Kornimate/medical-research-clean huggingface dataset:
a study on the safety and effectiveness of twice-daily nelfinavir plus twice-daily indinavir plus efavirenz in hiv-positive patients who have never taken non-nucleoside reverse transcriptase inhibitors (nnrtis) or protease inhibitors

Conditions: HIV Infections

Summary: indinavir is usually taken three times a day. the purpose of this study is to see if it is safe and effective to take indinavir only twice a day plus nelfinavir (also taken twice a day) and efavirenz (taken once a day).

patients receive a treatment regimen consisting of nelfinavir, indinavir, and efavirenz for 48 weeks. during the study, patients are evaluated for changes from baseline in plasma hiv-1 rna levels and lymphocyte subsets and for development of adverse events and toxicities. after week 48, patients with documented virologic response are eligible to continue receiving study treatments and to attend scheduled follow-up visits. patients who experience virologic failure are discontinued from the study.

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * are hiv-positive. * are at least 13 years old (consent of parent or guardian required if under 18). * have a viral load of at least 10,000 copies/ml within 30 days of study entry. * agree to use a barrier method of birth control, such as condoms, during the study. exclusion criteria you will not be eligible for this study if you: * have hepatitis. * have any other serious medical condition besides hiv infection. * are allergic to indinavir, nelfinavir, or efavirenz. * have ever taken nnrtis or protease inhibitors. * have had chemotherapy or radiation therapy within 30 days of study entry. (local radiation therapy is allowed.) * have taken certain other medications that might affect your immune system such as interleukin-2, interferon, or a vaccine within 30 days of study entry. * are enrolled or plan to enroll in another anti-hiv drug study during this study. * are pregnant or breast-feeding. * abuse alcohol or drugs.

Keywords: drug therapy, combination hiv protease inhibitors indinavir nelfinavir reverse transcriptase inhibitors anti-hiv agents efavirenz
the vision system for mandibular trajectory assessment in women with mild temporomandibular joint disorder

Conditions: Mandibular Deviation

Summary: recording mandibular movements plays an important role in stomatognathic system diagnosis and has been the subject of numerous research projects. this study presents theoretical assumptions and a practical solution in the form of a novel method of mandibular motion assessment.

in the presented method, mandibular movements are recorded by a mono vision system where a digital camera is fixed on a special extension arm attached to patient's head. during movement the camera records changing positions of two markers placed on two selected two points on a patient's face. with such data, it possible to assess the absolute range of mandibular abduction as well as displacements from optimal trajectory occurring during movement, which indicative of stomatognathic dysfunctions.

Eligibility criteria:
inclusion criteria: * temporomandibular joint disorder * qualitative and quantitative impairments of mandibular movements exclusion criteria: * no impairments of mandibular movements

Keywords: mandibular deviation mandibular movement recording
an analysis of the relationship between the genetic polymorphisms of plasminogen activator inhibitor-1 and ulcerative colitis in chinese patients

Conditions: Colitis, Ulcerative

Summary: from january 2019 to february 2025, diagnosed ulcerative colitis(uc) patients and gender- and age-matched normal controls were enrolled from the department of gastroenterology, the second affiliated hospital of wenzhou medical university. our study aimed to explore the associations of plasminogen activator inhibitor-1 (pai-1) gene polymorphisms with the risk and clinicopathological characteristics of uc, and to analyze the effects of pai-1 gene variations on the clinical response of vedolizumab (vdz) treatment in uc patients.

from january 2019 to february 2025, diagnosed ulcerative colitis(uc) patients and gender- and age-matched normal controls were enrolled from the department of gastroenterology, the second affiliated hospital of wenzhou medical university. genotypes of pai-1 were determined by multiplex polymerase chain reaction-ligase detection reaction technique. chi-square test and unconditional logistic regression model were used to analyze the difference in distribution of pai-1 gene polymorphisms between uc group and normal control group, as well as the effects of pai-1 gene variations on the clinicopathological characteristics and 14-week clinical response to vdz treatment of uc patients.

Eligibility criteria:
inclusion criteria: * diagnosed uc based on comprehensive clinical, colonoscopy, histopathological, laboratory, and radiographic examination results exclusion criteria: * rheumatoid arthritis, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis, tumors, etc.
tinn pharmacokinetics (pk) study treat infections in neonates

Conditions: Pharmacokinetics of Ciprofloxacin in Neonates

Summary: phase i, open-label study to evaluate the pharmacokinetics, tolerability and short-term safety of ciprofloxacin in neonates with suspected (or proven) gram negative infection. objectives: to evaluate the multiple-dose pharmacokinetics of ciprofloxacin in neonates and young infants (24 - 52 weeks postmenstrual age) with suspected or proven gram negative infection. to evaluate the tolerability and describe short-term safety of ciprofloxacin in neonates and young infants with suspected (or proven) gram negative infection. to describe the clinical outcomes of neonates treated with ciprofloxacin

this study is part of tinn 'treat infections in neonates' a comprehensive project that is evaluating the safety of ciprofloxacin and how it is tolerated by neonates. ciprofloxacin is an antibiotic that has been used for many years in newborn babies and infants less than 3 months old to treat bacteria that are resistant to other antibiotics. ciprofloxacin is unlicensed for this age group. the european medicines agency and who have prioritised research about this drug. the tinn consortium aims to conduct the work required for a license (marketing authorization) in newborn babies and infants less than 3 months old. the aim of this study is to describe how newborn babies and young infants deal with this medicine. blood samples will be taken at the beginning of the course of antibiotics and at the end. a minimal amount of blood will be required (less than half a teaspoon) in total and collected by staff experienced in blood sampling from neonates in a way that causes the least disruption to the baby. the levels of ciprofloxacin in the blood will be measured. the levels will be used to work out how quickly the body gets rid of the medicine. this will allow recommendations about the best dose and how often the medicine should be given. we aim to recruit 50 neonates and infants under the age of 3 months who have been prescribed ciprofloxacin as inpatients for suspected or proven infection. they will be recruited over 2 years from the neonatal unit at liverpool women's nhs foundation trust and alder hey children's nhs foundation trust. consent will be requested for babies to have more detailed investigation to see if there if genetic factors affect the way the body handles ciprofloxacin.

Eligibility criteria:
inclusion criteria: * receiving ciprofloxacin following clinical decision by attending physician exclusion criteria: * likely not to survive 48 hours in the judgement of attending physician * ciprofloxacin commenced before 5th day of life

Keywords: ciprofloxacin neonates gram negative infection
xenon compared to sevoflurane and total intravenous anaesthesia for coronary artery bypass graft surgery

Conditions: Coronary Artery Disease; General Anesthetic Drug Allergy; Coronary Artery Bypass Graft Surgery

Summary: xenon is a gaseous anaesthetic agent registered in several european countries. it has been administered safely during cardiac surgery in pilot studies. in animal studies, xenon decreases the size of experimental myocardial infarction. this 3-arm study will compare xenon, sevoflurane and a propofol-based total intravenous anaesthesia for maintenance of anaesthesia during coronary artery bypass graft surgery conducted with extra-corporeal circulation. xenon and sevoflurane will be administered before and after extracorporeal circulation. propofol will be administered during extracorporeal circulation in the three groups of patients. the study will compare the postoperative myocardial damage observed 24 hours after surgery from blood levels of troponin i, a largely accepted biomarker of myocardial necrosis. the main hypothesis is that the myocardial damage observed after xenon administration will not be superior to the damage observed after sevoflurane administration (non-inferiority). the second hypothesis is that the myocardial damage observed after xenon administration will be inferior to the damage observed after total intravenous anaesthesia.


Eligibility criteria:
inclusion criteria: * coronary artery disease * elective surgery, planned coronary artery bypass graft * moderate hypothermia or normothermia * cardiac arrest cold and warm cardioplegia * normal of moderately impaired left ventricular systolic function * written informed consent exclusion criteria: * pregnancy or child bearing potential * ongoing treatment with nicorandil or sulfonylurea medication * severe renal or hepatic dysfunction * ongoing myocardial infarction or unstable angina

Keywords: xenon sevoflurane propofol total intravenous anaesthesia anaesthesia coronary artery disease coronary artery bypass graft
bevacizumab after chemoradiotherapy for locally advanced lung adenocarcinoma

Conditions: Lung Adenocarcinoma

Summary: this prospective phase ii study is to determine the efficacy and safety of bevacizumab maintenance therapy after concurrent chemoradiotherapy in locally advanced lung adenocarcinoma

this prospective phase ii study is to determine the efficacy and safety of bevacizumab maintenance therapy after concurrent chemoradiotherapy in locally advanced lung adenocarcinoma. all patients received 4 cycles of weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡)(dp), each of 1 day's duration, combined with split-course thoracic radiotherapy, with one-month break.bevacizumab maintenance therapy starts 1-2 months later after the chemotherapy.the recommended dose for intravenous infusion is 15mg/kg body weight, and the drug is given every 3 weeks for up to 1 year. toxicities will be graded according to national cancer institute common terminology criteria for adverse events (ctcae) v. 4.0.

Eligibility criteria:
inclusion criteria: * pathologic confirmation of lung adenocarcinoma * patients have measurable or evaluable lesions based on the response evaluation criteria in solid tumors (recist) criteria. * eastern cooperative oncology group (ecog) performance status 0-1. * unresectable, refusing surgery or after r2 surgery ,confirmed by pet-ct or chest and abdominal ct, craniocerebral mri, and ect. * after radiotherapy and chemotherapy, the tumor is in partial remission, complete remission or stable. * 1-2 months after chemoradiotherapy ends. * organ and bone marrow functions were normal within the first 30 days of enrollment, including: • ast, alt≤ 2.5\*uln or ≤5\*uln (with liver metastasis); • tbil ≤ 1.5 uln • neutrophils absolute value ≥500 cells/mm3 • creatinine clearance ≥45 ml/min ;• platelets≥50,000 cells/mm3. * cb6 within normal limits * patients and their family signed the informed consents exclusion criteria: * lung squamous carcinoma. * the tumor has completely approached, encircled, or invaded the intravascular space of the great vessels (e.g., the pulmonary artery or the superior vena cava). * the tumor was associated with a cavity over 2cm in diameter. * bleeding tendency or coagulation disorder. * patients with hemoptysis (1/2 teaspoon blood/day) within 1 month. * full-dose anticoagulation therapy was used within the past 1 month. * severe vascular disease occurred within 6 months. * gastrointestinal fistula, perforation or abdominal abscess occurred within 6 months. * hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (new york class ii or above), active cerebrovascular disease or cardiovascular disease occurred within 6 months. * uncontrolled hypertension (systolic \> 150mmhg and/or diastolic \> 100mmhg). * major surgery within 28 days or minor surgery or needle biopsy within 48 hours. * urine protein 3-4+, or 24h urine protein quantitative \>1g. * degree 3 esophagitis after chemoradiotherapy has not recovered. * elderly patients (age 75 years). * the investigator does not consider the participant to be eligible for this study.

Keywords: bevacizumab split-course chemoradiotherapy
covid-19 vaccine induced immunity

Conditions: Covid19

Summary: this study aims to address the following three objectives: 1. longitudinal evaluation of the development of cmi responses in response to sars-cov-2 vaccine: t cells isolated from the blood of covid-19 vaccine recipients will be evaluated for their functionality in response to vaccine antigens. the temporal and functional properties of cmi responses will be correlated with the humoral or antibody responsiveness. cmi responses will be measured in vaccine recipients prior to vaccination to determine whether the presence or functionality of pre-existing responses to common cold coronaviruses (cccs) or previous sars-cov-2 infections affect the development of cmi responses to the covid-19 vaccine. 2. identification of cellular and soluble factors that influence vaccine responsiveness: while it is known that poor clinical outcomes in covid-19 patients are strongly associated with markers of systemic inflammation, the influence these systemic markers will have on covid-19 vaccine responsiveness is not clear. using systems biology approaches, the investigators will perform comprehensive profiling of cellular immune subsets, inflammatory signatures to identify determinants influencing the development of cmi responses to vaccine. 3. examine variability of immune and viral genes and their relationship to vaccine induced immune responses: human leukocyte antigen (hla), t cell receptor (tcr) and b cell receptor (bcr) proteins are highly genetically diverse and critical to development of protective immunity. the investigators will perform hla sequencing on whole blood-derived dna samples and tcr and bcr sequencing on sorted, sars-cov2 vaccine antigen-specific t cells and b cells, respectively, to assess how different sequence combinations impact the cmi responses to vaccine.


Eligibility criteria:
inclusion criteria: * all individuals eligible to receive one of the approved sars-cov-2/covid-19 vaccines. exclusion criteria: * individuals under 18 years of age
prep plus: upper limb stroke rehabilitation in the community

Conditions: Stroke

Summary: prep plus aims to create support for those who have survived stroke(s) and are still experiencing weakness in the upper limbs. in conjunction with the prep programme, and based on the grasp programme, the aim is to evaluate the feasibility, acceptability, and efficacy of an upper limb intervention support for survivors. integration of an evidence based upper limb programme to an established physical activity programme will be a feasible method to support long term upper limb rehabilitation to community dwelling stroke survivors.

the main objectives for overall study is to assess acceptability of the demand of the trial as well as the prep plus intervention placed on survivors and their carers. within this mixed methods study, the investigators aim to recruit participants in a total of three waves. each site will deliver 6 weeks of the intervention / control with a new set of participants before post intervention qualitative measures (focus groups and 1:1 interviews) are used to inform the design of the next wave. with having the trial in three waves, their objective is to optimise the design of upper limb rehab and the delivery by therapists with preparing them with adequate training and resources aimed toward upper limb rehab in survivors of stroke. participant recruitment will integrate into the current prep programme design. all participants will complete one hour of circuit-based exercises followed by one hour of education. the exercise stations will focus on lower body/cardiovascular fitness station and upper limb strength exercises. each week the amount of time spent at each station will be increased by 30 seconds resulting in a final 3 minutes at each station. those in the intervention group, will have an additional five exercises that focus on upper limb stretching, arm stretching, hand stretching, coordination, and hand skills.

Eligibility criteria:
inclusion criteria: diagnosis of stroke have completed statutory rehabilitation able to follow two part written or spoken commands are medically fit to complete exercise, as determined by their gp having an impairment of their upper limb, as identified by the participant and/ or their community stroke team. exclusion criteria: pain score of 5/more in their impaired upper limb. not participating in any other trial

Keywords: upper limb physical activity rehabilitation
biomechanics and clinical outcomes in responders and non-responders

Conditions: Osteoarthritis, Knee; Arthroplasty, Replacement, Knee; Physical Therapy

Summary: knee osteoarthritis is a degenerative joint disease that affects many older adults. however, not all patients see improvements as a result of physical therapy management; therefore, a better understanding of biomechanics and assessment of clinical outcomes between responders and non-responders is required. the included participants will be provided with informed consent and an explanation of the study procedure before enrolling in data collection. the data collection will be arranged in the same order. practice trials will be provided before the start of data collection. the data collection will consist of standardized questionnaires, assessments, and tests commonly used in clinics.

during data collection, markerless motion capture systems will be placed around the area of interest. the markerless system does not require markers to be attached to the participant's body. the data collection will include: 1. demographic information such as age, sex, body height, body weight, body mass index, medical history, medical diagnosis, and the kellgren-lawrence score. 2. patient-reported questionnaires such as the numeric pain rating scale, knee injury and osteoarthritis outcome score, western ontario and mcmaster universities osteoarthritis, and depression, anxiety, and stress scale - 21 items. 3. clinical assessments such as the varus-valgus laxity test, foot posture index, range of motion, muscle flexibility, and muscle strength. 4. functional tests such as the timed up and go test, five times sit-to-stand test, four-meter walk test, and bipedal quiet stance test.

Eligibility criteria:
inclusion criteria: * diagnosis of knee osteoarthritis based on american college of rheumatology * pain intensity of ≥ 4 out of 10 at the pre-treatment day * ability to walk for at least six meters without an assistive device exclusion criteria: * history of previous lower limb surgery, such as total hip replacement * history of neurological disorder, such as stroke * history of vestibular disease, such as meniere's disease

Keywords: biomechanics assessment, outcomes
treatment of cortical myoclonus with repetitive transcranial magnetic stimulation

Conditions: Movement Disorder; Myoclonus; Nervous System Disease

Summary: myoclonus is a condition related to epilepsy of involuntary twitching or jerking of the limbs. the purpose of this study is to determine if stimulation of the brain with magnetic pulses can decrease myoclonus. researchers believe that this may be possible because in studies on normal volunteers, magnetic stimulation made areas of the brain difficult to activate for several minutes. in addition, early studies on patients with myoclonus have shown magnetic stimulation to be effective at decreasing involuntary movements. transcranial magnetic stimulation (tms) is a non-invasive technique that can be used to stimulate brain activity and gather information about brain function. it is very useful when studying the areas of the brain and spinal cord related to motor activity (motor cortex and corticospinal tract). repetitive transcranial magnetic stimulation (rtms) involves the placement of coil of wire (electromagnet) on the patient's scalp and rapidly turning on and off the electrical current. the changing magnetic field produces weak electrical currents in the brain near the coil. this permits non-invasive, relatively localized stimulation of the surface of the brain (cerebral cortex). the effect of magnetic stimulation varies, depending upon the location, intensity and frequency of the magnetic pulses. researchers plan to use rtms for 10 days on patients participating in the study. the 10 day period will be broken into 5 days of active repetitive magnetic stimulation and 5 days of placebo "ineffective" stimulation. at the end of the 10 day period, if the results show that rtms was beneficial, patients may undergo an additional 5 days of active rtms.

repetitive transcranial magnetic stimulation (rtms) at frequencies in the single hz range causes a decrease in the excitability of the primary motor cortex and there is preliminary evidence that it can suppress abnormal excess cortical activity. we plan to test 1 hz rtms as treatment for cortical myoclonus.

Eligibility criteria:
age 5 to 90 with severe cortical myoclonus. no intracranial metal hardware (excluding dental fillings), pacemakers, indwelling medication pumps, cochlear implants, intracardiac lines, significant intracranial masses or increased intracranial pressure. subject must not be pregnant.

Keywords: neurological disorders movement disorders physiology noninvasive brain stimulation cortical myoclonus