Kornimate/medical-research-clean huggingface dataset:
effect of pde5 inhibition on adipose metabolism in humans

Conditions: Obesity

Summary: this is a randomized, double-blinded, placebo-controlled study of the effects of pde5 inhibition with tadalafil on adipose tissue in obese individuals. adipose metabolism will be measured using magnetic resonance imaging (mri) scans and by aspirating a small amount of adipose to measure gene expression.

the purpose of this study is to test whether tadalafil causes subcutaneous adipose tissue to have a "beige" phenotype. participants will be randomized to either placebo or tadalafil for 12 weeks. investigators will study adipose metabolism using mri scans and aspiration of subcutaneous adipose from the abdomen. in addition to mri scans at room temperature, the investigators will use a cooling protocol to test the combined effects of tadalafil and on adipose metabolism. investigators will also measure the effects of the drug on body composition. in addition to the study visits, participants will wear an activity tracker (fitbit) and log their dietary intake several times using an online tool. there will be a small amount of radiation exposure. participants will be compensated for participation in this study.

Eligibility criteria:
inclusion criteria: * adults * obesity (bmi ≥ 30 kg/m2) exclusion criteria: * age \ 50 * bmi \< 30 kg/m2 * systolic blood pressure (sbp) \ 150 mmhg * current anti-hypertensive medication use, including diuretics * current use of organic nitrates * current use of pde-5 inhibitors (sildenafil, tadalafil, vardenafil) * history of reaction to pde-5 inhibitors * known hiv infection * use of medications that strongly alter cyp3a4 activity * history of myocardial infarction, angina, uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, or seizure * known non-arteritic ischemic optic retinopathy (naior) * history of hearing loss * estimated glomerular filtration rate (egfr) \< 60 ml/min/1.73 m2 by the modified diet in renal disease (mdrd) equation * hepatic transaminase (ast and alt) levels greater than three times the upper limit of normal * known pregnancy or breastfeeding or those unwilling to avoid pregnancy during the course of the study * history of priapism * use in excess of four alcoholic drinks daily * history of diabetes mellitus or use of anti-diabetic medications * known anemia (men, hct \< 38% and women, hct \<36%) * menopause * weight \> 300 pounds * individuals with circadian rhythm disorders, shift workers, or those who travel across time zones frequently
cohort study of volunteers that have participated to preventive hiv-1 vaccine trials

Conditions: HIV Infection; HIV Seronegativity

Summary: this cohort study should provide an exhaustive overview on long-term safety of various preventive hiv-vaccines administered in phase i and ii clinical trials to healthy volunteers of the anrs network.

since 1992, 16 phase i and ii clinical trials have been performed by the french national agency for research on aids and viral hepatitis (anrs) evaluating the safety of several hiv-1 vaccine candidates and their capacity to induce immune responses. the anrs program has evaluated a recombinant hiv-1 envelope protein rgp-160, canarypox alvac vectors, and mixtures of lipopeptides whose sequences represent ctl-epitopes of hiv-1 gag, pol and nef proteins. most of them have been administered intramuscularly but recently, mucosal immunization and intradermal route were used. previously compiled in a published meta-analysis, safety studies were restricted to the duration of the trials. anrs establishes a cohort study in order to describe the long-term safety of preventive hiv-vaccines administered in phase i and ii clinical trials to healthy volunteers of the "anrs volunteer-network" in france and to gather clinical and biological data in a database and blood specimen collection which could be analysed in case of a long-term safety issue in anrs vaccine trials or if pertinent, in other hiv vaccine trials anrs cov1-cohvac is a prospective, multicentric cohort study composed of participants in preventive hiv-vaccines phase i and ii trials. all anrs volunteers who ever received one dose of a candidate vaccine are eligible and those who are going to complete their participation to a clinical trial during the cohort study time. the anrs cov1-cohvac project relies on a long-term follow-up of the cohort (at least 7 years after the end of the vaccine trial), that includes the retrospective and prospective collection of medical and biological data \[severe health events (grade 3-4), as well as neurological, ophtalmological, and immunological events (any grade), starting from the first injection of a candidate vaccine, are recorded\], blood specimen collections and psycho-behavioral evaluations (self-questionnaires and interviews) in order to collect data about consequences of participation and experience of possible hiv vaccine-induced seropositivity in such trials. of the anrs "volunteer-network", 206 participants have been involved in the early trials and are actually eligible to participate in this cohort. altogether with the more recent studies completed or in progress, the cohort will comprise at least 400 individuals in 2009.

Eligibility criteria:
inclusion criteria: * healthy volunteers of the "anrs volunteer network" who have received at least one dose of a vaccine candidate in a hiv preventive clinical trial. * volunteers who have signed an informed consent exclusion criteria: * volunteers not covered by health insurance

Keywords: cohort hiv uninfected volunteers hiv preventive vaccine long term safety
cicatrix cream in post surgical scars and epidermic burn

Conditions: Post Surgical Scars; Epidermic Burn

Summary: the purpose of the study is to assess the effect of cicatrix (asian gotu kola or pennywort) usage in the treatment of epidermic burns or post surgical scars. the duration of this phase 2 clinical trial will be two months.


Eligibility criteria:
inclusion criteria: * patient with lesions characteristic of the investigated illness. * signed informed consent exclusion criteria: * patient that refer manifestations of high sensibility to the medication or to some of the components of the product * patient that don't want to participate in the study * patient not very cooperative * family responsible not very cooperative

Keywords: post surgical scars epidermic burn cicatrix cream
risk factors for post acl reconstruction pain

Conditions: Risk Factors for Post ACL Reconstruction Pain

Summary: in 2006, approximately 130,000 arthroscopic anterior cruciate ligament reconstructions were performed in the united states, and the number is increasing each year. despite being a minimally invasive procedure, pain is the most common postoperative problem after arthroscopic anterior cruciate ligament reconstruction associated with cost, postoperative opioid consumption, opioid-related side effects, quality of life, patient satisfaction, and delayed discharge. over two-thirds of the patient receiving arthroscopic anterior cruciate ligament surgery have moderate to severe pain.

at present, multimodal analgesia is a successful mainstay treatment for arthroscopic anterior cruciate ligament surgery which range from opioid, paracetamol, non-steroidal anti-inflammatory agents (nsaids), local anesthetic agents, ketamine, corticosteroid, and cold compression therapy. previous study showed femoral nerve block reduces pain score but also increases incidence of falling. afterward, a study on adductor canal block showed equivalent postoperative analgesia while preserving quadriceps strength. furthermore, a few studies were conducted to determine risk factors for postoperative pain after arthroscopic anterior cruciate ligament surgery, but results are contradictory. previous research found risk factors for postoperative pain after arthroscopic anterior cruciate ligament surgery are female, young age, smoker, preoperative visual analog scale score ≥3, tourniquet time \> 50 minutes, and cartilage injury. in addition, evidence showed higher preoperative visual analog scale, and previous opioid use are associated with greater amount of opioid consumption. in contrary, some evidence showed no effect of age, sex, body mass index (bmi), tourniquet time, type of anesthesia on post postoperative pain after arthroscopic anterior cruciate ligament surgery.

Eligibility criteria:
patients undergoing primary unilateral arthroscopic anterior cruciate ligament reconstruction with or without unilateral cartilage/meniscus injury with or without other ligaments injury (posterior cruciate ligament/medial collateral ligament/lateral collateral ligament) age ≥ 15 years
momelotinib combined with capecitabine and oxaliplatin in adults with relapsed/refractory metastatic pancreatic ductal adenocarcinoma

Conditions: Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma

Summary: this study will evaluate the safety, tolerability, and define the maximum tolerated dose (mtd) of momelotinib (mmb) combined with capecitabine and oxaliplatin in adults with relapsed/refractory metastatic pancreatic ductal adenocarcinoma.


Eligibility criteria:
key inclusion criteria: * relapsed or refractory metastatic pancreatic adenocarcinoma * received 1 prior chemotherapy regimen for metastatic pancreatic ductal adenocarcinoma (not including neoadjuvant and/or adjuvant therapy) * measurable disease per recist v1.1 * adequate organ function defined as * aspartate transaminase (ast) and alanine transaminase (alt) ≤ 3 x upper limit of normal (uln) or ≤ 5 x uln if liver metastases are present; total conjugated bilirubin ≤ 2 x uln * absolute neutrophil count (anc) ≥1500 cells/mm\^3, platelet ≥100,000 cells/mm\^3, hemoglobin ≥ 9.0 g/dl * creatinine clearance (crcl) \> 50 ml/min as calculated by the cockroft-gault method * eastern cooperative oncology group (ecog) performance status of 0 or 1 key exclusion criteria: * received more than 1 prior line of chemotherapy for metastatic pancreatic ductal adenocarcinoma * major surgery within 21 days of first dose of study drug * minor surgical procedure(s) within 7 days of enrollment or not yet recovered from prior minor surgery (placement of central venous access device, fine needle aspiration, or endoscopic biliary stent ≥ 1 day before enrollment is acceptable) * chemotherapy, immunotherapy, biologics, and/or investigational therapy within 21 days prior to first dose of study drug * known positive status for hiv, chronic active or acute viral hepatitis a, b, or c infection, or hepatitis b or c carrier * known dihydropyrimidine dehydrogenase deficiency * peripheral neuropathy ≥ grade 2 * any condition that impairs gastrointestinal absorption of drug * known or suspected brain or central nervous system metastases * diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma, adenocarcinoma originating from the biliary tree or cystadenocarcinoma * external biliary drain * documented myocardial infarction or unstable/uncontrolled cardiac disease within 6 months of enrollment note: other protocol defined inclusion/exclusion criteria may apply.
endoscopy in anemic children

Conditions: Refractory Iron Deficiency Anemia

Summary: assess the role of upper and lower gastrointestinal endoscopy in evaluation of refractory iron deficiency anemia in children


Eligibility criteria:
inclusion criteria: * children with iron deficiency anemia not responding to medical treatment for more than 6 weeks exclusion criteria: * children with iron deficiency anemia responding to medical treatment children below 1 years and above 18 years old
oral isl qm as prep in cisgender women at high risk for hiv-1 infection (mk-8591-022)

Conditions: HIV-I; Human Immunodeficiency Virus Type 1; Prophylaxis

Summary: this study will evaluate whether oral islatravir (isl) is effective in preventing human immunodeficiency virus type 1 (hiv-1) infection in women at high-risk for hiv-1 infection. the study will compare oral isl taken once a month with standard-of-care medication for prevention of hiv-1 infection, emtricitabine/tenofovir disoproxil (ftc/tdf), taken once per day. the primary hypothesis is that oral isl is more effective than ftc/tdf at reducing the incidence rate per year of confirmed hiv-1 infections.

based on laboratory findings of decreased lymphocyte and cd4+ t-cell counts across the islatravir program, dosing of blinded study intervention was halted on 13-dec-2021 and screening and randomization of new participants was ended. blinded assessments conducted prior to this date are designated as study part 1. during study part 2, participants from part 1 have the option to receive daily open-label ftc/tdf while continuing in the study for safety monitoring. study part 3 was added to unblind each participant's part 1 study intervention assignment, continue participants on ftc/tdf, and monitor safety.

Eligibility criteria:
inclusion criteria: * confirmed hiv-uninfected based on negative hiv-1/hiv-2 test results before randomization. * sexually active (vaginal and/or anal sex) with a male sexual partner in the 30 days prior to screening. * high risk for hiv-1 infection. * not pregnant or breastfeeding, and one of the following conditions applies: not a woman of childbearing potential (wocbp) or is a wocbp and is using an acceptable contraceptive method during the intervention period and for at least 42 days after the last dose. * a wocbp must have a negative pregnancy test within 24 hours prior to the first dose of study intervention. exclusion criteria: * hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator. * findings of chronic hepatitis b virus (hbv) infection or past hbv. * current or chronic history of liver disease. * history of malignancy within 5 years of screening except for adequately-treated basal cell or squamous cell skin cancer, or in situ cervical cancer. * past or current use of cabotegravir, lenacapavir, or any other long-acting hiv prevention product. * currently participating in or has participated in an interventional clinical study with an investigational compound or device, within 30 days prior to day 1. * expecting to conceive or donate eggs at any time during the study.

Keywords: preexposure prophylaxis (prep) prevention
adjunctive cb1 agonist nabilone in inpatients with active suicidal ideation

Conditions: Suicidal Ideation

Summary: suicide is a major crisis worldwide with rates projected to continue to increase. there is currently a dearth of novel pharmacologic treatment options for suicide available on the market. the endocannabinoid system has been recently shown to be associated with mood disorders including suicidality. the aim of the study is to determine whether treatment with nabilone is capable of reducing suicidal ideation in adults after 3 days.


Eligibility criteria:
inclusion criteria: * able to provide written informed consent * current suicidal ideation * columbia suicide severity rating scale (cssrs) score of ≥ 4 and scale for suicide ideation (ssi) first 5 items, score of ≥4 * current major depressive episode as evidenced by madrs score ≥ 20 exclusion criteria: * current diagnosis of a diagnostic and statistical manual v (dsm-v) psychotic disorder, psychotic symptoms, or personality disorder. * recent (\<72 hrs) use of illicit substances * comorbid substance use disorder diagnosis * urine drug screen (uds) positive for tetrahydrocannabinol (thc) * pregnant or nursing women * unstable medical condition
a multicenter trial of pla vs. surgery for treating ptmc

Conditions: Thyroid Cancer; Treatment Related Cancer

Summary: this is a multicenter prospective controlled trial of percutaneous laser ablation(pla) versus conventional surgery for the treatment of papillary thyroid microcarcinoma (ptmc).

pla is the acronym for "percutaneous laser ablation". the treatment consists in the destruction (ablation) of papillary thyroid micro carcinoma by means of optical fibers that deliver high-energy light (laser) into the lesion through skin puncturing (percutaneous). the procedure is performed under ultrasound imaging guidance (ultrasound-guided). the destruction of the lesion occurs through overheating and coagulation. pla, however, still needs a large-scale validation trial in order to be considered as an effective alternative to both surgery or follow-up for low-risk ptmc in elderly patients and/or in patients with co-morbidities that might expose the patients to a high surgical risk. after a comprehensive information, patients will be consecutively assigned to group 1 (surgery, preferentially lobectomy) or to group 2 (percutaneous laser ablation, performed according to the attached procedure).peri and post-operative complications, need of drug treatment, length of hospital admission and customer satisfaction will be registered. the aims of this study are as follows: 1.to establish the rate of cure or partial ablation; 2.to compare the complication rate, time expenditure and costs of two procedures; 3.to assess changes in thyroid function and the need of substitution therapy with two procedures; 4.to assess the tolerability of the procedure, the customer satisfaction and the impact on the quality of life of the patients between conventional surgery and pla.

Eligibility criteria:
inclusion criteria: * newly diagnosed ptmc (maximun diameter\> = 5 mm and \< = 10 mm) proved by fine needle aspiration biopsy with good thyroid function; * age≥ 18 y; * single nodule without thyroid capsule contact; * there had more than 3mm distance between nodules and trachea, carotid artery, recurrent laryngeal nerve (the distance should up to 5mm after injection of isolation fluid); * no coarse calcification or eggshell-like calcification; * imaging examination without local or distant metastasis; * without chemotherapy, radiotherapy and other related therapies; * a complete clinical, pathological and follow-up information; * get informed consent signed by the patient or family member. exclusion criteria: * multifocal ptmc; * combined with other types of thyroid cancer or hyperthyroidism; * lesion contact with thyroid capsule or located in the isthmus; * serious coagulation dysfunction; * contralateral vocal cord paralysis; * imaging examination with local or distant metastasis; * active tuberculosis and hiv-positive patients; * patients can not understand or follow research protocol; * pregnant woman.

Keywords: papillary thyroid microcarcinoma percutaneous laser ablation thyroidectomy ultrasonography double-blind
butorphanol in pain following ablation for hepatic tumor

Conditions: Visceral Pain; Microwave Ablation; Hepatic Tumor

Summary: the objective of this investigation was to evaluate the influence of butorphanol on postoperative pain mitigation in patients undergoing microwave ablation for hepatic tumor. employing a rigorously designed multicentral, randomized, and placebo-controlled format, patients subjected to microwave ablation were assigned randomly to either butorphanol (experimental group) or normal saline (control group). primary outcomes encompassed intraoperative pain levels assessed through patient-driven evaluation utilizing a 10-point visual analog scale (vas). secondary outcomes included postoperative pain levels at the 6-hour mark (vas) and comprehensive pain assessment outcomes.


Eligibility criteria:
inclusion criteria: patients performing microwave ablation sign the informed consent exclusion criteria: patients with a body mass index \> 30 kg/m2 a history of depression opioid dependence poorly controlled hypertension (systolic blood pressure \> 180 mmhg) myocardial infarction severe liver disease significant abdominal pain before surgery patients with sensory system or language dysfunctions who could not cooperate to complete the scale pregnant women.
effect of preoperative high-dose cholecalciferol in prevention of post-thyroidectomy hypocalcaemia

Conditions: Hypocalcemia

Summary: hypocalcaemia after thyroidectomy is observed with increasing frequency, often resulting in prolonged hospital stay with increased use of resources, delayed return to work and reduced quality of life. the administration of vitamin d is essential in the therapy of postoperative hypocalcaemia. what has not been examined so far is whether and how routine preoperative cholecalciferol prophylaxis can help to prevent postoperative hypocalcaemia

hypocalcemia following thyroid surgery is caused either due to parathyroid devascularization, stunning, or accidental removal of the parathyroid glandsmultiple risk factors have been identified which predispose patients to develop post-operative hypocalcemia. in light of the available evidence of prevalent vitamin d deficiency in the general population, and the observation of appearance of postthyroidectomy hypocalcemic symptoms at a much earlier stage than documented in previous literature, we postulate that a prophylactic vitamin d supplementation dose given in immediate preoperative period can significantly reduce acute symptomatic postoperative hypocalcemia in patients undergoing thyroid surgery

Eligibility criteria:
inclusion criteria: * adult patients (\> 18 years) * scheduled for tt * thyroid cancer treated with total thyroidectomy without lymph node dissection exclusion criteria: * lack of written consent * thyroid cancer treated with tt and lymph node dissection * mediastinal goiter with need for sternotomy * medication with thiazide diuretics, digitalis or lithium therapy * previous neck operations or radiation * preexisting hyperparathyroidism * chronic kidney failure.

Keywords: cholecalciferol, post-operative hypocalcemia, thyroidectomy
use of weightbearing radiographs to determine treatment of bi- and trimalleolar ankle fractures

Conditions: Ankle Fracture, Bimalleolar; Ankle Fracture, Trimalleolar

Summary: the aim of this study is to evaluate the outcomes after non-operative treatment of weightbearing stable bi-and trimalleolar ankle fractures.


Eligibility criteria:
inclusion criteria: * -with bi- and trimalleolar ankle fractures with less than 7 mm medial clear space on non-weightbearing radiographs that are deemed stable by weightbearing radiographs. * with type b medial malleolus fractures between the tip and the plafond and type c medial malleolus fractures at the level of the plafond (herscovici classification). (6) * with fractures in the distal 1/3 of fibula (not-maisonneuve) * enabling stability evaluation within 14 days after injury * 18-75 years of age * with pre-injury walking ability without aids exclusion criteria: * - with primary unstable ankle fractures, \> 7mm medial clear space on primary radiographs * with fracture reduction prior to initial radiographic evaluation, open fracture, fractures resulting from high-energy trauma or multi trauma and pathological fracture * with type a medial malleolus avulsion fractures \< 5mm (at the tip of the malleolus), that are not suitable for surgical intervention. * with herscovici type d fractures, involving lauge-hansen sa2 fractures (supracollicular fracture - vertical, oblique or transverse direction of the plafond) * with displaced posterior malleolus fractures that needs fixation in the judgement of the attending surgeon * with neuropathies and symptomatic joint diseases such as rheumatoid arthritis * that are assumed not compliant (such as drug abuse, cognitive- and/or psychiatric disorders) * with previous history ipsilateral ankle fracture * with previous history ipsilateral major ankle-/foot surgery * who live outside the hospital catchment areas not available to follow up * with insufficient norwegian or english language skills * non-compliant