Kornimate/medical-research-clean huggingface dataset:
retrospective study on registry data to evaluate the impact of ocrelizumab used in routine care in patients with rrms

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms) is a chronic, autoimmune, neurodegenerative disease; clinical events are mainly attributed to myelin destruction and inflammatory of the central nervous system. the diagnosis resides in clinical and radiological criteria according to 2017 mcdonald criteria. once the diagnosis of ms has been made, treatment should be initiated promptly, in order to delay the onset of severe disability in the long-term, even more ocrelizumab are a treatment of high efficacy. ocrelizumab is used as a first-line or second-line treatment in relapsing remitting ms (rrms) it is an anti-cd20 monoclonal antibody that provides rapid depletion of circulating cd20+ b lymphocytes by complement-dependent cytotoxicity and antibody-dependent cellular cytotoxicity. the main objective is the retrospective evaluation of the impact of ocrelizumab on the outcome of ms. the secondary objective is the search of predictive factors of response to treatment.


Eligibility criteria:
inclusion criteria: * major subject (≥18 years old) * suffering from relapsing-remitting ms (rrms) * supported in a neurology department at strasbourg or nancy university hospital between 10/01/2018 and 11/31/2020. * treated with ocrelizumab 600mg every 6 months during the period from 01/10/2018 to 01/05/2020. * have had an m0, m3 / m6 and m12 mri after initiation of treatment. * subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research exclusion criteria: * subject having expressed opposition to participating in the study * primary progressive multiple sclerosis (ms-pp), secondarily progressive (ms-sp) * subject not meeting all the inclusion criteria * impossibility of providing the subject with enlightened information (difficulties in understanding the subject, etc.) * subjects under safeguard of justice * subject under guardianship or guardianship

Keywords: ms-rr ocrelizumab switch
yoga vs. education for restless legs syndrome: a feasibility study

Conditions: Restless Legs Syndrome

Summary: the purpose of this study is to see whether adults with restless legs syndrome (rls) are willing to be in a 12-week study where they have a 50-50 chance of being placed in either a gentle yoga program or a film-based education program designed for people with rls. if so, do they complete the program, and does their rls, sleep, mood, or quality of life improve?


Eligibility criteria:
inclusion criteria: * ambulatory adults * at least 21 years of age * moderate-severe rls, defined as: 1. symptoms that meet all five of the international rls study group essential diagnostic criteria for rls (i.e., 1) an urge to move the legs, often associated with discomfort or disagreeable sensations in the legs, that 2) begins or worsen during periods of rest or inactivity; 3) is partially or totally relieved by movement; 4) is worse or only occurs in the evening or night; and 5) is not solely accounted for by another condition (e.g. leg cramps, positional discomfort, habitual foot tapping)); 2. rls symptoms at least 1x/wk for the previous 3 months; 3. a score of at least 2 points (moderate) irls question 6: "how severe was your rls as a whole?"; and 4. rls diagnostic criteria applied as per training by the study physician, a sleep medicine expert; these criteria will help ensure exclusion of mimics (e.g. leg cramps, positional discomfort). * willingness and ability to complete the 12-week yoga or educational film program and all study assessments; * willingness to avoid use of any new drugs or treatments other than the assigned intervention. exclusion criteria: * practiced yoga within the past year; * currently on dopaminergic agents (eg, ropinirole, pramipexole) or anti-psychotic medication; * changed dosage if any other central nervous system agents (e.g., sedative hypnotics, gamma-aminobutyric acid (gaba) analogs, narcotic analgesics, antiadrenergic agents, or anticonvulsants) within the past 3 months; * any orthopedic, neurologic or other condition that might prevent safe completion of a 12-week yoga program or confound assessments (e.g., neuropathy; parkinson's disease; stroke; rheumatoid arthritis; renal failure; uncontrolled sleep apnea; recent (within the last 6 months) myocardial infarction; heart failure; cancer (other than non-melanoma skin cancer); * pregnant or within 6 months post-partum).
agn 201904 versus esomeprazole in the prevention of aspirin-induced stomach or upper intestinal damage in healthy volunteers

Conditions: Peptic Ulcer

Summary: agn 201904, a proton pump inhibitor, versus esomeprazole in the prevention of stomach or upper intestinal damage following administration of high-dose aspirin in healthy volunteers


Eligibility criteria:
inclusion criteria: * healthy adult volunteers who have provided written informed consent exclusion criteria: * volunteers with a history of upper gastrointestinal disease or who have a current diagnosis of upper gastrointestinal disease. * female volunteers who pregnant, nursing, or planning a pregnancy * volunteers with a history of drug or alcohol abuse
a study of vismodegib in patients with relapsed/refractory acute myelogenous leukemia and relapsed refractory high-risk myelodysplastic syndrome

Conditions: Myelodysplastic Syndromes, Myelogenous Leukemia, Acute

Summary: this study will assess the safety and efficacy of vismodegib in patients with relapsed/refractory acute myelogenous leukemia (aml) and relapsed/refractory high-risk myelodysplastic syndrome (mds). patients in cohort 1 will receive single-agent vismodegib 150 mg orally daily. in cohort 2, patients will receive vismodegib 150 mg orally daily in combination with cytarabine 20 mg subcutaneously for 10 days. anticipated time on study treatment is until disease progression, intolerable toxicity, or patient withdrawal of consent.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * patients with documented relapsed or refractory aml, except acute promyelocytic leukemia (apl \[m3 subtype\]), or relapsed or refractory high-risk mds (high-risk mds defined as international prognostic scoring system (ipss) int-2 or high and \>/= 10% blasts in bone marrow) * eastern cooperative oncology group (ecog) performance status 0 to 2 * negative serum pregnancy test for women of childbearing potential and use of two forms of contraception while enrolled in the study and for 7 months after the patient discontinues from study * male patients with female partners of childbearing potential must agree to use a latex condom and to advise their female partner to use an additional method of contraception during the study and for 2 months after the last dose of vismodegib * all non-hematological adverse events of any prior chemotherapy, surgery, or radiotherapy must have resolved to national cancer institute common terminology criteria for adverse events (nci ctcae) grade \</= 2 prior to starting therapy * adequate hepatic and renal function exclusion criteria: * prior treatment with a hh pathway inhibitor * prior therapy for the treatment of malignancy within 14 days of day 1, with the exception of: hydroxyurea in patients who need to continue this agent to maintain white blood cell (wbc) counts \</= 50,000/ml. hydroxyurea must be discontinued by day 14 of the study * current evidence of active central nervous system (cns) leukemia * any other active malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix) * any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: unstable angina, symptomatic or otherwise uncontrolled arrhythmia requiring medication (does not include stable, lone atrial fibrillation), or myocardial infarction \</= 6 months before study treatment start any active (acute or chronic) or uncontrolled infection/disorders that impair the ability to evaluate the patient or for the patient to complete the study * pregnant or breast-feeding women * patients who refuse to potentially receive blood products and/or have a severe hypersensitivity to blood products
malnutrition using glim criteria and comparing ct and bia for muscle mass measurement

Conditions: Malnutrition

Summary: evaluation of malnutrition with the help of the glim criteria. muscle mass measurement, as recommended in the glim criteria was done with the help of abdominal ct scan and bia. both methods were compared and their association to the clinical outcome was assessed.

we retrospectively analysed 260 patients undergoing major abdominal surgery between january 2017 and december 2019. patients were prospectively screened and assessed for malnutrition with nutritional risk score (nrs) and subjective global assessment (sga). body composition was analysed with ct scan and bia within 30 days before surgery. glim criteria were retrospectively determined referring to the fat free mass from bia (ffmbia) and muscle mass from axial ct scan at lumbar level 3 (mmct). the prevalence of glim - malnutrition according to bia and ct was evaluated. multivariate logistic regression analysis was used to determine association between malnutrition and outcome parameters. roc-curves specified sensitivity and specificity of the different tools and areas under the curve were calculated.

Eligibility criteria:
inclusion criteria: * age above 18 years * bia and ct scan was available within 31 days before surgery * patients undergoing major abdominal surgery for gastrointestinal cancer exclusion criteria: * patients who were not able to agree to the participation * missing assessment of the nutritional status * leck of quality of the ct scan

Keywords: malnutrition, sarcopenia, glim criteria
detection of bacterial and viral pathogens infection among hospitalized patients feasibility study

Conditions: Infectious Disease

Summary: detection of bacterial and viral pathogens infection among hospitalized patients using breath analysis - feasibility study.

a diagnostic prospective single-site study, with no anticipated risks or constraints. primary objective: to identify a set of breath volatile organic compound biomarkers that enable the detection of pathogens infection and inflammatory response to pathogens infection among hospitalized patients.

Eligibility criteria:
inclusion criteria: * age 18 to 80 years at the time of consent * capable of understanding written and/or spoken language * able to provide informed consent * negative results for sars-cov-2 * diagnosed with suspected respiratory infection exclusion criteria: * under guardianship or deprived of liberty * pregnant or lactating woman * not able to breathe through mask for 8 minutes * intubated patients * patients in critical condition * diagnosed with hospital-acquired infection * medical history of malignancies
comparison between a live canine or toy dog on prosocial behavior and emotional regulation in autistic children

Conditions: Prosocial Behavior; Emotional Regulation; Human Animal Bonding; Human Animal Interaction; Autism

Summary: this study investigated the human-animal interaction (hai) and bond (hab) between a canine trained in therapy techniques or a canine plush toy and youth with autism spectrum disorder (asd) during animal-assisted therapy (aat) sessions. the purpose of this study is to explore identified gaps in knowledge pertaining to aat in pediatric asd care management by documenting human interaction between either a live canine or the plush toy canine during aat sessions and evaluating prosocial behaviors observed during and after aat sessions. this study addressed the following research questions: 1. how do children with autism ages 2 to 18 years interact with a live canine during aat sessions? 2. how do children with autism ages 2 to 18 years interact with a toy plush dog during aat sessions? 3. is there a difference in hai in the live canine group and the toy plush dog group? 4. is there a difference in prosocial behavior observed during aat sessions between the live canine group and the toy plush dog group? 5. is there a difference in behavior after aat sessions between the live canine group and the toy plush dog group? participants were randomly assigned to either the live canine or toy plush dog group. adaptive functioning and social responsiveness evaluations were obtained to compare baseline behavior between the two groups. participants attended an aat session once weekly for 6 to 8 weeks. each group received the same therapy provided by the therapist; the only difference being the incorporation of a live canine during the therapy session. caregivers completed a weekly assessment depicting participants' positive and negative affect at the beginning of each session. caregivers also completed a monthly assessment noting strengths and difficulties in social functioning and behavior at the start of the first, middle, and final session. aat sessions were recorded and behavior occurring during the sessions was coded to note hai and hab that occurred during the sessions.


Eligibility criteria:
inclusion criteria * clinical diagnosis of autism spectrum disorder, developmental delay, or behavioral concerns. exclusion criteria: * fearful of canines * allergic to canines

Keywords: animal-assisted therapy canine-assisted therapy pediatric autism spectrum disorder prosocial behavior emotional regulation mental health practitioners
transarterial chemoembolization plus hypofractionnated radiotherapy vs. surgery in locally advanced hepatocellular carcinoma: an iptw comparison

Conditions: Non-metastatic Hepatocellular Carcinoma

Summary: patients with non-metastatic unresectable hepatocellular carcinoma


Eligibility criteria:
inclusion criteria: * age ≥18 years of age * ecog 0-2 * histologically proven hepatocellular carcinoma or proven according to radiological and biochemical criteria (easl-aasld) in cirrhotic patients * child-pugh class a * absence of truncular or lobar portal vein invasion, or suprahepatic vein invasion exclusion criteria: * uncontrolled replication of hepatitis b virus * transplanted liver * previous abdominal irradiation * previous treatment of hcc with systemic therapy, or with surgical resection in the 2 previous years * metastatic illness

Keywords: liver neoplasms carcinoma hepatocellular radiation therapy tace transarterial chemoembolization
a study of intravenous ino-1001 plus oral temozolomide to evaluate tolerability, safety, and pharmacokinetics in patients with melanoma

Conditions: Melanoma

Summary: this is a prospective, open-label, non-randomized, multicenter study in adults, aged eighteen (18) or older, with newly-diagnosed or recurrent unresectable stage iii or stage iv melanoma. a maximum of 18 subjects will be enrolled in stage 1 of this study. (stage 1 completed enrollment in june 2006.) a maximum of 39 subjects will be enrolled in stage 2 of this study.


Eligibility criteria:
inclusion criteria: * biopsy proven malignant melanoma with metastasis that is unresectable stage iii or stage iv. subjects with recurrent melanoma that is unresectable are also eligible * measurable indicator metastases * age 18 years or older * ecog status 0-2 * an interval at the time of enrollment of at least: a) 2 weeks since surgical resection (if conducted); b) 4 weeks since prior radiotherapy or chemotherapy, and c) 6 weeks since chemotherapy with a nitrosourea * hematocrit \> 29%, anc \> 1500 cells/ul, platelets \> 100,000 cells/ul * serum creatinine within the laboratory's upper limit of normal * serum ast and alt ≤ 1.5 x the laboratory's upper limit of normal * subject signed informed consent prior to subject entry exclusion criteria: * female patients who are pregnant or breast-feeding. women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to administration of each cycle of the study drug regimen. * subjects of childbearing potential who are not willing or able to use an effective method of contraception, consisting of at least one-barrier method (e.g., condom and diaphragm), for the duration of the study and for at least 3 months after completing the treatment. * subjects previously treated with dtic or tmz * symptomatic central nervous metastases * concurrent severe and/or uncontrolled medical disease that could compromise participation in the study. * confirmed diagnosis of hepatitis or hiv infection * any medical, psychiatric, or social problem that might interfere with the performance, completion, and/or interpretation of the trial * patients who have had any surgery within two weeks prior to enrollment in this study, or who have not recovered from the side effects of this or any other therapy * patients unwilling to comply with the protocol or who in the judgment of the principal investigator are unable to abide by the rules of the protocol * subjects who have received a potent cyp3a4 inhibitor or inducer orally or parenterally within approximately 14 days prior to enrollment * subjects who have received amiodarone within 30 days of study drug administration * history of hypersensitivity reaction to more than three (3) drugs or to mannitol * patients who have received any investigational study agent within 30 days of day 1 of cycle 1

Keywords: ino4136g inotek parp temodar
prospective observational study of clostridium difficile infection in asian pacific countries

Conditions: Clostridium Difficile Infection

Summary: the aim of this study is to conduct an asia-pacific, multi-center, prospective observational study to characterize patients with cdi as well as to understand treatment and management of the disease.


Eligibility criteria:
inclusion criteria: * patients with a confirmed diagnosis of cdi, as documented by diarrheal symptoms and positive stool test result for cdt or toxigenic c. difficile, or colonoscopic findings of pmc * patients and/or legal guardian willing to provide informed consent and/or informed assent or data release, according to local regulations exclusion criteria: * patients with diarrheal symptoms caused by bacteria other than c. difficile, such as salmonella, campylobacter, vibrio, shigella, and escherichia coli.
efficacy analysis of minimally invasive carroll's technique in treatment of congenital idiopathic clubfoot

Conditions: Congenital Clubfoot

Summary: congenital clubfoot(ccf) is a kind of common congenital foot deformities in children. though ponseti method can cure most of the ccf patients, there are still part of patients can not get satisfactory recovery, especially those children classified as dimeglio grade ⅲ and ⅳ. carroll's technique is considered to be an ideal method of surgical treatment. but the postoperative scar is relatively large, and accordingly the postoperative complications is still common. based on the clinical practice of the investigator's group, a modification of carroll's technique, minimally invasive carroll's technique, was applied. for the dimeglio grade ⅲ and ⅳ ccf, the postoperative excellent and good rate was over 90%. therefore, the investigator conducted a multicenter randomized controlled trial on treatment of congenital idiopathic clubfoot with minimally invasive carroll's technique.


Eligibility criteria:
inclusion criteria: * first diagnosed congenital idiopathic clubfoot cases classified as dimeglio grade ⅲ and ⅳ exclusion criteria: * age≤28 days, and age\>4 years. * accompanied by serious diseases of other organs. * children with inherited metabolic disease and connective tissue disease. * clubfoot caused by trauma, cerebral palsy, congenital multiple joint contracture, polio, spina bifida occulta, and clubfoot derived from spinal cord disease.

Keywords: congenital clubfoot
effect of electroacupuncture on symptoms of female pelvic organ prolapse(level ii - iii)

Conditions: Pelvic Organ Prolapse

Summary: the purpose of the study is to assess the efficacy and safety of electroacupuncture among women with pelvic organ prolapse(level ii - iii), compared with sham electroacupuncture.

after being informed about the study and potential risk, all patients giving written informed consent form will be undergo a 1-week screening period to determine eligibility for study entry. eligible patients will be randomly assigned to one of the two groups 1) electroacupuncture group: electroacupuncture will be provided to patients at bl33, bl35 and sp6 for 3 time per week for the first 4 weeks, then twice a week for 4 weeks, and once a week for the last 4 weeks. there will be 24 times of treatment in total in 3 month; 2) sham electroacupuncture group: sham electroacupuncture will be provided to patients at sham acupoints to bl33, bl35 and sp6 with the same schedule as electroacupuncture group.the follow-up time for the two groups are 6 months after treatment. primary and secondary outcome will be measured at 3, 6, and 9 months from the start of the treatment, respectively.

Eligibility criteria:
inclusion criteria: 1. female patients with pelvic organ prolapse at level 2-3 via pop-q examination; 2. patients at the age of 35 years or older; 3. patients who have a sensation of bulging or protrusion from virginal area, with or without urinary, bowel, and sexual disorders; 4. patients who have a score of pfdi-20 \> 24. 5. patients who have signed informed consent form and are willing to participate the study voluntarily. patients will be included if all above 5 items are met. exclusion criteria: 1. patients who have cognitive disorders and cannot understand the content of questionnaires; 2. patients who have severe heart, lung, brain, liver, kidney, hematopoietic system, and immune system diseases, or severe malnutrition; 3. patients who have cancer or are at terminal stage of severe diseases; 4. patients who need finger assistance for defecation, or have severe prolapse of rectum, sigmoid colon or small intestine; 5. patients who have received(or are receiving) treatments for pelvic floor disorders , including pelvic organ prolapse, stress urinary incontinence, and etc in the past one month; 6. patients who are receiving any treatment for other gynecological diseases; 7. patients who have symptomatic urinary tract infection with urinary pain and urge, or have residual urine volume ≥ 100ml; 8. patients who have diseases affecting the neurological function of pelvic organ, e.g. spinal cord injury, or peripheral nerve injury caused by surgery at lumbosacral area or pelvic floor . patients will be excluded if they meet any of the above criteria.

Keywords: electroacupuncture sham acupuncture randomised controlled trial pelvic organ prolapse