Kornimate/medical-research-clean huggingface dataset:
catechol thioethers in parkinson's disease

Conditions: Parkinson's Disease

Summary: the goal of the clinical trial aim in this project is to test whether catechol thioethers can be used as biomarkers of dopaminergic neurodegeneration.


Eligibility criteria:
first diagnosis of parkinson's disease.

Keywords: catechol thioethers parkinson's disease neurodegenerative disease
obstructive sleep apnoea in patients with intermittent claudication

Conditions: Sleep Apnea

Summary: the main aim of this study is to determine how common undiagnosed obstructive sleep apnoea is in individuals with intermittent claudication.

in patients with peripheral artery disease (pad), exercise induced limb ischemia (claudication) which limits walking capacity. symptoms are due to pain at hip and/or buttock. couple of origins may induce this pain such as vascular, cardiac, respiratory, musculoskeletal, neurologic, hematologic etc. the rate of associated respiratory pathology to patients with lower extremity artery disease (lead) is around 15%. the intolerance to walk could be link to an exercise hypoxia which appears with lower limb pain with or without associated dyspnea. the exercise hypoxemia becomes a diagnostic for an intermittent vascular claudication. tests which are performed to diagnose an intermittent claudication are the ankle to brachial systolic pressure index (abi), the echo-doppler of lower limb arteries and the walking test on a treadmill associated to a measurement of the distal and chest transcutaneous oxygen pressure (tcpo2). thus, the purpose of the present research is to determine the prevalence of obstructive sleep apnoea in patient with pad.

Eligibility criteria:
inclusion criteria: * register to the social health insurance * referred for a walk test because of claudication * maximal walking ditance \< 750m * older than 18 years old * able to understand the protocol of the study exclusion criteria: * cardiac insufficiency already known, stage iii or iv i.e. dyspnea at rest unstable angina or myocardial infarction within the previous three months inclusion * severe reparatory disease already known * parkinson disease, hémiplégia ou paraplégia * does not want to participate to the protocol * pregnant women * adults to enhanced protection, deprived of their liberty by judicial or administrative authority, without consent hospitalized or admitted to a health facility or social purposes other than research * being in a period of exclusion from another biomedical study

Keywords: obstructive sleep apnoea intermittent claudication respiratory disease peripheral artery disease
observational study to evaluate the safety and efficacy for levacalm tab. versus valsartan/amlodipine combination therapy in essential hypertension patients

Conditions: Lower Leg Edema; Orthostatic Hypertension

Summary: levacalm tab. was approved in jul 2013 by mfds in south korea. levacalm tab. is combination drug of valsartan as an angiotensin ii receptor blocker and lercanidipine as a calcium channel blocker. it is a new drug of combination of valsartan and lercanidipine. thus, there's no enough safety data and efficacy data defined from the clinical study. also, many combination drugs of valsartaa and amlodipine are widely used in the market. lgls will compare the safety(adverse events especially the lower leg edema) and efficacy (blood pressure and pulse) of levacalm and valsartan/amlodipine combination drug from this study.


Eligibility criteria:
inclusion criteria: * patients aged over 19 with essential hypertension * those who meet the inclusion criteria, fall under any of the following 3 cases and determined by the investigator to be prescribed levacalm or valsartan/amlodipine combination: 1. those who can't maintain the blood pressure with the antihypertensive drug before. 2. those who diagnosed to a hypertension stage 2.(dbp is higher than 160mmhg or sbp is higher than 100mmhg) 3. those who fall under the following :cardiovascular disease, cerebrovascular disease, chronic renal disease, diabetes mellitus, peripheral vascular disease * those who were informed of the purpose, method, and effect etc. of this study and signed the informed consent form. exclusion criteria: 1. those who are included in the contraindication of study drug following the information for use of the product 2. those who is/will be participated in other drug clinical trial 3. those who adminitrated other antihypertensive drugs beside the levacalm or valsartan/amlodipine combination drug. 4. those who judged by the invesigator as ineligible for this clinical study

Keywords: safety data hypertension therapy
the long-term safety study of idursulfase-beta in hunter syndrome(mucopolysaccharidosis ii) patients

Conditions: Hunter Syndrome

Summary: the objective of this study is to evaluate the long term safety and efficacy of once weekly dosing of idurasulfase-beta 0.5mg/kg administered in hunter syndrome(mucopolysaccharidosis ii) patients


Eligibility criteria:
inclusion criteria: * patients who have a diagnosis of hunter syndrome(mucopolysaccharidosis ii). * patients who are administered idurasulfase-beta or willing to be administered idurasulfase-beta. * patient's parent(s), or patient's legal guardian must have given voluntary written consent to participate in the study. exclusion criteria: * patients who have participated in any other blind clinical trials. * patient who cannot be tracked about safety. * patients who are judged disqualified to participate clinical trials by investigator for other causes.

Keywords: hunter syndrome mucopolysaccharidosis ii hunterase
comparison of the effectiveness of reformer pilates and conventional physiotherapy in lumbar disc herniation

Conditions: Disc Herniation

Summary: this study aims to examine the effects of reformer pilates on patient-reported outcomes such as pain level, fatigue, sleep quality, anxiety, kinesiophobia, and quality of life in individuals with lumbar disc herniation (ldh) and to compare its effectiveness with conventional physiotherapy protocols.

all participants underwent a rehabilitation program for six weeks. pre- and post-treatment assessments were conducted, and the results of the groups were compared. the reformer pilates group participated in a 12-session pilates exercise program, performed twice a week for 45-50 minutes per session, while the conventional physiotherapy group underwent a 30-session conventional physiotherapy program, performed five days a week for 45-50 minutes per session. assessment tools included the mcgill-melzack pain questionnaire, fatigue severity scale, pittsburgh sleep quality index, beck anxiety inventory, tampa scale of kinesiophobia, and sf-36 quality of life scale. measurements were taken twice: before and after treatment. in post-treatment group comparisons, a significant difference was found in pain levels in the reformer pilates group and fatigue levels in the conventional physiotherapy group. within-group analyses showed significant improvements in pain, fatigue, kinesiophobia, and physical function subdomains in the reformer pilates group, while the conventional physiotherapy group showed significant improvements in fatigue, anxiety, and kinesiophobia scores. in conclusion, reformer pilates was found to be an effective method for pain management, whereas conventional physiotherapy provided more notable benefits for fatigue management. both methods were effective in managing kinesiophobia and fatigue, highlighting the importance of tailoring treatment plans to meet the individual needs of patients.

Eligibility criteria:
inclusion criteria: * aged between 21 and 50 years * complaints of low back pain for at least three months * diagnosed with lumbar disc herniation * no spinal surgery in the last six months * regular participation in the program * ability to communicate * exclusion criteria: * presence of systemic diseases affecting pain, such as fibromyalgia * presence of neurological or orthopedic disorders * receiving physical therapy in the past eight weeks * presence of spinal stenosis, spondylolysis, spondylolisthesis, or other lumbar -degenerative diseases * pregnancy status

Keywords: reformer pilates conventional physiotherapy lumbar disc herniation pain management fatigue
psychotherapy outcome and self-selection effects in panic disorder

Conditions: Panic Disorder (With or Without Agoraphobia)

Summary: the efficacy of two forms of psychotherapy with panic disordered patients, a cognitive-behavioral and a psychodynamic one, are compared under two different, randomized conditions: randomization or self-selection. the basic hypotheses are that the efficacy of both treatments is higher and that the efficacy difference is smaller under self-selection than randomized conditions.

after thorough assessment persons with a panic disorder diagnosis are randomly assigned to three arms: one randomization, one self-selection, and one a low-contact waiting list one. in the randomization arm (r) 95 persons are randomly assigned to panic control treatment (pct) or panic-focused psychodynamic psychotherapy (pfpp); in the self-selection arm (ss) 95 persons are offered, after adequate information, to choose which of the two they prefer. twenty-six persons are initially randomized to a three-month waiting list (with sparse contact over telephone), after which they will be re-randomized, either to further randomization (to pct or pfpp) or to self-selection. the four groups (r/pct; r/pfpp; ss/pct; ss/pfpp) will be compared on the basis of intake and repeated outcome/follow-up assessment.

Eligibility criteria:
inclusion criteria: * a diagnostic and statistical manual (dsm-v) diagnosis of panic disorder, with or without agoraphobia * age between 18 and 60 * willingness to stop other on-going psychotherapy treatments and to refrain from nonstudy treatments during follow up * ability to complete the active treatment phase (not including follow-ups) within 16 weeks exclusion criteria: * active substance dependence (6 months remission necessary) * current psychosis, delusions, mania, or active addiction * acute suicidality * a history and clinical presentation of at least one clinically-significant medical condition if, due to their cognitive or physical impairments, they are unable to fully participate in the psychotherapy treatments being offered * active involvement in a legal dispute related to their mental health issues * three or more unexcused absences
an international, multicenter, prospective registry on post-traumatic long bones defects

Conditions: Limb Fracture; Bone Loss

Summary: long bone defect (lbd) is defined as a focalized loss of bone tissue in any long bone of the upper or lower extremity. long bone defects are a complex problem, that may arise as a complication of many different pathologies, such as trauma, tumors or infection. whereas post-traumatic defects are the largest group. reports estimate that there are almost 4 million bone grafting procedures worldwide per year. however, limb reconstruction in the context of a bony defect is challenging and up to date there is little evidence and treatment recommendations. in a multi-national approach, the aim of this project is to set up an international, multicenter registry to gather information and details on prevalence or incidence, current treatments, complications and outcome.

the purpose of this project is to set up an international, multicenter registry of patient presenting with defects in long bones. up to date, treatment remains challenging with little evidenced-based recommendations. for this purpose, any patient who presents at a study center with a bone defect of the defined expansion of any long bone is eligible for inclusion. over a 3-year period as many patients as possible are included from the participating sites, at least 600 patients should be included in the registry. details on any surgical intervention that is used to treat a bone defect will be recorded. further patient-related and other pre-defined outcome measures will be collected. there is no formal hypothesis to this registry, hence it will help to identify prevalence and underlying etiologies, evaluate treatment strategies, and highlight possible challenges and complications - and will so help to gather clinical evidence to provide better treatment for patients suffering from a long bone defect.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * skeletally mature * post traumatic bone defect \> 2 cm either * initially after injury or * after surgical debridement * informed consent obtained, i.e.: * ability to understand the content of the patient information/icf * willingness and ability to participate in the clinical investigation according to the registry plan * signed and dated ec/irb approved written informed consent or * written consent provided according to the irb/ec defined and approved procedures for patients who are not able to provide independent written informed consent exclusion criteria: * any oblique defect that has less than 8cm expansion when adding the defect size of all four cortices * any not medically managed severe systemic disease * pregnancy * prisoners * participation in any other medical device or medicinal product registry within the previous 3 months that could influence the results of the present registry

Keywords: long bone defect
intracapsular tonsillectomy in the treatment of obstructive sleep apnea in adults

Conditions: Tonsillar Hypertrophy; Sleep Apnea, Obstructive

Summary: treating sleep apnea in adults caused by tonsillar hypertrophy with intracapsular tonsillectomy by coblation

the investigators aim to study if good surgical results can be achieved by intracapsular tonsillectomy with coblation while monitoring safety, efficiency and cost-effectiveness. in adult tonsil surgery, the current practice in finland is commonly extracapsular tonsillectomy with monopolar electrosurgery.

Eligibility criteria:
inclusion criteria: * age 16-64 * planned tonsil surgery with informed concent * obstructive sleep apnea (ahi \> 15) * tonsillar size of 3-4 on the friedman scale exclusion criteria: * bmi \> 35 (based on finnish käypä hoito -recommendations) * central sleep apnea * weight loss of more than 10% within the study period * untreated obstruction of nasal breathing * treated peritonsillar abscess \<1 month before enrollment * active tonsillar infection * previous tonsillar surgery (excluding incision of abscess) * malignancy * high use of analgesics \>1 ddd daily during last 4 weeks * untreated reflux * anticoagulative medication * any condition of hemophilia * pregnancy, lactation * other, evaluated by treating physician

Keywords: tonsil surgery tonsillectomy obstructive sleep apnea coblation intracapsular
a study of abatacept in participants that only recently started to develop rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is a long-term study of abatacept in participants that only recently started to develop rheumatoid arthritis, a chronic inflammatory disorder affecting mainly joints.


Eligibility criteria:
inclusion criteria: * participants recently (within the last 24 months before enrollment) diagnosed with established moderate to severe active ra * participants naïve of abatacept and who, at their physician's discretion, are initiated with abatacept according the german label/smpc (summary of product characteristics) exclusion criteria: * participants who are currently included in any interventional clinical trial in ra other protocol defined inclusion/exclusion criteria could apply
a trial to reduce hepatitis c among injection drug users - 1

Conditions: HCV Negative Status; HCV Risk Behavior

Summary: the purpose of this study is to examine the efficacy of a brief motivational intervention on the cumulative incidence of hepatitis c.

injection drug users are at high risk for blood-borne viral infections during their first years of injecting when they are least likely to seek formal substance abuse treatment, and are likely to be practicing risky drug-use behaviors. research has demonstrated that a brief motivational intervention that includes booster sessions and addresses drug and sex risks is effective in reducing hiv risk behaviors among injection drug users. because hepatitis c virus is a bloodborne pathogen like hiv, and transmission occurs via similar behaviors, successful hiv prevention strategies should be robust in preventing hcv but need to be tested. motivational interventions, which aim to elicit a goal and plan from the patient to reduce injection and sexual risk taking, are particularly suited to address behaviorally-based changes. motivational interventions are individualized and tailored to the risks and concerns of the participant, but can be standardized and evaluated to make this technique applicable in a variety of settings. the occurrence of injection drug use in a population with traditionally poor linkage to primary care, an enormous burden of illness, and high hcv and other blood-borne pathogen transmission risk, supports the use of motivational interventions in this group. comparison(s): participants are assigned, in this 24 month longitudinal study, to an assessment-only condition or an assessment plus motivational intervention condition. participants in the intervention condition receive up to 4 sessions of motivational interviewing during the first 6 months of the study.

Eligibility criteria:
inclusion criteria: * current opiate or cocaine use * hcv seronegative * able to complete the study procedures in english exclusion criteria: * current enrollment in a formal substance abuse treatment program

Keywords: hepatitis c injection drug use
effective treatments for thoracic aortic aneurysms (ettaa study): a prospective cohort study

Conditions: Thoracic Aortic Aneurysm

Summary: this is a prospective observational cohort study that will collect data from the point of referral through to secondary care, aiming for 3 years median follow-up (range 1-5 years). the data collected will allow estimation of the success of any intervention (in terms of reducing rate of aneurysm growth, rupture or dissection) as well as estimation of the risks associated with the three procedures. clinical outcomes in the three treatment groups will be described. aims we aim to answer the following questions: 1. without procedural intervention for chronic thoracic aortic aneurysm (ctaa), what is the risk of aneurysm growth, dissection, rupture, permanent neurological injury or death? what is the effect on quality of life (qol)? 2. if a patient has endovascular stent grafting (esg) or open surgical repair (osr), what is the risk of growth, dissection, rupture, permanent neurological injury or death? 3. how does qol change from pre- to post intervention? 4. can aneurysm or patient related predictors of good/poor treatment outcomes be determined? 5. what is the most cost-effective strategy in: 1. patients eligible for either esg or osr? 2. patients eligible for either esg or best medical therapy (bmt)? 3. patients eligible for either watchful waiting (ww) or intervention (esg/ osr)? 6. what further research is required? what would be the most important research to pursue?


Eligibility criteria:
inclusion criteria: * thoracic aortic aneurysm \> 4cm * age ≥18 years * able to give informed consent exclusion criteria: * intervention required below the level of the coeliac axis * acute dissection or malperfusion syndromes (such as myocardial infarction,acute stroke or limb ischaemia)
inspired oxygen on oxidative stress and breath volatile organic compound composition in healthy volunteers

Conditions: Oxidative Stress

Summary: high inspiratory oxygen fractions are known to induce oxidative stress and lipid peroxidation. the degrading products of oxidative stress induced lipid peroxidation are in part volatile and appear in breath where they can be measured non-invasively. however, there is lack of knowledge on the correlation of blood and breath biomarkers of oxidative stress. this study aims to investigate the effects of a high inspiratory oxygen fraction on oxidative stress in healthy volunteers. the primary outcome is the appearance of exhaled breath biomarkers of oxidative stress by electrochemical sensors and ion mobility mass spectrometry. secondary outcomes are changes in oxidative stress biomarkers in blood and their relationship to breath biomarkers.


Eligibility criteria:
inclusion criteria: * healthy male volunteers who have given an oral and written informed consent exclusion criteria: * smoker or ex-smoker * any pulmonary disease * any heart disease * any chemotherapy in the past * any kind of daily medication
a study of the malt1 inhibitor jnj-67856633 and ibrutinib in combination in b-cell nhl and cll

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin

Summary: the purpose of this study is to determine the safety and recommended phase 2 dose (rp2d) of jnj-67856633 and ibrutinib in combination in participants with b cell non-hodgkin lymphoma (nhl) and chronic lymphocytic leukemia (cll).

non-hodgkin lymphoma (nhl) represents the most frequent hematologic malignancy in the world and represents a diverse set of diseases. jnj-67856633-zaf (referred as jnj-67856633) is an orally bioavailable, potent, and selective first-in-class mucosa-associated lymphoid tissue lymphoma translocation protein-1 (malt1) inhibitor. jnj-67856633 binds to an allosteric site on malt1 with a mixed-type mechanism. ibrutinib is a first-in-class, orally administered, potent, orally administered covalently binding small-molecule inhibitor of bruton's tyrosine kinase (btk), as well as interleukin-2-inducible kinase (itk), a tyrosine protein (tec) kinase family member present in t cells. the doses will be escalated in the study and one or more recommended phase 2 dose (rp2ds) of jnj-67856633 will be determined. the study is divided into 3 periods: a screening phase, a treatment phase, and a post-treatment follow-up phase. efficacy assessments will include radiographic image assessments, positron emission tomography scan, bone marrow assessment, endoscopy etc. safety assessment like physical examination, vital signs, electrocardiogram (ecg), eastern cooperative oncology group (ecog) performance status, and adverse events monitoring will be performed during the study. total duration of the study will be up to 2 years and 9 months.

Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status grade of 0 or 1 * cardiac parameters within the specified range * women of childbearing potential must agree to all of the following during the study and for 3 months after the last dose of study drug: a) use a barrier method of contraception; b) use a highly effective contraceptive methods; c) not to donate eggs (ova, oocytes) or freeze them for future use for the purposes of assisted reproduction during the study; d) not to plan to become pregnant; e) not to breast-feed * willing and able to adhere to the lifestyle restrictions specified in this protocol * participants must have tumor tissue availability * adequate organ functions exclusion criteria: * known (active) central nervous system (cns) involvement * prior treatment with jnj-67856633 or another malt1 inhibitor that is associated with disease progression or intolerable toxicities