Kornimate/medical-research-clean huggingface dataset:
study evaluating nelotanserin for treatment of rem sleep behavior disorder in subjects with dementia (dlb or pdd)

Conditions: Dementia With Lewy Bodies; REM Sleep Behavior Disorder; Parkinson's Disease Dementia

Summary: this study seeks to evaluate the safety and efficacy of nelotanserin for the treatment of rapid eye movement (rem) sleep behavior disorder (rbd) in subjects with dementia with lewy bodies (dlb) or parkinson's disease dementia (pdd).

this is a double-blind, randomized, placebo-controlled, parallel-arm study in subjects with dlb or pdd who have rbd. subjects who meet the randomization criteria will be randomized 1:1 to receive nelotanserin or placebo for 28 days during the double-blind period.

Eligibility criteria:
inclusion criteria: * adult subjects at least 50 years of age, with a diagnosis of dlb or pdd and rbd based on diagnostic and statistical manual of mental disorders fifth edition (dsm-5) diagnostic criteria * presence of frequent rem sleep behavior episodes * mini mental state examination score ≥ 18 exclusion criteria: * subjects have a current diagnosis of significant psychotic disorders including, but not limited to, schizophrenia or bipolar disorder * subjects' rbd symptoms are secondary to or better accounted for by another medical condition, psychiatric disorder, or substance abuse * subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid, gastrointestinal, renal, hematologic or other medical disorder

Keywords: dementia with lewy bodies lewy bodies rem sleep behavior disorder parkinson's disease dementia
lamivudine(lam) good responder study

Conditions: Hepatitis B, Chronic

Summary: this is to evaluate the proportion of subjects who show good responses to lam treatment in korea.

this is to evaluate the proportion of subjects who show good responses to lam treatment such as hbv dna negativity, hbv dna less than 4 log, no resistant mutation, hbeag seroconversion and normalization of alt in naïve chb patients with certain pre-treatment characteristics, i.e. hbv dna less than 9log copies per ml and alt more than 2 times uln in hbeag positive subjects, hbv dna less than 7log copies per ml and elevated alt in hbeag negative subjects.

Eligibility criteria:
inclusion criteria: 1. chb or liver cirrhosis due to hepatitis b virus who had started lam between jan 1, 2003 and dec 31, 2004 and maintained lam at least 6 months 2. hbsag positive at least for 6 months at the beginning of observation 3. hbv dna positive before lam administration 4. subjects with certain pre-treatment laboratory findings as follows; hbv dna less than 9log copies per ml and alt more than 2 times uln in hbeag positive patients, hbv dna less than 7log copies per ml and elevated alt in hbeag negative patients exclusion criteria: 1. documented co-infection with hcv, hiv at the beginning of lam treatment 2. decompensated liver cirrhosis at the beginning of lam treatment 3. hcc at the beginning of lam treatment

Keywords: retrospective naïve chronic hepatitis b (chb) patients cohort study lamivudine
a study of the safety and efficacy of uhe-105 shampoo in subjects with scalp psoriasis

Conditions: Scalp Psoriasis

Summary: this study is to compare the safety and efficacy of uhe-105 shampoo with that of the vehicle (veh) shampoo in subjects with scalp psoriasis. half of the subjects will receive the uhe-105 shampoo, while the other half will receive the veh shampoo with no active drug.


Eligibility criteria:
inclusion criteria: * subject is a male or non-pregnant female 18 years of age or older. * subject has provided written informed consent. * females must be post-menopausal , surgically sterile or use an effective method of birth control. , women of childbearing potential must have a negative urine pregnancy test at visit 1/baseline. * subject has a clinical diagnosis of stable moderate to severe scalp psoriasis affecting at least 10% of the scalp. * subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study. * subject, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation of scalp psoriasis or exposes the subject to an unacceptable risk by study participation. exclusion criteria: * subject is pregnant, lactating, or is planning to become pregnant during the study. * subject has spontaneously improving or rapidly deteriorating scalp psoriasis. * subject has guttate, pustular, erythrodermic, or other non-plaque forms of scalp psoriasis. * subject has any physical condition which, in the investigator's opinion, could impair evaluation of scalp psoriasis, adrenal axis function (e.g., addison's disease, cushing's syndrome), or which exposes the subject to an unacceptable risk by study participation. * subject has scalp psoriasis that necessitates systemic or other concomitant topical therapies during the study. * subject has a history of psoriasis unresponsive to topical treatments. * subject has any hair on their scalp of a length that extends beyond the subject's chin. * subject has any open sores, lesions, cuts, or infections, etc. on the scalp or has had a scalp surgical procedure within the past 30 days. * subject is currently enrolled in an investigational drug or device study. other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.
a prospective randomized study for comparison of y-composite grafts

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to compare early and 1-year graft patency rates of saphenous vein composite grafts with those of right internal thoracic artery composite graft and mid-term clinical outcomes in patients who undergo off-pump coronary artery bypass grafting(opcab). we also evaluate microscopic findings of saphenous vein graft harvested no touch technique and used as composite graft.

the saverita trial was designed as a randomized, controlled trial to recruit 224 patients who undergo off-pump coronary artery bypass using y-composite graft based on the left internal thoracic artery. patients were randomized by use of a randomization table. composite conduit was made using saphenous vein or right internal thoracic artery according to the randomization result. the primary end point is to evaluate early and 1-year postoperative graft patency. the secondary end points are overall survival, freedom from cardiac death and freedom from macce(major adverse cardiac or cerebrovascular events). in saphenous vein group, 20 remnant saphenous vein specimen was evaluated histologically to compare the difference between composite grafted vein and manually dilated saphenous vein.

Eligibility criteria:
inclusion criteria: * age equal or more than 40 * age equal or less than 75 * patients who agree to the enrollment exclusion criteria: * patients with heart failure (left ventricular ejection fraction \< 25%) * patients who have intractable ventricular arrhythmia * patients who has been treated for cancer * patients who has infectious disease * patients who are planned to undergo combined cardiac surgery * patients who has medical co-morbidity with expected survival less than 1 year * patients who has a problem using right internal thoracic artery or saphenous vein * patients with a history of previous cardiac surgery * patients with chronic renal failure * patients who undergo emergency operation

Keywords: coronary artery bypass off-pump surgery composite graft saphenous vein internal thoracic artery
a metacognitive group therapy of depression and anxiety in youth with autism

Conditions: Anxiety Depression

Summary: the goal of this open clinical trial is to try out and evaluate a group metacognitive treatment protocol, for adolescents aged 15-18 years of age with anxiety and/or depression and an autism diagnosis. the main questions it aims to answer are: 1. how does the recruitment to the study work and what is the retention rate? 2. what is the level of participant compliance? 3. is the treatment adherence satisfactory, are there any practical problems with treatment delivery? 4. are the outcome measures and assessment procedures feasible? 5. do the participants accept the treatment, are there any reports of adverse effects? 6. what are the preliminary effects of the treatment regarding 1. symptoms of anxiety and/or depression 2. quality of life 3. functional impairment 4. subjective level of stress 5. central metacognitive processes 7. are changes in metacognitive processes related to changes in anxiety and depression? the participants will partake in metacognitive group treatment of 10 sessions following an initial screening.

participants in the study are youth (15 to 18 years of age) seeking help for anxiety and depression within child and youth psychiatry. there will a consecutive inclusion to form 6 treatment groups with 6 persons in each. the groups will meet once every week. assessments will take place at pre- and post-treatment as well as at 6-month follow-up. some metacognitive processes will also be monitored at each group session. the therapists have undergone a specialist training in metacognitive therapy and are experienced in using the methods. the main focus of the study is on feasibility, acceptability and preliminary effects of the treatment. these will be analyzed with paired sample t-test on primary and secondary outcomes.

Eligibility criteria:
inclusion criteria: * age of 15 to 18 years * seeking medical care prima psychiatric clinic for children and youth in stockholm * diagnoses of anxiety disorder or depression as well as autism established in a clinical interview * mastering the swedish language enough to take part of the treatment * willingness/ability to participate after receiving information about what participation entails exclusion criteria: * assessed to meet one of the following diagnoses: bipolar syndrome, alcohol use syndrome, substance use syndromes, psychotic symptoms and affective syndromes with psychotic symptoms and antisocial personality disorder. * assessed to have a high suicide risk. * assessed to have extensive self-harm behavior or moderate to high risk of such. * participating in other psychological treatment or about to start such treatment during the time interval of the study. * has not had stable medication in the last month or is planning a deposit/medication adjustment during the time interval of the study.
mesenchymal stromal cell derivatives in the treatment of chronic diabetic foot ulcers type 1 and 2

Conditions: Foot Ulcer, Diabetic

Summary: the goal of this study is to evaluate the safety and efficacy of using mesenchymal stromal cell derivatives (dac-mscs) in the treatment of chronic diabetic foot ulcers (type 1 and 2) in adults. a third of the participants will receive dac-mscs and triticum vulgare (fitostimoline) in combination, the other third mscs and fitostimoline in combination, and the last third only fitosimoline. this study will be a randomized, blind, and parallel and controlled-group trial.

conventional treatments such as dry, wet or active dressings are effective only in 50% of patients with diabetic foot ulcer. the remaining 50% of patients have non-responding recoveries that leads to amputation of the compromised limbs. currently, the administration of mesenchymal stem cells (mscs) in animal models or in small groups of patients with diabetic foot ulcer has shown to be safe and effective. particularly, the use of these cells induce regeneration, both in the dermis and the epidermis. nevertheless, msc transplantation has some limitations, for instance, time restrictions in the availability of cells due to their isolation and expansion as well as the complex and costly large-scale production. in the same manner, the cryopreservation might cause deleterious effects that affect the biological activity of the cells and a medical professional should conduct the cell administration. in addition, different studies report variability in the results due to the inconsistency in the methods that they used (extraction protocols, cultivation, expansion and administration). the investigators' recent studies in mice with skin lesions, particularly type 1 diabetes, have shown that the presence of the cells is not necessary to promote skin regeneration and the administration of dac-mscs is sufficient to stimulate would healing.

Eligibility criteria:
inclusion criteria: * males and females between the ages of 40 and 80 years, inclusive, with type 1 or 2 diabetes as defined by the american diabetes association * stable glycemic control * transcutaneous oxygen measurement \> 30 mmhg * ulcer present at least for 1 month * wound size between 0.5 and 5 cm2 * subjects that require endovascular surgical intervention * subjects must have adequate nutrition (albumin level \> 2 g/dl and prealbumin level \> 15 mg/dl) exclusion criteria: * previous or current diagnoses with one of the following: cancer, symptomatic coronary artery disease, brain disease, kidney failure, blood disorders * taking immunosuppressive and cytotoxic drugs * presence of active systemic infection

Keywords: mesenchymal stromal cells fitostimoline msc derivatives diabetes
effectiveness of modified health belief model based intervention to reduce body mass index

Conditions: Overweight

Summary: the purpose of this study is to effectiveness of modified health belief model based intervention to reduce body mass index for age in overweight junior high school students.

the purpose of this study is to effectiveness of modified health belief model based intervention to change behavior to reduce body mass index for age in overweight junior high school students.

Eligibility criteria:
inclusion criteria: * junior high school students * age 12 - 15 years * bmi for age ≥ median +1 sd * read and write thai language * agree to participate voluntarily . exclusion criteria: * students with medical conditions diagnosed by a physician and a barrier to participation .
comparison between efficacy of norepinephrine and phenylephrine boluses for prevention of spinal anaesthesia induced hypotension in obstetrical patients undergoing emergency cesarean section-a double blind randomized controlled trial

Conditions: Spinal Anesthesia Induced Hypotension

Summary: the goal of this clinical trial is to learn if norepinephrine is more effective than phenylephrine for prevention of spinal anesthesia induced hypotension. the main questions it aims to answer are: does norepinephrine lower the incidence of spinal anesthesia induced hypotension in emergency obstetrical patients? we will compare effectiveness of norepinephrine and phenylephrine for the prevention of spinal anesthesia induced hypotension. participants will: be administered prophylactic boluses of both drugs right after spinal anesthesia induction and maternal hemodynamic parameters and neonatal apgar scores will be recorded

spinal anesthesia is a common mode of anesthesia in cesarean delivery. spinal anesthesia induced hypotension is one of the most common complication that can affect both mother and fetus. for the management of spinal anesthesia induced hypotension, preloading with crystalloids and colloids, use on ionotropic agents and vasopressors have already been in practice. objective of this study is to compare efficacy of prophylactic use of norepinephrine and phenylephrine bolus dosage for spinal anesthesia induced hypotension. this study is being conducted at the department of anesthesiology ,k.m pfau civil hospital, dow university of health sciences, karachi , pakistan. data is being collected after taking approval from institutional review board and written informed consent from the participants. participants are being enrolled by primary investigator. all participants are undergoing simple randomization by lottery method. after enrollment of participants, demographic data, hemodynamic parameters and other relevant details are being recorded till delivery of the neonate. hemodynamic parameters that are heart rate, systolic and diastolic blood pressure, mean arterial blood pressure is being recorded every 3mins. apgar scoring of neonate is also being recorded. after completion of data collection, data will be done using statistical package for social sciences 26.

Eligibility criteria:
inclusion criteria: 1. american society of anesthesiologists ii and iii patients 2. age 18-40years 3. gestational age 32 weeks and above exclusion criteria: 1. patients with hypertensive disorders of pregnancy having baseline systolic blood pressure greater than 160 mmhg and diastolic blood pressure greater than 99 mmhg. 2. baseline mean arterial pressure less than 70 mmhg. 3. antepartum hemorrhage/intraoperative blood loss greater than 1000ml 4. history indicative of cardiovascular or neurological disease. 5. known fetal abnormality. 6. patients taking serotonin reuptake inhibitor, tricyclic antidepressants,monoamine oxidase inhibitors. 7. maternal situations requiring immediate administration of general anesthesia

Keywords: spinal anesthesia induced hypotension emergency lower segment cesarean section norepinephrine bolus prophylactic phenylephrine
pharmacokinetic and pharmacodynamic effects of passive cannabis inhalation

Conditions: Cannabis Toxicology

Summary: this primary aim of this study is to assess the effects of passive (second-hand) inhalation of cannabis smoke on toxicological analysis of "native" oral fluid (saliva), urine and blood specimens. the results of this study will help inform the validity of oral fluid as a biomarker of cannabis exposure and to determine whether, and for how long, passive inhalation of cannabis smoke could result in a positive toxicology result.


Eligibility criteria:
participants must: * be between the ages of 18 and 45 * be in good general health based on a physical examination, medical history, vital signs, 12-lead ecg and screening urine and blood tests * demonstrate ability to expectorate 3-5 ml of "native" oral fluid over a 5-minute period * be willing and able to abstain from use of any over-the-counter (otc) or prescription drugs (other than birth control medications) after providing written informed consent and continuing until discharged from the study. otc antacids may be taken up to 12 hours prior to dosing * not be pregnant or nursing (if female), and using effective birth control. all females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission. * have a body mass index (bmi) in the range of 19 to 33 kg/m2 * have head hair that is at least 4-6 cm (approximately two inches) in length on the back of the head. * blood pressure at screening visit must not exceed a systolic blood pressure (sbp) of 140 mmhg or a diastolic blood pressure (dbp) of 90 mmhg * must not have history of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures. * cannot have been enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing. * no history of panic/anxiety reaction to extended periods of confinement in close quarters, smoke filled areas, or tight social situations. * no history of adverse reactions to cannabis exposure, whether via direct use or passive exposure.
to demonstrate the relative bioavailability, parallel study of leflunomide 20 mg tablets under fasting conditions

Conditions: Rheumatoid Arthritis; Psoriatic Arthritis

Summary: to demonstrate the relative bioavailability, parallel study of leflunomide 20 mg tablets under fasting conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.
the effect of intraoperative tramadol on postoperative opioid

Conditions: Postoperative Pain

Summary: postoperative pain remains a very unpleasentevent, particularly in morbidly obese patients that may be associated with obstructive sleep apnea. bariatric surgery patients must get safe and efficient analgesia, which is essential given that up to 45 % of patients report substantial pain in the first two days following surgery. the study's purpose was to compare the efficacy and safety of combined tramadol with pethidine versus pethidine alone and to assess their impact on postoperative pethidine requirements after lsg for morbidly obese patients

this multicenter cohort research included patients with morbid obesity who had lsg between january 2021 and december 2022. the patients included in the study were allocated to one of two treatment groups that were not randomized but the patients were categorized according to the time of surgery: group a received pethidine alone in the period between january 2021 and december 2021, while group b got tramadol with pethidine in the period between january 2022 and december 2022. doses were based on the patient's actual body weight.

Eligibility criteria:
inclusion criteria: * patients with morbid obesity defined as a bmi of more than 40 or * bmi less than 35 with at least one comorbidity and * ages ranging from 16 to 65, were patients exclusion criteria: * patients under the age of 16 or over 65, * those with severe gerd, leakage * pregnancy, or * inflammatory bowel disease,

Keywords: laparoscopic sleeve gastrectomy morbid obesity postoperative pain tramadol pethidine