Kornimate/medical-research-clean huggingface dataset:
molecular landscape of complex lifestyle modification

Conditions: Obesity Prevention; Obesity; Metabolic Disease

Summary: the goal of this clinical trial is to detect the impact of the 3-month complex lifestyle intervention, consisting of dietary counselling, supervised exercise training and cognitive-behavioural intervention in middle-aged sedentary individuals with obesity, specific questions are: * what is the adaptive response to exercise training on the whole-body and skeletal muscle energy metabolism, insulin sensitivity, metabolic flexibility, muscle functional parameters and cardiopulmonary fitness? * would the intensity-related changes of the exercise-induced substrate preference (lipids vs carbohydrates) be a good predictive marker of metabolic flexibility i.e. the capacity to reduce the whole-body metabolic burden in patients with obesity? * is the signal driving the adaptive response to regular exercise contained in serum derived extracellular vesicles? researchers will examine effects of exercise training intervention on whole body energy metabolism, by integrating clinical, biochemical and molecular data. participants will: * undergo 3 months exercise - intervention program. * be submitted to examination of their obesity, energy metabolism and cardiopulmonary fitness related phenotypes using bioelectric impedance, indirect calorimetry, cycle spiroergometry. * blood samples will be taken both, at the baseline pre- and post- intervention.


Eligibility criteria:
inclusion criteria: bmi 30-45 kg.m-2 - exclusion criteria: smoking, cancer, -

Keywords: lifestyle intervention exerkines metabolic flexibility
a study of sys6020 injection in refractory active systemic lupus erythematosus

Conditions: Refractory Active Systemic Lupus Erythematosus

Summary: this study aimed to observe the safety and tolerability of sys6020 in adult participants with refractory active systemic lupus erythematosus, determine the recommended dose (rd) that may be explored for subsequent studies, and preliminly evaluate the clinical efficacy of this product,and explore the pharmacokinetics and immunogenicity of sys6020 injection in those participants.


Eligibility criteria:
inclusion criteria: * 1. age ≥18 years old, ≤70 years old; * 2. sle is diagnosed according to slicc 2012 or eular/acr 2019 revised criteria. * 3. patients are required to have received glucocorticoid combined with immunosuppressive agents and/or biological agents for more than 3 months, with a stable dose for more than 2 weeks, and the disease is still in an active state. * 4. antinuclear antibody, anti-ds-dna antibody and/or anti-smith antibody are positive. * 5. sledai-2k score≥7. * 6. bilag2004 meets one of the following two criteria:a）bilag grade a is defined as ≥1 organ system；b）bilag grade b is defined as ≥2 organ systems * 7. pga \> 1.0; exclusion criteria: * 1. severe lupus nephritis within 8 weeks before screening; * 2. sle or non-sle-related central nervous system disease or lesion within 8 weeks before screening; * 3. uncontrolled lupus crisis within 8 weeks before screening; * 4. clinically significant central nervous system diseases or pathological changes other than lupus before screening; * 5. vasculitis or inflammatory arthritis or skin disease other than sle or at screening; * 6. complicated with other autoimmune diseases; * 7. a b-cell-targeting agent have been used or is planned to be used within 8 weeks before screening， * 8. received renal replacement therapy（rrt）within 3 months before the screening period or anticipates the need for rrt during the study period; * 9. participants who will undergo major surgery or invasive intervention within 4 weeks prior to apheresis or plan for systemic or local tumor resection during the study period; * 10. participants with a known allergy, hypersensitivity, intolerance, or contraindications to sys6020 or any component of the drugs that may be used in the study, * 11. active bacterial, fungal, or viral infection within 2 weeks before apheresis;
direct measurement of motor cortical responses to tdcs

Conditions: Parkinson Disease; Chronic Stroke

Summary: transcranial direct current stimulation (tdcs) has shown the potential to improve symptoms in patients with movement deficits, such as parkinson's disease and chronic stroke. however, the effects of tdcs have so far not been proven on a wider scale due to lack of knowledge regarding exactly how tdcs works. this has limited the adoption of this potentially useful therapy for patients with parkinson's disease, chronic stroke and other conditions affecting movement. the investigators hypothesize that by studying the effects of tdcs in subjects performing a motor task, the brain signals mediating improvements in motor control will be identified. the investigators will use both noninvasive and invasive methods to explore this hypothesis. the investigators expect this combined approach to broaden understanding of tdcs application in conditions affecting movement and possibly lead to therapeutic advances in these populations.


Eligibility criteria:
inclusion criteria: * age 18 or older * previous consent to be contacted regarding potential participation in a research study at medical university of south carolina exclusion criteria: * subjects unable to actively participate in the consent process physically and/or cognitively * pregnancy * presence of scalp injury or disease * prior history of seizures * metal implants in head or neck * prior intracranial surgery * prior brain radiotherapy * prior history of intracranial tumor, intracranial infection or cerebrovascular malformation
a study to evaluate the efficacy and safety of cam-3001 (drug) in subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the primary objectives of this study is to assess the safety, tolerability and efficacy of multiple doses of the mavrilimumab (cam-3001) administered subcutaneously in subjects with moderately active rheumatoid arthritis (ra).

this is a phase 2, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the efficacy and safety of multiple doses of the mavrilimumab (cam-3001) (10 milligram \[mg\], 30 mg, 50 mg, and 100 mg) administered subcutaneously in adult subjects with moderately active ra.

Eligibility criteria:
inclusion criteria: * age 18 through 80 years (20 to 75 years in japan) * written consent * diagnosis of adult onset rheumatoid arthritis (ra) of at least 3 months duration as defined by the 1987 american college of rheumatology (acr) classification criteria (arnett et al, 1988) * treatment with methotrexate at a stable and tolerated doses * positive anti-cyclic citrullinated peptide (ccp) immuno-globulin g antibodies (more than \[\>\] 5 international unit per milliliter \[iu/ml\]) and/or rheumatoid factor (rf \>14 iu/ml) at screening * received more than or equal to (\>=) 5 milligram (mg) per week folic acid as a single or divided dose during the study. exclusion criteria: * a rheumatic autoimmune disease other than ra * a history of, or current, inflammatory joint disease other than ra or other systemic autoimmune disorder * subjects at a high risk of infection * subjects (male and female) of reproductive potential who are not willing to use contraception from screening through the end date of the trial * history of methotrexate or any drug-induced lung fibrosis or pneumonitis.

Keywords: rheumatoid arthritis mavrilimumab cam-3001
effect of cervical exercise combined with nerve mobilization on cervical spondylotic radiculopathy

Conditions: Radiculopathy, Cervical

Summary: the objective of this clinical trial was to investigate the effects of cervical spine exercises combined with nerve mobilization in patients with radiculopathy. the main questions it aims to answer are: 1. whether cervical spine operation combined with nerve mobilization is effective for cervical radiculopathy. 2. is there any difference between cervical spine operation combined with nerve mobilization and single method? the participants were patients with cervical radiculopathy and were divided into three groups in this study. 1. experimental group: received cervical spine operation combined with nerve mobilization 2. control group 1: cervical spine exercises were performed 3. control group 2: received neuromobilization

after being informed of the risks, participants are required to sign an informed consent form. eligible participants will be randomly assigned to cervical spine operation combined with nerve mobilizatio or cervical spine exercises or neuromobilization on a 1:1:1 ratio.

Eligibility criteria:
inclusion criteria: 1. meet the diagnostic criteria of csr and have no other complications; 2. age 18-65 years old, gender unlimited; 3. no other treatment for cervical spondylosis in the last 1 month; 4. no previous surgical treatment for cervical spondylosis; 5. good compliance; 6. good mental state, no history of mental illness; 7. informed consent, and sign the informed consent. exclusion criteria: 1. does not meet the diagnostic criteria; 2. women during pregnancy; 3. severe stenosis of the foramen; 4. osteoporosis combined with spinal cord tumor, osteomyelitis; 5. infectious diseases, skin defects, allergies; 6. have serious heart, lung and other important organ dysfunction; 7. unable to cooperate.
self-management behaviors of arabs and jews with parkinson's disease and their associations with health outcomes

Conditions: Parkinson Disease; Neuro-Degenerative Disease; Movement Disorders

Summary: the study will examine the reciprocal relationships between the community, healthcare system, and personal determinants of self-management behaviors in persons with parkinson's disease and their association with the performance of these behaviors in persons with parkinson's disease. in the first part of the study, data will be extracted from electronic medical records of 2500. in the second part of the study, a sub-sample of 200 participants with parkinson's disease will be asked to answer standardized questionnaires.

parkinson's disease is a chronic, protracted condition. its diverse symptoms affect the daily functioning and quality of life of patients and their families. the progressive disability is accompanied by medical complications and hospitalizations, which increase the economic burden on patients and healthcare systems. factors that can mitigate these adverse consequences include care from a neurologist, rehabilitative treatments, and patients' use of self-management strategies. however, studies suggest that patients with parkinson from minority groups are less likely to be treated by a neurologist. also, it is unclear whether patients with parkinson from minority groups are offered self-management strategies. the study objectives were: to (1) to identify the reciprocal relationships among extra- and intra-personal level determinants of self-management behaviors and their association with performance of these behaviors in persons with parkinson's disease, (2) identify the relationships between self-management behaviors (medical and lifestyle), function, and quality of life in patients with parkinson's disease. phase a of the study is a retrospective study based on extraction and analysis of data from electronic medical records, and phase b of the study is a cross-sectional study based on face-to-face meetings with a subsample of the patients whose data are included in the retrospective study.

Eligibility criteria:
inclusion criteria for the retrospective study: people diagnosed with parkinson's disease. exclusion criteria: none. inclusion criteria for the cross-sectional study: 1. diagnosis of pd. 2. jewish sector will be fluency in hebrew (comprehension, speaking, and reading), and for the arab sector, fluency in arabic or hebrew (comprehension, speaking, and reading). exclusion criteria for the cross-sectional study: 1. acute hospitalization in the last 3 months. 2. severe co-morbidities other than pd that affect daily living, special populations including pregnant women, minors (\<18 years old). 3. patients who are not eligible to sign consent forms due to physical or mental conditions. 4. people who have a guardian, score less than 20 in the mini-mental state exam test.

Keywords: self-management patient activation parkinson's disease
multifunctional approach in cardiac surgery

Conditions: Heart; Surgery, Heart, Functional Disturbance as Result

Summary: postoperative pain and swallowing disorders are complex, multifactorial phenomenon that frequently occur after cardiac surgery. preoperative anxiety and the interaction between sex and other sociocultural factors may predict greater sensitivity to postoperative pain, whereas the epidemiology and course of swallowing disorders has not been systematically investigated, along with the interaction between dysphagia, post-operative pain and emotional stress. cardiac rehabilitation is a multifunctional intervention which may address all these functional domains, improving patients' prognosis. the aim of the present study is to demonstrate the superiority of a multifunctional approach (omt, systematic swallowing screening and specific treatment according to good clinical practice associated with psychological counseling) compared to local clinical practice in the management of pain and swallowing disorders.

the titanic trial will provide evidence on whether a multifunctional intervention systematically implemented in the cardiac rehabilitation setting will improve the clinical course and prognosis of patients with recent cardiac surgery. the design is a randomized clinical trial with parallel group design. patients aged over 18 undergoing elective cardiac surgery and admitted to irccs fondazione don gnocchi, santa maria nascente, milan, for cardiac rehabilitation will be randomized to standard post-acute treatments (cardiovascular training, monitoring and logopedic treatment only in case of swallowing dysfunction) compared with an experimental approach which consists of osteopathic manipulative treatment (omt) treatments, swallowing screen protocol, psychological assessment and counseling. this study may help in the identification of a new diagnostic-therapeutic pathway in cardiac surgery patients that allows a reduction in the use of analgesics and anti-inflammatories and increases the early detection of swallowing disorders. furthermore, by allowing an integrated assessment of emotional needs, it can have a positive effect in reducing the need for post-operative clinical visits and assessments in the medium to long term, improving the patients' quality of life.

Eligibility criteria:
inclusion criteria (all the following must be satisfied): * patients with recent cardiac surgery (within one month) * without swallowing disorders already identified before discharge * with the presence of chest pain (nrs\>2). exclusion criteria: * patients who are unable to sign informed consent. * patients with already known psychological/psychiatric disorders.

Keywords: cardiac surgery cardiac rehabilitation swallowing disorders post-surgical pain psychological counseling osteopathic manipulative treatment
pet/ct imaging for radiation dosimetry, plasma pharmacokinetics, safety and tolerability in healthy volunteers and safety, tolerability and diagnostic performance of bay86-9596 in patients with non-small cell lung cancer, breast cancer, head and neck cancer and patients with inflammations

Conditions: Diagnostic Imaging

Summary: visual assessment of diagnostic pet/ct (positron emission tomography/computed tomography) images obtained after a single intravenous injection of bay86-9596 in patients with cancer and inflammation


Eligibility criteria:
inclusion criteria: * healthy volunteers only * males/females ≥ 50 years and ≤ 65 years of age * cancer patients and inflammation patients (inflammation patients in study part 2 = optional, in study part 3 mandatory) * males/females ≥ 30 and ≤ 80 years of age * patients had an fdg pet/ct for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass with high certainty, for 1. nsclc (non small cell lung cancer), or 2. adenocarcinoma of the breast (female patients) or 3. squamous cell cancer of head and neck and the cancer disease is histologically confirmed. 4. patients with confirmed/known inflammatory focus/foci after fdg-pet/ct imaging exclusion criteria: * exclusion criteria for all healthy volunteers and patients: * any concomitant disease (for healthy volunteers) and for patients any concurrent severe and/or uncontrolled and/or unstable other medical disease (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of bay86-9596, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study * for healthy volunteers and patients: known sensitivity to the study drug or components of the preparation. * tumor patients with known inflammatory disease, where images overlap inflammatory lesions with tumor lesions

Keywords: neoplasm pet/ct diagnosis pet tracer inflammation
reinforcing cp robotic training with auditory feedback

Conditions: Cerebral Palsy

Summary: the purpose of this study is to create a platform to prolong the adaption obtained from the cable-actuated gait training and encourage the individuals with cp to provide self-care at home.

the experiment protocol involves a maximum of ten sessions and will take two or three hours for each session. baseline data will be collected before the first session for both overground and treadmill walking. during this session, the sound level will be adjusted based on the feedback received from the users. the researcher will ask the comfortable sound level to the participant before starting the experiment. training will be conducted on the treadmill with the cable-actuated device for about 20 minutes. when the cables were removed, participants walked on the treadmill for 4 minutes during the post-training session. during training and post-training, participants will be exposed to feedback while walking on the treadmill. after treadmill walking, cp participants will be asked to take a ten-minute break and then practice overground walking for two minutes with auditory feedback (type a) and without it (type b). effects of 3 different types of auditory feedback will be explored namely, rhythmic sounds, movement sonification, and sound notifying erroneous gait. group a participants will be further divided into groups depending on the type of auditory feedback that will be provided. participants will participate in a maximum of 10 sessions, two or three times a week. before the first and after the last training, participants will be evaluated for functional gait assessment, 6-min-walk, leg strength using a dynamometer, and modified ashworth test by a physical therapist.

Eligibility criteria:
inclusion criteria: * adults with cerebral palsy (18-65 years old) * ambulation of a distance of 100 feet with or without the use of assistive devices. exclusion criteria: * severe equinovarus foot or genu recurvatum of the knee * surgery within 6 months will be excluded. * individuals with pregnancy * lower limb prosthetics * severe respiratory problems such as chronic obstructive pulmonary disease, heart disease, a loss of sensation, uncontrolled blood pressure, * seizure disorder * severe arthritis
beta cell function tests over time in patients with t2dm randomized to metformin or rosiglitazone

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to determine whether markers of b-cell function can predict changes in b-cell function over time in patients with type 2 diabetes mellitus (t2dm) randomized to treatment with metformin or rosiglitazone.

the study terminated on 17-jul-07 due to concerns about long-term cardiovascular safety of avandia and slow patient enrollment. there were no specific safety issues raised within the trial.

Eligibility criteria:
inclusion criteria: * male or female with type diabetes mellitus (diagnosed via ada criteria), newly diagnosed or treatment-naive (other than diet and exercise) and hba1c range of 7 to 9%. * 45-70 years of age. exclusion criteria: * evidence or history of clinically significant hematological, renal, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (excluding untreated, asymptomatic, seasonal allergies).
prevention for positives: an rct among vietnamese hiv-positive idu

Conditions: HIV

Summary: the purpose of this study is to determine whether a combined individual and structural level stigma reduction intervention is effective in reducing high risk injecting and sexual behaviors among hiv positive injecting drug users.

this study is a randomized controlled trial among hiv-positive injecting drug users (idus) to reduce high risk injecting and sexual behaviors in thai nguyen, vietnam. we will be conducting this study in collaboration with the thai nguyen centre for preventive medicine (cpm). we will compare standard hiv voluntary counseling and testing (vct) to an intervention that adds a continuum of psychosocial support for hiv-positive idus. the intervention consists of a two-tiered approach that addresses structural and individual level barriers to risk reduction: 1) the structural level of the intervention consists of community-based programs and targets hiv stigma that is a primary obstacle to risk reduction for hiv-positive individuals; 2) the individual level of the intervention consists of 2 hiv posttest counseling sessions and 2 skill-building support groups for hiv-positive idus. our research questions for the overall project are: 1. what is the impact of perceived hiv-related stigma on disclosure, social support, and coping among idus? 2. what roles do disclosure, social support, and coping play in facilitating the reduction of hiv-risk behaviors 3. are combined individual and structural level interventions more effective in reducing injecting and sexual behaviors among hiv-positive idus than individual or structural interventions alone and more effective than the standard hiv vct?

Eligibility criteria:
index participant inclusion criteria: * laboratory confirmed hiv positive diagnosis * able and wiling to bring an injecting network member for screening * injected drugs in previous 6 months * planned residence in thai nguyen for next 24 months exclusion criteria: * unwilling to provide locator information * unable to participate in group counseling sessions due to psychological disturbance, cognitive impairment or threatening behavior * currently participating in other hiv or drug use intervention activities network member participant inclusion criteria: * laboratory confirmed hiv negative diagnosis * injected or shared drug paraphernalia in past 6 months * interacts at least once a week with index participant exclusion criteria: * unwilling to provide locator information * having psychological or cognitive impairment * currently participating in other hiv intervention

Keywords: hiv drug abuse social stigma vietnam
post-marketing study of kamrab administered as a single dose with active rabies vaccine in children exposed to rabies

Conditions: Rabies

Summary: the primary purpose of this study is to confirm the safety of kamrab (human rabies immunoglobulin) in children ages 0 months to \<17 years, when administered as part of post-rabies exposure prophylaxis (pep).


Eligibility criteria:
inclusion criteria: * healthy children (male and female) ages 0 months to \<17 years. * have been exposed or possibly exposed to rabies. * are indicated to receive post-exposure prophylaxis (pep) against rabies infection. * have documented informed consent from the child's parent(s) or legal guardian(s) and assent from the child if appropriate. exclusion criteria: * history of previous administration of rabies vaccine or human rabies immune globulin (hrig) * rabies exposure or possible rabies exposure more than seven days prior to initiation of pep, or timing of exposure unknown