Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the pharmacokinetics and safety between single oral administration of br3006 and co-administration of br3006a, br3006b and br3006c in healthy adult volunteers under fed conditions

Conditions: Type 2 Diabetes

Summary: the purpose of this clinical study is to evaluate the pharmacokinetics and safety between single oral administration of br3006 and co-administration of br3006a, br3006b and br3006c in healthy adult volunteers under fed conditions


Eligibility criteria:
inclusion criteria: * those who have body mass index (bmi) of 18.0kg/m2 to 30.0kg/m2 at screening visit. * for men, those who weigh 55 kg or more * for women, those who weigh 50 kg or more * those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\* from the date of consent to 14 days after the last administration and disagree to provide their sperm or ovum. * methods of contraception accepted in clinical trial: combined use of non hormonal intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used. * those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the investigational products, expected adverse events, etc. exclusion criteria: * those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken ethical drugs, over the counter drugs, herbal medicines, health functional foods concerned about affecting this clinical trial within 10 days before the first administration date. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as interaction of investigational products, half-life of concomitant drugs, etc.) * those who have a medical history of gastrointestinal resection (except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs. * those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months before the first administration date(however, the termination for participation in other clinical trials are based on the last administration date of their investigational products) * in the case of a female subject, pregnant woman or those suspected pregnancy or lactating woman.
clearance rate of peritoneal fluid after full conditioning pneumoperitoneum

Conditions: Laparoscopic Hysterectomy

Summary: measurement of residual peritoneal fluid after laparoscopic surgery

primary endpoints * to evaluate whether the clearance rate of peritoneal fluid is exponential or linear over time. (absorption rate expected for adept \~30-60 ml/h) * to evaluate the role of the mesothelial barrier in this clearance rate. knowing that diffusion to and from peritoneal fluid decreases with increasing molecular weight (mw), our hypothesis is that clearance rate will decrease following peritoneal conditioning. indeed a decreased mesothelial trauma (either through hypoxia or through denudation) and retraction will expose less the basal membrane secondary endpoints: -to confirm the decrease in post-operative pain as measured by vas-score and inflammation as measured by crp and leucocytosis with the full conditioning of the pneumoperitoneum.

Eligibility criteria:
inclusion criteria: * women planned to undergo a total or subtotal laparoscopic hysterectomy and having signed the informed consent. * no limitation in body mass index or uterine size is made. exclusion criteria: * pregnancy * immunodeficiency * refuse or unable to sign informed consent * chronic disease (i.e. copd, crohn, cardiac...) * known allergy for adept©

Keywords: women laparoscopic subtotal hysterectomy
immediate weight bearing versus protected weight bearing in supracondylar distal femur fractures

Conditions: Closed Supracondylar Fracture of Femur

Summary: this study is designed to examine if immediate weight bearing on a distal femur fracture fixed with a primary locking plate, either a distal condylar locking plate or a liss (less invasive stabilization system), is safe and promotes more rapid fracture healing than partial weight bearing, which is standard of care.

this study is designed to examine if immediate weight bearing on a distal femur fracture fixed with a primary locking plate, either a distal condylar locking plate or a liss (less invasive stabilization system), is safe and promotes more rapid fracture healing than partial weight bearing, which is standard of care. historically and currently patients are kept partial weight bearing after fixation of these fractures for 6-12 weeks until callous formation is observed on radiographs. the hypothesis is that participants allowed to bear weight immediately will heal at least as quickly as those who have weight bearing status protected with the added benefits from early mobilization. fracture healing will be monitored closely by follow up appointments and complications will be documented.

Eligibility criteria:
inclusion criteria: * aged \> 18 yo * distal supracondylar femur fracture (supracondylar distal femur fractures treated with a locked plate, either a distal condylar locking plate or a liss (less invasive stabilization system), including peri-prosthetic fractures) * both male and female exclusion criteria: * patients with an intracondylar split, * polytrauma patients with associated trauma that will inhibit their ability to weight bear, * metastatic disease, * incomplete follow up, * subjects with questionable ability to bear weight (ie advanced dementia), * open fractures with bone loss.
pre-hiv test counseling intervention to reduce hiv infection risk behavior in men who are not hiv infected

Conditions: HIV Infections

Summary: this study will evaluate the effectiveness of a single specialized pre-test counseling session in reducing hiv infection risk behavior in men who are not hiv infected.

in san francisco, hiv infection rates among men who have tested for hiv three or more times is almost triple the hiv infection rates of all other testers. past research has shown that hiv uninfected gay and bisexual men who receive counseling are less likely to engage in high-risk sexual behavior. counseling provided by trained mental health professionals within a clinical study setting helped individuals identify and re-evaluate their "self-justifications," which are their thoughts, attitudes, and beliefs when deciding to engage in unprotected sex. this study will focus on implementing a "real-world" counseling intervention designed specifically for men who are at the greatest risk of becoming infected with hiv: men who engage in high-risk sexual activity with other men and who repeatedly test for hiv. this specialized intervention will be administered by trained paraprofessional counselors during a pre-test counseling session prior to an hiv test. the purpose of this study is to evaluate the effectiveness of the specialized pre-test counseling intervention versus a standard pre-test counseling intervention in promoting safer sexual activity among hiv uninfected men. the men will have reported having unprotected sex with males of unknown hiv status or known hiv infection. this 12-month study will enroll 300 men who will be recruited upon scheduling an anonymous hiv test at the participating clinic. participants will be randomly assigned to receive either the enhanced pre-test counseling session or a standard pre-test counseling session prior to an hiv test. outcome measurements will be assessed 6 and 12 months after the counseling session and will include self-reports of unprotected anal sex with non-primary partners and reported satisfaction levels with the pre-test counseling.

Eligibility criteria:
inclusion criteria: * history of two or more hiv antibody tests prior to study entry * history of at least one episode of unprotected anal intercourse (receptive or insertive) within 12 months prior to study entry exclusion criteria: * history of injection drug use within 12 months of study enrollment * insufficient proficiency in english

Keywords: hiv msm men who have sex with men men who have sex with men cognitive-behavioral hiv counseling and testing hiv seronegativity
feasibility and acceptability of group pain reprocessing therapy for veterans with chronic neck/back pain

Conditions: Chronic Back Pain; Chronic Pain; Neck Pain; Back Pain

Summary: the investigators are conducting a trial that evaluates the feasibility of telehealth group pain reprocessing therapy (prt), with no comparison group, for the treatment of chronic back pain in a population of veterans. prt is a psychotherapy for chronic pain that aims to help patients reconceptualize their pain as a non-dangerous signal. it has been shown to be effective in a previous rct (n=151).


Eligibility criteria:
inclusion criteria: * at least 6 months of back pain with last week average back pain at least 4/10 * able to attend at least 7/8 telehealth group sessions * access to safe living space, quite room, reliable internet, and electronic device that can be used to attend telehealth therapy sessions. exclusion criteria: * leg pain that is worse than back pain * suicide attempt, si, hi, or inpatient psychiatric hospitalization in the past 5 years * not receiving/has not received disability or workers compensation related to back pain in the past 2 years. * is not currently involved in litigation regarding chronic back pain. * current misuse or overuse of alcohol or drugs * major surgery or other major medical events in the next 6 months * known vertebral/spinal fracture or tumor. * back surgery within last 2 years * difficulty controlling bowel movements * current or recent diagnosis of cancer * current or recent diagnosis of severe cardiovascular disease * unexplained or unintended greater than 20 pound weight loss in the past year * diagnosis of rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus, polymyositis, or other specific inflammatory disorders
heparin vs placebo for cardiac catheterization

Conditions: Cardiac Disease

Summary: patients undergoing cardiac catheterization will be randomized to 3 groups: no anticoagulant, low dose anticoagulant and high dose anticoagulant.

patients undergoing diagnostic cardiac catheterization via the trans-radial approach will be randomly allocated (1:1:1) to receive either low-dose ufh (25 iu/kg -maximal dose 3,000 iu), high-dose ufh 50 iu/kg -maximal dose 5,000 iu) or n/s 0.9%. after 30 minutes, patients will undergo a gradual wrist band release. hematoma and radial artery occlusion will be assessed.

Eligibility criteria:
inclusion criteria: * diagnostic cardiac catheterization; small size sheath; patency of the ulno-palmar circulation exclusion criteria: abnormal ulno-palmar circulation; prior radial artery thrombosis; prior surgery close to the access site; emergent cardiac catheterization; history of hit or allergy to heparin; patients requiring anticoagulation
genetic variability to glp1 treatment

Conditions: Type 2 Diabetes; Obesity

Summary: the goal of this retrospective study is to assess whether a selection of genetic variants may allow us to identify individuals who will have a satisfactory response after glp-1 treatment in terms of weight loss, sugar level reduction, and adverse events. participants will the study consists of a single visit at the diabetes unit clinic at the involved study sites. the following will be performed for every subject at the study screening enrollment visit: * informed consent * study eligibility (inclusion / exclusion criteria) * collection of demographic data (age (date of birth), gender, ethnic origin) * general and t2dm medical history review (per subject file) * concomitant medication review (at enrollment) * physical attributes (body weight, height, bmi) * allocation to study cohort and study subgroup * saliva and blood collection for genetic tests * self-reported questionnaire for ozempic (semaglutide) experience


Eligibility criteria:
inclusion criteria: 1. diagnosed with type 2 diabetes (for participant in cohort a) or obese (for participant in cohort b) and treated with ozempic (semaglutide) s.c. injection for at least 24 weeks. 2. subject is male/female between 18 to 80 years old (both inclusive) at the time of enrollment. 3. subject bmi above 30 kg/m2 at treatment initiation. 4. subject does not belong to any vulnerable population, is willing and able to provide written informed consent prior to any study procedure. 5. participant understands the nature of the procedure and is willing and able to comply with all requirement of the protocol. exclusion criteria: 1. subject falls under contraindications to ozempic (semaglutide) label 2. subject known or suspected for hypersensitivity to any glp-1ra or related products, or allergic constitution 3. subjects suffers from any other condition affecting body weight. 4. subject with history of chronic or acute pancreatitis 5. subject have a history of a major cardiovascular and/or cerebrovascular disease within the 6 months before screening. 6. presence or history of malignant neoplasm within 5 years prior to screening day. 7. subject suffers from any renal impairment (cr \> 2 mg/dl). 8. subject suffers from any impaired hepatic function (alt, ast or ggt 2-fold higher than normal upper limit). 9. any disorder, which in the investigator's opinion might jeopardize patient's safety or compliance with the protocol. 10. subject is a female who is pregnant, breastfeeding or intends to become pregnant or is of child bearing potential without medically acceptable methods of contraception. 11. participation in another clinical study in prior 4 weeks.
effect of intensive monitoring of patients with poorly controlled type 2 diabetes with different glycemic background

Conditions: Type 2 Diabetes; Poor Glycemic Control

Summary: in turkey, only 55% of patients with type 2 diabetes have been diagnosed, and 91% of these patients have been receiving treatment. the rate of patients reaching the treatment target is 50%. the pandemic has also affected diabetic patients. it is aimed to determine the characteristics of patients with type 2 diabetes (hba1c \>=10) with poor metabolic control and to evaluate the extent to which metabolic control can be achieved in 12 months.

patients who applied to istanbul medeniyet university goztepe prof. dr. suleyman yalcin city hospital diabetes polyclinics and have an hba1c levels of \>= 10% in their examinations will be admitted to the study. detailed history, including medication usage and previous blood tests will be questioned. the patients will be asked to complete questionnaires about their eating patterns (mindful eating questionnaire), their physical activities (general practice physical activity questionnaire), and whether the participants have depression (beck depression questionnaire). anthropometric measurements will be taken, and biochemical data will be recorded. patients will be grouped according to their previous hba1c values as a) newly diagnosed, b) those whose diabetes was previously controlled, c) those whose diabetes was previously not at the target range but now worsened, and d) those whose diabetes was poorly controlled from the beginning. diabetes follow-up will be continued by their respective physicians. the patients will be called again three months after their enrollment to record the most recent biochemical data. patient characteristics (age, gender, educational status, depression status, eating awareness, exercise characteristics) will be evaluated in accordance with the predetermined hba1c groups. again, according to the patient groups, the difference in hba1c after three months, the frequency of reaching the target, and possible factors associated with the findings will be evaluated.

Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes * give consent to the study * accessibility to the previous and recent test results exclusion criteria: * acute infection or inflammation lasting more than a week * acute metabolic decompensation * unable to attend to the follow-ups * having non-thyroid endocrine diseases * active oncologic treatment

Keywords: type 2 diabetes poorly metabolic control
detection of spinal cord lesions using the mp2rage sequence in inflammatory diseases of the neuraxis

Conditions: Multiple Sclerosis

Summary: since the last revision of the mri guidelines in multiple sclerosis (ms, magnims) and the mcdonald criteria in 2017, all spinal cord lesions must be counted to increase the sensitivity and specificity of the diagnosis of ms. focal lesions of the spinal cord are more frequently located in the cervical segments than in the lower segments of the spinal cord and occupy the lateral and posterior columns, although the central grey matter may not be spared. cervical involvement is difficult to study because of the small size of the lesions and the loss of signal in the cervical region. as a result, the detection of cervical lesions on mri is sub-optimal. in this context, standardised acquisition protocols have been proposed. for mri of the spinal cord, at least two of the following sagittal sequences are recommended: t2, stir, double inversion recovery, t1 with gadolinium injection, and/or t2 axial acquisitions. recently, our team validated the superiority of 3d psir and 3d fgapsir sequences, which offer better detection performance than t2 and stir on 3 tesla mri. other studies have also shown the contribution of the mp2rage sequence to the detection of spinal cord lesions in ms, compared with the set of sequences classically recommended. the mp2rage sequence is a t1 sequence, which creates a composite image, limiting field inhomogeneity bias while providing a quantitative t1 map. it has recently been optimised for the spinal cord, and has been only minimally evaluated in the context of ms. the aim of this study is to evaluate the effectiveness of the mp2rage sequence in comparison with the set of conventional sequences recommended for the detection of spinal cord lesions in ms patients.


Eligibility criteria:
inclusion criteria: * patient aged over 18 years * scheduled to undergo 1.5t or 3t mri of the spinal cord as part of an initial assessment or reassessment of inflammatory neuraxial disease. * express consent to participate in the study * member or beneficiary of a social security scheme exclusion criteria: * patient benefiting from a legal protection measure * pregnant women * absolute or relative contraindication to 1.5t or 3t mri
just in time intervention to enhance physical activity among stroke survivors

Conditions: Stroke

Summary: a 3-month single-arm pilot trial to evaluate the feasibility of an automated and individualized coping intervention among stroke survivors.


Eligibility criteria:
inclusion criteria: 1. adult patients diagnosed with stroke: participants must be adults (age ≥ 18) who have been clinically diagnosed with a stroke between 3 months and 3 years. 2. community-dwelling: participants should be living independently in the community rather than in institutional settings such as nursing homes or hospitals. 3. independently mobile: participants must be able to walk without any aid or assistance, corresponding to a modified rankin scale (mrs) score of 0-2. 4. physically inactive: participants should have engaged in less than 10 minutes of moderate-to-vigorous physical activity (mvpa) in the past week. 5. internet access: participants must have access to the internet for at least a few hours every day. 6. medically cleared to participate: before enrollment, participants must obtain medical clearance to ensure they are fit to participate in the study. exclusion criteria: 1. participating in another research project involving physical activity: to avoid potential confounding variables that could affect the study's outcomes. 2. planning to move or have surgery in the next 6 months: participants who plan to move or undergo surgery within the next six months may face disruptions that could affect their ability to complete the study. 3. cognitive impairment: cognitive impairment can affect a participant's ability to understand and follow study protocols, which is crucial for informed consent and reliable data collection.

Keywords: stroke physical activity wearable tracker smart phone
role of 'pentoxifylline and or igm enriched intravenous immunoglobulin in the treatment of neonatal sepsis'

Conditions: Sepsis of the Newborn

Summary: the investigators aim is to investigate whether adjuvant pentoxifylline , igm enriched ivig or pentoxifylline plus igm-enriched ivig reduced mortality from neonatal sepsis.


Eligibility criteria:
inclusion criteria:: * all infants thought/diagnosed to have late or early onset sepsis. exclusion criteria: * pentoxifylline or pentaglobin has already been given * pentoxifylline or pentaglobin is thought to be needed or contra-indicated * major congenital anomaly * intraventricular hemorrhage (grade 3 veya 4) * congenital infections * inborn errors of metabolism

Keywords: neonatal sepsis pentoxyfilline pentaglobin biomarker to reduce mortality in neonatal sepsis
pilot of mpowerment for young men who have sex with men (ymsm) in beirut

Conditions: HIV

Summary: this project will adapt and pilot a multi-level, community-based intervention to promote hiv prevention and sexual health among young men who have sex with men in beirut.

mpowerment (mp) is an evidence-based community-level, structural, social and behavioral intervention for hiv prevention developed for ymsm that targets individual and community empowerment and mobilization, self-affirmation, sexual self-knowledge, and creation of a supportive social environment. mp has been widely used in the u.s., but not in a mostly muslim setting. this project will adapt and pilot mp for the sociocultural issues facing ymsm (age 18-29) in beirut. there will be a 2-year pilot implementation of mp, with longitudinal cohorts of ymsm in beirut and jounieh, the latter being the control community. primary outcomes will be unprotected anal sex and hiv testing, with secondary outcomes being engagement in peer outreach, and perceived peer norms related to condom use and hiv testing.

Eligibility criteria:
inclusion criteria: * men aged 18-29, who have had anal sex with men in the past 6 months exclusion criteria: * not residing in lebanon