Kornimate/medical-research-clean huggingface dataset:
a post-authorization safety study of interferon beta therapy in participants with multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the purpose of this study is to investigate the safety of subcutaneous (sc) interferon beta therapies with regard to frequency of injection site reactions (isr) and flu-like symptoms (fls) as reported by the relapsing-remitting multiple sclerosis (rrms) participants.


Eligibility criteria:
key inclusion criteria: * ability to understand the purpose of the study and provide signed and dated informed consent * diagnosed relapsing-remitting multiple sclerosis * currently receiving a sc interferon beta treatment (label conform) * stable on sc interferon beta treatment for three months or longer (switch between sc interferon beta treatments possible). key exclusion criteria: * contraindications according to the fachinformation (german equivalent to summary of product characteristics \[smpc\]) * treatment with glatiramer acetate and intramuscular (im) interferon beta-1a * participation in a non-interventional or interventional clinical study of biogen

Keywords: subcutaneous interferon beta therapy multiple sclerosis (ms) injection site reactions (isr) flu-like symptoms (fls) non-interventional study (nis) sc peginterferon beta-1a sc interferon beta-1a sc interferon beta-1b plegridy® betaferon® extavia® rebif®
impact of progestin-only contraception on bleeding patterns in individuals initiating gatt

Conditions: Gender; Contraception

Summary: gender diverse individuals who use gender-affirming testosterone therapy (gatt) to reduce gender dysphoria may also use progestins for contraception and to manage or suppress uterine bleeding. research is limited, however, regarding expected bleeding patterns for individuals who choose to initiate gatt concurrently with a progestin. clinicians who prescribe gatt do not have sufficient data to adequately counsel patients on side effects of concurrent progestin use and therefore extrapolate from studies conducted in cisgender women. this study is a prospective cohort study evaluating bleeding patterns and satisfaction among patients initiating gatt with or without concurrent initiation of a progestin contraceptive. the results from this study will enable clinicians to more accurately counsel patients using gatt on how the use of a progestin might affect their bleeding and whether this differs by progestin method.


Eligibility criteria:
inclusion criteria: * english-speaking currently have a uterus and ovaries * desire to initiate gatt * potential desire to initiate a progestin (within 14 days of gatt initiation) exclusion criteria: * previous gender-affirming surgery to remove their uterus and/or ovaries

Keywords: progestin testosterone gender-affirming bleeding
detection of asymptomatic venous thrombosis in gynecological patients with pelvic masses

Conditions: Silent; Thrombosis

Summary: venous thromboembolism (vte) is a serious preventable complication of gynecological surgery. high incidence of silent vte before surgery seems attributable to the high incidence of vte after surgery in ovarian cancer .so the aim of work is to detect silent venous thrombosis in gynecological patients suffering from pelvic masses using different imaging modalities .

high incidence of silent vte before surgery seems attributable to the high incidence of vte after surgery in ovarian cancer . the incidence rate of dvt is about 10% to 40% in medical or general surgical patients without prophylaxis .with prophylaxis, the postoperative incidence of vte was 1.14% in women with gynecological disease, and 0.7% in patients undergoing laparoscopic gynecological surgery, 0.3% in patients undergoing urogynecological surgery, and 4% in gynecological cancer patients, respectively. most of published studies enrolled only symptomatic patients with dvt, whereas asymptomatic patients could be easily neglected under the absence of effective detection. in fact, approximately 50% of dvt patients are silent, so the actual incidence of postoperative dvt might be higher than reported . the asymptomatic dvt has been confirmed to increase the development of post-thrombotic syndrome (pts). the essence of any surveillance strategy would be the identification of dvt in the expectation that anticoagulation at the presymptomatic stage would prevent fatal pulmonary embolism . a number of imaging modalities are currently available to evaluate deep venous system in a comprehensive manner allowing correct assessment of presence of thrombosis . color doppler ultrasound has become the primary non invasive diagnostic method for dvt. all patients are going to be examined by color doppler ultrasound and by direct mdct venography .

Eligibility criteria:
inclusion criteria: * female patients in different age groups with gynecological masses detected by clinical examination and different imaging modalities. exclusion criteria: 1. patients with chronic kidney disease in case of contrast . 2. patients complaining from hematological diseases that may cause venous thromboembolism . 3. pregnant patients . 4. patients already diagnosed with deep venous thrombosis. 5. patients not fit for surgery.
hemostasis in covid-19: an adaptive clinical trial

Conditions: COVID-19

Summary: hypercoagulability has been demonstrated in covid-19, leading to respiratory distress and increased mortality. this is an adaptive clinical trial to compare the efficacy and safety of two experimental strategies in patients with covid-19: asa or inhaled ufh associated with standard vte prophylaxis.


Eligibility criteria:
inclusion criteria: * adult ≥18 years of age at time of enrollment * subjects with a positive covid-19 diagnosis by rt-pcr or serologic testing * subject (or legally authorized representative) must be willing, understanding and able to provide written informed consent. * only at phase 2: * onset of symptoms must not exceed 4 weeks * icu patients * pao2 to fio2 ratio \< 200 exclusion criteria: 1. general * indications for therapeutic anticoagulation * history of chronic lung disease oxygen dependent * pregnancy * death considered imminent and inevitable within 24 hours * patients under exclusive palliative care * participation in another trial of investigational drug * body weight \< 40 kg * total bilirubin \> 20 mg/dl * severe active bleeding * persistent gi bleeding * known allergy to ufh or lmwh * history of heparin-induced thrombocytopenia (hit) within the past 6 months 2. exclusion criteria at phase 1 * platelet count \< 25,000/mm3 * bacterial endocarditis 3. exclusion criteria at phase 2 * platelet count \< 50,000/mm3 * history of surgery in the last 30 days * intervention a: allergy to asa and long-term use of antiplatelet drug * intervention b: inhaled nitric oxide use

Keywords: sars-cov-2 thrombosis coagulopathy anticoagulation respiratory failure
the effect of a short-term very low calorie diet on heart rate variability in obese individuals

Conditions: Obesity

Summary: the purpose of this study is to determine whether short-term adherence to a very low calorie diet is effective in improving heart rate variability in obese individuals.


Eligibility criteria:
inclusion criteria: * healthy, non-smoking men and women * aged 32-65 years * bmi 30-42 kg/m2 exclusion criteria: * history of cardiovascular disease, diabetes, cancer, renal or liver disease or chronic gastrointestinal disorder * epileptic or history of fainting * adhered to a vlcd in the past 6 months * history of drug or alcohol abuse including heavy drinking. * pregnancy, planning to get pregnant or breastfeeding * currently taking medications to control blood pressure * weight change of over 3kg in the past two months
cornual pregnancy: results of a single-center retrospective experience and systematic review on reproductive outcomes

Conditions: Ectopic Pregnancy

Summary: to present our experience in the diagnosis and management of cornual pregnancy. a systematic review was also conducted to investigate reproductive outcomes after treatment.


Eligibility criteria:
inclusion criteria: * age ≥18 years; * patients with a diagnosis of cornual pregnancies. exclusion criteria: * all patients whose medical records did not contain the data deemed necessary for study analysis or who did not consent to the publication and use of their data; * other type of ectopic pregnancies.

Keywords: cornual pregnancy ectopic pregnancy laparoscopy methotrexate fertility
the duke-reinvestment partners community collaborative (drc)- healthy homes

Conditions: Asthma in Children

Summary: the goal of this open-label, single arm home intervention feasibility study is to improve quality of life for children ages 4-16 years with asthma. the main questions it aims to answer are: * how can home-based environmental interventions (hei) improve home air-quality problems in the home? * how can hei improve asthma outcomes in children? participants will be receiving hei and completing asthma surveys.

all participants will receive an intervention kit, which could help with reducing environmental exposures. participants will be monitored closely with up to 2 clinic visits, 2 home visits and up to 4 phone call visits. during the home visits, a study team will ask questions about your home and asthma, conduct home assessments, and provide training on use of the home kit. participants may benefit from participation in this study through home-based environmental interventions by improving home air-quality and asthma outcomes. study duration is approximately 24-30 weeks with 8 weeks of intervention, which includes baseline interview, questionnaires, spirometry testing, and participants receiving an intervention kit.

Eligibility criteria:
inclusion criteria: * parent/legal guardian has provided informed consent (child has provided assent if needed) * 4-16 years of age with medical provider -diagnosed asthma * evidence of recent poor asthma control, defined as either: 1. asthma exacerbation requiring systemic steroids within 3 month of consent or 2. acq6 \> 1.0; or act/cact ≤ 19 during ambulatory visit within 3 months of consent * family lives in one of the following central nc counties: alamance, chatham, durham, franklin, granville, johnston, lee, orange, person, vance, or wake counties * family is not planning to move out of one of the approved counties accessible to reinvestment partners in the next 6 months exclusion criteria: * lack of informed consent * any major chronic illness that in the opinion of the principal investigator (pi) would interfere with participation in the intervention or completion of the study procedures * inability to complete baseline measurements in a satisfactory manner according to the judgment of the research coordinator or pi * parent/caregiver unable to consent in english or spanish * sensitivity or allergy to silicone
a study of dpp-iv inhibitor in patients with type 2 diabetes

Conditions: Diabetes Mellitus Type 2

Summary: this study will assess the efficacy, safety and tolerability of dpp-iv inhibitor compared to placebo in patients with type 2 diabetes. the anticipated time on study treatment is \< 3 months and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients 18-75 years of age; * type 2 diabetes diagnosed \>=1 month before screening; * no previous treatment, or previous treatment with no more than 2 oral medications. exclusion criteria: * type 1 diabetes; * type 2 diabetes treated with insulin or a ppar gamma agonist during the 3 months before screening; * patients who are pregnant, breastfeeding or not using a reliable contraceptive method.
inhaled nitrous oxide for treatment-resistant depression: optimizing dosing strategies

Conditions: Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant

Summary: the purpose of the study aims to determine whether different concentrations of nitrous oxide (n2o) have different antidepressant effects for adults with treatment-resistant major depression.

most clinical major depression responds to standard treatments (medication and psychotherapy); however, a significant subset of depressed patients (15-20%) do not respond to these treatments and are referred to as treatment-resistant major depression (trmd). new treatments for trmd are needed, and one promising line of research are drugs known as n-methyl-d-aspartate (nmda) glutamate receptor antagonists. in a recent pilot study, our group demonstrated that the nmda antagonist nitrous oxide is effective in trmd. all patients will receive 3 randomized, one hour nitrous oxide inhalations to placebo (0% n2o), low dose (25% n2o), and high dose (50% n2o). inhalation sessions will be at least 4 weeks apart. mood will be assessed at baseline, 2 and 24 hours, and 1, 2, and 4 weeks post-inhalation for each dose.

Eligibility criteria:
inclusion criteria 1. adults 18-75 years of age; 2. current diagnosis of unipolar major depressive disorder (mdd) without psychosis as confirmed by structured clinical interview for dsm-iv disorders; 3. a score of \>= 9 on the montgomery-åsberg depression rating scale (madrs); 4. documented (i.e., chart review) lifetime failure to respond to \>=3 adequate dose/duration antidepressant treatment trials, ≥1 medication failure in the current depressive episode; 5. good command of the english language. exclusion criteria 1. meets criteria for any dsm-iv diagnosis for schizophrenia, bipolar, schizoaffective, obsessive-compulsive, personality, or panic disorders; 2. any recent (within past 12 months) history of substance dependence or abuse (except tobacco), determined by reported history or urine drug screen; 3. ability to become pregnant and not using effective contraception; 4. contraindication against the use of nitrous oxide: 1. pneumothorax 2. bowel obstruction 3. middle ear occlusion 4. elevated intracranial pressure 5. chronic cobalamin and/or folate deficiency treated with folic acid or vitamin b12 6. pregnant patients 7. breastfeeding women 5. inability to provide informed consent; 6. any other factor that in the investigators' judgment may affect patient safety or compliance

Keywords: depression treatment-resistant
ce mark study for the harpoon medical device

Conditions: Mitral Valve Regurgitation; Mitral Valve Prolapse; Mitral Valve Insufficiency

Summary: the purpose of this study is to evaluate the safety and performance of the harpoon medical device. it is anticipated, that the harpoon medical device will provide advantages over current surgical interventions including: 1) a small minimally invasive incision, 2) no sternotomy, 3) no cardiopulmonary bypass, 4) no aortic manipulation, 5) a direct path to the valve plane, 6) performed on a beating heart, 7) real-time toe-guided chordal length adjustment and 8) less complicated procedure that is teachable and adoptable.

the device is designed to reduce the degree of mitral regurgitation by delivering and anchoring artificial chordae tendineae to the affected mitral valve leaflet(s) in a beating heart.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patient referred for mitral valve surgery * presence of severe mr as read on an echocardiographic study performed within 60 days prior to procedure * estimated post-eptfe chordae tendineae implantation coaptation surface is adequate in the judgment of the operating surgeon and the patient eligibility committee * degenerative mitral valve disease * patient is able to sign informed consent and able to return for follow-up and is capable of participating in all testing associated with this clinical investigation * women of child-bearing potential have a negative pregnancy test exclusion criteria: * age \< 18 years * infective endocarditis * anterior or bileaflet prolapse * functional mr * history of mediastinal radiation * inflammatory (rheumatic) valve disease * requirement for concomitant cardiac surgery (e.g., coronary artery bypass grafting (cabg), aortic valve surgery, etc.) * symptomatic coronary artery disease * cardiogenic shock at the time of enrollment * st segment elevation myocardial infarction requiring intervention within 30 days prior to enrollment * evidence of cirrhosis or hepatic synthetic failure * pregnancy at the time of enrollment (women of child bearing age should have negative pregnancy within 14 days of surgery) * severe pulmonary hypertension (pa systolic pressure \> 70 mmhg) * previous cardiac surgery, or surgery on the left pleural space * left ventricular, atrial or appendage thrombus * severely calcified mitral leaflets * recent stroke (\< 6 months) with permanent impairment * euroscore (for mitral valve repair) \> 8% * patients with contraindications to transoesophageal echocardiography * severe left or right ventricular dysfunction * nyha class iv * renal insufficiency ckd stage 3b or worse (gfr \< 45 ml/min/1.73 m2) * patient is participating in another clinical study for which follow-up is currently ongoing. (co-enrollment in an investigational device or interventional study) * patient with non-cardiac co-morbidities and life expectancy \< 1 year * patient has a condition or conditions that, in the opinion of the investigator, preclude participation, including willingness to comply with all follow-up procedures

Keywords: mitral valve repair transapical artificial chordae
effects of chest wall elastance on pulmonary mechanics of acute respiratory failure (arf)

Conditions: Airway Pressure Stress Index; Transpulmonary Pressure Stress Index; Acute Respiratory Failure; Chest Wall Elastance

Summary: patients with chest wall elastance increasing could worsen lung function. increasing of chest wall elastance plays a great role in lung mechanics, and could influence mechanical ventilation settings. therefore, it could help the physicians to find appropriate indicators and optimize the treatments of arf patients to explore the mechanisms of lung mechanics changse in the patients with high chest wall elastance.

mechanical ventilation(mv) is an important treatment for acute respiratory failure(arf) patients, could improve hypoxemia, maintain lung volume and promote alveolar opening. however, because of barotrauma, volutrauma and biotrauma, mv could cause or aggravate acute lung injury not only in acute respiratory distress syndrome(ards) patients, but in patients with normal lung function1,2. patients with chest wall elastance increasing could worsen lung function. increasing of chest wall elastance plays a great role in lung mechanics, and could influence mechanical ventilation settings. therefore, it could help the physicians to find appropriate indicators and optimize the treatments of arf patients to explore the mechanisms of lung mechanics changse in the patients with high chest wall elastance. the present study is set out to examine the effects of high chest wall elastance on changes of lung mechanics and the correlation of airway pressure(paw) stress index and transpulmonary pressure(pl) stress index.

Eligibility criteria:
inclusion criteria: * arf * mechanical ventilation * cardiovascular stable exclusion criteria: * age \ 85y * pregnancy * copd or chronic pulmonary disease

Keywords: airway pressure stress index transpulmonary pressure stress index acute respiratory failure chest wall elastance lung stress
safety and efficacy trial of delamanid for 6 months in participants with multidrug-resistant tuberculosis

Conditions: Multidrug-resistant Tuberculosis

Summary: the purpose of this trial is to determine whether delamanid is effective in the treatment of multidrug-resistant tuberculosis (mdr tb) in combination with other mdr tb medications during 6 months of treatment.

the primary objective of this trial is to evaluate the efficacy of delamanid administered orally as 100 milligrams (mg) twice daily (bid) for 2 months followed by 200 mg once daily (qd) for 4 months in combination with an optimized background treatment regimen (obr) versus placebo with obr during the 6-month intensive period of mdr tb treatment. following the 6-month intensive period, obr was administered alone during the continuation period for 12 to 18 months (from month 7 up to month 24). the trial also included a post-treatment follow-up period of 6 to 12 months (month 19 to month 24 to the end of month 30). obr given throughout the study was administered as per world health organization (who) guidelines and national treatment norms. this trial is a multicenter, randomized, double-blind, stratified, placebo-controlled trial that was conducted globally in 2 parallel groups at 17 sites in 7 countries qualified to treat mdr tb.

Eligibility criteria:
inclusion criteria: * provide written, informed consent * current diagnosis of mdr tb * chest radiograph consistent with tb * able to produce sputum * negative urine pregnancy test and agree to use a highly effective method of birth control and/or adequate method of contraception exclusion criteria: * allergy to any nitro-imidazoles or nitro-imidazole derivates * diseases or conditions in which the use of nitro-imidazoles or nitro-imidazole derivates is contra-indicated * use of disallowed medications * renal impairment * abnormal electrocardiogram (ecg) results * cardiovascular disorders * body mass index (bmi) \< 16 kg/m\^2 * karnofsky score \< 50% * significant metabolic, gastrointestinal, neurological, psychiatric, or endocrine diseases, active malignancy * alcohol abuse * pregnant, breast-feeding, or planning to conceive or father a child * recent use of methadone, benzodiazepines, cocaine, amphetamine/methamphetamine, tetrahydrocannabinol, barbiturates, and opiates * previous exposure to delamanid * administered an investigational medicinal product (imp) within 1 month prior to screening (days -21 to -2). * evidence of extensively drug-resistant tb based on the definition from who * human immunodeficiency virus (hiv) co-infection for participants screened at sites not participating in the hiv subtrial (data from the hiv subtrial will be reported separately from the clinical study report for study 242-09-213).

Keywords: multidrug-resistant tuberculosis
blood transfusion management in patients with mitral valve replacement in china

Conditions: Mitral Valve Replacement; Transfusion Reaction; Blood Transfusion Complication

Summary: the evaluation uses δhb as an independent factor combined with artificial intelligence (ai) to predict its impact on the prognosis and blood transfusion of patients undergoing cardiac surgery, thereby guiding perioperative clinical blood use and improving patient prognosis.

1. select 8 hospitals to form a multi-center team, and enter the keyword "mitral valve replacement" in the case system of 8 hospitals to collect information on 2000 heart surgery patients. 2. mainly collect information on preoperative, intraoperative and postoperative test indexes (blood routine, liver and kidney function, coagulation function, blood gas), cardiac color doppler, blood transfusion and prognosis of patients undergoing cardiac surgery, using statistical methods for analysis. identify key observations. 3. gradually incorporate and exclude data, and use statistical methods to conduct preliminary analysis on the collected data. the ai prediction model was established by machine learning algorithm to predict intraoperative blood transfusion, verify the specificity and sensitivity of the blood transfusion prediction model, and scientifically guide clinical blood use.

Eligibility criteria:
inclusion criteria: 1. patients undergoing "mitral valve replacement" surgery; 2. age 18-75 years old; 3. 48h biochemical indicators before surgery, blood general indicators, coagulation indicators are complete. exclusion criteria: 1. lack of necessary tests and patient test information is not detailed, blood transfusion information is not detailed; 2. the blood transfusion information is not detailed in the same period as other cardiac operations (such as aortic valve surgery, coronary artery bypass grafting, etc.), but the tricuspid valvuloplasty is not ruled out at the same time; 3. heart surgery or emergency surgery again.

Keywords: mitral valve replacement predictive model blood transfusion perioperative period