Kornimate/medical-research-clean huggingface dataset:
a study to evaluate sage-217 in participants with parkinson's disease

Conditions: Parkinson Disease

Summary: this study assesses the safety, tolerability, pharmacokinetics and efficacy of sage-217 in 29 participants with moderate to severe parkinson's disease.

part a of the study is an open-label design with dosing of levodopa for 3 days followed by sage-217 for 4 days. part b of the study is an open-label design with evening dosing of sage-217 for 7 days as an adjunct to antiparkinsonian agent(s). this study was previously posted by sage therapeutics. in november 2023, sponsorship of the trial was transferred to biogen.

Eligibility criteria:
inclusion criteria: * participant has a diagnosis of idiopathic parkinson's disease (hoehn and yahr stage 2 or stage 3) with a duration of less than 7 years prior to screening \[part a\] * participant has a diagnosis of idiopathic parkinson's disease (hoehn and yahr stage 1-4, assessed during the "on" period) \[part b\] * participant is on a stable dose (at least 1 month prior to baseline visit) of an antiparkinsonian agent and is willing to remain on this dose for the duration of the study exclusion criteria: * participant has early (hoehn and yahr stage 1) or advanced (hoehn and yahr stage 4 or stage 5) parkinson's disease \[part a\] * participant has advanced (hoehn and yahr stage 5) parkinson's disease \[part b\] * participant with presence of drug-induced parkinsonism, metabolic identified neurogenetic disorders, encephalitis, or other atypical parkinsonian syndromes * participant with medical history of electroconvulsive therapy or stereotaxic brain surgery for parkinson's disease * participant with medical history of suicide attempt within 2 years of screening or current suicidal ideation * participant with medical history of impulse control disorder

Keywords: parkinson's
the effect of distraction methods on children aged 3-6 years receiving inhaler therapy

Conditions: Respiration Disorders

Summary: the aim of this study is to observe the effect of distraction methods on children aged 3-6 years who apply to the emergency department due to respiratory complaints and receive inhaler medication.

the research was designed based on voluntary participation in threegroups: the experimental group (doll and musical keyboard or musical book) and the control group. the inhaler drug application process is planned to be 10 minutes. first, routine explanations are given to the children in the experimental group, and the child is ensured to be in an upright position for the parent to be present and to administer the inhaler medication. the child is explained that a doll will accompany him during the inhaler medication administration, and a nebulization mask is attached to the doll. before starting the inhaler medication administration, the doll is placed next to the child in a sitting position. the child is asked to sit with the doll for 5 minutes and the child is asked whether he/she will play with a musical book or a musical piano.after the child decides which toy he/she will play with and plays with the toy for 5 minutes, the child fear scale (ccs) and the children's emotional indicators scale (çegö) are evaluated by the child, parent, researcher, nurse and vital signs before starting the procedure. later, when the researcher decides that the child is ready for the procedure, inhaler medication administration is started. after the drug administration is completed, the child, parent, researcher and nurse evaluate the cqs and cegrs, and vital signs are evaluated by the researcher, and the parent gives a parental satisfaction score. in the control group, a routine explanation of the emergency department is given to the child and the parent, the parent is next to the child and the child is ensured to sit upright during the inhaler medication administration. to the children in the control group, the researcher shows how the procedure will be done with a nebula mask on himself. the procedure begins after the necessary explanations are made and the researcher decides that the child is ready for inhaler medication administration. before starting the procedure, the child, parent, researcher, nurse and vital signs are evaluated by the researcher. after the inhaler intake is completed, çös and çegö child, researcher, nurse, parent; vital signs are evaluated by the researcher and parental satisfaction score is given by the parent.

Eligibility criteria:
inclusion criteria: * people who volunteer * children between 3 and 6 years old * children without mental problems children presenting to the emergency department with respiratory illnesses exclusion criteria: * children with a mental problem * non-volunteers
feedback intervention and treatment trial in patients with out-of-hospital cardiac arrest

Conditions: Out-Of-Hospital Cardiac Arrest

Summary: the trial collects and analyzes data from cardiac arrest centres in patients with out-of-hospital cardiac arrest (ohca).

with around 70,000 cases per year, out-of-hospital cardiac arrest (ohca) is one of the most common causes of death in germany. only less than 10% of patients with an ohca can currently be discharged with a satisfactory neurological outcome. the fitt-ohca trial is a quality management project and collects data from cardiac arrest centres on pre-hospital care and early post-resuscitation treatment in a standardized manner. the aim is to optimize the treatment process in patients following successful prehospital resuscitation through systematic data collection and feedback to the members of the rescue and treatment chain. the study includes cluster randomization of the participating hospitals.

Eligibility criteria:
inclusion criteria: * patients after cardiac arrest exclusion criteria: * refused register participation by patient or legal representative

Keywords: ohca out-of-hospital cardiac arrest in-hospital cardiac arrest resuscitation cardiac arrest center feedback intervention acute care medicine
a multiple dose study of bay1834845 in healthy male subjects and in patients with psoriasis

Conditions: Healthy Volunteers; Psoriasis

Summary: to assess safety and tolerability of multiple oral doses of bay1834845 in healthy male subjects (part 1) and in patients with psoriasis (part 2). to assess the pharmacokinetic (pk) properties of total bay1834845 in plasma after oral multiple doses of bay1834845 in healthy male subjects (part 1) and patients with psoriasis (part 2).


Eligibility criteria:
inclusion criteria: part 1 (healthy male subjects) * healthy male subjects, 18 to 50 years of age (inclusive), and in good health as determined by medical history, physical examination, vital signs, electrocardiogram (ecg), and laboratory tests at screening * body mass index (bmi) above or equal to 18.5 and lower or equal to 30 kg/m2 (bmi = body weight (kg) / \[height (m)\]2 and a body weight above or equal 50 kg part 2 (patients with psoriasis) * male patients, 18 to 70 years of age (inclusive) or female patients of non-child bearing potential, 30 to 70 years of age (inclusive) * body mass index above or equal to 18.5 and lower or equal to 35 kg/m\*2 and a body weight above 50 kg * a documented diagnosis of psoriasis, with a history of at least 6 months prior to study drug administration. moderate to severe plaque psoriasis at screening, defined by: a) an involved body surface area (bsa) above or equal to 10% of bsa, b) a psoriasis area and severity index (pasi) score of above or equal, 12 c) a physician's global assessment (pga) score of above or equal 2. exclusion criteria: * history of hypersensitivity to any of the components of the study drug * any clinically relevant abnormal findings in safety laboratory parameters and ecg * history of tuberculosis (tb) or active or latent tuberculosis * receipt of live or attenuated vaccine 90 days prior to the first dosing
impact of heparin on the need for mechanical ventilation in neonates

Conditions: Respiration, Artificial; Hemorrhage

Summary: this study is designed to test an incidental finding of a previous trial in which post hoc analysis showed that the rate of intensive care newborns requiring mechanical ventilation was lower in the group receiving heparin with the continuous infusion as compared to the placebo group.

title: randomized double blind trial comparing heparin and placebo as additives to continuous infusion in intensive care neonates for prevention of mechanical ventilation primary endpoint: percentage of neonates requiring mechanical ventilation in both groups secondary endpoints: duration of dependency on mechanical ventilation; major bleedings, incidence of heparin-induced thrombocytopenia and of anti-platelet factor 4/heparin antibodies

Eligibility criteria:
inclusion criteria: * newborns \< day 28 of life * necessity for intensive care treatment * necessity for parenteral drug or fluid application for at least five days * informed consent of parents exclusion criteria: * body weight \< 500g * mechanical ventilation directly after birth * major malformations * absolute indication for heparin * inborn hemorrhagic disease (e.g. hemophilia, von willebrand disease) * cerebral bleeding or other major bleeding * platelet count \< 50,000/µl
work of breathing in term infants

Conditions: Work of Breathing; Term Infant

Summary: this is a prospective observational cohort study conducted in the mother-baby unit at christianacare. the study is designed to assess work of breathing indices and oxygen saturation stability at discharge in full-term infants. data obtained will be used to perform a comparative analysis on work of breathing data for premature infants obtained from our previous study. we hypothesize full term (≥37 weeks gestation) infants have decreased work of breathing indices (i.e., phase angle) compared to premature infants (born 26-37 weeks gestation) at discharge.


Eligibility criteria:
inclusion criteria: * infants born ≥37 weeks gestation * admitted to the mother-baby unit * within 24 hours of expected discharge exclusion criteria: * infants born between \< 37week gestation admitted to the mother-baby unit at cchs * infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of work of breathing measurements will also be excluded.
effect of thoracic mobilization in females with coccydynia

Conditions: Coccyx Disorder

Summary: coccydynia is common and prevalent among the females and several types of exercises and electrotherapy are advised. pain can reduced significantly with both short wave diathermy and muscles stretches. there is limited evidence on indirect method like thoracic mobilization techniques to improve coccydynia. this study will determine the effects of thoracic mobilization techniques on coccydynia.

coccydynia, refers to pain in the coccyx region. it can be caused by various factor including trauma or injury (such as falls or child birth ), repetitive strain, prolong sitting on hard surface, or even idiopathic reasons. treatment options for coccydynia may include conservative measures, such as pain medication, using cushion or donut-shaped pillows to relieve pressure, applying heat or cold packs, and avoiding activities that's exacerbate the pain. physical therapy including exercises such as stretching, muscle energy technique (met) can also be beneficial in some cases. thoracic manual therapy, which involves hands-on techniques applied to the thoracic spine, can indeed be beneficial for improving spine mobility. while it may not directly target the coccyx itself, improving overall spinal mobility can have indirect effects on coccyx pain and dysfunction.

Eligibility criteria:
inclusion criteria: * diagnosed females coccydynia patients. exclusion criteria: * pregnancy * 6 months past surgery, fracture or dislocation of coccyx. * malignancy or cyst in the pelvic area.

Keywords: coccyx disorder thoracic
improving sympathetic activity, hot flashes, and sleep in midlife women using inspiratory muscle strength training

Conditions: Menopause; Hot Flashes; Blood Pressure Regulation

Summary: the purpose of this research is to understand how training the muscles used for breathing (inhalation) affects menopausal hot flashes, sympathetic nerve activity and sleep.


Eligibility criteria:
inclusion criteria: * females aged 45-60 with hot flashes. * participants will be recruited from rochester, mn and surrounding areas. * non-smokers. * bmi \< 40kg/m\^2. * no history of cardiovascular disease, except for hypertension. exclusion criteria: * detailed medical and social histories will be collected. to allow for ecological validity, participants will not be excluded for use of menopausal hormone therapy or medications affecting cardiovascular function so long as they have been on a consistent regimen for ≥3 months and during the study period. this approach to medications is consistent with recent work in this area. * participants will be screened for contraindications to inspiratory muscle strength training including, a history of spontaneous pneumothorax, collapsed lung that has not healed fully, a perforated eardrum that has not healed fully, and/or any other condition of the eardrum. * additional exclusion criteria will include the use of sleep aids (i.e., prescription, melatonin, doxylamine, valerian root, etc.).

Keywords: menopause blood pressure inspiratory training hot flashes
pet-ct in aml for detection of extramedullary aml manifestations

Conditions: Newly Diagnosed or Relapsed Acute Myeloid Leukemia

Summary: myeloid sarcoma (or granulocytic sarcoma or chloroma) is well defined by the who. however, there are currently no data about the prevalence, sites of occurence and thr prognostic value for patients with aml with this finding. information about this condition is based on retrospective analyses since there have been no studies trying to define the role of myeloid sarcoma in aml so far. this observational trial will include adult patients with newly diagnosed and relapsed aml in order to perform 18fdg-pet-ct imaging prior to induction chemotherapy. furthermore, a second 18fdg-pet-ct will be performed after induction chemotherapy to define the responsiveness of these tumors to chemotherapy. the primary endpoint of this study is the prevalence of 18fdg-pet-ct positive extramedullary aml manifestations (myeloid sarcoma) in patients with newly diagnosed or relapsed aml.


Eligibility criteria:
inclusion criteria: * patients with newly diagnosed or relapsed aml * aml fab m0-2, m4-7 * signed informed consent after patient information * male and female patients with aml age 18-80 * 18fdg-pet-ct is available within a period of 5 days after diagnosis of aml exclusion criteria: * aml fab m3 (promyelocytic leukemia) * lacking willingness to cooperate * pregnancy or insufficient contraception * 18fdg-pet-ct is not available within a period of 5 days after diagnosis of aml * medical condition of the patients requires an immediated start of chemotherapy

Keywords: acute myeloid leukemia myeloid sarcoma extramedullary acute myeloid leukemia 18fdg-pet-ct
evaluation of the impact of the pronetect education hub vs. classic lecture, on the competencies of nursing students

Conditions: Prone Position; Pressure Ulcer

Summary: the goal of this randomised controlled trial is to compare the impact of online educational material versus a classic lecture on the confidence levels, knowledge and knowledge application of final-year nursing students. participants will be asked to complete a baseline self-efficacy evaluation and a baseline knowledge test which were validated by the 11-member international expert panel previously established. after randomization, the control group will be asked to attend a classic 1-hour lecture at the nursing school about the topic of prone positioning and skin/tissue damage prevention. the experimental group will get access to the pronetect educational website containing short simulation videos and other learning materials. three weeks later the participants will be asked to complete the self-efficacy evaluation and knowledge assessment again, additionally a knowledge application assessment. all the questionnaires will be administered via qualtrics.


Eligibility criteria:
inclusion criteria: * final year nursing students studying towards their bachelor in nursing degree * chosen topics of critical care nursing as supplementary subject or critical care subjects as part of their course or complex wound management as part of their course. exclusion criteria: nursing students who are not yet in their final year of studies.
role of aging and individual variation in exercise training responsiveness

Conditions: Prediabetic State; Cardiovascular Diseases; Insulin Resistance; Obesity

Summary: the primary purpose of this study is to assess the effects of aging on markers of physical reserve and exercise-induced adaptations in resilience in older adults who completed a structured exercise program within the last 15 years (parent trial: strride-pd; nct00962962). this feasibility pilot study will enroll up to 8 participants to complete a 6-month aerobic exercise intervention.


Eligibility criteria:
inclusion criteria: * individuals who completed participation in the strride-pd trial (nct00962962) * body mass index (bmi) \> 18 and \< 45 kg/m2 * stable dose (≥1 month) of any cardiometabolic medications exclusion criteria: * poor vein access * current use of tobacco or any nicotine products, including e-cigarettes * insulin-dependent diabetes * active untreated hyper or hypothyroidism with thyroid stimulating hormone (tsh) concentrations \ 10.0 uiu/ml * systemic inflammatory or connective tissue disease, chronic infectious disease, chronic pulmonary disease or symptomatic cardiovascular disease with positive functional study by ecg or imaging * current, actively treated malignancy other than dermatologic conditions * absolute contraindications to exercise testing: ongoing unstable angina; uncontrolled cardiac arrhythmia with hemodynamic compromise; active endocarditis; symptomatic severe aortic stenosis; decompensated heart failure; acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis; acute myocarditis or pericarditis; acute aortic dissection; physical disability that precludes safe and adequate testing * relative contraindications to exercise testing: known obstructive left main coronary artery stenosis; moderate to severe aortic stenosis with uncertain relation to symptoms; tachyarrhythmias with uncontrolled ventricular rates; acquired advanced or complete heart block; hypertrophic obstructive cardiomyopathy with severe resting gradient; recent stroke or transient ischemic attack; mental impairment with limited ability to cooperate; uncorrected medical conditions, such as hypertension, significant anemia, important electrolyte imbalance, and hyperthyroidism * modified testing contraindications: acute myocardial infarction (mi) within six months; resting hypertension with systolic or diastolic blood pressures \>160/90 mmhg * unable to safely participate in an exercise program per study protocol per pi discretion * planned, intentional weight loss during study

Keywords: exercise cardiorespiratory fitness functional capacity cardiometabolic risk physical reserve physical resilience
iron supplementation in tavi and savr patients with iron deficiency

Conditions: Aortic Stenosis; Iron-deficiency

Summary: the inertia trial is a multicenter double-blinded randomized trial of intravenous iron supplementation in patients with severe aortic stenosis and iron deficiency undergoing tavi or savr. the primary endpoint is the time to hf hospital admission or cardiovascular death. secondary endpoints will assess quality of life indicators and functional capacity at 6 months.


Eligibility criteria:
inclusion criteria: * severe aortic stenosis * enrolled for tavi or savr procedures * documented iron deficiency with either: ferritin \<100ug/l or ferritin between 100-299ug/l and transferrin saturation \< 20%. exclusion criteria: * use of packed red blood cells or whole blood in the past 3 months; * use of erythropoietin-stimulating agent or iv iron in the past 3 months; * use of oral or iv iron (\>100mg/day) in the past 3 months; * haemoglobin (hb) levels \> 15g/dl or \< 8g/dl; * active cancer; * infection requiring antibiotic treatment at the time of first scheduled dose; * any known contraindication to study intervention
immunogenicity and safety of pentaxim in south african infants

Conditions: Diphtheria; Tetanus; Haemophilus Infections; Pertussis; Poliomyelitis

Summary: the present clinical study will assess the immunogenicity and reactogenicity of aventis pasteur's dtacp-ipv// prp\~t combined vaccine (pentavac™ or pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of age followed by a booster dose during the second year of life in order to meet the requirements for application for the use of the product in the expanded program on immunization (epi) in south africa.


Eligibility criteria:
inclusion criteria: * aged \< 24 hours on the day of inclusion exclusion criteria: * at visit 01 (screening) * illness at a stage that could interfere with trial conduct or completion. * any vaccination preceding the trial participation (except bacille calmette-guerin \[bcg\]) * acute illness on the day of screening. at visit 01 and visit 02 (screening and first study vaccination). * planned participation in another clinical trial during the present trial period * blood or blood-derived products received since birth. * mother known as seropositive to hiv or hepatitis b. * known thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination * history of/current seizures at visit 02 (first study vaccination) * participation in another clinical trial preceding the first trial vaccination * congenital or acquired immunodeficiency; immunosuppressive therapy such as long-term systemic corticosteroid therapy. * systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances * chronic illness at a stage that could interfere with trial conduct or completion. * any vaccination preceding the first trial vaccination (except bcg) * history of diphtheria, tetanus, pertussis, poliomyelitis, haemophilus influenzae type b and hepatitis b infection (confirmed either clinically, serologically or microbiologically). * previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, haemophilus influenzae type b and hepatitis b infection with the trial vaccine or another vaccine. * febrile illness (rectal temperature ≥ 38.0°c or axillary temperature ≥ 37.4°c) or acute illness on the day of first vaccination

Keywords: diphteria tetanus haemophilus influenzae type b poliomyelitis pertussis