Kornimate/medical-research-clean huggingface dataset:
propafenone versus amiodarone in septic shock

Conditions: Supraventricular Arrhythmia; Septic Shock

Summary: arrhythmias accompany septic shock in increased rates than in other icu cohorts and their presence and management are related to patient´s prognosis. 1c class antiarrhythmics are seldom administered in intensive care due to a dose dependent toxicity published in case reports and unfavourable outcome reported in a few prospective trials done on cardiology patients. the papers on 1c class antiarrhythmics do not take into consideration a complex haemodynamic assessment using echocardiography. the authors have recently presented a retrospective study on sv arrhythmias in septic shock patients demonstrating favourable effect and safety of propafenone which showed higher antiarrhythmic efficacy than amiodarone.

primary aim is to verify the conclusions of the retrospective study, i.e. efficacy and safety of propafenone, in a prospective blinded randomized trial performed in two large intensive care units. secondary aims are to monitor the electromechanics of left atrium in patients with sv arrhythmias in septic shock.

Eligibility criteria:
inclusion criteria: * septic shock with a new onset sv arrhythmia * lv systolic function normal to moderately reduced according to echocardiography. exclusion criteria: * severe lv systolic dysfunction * more than 1st degree av block * high dose vasopressor therapy with continuous noradrenaline \> 1.0 ug/kg.min * known intolerance to amiodarone or propafenone * absence of septic shock * chronic af * dependence on pacemaker * status after maze procedure

Keywords: supraventricular arrhythmia septic shock propafenone amiodarone intensive care
bendamustine and rituximab as salvage therapy in patients with chronic lymphoproliferative disorders

Conditions: Relapsed or Refractory Chronic Lymphoproliferative Disorders

Summary: this retrospective study collects and evaluates the clinical experience reached in italy on the use of bendamustine alone or combined with rituximab as treatment of patients with relapsed or refractory chronic lymphoproliferative disorders.


Eligibility criteria:
inclusion criteria: * patients with relapsed or refractory chronic lymphoproliferative disorders * salvage treatment with bendamustine +/- rituximab * age ≥ 18 years exclusion criteria: * previous treatment with bendamustine
music listening and sleep in rehabilitation of people with acquired brain injury

Conditions: Brain Injuries; Sleep Disturbance

Summary: an injury to the brain may lead to sleep-wake disturbances which may negatively influence functional recovery, quality of life and general rehabilitation. the purpose of this study is to investigate the effect of music listening on sleep disturbances after acquired brain injury (abi). during a 2 week intervention period patients with abi will listen to music for appr. 30 minutes before going to sleep. records of their sleep quality are compared to records of sleep quality from 2 weeks without music intervention. h1 hypothesis: music listening (ml) improves sleep quality after abi in patients. h0 hypothesis: music listening (ml) has no effect on sleep quality after abi in patients.

participants are recruited from vejlefjord rehabilitation - a neurorehabilitation center in denmark. patients who meet the inclusion criteria are enrolled in the study after informed consent. participants are randomly allocated to two conditions (ml+treatment as usual (tau) or tau only in a crossover design. randomization is done by sealed envelope, and after two weeks of either ml+tau or tau the participants switch condition. participants are asked to select one of four music playlists and listen to it for appr. 30 minutes at bedtime during the intervention period. participants will rate sleep quality and liking of the intervention. information about injury, demographic and socioeconomic status are derived from patient journals.

Eligibility criteria:
inclusion criteria: * in-patients with abi being treated at vejlefjord rehabilitation during the entire project period * age \> 18 years * sleep-wake disturbances corresponding a score of 5 or more on pittsburgh sleep quality index (psqi). * mentally and physically capable of administering music equipment, actigraph and self-report questionnaires. exclusion criteria: -

Keywords: brain injury acquired brain injury sleep disturbance music music therapy
comparison of cage versus plate in one level cervical disc disease

Conditions: Cervical Disc Disease

Summary: there are largely 2 surgical methods for one-level cervical disc disease; cage only and plate/graft. even there are many reports about the efficacy of either cage only or plate/graft, prospective comparative study is few. the object of the present study is to present design of prospective study and to demonstrate preliminary result.

prospective study was started from april 2004 after permission by our institutional review board. inclusion criteria were single cervical disc disease with radiculopathy/myelopathy. we excluded patients with severe spondylosis, multiple disc disease, overt instability, osteoporosis or previous cervical operation history. operation method was randomized using the table of random sampling numbers. all operations were performed with standard anterior-medial approach. two types of cages and 2 types of plates were used: cage, mc+ cage (ldr, austin, tx, usa) or solis cage (stryker, kalamazoo, michigan, usa); plate, black stone (orthofix, mckinney, tx, usa) or atlantis (medtronic, minneapolis, mn, usa). we checked neck disability index (ndi), neck visual analogue scale (vas) and limb vas before operation and 1/3/6/12/24/36 months after operation. disc height ratio, cervical lordosis, bone fusion status and segmental lordosis at the index level were measured from x-rays and follow-up x-rays were obtained at before operation and 1/3/6/12/24/36 months after operation. the present prospective study was planned until 80 patients (cage n = 40, plate/graft n = 40) were enrolled.

Eligibility criteria:
inclusion criteria: * inclusion criteria were single cervical disc disease with radiculopathy/myelopathy. exclusion criteria: * we excluded patients with severe spondylosis, multiple disc disease, overt instability, osteoporosis or previous cervical operation history.

Keywords: difference
a research study to see how much cagrisema lowers blood sugar and body weight compared to tirzepatide in people with type 2 diabetes treated with metformin with or without an sglt2 inhibitor

Conditions: Type 2 Diabetes

Summary: this study will look at how well cagrisema helps people with type 2 diabetes lower their blood sugar and body weight. cagrisema is a new investigational medicine. doctors may not yet prescribe cagrisema. cagrisema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. participants will get either cagrisema or tirzepatide. which treatment participant get is decided by chance like flipping a coin. participant will have an equal chance of receiving either drug. for each participant, the study will last for up to one and a half years.


Eligibility criteria:
inclusion criteria: * male or female (sex at birth). * age 18 years or above at the time of signing the informed consent. * diagnosed with type 2 diabetes ≥ 180 days before screening. * stable daily dose(s) ≥ 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without an sodium-glucose co-transporter-2 (sglt2) inhibitor. * hba1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening. * body mass index (bmi) of ≥ 30.0 kilogram per square meter (kg/m\^2) at screening. bmi will be calculated in the electronic case report form (ecrf) based on height and body weight at screening. exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method. * renal impairment with estimated glomerular filtration rate \< 30 milliliter per minute per 1.73 square meter (ml/min/1.73 m\^2) as determined by central laboratory at screening. * treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. however, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed. * uncontrolled and potentially unstable diabetic retinopathy or maculopathy. verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
swelling or malrotation of metacarpal shaft fractures in the evaluation of rotational deformity

Conditions: Metacarpal Shaft Fractures

Summary: rotational deformity or malunion causes the most significant functional deficit in these common fractures. the evaluation of the rotation may be performed with the metacarpophalangeal joints flexed although postoperative swelling may not enable this examination with flexion of the fingers. furthermore, it has been shown that swelling may cause rotation of the digit itself. the investigators propose that the swelling may cause a mistake in the estimation of rotation, during surgery and early follow up period. this is of special importance when open reduction and rigid fixation is performed. methods: prospective analysis of xx isolated metacarpal fractures treated, in yy patients was performed. end-on view of the finger-nail was taken with a digital camera on the day of or, at 2 weeks and at 1 year. the photos were taken on a standard apparatus and from a distance of xx cm and evaluated using zz software in comparison with photos taken of the other hand, according to the involved digit. range of motion, type of fracture and type of fixation were compared.


Eligibility criteria:
inclusion criteria: 1. isolated metacarpal fractures in one hand- fingers 2, 3, 4, 5 2. treated with cast or surgical treatment , closed or open reduction exclusion criteria: 1. multiple fractures simultaneously 2. fractures in both hands 3. former fracture in one of the fingers, two palms,metacarpal,proximal phalanx (with exception of the thumb) 4. open fracture, open wounds, infection 5. pregnancy, inability performing full x-ray follow up
personal values, interpersonal needs, and suicidal ideation in a veteran population

Conditions: Suicide Prevention

Summary: the primary aim of this study is to examine the relationship between personal values and suicidal thoughts in a sample of u.s. veterans.


Eligibility criteria:
inclusion criteria: * currently receiving care through the denver va medical center behavioral health interdisciplinary team * over the age of 18 * willing to travel to the denver vamc to complete assessment measures. * provide informed consent to participate exclusion criteria: * inability to adequately respond to questions regarding the informed consent procedure

Keywords: personal values suicidal thoughts
comparison of serum calcium level between preoperative vitamin d and non-vitamin d regimen of total parathyroidectomy in end-stage renal failure patients in rajavithi hospital

Conditions: End Stage Renal Disease

Summary: this research is compare about iv calcium between end-stage renal failure patients who take vitamin d and non-vitamin d preoperative parathyroidectomy


Eligibility criteria:
inclusion criteria: * new end-stage renal failure patients and have ipth\>800 pg/dl at least 6 months * patients who no response hyperphosphatemia with high dose vitamin d exclusion criteria: * allergy vitamin d * pregnancy * patients who parathyroidectomy have less than 4 gland

Keywords: hypocalcemia hyperparathyroidism end stage renal disease (esrd) calcitriol
pilot clinical study of the lrs thermosuit™ system in post arrest patients

Conditions: Heart Arrest; Coma

Summary: the purpose of this study is to determine if the life recovery systems thermosuit(r) system is able to quickly and conveniently cool patients who are comatose after resuscitation from cardiac arrest.

the primary purpose of this study is to clinically evaluate the use of a new cooling device (the lrs thermosuit(r) system) to cool patients who are comatose following resuscitation from cardiac arrest. this device cools by circulating cold water directly against the skin of the patient. cooling to a state of mild hypothermia (32 to 34 degrees c, maintained for 12 to 24 hours) is recognized by the american heart association, european resuscitation council, and the canadian association of emergency care physicians as a promising therapy for such patients, and is likely to be most effective if administered quickly following resuscitation. it is hypothesized that this new device will cool patients much more quickly than by historical means. patients will be monitored for physiologic parameters such as body temperature during the cooling therapy, and will be tracked for neurological outcomes following treatment.

Eligibility criteria:
inclusion criteria: * cardiac arrest prior to or during hospital admission, with restoration/return of spontaneous circulation (rosc). * cardiac arrest of presumed cardiac origin. * initial (pre-resuscitation) cardiac rhythm of ventricular fibrillation, non-perfusing ventricular tachycardia, pulseless electrical activity, or asystole. * estimated or known age \> 18 years. * intubation, ventilation and placement of esophageal probe. * estimated time from collapse to the initiation of advanced cardiac life support (acls) \< 15 minutes and return of spontaneous circulation with defibrillation within 60 minutes of collapse. * persistent neurologic dysfunction i.e. comatose upon enrollment \[gcs ≤ 8\]. exclusion criteria: * height greater than 188 cm. * elbow-to-elbow width greater than 60 cm (as measured above the supine patient). * core temperature less than 34°c after rosc (as measured at the tympanic membrane, esophagus, sub-lingual space, nasopharynx, or central blood vessel). * comatose state before the cardiac arrest due to the administration of drugs that depress the central nervous system. * known pregnancy. * response to verbal commands after rosc (but before enrollment). * known terminal illness that preceded the arrest. * known enrollment in another study of a device, drug, or biologic. * major trauma or other co-morbidity requiring urgent surgery. * improving neurologic status. * \> 8 hours since return of spontaneous circulation. * unknown time of arrest. * severe or known coagulopathy (with active bleeding). * hemodynamic instability despite vasopressors (sbp \ 30 minutes after rosc and before enrollment).

Keywords: resuscitation hypothermia
a study comparing lbec0101 to enbrel® in subjects with active rheumatoid arthritis despite methotrexate therapy

Conditions: Arthritis, Rheumatoid

Summary: this is a randomized, double-blind, parallel group, multicenter clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of lbec0101 compared to enbrel in subjects with active rheumatoid arthritis despite methotrexate therapy.


Eligibility criteria:
inclusion criteria: * male or female patients from 20 years to 75 years of age when signing informed consent. * diagnosed as having ra according to the revised 1987 acr criteria for at least 6 months prior to screening * patients who have inadequate response to mtx administered for at least 12 weeks before the beginning of screening period and on a stable dose. exclusion criteria: * patients with active tuberculosis or latent tuberculosis based on current clinical symptoms, chest x-ray test and ifn-γ release assay at screening * patients with any of the following concomitant diseases and/or history within 24 weeks before the first administration of investigational products in this study; serious infectious disease, opportunistic infection, chronic or recurrent infectious disease * patients with any seropositive result for hepatitis b or hepatitis c or hiv * patients who have any of the following diseases; sepsis, demyelinating disorders, lymphoproliferative disease, infection with prosthetic joint, autoimmune diseases other than rheumatoid arthritis
association between mitochondrial dna content and risk of acute leukemia

Conditions: Lymphoblastic Leukemia in Children

Summary: compelling epidemiological evidence indicates that alterations of mitochondrial dna, including mutations and abnormal content of mitochondrial dna (mtdna), are associated with the initiation and development of acute lymphoblastic leukemia (all).the aim of this study was to explore association between mtdna content in peripheral blood cells could be used as a risk predictor for all.


Eligibility criteria:
inclusion criteria: * 1.histological confirmed chronic lymphocytic leukemia; 2.preparing for chemotherapy; 3.no preoperative anticancer treatment. exclusion criteria: * 1.history of other malignancy; 2.blood transfusion within one month or prior bone marrow transplantation; 3.patients who reluctant to sign informed consent.

Keywords: mitochondrial dna
tso for plaque psoriasis

Conditions: Plaque Psoriasis

Summary: this is a randomized, blinded, multicenter study to assess the safety and treatment effect of 12 weeks of trichuris suis ova in subjects diagnosed with moderate to severe chronic plaque psoriasis.


Eligibility criteria:
inclusion criteria: * males or females, 18 to 75 years old. * diagnosis of stable plaque type psoriasis for at least 6 months prior to baseline * baseline moderate to severe psoriasis, defined as both of the following: 1. psoriasis covering a body surface area (bsa) ≥ 10%, and; 2. pga ≥ 3, and; 3. pasi ≥ 12 exclusion criteria: * patients who are currently taking or have taken in the past 30 days, for any reason, any medication that, in the opinion of the investigator, suppressed the immune response. this may include but is not limited to systemic steroids, azathioprine, methotrexate, cyclosporine, fk506, mycophenolate mofetil, mycophenolic acid, etanercept, adalimumab, infliximab, ustekinumab, cimzia, or any other biologic agent targeted to any cell or cytokine in the immune system. patients who are on inhaled or ophthalmic steroids are allowed. * patients who have demonstrated a primary lack of response to any one of the following biologic agents: etanercept, adalimumab, infliximab or ustekinumab. patients who initially responded to one of these agents but subsequently lost response (secondary lack of response) are eligible for study entry; however, secondary lack of response to more than one of these agents will exclude the patient from study entry.

Keywords: tso ova psoriasis plaque psoriasis plaque-type coronado moderate to severe plaque psoriasis
safety of hlf1-11 for the treatment of infectious complications among hsct recipients

Conditions: Fungal Infection; Bacterial Infection

Summary: the safety and tolerability of hlf 1-11 given in multiple doses has to be established first in hsct recipients who are at risk of developing, but have not yet developed, infectious complications due to invasive fungal or bacterial disease. these patients are different from healthy volunteers because they have received myeloablative treatment, which not only arrests haematopoiesis resulting in neutropenia but also induces mucosal barrier injury both of which predispose to infections, which typically occur during the week after transplant. it is therefore essential to know that hlf 1-11 is safe and well tolerated when given during neutropenia and mucosal barrier injury before infections ensue.

human lactoferrin (hlf) is a glycoprotein containing 692 amino acids and found in the saliva, milk, tears, and other body fluids. the peptide representing the first cationic domain, i.e. the peptide comprising the first eleven residues of hlf (further referred to as hlf1-11) was significantly more effective than the full length protein or the peptide representing the second cationic domain. as with other antimicrobial peptides, hlf1-11 shows poor antimicrobial activity under physiological conditions in vitro, but it is highly effective in vivo against infections due to a variety of microorganisms, including gram negative and gram positive bacteria and fungi. the objective is to develop hlf1-11 for the treatment of fungal and bacterial infections that develop during neutropenia that results from myeloablative therapy to prepare for a haematopoietic stem cell transplant(hsct) formerly referred to as bone marrow transplant. rates of infection and related morbidity are high in this population, making it an attractive target for testing clinically the proof-of-principle that hlf1-11 can provide effective treatment. subsequently, hlf1-11 will be developed further as a systemic antifungal agent

Eligibility criteria:
inclusion criteria: recipients will be eligible for inclusions if they satisfy the following conditions: * has been admitted for an autologous hsct after myeloablative therapy with high-dose melphalan; * is being managed with a 3 or 4-lumen central venous catheter; * is at least 18 years old; * has a bmi \<30 kg/m2; * has no medical reason for not participating * has adequate renal function (creatinine \< 1.5 x uln) * has adequate liver function (asat, alat \< 2.5 x uln, bilirubin \< 1.5 x uln); * if a woman, is functionally post-menopausal * has not participated in a study of a new chemical molecular entity in the previous 3 months * is able and willing to participate; * has provided written informed consent.

Keywords: lactoferrin hlf neutropenia myeloablative treatment fungal bacterial infections bone marrow transplant
transdermal testosterone for poor responder patients undergoing controlled ovarian stimulation prior to ivf

Conditions: Infertility, Female

Summary: this study evaluates the efficacy of pre- ivf treatment with transdermal testosterone to enhance ovarian response in poor responders. a randomized controlled trial with two groups, treatment group with transdermal testosterone before ivf treatment and a control group with no treatment.

one of the major challenges of assisted reproduction technology is treating women with low ovarian response,those women achieve very poor pregnancy rate with ivf. in recent years there is a focus

Eligibility criteria:
inclusion criteria: * infertility patients undergoing art regular menses normal function of thyroid, liver and kidney normal bmi (19.3-28.9) without use of any fertility drugs in the previous two months exclusion criteria: * patients with recurrent implantations failure (3 cycles and more) previous ovarian surgery uncontrolled medical illness severe endometriosis (stage 3-4) contraindication for testosterone use

Keywords: poor responders
efficacy and safety of cipros 10 association on the isolated hypertriglyceridemia and dyslipidemia treatment

Conditions: Hypertriglyceridemia; Dyslipidemia

Summary: the purpose of this study is to evaluate the efficacy of cipros 10 association in the treatment of dyslipidemia treatment


Eligibility criteria:
inclusion criteria: * participants of both sexes, aged 18 years or more; * participants with the diagnosis of dyslipidemia presentinf low or intermediate cardiovascular risk, according to the brazilian guidelines on dyslipidemia and prevention of atherosclerosis; * signed consent. exclusion criteria: * diagnosis of familial hypercholesterolemia and other genetic diseases; * using medications that may interfere with the metabolism or serum levels of triglycerides; * any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants; * presence of concomitant cardiovascular disease, renal failure and hepatic failure; * decompensated diabetes; * current smoking; * history hypersensitivity to the active ingredients used in the study; * pregnancy or risk of pregnancy and lactating patients; * history of alcohol abuse or illicit drug use; * participation in clinical trial in the year prior to this study.