Kornimate/medical-research-clean huggingface dataset:
ribfix advantage™ post-market follow-up

Conditions: Rib Fractures

Summary: to confirm safety, performance, and clinical benefits for the use of ribfix advantage™ in the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone

retrospective review of subject demographic and hospital data with a prospective follow-up component evaluating clinical outcomes and quality of life for patients receiving ribfix advantage for surgical stabilization of rib fractures from 2019 to 2021

Eligibility criteria:
inclusion criteria: * 18-80 years of age, male or female * underwent reconstruction of the chest wall between february 2019 and september 2021 with ribfix advantage™ for the fixation, stabilization, or fusion of rib fractures * minimum amount of follow-up data available, including one visit post-surgery * willing and able to sign an informed consent for research * willing and able to and complete a post-operative follow-up survey at least 3 months post-surgery exclusion criteria: * latent or active infection with positive culture at the time of implantation * documented history of metal sensitivity * documented psychiatric condition preventing the patient from following post-op care instructions * fixation of the first and/or second (true) vertebrosternal rib * bilateral rib fractures * concurrent surgical procedures (i.e. splenectomy, aortic disruption repair, diaphragm injury repair, etc.) performed during the same hospitalization * lung injury (open pneumothorax, tension pneumothorax, hemothorax \> 1l, pulmonary contusion requiring mechanical ventilation)
prognostic impact of sleep apnea on cardiovascular morbidity and mortality, in end stage renal disease patients

Conditions: Obstructive Sleep Apnea; End Stage Renal Disease

Summary: the purpose of this study is to prospectively evaluate the impact of sleep apnea on the cardiovascular morbidity and mortality of patients with end-stage renal disease.

sleep apnea is more prevalent in end stage renal disease patients than in the general population, and may participate to the increased cardiovascular mortality observed in this group of patients. despite a significant increase in knowledge about the harmful effects of obstructive sleep apnea in the general population, the prognostic impact of sleep apnea in the end stage renal disease population has not yet been investigated. the purpose of this trial is to investigate the hypothesis that moderate to severe sleep apnea increase the risk of major cardiovascular events in patients with end stage renal disease. the severity of sleep apnea is measured at inclusion and the patients are followed during 3 years to assess the cardiovascular end-points. the result of the sleep study is communicated to the treating physician and the decision whether to treat or not sleep apnea is left to the treating physician, independently of the study protocol. the comparison will include three groups: patients without sleep apnea, untreated patients with moderate to severe sleep apnea and treated patients with sleep apnea.

Eligibility criteria:
inclusion criteria: * end stage renal disease on renal replacement therapy * age ≥ 18 years exclusion criteria: * unstable congestive heart failure * active psychiatric disease

Keywords: obstructive sleep apnea end stage renal disease cardiovascular events
hemostasis with quikclot® radial® pad versus tr band® after transradial artery access

Conditions: Coronary Artery Disease

Summary: to evaluate the efficacy and safety of the quikclot® radial® pad on hemostasis after transradial access (tra), compared to the standard of care tr band®, to hopefully develop a safe and efficacious technique to achieve more rapid patent hemostasis after tra, and improve patient care by optimizing radial hemostasis management.

the quikclot® radial® (qc) pad will be applied over the radial artery access site covered with either a coban™ bandage or a tegaderm™ dressing after tra. firm manual compression will then be applied over the qc pad after the sheath is removed for 5 minutes. the coban™ cohort will then have the coban™ bandage removed after an additional 25 minutes, then be covered with a tegaderm™ dressing. the tegaderm™ only cohort will be closely observed for 25 minutes after release of manual pressure. both cohorts will remove the tegaderm™ dressing the following morning. consented subjects will be randomly assigned in the cardiac cath lab upon completion of their procedure into one of the following arms: arm 1 - standard of care with a tr band® arm 2 - qc pad combined with a coban™ bandage arm 3 - qc pad combined with a tegaderm™ dressing. this arm was stopped after the enrollment of 73 patients and replaced by the qc/tr band® arm arm 4- qc pad was applied on the radial arterial access site with 30 minutes of compression under a tr band® inflated with 8-10 ml of air. then the tr band® was removed, leaving the qc pad covered with a tegaderm™ dressing.

Eligibility criteria:
inclusion criteria: 1. patients undergoing cardiac catheterization (cc) and/or percutaneous coronary intervention (pci) via the radial artery as part of their standard of care treatment 2. patients able and willing to give written informed consent 3. patient \> 18 years of age exclusion criteria: 1. patients presenting with acute st-segment elevation myocardial infarction (stemi) 2. oral anticoagulation therapy as described below: 1. if on a doac (direct-acting oral anticoagulants - ie dabigatran, rivaroxaban, apixaban, edoxaban), patients will be excluded if doac taken within 48 hours and egfr \> 30 ml/min or doac taken within 72 hours and egfr \< 30 ml/min. 2. if the patient is on warfarin, excluded if inr \> 1.5 3. liver failure 4. life-threatening illness that the patient would not be expected to live more than 6 months post-procedure 5. major unanticipated event in the cardiac cath lab (i.e. cardiac arrest) of an already consented patient, but before randomization, where the operator believes participation in this trial is now inappropriate. 6. thrombocytopenia, with a platelet count of \< 75,000.

Keywords: transradial access hemostasis
aggressive acts among patients with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this series of study has a many-fold intention depicted as follows: to describe and characterize schizophrenic patients' aggressive acts in hospital and community, to identify and specify heterogeneity in their structure, and to look for and set up risk factors for prevention. this study investigates four major issues: (1) establishing an objective behavior rating scale for measuring aggressive acts; (2) understanding the characteristics and incidence of aggressive acts by patients with schizophrenia; (3) exploration of the heterogeneous structure of aggressive acts by patients with schizophrenia; and (4) identifying the risk factors of aggressive acts of patients with schizophrenia.

psychiatric patients' aggressive acts can occur frequently and are recognized as a significant problem in psychiatric services. understanding of aggressive acts in clinical settings and community is still incomplete and the clinical care of aggressive acts remains unsatisfactory. this study investigates four major issues: (1) establishing an objective behavior rating scale for measuring aggressive acts; (2) understanding the characteristics and incidence of aggressive acts by patients with schizophrenia; (3) exploration of the heterogeneous structure of aggressive acts by patients with schizophrenia; and (4) identifying the risk factors of aggressive acts of patients with schizophrenia. at first, the content validity, construct validity, and internal consistency of the chinese version of violence scale were examined. both of retrospective survey and prospective panel design were used for data collection. patients fulfilling the dsm-iv criteria of schizophrenia in hospital and community, and their siblings and family caregivers, were recruited as different phases of study subjects, after signing informed consent for understanding their past history, prospective occurrence of aggressive acts, and the related risk factors. it is therefore to establish objective measures and to develop insights into the heterogeneity and related risk factors of aggressive acts, for improvement in the management and prevention of aggressive acts.

Eligibility criteria:
inclusion criteria: patients with clinical diagnosis of schizophrenia spectrum, fulfilling the diagnostic criteria of the 4th version of diagnostic and statistical manual (dsm-iv)(apa, 1994)were recruited as study subjects, after signing informed consent. their families, including their siblings and family caregivers, were also recruited in the study. exclusion criteria: exclusion criteria of the patient samples include co-mobility with mental retardation, personality disorder, organic brain disorders, and alcohol or substance abuse/ dependence.

Keywords: aggressive acts
assessing the utility of tissue dielectric constant (tdc) measurements to differentiate breast cancer from healthy breasts

Conditions: Breast Cancer

Summary: patients with pending breast biopsies will have the tumor site's tissue dielectric constant (tdc) measured prior to the biopsy. similar tdc measurements will be made at a standard breast site on the biopsied breast and on mirrored sites on the non-affected breast.

patients with pending breast biopsies will have the tumor site's tissue dielectric constant (tdc) measured prior to the biopsy. similar tdc measurements will be made at a standard breast site on the biopsied breast and on mirrored sites on the non-affected breast. values obtained at the biopsy site will be compared against the outcome of the biopsy analysis: benign vs. malignant. in addition the measurements obtained at the standardized site for all breasts will be used to establish a set of reference values to characterize breast tdc values. in addition, inter-breast differentials will be used to characterize these ranges for future studies and clinical assessments.

Eligibility criteria:
inclusion criteria: * you must be scheduled for a breast biopsy of a breast mass or abnormality with the collaborating centers exclusion criteria: * you have any open wounds over the breasts * you have had breast cancer * you have or have had breast implants or have undergone any breast surgery or breast biopsy * you have any implantable wires, this includes a pacemaker, implantable cardioverter ° defibrillators (icds), and/or left ventricular assist device (lvad) * you are pregnant

Keywords: tissue dielectric constant breast cancer tumor biopsy
input of the use of indometacin in gitelman syndrome as compared to potassium sparing diuretics

Conditions: Gitelman Syndrome

Summary: gitelman syndrome is a rare renal disease where the kidneys are unable to normally retain some salts (sodium, potassium and magnesium). main consequences of these renal leaks of salts are a tendency toward low blood pressure, hypokalemia and hypomagnesemia both contributing to cardiac and muscles symptoms.

patients with received in random order 75mg/day indometacin (chronoindocid®), 10-20 mg/day amiloride and 50-150 mg /day eplerenone (inspra ®). the three 6 weeks-periods of treatment will be followed by six weeks washout period. 3-6 weeks before the first period of treatment, a supplementation with potassium and magnesium will be orally given, and maintained at the same dose throughout the study and stoped 6 weeks after the end of the third period of treatment.

Eligibility criteria:
inclusion criteria: * patients 18-60 yrs old, both sex, with genetically proven gitelman's syndrome, under birth pill control for woman. exclusion criteria: * counter-indication to treatment under study * other diuretic or nais treatments than amiloride, spironolactone, or indometacin

Keywords: hypokalemia hypomagnesemia salt loosing nephropathy
sci-210 in the treatment of children and young adults with autismevaluate the safety, tolerability and efficacy of sci-210 in children with autism spectrum disorder (asd)

Conditions: Autism Spectrum Disorder (ASD)

Summary: to evaluate the safety and efficacy of sci-210 in the treatment of autism spectrum disorders (asd)

the innovative compound sci-210 consists of cbd oil combined with cannamide (pea formulation) using the "entourage effect" to enhance efficacy of cbd. it is believed that pea potentiates anandamide responses in non-vascular tissues. this effect is called "entourage effect". the "entourage effect" can be achieved by enhancing the action of endogenous anandamide through an increase in the affinity for receptors and/or a decrease in enzymatic degradation of anandamide (primarily by fatty acid amide hydrolase, faah). thus, the combination of cbd oil with pea is believed to be more effective than cbd oil alone, while aes are not increased by the addition of the natural substance pea. sci-210 has not been tested in clinical trials before, but anecdotal evidence of combined use of cbd and cannamide in asd patients has been accumulated in recent months. the evidence suggests the beneficial effects of the combination in alleviating asd symptoms with no reported adverse events associated with the treatment.

Eligibility criteria:
inclusion criteria: 1. males or females aged between 5 and 18 years of age (inclusive) 2. diagnosis of asd confirmed by the ados-2 and dsm-5 criteria 3. moderate or greater behavioral problems as measured by a rating of moderate or higher (≥4) on the clinical global impression-severity (cgi-s) 4. presence of a parent/legal guardian who is able to consent for their participation and completes assessments regarding the child's development and behavior throughout the study 5. patients eligible for cannabis treatment as regulated by the israeli ministry of health, as out lined in the medical cannabis unit circular on licenses for cannabis use, procedure number 106, version 5 dated jan 2021 exclusion criteria: 1. children who are already receiving cannabis, antipsychotic drugs, or stimulants. 2. children with heart, liver, renal or hematological disorders. 3. history of active seizure disorder or epilepsy; patients who are seizure free for more than 3 years can take part in the study 4. exposure to any investigational agent in the 30 days prior to trial onset. 5. a current psychiatric diagnosis of bipolar disorder, major depressive disorder (mdd), psychosis, schizophrenia, or post-traumatic stress disorder (ptsd) 6. subjects who have had changes in non-exclusionary psychotropic medications within 4 weeks of initiation of trial. 7. allergic to cannabinoids or pea tablet components. 8. history of substance abuse (including alcohol abuse or dependence) or laboratory evidence of drug abuse on the visit 1 drug-screening panel. 9. any condition which, in the opinion of the investigator, places the patient at unacceptable risk if he or she were to participate in the study.
peripheral artery occlusive diseases (paod) study - clinical assessment

Conditions: Peripheral Artery Disease

Summary: to assess the clinical efficacy and to simultaneously explore the underlying molecular mechanisms of the beneficial effects of flavanol-rich cocoa on vascular function diabetic patients with peripheral artery occlusive diseases (paod) of the lower extremities will be investigated.

50 type 2 diabetics according to the criteria of the american diabetes association suffering from paod with a pain free walking distance less than 200 m will be enrolled. in a randomized controlled parallel group study the before established novel 5-level approach of vascular diagnostics will be realised. in order to test the hypothesis, whether cocoa rich in flavanols improves vascular function of diabetic paod subjects will regularly intake flavanol rich cocoa (group 1: 975 mg/d, n=50 versus group 2: 90 mg/d, n=50) over a period of two months. clinical endpoints are the ankle-brachial-index, measured by doppler ultrasound and the pain-free walking distance determined by a treadmill ergometer. all parameters of vascular diagnostic (see 5-level approach above) will be determined before and two month after cocoa ingestion.

Eligibility criteria:
inclusion criteria: 1. diabetes mellitus type 2 defined by the criteria of the american diabetes association * fasted plasma glucose greater than 126 mg/dl * plasma glucose levels greater than 200 mg/dl 2 hours after ogt * casual plasma glucose greater than 200 mg/dl combined with diabetic symptoms. 2. endothelial dysfunction defined by fmd \<4% 3. no changes of medication for 2 months 4. significant paod (level iib, iii) exclusion criteria: 1. ejection fraction \<30% 2. malignoms 3. terminal renal failure with hemodialysis 4. relevant cardiac arrhythmias 5. acute inflammation defined as crp \>0,5 mg/dl 6. paod (level iv)

Keywords: paod diabetis vascular function in diabetics with paod
physical therapy on pelvic organ prolapse

Conditions: Pelvic Organ Prolapse

Summary: objective: to find out the effectiveness of physical therapy for stages i and ii pelvic organ prolapse. design: randomized, controlled and single blinded clinical trial. patients will be randomly assigned to one of these groups: experimental group: physical therapy + training in lifestyle advice; control group: just training in means of lifestyle advice. in both groups several physical therapy assessments will be undertaken: 1st before intervention; 2nd immediately after completing intervention; 3rd, 4th, 5th and 6th after 3, 6, 12 and 24 months. subjects: women with previously untreated prolapse of stage i or ii (confirmed by their gynaecologist using the pop-q) in príncipe de asturias hospital, provided that there is no contraindication for physical therapy, and after reading, understanding and freely signing an informed consent form. sample size: a total of 120 subjects will be included in the study (60 subjects in each group). data analysis: a descriptive analysis will be done of all the variables, as well as bivariate analysis in order to find all the possible relationships between the variables. a confidence level of 95% (p\<0.05) will be established for all the cases. effectiveness will be evaluated by comparing between the two groups of the change in outcome variables between visits.


Eligibility criteria:
inclusion criteria: * women with pop of any stage i or ii according to pop-q system. exclusion criteria: * women diagnosed with pop stage iii or iv according to pop-q system * women with a history of conservative pop treatment or surgery * women with concomitant disease that may affect treatment (neurological, gynecological or urological) or urinary tract infection or recurrent hematuria * women who are pregnant or have had a vaginal birthing the last six months * women with cognitive limitations in understanding the information, answer questionnaires, consent and / or participate in the study
df4 connector system post-approval study

Conditions: Ventricular Tachycardia; Ventricular Fibrillation; Sudden Cardiac Death; Heart Failure

Summary: the purpose of this study is to evaluate long-term performance of the df4 connector system. this evaluation is based on the number of df4 lead-related complications occurring during the study compared to the number of leads enrolled in the study. the df4 systems will be followed for 5 years after implant. this study is required by fda as a condition of approval of the df4 connector systems. this study is conducted within medtronic's post-market surveillance platform.


Eligibility criteria:
inclusion criteria: * subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * subject is intended to be implanted or is within 30 days post-implant of a df4 connector system with a medtronic df4 lead used for a pacing, sensing and/or defibrillation application exclusion criteria: * subject who is, or will be inaccessible for follow-up at a study site * subject with exclusion criteria required by local law (europe, central asia \[eca\] only) * implant and follow-up data, including any adverse device effects and system modifications at implant through the time of enrollment are unavailable

Keywords: icd crtd df4
assessment of varying oral dosing regimens for f901318 in healthy subjects

Conditions: Invasive Aspergillosis

Summary: a phase i, open label study evaluating safety, tolerability and pharmacokinetics of f901318 in healthy subjects following up to 28 days dosing, where f901318 is given orally . the effect of food upon the pharmacokinetics of f901318 and the effect of f901318 upon the pharmacokinetics of midazolam will also be assessed.

each cohort will comprise 12 healthy subjects and cohorts a1 (a2), b1 and b2 will be conducted in a sequential manner such that the dose level can be optimised upon review of emerging safety, tolerability and pk data.

Eligibility criteria:
inclusion criteria: * subjects will be males or females of any ethnic origin between 18 and 55 years of age, weighing between 60 and 100 kg, with a body mass index (bmi) between 18 and 30 kg/m2. * subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ecg) and clinical laboratory evaluations (congenital non-haemolytic hyperbilirubinaemia is not acceptable) * male subjects and female subjects of childbearing potential must agree to use appropriate contraception from screening, during the study and for 3 months after the last dose of study drug exclusion criteria: * female subjects who are pregnant or lactating. * subjects who have received any prescribed systemic or topical medication (other than hormonal contraception or hormone replacement therapy) within 14 days of the dose administration unless in the opinion of the investigator and the medical monitor the medication will not interfere with the study procedures or compromise safety. * subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the dose administration (with the exception of vitamin/mineral supplements) unless in the opinion of the investigator and the medical monitor the medication will not interfere with the study procedures or compromise safety. * subjects who have received any medications, including st john's wort, known to chronically alter drug absorption or elimination processes within 30 days of the dose administration unless in the opinion of the investigator and the medical monitor the medication will not interfere with the study procedures or compromise safety.