Kornimate/medical-research-clean huggingface dataset:
epicardial mitral repair trial - enrapt-mr

Conditions: Mitral Regurgitation

Summary: mitral touch system this device is designed to epicardially reshape the mitral valve annulus without the need for cardiopulmonary bypass (cpb) and open heart access (atriotomy), in patients with left ventricular dilation and ischemic or functional mr (mitral regurgitation (mr)).

mitre medical has developed an epicardial mitral annuloplasty device that can be implanted concomitant during planned coronary artery bypass surgery to help treat the mr patients. the mitral touch is designed to restore the s-l dimension and has the advantage of being placed without stopping the heart and placing the patient on a bypass pump.

Eligibility criteria:
inclusion criteria: * patient has moderate (2+), moderate-to-severe (3+) or severe (4+) ischemic or functional mitral regurgitation per 2d or 3d echocardiography, symptomatic or asymptomatic * patient is 18 years of age or older * patient is willing and able to sign informed consent form exclusion criteria: * history of endocarditis or current endocarditis * structural abnormalities of the leaflets and papillary muscles\* * dysfunctional chordae\* * any prior cardiac surgery including but not limited to cabg, mitral valve repair surgery, mechanical prosthetic valve, or ventricular assist device, prior sternotomy\* * ejection fraction \<25% * new york hheart association (nyha) class iv * mv diameters \> 7cm * myxomatous mitral regurgitation * renal insufficiency (egfr \&lt; 30 ml/min) * severely calcified (posterior) mitral valve annulus * women who are pregnant (by history of menstrual period or pregnancy test if history is considered unreliable) * any coronary artery calcification at site of placement as determined by angiogram. * abnormal cardiac anatomy discovered prior to surgery or during procedure. * pericardial adhesions * note: patients with prior or concurrent mitral chordae repair (example: ptfe or neochord) are potential candidates for the mitraltouch
apatinib combined with vinorelbine for non-driver gene mutation non-small cell lung cancer

Conditions: Advanced Non Small Cell Lung Cancer

Summary: the purpose of this study is to assess the safety and effectiveness of apatinib combined with vinorelbine used for driver gene mutation negative third-line and third-line posterior advanced non-small cell lung cancer

this efficacy and safety research plan to explore the use of apatinib combined with vinorelbine to driven gene mutation negative three line and three line later non-small cell lung cancer.according to the result of tax317,the investigators expect the effective rate is 20% and 80% of degree of assurance.single arm bilateral experiment's sample size is calculated 27, according to 10% censoring,the expected sample size is 30.

Eligibility criteria:
inclusion criteria: * 18，pathologically proven non small cell lung cancer * adenocarcinoma，no-drive gene mutaion (egfr、alk、ros1） by ngs * squamous cell carcinoma，no gene detection * progress after second line * ps score \>2 exclusion criteria: * patients received apatinib or vinorelbine treatment before * egfr, alk or ros1 mutation * patients with contraindication of chemotherapy * pregnant or breast feeding women

Keywords: apatinib plus vinorelbine nsclc
the impact of docosahexaenoic acid on the prevention of necrotizing enterocolitis in preterm neonates

Conditions: Necrotizing Enterocolitis

Summary: the study will assess the efficacy of docosahexaenoic acid in reducing the incidence of necrotizing enterocolitis in premature infants.

the efficacy of docosahexaenoic acid in reducing the incidence of necrotizing enterocolitis in preterm neonates will be evalutaed through measuring its immune-modulatory effect on proinflammatory cytokines.

Eligibility criteria:
inclusion criteria: * preterm neonates having a gestational age equal or less than 34 weeks at birth. * weight (less than or equal 1.500 kg) * clinically stable to begin enteral feeding exclusion criteria: * persistent bleeding at any level. * receiving medication to avoid coagulation. * persistent vomiting. * gastrointestinal malformations. * mother taking omega-3 supplements and planning to breastfeed.
amniotic membrane in carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: carpal tunnel syndrome (cts) is the most frequent mononeuropathy. cts is more frequent in females than in males, it has been associated to work activities, hormone exposure and obesity. although its primary treatment is conservative, there is strong evidence that patients who retard surgery are more prone to develop worse outcomes. surgery to treat cts consists in liberating carpal tunnel in order to ameliorate median nerve symptoms; however, more than 20% of patients who undergo surgery have recurrent cts (rcts). rcts is due to a fibrotic process in the site of the surgery. amniotic membrane (am) is the inner layer of the placenta which has been used to treat different pathologies. am transplantation (amt) has demonstrated to significantly inhibit inflammation and fibrosis. therefore, the aim of the present study was to determine the effect of amt in cts surgery. the present is a randomized, open labeled, controlled clinical study. the investigators included patients with recent diagnosis of cts and divided into two groups. the experimental group received amt concomitantly with conventional surgery; whilst, the control group received only the conventional surgery. clinical status of patients measured with the bctq questionaire was the main outcome. both groups showed similar bctq punctuation at the beginning of the study. however, the results of the experimental group were significantly better than those from the control group through time, until the finish of the study. none of the patients presented complications or adverse effects related to the amt. these results indicate that amt is a secure and suitable treatment for cts presenting better clinical outcomes at one-year follow-up.


Eligibility criteria:
inclusion criteria: * patients with recent cts diagnosis * patients that undergo cts surgery * patients that accept to participate in the study * patients that sign informed consent exclusion criteria: * patients with recurrent cts diagnosis; * patients with concomitant hand/arm comorbidities * patients with any systemic disease that comprises muscles and bones * collagenopathies * systemic lupus erythematosus

Keywords: amniotic membrane transplantation
laparoscopic lateral suspension with mesh & sacrocervicopexy for the treatment of uterine prolapse

Conditions: Pelvic Organ Prolapse; Pelvic Floor Prolapse

Summary: this study is aimed to compare the efficiency of two uterus-preserving laparoscopic methods to treat uterine prolapse in a randomized controlled trial. laparoscopic lateral suspension with mesh (llsm) will be compared with laparoscopic sacrohysteropexy (ls). both procedures are known as sufficient uterus preserving methods. llsm was introduced to be an alternative to others with avoiding dissection of promontory and therefore being safer, faster and feasible technique.

patient with uterine prolapse can participate in this study. a total of 44 women will be included. at random 22 patients undergo laparoscopic lateral suspension with mesh operation and 22 patients undergo laparoscopic sacrohysteropexy operation. evaluation will take place during the surgery, at the postoperative visit after 4 weeks, 6th months and 12th months. quality of life, degree of vaginal prolapse, safety, operation time and complications will be evaluated. subjective assessments will include female sexual function index (fsfi), michigan incontinence severity index (m-isi), prolapse quality of life questionnaire (pqol), pelvic organ prolapse symptom score (pop-ss) and visual analog score (vas). objective assessments will include routine gynecologic sonography, pelvic organ prolapse quantification system (pop-q) and pelvic floor biometry measured by transperineal sonography. transperineal sonography will include those measurements: urethral rotation, pelvic organ descent, hiatal diameter and the anatomical localization of apex.

Eligibility criteria:
inclusion criteria: * \>18 years old * \> symptomatic prolapse of central compartment with a pelvic organ prolapse quantitative (pop-q) stage 2 associated or not with anterior or posterior compartment prolapse. * patients who are not comfortable with using or refusing pessary * wish to preserve the uterus exclusion criteria: * any cue for gynecologic oncological condition * patients who approves le fort colpocleisis among who does not have any sexual intercourse

Keywords: pelvic organ prolapse translabial ultrasound transperineal ultrasound lateral mesh suspension descensus uteri laparoscopic pelvic organ prolapse repair uterus preserving hysteropexy uterine-preserving fertility-sparing sacropexy cervicopexy sacrocervicopexy sacrohysteropexy mesh prolapse surgery
the immunogenicity and safety of inactivated and live attenuated hepatitis a vaccines

Conditions: Hepatitis A

Summary: the purpose of this phase 4 trial is to assess the safety, immunogenicity, three-year immune persistence of inactivated hepatitis a vaccine (hav) and live attenuated hav vaccine.

hepatitis a refers to liver inflammation caused by infection with the hepatitis a virus. hav is is one of the most common hepatitis viruses that can cause hepatitis in china. the data from the phase 1, 2 and 3 trials suggested that both inactivated hepatitis a vaccine and live attenuated hepatitis a vaccine had a clinically acceptable safety and good immunogenicity for healthy chinese people.

Eligibility criteria:
inclusion criteria: * only subjects fulfilling all of the following criteria will be eligible for the study: * people aged from 18 months to 65 years old. * the subjects or subjects' guardians are able to understand and sign the informed consent * the subjects or subjects' guardians allow to comply with the requirements of the protocol * subjects with temperature \<=37.0°c on axillary setting * the subjects have signed informed consent already exclusion criteria: * subjects will not be eligible for the study if any of the following criteria is met: * subject who has a medical history of serious disease including tumor, autoimmune disease, progressive atherosclerosis diseases or complications of diabetes, chronic obstructive pulmonary disease (copd), kidney disease, congestive heart failure etc. * have a history of neurological symptoms or signs * have medical history or family history relating to allergies, seizures, epilepsy, brain and spirit etc. * suffering from serious chronic diseases * suffering from known or suspected of diseases including respiratory diseases, acute infection , mothers have hiv infection, cardiovascular disease, severe hypertension, skin diseases, malignant tumor * allergic to any ingredient in research, history of allergies to any vaccination (always), especially for people allergic to high protein food like eggs and milk * any prior known or suspected damage or abnormal immune function. as for patients who are treated with immune inhibitors or immune enhancer medicine, accept with immunoglobin, blood products and plasma extraction within 3 months * any prior diseases including human immunodeficiency virus infection or related * bleeding constitution or prolong bleeding time situation * accept hepatitis a vaccination within a month * received vaccines, other immune globulin, any research drug injections in the past 4 weeks * people who had any acute illness, needed systemic antibiotics or antiviral treatment in the past 7 days * caught a fever with axillary temperature 38°c or higher in past 3 days * take part in another clinical researchers * any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent * pregnancy test result is positive

Keywords: hepatitis a vaccine safety efficacy
activated recombinant human factor vii in pelvic-acetabular fracture reconstruction

Conditions: Acquired Bleeding Disorder; Trauma

Summary: this trial is conducted in europe. the aim of this trial is to evaluate the efficacy of activated recombinant human factor viigiven in conjunction with standard therapy in patients undergoing major orthopaedic surgery following traumatic pelvic or pelvic and acetabular fractures.


Eligibility criteria:
inclusion criteria: * injury due to a blunt or penetrating trauma causing pelvic or pelvic and acetabular fracture amenable to surgical reconstruction * scheduled for a semi-elective reconstruction surgery for fracture(s) of pelvis or pelvis and acetabulum, which was expected to be a "large" complex procedure with the potential of blood loss more than 50% of circulating blood volume exclusion criteria: * a history of thrombosis (deep vein thrombosis, pulmonary embolism, cerebral thrombosis) * patients with severe head injuries or an abnormal computed tomography (ct) scan of the head due to head injuries * body weight exceeding 135 kg * cardiac arrest following trauma and prior to surgery * known congenital bleeding disorders * known pregnancy or positive pregnancy test at enrolment
a pharmacokinetic study to compare the dosing of valproic acid in subjects with different body weights

Conditions: Healthy; Obesity; Pharmacokinetics

Summary: the purpose of this study is to compare the blood levels of valproic acid in subjects with different body weights and to evaluate whether the pharmacokinetic parameters of this drug is altered in the obese population.

many pharmacologic agents are dosed based on the weight of the patient, and studies are conducted to determine the appropriate doses of drugs for patients with different weights in order to find the safest and most effective dose for various weights. valproic acid is a commonly used agent for the treatment of epilepsy, as well as migraine headaches and psychiatric disorders. this prospective study is designed to evaluate the effects of obesity on the pharmacokinetic parameters of valproic acid when compared to individuals at their healthy weight.

Eligibility criteria:
inclusion criteria: * male or female age 21-60 years * normal healthy volunteers as per interview at screening * willing and able to provide written informed consent and comply with the study protocol exclusion criteria: * inability to take oral medications * pregnant or lactating females * known hypersensitivity to valproic acid * bmi less than 18.5 kg/m\^2 * bmi between 25 and 29.9 kg/m\^2, inclusive * taking any drug or dietary supplement within one week prior to study period * consumption of food 6 hours prior to study drug ingestion * know family history or history of urea cycle disorders * past history of pancreatitis * past history of liver disease

Keywords: healthy obesity pharmacokinetics
a pilot study evaluating the effect of 2d antiscatter grids on cbct image quality

Conditions: Prostate Cancer; Head and Neck Cancers; Upper Abdomen Cancers

Summary: this is pilot study that investigates the cbct(cone beam computed tomography) image quality improvement provided by the 2d antiscatter grid technology. the primary objective is to assess the improvement in tissue visualization in an observer study, which will be conducted in a blinded fashion.

this is a single arm study, where all participants will be scanned with a cbct system equipped with 2d antiscatter grid technology, referred to as research cbct. each participant will also be scanned with a standard clinical cbct as part of their standard clinical care, which will serve as the baseline, or control. thus, the image quality improvement in research cbct will assessed with respect to standard clinical cbct.

Eligibility criteria:
inclusion criteria: 1. provision to sign and date the consent form. 2. stated willingness to comply with all study procedures and be available for the duration of the study. 3. be a male or female aged 18-100. 4. participants who will be treated or are currently being treated with cbct-guided photon therapy for prostate or prostate-bed, abdomen head and neck, or pelvic cancers, or with image-guided proton therapy for prostate or prostate bed cancer. exclusion criteria: 1. metallic implants in the cbct scan volume, such as hip prostheses or spine stabilization hardware. patients with pacemakers, defibrillators, or other implanted electronic devices. dental implants, fillings, or fiducial markers may be acceptable, and the decision for inclusion/exclusion will be on a case-by-case basis, by reviewing prior ct images of the study candidate. patient's prior ct images will be reviewed by the pi or the site pi. 2. patients who do not have the ability to lie still for the duration of his/her cbct imaging and treatment should be excluded. if image artifacts in prior scans are deemed excessive, the patient will be excluded from the study. 3. known pregnancy. (per soc, a pregnancy test will be performed prior to cbct scan on day 1. at this time, women of child-bearing potential (wocbp) will receive a pregnancy test to re-confirm eligibility). * women of child-bearing potential are described as: 1. age 55 or younger who have not had a negative pregnancy test within 3 days. this excludes patients who have had tubal ligation or are already post-menopausal.
effect of oral menthol on the swallow response of patients with oropharyngeal dysphagia associated with neurological diseases and aging

Conditions: Deglutition Disorders

Summary: oropharyngeal dysphagia (od) is the most frequent digestive disorder in older people (\>70 years) and has been recently recognized as a geriatric syndrome. the main features of od are: a high prevalence and severe complications either related with the decreased swallowing efficacy with 45% prevalence of malnutrition or due to decreased swallowing safety with 50% prevalence of aspiration pneumonia that increases hospital stay by 100% and leads to a 50% of mortality rate. however, there is no specific pharmacologic treatment for od in older patients yet. treatments are now evolving from compensation to active treatments aiming to restore the swallowing dysfunction and some groups have been looking for new therapeutic strategies. the main goal of this study is to evaluate the effect of administering menthol in bolus on the swallowing response in elderly and neurogenic patients with od. in addition, this study will also assess the side effects of this pharmacological strategy.


Eligibility criteria:
inclusion criteria: * patients with suspicion of od associated with aging (\>70 years), neurodegenerative diseases or stroke. exclusion criteria: * patients with suspicion that they will not be able to compliment the protocol, patients participating or have participated in a clinical study the last 4 weeks and patients with alcoholic or drugs dependence
a study to assess effectiveness of venclexta (venetoclax) in patients with relapse or refractory chronic lymphocytic leukemia in routine clinical practice in russian federation

Conditions: Chronic Lymphocytic Leukemia (CLL); Cancer

Summary: this study seeks to assess the effectiveness and safety of venetoclax in patients with relapsed and refractory chronic lymphocytic leukemia (cll) in a real-world setting across clinical practice in the russian federation.


Eligibility criteria:
inclusion criteria: * has a confirmed diagnosis of relapsed or refractory cll. * patient for whom the physician has decided to initiate cll treatment with venetoclax (mono and combo therapy), or up to 4 weeks after venetoclax treatment initiation * patient voluntarily agrees to participate in this study and signs informed consent form exclusion criteria: * has contraindications to venetoclax as listed on the approved local label in russian federation. * has richter syndrome * participated in a clinical trial with an investigative drug for cll within 30 days prior to treatment initiation

Keywords: chronic lymphocytic leukemia (cll) cancer observational study venetoclax relapsed chronic lymphocytic leukemia refractory chronic lymphocytic leukemia
a study for assessing treatment of patients ages 10-17 with bipolar depression

Conditions: Bipolar Depression

Summary: the main goal of this study is to help answer the following research question(s) and not to treat the child's illness. * can this study drug make children with bipolar depression feel better? * does this study drug work better than a placebo (sugar pill)? * does this study drug cause side effects in children who take it? * is this drug safe to use in children? (the study drug is a mixture of olanzapine and fluoxetine)


Eligibility criteria:
inclusion criteria: * male or female inpatients or outpatients, 10-17 years of age, who have not reached their 18th birthday prior to screening. patient must weigh at least 20 kilograms (kg) at screening. * must meet diagnostic criteria for current major depressive episode of bipolar i disorder according to the diagnostic and statistical manual of mental disorders, fourth edition, text version (dsm-iv-tr) and confirmed by kiddie schedule for affective disorders and schizophrenia for school aged children-present and lifetime (k-sads-pl) * patients entering the study will also be scored by the children's depression rating scale-revised (cdrs-r) (entry score of greater than or equal to 40) as well as the adolescent-structured young mania rating scale (ymrs) (entry score of less than or equal to 15 with ymrs item 1 \[elevated mood\] score less than equal to 2). exclusion criteria: * patients will be excluded if they are, in the opinion of the investigator, actively suicidal * have an acute, serious or unstable medical condition * have clinically significant laboratory abnormalities * have had one or more seizures of unclear etiology * have a current or lifetime diagnosis of any of the following according to dsm-iv criteria: schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, psychotic disorder not otherwise specified, delirium of any type, amnestic disorder, any substance-induced disorder, or any psychotic disorder due to a general medical condition, unless there is substantive reason to believe patient was misdiagnosed

Keywords: bipolar i depression
tislelizumab in combination with chemotherapy as first-line treatment in adults with inoperable, locally advanced or metastatic gastric, or gastroesophageal junction carcinoma

Conditions: Gastric, or Gastroesophageal Junction Adenocarcinoma

Summary: this study was designed to compare the efficacy and safety of tislelizumab plus chemotherapy versus placebo plus chemotherapy as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (gej) adenocarcinoma.


Eligibility criteria:
key inclusion criteria: 1. locally advanced unresectable or metastatic gastric cancer (gc) or gastroesophageal junction (gej) carcinoma and have histologically confirmed adenocarcinoma 2. no previous systemic therapy for locally advanced unresectable or metastatic gastric/gej cancer. note: participants may have received prior neoadjuvant or adjuvant therapy as long as it was completed and have no recurrence or disease progression for at least 6 months. 3. eastern cooperative oncology group performance status (ecog ps) ≤ 1 within 7 days prior to randomization 4. adequate organ function ≤ 7 days prior to randomization key exclusion criteria: 1. has squamous cell or undifferentiated or other histological type gc 2. active leptomeningeal disease or uncontrolled brain metastasis 3. diagnosed with gastric or gej adenocarcinoma with positive her2 4. prior therapy with an anti-programmed cell death protein-1 (pd-1), anti-programmed cell death protein ligand-1 (pd-l1), anti-programmed cell death protein ligand-2 (pd-l2), or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways note: other protocol defined inclusion/exclusion criteria may apply.