Kornimate/medical-research-clean huggingface dataset:
relative bioavailability of intravenous gtx-104 compared to oral nimodipine capsules in healthy subjects

Conditions: Aneurysmal Subarachnoid Hemorrhage

Summary: this is a phase 1, single center, randomized, two-period crossover study in healthy male and female subjects designed to evaluate the relative bioavailability (ba) and safety at steady state of two formulations of nimodipine: gtx 104 (nimodipine for intravenous \[iv\] infusion; test formulation) and nimodipine oral capsules, rs (reference formulation).


Eligibility criteria:
inclusion criteria: * subject had a body mass index between 18 and 32 kg/m2, inclusive. * subject was in good general physical health as determined by absence of clinically significant (cs) medical or psychiatric history, physical examination findings, vital signs, clinical laboratory evaluations, and 12-lead ecg measurements. exclusion criteria: * history or presence of clinically significant medical illness, including, but not limited to, cardiovascular, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, psychiatric, renal, hepatic, chronic respiratory, or gastrointestinal disease, that could have interfered with the interpretation of the study. * had current or recent (within 6 months) history of gastrointestinal disease or any surgical or medical condition (eg, crohn's or liver disease) that could potentially alter the absorption, metabolism, or excretion of the study drug.
somatuline® depot (lanreotide) for acromegaly post-marketing observational study

Conditions: Acromegaly

Summary: to assess the safety and effectiveness of somatuline® depot (lanreotide) injection when administered by a health care professional (hcp), the patient, the patient's partner or parent/guardian as part of their routine acromegaly care.

the objectives of this post-marketing observational study are to assess the safety and effectiveness, as measured by insulin-like growth factor-1 (igf-1) and growth hormone (gh) levels, of somatuline® depot (lanreotide) injection when administered by a health care professional (hcp), the patient, the patient's partner or parent/guardian as part of their routine acromegaly care. treatment convenience and acromegaly symptom relief will also be assessed through questionnaires, and demographic and medical history information will be collected.

Eligibility criteria:
inclusion criteria: * the patient must have a clinical diagnosis of acromegaly * the patient must be treated with somatuline® depot (including patients newly prescribed somatuline® depot) * the patient or legally authorized representative must be able to understand the protocol and give signed informed consent. assent from the patient should also be obtained, where appropriate. signed informed consent and assent must be obtained before any study-related activities are conducted. exclusion criteria: * symptomatic, untreated biliary lithiasis * known hypersensitivity to somatostatin analogs or related compounds (e.g., octreotide)

Keywords: acromegaly
a p300 brain computer interface to operate power wheelchair tilt

Conditions: Healthy; Amyotrophic Lateral Sclerosis

Summary: the investigators want to develop a brain-computer interface (bci) that will eventually allow people who are completely paralyzed to independently control the tilt feature on their power wheelchairs. this study will allow healthy volunteers to test the feasibility and accuracy of controlling a bci using only their brain signals while seated in a tilting wheelchair.


Eligibility criteria:
inclusion criteria: * age 18 or older. * able to read text on a computer screen * able to understand and remember instructions concerning participation. exclusion criteria: * unable give informed consent. * unable to understand and follow instructions. * have abnormal tone or uncontrolled movements in the head-and-neck that would interfere with eeg recordings. * known to have photosensitive epilepsy. * open head lesions or sores.

Keywords: brain computer interface wheelchair control
follow-up study of gsk biologicals' human papilloma virus (hpv) vaccine to prevent cervical infection in young adults

Conditions: Infections, Papillomavirus

Summary: human papilloma virus (hpv) are viruses that cause a common infection of the skin and genitals in men and women. several types of hpv infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). this infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. if a woman is not infected by hpv, it is very unlikely that she will get cervical cancer. this is an observer blind follow up study of the study hpv-001, which evaluated the ability of the hpv vaccine to prevent hpv infection. the current study invites all of the 1113 subjects in the hpv-001 study that received all three doses of vaccine/placebo to be enrolled and followed-up for several additional years to see if the hpv vaccine prevents hpv-16 and hpv-18 infections and to evaluate the safety of the vaccine. subjects will remain in the same study group as in the primary study. no vaccine or placebo will be administered in this study. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.


Eligibility criteria:
inclusion criteria: * participated in study 580299/001 and received all three doses of vaccine/placebo. * written informed consent obtained from the subject prior to enrollment exclusion criteria: * decoding of the subject's treatment allocation to either the subject or the investigator in study 580299/001.

Keywords: hpv vaccine efficacy prophylaxis hpv 16/18 infections
prevalence of overweight and obesity in adult patients suffering from type 1 diabetes

Conditions: Type 1 Diabetes; Obesity

Summary: a registry of individuals with type 1 diabetes that visited the department of endocrinology of the university hospitals of leuven is established. the objective of this registry is to phenotype patients with type 1 diabetes and obesity and their response to treatment with regard to their outcomes

a registry/database is constructed with data of the individuals with type 1 diabetes that visited the department of endocrinology of the university hospitals of leuven. data will be obtained from all visits in terms of sociodemographics, disease origin and disease impact including but not limited to glycemic control, medical history, comorbidities, complications, clinical parameters, anthropometric parameters, biochemical blood values, medical therapy, lifestyle, ...

Eligibility criteria:
inclusion criteria: * signed informed consent * type 1 diabetes
medtronic revelution trial

Conditions: Coronary Artery Disease

Summary: the purpose of this trial is to evaluate the clinical safety and efficacy of the polymer-free drug-eluting coronary stent system for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (rvd) that allows use of stents between 2.25 and 3.50 mm in diameter.


Eligibility criteria:
inclusion criteria: * must be an acceptable candidate for percutaneous coronary intervention, stenting, \& emergent coronary artery bypass graft (cabg) surgery * must have evidence of ischemic heart disease * must require treatment of either a) a single target lesion amenable to treatment with a 2.25 mm - 3.50 mm stent or b) two target lesions located in separate target vessels, with at least one of the target lesions amenable to treatment with a 2.25 mm - 3.50 mm mm study stent * target lesion(s) must be de novo lesion(s) in native coronary artery(ies) exclusion criteria: * known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. biolinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated * history of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative * history of a stroke or transient ischemic attack (tia) within the prior 6 months * active peptic ulcer or upper gastrointestinal (gi) bleeding within the prior 6 months * history of bleeding diathesis or coagulopathy or will refuse blood transfusions * concurrent medical condition with a life expectancy of less than 5 years * currently participating in an investigational drug or another device trial that has not completed the primary endpoint * documented left ventricular ejection fraction (lvef) \< 30% at the most recent evaluation
efficacy and safety of rhtpo in combination with cyclosporine versus cyclosporine alone in the treatment of td-nsaa

Conditions: Aplastic Anemia; Transfusion-dependent Anemia

Summary: investigating the efficacy and safety of rhtpo in combination with cyclosporine versus cyclosporine alone for the treatment of td-nsaa

investigating the efficacy and safety of rhtpo in combination with cyclosporine versus cyclosporine alone for the treatment of transfusion-dependent aplastic anaemia of the non-severe type

Eligibility criteria:
inclusion criteria: 1. aged ≥ 18 years, male and female; 2. patients with a clear diagnosis of nsaa who are dependent on transfusion therapy: 1. meet the camitta nsaa criteria; 2. accompanied by at least one of the following abnormalities: (1) dependence on component blood transfusion therapy, at least one component blood transfusion every 8 weeks on average, and the duration of transfusion dependence ≥ 4 months, the indication of component blood transfusion: hgb ≤ 60g / l; (2) plt ≤ 10 × 10 \^ 9 / l, or plt ≤ 30 × 10 \^ 9 / l with a significant tendency to bleed; (3) neutrophils ≤ 0.5 × 10 \^ 9 / l. 3. excluding other haematological and non-haematological diseases that cause pancytopenia; 3. ecog ps score 0-2, expected survival ≥ 3 months with follow-up; 4. functional levels of major organs must meet the following requirements: 1) total bilirubin (tbil) ≤ 1.5 times the upper limit of normal (uln); 2) alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 2.5 x uln; 3) blood creatinine (cr) ≤ 1.5 x uln; 5. has not been treated with platelet receptor agonist (tpo-ra) analogues and other immunosuppressant analogues; 6. the subject is not suitable or willing to receive haematopoietic stem cell transplantation therapy; 7. no history of serious heart, lung, liver, kidney and other important organs and endocrine system diseases; 8. voluntarily enroll in the study, sign the informed consent, have good compliance and willing to cooperate with the follow-up. exclusion criteria: 1. have used other clinical investigational drugs within 4 weeks; 2. a history of primary myelodysplastic syndromes (mds), primary paroxysmal sleep haemoglobinuria (pnh) and leukaemia, as well as congenital bone marrow failure syndromes (ibmfs), such as fanconi's anaemia (fa) and congenital dyskeratosis (dc) 3. history of cirrhosis or history of portal hypertension; 4. congestive heart failure, arrhythmia, peripheral arteriovenous thrombosis requiring medication within 1 year prior to enrolment, or myocardial infarction or cerebral infarction within 3 months prior to enrolment; 5. hiv infection; 6. severe autoimmune disease or immunodeficiency disease; 7. suffering from malignant tumour 8. severe mental disorders; 9. a known history of allergy to the drug components of this regimen; 10. in the opinion of the investigator, it is not appropriate to participate in this trial, e.g., any other medical, social or psychological factors that may affect safety or compliance with the study procedures. compliance with study procedures.
assessing the suitability of an imaging probe for use in clinical cell and gene therapy trials in cancer and rheumatoid arthritis

Conditions: Brain Cancer; Arthritis, Rheumatoid; Central Nervous System Neoplasms; Glioma

Summary: the purpose of this study is to determine whether \[18f\]fhbg is suitable for use as an imaging probe in cancer or rheumatoid arthritis patients enrolled in cell or gene therapy trials. in this phase 1 study we will assess the safety and biodistribution of \[18f\]fhbg in patients.

the success of cell and gene therapy depends on specific targeting of the therapeutic gene or cell that is administered to the patient. our goal is to develop an imaging method to non-invasively monitor the location of the therapeutic gene or cell. imaging should help in the design of better protocols and potentially reduce side-effects of cell and gene therapy.

Eligibility criteria:
inclusion criteria: - clinical diagnosis of brain tumor or rheumatoid arthritis exclusion criteria: - below 18 years of age
a multi-center study to evaluate acute safety and clinical performance of paladin® carotid post-dilation balloon system with integrated embolic protection

Conditions: Carotid Artery Stenoses

Summary: the purpose of this study is to assess the safety and clinical performance of paladin system in patients with carotid artery stenosis.


Eligibility criteria:
inclusion criteria: * documented stenotic atherosclerotic lesion located at carotid bifurcation and / or proximal internal carotid artery (ica) * subject is either (a) symptomatic within 6 months of procedure, with an ipsilateral carotid stenosis ≥ 50% by angiography, or (b) asymptomatic with carotid stenosis ≥ 70% by angiography * target lesion can be covered by a single stent of no more than 40 mm in length * target lesion reference vessel diameter (rvd) is 4.0 mm - 7.0mm * sufficient landing zone required for successful deployment of integrated embolic protection filter * willing to comply with all follow-up required study visits * provision of written informed consent before index procedure exclusion criteria: * life expectancy of less than one year * an evolving, acute or recent stroke within 14 days of study evaluation * acute myocardial infarction within 72 hours before procedure * known sensitivity to contrast media that cannot be adequately controlled with pre-medication * subject has a total occlusion of target carotid artery * subject has a previously place stent in ipsilateral carotid artery * severe circumferential lesion calcification that may restrict full deployment of carotid stent * presence of filling defect or thrombus in target vessel * presence of "string sign" of target vessel * carotid (intracranial) stenosis located distal to target lesion * greater than 50% stenosis of common carotid artery proximal to target lesion. * known mobile plaque in aortic arch

Keywords: embolic protection carotid artery stenting
encapsulated juice powder concentrate for preventing common cold symptoms

Conditions: Common Cold

Summary: the primary objective of this study is to determine the effect of an encapsulated juice powder concentrate on the number of days with at least moderate common cold symptoms over winter time.

common cold is the most frequent acute illness in industrialised societies. though it is usually benign, it is a leading cause of absence from work and doctor visits, causing an enormous economic burden including lost productivity and treatment costs. common cold is caused by a variety of viruses, with rhinoviruses and corona viruses as the most common. there is currently no treatment for common cold, thus therapy is focussed on symptom relief only. prevention strategies for common cold include lifestyle measures such as avoiding infected people and regular hand washing during cold season. dietary supplements including herbs and vitamins have been suggested as preventive strategies for common cold. juice plus+® is a dietary supplement composed primarily of juice powder concentrate and pulp from fruits and vegetables. it contains several antioxidants including vitamin c, vitamin e, beta-carotene and folate. one randomized study reported reduction in work days lost to illness in the juice plus+® group compared to the placebo group. however, the clinical benefit for preventing common cold symptoms has not yet been tested in a large adult population.

Eligibility criteria:
inclusion criteria: * female or male, 18-65 years of age. * able and willing to take the active or placebo capsules over the whole study period. * health care professionals with essential patient contact (physicians, nurses, physiotherapists, etc) in berlin, germany. * written informed consent. exclusion criteria: * known or suspected hypersensitivity or allergy to one of the ingredients of juice plus+®. * refusal to stop intake of additional vitamin supplements during study. * pregnancy or lactation. * alcohol addiction, drug abuse or any other condition considered by the investigator to interfere with study procedures. * language limitations regarding interviews and questionnaires.

Keywords: common cold prevention dietary supplement
psychotherapy and cardiovascular risk factors in depression

Conditions: Depression

Summary: prospective studies indicate that patients with depression are at increased risk for cardiovascular disease. depression is also associated with a number of hemodynamic features, which are known risk factors for cardiovascular morbidity such as increased heart rate, reduced heart rate variability and blood pressure alterations. these hemodynamic alterations may explain in part the increased cardiovascular risk associated with depression. the purpose of this study is to determine whether treatment for depression with cognitive behavior therapy (cbt) is effective in reducing hemodynamic cardiovascular risk factors. hemodynamic assessments including heart rate, heart rate variability, continues blood pressure, blood pressure variability, baroreceptor sensitivity and peripheral vascular resistance will be conducted at baseline, after treatment and 2-month follow up. in addition, circadian hemodynamic variations such as 24-hour heart rate variability, nocturnal blood pressure dipping and immunological biomarkers will be assessed. eighty patients with major depression will be randomly assigned to either a cbt treatment condition (14 hour-long, weekly sessions) or a waitlist condition, to control for potential changes in hemodynamic parameters without any intervention and the impact of repeated-measurement.


Eligibility criteria:
inclusion criteria: * patients with major depression (dsm iv), bdi \>=14 * age:18-65 years * patients without antidepressive medication (stable for at least 2 weeks) * comorbidity with other psychiatric disorders is permitted, as far as depressive symptoms are dominating exclusion criteria: * current psychotherapy * psychotic disorder * serious drug-addiction * drugs which seriously affect immune status (except contraceptives) or central * nervous system functions (except antidepressants) * infections during the last 2 weeks * injuries during the last 2 weeks * neurological disorders * diseases which affect immune status or central nervous system functions (e.g. rheumatoid arthritis, cvd,etc.)

Keywords: cognitive behavioral therapy psychotherapy cardiovascular health psychoneuroimmunology
mucosal healing study in crohn's disease (cd)

Conditions: Crohn's Disease

Summary: the aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active crohn's disease.


Eligibility criteria:
inclusion criteria: * patients suffering from active crohn's disease \[crohn's disease activity index(cdai) ≥ 220 and ≤ 450\] and at least 2 segments with endoscopic ulcerative lesions with baseline crohn's disease endoscopic index of severity (cdeis) ≥ 8 * patients who need to be treated by anti-tumor necrosis factor (anti-tnf) therapy exclusion criteria: * obstructive intestinal strictures, bowel resection, proctocolectomy or total colectomy, current total parenteral nutrition, short bowel syndrome * history of tuberculosis or positive tests for tuberculosis at screening * all the concomitant diseases or pathological conditions that could interfere with crohn's disease assessment or to be harmful for the well being of the patient * previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial

Keywords: certolizumab pegol crohn's disease mucosal healing
smartphone delivered acceptance and commitment therapy for adolescents with longstanding pain

Conditions: Chronic Pain

Summary: intervention study with uncontrolled design investigating the effects of smartphone delivered acceptance and commitment therapy for longstanding pain in adolescents. primary outcome is pain interference. internet-based parental support will be offered to the adolescents' caregivers.


Eligibility criteria:
inclusion criteria: * pain duration of ≥ 3 months; * the pain condition has been examined by a medical doctor * able to communicate in swedish * access to a smartphone and internet connection on a daily basis * stable medication use since 2 months time, with no planned changes exclusion criteria: * previous act or cbt treatment during the past 6 months * severe psychiatric co-morbidity (e.g. psychosis or high risk of suicide) as assessed by the psychologist in a semi-structured interview

Keywords: adolescents acceptance and commitment therapy smartphone
hypertension treatment adherence improving trial

Conditions: Hypertension,Essential

Summary: persistent adherence to lifestyle modifications and blood pressure lowering medications were the best way to control blood pressure. but low adherence was noted in reviews and studies resulting those taking blood pressure lowering medications could not achieve a controlled blood pressure. in this study, a theory-guided educational program will be developed with an aim to improve the blood pressure, self-efficacy and adherence behaviors among those diagnosed with high blood pressure in the community. 148 participants will be recruited and divided into control group and intervention group randomly in a ratio of 1:1. the intervention group will receive the theory-guided educational program, while the control group will receive the usual care. the study will last for 12 weeks. data will be collected at baseline, week 8 and week 12. spss and generalized estimating equations model will be employed for data analysis. the results will inform an effective way to conduct health promotion in community. the improved adherence to lifestyle modifications and medications will be beneficial to the clients' health.

persistent adherence to lifestyle modifications and anti-hypertensive medications were emphasized in hypertension guidelines to control blood pressure effectively. but low adherence to lifestyle modifications and medication were noted in reviews and studies. low adherence would lead to those received hypertension treatment did not achieve a controlled blood pressure. in this study, an educational program guided by the health promotion model will be conducted to examine the effect on blood pressure, self-efficacy and treatment adherence among hypertensive patients in the community. a 2-arm parallel randomized control trial will be conducted. 148 participants will be recruited and divided into control and intervention group in a ration of 1:1. the intervention group will receive the theory-guided educational program, while the control group will receive the usual care. the study will last for 12 weeks. data will be collected at baseline, week 8 and week 12. spss and generalized estimating equations model will be employed for data analysis. the results will inform community healthcare professionals about the effective way for health promotion, to enhance the adherence to lifestyle modifications and medications among hypertensive clients resulting sustainable benefits to the clients' health.

Eligibility criteria:
inclusion criteria: * own a mobile phone and able to use * able to communicate with cantonese and read chinese * diagnosed with hypertension and taking at least one anti-hypertensive medication * sbp = 131\~159 mmhg or dbp = 81\~99 mmhg exclusion criteria: * renal hypertension * mini-cog \< 3

Keywords: hypertension adherence self-efficacy educational intervention