Kornimate/medical-research-clean huggingface dataset:
impact on t cell immune activation and inflammation of triptolide woldifii in hiv-infected immunological non-responders

Conditions: HIV

Summary: this study is a prospective, multicenter, randomized, placebo-controlled clinical trial, to evaluate impact of triptolide wilfordii on t cell immune activation and inflammation biomarkers in hiv-infected immunological non-responders.

about 120 patients will be recruited from 4 hiv/aids clinical centers in china and randomized 1:1 into intervention group and placebo-controlled group. triptolide wilfordii (20mg tid po) would be given to invention group for 24 weeks. t cell activation and inflammation biomarkers including cd8+hla-dr+cd38+, il-6, d-dimer and high-sensitivity c-reactive protein (hscrp), protein degradation-1 (pd-1), ki67 ,soluble cd14 and cd163, pd-1, ccr5 and cd57 would be tested. patients in placebo-controlled group will change to take triptolide wilfordii (20mg tid po) for another 24 weeks. all patients will be followed up till 48 weeks. we hypothesis that triptolide wilfordii might reduce immune activation and inflammation of hiv immunological non-responders and increase cd4 t cell count, which provides a new strategy for treatment of hiv-infected immunological non-responders.

Eligibility criteria:
inclusion criteria: * continuous antiretroviral therapy \> 24 months ， and consistent hiv-rna\< 40 copies/ml more than 12 months ; * 18-65 years old; * male or female; * good adherence and promise to follow-up; * inform consent signed; * cd4 t cells less than 250/ul . exclusion criteria: * active opportunistic infection (not stable within 4 weeks 2 weeks ) or aids-related carcinoma; * hemoglobin (hgb) \ 1.5x uln 、 alt or ast or alkaline phosphatase (alp) \>3x upper limit of normal (uln) 、 total bilirubin (tbil) \>2x uln 、 creatine kinase (ck) \> 2x uln; * pregnant or breastfeeding woman or woman with pregnancy plan; * active drug-user; * severe neurological defects; * active alcohol abuse; * severe gastrointestinal ulcer . * end-stage disease such as cirrhosis, chronic obstructive pulmonary disease, congestive heart failure, recent myocardial ischemia,tumor, etc * those who are undertaking steroids, immunomodulator, anti-inflammatory agents

Keywords: hiv-infected immunological non-responders triptolide immune activation inflammation cd4 t cell
a study to evaluate the long-term safety of patients with advanced lymphoid leukemia who have been previously administered with ucart19

Conditions: Advanced Lymphoid Leukemia

Summary: the purpose of this study is to evaluate the long-term safety and efficacy of ucart19 administration to patients with advanced lymphoid leukemia.


Eligibility criteria:
inclusion criteria: * written informed consent obtained prior any study-specific procedure (patient or parent(s) or legal representative) * patient dosed with ucart19 who completed or discontinued early from a sponsored or from any investigator-initiated study that tested ucart19, or patients who were administered ucart19 under a special access scheme (compassionate use); * female patients of childbearing potential and male patients with partners of childbearing potential must continue to use an effective method of birth control as well as their partners for a 12-month duration after the last ucart19 administration. exclusion criteria: - no exclusion criteria for this study
impact of metabolic dysfunction and mucus plugging on asthma physiology

Conditions: Asthma

Summary: this is a single-center study of 80 subjects with asthma including those with obesity and metabolic dysfunction (md), those with obesity and without metabolic dysfunction, those with severe asthma and mucus plugging and those with severe asthma and without mucus plugging. screening data will be reviewed to determine participant eligibility. participants who meet all inclusion criteria will participate in a cardiopulmonary exercise testing (cpet) visit to compare lung function markers and change in oxygen saturation between obese patients with and without md and severe asthma patients with and without mucus plugging.

the mechanism of poor exercise tolerance in patients with severe asthma is poorly understood. in preliminary data, the investigators have identified increases in air trapping in patients with obese asthma and metabolic dysfunction and patients with asthma and mucus plugs. the investigators have also found air trapping on ct (computerized tomography) scans of severe asthma patients with mucus plugs. therefore, the investigators hypothesize that obese patients with metabolic dysfunction (md) and severe asthma patients with mucus plugs develop changes in lung function during exercise. to test this hypothesis, this protocol will plan for cardiopulmonary exercise testing in patients with obesity or severe asthma. the analyses will compare dynamic hyperinflation, expiratory flow limitation, and the rv/tlc ratio (ratio of residual volume to total lung capacity) before and after exercise between obese patients with and without md and severe asthma patients with and without mucus plugs.

Eligibility criteria:
inclusion criteria: 1. male or female ≥ 18 years old at visit 0 2. written informed consent obtained from subject and ability for subject to comply with the requirements of the study. 3. history of physician diagnosed asthma 4. evidence of bronchodilator reversibility (12% improvement in fev1 after albuterol administration) or positive methacholine challenge pc20 or pd20. historical evidence is accepted. 5. meets criteria for obesity or severe asthma a. obesity: bmi≥30 i. metabolic dysfunction is defined as presence of either: 1. il-6 high: plasma il-6 \> 3.0 pg/ml 2. insulin resistance: homa-ir \> 3 mass units b. severe asthma: requires treatment with high dose inhaled corticosteroids plus a second controller, systemic corticosteroid, or biologic therapy. i. mucus plugging is defined as mucus plug score ≥ 4 exclusion criteria: 1. asthma exacerbation or uri within the previous 6 weeks. 2. history of smoking 1. if \<30 years old: smoked for ≥5 pack-years 2. if ≥30: smoked for ≥10 pack years 3. pregnancy 4. absolute or relative contraindication to exercise testing per ats criteria 5. any other criteria that place the subject at unnecessary risk according to the judgment of the principal investigator and/or attending physician of record.
use of exparel for postoperative analgesia following bariatric surgery

Conditions: Post Operative Pain

Summary: the aim of this study is to evaluate the efficacy of liposomal bupivicaine in post operative analgesia for patients undergoing bariatric surgery when compared to conventional local analgesia. patients will be randomly selected to receive either liposomal bupivicaine or conventional bupivicaine via a transversus abdominal plane block during surgery. patients will be followed post-operatively to assess use of narcotics, post-operative pain and nausea scores, and length of stay.

optimizing pain management following bariatric surgery is an important aspect of patient care and post-surgical recovery. despite advances in post-operative pain management, this remains a challenge and opioids continue to dominate as the most widely used analgesia for post-surgical pain management. opioid use especially in the opioid-naive patient carries significant short term and long term risks including over dependence and chronic opioid use. movements towards minimizing post-operative opioid use has shown regional anesthetic techniques to be highly effective in the management of pain in surgical patients. more specifically, liposomal bupivicaine (exparel) is a novel non-opioid local analgesia that takes advantage of a multi-vesicular liposomal system to provide extended analgesia release over 72-96 hours. the purpose of this study to evaluate the use of liposomal bupivicaine in the management of post-operative pain following bariatric surgery via a transversus abdominis plane (tap) block. patients will be randomized to receiving either liposomal bupivicaine or traditional 0.25% bupivicaine locally infiltrated at the time of bariatric surgery. both liposomal bupivicaine and traditional bupivicaine will be administered via tap block after identification of planes via laparoscopy by the bariatric surgeon. patients will be followed post-operatively to assess use of opioid analgesia between the two arms. in addition, they will be assessed with respect to pain and nausea using analog scores, as well as hospital length of stay.

Eligibility criteria:
inclusion criteria: * the patient previously met nih criteria for bariatric surgery and has not received a previous bariatric surgical procedure * the patient is aged 18-65 years and has completed the screening and preparation process prescribed by the ontario bariatric network exclusion criteria: * inability to give informed consent * asa \> 4 * planned procedure other than roux-en-y gastric bypass (rygb) or contraindications to rygb * bmi \> 55 kg/m2 * revisional procedure * allergies or suspected allergies to local anesthetic medications (bupivicaine) * renal insufficiency (gfr \< 30ml/min) * history of chronic pain needing daily medications for the last \>3 months
the effects of therapeutic recreation activities on emotional adjustment of individuals with intellectual disabilities

Conditions: Emotional Adjustment; Intellectual Disability

Summary: the aim of this study was to determine the effect of therapeutic recreation activities on emotional adjustment of adolescents with intellactual disabilities. the research was carried out at meram melike hatun special education vocational school in konya. the study took place between march 2019 and may 2019. the parents of the participants who participated in the study consisted of the experimental group (n = 17) and the remaining parents (n = 17) formed the control group and the sample group (n = 34). the personal information form which measures demographic characteristics developed by the researchers according to the literature, and hacettepe emotional adjustment scale were used. data were analyzed in spss 22 program. according to kolmogorov-smirnov z test, sample group was not normal. for this reason, non-parametric tests were performed. in descriptive data, the mean, number, percentage will be used; comparative statistics were made according to the assumptions of non-parametric test (wilcoxon test, mann whitney u test). therapeutic recreation activities was applied as total of 16 sessions, consisting of two sessions per week and each session lasting about 1 hour. the program was implemented by researcher.


Eligibility criteria:
inclusion criteria: - exclusion criteria: * having a physical disability, * having down syndrome

Keywords: game therapeutic recreation intellectual disability
a safety and efficacy study of vitreosolve® for non-proliferative diabetic retinopathy subjects

Conditions: Diabetic Retinopathy

Summary: the purpose of this study is to determine the safety and efficacy of vitreosolve in diabetic retinopathy patients.


Eligibility criteria:
inclusion criteria: * subjects with a history of systemic diabetes (type i or ii) * subject with a documented history of non proliferative diabetic retinopathy (npdr) * subjects with no pvd at baseline exam in the study eye. exclusion criteria: * subjects with retinal pathology in the study eye other than (npdr) * subjects with high myopia in the study eye * subjects who have monocular vision or contra lateral vision of 20/200 or worse bcva in the non-study eye. * subjects with an aphakic study eye or if pseudophakic, cataract extraction surgery less than 6 months prior to study enrollment * subjects that have had either vitrectomy surgery, intravitreal injections, or laser treatments in the study eye.

Keywords: diabetic retinopathy
observe the frequency of extra-axial symptoms in korean ankylosing spondylitis (as) patients

Conditions: Ankylosing Spondylitis

Summary: this was a prospective mono-country, multi-center study of the frequency of extra-axial manifestations (eams) in ankylosing spondylitis (as) participants treated with adalimumab in routine clinical practice.

a baseline assessment was performed prior to the first dose of adalimumab. participants received 40 mg of adalimumab every other week for one year. study visits were conducted at 12, 28, 36 and 52 weeks. all participants were to have one follow-up approximately 70 days after the last dose of adalimumab.

Eligibility criteria:
inclusion criteria: * participant must be ≥19 years of age * participant has been diagnosed with ankylosing spondylitis (as) according to the 1984 modified new york criteria for at least 3 months * participant has active disease defined by a bath ankylosing spondylitis disease activity index (basdai) score ≥4, despite treatment with at least 2 nonsteroidal anti-inflammatory drugs (nsaids) or with disease-modifying antirheumatic drugs (dmards) for more than 3 months based on korea as reimbursement guideline * participant is eligible for adalimumab in daily rheumatologic practice * participant must provide written authorization form to use personal and/or health data prior to the entry into the study exclusion criteria: * female participants who are pregnant or breastfeeding * participants who are contraindicated to any anti-tumor necrosis factor (tnf) agent * participant is enrolled in other clinical trials

Keywords: bath ankylosing spondylitis disease activity index (basdai) score eams adalimumab
virtual reality (vr) could be a good alternative to relaxing or pain-relieving medication

Conditions: Virtual Reality; Distraction; Elderly (people Aged 65 or More)

Summary: we want to investigate whether virtual reality (vr) could be a good alternative to the relaxing or pain-relieving medications that are often used to alleviate anxiety when patients undergo surgery under local anesthesia.

this study is a randomized controlled trial based on both quantitative and qualitative methods. inclusion criteria are elderly patients aged ≥65 years with an estimated surgery time of a maximum of 90 minutes, who undergo surgery/treatment under local anesthesia and sedation. randomization is to either standard sedation or sedation/vr. randomization is carried out using mixed, sealed envelopes. the studies will be conducted at the following locations: hallands hospital, kungsbacka: open inguinal hernia surgery with implant, anesthesia type is infiltration anesthesia. sahlgrenska hospital: intervention, cannulation of the groin and vascular surgery performed via catheters/guides on blood vessels, liver, pancreas, and abdominal organs, with anesthesia type infiltration. alingsås hospital: surgery on the hand, arm, lower extremity, urology, with anesthesia type block and infiltration. data collection will include baseline preoperative stress levels measured with the state-trait anxiety inventory (stai-s) and pain assessment using a numerical rating scale (nrs) from 0-11. we also plan to use an objective marker for measuring anxiety-induced stress perioperatively, such as heart rate variability or skin conductance measurement. postoperative data will include stai-s, nrs, intraoperative sedative medication (type and dosage in mg/kg), time to urination, time to oral nutrition, discharge time, and time spent in the postoperative ward. the patient will assess their well-being with the qor 15 and nrs during the first five days postoperatively. the patient will be contacted to schedule a follow-up individual interview with semi-structured questions via zoom two weeks after the surgery. the primary outcome effect of vr glasses on mg/kg of propofol used intraoperatively or another sedative drug and/or the amount of local anesthetic used in mg. the secondary outcome effect of vr glasses on anxiety-induced stress perioperatively, where data collection will be conducted using eeg spectral edge frequency and the state-trait anxiety inventory (stai-s).

Eligibility criteria:
inclusion criteria: * over 65 years, planed surgery in local anesthesia/regional anesthesia exclusion criteria: * dementia, unable to cooperate, cognitive impairment

Keywords: virtual reality distraction
a study of retatrutide (ly3437943) compared to tirzepatide (ly3298176) in adults who have obesity

Conditions: Obesity

Summary: the main purpose of this study is to evaluate the efficacy and safety of retatrutide compared to tirzepatide in adults who have obesity. the study will last about 89 weeks.


Eligibility criteria:
inclusion criteria: * have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight. exclusion criteria: * have a self-reported change in body weight \>5 kilograms (kg) (11 pounds) within 90 days before screening. * have a prior or planned surgical treatment for obesity. * have a prior or planned endoscopic procedure and/or device-based therapy for obesity. * have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening. * have a family or personal history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men-2). * have had within the past 90 days before screening: * acute myocardial infarction * cerebrovascular accident (stroke) * coronary revascularization * hospitalization for unstable angina, or * hospitalization due to congestive heart failure. * have new york heart association functional classification class iv congestive heart failure. * have a history of chronic or acute pancreatitis.
discovering factors in metastatic breast cancer patients' clinical trial experiences

Conditions: Metastatic Breast Cancer

Summary: enrollment in clinical trials usually favors a particular demographic group. but there is limited research available to explain what study attributes affect the completion of these specific demographic groups. this trial will evaluate the safety and efficacy of metastatic breast cancer treatments. the focus will be on tracking the rates of completion and withdrawal among these individuals. it will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future metastatic breast cancer studies.


Eligibility criteria:
inclusion criteria: * patient is at least 18 years of age * patient is able and willing to comply with the treatment/follow-up schedule and requirements * patient must provide written informed consent exclusion criteria: * women who are pregnant, intend to become pregnant, or are lactating * inability to perform regular electronic reporting * participants who are vulnerable to any intervention

Keywords: metastatic breast cancer
hydrodissection as a treatment for carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: this is a pilot study designed to acquire data on the added value of hydrodissection when using a corticosteroid injection as a treatment for patients with carpal tunnel syndrome. hydrodissection is part of a standard clinical care injection under ultrasound guidance in which the fluid is used to separate the nerve from surrounding structures.


Eligibility criteria:
inclusion criteria: * clinical cts diagnosis with indication for steroid injection as determined by attending physician (if both hands are involved, only the side with the most severe cts as indicated by electromyography (emg) will be included) and * adult men and women between age 21 and 80 and * no more than moderate severity as indicated by emg and * symptoms of numbness or tingling for at least 4 weeks in the median nerve distribution area and * classic or probable carpal tunnel syndrome on katz-stirrat hand diagram and * ability to complete english-language questionnaires and clinical evaluations and * is reachable by phone for the follow up contact exclusion criteria: exclusion criteria are largely based on the premises of only including patients with idiopathic carpal tunnel syndrome without expected interferences of the acquisition of the ultrasound images or corticosteroid treatment. * previous carpal tunnel release (ctr) or other volar wrist surgery on the study hand or known tumor/mass or deformity of the study hand/wrist or * previous history of steroid injection into carpal tunnel or * currently taking a steroid medication either regularly or on an as needed basis or * any of the following clinical diagnoses or conditions: cervical radiculopathy; rheumatoid or other inflammatory arthritis, including gout; osteoarthritis in the wrist; renal failure; sarcoidosis; peripheral nerve disease; diabetes, thyroid disease or other metabolic disorder; pregnancy; amyloidosis; or major trauma (fractures or complete ligamentous tears) to the ipsilateral arm or * prisoners, institutionalized individuals, or others who may be considered vulnerable populations, such as individuals with dementia
comparative efficacy of metformin and berberine among tcf7l2 (rs7903146) tt vs. cc genotype carriers with type 2 diabetes

Conditions: Diabetes Mellitis

Summary: this pilot 12-week randomized open-label study compares metformin and berberine in newly diagnosed type 2 diabetes patients stratified by the tcf7l2 (rs7903146) genotype (tt vs. cc). the primary goal is to assess changes in hba1c between metformin and berberine treated groups within each genotype. secondary outcomes include fasting and postprandial glucose, insulin levels, homa-ir, body weight/bmi, lipid profile and adverse events. the central hypothesis is that berberine, through its additional effect on tcf7l2-linked pathways, will provide superior glycemic control in high-risk tt carriers compared to metformin, whereas both treatments will yield comparable results in cc carriers. by enrolling only tt and cc genotypes, this study aims to estimate effect sizes and feasibility, guiding a future, larger-scale trial on genotype-tailored diabetes therapies.


Eligibility criteria:
inclusion criteria: * adults aged 30-65 years; * newly diagnosed t2dm ≤1 year; * baseline hba1c: 7.0-9.0% (53-75 mmol/mol); * no prior use of antihyperglycemic agents or ≤4 weeks of usage; * willing to sign informed consent and undergo tcf7l2 genotyping; * tt or cc genotype (rs7903146) exclusion criteria: * severe comorbidities (hepatic, renal, cardiac dysfunction); * pregnancy or lactation; * known allergy or intolerance to metformin or berberine; * participation in another clinical trial within the last 3 months; * tc genotype (excluded).

Keywords: genetics polymorphysm supplements berberine