Kornimate/medical-research-clean huggingface dataset:
investigations on the influence of bariatric surgery on the metabolism and absorption of atorvastatin

Conditions: Morbid Obesity

Summary: altered bioavailability of drugs will potentially affect both drug efficacy as well as safety. in patients subjected to bariatric surgery due to morbid obesity the gastro intestinal tract is considerably reconstructed and a change in drug bioavailability is very likely. getting further knowledge on important mechanisms responsible for altered bioavailability would help in predicting clinically relevant consequences on different drugs. in the present study we aim to investigate the effect of bariatric surgery on atorvastatin bioavailability. atorvastatin is subjected to both extensive metabolism and drug transport and will potentially be a good predictor for mechanisms relevant for other drugs as well. in addition will the expression of different enzymes and transporters be measured in the gastrointestinal tract and in the liver to elucidate on mechanism behind the eventual effects.

the primary objective of the study is to compare the effect of gastric bypass and bpd+ds operations on atorvastatin bioavailability. secondary objectives are to determine the relative change in atorvastatin bioavailability following gastric bypass as well as bpd+ds operations. in addition will the individual cyp3a4, cyp3a5 and p-gp activity in the different organs from where biopsies can be obtained be descriptively compared with atorvastatin pharmacokinetic variables.

Eligibility criteria:
inclusion criteria: * scheduled for bariatric surgery. * 18 years of age or older. * ongoing treatment with statin. * able and willing to donate gi-tract and liver biopsies. * signed informed consent. exclusion criteria: * concomitant treatment with drugs and/or other factors that may influence atorvastatin pharmacokinetics

Keywords: bariatric surgery bioavailability bioequivalence atorvastatin cyp's p-gp oatp
cle for differential diagnosis of ibd

Conditions: Inflammatory Bowel Diseases

Summary: differential diagnosis between ulcerative colitis (uc) and crohn's disease (cd) is of pivotal importance for the management of inflammatory bowel disease (ibd) as both entities involve specific therapeutic management strategies. confocal laser endomicroscopy (cle) allows on demand in vivo characterization of architectural and cellular details during endoscopy. here, we assessed the efficacy of cle to differentiate between uc and cd.


Eligibility criteria:
inclusion criteria: * equal or above 18 years of age * ability to provide written informed consent * well-established diagnosis of cd or uc exclusion criteria: * history of ibd reclassification in the last 3 years * boston bowel preparation scale score's \< 2 in at least one of the three broad regions of the colon (i.e. rectum plus left side colon, transverse colon plus left and right flexures, right colon) * inability to provide written informed consent * severe uncontrolled coagulopathy * impaired renal function * pregnancy or breast feeding * active gastrointestinal bleeding * known allergy to fluorescein * residence in institutions
magnetic seizure therapy for schizophrenia

Conditions: Schizophrenia

Summary: this trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (mst) and its safety among schizophrenia patients. half of the participants will be randomized to mst group, while the other half will be randomized to receive electroconvulsive therapy (ect).

magnetic seizure therapy (mst) is likely to be an alternative options to electroconvulsive therapy (ect). widespread stimulation of cortical and subcortical regions is inevitable for ect since the substantial impedance of the scalp and skull shuts most of the electrical stimulus away from the brain. nevertheless, magnetic pulses are capable to focus the stimulus to a specific area of the brain because they can pass the scalp and skull without resistance. in addition, electric current will penetrate into deeper structures, while magnetic stimulus are only capable to reach a depth of a few centimeters. as a consequence, mst are able to generate focus stimuli on superficial regions of the cortex while ect can't, which may give mst the capability to produce comparable therapeutic benefits with the absence of apparent cognitive side effects.

Eligibility criteria:
inclusion criteria: 1. dsm-5 diagnosis of schizophrenia; 2. convulsive therapy clinically indicated, such as severe psychomotor excitement or retardation, attempts of suicide, being highly aggressive, pharmacotherapy intolerance, and ineffectiveness of antipsychotics; 3. the positive and negative syndrome scale (panss)\[20\] score ≥ 60; 4. informed consent in written form. exclusion criteria: 1. diagnosis of other mental disorders; 2. severe physical diseases, such as stroke, heart failure, liver failure, neoplasm, and immune deficiency; 3. present with a laboratory abnormality that could impact on efficacy of treatments or safety of participants; 4. failure to respond to an adequate trial of ect lifetime; 5. are pregnant or intend to get pregnant during the study; 6. other conditions that investigators consider to be inappropriate to participate in this trial.

Keywords: magnetic seizure therapy randomized controlled trials schizophrenia cognition
cognition with vericiguat evaluation in heart failure

Conditions: Heart Failure; Cognitive Impairment

Summary: converge-hf is a 4-center pilot phase iib randomized control trial in ambulatory patients with chronic heart failure (≥ 6 months) and mild-to-moderate cognitive impairment.

converge-hf is a randomized, open label, phase iib trial evaluating the effect of sgc stimulator, vericiguat versus standard of care on imaging markers and blood markers of cerebral and coronary small vessel diseases, function status, cognitive status, quality of life and clinical events in patients with heart failure and mild-to-moderate cognitive impairment. patients will be randomized and allocated to either vericiguat or standard of care, for 26 weeks including the greater than 4 weeks timeframe for the uptitrations to the target dose.

Eligibility criteria:
inclusion criteria: 1. adult patients 2. established chronic heart failure (≥ 6 months) 3. mild-to-moderate cognitive impairment (as per the diagnosis of cognitive impairment or a montreal cognitive assessment (moca) score 10-25). exclusion criteria: 1. patients who have contraindications for sgc stimulator and vericiguat therapy (i.e. use of long-acting nitrates, other soluble guanylate cyclase stimulators (e.g., riociguat), or phosphodiesterase type 5 (pde-5), pregnancy or breast-feeding) 2. unable to undergo cmr imaging or brain mri. 3. cmr exclusions: renal failure \[a glomerular filtration rate \&lt;30 ml/min)\], incompatible implantable cardiac device (icd or crt), uncontrolled atrial fibrillation or recurrent ventricular arrhythmias). 4. general medical conditions: uncontrolled thyroid disorders, hepatic failure, or myocardial revascularization procedures \[coronary angioplasty and/or surgical revascularization in the previous 3 months\], cancer/malignancy, or with severe dementia). 5. patients with allergies to the study products. 6. patients currently hospitalized.

Keywords: heart failure cognitive impairment vericiguat
observational study to evaluate risks of side effects, drug abuse and dependence in patients who received xyrem ® on prescription

Conditions: Narcolepsy

Summary: patients will be followed up for max 18 months. information on the adverse events and potential misuse or abuse of xyrem ® will be collected.


Eligibility criteria:
inclusion criteria: * patients who received xyrem ® on prescription exclusion criteria: * no limitations

Keywords: narcolepsy cataplexy oxybate xyrem misuse safety
effect of treatment for vitamin d deficiency on thyroid function and autoimmunity in hashimoto's thyroiditis.

Conditions: Hashimoto Disease; Treatment Levothyroxine; Vitamin D Deficiency

Summary: the objective of this study is to evaluate the effect of vitamin d supplementation on thyroid autoimmunity, thyroid function, and other metabolic and clinical variables associated with the thyroid axis in patients with hashimoto's thyroiditis and vitamin d deficiency.


Eligibility criteria:
inclusion criteria: * women between 18-45 years old (pre-menopausal stage) * men between 18-60 years old * bmi between 18.5-34.9 kg/ m2 * medical diagnosis of hashimoto's thyroiditis * treatment with levothyroxine (lt4) with stable dose (from four months from the start of the intervention) * positive antithyroid antibody (peroxidase and/or thyroglobulin) * serum 25 (oh) d levels \<20 ng / ml. exclusion criteria: * radioiodine, thyroidectomy, antithyroid treatment * disease, condition or drug treatment that alters the immune system or hypothalamic-pituitary-thyroid axis or vitamin d metabolism. * disorder of kidney, liver, or bone-metabolic function * graves disease, toxic nodular goiter, postpartum thyroiditis, coronary heart disease, epilepsy, cancer, turner or down syndrome, primary hyperparathyroidism * vitamin d, calcium, complex b, omega-3 supplements * pregnant or breastfeeding * type 2 diabetes or dyslipidemia with drug treatment at unstable doses * intense physical activity

Keywords: hashimoto disease vitamin d antithyroid antibodies thyroid stimulating hormone
study of pituitary size and function in familial dwarfism of sindh

Conditions: Growth Hormone Deficiency

Summary: objectives: i. assess pituitary size and anatomic configuration by magnetic resonance imaging (mri) in 4 affected dwarfs in the province of sindh, pakistan. ii. evaluate ultradian growth hormone (gh) secretory patterns in 4 affected dwarfs.

protocol outline: pituitary size and anatomy and growth hormone response are evaluated. all patients undergo mri of the pituitary fossa on day 1. on day 2, homozygous patients receive a slow infusion of normal saline with blood sampling every 10 minutes.

Eligibility criteria:
* familial dwarfism of sindh * severe short stature but proportionate without dysmorphic features * normal body size and weight at birth * bone age is severely delayed * puberty is somewhat delayed (age 15-16) * fertility present in at least 3 dwarfs

Keywords: endocrine disorders growth hormone deficiency rare disease
management of lumbar discectomy by endoscopy and conventional microscopic discectomy

Conditions: Radiculopathy

Summary: currently, microscopic discectomy is performed as a minimally invasive surgery, thus reducing impact of so-called conventional "open" discectomies. although more technically demanding, discectomy with full endoscopy made possible a significant reduction of surgery invasive impact, thus making possible to broaden the field of endoscopic surgery indications. this study is based on hypothesis that complete endoscopic discectomy offers several advantages over traditional microscopic discectomy, including a smaller skin incision and therefore fewer scars and less muscle damage, lower infection rate, less blood loss, less painful post-operative recovery and shorter hospital stay length.

discectomy is the most common surgical technique to solve lumbar radiculopathy caused by disc herniation and nerve roots compression . currently, microscopic discectomy is performed as a minimally invasive surgery, thus reducing the impact of so-called conventional "open" discectomies. minimally invasive spinal surgery was developed using a retractor tube, a microscope, and an endoscope to perform efficient nerves decompression while preserving spinal cord stabilizing structures. although more technically demanding, discectomy with full endoscopy made possible a significant reduction of surgery invasive impact, thus making possible to broaden the field of endoscopic surgery indications. this study is based on hypothesis that full endoscopic discectomy offers several advantages over traditional microscopic discectomy, including a smaller skin incision and therefore fewer scars and less muscle damage, lower infection rate, less blood loss, less painful post-operative recovery and shorter hospital stay length.

Eligibility criteria:
inclusion criteria: * patient, male or female, aged ≥ 18 years * patient operated under endoscopy for lumbar disc herniation between february 2020 and may 2022 * patient operated by conventional microscopic surgery for lumbar disc herniation before february 2020 * patient having been informed of the research and not opposing its data use as part of this research exclusion criteria: * none
sintilimab versus pembrolizumab for advanced-stage non-small-cell lung cancer

Conditions: Nsclc

Summary: this study is a single-center, randomized controlled, phase ii clinical trial, aiming at giving a comparison of sintilimab and pembrolizumab in stage iiib-iv nsclc patients at first-line treatment setting.

this trial has been set up with two arms. screened patients would be included into one of the arms based on tumor pd-l1 expression. the purpose of this study is to compare the efficacy of the approved checkpoint inhibitor pembrolizumab and home-made drug sintilimab in patients with advanced nsclc whose tumor have high pd-l1 expression and low or negative expression.

Eligibility criteria:
inclusion criteria: 1. age≥18 years. signed informed consent form. 2. stage iv nsclc confirmed by histology/ cytology or stage iiib-iiic nsclc that could not be treated with radical radiation therapy (8th edition of iaslc lung cancer staging system). 3. fresh tumor tissue or paraffin tissue within 6 months is adequate for pd-l1 expression (tps) testing in the central laboratory. 4. tumor tissue without egfr mutation or alk rearrangement must be confirmed. 5. per recist 1.1 the efficacy evaluation criteria for solid tumors, at least one radiologically measurable lesion which was not treated with radiotherapy or had obvious disease progression after radiotherapy. 6. patients who received no systemic chemotherapy or any other systemic treatment for advanced nsclc. for patients who received preoperative neoadjuvant chemotherapy or postoperative adjuvant chemotherapy or radical chemoradiotherapy, if the disease progresses occurred one six months after the last treatment, they can be enrolled. patients who received targeted therapy or immunotherapy can not be enrolled. exclusion criteria: 1. active hepatitis b. active hepatitis b is defined as hbsag positive and the detected hbv-dna copy number is larger than the upper limit of normal value in the laboratory of the study site. 2. currently or prior clinically active interstitial lung disease. currently active pneumonia. current radiation pneumonitis for which corticosteroid treatment is required. 3. known hiv antibody positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation. 4. fever and the body temperature is above 38°c or clinically significant infection within 1 week prior to the enrollment. 5. active tuberculosis. evidence of severe or uncontrollable systemic diseases (such as severe mental, neurological diseases, seizure, or dementia, unstable or non-compensatory respiratory, cardiovascular, hepatic or renal diseases, and uncontrolled hypertension \[ctcae grade 2 hypertension or above after drug treatment\]). 6. patients with active bleeding or new thrombotic diseases who are orally taking with anticoagulant drugs or have bleeding tendency.

Keywords: pd-1 inhibitors, immunotherapy, nsclc, pd-l!
cd30 targeted car-t in treating cd30-expressing lymphomas

Conditions: Hodgkin Lymphoma; Anaplastic Large Cell Lymphoma

Summary: car-t cells have been validated effective in treating cd19 positive b cell lymphoma. other lymphomas like hodgkin's lymphoma and anaplastic large cell lymphoma are cd30 positive. in this study, a newly cd30 targeted cart therapy icar30 is designed to specifically kill those cd30 expressing malignancies including hodgkin's lymphoma and cd30+ anaplastic large cell lymphoma. the subjects will receive several doses of autologous icar30 t cells infusion and then the safety, treating effects and lasting period of these cells in vivo will be evaluated.


Eligibility criteria:
inclusion criteria: hodgkin's lymphoma, anaplastic large cell lymphoma and other cd30 positive malignancies, relapsed or refractory: * karnofsky or lansky score \>50; * expected survival\>12 weeks; * hgb \> 8.0; * fev1, fvc and dlco ≥50% of expected corrected for hemoglobin; * lvef≥50%; * creatinine\<2.5mg/dl; * bilirubin\<2.5mg/dl; * alt (alanine aminotransferase)/ast (aspartate aminotransferase)\<3 fold normal; * patients must sign an informed consent. exclusion criteria: * pregnant or lactating; * uncontrolled active infection including hepatitis b or c; * hiv positive; * active clinically significant cns dysfunction; * current use of systemic steroids; * heterogenous lymphocyte treatments within recent 6 months;
innovations in hiv testing

Conditions: Human Immunodeficiency Virus

Summary: the investigators propose to improve hiv prevention and care through expanding hiv testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care.

the investigators propose to improve hiv prevention and care through expanding hiv testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care. in this study the investigators proposed two phases. the first phase, previously completed, is formative and involved two parts: 1) conducting formative qualitative research to understand perceptions of hiv testing and hiv self-testing in the study population and 2) conducting observed hiv self-testing to better understand any challenges with self-testing and the materials needed to make the process clear. the second phase of the study is a randomized controlled trial where the investigators will randomize approximately 400 young women to receive either 1) choice of self-testing or clinic-based hiv counseling and testing (hct) or 2) clinic based hct. once young women have been randomized, they will be asked to recruit up to 4 peers or male sex partners to test with the method of their randomization group.

Eligibility criteria:
eligibility inclusion criteria index: * females ages 18-26 * have had sex in the past 3 months and plan to have sex again in the next 3 months * planning on staying in the agincourt health and demographic surveillance system (ahdss) area for the next nine months * able and willing to provide informed consent * willing to comply with study procedures * not known to be hiv positive (not reporting a previous positive test) eligibility inclusion criteria peer/partner: * females and males ages 18 and older * able and willing to provide informed consent * willing to comply with study procedures
an integrated smoking cessation and alcohol intervention for young people

Conditions: Smoking Cessation; Alcohol Drinking

Summary: the study will be a three-arm randomized controlled trial in a convenience sample of 150 smokers aged 18-25 years with a drinking habit who will be recruited from smoking hotspots in mong kok. participants will be randomized into a standard treatment (st), ii, or control arm. participants in the st arm will receive a brief smoking cessation intervention based on the asking about tobacco use, advising smokers to quit, assessing their willingness to quit, assisting in quitting, and arranging for follow-up and relevance, risks, rewards, roadblocks and repetition models. participants in the ii arm will receive brief advice on alcohol use based on the frames model in addition to the brief smoking cessation intervention. booster interventions will be provided to both st and ii arms at 1-week, 1-month, 3-month, and 6-month follow-up. participants in the control arm will receive leaflets on smoking cessation and alcohol abstinence. data collection will be done at baseline and at 1-week, 1-month, 3-month, and 6-month follow-ups. self-reported quitters at 6-month follow-up will be invited for biochemical validation.


Eligibility criteria:
inclusion criteria: * smoked at least one cigarette in the past 30 days * have consumed at least one cup of alcohol (10 ounces of beer, 4 ounces of wine, or 1 ounce of liquor) in the past 30 days * speak cantonese. exclusion criteria: * have a compromised mental status and/or communication problems * participating in other smoking cessation interventions
proximal hamstring avulsion surgery cohort study

Conditions: Proximal Hamstring Rupture

Summary: proximal hamstring rupture is a rare injury, which may be immediately diagnosed. in 1996, sallay showed that functional results of surgical repair were better than those of conservative treatment. surgery is now the rule. the main aim of this study is to obtain a more detailed and quantified description of the postoperative outcomes.


Eligibility criteria:
inclusion criteria: * a partial or complete hamstring proximal rupture, * treated surgically * diagnosis of rupture based on clinical signs and confirmed on mri exclusion criteria: * no exclusion criteria
effectiveness of point of care blood analysis obtained from skin puncture blood

Conditions: Cardiovascular Diseases; Acute Abdomen; Respiratory Disease; Renal Disease; Cerebrovascular Disorders

Summary: this study aimed to evaluate the correlation between the point of care blood analysis obtained from skin puncture blood and conventional blood analysis obtained from venous and arterial blood.


Eligibility criteria:
inclusion criteria: * the patients who simultaneously require the venous blood test, skin puncture blood test and arterial blood gas analysis exclusion criteria: * unstable patients * patients receiving the medications affecting the results of blood analysis.

Keywords: venous blood arterial blood capillary blood
initial experience with the angiovac venous drainage cannula

Conditions: Heart Disease

Summary: this is a retrospective, record-based study of approximately 100 patients across up to 12 centers within the united states. all patients who have been treated with the angiovac venous drainage cannula and the extracorporeal circuit will be considered for study participation. eligible subject must meet all of the inclusion criteria and none of the exclusion criteria to be considered enrolled in the study. the purpose of the study is to describe initial experience with the angiovac venous drainage cannula and the extracorporeal circuit.


Eligibility criteria:
inclusion criteria: * consecutive patients treated at each study site between february 1, 2013 and february 28, 2015 will be included. exclusion criteria: * patients treated with the angiovac venous drainage system outside of those dates.