Kornimate/medical-research-clean huggingface dataset:
get-a-grip lifestyle management programme

Conditions: Overweight and Obesity; Hypertension; Dyslipidemias; Diabetes

Summary: the primary aim of this study was to examine weight reduction in primary care in obese or overweight subjects with a comorbidity that would benefit from weight loss during 1-year comprehensive lifestyle management programme including medical examinations, personalized dietary and exercise advice, guidance on shopping behaviour and food preparation, and group discussions.

obesity is associated with altered glucose and lipid metabolism, and elevated blood pressure (bp) increasing the risk of cardiovascular morbidity and mortality. obesity-induced complications are increasingly encountered in the health care system and especially in primary care. thus, there is a growing need for individually tailored weight management programs aiming to permanent lifestyle and dietary changes for the prevention and treatment of obesity-related health hazards. the study investigated weight reduction during 1-year comprehensive lifestyle programme in 134 obese or overweight subjects (bmi\>30, or bmi\>25 with a comorbidity including diabetes, hypertension, arthrosis, asthma, chronic obstructive lung disease, sleep apnoea). the participants were recruited from the local diabetes centre and health care providers. the programme aimed at 5-10 % weight reduction utilizing exercise program supervised by personal trainer, advice on diet and on-location shopping behavior by a registered dietician, hands-on cooking classes by a professional chef, examinations by a medical doctor, and group discussions. the efficacy of the program was followed by measuring change in weight, bmi, waist circumference, fat and muscle percentage, visceral fat, and systolic and diastolic bp. the study protocol has been approved by the ethics committee of the pirkanmaa hospital district (r12099).

Eligibility criteria:
inclusion criteria: * bmi \>30 * bmi\>25 with a co-morbidity that would benefit from weight loss (diabetes, hypertension, arthrosis, asthma, chronic obstructive lung disease, sleep apnoea) exclusion criteria: * physical condition that prevented exercise * abuse of alcohol or drugs * medical history suggesting poor adherence * severe concurrent disease * moderate to severe dementia

Keywords: diet exercise lifestyle weight control
effectiveness of yoga on ambulatory blood pressure in patients with pre- and stage i hypertension

Conditions: Hypertension

Summary: the proposed study will compare a well defined and integrated yoga practice (postures/breath control/meditation) to a conventional exercise program in reducing hypertension. the expected outcomes include data on the effects of yoga on ambulatory blood pressure, psychosocial stress, and the autonomic system in individuals with pre- and stage i hypertension. the information gained in this study will have a positive impact by providing critical preliminary and feasibility data to support a larger multi-ethnic randomized clinical trial on the effects of yoga on individuals with hypertension.


Eligibility criteria:
inclusion criteria: * age: 21-64; pre- or stage i hypertension with mean office blood pressure (two measurements using aneroid sphygmomanometer) of systolic between 120 and 159 mmhg or diastolic between less than or equal to 80 and 99 \[1\] * medically stable on any current medications; bmi (kg/m2) between 18.5 - 40 * english speaking exclusion criteria: * taking anti-hypertensive medication; current use of insulin or oral hypoglycemic agents * previous cardiovascular event (prior myocardial infarction, stroke, or angina pectoris) * current or previous cancer diagnosis * congestive heart failure * history of kidney disease * signs or symptoms of significant peripheral vascular disease * significant co-morbidities that preclude successful completion of the study * yoga practitioner (participated in more than 3 yoga sessions within the last year)

Keywords: yoga, hypertension blood pressure autonomic nervous system
a pharmacovigilance study of brain oedema

Conditions: Brain Edema; Brain Edema Caused by Drugs

Summary: literature reports the development of brain oedema following the use of certain drugs. therefore, this study aims to present a comprehensive disproportionality analysis of brain oedema cases reported to the food and drug administration adverse event reporting system (faers).

brain oedema is a serious neurological condition, as it possesses a significant impact on the functional abilities of an individual by causing irreversible brain damage and potentiates the risk of mortality. apart from a number of medical conditions causing brain oedema, evidence suggests the association of various drugs with brain oedema. therefore, this study aims to provide a comprehensive disproportionality analysis of the drug-induced brain oedema reports in the faers database.

Eligibility criteria:
inclusion criteria: * brain oedema cases reported in the faers database till 31/03/2019 * adverse event reported was included using the meddra term: brain oedema exclusion criteria: * drugs with less than 19 brain oedema reports
multicenter orthopaedic outcomes network (moon) acl reconstruction (aclr): 10 year onsite follow-up

Conditions: Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Summary: in this study the investigators will examine patients who have undergone unilateral acl reconstruction surgery to determine which structural and functional characteristics of the knee two and ten years post reconstruction surgery, aspects of the original injury and repair, and patient characteristics are risk factors for osteoarthritis after acl reconstruction surgery.

the purpose of this study is to identify risk factors for signs and symptoms of osteoarthritis two and ten year post acl reconstruction from information available at the time of surgery. hypothesis: smoking status, older age, higher bmi, increased severity of cartilage injuries, increased meniscal resection, revision surgery, and incidence of additional arthroscopic procedures will result in more symptoms and signs of osteoarthritis at 10-year follow-up. primary outcome measures will be the joint space width measured on weight-bearing radiographs, as well as the pain subscale of the knee injury and osteoarthritis score (koos). secondary outcome measures will include the knee related quality of life subscale of the knee injury and osteoarthritis score (koos).

Eligibility criteria:
inclusion criteria: * had primary unilateral acl reconstruction performed by dr. kurt spindler (vanderbilt university), dr. christopher kaeding (the ohio state university), dr. rick parker (cleveland clinic), dr. jack andrish (cleveland clinic), dr. rick wright (washington university, st. louis), or dr. matthew matava (washington university, st. louis). * participated in the 2 yr onsite visit exclusion criteria: * unable to be consented * unable to participate for health reasons * history of intra-articular knee infection * history of total knee arthroplasty on either knee

Keywords: anterior cruciate ligament / injuries anterior cruciate ligament / surgery knee injuries / surgery outcomes research prospective studies osteoarthritis
surfactant application during spontaneous breathing with continuous positive airway pressure (cpap) in premature infants < 27 weeks

Conditions: Respiratory Distress Syndrome, Newborn

Summary: this study investigates the efficacy of surfactant application during spontaneous breathing with cpap in avoiding death and chronic lung disease (cld) in very immature infants with a gestational age of less than 27 weeks.

80 % of extremely preterm infants with a gestational age of less than 27 completed weeks suffer from severe idiopathic respiratory distress syndrome (irds). they are still at high risk of mortality and long term morbidity especially of the lung and the brain. at least death and chronic lung disease (cld) are related to the need and the duration of mechanical ventilation. continuous positive airway pressure (cpap) has been shown to be effective to avoid mechanical ventilation in the treatment of irds but it often fails in the most immature infants. early or prophylactic surfactant application is effective in the treatment of irds and is the only causal therapy, but it is usually related to intubation and mechanical ventilation that should be avoided.therefore to overcome the dilemma between need for mechanical ventilation with surfactant administration on the one hand and surfactant withholding with the use of cpap on the other hand, a strategy was developed to administer surfactant during spontaneous breathing with cpap (1). in the proposed prospective randomised controlled trial this strategy shall be compared with the recent gold standard in the therapy of extremely preterm infants with irds, that is intubation, mechanical ventilation and surfactant administration. based on the results of a feasibility (1) study and some clinical observations it is hypothesised that the new approach is superior in avoidance of death and chronic lung disease compared to the recent gold standard.

Eligibility criteria:
inclusion criteria: * irds with silverman-score ≥ 5 and / or fio2 ≥ 0,3 * postnatal age of more than 10 min. and less than 2 hours * gestational age ≥ 23+0 and \< 27+0 exclusion criteria: * primary cardio- pulmonary resuscitation * prenatally diagnosed severe malformation * no parental consent * participation in another interventional trial

Keywords: continuous positive airway pressure (cpap) extremely preterm infant idiopathic respiratory distress syndrome (irds) surfactant
a phase iii superiority study of vernakalant vs amiodarone in subjects with recent onset atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the primary objective of the study is to demonstrate the superiority of vernakalant injection over amiodarone injection in the conversion of atrial fibrillation (af) to sinus rhythm (sr) within 90 minutes of the start of drug administration. the secondary objective is to compare the safety of vernakalant to amiodarone.

this is a double-blind, active-controlled, double-dummy, multi-center, randomized trial in subjects with symptomatic af of 3 to 48 hours duration. subjects will be randomized to receive vernakalant injection or amiodarone injection in a 1:1 ratio. safety will be assessed through the monitoring of adverse events, vital signs, continuous telemetry monitoring, 12-lead holter monitoring, 12-lead ecgs, and laboratory tests. at 2 hours after the start of infusion, electrical cardioversion may be performed or rate control medication may be administered. class i and class iii antiarrhythmics are not to be administered for 24 hours after the start of infusion. subjects are to remain in the clinic for at least 6 hours after the start of infusion. subjects will attend a follow-up visit at 7 (±2) days after treatment and will receive a follow-up telephone call at 30 (±3) days for assessment of serious adverse events, concomitant medications related to serious adverse events, and recurrence of af. all roles were blinded with the exception of each site's designated unblinded personnel who were responsible for randomization and preparation, dispensation and accountability of the study medication. expanded access was not available through this protocol.

Eligibility criteria:
key inclusion criteria: * have symptomatic af of 3 to 48 hours duration at baseline. * be eligible for cardioversion. * have adequate anticoagulation therapy for cardioversion in accordance with standard of practice as recommended by acc/aha/esc guidelines \[1\]. * be hemodynamically stable and have systolic blood pressure (bp) above 100 mmhg and less than 160 mmhg and diastolic bp less than 95 mmhg at screening and baseline. key exclusion criteria: * known or suspected prolonged qt or uncorrected qt interval of \>440 msec as measured at screening on a 12 lead ecg, familial long qt syndrome, or previous torsades de pointes, ventricular fibrillation; or sustained ventricular tachycardia (vt). * symptomatic bradycardia, sick sinus syndrome, or ventricular rate less than 50 beats per minute (bpm) as documented by 12-lead ecg at screening. * a qrs interval \>140 msec. * atrial flutter. * significant valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis. * documented previous episodes of second or third degree atrioventricular (av) block. * had a myocardial infarction (mi), acute coronary syndrome or cardiac surgery within 30 days prior to entry into the study. * uncorrected electrolyte imbalance of serum potassium or magnesium. both k+ and mg2+ must be corrected prior to dosing.

Keywords: atrial fibrillation atrial fib af
non-invasive reduction of fat in the inner thighs

Conditions: Body Fat Disorder

Summary: evaluate the safety and efficacy of non-invasive fat reduction in the inner thighs with the zeltiq coolsculpting system.

the zeltiq coolsculpting system, which reduces subcutaneous fat in specific areas of the body, will be studied for safety and efficacy when used in the inner thigh.

Eligibility criteria:
inclusion criteria 1. male or female subjects \> 18 years of age and \< 65 years of age. 2. subject has clearly visible fat on the inner thighs and in the investigator's opinion, may benefit from the treatment. 3. subject has not had weight change exceeding 10 pounds in the preceding month. 4. subject with body mass index (bmi) up to 30. \[bmi is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.\] 5. subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in his/her diet or lifestyle during the course of the study. 6. subject has read and signed a written informed consent form. exclusion criteria 1. subject has had a surgical procedure(s) in the area of intended treatment. 2. subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment. 3. subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months. 4. subject needs to administer, or has a known history of, subcutaneous injections (e.g., heparin, insulin) into the area of intended treatment within the past month. 5. subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria. 6. subject has a known history of raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin. 7. subject has a history of a bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising. 8. subject is taking or has taken diet pills or supplements within the past month. 9. subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion). 10. subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system 11. subject is pregnant or intends to become pregnant in the next 8 months. 12. subject is lactating or has been lactating in the past 6 months. 13. subject is unable or unwilling to comply with the study requirements. 14. subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. 15. any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data, or would pose an unacceptable risk to the subject.

Keywords: cryolipolysis fat reduction
trimethoprim/sulfamethoxazole combined with caspofungin as first-line therapy in pcp

Conditions: Pneumocystis Pneumonia

Summary: this is a prospective, randomized clinical trial. during the study, non-hiv patients who are admitted to icu due to pneumocystic pneumonia (pcp) and have not received anti-pcp therapy or have received therapy less than 48hrs will be randomized (1:1) to received caspofungin combined with trimethoprim-sulfamethoxazole or trimethoprim-sulfamethoxazole alone. the aim of this study is to compare the effectiveness of caspofungin combined with trimethoprim-sulfamethoxazole with that of conventional therapy (trimethoprim-sulfamethoxazole alone) as first-line therapy in the treatment of severe pneumocystis pneumonia (pcp) in non-hiv patients.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old 2. non-hiv immunosuppressed patients admitted to the icu 3. confirmed or suspect pcp 3) not receiving anti-pcp treatment or anti-pcp treatment \< 48 hours exclusion criteria: 1. age less than 18 years old 2. known pregnancy 3. allergy to tmp/smz or caspofungin 4. decision to withhold life-sustaining treatment 5. patients with advanced pulmonary fibrosis 6. severe liver dysfunction(child-pugh c )
electronic medical records and genomics (emerge) phase iii

Conditions: Cardiac Disease; Cancer; Hypercholesterolemia; Diabetes; Kidney Diseases; Neuromuscular Diseases

Summary: the electronic medical records and genomics (emerge) network is in its third phase and during this time is enrolling and sequencing 25,000 individuals on a custom sequencing panel of clinically relevant, actionable genes. the genetic results will be returned to participants and outcomes tracked through the electronic health records.

the electronic medical records and genomics (emerge) network is a national human genome research institute (nhgri)-funded consortium tasked with developing methods and best practices for utilization of the electronic medical record (emr) as a tool for genomic research. phase iii is focused on returning actionable gene variants to patients and measuring clinical outcomes. ultimately, emerge hopes its efforts will result in improvements in health care, through safer and more effective prescription methodology, augmentation of primary and secondary prevention strategies, and enhanced understanding of the biology of disease. emerge is composed of 10 clinical sites \[ childrens hospital of pennsylvania (chop); cincinnati children's medical center (cchmc); columbia university; geisinger; kaiser permanente washington with washington university and the fred hutchinson cancer research center; harvard university; mayo clinic; meharry medical college; northwestern university; vanderbilt university medical center (vumc)\], one non clinical site: marshfield clinic, two sequencing centers \[baylor college of medicine; partners healthcare with broad institute\], a coordinating center (vumc), and the nhgri. more information on the emerge network can be found at www.gwas.org. each sites' research study is tailored to their specific interests. an emerge specific sequencing panel was designed and ran on participants covering 109 genes and 1551 single nucleotide variants (snvs), of which 68 genes and 14 snvs are clinically actionable and are being returned to patients.

Eligibility criteria:
inclusion criteria: * age: 1 day old * vital status: alive exclusion criteria: -none
multidisciplinary team intervention in cardio-oncology (titan study)

Conditions: Breast Cancer

Summary: people with breast cancer often experience many short and long-term side effects as a result of both the cancer and the necessary treatments. receiving extra assessments and care from teams of multiple health professionals has been shown to be helpful for people with other health problems, such as heart disease. these 'multidisciplinary' teams may include nurses, doctors, pharmacists, dietitians, exercise therapists, counselors, and other specialists. currently, the investigators do not know if receiving extra assessments from a multidisciplinary team is helpful for people receiving cancer treatment. in this study, the investigators hope to learn the effect of extra assessments and early interventions from teams of health care professionals in people diagnosed with cancer, during and after the treatment period. after initial assessments, participants will be randomized to multidisciplinary team intervention or usual care.


Eligibility criteria:
inclusion criteria: * histologically confirmed malignancy (breast or lymphoma); * scheduled to receive anthracycline and/or trastuzumab-based chemotherapy; * age ≥ 18 years; * willing to attend follow-up visits. exclusion criteria: * physical disability preventing exercise testing or dexa scan; * psychiatric disease or disorder precluding informed consent; * participation in other cardiotoxicity or exercise intervention study; * contraindication to anti-cancer therapy, including known heart failure, cardiomyopathy, or baseline lvef \< 50%; * previous anthracycline or trastuzumab-based therapy; * previous radiotherapy to thorax.

Keywords: multidisciplinary team exercise nutrition cardiology physiotherapy imaging
impact of a triage liaison physician

Conditions: Emergencies; Triage

Summary: due to an increasing number of patients admitted in emergency departments, many patients cannot be evaluated immediately after their admission. the function of "triage liaison physician" was introduced in spring 2015. the objective of this study is to evaluate the impact of this new function on patients' flow in the ed.

geneva university hospitals (guh) emergency department (ed) admits more than 64000 patients every year. these patients are triaged using the swiss emergency triage scale (sets), a 4-level triage scale. the sets imposes time objectives until the first medical evaluation (20 minutes for sets 2, 2 hours for sets 3). in 2014, only 60% of level-2 and 63% of level-3 emergencies were evaluated within 20 and 120 minutes respectively. a triage liaison physician was introduced in spring 2015 with the mission to help triage nurse in their decisions and to evaluate quickly the patients that cannot be immediately installed in an ed evaluation room. the objective of this study is to evaluate the impact of the triage liaison physician on the times to first medical evaluation.

Eligibility criteria:
inclusion criteria: * \>= 16 y * admitted in guh ed exclusion criteria: * patients triaged to outpatient clinics