Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of ropinirole pr/xr tablets in monotherapy for parkinson's disease (pd)

Conditions: Parkinson Disease

Summary: this study was designed to evaluate the pharmacokinetic profile, safety and efficacy in parkinson's disease patients.


Eligibility criteria:
inclusion criteria: * patients who are diagnosed with pd with severity of the modified hoehn \& yahr staging at stage i to iii. * age: 20 years or older (at the time of giving informed consent) * gender: male and female * both inpatient and outpatient status * informed consent: patients who are able to give informed written consent in person (i.e. patients who are capable of giving informed written consent on one's own) * limited prior exposure to low or moderate doses of l-dopa (up to 3 months in total) or dopamine agonists (up to 6 months in total) provided treatment is discontinued for a minimum of 4 weeks prior to screening. exclusion criteria: * patients who present serious physical signs and symptoms other than those of the pd (e.g. cardiac/hepatic/renal disorder and haematopoietic disorder). the seriousness refers to grade 3 according to "the classification of the severity of adverse experiences (pharmaceutical affairs bureau/safety division (pab/sd) notification no. 80, dated 29 june 1992). * patients with symptomatic postural hypotension. (e.g. dizziness and syncope). * patients who have had serious psychiatric symptoms (e.g. confusion, hallucination, delusion, abnormal behaviour, alcohol or drug dependence) during the past six months (26 weeks) (including symptoms caused by anti-parkinson drugs). * patients who have been treated with the following drugs at week -4, and whose treatment regimen of the drug has been changed from week -4 to week 0. * anticholinergic agents: trihexyphenidyl hydrochloride (e.g. artane®), piroheptine hydrochloride (trimol®), mazaticol hydrochloride (pentona®), metixene hydrochloride (cholinfall®), biperiden hydrochloride (akineton®), profenamine (parkin®) * amantadine hydrochloride (e.g. symmetrel®) * droxidopa (dops®) * citicoline (e.g. nicholin®) * selegiline hydrochloride (fp®) * zonisamide * estrogen: estriol (e.g.estriel®) * cyp1a2 inhibitors: ciprofloxacin hcl (e.g. ciproxan®, enoxacin and fluvoxamine) * patients with severe dementia such as score 3 or 4 of the updrs part i (mentation, behaviour, and mood) * female patients who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study or within 30 days after the last dose of the study drug. * patients with current history or complication of carcinoma or malignant tumour. * patients who have history of drug allergy to ropinirole hydrochloride (hcl). * patients who have received surgical treatment for pd in the past (e.g. pallidectomy, deep brain stimulation). * patients who have been treated with any other investigational drug within 12weeks prior to the treatment phase. * others whom the investigator (sub investigator) considers ineligible for the study.

Keywords: parkinson's disease pd
a retrospective survey of the burden of rotavirus gastroenteritis (rv ge) and nosocomial rv ge in japan

Conditions: Nosocomial Rotavirus Gastroenteritis; Rotavirus Gastroenteritis

Summary: the purpose of this study is to evaluate the epidemiology and baseline disease burden of rotavirus gastroenteritis in children \< 6 years of age, in japan.

this is a retrospective database study wherein data on children who have been diagnosed with acute gastroenteritis or rotavirus gastroenteritis will be collected from the electronic admission database or any other applicable database of the participating hospitals.

Eligibility criteria:
inclusion criteria: * a male or female child aged \<6 years at the time of admission in hospital. a child will become ineligible on the day of her/his sixth birthday. * a subject who is hospitalized with any acute gastroenteritis or rotavirus gastroenteritis during the survey period. exclusion criteria: * participants of any kind of rotavirus vaccine clinical trial.
remdesivir efficacy in management of covid-19 patients

Conditions: Covid19

Summary: the study is open label randomized interventional phase 3 clinical trial. patients with confirmed covid-19 cases who was hospitalized in two university isolation hospitals (ain shams university and assiut university ) assigned hospitals for isolation.

the study is open label randomized interventional phase 3 clinical trial. patients with confirmed covid-19 cases who was hospitalized in two university isolation hospitals (ain shams university and assiut university ) assigned hospitals for isolation. the included patients receive. intervention group: remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days + methylprednisolone 1-2mg/kg for 5-7 days control group: standard of care without remdesivir

Eligibility criteria:
inclusion criteria: adult 18 -80 years old must have laboratory confirmed covid-19(a patient with laboratory confirmation (positive rt-pcr) of covid-19 infection, irrespective of clinical signs and symptoms according to ain shams university hospitals consensus statement on management of adult covid-19 patients. must have severe or immediately life-threatening covid-19, * severe disease is defined as: * dyspnea, * respiratory frequency ≥ 30/min, * blood oxygen saturation ≤ 93%, * partial pressure of arterial oxygen to fraction of inspired oxygen ratio \ 50% within 24 to 48 hours * life-threatening disease is defined as: * respiratory failure, * septic shock, and/or * multiple organ dysfunction or failure * must provide informed consent by patient or his/her legal guardian or professional legal representative exclusion criteria: * mild to moderately affected covid 19 confirmed patients. * pregnancy, lactation. * known hepatic failure. * patient who is not likely to comply to study procedures. * creatine clearance \<30 ml/min. * elevated transaminases \> 5 fold uln.
safety and efficacy study of clindamycin phosphate 1.2% and tretinoin 0.025% gel to treat rosacea

Conditions: Rosacea

Summary: the purpose of this study is to determine whether clindamycin phosphate 1.2% and tretinoin 0.025% gel are effective and safe in the treatment of papulopustular rosacea.

currently, there is no known cure for rosacea. the most effective treatment is systemic antibiotics, particularly of the tetracycline family. topical treatments include metronidazole, antibacterials such as erythromycin and clindamycin, sulfacetamide and benzoyl peroxide. isotretinoin (accutane) is also used.

Eligibility criteria:
inclusion criteria: 1. subjects 18 years of age and older. 2. clinical diagnosis of papulopustular facial rosacea. 3. a minimum of 4 but not more than 50 facial inflammatory lesions (papules plus pustules). 4. willing and able to understand and sign informed consent. 5. able to complete study and comply with study procedures. exclusion criteria: 1. acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment. 2. history or presence of regional enteritis or inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis, bloody diarrhea) or similar symptoms. 3. use of topical rosacea treatments in the past 2 weeks. 4. use of systemic antibiotics in the past 4 weeks. 5. use of systemic retinoids within the past 3 months. 6. use of laser or light based rosacea treatments within the past 2 months. 7. concomitant use of medications that are reported to exacerbate rosacea, such as topical and systemic steroids as these may impact assessments. 8. current drug or alcohol abuse. 9. other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or acne vulgaris. 10. clinically significant abnormal findings or conditions (other than rosacea), which might, in the opinion of the investigator, interfere with study evaluations or pose a risk to subject safety during the study. 11. subjects who are pregnant or planning a pregnancy. 12. use of any investigational therapy within the past 4 weeks. 13. known hypersensitivity or previous allergic reaction to clindamycin or retinoids

Keywords: rosacea clindamycin tretinoin clinical study treatment
retrospective observational study on prediction of response to pd-1 immunotherapy in patients with nsclc

Conditions: Advanced Non Small Cell Lung Cancer

Summary: therapeutic antibodies that block the programmed death-ligand 1 (pd-l1)/programmed death-1 (pd-1) pathway have revolutionized immuno-oncology by inducing robust and durable responses in patients with various cancer including advanced non-small-cell lung cancer (nsclc). however, these responses only occur in a subset of patients, even in case of pd-l1 overexpression. elucidating the determinants of response and resistance but also of severe immune-mediated adverse events is key to improving outcomes and developing new treatment strategies. biomarkers that predict immune checkpoint inhibitors efficacy and toxicity are urgently needed and could emerge from characterization of tumor microenvironment. the purpose of prediction project is to elucidate response and toxicity predictive immunophenotypic signatures using a new in situ multiplexed strategy with imaging mass cytometry hyperion. patients treated with anti-pd-1 pembrolizumab will be selected on their response and toxicity profiles. then, tumor samples will be analysed with hyperion technology, allowing delineation of cell subpopulations and cell-cell interactions, highlighting tumor heterogeneity and to determine correlations between response and toxicity features. the number of co-analysable markers enables global vision on the same tissue section. a better understanding of the tumor microenvironment complex system will lead to discover new predictive biomarkers potentially transferable to current practice.


Eligibility criteria:
inclusion criteria: * adult patients * advanced nsclc with pd-l1 tps of 50% or greater * administration of first line pembrolizumab between january 2017 \& december 2019 exclusion criteria: * auto-immune disease * prior exposure to immunotherapy * first dose pembrolizumab administered after december 2019

Keywords: pembrolizumab biomarkers multiplex imaging
clinical pharmacokinetics study of art-123 in disseminated intravascular coagulation (dic) subjects with renal impairment

Conditions: Disseminated Intravascular Coagulation

Summary: to investigate the impact of impaired renal function on the pharmacokinetics of art-123 in patients with disseminated intravascular coagulation. to investigate the safety of art-123 in patients with disseminated intravascular coagulation.


Eligibility criteria:
inclusion criteria: * japanese association for acute medicine-defined dic criteria score \>= 4 * written informed consent from patient or guardian exclusion criteria: * patients showing intracranial, pulmonary, gastrointestinal hemorrhage * patients with a history of cerebrovascular disorders within the past 52 week * patients with a history of hypersensitivity to the ingredients of art-123 preparations * pregnant women, nursing mothers or possibly pregnant women

Keywords: art-123 disseminated intravascular coagulation pharmacokinetics
caring for caregivers: supporting caregivers of youth with spinal cord injury

Conditions: Spinal Cord Injuries

Summary: the current study will implement and evaluate a multi-component, psychoeducational intervention for caregivers of children with spinal cord injury (sci) ages 7-12. two hypotheses will be tested. first, caregivers who participate in the intervention group will demonstrate better outcomes than caregivers in the control group. second, children with sci whose caregivers participate in the intervention group will demonstrate better outcomes than children with sci whose caregivers participate in the control group.

the primary objective of this study is to implement and evaluate an intervention for caregivers of children with spinal cord injury (sci) ages 7-12. a further objective of this pilot study is to identify which outcomes are being affected by the intervention. past research has highlighted psychoeducational intervention (i.e., interventions including both educational/skills-building components and psychological support) as most effective in terms of impacting caregiver functioning. the current study will recruit 44 caregivers and their children with sci. all caregivers will participate in a 2-day parent forum, an in-person educational session. caregivers will then be randomly assigned to receive monthly phone calls from a mental health professional ("intervention group") or no additional targeted support ("control group"). we expect that caregivers who participate in the intervention group and their children will demonstrate better outcomes than caregivers in the control group and their children.

Eligibility criteria:
inclusion criteria: * primary caregivers of youth with sci ages 7-12 years. * youth sustained their sci at least one year ago. * both the caregiver and child are able to speak english. * both the caregiver and child are able and willing to sign informed consent/assent and health insurance portability and accountability act (hipaa) compliant research authorization. exclusion criteria: * caregiver or child has significant cognitive limitations and/or psychiatric comorbidities. these conditions will be identified by a clinical psychologist or physician.

Keywords: caregivers spinal cord injuries psychology, educational counseling outcome assessment (health care)
eating disorders genetics initiative

Conditions: Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder

Summary: the overarching intention of the eating disorder genetics initiative (edgi) is to lay the foundation for all future genomic discovery in eating disorders--anorexia nervosa (an), bulimia nervosa (bn), and binge-eating disorder (bed)--by exploring both genetic and behavioral factors. to do this, information will be collected from 4000 people who have provided dna samples for the anorexia nervosa genetics initiative (angi) and the same information and dna will be collected from an additional 16,000 people. the goal is to better understand eating disorders and how they relate to each other so that better treatments can be developed.


Eligibility criteria:
inclusion criteria: * a lifetime history of anorexia nervosa, bulimia nervosa, binge-eating disorder, or no history of any disordered eating behavior * age 15-99 years exclusion criteria: * history of subthreshold disordered eating behaviors

Keywords: anorexia nervosa bulimia nervosa binge-eating disorder
at-home gait assessment

Conditions: Multiple Sclerosis

Summary: the goal of this study is to validate an ms gait remote capture and analysis (ms-grca) system based on wearable shoe-based motion sensors for home-based and repeatable gait assessments.

this is a single-site observational longitudinal study to validate an ms gait remote capture and analysis system for home-based and repeatable gait assessments. the investigators will recruit 30 participants who will have an in-person baseline visit (informed consent, standard gait assessment, sensor-based gait assessment, self-reported questionnaires), followed by three remote visits (sensor-based gait assessment, sus questionnaire \[last remote visit only\]).

Eligibility criteria:
inclusion criteria: * ages 18-70 years old (inclusive) * confirmed diagnosis of ms (any ms subtypes, relapsing remitting \[rr\], primary progressive \[pp\], or secondary progressive \[sp\]) * pdss score from 0 to 5 * stable and continuous access to internet at home * adequate home facilities (enough space, quiet and distraction free area) * ability to provide informed consent. exclusion criteria: * below average estimated premorbid cognitive functioning (based on wrat-4 reading recognition standard z-score \< 85). * presence of severe cognitive impairment (based on sdmt age normative z-score \< -3.0). * presence of primary neurological disorders other than ms or primary psychiatric disorder that would influence ability to complete assessments.

Keywords: gait analysis telehealth sensor-based gait analysis home-based
safety and efficacy of xj-procedure in patients with acute type a aortic dissection surgery

Conditions: Type A Aortic Dissection; Complication of Surgical Procedure; Aortic Diseases

Summary: this is a national, multicenter, open-label, randomized, controlled, endpoint-blinded clinical trial of patients diagnosed with ataad and undergoing "sun's procedure" coordinated by the first affiliated hospital of xi'an jiaotong university, china. per the protocol, "sun's procedure" combined with "xj-procedure" in the anastomosis of the aortic root and sun's procedure combined with regular suturing methods of the aortic root will be compared.

in this study, the investigators will prospectively enroll patients diagnosed with ataad and undergo "sun's procedure" from november 2024 to november 2027 in several centers, including the first affiliated hospital of xi'an jiaotong university, and will randomly divide them into xj-procedure group and control group. "the patients in the xj-procedure group will undergo "sun's procedure", in which the anastomosis of the aortic root will be performed with the xj-procedure. the patients in the control group will also undergo "sun's procedure", in which the anastomosis of the aortic root will be performed with each center. the primary outcome event is all-cause mortality within 12 months after surgery. secondary outcome events are (1) incidence of residual aortic root entrapment (during hospitalization, follow-up 3 months, 6 months, 12 months) (2) rate of secondary surgery for hemostasis due to root hemorrhage (during hospitalization) (3) incidence of anastomotic pseudoaneurysm (during hospitalization, follow-up 3 months, 6 months, 12 months) (4) rate of severe regurgitation of residual aortic valves (during hospitalization, follow-up 3 months, 6 months, 12 months) (5) incidence of major adverse cardiovascular and cerebrovascular events (macce) (during hospitalization, follow-up 3 months, 6 months, 12 months).

Eligibility criteria:
inclusion criteria: * age 18-70 years; * patients with ataad attending the relevant department who have been assessed by a clinician as needing "sun's procedure". exclusion criteria: * severe aortic root involvement (root diameter \>45 mm, root tear, severe destruction of the aortic root, combined valve disease); * combined coronary artery disease requiring concomitant coronary revascularization; * prior aortic or cardiac surgery; * preoperative severe malperfusion syndromes such as: severe cerebral complications (acute cerebral infarction, cerebral hemorrhage, coma, etc.); malperfusion of abdominal organs or lower extremities \>12 h; * preoperative combination of severe single or multiple organ failure; * pregnant women; * refused to sign the informed consent form and refused to participate in this study.

Keywords: type a aortic dissection aortic root reinforcement cardiovascular surgery postoperative complication
safety and efficacy of turoctocog alfa in previously treated male children with haemophilia a

Conditions: Congenital Bleeding Disorder; Haemophilia A

Summary: this trial is conducted in asia, europe, and north and south america. the aim of this clinical trial is to investigate the safety and efficacy of turoctocog alfa (recombinant factor viii, rfviii (n8)) in male previously treated paediatric subjects with haemophilia a.


Eligibility criteria:
inclusion criteria: * male patients with severe (baseline fviii less than or equal to 1%) haemophilia a * age below 12 years and weight at least 11 kg exclusion criteria: * surgery planned to occur during trial participation (exceptions are port placement, dental extractions, and minor, uncomplicated emergent procedures) * congenital or acquired coagulation disorders other than haemophilia a * any history of fviii inhibitors (greater than or equal to 0.6 bu/ml)
symptom clusters in cancer patients and their caregivers- a longitudinal study

Conditions: Cancer; Pain; Fatigue; Depression; Sleeping Problems

Summary: the complexity of cancer patients' symptoms and health problems constitutes considerable distress and burden for patients and their family caregivers. to help them manage the illness effectively, there is a need to better understand the complexity of symptoms and symptom clusters in patients and caregivers. therefore, the purpose of this research is to explore a set of important fundamental research questions to advance the scientific knowledge of cancer patients' and caregivers' symptoms, symptom clusters and health-related quality of life. the investigators will follow 500 cancer patients and their caregivers with repeated measures over 6 months to assess their symptoms, symptom clusters, and quality of life over time. caregiver burden will also be examined in the caregivers.

the specific aims of the study, where we will follow 500 cancer patients and their caregivers with repeated measures over 6 months, are to: 1. explore cancer patients' symptoms, symptom clusters and symptom changes over time; and identify subgroups of patients with different symptom clusters. 2. identify genomic markers for the different patient subgroups. 3. explore symptoms, symptom clusters and burden in caregivers of cancer patients. 4. explore relationships between patients' and caregivers' symptoms, symptom clusters, quality of life and caregiver burden. patients will be asked to complete questionnaires to collect demographic characteristics and self-reported medical history information, a general symptom inventory, specific measures of the symptoms of pain, sleep disturbance, fatigue, depression, functional status and quality of life. the patients' medical record will be reviewed for disease and treatment information. the caregivers will also be asked to complete questionnaires about a general symptom inventory, specific measures of the symptoms of pain, sleep disturbance, fatigue, depression, functional status, quality of life and caregiver burden. data analyses will be done to identify symptom clusters of the different symptoms, and to identify patient subgroups based on their symptom experience and quality of life. variations in symptom clusters and quality of life over time will also be evaluated. genetic analyses will also be done in the patients.

Eligibility criteria:
inclusion criteria for patients are: * diagnosed with breast, colon, head and neck or ovarian cancer * receiving active treatment for their cancer (chemo- or radiation therapy) * above 18 years of age * able to read / write /speak norwegian. inclusion criteria for caregivers: * above 18 years * read and speak norwegian * and written informed consent. exclusion criteria: * patients who had received radiation on the brain as this may affect their abilities to reliably complete questionnaires.

Keywords: symptoms pain fatigue depression sleeplessness genetic markers caregiver burden.
assessment of admission to the icu of onco-hematological patients.

Conditions: Hematological Diseases; Critical Illness

Summary: multicenter, observational and prospective study.

the data collection period will include 6 consecutive months, starting from the date of acceptance or conformity of the ceic. or, until an adequate sample size is reached that guarantees the statistical relevance of said analysis. all patients will subsequently be followed up 3 months after discharge from the icu.

Eligibility criteria:
inclusion criteria: * adults * solid organ tumor or hematological malignancy, exclusion criteria: -under 18 years old