Kornimate/medical-research-clean huggingface dataset:
endobarrier register deutschland-safety and efficacy of the endoscopic duodenal-jejunal bypass sleeve

Conditions: Obesity; Diabetes Mellitus

Summary: the purpose of this study ist to determine long-term safety and efficacy in weight reduction and improvement of diabetes mellitus of the temporary, endoscopic duodenal-jejunal bypass-sleeve endobarrier® in a national registry.

long-term data are collected by approximately 30 german centers. an electronic case-report-form (ecrf) was designed to collect relevant pre-specified items by the clinical trial center north (ctc). all german sites that have implanted endobarrier® since 2010 were invited to provide patient results. data-acquisition is projected to a period of 5 years and a maximum of 1000 patients. an extension of data-acquisition is planned.

Eligibility criteria:
inclusion criteria: * clinical decision for treatment with endobarrier * informed consent for registry participation exclusion criteria: * patients not meeting the inclusion criteria * age \< 18
frequency of gastrointestinal and hepatic manifestations among patients with multiple sclerosis, a clinical hospital based study

Conditions: MS (Multiple Sclerosis)

Summary: the aim of this work is to identify different pattern of gastrointestinal and hepatic symptoms and its frequency among patients with multiple sclerosis

historically, the routine evaluation of symptoms in ms patients focused on skeletal muscle impairments that restricted mobility. within the last two decades, symptoms such as dysphagia, bladder and bowel dysfunction, among others, have been increasingly recognized and incorporated into patient assessments \[1-3\]. the gi problems felt to be most common in ms patients involve deglutition and defecation and require volitional muscle coordination. this association may link the development of such gi problems to underlying ms disease progression. however, gi symptoms that are not dependent upon skeletal muscle control are common in the general population and may also be present in ms patients. more than two decades ago, hinds and colleagues described a high prevalence of anorectal dysfunction in a large cohort of ms patients \[4\]. since then, the diagnostic and clinical approach to ms care has changed dramatically and now emphasizes the early introduction of disease modifying therapies \[5\]. however, despite changes in ms care, anorectal dysfunction and swallowing problems continue to be an important problem for ms patients . little is known about other gi symptoms in ms patients in this new era of pervasive use of disease modifying therapies. to address this gap in knowledge, the investigators sought to define the prevalence of gi symptoms and syndromes in a large sample of contemporary ms patients

Eligibility criteria:
inclusion criteria: * 1- both sex 2- all patients diagnosed ms ( in recovery on dmt) according to the 2017-mcdonalds criteria. 3- pt with ms suffer from git and hepatic symptoms not explained by known cause as hepatitis virus،metabolic disorders as wilson . hemochromatosis,etc drug induced , alcohol , git symptoms as dysphagia, vomiting,reflux 4- an informed consent will be obtained from all the patients, the study will be approved by ethical committee in faculty of medicine assiut university exclusion criteria :1-patients already diagnosed with other git disorders before diagnosis of ms 2_ presence of other disorder or on medications that may affect the neurological or git disorders. 3_ patients failed to commit to the follow up visits and regular mri scans 4_ patients refused to sign the written informed consent patients who will meet the inclusion and exclusion criteria will be assessed in the 1st visit by direct interview followed by clinical examination and neuropsychological assessments. baseline mri scans will be obtained at the first visit -
motor and sensory deficits following partial meniscectomy

Conditions: Meniscus Tear

Summary: to determine changes in thigh muscle function and knee pain after a partial meniscectomy surgery and to also determine the effects of applying electrical stimulation to the knee to determine if this improves thigh muscle function and decreases pain.

the objective for this study is to determine the differences in corticospinal excitability and central sensitization of nociceptive pathways in individuals with a history of arthroscopic partial meniscectomy compared to healthy controls. our central hypothesis is that quadriceps weakness following partial meniscectomy is due to higher levels of corticospinal excitability and central sensitization of nociceptive pathways, which can be modified with therapeutic interventions.

Eligibility criteria:
inclusion criteria: * age 15-65 * arthroscopic partial meniscectomy with in the past 15 years exclusion criteria: * history of traumatic spine or lower extremity injury within the last 6 months * previous adverse reaction to electrical stimulation (i.e. burns or hypersensitivity) * cardiac pacemaker * metal implants in head * current pregnancy * neurological disorders * history of seizures * unable to give consent or understand the procedures of this study

Keywords: meniscectomy arthroscopic partial meniscectomy meniscus
hypofractionated radiotherapy in breast cancer

Conditions: Cancer, Breast; Inflammation

Summary: as the number of breast cancer (brca) survivors has markedly increased, clinicians are now seeking to reduce treatment-related toxicities and inconveniences of treatment, namely the traditional 6 weeks of daily radiation treatment (xrt). skin thickening, fibrosis, and edema are some of the most common acute and potentially long-term debilitating toxicities of brca xrt. the purpose of this study is to learn if three weeks of daily radiation treatment (rt) to the breast is safe in breast cancer patients who are usually prescribed 6 weeks of daily radiation after breast surgery (e.g. lumpectomy or mastectomy) as standard of care.

as the number of breast cancer (brca) survivors has markedly increased, clinicians are now seeking to reduce treatment-related toxicities and inconveniences of treatment, namely the traditional 6 weeks of daily radiation treatment (xrt). skin thickening, fibrosis, and edema are some of the most common acute and potentially long-term debilitating toxicities of brca xrt. the purpose of this study is to learn if three weeks of daily radiation treatment (rt) to the breast is safe in breast cancer patients who are usually prescribed 6 weeks of daily radiation after breast surgery (e.g. lumpectomy or mastectomy) as standard of care. investigators seek to assess the rate of cutaneous toxicity, the rates of lymphedema determined by arm measurements and grade 3 brachial plexopathy in patients receiving regional nodal irradiation, as well as local control, quality of life, and fatigue levels.

Eligibility criteria:
inclusion criteria: participants must have one or more of the following characteristics and be eligible for breast or chest wall with or without regional nodal radiotherapy: * prior chemotherapy for breast cancer * greater than 25 cm of breast separation (the largest distance on an axial slice of the planning ct simulation scan between the entry and exit points of the radiation beam on the body) * non-caucasian race * less than or equal to 50 years of age * requiring regional nodal irradiation without evidence of n3 disease exclusion criteria: * males will be excluded * women who are pregnant or nursing a child may not take part in this study

Keywords: psychiatry radiation therapy
investigating the effect of an information video for neck injuries in a emergency department setting

Conditions: Whiplash Syndrome

Summary: a randomized controlled trial (rct) to investigate the effect of a information video, consisting of a multiprofessional team, on patients with acute whiplash associated disorder (wad).

patients seeking medical care at södersjukhuset hospital, sweden, after a motor vehicle accident resulting in neck trauma are offered to be included in the study. inclusion criterias involve spine fractures, need for in house care, \<18\<65 years of age and low knowledge of the swedish language. a randomization is performed with two arms, one being "treatment as usual" i.e. an information folder with physiotherapeutic exercises, the other one being the information video. the patients are contacted per telephone and a questionnaire with baseline data is sent via e-mail within a week after the accident. they also receive a link to the websites with the information. the follow up time is 6 months and after that the patients receive a new questionnaire with questions regarding neck-specific status (wdq), health related quality of life (sf-12) and pain. the primary outcome is level of pain (nrs)

Eligibility criteria:
inclusion criteria: * knowledge of the swedish language * traffic injury with neck pain exclusion criteria: * fractures * in house care needed

Keywords: wad whiplash information video
assessing the ontogeny of p-glycoprotein expression in blood of pediatric leukemic patients

Conditions: Acute Lymphocytic Leukemia

Summary: determine p-glycoprotein expression in blood samples of acute lymphocytic leukemia (all) pediatric patients receiving mtx treatment and trace its ontogeny and compare it with its expression in pediatric healthy subjects. in addition, to determine the correlation of p-glycoprotein expression and methotrexate concentration at steady state.

the 20 leukemic patients will be classified into three age groups according to the ages that will be available at the time of sample collection. * all patients will be recruited from tanta oncology center, tanta university. * the study will be approved by the research ethics committee of tanta university and college of pharmacy ethical committee. * an informed consent will be obtained from parents of all patients in this research before enrollment. * all patients' data will be private and confidential. any unexpected risks that may appear during the course of the research will be reported to patients and the ethical committee on time. blood samples will be obtained from healthy pediatric subjects of the same ages of the diseased group subjects (samples will be obtained from subjects from a primary care center during their routine blood analysis excluding patients of chronic diseases, patients receiving any medications, and patients of impaired kidney or liver functions). p-glycoprotein expression will be estimated in all samples using permeability glycoprotein (p-gp), elisa kit, and its expression will be traced with development from the youngest till the oldest age available, this will also be compared with normal healthy pediatric subjects.

Eligibility criteria:
inclusion criteria: * pediatric acute lymphocytic leukemia patients * aged \< 18 years old * who are already taking the all mtx protocol. exclusion criteria: * severe renal impairment (egfr\< 30 ml/min/1.73 m2 at screening) * critically ill patients. * other types of cancer
head-neck coordination analysis after minimally invasive surgery in the dorsal cervical spine

Conditions: Multilevel Cervical Spinal Stenosis; Single Brachial Radiculopathy

Summary: to proof patients' benefit of minimally invasive surgery in the dorsal cervical spine an apparatus to examine head-neck-coordination was constructed. two different surgical techniques will be compared: laminoplasty: open approach vs minimally invasive surgery (mis)-approach; foraminotomy: open approach vs mis-approach. each patient will be tested before surgery, postoperative as well as 3 and 12 month follow-up. hypothesis is that patients after mis-approaches perform better in their head-neck-coordination as patients with open approaches.


Eligibility criteria:
inclusion criteria: * radicular or myelopathic compression syndrome in the cervical spine exclusion criteria: * neurological diseases with influence on the neuromuscular function * previous surgery on the cervical spine
avatrombopaq in patients with cirrhosis

Conditions: Thrombocytopenia; Drugs; Cirrhosis, Liver; Procedural Bleeding

Summary: thrombocytopenia is a frequent issue in patients with cirrhosis undergoing various types of procedures (e.g. liver biopsy, endoscopy and minor surgical interventions). thrombocytopenia \< 50\*10\^9/l increases the risk of perioperative and postoperative bleedning and might prevent patients with cirrhosis to undergo important procedures. doptelet is a small molecular trombopoetin agonist, which results in proliferation and differentiation of megakaryocytes in the bone marrow resulting in increased levels of thrombocytes. it is given orally as a pill and is used to increase platelet count in patients with severe thrombocytopenia (\< 50\*10\^9/l) and cirrhosis and thus not to normalize platelet count. this study investigates the safety and efficacy of doptelet in patients with cirrhosis and thrombocytopenia (\< 50\*10\^9/l) undergoing minor procedures like transjugular adjusted liver biopsy (tjalb) and gastroscopy.


Eligibility criteria:
inclusion criteria: * age: \>17 years and ≤80 years * asa i-iii * patients who read, understood and signed informed consent. * patients with a diagnosis of cirrhosis * thrombocytopenia \<50\*109 * the patient is scheduled for one of the following procedures: transjugular adjusted liver biopsy (tjalb), gastroscopy or percutan paracentesis of ascites in the following month. exclusion criteria: * patients who do not speak and understand danish. * patients who cannot cooperate within the trial. * patients who did not sign an informed consent regardless of the cause. * active drug abuse - to the discretion of the investigator. * thrombocytes \>50\*10\^9 * patients with hereditary trombolic diseases (e.g. factor v leiden, antithrombin deficiency, protein s and c deficiency, prothrombin g202110a mutation). * inr \> 1,7 * ongoing infection verified by blood culture, clinical examination, and acute phase reactants (e.g. crp)

Keywords: cirrhosis thrombocytopenia
casodex 150-mg compassionate use trial for subjects with prostate cancer

Conditions: Adenocarcinoma of the Prostate

Summary: this study provides compassionate use of bicalutamide (casodex) at a 150-mg dose for subjects with prostate cancer prior to it becoming commercially available. the patient will receive bicalutamide 150-mg as long as the physician feels that the subject is benefiting from this therapy and safety information is provided regularly to astrazeneca. treatment will be discontinued after bicalutamide 150-mg becomes commercially available.


Eligibility criteria:
inclusion criteria: * patients with adenocarcinoma of the prostate * subjects with locally advanced, and/or metastatic prostate cancer for whom surgical castration or other medical interventions are not considered appropriate or acceptable exclusion criteria: * any known history of abnormal liver function tests * any severe concomitant condition that would make it undesirable, in the clinician's opinion, for the subject to participate in the trial. * known hypersensitivity to bicalutamide or any of the components found in bicalutamide

Keywords: prostate cancer casodex
a non-interventional study of patients with persistent symptoms of schizophrenia to describe medical resource utilization and burden of illness

Conditions: Schizophrenia

Summary: this non-interventional, cross-sectional survey and retrospective review will evaluate the medical resource utilization and burden of illness in patients who have persistent symptoms of schizophrenia despite receiving adequately dosed antipsychotic treatment and who have not had an acute exacerbation in the 3 months prior to enrolment. medical records will be reviewed for a minimum of 3 months and up to 12 months prior to screening. data collection at a single visit will include rating scales and questionnaires that reflect the clinical status and the quality of life of the patients and the economic impact of schizophrenia.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * patients who have a clinical diagnosis of schizophrenia as documented in their medical records * patients who, in the opinion of the investigator, have had on-going, persistent symptoms of schizophrenia for at least the last 3 months prior to enrolment * patients who, in the opinion of the investigator, have been prescribed adequate doses of antipsychotic treatment for at least the last 3 months * patient has adequate spoken local language exclusion criteria: * acute exacerbation of schizophrenia within the last 3 months prior to enrolment * enrolment in an interventional study
transformed waldenström macroglobulineamia

Conditions: Transformed Waldenström Macroglobulineamia

Summary: histological transformation to diffuse large b-cell lymphoma is a rare complication which may occur in waldenstrom macroglobulinemia. in this multicenter study, we retrospectively analyzed the clinico-biological features, therapy, outcomes and prognostic factors in 77 waldenstrom macroglobulinemia patients with biopsy-proven transformation to diffuse large b-cell lymphoma.

histological transformation to diffuse large b-cell lymphoma is a rare complication which may occur in waldenstrom macroglobulinemia. in this multicenter study, we retrospectively analyzed the clinico-biological features, therapy, outcomes and prognostic factors in 77 waldenstrom macroglobulinemia (wm) patients with biopsy-proven transformation to diffuse large b-cell lymphoma (dlbcl). we retrospectively searched the databases of french and belgian centers for patients older than 18 years diagnosed with wm and a concurrent or sequential diagnosis of dlbcl between 1995 and 2016. nineteen centers belonging to the french innovative leukemia organization (filo) group participated in this study. patients with a diagnosis of indolent lymphoma other than wm were excluded. the diagnosis of wm was based on criteria established in the second international workshop on wm. clinical, biological data and prognostic scores were recorded. quantitative variables were expressed as median and range and qualitative variables as number and percentages. multivariate analyses using cox proportional hazard model were conducted to investigate the factors independently related to progression-free survival and overall survival.

Eligibility criteria:
inclusion criteria: * patients older than 18 years diagnosed with waldenstrom macroglobulineamia and a concurrent or sequential diagnosis of diffuse large b-cell lymphoma between 1995 and 2016 exclusion criteria: * patients with a diagnosis of indolent lymphoma other than waldenstrom macroglobulineamia
aripiprazole in children and adolescents with bipolar disorder and attention deficit hyperactivity disorder (adhd)

Conditions: Bipolar Disorder; Attention Deficit Hyperactivity Disorder

Summary: there is a scarcity of clinical trials assessing the effects of medications in children with bipolar disorder. this study aims to assess the efficacy of aripiprazole (a novel anti-psychotic drug) for the treatment of children and adolescents with bipolar disorder comorbid with adhd. the study design is a 8-week randomized, double blind, parallel group trial. patients were randomized to either aripiprazole or placebo. the main hypotheses are: 1. aripiprazole will significantly reduce maniac scores compared to placebo 2. aripiprazole will significantly reduce adhd scores compared to placebo

bipolar disorder (bd) is a chronic disorder that severely affects the normal development of children and adolescents. the disorder is associated with high rates of suicide tentative and high-risk behaviors like sexual promiscuity and drug abuse. bipolar disorder in children is also associated with high rates of comorbidity, especially with attention-deficit hyperactivity disorder (adhd). there is a scarcity of clinical trials assessing the effects of medications in children with bd. moreover, the frequent presence of comorbid adhd might determine lower response to treatment. aripiprazole is a novel anti-psychotic drug. its mechanism of action seems to be related to a stabilization of dopaminergic transmission, acting as a partial agonist especially in dopaminergic d2 receptors. it also has effects in 5-ht1a serotonergic receptors. thus, it might have a promising effect in children and adolescents with comorbid bd and adhd. a retrospective chart review, recently published, suggests the efficacy of this drug in children with bd. this study aims to assess the efficacy of aripiprazole (a novel anti-psychotic drug) for the treatment of 50 children and adolescents (age range: 08 to 17 years-old) with bipolar disorder comorbid with adhd. the study design is an 6-week randomized, double blind, parallel group trial. patients were randomized to either aripiprazole or placebo. the hypotheses are: 1) aripiprazole will significantly reduce maniac scores compared to placebo; 2)aripiprazole will significantly reduce adhd scores compared to placebo; 3) aripiprazole will not be significantly associated to weight gain compared to placebo.

Eligibility criteria:
inclusion criteria: * age: 8-17 * bd type i or ii comorbid with adhd * baseline score in the ymrs \> or = 20 exclusion criteria: * iq \< 70 * pharmacologic treatment in the last month * pregnancy or absence of a contraceptive method in fertile girls * diagnoses: pervasive development disorder, schizophrenia, drug abuse or dependency * risk of suicide or homicide * clinical condition that might interfere in the study * known sensibility to aripiprazole

Keywords: clinical trial aripiprazole bipolar disorder attention-deficit hyperactivity disorder adhd
determinants of cardiac risk factor modification in latinos with coronary artery disease

Conditions: Coronary Artery Disease

Summary: this is an observational study among latino patients who have coronary artery disease. the goal of the study is to determine the association between having depressive symptoms and the ability to modify one's health behavior. specifically, participate in physical activity.

specific aims: among 213 latino adult patients who have had coronary artery angioplasty within the past month, the specific aims of the proposed study are: 1. to determine whether patients who have more depressive symptoms at the time of angioplasty are less likely to be active in physical activity at two years. physical activity will be measured by a survey that asks patients to describe their activities including leisure activities or housework. 2. to determine whether lower perceived social support, lower self-efficacy for engaging in physical activity, and greater perceived stress mediate the effects of depressive symptoms on participation in physical activity. long-term objectives: the long-term objective of this study is to use these data to develop a culturally tailored intervention to increase participation in physical activity and ultimately improve the overall health and well being of latino adults with coronary artery disease. outcome: the outcome is being in the action or maintenance stage of physical activity two years after angioplasty the stage of physical activity participation will be based on the stages of change model. this model describes behavior change as a continuum from pre-contemplation to contemplation.

Eligibility criteria:
inclusion criteria * patients must identify their ethnicity as latino or hispanic * patients must be able to complete a questionnaire in either english or spanish. * patients must have angiographic evidence of coronary artery disease requiring angioplasty * patients must also be clinically stable for an interview * patient must be able to provide informed consent. exclusion criteria * patients who are not clinically stable such as those who had cardiac arrest, who are intubated, who have active psychosis, or who are cognitively impaired. * patients who are unable to provide consent.

Keywords: coronary artery disease depressive symptoms latino american