Kornimate/medical-research-clean huggingface dataset:
sincalide (cholecystokinin octapeptide) versus placebo in neonates at high risk for developing parenteral nutrition associated cholestasis

Conditions: Cholestasis

Summary: objectives: i. compare conjugated bilirubin levels and serum bile acid levels in severely premature newborns on long term parenteral nutrition and given either sincalide or placebo. ii. compare morbidity and mortality rates in this patient population. iii. evaluate ultrasonographic images of the hepatobiliary tree during and 1 to 2 years after the administration of sincalide or placebo to assess the development of biliary sludge and biliary stone formation.

protocol outline: this is a randomized, placebo controlled, double blind, multicenter study. patients are stratified according to prematurity or surgical group. patients are randomized to receive either placebo or sincalide iv over 10 to 15 minutes every 12 hours until a total of 8 weeks of therapy is administered or greater than 50% of their nutrition is enteral. patients are followed for a maximum of 2 years. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- severely premature neonates (less than 1000 g at birth and estimated gestational age of no greater than 28 weeks) that require greater than 50% of caloric requirements by parenteral means within 7 days of birth or neonates with one or more of the following surgical conditions: necrotizing enterocolitis gastroschisis severe jejunal-ileal atresia within 7 days of diagnosis --prior/concurrent therapy-- biologic therapy: not specified chemotherapy: not specified endocrine therapy: not specified radiotherapy: not specified surgery: see disease characteristics no other cardiovascular (thoracotomy) or major gastrointestinal surgery (laparotomy) during the newborn period other: no prior or concurrent ursodeoxycholic acid no concurrent use of extracorporeal life support --patient characteristics-- performance status: not specified hematopoietic: not specified hepatic: conjugated bilirubin no greater than 1.0 mg/dl no primary or secondary liver disease no hepatic insufficiency as documented by either a biopsy with cirrhosis or elevated prothrombin time without evidence of systemic coagulopathy and no administration of an anticoagulant renal: no renal failure as indicated by a progressive increase in creatinine levels other: no hemodynamic instability no documented communicable infection (including infectious hepatitis or hiv) no metabolic pathway defect that is associated with liver dysfunction in the neonatal period including hereditary fructose intolerance, galactosemia due to transferase deficiency, and neonatal tyrosinemia

Keywords: cholestasis gastrointestinal disorders rare disease
stem cell therapy for amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: the effect of autologous bone marrow mononuclear cells on duration of survival in amyotrophic lateral sclerosis patients.

survival duration in amyotrophic lateral sclerosis patients who received cellular transplantation was compared to patients who did not receive cellular transplantation. kaplan-meier survival analysis was used for this comparison.

Eligibility criteria:
inclusion criteria: * patients with the diagnoses of definite amyotrophic lateral sclerosis. * clear information about date of onset of symptoms, documented contact information and follow up information exclusion criteria: * patients with diagnoses of progressive lateral sclerosis, progressive bulbar plasy, progressive spinal muscular atrophy, progressive muscular atrophy, monomelicamyotrophy or madras motor neuron disease. * patients with co-morbidities like presence of acute infections such as human immunodeficiency virus/hepatitis b virus/hepatitis c virus, malignancies, bleeding tendencies, renal failure, severe liver dysfunction and other acute medical conditions such as respiratory infection and pyrexia.
upper cross syndrome rehabilitation strengthening of the dorsal erector muscles

Conditions: Neck Pain

Summary: the purpose of this study is to determine which treatment is more effective for chronic neck pain associated with upper cross syndrome.

patients will divided in two groups, control and intervention. control group will do exercises of strengthening of deep cervical flexors, shoulder external rotators and adduction of scapulae. intervention group will do the same plus strengthtening of erector thoracic.

Eligibility criteria:
inclusion criteria: * chronic neck pain for at least 3 months * 52º or less in the craniovertebral angle * 50º or less in the shoulder angle exclusion criteria: * herniated disk, radiculopathy, diseases of the spine

Keywords: chronic neck pain upper crossed syndrome rounded shoulder posture
evaluation of an early management strategy for obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the primary objective of this study is to evaluate the effect of more timely care for obstructive sleep apnea (osa) on adherence to positive airway pressure (pap) therapy at three months after treatment initiation. the secondary objectives are to determine if earlier care improves the treatment effect of pap on patient reported sleepiness, quality of life and patient satisfaction. we will also evaluate the impact of shorter wait times on patient engagement in therapy by assessing initial acceptance of pap therapy, patient activation and self-efficacy with respect to osa treatment. the study hypothesis is that the early management strategy will be superior to usual care with respect to the primary outcome of pap adherence at three months.


Eligibility criteria:
inclusion criteria: * hsat odi \>= events/hr and ess 10 - 15 or * hsat odi 15 - 30 and ess 15 or lower exclusion criteria: * severe nocturnal hypoxemia on hsat (mean oxygen saturation by pulse oximetry (spo2) ≤ 85%) * severe hypersomnolence (epworth sleepiness scale score ≥ 16) * employed in safety-critical occupation * recent motor vehicle collision reported on screening questionnaire (within one year) * severe hypertension requiring ≥ three antihypertensive medications * recent admission to hospital due to unstable cardiopulmonary disease (within 30 days) * upcoming major surgery (within six months) * prior history of osa treatment * significant co-morbid sleep disorder that would interfere with pap acclimatization and adherence (e.g., severe insomnia, restless leg syndrome)

Keywords: access to health care time to treatment treatment adherence quality of care
the power of self-efficacy-based interventions in fostering caring self-efficacy and overcoming job-related stress and perceived stigma among psychiatric nurses

Conditions: Caring Efficacy

Summary: people with high self-efficacy set goals to challenge and improve their task achievement rate; however, people with low self-efficacy tend to have fluctuation in their ways of thinking, which results in dampened spirits. self-efficacy affects mental health. therefore, psychiatric nurses' achievements that affect their self-efficacy may differ from those of general workers or other nurses. in such a situation, psychiatric nurses feel that uncertainty of care and an unmotivated appearance of the patient can lead to reduced self-efficacy. consequently, nurses are likely to give up active involvement with patients who will not be leaving the hospital.

the intervention aims at increasing self-efficacy and consists of cognitive behavioural therapy (cbt)-based exercises related to sources of self-efficacy beliefs: 1) mastery experiences, 2) vicarious experiences, 3) verbal persuasions, and 4) emotional and physiological states.

Eligibility criteria:
inclusion criteria: * only psychiatric nurses. * still working at the time of data collection * willing to participate in the study
the effects of intravenous iron on mobility in elderly patients following hip fracture surgery

Conditions: Hip Fracture; Anemia

Summary: the primary aim of this clinical trial is to investigate the effects of intravenous iron on recovery in mobility compared to the pre-fracture level in patients with a hip fracture the main questions it aims to answer are: it is hypothesize that intravenous iron will enhance gains in mobility and hereby recovery of mobility, increase hemoglobin (hgb), lower fatigue, have a positive effect on skeletal muscles in the weeks and months after administration. the primary objective is to compare the effect of a single dose of ferric derisomaltose (fdi) (20 mg/kg body weight) relative to placebo on patients' recovery of functional mobility, measured as the change from baseline in the new mobility score. participants will: - receive either a single dose of intravenous fdi (20 mg/kg body weight) (and saline) or placebo (saline) at 1-5 days after surgery. this trial will be conducted at three hospitals in denmark, involving an anticipated 210 participants.


Eligibility criteria:
inclusion criteria: 1. 65 years of age or older 2. acute proximal femur fracture surgery 3. a hemoglobin measurement ≤6.5 mmol/l (10.5 g/dl) on day 1 to 5 postoperatively 4. independent prefracture indoor walking ability, indoor nms ≥ 2 5. ability to speak and understand danish 6. able to provide informed consent on the participants own behalf exclusion criteria: 1. known allergy to intravenous iron 2. residing permanently at a nursing home 3. hematological conditions with a risk of iron overload e.g. haemochromatosis, hemosiderosis, or where alternative treatments are necessary e.g. haematological malignancies 4. other contraindication to iron treatment, e.g. severe liver cirrhosis and hepatitis 5. severe uncontrolled infection as assessed by the responsible clinician (e.g. bacteraemia or sepsis) 6. plasma sodium levels below 125 or above 150 mmol/l on the day of inclusion 7. renal replacement therapy 8. severe dementia assessed by physician 9. recent intravenous iron injection, 4 weeks prior to surgery 10. patient declared terminally ill 11. pathologic fracture

Keywords: hip fracture anemia iv iron mobility perioperative optimisation randomized controlled trial
to evaluate the effectiveness(immunogenicity) and safety of 'gc3102c' administered intramuscularly in healthy adults

Conditions: Prophylaxis Against Influenza

Summary: the primary objective is to demonstrate the immunological non-inferiority between gc3102c and gc flu inj. influenza vaccines by assessing geometric mean titers(gmts) in healthy adults


Eligibility criteria:
inclusion criteria: * healthy adults, 18 to \<60 years old * subjets willing to provide written informed consent and able to comply with the requirements for the study exclusion criteria: * subjects with a history of hypersensitivity, especially anaphylactic reactions to egg, egg proteins, chicken or components of vaccine such as gentamicin, gelatin, and arginine * subjects with a history of guillain-barré syndrome * subjects with severe chronic diseases (e.g., cardiovascular diseases without controllable hypertension, hemoglobinopathy, respiratory, metabolic, and renal disorders) who are considered by the investigator to be ineligible for the study * subjects previously treated with anti-coagulant therapy or hemophiliac patients who may be at risk of severe hemorrhage after an intramuscular injection * subjects who have had an acute febrile (at least 38.0°c) episode at some time during the 72 hours before enrollment * subjects who have received a vaccination within 7 days before enrollment or who are scheduled for another vaccination (excluding the study vaccine) during the study * immunocompromised subjects with immunodeficiency diseases or those who are receiving immunosuppressive or immunomodulatory therapy, e.g., azathioprine, cyclosporin, interferon, granulocyte-colony stimulating factor, tacrolimus, everolimus, sirolimus * subjects who have received high-dose corticosteroids in the 3 months before vaccination or who will be administered a cumulative dose of 700 mg of corticosteroids during the study. inhaled, intranasal, and local application of corticosteroids is permitted, regardless of dosage, and corticosteroids such as prednisolone at a maximum dose of 15 mg/day are allowed * subjects who have been administered immunoglobulins or blood-derived products 3 months before enrollment or who are scheduled for the administration during the study * subjects who have received an influenza vaccine within 6 months of enrollment * a female subject who is pregnant or who is breast-feeding. subjects of childbearing potential without an appropriate contraceptive measure within 30 days before enrollment and who do not agree to use a clinically acceptable method of birth control during the study (e.g., oral contraceptives, condom, diaphragm or intrauterine device, or vasectomy of male partner) * subjects who have participated in any other clinical trials within 30 days of the administration of the study vaccine * individuals with other clinically significant medical or psychological condition who are considered by the investigator to be ineligible for the study
the effect of foot massage and bed bath on individuals with cancer

Conditions: Patients

Summary: foot massage or bed bath will be applied to improve sleep quality and reduce fatigue levels of individuals with cancer.

foot massage provides relaxation of the body with rubbing movements applied to the feet. the bathroom was an important part of the individual's general hygienic care in addition, it also ensures the physical and psychological comfort, safety and well-being of the individual.massage and bed bath are among the independent interventions of the nurse that help the individual to relax within the scope of the nursing regulation. this study was planned to determine the effect of foot massage and bed bath on fatigue and sleep level in individuals with cancer.

Eligibility criteria:
inclusion criteria: * over 18 years, * illiterate, * diagnosed with cancer * volunteer to participate in the study exclusion criteria: * unable to communicate verbally * patients who do not meet the inclusion criteria.

Keywords: cancer sleep quality fatigue bed bath foot massage
prescription patterns of antidepressants, analgesics, and antiepileptics drugs in adult with acquired brain injury

Conditions: Acquired Brain Injury Including Stroke

Summary: acquired brain injury (abi), primarily caused by stroke and traumatic brain injury (tbi), leads to severe disabilities and requires complex pharmacological management during post-acute rehabilitation. the lack of dedicated guidelines and regular treatment re-evaluation increases the risk of adverse drug reactions (adrs). retrospective, bicentric study in two rehabilitation centers in normandy, france, from november 1, 2020, to october 31, 2023, to describe prescription patterns of antidepressants, antiepileptics, and analgesics, as well as potential drug-related complications.


Eligibility criteria:
inclusion criteria: * adults hospitalized in a rehabilitation center for acquired brain injury (abi) after passing through an acute care department. * abi must be the primary diagnosis in the pmsi (french medical information system). * the pharmacological classes of interest (antidepressants, antiepileptics, analgesics) must have been introduced during acute care or within the first month of hospitalization in the rehabilitation center. exclusion criteria: * patients who did not receive new prescriptions for the pharmacological classes of interest during acute care or the first month of hospitalization in the rehabilitation center. * patients who were already prescribed these drugs prior to the abi. * patients who were not hospitalized immediately after discharge from acute care (patients must have been transferred directly from acute care to the rehabilitation center, without spending time in another department or at home). * patients who were transferred to an emergency department during rehabilitation and did not return to the rehabilitation center. * patients who died during hospitalization or were discharged against medical advice.

Keywords: acquired brain injury stroke traumatic brain injury rehabilitation prescription patterns antidepressants antiepileptics analgesics drug complications adverse drug reactions drug-drug interactions pharmacological management post-acute care
treatment of optic neuropathies using autologous bone marrow-derived stem cells

Conditions: Optic Neuropathy

Summary: a single arm, single center trial to assess the safety and efficacy of restoring function in damaged optic nerves using autologous purified populations of bone-marrow derived stem cells (bm-scs) through a 24 month follow up period.

optic nerve atrophy (ona) is a condition defined as a damage to the optic nerve that harmfully affects central and peripheral vision. ona may occur as a result of optic neuritis, compression by tumors or aneurysms, toxic and nutritional neuropathies, trauma, or as a secondary complication to other systemic diseases such as diabetes. symptoms of ona vary diversely, but mainly include blurred vision and a reduction in optic sharpness and color visualization. ona is irreversible process, and current medical strategies focus on finding the underlying cause, and trying to prevent further vision loss and protect the other healthy eye. this is a single arm, single center trial to assess the safety and efficacy of purified adult autologous bone marrow derived cd34+, cd133+, and cd271+ stem cells through a 24 month follow-up period. the combination of these three cell types was based on their diverse potentialities to differentiate into specific functional cell types to regenerate damaged optic nerves and supporting issues and vasculature, and the availability of clinical-grade purification system (clinimacs) and microbeads to purify the target cell populations in clinically-approved methods. anticipated outcomes of this study are defined in an overall improvement of vision, restoration of functions to damaged optic nerves, and improvement in quality of life of patients.

Eligibility criteria:
inclusion criteria: * patient should suffer from optic nerve atrophy diseases like diabetic retinopathy and retinal pigmentation. * age in between 18-55 years old * willingness to undergo bone marrow derived autologous cell therapy. * ability to comprehend the explained protocol * ability and willingness to regularly visit to hospital for protocol and follow up exclusion criteria: * patients with preexisting or current systemic disease such as lung, liver, gastrointestinal, cardiac, immunodeficiency, syphilis, or clinically relevant polyneuropathies. * history of life threatening allergic or immune- mediated reaction

Keywords: optic neuropathies stem cell therapy
low vs. standard daily doses of antiepileptic drugs in newly diagnosed, previously untreated epilepsy(standlow)

Conditions: Epilepsies, Partial

Summary: there are no guidelines on the first maintenance daily dose of antiepileptic drugs (aeds) in newly diagnosed, previously untreated epilepsy. original trials and cochrane reviews show that seizure remission can be achieved with differing daily doses. in clinical practice, the first maintenance dose varies significantly. in contrast, the risk of adverse treatment effects increases with dosage. there is thus the need to identify the lowest effective dose for treatment start. this background prompted us to undertake a randomized multicenter pragmatic non-inferiority trial comparing standard to low daily doses of aeds to demonstrate that low doses are at least as effective as standard doses (as indicated by the national formulary) but are better tolerated and are associated with a better quality of life. if proven as effective as the standard dose, a low daily dose of aeds is a benefit to the patient in terms of tolerability and safety and a source of savings for the national health system.


Eligibility criteria:
inclusion criteria: 1. age 18 years or older; 2. newly diagnosed previously untreated epilepsy, defined according to the ilae definition (fisher et al, 2014); 3. having experienced focal seizures, defined according to the ilae criteria (commission, 1981); 4. able to understand and comply with the study requirements and release a written informed consent. exclusion criteria: a patient will be excluded if at least one of the following criteria will be met: 1. age less than 18 years; 2. having experienced primarily or secondarily generalized tonic and/or clonic seizures, or other (non-focal) seizure types; 3. previous exposure to aeds; 4. requiring low or standard doses on account of individual needs; 5. inability to understand the aims or modalities of the study; 6. current pregnancy or planning to become pregnant during the study period (e.g. who are not post-menopausal, surgically sterile, or using inadequate birth control). a postmenopausal state is defined as no menses for 12 months without an alternative medical cause; 7. previous treatment with an antiepileptic drug; 8. men unable to practice contraception for the duration of the treatment. 9. poor compliance with assigned treatments; 10. refusal to release written informed consent; 11. the study investigators will receive the summary of product characteristics (spc) available for each study drug. patients cannot be enrolled in the study if the contraindications/warnings described in the spc are met.

Keywords: epilepsy antiepileptic drugs low dose standard dose new diagnosis