-term effects of two commonly prescribed nonsteroidal and cholesterol lowering medications, ibuprofen and lovastatin, on the levels of cerebrospinal fluid beta-amyloid(1-42) in a group of normal controls 'at risk' for developing ad.

Eligibility criteria:
inclusion criteria: 1. normal volunteer over the age of 18 2. cognitively within normal limits at baseline evaluation 3. previously evaluated in protocol 95-m-0096 4. women of child-bearing potential will be advised not to become pregnant during the treatment period exclusion criteria: 1. known allergies to lovastatin or ibuprofen 2. use of regular dosing of nsaid or statin during the previous month 3. concurrent use of cyclosporine, itraconazole, ketoconazole, gemfibrozil, niacin, erythromycin, clarithromycin, hiv protease inhibitors or nefazodone because of possible drug interactions with lovastatin. 4. women who are currently pregnant 5. concurrent use of anticoagulants, aspirin, beta-adrenergic agents, cimetidine, digoxin and oral hypoglycemics because of possible drug interactions with ibuprofen. 6. peptic ulcer disease by history 7. autoimmune disease by history

Keywords: cerebrospinal fluid cholesterol statin nsaid antiinflammatory dementia alzheimer's disease nonsteroidal antiinflammatory healthy volunteer
pharmacogenomics study of cpt-11 as the first-line chemotherapy for mcrc

Conditions: Colorectal Cancer

Summary: irinotecan (cpt-11) is now widely used as the first-line chemotherapy for mcrc. there were 4 key enzymes for cpt-11 metabolizing, cyp3a4, udp-glucuronosyltransferase, carboxylesterase(ces), and atp-binding cassette (abc) transporters. genetic variations of those enzymes may cause the heterogeneity in safety and efficacy of cpt-11. the aim of this study is to figure out the correlation between the genetic polymorphism and the drug response.

collect blood samples,determining genetic contribution to the safety and efficacy of cpt-11.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed colorectal cancer 2. ≥ 18 years old 3. measurable disease, defined as to recist criteria 4. unresectable metastatic disease or first recurrence/metastasis after adjuvant therapy and not suitable for operation 5. folfiri±cetuximab/bevacizumab as the first-line therapy 6. without expected course of radiotherapy during the first-line chemotherapy 7. no previous cpt-11 chemotherapy 8. ecog performance status (ps) 0-2 9. not pregnant or nursing and negative pregnancy test 10. voluntarily signed the informed consent 11. total bilirubin ≤ 1.5 times upper limit of normal (uln) 12. ast and alt ≤ 2.5 times uln (≤ 5 times uln if f liver metastases present) 13. creatinine clearance \> 50 ml/min or serum creatinine ≤ 1.5 times uln exclusion criteria: 1. brain metastases with obvious symptoms 2. severe bone marrow failure and can not be corrected 3. chronic diarrhea history 4. bowel obstruction without control 5. mental illness without control 6. clinically significant (i.e., active) cardiovascular disease, including any of the following: cerebrovascular accidents/ myocardial infarction/ unstable angina/ new york heart association class ii-iv congestive heart failure/ serious cardiac arrhythmia requiring medication/ uncontrolled hypertension 7. other co-existing malignancy or malignancy diagnosed within the past 5 years, except for basal cell or squamous cell carcinoma, or carcinoma in situ of the cervix 8. pelvic radiotherapy for the past 1 year 9. known allergy to any of the components of the study medications 10. serious, nonhealing wound or ulcer

Keywords: cpt-11,pharmacogenomics,colorectal cancer