Kornimate/medical-research-clean huggingface dataset:
study of cilostazol and probucol to assess their effects on atherosclerosis related biomarker

Conditions: Type 2 Diabetes Mellitus; Arteriosclerosis Obliterans

Summary: 1. to evaluate the efficacy of cilostazol and probucol alone and in combination on atherosclerosis related biomarker 2. to evaluate the safety of cilostazol and probucol alone and in combination on atherosclerosis related biomarker

efficacy evaluation: primary efficacy index: after 12 weeks of treatment, the change of arteriosclerosis related biomarker in 4 modality groups, comparing with the base line information secondary efficacy index: after 8 weeks of treatment, the change of arteriosclerosis related biomarker in 4 modality groups, comparing with the base line information safety evaluation: 1. adverse event 2. vital sign and physical examination 3. 12-lead ecg 4. laboratory tests (including blood routine examination, routine urine analysis, blood biochemistry examination, glycosylated hemoglobin)

Eligibility criteria:
inclusion criteria: * 40\~75-year-old male or female * clarified diagnosis of type 2 diabetes mellitus * arteriosclerosis obliterans (aso) is diagnosed (aso diagnoses should meet at least one of the conditions as below: * abi\<1.0; * the pulse of popliteal artery or dorsalis pedis artery is weeken significantly or is different between left and right sides * intermittent claudication, diagnosed as aso by doctor * ultrasonogram showed that there was atherosclerotic plaque in lower limb within 1 year * informed consent form signature exclusion criteria: * has an allergic history to study drugs * use one of the following drugs: other antiplatelet or anticoagulation agents except aspirin, other hypolipidemic agents except statins * type 1 diabetes mellitus, specific diabetes mellitus, or gestational diabetes mellitus * has severe aso above fontaine iib, * hemorrhagic tendency or hemorrhagic disease (such as gastrointestinal tract hemorrhage, etc.) * had a myocardial infarction, angina pectoris, or cerebral infarction within the last 3 months * congestive heart failure * is pregnant, or potentially pregnant, or breastfeeding * severe hepatic insufficient or severe renal insufficiency (ast or alt is 2.5 times higher than the upper limit of the normal value range, or serum creatinine is 1.2 times higher than the upper limit of the normal value range) * persistent or hardly controlled hypertension (such as malignant hypertension, bp\> 160/100 mmhg) * severe ventricular arrhythmia (such as multiple and multifocal premature ventricular contractions) * has a medical history that includes a cardiac syncope or a primary syncope * has conditions that may prolong qt interval (such as congenital long qt syndrome, taking drugs which prolong qt interval, hypokalemia or hypomagnesemia, etc.) * has severe complications (such as diabetes mellitus ketoacidosis, nonketotic hyperosmolar diabetic coma, malignant tumor, severe anaemia, severe hematologic diseases, etc.) * other conditions that would exclude the subject from this study by doctor's judgement

Keywords: type 2 diabetes mellitus, with arteriosclerosis obliterans
inter-regional project of the great western exploration approach for exome molecular causes severe intellectual disability isolated or syndromic

Conditions: Severe Intellectual Disability

Summary: intellectual disability (id) moderate or severe affects about one child in 250, with 3000 to 4000 new cases each year. chromosomal or molecular pathology causes are not identified in half of the cases by current techniques. studies show that de novo mutations are common in many different genes. the "exome" approach by high-throughput sequencing (ngs) has emerged as the technique of choice for identifying and comparing the exome of the child to the parent. we wish to evaluate this approach and its contribution in the diagnostic management of 50 patients with di seen in genetics in 6 chu great west. genomics platform ibisa / biogenouest will provide technological and bioinformatics support this project.


Eligibility criteria:
inclusion criteria: * patients with severe intellectual disability (iq \<35 ) or moderate (iq \<50) isolated or syndromic presentation but undiagnosed . the diagnosis is established during genetic counseling of a 6 chu interregion * lack of family history ( parents). we are interested in this project to patients who do not have family history in order to increase the probability of identifying a de novo mutation . we do not however exclude the hypothesis for some patients a mechanism recessive autosomal or x-linked . * recruitment in 6 chu hugo . patients are required to have been seen in genetics in a 6 chu interregion . molecular analyzes of the fragile x syndrome and the cgh technique must be negative. * indication sequencing exomique adopted by the scientific committee. the scientific committee hugodims project role to select patients whose dna will be studied in order to optimize the chances of success for sequencing . this selection must take into account clinical parameters , but also genetic parameters ( potential inbreeding ) . the files will be selected by videoconferencing at the end of the monthly meeting of clad . the methodologist of the study will be invited to videoconferencing. * specific consent obtained for the study. exclusion criteria: * parents patient with moderate or severe intellectual disability disagree with the preferred hypothesis of de novo mutation or recessive transmission mechanism. * form with known syndromic diagnosis can be targeted molecular studies (clinical signs). * cause molecular di identified by targeted molecular analysis or cgh. * explicit refusal to participate in the study of the patient, parents, or one of the two parents. * any other indication that intellectual disability. * the parents of the patient or the patient may be removed.

Keywords: severe intellectual disability, genetic, de novo exome
randomised study comparing three chemotherapy regimens in non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this study is to determine if cisplatin-based chemotherapy, cisplatin-gemcitabine-ifosfamide or cisplatin-docetaxel, will improve survival in comparison to the combination gemcitabine-ifosfamide in patients with advanced nsclc


Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of non-small cell lung cancer * advanced (unresectable or functionally inoperable) stage iii or stage iv disease * availability for participating in the detailed follow-up of the protocol * presence of an evaluable or measurable lesion * informed consent exclusion criteria: * prior treatment with chemotherapy * operable patient with resectable tumour * performance status \< 60 on the karnofsky scale * a history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval) * polynuclear cells \< 2,000/mm³ * platelet cells \< 100,000/mm³ * serum bilirubin \>1.5 mg/100 ml * serum creatinine \> 1.5 mg/100 ml and/or creatinine clearance \< 60 ml/min * perception hypoacousia * peripheral neuropathy * recent myocardial infarction (less than 3 months prior to date of diagnosis) * congestive cardiac failure requiring medical therapy or uncontrolled cardiac arrhythmia * uncontrolled infectious disease * serious medical or psychological factors which may prevent adherence to the treatment schedule

Keywords: randomised phase iii chemotherapy advanced non-small cell lung carcinoma
the effect of tramadol, metamizol and dexketoprofen combination on chronic pain development after heart surgery

Conditions: Heart Surgery

Summary: non coronary heart surgery scheduled for the study , in patients with acute postoperative period use of tramadol retard, metamizol and dekxketoprofen the effects on pain and character has been seen in the chronic phase targeted.

this prospective study analyzed surgical thoracotomy and sternotomy patients treated with analgesic drug when higher than 4 regularly. clinical parameters include general demographics, preoperative and postoperative clinical examination status, pain scores, neuropathic pain scores, medication side effects, additional analgesic, antiemetic and lacsatif needs, vital functions, chest drains, blood transfusion needs, duration of cardiopulmonary bypass, cross clamp time and anaesthesia time. the screening tests for neuropathic pain is the douleur neuropathique 4. using at postopertative 3.month dn4 questionnaires predict persistent postoperative neuropathic pain.

Eligibility criteria:
inclusion criteria: * patients included between 20-70 years * asa 1-4 * euroscore value lower than 7 * undergoned non coronary heart surgery (minithoracotomy and sternotomy) * intensive care has been discharged from the service in 24 hours , with patients given tramadol retard , metamizol, dexketoprofen on postoperatif first day to discharged from the hospital. exclusion criteria: * diabetes mellitus * chronic renal failure * copd * uncontrolled hypertension * epilepsy * psychiatric disease * malignancy * patients with a history of cerebrovascular disease * patients with ischemia * patients suffering from chronic pain and analgesic use * patients taking antidepressants and antiepileptic drug * off-pump technique used or redo undergo cases * ongoing postoperative time thoracic or mediastinal drains more than 48 hours remaining patients, bleeding or patients who received repeated revisions due to infection * more than 24 hours remaining in intensive care patients * patients with long discharge duration 1 week * patients who discontinued due to side effects of tramadol may begin after medicines. * postoperative wound infection.
continuous renal replacement therapy in the setting of orthotopic liver transplant

Conditions: Acute Kidney Injury; Liver Disease; Chronic Kidney Disease; End Stage Kidney Disease

Summary: to evaluate the efficacy of continuous renal replacement therapy (crrt) during orthotopic liver transplantation (olt) in clearing excess solutes and improving acid-base parameters. the investigators hypothesize that the use of intra-operative crrt in olt recipients is associated with increased solute removal and improved acid-base statues when compared to controls who do not receive crrt

as above

Eligibility criteria:
inclusion criteria: * age 18 or older and able to sign consent (or surrogate) * receiving liver or combined liver-kidney transplant * egfr \< or equal to 40 ml/min immediately prior to transplant or currently on any form of renal replacement therapy for acute kidney injury or end-stage renal disease * pre-operative potassium of \< or equal to 5.5 meq/l exclusion criteria: * pre-operative hemoglobin \< or equal to 7 g/dl * pre-operative weight \> or equal to 125 kig

Keywords: acute kidney injury continuous renal replacement therapy liver transplant
assessment of combined bowel preparation for capsule endoscopy study

Conditions: Gastrointestinal Hemorrhage

Summary: the investigators are conducting a study to see if taking a bowel preparation before having a capsule endoscopy is more helpful than the standard preparation of not eating after 7 pm the night before a capsule endoscopy in making it easier to see the small bowel in order to find the source of gastrointestinal bleeding.

this is a single-blind, prospective randomized controlled study to determine if a combination of purgative agent, prokinetic agent, simethicone, and position will improve small bowel visualization, diagnostic yield, and completion rate of capsule endoscopy.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years old 2. gastrointestinal bleeding as indication for capsule endoscopy. 3. ability to give informed consent exclusion criteria: 1. subject has an allergy to polyethylene glycol or other adverse reaction to a previous bowel preparation with peg3350 (moviprep®), metoclopramide, or simethicone; 2. subjects has gastrointestinal motility disorder; 3. subjects had stomach or small bowel resection; 4. pregnancy; 5. subjects has pheochromocytoma; 6. subjects has uncontrolled hypertension; 7. subjects has seizure disorders; 8. subjects has concurrent mao inhibitor use; 9. subject has g6pd deficiency; 10. subjects has swallowing disorder (including impaired gag reflex); 11. subjects has hyponatremia with serum sodium less than 130 mm0l/l

Keywords: anemic bleeding blood in stool abdomen pain gastrointestinal bleeding capsule endoscopy (ce)
nebula study - screener apps and hsat vs. psg comparison

Conditions: Sleep Apnea, Obstructive

Summary: this is a prospective, unblinded, open-label, single group study. all subjects will undergo concurrent screener app, hsat testing, and in-lab polysomnography.


Eligibility criteria:
inclusion criteria: * participant is 18 years of age or older * participant is willing to provide informed consent * participant is willing to participate in all study related procedures exclusion criteria: * unable to cease pap therapy during psg (if currently using) * requires use of oxygen therapy during sleep * diagnosis of untreated clinically relevant sleep disorder (other than sdb) * pregnant * participant is unsuitable to participate in the study in the opinion of the investigator * participant has a permanent pacemaker, sustained non-sinus cardiac arrhythmias, and/or takes alpha blocker or short acting nitrate medication.

Keywords: osa sleep apnea osa screeners home sleep apnea test
a study to investigate the efficacy and safety of volrustomig ± casdatifan vs nivolumab + ipilimumab as 1l treatment for advanced ccrcc

Conditions: Advanced Clear Cell Renal Cell Carcinoma

Summary: this is a phase ib/iii, randomized, multicenter, global study evaluating the efficacy and safety of volrustomig in combination with casdatifan for the first-line (1l) treatment of participants with advanced clear cell renal cell carcinoma (ccrcc).

the primary purpose of this study is to determine the recommended phase iii dose (rp3d) of volrustomig and measure the efficacy and safety of volrustomig in combination with casdatifan compared with nivolumab plus ipilimumab in participants with advanced ccrcc (as 1l treatment). the study comprises of 2 parts - in phase 1b part of the study, participants will be randomized in a 1:1 ratio to receive either dose 1 or dose 2 of volrustomig in combination with casdatifan. in phase iii part of the study, participants will be randomized in 1:1:1 to receive either volrustomig (at the dose to be determined in the phase ib) in combination with casdatifan, volrustomig monotherapy or standard of care (nivolumab plus ipilimumab).

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed rcc with clear cell component. * advanced/metastatic rcc or recurrent disease that has not previously been treated with systemic therapy in the 1l setting. * karnofsky performance status ≥ 70%. * provision of acceptable tumor sample. * at least one lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with computed tomography (ct) or magnetic resonance imaging (mri) and is suitable for accurate repeated measurements. exclusion criteria: * history of leptomeningeal disease or spinal cord compression. * symptomatic brain metastases. * medical history of severe chronic obstructive pulmonary disease. * active or prior documented autoimmune or inflammatory disorders. * prior systemic therapy for advanced/metastatic rcc. note - other inclusion and exclusion criteria may apply as stated in the protocol.

Keywords: programmed cell death-ligand-1 cytotoxic t-lymphocyte-associated antigen-4 (ctla-4) first-line treatment (1l) immunotherapy kidney cancer clear cell renal carcinoma immuno-oncology bispecific (io-bispecific) volrustomig casdatifan hypoxia-inducible factor-2α (hif-2α)
clinical research on the efficacy of bosinji on herniated intervertebral disc of lumbar spine

Conditions: Lumbar Disc Herniation

Summary: this randomized controlled clinical trial is designed to evaluate the efficacy and safety of bosinji on low back pain and radiating pain of lumbar herniated intervertebral disc (l-hivd) by assessing pain, function, and quality of life.

seventy-four patients between the ages of 19 and 70 with l-hivd will be recruited by eligibility criteria and randomly allocated to the experimental group and the control group. in the experimental group, 2.5g of bosinji granule (tsumura \& co., tokyo, japan) will be orally administered three times a day at 30 minutes after the meal for 6 weeks. in the control group, loxonine tab. (loxoprofen 60mg, dong wha pharm co., ltd, seoul, korea) will be orally administered in the same usage and period with the experimental group. in addition, both group will receive the same acupuncture treatment on 20 acupoints once a week for 6 weeks. 100 mm visual analogue scale (vas) for low back pain will be assessed as a primary outcome at baseline and treatment end. also, 100mm vas for radiating pain, oswestry disability index (odi), rolland morris disability questionnaire (rmdq), eq-5d-5l and global perceived effect (gpe), deficiency syndrome of kidney index (dski) will be measured as secondary outcomes at baseline, 3 weeks after screening, treatment end (6 weeks, primary endpoint) and follow-up sessions (10 weeks).

Eligibility criteria:
inclusion criteria: 1. men or women aged over 19 years 2. radiating pain matched with severer abnormality than bulging shown by ct or mri on lumbar spine 3. low back pain between 40 and 80 point on 100mm pain visual analogue scale 4. volunteers who agree to participate and sign the informed consent form, following a detailedexplanation of clinical trials exclusion criteria: 1. congenital abnormalities or surgical history on lumbar regions 2. red flag signs that may be suspected of cauda equina syndrome, such as bladder and bowel dysfunction or saddle anesthesia 3. tumor, fracture or infection in lumbar regions 4. injection treatment on lumbar regions within 1 week 5. psychiatric disorder currently undergoing treatment such as depression or schizophrenia 6. liver function abnormality (ast or alt over 2times normal range) 7. renal fuction abnormaility (serum creatinine \> 2.0㎎/㎗) 8. other diseases that could affect or interfere with therapeutic outcomes, including severe gastrointestinal disease, cardiovascular disease, hypertension, diabetes, renal disease, liver disease or thyroid disorder 9. contraindication of nsaids including intercurrent disease, hypersensitivity reaction or other medication 10. inappropriate condition for acupuncture due to skin disease or hemostatic disorder (pt inr \> 2.0 or taking anticoagulant) 11. women who is pregnant, breastfeeding or having pregnancy plan 12. other inappropriate condition for herbal medicine treatment 13. participation in other clinical trial with 1 month

Keywords: herniated intervertebral disc of lumbar spine low back pain radiculopathy bosinji herbal medicine
a study to evaluate the safety, tolerability, and pharmacokinetics of biib094 in adults with parkinson's disease

Conditions: Parkinson's Disease

Summary: the primary objective of this study is to evaluate the safety and tolerability of single and multiple doses of biib094 administered via intrathecal (it) injection to participants with parkinson's disease (pd). the secondary objective of this study is to evaluate the pharmacokinetic (pk) profile of biib094.the study is open for pd patients with verified presence or absence of variations in the leucine-rich repeated kinase 2 (lrrk2) gene, but also for patients without any verified pd-related genetic variant.


Eligibility criteria:
key inclusion criteria: * ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local participant privacy regulations. * diagnosed with pd within 7 years at the time of initial enrollment (i.e., at time of sad enrollment for rollover participants), without major motor fluctuations or dyskinesia that may interfere with study treatment and assessments in the opinion of the investigator after consultation with the sponsor. * modified hoehn and yahr stage ≤ 3. key exclusion criteria: * montreal cognitive assessment (moca) score less than (\<) 23, dementia, or other significant cognitive impairment that, in the opinion of the investigator, would interfere with study evaluation. * history of any brain surgery for pd or a history of focused ultrasound treatment at any time; or history of neuromodulation procedures. * transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year before screening. * history of unstable angina, myocardial infarction, chronic heart failure, or clinically significant conduction abnormalities within 1 year before screening. * poorly controlled diabetes mellitus, as defined by having dosage adjustment of diabetic medication within 3 months before dosing (day 1) or glycosylated hemoglobin value greater than or equal to (≥) 8 percent (%) at screening. * history or positive test result at screening for human immunodeficiency virus. * history or positive test result at screening for hepatitis c virus antibody. note: other protocol defined inclusion/exclusion criteria may apply.
long term safety and tolerability of sar339658 in patients with ulcerative colitis (uc)

Conditions: Ulcerative Colitis

Summary: primary objective: to assess the long term safety and tolerability of sar339658 secondary objective: to assess the long term efficacy of sar339658

the study period per patient will include 62 weeks treatment, 6 weeks post treatment safety follow-up, followed by a long term safety follow-up performed in the form of a phone interview at 3, 6, 12, 18 and 24 months from the last administration of the study medication.

Eligibility criteria:
inclusion criteria: * patients with ulcerative colitis (uc) who were previously randomized and have completed the 8-week treatment in act12688 study with an acceptable safety profile. patients who for administrative reasons could not be enrolled in the lts12593 study right after completion of the 8-week treatment in the act12688 study must be enrolled within 3 months from the end of the act12688 study * signed written informed consent for study lts12593 exclusion criteria: * patient with any adverse event leading to study drug (active or placebo) treatment discontinuation from act12688 study. * patient with any abnormalities or adverse events that per investigator judgment would adversely affect patient's participation in the long-term extension study. * use of any immunosuppressant (if patient is on immunosuppressant he or she must discontinue immunosuppressant before starting the lts12593). * if the patient started biological treatment for uc while waiting to be enrolled in the lts12593, then he or she must stop the biological treatment and must have 8 weeks of wash out period before starting treatment with sar339658 (only anti-tumor necrosis factors (tnfs) are allowed) * patients exposed to an anti-integrin or any investigational drug administered after the end of treatment in act12688 * positive pregnancy test * breast feeding woman * women of childbearing potential not protected by highly effective contraceptive method of birth control and/or who are unwilling and unable to be tested for pregnancy. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.