Kornimate/medical-research-clean huggingface dataset:
acute bronchodilator response of a single dose of atrovent or berotec on top of pharmacodynamic steady state of spiriva

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: to evaluate acute effect of single dose of ipratropium (atrovent) or fenoterol (berotec) in comparison to placebo when given to copd patients on pharmacodynamic steady state of tiotropium (spiriva)

in case mono-bronchodilator therapy does not control symptoms of copd adequately or if regular maintenance therapy is desired, a therapeutic intervention with a combination of bronchodilators is recommended. the risks of side-effects increases with increasing dose of any drug and, therefore, the most important rationale for combination therapy is a very favourable ratio of efficacy and safety. knowing that anticholinergic and beta-adrenergic agents achieve their bronchodilating effects by different mechanisms, in particular the combination of these agents has proven to be beneficial in the management of copd. based on the established clinical benefits, tiotropium is an attractive and promising agent for the first-line long-term maintenance therapy in copd. this also implies that a therapeutic intervention with other bronchodilators will be prescribed in daily practice. at present no studies on combination therapy with short-acting agents are available. therefore, using a double-blind, randomised, crossover design, the bronchodilator effects of single doses of ipratropium or fenoterol were compared with placebo when added on top of steady state tiotropium. patients were pre-treated with tiotropium to achieve this pharmacodynamic steady state. serial lung function tests (fev1, fvc, raw, sgaw) were conducted following add-on of the short-acting bronchodilators or placebo. study hypothesis: h0: there is no difference between treatments in mean peak fev1 h1: there is a difference between treatments in mean peak fev1 comparison(s): add-on of placebo was compared to add-on of ipratropium or add-on of fenoterol. the comparison of ipratropium with placebo was primary. the other 2 pair-wise comparisons were secondary.

Eligibility criteria:
inclusion: * diagnosis of copd * fev1 \< 60% of predicted * fev1 \< 70% of fvc * smoking history of 10 pack-years exclusion: * significant other disease than copd * history of asthma, allergic rhinitis or blood eosinophil count \> 600mm3 * cardiac arrhythmia requiring drug therapy * symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma * recent history of mi (within past year) * history of cancer within past 5 years * life-threatening pulmonary obstruction * cystic fibrosis or bronchiectasis; tuberculosis * pulmonary resection
stabilometry after pressure release of the flexor digitorum brevis muscle versus a non-emission laser: clinical trial

Conditions: Flatfoot

Summary: thirty-six subjects randomly distributed between a pressure release intervention group and a control group whose intervention is a non-emission laser. all the subjects will be measured before and after the interventions of each group. the measurements will be made on a pressure platform to record the stabilometry variables.

thirty-six subjects randomly distributed between a pressure release intervention group and a control group whose intervention is a non-emission laser. all the subjects will be measured before and after the interventions of each group. the measurements will be made on a pressure platform to record the stabilometry variables with eyes closed and open.

Eligibility criteria:
inclusion criteria: * must have latent trigger point in flexor brevis digitorum muscles with no other pathologies exclusion criteria: * previous lower extremities surgery. history of lower extremities injury with residual symptoms (pain, "giving-away" sensations) within the last year. leg-length discrepancy more than 1 cm balance deficits (determined by oral questionnaire regarding falls)

Keywords: foot stabilometry trigger point
a trial of a preventive intervention program for chilean families with depressed parents

Conditions: Depression

Summary: the overall aim of this pilot study is to evaluate the acceptability and feasibility of an adaptation of beardslee's 'preventive intervention program (pip) for depression' in chilean families. the pip is a family intervention directed towards strengthening family functioning and enhancing resilience in children of depressed parents. it comprises several modules that work on psycho-education and skill development within the family nucleus. a single-blind randomized controlled trial will be conducted with two arms, the intervention arm (n=32) which will receive a home-based pip for depression, and the tau arm (n=32).

being a child with depressed parents is associated with poor health and academic outcomes as well as having four times the likelihood of developing a mood disorder compared to children of non-depressed parents. objectives: to evaluate acceptability and feasibility of an adaptation of beardslee's 'preventive intervention program (pip) for depression' in chilean families, and to measure the clinical effects of this intervention. participants: parents with an episode of depression in the past 3 months with at least one non-depressed child between the ages of 6-12. design: single-blind randomized controlled trial with two groups; the intervention group (n=32), which will receive a home-based pip for depression, and the treatment-as-usual control group (n=32). results: acceptability and feasibility will be measured by determining whether the trial was successfully conducted and well received by the families and preventionists. recruitment and delivery of the intervention will be assessed as well as whether there was appropriate response and follow-up, and whether the objectives of the study were reached. secondary outcomes will look at depressive symptoms, family function, psycho-education, parental competence, adaptive behavior and resilience in children. follow-up times: t = 0 baseline, t= 2 months (post-intervention), t=5 months, t=8 months, t=11 months.

Eligibility criteria:
inclusion criteria: * patients who are currently undergoing a depressive episode or have done so in the past 3 months. exclusion criteria: for parents: * alcohol or drug dependence or abuse as assessed by the mini or being in treatment for substance use. * psychosis, personality disorder, bipolar disorder or suicide ideation as assessed by the mini. * having a relationship crisis with current partner. assessed by self-report or by having attended couple's therapy in the past month. * attending family therapy. for children: * being outside the age range of 6-12 years at the time of recruitment. * intellectual disability * having depression as assessed by the mini kid * being in treatment for a psychiatric disorder or having taken psychotropic medication in the last month.

Keywords: prevention family intervention depression children
fiberoptic bronchoscope of double lumen tube and single lumen tube in patients with semi-regid neck collar.

Conditions: Intubation;Difficult; Thoracic Diseases

Summary: many intrathoracic procedures demand optimal collapse of the operative lung to facilitate surgical exposure. single-lung ventilation can be achieved using a double-lumen tube (dlt), a univent tube, or an independent bronchial blocker. insertion of a dlt using a direct laryngoscope can be more difficult than that of single-lumen tube (slt), especially in patients for whom airway difficulty is anticipated. the safest of the proposed methods involves the placement of an slt with the aid of an fibreoptic bronchoscope (fob), following which the slt is replaced with a dlt using an airway exchange technique in these patients. humanbroncho® (insung medical, seoul, korea) is a new silicone dlt with a soft, flexible, non-bevelled, wire-reinforced tip. the oval shape, obtuse angle, and short lateral internal diameter of the bronchial lumen and its flexibility may allow for advancement to the trachea over the fob with as much as ease as a standard slt. in the present study, the investigators aimed to test the hypothesis that the humanbroncho® dlt would be non-inferior to a standard slt with regard to intubation time over an fob in patients with semi-rigid neck collar simulating difficult airway.


Eligibility criteria:
inclusion criteria: * patients undergoing thoracic surgery requiring one lung ventilation. american society of anesthesiologist, physical status 1,2 exclusion criteria: * abnormality of upper airway gastroesophageal disease risk of aspiration bmi \> 35

Keywords: fibreoptic intubation double lumen tube difficult intubation
a multiple ascending dose study of bms-707035 in hiv-1 infected subjects

Conditions: HIV Infections

Summary: the purpose of this clinical research study is to assess the safety, pharmacokinetics and pharmacodynamics of bms-707035 in subjects infected with hiv-1


Eligibility criteria:
inclusion criteria: * hiv-1-infected subjects with cd4+ lymphocyte count ≥ 200 cells/mm3 and with plasma hiv-1 rna ≥ 5000 copies/ml who have not been on antiretroviral (arv) therapy for ≥ 8 weeks or who are naive to arv, and who are otherwise medically stable as determined by medical history, physical examination, 12 lead electrocardiogram, and clinical laboratory evaluations will be eligible to participate in the study. in addition, subjects must have had no prior exposure to the integrase inhibitor class of compounds. * female subjects must not be nursing, pregnant, or of childbearing potential

Keywords: hiv treatment experienced
patient educational materials for prostate cancer screening

Conditions: Patient Educational Materials

Summary: although the harms of screening for prostate cancer with the prostate-specific antigen (psa) test outweigh the benefits, 560,000 ontario men undergo psa screening each year. guideline developers, such as the canadian task force on preventive health care (ctfphc), have disseminated patient educational materials (pems) on psa screening widely in ontario, yet men remain confused about screening harms and benefits. one potential contributing factor may be that pems are typically developed by researchers and clinicians and may not address patient barriers to change. the investigators will assess whether a psa screening pem that is co-created with patients provides added value over pems developed using the traditional approach (i.e., researchers and clinicians develop a pem with patient involvement in usability testing only. the investigators will also assess satisfaction with the engagement process and calculate the costs and resources required for each method (i.e. co-creation, usability, and recommendations only). this study will generate a psa screening pem to help patients make evidence-based screening decisions. it will also help ontario organizations, including cancer care ontario, identify optimal methods for developing pems for psa screening and other areas of preventive health care, such as breast and colorectal cancer screening.


Eligibility criteria:
inclusion criteria: * english-speaking men aged 40+ years will be eligible to take part in the project if they have never been diagnosed with prostate cancer and do not have any signs or symptoms of prostate cancer. exclusion criteria: * individuals will not be eligible for the project if they indicate that they are a health care professional or have any conflicts of interest relevant to the guideline topic (e.g., owning shares in a company related to prostate cancer treatment).

Keywords: patient educational materials; prostate cancer; co-creation
cognitive process-based real-time fmri neurofeedback in mdd and rumination

Conditions: Depression; Anxiety

Summary: the purpose of this study is to assess the feasibility and efficacy of real-time fmri neurofeedback for rumination.

neuroimaging mri techniques for measuring brain structure, tissue composition, and blood oxygenation level dependent functional magnetic resonance imaging (bold fmri) will be used to measure task-dependent and task-independent brain hemodynamic and electrophysiological changes in human subjects with major depressive disorders (mdd). after being informed about the study and potential risks, all participants giving written informed consent will undergo one session of the cognitive process-based fmri neurofeedback (cnf) targeting the rumination-related brain functional connectivity, and a one-week follow-up. participants will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to active (receiving feedback from their own brain activity) or sham (receiving artificially generated feedback).

Eligibility criteria:
inclusion criteria: * good general health * dsm-5 diagnosis of major depressive disorder (mdd) exclusion criteria: general exclusion criteria: * pregnancy medical conditions: * moderate to severe traumatic brain injury (\>30 min. loss of consciousness or \>24 hours posttraumatic amnesia) or other neurocognitive disorder with evidence of neurological deficits. * presence of co-morbid medical conditions not limited to but including cardiovascular (e.g., history of acute coronary event, stroke) and neurological diseases (e.g., parkinson's disease), as well as pain disorders. * presence of an uncontrolled medical condition that is deemed by the investigators to interfere with the proposed study procedures, or to put the study participant at undue risk. psychiatric disorders: * current severe suicidal ideation or attempt within the past 12 months. * psychosis * bipolar disorder * substance abuse or dependence within the previous 6 months contraindications for mri: * bodily implants of unsafe paramagnetic materials such as pace-makers and aneurysm clips. * claustrophobia that is severe enough to preclude mri scanning. medications: * evidence of recreational drug use from a urine test.

Keywords: neurofeedback real-time fmri rumination
the effects of cupping massage in patients with chronic neck pain - a randomized controlled trial

Conditions: Neck Pain; Mechanical/Motor Problems With Neck and Trunk

Summary: the study aims to investigate the influence of 5 cupping massage treatments on chronic non specific neck pain. 50 patients with neck pain are randomised into cupping treatment and waiting list control group. before and after the intervention the investigators evaluate the neck pain (vas), the neck related disability (ndi), pain on movement (pom) and the quality of life (sf36) and safety. to investigate neurophysiological effects of cupping the investigators also measure mechanical detection threshold (mdt), vibration detection threshold (vdt) and pressure pain threshold (ppt) and the two point discrimination threshold at pain related and control areas. the treatment group receives 5 cupping treatments over a period of 3 weeks.

see above

Eligibility criteria:
inclusion criteria: * age between 18 and 75 * permanent neck pain for at least three months in a row * a minimum of 40mm of neck pain on a 100mm visual analogue scale (vas) exclusion criteria: * neck pain caused by trauma, inflammatory or malignant disease, by congenital malformation of the spine or if pain was accompanied by radicular symptoms such as radiating pain, paresis, prickling or tingling. * invasive treatments within the last 4 weeks, surgery to the spine within the last year, corticosteroid or opioid treatment. * serious acute or chronic organic disease such as diabetes or cancer, mental disorders, pregnancy, and haemorrhagic tendency or anticoagulation treatment. * non steroidal pain medication and physiotherapy were allowed if the treatment regimen was not altered for four weeks before and continued during the study.
evaluation of the titan 3-d™ wedge system

Conditions: Flat Foot; Lateral Column Lengthening; Medial Cuneiform Osteotomy

Summary: evaluate clinical healing and radiographic maintenance of correction following an lcl procedure or medial cuneiform osteotomy (cotton) at 6 months following the use of the titan 3-d™ wedge. subjects who receive one or more titan 3-d™ wedges will obtain satisfactory levels of clinical healing and radiographic maintenance of correction at 6 months.


Eligibility criteria:
inclusion criteria: 1. the subject has foot pain/discomfort on the foot in question. 2. the subject has activity limitations due to the foot in question. 3. the subject agrees to comply with the requirements of the study and complete the study measures. 4. the subject (or representative of the subject in the case of a minor) is willing and able to provide written informed consent. 5. the subject plans on undergoing an lcl procedure and/or medial cuneiform osteotomy with a titan 3-d™ wedge. exclusion criteria: 1. the subject is pregnant. 2. the subject had been previously sensitized to titanium. 3. the subject is scheduled for a same day bilateral lcl procedure or medial cuneiform osteotomy procedure. 4. the subject is not expected to complete the study according to the investigation plan. 5. the subject has been deemed physiologically or psychologically inadequate by the enrolling physician. 6. the subject is: a prisoner, unable to understand what participation in the study entails, mentally incompetent, a known abuser of alcohol and/or drugs or anticipated to be non-compliant.

Keywords: titanium wedge evans cotton
does antibiotic prophylaxis reduce wound complications after vulvar excision of premalignant lesions

Conditions: Premalignant Vulvar Lesion; Benign Vulvar Lesion

Summary: a randomized control trial will provide the most reliable data to determine the role of prophylactic antibiotics to decrease the wound complication rate. the investigators plan to perform a pilot study to evaluate actual rates of wound complications and how long it takes to recruit 50 patients.


Eligibility criteria:
inclusion criteria: * all women, \>=18 undergoing vulvar surgery * biopsy proven benign or premalignant lesion requiring surgical management. * women of childbearing age will be required to have a negative human chorionic gonadotropin (hcg) test within seven days of surgery. * scheduled to undergo surgical management for their vulvar disease supervised by a faculty member within the division of obgyn at washington university school of medicine * ability to understand and willingness to sign an irb approved written informed consent document (or that of legally authorized representative, if applicable). exclusion criteria: * women who are pregnant * women scheduled to undergo a radical vulvectomy * women scheduled to undergo a concomitant graft, flap or plastic surgery * women \<18 years of age * history of prior vulvar radiation * inability to sign an informed consent form prior to registration on study * inability to understand spoken or written english * prisoner
ultrasound analysis of suspected long bone fractures in the emergency department - diagnostic performance compared to radiography.

Conditions: Bone Fracture

Summary: ultrasound tool in bones trauma is underused in the emergency department of the university hospital of saint-etienne. this prospective non randomized monocentric study will measure how much this non irradiant method of diagnostic is sensible and specific in long bones fractures, and will evaluate it advantages versus conventional x ray examination.

this study is based on physical examination (swelling, hematoma, edema) and concerns all long bones, including benign trauma (non deforming and closed fractures). the necessary time to make an ultrasound conclusion and the operator certitude degree will be measured.

Eligibility criteria:
inclusion criteria: * children with low kinetic, non-deforming, non-open long bone trauma exclusion criteria: * opened fracture, deforming trauma

Keywords: bone trauma bone ultrasound fracture radiography
thalidomide and temozolomide in relapsed or progressive cns disease or neuroblastoma

Conditions: Central Nervous System Tumor, Pediatric; Neuroblastoma

Summary: rationale: thalidomide may stop the growth of tumor cells by stopping blood flow to the tumor. drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. combining thalidomide with temozolomide may kill more tumor cells. purpose: this phase ii trial is studying the effectiveness of combining thalidomide with temozolomide in treating young patients who have relapsed or progressive brain tumors or recurrent neuroblastoma.

objectives: primary * determine the feasibility of thalidomide and temozolomide in pediatric patients with relapsed or progressive poor prognosis brain tumors or recurrent neuroblastomas. secondary * determine preliminarily evidence of biologic activity of this regimen in these patients. * determine the toxic effects of this regimen in these patients. statistical design: the primary data analysis will estimate the percentage of patients who can complete 6 months of therapy in the mixed population. with a target accrual of 20 patients the 90% confidence for the true feasibility rate will be no wider than 40%.

Eligibility criteria:
disease characteristics: * histologically confirmed\* diagnosis of 1 of the following: * poor prognosis brain tumor * relapsed or progressive disease * no curative therapy exists * neuroblastoma * recurrent disease note: \*histologic confirmation not required for brain stem glioma; patients with brain stem glioma must have clinical and radiographic evidence of disease * patients with brain stem glioma must have symptoms lasting \< 3 months comprising cranial nerve deficits (often vi or vii) and/or ataxia and/or long tract signs patient characteristics: age * 21 and under performance status * karnofsky 50-100% or * lansky 50-100% life expectancy * more than 2 months hematopoietic * hemoglobin ≥ 9.0 g/dl * platelet count \> 75,000/mm\^3 * wbc \> 2,000/mm\^3 * absolute neutrophil count \> 1,000/mm\^3 hepatic * bilirubin ≤ 1.5 mg/dl * sgot and sgpt ≤ 2 times normal (sgot ≤ 4 times normal for patients taking zantac) * alkaline phosphatase ≤ 2 times normal * no active hepatic disease ≥ grade 3 renal * creatinine \< 1.5 mg/dl or * creatinine clearance ≥ 70 ml/min * no active renal disease ≥ grade 3 cardiovascular * no active cardiac disease ≥ grade 3 pulmonary * no active pulmonary disease ≥ grade 3 other * not pregnant or nursing * fertile patients must use effective contraception during and for 4 weeks after study participation * willing and able to participate in the system for thalidomide education and prescription safety (s.t.e.p.s.\^®) program * no active psychiatric disease ≥ grade 3 prior concurrent therapy: biologic therapy * prior biologic therapy allowed * no prior thalidomide chemotherapy * prior chemotherapy allowed * no prior temozolomide endocrine therapy * concurrent steroids allowed radiotherapy * prior radiotherapy allowed surgery * prior surgery allowed other * concurrent antiseizure medications allowed * no other concurrent investigational agents