Kornimate/medical-research-clean huggingface dataset:
sensitive troponin i in out-of-hospital cardiac arrest

Conditions: Cardiac Arrest; Acute Coronary Lesion; Stable Obstructive Coronary Disease; Non-obstructive Coronary Disease

Summary: troponin is a major diagnostic criterion of acute myocardial infarction (ami) which confirms myocardial damage and necrosis. in out-of-hospital cardiac arrest (ohca) patients its dynamics and diagnostic value is often controversial and has not been well described. most of prior studies were retrospective, using first generation troponin assays and assessing only admission troponin. the aim of this work is to correlate dynamics of sensitive troponin i with urgent coronary angiography. patients resuscitated after ohca will be prospectively divided in three groups based on the results of their urgent angiographies. serial assessment of sensitive troponin i will be obtained over initial 48 hours. we expect admission troponin will not be predictive of ami. over next hours troponin levels will be highest in patients with acute coronary lesion, lower in stable obstructive coronary disease and insignificant in non-obstructive coronary disease. we also expect significant difference in highest values and dynamics of troponin in sub-group with spontaneous reperfusion (timi flow 2 and 3) comparing to patients with coronary occlusion (timi flow 0 and 1). in patients with non-obstructive disease we expect troponin levels to correlate with duration of cardiac arrest, number of external electric shocks and cumulative dose of adrenaline administered.


Eligibility criteria:
inclusion criteria: * female and male over 18 years old * comatose survivors after out-of-hospital cardiac arrest (ohca) * absence of an obvious non-coronary cause * urgent coronary angiography at admittance * less than 3 hours from ohca to first troponin assessment at admittance exclusion criteria: * sub-acute myocardial infarction * coronary spasms or in-stent thrombosis within first 48 hours after admission * coronary surgery or death within first 48 hours after admission

Keywords: cardiac arrest troponin i coronary anatomy
phase 3 study of kp-100li in subjects with vocal fold scar

Conditions: Vocal Fold Scar

Summary: the purpose of this study is to confirm the efficacy and safety of kp-100li, a intracordal formulation containing recombinant human dhgf as the active pharmaceutical ingredient, for voice function improvement therapy in patients with vocal fold scar (including vocal fold sulcus).


Eligibility criteria:
inclusion criteria: 1. 18 years to 75 years 2. presence of bilateral vocal fold scar or sulcus diagnosed 3. no other vocal lesion or vocal movement disorder 4. voice handicap index-10 (vhi-10) score of 11 or higher 5. no laryngoplasty, collagen or lipid infusion to vocal cord, removal scar, fascial graft, or administration of steroid or hyaluronic acid to vocal cord exclusion criteria: 1. no movement disorders of the vocal fold including paralysis 2. airway disease caused by burn 3. history of malignant tumor 4. history of allergy to local anesthesia agent 5. with impaired coagulation-fibrinolysis, or taking anticoagulant or antiplatelet drugs 6. serious concomitant disease 7. pregnant (including suspected), nursing, wishing to become pregnant, or unable to prevent conception during the trial period using contraceptive methods

Keywords: hepatocyte growth factor hgf kp-100li kp-100 intracordal injection
flow regulation by opening the septum in patients with heart failure trial

Conditions: Heart Failure With Normal Ejection Fraction

Summary: to investigate the safety and efficacy of a novel atrial flow regulator (afr) device in patients with heart failure and preserved ejection fraction.

the study will allow us to demonstrate the safety of the afr device as well as determine the clinical response of the therapeutic intervention. in addition, the invasive exercise hemodynamics will provide objective data for the changes in the cardiac hemodynamics and delineate underlying mechanisms of creating a permanent inter atrial shunting.

Eligibility criteria:
inclusion criteria: * informed consent * age \> 40 years * lvef \> 45% documented within the last 3 months. * nyha class ≥ii status or 6mwt distance \<80% predicted. * left atrial enlargement * pcwp ≥25 mmhg during supine bicycle exercise on hemodynamic monitoring. * left atrial pressure greater than right atrial pressure by ≥5 mmhg on hemodynamic monitoring. exclusion criteria: * recent mi, pci or cabg * untreated cad with indication for revascularization * recent stroke, pulmonary embolism or major surgery * uncontrolled atrial fibrillation * h/o cardiomyopathy (hypertrophic, restrictive, infiltrative) or pericardial disease * inability to perform a 6-minute walk test. * clinically significant valvular disease * uunsuitable for study participation at investigator discretion. * severe copd, anemia or morbid obesity * uncontrolled hypertension * women of child bearing age * ra pressure \>15 mmhg or pvr \>4 wood units
anet electrosurgery applicator pilot evaluation study

Conditions: Lung Cancer; Lung Cancer Metastatic

Summary: evaluate the preliminary safety and performance of the electrosurgery applicator (anet device) during and after bronchoscopic ablation of a target pulmonary nodule/tumor.

this study is a prospective, single arm, single center study that will evaluate the effectiveness of the anet electrosurgery applicator in up to 10 subjects. subjects who consent to participate in this study will have a lung tumor that is scheduled to be removed surgically as part of their normal treatment. during the surgical procedure, just prior to resection the subject's tumor will be treated with the anet device. the anet device uses a bronchoscope to reach the tumor. ultrasound on the bronchoscope, ct, and x-rays are used to make sure the anet device is in the tumor. once in the tumor, the anet device uses radio-frequency (rf) ablation to treat the tumor. after standard surgical resection the tumor and surrounding tissue is evaluated to characterize the effect of the anet.

Eligibility criteria:
inclusion criteria: 1. subject with stage i or stage ii primary lung cancer or metastatic lung tumor 2. pathological proof of target nodule/tumor type and malignancy 3. target nodule/tumor which can be accessed via ebus bronchoscopy 4. resection/surgical candidate 5. participants must be at least 18 years old and able to provide consent exclusion criteria: 1. subjects in whom flexible bronchoscopy is contraindicated 2. target nodule \< 1.0 cm 3. prior radiation or neo adjuvant chemotherapy of the target nodule/tumor 4. any comorbidity that the investigator feels would interfere with the safety of the subject or the evaluation of study objectives 5. pacemaker, implantable cardioverter, or other electronic implantable device

Keywords: electrosurgery rf ablation minimally invasive lung cancer lung metastasis lung tumor primary metastatic endobronchial ultrasound ebus
audiological benefit and quality of life with two bone conduction systems: adhear vs. contact mini

Conditions: Conductive Hearing Loss

Summary: patients with conductive hearing loss fitting the inclusion criteria will be asked to participate in the study. all subjects will be randomized to wear either first the adhesive or the conventional bone conduction hearing aid. they will wear either device for two weeks. they will use the second device for another two weeks. audiologic tests and quality of life questionnaires will be assessed at the beginning of the study after two weeks with the first device and after two weeks with the second device. additionally, all patients will be asked to keep a diary including daily wearing time of the device.

the primary objective of this study is to show, that the adhear will be worn \~75%(\~11 to 15 hours per day) of the waking hours, whereas the contact mini will be worn \~ 50% (\~5 - 8 hours per day) of the waking hours (p\<0.05). the authors expect this difference due to increased wearing comfort, reduced/no pressure to the skin of the adhear. the primary objective will be assessed with the diary patients are asked to use. audiologic testing will consist of free field audiometry, freiburger monosyllables test and oldenburg sentence test. all tests will be performed with and without the devices. quality of life and hearing related questionnaires will consist of the aqol-8d and the ssq12.

Eligibility criteria:
inclusion criteria: * inclusion criteria * unilateral and/or bilateral conductive hearing loss (chl) * the bone conduction threshold for the patient's affected ear shall be better than or equal to 25 db hl (pta bc for 0.5, 1, 2, 3 khz). * subjects aged 13 years or older * capable of the german language * willingness and ability to perform all tests required for the study * signed, and dated informed consent before the start of any study specific procedure exclusion criteria: exclusion criteria * pregnancy or breastfeeding * patient is intolerant of the materials as described by manufacturer's ifu * patient presents with a skin or scalp condition that may preclude the attachment of the adhesive adapter. * patient cannot perform the audiological tests or is unable to fill out the questionnaires. * patient presents with retrocochlear, or central auditory disorder. * any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures
study of sagittal pelvic statics in the sitting position in children with cerebral palsy

Conditions: Cerebral Palsy Infantile

Summary: cerebral palsy is the leading cause of motor disability in children. children with little or no walking (gmfcs iii, iv and v) represent 43% of children with cerebral palsy, the majority of whom present pelvic and spinal deformities in the frontal and sagittal planes. however, sagittal pelvic spinal statics have been little studied, especially in the sitting position, which is the functional position of these children. moreover, there are currently no recommendations on how to perform follow-up radiographs of the spine in children who do not walk much. a better understanding of pelvic and sagittal spinal statics would help prevent deformities and their complications. standardizing the method of performing pelvic-spinal radiographs in the sitting position will make monitoring of spinal statics more reliable.


Eligibility criteria:
inclusion criteria: * child or adolescent aged 4 to 17 years * child or adolescent with cerebral palsy gmfcs iii, iv or v * child or adolescent whose parents, or the child if possible, have given free, informed and written consent * child or adolescent affiliated or beneficiary of a health insurance plan exclusion criteria: * child or adolescent with history of spinal surgery * child or adolescent with parents unable to give consent * child or adolescent participating in a therapeutic research study (riph 1 or drug study) * child or adolescent in an exclusion period determined by another study * child or adolescent under court protection, guardianship or curatorship * pregnant, parturient or breastfeeding patient

Keywords: spine child adolescent pelvis postural balance posture radiography
the long-term evar assessment and follow-up (leaf) study for the afx2 system

Conditions: Abdominal Aortic Aneurysm

Summary: this is an observational, retrospective, multicenter study to evaluate the performance of the afx2 system using real world evidence from vqi-vision.

evaluate the clinical performance of the afx2 system patients against other commercially available evar devices and evaluate the type iii endoleak occurrence in afx2 system patients through 5 years.

Eligibility criteria:
inclusion criteria: * all patients implanted with the afx2 system or the 3 most commonly used comparator devices who underwent evar as their first abdominal aortic aneurysm repair in the vqi evar registry will be included in this study. exclusion criteria: * ruptured aaa repair with the afx2 or comparator device * patients with afx2 in afx relining, or relined comparator grafts.
the effectiveness of auricular acupressure on body weight parameters on patients with schizophrenia

Conditions: Schizophrenia; Obesity

Summary: the purpose of this study is to examine whether auricular acupressure is effective in reducing body weight, waist circumference, or lipid profile.


Eligibility criteria:
inclusion criteria: 1. icd:295,living in chronic ward for more than 2 month 2. body mass index (bmi) \>or=24 3. age between 20 to 60 4. psychotic status stable and can communicate exclusion criteria: 1. unstable psychotic status 2. participants who have endocrine disease 3. participants who have cardiac disease 4. participants who have immunological disease 5. participants who have liver or renal function impairment 6. pregnant woman or in milking stage 7. cerebrovascular accident (cva) stroke and disability 8. participant who attends weight control programs in recent 3 months 9. any conditions that clinical doctors refuse to let join in this study

Keywords: auricular acupressure obesity schizophrenia body weight
apollo: the study of an investigational drug, patisiran (aln-ttr02), for the treatment of transthyretin (ttr)-mediated amyloidosis

Conditions: TTR-mediated Amyloidosis; Amyloidosis, Hereditary; Amyloid Neuropathies, Familial; Familial Amyloid Polyneuropathies; Amyloid Neuropathies; Amyloidosis, Hereditary, Transthyretin-Related

Summary: the purpose of this study is to evaluate the safety and efficacy of patisiran (aln-ttr02) in patients with transthyretin (ttr) mediated amyloidosis. an open-label, single-arm, long-term follow-up extension study nct02510261 (aln-ttr02-006) was initiated to provide participants who completed this study with continued patisiran-lnp (lipid nanoparticle) treatment.


Eligibility criteria:
inclusion criteria: * male or female of 18 to 85 years of age (inclusive); * have a diagnosis of fap * neuropathy impairment score requirement of 5-130 * meet karnofsky performance status requirements * have adequate complete blood counts and liver function tests * have adequate cardiac function * have negative serology for hepatitis b virus (hbv) and hepatitis c virus (hcv) exclusion criteria: * had a prior liver transplant or is planned to undergo liver transplant during the study period; * has untreated hypo- or hyperthyroidism; * has known human immunodeficiency virus (hiv) infection; * had a malignancy within 2 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated; * recently received an investigational agent or device * is currently taking diflunisal, tafamidis, doxycycline, or tauroursodeoxycholic acid

Keywords: rnai therapeutic fap familial amyloid polyneuropathy ttr transthyretin amyloidosis
a study of star-0215 in participants with hereditary angioedema

Conditions: Hereditary Angioedema

Summary: the goal of this clinical trial is to test the drug star-0215 in participants with hereditary angioedema (hae). one group of participants will get 1 dose of star-0215, and two other groups will get 2 doses of star-0215. researchers will study the effects of star-0215 in participants with hae as this is the first time that the drug has been given to participants with hae.

this is a phase 1b/2 single and multiple dose trial evaluating the safety, tolerability, clinical activity, pharmacokinetics, pharmacodynamics, and immunogenicity of subcutaneous administration of star-0215 in participants with type i or type ii hae in 3 dose cohorts. the first cohort will receive 1 dose of star-0215; the second and third cohorts will receive 2 sequential doses. this is the first trial of star-0215 in participants with hae and the first evaluation of a multiple-dose regimen. after the required follow up period, participants who are willing and eligible to consent can begin participation in the long-term open label extension study (star-0215-202, alpha-solar).

Eligibility criteria:
inclusion criteria: 1. documented diagnosis of hae (type i or ii). the following must be met: a. documented clinical history consistent with hae (for example, subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria). 2. experienced at least 2 hae attacks during the run-in period, as confirmed by an investigator based on meeting the protocol-specified definition of an hae attack. exclusion criteria: 1. any concomitant diagnosis of another form of chronic angioedema, such as acquired c1 inhibitor deficiency, hae with normal c1-inh (also known as hae type iii), idiopathic angioedema, or angioedema associated with urticaria. 2. use of therapies prescribed for the prevention of hae attacks prior to screening: 1. lanadelumab within 90 days 2. berotralstat within 21 days 3. all other prophylactic therapies, within 7 days 3. any exposure to angiotensin-converting enzyme inhibitors or any estrogen containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 28 days prior to screening. 4. any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to screening.

Keywords: hae angioedema
effect of altitude on postdural puncture headache after caesarean delivery

Conditions: Post-Dural Puncture Headache

Summary: the aim of this study is to examine the effects of altitude (high altitude versus low altitude) on incidence and severity of postural puncture headache (pdph) following spinal anaesthesia for caesarean delivery. the investigators hypothesized that the risk of pdph would be higher in highlander parturients than in lowlander parturients.

this will be a prospective cohort study conducted in two different altitudes in nepal. the high-altitude site is in jumla, approximately 2514 m above the sea level, and a low altitude city is dharan, located at 350 m from sea level. the investigators will screen the eligible participant admitted to the in-patient obstetric unit. the investigator will also record patient baseline characteristics, preoperative anxiety, antenatal depression, presence of chronic pain conditions or preexisting headache. spinal anaesthesia will be administered in the sitting position at the l3-l4 or l4-l5 interspace using a 25-g pencil point spinal needle (pencan® 25-gauge). the diagnosis of post-dural puncture headache will be based on the international headache society icdh-3 criteria

Eligibility criteria:
inclusion criteria: * parturient, aged more than or equal to 18 years * american society of anesthesiologist 2 and 3 * scheduled for elective and non-elective (category 2 \& 3) caesarean delivery with spinal anesthesia * native to their resident altitude i.e., those born, raised, and have continuously lived at the same altitude, at least for the past 1 year. exclusion criteria: * hypertensive disorder * cerebrovascular disease * mental disorder (schizophrenia and other psychotic disorders) * known fetal anomalies * contraindication to spinal anaesthesia. * those requiring general anaesthesia for delivery due to failed spinal anesthesia * major post-delivery complications (severe haemorrhage, sepsis, or icu admission) * those who migrate from their resident altitude (either low to high or vice versa) within 7 days post-delivery will also be excluded.

Keywords: spinal anesthesia, cesarean section
trial to evaluate the efficacy and safety of nitazoxanide (ntz) for post-exposure prophylaxis of covid-19 and other viral respiratory illnesses in elderly residents of long-term care facilities (ltcf)

Conditions: COVID-19; Viral Respiratory Illnesses

Summary: trial to evaluate the efficacy and safety of ntz for post-exposure prophylaxis of covid-19 and other vris in elderly ltcf residents.

multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of ntz for post-exposure prophylaxis of covid-19 and other vris in elderly ltcf residents.

Eligibility criteria:
inclusion criteria: * male and female residents of ltcfs at least 55 years of age. * willing and able to provide written informed consent and comply with the requirements of the protocol. * at least one symptomatic laboratory-confirmed covid-19 illness identified among residents or staff of the ltcf within 10 days prior to randomization. exclusion criteria: * alzheimer's disease, dementia, or other mental incapacity which precludes comprehension of the study requirements or symptom diary. * subjects expected to require hospitalization within the 8-week treatment and follow-up period. * subjects with a history of covid-19 or known to have developed anti-sars- cov-2 antibodies. * subjects who experienced a previous episode of acute upper respiratory tract infection, otitis, bronchitis or sinusitis or received antibiotics for these conditions or antiviral therapy for influenza within two weeks prior to and including study day 1. * receipt of any dose of ntz within 7 days prior to screening. * treatment with any investigational drug or vaccine within 30 days prior to screening or unwilling to avoid them during the course of the study. * known sensitivity to ntz or any of the excipients comprising the study medication. * subjects unable to swallow oral tablets or capsules. * subjects taking medications considered to be major cyp2c8 substrates. * subjects who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.

Keywords: covid-19 viral respiratory illnesses
effects of cash transfers on severe acute malnutrition

Conditions: Severe Malnutrition

Summary: cash transfer, aims to strengthen food security for vulnerable households by giving families enough purchasing power to consume an adequate and balanced diet, maintain a good standard of hygiene, access health services, and invest in their own means of food production in addition to their children's growth and development. while cash transfer to vulnerable households has shown a long-term positive impact on growth and on malnutrition-related mortality in children aged 0-5 years, there is little conclusive evidence their effectiveness in sub-saharan africa that cash transfer has a direct effect on the community-based management of acute malnutrition (cmam). here, the investigators will perform a cluster-randomized trial to investigate during 6 months the effects of unconditional cash transfers on the management of severe acute malnutrition (sam) in children from 6 to 59 months according to the national protocol in the democratic republic of congo.


Eligibility criteria:
inclusion criteria: * living in the catchment area of one of the 20 outpatient therapeutic program site participating in this cluster randomized trial; * 6-59 months of age; * weight for height zscore \<-3 sd (who growth standards 2006) and/or mid-upper arm circumference \<115mm and/or with bilateral edema; * no major clinical complications; * positive appetite test; * accept to participate at the study. exclusion criteria: * not living in the catchment area of the outpatient therapeutic program site of the cluster randomized trial; * weight-for-height z-score ≥-3 (who growth standards 2006) and mid-upper arm circumference ≥115mm without bilateral edema; * major clinical complications; * failure to appetite test; * refuse to participate at the study.

Keywords: malnutrition severe acute malnutrition cash transfer democratic republic of congo cluster randomize trial