Kornimate/medical-research-clean huggingface dataset:
open label clinical trial of vitamin d in children with autism

Conditions: Autism; Vitamin D Deficiency

Summary: primary: to investigate tolerability of interventional high dose vitamin d3 supplementation, titrated to reach serum levels near the high end of the reference range (30-100 ng/ml), in vitamin d deficient pediatric autism spectrum disorder (asd) patients. the study will determine if initial safety and effect estimates predict that a double blind randomized control trial (rct) with a larger set of patients will be worthwhile in the localization of this treatment aimed at improving the symptoms of asds. exploratory: to determine efficacy of high dose d3 replacement for improvement in the core symptoms of autism, including sociability, eye contact, anger outbursts, stimming behavior, and sleep, as determined by parental and clinical evaluation scales.

data is still being collected

Eligibility criteria:
inclusion criteria: * diagnosis of autism from dsm-iv tr and ados * moderate but less than severe on cgi-severity scale * iq \> 40 * zrt 25(oh)d blood spot test \< 30 ng/ml * age 3-8 years old exclusion criteria: * developmental delays prior to 12 months of age * history of head trauma * seizure in the past year * bleeding disorder * history of kidney or liver disease * clinically significant low white blood cell count * pdd-nos, rett's syndrome, childhood disintegrative disorder or fragile x syndrome * current supplementation with vitamin d, vitamin a or cod-liver oil
evaluation of thromboprophylaxis appropriateness in hospitalized medical patients

Conditions: Deep Vein Thrombosis; Pulmonary Embolism; Venous Thromboses

Summary: considering observational studies that suggested a relationship between acutely ill medical patients and venous thromboembolism (vte), interventional studies with anticoagulant medications indicated a marked decline in vte during and after hospitalization. despite the therapeutic value of lowering this result, there is a low inclination to utilize anticoagulants in patients hospitalized for acute medical diseases. this observational research aims to assess the appropriateness of venous thromboprophylaxis offered to patients admitted to internal medicine wards.

epidemiological studies have shown a significant prevalence of thromboembolism in patients admitted to medical wards. based on this, various clinical studies using anticoagulants such as unfractionated heparin (ufh), low-molecular-weight heparin (lmwh), and fondaparinux to prevent thromboembolism have been conducted in patients hospitalized for acute medical illness. interventional studies have repeatedly shown that anticoagulant prophylaxis lowers the incidence of deep venous thrombosis (dvt), pulmonary embolism (pe), and dvt-related mortality. these findings led to recommendations to employ anticoagulant prophylaxis in patients hospitalized for acute medical disease; yet, anticoagulant prophylaxis is often underutilized in-hospital medical wards. this study's primary objective is to assess the adequacy of venous thromboprophylaxis delivered to medical inpatients who need pharmacologic intervention in accordance with the american college of chest physicians (accp) guideline using the padua prediction score.

Eligibility criteria:
inclusion criteria: * age ≥18 years * hospitalized for any cause in the internal medicine ward * ability to give informed consent, as informed by the physicians in charge of the patient exclusion criteria: * expected hospital stay \< 48 h * patients unable to give informed consent, as informed by the physicians in charge of the patient * patients with therapeutic anticoagulation at hospital admission * patients admitted for a disease requiring therapeutic anticoagulation * patients admitted to non-medical hospital wards

Keywords: padua prediction score pulmonary embolism deep vein thrombosis venous thromboses acute medical illness
effect of physiotherapy methods on functional and respiratory outcomes in icu patients with respiratory failure

Conditions: Respiratory Insufficiency

Summary: the aim of the biomedical study is to assess the changes in functional and qualitative indicators of critically ill patients with respiratory failure by applying different physiotherapy methods. by conducting this study and developing the "physiotherapy protocol for critically ill patients treated in the icu," physiotherapists worldwide could be encouraged to work using a unified and adapted method. it is expected that the results, conclusions, and practical clinical recommendations derived from this study will be beneficial not only for rehabilitation specialists and intensivists in lithuania but also for medical professionals working with respiratory diseases, including covid-19 patients, at various stages of their treatment and consultation. implementing an appropriate physiotherapy procedure protocol is anticipated to bring economic benefits, as early physiotherapy is safe and can reduce the incidence of delirium, decrease the duration of patient sedation, shorten the number of days on mechanical ventilation, and minimize hospital stay duration. additionally, it aims to restore or improve patients' functional and independence levels, help prevent icu-acquired weakness, and can be easily implemented in intensive care units.


Eligibility criteria:
inclusion criteria: * adults (≥18 years of age) * hospitalized in the department of reanimation and intensive therapy at lsmu kaunas clinics * diagnosis of respiratory failure (kfn) based on the following tlk-10-am codes: j96.00, j96.01, j96.9, j96.10, j96.11, j96.19, j96.90, j96.91, j96.99 * signed informed consent obtained from the patient or their legal representative exclusion criteria: * conscious patients who refuse to participate in the study * unconscious patients whose legal representative does not consent * recent episode of myocardial ischemia * pregnancy * heart rate \ 130 bpm * mean arterial pressure \ 110 mmhg * oxygen saturation (spo₂) ≤ 85% * body temperature ≥ 38.5°c or ≤ 36.0°c
comparison of two arthroscopic rotator cuff repair techniques: knot-tying versus knotless suture-bridge technique

Conditions: Rotator Cuff Tears; Rotator Cuff Injuries

Summary: suture-bridge technique has been widely used for rotator cuff tears with many studies showing superior clinical results and lower failure rates compared to other techniques. this study aims to compare clinical outcomes and radiological integrity of arthroscopic rotator cuff repair between knot-tying and knotless suture-bridge techniques. the possibility of tendon strangulation and necrosis at the medial row when performing a suture-bridge technique may lead to retear and structural failure. in order to avoid this complication, the knots used at the medial row and their tension might be a factor to consider. our hypothesis is that a knotless suture-bridge technique might avoid tendon strangulation thus might have lower retear rates.

this study has been planned as a prospective randomized clinical trial. we used a completely computer-generated list in order to randomize all participants to receive one of two treatments (https://www.random.org/sequences/). rotator cuff tear diagnosis will be made by physical examination and magnetic resonance imaging. participants who agree to be enrolled to study will be examined one day prior to surgery. half of the participants will undergo an arthroscopic rotator cuff repair with knot-tying suture-bridge technique, while the other half will receive a knotless suture-bridge technique. all the surgeries will be performed by the same senior surgeon experienced in shoulder surgery under general anesthesia with participant in beach-chair position. all participants will receive a standard postoperative rehabilitation program starting immediately after surgery with active elbow and passive shoulder exercises. the operated upper extremity will be placed in a sling for 6 weeks. active-assisted exercises will be started at 6 weeks postoperatively. postoperative evaluations will be performed regularly at 2 weeks, 6 weeks, 3 months, 6 months, 12 months postoperatively and each following year. the results of last follow-up will be analyzed. to assess repair integrity and tendon healing, a postoperative magnetic resonance imaging scan will be performed to all participants at 6 months postoperatively. the results of prospective clinical follow-up data and radiological evaluation will be analyzed in order to compare clinical outcomes, failure rates and patterns of knot-tying and knotless suture-bridge arthroscopic rotator cuff repair techniques.

Eligibility criteria:
inclusion criteria: * full thickness rotator cuff tear repaired by arthroscopic suture-bridge technique exclusion criteria: * partial thickness rotator cuff tear * presence of a full thickness subscapularis tear that requires a repair * history of a neurological disease * presence of severe glenohumeral or acromioclavicular arthritis * presence of a metal implant which prevents magnetic resonance imaging scan * tears repaired with other techniques * revision surgeries

Keywords: shoulder rotator cuff tear arthroscopic repair suture-bridge technique retear knotless knot-tying
a study evaluating the effectiveness of tecfidera (dimethyl fumarate) on multiple sclerosis (ms) disease activity and patient-reported outcomes

Conditions: Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis

Summary: the primary objective of the study is to estimate the annualized relapse rate (arr) in participants with relapsing remitting multiple sclerosis (rrms) who are treated with dimethyl fumarate (dmf) over a 12-month period. the secondary objectives of this study in this population are to assess the impact of dmf over a 12-month period on participants -reported health-related quality of life (hrqol) outcomes, additional clinical effectiveness outcomes, and health economics-related outcomes, and to characterize participants-reported adherence to dmf.


Eligibility criteria:
key inclusion criteria: * have a diagnosis of relapsing-remitting multiple sclerosis (rrms) and satisfy the approved therapeutic indication for dmf (per the local dmf product information). * must be naïve to dmf, fumaderm®, and other compounded fumarates, and to ms therapies that are primarily prescribed second-line (e.g., natalizumab, fingolimod) and to alemtuzumab. * have a recent complete blood count (cbc) that does not preclude the subject's participation in the study, in the judgment of the investigator. key exclusion criteria: * are unwilling or unable to comply with study requirements, or are deemed unsuitable for study participation as determined by the investigator. * have major comorbid conditions that preclude participation in the study, as determined by the investigator. * are pregnant, unless dmf is clearly needed and the potential benefit of dmf to the subjects justifies the potential risk to the fetus, in the judgment of the investigator (in all countries except austria). in austria, pregnant subjects are excluded from participation in the study. * are women of childbearing potential and are not using appropriate contraception (per the local dmf product information) as determined by the investigator. * women who are breastfeeding may be excluded (per the local dmf product information) at the discretion of the investigator. * have previously received or are receiving treatment with ms therapies primarily used second-line (e.g., natalizumab, fingolimod) or alemtuzumab, or are currently receiving and planning to continue on other disease-modifying therapies for rrms. * are hypersensitive to the active ingredient in the dmf drug product (i.e., dmf) or to any of the excipients listed in the local dmf product information. * current enrollment in any clinical trial except for the biogen idec dmf pregnancy exposure registry or other studies that, according to the study medical director, do not conflict with this study (e.g., health economics studies or local registries). other protocol-defined inclusion/exclusion criteria may apply.

Keywords: bg-12
open versus laparoscopic right hemicolectomy for right colon cancer

Conditions: Colonic Cancer

Summary: the aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of laparoscopic right hemicolectomy with cme and cvl compared to open surgery.

the aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of laparoscopic right hemicolectomy with cme and cvl compared to open surgery. enrolled patients in the study were randomized to either laparoscopic or open right hemicolectomy with cme and central vascular ligation. the randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse. the primary outcome was the number of lymph nodes (lns) harvested among both groups. secondary outcomes included operative time, blood loss, postoperative complications, and hospital stay.

Eligibility criteria:
inclusion criteria: * patients with right colonic cancer exclusion criteria: * patients with distant metastasis, large tumors with extra-colonic invasion emergency presentation (bowel obstruction or perforation)

Keywords: colonic cancer laparoscopic right hemicolectomy complete mesocolic excision
cognitive dysfunction in parkinson's disease

Conditions: Parkinson's Disease

Summary: this study plans to learn more about the brain function related to thinking problems in individuals with parkinson's disease.

dementia is the leading cause of nursing home placement in parkinson's disease (pd) yet little is known about the cause(s) of cognitive dysfunction in pd and there are no effective treatments. the investigators preliminary data and other published studies suggest that abnormalities in brain activity involving networks important for normal thinking and memory may contribute to cognitive dysfunction in pd and may represent a target for treatment. this proposal will identify abnormalities in cortical activity related to cognitive dysfunction in pd using magnetoencephalography and will perform a randomized control trial of bifrontal repetitive transcranial magnetic stimulation to determine the therapeutic potential of modulating this brain activity.

Eligibility criteria:
inclusion criteria: * diagnosis of probable pd (using united kingdom brain bank criteria) * diagnosis of mild cognitive impairment * no unstable medical condition exclusion criteria: * features suggestive of other causes of parkinsonism or other neurological disorders * prior deep brain stimulation (dbs) or ablation surgery * evidence for active depression or hospital anxiety and depression scale (hads) score greater than or equal to 11 * motor symptoms expected to interfere with scanning (e.g. sever tremor) * contraindications to tms, meg, or mri such as pregnancy, pacemaker, unstable cardiac disease, skull lesion, claustrophobia, history of epilepsy, or on medications known to lower seizure threshold * implanted electronic devices or metal

Keywords: parkinson's tms kluger
effect of exercise and protein supplementation on muscle function in patients with hemodialysis

Conditions: Sarcopenia

Summary: sarcopenia can be easily observed in patients with hemodialysis. however, there were few studies on the precise concept and diagnostic criteria for sarcopenia in patients with hemodialysis. the investigators have already recognized the sarcopenia-associated mortality and morbidity in patients with hemodialysis. however, intervention studies on hemodialysis patients with sarcopenia have not been conducted until now. here, the investigators aim a pilot study to evaluate the effectiveness of the combined exercise and nutrition intervention for sarcopenia in patients with hemodialysis. this is a prospective study with 60 patients with hemodialysis who were diagnosed as sarcopenia or frailty in our previous cohort study. combined intervention will consist of resistance exercise and nutritional supplementation for 12 weeks. the primary outcome of this study is muscle mass and handgrip strength after 12 weeks' intervention. all functional outcomes will be measured at 0, 12, and 24 weeks after intervention. the data will be analysed using the intention-to-treat principle.

while feasible, inexpensive, and non radiation-exposed tools such as bioimpedance analysis have been used to measure appendicular skeletal muscle mass. in addition, isokinetic strength will be measured by a dynamometer for hand grip strength to evaluate sarcopenia. the main two axes of treatment of conventional sarcopenia are muscle resistance exercises and protein supplementation including branched chain amino acids. therefore, it is necessary to confirm the clinical effect by intervention for resistance exercise and nutritional supplementation in patients with hemodialysis.

Eligibility criteria:
inclusion criteria: * patients with hemodialysis * community-dwellers * able to walk with or without assistive devices for more than 100 meters exclusion criteria: * a person with cancer disease. * people with psychiatric symptoms. * a person who has an absorption disorder or has a history of resection of the small intestine or colon * pregnant women * a person treated for acute bacterial infections * a person who is in a wheelchair due to inconvenience in walking.
comparison of pamidronate with zoledronic acid for transplant related bone loss prevention

Conditions: Osteopenia; Complications of Heart-lung Transplant; Other Complications of Lung Transplant

Summary: the purpose of this trial is to see whether zoledronic acid is better than pamidronate to treat low bone density in heart and lung transplant patients.


Eligibility criteria:
inclusion criteria: * reduced bone density as indicated by a bone density t score \<-1.in either the lumbar spine or femoral neck * have undergone or are on the waiting list for heart or lung transplantation * are receiving adequate calcium and vitamin d therapy * have provided written informed consent prior to participation in the trial exclusion criteria: * untreated hypogonadism, hypothyroidism or hyperthyroidism * acute or major organ rejection or intercurrent illness * pregnancy or breastfeeding
immunogenicity and safety of adacel™ as fifth dose in taiwan

Conditions: Diphtheria; Tetanus; Pertussis

Summary: to assess the immunogenicity profile of adacel™, tetanus and diphtheria toxoids adsorbed combined with component pertussis vaccine (tdcp vaccine) one month after administration. to describe the safety profile of adacel™ (tdcp vaccine) when given as a fifth dose.


Eligibility criteria:
inclusion criteria: * aged from 6 to 8 years on the day of inclusion * informed consent form (icf) signed by parent(s)/legal representative * able to attend all scheduled visits and to comply with all trial procedures * written documentation of complete primary series and fourth dose of diphtheria, tetanus toxoids and whole cell pertussis vaccine (dtp) * parent(s)/legal representative present or fully completed pre-inclusion medical questionnaire exclusion criteria: * participation in another clinical trial in the 4 weeks preceding the trial vaccination * planned participation in another clinical trial during the present trial period * congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long term systemic corticosteroids therapy * systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances with specific focus on subjects who had, after previous administration of dtp or diphtheria and tetanus toxoids and acellular pertussis (dtap) vaccine, one of the following adverse events 1. encephalopathy not attributable to another identifiable cause within 7 days of administration of a previous dose 2. temperature of \> 40.5 °c within 48 hours not due to another identifiable cause 3. collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours 4. persistent, inconsolable crying lasting \> 3 hours, occurring within 48 hours 5. seizure with or without fever occurring within 3 days * chronic illness at a stage that could interfere with trial conduct or completion. * blood or blood-derived products received in the past 3 months * any vaccination in the 4 weeks preceding the trial vaccination (except oral poliomyelitis vaccine \[opv\]) * any vaccination planned during the present trial period (except opv) * history of diphtheria and/or tetanus and/or pertussis infection (confirmed either clinically, serologically or microbiologically) * previous fifth vaccination against diphtheria and/or tetanus and/or pertussis infection with the trial vaccine or another vaccine * clinical or serological evidence of systemic illness including hepatitis b, c or human immunodeficiency virus (hiv) * thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination * history of/current seizures * febrile illness (axillary temperature ≥ 37.4 °c) or acute illness on the day of inclusion

Keywords: adacel™ tetanus diphteria acellular pertussis
a retrospective study evaluating the use of the solopath® sheath in reducing vascular and bleeding complications

Conditions: Vascular Access Complication

Summary: this study is a retrospective, single center data collection to assess bleeding and vascular complications associated with tavi when a solopath® balloon expandable transfemoral introducer is used for vascular access.

this study is intended to collect data on the rate of vascular complications in subjects having transfemoral tavi when the solopath® balloon expandable transfemoral introducer is used as a guide for introduction and delivery of tavi devices. the use of a small profile sheath could possibly reduce the incidence of post procedure vascular complications associated with tavi and further enhance the safety of accessing the femoral delivery route. in addition, this study will examine the impact of arterial morphology and other subject risk factors as a predictor of clinical outcomes within 30 days following tavi.

Eligibility criteria:
inclusion criteria: 1. subject must have undergone a tavi procedure with femoral access achieved with a 19fr (id) solopath (stfi) sheath. 2. male or female ≥ 18 years old. exclusion criteria: 1. subjects with femoral or iliac vessels less than 6mm on side of tavi access will be excluded. 2. subjects treated before january 1, 2011, are excluded from this analysis.