Kornimate/medical-research-clean huggingface dataset:
validation and test-retest study of the star-shaped manual dexterity test.

Conditions: Manual Dexterity

Summary: the purpose of this study is to measure test-retest reliability and validate the star shaped test of manual dexterity. the purpose of this is to see if there is any significant learning effect, and if the test can discriminate between individuals who are at their normal skill level, and when they are stressed and/or fatigued. the test is designed to test hand to eye coordination and precision control. this is done by following a star shaped track with a pair of a surgical scissors. this is done 10 times, 5 times clockwise and 5 times counter clockwise. each time the scissors come into contact with the border of the track, an error is counted. overall completion time is recorded. as a randomized crossover study, we will have 20 test subjects complete the test 4 times. each test will be conducted with a pause of two breaks between the tests. before each test, the test subjects are randomized to: no intervention, physical fatigue prior to testing, distractions during the test or both physical fatigue prior to testing and distractions during the test. all participants will complete a test with all four interventions. furthermore, a test-retest trial will be conducted on 4 test-subjects. each subject will complete the test two times with no interventions, with two days apart.


Eligibility criteria:
inclusion criteria: * age between 20 and 55 years exclusion criteria: * diagnosed heart disease * diagnosed endocrinological disease * diagnosed neurological or autoimmune disease * diagnosed sleep disorder * diagnosed orthopedic diseases or former orthopedic surgery (e.g. arthrosis, rotator cuff syndrome)

Keywords: manual dexterity hand to eye coordination stress fatigue
a metagenome-wide association study of gut microbiota in gastrointestinal non-hodgkin's lymphoma patients

Conditions: Gastrointestinal Lymphoma

Summary: this is a observational study on the fecal microbiota in primary/secondary gastrointestinal lymphoma patients.

this observation study is aimed at investigating the gut microbiota alteration in gastrointestinal lymphoma (gil) patients by performing metagenomic shotgun sequencing on gil patients' fecal specimen. before immuno-chemotherapy, the feces specimen of gil would be collected and stored for further laboratory examination. this study would not alter the subsequential treatment of the patients.

Eligibility criteria:
inclusion criteria: * gastrointestinal lymphoma with a clarified pathological diagnosis * de novo gastrointestinal lymphoma patients who haven't received chemotherapy * bmi in normal range exclusion criteria: * antibiotics or probiotics application within a month * overweight (bmi≥25) or malnourished (bmi\<18.5) patients * patients who have been accepted gastrointestinal fistulation * gastrointestinal patients with inflammatory bowel disease (ibd), colorectal carcinoma (crc) or any other chronic intestinal disease * patients infected by hiv
smoking and alcohol initiation

Conditions: Smoking; Alcohol Drinking

Summary: this study evaluates multi-attribute utility, a modification of subjective expected utility, as a descriptive model of the adolescent's decision to initiate smoking or alcohol use. according to the model, the young decision maker envisions a set of consequences that will follow the two decision options, either to continue as a non-user or to initiate usage. each consequence has three components. the components are the worth of the consequence, which may be positive or negative, the judged likelihood that the consequence will happen, and the importance of the consequence. within an individual, importances will change with mood or circumstance, which is how the model accounts for impulsive decisions that may occur in social settings. the model will be tested by eliciting components of ten independent consequences from a large group of students early in the seventh-grade year. current usage will also be examined; extant data suggest that most students will be non-users at that time. it is known that a fair amount of initiation takes place during the seventh and eighth grade years. the hypothesis is that those non-users whose model scores are high will be more likely to initiate usage than those whose scores are low. the same students will be queried regarding usage eighteen months later to evaluate the hypothesis. it is now well known that differential knowledge regarding the harmful effects of drug use does not distinguish adolescent users from non-users. the model approach quantifies the idea that anticipated positive consequences play a prominent role in the decision of those who choose to initiate. an important implication is that prevention campaigns might profit by addressing positive as well as negative consequences of usage.

a book entitled "a science of decision making: the legacy of ward edwards" and 4 chapters were published (oxford university press, 2008) with the support of this funding.

Eligibility criteria:
inclusion criteria: * enrolled middle school students exclusion criteria: * n/a
parent mentor interventions for early childhood obesity

Conditions: Obesity, Childhood

Summary: the purpose of this clinical trial is to identify the most effective strategy for intervention to change behaviors and affect weight status in obese children 2-5 years of age within the context of early childhood education centers.

the primary aim is to test an intervention to disseminate and promote the adoption of positive deviance behaviors among parents of obese hispanic children using peer mentors. this trial will evaluate the efficacy and feasibility of this approach in reducing adiposity among a high-risk population of children. our central hypothesis is that children randomized to the intervention with a parent mentor using positive deviance methods with have a greater reduction in adiposity as measured by body mass index (bmi) compared with a parent mentor using traditional education or a control receiving usual education.

Eligibility criteria:
inclusion criteria: * 2-5 years of age child, hispanic ethnicity, attends the head start facility exclusion criteria: * any major medical disorder impairing growth or development
effects of transcutaneous vagus nerve stimulation in chronic pain patients and healthy controls

Conditions: Restless Legs Syndrome; Chronic Pain

Summary: the tvns-pp trial investigates the effects of transcutaneous vagus nerve stimulation (tvns) on autonomic functions, immune responses, and disease severity in chronic pain and restless legs syndrome (rls) patients as compared to healthy controls.

a pilot study with healthy participants will investigate whether transcutaneous vagus nerve stimulation at the inner tragus reduces heart rate variability and lowers blood pressure without causing undesirable, severe side effects. in addition, changes in immune markers will be analyzed in blood samples before and after the interventions. patients with primary restless legs syndrome will undergo a similar experimental protocol, except that transcutaneous vagus nerve stimulation will be performed daily. the aim is to determine whether stimulation reduces disease severity and chronic pain while improving quality of life.

Eligibility criteria:
inclusion criteria: * male and female participants between 18 and 80 years old * written informed consent exclusion criteria: * age younger than 18 years or older than 80 years * participants with somatic or mental comorbidities, especially malignant tumor diseases, cardiac insufficiencies \> nyha ii, severe depressive episodes, psychosis or dementia * pregnancy or breast feeding * addictions to alcohol, medications or drugs (except tobacco) * an existing legal guardianship * participation in another scientific study within the previous eight weeks before enrollment * restless legs syndrome patients with one of the following secondary predispositions: iron deficiency, polyneuropathy, prolapsed disk, spinal stenosis or chronic obstructive pulmonary disease

Keywords: rls, vagus nerve stimulation
expanded access single named patient program with elotuzumab (bms-901608) for the treatment of patient r-a with relapsed/refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: to provide elotuzumab treatment for single-patient use.


Eligibility criteria:
inclusion criteria: * signed written informed consent a) before any program procedures are performed, the patient will have the details of the program described to him or her, and she or he will be given a written informed consent document to read. then, if the patient consents to participate in the program, she or he will indicate that consent by signing and dating the informed consent document in the presence of program personnel. * other criteria a) patients must be willing to refrain from blood donations during program drug therapy and for 8 weeks after therapy. * age and reproductive status 1. men and women, aged 18 years 2. women of childbearing potential (wocbp) must have a negative serum or urine pregnancy test (minimum sensitivity 25 iu/l or equivalent units of hcg) within 24 hours prior to the start of study drug. 3. women must not be breastfeeding 4. wocbp must use method(s) of contraception as indicated in the informed consent form. because of the teratogenic potential of elotuzumab, a highly effective method(s) of contraception (failure rate of less than 1% per year) is required. the individual methods of contraception and duration should be determined in consultation with the investigator. in this study men and wocbp must be using methods of contraception for at least 1 month (4 weeks) before and women for up to 8 weeks, men for up to 90 days, after the last dose of elotuzumab. 5. males who are sexually active with wocbp must use any contraceptive method with a failure rate of less than 1% per year. the investigator shall review contraception methods and the time period that contraception must be followed. men that are sexually active with wocb must agree to follow instructions for method(s) of contraception for the duration of treatment with elotuzumab plus 5 half-lives of the program drug plus 90 days (duration of sperm turnover) for a total of 90 days post-treatment completion. 6. women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile and azoospermic men do not require contraception. exclusion criteria: * sex and reproductive status 1. wocbp not using 2 forms of effective birth control. 2. women with a positive pregnancy test at enrollment or prior to administration of program medication. * other exclusion criteria 1. prisoners or patients who are involuntarily incarcerated. 2. patients who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness. elotuzumab ca204022 bms-901608 expanded access guidance document 23 eligibility criteria for this program have been carefully considered to ensure the safety of the program patients and to ensure that the results of the program can be used. it is imperative that patients fully meet all eligibility criteria.

Keywords: relapsed/refractory multiple myeloma
the impact of chronic mitochondrial antioxidant supplementation on cardiovasculartoxicity in breast cancer patients

Conditions: Breast Neoplasms

Summary: investigate the protective effect of chronic mitoq supplementation on cardiovascular toxicity induced by doxorubicin-based adjuvant chemotherapy in breast cancer patients.

test the hypothesis that chronic mitoq supplementation in breast cancer patients treated with doxorubicin prevents: 1. increased mitochondrial oxidative stress; 2. the increase in cardiac markers (b-type natriuretic peptide and troponin i); 3. changes in left ventricular deformity (speckle tracking, strain) and reduction in lvef; 4. endothelium-dependent dysfunction of peripheral vascular beds; 5. the increase in endothelial microvesicles; 6. the increase in material stiffness; 7. the elevation of central blood pressure.

Eligibility criteria:
inclusion criteria: * patients ≥18 years old, diagnosed with breast cancer (ductal, lobular and mixed carcinoma), in stage 1-3, with indication for the adjuvant ac-t therapeutic scheme, doxorubicin (60 mg/m2) plus cyclophosphamide, will be considered eligible for the study (600 mg/m2) in the regimen of 1 cycle every 21 days, followed by weekly taxane for 12 cycles. exclusion criteria: * patients with metastasis, severe lymphedema, renal failure, acute myocardial infarction, heart failure, stroke and chronic liver disease.

Keywords: breast cancer doxorrubicin mitoquinone cardiotoxicity peripheral vascular function
efficacy and safety study of ursodeoxycholic acid to treat chronic hepatitis c

Conditions: Chronic Hepatitis C

Summary: this study is a 24-week multicenter, randomized, double-blind control trial with ursodeoxycholic acid (udca) in patients with chronic hepatitis c in japan. the primary objectives of this study are to verify the superiority of efficacy of udca 600 or 900mg/day to that of 150mg/day and the safety of udca treatment.

this study is a 24-week multicenter, randomized, double-blind control trial with ursodeoxycholic acid (udca) in patients with chronic hepatitis c in japan. the primary objectives of this study are to verify the superiority of efficacy of udca 600 or 900mg/day to that of 150mg/day and the safety of udca treatment. the primary endpoint was percent changes of serum alanine aminotransferase(alt) levels at 24-week of administration compared to pre-administration levels and secondary endpoints, serum aspartate aminotransferase(ast) and gamma-glutamyltranspeptidase(gamma-gtp) levels. further, changes of bile acid composition and hcv-rna levels at 24-week of administration were examined.

Eligibility criteria:
inclusion criteria: 1. subject must have a clinical diagnosis to apply the conservative medication for chronic hepatitis c. 2. serum alanine aminotransferase levels measured at 4-week before the initiation of treatment must be over 61 iu/ml. 3. subject's age must be 20 years or older. exclusion criteria: 1. subject who received a treatment of antiviral agents (interferon) within 20 weeks before the start of 8-week observation period 2. subject who received a treatment of corticosteroids, immunosuppressive drugs, glycyrrhizic acid, cholestyramine or other drugs which could interfere with hepatic function during 8-week observation period. 3. subject with decompensated cirrhosis 4. subject infecting with other hepatic virus 5. subject receiving a treatment for autoimmune disease, alcohol or drug-induced hepatic disorder, neoplasia, hepato-cholangiolar disease, fulminant hepatitis or peptic ulcer 6. subject who require hospitalization for complications of the heart, kidney or pancreas 7. pregnancy 8. alcoholics 9. alcohol intake more than 27 ml/day 10. subject who involved in other clinical trial within 4 weeks before the start of observation period 11. subject with a history of sensitivity to ursodeoxycholic acid or bile acid-products

Keywords: chronic hepatitis c, ursodeoxycholic acid
efficacy and safety of aqx-1125 in ic/bps

Conditions: Interstitial Cystitis; Bladder Pain Syndrome

Summary: the primary objective of this study is to evaluate the effect of 6 weeks of treatment with once daily administration of aqx-1125 compared to placebo on average daily pain in subjects with interstitial cystitis/bladder pain syndrome (ic/bps), during and after treatment, using a standardized 11-point numerical rating scale (nrs) pain score recorded by electronic diary


Eligibility criteria:
inclusion criteria: * be females, ≥18 and ≤75 years of age, who have consistently had symptoms of bladder pain in addition to urinary urgency and/or urinary frequency for more than 12 months * have had the diagnosis of interstitial cystitis for \> 6 months (pain for at least 12 months) but ≤15 years * have average daily pain score of at least 5 out of 10 on the 11-point numerical rating scale \[nrs\] pain scale in the 9 days prior to baseline * have undergone a cystoscopy and have documented visible signs of bladder bleeding, lesions or glomerulation within the last 36 months prior to baseline. * subjects if of child bearing potential, must agree to avoid pregnancy and use medically acceptable method of contraception from screening visit and throughout the study. * must be capable of voiding independently exclusion criteria: * pelvic floor pain (\>5 out of 10 on the 11-point nrs pain scale following a pelvic pain assessment) * have a body mass index \[bmi\] of \ 39 kg/m2 * have had a urinary tract infection including bacterial cystitis within the past 30 days. * have greater than 1+ hematuria on dipstick test at screening from an unknown cause * history of previous procedure(s) (augmentation cystoplasty, cystectomy, or cystolysis) that has affected bladder function

Keywords: interstitial cystitis bladder pain syndrome ic/bps aqx-1125 ship1
impact of preoxygenation time on end-tidal oxygen concentration and on hypoxic events occurring after intubation in the intensive care unit.

Conditions: Preoxygenation; Intubation; Intensive Care Unit

Summary: preoxygenation is recommended before performing tracheal intubation. in intensive care units (icu) patients, there is no specific recommendation regarding the duration of preoxygenation, which usually is applied for 3 to 5 minutes. monitoring the effectiveness of preoxygenation with end-tidal oxygen concentration (eto2) is strongly recommended in the operating room but it is never used in icus. the first aim of this pilot study is to assess the effect of the preoxygenation duration on eto2, and secondarily, as an exploratory objective, to determine whether targeting a given value of eto2 during preoxygenation might insure a safer intubation than when targeting pulse oximetry (spo2).

this is a multicenter randomized controlled pilot study. 110 patients who require intubation in the icu will be randomly assigned, with a 1:1 ratio, to 3 or 5 minutes of preoxygenation duration. eto2 will be continuously measured but hidden to the clinician. the primary outcome measure will be the obtention of an optimal preoxygenation defined by an eto2 \>90%. secondary outcomes include the occurrence of hypoxia and complications during the procedure. a pulse oximetry (spo2) greater than or equal to 96% (spo2 ≥ 96%) at the end of preoxygenation will be the target in each group. if at the end of the preoxygenation, spo2 is still lower than 96%, clinician will be allowed to extend the duration of preoxygenation (up to 5 minutes in the 3 minutes period of preoxygenation group and up to 8 minutes in the 5 minutes period of preoxygenation group). end-tidal oxygen concentration (eto2) will be measured during preoxygenation and will be hidden to the clinician in order to not influence the duration of preoxygenation.

Eligibility criteria:
inclusion criteria: * patients older than 18 years * requiring intubation in icu * free express oral and informed consent of the patient or a proxy in case of impossibility for the patient to consent; emergency inclusion possible when legal representatives and patient's family are not present exclusion criteria: * intubation for cardiac arrest * end-tidal oxygen concentration monitoring not available * preoxygenation with high-flow nasal oxygenation * previous participation to the study * patient known, at time of inclusion, as being under guardianship, tutorship or curator * pregnancy or breastfeeding * lack of social security number

Keywords: preoxygenation intubation end-tidal of oxygen concentration intensive care unit critically ill patients
cupping in osteoarthritis of the knee

Conditions: Osteoarthritis of the Knee

Summary: the purpose of this exploratory randomised trial is to study the effect of pulsatile cupping in osteoarthritis of the knee compared to waiting list control.

cupping is a traditional therapy in many cultures of the world and is used to treat osteoarthritis of the knee. in this randomised trial we want to study the effect of pulsatile cupping in osteoarthritis of the knee compared to waiting list control. pulsatile cupping is administered by a special cupping machine (hevatec) with silicone cupping glasses to the knee joint. pulsatile pressure is generated by a pump that generates vacuum.

Eligibility criteria:
inclusion criteria: * osteoarthritis of the knee according acr-criteria * x-ray classification minimum kellgren-lawrence criteria grade 2 * pain intensity \> 40 mm vas * only therapy with nsaidin the last 4 weeks * informed consent exclusion criteria: * use of anticoagulants (phenprocoumon, heparin) * coagulopathy * cupping in the last 12 months * intraarticular injection of corticosteroids or nsaid into the knee joint in the last 4 months * use of systemic corticosteroids in the last 4 weeks * physical therapy, leeches or acupuncture in the last 4 months * other cam therapies for the osteoarthritis in the last 4 weeks * arthroscopy of the knee joint in the last 12 months * paracetamol allergy or intolerance

Keywords: osteoarthritis
treatment of severe limb ischemia with autologous bonemarrow derived mononuclear cells

Conditions: Ischemia

Summary: the aim of the study is to investigate whether implantation of autologous bone marrow derived stem cells in ishemics limbs will improve vascularization

10 patients with severe lower limb ischemia will be included in this pilote trial. bonemarrow aspiration will be performed and and the monocuclear cells isolated an injected into the gastrocnemius. the patiens are followed for 4 months. were trancutaneous oxygenpressure, ankel and toe blood pressure is measured.

Eligibility criteria:
inclusion criteria: * ankle blood pressure \< 70 mmghg * either pain at rest and/or ischemic wound * no possible surgical treatment exclusion criteria: * infection * malignant disease

Keywords: cli paod severe lower limb ischemia