Kornimate/medical-research-clean huggingface dataset:
neurovascular navgation with remotely controlled deflectable guidewire, study i (neuronav study i)

Conditions: Unruptured Cerebral Aneurysm

Summary: the aim of the study is to confirm the safe and successful use of the smartguide guidewire, when used in neuro interventions. the performance of the smartguide guidewire in terms of safe and successful navigation within the neurovasculature will be compared to standard of care guidewire on the market.


Eligibility criteria:
inclusion criteria: * \>18 years of age * informed consent signed by the patient * confirmed cerebral unruptured aneurysm treatable via transcatheter approach exclusion criteria: * pregnancy or lactation * known disorder of vascular fragility with propensity to vascular injury (e.g., ehlers-danlos syndrome) * known prior vascular stenosis or dissection or injury to vessels intended to be catheterized during study procedures * acute phase myocardial infarction or uncontrolled cardiac arrhythmia * uncontrolled serum electrolyte imbalance * bleeding disorder which limits the use of antiplatelet and/or anticoagulant therapy * known contraindication to intravascular contrast material that cannot be adequately controlled with pre-medication * known hypersensitivity to nickel * subjects currently enrolled in another investigational device or drug study that clinically interferes with the current study endpoints
insulin novorapid versus actrapid in treatment of type 1 diabetic patients during daily adjustment of insulin dose

Conditions: Type 1 Diabetes Mellitus

Summary: the main purpose of the study is to investigate the reason for the reduced number of hypoglycaemic attacks in type 1 diabetic patients when, for a period of time, using insulin aspart at meals together with nph insulin mornings and evenings, and when, in another period of time, using human fast-working insulin at meals and nph insulin mornings and evenings, and when the patients in both periods simultaneously take extra insulin at meals if high blood glucose values are found before meals.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus treated with insulin four times daily (basal bolus treatment) at least three months before screening. * age: 18-60 years * bmi: 18-27.5 * no nefro- or neuropathy; i.e. s-creatinin below 120 μmol/l and normal monofilament examination * written informed consent exclusion criteria: * pregnant women or patients planning to become pregnant during the investigation period * reduced eyesight; i.e. visus \> 0.3 evaluated at the latest eye exam. * patient lacking the ability to sens insulin sensitivity * serious rival disease, i.e. heart disease, severe liver or lung impairment, severe psychiatric disease. * suspicion of abuse or non-compliance * participation in another clinical trial

Keywords: type 1 diabetes mellitus hypoglycaemia insulin profiles growth hormone cortisol glucagon
a long-term extension study of mirikizumab (ly3074828) in participants with crohn's disease

Conditions: Crohn's Disease

Summary: the reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with crohn's disease.


Eligibility criteria:
inclusion criteria: * participants must have completed study i6t-mc-amag (nct02891226) or study i6t-mc-amam (nct03926130) * if female, participant must meet the contraception requirements exclusion criteria: * participants must not have developed a new condition, including cancer in the previous study (i6t-mc-amag or i6t-mc-amam) that would pose an unacceptable risk in the trial. * participants must not have any important infections including, but not limited to, hepatitis b, hepatitis c, hiv/aids, and active tuberculosis (tb) during either previous study. note: participants with a history of active tb with documentation of treatment by the centers for disease control (cdc) and/or world health organization (who) criteria prior to the originator study are not excluded from the study. * participants must not have a known hypersensitivity to any component of mirikizumab or have experienced acute systemic hypersensitivity event with previous study drug administration in the originating study that precludes mirikizumab therapy. * participation must not be pregnant, lactating, or planning to become pregnant while enrolled in the study or 16 weeks after receiving the last dose of study drug.
intraoperative fentanyl consumption guided by analgesia nociception index

Conditions: Postoperative Pain; Postoperative Complications

Summary: balanced anesthesia needs optimization of hypnotic, relaxant, and narcotic. administration of hypnotic drugs can be monitored by bispectral index score (bis), while the dosage of muscle relaxants can be guided by train-of four (tof). however, administration of narcotics lacks objective monitor. overdosage of narcotic may lead to delayed awakening, while underdosage may lead to high degree of postoperative pain. recently, there is a monitor, analgesic nociceptive index (ani) monitor, designed to guide the administration of narcotics. there are many descriptive studies supporting the correlation of ani score and pain score but there are still very few randomized control studies which report the efficacy of ani in clinical practice.

objective: to evaluate the efficacy of ani to guide the administration of intraoperative fentanyl. methods: sixty female patients undergoing breast surgery with balanced anesthesia will be randomized into 2 groups. the first group will receive fentanyl according to standard practice of attending anesthesiologists. the second group will receive fentanyl according to ani score protocol. primary outcome: postoperative pain numeric rating scale (nrs) score during 60 minutes in postanesthetic care unit (pacu). secondary outcomes: total intraoperative dose of fentanyl and postoperative nausea/vomiting and sedation score in pacu.

Eligibility criteria:
inclusion criteria: * adults female undergoing elective breast surgery * american society of anesthesiologists (asa) classification i-iii * body mass index (bmi) 18.5-35 kg/m2 exclusion criteria: * implanted pacemaker * cardiac arrythmia * autonomic nervous system (ans) disorder, e.g. epilepsy, stroke * chronic opioid use * chronic pain * on beta-blocker, calcium channel blocker, or other drugs to control arrythmia * previous mastectomy * pregnancy * on nsaids
enhanced biofeedback for musculoskeletal pain

Conditions: Musculoskeletal Pain

Summary: the purpose of this study is to assess whether a novel, enhanced form of biofeedback can help individuals regulate their chronic musculoskeletal pain more effectively.

relaxation is a low-cost treatment for managing pain with little or no side effects. the proposed study will use a novel biofeedback treatment to try and enhance the capacity of relaxation to engage pain inhibitory circuits. specifically, a biofeedback system (biofeedback training for conditioned pain regulation, bt-cpr) will be used to monitor the participant's level of sympathetic arousal and will use this to control the intensity of painful stimulations delivered to the participant during biofeedback training. thus, when the participant successfully relaxes (and reduces their arousal), the intensity is lowered and produces pain relief. efficacy of the treatment will be tested in a small, randomized controlled trial in which individuals with a verified diagnosis of chronic musculoskeletal pain will receive 10 treatment sessions, or 10 sessions of a control condition (traditional biofeedback, to control for the effects of relaxation on pain). the aim will be to assess whether the treatment results in improvements in clinical pain outcomes (e.g., pain intensity, quality of life, pain interference) and psychosocial variables (e.g., coping, self-efficacy, mood).

Eligibility criteria:
inclusion criteria: * adults (18 years or older) with a verified diagnosis of chronic musculoskeletal pain and currently experiencing pain exclusion criteria: * under 18 years of age (given the nature of the treatment study) * if female, currently pregnant * persistent feelings of numbness in hands and feet * difficulty being able to feel or sense things * lack of access to a computer or smartphone (to complete electronic pain diaries) * injuries that prevent sensor application * use of narcotic pain medications with 48 hours of treatment sessions

Keywords: chronic pain
comparison of efficacy different treatment regimens in pulmonary hypertension secondary to lung disease and or hypoxia

Conditions: Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia

Summary: this is an open label, randomized, interventional study indented to find the efficacy of different treatment regimens in treatment of pulmonary hypertension secondary to lung disease and/or hypoxia.this is to find out when to start combination therapy (sildenafil plus bosentan) in treatment of pulmonary hypertension secondary to lung disease and/or hypoxia.

this is an open label, randomized, interventional study indented to find the efficacy of different treatment regimens in treatment of pulmonary hypertension secondary to lung disease and/or hypoxia. it involves 3 arms, one getting monotherapy with sildenafil for 6 months, 2nd getting bosentan monotherapy initially for 3 months and then combination of sildenafil and bosentan for 3 months, 3rd getting combination sildenafil and bosentan from the beginning for 6 months. the aim is to decide when is the best time to start combination therapy either from start or at the time of drug failure. improvement will be assessed by change in functional class, pulmonary pressures measured by echo, pulmonary function test, six minute walk test and biochemical markers. lack of randomized trials and indian data is there on the subject. also adverse events and serious adverse events will be closely monitored and reported to the ethics committee and dcgi immediately.

Eligibility criteria:
inclusion criteria: 1. pulmonary artery hypertension diagnosed by doppler echocardiography as mean pulmonary artery pressure 25 mmhg (done in department of cardiology, aiims) 2. age more than 18 years 3. pulmonary artery hypertension due to hypoxia, either chronic obstructive airway disease or diffuse pulmonary lung disease 4. willing to consent to participate in the trial 5. who functional class i,ii, iii exclusion criteria: 1. who functional class iv 2. patient participating in any other trial 3. concomitant coronary artery disease 4. nitrate intake 5. liver dysfunction 6. pregnancy and lactation -
physical activity and fatigue in early multiple sclerosis (ms)

Conditions: Multiple Sclerosis

Summary: the purpose of this observational study is to obtain a survey on physical activity in patients who for the first time have experienced symptoms which indicate a high risk for developing multiple sclerosis (ms) and in patients with recently diagnosed ms, and to obtain information on factors potentially influencing the patients' level of activity.


Eligibility criteria:
inclusion criteria: * multiple sclerosis diagnosed within the last 12 months * clinically isolated syndrome (cis), under interferon-beta-1b treatment

Keywords: physical activity fatigue rrms cis
pakistan flocculent health outcome study

Conditions: Diarrhea

Summary: this study is designed to evaluate the effect of different methods of drinking water treatment on the occurrence of diarrhea among children living in squatter settlements in karachi, pakistan, and the marginal benefit of adding handwashing to water treatment. 260 households will receive a new product which combines flocculation with chlorination to produce clearer, less chemically contaminated drinking water. 260 households will receive dilute sodium hypochlorite, i.e. bleach to treat their water. 260 households will receive soap and encouraged to wash their hands regularly. 260 households will receive both soap and the combination flocculation/chlorination water treatment. 260 households will continue their standard water treatment and handwashing practices. the households will be visited each week for 9 months, and the episodes of diarrhea from each child in the household recorded. the rate of diarrhea between the groups will be compared. at the end of 9 months, households who were part of the standard habits and practice group will receive a water storage vessel and disinfectant.


Eligibility criteria:
inclusion criteria: * households in study neighborhoods * contain a child \< 5 years old * have access to water for handwashing exclusion criteria: * participated in handwashing or drinking water treatment programs with hope previously

Keywords: diarrhea handwashing point-of-use water treatment diarrhea longitudinal prevalence
study to assess efficacy of tacrolimus + methotrexate versus placebo + methotrexate in treatment of rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the efficacy of the combination of tacrolimus + methotrexate compared to methotrexate alone in the treatment of the signs and symptoms of rheumatoid arthritis over 6 months in patients with partial response to methotrexate.

this is a phase iii, 6 month randomized, double-blind, placebo controlled multi-center study with a 6 month open-label extension. patients will be randomized to the tacrolimus + methotrexate arm or the placebo + methotrexate arm in a ratio of 2:1. patients who complete the 6-month double-blind phase will be eligible to enroll in the open-label phase of the study.

Eligibility criteria:
inclusion criteria * willing to discontinue dmards, other than methotrexate * has a diagnosis of rheumatoid arthritis using american college of rheumatology criteria, of at least 6 months duration * have been receiving oral or parenteral methotrexate for at least 3 months exclusion criteria * has received tacrolimus for any indication * has moderate or severe liver disease * has a known history of hiv infection * has serum creatinine outside the normal range

Keywords: tacrolimus, prograf®, fk506
prevalence, management and follow-up of patients with addiction to opioid analgesics

Conditions: Analgesics Grade 2's Addiction

Summary: the demand for addiction care for patients with addiction to analgesics increases with the number of prescription of analgesics grade 2; this is a public health problem there is no support for repositories to date in the context of addiction analgesics grade 2. risk factors of misuse as well as diagnostic tools were identified.

the demand for addiction care for patients with addiction to analgesics increases with the number of prescription of analgesics grade 2; this is a public health problem there is no support for repositories to date in the context of addiction analgesics grade 2. risk factors of misuse as well as diagnostic tools were identified. the objectives of our research are to determine the characteristics of the individuals suffering from an addiction to analgesics of level 2 followed in consultation of addictology in the hospital of montpellier and nimes and to describe the type of follow-up proposed to the patients in these two centers. it is a retrospective and descriptive study. as part of this research, we will solicit all the patients followed in consultation of addictology or in hospitalization to the hospital of montpellier or nîmes for an addiction to the analgesics of grade 2 between the 1st of january 2014 and the 10th of july 2017 with requests of management for withdrawal or reduction of doses, opioid analgesics in the absence of pain or in chronic non-cancer pain, opioid analgesics to avoid withdrawal syndrome or hyperalgesia and consumptions chronic to dosages inadequate to the functional complaint evaluated by the rhumatology or algology services. the data are collected in the medical file at the two participating institutions (montpellier and nîmes) and if necessary, patients not seen in consultation for more than 6 months will be recontacted.

Eligibility criteria:
inclusion criteria: * requests for management for weaning or reduction of doses * take opioid analgesics in the absence of pain or as part of chronic non-cancer pain * opioid analgesics to prevent withdrawal syndrome or hyperalgesia * chronic consumption at inadequate dosages compared to the functional complaint evaluated by the mpr / algologie services * patients over 18 years and who agree with the study exclusion criteria: * language barrier * severe cognitive and / or psychiatric disorders

Keywords: descriptive support retrospective survey
communication bridge speech therapy research study

Conditions: Primary Progressive Aphasia; Frontotemporal Dementia

Summary: this is a study on internet-based video-practice speech and language therapy for persons with primary progressive aphasia (ppa), behavioral-variant frontotemporal dementia (bvftd), or related conditions.

the purpose of this study is: 1. to evaluate the effectiveness of speech and language therapy on a person's ability to communicate immediately after treatment, 6-months after treatment, and 12-months after treatment. 2. to identify the most effective speech and language therapy strategies for persons with these conditions. 3. to determine the feasibility of internet-based video-practice of speech and language therapy for persons with these conditions. the study will involve 12 to 15 session over the course of 12 months. some of these sessions will be in-person at the northwestern cognitive neurology and alzheimer's disease center (chicago, il), while others will take place over the internet, using an online study portal.

Eligibility criteria:
inclusion criteria: * diagnosis of dementia with language as a primary symptom (i.e. aphasia) * an informant who knows the participant well and can answer questions the participant's communication ability * adequate hearing to follow conversation (correction permitted) * adequate vision (correction permitted)

Keywords: primary progressive aphasia progressive nonfluent aphasia progressive aphasia frontotemporal dementia frontotemporal lobar degeneration
immunogenicity and safety of gsk biologicals' hbv-mpl vaccine (2 doses), and of engerix™-b (3 doses) in healthy adults

Conditions: Hepatitis B

Summary: this study is undertaken to assess the immune response and safety profile of 4 lots of the novel adjuvanted hepatitis b vaccine that were formulated following different processes, with engerix™-b as the control vaccine

this is an open, randomized study with five groups, but the four groups receiving hbv-mpl candidate vaccine are double-blinded. at the time of conduct of this study, the sponsor glaxosmithkline was known by its former name smithkline beecham

Eligibility criteria:
inclusion criteria: * a male or female between 15 and 50 years of age at the time of the first vaccination. * free of obvious health problems as established by medical history and clinical examination before entering into the study. * written informed consent obtained from the subject and/or from the parents or guardians of the subject. * if the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to vaccination and up to two months after the last vaccination exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine. * administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. * planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after. * previous vaccination against hepatitis b. * history of significant and persisting hematological, hepatic, renal, cardiac or respiratory disease. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * a family history of congenital or hereditary immunodeficiency. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * acute disease at the time of enrollment. * hepatomegaly, right upper quadrant abdominal pain or tenderness. * oral temperature of ≥37.5°c (99.5°f). * administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period. * pregnant or lactating female. * history of chronic alcohol consumption and/or intravenous drug abuse

Keywords: hepatitis b adjuvanted hepatitis b vaccine recombinant hepatitis b vaccine
24h continuous intraocular pressure (iop) monitoring vs goldmann applanation tonometry

Conditions: Primary Open Angle Glaucoma

Summary: a study in which intraocular pressure (iop) will be monitored over 24 hours using the sensimed triggerfish® device and goldmann applanation tonometry (gat) in primary open angle glaucoma patients. the aim of this study is to investigate the comparability of diurnal iop patterns emerging from sensimed triggerfish and gat.


Eligibility criteria:
inclusion criteria: * signed informed consent for the investigation * patients with primary open angle glaucoma (poag), defined as open angle ≥ 30°, confirmed visual field loss (mean defect/least variance ≤ 2db) and/or optic nerve head damage (cup disc ratio \> 0,5) * age 40-70 years at inclusion * not more than 4 diopters spherical equivalent on the study eye * not more than 2 diopters cylinder equivalent on the study eye * for women of childbearing potential, adequate contraception * stable anti-glaucomatous therapy 4 weeks before the first 24-hour iop assessment session and throughout the investigation exclusion criteria: * patients not able to understand the character and individual consequences of the investigation * patients committed to an institution by virtue of an order issued either by the courts or by an authority * absence of or withdrawn informed consent * patients with contraindications for silicone contact lens wear * wear of full frame metallic glasses during sensimed triggerfish monitoring * eye disorders including severe dry eye * eye disorders secondary to poag * patient who have had ocular surgery within the last 3 months * corneal or conjunctival abnormality or irregularity hindering correct contact lens adaptation * pregnancy and lactation * allergy to oxybuprocaine (ocular anesthesia) * simultaneous participation in other clinical research