Kornimate/medical-research-clean huggingface dataset:
treatment of patients suffering of alcohol dependence and impaired liver function with selincro® as-needed use

Conditions: Alcohol Dependence

Summary: the purpose of this study is to explore the treatment effects of selincro in alcohol dependent patients with liver impairment.


Eligibility criteria:
inclusion criteria: * the patient has alcohol dependence, diagnosed at screening according to dsm-iv-tr™ * the patient has had an average alcohol consumption at, at least, a high drinking risk level (that is \>60 g of alcohol/day for men and \>40 g of alcohol/day for women) in the 4 weeks preceding the screening visit and in the period between the screening and inclusion visits (that is, in the screening period) * the patient has liver impairment defined by elevated liver stiffness and elevated liver enzymes at the screening visit (both criteria have to be fulfilled): liver stiffness (ls) as measured by fibroscan \>6 kpa, elevated transaminases (ast or alt). transaminase levels up to 5 times the upper limit of the reference range and γgt levels up to 10 times the upper limit of the reference range are allowed. at the discretion of the investigator, transaminase levels \>5 times the upper limit of the reference range and γgt \>10 times the upper limit of the reference range can be allowed if considered habitual for the patient, either confirmed by patient records or a repeat measurement during the screening period * the patient has a breath alcohol concentration (brac) \<0.02% at the screening visit. * the patient provides a stable address and telephone number * the patient is a man or woman, aged ≥ 18 years * the patient has bmi≤30 kg/m2 exclusion criteria: * the patient has any psychiatric disorder or axis i disorder (dsm-iv-tr™ criteria), established as the primary diagnosis, other than alcohol dependence assessed using the mini international neuropsychiatric interview (mini) or another diagnostic interview , that in any way will interfere with the ability of the patient to take part in the study * the patient has reported current use of, or has been tested positive for, drugs of abuse (opiates, methadone, cocaine, amphetamines \[including ecstasy\], barbiturates) * the patient has severe liver impairment classified with a child-pugh score c * the patient has one or more clinical laboratory test values outside the reference range, based on the blood and urine samples taken at the screening visit, that are of potential risk to the patient's safety, or the patient has: severe renal impairment (egfr \ 300 mg/dl, (\>7,758 mmol/l), and/or bilirubin \> 3 mg/dl (50 μmol/l) * the patient has had \ 60 g for men or \>40 g for women) in the 4 weeks preceding the screening visit * the patient has \>5 consecutive abstinence days in the 4 weeks preceding the screening visit * the patient has a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures, or delirium tremens) other protocol-defined inclusion and exclusion criteria may apply.

Keywords: nalmefene, alcohol consumption, liver effects
nutritional status in patients with acute exacerbation of chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: a cross sectional observation study of body composition in copd patients consecutively hospitalized with acute exacerbation.

skeletal muscle dysfunction and changes in body composition are important extra-pulmonary manifestations of chronic obstructive pulmonary disease (copd) that occur in all stages of disease and are associated with poor outcome. in patients with copd, bioelectrical impedance analysis (bia) has usually been used to estimate fat-free mass (ffm) and body composition through predictive equations. very few studies had focused on raw bia data. the aim of this study is first describe the measurement of phase angle in patients with with acute exacerbation and second to determine the validity of phase angle in this group by assessing its relationship with established markers of function, disease severity and prognosis.

Eligibility criteria:
inclusion criteria: * previous diagnosis of copd based on history * hospitalization with acute copd exacerbation exclusion criteria: * patients with history of recent surgery (major) and trauma (major) * patients with concomitant disease that might alter nutritional status (heart disease, cirrhosis, uncontrolled diabetes, chronic renal failure, uncontrolled cor pulmonale). * contraindication to bia including an implanted pacemaker, defibrillator or joint prosthesis

Keywords: diet nutritional status acute exacerbation phase angle
robot-assisted rehabilitation of hand by paralysis of the upper limb after stroke

Conditions: Stroke

Summary: the investigators evaluate the effectiveness of the application of continuous passive motion device for hand rehabilitation in two classes of patients: with a residual active motion and without a residual active motion.

we will conduct a double blind clinical trial. a sample size calculation were performed to determine the necessary number of subjects needed for this study and was based upon the results of a previous pilot study. all patients had functional impairments of their upper extremities after the stroke. we hypothesized that the hand-rehabilitation oriented with robotics assistance, would improve edema by paralysis of the upper limb even in patient without sensory pathway recovery.

Eligibility criteria:
inclusion criteria: * a history of acute phase of stroke (less than 12 months post onset), * first stroke episode, * no history of peripheral nerve injury or musculoskeletal disease in the affected upper extremity, * no contracture of the affected wrist or fingers (modified ashworth\<3), * no history of any invasive procedure (botulinum toxin type a) for the treatment of spasticity for at least 6 months before the start of this study, * for p-rom patients, the absence of active hand movements, * for the a-rom patients, the presence of active hand movements. exclusion criteria: * unstable medical disorders, * active complex regional pain syndrome (crps), * severe spatial neglect, * aphasia, * cognitive problems.

Keywords: hand edema exercise therapy
exercise and cognition among stroke survivors

Conditions: Aerobic Exercise; Resistance Exercise

Summary: this study aimed to: (1) identify a suitable cardiopulmonary exercise testing protocol for people with moderate to severe movement impairments after stroke by investigating the safety and feasibility of delivering two methods of cpet modes: treadmill with body-weight support (tbws) and cycle ergometry (ce); and (2) explore the safety and feasibility of a delivering a 6-week exercise-based intervention or people with moderate to severe movement impairments after stroke, with a view to improve cognitive health.


Eligibility criteria:
inclusion criteria: * have provided informed consent, * are aged \>18 years, * are more than 6 months post-stroke, * score 2-3 on the functional ambulation category * can follow 1-stage commands i.e. sufficient communication/orientation for interventions in the trial. exclusion criteria: * attending any other community exercise class/gym/walking group/rehabilitation class, * a previous diagnosis of dementia or any other significant cognitive decline, * any musculoskeletal or neurophysiological disorder preventing participation in exercise, * have uncontrolled hypertension, atrial fibrillation, heart failure or diabetes. * weigh over 250lbs/113kg (due to weight restrictions on body-weight support harness on treadmill), * meeting any absolute or relative contraindication to exercise from american college of sports medicine (acsm) contraindications to exercise 2014, see below: absolute contraindications to exercise: * a recent significant change in the resting ecg suggesting significant ischaemia, recent myocardial infarction (within 2 days) or other acute cardiac event * unstable angina * uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise * symptomatic severe aortic stenosis * uncontrolled symptomatic heart failure * actuate pulmonary embolus or pulmonary infarction * acute myocarditis or pericarditis * suspected or know dissecting aneurysm * acute systematic infection, accompanied by fever, body aches or swollen lymph glands relative contraindications to exercise: * left main coronary stenosis * moderate stenotic valvular heart disease * electrolyte abnormalities e.g. hypokalaemia, hypo-magnesia * severe arterial hypertensions i.e. systolic bp of \>200mmhg and/or diastolic bp of \>110mmhg at rest * tachydysrthythmia or bradydsrhythmia * hypertrophic cardiomyopathy and other forms of outflow tract obstruction * neuromuscular, musculoskeletal or rheumatoid disorders that are exacerbated by exercise * high-degree atrioventricular block * ventricular aneurysm * uncontrolled metabolic disease e.g. diabetes, thyrotoxosis or myxedemia chronic infectious diseases e.g. mononucleosis, hepatitis, aids * mental or physical impairment leading to inability to exercise adequately
an evaluation of a web-based system for optimization of behavioral childhood obesity treatment

Conditions: Childhood Obesity

Summary: this study evaluates the families' and health care professional's experience from using a web based support system including mobile applications for self-monitoring weight and physical activity. changes in bmi standard deviation score are compared between usual care (control) and usual care with complementary web-based support system (intervention).

in this study children with obesity were randomized to either usual care according to regular routine (control group) or to usual care plus a web-based support system (intervention group). the system is based on a smartphone application connected to a scale and an activity measuring wrist-band. data is automatically transferred from the accessories to the smartphone, where data is presented graphically. the data is transferred to the clinic for support. the system is developed for communication between the clinic and family. the randomization was done at the start of individual treatment and lasted for 6 months. investigators studied the families and health care professional's experience of using the web-based support system as well as changes in bmi standard deviation score in the control and intervention group.

Eligibility criteria:
inclusion criteria: * obesity according to international obesity task force (iotf) * swedish speaking parents * parents able to use a smart phone * no pharmacological treatment that could intervene the obesity treatment exclusion criteria: * diagnosed with or undergoing assessment of neuropsychiatric disorder * structured obesity treatment the past 6 months * hypothalamic obesity

Keywords: mobile health, self-monitoring, behavioural treatment
long-term evaluation of the i-stop sling in stress urinary incontinence treatment

Conditions: Stress Urinary Incontinence (SUI)

Summary: evaluate quality of life and rate of reoperation after implantation of the i-stop sling for stress urinary incontinence

this is a prospective, multicenter, non-comparative, interventional post-marketing clinical follow-up study (pmcf) on a population of patients with sui requiring surgical treatment with implantation of an i-stop sling to document safety, the performance and effectiveness in the short, medium, and long term of these i-stop® implants used in their intended purpose.

Eligibility criteria:
inclusion criteria: * adult woman aged over 18 ; * patient with sui, having escaped "conservative" medical treatment, with indication for surgical treatment with implantation of an i-stop® strip via trans-obturator or retropubic route as indicated in the instructions for use of the sui implant ; * patient affiliated to a social security scheme; * patient capable of completing a self-questionnaire; * patient able to understand the protocol and follow the visit schedule; * patient having signed informed consent. exclusion criteria: * minor patient, pregnant or breastfeeding ; * adult patient subject to a measure of legal protection, guardianship, curatorship or deprived of liberty by judicial or administrative decision ; * patient presenting a contraindication to the use of the implant indicated in the instructions for use of the implant ; * patient with a medical contraindication to surgery and/or anaesthesia.

Keywords: i-stop mus sling
evaluation of the effects of teriparatide on skeleton images in postmenopausal women with osteoporosis

Conditions: Osteoporosis

Summary: the purpose of this study is to evaluate the effects of teriparatide on skeleton images in postmenopausal women with osteoporosis. teriparatide is a bone formation agent that stimulates the production of new bone in the skeleton. this process of bone formation can be studied using a technique commonly referred to as a bone scan or nuclear scintigraphy. this trial will test whether bone scans will identify areas of the skeleton that are forming new bone during teriparatide therapy. it also will study what these areas look like after therapy is stopped.


Eligibility criteria:
inclusion criteria: * ambulatory with osteoporosis * hip or spine bone mineral density (bmd) measurement more than 2.5 standard deviations below the average bone mass of young healthy women or more than 2.0 standard deviations in women who have a history of a vertebral or nonvertebral fragility fracture. exclusion criteria: * diseases of bone other than osteoporosis * treatment with estrogens in the 3 months prior to enrollment or for more than 2 months in the past year * treatment with oral bisphosphonates in the 3 months prior to enrollment or for more than 2 months in the past year; treatment with intravenous bisphosphonates in the 12 months prior to enrollment * increased risk for the development of osteosarcoma
an extension study of tocilizumab (myeloma receptor antibody [mra]) in patients completing treatment in tocilizumab core studies

Conditions: Rheumatoid Arthritis

Summary: this single-arm study evaluated the long-term efficacy and safety of tocilizumab in participants who had completed treatment in the tocilizumab core studies (nct00106522 \[roche protocol wa18062\], nct00106574 \[roche protocol wa18063\], and nct00109408 \[roche protocol wa17824\]) of adults with rheumatoid arthritis. participants received tocilizumab alone or in combination with standard anti-rheumatic treatment.


Eligibility criteria:
inclusion criteria: * patients who have completed participation in 1 of the core studies in adult rheumatoid arthritis. exclusion criteria: * treatment with any investigational agent since the last administration of study drug in the core studies. * treatment with iv gamma globulin, plasmapheresis, or prosorba column since the last administration of study drug in the core studies. * treatment with an anti-tnf or anti-il1 agent, a t-cell co-stimulation modulator, or any biologic since the last administration of study drug in the core studies. * immunization with a live/attenuated vaccine since the last administration of study drug in the core studies. * previous treatment with any cell-depleting therapies, including investigational agents. * parenteral, intramuscular, or intra-articular corticosteroids within 6 weeks prior to baseline in this study.
safety, pharmacokinetics (pk), and effectiveness of hydrocodone bitartrate (hyd) extended-release tablets in children

Conditions: Pain

Summary: the purpose of this study is to evaluate the safety, pharmacokinetics (pk), and effectiveness of hydrocodone bitartrate (hyd) tablets in children with moderate to severe pain requiring around-the-clock opioid analgesics.


Eligibility criteria:
inclusion criteria include: 1. males and females, aged 12 to 17 years, with pain severe enough to require daily, around-the-clock opioid treatment at a dose equivalent to at least 20 mg daily of hydrocodone for at least 2 weeks. 2. patients must have stable vital signs and hemoglobin oxygen saturation, eg, measured by pulse oximetry (spo2). 3. patients must be willing and able to swallow medicinal tablets. 4. female patients of childbearing potential must have a negative pregnancy test within 24 hours prior to the start of study drug treatment. 5. female patients who are sexually active must be using (and continue using throughout the study) an acceptable method of birth control, per investigator's discretion. 6. patients and patient's parent/caregiver must be compliant with the protocol, ie, must be able to perform study assessments and understand and complete the age-appropriate scale to rate pain intensity. 7. patients must not have a cognitive developmental delay or any other condition that would preclude them from completing the age-appropriate pain scale. exclusion criteria include: 1. patients who require a starting total daily dose of hyd \> 120 mg. 2. patients who have had surgery within 72 hours prior to the start of study drug treatment. 3. patients who have any planned surgery during the study will be excluded. 4. female patients who are pregnant or lactating. 5. patients who are allergic to hydrocodone or any other component of hyd or have a history of allergies to other opioids. 6. patients who receive or are expected to receive an investigational drug/therapy during the study drug treatment or follow-up period. 7. patients who are anticipated to receive any hydrocodone- or hydromorphone-containing products (other than study drug) during the study or 3 days prior to initiation of treatment with study drug. 8. patients with a history of alcohol, medication, or illicit drug abuse or addiction and/or opioid abuse or addiction at any time. 9. patients with contraindication to blood sampling. other protocol-specific inclusion/exclusion criteria may apply.
effect of an 8-week heartfulness meditation program on burnout and stress at veterinary specialty hospital

Conditions: Stress; Burnout, Professional

Summary: this quantitative study assesses the effects of meditation and relaxation practices on the reduction of burnout and stress in veterinary care workers. assessments at baseline will include the perceived stress scale (pss) and maslach burnout toolkit, and the same questionnaires were collected in week 8 and week 16. the google form questionnaire will ask the participant for their email address. the form will also include a question eliciting interest in participation in the 8-weeks heartfulness meditation program. the program will include tools that promote a heart-based nurturing environment focusing on relaxation, and tools to cope with burnout.

the purpose of this research is to investigate the effects of meditation and relaxation practices on the reduction of burnout and stress in veterinary care workers.

Eligibility criteria:
inclusion criteria: * above the age of 18 years * an employee of mspca-angell hospital exclusion criteria: * experience suicidal ideation * diagnosed with manic-depressive disorders * diagnosed with post-traumatic stress disorder (ptsd) * diagnosed with psychotic disorders, or any other psychiatric conditions requiring treatment all eligible members are encouraged to check with their healthcare provider before participation.

Keywords: heartfulness
prevalence and prognostic relevance of tricuspid regurgitation in different heart failure entities

Conditions: Tricuspid Regurgitation; Heart Failure

Summary: the present study includes patients with tricuspid regurgitation and heart failure diagnosed with echocardiography. the aim is to evaluate the physical performance of patients with tricuspid regurgitation and heart failure, to observe the course of the diseases and to allow a better understanding of new therapy options.

moderate to severe tricuspid regurgitation (tr) is a frequent result of left heart failure causing a limiting prognosis. the new interventional therapies have given more relevance to the questions of the prognostic significance of severe tr in the various heart failure entities. important but currently unanswered questions for the establishment of successful, interventional therapies of tr are: 1. what effect does tr have on patients with heart failure? 2. which patients at which stage of the disease benefit from interventional tr-therapies? in order to answer these questions, the aim of the study is to prospectively record the prevalence of tr (including quantification) in all heart failure patients at the charité, followed by long-term observation to assess its prognostic relevance. in addition to answering the above-mentioned questions, the project will allow a central registration of all symptomatic heart failure patients. a comparative outcome analysis per propensity score matching with the untreated patients of the registry would allow to give first considerations which patients are ideal candidates for interventional therapies. primary endpoint: death secondary endpoint: hospitalization due to cardiac decompensation, exercise capacity according to nyha classification

Eligibility criteria:
inclusion criteria: * patients with transthoracic echocardiography (tte) and heart failure * reported heart failure symptoms within the last two years * \>18 years * written, documented consent exclusion criteria: - patients in care or unable to consent
laparoscopic hernia defect obliteration with proflor-e

Conditions: Inguinal Hernia

Summary: this feasibility study highlights the features of the 3d dynamic responsive prosthesis proflor-e® for fixation free obliteration of inguinal hernia defect

the 3d dynamic-responsive prosthesis for inguinal hernia repair proflor-e® recently introduced to the market has been laparoscopically employed for the repair of one recurrent inguinal hernia previously managed with anterior open approach. the scope of this feasibility study is to demonstrate that the positive effects of the 3d implant already proven in open inguinal hernia repair are also effective or even superior for the laparoscopic of recurrent/bilateral inguinal hernias compared to conventional treatment concept.

Eligibility criteria:
inclusion criteria: * patients with recurrent inguinal hernia already repaired with open approach or suffering by bilateral inguinal hernias exclusion criteria: * asa \>4 patients

Keywords: inguinal hernia laparoscopic inguinal hernia repair inguinal hernia defect obliteration fixation free hernia repair regenerative scaffolds
fasting mimicking diet with chemotherapy in patients with leukemia

Conditions: Fasting Mimicking Diet; Leukemia

Summary: the goal of this clinical trial is to investigate the effect of fasting mimicking diet with chemotherapy on the number of blasts and platelets and quality of life in patients with acute lymphoid leukemia and acute myeloid leukemia.

the goal of this clinical trial is to investigate the effect of fasting mimicking diet with chemotherapy on the number of blasts and platelets and quality of life in patients with acute lymphoid leukemia and acute myeloid leukemia

Eligibility criteria:
inclusion criteria: * people who have recently been diagnosed with acute leukemia pathology and have been prescribed chemotherapy * willingness to cooperate * bmi \>18.5 exclusion criteria: * diabetes * metastases to other organ * unwillingness to continue the study by patients