Kornimate/medical-research-clean huggingface dataset:
a study in healthy men to test how bi 1595043 is taken up in the body when given with or without food

Conditions: Healthy

Summary: the main objective of this trial is to investigate the relative bioavailability of bi 1595043 under fed state (test, t) and under fasted state (reference, r).


Eligibility criteria:
inclusion criteria: * healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (bp), pulse rate (pr), body temperature), 12-lead electrocardiogram (ecg), and clinical laboratory tests * age of 18 to 50 years (inclusive) * body mass index (bmi) of 18.5 to 29.9 kg/m2 (inclusive) * signed and dated written informed consent prior to admission to the study, in accordance with gcp and local legislation * male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion: * use of adequate contraception, i.e. use of condom (male subjects) plus any of the following methods (female partners): intrauterine device, hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration to the male subject, or barrier method (e.g. diaphragm with spermicide), or surgically sterilised (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy), or postmenopausal, defined as at least 1 year of spontaneous amenorrhea * sexually abstinent * vasectomised (vasectomy at least 1 year prior to enrolment) in combination with a barrier method (i.e. condom) unprotected sexual intercourse (i.e. without use of condom) with a pregnant female partner and sperm donation is not allowed throughout the study and until 30 days after trial completion exclusion criteria: * any finding in the medical examination (including bp, pr or ecg) deviating from normal and assessed as clinically relevant by the investigator * repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmhg), diastolic blood pressure outside the range of 50 to 90 mmhg, or pulse rate outside the range of 45 to 90 beats per minute (bpm) * any laboratory value outside the reference range that the investigator considers to be of clinical relevance * any evidence of a concomitant disease assessed as clinically relevant by the investigator * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) * 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 * further exclusion criteria apply
mobile apps enhancing acupressure therapy compliance and efficacy for asthenopia

Conditions: Asthenopia

Summary: the goal of this clinical trial is to learn if a mobile application works to improve adherence to acupressure therapy in asthenopia. it will also learn about the efficacy of acupressure as a therapy for asthenopia. the main questions it aims to answer are: -does a mobile application have a role to improve therapy compliance and efficacy of self-guided acupressure in asthenopia? researchers will compare users of a mobile app to non-users of a mobile app to see if a mobile app works to improve adherence to acupressure therapy in asthenopia participants will: * do acupressure 2 times every day for 4 weeks * filling in the absence link has been after doing acupressure every day * fill out the link regarding the condition of asthenopia once per week

this is a clinical trial study to evaluate the role of a mobile application in therapy compliance and acupressure efficacy in asthenopia sufferers. participants are 60 males/females aged 18-64 years. they will be divided into 2 groups: (1) acupressure mobile app users and (2) non-acupressure mobile app users. acupressure is scheduled 2 times every day for 4 weeks. therapy compliance will be assessed from the absence link that participants fill out every day, while therapy efficacy will be assessed once per week for 4 weeks.

Eligibility criteria:
inclusion criteria: * using a smartphone with the android platform. * work or use digital gadgets for at least 4 hours a day. * suffering from asthenopia as indicated by a cvs-q score ≥ 6. * can be contacted with the whatsapp application. * willing to take part in this research until completion and agree to informed consent. exclusion criteria: * there are tumors, wounds or skin infections in the eye area.
the effect of "cerclage pacing" for the heart failure patients who need cardiac resynchronization therapy (crt)

Conditions: Heart Failure; LBBB Complete

Summary: trans-coronary sinus intraseptal pacing (cerclage pacing)

this study is aimed at looking at the effect of "cerclage pacing" for the heart failure patients who need cardiac resynchronization therapy (crt). the study hypothesis is that parahisian pacing by 'cerclage pacing' may have a similar benefit as is seen with permanent hisian pacing

Eligibility criteria:
inclusion criteria: * who need cardiac resynchronization therapy (crt) or crt-non responder * left bundle branch block \[lbbb\]) \> 120ms of qrs width * ejection fraction (ef) \< 35% * nyha class iii-iv in spite of optimal medical tx exclusion criteria: * unsuitable coronary vein anatomy on cardiac ct * subjects with prosthetic mechanical tricuspid valve * active infection * life expectancy less than 6 months

Keywords: cerclage pacing cerclage-crt wide qrs
walking characteristics of patients with amputation

Conditions: Amputation

Summary: the main purpose of the study is to reveal the early and late changes in the walking characteristics of patients with lower extremity amputation. secondly, it is planned to reveal the factors affecting the walking characteristics of patients with amputation and to compare individuals with different levels of amputation in terms of clinical outcome measures.

it is important to investigate the long-term changes in walking characteristics of patients with amputation and the factors affecting walking characteristics in these patients regarding prosthesis rehabilitation. the main purpose of the study is to reveal the early and late changes in the walking characteristics of patients with lower extremity amputation. secondly, it is planned to reveal the factors affecting the walking characteristics of patients with amputation and to compare individuals with different levels of amputation in terms of clinical outcome measures.

Eligibility criteria:
inclusion criteria: * aged between 18 and 65 * presence of lower extremity amputation exclusion criteria: * conditions that prevent the use of prosthesis (wound, pain, etc.) * having a history of rheumatic disease * having cardiac pathology * having pulmonary pathology * having a situation that prevents communication * not giving written consent

Keywords: amputation walking satisfaction pain
systematic psychological and medical care for children with scd

Conditions: Anemia, Sickle Cell

Summary: sickle cell disease (scd), a genetically transmitted blood disease, necessitates life-long care. in children, the disease may cause intense pain and other severe complications. studies show that sources of stress, as well as complex psychological and intercultural issues associated with scd, often aggravate symptoms. at louis mourier hospital, the treatment model used is systematic psychological and medical care. our hypothesis is that this care is beneficial for both the children and their families as seen in improved quality of life and positive impact on medical symptoms.

in this observational multicentric pilot study, our goal is to assess the effectiveness of a systematic medical-psychological approach in place for the past 6 years at the louis mourier hospital, as compared to the usual practice in 2 other pediatric hospitals for scd which focus essentially on the medical issues associated with scd. two psychologists will interview 80 children and their primary care-takers at louis mourier hospital, and 80 children and their care-takers of the other two centers, using a standard comprehensive care for scd. for the parents, we propose to use a semi-structured interview including a prepared interview guide, the loneliness questionnaire, and the parents' version of kidscreen (10 items). for the children, according to their age, the rey-osterrieth complex figure test (rocf), the draw a person in the rain test (dpr), the kidscreen questionnaire, and semi-directed interview will be used. relevant information from the patients' medical record directly related to the symptomatic expression of the scd will be noted on a data collection form. this phase is scheduled to last 12 months. a statistical and qualitative analysis of the results will be carried out at the end of the study.

Eligibility criteria:
inclusion criteria: * children with sickle cell disease * treated in one of the three investigational centers * all major forms of the disease will be studied regardless of the country of origin. exclusion criteria: * refusal of the parents or the child to participate. * child or parent living in france for less than 6 months

Keywords: sickle cell disease psychological support quality of life
early tracheostomy in ventilated stroke patients

Conditions: Ischemic Stroke; Intracerebral Hemorrhage; Subarachnoid Hemorrhage

Summary: patients with severe ischemic and hemorrhagic strokes, who require mechanical ventilation, have a particularly bad prognosis. if they require long-term ventilation, their orotracheal tube needs to be, like in any other intensive care patient, replaced by a shorter tracheal tube below the larynx. this so called tracheostomy might be associated with advantages such as less demand of narcotics and pain killers, less lesions in mouth and larynx, better mouth hygiene, safer airway, more patient comfort and earlier mobilisation. the best timepoint for tracheostomy in stroke, however, is not known. this study investigates the potential benefits of early tracheostomy in ventilated critically ill patients with ischemic or hemorrhagic stroke.

background: tracheostomy is a common procedure in critical care patients. advantages of a short tracheal tube compared to a long orotracheal one are the avoidance of laryngeal lesions and sinusitis, facilitation of nursing care and physiotherapy and the reduction of analgosedatives. the optimal point in time for tracheostomy is still unknown, but it is commonly done not later than 2-3 weeks and after one or several failed extubation trials. studies in different sets of critical care patients have suggested additional advantages of early tracheostomy: less pneumonias and other complications, more patient comfort, less analgosedation, shorter duration of ventilation and of icu stay. these questions have not been looked at in non-traumatic neurocritical care patients, although these might have a special weaning benefit by early tracheostomy, being mainly compromised in securing their airway, but not in breathing. method: non-traumatic neurocritical care patients with ischemic strokes, intracerebral hemorrhage or subarachnoid hemorrhage so severly affected that 2 weeks of ventilation need are estimated, are principally eligible for the study. after randomization, one group receives tracheostomy within the first 3 days after intubation. the other group stays orotracheally intubated and is either weaned and extubated or receives tracheostomy within 7 to 14 days after intubation. tracheostomy is done as percutaneous dilatation by neurologists.

Eligibility criteria:
inclusion criteria: * age \> 18 years * informed consent from legal representative * non-traumatic cerebrovascular disease * estimated ventilation need for at least 2 weeks exclusion criteria: * age \< 18 years * informed consent not obtainable * intubated for more than 3 days * death within 3 weeks likely * severe chronic pulmonary disease * severe chronic cardiac disease * emergency situation * intracranial pressure difficult to control * need for a permanent tracheostoma * contraindications for dilatative tracheostomy * severe coagulopathy * severe respiration difficulties * intubation/extubation/tube exchange difficulties

Keywords: neurocritical care ischemic stroke intracerebral hemorrhage subarachnoid hemorrhage tracheostomy tracheotomy percutaneous dilatative tracheostomy weaning ventilation
a single dose study of mk-8266 (mk-8266-001)

Conditions: Hypertension

Summary: a three panel study, to determine if mk-8266 given as a single dose is sufficiently safe and well tolerated. panel a and b will consist of healthy young males and panel c will consist of subjects with mild to moderate hypertension. the primary hypotheses for the study are that mk-8266 given as single doses is sufficiently safe and well tolerated to permit continued clinical investigation in healthy young male volunteers and male participants with mild-to-moderate hypertension and that in males with mild to moderate hypertension, at a single oral dose of mk-8266 that is sufficiently safe and well-tolerated, postdose mean time-weighted average across 24 hours of aortic augmentation index (twa0-12hrs aix) is reduced compared to placebo. a mean decrease of ≥ 5 percentage points is considered clinically meaningful.

three panels, each consisting of either 8 or 9 participants (8 healthy young males in panel a and panel b; and 9 participants with mild to moderate hypertension in panel c) will be randomized to receive either mk-8266 or matching placebo in either a 6:2 ratio (panel a and panel b) or 6:3 ratio (panel c), respectively, in up to 5 treatment (1 to 5) periods in panel a and up to 4 treatment (1 to 4) periods in panel b and panel c. in all panels, doses will be escalated in a rising, fixed sequence. some participants took study drug after fasting and some with food.

Eligibility criteria:
inclusion criteria: * for panel a and b participant is a healthy male between 18 to 45 years of age. for panel c participant is a male with essential hypertension between 18 to 55 years of age * a non-smoker exclusion criteria: * has a history of stroke, chronic seizure or major neurological disorder * has a disability that can interfere with rising from a sitting position to the standing position * has a personal of family history of bleeding or clotting disorders * has a history of cancer * is unable to refrain from or anticipates the use of any prescription or nonprescription drug during the study * consumes excessive amounts of caffeine or alcohol * has had major surgery, donated blood or participated in another investigational study in the past 4 weeks
modula modul 5 beat-hf

Conditions: Heart Failure

Summary: detektion and registration of atrial tachyarrhythmias at patients with heart failure; what proportion of patients with crt-therapy are affected at least temporarily by atrial arrhythmia?

how many patients with crt-therapy are affected at least temporarily by atrial arrhythmia in terms of rate, characteristics and severity of atrial rhythm disturbances at patients with crt-therapy within 12 months after implantation of a crt-device.

Eligibility criteria:
inclusion criteria: * patient under crt-d or crt-p therapy exclusion criteria: * patients with permanent atrial fibrillation
a pilot study of prep acceptance among young black msm

Conditions: HIV Infection

Summary: the overarching goal of the proposed study is to determine effective outreach methods designed to recruit and improve acceptance of high-risk hiv-negative ybmsm to initiate prep and to identify and modify psychosocial and structural predictors of prep acceptance. specifically, the objective of this pilot study is to test the feasibility of a motivational interview-based intervention designed to improve prep acceptance among ybmsm.

the study will occur in conjunction with standard clinical practice, which now includes offering high-risk ybmsm prep. if a person accepts this offer the person will be provided the service, but the person will not be asked to participate in the proposed study. indeed, the study is designed for men who initially refuse this offer. thus, for those who refuse researchers will offer study enrollment. for those who accept this offer and enroll, researchers will conduct baseline assessment and then randomize to i (intervention) versus c (control). volunteers will receive the i or c condition immediately. the intervention condition will be called mi-prep. this is a one-hour motivational interviewing-based, one-to-one session that will help ybmsm think more about going on prep. the control condition is a one-hour, theory-based, one-to-one session that will help ybmsm think more about using condoms consistently and correctly with every sex partner. this is the same program that is currently being tested at crossroads, known as focus on the future. both conditions (i and c) will include the provision of free condoms and lubricants - selected from a buffet of condoms and lubricants designed to offer men a broad selection of high quality products that can optimize the "fit and feel" of condoms during sex. after receiving the i or c condition, researchers will collect extensive contact information for the volunteer and explain to the participant that researchers will make contact each week for the next 4 weeks, at which time researchers would like the participant to return to complete a second computer-assisted self-administered survey. thus, approximately 4 weeks (but no later than six weeks) after study enrollment, the volunteer will return to the clinic for a second assessment. at this time, a second formal offer of prep by the clinician will be made (note: participants may accept the initial offer at any time up until this point). for persons accepting the offer of prep at this time, researchers will follow standard of care procedures and administer the prep. nonetheless, this person will remain in study until 6 months has elapsed since enrollment occurred. at the conclusion of that 6-month period, blood will be collected to test for prep levels plus self-reported adherence measures will be collected and a follow-up computer-assisted self-interview will be given.

Eligibility criteria:
inclusion criteria: * 18 to 29 years of age * identification as black or african american * eligible for prep exclusion criteria: * none
the clinical effect of normal diet and absolute diet on post-polypectomy patients: an open-label, randomized controlled trial

Conditions: Polyp Colorectal

Summary: there is no evidence to prove the impact of post-procedural diet on post-polypectomy bleeding (ppb) or delayed perforation. no relevant study has been conducted and it is yet to be determined if absolute diet is necessary for post-polypectomy patients, and the comparison between normal diet and absolute diet also remains unclear. therefore, we carried out this randomized controlled study to evaluate and compare tthe clinical effect of different diets on post-polypectomy patients.


Eligibility criteria:
inclusion criteria: 1. 18-75 patient with initial diagnosis of colorectal polyp by colonoscopy; 2. the maximum size of polyp is more than 20mm; 3. the patients underwent single esd procedure for the polyp and agreed to participate this trial. exclusion criteria: 1. uncontrollable hypertension or diabetes； 2. severe comorbidities such as cancer and organ failure etc； 3. patients who were pregnant; 4. patients had anticoagulants during perioperative period; 5. patients with poor compliance. -
comparison of the postoperative analgesic efficacy of spsipb and isbpb

Conditions: Shoulder Arthroscopy; Peripheral Nerve Block; Pain Management

Summary: shoulder arthroscopy is one of the common surgical procedures performed today. after shoulder surgery, providing adequate analgesia is necessary for both the comfort of the patient and the ability to perform the necessary post-operative rehabilitation exercises early and regularly. nerve blocks reduces opioid consumption in the postoperative period by providing better pain control and therefore has advantages such as fewer side effects and less risk of pulmonary and cardiac complications. in this study; it was aimed to compare the analgesic effectiveness of interscalene brachial plexus block and serratus posterior superior intercostal plane block, with each other and with the control group in the postoperative period in patients who underwent shoulder arthroscopy.


Eligibility criteria:
inclusion criteria: * patients aged 18-80 years * american society of anesthesiologists (asa) score i-ii-iii * body mass index (bmi) between 18-30 kg/m2 exclusion criteria: * patients under 18 and over 80 years of age * asa score iv and above * patients with a history of bleeding diathesis * bmi below 18 or above 30 kg/m2

Keywords: shoulder arthroscopy interscalene brachial plexus block serratus posterior superior intercostal plane block
bortezomib with combination of gemcitabine, ifosfamide and oxaliplatin in untreated nk/t cell lymphoma

Conditions: Extranodal NK-T-CELL LYMPHOMA

Summary: * assess responses, progression free survival (pfs) and overall survival (os) of the combination of gifox-b chemotherapy with intensity-modulated radiation therapy (imrt) in stage ib or bulky disease - ii and without imrt in stage iii - iv. * assess the toxicity and maximum tolerated dose of bortezomib administered in combination with gifox chemotherapy.


Eligibility criteria:
inclusion criteria 1. extranodal nk/t-cell lymphomas 2. confirmed pathological diagnosis by the department of pathology sgh/nuh/ttsh. 3. age more than or equals to 21 years. 4. stages ib or bulky disease, ii - iv 5. ecog performance 0-2 6. laboratory tests: anc more than or equals to 1000/mm3, platelet more than or equals to 75,000/mm3. creatinine less than or equals to 2x uln or creatinine clearance more than or equals to 50 ml/min; ast and alt less than or equals to 3x uln. total bilirubin \ 80% unconjugated hyperbilirubinemia without other known cause); unless impairment is due to organ involvement by lymphoma. 7. ability to understand and willingness to sign a written informed consent document. exclusion criteria 1. had prior systemic chemotherapy. patients may be entered if they have had prior limited-field radiotherapy or a short course of glucocorticoids or single agent chemotherapy for an urgent local problem at diagnosis (e.g. epidural cord compression, superior vena caval syndrome). 2. history of peripheral neuropathy 3. hiv positive 4. presence of cns disease 5. hypersensitivity to bortezomib, boron, or mannitol 6. contraindication to any cytotoxic drug contained in the chemotherapy regimen. 7. female subject of child-bearing potential not willing to use an acceptable method of birth control (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and one year beyond treatment completion. 8. female subject pregnant or breast-feeding. confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotrophin (β-hcg) pregnancy test result obtained during screening. pregnancy testing is not required for women without child-bearing potential. 9. invasive or active malignancy in past 2 years. 10. serious concomitant medical illnesses that would jeopardize the patient's ability to receive the regimen with reasonable safety.