Kornimate/medical-research-clean huggingface dataset:
phase ii clinical trial of kj101in the treatment of deep ii degree burns

Conditions: Burn; Burn Wounds - Partial Thickness (2nd Degree)

Summary: this multicentre, randomised, double-blind, dose-finding, active- and placebo-controlled phase ii clinical trial will evaluate the safety, efficacy, pharmacokinetic profile, and immunogenicity of kj101 for the debridement of deep second-degree burns. the trial will provide supporting evidence for subsequent phase iii trials.

this multicentre, randomised, double-blind, dose-finding, active- and placebo-controlled phase ii clinical trial will evaluate the safety, efficacy, pharmacokinetic profile, and immunogenicity of kj101 in the debridement of deep second-degree burns. the aim is to provide supporting evidence for subsequent phase iii clinical trial. the study comprises four treatment groups: kj101 at a dose of 800 u/ml; kj101 at a dose of 1200 u/ml; an active comparator group receiving chymotrypsin at a dose of 800 u/ml; and a placebo control group. approximately 144 screened and qualified subjects will be randomised at a ratio of 1:1:1:1 to one of the four groups. all interventions will be administered locally to the target wound at the following frequencies: once daily prior to complete necrotic tissue debridement, and then every other day post-debridement. treatment will continue until complete wound healing is achieved (with a maximum treatment duration of 28 days), after which there will be a one-week safety follow-up period will be conducted.

Eligibility criteria:
inclusion criteria: 1. male and female subjects aged 18 to 65 years inclusive, who are neither pregnant nor lactating; 2. clinically diagnosed with superficial or deep ii degree burns within 72 hours of injury, with a total burn area of ≤30% tbsa. the target burn wound must be isolated or have distinguishable boundaries, with an area between 40 and 200 cm². 3. subjects of childbearing age must agree to use effective and safe contraceptive methods during the treatment period and for three months after the final administration. exclusion criteria: 1. individuals who are known to be allergic to any component of the test drug or who have a tendency to allergies. 2. burns caused by specific factors, such as electrical or chemical burns. 3. subjects with shock or inhalation lung injury; 4. subjects with target wounds complicated by inflammatory skin diseases (e.g. atopic dermatitis, eczema or psoriasis), or who have undergone enzymatic debridement (e.g. with collagenase, papain, bromelain, chymotrypsin or trypsin). 5. subjects who, during screening, are judged by the investigator to have other severe systemic infections requiring systemic treatment; 6. abnormal liver or kidney function.
mobility assessment of patients with total hip arthroplasty

Conditions: Osteoarthritis; Arthroplasty; Hip Replacement

Summary: the purpose of this study is to describe the 3d joint biomechanics of the lower extremities of patients having had a total hip replacement or hip resurfacing surgery as compared to a healthy age and weight matched control group during level walking, stair ascent and descent, and entering and exiting the front seat of a car.

much research has shown that patients are generally satisfied with pain relief in the months and years following a total hip replacement (thr) or hip resurfacing procedure. however, many express dissatisfaction with their ability to perform daily activities, a reduced walking ability and long-term lower extremity muscle weakness. given the general lack of knowledge surrounding joint motion of the lower extremities in the thr population, there is a need to characterize the joint mechanics of people having undergone thr, so that interventions and rehabilitation strategies can be designed to reduce post-operative complications and improve mobility.

Eligibility criteria:
inclusion criteria: * 15 patients between the ages of 50 and 75 yrs having undergone a primary total hip replacement or hip resurfacing within 6 to 18 months of the study will participate, as well as an equal number of age, sex, height and weight matched healthy control participants. exclusion criteria: * potential participants for the control group will be asked if they have had previous lower limb ailments or surgery, and if they have they will be excluded. moreover, the thr participants cannot have had secondary hip replacement due to infection, revision surgery, or a concomitant surgical procedure (i.e., graft). participants from both groups cannot have had any medical conditions which could affect physical movement such as a stroke.

Keywords: arthroplasty hip replacement motion analysis
ethosomal gel bearing losartan 5% for keloid treatment

Conditions: Keloid

Summary: the objectives are to compare the efficacy of pre and post-treatment and between 5% losartan potassium loaded in ethosomal gel and 10 mg/ml triamcinolone acetonide injection based on the indicator score of the patient and observer scar assessment scale 3.0 (posas 3.0), degree of erythema and pigmentation, area size, thickness and density of human keloids.

after being informed about the study and the associated risks and benefits, participants will be randomly allocated to one of two groups, each consisting of 23 individuals. after being informed about the study and the associated risks and benefits, participants will be randomly allocated to one of two groups, each consisting of 23 individuals. one group will receive the topical application of 5% losartan gel, while the other will receive an injection of triamcinolone acetonide 10mg/ml. after being informed about the study and the associated risks and benefits, participants will be randomly allocated to one of two groups, each consisting of 23 individuals. to measure the subjective and objective changes that occur in the keloid before and after treatment, outcome assessors will be blinded. measurements will be taken four times over the course of three months.

Eligibility criteria:
inclusion criteria: * keloid patients who came to the outpatient clinic of general hospital syafira pekanbaru during 2023-2024, * age is greater than or equal to 18 year * keloid scar than or equal to 25 cm2 * duration of keloids longer than or equal to 6 months * no drug interventions or not currently on keloid medications for the last two months. exclusion criteria: * subjects who do not understand the rubric of the patient and observer scar assessment scale (posas) and were not willing to participate * subjects with nodular keloids * subjects within antihypertensive therapy, pregnancy, malignancy, history of allergies, active skin lesions or bleeding in the keloid area. * subjects in the treatment of keloid within the last month.

Keywords: angiotensin ii angiotensin ii blocker 5 % losartan gel 10 mg/ml triamcinolone acetonide keloid
pharmacodynamic study of emixustat hydrochloride in subjects with macular atrophy secondary to stargardt disease

Conditions: Stargardt Disease; Macular Atrophy

Summary: this is a pharmacodynamics study of emixustat hydrochloride in subjects with macular atrophy secondary to stargardt disease.

this is a multicenter, randomized, masked study to characterize the pharmacodynamics, safety and tolerability of emixustat in subjects with macular atrophy secondary to stargardt disease.

Eligibility criteria:
inclusion criteria, including, but not limited to: * clinical diagnosis of macular atrophy (ma) secondary to stargardt disease (stgd) in one or both eyes * at least 2 pathogenic mutations of the abca4 gene * early treatment diabetic retinopathy study bcva of ≥ 20 letters (approximately ≥ 20/400 snellen) in the study eye * adequate clarity of ocular media and adequate pupillary dilation to permit good quality imaging of ma in the study eye * able and willing to provide written informed consent before undergoing any study-related procedures * able to reliably administer oral medication by self or with available assistance exclusion criteria, including, but not limited to: * macular atrophy associated with a condition other than stgd in either eye. * presence in either eye of an active ocular disease that in the opinion of the investigator compromises or confounds visual function. * history of any intraocular or ocular surface surgery in either eye within 3 months of screening. * current or previous participation in an interventional study to treat stgd using gene therapy or stem cell therapy at any time, or participation in an interventional study of a vitamin a derivative ≤3 months prior to screening. * pre-specified laboratory abnormalities at screening * presence of other medical or ophthalmic disease, physical examination finding, or clinical laboratory finding that in the opinion of the investigator may contraindicate the use of an investigational drug and place the subject at risk * current or history of cancer (except for adequately treated basal cell or squamous cell carcinoma of the skin) within 1 year of screening * history of myocardial infarction, stroke, unstable ischemic heart disease, uncontrolled cardiac arrhythmia, or hospitalization for congestive heart failure within 6 months of screening. * anticipated hospitalization for a medical/surgical procedure(s) that could result in interruption/premature cessation of study treatment or participation. * electrocardiogram with a clinically significant abnormal finding * female subjects who are pregnant or lactating * female subjects of childbearing potential or male subjects who are not surgically sterile who are not willing to practice a medically accepted method of birth control with their sexual partner from screening through 30 days after the final dose of study drug
mi-iron - moderately increased iron - is reducing iron overload necessary?

Conditions: Hereditary Haemochromatosis

Summary: haemochromatosis is a preventable genetic iron overload disorder. untreated, it can shorten life due mainly to liver cirrhosis and cancer. it can be prevented by blood donation to maintain normal iron levels. it is unclear, however, whether treatment is necessary when individuals have moderate elevation of iron in the body. this research project will study the effects of treatment in this group by assessing a number of scans, questionnaires and blood tests in treated and untreated individuals.

there is mounting evidence that treatment of moderate iron overload in hfe related hereditary haemochromatosis (hh) is not necessary. this project aims to undertake a randomised patient-blinded trial of erythrocytapheresis compared to sham erythrocytapheresis (using plasmapheresis) in individuals who have serum ferritin (sf) above the upper limit of the normal range but \< 1000ug/l (defined here as moderate iron overload) due to hfe mutations and to compare the prevalence of symptoms and objective markers of disease in the two treatment arms.

Eligibility criteria:
inclusion criteria: 1. hfe c282y homozygous. 2. aged 18 - 70 years . 3. sf above the upper limit of the normal range of 300µg/l but less than 1000µg/l with a currently or previously raised ts (\>greater than the upper limit of normal for the testing laboratory). exclusion criteria: 1. hh due to genotypes other than hfe c282y homozygosity. 2. normal sf, sf \> 1000µg/l. 3. other major risk factor(s) for liver toxicity or other significant co-morbidities including positivity for hepatitis b or c, excess alcohol consumption (\> 60g/day in males and 40g/day in females) or body mass index \> 35. 4. has had venesection therapy for hh in the last two years.

Keywords: hereditary haemochromatosis moderate iron overload serum ferritin treatment
radiotherapy in primary mediastinal lymphoma

Conditions: Adjuvant Radiotherapy on Complete Remission Patients

Summary: the use of rituximab has been proposed to be useful and avoid the use of radiotherapy in diffuse large b-cell lymphoma with bulky disease.we assess efficacy of adjuvant radiotherapy in patients treated with r-chop


Eligibility criteria:
inclusion criteria: diagnosis of primary mediastinal lymphoma no previous treatment performance status \< 2 hiv, hepatis b and c negative normal :renal, hepatic, pulmonary and cardiac function exclusion criteria: pregnancy -

Keywords: primary mediastinal lymphoma radiotherapy chemotherapy rituximab
study evaluating venlafaxine extended-release in depressed and anxious patients

Conditions: Anxiety Disorders; Depression

Summary: to examine the efficacy and safety of venlafaxine xr in the treatment of physical and emotional symptoms in patients with an operationally-defined diagnosis of multisomatoform disorder (msd).

the purpose of this study is to examine the efficacy and safety of venlafaxine xr in the treatment of physical and emotional symptoms in patients with an operationally-defined diagnosis of msd. primary efficacy will be evaluated using the phq-15 scale, and secondary efficacy will be evaluated using the ham-d17, ham-a, cgi, mqol-ps, vas and sf-36 evaluation scales. assessment scales and questionnaires will be administered at specified clinical visits between screening and week 12 (or discontinuation).

Eligibility criteria:
inclusion criteria: · subjects must be at least 18 years of age and meet dsm-iv diagnostic criteria for major depressive disorder, generalized anxiety disorder, and/ or social anxiety disorder, meet clinical criteria for msd, have a total score of greater than or equal to 14 on the ham-d17 or a total score of greater than or equal to 12 on the ham-a at screening and no more than a 25% decrease in total ham-d17 score or total ham-a score from screening to randomization. exclusion criteria: * a history of an inability to tolerate or failure to respond to greater than or equal to 2 antidepressants of sufficient dose and duration of administration for the treatment of symptoms present in the current illness; * a current or past history of mania, bipolar disorder, schizophrenia, or other psychotic disorder; * history of seizure disorder other than childhood febrile seizure; * presence of a serious or clinically unstable medical illness or psychiatric condition that would compromise the participation in the study; * previous intolerance or hypersensitivity to venlafaxine or venlafaxine xr or nonresponse to a previous adequate trial of any of these drugs, or use of any nonpsychopharmacologic drug with psychotropic effects within 7 days of study randomization; * use of maoi or fluoxetine within 30 days of screening; or * use of ect within 3 months of screening.
a clinical trial to evaluate the blood pressure lowering effect of a candemore plus tab versus cantabell tab in hypertensive patients inadequately controlled by candesartan monotherapy

Conditions: Hypertension

Summary: phase 4 clinical trial to evaluate the blood pressure lowering effect of a candesartan/hydrochlorothiazide(candemore plus tab) versus candesartan/amlodipine(cantabell tab) in hypertensive patients


Eligibility criteria:
inclusion criteria: * over 19 years old * agreement with written informed consent * hypertensive patients exclusion criteria: * patients with secondary hypertension * participated in other trial within 30 days * in investigator's judgement
topical ice-therapy for intravitreal injections

Conditions: Anesthesia; Hypothermia; Injection Site Irritation

Summary: purpose: to examine the difference in patient's pain experience in the setting of intravitreal anti-vegf injections with pretreatment of topical ice-therapy compared with no-ice.


Eligibility criteria:
inclusion criteria: * all patients aged 18 or older evaluated by a single retina specialist at the university of minnesota department of ophthalmology with a clinical indication necessitating an anti-vegf intravitreal injection exclusion criteria: * n/a
gene therapy for ighmbp2-related diseases

Conditions: SMARD1; CMT2S

Summary: open-label, single intrathecal injection study of a aav9 vector carrying the ighmbp2 gene for ighmbp2-related diseases.


Eligibility criteria:
inclusion criteria: * confirmation of two pathogenic variants in the ighmbp2 gene from a clia-certified lab * pre-ambulant (not yet walking and less than 18 months) or ambulant (as defined by the ability to walk 10 meters without assistance) or non-ambulant (inability to walk more than 10 meters unassisted) * ability to cooperate with functional assessments as per pi's discretion exclusion criteria: * prior participation in a gene or cell therapy program for any kind. * immunizations of any kind in the month prior to the study. * active infection based on clinical observations * serological evidence of hiv infection, or hepatitis b or c infection * diagnosis of (or ongoing treatment for) an autoimmune disease * persistent leukopenia or leukocytosis (wbc ≤ 3.5 10\^3/μl or ≥ 20.0 10\^3/μl) or an absolute neutrophil count \< 1.5 10\^3/μl * abnormal liver function as indicated by an elevated ggt (\>2x normal if no other laboratory abnormalities), bilirubin and/or abnormal pt/inr * concomitant illness or requirement for chronic drug treatment that in the opinion of the pi creates unnecessary risks for gene transfer * aav9 binding antibody titers \> 1:50 as determined by elisa immunoassay performed by athena diagnostics * abnormal laboratory values in the clinically significant range, based upon normal values in the nationwide children's hospital laboratory * diagnosis of any other systemic illness that increases the risk of gene transfer per the pi's opinion; has a medical condition or extenuating circumstance that, in the opinion of the pi, might compromise the subject's ability to comply with the protocol required testing or procedures or compromise the subject's well-being, safety, or clinical interpretability * any requirement for immune modulatory therapy and for which it would be unsafe for the subject to undergo an appropriate wash out period * contraindication for intrathecal injection * a positive jcv antibody test of \>0.40

Keywords: ighmbp2
a study of ly2963016 compared to lantus® in adult chinese participants with type 1 diabetes mellitus

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to compare long-acting basal insulin analog ly2963016 to lantus® in combination with mealtime insulin lispro in adult chinese participants with type 1 diabetes mellitus (t1dm).


Eligibility criteria:
inclusion criteria: * have t1dm based on the disease diagnostic criteria (world health organization \[who\] classification). * have duration of t1dm ≥1 year. * have hba1c ≤11 %. * have been administered with basal-bolus insulins or pre-mixed insulins for at least 90 days prior to screening. * have a body mass index (bmi) ≤35 kilograms per meter squared. exclusion criteria: * exposure to an insulin glargine other than lantus® within previous 30 days. * have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study. * have had more than one episode of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within 6 months prior to entry into the study. * have known hypersensitivity or allergy to any of the study insulins (lantus® or insulin lispro) or to excipients of the study insulins. * are pregnant, intend to become pregnant during the course of the study. * women who are breastfeeding. * are currently taking traditional medicine (herbal medicine or patent medicine) with known/specified content of anti-hyperglycemic effects within 3 months before screening. * have congestive heart failure class iii and iv. * have obvious clinical signs or symptoms, or laboratory evidence, of liver disease. * have any active cancer. * have a history or diagnosis of human immunodeficiency virus (hiv) infection. * have presence of clinically significant gastrointestinal disease. * have a history of renal transplantation, or are currently receiving renal dialysis. * are receiving chronic systemic glucocorticoid therapy at pharmacological doses.

Keywords: insulin glargine
effects of long-term foam rolling compared to static stretching on hamstring muscle flexibility

Conditions: Muscle Hypertonia

Summary: the purpose of this study to to compare the long-term effects of foam rolling in comparison to static stretching and a control group on hamstring flexibility. the investigators hypothesize that participants in the foam rolling and static stretching group will demonstrate increased flexibility to the control group, but will a difference will not be observed between the foam rolling and static stretching groups.


Eligibility criteria:
inclusion criteria: * active 90/90 hamstring length goniometric measurement of greater than 10 degrees at baseline * active straight leg raise of less than 90 degrees exclusion criteria: * history of lower extremity injury including but not limited to sprain, strain, fracture, or any surgical intervention that lead to a decrease in activity greater than two weeks within the last six months * current involvement in a lower extremity flexibility program outside of their regular activity
"the evaluation of stimulant withdrawal"

Conditions: Anxiety; Relapse; Substance Addiction

Summary: the purpose of this research study is to determine whether carvedilol, an fda approved beta blocker, when administered for an 8-week period to veterans currently undergoing treatment for methamphetamine dependence (1) improves their ability to stay in treatment longer, (2)eases the aversive symptoms that accompany stimulant withdrawal, and (3) increases the time they remain abstinent from methamphetamine.


Eligibility criteria:
inclusion criteria: * must have entered treatment into the outpatient clinical addiction rehabilitation section (cars) through the us portland veterans affairs medical center * must meet the clinical definition for methamphetamine dependence * self-reported methamphetamine use within 10 days of entering the study * must be able to understand and sign the consent form exclusion criteria: * dependent on any other drug except nicotine, caffeine, marijuana and alcohol * pregnant or nursing mothers * psychosis * dementia * any serious medical condition that could be aggravated by the study protocol (allergic reaction, hypotension, asthma, bronchospastic conditions, angina, bronchitis, emphysema, bradycardia, heart or blood vessel disease, diabetes mellitus, low blood sugar, kidney disease, liver disease or overactive thyroid) * history of withdrawal seizures or delirium tremors * use of mao inhibitors within the last two weeks * considerable hepatocellular injury, including cirrhosis of the liver or liver function test levels higher than 2 times normal

Keywords: methamphetamine coreg withdrawal anxiety substance addiction
a study of ly3541105 in healthy and overweight participants

Conditions: Overweight; Healthy

Summary: the main purpose of this study is to evaluate the safety and tolerability of ly3541105 in healthy and overweight participants. blood tests will be performed to check how much ly3541105 gets into the bloodstream and how long it takes the body to eliminate it. the study will also evaluate the effects of ly3541105 on body weight and assess safety and tolerability of ly3541105. this is a 3-part study and may last up to 15, 26 and 24 weeks for each participant and may include up to 7, 15 and 16 visits in parts a, b and c, respectively.


Eligibility criteria:
inclusion criteria: * participants who are overtly healthy as determined by medical evaluation * male participants who agree to refrain from sperm donation and to use contraceptive methods and female participants not of childbearing potential * have a body mass index (bmi) in the range of greater than or equal to (\>/=) 18.5 to less than (\ /=27 to \<40 kg/m², both inclusive (in part b and c) * have had a stable weight for the last 3 months exclusion criteria: * have history of diabetes (except gestational diabetes) or current diagnosis of diabetes * clinically significant abnormal electrocardiogram (ecg) at screening, as judged by the investigator * have history or current evidence of a clinically significant cardiovascular condition

Keywords: obesity