Kornimate/medical-research-clean huggingface dataset:
cost effectiveness of laparoscopic colorectal surgery

Conditions: Colorectal Surgery

Summary: hypothesis: the total costs of laparoscopic colorectal surgery are less than those of open surgery. secondary hypothesis: patients quality of life is higher following laparoscopic surgery, as compared to open colorectal surgery. research objectives: 1. to estimate the cost implications and clinical benefits of incorporating laparoscopic colorectal surgery into routine clinical practice. 2. to examine whether the increased operative costs of laparoscopic surgery are compensated for by a faster recovery, shorter duration of hospital stay, and a reduction in late complications, as compared to open surgery. 3. to investigate whether there are differences in quality of life following laparoscopic colorectal surgery as compared to open surgery. lay summary: patients needing an operation for a bowel problem have traditionally had an open operation with an incision on the abdomen, and this is the type of operation that is currently performed in the majority of cases in the united kingdom today (over 90%). laparoscopic (or keyhole) surgery has been introduced into bowel surgery, but is currently not widely performed. this is because thus far there have been no clear-cut benefits demonstrated with this technique and the perceived costs are higher than an open operation. the investigators aim to evaluate both of these issues.


Eligibility criteria:
inclusion criteria: * all patients having a colorectal resection, including benign and malignant tumours, inflammatory bowel disease, diverticular disease, and endometriosis exclusion criteria: * children * emergency procedures * patients unable to consent, unable to complete a quality of life diary

Keywords: laparoscopy colorectal surgery quality of life economic analysis patients undergoing laparoscopic colorectal surgery
a prospective study of risperdal (risperidone) for the treatment of behavioral disorder following psychological therapy for challenging behavior in learning disabled children

Conditions: Learning Disorders; Child Behavior Disorders

Summary: the purpose of this study is to assess whether risperidone (an antipsychotic medication) is safe and effective in treating behaviour disorder in learning disabled children, which does not improve with psychological therapy.

there is a high incidence of behaviour disorder in people who are learning disabled. the purpose of this study is to assess whether risperidone is safe and effective in the treatment of learning disabled children diagnosed with behaviour disorder, which does not improve with psychological therapy. if the learning disability is very severe, or the behaviour disorder is very severe, such therapy is not appropriate and thus is not attempted; these patients are nevertheless eligible to participate in the study. at the beginning of treatment, the dose of risperidone is titrated, by gradual increase from 0.25 mg/day up to a maximum of 4 mg/day, based on therapeutic response, with decreases allowed in case of adverse reactions. patients will be assessed over six months. the primary measure of effectiveness is the change compared to baseline in the total score on the aberrant behaviour checklist (abc). the epss is used to monitor the appearance of extrapyramidal symptoms. based on results from other studies and the differences observed as a result of treatment, the investigator and his team expect to be able to detect a statistically and clinically significant result if data are available for 15 evaluable patients. twenty patients will be recruited, taking account of possible drop outs. 0.25 mg of risperidone per day, taken orally, up to a maximum daily dose of 4 mg/day, for a treatment period of 6 months.

Eligibility criteria:
inclusion criteria: * dsm-iv axis ii diagnosis of mental retardation * behavioural and family therapy tried for 6 months but has failed * in school, at least part time * score of \>=8 on hostility scale * subject is otherwise healthy exclusion criteria: * patients with a seizure disorder requiring repeated change of medication * extrapyramidal symptoms not well controlled by medication * abnormal and clinically significant electrocardiogram (ecg) changes * history of tardive dyskinesia (a condition of uncontrollable movements of the tongue, lips, face, trunk, hands and feet that is seen in patients receiving long-term medication with certain types of antipsychotic drugs), or neuroleptic malignant syndrome (a rare condition in patients receiving antipsychotic medication in which patients may develop fever, sweating, unstable blood pressure, rigid muscles, and other symptoms, including changes in their normal mental state) * known hypersensitivity to antipsychotic medications, including risperidone.

Keywords: learning disorder children behaviour disorder risperidone
an implementation trial to improve access to pulmonary rehabilitation in people with copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: people with chronic obstructive pulmonary disease (copd) experience distressing breathlessness and high health care utilisation. there is compelling evidence that pulmonary rehabilitation improves symptoms and reduces hospitalisation, but is delivered to \<10% of patients who would benefit. the investigators developed a low cost model of pulmonary rehabilitation that can be delivered entirely at home. the homebase model had equivalent outcomes to centre-based pulmonary rehabilitation in a phase ii efficacy trial, with higher completion rates. the investigators hypothesise that a patient centred model offering a choice between home or centre-based pulmonary rehabilitation may increase program completion rates, with improved outcomes for patients and the health system. this is a cluster randomised implementation trial investigating whether offering a choice of home or centre-based pulmonary rehabilitation can reduce hospitalisation, improve pulmonary rehabilitation completion and enhance patient outcomes in people with copd. 14 pulmonary rehabilitation programs located across australia will each recruit 35 people with copd. intervention centres: people with copd will be offered the choice of centre-based pulmonary rehabilitation or the homebase model. comparison centres: only the existing centre-based model will be offered. the primary outcome is all cause, non-elective hospitalisation at 12 months. other outcomes are symptoms, exercise capacity and quality of life at 8 weeks and 12 months; and health care costs at 12 months for full economic evaluation.


Eligibility criteria:
inclusion criteria for pulmonary rehabilitation programs: • outpatient pulmonary rehabilitation programs that admit at least 50 people with copd each year. inclusion criteria for participants: * diagnosis of copd confirmed on spirometry * able to read, write and speak english * able to provide informed consent. exclusion criteria: * attended pulmonary rehabilitation within 1 year * comorbidities which preclude exercise training.

Keywords: pulmonary rehabilitation implementation copd
copana - a09 pcsk 9 substudy: impact of protease inhibitors on pcsk9 levels in naive hiv-infected patients

Conditions: HIV Seropositivity; Dyslipidemias; PCSK9

Summary: evaluation of the impact of initiation of protease inhibitor/ritonavir on pcsk9 levels in hiv-infected antiretroviral-naïve patients from the anrs c09 copana cohort.

background: hiv-infected subjects are at high risk of coronary heart disease (chd) partly in relation with atherogenic dyslipidemia including increased triglycerides (tg) and ldl-cholesterol (ldl-c). mechanisms of hiv-associated dyslipidemia are complex, involving hiv itself and some antiretrovirals (arv), particularly protease inhibitors (pi/r). elevated proprotein convertase subtilisin kexin 9 (pcsk9) level is associated with increased ldl-c in the general population. how pcsk9 level is regulated in hiv-infected treated patients has never been investigated. objectives: we aimed to identify factors associated with circulating pcsk9 concentration in art-naïve and treated patients and to evaluate the impact of 1st line arv therapy (art) comprising a pi/r, on pcsk9 level in hiv-infected patients. methods: fasting plasma concentrations of pcsk9 were measured using elisa assay in hiv-infected individuals from the anrs copana cohort, at art initiation and after one year of pi/r-based therapy without any disruption. subjects not virologically suppressed at follow-up, or taking any lipid lowering therapies at baseline or during follow-up were excluded. spearman's correlation coefficient was used to determine the association between pcsk9 levels and metabolic parameters at baseline and under pi/r.

Eligibility criteria:
inclusion criteria: * naive hiv-infected male or female \> 18 years * initiation of antiretroviral therapy including a protestase inhibitor during the follow up with blood samples available * patients controlled at one year with a vl\<400 copies/ml exclusion criteria: * subjects under statin or other lipid lowering drugs (fenofibrate, ezetimibe)

Keywords: hiv, dyslipidemia dyslipidemia protease inhibitor ritonavir pcsk9 observational
patch test skin irritation/sensitization of cetaphil daily advance ultra hydration lotion

Conditions: Determine Sensitivity of Skin to Cetaphil Daily Advance Ultra Hydrating Lotion

Summary: determine if cetaphil daily advance ultra hydrating lotion proves to be a contact sensitizer or irritant in certain individuals.


Eligibility criteria:
inclusion criteria: * not currently under a doctor's care * free of dermatological or systemic disorder which would interfere with the results * free of any acute or chronic disease * will complete a preliminary medical history form and are in general good health * can read, understand, and sign informed consent exclusion criteria: * under 18 years old * currently under doctor's care * currently taking any medication * history of acute or chronic disease * diagnosed with chronic skin allergies * pregnant or lactating
rehabotics: integrated rehabilitation system for people with motor disabilities

Conditions: Stroke; Spasticity, Muscle; Upper Extremity Dysfunction

Summary: the goal of the rehabotics project is the development of a comprehensive rehabilitation system to provide highly individualized treatment of upper limb function in patients with motor disorders due to acquired brain damage (eg stroke) or neurodegenerative disease (eg sclerosis), having as central pillar the integration of robotic systems and support functions. a key part of the proposed system is the development and evaluation of an innovative robotic extraskeletal device that will be applied in the form of a glove to the diseased limb of the neurological patient. the proposed robotic system: 1. will measure various motor and kinematic parameters of the extremity in order to assess the patient's condition and progress, and 2. will offer a specialized rehabilitation program (therapeutic exercises, retraining of functional movements and support of daily activities) through an interactive virtual environment provided by the rehabotics platform. the aim is to provide an environment for the provision of a high level of treatment and support services to patients with hand mobility disorders which will take place both in the clinical environment and in the patient's home through telemedicine applications. to demonstrate the efficiency of the proposed system, rehabotics will be applied on post-stoke patients for rehabilitation while also using a control group receiving traditional physiotherapy.


Eligibility criteria:
inclusion criteria: * stroke pathology, * ashworth scale ≤ 3, * 6 months maximum time since the incident exclusion criteria: * presence of neurological pathologies that affect hand motion (parkinson's disease) * musculoskeletal deficits that affect normal finger range of motion (e.g. finger fractures, joint stiffness/pain, arthritis that affect joint motion) * ashworth scale \> 3, * over 6 months since the incident
non-invasive sexually transmitted disease testing in women seeking emergency contraception or urine pregnancy testing

Conditions: Trichomonas Vaginitis; Chlamydia Trachomatis; Neisseria Gonorrhoeae Infection

Summary: the purpose of this study is to determine the prevalence and treatment rates of t. vaginalis, c. trachomatis, and n. gonorrhoeae in women seeking emergency contraception or urine pregnancy testing in the magee-womens hospital outpatient clinic using a non-invasive urine std test.

this study has three primary objectives: 1) to determine the prevalence of t. vaginalis, c. trachomatis, and n. gonorrhoeae in women seeking emergency contraception or urine pregnancy testing - a population likely at increased risk of acquiring stds; 2) to determine the rate of successful treatment in women diagnosed with stds in this venue.

Eligibility criteria:
inclusion criteria: * females at least age 15 at time of enrollment who are presenting at magee-womens hospital for emergency contraception or urine pregnancy testing. * ability to provide written informed consent. exclusion criteria: * diagnosis and/or treatment for an std within 4 weeks of enrollment in the study.

Keywords: trichomonas chlamydia gonorrhea emergency contraception emergency contraception use
brain function predictors and outcome of weight loss and weight loss maintenance

Conditions: Obesity

Summary: by doing this study, researchers hope to learn whether a person's motivation for food is different after he or she loses weight, and if imaging techniques such as fmri can be used to predict whether the person will maintain that weight loss over time.


Eligibility criteria:
inclusion criteria: * bmi equal to or greater than 30 kg/m2 or 18 to 24.9 * declaration they do not have plans to move out of the greater kansas city area for at least 1 year * willingness to be randomized * individuals undergoing weight loss will have to present written approval from a licensed physician that they are healthy enough to participate in a program of moderate diet restriction and moderate physical activity. exclusion criteria: * participation in a research project involving weight loss or pa in the previous 6 months, as these proximal experiences may impact the results of this study. * subjects who smoke * subjects who use special diets (i.e. vegetarian, adkins, etc.), use medications that affect metabolism (i.e. thyroid, beta blockers), use medications that affect appetite (i.e. meridia) or cannot exercise (i.e. walk). * exhibit signs of eating disorders, restraint, depression * participant has any metabolic disease that would affect energy balance (e.g. diabetes mellitus or hypothyroidism). * individuals who report being pregnant during the previous 6 months, are lactating, or planned pregnancy within 12 months * individuals who are not weight stable (± 4.5kg) within the previous 3 months or have more than 500 kcal/wk of planned physical activity * serious medical risk such as type 1 diabetes, cancer, recent cardiac event (i.e. heart attack, angioplasty, etc.)

Keywords: weight loss diet
substudy - evaluation of patients with iliac vein thrombosis

Conditions: Iliac Vein Thrombosis

Summary: patients with previous diagnosis of iliac vein thrombosis are enrolled in this registry. using standardized questionnaire, clinical data detailing venous thromboembolism and contributing vte risk factors are recorded. results of technical and laboratory investigations including screening of thrombophilic disorders were additionally entered into the database.


Eligibility criteria:
inclusion criteria: * \>18 years * subjects with iliofermoral thrombosis, which has been proven by objective measurements (duplex sonography, phlebography, ct/mrt) later than 1996 exclusion criteria: * \<18 years * \> 80 years * surface or deep vein thrombosis without affection of pelvis

Keywords: vte thrombophilia screening patients risk factors post-thrombotic syndrome
a study of safety & blood levels of idl-2965 in healthy subjects and patients with a special type of pulmonary fibrosis

Conditions: Healthy Volunteers; Idiopathic Pulmonary Fibrosis

Summary: the purpose of this study is to test the safety and tolerability of the drug candidate idl-2965 and to see how it is absorbed, processed, and removed by the body.

idl-2965 is an oral integrin antagonist antifibrotic being studied as a potential treatment for ipf and nonalcoholic steatohepatitis (nash). this double-blind, randomized, placebo-controlled, single and multiple oral dose study will be conducted in 3 parts. part a will comprise a single-dose, sequential-group design in healthy subjects, incorporating a food-effect evaluation. part b will consist of a multiple-dose, sequential-group design in healthy subjects. part c will be a multiple-dose, sequential-group design in subjects with ipf.

Eligibility criteria:
inclusion criteria: healthy subjects: • male and female subjects aged between 18 and 60 years, with a body mass index between 18.0 and 32.0 kg/m2. ipf subjects: * male and female subjects over 40 years of age. * diagnosis of idiopathic pulmonary fibrosis * idiopathic pulmonary fibrosis has been stable for at least 3 months. exclusion criteria: healthy subjects and ipf subjects: * significant history or clinical manifestation of any disease/disorder, other than ipf. * history of significant hypersensitivity, intolerance, or allergy to any drug compound * poor peripheral venous access * use or intend to use any medications, tobacco or nicotine containing products or electronic cigarettes. * history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs ipf subjects: • pulmonary function tests and other diagnostic procedures inconsistent with diagnosis of idiopathic pulmonary fibrosis.
multiple effects of dual-task focused training in individuals with chronic stroke

Conditions: Chronic Stroke; Dual Task; Physiotherapy

Summary: the aim of this study is to comprehensively investigate dual-task-focused training on balance, functionality, anxiety, healthy function and quality of life in chronic individuals. stroke is a clinical condition that occurs as a result of deaths in the brain blood and is an important public health problem, ranking third among the causes of death in the world and first among the diseases that cause disability. there are a limited number of studies in the literature investigating the effectiveness of dual task training in stroke rehabilitation.

unlike other studies in the literature, this designed study evaluates balance, functionality, anxiety, cognitive functions and quality of life in addition to walking, making it unique. in the light of all this information, the hypothesis of the study is as follows: application of dual-task-oriented training in addition to the regular physiotherapy program in individuals with chronic stroke affects balance, functionality, anxiety levels, cognitive functions and quality of life. it is planned to include 40 participants who meet the inclusion criteria in the study. after giving the necessary verbal and written information about the study, participants who receive informed consent will be randomized and divided into 2 groups of 20 people each. group 1 will receive 30 sessions of traditional neurological rehabilitation program every day for 6 weeks. in group 2, in addition to traditional neurological rehabilitation, a dual-task-oriented training program will be applied for a total of 12 sessions, twice a week. participants will be evaluated twice, before and after treatment. researchers will record personal information through a socio-demographic data form. balance will be evaluated with the berg balance test, functional status will be evaluated with the 10 meter walk test and timed up and go test, anxiety level will be evaluated with the beck anxiety scale, cognitive functions will be evaluated with the verbal fluency test, and standardized mini mental test and quality of life will be evaluated with the stroke specific quality of life scale.

Eligibility criteria:
inclusion criteria: * volunteering to work * being between the ages of 40-70 * being diagnosed with stroke * those who are not bedridden or wheelchair bound exclusion criteria: * people with sensory impairments (those with severe hearing and vision loss) * those with incompletely unioned fractures * people with infection * those who have vestibular problems and balance problems * those who cannot cooperate due to psychiatric or cognitive problems * serious heart failure etc. those with systemic disease * bilateral involvement * accompanying serious orthopedic problem
hfnc compared with facial mask in patients with chest trauma patients

Conditions: Chest Trauma; Hypoxia

Summary: guidelines for noninvasive ventilation (niv) recommend continuous positive airway pressure in patients with thoracic trauma who remain hypoxic . however, no any suggestion was applied for high flow nasal cannula (hfnc). therefore, our aim was to determine whether hfnc reduces intubation in severe trauma-related hypoxemia.

this would be a three-center randomized clinical trial of a level i trauma hospital. inclusion criteria were patients with arterial oxygen level (pao2/)fraction of inspired oxygen inspired oxygen fraction(fio2)\<300 while receiving oxygen by high-flow mask within the first 72 h after thoracic trauma. patients were randomized to remain on high-flow oxygen mask/ noninvasive ventilation or to receive hfnc. the interface was selected based on the associated injuries.

Eligibility criteria:
inclusion criteria: patients who have the following condition within 72 hours of chest trauma despite receiving standard nasal cannula oxygen therapy \[≥10 l/min\], are eligible for inclusion. * severe hypoxemic respiratory failure \[arterial partial pressure of oxygen (pao2)/fraction of inspired oxygen fraction(fio2) \<300 mmhg\] * with a respiratory rate \>25 breaths/minute and difficulty breathing, or respiratory distress * paco2 of 45 mmhg or higher (if the patient requires emergency surgery with endotracheal intubation and mechanical ventilation, the time of inclusion will be the start of the post-extubation period. (note: for patients who receive emergency trauma surgery with endotracheal intubation and mechanical ventilation, the time of inclusion assessment will be 72 hours after extubation.) exclusion criteria: 1. patients with a glasgow coma scale less than 8 or severe brain injury. 2. patients with any contraindications to non-invasive ventilation, including acute gastrointestinal bleeding, upper airway obstruction, or hemodynamic instability. 3. facial trauma involving skull base fractures, facial bone fractures, or orbital floor fractures. 4. severe injuries involving the nasal sinuses. 5. patients with cervical spine injuries. 6. patients with increased intracranial pressure. 7. patients with facial, nasal, or airway structural abnormalities or surgery that prevents the use of appropriate nasal cannula. 8. patients after upper airway surgery. 9. patients who are unable to clearly express their willingness to sign informed consent.