Kornimate/medical-research-clean huggingface dataset:
a study evaluating drug drug interaction between milvexian and atorvastatin in healthy participants

Conditions: Healthy

Summary: the purpose of this study is to evaluate the potential pharmacokinetics (pk) interaction between milvexian and atorvastatin (and its metabolites) in healthy participants at steady state.


Eligibility criteria:
inclusion criteria: * healthy on the basis of physical examination, medical history, vital signs, electrocardiogram (ecg), and laboratory test results, including serum chemistry, blood coagulation, hematology, and urinalysis, performed at screening. * normal renal function at screening as evidenced by an estimated glomerular filtration rate (egfr) of greater than or equal to (\>=) 90 milliliter per minute per 1.73 square meters (ml/min/1.73 m\^2) calculated with the chronic kidney disease epidemiology collaboration (ckd-epi) formula * must sign an informed consent form (icf) indicating they understand the purpose of, and procedures required for, the study and are willing to participate in the study * if a woman, except for postmenopausal women, must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hcg\]) at screening and urine (beta-hcg) pregnancy test on day 1 of each treatment period * contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies exclusion criteria: * participant is a woman who is pregnant, breastfeeding, or planning to become pregnant during this study or within 34 days after the last study drug administration * history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, gastrointestinal disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results * clinically significant abnormal values for hematology, coagulation, clinical chemistry (including thyroid-stimulating hormone \[tsh\] at screening only), or urinalysis at screening or on day 1 prior to the first dosing, including: hemoglobin and hematocrit less than (\ ) 1.2\* upper limit of normal (uln) * clinically significant abnormal physical examination, vital signs, or 12 lead ecg at screening or at admission to the study center on day 1 prior to first dosing, as deemed appropriate by the investigator * participants with a history of excessive menstrual bleeding
srs sequential sindilimab in brain metastasis of nslsc

Conditions: NSCLC Stage IV; Brain Metastases; SRS; Sintilimab

Summary: a phase ii study on the treatment of advanced non-small cell lung cancer with brain metastasis by srs sequential sintilimab


Eligibility criteria:
inclusion criteria: * non-small cell lung cancer patients with less than brain metastases * patients must have received at least the first-line anti-tumor treatment, and the front-line treatment must include chemotherapy or targeted treatment with a platinum containing combination scheme, but not anti-pd-1 / l1 treatment * patients who have not received intracranial local treatment before exclusion criteria: * patients who toke major surgery within 4 weeks prior to enrollment or had ununited wounds * patients with hemorrhage in intracranial metastasis
doppler flow wires in cerebral angiography

Conditions: Aneurysm; Cerebral Aneurysm

Summary: the purpose of this study is to use a wire with a doppler tip to measure blood flow in vessels in the brain and determine hemodynamic factors associated with treatment success or failure. many neurological diseases cause abnormal blood flow in the brain in specific vessels. the special wire used in this study is place into brain blood vessels during standard of care procedure to treat such diseases, and blood flow parameters (such as velocity and pressure) are measured to gain better understanding of these neurological diseases.

current treatments of cerebral aneurysms are imperfect, and aneurysmal hemodynamics is an important factor in treatment failure. the identification of hemodynamic factors that influence treatment success could predict outcome. published studies show that the hemodynamic environment of aneurysms changes after treatment, and there is limited retrospective evidence that the degree of change affects treatment success. however, previous hemodynamic calculations did not have access to patient-specific measurements of blood flow, which substantially reduced their accuracy. in addition, no prospective studies of the predictive value of post-treatment aneurysm hemodynamics have been done. methods: prospectively test new aneurysm patients for hemodynamic predictors of treatment outcome based upon the hypothesis long-term aneurysm treatment outcome can be prospectively predicted by measuring the immediate hemodynamic effects of aneurysm treatment with novel patient-specific modeling techniques. task 1: in a new cohort of patients undergoing aneurysm treatment, the investigators will again use doppler guidewire measurements to create patient-specific hemodynamic models of treatment effects. by prospectively applying the knowledge of crucial hemodynamic changes the investigators will use immediate post-treatment hemodynamics to predict long-term treatment outcome.

Eligibility criteria:
inclusion criteria: * patient with an unruptured intracranial aneurysm ≥ 5mm in size undergoes endovascular treatment and subsequent angiographic follow-up exclusion criteria: -previously enrolled in the study
endorectal three-dimensional ultrasound in the diagnosis of cryptogenic fistulas of the rectum.

Conditions: Anal Fistula

Summary: prospective comparative parallel ultrasound diagnostic transrectal study in the diagnosis of cryptogenic fistulas of the rectum

it is planned to investigate 150 patients with cryptogenic fistulas. patients will be divided into two groups: complete and incomplete internal fistulas of the rectum. patients of the first group will undergo preoperative examination in the framework of transrectal ultrasound in b-mode, three-dimensional reconstruction of the image with a contrast of the fistula course with a solution of 1.5% hydrogen peroxide. patients with incomplete internal fistulas of the rectum will also undergo transrectal ultrasound examination in b-mode and with three-dimensional image reconstruction. the results obtained in the two groups will be compared with the intraoperative revision.

Eligibility criteria:
inclusion criteria: * patients diagnosed with "fistula of the rectum" * patients diagnosed with cryptogenic fistulas * patients who have signed informed consent exclusion criteria: * patients with perianal complications of crohn's disease * рatients with post-traumatic fistulas * рatients with fistulas, drain pararectal cysts * рatients with anal fissures, complicated by rectal fistula * рatients who refused to participate in the study of their own free will
testing palbociclib (pd-0332991) as a potential targeted treatment in cancers with ccnd1, 2, 3 amplification (match-subprotocol z1b)

Conditions: Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm

Summary: this phase ii match treatment trial identifies the effects of palbociclib in patients whose cancer has genetic changes called ccnd1, 2, or 3 amplification. palbociclib blocks proteins called cdk4 and cdk6, which may stop cancer cell growth when ccnd1, 2, or 3 amplifications are present. researchers hope to learn if palbociclib will shrink this type of cancer or stop its growth.

primary objective: i. to evaluate the proportion of patients with objective response (or) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma. secondary objectives: i. to evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas/multiple myeloma. ii. to evaluate time until death or disease progression. iii. to identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (rna), protein and imaging-based assessment platforms. iv. to assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens. outline: patients receive palbociclib orally (po) once daily (qd) on days 1-21. cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed up every 3 months if less than 2 years from study entry, and then every 6 months for year 3 from study entry.

Eligibility criteria:
inclusion criteria: * patients must have met applicable eligibility criteria in the master match protocol prior to registration to treatment subprotocol * patients must have amplification of ccnd1, 2, or 3, or another aberration, as determined via the match master protocol * patients must have an electrocardiogram (ecg) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ecg (e.g. complete left bundle branch block, third degree heart block) exclusion criteria: * patients must not have known hypersensitivity to palbociclib or compounds of similar chemical or biologic composition * patients must not have breast cancer, mantle cell lymphoma or myeloma * patients with known or symptoms of left ventricular dysfunction will be excluded * patients must not have had prior treatment with palbociclib, ribociclib, abemaciclib or any other cdk4/6 inhibitors * patients must not be using drugs or foods that are known potent cyp3a4 inhibitors or inducers, or are cyp3a4 substrates with narrow therapeutic indices
efficacy and safety of ureteroscopic lithotripsy (including flexible ureteroscopy) without indwelling urinary catheter

Conditions: Urolithiasis; Catheter-related Bladder Discomfort

Summary: a prospective, multicenter, randomized, controlled clinical trial was conducted to compare the efficacy and safety of non-indwelling catheter and indwelling catheter in relieving postoperative catheter-related complications after ureteroscopic lithotripsy. by comparing the pain score and urination urgency score (ppius) of patients after ureteroscopic lithotripsy (including flexible ureteroscopy) lithotripsy to provide a reliable scientific basis for indwelling catheter after ureteroscopic lithotripsy.


Eligibility criteria:
inclusion criteria: * patients with upper urinary tract calculi undergoing rigid ureteroscopic and soft ureteroscopic lithotripsy; * normal renal function; * aged between 18 and 70 years old * complete the operation under general anesthesia exclusion criteria: * solitary kidney; * previous history of renal transplantation or urinary diversion; * congenital malformation of urinary system; * abnormal coagulation mechanism due to blood system diseases, liver diseases, etc. * severe heart or lung disease, malignant tumor and immunodeficiency state * urethral stricture * neurogenic bladder * operation under epidural anesthesia or spinal anesthesia * large amount of bleeding during operation should be observed by indwelling catheter to observe urine color * high risk factors such as large amount of pus fur should be observed during operation. * urethral injury during operation leads to false passage * operation time is more than 90 minutes. higher risk of bleeding or infection
assessment of the efficacy of a fatigue management therapy in schizophrenia

Conditions: Schizophrenia

Summary: fatigue is commonly experienced in numerous pathologies, including schizophrenia. research has shown that chronic fatigue can exacerbate clinical symptoms. several evidence-based interventions for fatigue syndrome have been shown to be effective in other medical conditions, but up to this date no research has assessed interventions in fatigue management within psychotic populations. the aim of this study is to evaluate (in a multisite single blind randomized clinical trial) the efficacy of a cognitive-behavioral therapy (cbt) intervention of fatigue management in people diagnosed with schizophrenia. secondary objectives include the examination of changes in fatigue scores as well as clinical symptoms, physical \& cognitive functioning, quality of life at 9-month post cbt intervention. another aim in this study is to assess - microbiate the investigators hypothesize that following the cbt treatment intervention, patients will demonstrate reduced level of fatigue. no change in the severity of fatigue is expected in the group receiving treatment as usual.


Eligibility criteria:
inclusion criteria: 1. aged between 18 and 60 years, 2. patients with a diagnosis of schizophrenia according to dsm 5 validated after a clinical evaluation by one psychiatrist investigators, 3. patients with a score at the 4th subscale of "multidimensional fatigue inventory " greater or equal to 10 4. patients with a follow-up in a day hospital at inclusion, 5. subjects must be able to attend all scheduled visits and comply with all trial procedures, non inclusion criteria: 1. subject unable to read or/and write french, 2. planned long-term stay outside of the study region that prevents compliance with the visit plan, 3. patients with a history of severe brain trauma, 4. patients with a history of neurological pathology, 5. patients pregnant or breast-feeding 6. patients deprived of liberty 7. patients participating in another ongoing biomedical study 8. patients not affiliated with a french social security scheme or beneficiary of such a scheme 9. absence of signed informed consent form by the patient and the patient's tutor if he has one

Keywords: fatigue schizophrenia microbiota cognitive behavioral therapy
integrated case management for burns care in pakistan

Conditions: Unintentional Burn Injury; Depression; Anxiety; Burns

Summary: to test whether a culturally adapted multicomponent intervention for improving burns care and patient/family rehabilitation is effective in improving survival among burn victims in pakistan and is cost-effective. the comparator will be usual care plus brief written self-help advice (enhanced usual care). the study is designed as a multicentre, pragmatic, parallel group, individually randomised trial. participants in the intervention arm will receive 8 sessions delivered by the case managers (6 low-intensity sessions lasting 30-60 minutes in the hospital/community and 2 follow-up sessions lasting 30 minutes in the community). assessments will be conducted at baseline, at 3 months, 6 months and at 12-months post-intervention.

the burns trial will be conducted in six cities of pakistan; karachi, hyderabad, lahore, rawalpindi, peshawar and quetta to compare integrated intervention with enhanced usual care. participants will be randomized either to the intervention or enhanced usual care. the intervention consists of multiple culturally adapted components such as psychological bundle, emergency care, surgical and rehab bundle to improve care within burn units, transitional care, and patient and family rehabilitation (known as 'integrated case management for improved psychosocial and physical rehabilitation of burn survivors and their families'). the comparator will be usual care (emergency, surgical and rehab care ) plus brief written self-help booklets will be given(enhanced usual care). the intervention will be carried out by case managers (trained allied health professionals such as nurses, physiotherapists, psychologists etc) and will be started during hospital stay to enhance physical health outcomes by educating patients about self-care/ medications and adherence to treatment resources provided to the case managers and upon discharge to the participants and their carers. participants in the intervention arm will receive 8 sessions delivered by the case managers (6 low-intensity sessions lasting 30-60 minutes in the hospital/community and 2 follow-up sessions lasting 30 minutes in the community). assessments will be conducted at baseline, at 3 months, 6 months and at 12-months post-intervention.

Eligibility criteria:
inclusion criteria: * adults 18 years and over * accidental burn injury and meet the criteria for admission to burn centres * clinician judgment for participation readiness * ability to provide informed consent exclusion criteria: no intentional burn injuries • lacking capacity to provide informed consent

Keywords: burns rehabilitation culturally adapted cost effectiveness multicenter trial pakistan burns injury
safety and efficacy study of rifalazil for the treatment of chlamydia trachomatis infection in women

Conditions: Chlamydia Trachomatis Infection

Summary: this study will test the safety and effectiveness of an investigational antibiotic drug, rifalazil for the treatment of uncomplicated genital chlamydia trachomatis infection. this study will examine the effects of 25 milligram of rifalazil compared with azithromycin 1 gram, which will be given as a single dose to women who have genital chlamydial infection.


Eligibility criteria:
inclusion criteria: * female ≥ 19 years old diagnosed with genital chlamydia trachomatis infection. * use an effective method of contraception. * agree to be abstinent or to have partners use condoms for all sexual activities during the study. exclusion criteria: * subject or sexual partner is known to have gonorrhea. * history of repeated chlamydia trachomatis infection. * hiv, syphilis, or active hepatitis b or c infection. * treatment with antimicrobial therapy with known activity against chlamydia trachomatis within 4 weeks of enrollment.

Keywords: chlamydia
effects of mobile application-based lifestyle counselling on body weight loss in obese subjects

Conditions: Obesity

Summary: the aim of the trial is to study the effect of a mobile application-based lifestyle change program on body weight loss in adult subjects with obesity. the main focus is to motivate and support beneficial lifestyle changes targeting long-term weight management. this study comprises two randomly assigned study arms: mobile application-based lifestyle change program and "waiting-list" control. the mobile application-based lifestyle change program consists of twice a week content for the first 6 months, continuing with less frequent contents for the following 6 months (the length of intervention 12 months). the "waiting-list" control group will receive mobile application-based lifestyle change program after 6 months followed by intervention for 12 months. the main aim is to demonstrate that the users of mobile application-based lifestyle change program lose more weight than controls at 6 month timepoint and weight loss is maintained for 18 months (6 months after the end of mobile application-based lifestyle change program use). weight is measured and blood samples (lipids, glucose and metabolic syndrome measures) are collected at 0, 6, 12, and 18 months. the mobile application-based counselling contains aspects of cognitive behavior therapy and persuasive system design and consists of twice a week reminders, tasks, self-monitoring, and reflection. the main outcome is the decrease in body weight. secondary outcomes are changes in eating behavior, psychological factors, components of metabolic syndrome (waist circumference, plasma lipid and glucose values, blood pressure), and calculated scores of metabolic condition and adiposity.


Eligibility criteria:
inclusion criteria: * body mass index 30 to 40 kg/m2 * ownership of a smartphone exclusion criteria: * untreated hypothyroidism * oral glucocorticoid treatment * pregnancy or lactation * no possibility to use mobile phone or tablet * no knowledge of finnish language * presumed lack of adherence to the study * participation in another ongoing weight management program * diagnosed or suspicion of cardiovascular disease causing restrictions to exercising * bariatric operation planned * usage of any anti-obesity drug
hypertensive treatment and epidemiological analyses

Conditions: Cardiovascular Diseases; Hypertension; Heart Diseases; Coronary Disease

Summary: to determine the impact of the treatment of hypertension on the epidemiological analyses of blood pressure from observational studies.

background: with the use of antihypertensive medication increasing steadily over the last 25 years, treatment for hypertension is now common. given the high prevalence of treatment for hypertension, researchers can no longer assume that participants in epidemiologic studies represent natural blood pressure measures, as opposed to treated blood pressure measures. the effect of this high prevalence of treatment, however, has not been fully investigated. although it might seem that studies of "natural history" are no longer relevant, great interest currently exists in establishing both environmental and genetic determinants of blood pressure. additionally, there currently is a renewed interest in refining treatment guidelines. for example, the need to account for absolute as well as relative risk has been hotly debated in recent years. the need will continue to exist, therefore, to analyze observational data sets to meet the evolving interest in the determinants of blood pressure and to meet the requirements for more refined risk estimates. design narrative: to investigate the effect of blood pressure treatment on the analysis of epidemiologic studies, the investigators conducted two interrelated analyses using simulation studies and data from five observational studies: the framingham heart study; the nhanes i, ii, and iii cohorts; and the international collaborative study of hypertension in blacks (icshib). they first conducted simulation studies to examine the behavior of different methodologies in each of two common analytic settings: relating body mass index to level of systolic blood pressure and relating level of systolic blood pressure to coronary heart disease mortality. they planned to use the data from the five studies to derive the parameters for use in the simulation studies. in these studies they quantified the level of bias that results from ignoring the presence of blood pressure treatment in observational data. after conducting their simulations studies, they repeated the analysis of the relationship between body mass index and systolic blood pressure using available empirical data. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria