Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the efficacy and safety of once-weekly met097 in adults with obesity or overweight and t2dm

Conditions: Obesity in Diabetes; Type 2 Diabetes Mellitus (T2DM)

Summary: this study is designed to test how well once-weekly met097 (an ultra-long-acting glp-1 receptor agonist) works to treat adults with obesity or overweight and type 2 diabetes mellitus (t2dm) compared to placebo. met097 or placebo will be administered to individuals via subcutaneous injection once weekly for 28 weeks. if an individual is randomly assigned to met097 they will receive one of four different dose regimens.

this is a 28-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy, safety, and tolerability of four different once-weekly met097 dosing regimens vs. placebo for body weight loss in adults (18-75 years of age) with obesity or overweight (body mass index \[bmi\] ≥27 to ≤50 kg/m2) and t2dm . after completing 28 weeks of study treatment, all participants will be followed for approximately 4 weeks after administration of the last dose of study treatment.

Eligibility criteria:
inclusion criteria: * bmi ≥27.0 kg/m2 to ≤50.0 kg/m2 at screening * type 2 diabetes mellitus (\*t2dm) for at least 3 months before screening * glycated hemoglobin (hba1c) value between ≥7.0% (53.0 mmol/mol) and ≤10.5% (91.3 mmol/mol) at screening and treated with stable therapy for at least 30 days prior to screening/visit 1 (diet and exercise alone or in combination with metformin monotherapy and/or sglt-2) * stable body weight (increase or decrease ≤5 kg) within 3 months prior to screening exclusion criteria: * female who is lactating or who is pregnant * estimated glomerular filtration rate (egfr) \<60 ml/min/1.73 m2 * fasting triglycerides ≥ 5.6 mmol/l (≥500 mg/dl) * poorly controlled hypertension * history of stroke * significant cardiovascular disease including but not limited to unstable angina or valvular heart disease or has a history of myocardial infarction, coronary artery bypass graft, percutaneous coronary artery re-vascularization, or congestive heart failure * diagnosis of type 1 diabetes * history of acute or chronic pancreatitis * family or personal history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men-2) * history of significant active or unstable major depressive disorder (mdd) or other severe psychiatric disorder within the last 2 years * diagnosis of type 1 diabetes * relevant surgical history including all bariatric or weight loss surgeries

Keywords: glp-1 metsera t2dm obesity overweight weight loss
plateau antibody levels of a recombinant (e.coli) hpv nonavalent vaccine versus gardasil®9 in young women

Conditions: Cervical Cancer; Condylomata Acuminata

Summary: this study is designed to compare plateau antibody levels of a novel recombinant human papillomavirus vaccine (types 6,11,16,18,31,33,45,52,58 )(e.coli) manufactured by xiamen innovax biotech co., ltd., with gardasil®9 in females 18-26 years of age.


Eligibility criteria:
inclusion criteria: * subject who had previously participated in the randomized, single-blind study to compare immunogenicity of a recombinant human papillomavirus nonavalent (types 6,11,16,18,31,33,45,52,58) vaccine(e.coli) (xiamen innovax biotech co.,ltd.) versus gardasil®9 (merck \& co., inc.) in healthy females 18-26 years of age (protocol no.: hpv-pro-011, identifiers: nct04782895), and received at least one dose ; * subject is able to understand and comply with the requirements of the protocol(e.g. biological specimen collection, return for follow-up visits), and written informed consent must be obtained from the subject prior to enrollment; exclusion criteria: * subject who had used other hpv vaccine products (including marketed and unmarketed vaccines) after participating in the randomized, single-blind study to compare immunogenicity of a recombinant human papillomavirus nonavalent (types 6,11,16,18,31,33,45,52,58) vaccine(e.coli) (xiamen innovax biotech co.,ltd.) versus gardasil®9 (merck \& co., inc.) in healthy females 18-26 years of age (protocol no.: hpv-pro-011, identifiers: nct04782895) ; * subject has abnormal coagulation function (such as coagulation factor deficiency, coagulopathy, platelet abnormalities) or coagulation disorders; * medical, psychological, social conditions, occupation or other factors, which considered by the investigator that may influence the conduct of the clinical study.

Keywords: human papillomavirus vaccine
pain perception: lidocaine rate/temp/buffer

Conditions: Pain

Summary: this study will collect data from multiple academic institutions. the primary objective for part a of this study is to determine the impact of anesthetic injection rate and temperature on pain perception during dermatologic procedures, and the objective for the part b of this study is to determine if buffering of the anesthetic solution alters pain perception. this study is a pilot study designed to determine feasibility of these procedures.


Eligibility criteria:
inclusion criteria: * subjects who are undergoing dermatologic procedures. * subjects ages 18-89 year old. * the subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator. exclusion criteria: * subjects who are allergic to lidocaine. * history of bleeding tendency or coagulopathy. * pregnant or lactating. * active skin disease or skin infection in the treatment area. * unable to understand the protocol or give informed consent. * any other condition, in the professional opinion of the investigator, that would potentially affect response or participation in the clinical study, or would pose as an unacceptable risk to the subject.
re-link hcv in substance-use telemedicine program

Conditions: Hepatitis C

Summary: this is an observational, retrospective \& prospective cohort study. the retrospective element of the study is a chart review to identify people with diagnosed but untreated hcv and re-link them to care. the observational prospective cohort element of the study will examine the hcv linkage to care, treatment initiation, treatment completion \& cure rates of these hcv clients achieved through this chart review and re-linking approach.

the study, led by truenorth medical center in ontario, focuses on re-linking people diagnosed with untreated hepatitis c (hcv) to care through a community-based substance-use telemedicine program. hcv is a significant health concern in canada, especially among people who inject drugs (pwid), who face barriers to accessing treatment. integrating hcv treatment with substance use care may improve treatment uptake. this observational study includes both retrospective and prospective cohorts. the retrospective aspect involves chart reviews to identify untreated hcv patients for re-linking, while the prospective cohort examines treatment outcomes such as linkage to care and cure rates. participants include individuals over 18 with a positive hcv rna result who have not completed a course of direct-acting antiviral (daa) treatment. excluded are those unable to consent or with restricted access to their health records. study procedures involve identifying untreated hcv patients, attempting re-linkage via telecommunication, and offering treatment through the program. outcome measures include the number of patients re-linked to care and their treatment outcomes. data analysis will utilize ibm spss for logistic regression and descriptive statistics, aiming to evaluate the efficacy of this telemedicine approach in improving hcv care among pwid. ethical considerations include informed consent and data privacy, with oversight by the advarra canadian institutional review board. the study seeks to address hcv care gaps in pwid populations by leveraging telemedicine for improved access and treatment outcomes.

Eligibility criteria:
inclusion criteria: for the retrospective chart review element of the study, inclusion criteria includes anyone who had a telemedicine visit at the community based substance use telemedicine program between january 1st 2023 and december 31st 2024. for the prospective cohort element of the study, the inclusion criteria are listed below: aged ≥18. ability and willingness of the participant to provide informed consent. having a positive hcv rna laboratory result and lacking a sufficient previous course of daa treatment. exclusion criteria: for the retrospective chart review element of the study, exclusion criteria is: a consent directive to restrict access to their olis record. for the prospective cohort study, exclusion criteria is an inability or unwillingness of the participant to provide informed consent. -
intraoperative evaluation of axillary lymphatics

Conditions: Lymphedema; Surgery; Breast Cancer

Summary: this study will assess the feasibility of using the onlume imaging system for fluorescence-guided surgery along with indocyanine green (icg) dye in the operating room for the axillary reverse mapping (arm) procedure in women with breast cancer scheduled to have axillary dissection (ad) or sentinel lymph node (sln) biopsy.

lymphatic drainage from the upper arm is often different from that of the breast, allowing safe removal of only the lymphatics of the breast and protection of the lymphatic channels draining the upper extremity during axillary dissection (ad) or sentinel lymph node (sln) biopsy, thereby reducing the risk of arm lymphedema. in this prospective study, breast cancer patients undergoing sln biopsy (n=0-20) or axillary lymph node dissection (n=0-15) will be enrolled to undergo axillary reverse mapping (arm) using isosulfan blue dye. participants will also receive icg injection with visualization through the onlume imaging system to allow comparison of blue dye versus icg lymphatic identification. the standard of care (blue dye) will be used for clinical care while the onlume imaging system is being used to determine feasibility of the product.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * diagnosis of breast cancer requiring surgical lymph node evaluation either by sentinel lymph node biopsy or axillary lymph node dissection * surgery at university of wisconsin hospital and clinic exclusion criteria: * pregnant or breast feeding * unable to provide informed consent * allergy to indocyanine green * patients with clinically positive lymph nodes undergoing sentinel lymph node biopsy, with or without axillary lymph node dissection, after neoadjuvant chemotherapy
evaluation of depression and sleep disorders in endometriosis patients

Conditions: Endometriosis; Sleep; Depression

Summary: the aim of this study was to compare the depression and sleep disturbances of operated endometriosis patients before and after the operation. the main objective here is to provide data on how patients' psychological states and sleep patterns are affected by the symptoms of endometriosis and how these effects can be corrected. in this way, it is aimed to determine whether the patients have psychological support needs and to give the planned treatment due to endometriosis in the early period. as a secondary goal, it is planned to keep the patients in follow-up with their improved sleep and psychological conditions, and to improve their adherence to treatment and quality of life.


Eligibility criteria:
inclusion criteria: * 18-49 years of age with no known psychiatric disorder and * endometriosis patients with indications for operation exclusion criteria: * patients receiving only medical treatment without any indication for operation, * those with a known psychiatric disease, * patients with sleep disorders due to another reason, * patients over the age of 49, patients under the age of 18, * patients with malignancy, * pregnant women
description of patients with type 1 diabetes treated with teplizumab

Conditions: Type 1 Diabetes

Summary: type 1 diabetes mellitus (t1d) is a chronic autoimmune disease caused by the destruction of pancreatic β cells. t1d pathogenesis progresses through several stages: stage 1 t1d includes the presence of β cell autoimmunity and thus presence of islet autoantibodies, without the presence of dysglycemia and symptoms. stage 2 t1d includes the presence of islet autoantibodies and dysglycemia, also with no symptoms. stage 3 t1d includes presence of islet autoantibodies, overt hyperglycemia, and symptoms; most patients with stage 3 t1d meet standard diagnostic criteria for diabetes and require insulin treatment. teplizumab has been shown to delay progression to stage 3 in participants at stage 2 in a phase 2 clinical trial, leading to subsequent approval in the united states of america (usa). patients outside of the usa are able to receive the treatment through pre-registration import licenses and managed access programs. the current study will collect data on the use of teplizumab in routine care, to better understand which patients received teplizumab and how these patients were managed after they received the treatment.


Eligibility criteria:
inclusion criteria: * patient informed consent or assent (for patients \< 18 years old) according to local regulations or appropriate informed consent waivers prior to any study related activity. * patient received ≥ 1 day of teplizumab treatment. exclusion criteria: * participation in an interventional clinical study on the index date. participation in an interventional clinical study is defined as initiating the product/procedure or control under investigation. an interventional clinical study is a study that requires deviation from standard clinical practice by following a study protocol.

Keywords: teplizumab type 1 diabetes real-world study stage 2 type 1 diabetes stage 3 type 1 diabetes disease progression treatment patterns patient monitoring
sbrt as bridging therapy for hepatocellular carcinoma patients on transplant waitlist

Conditions: Hepatocellular Carcinoma

Summary: this is a single center, prospective study to assess the efficacy and safety of using stereotactic body radiation therapy (sbrt) as bridging treatment for hepatocellular carcinoma (hcc) patients on transplant waitlist.

the study population includes patients 18 years of age or older with hcc, who are accepted on waiting list for deceased donor liver transplantation (ddlt). patient will be assessed in a multidisciplinary committee and they will receive sbrt unless otherwise contraindicated. patients will undergo sbrt under standard protocol. patients with hcc beyond university of california, san francisco criteria (ucsf) will be removed from waitlist.

Eligibility criteria:
inclusion criteria: 1. radiological diagnosis of hcc confirmed according to aasld criteria 2. all patients who are accepted on deceased donor waiting list 3. hcc within ucsf criteria (defined as solitary tumor \<=6.5cm or up to 3 tumors \<=4.5cm, total sum \<=8cm) exclusion criteria: 1. age \<18 year old; 2. child's c cirrhosis; 3. eastern cooperative oncology group (ecog) score \>2; 4. presence of extrahepatic metastasis; 5. radiological tumor invasion to portal, hepatic vein or its branches; 6. absolute contraindications to rt (e.g. previous rt to liver); 7. positive pregnancy test; 8. unwilling or unable to adhere to study requirements and procedure; 9. any other condition, in the investigator's judgment, that increases the risk of sbrt or prevents safe trial participation.
wearable devices to promote physical activity

Conditions: Cardiovascular Diseases

Summary: this study evaluates the effect of a new wearable device, that measures physical activity level based on heart rates, on relevant health outcomes including cardiorespiratory fitness. half of participants will be instructed in using the mio slice wristband, while the other half will be requested to follow today's recommendations for physical activity.

two critical challenges precluding the full potential of physical activity in preventive healthcare are: 1) the majority of people are not sufficiently active, and 2) there is a lack of large, long-term intervention studies documenting the effect of personalized activity and improved health in the population. using hunt data an algorithm called personal activity intelligence (pai) has been developed. pai was integrated in a smartphone application and user friendly wristband (mio slice), that measures heart rate continuously and estimates an individual threshold for total physical activity (defined as 100 weekly pai) that is associated with reduced risk of cardiovascular disease and mortality. the primary aim of the study is to reveal whether using the wristband will increase cardiorespiratory fitness, determined by maximal oxygen uptake, after 4 months among low-fit participants. the secondary aims includes the effect on reversing cardiovascular risk factors, cardiac structure and function, adherence to physical activity and identification of barriers after 16 weeks and 1 year.

Eligibility criteria:
inclusion criteria: * participated in hunt 3 and hunt 4 fitness study * vo2peak in hunt4 in the lowest sex- and age-specific tertile. exclusion criteria: * illness or disabilities that preclude completion of the study or make exercise contraindicated * uncontrolled hypertension, arrhythmias or angina * heart failure * primary pulmonary hypertension * diagnosed dementia * chronic communicable infectious diseases * participation in conflicting interventions

Keywords: exercise cardiorespiratory fitness risk factors monitoring, physiologic monitoring, ambulatory prognosis norway
comparison of silodosin and tamsulosin in medical expulsive therapy of distal ureteric calculi

Conditions: Silodosin, Tamsulosin, Medical Expulsive Therapy, Distal Ureteric Calculi

Summary: to compare efficacy and safety of silodosin and tamsulosin in medical expulsive therapy of distal ureteric calculi.

to compare efficacy and safety of silodosin and tamsulosin in medical expulsive therapy of distal ureteric calculi in our local setup to find out the optimal drug which promptly and quickly cures the disease thus enabling the person to return to routine activity with less adverse effects.

Eligibility criteria:
inclusion criteria: * symptomatic, unilateral, single, uncomplicated distal ureteric calculi of \<10 mm in size (on plain ct kub) exclusion criteria: * solitary kidney, bilateral ureteric stones, uti, renal impairment, high-grade hydronephrosis (grades 3 and 4), any history of previous endoscopic or surgical interventions, pregnancy, diabetes mellitus,
locally delivered atorvastatin & rosuvastatin for treatment of furcation defects in chronic periodontitis

Conditions: Chronic Periodontitis

Summary: statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme a reductase; which is a rate limiting enzyme for cholesterol synthesis. rosuvastatin (rsv) and atorvastatin (atv) have shown to have bone stimulatory and anti-inflammatory effects.. the present study aims to explore the efficacy of 1.2% rsv and 1.2% atv gel as a local drug delivery and redelivery system as an adjunct to scaling and root planing (srp) for the treatment of degree ii furcation defects.

statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme a reductase; which is a rate limiting enzyme for cholesterol synthesis. rosuvastatin (rsv) and atorvastatin (atv) have shown to have bone stimulatory and anti-inflammatory effects.. the present study aims to explore the efficacy of 1.2% rsv and 1.2% atv gel as a local drug delivery and redelivery system as an adjunct to scaling and root planing (srp) for the treatment of degree ii furcation defects. methods: ninety patients with mandibular buccal class ii furcation defects were randomly allocated into three treatment groups: srp plus placebo gel (group 1), srp plus 1.2% rsv gel (group 2) and 1.2% atv gel (group3). clinical and radiographic parameters were recorded at baseline then after 6 months. the gels were redelivered at the respective sites at this 6 month appointment. then again all clinical and radiographic parameters were recorded after 3 months. (9 months from baseline)

Eligibility criteria:
inclusion criteria: * systemically healthy patients with mandibular class ii furcation defects and asymptomatic endodontically vital mandibular molars with radiolucency in furcation area with pd ≥ 5mm and horizontal pd ≥ 3mm and with no history of antibiotic or any periodontal therapy in past 6 months were included in the study exclusion criteria: * subjects with any known systemic disease, allergic to statins, on systemic statin therapy, alcoholics, tobacco users, pregnant or lactating women
incidence and risk factors of extubation failure in pediatric resuscitation

Conditions: Respiratory Insufficiency

Summary: the failure of extubation in pediatric resuscitation is most often described as the need for reintubation within 48 hours after extubation. the failure rate of extubation in pediatric intensive care varies in the literature there is 4 to 22% failure. these failures result in increased mortality, morbidity with a use of larger tracheostomy, a prolonged residence time. some risk factors are well defined in the literature as the duration of intubation, ent and neurological history, the persistence of a respiratory disease, a high level of sedation. other factors are more controversial as age, ventilatory parameters just before extubation before extubation blood gases, the interest of a leak test. also pediatric populations are extremely heterogeneous, so the investigators would like to highlight to extubation failure risk factors in hautepierre pediatric icu to better support these high-risk children.


Eligibility criteria:
inclusion criteria: * children hospitalized in pediatric intensive care, under 18 years, intubated, ventilated for more than 2 hours and for which planning extubation or intubated children for whom an unplanned extubation just happened. * children whose holding parental authority are not opposed to the use of clinical data from their child for research purposes. exclusion criteria: * refusal to participate in the study

Keywords: extubation pediatric resuscitation reintubation failures of extubation. respiratory insufficiency