Kornimate/medical-research-clean huggingface dataset:
impact of congenital heart disease on neurodevelopmental outcome

Conditions: Heart Defects, Congenital

Summary: the project aims toward clarifying the underlying mechanism and the long-term impact of congenital heart disease on neurodevelopment.

the project provides detailed information on the impact of congenital heart disease on neurodevelopmental outcome in adulthood. the study investigates if brain maturation and development, and the neurocognitive outcome is compromised in patients with atrial or ventricular septal defects more than 20 years after diagnosis and treatment. data on brain morphology, brain tissue architecture, and resting-state function will be obtained by 3.0 tesla mri. data on neurocognitive outcome will be obtained by a customized wide neuropsychological test battery. this study will clarify the extent of these patients' neurodevelopmental challenges and guide evaluate targeted interventions to alleviate potentially long-term effects.

Eligibility criteria:
inclusion criteria: * icd codes dx q21.0 (vsd) or dx q21.1 (asd), surgically repaired vsd or open asd exclusion criteria: * lack of medical record, suffering from coronary artery disease or other congenital cardiac abnormalities, diagnosed syndromes, spontaneous closure of the atrial septum defect before inclusion-date, magnetic implants or non-mri compatible foreign objects, pregnancy, lack of danish language skills or suffering from severe lung disease

Keywords: magnetic resonance imaging brain neuropsychology heart defects, congenital follow-up studies
pharmacokinetic properties of lorcaserin in obese or overweight elderly subjects

Conditions: Obesity

Summary: the purpose of this study is to evaluate the pk properties of lorcaserin in obese or overweight elderly subjects.


Eligibility criteria:
inclusion criteria: 1. males or females 2. control (adult) group: aged between 18 and 65 years (inclusive) 3. elderly group: aged \> 65 years (includes subjects 1 day or more beyond the 65th birthday) 4. able to give signed informed consent 5. bmi 27-45 kg/m2, inclusive 6. eligible male and female subjects must agree not to participate in a conception process (i.e. active attempt to become pregnant or to impregnate, egg or sperm donation, in vitro fertilization). 6. considered to be in stable health in the opinion of the investigator exclusion criteria: 1. prior participation in any study of lorcaserin. 2. clinically significant new illness in the 1 month before screening 3. not suitable to participate in the study in the opinion of the investigator including an existing physical or mental condition that prevents compliance with the protocol 4. history of any of the following cardiovascular conditions: * myocardial infarction (diagnosed by cardiac enzyme\[s\] and/or diagnostic ecg), cerebral vascular accident (cva), transient ischemic attack (tia) or reversible ischemic neurologic deficit (rind) within 6 months of screening * cardiac arrhythmia requiring initiation of new medical or surgical treatment within 6 months of screening (stable medical therapy for \> 6 months, pacemakers and/or defibrillators implanted \> 6 months prior to screening are acceptable) * unstable angina * history of pulmonary artery hypertension 5. positive result of hiv, hepatitis b or hepatitis c screens 6. initiation of a new prescription medication within 1 month prior to screening with the following exceptions: 7. use of ssris, snris, and other medications must meet washout period. 8. participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening
an open, single-arm, multi centre pilot investigation to evaluate the debriding effect of chlorasolv® on chronic wounds

Conditions: Chronic Ulcer at Lower Leg

Summary: the primary objective of this clinical investigation is to evaluate the debriding effect of chlorasolv® on chronic (more than 1 moth) lower leg ulcer.

approximately 58 subjects from at least two sites in sweden will be included. subjects presented with lower leg ulcer, covered with devitalised tissue for 50% or more and being candidate for cleansing, debridement/desloughing will be enrolled. weekly application of investigational product for 6 weeks. follow-up for wound status evaluation after 12 weeks from baseline. total time in investigation is 12 weeks.

Eligibility criteria:
inclusion criteria: 1. full skin ulcer at lower leg covered with devitalised tissue ≥50% 2. candidate for cleansing, debridement/desloughing 3. wound area ≥2 cm² 4. male or female, 18 years of age and above 5. able to read and understand the patient informed consent and to provide meaningful written informed consent 6. able and willing to follow the protocol requirements exclusion criteria: 1. clinical signs of system progression infection with or without ostemyelitis 2. wound located where treatment is not possible 3. subjects not suitable for the investigation according to the investigator's judgment 4. subjects included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator 5. known allergy/hypersensitivity to any of the components of the investigational device 6. pregnant or breast feeding women 7. other significant medical condition that the investigator determines could interfere with compliance or study assessments 8. subjects with wounds of duration less than one month 9. wound area greater than approximately 60 cm²
brivaracetam as add-on treatment in adolescents and adults suffering from epilepsy

Conditions: Epilepsy

Summary: this study will compare the safety and efficacy of brivaracetam at flexible dose with placebo in subjects suffering from epilepsy.


Eligibility criteria:
inclusion criteria: * subjects were aged from 16 to 70 years, inclusive. subjects under 18 years of age were only included where legally permitted and ethically accepted * subjects had well-characterized localization-related epilepsy or generalized epilepsy according to the international league against epilepsy (ilae) classification * for subjects suffering from localization-related epilepsy: subjects had at least 2 partial-onset seizures (poss) whether or not secondarily generalized per month during the 3 months preceding visit 1 according to the ilae classification * for subjects suffering from localization-related epilepsy: subjects had at least 4 partial-onset seizures (poss) whether or not secondarily generalized during the 4-week baseline period according to the ilae classification * for subjects suffering from generalized epilepsy: subjects had at least 2 type ii-seizure days per month during the 3 months preceding visit 1 according to the ilae classification * for subjects suffering from generalized epilepsy: subjects had at least 4 type ii-seizure days during the 4 week baseline period according to the ilae classification * subjects were uncontrolled while treated by 1 to 3 permitted concomitant antiepileptic drugs (aeds). vagal nerve stimulation was allowed and was not counted as a concomitant aed exclusion criteria: * for subjects who suffered from localization-related epilepsy: history or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before visit 2 or occurring only as type ia non-motor * subjects with a history or presence of status epilepticus during the year preceding visit 1 or during baseline

Keywords: epilepsy brivaracetam partial onset seizures
non-steroidal anti-inflammatory drugs (nsaids) and risk of acute kidney injury in patients with heart failure

Conditions: Heart Failure

Summary: the purpose of this study is to evaluate whether non-steroidal anti-inflammatory drugs (nsaids) were associated with acute kidney injury (aki) in patients with heart failure. in addition, the investigators would like to assess the risk of admission for acute decompensated heart failure following exposure to nsaids within 30 days.


Eligibility criteria:
inclusion criteria 1. patient's age was more than 20 years old 2. diagnosis of heart failure 3. with prescription of nsaids (only oral and intravenous form are included) exclusion criteria 1. with prescription of nsaids administered by topical use 2. patient was pregnant

Keywords: nsaids heart failure acute kidney injury
multi station training in soccer players hamstrings strain

Conditions: Sports Physical Therapy

Summary: the study is a randomized controlled trial. ethical approval is taken from ethical committee of riphah international university, lahore. participants who meet the inclusion criteria will be enrolled and allocated in group a \& b through sealed envelope method by non-probability convenient random sampling technique. group a will be the wobble board proprioceptive training program lasting for four weeks, while group b will be administered the multi-station proprioceptive training program lasting for four weeks.

the objective of the study is to determine the effects of multi-station proprioceptive training on hamstring strains in soccer players. the study is a randomized controlled trial. ethical approval is taken from ethical committee of riphah international university, lahore. participants who meet the inclusion criteria will be enrolled and allocated in group a \& b through sealed envelope method by non-probability convenient random sampling technique. group a will be the wobble board proprioceptive training program lasting for four weeks, while group b will be administered the multi-station proprioceptive training program lasting for four weeks. outcome measures will be assessed by using nprs, sit and reach test. lower extremity functional scale. proximal hamstring injury questionnaire. balance training tool. the collected data will be analyzed in statistical package for the social sciences (spss) 25.0 .parametric ∕non\|-parametric tests will be applied after test normality of data

Eligibility criteria:
inclusion criteria: * male football players (trained - not trained) between 14 and 30 years of age, players with a history of hamstring strain had reduced slh scores, players with a history of right knee injury also had reduced slhb scores on the injured side exclusion criteria: * children and older adults, upper body proprioceptive training, presence of pain in any part of upper limb,lower limb, trunk or body which can interfere in training session

Keywords: multistation proprioceptive training soccer players hamstrings strain
pharmacokinetics of doxorubicin in ctace of liver cancer

Conditions: Liver Cancer

Summary: patients with primary and secondary liver cancer may participate in this study. the purpose is to perform an analysis of the effects of doxorubicin and its metabolite doxorubicinol on the body (doxorubicin pharmacokinetics ) after conventional transarterial chemoembolization (ctace). ctace is a procedure in which chemotherapy drugs are injected, followed by an injection of small beads to block the tumor-feeding arteries. doxorubicin is a chemotherapeutic agent used in the ctace procedure. this study will examine doxorubicin pharmacokinetics in patients who: 1) receive whole liver ctace; and 2) receive super-selective ctace (i.e., delivered in close proximity to the tumor).

patients with primary and secondary liver cancer may participate in this study. the purpose is to perform an analysis of the effects of doxorubicin and its metabolite doxorubicinol on the body (doxorubicin pharmacokinetics ) after conventional transarterial chemoembolization (ctace). a pharmacokinetics profile (pk profile) will be constructed and will include peak of plasma concentration (cmax), time of maximum concentration (tmax), and area under the concentration curve (auc). this composite measure will be used to compare patients in ctace lobar administration and ctace superselective administration. in addition, the pk profile will be correlated with toxicity, tumor burden, body surface area, and gender. feasibility and safety will also be assessed.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. histologically, cytologically, or radiologically confirmed liver dominant or liver only malignancy. 3. preserved liver function (child-pugh a-b class) without significant liver decompensation. 4. eastern cooperative oncology group (ecog) performance status of 0-1 at study entry. 5. measurable or evaluable disease that will be directly treated with intrahepatic therapy (as defined by response evaluation criteria in solid tumors \[recist\] 1.1). 6. suitable for tace based on blood parameters such as platelet count, bilirubin, and international normalized ratio. 7. may be enrolled with a history of prior liver directed intra-arterial therapy if intra-arterial therapy to the target lesion occured \> 1 year prior to enrollment date. intra-arterial therapy to different targets within 1 year prior to enrollment date will not exclude subjects. exclusion criteria: 1. serum total bilirubin \> 3.0 mg/dl 2. creatinine \> 2.0 mg/dl 3. platelets \< 50000/µl 4. complete portal vein thrombosis with reversal of flow 5. ascites (trace ascites on imaging is acceptable)
an exercise trial for acute myeloid leukaemia (aml) patients undergoing induction chemotherapy

Conditions: Acute Myeloid Leukemia

Summary: reduced quality of life, fatigue, and loss of physical function are common in patients getting chemotherapy for acute myeloid leukaemia (aml). the investigators completed a pilot study showing that exercise during active chemotherapy for aml is feasible, safe, and may improve symptoms and physical function. the investigators now propose to compare our hospital-based supervised exercise program to usual care to see if exercise can improve symptoms, physical function, and improve treatment tolerability.

acute myeloid leukaemia (aml) is a life-threatening malignant blood disorder. curative treatment requires multiple cycles of intensive chemotherapy. the first cycle, induction, is the most intense and intended to achieve complete disease remission (cr). induction therapy requires 4-6 weeks of inpatient admission and is associated with extended bed rest and multiple toxicities, leading to physical deconditioning. regular exercise during induction may reduce declines in physical fitness, leading to improved quality of life (qol), reduced fatigue, improved tolerance of chemotherapy, and potentially greater survival. four prior studies of exercise in aml patients undergoing induction have suggested improvements in qol, fatigue, physical function, and treatment tolerability. however, all 4 studies suffered from major limitations including small sample sizes, design limitations, generalizability concerns, and limited safety information. the investigators conducted a pilot non-randomized study in 35 aml patients and demonstrated feasibility, safety, and potential improvements in qol, fatigue, and physical fitness outcomes. the investigators now propose a rigorous evaluation of the intervention in a phase ii randomized controlled trial (rct). primary objectives include: (1) to determine the efficacy of a supervised mixed-modality exercise program during induction chemotherapy on qol and fatigue; (2) to determine the efficacy on physical fitness. our secondary objective is to determine the efficacy on aml treatment tolerability (hospital length of stay, development of sepsis, intensive care unit (icu) admission, delays in consolidation chemotherapy).

Eligibility criteria:
inclusion criteria: * is ≥ 18 years old * has newly diagnosed aml, or relapsed aml after having been in cr for at least 6 months * is initiating induction chemotherapy * is ambulatory without need for human assistance * has consented to study * is medically cleared for participation by the attending physician exclusion criteria: * has another active malignancy * has life expectancy \< 1 month, physician determined * has significant comorbidity * has uncontrolled pain * has haemodynamic instability * lacks fluency in reading and writing english, and there is no translator available for each visit

Keywords: chemotherapy exercise quality of life cancer-related fatigue elderly physical fitness
off- loading shoe to improve healing and prevention of recurrence of neuropathic diabetic plantar foot ulcers

Conditions: Diabetes Mellitus; Diabetic Neuropathic Foot Ulcer

Summary: it's a pilot prospective opened multicentric randomised study. we measure the efficiency and the safety of a new concept of off-loading shoe (sanidiab) compared with an old one (barouk) to treat chronic diabetic foot ulcer which involved a high risks of amputation 64 diabetic patients with a plantar neuropathic ulcer of the fore foot without infection, osteomyelitis or angiopathy, will be included. 32 patients will be treated with sanidiab shoe and 32 with barouk shoe

name of the study : saniba objective: the gold standard to heal diabetic foot ulcers is complete off-loading. to wear continuously off loading shoe is very difficult the bad compliance of the patients can lead to infection of the ulcer and amputation of the foot. the purpose of this study is to compare the efficacy of a new concept of off-loading shoe (a pair of sanidiab shoes) with a single barouk shoe to treat chronic plantar diabetic foot ulcer of the fore foot. the hypothesis is that the new concept is more efficient because of a good off-loading associated with a best compliance to wear the new concept of shoes. the study will last 18 months with a duration of study of 6 months per patient it's a pilot prospective multicenter randomised study of 64 diabetic patients with a plantar neuropathic ulcer of the fore foot, treated after randomisation by an off loading shoe barouk or a pair of off loading shoes sanidiab. patients will be followed in a diabetic foot department every 14 days until healing and after healing until 6 months after inclusion in the study. the main outcome measure is the healing duration of the diabetic foot ulcers in both group of treatment. the secondary outcome measure is the rate of reulceration after healing , the rate of amputation and compliance of patients 64 patients will be included in 2 groups: 32 will wear sanidiab shoes and 32 barouk shoe.

Eligibility criteria:
inclusion criteria : * more of 18 years old man or woman * type 1 or 2 diabetes mellitus * a new plantar ulcer of the fore foot or the toes * grade 1a or 2 a of the university of texas classification * neuropathy assessed by absence of sensation in 10g monofilament test exclusion criteria * severe angiopathy (grade 3 of the pedis classification) * osteomyelitis or cellulitis of the foot * transmetatarsal amputation * other study in course * immunosuppressive drugs, antibiotic therapy, * hepatic insufficiency * no possibility to follow the patients every 14 days * no state health insurance * pregnancy

Keywords: diabetic foot ulcer off loading compliance healing duration amputation rate
a family-based alcohol preventive intervention for latino emerging adults

Conditions: Binge Alcohol Consumption; Risk Behavior, Health; Driving Under the Influence; High-Risk Sex; Identity, Social; Parenting

Summary: the purpose of the proposed study was to develop a family-based drinking prevention intervention for latino emerging adults (eas) and latino parents of eas. although drinking rates for latinos are lower than those for whites in terms of the prevalence of alcohol use, the consequences of alcohol use (e.g., drunk driving, unplanned/unprotected sex, alcohol-related injuries) appear to be more severe for latinos, especially those 18-23 years old. the investigators developed a brief (4 session) intervention for each of eas and parents focused on identity development and parent support for eas, respectively.

the purpose of the proposed study was to develop a family-based drinking prevention intervention for latino emerging adults (eas) and latino parents of eas. the investigators specifically targeted eas aged 18-23. although drinking rates for latinos are lower than those for whites in terms of the prevalence of alcohol use, the consequences of alcohol use (e.g., drunk driving, unplanned/unprotected sex, alcohol-related injuries) appear to be more severe for latinos, especially those 18-23 years old. the intervention program included four sessions with emerging adults (ea) in a group setting, and four sessions with groups of parents of eas. this dual-site project was developed in oregon and florida in three phases: (1) development of the intervention components; (2) initial pilot testing and focus group feedback (including modifying the intervention and revising the manuals); and (3) a randomized pilot study. the ea component was developed by integrating identity-based intervention strategies that have been used successfully with adolescents and eas, ensuring that they are developmentally and culturally appropriate. the parenting component was developed by adapting efficacious parenting strategies used with adolescents so that the activities were developmentally and culturally appropriate for parents of eas. as the pilot study launch coincided with the start of the covid-19 pandemic, the investigators adapted the original in-person approaches for online delivery.

Eligibility criteria:
inclusion criteria: emerging adult criteria: * between the ages of 18 and 23 years old upon recruitment * identify as latina/o, hispanic, chicana/o, or have been born or descended from a parent or grandparent from mexico or another nation in central or south america or the spanish-speaking caribbean * intend to remain in the area for the four months following their recruitment into the study in order to participate in the intervention, if selected parent criteria: * have a child between the ages of 18 and 23 years old * identify as latina/o, hispanic, chicana/o, or have been born or descended from a parent from mexico, or a nation in central or south america or the spanish-speaking caribbean * speak and understand spanish exclusion criteria: emerging adult criteria: • eas are not themselves a parent or stepparent