Kornimate/medical-research-clean huggingface dataset:
a phase 3 study of efficacy and safety of ak101 in subjects with psoriasis

Conditions: Psoriasis Vulgaris

Summary: this is a randomized, double-blind, placebo-controlled, multicentered phase iii clinical study to evaluate the efficacy and safety of ak101 in the treatment of subjects with moderate-to-severe plaque psoriasis.

this is a randomized, double-blind, placebo-controlled, multicenter phase iii clinical study. the purpose of this study is to evaluate the efficacy and safety of ak101 in the treatment of subjects with moderate-to- severe plaque psoriasis. subjects will be randomized to receive ak101 or placebo injection subcutaneously, and follow up to week 16.

Eligibility criteria:
inclusion criteria: 1. male or female subjects aged ≥ 18 years. 2. subjects diagnosed with moderate-to-severe plaque psoriasis for at least 6 months before screening. 3. at screening and baseline, pasi score ≥ 12, body surface area bsa (bsa) ≥ 10%, spga ≥ 3. 4. subjects with a history of an inadequate response, intolerable or medically inappropriate use of systemic therapy and/or phototherapy. 5. subjects who are women of childbearing potential must have a negative pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 6 months after the last study drug administration. exclusion criteria: 1. forms of psoriasis other than chronic plaque-type psoriasis. 2. history or evidence of active tb. patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol. 3. positive results of confirmatory test for hepatitis b, hepatitis c, human immunodeficiency virus (hiv) or syphilis. 4. history of repeated chronic infection, had any serious infection or systemic infection within 2 months before screening. 5. history of prohibited psoriasis treatments within 2/4 weeks before randomization. 6. history of il12/23 or il-23 inhibitors therapy. 7. inadequate washout period of prior biological therapy. 8. history of malignant tumour within 5 years before screening. 9. any medical or psychiatric condition, laboratory, or ecg parameter which, in the opinion of the investigator would place the subject at risk, interfere with participation or interpretation of the study.
nox-e36 in patients with type 2 diabetes mellitus and albuminuria

Conditions: Type 2 Diabetes Mellitus; Albuminuria

Summary: primary objective: - to characterize the effects of 12 weeks treatment with study drug on albumin-creatinine ratio (acr) in patients with type 2 diabetes and albuminuria secondary objectives: * to characterize the effect of study drug on glycosylated hemoglobin fraction (hba1c) * to evaluate the effect of study drug on markers of glycemic disorders, systemic inflammation, renal and liver disease and cardiovascular function * to assess the safety and tolerability of study drug * to determine the population pharmacokinetics (pk) of study drug


Eligibility criteria:
inclusion criteria: 1. type 2 diabetes mellitus according to american diabetes association (ada) definition 2. age ≥ 18 3. hba1c between 6.0% and 10.5%, inclusive 4. acr \> 100 mg/g calculated 3 times in first morning void urine, at least 2 of the measurements \> 100 mg/g 5. patients on stable (unchanged medication for at least 3 months) treatment to control hypertension, hyperglycemia and (if applicable) dyslipidemia 6. stable treatment with angiotensin-converting enzyme inhibitors (acei) and/or angiotensin ii receptor blockers (arbs) (renin-angiotensin system \[ras\] blockade) 7. willing and able to understand and sign an approved informed consent form 8. men must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment. women must be of non-childbearing potential. exclusion criteria: 1. type 1 diabetes mellitus 2. estimated glomerular filtration rate (egfr) ≤25 ml/min/1.73m2 (calculated by the chronic kidney disease epidemiology collaboration \[ckd-epi\] formula) 3. recent cardiovascular events (3 months) 4. uncontrolled hypertension (upper limits 180/110 mmhg) 5. dialysis and/or acute kidney injury within 3 months before screening 6. significant edema, infectious diseases, leg ulcers 7. severe concurrent disease which, in the judgment of the investigator, would interfere significantly with the assessments of safety and efficacy during this study 8. treatment with any other investigational agent, or participation in another clinical study within 90 days prior to baseline visit 9. patient with known infection with human immunodeficiency virus (hiv), hepatitis b or hepatitis c 10. in the judgment of the clinical investigator, clinically significant abnormal laboratory values at the screening visit 11. use of thiazolidinedione class drugs, immune suppressants, steroid therapy (except for topical use or inhalation), chronic use of non-steroidal anti-inflammatory drug (nsaids), cyclooxygenase type 2 (cox-2) inhibitors, two or more diuretic drugs and/or aliskiren 12. in the judgment of the clinical investigator, patients who are likely to be non-compliant or uncooperative during the study. 13. previous participation in this study.
comparison of normal walking vs brisk walking in over-weight adults

Conditions: Overweight; Walking

Summary: the goal of this clinical trial is to see the comparison of normal walking vs brisk walking on body fat, hypertension, diabetes, and level of happiness in over-weight adults. the main question it aims to answer is: will there be a difference between the effectiveness of normal walking and brisk walking on improving body fat, hypertension, diabetes, and level of happiness in over-weight adults.. the participants will be divided into two groups; group a and group b. group a will perform normal walk and group b will perform brisk walk.

in the modern times, despite the fact that the benefits of regular physical activity are widely known, the choice of a sedentary lifestyle is increasing in prevalence. with the help of simple and natural movements, walking is considered as a moderate level of workout intensity that promotes a long and healthy lifespan. meanwhile, it provides the added advantage to individuals by reducing chances of injury, making it an excellent choice for middle-aged and elderly individuals. walking tends to be the widely preferred choice of most diabetic patients worldwide for improving glycemic control. moghetti et al. showed the correlation between walking and type 2 diabetes in their recent research where they employed meta-analysis (supported with short and long term rcts) to prove that sufficient amount of walking can lead to improved levels of hba1c. walking can improve functional capacity of people with t2dm and cast favorable impacts on chronic complications of diabetes the research carried out to advocate strong relation between walking and healthy lifestyle is widely available to us. however, it mainly focuses on elderly people (with age above 60) instead of young and middle-aged people who have been equally pushed at the verge of risks to develop obesity, cardiovascular diseases and t2d due to astonishingly common sedentary lifestyle prevailing in today's world. also, it is limited in terms of defined intensities for walking and their comparison for guiding an appropriate course of action for obese or hypertensive adults. therefore, this research will evaluate and compare the impacts of normal and brisk walking on middle-aged people struggling with diabetes, hypertension, obesity or other cardiovascular diseases. also, it will define the basis for a well-informed and focussed approach to enhance quality of life in adults.

Eligibility criteria:
inclusion criteria: * age between 36-55 years * hypertensive middle-aged adults * bmi \> 25 * type 2 diabetes middle-adults * body fat \> 25% exclusion criteria: * severe psychological illness * physical defect or deformity * experience of diabetic coma * engagement in other training programs * any other serious illness like tb, cancer.

Keywords: blood pressure blood glucose walking body mass index physical activity exercise
extracorporeal carbon dioxide removal using prismalung in reducing ventilator induced lung injury

Conditions: ARDS, Human

Summary: lung protective ventilation with low tidal volumes and low driving pressure are known to reduce mortality in mechanically ventilated patients with acute respiratory failure. this reduction in mortality is known be due to reduction of ventilator induced lung injury that occurs due to high tidal volumes and high driving pressure. when receiving such mechanical ventilation, some patients develop hypercapnia and associated hypercapnic acidosis. such patients have an increased risk of mortality. while the exact reasons for such increase in mortality is not known, it is recommended to minimise hypercapnia and hypercapnic acidosis during lung protective ventilation. minimally invasive extracorporeal carbon dioxide removal (ecco2r) devices are shown to reduce hypercapnia and hypercapnic acidosis. there are several devices that are currently available in the current clinical practice. however, the effect of these devices on reduction in ventilator induced lung injury is not clearly demonstrated. this study aims to assess the use of an ecco2r device called prismalung in reducing ventilator induced lung injury. prismalung is currently used in our intensive care unit. this assessment is done by measuring interleukins in bronchoalveolar lavage fluid and blood interleukin levels as well as clinical assessment including the reduction of driving pressure.


Eligibility criteria:
inclusion criteria: adult patients (18 years or older) with diagnosis of ards as per berlin definition21. driving pressure (δp) \> 14 and/or plateau \>/= 25 (δp is calculated using as plateau pressure minus positive end-expiratory pressure)20 respiratory rate \> 20 breaths per minute ph \ 45 exclusion criteria: ards lasting more than 72 hours at the time of inclusion high pressure (plateau pressure \>30 cm h2o) or high fio2 (\>0·8) ventilation for more than 168 h (7 days); life threatening hemodynamic instability as defined by ongoing arrhythmias that is not responsive to treatment contraindication to limited anticoagulation treatment limitation including not for resuscitation and not for reintubation patients with potentially irreversible respiratory failure caused by conditions such as pulmonary fibrosis.

Keywords: ecc2r, carbon dioxide, ventilator induced lung injury
effects of infant massage on development of down syndrome babies

Conditions: Down Syndrome

Summary: the aim of ths study is to know the effects of infant massage in the maturation of the baby with down syndrome. scale psychomotor development early childhood brunet-lézine-revised will be used to measure the maturational development of the baby with down syndrome . investigators will analyze two groups of intervention, the experimental group, in which parents will participate and will apply the knowledge learned in the course of infant massage and control, which does not receive the infant massage course during the study. babies in both groups will be evaluated twice, at the beginning of the intervention (pretest) and end it after five weeks (posttest). the study population consists of 32 babies with down syndrome between 4 and 8 months old.

in this study, the investigators will compare the maturational development of the experimental group down syndrome babies (will receive infant massage in the period between the two measurements) with the maturational development of the control group down syndrome babies (will receive infant massage after two measurements). assess both the development partial motor, cognitive, language and social, and also the maturational development global. finally, measure also the ratio of development, both in the pretest as on the posttest. the test that will use to measure the development of them babies is the scale of development psychomotor of her first childhood brunet-lezine-r. the babies of the study may hay between 4 and 8 months old.

Eligibility criteria:
inclusion criteria: * babies with down syndrome that received early attention. exclusion criteria: babies with down syndrome: * with associated pathology. * adopted. * have received infant massage course.

Keywords: massage development
the efficacy of pulsed dye laser in dermatophytosis

Conditions: Cutaneous Dermatophytosis; Pulsed Dye Laser

Summary: the purpose of this study is to determine whether pulsed dye laser therapy are effective in the treatment of cutaneous dermatophytosis.

this study was conducted to determine the efficacy of pulse dye laser in skin fungal infection, if this study showed that laser could be effective, this would be introduced as a new treatment modality.

Eligibility criteria:
inclusion criteria: * patients with positive koh smear skin plaques exclusion criteria: * tinea capitis,onychomycosis * pregnancy and feeding
sonovue®-enhanced ultrasound versus unenhanced us for focal liver lesion characterization

Conditions: Liver Neoplasms

Summary: the purpose of this study is to demonstrate the superiority of sonovue®-enhanced ultrasound versus unenhanced ultrasound for characterization of focal liver lesions using final diagnosis based on histology or combined imaging/clinical data as truth standard.

unit of analysis for the outcome measures was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.

Eligibility criteria:
inclusion criteria: * male/female. * provides written informed consent and is willing to comply with protocol requirements. * is at least 18 years of age. * has at least 1 focal liver lesion (fll) (target lesion) requiring work-up for characterization. target lesions may include those: * incidentally detected, * in subjects with chronic hepatitis or liver cirrhosis, * in subjects with known history of malignancy. * is scheduled for surgical removal or biopsy of the target lesion from 24 hours to 30 days after the sonovue® administration or * in case tissue biopsy is not indicated nor surgery planned, is scheduled for or has performed a contrast-enhanced (ce) ct and/or ce-mri of the target lesion from 30 days to 48 hours prior to or from 24 hours to 30 days after the administration of sonovue®. exclusion criteria: * has an acoustic window insufficient for adequate ultrasound examination of the liver. * has a fll that cannot be identified with unenhanced ultrasound. * has received or is scheduled for antineoplastic chemotherapy or an invasive procedure in the time period between test procedures and truth standard assessments which may have modified the target lesion. * is receiving any other contrast medium, within the 48 hours before and up to 24 hours following the administration of sonovue®. * has previously been enrolled in and completed this study. * known right to left cardiac shunt, bidirectional or transient. * has any known allergy to 1 or more of the ingredients of the investigational product (sulfur hexafluoride or to any components of sonovue®). * has any contraindication to 1 of the planned imaging procedures (ultrasound, ct or mri), e.g., implants, claustrophobia, inadequate medical conditions etc. * has received an investigational compound within 30 days before admission into this study. * has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations. * is determined by the investigator that the subject is clinically unsuitable for the study. * is a pregnant or lactating female. exclude the possibility of pregnancy by: * testing on site at the institution serum beta-human chorionic gonadotropin (βhcg) within 24 hours prior to the start of sonovue® administration, * surgical history (e.g., tubal ligation or hysterectomy), * post menopausal with a minimum 1 year without menses.
occupational therapy for cancer patients: a randomised, controlled study

Conditions: HRQOL (Health Related Quality of Life)

Summary: the aim of this study is to investigate the effect of occupational therapy, in shape of activities of daily living, for cancer patients.

background cancer patients often experience serious dysfunctions leading to problems with activities of daily living (adl) and reduced quality of life. occupational therapy is believed to be effective in handling many of the problems with adl experienced by patients with cancer, but the evidence is sparse. aim the purpose of this study is to analyse the effects of an occupational therapy intervention targeting cancer patients. outcome measures are the patients self-reported quality of life and the patients ability to perform adl. methods randomised controlled trial with 288 patients with cancer treated at naestved hospital in denmark. occupational therapy intervention programme for the intervention group (n=144) and standard treatment and care for the controls (n=144). a systematic review including studies of adl intervention for cancer patients will be carried out. feasibility of the recruitment and the intervention will be analysed and published. the patients need for occupational therapy will be analysed using baseline information from the randomised controlled trial. the effects of the intervention will be analysed using patient validated questionnaires including eortc qlq-c30 and the adl taxonomy questionnaire.

Eligibility criteria:
inclusion criteria: * cancer patients * disability comparable with a performance status of 10 to 70 on karnofsky performance status scale * able to read and understand danish exclusion criteria: * referred to occupational therapy before study start

Keywords: hrqol occupational therapy adl intervention cancer patients
digital behavioral interventions in inflammatory bowel disease

Conditions: Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Diseases; Stress, Psychological; Depression, Anxiety

Summary: given the bidirectionality between psychological distress and disease activity in inflammatory bowel disease (ibd), whereby increased psychological distress exacerbates disease activity and vice versa, psychosocial aspects of ibd care are receiving increased attention. however, proposed interventions are generally resource-intensive and have been tested in majority white populations. while people of color are an increasing segment of the ibd population, they are currently underrepresented in research studies. the purpose of this study is to evaluate the efficacy and implementation of internet-based cognitive behavioral therapy (icbt) among ibd patients of color with elevated psychological distress.

the investigators propose a 1:1 randomized trial design to evaluate the efficacy of icbt among a population of black and latinx ibd patients and to assess factors influencing its implementation. patients within the integrated health system at montefiore medical center will be actively recruited and screened to identify those with elevated psychological distress. eligible patients will be randomized to receive 8 weeks of icbt or digital mood tracking to evaluate the effect of icbt on levels of psychological distress, hrqol and disease activity post-intervention. the investigators will also evaluate individual process level barriers and facilitators to icbt implementation via surveys and semi-structured interviews.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * race/ethnicity self-identified as black/african american or hispanic/latino * established diagnosis of crohn's disease or ulcerative colitis * elevated psychological distress: at least one t-score within two standard deviations above the mean in the domains of anxiety or depression on the national institutes of health patient reported outcomes measurement information system-29 (promis-29) with or without a t-score within two standard deviations above the mean for perceived stress on the national institute of health toolbox perceived stress scale (perceived stress scale) * internet access (smartphone/mobile device with data plan, computer with internet) * ability to provide informed consent in english or spanish exclusion criteria: * promis-29 anxiety or depression t-scores in the severe range (above 2 standard deviations) * current suicidal ideation, past suicidal attempt or hospitalization
effect of dmmet-01 on insulin sensitivity in naive type 2 diabetes patients (clamp)

Conditions: Diabetes Type 2

Summary: the aim of this study is to determine the effect of dmmet-01 on insulin sensitivity by glucose clamp technique in mexican type 2 diabetes patients, after 2 months of treatment.


Eligibility criteria:
inclusion criteria: * ages eligible for study: 40 to 60 years * with type 2 diabetes evolution \< 5 years without pharmacological treatment 1 month prior to the screening * fasting glucose = 130-200 mg/dl * aic of 7% to 9% * blood pressure \< 140/80 mmhg * ability to communicate and meet the requirements of the study * signed written informed consent before to conducting any study * body mass index (bmi) of 25 kg/m2 to 35 kg/m2 exclusion criteria: * suspected or confirmed pregnancy * nursing * inability to secure the non-pregnant during the study duration * hypersensitivity to any biguanides * use of an investigational drug within 30 days prior to the screening * liver failure, heart failure, kidney failure or thyroid disease * periods of acute or chronic diarrhea or vomiting * chronic hepatic disease * total cholesterol \> 300 mg/dl * triglycerides \> 400 mg/dl

Keywords: diabetes type 2 monotherapy antidiabetics metformin