Kornimate/medical-research-clean huggingface dataset:
the young adult and pediatric bipolar study

Conditions: Bipolar I Disorder

Summary: to examine the safety and effectiveness of extended-release carbamazepine in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar i disorder.


Eligibility criteria:
inclusion criteria: * key inclusion criteria: 1. dsm-iv diagnosis of bipolar i disorder, most recent episode manic or mixed. 2. a lifetime history of bipolar disorder symptoms for at least 2 months. 3. ymrs score greater than or equal to 16. 4. cgi-s score greater than or equal to 4. 5. male or female outpatient aged between 10-17 years old inclusive at the time of consent. 6. functioning at an age-appropriate level intellectually, as deemed by the investigator. 7. the subject has no co-morbid illness that could affect efficacy, safety, or tolerability or in any way interfere with the subject's participation in the study. 8. must have a satisfactory medical assessment with no clinically significant and relevant abnormalities. exclusion criteria: * key exclusion criteria: 1. current controlled or uncontrolled, co-morbid psychiatric diagnosis that could interfere with clinical assessments or study conduct. 2. a history of lack of therapeutic response or hypersensitivity to the study drug. 3. a greater than or equal to 50% reduction in ymrs between screening and baseline. 4. acutely at risk for suicidal or violent behavior or a history of suicide attempts requiring medical intervention. 5. a history of aplastic anemia, agranulocytosis or bone marrow depression. 6. a history of seizure disorder, other than a single childhood febrile seizure. 7. a history of severe, unstable asthma. 8. current hospitalization for psychiatric symptoms. 9. history of alcohol or other substance abuse or dependence. 10. pregnant or lactating females. 11. body weight less than or equal to 25 kg.
h+ mobilization with dialysate bicarbonate variation

Conditions: Chronic Kidney Disease

Summary: the aims of the proposed studies are first to delineate the physiological response of end stage kidney disease (eskd) patients to exposure to a bath \[hco3-\] of 35 meq/l and an \[acetate\] of 4 meq/l, and second, to determine whether reducing bath \[hco3-\] will have the expected effect of decreasing or abolishing stimulation of organic acid production. a secondary endpoint will be whether the patients tolerate such a reduction and its impact on pre-dialysis blood \[hco3-\]. if the outcome is positive in both regards, future studies will measure well-being and outcomes with reduced bath \[hco3-\].


Eligibility criteria:
inclusion criteria: 1. patients must be 18 years or older, 2. have been on dialysis for at least 1 year, 3. be stable on treatment (i.e., without frequent changes in their dialysis prescription, or recent hospitalizations), 4. be reasonably nourished (serum albumin \> 3.5 g/dl and not currently receiving oral nutritional supplement through dci). 5. self-reported urine output of \<200 cc/day 6. functioning arteriovenous fistulas or grafts for dialysis access 7. currently dialyzing at a dialysate \[hco3-\] of 33-37 meq/l. exclusion criteria: 1. pregnancy, 2. acute illnesses of any kind, 3. hospitalization in the prior 3 months (except for vascular access related), 4. significant congestive heart failure, liver or lung failure. 5. pre-dialysis blood \[hco3-\] \<19 meq/l) (to reduce the risk of metabolic acidosis )
real-time continuous glucose monitoring in pre-school children with type-1 diabetes mellitus

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to compare glucose control, quality of life and number of hypoglycemias in preschool children before and after using a real-time glucosensor. nocturnal hypoglycemia can be missed even when the parents check their children's blood glucose several times at night. the investigators hypothesise that nocturnal hypoglycemia can be prevented by using the sensor in this age group. as a consequence, quality of life of the families will improve. the investigators also hypothesise that diabetes control will improve at 3-6 months from the beginning of the study.


Eligibility criteria:
inclusion criteria: * duration of diabetes for more than 6 months * use of insulin pump for more than 3 months

Keywords: diabetes mellitus
reducing obesity and cartilage compression in knees

Conditions: Obesity; Osteoarthritis; Knee Osteoarthritis

Summary: oa is a degenerative joint disease that involves the degradation of articular cartilage and underlying subchondral bone. obesity is identified as a critical and potentially modifiable risk factor for the development and progression of oa. the first objective of the study is to determine the effects of obesity on cartilage composition and function. the second objective of the study is to determine whether weight loss restores cartilage composition and function. study activities would require getting mr imaging, evaluation of joint loading using gait analysis techniques, cartilage strain measurement, and participating in weight loss intervention. the study will target a population age group between 18 and 45 years with a bmi greater than or equal to 29. data analyses will be blinded to reduce potential bias. all subjects participating in this study will be informed of the risks involved and sign an irb-approved consent form.

appropriate study power will be achieved with 35 participants in the weight loss group and 35 participants in the weight maintenance control group (see data analysis and statistical considerations). we will recruit and enroll obese (bmi ≥29 - ≤40) men and women, age 18 to 45, with no previous history of lower extremity injury, no evidence of symptoms oa, no knee misalignment (neutral alignment between 178° and 182°), or other injury that would prevent them from performing the walking task required by this study. all inclusion criteria specific to knee injury, oa, and alignment will be verified by mri scan. all participants in this study will be informed of the risks involved. upon expressing interest in study participation, participants will be asked questions to determine whether they are free of lower extremity injury and their height and weight will also be recorded to determine their bmi. potential participants will be pre-screened by phone using a phone script with a list of questions. once it is determined they meet all study inclusion criteria, they will be invited to attend a consent meeting.

Eligibility criteria:
inclusion criteria: * bmi (bmi ≥29 - \<40) * age between 18 - 45 exclusion criteria: * history of lower extremity injury * evidence of symptoms of knee oa * knee misalignment * evidence of pregnancy * thigh unable to fit in mri coil * body waist fit in mri * have no metals in the body

Keywords: weight loss mri arthritis knee health
evaluation of safety and efficacy of rehub in patients who underwent primary total knee arthroplasty

Conditions: Knee Osteoarthritis

Summary: this is a randomized, non-blinded, parallel assignment, clinical trial for the evaluation of safety and efficacy of rehub, a telerehabilitation system made up of a cloud platform and an exercise kit with smart sensors, for performing rehabilitation exercises after a primary total knee arthroplasty. primary tka patients are allocated randomly to the control arm or the experimental arm with a 1:1 ratio. both arms follow the usual rapid recovery protocol for tka surgeries at hospital clínic de barcelona, which includes discharge after 2-3 days from the surgery, the prescription of a daily plan of 5 exercises for autonomous rehabilitation and domiciliary visits by a physiotherapist starting approximately 2 weeks after the surgery. the experimental arm participants use rehub to do their exercises instead of working independently and physiotherapists monitor their performance and adherence remotely. outcomes assessment is performed at hospital discharge (baseline), at stitch removal (2 weeks after baseline) and 2 weeks after stitch removal (4 weeks after baseline).


Eligibility criteria:
inclusion criteria: * candidates to primary tka * age from 18 to 75 years old * ability to understand and accept the clinical study procedure and to sign an informed consent form * good predisposition to the use of technology or cohabitation with someone that can give them technological support * availability to attend the hospital for control visits * patient resides in the area of influence of hospital clínic de barcelona exclusion criteria: * reluctance or inability to use technology * any type of disability that could alter the homogeneity of the study * sensory and/or cognitive impairment * concomitant medical conditions that may influence the rehabilitation process * any local or systemic complications after tka surgery (e.g. surgical wound infection, suspicious of deep vein thrombosis)
comparison 1 plane-2 injection and 2 plane-2 injection ultrasound-guided supraclavicular brachial plexus block

Conditions: Radius Fractures

Summary: the supraclavicular block can provide effective surgical anesthesia of the forearm and hand. there have been many different approaches to ultrasound-guided supraclavicular brachial plexus block (us-scbpb) according to the needle injection site (e.g. corner pocket approach, cluster approach) or number of needling (single or double injection). numerous studies demonstrates good results (e.g. faster onset time) when using double injections rather than single injection. but double injection does not guarantee complete sensory block because ulnar nerve tends to be spared by its anatomical location.

the investigators hypothesized that double injection in different plane (we call this new approach as a 2 plane-2 injection approach;2p2i) would overcome the weakness of the existing double injection in same plane (we call this approach as a 1 plane-2 injection approach;1p2i) like "ulnar nerve sparing effect", and could have a good results (e.g. shortening the onset time or increasing rate of all four nerves block). because 2p2i can achieve an effect of a "tridimensionally administered la", rather 1p2i only achieve an effect of a " two-dimensionally administered la".

Eligibility criteria:
inclusion criteria: * all patients anticipating surgery of the wrist or hand * age: 18 to 80 years * american society of anesthesiologists physical status (asa): i or ii exclusion criteria: * neuropathy in the operated limb * asa greater than iii * coagulation disorders * known allergy to local anesthetics * local infection at the puncture site * chronic obstructive pulmonary disease or respiratory failure * pregnancy or breast-feeding * prior surgery in the supraclavicular region * bmi ≥ 35 kg/㎡ * uncooperative patients * patients' refusal

Keywords: brachial plexus block nerve stimulator ultrasound
bioavailability study of fluconazole tablets 200 mg under fed conditions

Conditions: Healthy

Summary: the objective of this study was an open-label, randomized, 2-way crossover to compare the single-dose relative bioavailability of dr. reddy's laboratories, ltd. and pfizer (diflucan®) 200 mg fluconazole tablets under fed conditions.

detailed description : the study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 16 healthy adult male volunteers. a total 15 subjects completed the clinical phase of the study. in each period, subjects were housed from the mornings dosing until after the 72-hour blood draw. single oral 200 mg doses were separated by a washout period of 21 days.

Eligibility criteria:
inclusion criteria: exclusion criteria: history or presence of significant: • cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease. in addition, history or presence of: * alcoholism or drug abuse within the past year; * hypersensitivity or idiosyncratic reaction to fluconazole or other azoles. subjects who have used any drugs or other substances known to be strong inhibitors of cyp (cytochrome p450) enzymes within 10 days prior to first dose. subjects who have used any drugs or other substances known to be strong inducers of cyp (cytochrome p450) enzymes within 28 days prior to first dose. subjects who have been on an abnormal diet (for whatever reason) during the 28 days prior to the first dosing. subjects who, through completion of the study, would have donated in excess of: * 500 ml of blood in 14 days, or * 500 - 750 ml of blood in 14 days (unless approved by the principal investigator), * 1000 ml of blood in 90 days, * 1250 ml of blood in 120 days, * 1500 ml of blood in 180 days, * 2000 ml of blood in 270 days, * 2500 ml of blood in 1 year. subjects who have participated in another clinical trial within 28 days prior to the first dosing.

Keywords: bioequivalence fluconazole crossover
partial oral treatment of endocarditis

Conditions: Endocarditis

Summary: background current management of infective endocarditis include admission and treatment with parenteral antibiotics for 4 weeks - 6 weeks. resource demands and psychological issues of present management strategy make it highly relevant to seek for alternative more lenient alternatives. experiences with oral treatment are only sporadically described, but observational data suggest that oral treatment could be a feasible option. the investigators have in 2010 treated 12 endocarditis patients with partial oral antibiotics with a 100% success rate. study design the poet study is a danish multicenter, prospective, randomized, open label study. the primary aim is to show non-inferiority of partial oral treatment with antibiotics of endocarditis compared to full parenteral treatment. stable patients (n=400) with streptococci, staphylococci or enterococci infecting the mitral valve or the aortic valve will be included. after a minimum of 10 days of parenteral treatment, patients will be randomized to oral therapy or parenteral therapy. special recommendations for oral treatment have been developed based on expected minimal inhibitory concentrations and pharmacokinetic calculations. patients will be followed for 6 months after completion of antibiotic therapy. the primary endpoint is a composition of all cause mortality, unplanned cardiac surgery, embolic events and relapse of positive blood cultures with the primary pathogen.


Eligibility criteria:
inclusion criteria: * left-sided endocarditis based on the duke criteria * infected with one of the following microorganisms: * streptococci * enterococcus faecalis * staphylococcus aureus * coagulase-negative staphylococci. * ≥ 18 years * at least 10 days of appropriate parenteral antibiotic treatment overall, and at least 1 week of appropriate parenteral treatment after valve surgery * afebrile (t \ 2 days * decreasing infection parameters (crp dropped to less than 25% of peak value or \< 20 mg/l, and white blood cell count \< 15 x 109/l) during antibiotic treatment * no sign of abscess formation by echocardiography * transthoracic and transoesophageal echocardiography performed within 48 hours prior to randomization exclusion criteria: * body mass index \> 40 * concomitant infection requiring intravenous antibiotic therapy * inability to give informed consent to participation * suspicion of reduced absorption of oral treatment due to abdominal disorder * reduced compliance
the overall survival of patients with unresectable hcc in real-life

Conditions: Hepatocellular Carcinoma

Summary: liver cancer is the fifth most common cancer and the second most frequent cause of cancer-related death globally. hepatocellular carcinoma represents about 90% of primary liver cancers and constitutes a major global health problem. the pattern of hcc occurrence shows a significant geographical imbalance, with the highest incidence rates in east asia (more than 50% of the cases occurring in china). the aim of this study is to investigate the overall survival (os) of patients diagnosed with unresectable hepatocellular carcinoma under real-world practice conditions in asia pacific region.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of unresectable hepatocellular carcinoma * able to comprehend and provide written informed consent in accordance with institutional guidelines. exclusion criteria: * patients not willing to participate and/or give their written informed consent.
allogeneic hematopoietic stem cell transplantation

Conditions: Solid Tumors; Hematologic Neoplasms

Summary: to assess the engraftment of hematopoietic stem cells following reduced-intensity conditioning in children presenting with solid tumors or hematological malignancy by evaluating post-transplantation chimerism and hematological reconstitution. to study acute and/or chronic graft-versus-host reaction (incidence and severity) and immune reconstitution, post-transplantation to study the effectiveness of the protocol on tumor response. to study overall survival.

primary criterion * hematological reconstitution and chimerism post-transplantation secondary criteria * adverse effects, graft-related mortality at d90 and at 12 months, incidence and severity of acute and/or chronic gvh reactions * analysis of variations in post-transplantation immunological function profiles * median duration of response in therapy-responsive patients and median duration of stability in stabilized patients

Eligibility criteria:
inclusion criteria: * patients aged less than 20 years old * lansky score \> 60% * life expectancy greater than 2 months * diagnoses: 3- solid tumor or hematological malignancy remaining unresponsive to the reference strategies according to french best practices in pediatrics. 4- malignancies for which allografting is the recognized indication but is contraindicated with myeloablative conditioning. * usual criteria for allogeneic grafting (pre-graft profile) * having a hla-identical sibling donor for hla-a, hla-b and hla-dr antigens or a hla mismatch on only one antigen, or having a 10/10 pheno-identical donor, or compatible cord blood. * signed informed consent exclusion criteria: * patient presenting rapidly-progressive malignancy * in cases where the potential donor is related, sibling presenting contraindication against hematopoietic stem cell donation * unable to sufficiently understand the treatment and its consequences, even after explanation

Keywords: allograft children malignancy reduced intensity conditioning fludarabin busulfex thymoglobulin
three weeks of cast immobilisation versus one week of brace immobilisation in distal radius fractures

Conditions: Distal Radius Fractures; Fractures, Bone

Summary: three weeks of cast immobilisation versus one week of brace immobilisation in non- or minimally displaced distal radius fractures in adult patients \<50 years of age treated non-operatively.

background: currently, non- or minimally displaced distal radius fractures are treated by three to five weeks of cast immobilisation. many patients with a distal radius fracture suffer from long-term functional restrictions, which might be related to stiffness due to cast immobilisation. current literature indicates that one week of immobilisation might be safe, however, no level one evidence is available. this trial aims to compare one week of brace immobilisation with three weeks of cast immobilisation in patients with distal radius fractures that do not need reduction. methods: the aim of this trial is to evaluate the non-inferiority of one week of brace immobilisation in patients with non- or minimally displaced distal radius fractures. a single blinded multicentre randomised clinical trial will be conducted in three hospitals. adult patients, between 18-50 years old, independent for activities of daily living, with a non- or minimally displaced distal radius fracture can be included in this study. the intervention group is treated with one week of brace immobilisation, and the control group with three weeks of cast immobilisation. primary outcome is the patient-related wrist evaluation-score at six months. secondary outcomes are: quick disabilities of the arm, shoulder and hand-score at six weeks and six months, prwe at six weeks, range of motion, pain, radiological outcome, complications and cost effectiveness measured by the euroqol 5 dimension questionnaire, medical consumption questionnaire and productivity cost questionnaire. discussion: this study will provide evidence on the optimal period of immobilisation in non-operatively treated displaced and reduced distal radius fractures. both treatment options are accepted treatment protocols and both treatment options have a low risk of complications. follow-up will be according to the current treatment protocol. this study will provide level one evidence on the optimal period and way of immobilisation for non- or minimally displaced distal radius fractures in adult patients.

Eligibility criteria:
inclusion criteria: 1. 18-50 years (to eliminate osteoporosis); 2. primary non- or minimally displaced drf; 3. independent for activities of daily living. exclusion criteria: 1. fracture of the contralateral wrist; 2. ipsilateral fractures, proximal of the drf; 3. pre-existent abnormalities or functional deficits of the fractured wrist; 4. open fractures; 5. polytrauma patients 6. language disability to understand the dutch patient information and questionnaires.

Keywords: distal radial fractures non-operative treatment immobilisation period
arm swing during walking in early multiple sclerosis

Conditions: Multiple Sclerosis; Upper Extremity Problem; Gait Disorders, Neurologic

Summary: multiple sclerosis (ms) is the most common central nervous system inflammatory demyelinating disease which causes motor and sensory deficits, cerebellar symptoms, and balance problems. due to these symptoms, gait abnormalities are common in ms, even in patients with low degrees of impairment. the upper limb has an important role on postural control and gait stability. affected arm swing movement and asymmetry during gait are common in neurological disorders such as parkinson's disease (pd) even in early stages of the disease and arm swing treatment has been acknowledged to enhance gait and normalize arm swing in individuals with pd. the presence of arm swing changes during walking in ms patients, similar to pd, especially in the early period, may be an indicator of balance problems, this was, however, not investigated as such. therefore, the aim of the current study is to assess the arm swing during gait in people with ms shortly after their diagnosis in early ms.


Eligibility criteria:
inclusion criteria: * patients who were diagnosed with ms in the last 30 days, * patients who were recovered from their symptoms and were clinically stable exclusion criteria: * patients who had an acute medical illness in the past 6 months, any other neurological and psychiatric diseases * patients who had any orthopedic, rheumatologic, or vestibular conditions that affect walking * patients who had exacerbations between the first and second evaluations

Keywords: arm swing, multiple sclerosis, gait, foot pressure analysis