Kornimate/medical-research-clean huggingface dataset:
rc48-adc in breast cancer

Conditions: Breast Cancer

Summary: to evaluate the efficacy and safety of disitamab vedotin (rc48-adc) in patients with breast cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed breast cancer; * prior or current use of disitamab vedotin (rc48-adc); exclusion criteria: * participating in clinical trials involving disitamab vedotin (rc48-adc) or not.
the effect of telerehabilitation on balance in people with multiple sclerosis

Conditions: Telerehabilitation

Summary: the study will compare the effect of individual telerehabilitation with offline remote exercise through videos and with a control group without intervention. the monitored group will be people with multiple sclerosis with balance impairment. the duration of the intervention will be 12 weeks.

total of 60 persons will be randomly divided into two experimental and one control groups. after dividing into individual groups, all probands will be examined using objective and subjective tests for balance and walking. the same testing will be done after the end of the 12-week intervention. the group with individual telerehabilitation will exercise twice a week. the exercise will consist of strength and balance exercises using the homebalance ® system. for direct synchronous contact between the physiotherapist and the patient, an audiovisual link via the freely available zoom app was used. the second experimental group will receive 12 video recordings of exercises created by a physiotherapist for home exercises, according to which they will also exercise twice a week. the control group receives no intervention.

Eligibility criteria:
inclusion criteria: * a diagnosis of definite ms * subjectively perceived balance impairment * clinically stable ms (at least 30 days since the last attack of the disease) * ability to independently operate a pc or tablet, and exclusion criteria: * severe cognitive deficits that would interfere with understanding exercise instructions * presence of other disease adversely affecting balance impairment

Keywords: multiple sclerosis telerehabilitation remote rehabilitation exergaming balance
effect of metabolaid® on ampk activation for weight loss

Conditions: Metabolic Syndrome

Summary: the objective of this study was to establish a formulation, containing both hibiscus sabdariffa l. (hs) and lippia citriodora l. (lc) extracts (metabolaid®) that had significant capacity to activate the ampk-enzyme and to reduce triglyceride accumulation in the hypertrophied adipocyte model. then, we assessed the efficacy of this combination in light-to-moderate-overweight subjects under risk of developing metabolic syndrome.

amp-activated protein kinase (ampk) has been postulated as a molecular target in the amelioration of obesity-related diseases, where most therapeutic approaches have failed. plant-polyphenols have shown the capacity to ameliorate obesity-induced metabolic disturbances. a combination of polyphenols (lc-hs) derived from hibiscus sabdariffa l. (hs) and lippia citriodora l. (lc) (lemon verbena) (metabolaid®) was assessed for triglyceride accumulation and ampk activation in the hypertrophied adipocyte model 3t3-l1. a dietary supplement containing 500 mg of lc-hs was evaluated in a double blind, placebo-controlled and randomized trial in 56 overweight subjects for two months. anthropometric and circulating biochemical parameters were determined.

Eligibility criteria:
inclusion criteria: * participants with a body mass index (bmi) from 24 to 34 kg/m2 exclusion criteria: * total cholesterol lower than 200 mg/dl. * use of prescription medication for cholesterol or hypertension. * presence of any obesity-related pathology. * hormone replacement therapy. * consumption of antioxidant supplements/drugs. * alcohol addiction. * women who were pregnant or lactating.
preventive and reversional effect of vitamin d on parenteral nutrition associated liver disease

Conditions: Liver Disease

Summary: patients who accept long-term parenteral nutrition tend to suffer from liver injury. the mechanism for this injury has two possible explanations. the first possible reason is intrinsic toxic effects of parenteral nutrition. the second is the basic pathological condition of intestinal failure which includes infection, bacterial translocation, etc. cholestasis is the lethal presentation of this kind of liver disease. farnesoid x receptor (fxr) is a member of ligand-activated nuclear receptor superfamily. fxr serves as a sensor for bile acids and promotes enterohepatic clearance of bile acids by controlling the expression of genes involved in their transport and metabolism. considering the activation of vitamin d receptor (vdr) by vitamin d can induce fxr-related genes in the liver.the hypothesis of this study is that vitamin d plays a key role in the prevention and reversion of the liver via vdr and/or fxr signaling pathway. using a mouse cholestasis model based on short bowel syndrome and parenteral nutrition, the researchers will investigate the dynamic change of plasma vitamin d level. afterward, intravenous supplement of vitamin d was added to this model to demonstrate vitamin d can ameliorate cholestasis. an in vitro system was developed to investigate the importance of fxr signaling pathway in this effect.


Eligibility criteria:
inclusion criteria: * patients with short bowel syndrome supported by total parenteral nutrition. * patients have intestine more than 50cm. * requirements of informed consent and assent of participant, parent or legal guardian as applicable consciousness and ability cooperate. exclusion criteria: * patients have obstruction of biliary tract, infection, autoimmune disease, cancer. * patients have intestine less than 50cm. * a clinically significant laboratory abnormality or a history of significant cardiac, pulmonary, hepatic, or renal disease. * female with positive pregnancy. * allergy to ursodeoxycholic acid.

Keywords: parenteral nutrition associated liver disease vitamin d short bowel syndrome farnesoid x receptor cholestasis
pharmacokinetics of ethionamide and ethionamide sulfoxide in patients established on treatment for tuberculosis.

Conditions: Tuberculosis, Pulmonary

Summary: to determine the pharmacokinetics of ethionamide (eto) and ethionamide-sulfoxide (eto-so) in participants with tuberculosis (tb) when eto is dosed under programmatic conditions.

a single-centre, open-label, exploratory pharmacokinetic study. this study is designed to collect blood samples from participants established on a tb treatment regimen which includes eto. these samples will be analysed for concentrations of eto and its metabolite eto-so. the medication will not be provided by the study, participants will receive their standard of care medication from their local clinic. participants will continue to take their total daily dose of eto on study as prescribed by their primary caregiver, this will not change for their participation on study.

Eligibility criteria:
inclusion criteria: * provide written, informed consent prior to all trial-related procedures. * male or female, aged between 18 and 65 years, inclusive. * receiving eto as a component of a treatment regimen for tuberculosis for at least one month at the time of enrolment. * ability and willingness of participant or legally authorized representative to provide informed consent. exclusion criteria: * evidence of clinically significant conditions or findings, other than tb, that might compromise safety of the participant or the interpretation of trial endpoints, per discretion of the investigator. * receiving prohibited concomitant medications (see prior and concomitant medications) * evidence of illicit substance use (cannabis, methamphetamines, opiates) * pregnant or breastfeeding or planning to become pregnant during the study period. * laboratory values: participants with the following laboratory values at screening * creatinine \>1.5 times upper limit of normal \[uln\]; * haemoglobin \<8.5 g/dl; * alanine aminotransferase (alt) ≥2.0 x uln;
intensity of task-oriented exercises

Conditions: Stroke

Summary: in an observational study, the energy consumption of stroke individuals during performing the structured, progressive task-oriented exercise program for walking rehabilitation will be measured in order to confirm the intensity demand in the range of moderate to vigorous.

community reintegration is often significantly affected in the majority of stroke individuals. to fulfill the requirements of a proper home exercise program in walking rehabilitation for stroke victims, investigators structured the task-oriented exercise program with minimal supervision. this exercise program is structured with challenging walking-related activities based on motor learning principle and gentile's progression of the motor task. the strengthening and balance components, aerobic conditioning and walking adaptability are composed of an exercise program to optimize walking ability. there are sixty minutes last ten exercises in each three progression steps of this exercise program. for the training effect to occur, each step of exercise program is designed by increasing demand of intensity in the range from moderate to vigorous. to confirming progressive energy demand, the purpose of this study is to investigate the intensity demand of three steps task- oriented home exercise program on walking competency in individual post stroke.

Eligibility criteria:
inclusion criteria: 1. either side of both type first stroke with confirmatory diagnosis by ct scan and mri. 2. age above 20 years old. 3. moderate severity of stroke measured by the modified rankin scale (mrs- 3) 4. able to comprehend the instructions with good cognition measured by mini-mental state examination (mmse \> 23). exclusion criteria: 1. diagnosed with other neurological disorder such as parkinson's disease, peripheral nerve injury. 2. serious cardiac conditions (angina and myocardial infarction during the previous month, resting heart rate of more than 120, a systolic blood pressure of more than 180 mm hg, and a diastolic blood pressure of more than 100 mm hg) 3. fugl meyer assessment score (lower extremity) less than ≤ 21 4. significant hip, knee and ankle contracture that would limit ambulation (fugl meyer (rom) ≤1 in each joint). 5. orthopedic and rheumatological disorder with weight bearing pain (fugl meyer (pain) ≤ 1 in hip, knee and ankle joint movement).

Keywords: stroke walking competency task-oriented exercise program exercise intensity
safety and efficacy study of prosaptide to treat neuropathic pain in hiv-positive patients

Conditions: HIV; Peripheral Nervous System Disorders

Summary: this is a double-blind, placebo-controlled, parallel groups study to determine whether prosptide is effective in relieving pain in patients who have sensory neuropathic pain related to their hiv infection or the drugs used to treat it.

sensory neruopathies are the most frequent neurological complicaton of hiv infection and its treatmet with antiretrovirals. to date, there are few effective treatments, and all are symptomatic treatments for pain. management typically involves the intiation and adjustment of pain-modifying therapies, and the adjustment or discontinuation of potentially neurotoxic antiretrovirals, thereby limiting the choice of haart regimens. in precinical animal models,prosaptide has been shown to be efficacious in the treatment of neuropathic pain caused by a variety of different mechanisms. hypothesis: prosaptide will improve neuropathic pain in hiv-associated sensory neuroathies,and will be safe and well tolerated in subjects. comparisons: 4, 8, or 16 mg prosaptide vs. placebo

Eligibility criteria:
inclusion criteria: * ages 18 years and older
chronic total coronary occlusion treatment results 6 years after bioresorbable scaffold implantation

Conditions: Angina Pectoris; Coronary Artery Disease; Occlusion, Coronary

Summary: aim of the study is to evaluate chronic total coronary occlusion treatment results 6 years after bioresorbable scaffold implantation by quantitative coronary analysis, intravascular ultrasound and optical coherence tomography.

the study aims to assess the outcomes of treating chronic total coronary occlusion (cto) using bioresorbable scaffolds six years after implantation. the evaluation employs quantitative coronary analysis (qca), intravascular ultrasound (ivus), and optical coherence tomography (oct) as invasive imaging tools. clinical follow-ups were conducted at one and six years post-implantation to ensure a comprehensive understanding of the long-term safety and feasibility of bioresorbable scaffold implantation for cto. the primary outcome measure is defined as the target lesion failure of the treated chronic total coronary occlusion segment. target lesion failure typically encompasses a composite endpoint that includes clinical events such as cardiac death, target vessel myocardial infarction, and clinically-driven target lesion revascularization. the use of qca allows for the quantitative assessment of the coronary arteries, providing measurements of vessel diameter and lesion length. ivus is employed to obtain detailed images of the vessel wall, helping to visualize the morphology of the treated segment and assess the presence of any complications such as stent malapposition or edge dissections. oct, with its high resolution, allows for detailed imaging of the coronary artery, providing information on plaque composition and stent apposition. by combining these invasive imaging tools with clinical follow-ups at specified intervals, the study aims to provide a comprehensive evaluation of the long-term efficacy and safety of bioresorbable scaffold implantation in the treatment of chronic total coronary occlusion. the focus on target lesion failure as the primary outcome measure ensures a clinically relevant assessment of the success of the intervention.

Eligibility criteria:
inclusion criteria: * 100% occlusion of a coronary artery for a duration of greater than or equal to 3 months based on angiographic evidence. exclusion criteria: * participant withdrawal from study.

Keywords: atherosclerosis chronic total coronary occlusion intravascular ultrasound optic coherence tomography
chitocare medical wound healing gel pmcf study on healing of chronic wounds

Conditions: Diabetic Foot Ulcer; Venous Leg Ulcer; Pressure Ulcer

Summary: we are testing a gel intended for the protection and healing of chronic wounds as a support for standard therapy. the main component of the gel is chitosan, a natural polymer that has the ability to stop bleeding, has a positive effect on wound healing, and has antimicrobial properties.

the purpose of this pmcf study is to evaluate the safety and efficacy of chitocare medical wound healing gel for the healing of chronic wounds. the study will enroll patients with diabetic foot ulcer, venous ulcer or pressure ulcer. patients will be randomly assigned to an active or control group. the active group will apply the gel to the wound, in addition to the standard of care, while the control group will receive only standard care. the study will last from 3 to 18 months for an individual patient (15-month recruitment period and 3 months of follow-up after the last patient is enrolled) or until event occurrence (complete wound healing/exclusion from the study). the study envisages four visits: visit 1 - screening and inclusion visit, visit 2 (after 4 weeks), visit 3 (after 12 weeks) and visit 4 - end of study visit: the final visit will take place when the event occurs (complete healing/exclusion from study). on each visit, the patients will have their wound photographed and assessed after debridement. adverse events will be followed throughout the whole study.

Eligibility criteria:
inclusion criteria: 1. written informed consent must be given 2. patient ≥ 18 years old 3. presence of chronic wound (wagner grade i and ii diabetic foot ulcer, venous leg ulcer or pressure ulcer) that meets the following criteria: * size of the wound ≥ 0.5 cm2 * wound is not infected at the time of randomization * wound is present for at least 4 weeks 4. able to understand and comply with the requirements of the study exclusion criteria: 1. patients with serious concomitant disease (cancer, heart failure (nyha class iv), severe anaemia (hb\<100 g/l), neoplasia) 2. any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness) 3. patients that will require surgical procedure to treat their ischemic condition on the limb where the wound is present as assessed by the investigator 4. patients diagnosed with autoimmune connective tissue diseases 5. previous treatment under this clinical protocol 6. participation in another clinical trial 7. receiving or scheduled to receive a medication or treatment which, in the opinion of the investigator, was known to interfere with, or affect the rate and quality of wound healing 8. allergy to shellfish (for active study group) 9. medical condition likely to require systemic corticosteroids during the study period 10. pregnant and lactating women
hepsera versus hepsera plus lamivudine for treatment of chronic hepatitis b in patients with normal alt

Conditions: Hepatitis B

Summary: this project is a randomized, open-label trial of adefovir dipivoxil (hepsera) and lamivudine combination therapy versus adefovir dipivoxil (hepsera) monotherapy. both adefovir dipivoxil and lamivudine are nucleoside analogues approved by the u.s. fda for the treatment of chronic hepatitis b. the primary hypothesis is that subjects treated with combination therapy will see their viral dna count decrease in an amount greater than subjects treated with monotherapy. the secondary hypothesis is that subjects treated with combination therapy will have a higher hbeag conversion rate compared to historical controls of subjects treated with lamivudine or adefovir dipivoxil monotherapy.


Eligibility criteria:
inclusion criteria: * older than 18 years * hbsag+ at screening and for at least 6 months prior to study entry * hbeag+ * hbv dna greater than 6 log10 copies/ml * platelet count greater than 50,000 platelets/mm3 * hemoglobin greater than 7.5 g/dl * alt less than uln * estimated creatine clearance\>50 ml/min as estimated by the crockcroft-gault equation ((140-age) x (kg)/(serum creatine x 72) (for women x 0.85)) * female and male participants must be practicing an effective form of contraception (male or female condom with spermicide, diaphragm or cervical cap with spermicide, intrauterine device, hormonal contraception) * serum alpha-fetoprotein less than 50 ng/ml within 30 days of study entry * childs-pugh score less than 7 and no ascites, variceal bleeding, or hepatic encephalopathy * able to give written informed consent and to comply with the study protocol exclusion criteria: * history or evidence of hiv, hepatitis c or hepatitis d * known or suspected hypersensitivity to adefovir or other nucleoside/nucleotide analogs. * history of clinically significant renal dysfunction * any active medical or psychiatric illness that, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol * pregnancy or breastfeeding * receipt of systemic corticosteroids within 90 days of study entry * receipt of nephrotoxic drugs within 8 weeks prior to study screening or expected use of these agents during the course of the study

Keywords: hepatitis b
deep squat, cross-legged sitting and low back pain

Conditions: Low Back Pain; Hip Pain Chronic

Summary: the goal of this randomized experimental study is to learn if regular deep squat or cross-legged sitting practice can improve mobility, reduce pain, and enhance visceral functions in adults with chronic low back pain (lbp). the main questions it aims to answer are: does practicing deep squat or cross-legged sitting increase joint mobility (hip, spine, ankle) and flexibility? does it reduce pain levels in the lumbar spine and hip region? does it improve visceral functions related to digestion and bowel movements? researchers will compare a deep squat group, a cross-legged sitting group, and a control group to see if these interventions lead to significant improvements in mobility, pain reduction, and visceral function compared to no intervention. participants will: be randomly assigned to one of three groups (deep squat, cross-legged sitting, or control). practice their assigned position for 20 minutes per day, 6 days a week, for 6 weeks. undergo baseline and post-intervention assessments, including mobility tests, pain evaluation, and quality-of-life questionnaires.

this randomized experimental study explores the effects of deep squat and cross-legged sitting practice on musculoskeletal mobility, pain perception, and visceral functions in adults with chronic low back pain (lbp). by examining these interventions over a six-week period, the study seeks to determine their potential role as non-pharmacological strategies for managing chronic pain and mobility limitations. participants will receive structured guidance to ensure proper execution of the assigned positions and adherence to the intervention protocol. standardized assessments will be conducted before and after the intervention to evaluate changes in joint mobility, flexibility, pain levels, and quality of life. the study is designed to contribute to evidence-based rehabilitation practices, offering insights into how simple, posture-based exercises might improve physical function and well-being. findings may have implications for physiotherapy, rehabilitation, and self-management strategies in individuals with chronic lbp.

Eligibility criteria:
inclusion criteria: * age 20-60 years, chronic lower back or hip pain lasting at least 3 months, presence of bowel problems at least twice a month for at least 3 months) exclusion criteria: * acute health problem, pregnancy, hip or knee tep, patellofemoral syndrome or recent lower limb surgery
the gut microbiota and delirium in the icu

Conditions: Delirium of Mixed Origin; Microbial Colonization

Summary: to investigate whether the composition of the gut microbiota is different in patients that develop delirium during critical illness as compared to patients who do not.

we plan to include an equal number of patients admitted to the icu, that either do or don't develop delirium during their course of critical illness. samples of feces/rectal swaps will be taken at admission and again either when the patients become cam-icu positive, alternatively after 5 days admssion/at discharge in patients that remain cam-icu negative. samples are then sent to analyses for purification of bacterial dna and metagenomic analysis.

Eligibility criteria:
inclusion criteria: admission to the icu, disability to make informed consent due to critical illness - exclusion criteria: dementia. delirium diagnosed prior to the icu admission on the non-icu floors. coma. indication for deep sedation (-4/-5). -