Kornimate/medical-research-clean huggingface dataset:
effects of chronic dietary grape seed extract supplementation on aortic stiffness and hemodynamic responses to exercise in obese males

Conditions: Obesity Adult Onset

Summary: it was demonstrated that acute dietary supplementation with gse reduced arterial blood pressure via reduction in q in obese individuals. however, no studies have investigated the chronic effects of dietary gse supplementation on hemodynamic responses during exercise. given the fact that obesity is associated with an impaired function of enos, the effect of chronic dietary gse supplementation on abnormal blood pressure response to exercise and aortic stiffness (aos) needs be elucidated. thus, it is hypothesized that gse decreases systolic blood pressure (sbp), diastolic blood pressure (dbp), mean arterial pressure (map), q, and aortic stiffness at rest and during exercise. this study would determine that this supplementation may be used as a non-pharmacological intervention to prevent incident hypertension and cardiovascular events during exercise via enhanced endothelial function.

we investigated whether elevated blood pressure and aortic stiffness (aos) characterized in obese and overweight males (n=10) are reduced following chronic gse supplementation during exercise. systolic blood pressure (sbp), diastolic blood pressure (dbp), mean arterial pressure (map), heart rate (hr), stroke volume (sv), cardiac output (q), total vascular conductance (tvc), and aos to two submaximal cycling exercises (40% and 60% vo2peak) were compared 7 days after ingestion of gse or placebo (pl) within an one week washout period. compared with pl, gse supplementation significantly decreased map at rest, 40%, and 60% workloads. aos was significantly reduced at rest. q tended to be decreased, but there was no significant difference. gse had no effect on hr, tvc, and sv. our study indicates that chronic supplementation with gse reduces arterial pressure at rest and during exercise primarily via the combined reduction of aos and q. thus, gse can be a dietary supplement to treat augmented blood pressure responses in obese and overweight males at rest and during exercise.

Eligibility criteria:
inclusion criteria: * overweight: 25-29.9 kg/m2 * obese: \> 30 kg/m2 * waist circumference: \> 90 cm exclusion criteria: * antihypertensive medication * major systemic disease (cancer) * musculoskeletal diseases * cardiovascular diseases or symptoms including chest pain * myocardial infarction * arrhythmias * heart failure
evaluation of erythroferrone as a new biomarker of erythropoesis stimulating agents

Conditions: Sports Drug Abuse

Summary: the main objective of this research is to demonstrate the possible use of erythroferrone (erfe) as a potential marker of recombinant human erythropoietin (rhuepo) use to be included in the athlete biological passport (pba) developed by the world anti-doping agency (wada).


Eligibility criteria:
inclusion criteria: * man between 18 and 49 years old * beneficiary of a social protection scheme * able to sign informed consent exclusion criteria: * hematocrite\>50% or hemoglobin\> 17d/dl or ferritin\<30 ug/l * hypersensitivity to the active substance or to any of the excipients ofeprex * erythroblastopenia already reported following treatment with erythropoietin * uncontrolled hypertension * any medication taken as part of a chronic treatment * absence of stable or evolutionary pathology without treatment * history of convulsion or epilepsy * history of thrombotic vascular events * large blood loss due to an accident, pathological condition or other similar situation. * donation of blood or blood transfusion within three months prior to inclusion in the protocol.

Keywords: antidoping
dose-ranging study evaluating ave1625 in abdominally obese patients with atherogenic dyslipidemia

Conditions: Obesity; Dyslipidemia

Summary: primary objective: to assess the effect of ave1625 on weight loss over a period of 24 weeks in abdominally obese patients with atherogenic dyslipidemia. secondary objectives: - to assess the dose effect relationship of ave1625 on hdl-cholesterol and triglycerides plasma levels over a period of 24 weeks - to assess the efficacy of ave1625 on secondary parameters such as waist circumference and other metabolic parameters over a period of 24 weeks - to assess the safety and tolerabillity of ave1625 over a period of 24 weeks.


Eligibility criteria:
inclusion criteria: * abdominal obese patients with · * waist circumference \> 102 cm in men and \>88 cm in women * dyslipidemia consisting of : * triglycerides ≥ 1.50 g/l (i.e 1.69 mmol/l) and ≤ 7.0 g/l(i.e. 7.90 mmol/l)and/or * hdl-cholesterol \< 50 mg/dl (i.e. 1.29 mmol/l) in women and \< 40 mg/dl (i.e. 1.04 mmol/l) in men exclusion criteria: * pregnancy or lactation * women of child-bearing potential with no medically approved contraception * patients with type 1 diabetes * patients with type 2 diabetes must be on a stable dose of oral antidiabetic drugs (excluding glitazones, exenatide, sulfonylurea and nateglinide) and should not receive insulin therapy * patients with any clinically significant endocrine disease * patients on anticoagulants (heparin, warfarin) or with bleeding disorders * clinically relevant disease interfering with subject's safety or making implementation of the study protocol or interpretation of study results difficult * patients with mental retardation or any clinically significant psychiatric disorder * history or concurrent substance abuse (other than nicotine or caffeine especially marijuana or hashish) * chronic systemic corticotherapy * patients with weight change \> 5kg within 3 months prior to screening * patients should not have received anti-obesity drugs or other drugs for weight reduction in the 3 months prior to screening. * the investigator will evaluate whether there are other reasons why a patient may not participate

Keywords: obesity and dyslipidemia
a study of mil62 in patients with neuromyelitis optica spectrum disorder (nmosd)

Conditions: Neuromyelitis Optica Spectrum Disorder

Summary: this study will evaluate the safety and efficacy of mil62 in patients with neuromyelitis optica spectrum disorder.


Eligibility criteria:
inclusion criteria: 1. patient with nmosd as defined by 2015 nmosd diagnostic criteria by ipnd (international panel for nmo diagnosis) with anti-aqp4-igg seropositive status. 2. male or female aged 18～60 years. 3. expanded disability status scale(edss) score ≤6.5. 4. a documented history of at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years prior to screening. 5. subjects who have had a relapse immediately prior to screening must have at least 12 weeks in which their relapse symptoms are stable prior to the first administration. exclusion criteria: 1. cd20+ b cell counts below the lower limit of normal (lln). receipt of rituximab or any b-cell depleting agent within the 6 months prior to screening, unless the subject has b-cell counts above the lln. cd4 t lymphocyte count \<300 cells/μl(cd4：cd8≤1.4). 2. receipt of tocilizumab, eculizumab within 3 months prior to the first administration. 3. receipt of any of the following prior to the first administration: azathioprine,mycophenolate mofetil,tacrolimus,cyclosporin, methotrexate,cyclophosphamide,and patients discontinued more than 5 times the half-life of the drug before they could get into the group . 4. receipt of ivig, plasmapheresis or blood transfusion within 28 days prior to the first administration. 5. any live or attenuated vaccine within 28 days prior to the first administration.
a research study of how the medicine nnc0480-0389 taken with semaglutide works in the body of healthy chinese men

Conditions: Diabetes Mellitus, Type 2

Summary: this study looks at how the new medicine called nnc0480-0389 works in the body of chinese men when it is given at different doses together with a fixed dose of semaglutide. participants will get one injection of nnc0480-0389 and one injection of semaglutide - which dose of nnc0480-0389 participants get is decided by chance. nnc0480-0389 is a new medicine that has not been previously approved. it means that the medicine has not yet been approved by the health authorities. semaglutide is a newly approved antidiabetic medicine that helps to lower blood sugar levels in people with type 2 diabetes. nnc0480-0389 is being developed to be given together with semaglutide. nnc0480-0389 targets a different part of the system that regulates sugar levels in the body than semaglutide. therefore, it is expected that together nnc0480-0389 and semaglutide will more effectively lower sugar levels in the blood in people with type 2 diabetes. participants will get 2 injections of the study medicine (one of each). it will be injected with a needle into a skin fold on participants abdomen. the study will last for a maximum of 72 days. partcicipants will have 10 scheduled visits with the study doctor. for 1 of the visits participants will stay at the clinic for 6 days (5 nights). the study includes blood sampling.


Eligibility criteria:
inclusion criteria: * chinese male participants aged 18-55 years (both inclusive) at the time of signing informed consent. * body mass index (bmi) between 20.0 kg/m\^2 and 27.9 kg/m\^2 (both inclusive). * body weight equal to or greather than 54.0 kg. * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. exclusion criteria: * any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * glycated haemoglobin (hba1c) geather han or equal to 6.5 % (48 mmol/mol) at screening. * use of prescription medicinal products or non-prescription drugs (including chinese traditional medicine or local medicine), except routine vitamins, occasional use of paracetamol, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation, within 14 days before screening. * presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
cohort study in senegal comparing artesunate + amiodaquine in the treatment of repeated uncomplicated plasmodium falciparum malaria attacks

Conditions: Malaria

Summary: primary objective: to demonstrate the non-inferiority of pcr adjusted adequate clinical and parasitological response at d28 of artesunate + amiodaquine versus artemether + lumefantrine, based on the first malaria attack of each subject. secondary objectives: for the first attack: to compare the two groups of treatment in terms of: * d14 efficacy * parasitological and fever clearance * clinical and biological tolerability * evolution of gametocyte carriage * cardiac tolerability (qtc) for the repeated attacks: to compare the two groups of treatment in terms of: * d14 and d28 clinical and parasitological effectiveness (pcr adjusted) * clinical and biological tolerability * proportion of patients without fever at d3 * proportion of patients without parasite at d3 * compliance * impact on anaemia during the total follow-up of the cohort: to compare the two groups of treatment in term of: * treatment incidence density * impact of repeated treatment on clinical and biological safety * impact of repeated treatment on hearing capacity


Eligibility criteria:
lists of inclusion and exclusion criteria: inclusion criteria: * adults or children weighting more than 5 kg * axillary temperature \>=37.5°c at d0 or history of fever within the previous 24hrs * confirmed plasmodium falciparum monoinfection, with parasitemia\>1000mcl * negative urinary pregnancy test for women of child bearing age before each new administration of treatment exclusion criteria: * presence of any serious or clinical danger sign of malaria: prostration, consciousness disorders, recent and repeated convulsions, respiratory distress, inability to drink, uncontrollable vomiting, macroscopic haemoglobinuria, jaundice, haemorrhagic shock, systolic bp\< 70 mmhg in adults or \< 50 mmhg in children, spontaneous bleeding, inability to sit or stand * severe concomitant disease * allergy to one of the investigational drugs. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
ucb stem cells for autism spectrum disorders

Conditions: Autism Spectrum Disorder

Summary: purpose. the goals of the study are to assess the safety of the intravenous infusion of umbilical cord blood (ucb) cells in patients with autism and to confirm changes in social/ communicative skills and cognitive functioning after four infusions of abo/rh-matched ucb stem cells. material and methods. the sample comprises 30 patients (27 males, 3 females) aged between 3 and 11 years with asd under the care of the national medical research center for psychiatry and neurology (saint-petersburg, russia). participants are randomly assigned to either the control group (14 males, 1 female) or the experimental group (13 males, 2 females). the experimental group receives intravenous injections of ucb cells four times with a two-week gap between injections. the control group receives standard therapy. the dynamic of cognitive functions and social/communicative skills assess with checklist for autism spectrum disorders (casd), autism treatment evaluation checklist (atec), subscales of wechsler intelligence scale for children (wisc) - "digit span", "picture completion", "block design", "coding".


Eligibility criteria:
inclusion criteria: * diagnosed asd by icd-10 criteria exclusion criteria: * acute somatic diseases * indication for surgical (neurosurgical) therapy * acute or chronic infectious diseases * history of acute allergic reactions
evaluation on the effects of two rehabilitation treatment and tape for functional and motor recovery of lbp patients

Conditions: Low Back Pain; Orthopedic Disorder; Physical Therapy; Core Strengthening; Rehabilitation

Summary: the objective of this study is to verify which is the most effective type of rehabilitation treatment (rehabilitation based on core strengthening vs pilates) in patients suffering from low back pain. the secondary objective is to verify whether the use of kinesio tape (kt) associated with rehabilitation treatment can have greater effects in the motor and functional recovery of patients suffering from low back pain than traditional rehabilitation.

patients will undergo an initial assessment with the physical medicine and rehabilitation unit physicians, during which the participants will sign the informed consent. after that a first evaluation will be carried out (t-1) during which the subjects will be asked to perform 10 consecutive sit-to-stand tests and 10 consecutive front bending tests. during the sit-to-stand and front bending tests, the kinematics of the spine will be recorded using two mimu - xsens dot. the following scales will also be administered: * roland and morris disability questionnaire * numerical rating scales (nrs) 11-point scale to assess the average intensity of pain during the last week * the short form health survey 36 (sf-36) questionnaire to assess quality of life * the modified somatic perception questionnaire (mspq) to assess pain somatization * the hospital anxiety and depression scale (hads) scale to assess anxiety and depression * the pain catastrophizing scale (psc) to assess the catastrophization of pain * the pain self-efficacy questionnaire (pseq) for multidimensional pain assessment * the fear avoidance beliefs questionnaire (fabq) to assess pain avoidance beliefs patients will be randomized in 2 groups (group a and group b). for both groups there will be 12 treatment sessions, 3 times a week. (4 weeks) at mid-treatment (after 2 weeks), at the end of treatment (t1), and in follow-ups following 1 month (t2), 3 months (t3), 6 months (t4) and 12 months (t5) the same assessments of the first visit will be repeated.

Eligibility criteria:
inclusion criteria: * age \> 18 years * signing of informed consent * chronic low back pain defined as non-specific self-reported low back pain that persists daily for at least 3 months or at least half of the days in the last 6 months. exclusion criteria: * specific cause of low back pain: disc herniation, spinal stenosis, cauda equina syndrome, infection, fracture, tumor. * pregnant women * neurological disorders and neurological signs (e.g. cns disorders, weakness, paresthesia) * respiratory disorders * previous spinal surgery. * pain in the lower limbs or lesions limiting their function * taking pain medication

Keywords: low back tape tape kinesio tape core strengthening pilates rehabilitation physical therapy athletic tape
psychoeducation intervention for caregivers of children with cancer

Conditions: Pediatric Cancer

Summary: this randomized controlled trial aims to evaluate the effectiveness of the psychoeducation intervention on anxiety, depressive symptoms, coping, and hrqol in caregivers of children with cancer. the study is a two-arm parallel-group single-blind, randomized controlled trial that will be conducted in two hospitals in malawi.

aim of the study to develop and implement psychoeducation intervention that meet the need of caregivers of children with cancer in malawi. objectives of the study 1. to develop a psychoeducation intervention that addresses the needs of caregivers of children with cancer in malawian culture. 2. to evaluate the effectiveness of the pei in reducing anxiety and depressive symptoms and enhancing coping and hrqol among caregivers of children with cancer in malawi. hypotheses of the study 1. compared with the control group, caregivers in the intervention group will have significantly lower anxiety levels immediately after the intervention, and at 3 months post-intervention. 2. compared with the control group, caregivers in the intervention group will have significantly fewer depressive symptoms immediately after the intervention, and at 3 months post-intervention. 3. compared with the control group, caregivers in the intervention group will have significantly better hrqol, immediately after the intervention, and at 3 months post-intervention. 4. compared with the control group, caregivers in the intervention group will have significantly better coping skills immediately after the intervention, and at 3 months post-intervention.

Eligibility criteria:
inclusion criteria: * caregivers will be included if the child is within the one-year post-cancer diagnosis and on treatment, the primary carer of the child, the child is aged ≤ 15 years, caregivers are above 18 years, and caregivers must have a score of more than five on gad-7 score. a score of 5 is the cut-off point for anxiety in this questionnaire. exclusion criteria: * caregivers of children with other co-morbidities will be excluded from the study.

Keywords: anxiety cancer caregivers children coping depressive symptom health-related quality of life psychoeducation intervention
valsalva manoeuvre and intravenous dexmedetomidine on attenuating pain during propofol injection in upper git endoscopy

Conditions: Injection Site Irritation

Summary: no previous study has cited the use of the valsalva manoeuvre for the reduction of pain on propofol injection in comparison with dexmedetomidine injection. therefore, investigators plan a study to evaluate the analgesic efficacy of the valsalva manoeuvre in alleviating pain during propofol injection as compared to dexmedetomidine injection.

propofol is a commonly used anaesthetic for inducing general anaesthesia. pain on propofol injection is distressing and is one of the limitations of its use. propofol is a phenol compound, which irritates nerve endings on the venous endothelium to produce immediate pain, whereas delayed pain is mediated by the release of bradykinin. bradykinin causes vasodilation and increases venous permeability, thereby facilitating contact of the aqueous phase of propofol with nerve endings. delayed pain occurs 10-20 seconds after injection. various methods have been tried so far to reduce pain on propofol injection. a commonly used technique is lignocaine either as pre-treatment or mixed with propofol. other methods include the use of butorphanol, ondansetron, metoclopramide, opioid, or thiopentone. propofol injection into a large vein, pre-injection cooling, or warming of propofol have also been investigated. the valsalva manoeuvre is a physiological technique, used in the reduction of pain associated with several procedures. the valsalva manoeuvre alleviates both the somatic and psychological aspects of painful procedures. dexmedetomidine is an alpha-2 adrenoceptor agonist that has analgesic and sedative properties, it has been evaluated for reducing the incidence and intensity of propofol-induced pain, but reported results are inconsistent. in this study, investigators will study the effect of valsalva manoeuvre as compared with dexmedetomidine injection in reducing the pain associated with propofol injection in upper gastrointestinal endoscopies.

Eligibility criteria:
inclusion criteria: 1. adult patients aged 30-60 years old. 2. american society of anesthesiologist physical status(asa) grade i and ii. 3. upper gastrointestinal endoscopies. exclusion criteria: 1. patients with mental illness, restlessness. 2. cardio-respiratory disease. 3. chronic pain disorder. 4. use of preoperative analgesic medication. 5. history of propofol allergy. 6. history of drug abuse. 7. inability to perform the valsalva manoeuvre. -

Keywords: propofol injection pain dexmedetomidine valsalva maneuver
three-year follow-up study of subjects who participated in a previous lambda (bms-914143) chronic hepatitis c clinical trial

Conditions: Hepatitis C

Summary: the primary purpose of this study is to determine whether the hepatitis c virus continues to remain unable to be detected in subjects who were previously treated with bms-914143 and achieved sustained virologic response


Eligibility criteria:
inclusion criteria: * subjects must have received lambda in a previous trial and have hepatitis c virus (hcv) ribonucleic acid (rna) \< loq at the completion of the required post-treatment follow-up (must enter this study within 6 months of completion of the required post-treatment follow-up in the previous trial) note: for blinded parent trials, subjects who have hcv rna \<loq at the completion of the required post-treatment follow-up may enter this study without knowledge of their treatment assignment in the parent study. subjects who received control agents (eg, pegylated-interferon alfa) in the previous protocol will be allowed to participate until unblinded treatment information is released; at that time subjects will have the option to continue in the study exclusion criteria: * subjects must not have been treated with any antiviral or immunomodulatory drug for chronic hepatitis c after completion of the previous study of lambda