Kornimate/medical-research-clean huggingface dataset:
buprenorphine transdermal patches (btds) in subjects with osteoarthritis pain. includes a 52-week extension phase.

Conditions: Osteoarthritis

Summary: the original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (btds) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. the double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen) will be provided to all subjects in addition to study drug. this study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.

buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Eligibility criteria:
inclusion criteria: * osteoarthritis of the hip, knee, or spine for 1 year or longer. * taking between 30-80 milligrams (mg) of oral morphine sulfate or equivalent/day, at least 4 days a week. exclusion criteria: * taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment. * requiring frequent analgesic therapy for chronic conditions in addition to osteoarthritis. other protocol-specific exclusion/inclusion criteria may apply.

Keywords: chronic pain osteoarthritis transdermal
safety and efficacy of psilocybin for body dysmorphic disorder

Conditions: Body Dysmorphic Disorders

Summary: in this pilot study 12 adult outpatients with body dysmorphic disorder that has not responded to at least one adequate trial of a serotonin reuptake inhibitor will be treated openly with a single oral dose of psilocybin. followup visits to monitor safety and clinical outcome will be conducted over a 3 month period.

in this pilot study, up to 12 adult outpatients with body dysmorphic disorder that has not responded to at least one adequate trial of a serotonin reuptake inhibitor will be treated openly with a single oral dose of psilocybin. procedures will follow those previously established in depression studies of psilocybin. patients will receive intensive preparation and support from two therapists, including 8-9 hours accompanying the patient on the day of medication administration in the biological studies unit of new york state psychiatric institute. followup visits to monitor safety and clinical outcome will be conducted at day 1, week1, and months 1,2, and 3 post-administration. resting state function magnetic resonance imaging will be conducted prior to and one day after psilocybin administration to assess the effect of medication on brain circuits.

Eligibility criteria:
inclusion criteria: * body dysmorphic disorder of at least moderate severity, non-delusional subtype, for \>6 months * history of intolerance of, or nonresponse to, a prior adequate trial of a serotonin reuptake inhibitor (ssri) or serotonin-norepinephrine reuptake inhibitor (snri) * currently in psychotherapy (other than cognitive behavioral therapy (cbt) for body dysmorphic disorder exclusion criteria: * current major depressive disorder of greater than moderate severity * other significant psychiatric or medical comorbidity or conditions that could interfere with safety of participation or interpretation of outcomes * use of: investigational medication within 3 months of baseline; depot antipsychotic within 6 months of baseline; serotonergic medication within 2 weeks of baseline (6 weeks for fluoxetine). * females who are pregnant, breastfeeding, or sexually active and not willing to use adequate contraception * enrollment in any investigational drug or device study in past 30 days * prior adverse effects from psilocybin
geoasma: pilot and evaluation of a clinical decision support system and a mobile app for the management of asthma patients.

Conditions: Asthma

Summary: geoasma is a study for the definition, validation and evaluation of predictive models on the influence of the environment on asthmatic patients in andalusia.

although for decades there have been multiple studies on the association of asthma with factors such as weather conditions, pollution, pollen and the social condition of patients, the geoasma project aims to advance the study of environmental factors that influence the health of asthmatic patients by combining bigdata technology and data mining analysis, geographic information systems and open data provided by official sources with data from the electronic health record of the andalusian health system, that provides healthcare services to more than 8,000,000 citizens. this project aims to study through data mining techniques and multilevel analysis the influence of clinical and environmental factors: pollen level, air pollution, atmospheric conditions and social determinants in more than 800,000 asthmatic patients during the last 15 years in andalusia, the southernmost region of spain. it is expected that the results of this study will serve to define predictive models that will help professionals and patients in our region to make decisions. after the validation of the models, a decision support system will be implemented in a web platform and in a mobile application. its impact on the reduction of exacerbations, control, quality of life and resource consumption of asthmatic patients will be analysed. this evaluation will be carried out through a pilot with 214 patients with a follow-up period of 12 months with asthma in the hospitals participating in this proposal.

Eligibility criteria:
inclusion criteria: * diagnosed with bronchial asthma in its intermittent and persistent degrees mild/moderate. * no respiratory infections in the month prior to testing. * availability and/or ability to use a smartphone. exclusion criteria: * severe persistent asthmatics. * pregnant women, breastfeeding women or women who want to become pregnant during the duration of the study. * subjects with malignant disease, uncontrolled risk factors or any pathology that compromises the safety of the study. * treatment with systemic corticosteroids during the 6 months prior to or during the study. * subjects with problems that limit their ability to cooperate. * subjects unable to perform correct spirometric maneuvers.
sentinel™ trial: a prospective study evaluating the performance and clinical benefit of personalized ctdna-based mrd testing to detect recurrence and monitor treatment response in patients with solid tumors

Conditions: Cancer

Summary: the sentinel™ trial is a non-randomized, large-scale observational trial designed to: 1) evaluate the ability of circulating tumor dna (ctdna)-based minimal residual disease (mrd) testing to detect recurrence in advance of standard-of-care techniques across solid tumors, and 2) determine the clinical benefit of therapy in ctdna-positive participants. the study offers the opportunity to 1) serially monitor participants for ctdna changes, 2) define ctdna kinetics across tumor and therapy types, 3) identify participants with ctdna evidence of mrd, and 4) understand the clinical benefit of ctdna status on treatment outcomes.

patients with a confirmed diagnosis of a stage i through iii solid tumor who have had definitive therapy or curative surgery within the last 5 years or are planning curative surgery may be eligible for the sentinel trial. patients must have a surplus formalin-fixed paraffin-embedded tumor specimen available at screening, or a planned resection within 28 days of screening. to support ctdna assessment, study procedures will be limited to serial blood draws repeated every 12 weeks until investigator determined recurrence. upon recurrence, participants will remain on study for 3 years in survival follow-up.

Eligibility criteria:
study participants must meet all the inclusion criteria below to enroll: 1. male or female participants ≥ 18 years of age; 2. confirmed diagnosis of a stage 1-3 solid tumor; 3. curative surgery or definitive therapy (e.g., chemoradiation, stereotactic body radiation therapy \[sbrt\]) completed \<5 years ago without any current evidence of radiographical or biochemical recurrence, or planned within 28 days of consent; 4. surplus formalin fixed paraffin embedded tumor specimen available; 5. able to tolerate venipuncture for blood draws; 6. primary diagnosis is not glioma or cns disease; 7. both the tumor tissue sample and blood sample pass the quantity and quality parameters to allow for a successful mrd test result.
the champ (chondral lesions and meniscus procedures) trial

Conditions: Meniscal Tear; Chondromalacia

Summary: the purpose of this randomized controlled trial is to determine the effectiveness of treating cartilage lesions found during knee arthroscopy.

normal wear-and-tear on the knee can cause tissue, or cartilage, in the knee to soften over time forming chondral lesions. worn out cartilage is often found during knee surgery for other conditions. typically, surgeons will remove any worn out cartilage that is found using a procedure called debridement. however, the investigators do not know if surgically treating the worn out cartilage is better than leaving the tissue untreated, so it is necessary to compare the two. patients who are found to have worn out cartilage during arthroscopy, will be randomly assigned to either receive treatment (debridement) or non-treatment (observation) of their cartilage. patients without worn out cartilage will also be included in this study and observed postoperatively. the primary objective of this study is to examine the effects of treatment of worn out cartilage (versus non-treatment of worn out cartilage and versus patients without worn out cartilage), on self-reported knee pain following arthroscopic meniscectomy using a double-blinded randomized controlled trial design. secondary objectives of this study include examining the effects of treating worn out cartilage on other outcomes (subjective knee and general health scores and knee measurements including range of motion, presence of effusion and quadriceps circumference) and also to calculate the intra-operative costs associated with treatment, including the amount of time and instruments needed for debridement.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo a meniscectomy * patients with chondral lesions found during meniscectomy * patients without chondral lesions are not eligible for randomization to one of the study arms, but will still be included in the study and observed after surgery exclusion criteria: * osteochondritis dissecans * large chondral flaps judged to be impending loose bodies * joint space loss of affected compartment greater than 50% compared to opposite side * visible osteophytes of the medial or lateral compartment * previous knee surgery on the affected side * previous major knee trauma * history of inflammatory joint disease, gout, or chondrocalcinosis * presence of worker's compensation claim * patients undergoing meniscal repair * patients undergoing microfracture for contained grade iv chondral lesions * presence of significant ligamentous instability in the operative knee (i.e., complete acruciate ligament (acl) or posterior cruciate ligament (pcl) tear, grade iii medial or lateral side instability) * major neurologic deficit * serious medical illness with limited life expectancy or that poses high intraoperative risk * pregnancy

Keywords: arthroscopy debridement
leptin and ghrelin in icu

Conditions: Critically Ill

Summary: enteral alimentation is the preferred modality of support in critical patients who have acceptable digestive function and are unable to eat orally, but the advantages of continuous versus intermittent administration are surrounded by controversy. this prospective, randomised study was designed to compare two enteral feeding methods with respect to changes in levels of leptin and ghrelin in icu.


Eligibility criteria:
inclusion criteria: * who were unable to ingest an oral diet * given decision on enteral feeding exclusion criteria: * carcinomatosis * irreversible coma * death or discharge before 14 days of observation * contraindication to enteral feeding * intolerance to the prescribed nutrients or infusion regimen * burn * multiple trauma * morbid obesity * end stage liver or renal or lung disease * severe sepsis or septic shock * patients with percutaneous endoscopic gastrostomy * immunosuppressive drug use * severe hemodynamic instability * massive blood transfusion

Keywords: leptin levels ghrelin levels
analysis of skin lesions for melanoma presence by volatile spectroscopy techniques

Conditions: Melanoma

Summary: the purpose of this research study is to determine if a very sensitive chemistry lab analyzer can be used to smell a skin cancer (like melanoma) similar to some dogs.

types of skin cancer, like melanoma, are likely to spread and are becoming increasingly common. at this time, healthcare providers look at patient's skin and remove a sample of suspicious areas of the skin (biopsy) to test for cancer. this research study will inspect cotton and cloth swabs of normal skin and suspicious areas of the skin that are going to be biopsied just before the biopsy. the swabs will be looked at with a very sensitive chemistry lab analyzer to see if the lab analyzer can confirm conventional lab test findings.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * seen at the dermatology clinic \& determined to need a skin biopsy of a suspicious lesion exclusion criteria: * \< 18 years of age

Keywords: skin cancer suspicious lesion skin biopsy noninvasive screening
a randomized controlled trial to assess the role of emergent vs early endoscopy in child b and c cirrhotic patients with acute variceal bleed (avb)-early - avb

Conditions: Acute Variceal Bleed

Summary: summary-variceal bleeding - 70% of all upper gastro-intestinal bleeding episodes in patients with portal hypertension, and they result from esophageal varices (evs), gastric varices (gvs), or ectopic varices. management of acute variceal bleeding includes endoscopic variceal ligation (evl) along with vasoactive agents. inspite of successful hemostasis, this is associated with high variceal rebleeding (vrb) in child b and c cirrhosis and have higher 6-week mortality rates and liver related adverse events. from time of presentation to emergent endoscopy that is 4 hours can reduce the mortality when compared early endoscopy within 4-12 hours so that mortality rate related to bleed can reduced and early hemostasis can be achieved.

1. aim and objectives -to assess the role of emergent endoscopy vs early endoscopy in patients with acute variceal bleed in child b\&c cirrhosis. 2. hypothesis - early use of endoscopy along with adequate resuscitation and medical optimization in patients with child b/c cirrhosis would lead to higher rates of endoscopic hemostasis thereby associated with better clinical outcomes, in terms of in hospital mortality rate and liver failure related mortality in post bleed, recurrent bleeding rates. study population- patient presenting with avb as per definition in child b \&c cirrhotics. study design- randomized control trial non inferior trial. study area- ilbs , delhi intervention: patient after screening for all exclusion criteria will be randomized into either emergent endoscopy or early endoscopy monitoring and assessment: all patients would undergo vital and baseline parameter screening before randomization. based on randomization they will undergo the endoscopy procedure.post procedure patient will be followed and evaluated for rebleed, mortality, liver related events if any like hepatic encephalopathy, ascites, ischemic hepatitis.

Eligibility criteria:
inclusion criteria: 1. child b and c cirrhotic patients with history of avb 2. \>18yrs and \<75 yrs. 3. fluid responsive within 1 hour after resuscitation exclusion criteria: 1. ehpvo / ncph 2. lack of consent pregnancy 3. child a cirrhotics 4. severe cardiopulmonary disease requiring optimization (deemed contraindication for endoscopy within 12 hours). 5. need of dual vasopressors at presentation in hospital patients with bleed 6. hcc patients with avb 7. patients presented with avb on going antiplatelets/anticoagulants.
safety, efficacy, and pharmacokinetic profile of dnb-001 in subjects with elevated intraocular pressure

Conditions: Ocular Hypertension; Elevated IOP; Glaucoma

Summary: a multi-centre, double-blind, randomised, parallel-group, placebo-controlled phase 1i study to investigate the safety, efficacy, and pharmacokinetic profile of twice-daily dnb-001 in previously untreated patients with intraocular hypertension

to evaluate the efficacy of four dosages of mg dnb-001 administered twice daily (bid) per os (p.o.) as an anti-ocular hypertensive agent, compared with placebo administered bid po, for 28 days, in patients with ocular hypertension.

Eligibility criteria:
inclusion criteria: * male or female, at least 18 years old, in general good health, not presently treated for elevated intraocular pressure (iop), with best corrected early treatment diabetic retinopathy study (etdrs) visual acuity score equivalent to a snellen score of 20/50 or better in each eye and lop of 21 to 29 mm hg at baseline. exclusion criteria: * use of intraocular pressure lowering medication within the past 3 months or any history of ocular surgery for glaucoma * evidence of potential angle closure by gonioscopy * abnormal optic disc or visual field consistent with glaucoma * use of topical ocular medications during the study and any evidence of systemic disease that might interfere with the conduct of the study.

Keywords: ocular hypertension elevated iop glaucoma neuroprotection
study on the construction and application of early warning model of sepsis in critically ill patients

Conditions: Sepsis; Sepsis and Septic Shock; Infection

Summary: the condition of sepsis patients changes rapidly, whom are often accompanied by impaired respiratory, circulatory, renal, and coagulation functions. so far, the prognosis of sepsis at home and abroad is not ideal. participants was randomly included in this research project on the pathogenesis and prevention of sepsis due to typical sepsis symptoms. the investigators will collect appropriate clinical specimens for analysis of immune cell functions and pathogenic microorganisms combined with individual patient research. this study will enable sepsis patients to be identified early and receive earlier anti-sepsis treatment, which is expected to improve the prognosis of sepsis, shorten hospitalization time, and reduce treatment costs. the above-mentioned tests and analyses do not increase the economic burden on the participants, and the required expenses are all paid from the project funds; they do not affect the prognosis and rehabilitation process of participants, and do not have adverse effects on the health of participants.


Eligibility criteria:
inclusion criteria: 1. temperature \> 38°c or \< 36°c; 2. heart rate \> 90 beats/min; 3. respiratory rate \> 20 breaths/min or paco₂ \< 32 mmhg; 4. white blood cell count \> 12.0 × 10⁹/l or \ 10% immature neutrophils; 5. initial septic shock diagnosis; 6. organ dysfunction (cardiovascular, respiratory, or ≥ 2 other organs); 7. complete clinical data. exclusion criteria: 1. cancer history; 2. chemotherapy; 3. radiotherapy; 4. incomplete data. 5. controls were free of infectious or inflammatory diseases and glucocorticoid use.

Keywords: sepsis septic shock biomarker warning model
the role of oxytocin-receptor signalling in physiological regulation of eating behaviour in individuals with obesity

Conditions: Adiposity

Summary: the present study evaluates appetite, glucose metabolism, gastrointestinal motility and energy expenditure in men and women with obesity (bmi 30-40 kg/m2) under oxytocin exposure compared to placebo.

in a randomised, double-blind, placebo-controlled, crossover fashion, 24 participants will complete two experimental days (a and b) including a mixed meal test and an ad libitum meal test. the procedures during the two experimental days are similar except for intravenous infusion of oxytocin on experimental day a and placebo (saline) on experimental day b, respectively. on experimental days, oxytocin or placebo infusion will be started at timepoint -60 minutes. at timepoint 0 minutes, participants will ingest a liquid mixed meal. after 190 minutes, participants are served an ad libitum meal followed by ad libitum snacks.

Eligibility criteria:
inclusion criteria: * age 18-65 years * bmi between 30 and 40 kg/m2 (both included) * percentage body fat (bf%) ≥25 for men and ≥32 for women (assessed by bioelectrical impedance analysis) * informed oral and written consent exclusion criteria: * anaemia (haemoglobin below normal range) * alanine aminotransferase (alt) \>2 times normal values * history of hepatobiliary and/or gastrointestinal disorder(s) * kidney disease (serum creatinine above normal range and/or urine albumin-creatinine ratio (uacr) \>30 mg/g confirmed by two measures) * previous gastric or intestinal resection, cholecystectomy and/or any major intra-abdominal surgery (including bariatric surgery) * previous pancreatic disease and/or neoplasia * regular tobacco smoking and/or use of other nicotine products * glycated haemoglobin (hba1c) ≥48 and/or type 1 diabetes or type 2 diabetes requiring medical treatment * pituitary gland disorders * initiation of special diets, lifestyle changes and/or weight loss \>5% of total body weight within three months prior to or during study period * pregnancy or breastfeeding * long qtc on electrocardiogram (ecg) at screening (≥0.45 seconds for men and ≥0.46 seconds for women) * any physical or psychological condition or ongoing medication the investigator group suspect would interfere with trial participation

Keywords: oxytocin appetite regulation gastrointestinal motility energy expenditure
feasibility of the innovein valve and delivery system for chronic venous insufficiency

Conditions: Chronic Venous Insufficiency

Summary: this objective of this feasibility study is to evaluate the safety of the innovein valve and delivery system for treatment of chronic venous insufficiency.

chronic venous insufficiency occurs when the venous wall and/or valves in the leg veins are not working effectively, making it difficult for blood to return to the heart from the legs.the core etiology of the disease stems from increased venous pressure and incompetent venous valves leading to regurgitation of blood that accumulates in the legs. it has been shown that implantation or recreation of a functional valve can lead to clearance of excess blood and resolution of symptoms. the innovein valve and delivery system is a new, investigational biocompatible valve intended to support natural flow in vessels in patients with chronic venous insufficiency. the purpose of this study is to assess the safety of the innovein valve and delivery system for treatment of chronic venous insufficiency.

Eligibility criteria:
key inclusion criteria: * willing and able to provide written informed consent * diagnosis of symptomatic non-obstructive chronic valvular insufficiency of the femoral vein * willing and medically able to receive intraprocedural and post-procedural anticoagulation medication * life expectancy \>1yr * reflux time \>1s in the superficial femoral and/or popliteal vein key exclusion criteria: * any prior deep vein intervention within 6 months prior to the index procedure * history of 2+ dvts * inadequate inflow to the femoral vein or inadequate outflow through the femoral vein, iliac vein, or ivc * current ivc placement * history of pulmonary embolism within 6 months * conditions that increase the risk of device thrombosis or patient bleeding * any planned surgical or interventional procedure within 30 days prior to or after the index procedure * investigator or sponsor believes the subject would not benefit, would not be appropriate, be unable to follow-up, or be at high risk for non-compliance with the protocol