Kornimate/medical-research-clean huggingface dataset:
veliparib monotherapy for relapsed ovarian cancer with brca mutation

Conditions: Recurrent, Epithelial Ovarian Cancer

Summary: the main purpose of this study is to investigate the effect of veliparib in ovarian cancer patients with known brca 1/2 mutations who do no longer respond to conventional chemotherapy.

the side effects are modest, since parp inhibitors affect cancer cells to a much larger extent than normal cells. the effect of this parp-inhibiting treatment is evident although the greatest effect is seen in patients with mutations in brca genes. the reason for this is that brca deficient cancer cells are unable to repair both dna double strand and single strand breaks and undergo apoptosis to a large extent.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed epithelial, primary fallopian or primary peritoneal cancer. stages i-iv. 2. patients with known germline brca1/2 mutations 3. verified progression by either recist criteria and/or gcig ca125 criteria after previous first line chemotherapy or progression after later lines of cytotoxic treatment. 4. platinum resistance or partially platinum sensitive disease (relapsed within six months of prior first line/later lines of platinum-based therapy or relapsed within six to twelve months of prior first line/later lines of platinum-based therapy) 5. age ≥ 18 years. 6. performance status 0-2. 7. measurable disease by recist 1.1 or evaluable by ca125 gcig criteria 8. adequate bone marrow function, liver function, renal function and coagulation parameters (within 7 days prior to randomization): wbc ≥ 3.0 x 10\^9/l or neutrophils (anc) ≥ 1.5 x 10\^9/l platelet count ≥ 100 x 10\^9/l hemoglobin ≥ 9.7 g/dl (6 mmol/l) serum bilirubin ≤ 1.5 x uln serum transaminases ≤ 2.5 x uln serum creatinine ≤ 1.5 x uln 9. written informed consent. 10. tissue available for brcaness analysis. exclusion criteria: 1. previous treatment with a parp inhibitor. 2. platinum-refractory disease (disease that progressed or was stable during prior platinum therapy) 3. patients who have received (or are planning to receive) treatment with any other investigational regimen, or who have participated in another clinical trial within 28 days prior to entering this trial. 4. pregnant or breast-feeding patients. for fertile women a negative pregnancy test at screening is mandatory. 5. fertile patients not willing to use acceptable and safe methods of contraception during and for 6 months after treatment 6. other present or previous malignancy except curatively treated cervical cancer stage i, non-melanotic skin cancer or other cancer with minimal risk of relapse. curatively treated prior breast cancer is allowed if no relapse is suspected at time of inclusion. 7. cns metastasis. 8. history of any chronic medical or psychiatric condition or laboratory abnormality that is not medically controlled or in the opinion of the investigator may increase the risks associated with study drug administration. (e.g. diabetes, cardiac diseases, hypertension, renal or liver disease). 9. allergy to the ingredients of the study medication.

Keywords: brca1 mutation brca2 mutation ovarian cancer parp inhibitor
clinical and electrophysiological patterns of chronic dysimmune polyneuropathy

Conditions: Chronic Inflammatory Demyelinating Polyneuropathy

Summary: chronic dysimmune neuropathies (cdn) are a heterogenous group of acquired inflammatory demyelinating neuropathies including chronic inflammatory demyelinating polyneuropathies (cidp), lewis-sumner syndrome (lss), multifocal motor neuropathy (mmn) and other rare entities. despite their relatively low prevalence, cdn lead to substantial costs for patients and society. cdn are usually misdiagnosed due to progressive nature of the disease with little known data regarding disease activity and treatment response

cidp is the most common treatable cdn worldwide. its prevalence is ranging between approximately 1 to 8.9 cases per 100.000 . in addition, there is often the tendency to diagnose cidp in order to attempt a treatment option. this ultimately leads to overdiagnosis and overtreatment in some patients although the different cdn have varying underlying pathophysiology and clinical characteristics, they are all potentially treatable with immunomodulatory drugs. to date, diagnostic criteria, measurement of disease activity and treatment response of cdn are mainly based on clinical, electrophysiological, and patient related outcome parameters. the commonly used efns/pns diagnostic criteria for cidp seems to have the best sensitivity among different sets of diagnostic criteria

Eligibility criteria:
inclusion criteria: * age \> 18 years, both sexes, history of sensory and/or motor complaint with progressive course over more 2 months exclusion criteria: * \*patients with systemic diseases (dm, chronic kidney or liver disease, thyroid disease, vitamin b12 deficiency) * family history of peripheral neuropathy or neurological symptoms suggestive for heredo-familial neurological disorders * patients with infective cause as (hbv, hcv, hiv, leprosy) * toxic and drug induced polyneuropathy (chemotherapeutics, antimicrobial ..
quality of life evaluation with the sri questionnaire of als patient with non-invasive ventilation

Conditions: Amyotrophic Lateral Sclerosis

Summary: this study aims to measure the quality of life of als patients by the sri questionnaire, in two distinct patient groups : patient requiring initiation of niv, and patients 24 hours dependent on niv this study also seeks to assess the quality of life of the caregivers with the zarit burden interview in those two populations

the course of the study is as follows: patient newly ventilated with niv : inclusion is done on the day of starting niv. on the day of inclusion: clinical examination, completion of the als-frs score, completion of the sri score. for the caregiver: completion of the zarit burden inerview reassessment of scores (sri, zarit-burden, als-frs), at three-month and six-month follow-up patient dependent of niv : on the day of inclusion: clinical examination, completion of the als-frs score, completion of the sri score. for the caregiver: completion of the zarit burden inerview reassessment of scores (sri, zarit-burden, als-frs), at three-month follow-up

Eligibility criteria:
inclusion criteria: patients : * 18 years or more * patient followed for als probable or certain with awaji criteria * group 1 : severe chronic respiratory failure, with a decision by the attending physician to start niv * group 2 : complete dependence on niv caregivers : * 18 years or more * informed and does not object to the study * primary caregiver for more than 3 months of an als patient on niv (either at initiation or with 24 hours niv dependence) * more than 30 hours spent at home per week * met the inclusion criteria for group 1 (niv initiation) or group 2 (24 hours niv dependence) exclusion criteria: patients : * patient under legal protection/ guardianship * insufficient command of french * severe cognitive impairment, particularly in relation to frontotemporal degeneration * no indication criteria for niv. caregivers : * insufficient command of french * caregiver of a patient with another chronic pathology

Keywords: amyotrophic lateral sclerosis quality of life evaluation sri questionnaire zarit burden interview
nm404 as an imaging agent in patients with nsclc

Conditions: Non Small Cell Lung Cancer

Summary: this study seeks to determine imaging characteristics of radiolabelled 131-i-nm404 in ten patients with cancer, including calculations of pks, radiation dosimetry, biodistribution, and optimal imaging times (part 1 - complete). in addition, specific tumor accumulation and metabolic fate of 131-i-nm404 will be determined in nsclc tumors collected in 5 patients (part 2 - complete). lastly, the study will collect preliminary data on imaging nsclc tumors in up to 12 patients with evaluable disease (part 3 - ongoing).


Eligibility criteria:
inclusion criteria: part 3 * histologically or cytologically documented nsclc with measurable of disease * disease is evaluable by ct scan * at least 18 years old. women cannot be pregnant or breastfeeding * karnofsky score \>/= to 60 * adequate renal/hepatic function * adequate blood cell count levels exclusion criteria: * concomitant infection * other active cancers
prevail-j - transfemoral & transapical placement of aortic balloon expandable transcatheter valves trial (japan)

Conditions: Aortic Valve Stenosis

Summary: a single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the edwards sapien xt™ transcatheter heart valve (model 9300tfx), novaflex™ transfemoral delivery system, ascendra2™ transapical delivery system and crimper accessories. the trial includes a premarket pivotal cohort to evaluate the system performance as well as a post market clinical follow-up phase involving long term follow-up of all patients to evaluate the safety of investigational devices up to 5 years.

purpose: to evaluate the safety and efficacy of thv-9300 for patients who have severe symptomatic aortic stenosis attributed to calcification and degeneration of a valve leaflet and for whom undergoing a surgery safely would be difficult. follow-up: subject data collection will include clinical information at baseline and during the index procedure. subjects will undergo clinical follow-up at discharge, 30 days, 6 months and annually for 5 years.

Eligibility criteria:
inclusion criteria: * patients who were judged difficult to safely undergo avr * severe senile degenerative aortic valve stenosis * nyha functional class ii or greater * signed informed consent exclusion criteria: * aortic valve is congenital unicuspid or bicuspid * annulus size between \ 25 mm * lvef \< 20 %

Keywords: sapien xt valve, cardiovascular disease, valvular heart disease, aortic stenosis, heart valve therapy, transapical, transcatheter, transfemoral
antioxidant effects of melatonin in preterm

Conditions: Newborn Morbidity; Oxidative Stress; Pre-Term; Melatonin Deficiency

Summary: preterm infants are at risk of free radical mediated diseases from oxidative stress (os) injury. melatonin (mel) is a powerful antioxidant and scavenger of free radicals. in preterm neonates, melatonin deficiency has been reported. several studies tested the efficacy of melatonin to counteract oxidative damage in diseases of newborns such as chronic lung disease, perinatal brain injury, necrotizing enterocolitis, retinopathy of prematurity and sepsis, giving promising results. in these studies, the dosages of melatonin varied over a wide range. the present study was designed to test the hypothesis that oral administration of melatonin reduced os and consequentially, the occurrence of intraventricular haemorrhage (ivh), necrotizing enterocolitis (nec), retinopathy of prematurity (rop) and bronchopulmonary dysplasia (bpd) in preterm newborns.


Eligibility criteria:
inclusion criteria: * gestational age \<37 weeks * normal liver function tests * normal kidney function tests exclusion criteria: * all babies not born in the clinic * all babies with severe congenital malformations * sepsis * inborn errors of metabolism * babies suffering from perinatal asphyxia * babies born from mothers with mental disorders * sample hemolysis * insufficient sample * withdraw informed consent.
the impact of moderate resistance training on imat in elderly diabetes patients without obesity

Conditions: Type 2 Diabetes

Summary: data shows that high intensity resistance training reduces intermuscular adipose tissue (imat) in obesity adults. whether moderate resistance training reduces imat for non-obese elderly patients with diabetes is not clear. therefore, this study aimed to evaluate the impact of moderate resistance training on imat in elderly patients with type 2 diabetes, and the independent effect of imat reduction on metabolic outcomes. in this randomized control trial (rct), 85 type 2 diabetes patients were randomized into the resistance training group (42 participants) and control group (43 participants) for 6-month intervention. the control group was not asked to participate in any regular exercise. however, the group attended online group educational sessions about diabetes self management once a month, and were asked to record their daily physical activities. online mini program wechat was used for communication. the intervention group attended online group education sessions on diabetes self management as the control group, as well as resistance exercise training sessions three times weekly; the sessions were approximately 40 minutes long and included 5 minutes of warm up, followed by 30 minutes of resistance exercises and 5 minutes of cool down. the resistance training consisted of ten upper-body and lower-body exercises using elastic band. the initial sessions were 1 to 2 sets of 6 to 8 repetitions at 45% of the one-repetition maximum (1 rm). it was increased progressively to 2 to 3 sets of 8 to 12 repetitions at approximately 50% -55% of 1 rm. the primary outcome were the changes of imat measured by computed tomography（ct）scan and magnetic resonance imaging (mri) interactive decomposition of water and fat with echo asymmetry and least squares qualification sequence (ideal-iq). the secondary outcomes were the changes in metabolic parameters.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * ≥60 and \<75 years of age * normal muscle strength * body-mass index (bmi) ≤35 * glycosylated hemoglobin a1c (hba1c) \< 9% exclusion criteria: * patients who had severe chronic diabetes complications（e.g., stroke, myocardial infarction, end stage renal disease, proliferative retinopathy) * cognitive impairments
safety, tolerability, and pharmacokinetics of multiple rising doses of bi 425809 tablets for 12 days to young and elderly healthy male and female volunteers and comparison of pharmacokinetics of a single oral dose of bi 425809 (morning versus evening)

Conditions: Healthy

Summary: the aim of the study is to investigate the safety, tolerability, and pharmacokinetics of multiple rising doses of bi 425809 tablets given orally once daily for 12 days to young and elderly healthy male and female volunteers and to compare single dose pharmacokinetics of bi 425809 given in the morning and in the evening.


Eligibility criteria:
inclusion criteria: * healthy male or female subjects according to the investigator´s assessment, based on a complete medical history including a physical examination, vital signs (blood pressure (bp), pulse rate (pr), 12-lead electrocardiogram (ecg), and clinical laboratory tests * age of 18 to 50 years (incl.) for young healthy volunteers or age of 65 to 80 years (incl.) for elderly healthy volunteers * body mass index (bmi) of 18.5 to 29.9 kg/m2 (incl.) * signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (gcp) and local legislation * female subjects who meet any of the following criteria: 1. surgically sterilised 2. postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of follicle stimulating hormone (fsh) above 40 u/l and estradiol below 30 ng/l is confirmatory) exclusion criteria: * any finding in the medical examination (including bp, pr or ecg) is deviating from normal and judged as clinically relevant by the investigator * repeated measurement of systolic blood pressure outside the range of 90 to 140 mmhg, diastolic blood pressure outside the range of 50 to 90 mmhg in young subjects, and systolic blood pressure greater than 150 mmhg, diastolic blood pressure greater than 95 mmhg in elderly subjects, or pulse rate outside the range of 50 to 90 bpm * any laboratory value outside the reference range that the investigator considers to be of clinical relevance * any evidence of a concomitant disease judged as clinically relevant by the investigator * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication * diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders * history of relevant orthostatic hypotension, fainting spells, or blackouts * chronic or relevant acute infections * further exclusion criteria may apply
effects of a yoga program on the functionality of individuals

Conditions: Knee Osteoarthritis

Summary: there is a notable and emerging use of structured exercise programs incorporating yoga for chronic musculoskeletal pain. however, regarding knee osteoarthritis (koa), the effectiveness of yoga remains uncertain to justify its inclusion in therapeutic exercise programs in routine clinical practice. therefore, the aim of this project is to evaluate the effects of yoga on functionality in individuals with koa. for this purpose, participants with koa, including individuals of both sexes, aged 45 years or older, with a clinical diagnosis of koa, will be randomly allocated using a random sequence generated by software, organized in six blocks of 24 codes, with an allocation ratio of 1:1, numbered sequentially from 1 to 126. allocation will be concealed and performed after pre-intervention assessment and confirmation of eligibility criteria. participants will be distributed into two groups: (1) experimental group - yoga (n = 45) and (2) control group - therapeutic exercise (n = 45). the intervention will last 8 weeks, with assessments conducted at baseline, after 4 weeks, and after 8 weeks of the intervention programs. the following outcome measures will be used: knee injury and osteoarthritis outcome score (koos), berg balance scale (bbs), numeric pain rating scale (nprs), pain self-efficacy questionnaire (pseq), global perceived effect scale (gpe), 30-second sit-to-stand test (30s-sts), timed up and go test (tug), and maximal voluntary isometric contraction (mvic). data analysis will include a normality test to verify the distribution of the data, followed by the appropriate statistical tests for intra- and intergroup comparisons. the comparisons will consider two factors: time and group. a significance level of 5% (p \< 0.05) will be adopted for all analyses.


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of knee osteoarthritis (knee pain for \> 3 months) * morning stiffness \<30 minutes * crepitus * bone tenderness, and absence of palpable heat and/or diagnosis established radiographically (determined by kellgren and lawrence grade 1 to 3 on a scale 1 up to 4) exclusion criteria: * bilateral hip or koa * severe osteoporosis * fibromyalgia * clinical history of tumors or cancer * active inflammatory joint diseases (rheumatoid arthritis, gout), undergoing any joint replacement of the lower extremity * neurological diseases (parkinson's disease, stroke, multiple sclerosis, muscular dystrophies, neuromotor disease, alzheimer's disease) * infected wounds or osteomyelitis in the knee region * deep vein thrombosis or thrombophlebitis, sensory changes in the lower limbs * a cognitive and cardiopulmonary impairment that may prevent or limit the performance of exercises * use of a walking assistance device, history of recent trauma to the knee * be performing or having prior any form of treatment involving physiotherapy, intra-articular corticosteroids, anti-inflammatories, opioid medication, or chondroprotective in the six months before the start of interventions
5p15/ 9q22/ 15q22 hyperdiploidy and their significance in multiple myeloma patients

Conditions: Multiple Myeloma, Neoplasms

Summary: our study aims to detect 5p15/ 9q22/ 15q22 hyperdiploidy and thier significance in multiple myeloma patients

multiple myeloma is a malignancy of terminally differentiated b cells(immunoglobulin-producing long lived plasma cells ).its a bone marrow based,multifocal plasma cell neoplasm,multiple myeloma (mm) is the second most common hematologic malignancy.it is mostly observed in older adults with a median age of 66 to 70 years .the exact etiology of multiple myeloma is unknown. however, frequent alterationsand translocations in the promoter genes, especially chromosome 14, are commonly found in multiple myeloma and likely play a role in disease development.in addition, other oncogenes such as nras, kras, and braf may participate in plasma cell proliferation in the majority of patients,malignant proliferation of plasma cells causes the m protein (abnormal igg, igm, or iga or rarely ige or igd) in serum and/or urine. typical symptoms are hypercalcemia, renal failure, anaemia, or destructive bone lesions ("crab") the definition of hd in mm has varied across studies; one study defined hd as numerous chromosomal trisomies and low prevalence of igh translocations and another as a chromosome count of 48-65, with a gain of at least two odd chromosome, multiple myeloma can be distinguished into two major subgroups based on the genetic abnormalities that all patients harbor; hyperdiploid mm (≥47 and \ 75 chromosomes), h-mm has been defined by multiple chromosomal gains, preferentially of the odd chromosomes 3, 5, 7, 9, 11, 15, 19 and 21.hyperdiploidy is usually associated with a favourable prognosis. cytogenetic mutations in mm divided into two classes: primary and secondary. primary mutations that occur during the monoclonal gammopathy of undetermined significance (mgus) stage, a noncancerous condition that affects plasma cells.the primary mutations typically affect the immunoglobulin genes,the most common trusted source primary mutation is hyperdiploidy,which causes three chromosomes to develop instead of two, it can be observed in around half of the patients and is considered as a favorable prognostic factor, secondary mutations occur later in the disease or during its progression.secondary mutations can also be monosomic, where the mutation causes one member of a chromosome pair to be missing

Eligibility criteria:
inclusion criteria: newly diagnosed multiple myeloma patients - exclusion criteria: patient of multiple myeloma who received treatment -

Keywords: hyperdiploidy
single session of anodal cerebellar vs cerebral transcranial direct current stimulation in stroke patients

Conditions: Stroke

Summary: to compare the effect of anodal cerebellar transcranial direct current stimulation (ctdcs) vs anodal cerebral direct current stimulation on balance, mobility and cognition in stroke patients in stroke patients


Eligibility criteria:
inclusion criteria: * ability to give written consent. * able to walk unassisted * functional status allowing the participants to participate in the balance training. * score 6 or above on johns hopkins fall risk assessment tool exclusion criteria: * neurological diseases, such as parkinson, alzheimer * any history of psychological illnesses * receipt of electrotherapy that might affect the nervous system in the two weeks prior to the study * cerebellar disorders * use of any sedative medicines in the two days prior to the study * any symptoms of amnesia and depression; * memory disorders with scores below 21 on the mini mental status examination test * any signs of severe motor disorders in the lower extremity which cause any movement limitation or deformity * any signs of radiculopathy or root lumbar spinal cord involvement * any visual or auditory impairment, or vertigo reports * use of a heart rate regulator * any structural deformities in the lower extremities or the spine * any abnormalities in the vestibular system * history of recent fracture * inability to move without assistance

Keywords: transcranial direct current stimulation anodal cerebral