Kornimate/medical-research-clean huggingface dataset:
study on safety and clinical efficacy of azvudine in initial stage covid-19 patients (sars-cov-2 infected)

Conditions: COVID-19

Summary: phase iii, single-center with co-participating units, randomized, double-blind, parallel, placebo-controlled clinical study

hypothesis: azvudine has a therapeutic potential and safety profile for the treatment of patients infected with sars-cov-2. goals: main goal: to evaluate the efficacy and safety of azvudine (fnc) in patients infected with sars-cov-2, in a mild stage; specific objective: to assess the clinical outcome of mild-stage sars-cov-2 infected participants treated with azvudine (fnc) versus placebo statistical planning: statistical description: all statistical tests are performed by bilateral testing. a significance level of 5% will be adopted. baseline analysis: including subject distribution, data demographics, and baseline analysis.

Eligibility criteria:
inclusion criteria: individuals who present the following characteristics will be included in this study: 1. age ≥18 years, regardless of gender; 2. fluorescence rt-pcr test result of respiratory or blood samples must be positive for covid-19, or viral gene sequencing of respiratory tract samples must be highly homologous to covid-19; individuals with covid-19 must meet the diagnostic criteria in the "latest version of clinical guidelines for covid-19" issued by the world health organization (who) on june 4, 2020; 3. symptomatic patients who meet the case definition for covid-19, according to who, without evidence of bacterial pneumonia or hypoxia (sat o2 \< 95%) p. \[score 1-3\]; 4. voluntary participation and signing of the informed consent form. exclusion criteria: individuals who present one or more of the following characteristics will not be eligible to participate in this study: 1. know or suspect that you are allergic to any of the components of azvudine tablets (inactive ingredients: microcrystalline cellulose, lactose hydrate, polyvinylpyrrolidone k30, croscarmellose sodium, magnesium stearate); 2. individual presenting shortness of breath and sat o2 \< 95%; or any other symptom requiring treatment through hospital admission; 3. patients with liver disease (total bilirubin ≥2mg/dl, alt/tgp e ast/tgo ≥5 times above normal limit); 4. pactients with a history of known liver disease (cirrhosis with childpugh classification b and c); 5. patients with a history of renal insufficiency (glomerular filtration rate \< 60ml/min/1,73m2); 6. patients with history of congestive heart failure (nyha ¾ grade), untreated symptomatic arrhythmias ormyocardial infarction within 6 months; 7. individuals with malabsorption syndrome, or other conditions affecting gastrointestinal absorption, and circumstances in which patients require intravenous nutrition, or cannot take medications orally or nasogastrically; 8. total neutrophil count \<750 cells/l;

Keywords: azvudine sars-cov-2 covid-19 fnc
application of n-3 fatty to patient of jaundice

Conditions: Obstructive Jaundice; Surgical Procedure, Unspecified

Summary: the safety and efficacy of ω-3 fatty acid in patients with obstructive jaundice is not known. this study provided evidences that ω-3 fatty acid-based parenteral nutrition improved postoperative recovery for patients with obstructive jaundice.

lipid emulsion enriched in n-3 fatty acid (fa) has been reported to improve postoperative recovery for surgical patients with biliary tract disease, and to improve laboratory and clinical outcomes. the role of it for postoperative patients with jaundice is not clear yet. the object of this research was to evaluate the safety and efficacy of n-3 fatty acid-based parenteral nutrition (pn) for patients with jaundice following surgical procedure. this cohort study was a pragmatic, retrospective, single center, matched, clinical trial from may 2014 to june 2017.

Eligibility criteria:
inclusion criteria: * the diagnosis of obstructive jaundice must be clear (serum toal bilirubin \>51.3umol/l \& imaging evidence), and the obstruction is located in the extrahepatic bile duct; * duration of jaundice is less than 2 weeks; * nutritional support is needed * nutritional support was administrated during the perioperative period; * drainage treatment is effective. exclusion criteria: * contraindication for surgical procedure, including child-pugh classification c, severe hemorrhagic disorders, gastrointestinal hemorrhage, acute infectious disease, active phase of chronic hepatitis b \& c, severe circulatory disease, renal failure pre -operation, and other unknown cause; * abandon treatment; * length of stay in hospital \<5 day; * nutrition support \<5 day; * conservative treatment; * incomplete data; * allergic reactions against pn.

Keywords: n-3 parenteral nutrition jaundice propensity score match
laryngeal injuries after anesthesia induction with three different sevoflurane concentrations (without muscle relaxant)

Conditions: Other Specified Injuries of Vocal Cord, Sequela

Summary: anesthesia induction and tracheal intubation can be performed with and without neuromuscular blocking agents (nmbas). tracheal intubation can be performed with sevoflurane instead of nmbas; intubating conditions are similar and the incidence of vocal cord injuries are similar, too.

we perform tracheal intubation with propofol, remifentanil and sevoflurane; sevoflurane is administered with three dosages. during tracheal intubation intubating conditions are noted. after surgery, all patients are examined by video laryngoscopy; moreover all patients are asked for hoarseness and sore throat.

Eligibility criteria:
inclusion criteria: * ear-nose-throat surgery * orotracheal intubation for surgery of the ear * asa i-iii exclusion criteria: * obesity * allergy against the study drugs * patients with a known or suspected difficult airway * diseases of the larynx

Keywords: hoarseness sore throat intubating conditions vocal cord injuries sevoflurane
exercise into pain in chronic rotator cuff related shoulder pain: a prospective single-group feasibility study

Conditions: Shoulder Impingement Syndrome

Summary: the purpose of this study is to evaluate a) the feasibility of applying a painful exercise program in the treatment of subacromial shoulder pain and b) the time needed to collect clinical outcomes for a future randomized controlled trial.

exercise therapy is the first choice of treatment in the management of subacromial shoulder pain (ssp). guidelines suggest active rehabilitation program for at least three months and existing research highlights the importance of progressive loaded exercise therapy at higher dosage. however, it is not clear which is the best type of exercise and if pain should be provoked during exercise. recent research found that painful exercises are beneficial in short term on pain and function in patients with different kinds of chronic musculoskeletal pain. the aim of the future randomized clinical trial is to investigate if "exercising into pain" gives better results in term of clinical outcomes compared to a non-painful exercise program. since the intervention consists in painful exercises, it is essential to test the rate of adherence in the intervention group (both during physiotherapist-led session and home-based exercises). moreover, the practicability of clinical questionnaire via online survey will be tested and the time needed to collect clinical data will be calculated as well. furthermore, feedback from physiotherapists and participants will be collected and analyzed.

Eligibility criteria:
inclusion criteria: * age 18-65 years * shoulder pain for at least 3 months * pain in the antero-lateral shoulder region * at least 3 out of 5 of the following tests positive: neer test, hawkins-kennedy, jobe, painful arc between 60° and 120°, external resistance test * resting pain should be at 2/10 maximum on verbal nrs scale * all types of occupations were included: students, workers (including overhead workers or heavy duty workers), people on sick leave and retired people exclusion criteria: * bilateral shoulder pain * corticosteroid injections 6 weeks prior to the study * pregnancy, inability to understand spoken or written dutch * clinical signs of full-thickness rotator cuff tears (positive external and internal rotation lag tests and drop arm test) * evidence of adhesive capsulitis (50% or more than 30° loss of passive external rotation) * previous cervical, thoracic or shoulder surgery; recent fractures or dislocations on the painful shoulder * symptoms of cervical radiculopathy as primary complaint (tingling, radiating pain in the arm associated with neck complaints) * primary diagnosis of acromioclavicular pathology, shoulder instability * a radiologically confirmed fracture or presence of calcification larger than 5 mm * presence of competing pathologies (inflammatory arthritis, neurological disorders, fibromyalgia, malignancy) * more than 4h of training in sport overhead shoulder activities per week
anti-cd19 car-engineered nk cells in the treatment of relapsed/refractory acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia

Summary: this study is a single arm clinical study to observe the safety ，dose tolerance and pharmacokinetic characteristics of car nk-cd19 in patients with recurrent or refractory cd19 positive acute lymphoblastic leukemia, and preliminarily evaluate the effectiveness, the immunogenicity of the product and the correlation between the changes of cytokines after infusion and crs , icans.

it is planned to select 9-21 patients with recurrent or refractory cd19 positive acute lymphoblastic leukemia （all）, from the lowest dose group. it is expected that 3-6 cases will be enrolled in each dose group. the protocol will be performed into screening period (-30\~-10 days), prophase of lymophodepletion (-10\~-5 days), lymophodepletion (-5\~-3 days), pre-infusion evaluation (-2\~-1 days), infusion (day 0), and follow-up period (1-720 days). the incidence of dlt is observed after infusion. there are three preset dose groups in this clinical trial. the initial dose is 1.0 × 107 car positive nk cells/kg (body weight). subsequent dose groups included 2.0 × 107 and 3.0 × 107 car positive nk cells/kg (body weight). the specific dose is determined by src based on the patient safety data and pk data. the maximum sample size of this study is tentatively 21 cases.

Eligibility criteria:
inclusion criteria: * age ≥12 years in the single-dose exploration phase, age ≥3 years in the dose exploration phase, both sexes; * meet the diagnostic criteria for recurrent or refractory cd19 positive acute lymphoblastic leukemia. * the main organs have good organ function. * the estimated survival time is ≥12 weeks. * blood pregnancy tests for women of childbearing age are negative. * the patient himself/herself , and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form. exclusion criteria: * central nervous system involvement； * simple extramedullary leukemia or simple extramedullary recurrence； * received hematopoietic stem cell transplantation within the last 3 months and had graft-versus-host disease (gvhd) in the last 2 weeks, requiring immunosuppressive agents； * treated with high-dose corticosteroids in the last 1 week； * allogeneic cell therapy, major surgery, and live or attenuated vaccine had been received within 4 weeks prior to car nk-cd19 infusion； * had received other antitumor therapy or had an uncontrolled infection within 2 weeks prior to car nk-cd19 infusion； * systemic steroids were used within 3 days before car nk-cd19 infusion； * toxicity caused by previous treatment do not fully recover or do not stabilize to grade 1； * concomitant autoimmune diseases, central nervous system diseases, other active malignancies, infectious diseases, severe cardiovascular diseases, etc； * known allergies to study drugs or drugs that may be used in the study； * other conditions determined by investigator which are not suitable for participation in the study

Keywords: nk cd19 positive acute b lymphoblastic leukemia
a phase 3 study in participants with moderate to severe psoriasis (uncover-2)

Conditions: Psoriasis

Summary: this study will assess the safety and efficacy of ixekizumab (ly2439821) compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.


Eligibility criteria:
inclusion criteria: * present with chronic plaque psoriasis based on a confirmed diagnosis of chronic plaque psoriasis for at least 6 months prior to first dose of study drug * at least 10% body surface area (bsa) of psoriasis at screening and at first dose of study drug * static physician global assessment (spga) score of at least 3 and psoriasis area and severity index (pasi) score of at least 12 at screening and at first dose of study drug * candidate for phototherapy and/or systemic therapy * men must agree to use a reliable method of birth control or remain abstinent during the study * women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment exclusion criteria: * pustular, erythrodermic, and/or guttate forms of psoriasis * history of drug-induced psoriasis * prior use of etanercept * clinically significant flare of psoriasis during the 12 weeks prior to randomization * concurrent or recent use of any biologic agent * received non-biologic systemic psoriasis therapy or phototherapy (including psoralens and ultraviolet a \[puva\], ultraviolet b \[uvb\]) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization * cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study * have participated in any study with interleukin 17 (il-17) antagonists, including ixekizumab * serious disorder or illness other than plaque psoriasis * serious infection within the last 3 months * breastfeeding or nursing (lactating) women
defining the optimal hormonal replacement therapy in turner syndrome

Conditions: Turner Syndrome

Summary: the purpose of this study is to examine whether a larger dosage of estrogen than the one used today will secure the development of a normal sized uterus and increase the strength of the bones in girls and young women with turner syndrome. the purpose is also to evaluate whether aortic dilatation is present in this group of patients, and if the estrogen dosage will influence the emotional well-being and self-esteem of the patients.

turner syndrome is a common chromosomal disorder with only one x-chromosome or partial deletions in one x-chromosome in all or some of the cell-lines in the body. appr. 18 girls/year are being born with the syndrome in denmark. the syndrome is mostly known for reduced final height and the lack of pubertal development with infertility, but it is also known for diseases influencing other parts of the body like the heart with the risk of development of aortic dilatation and subsequently dissection with the risk of rupture, profuse bleeding and sudden death. reduced bone strength and increased risk of bone fracture are also features of the syndrome. treatment with growth hormone and female sex-hormones are well-established treatments. girls and young women with turner syndrome ages 10 to 21 years will participate. the girls ages 15 to 21 years will randomly and double blindly receive treatment with either 2 mg or 4 mg estrogen for 5 years. yearly examinations with blood tests, physical examinations, questionnaires, ultrasound and mr-scan of the internal female genitalia, dexa-scan of the bones and mr-scan of the heart will be performed.

Eligibility criteria:
inclusion criteria: * verified turner syndrome * ages 10-25 years exclusion criteria: * contraindications to the mr-scan * contraindications to the trial medication * severe or chronic sickness with impact on the parameters of the study or incompatibility with the trial medication * intake of medications with interactions with trial medication

Keywords: turner syndrome hormonal replacement therapy bone mineralization uterine size aortic root dilatation
a study of bedaquiline administered as part of a treatment regimen with clarithromycin and ethambutol in adult patients with treatment-refractory mycobacterium avium complex-lung disease (mac-ld)

Conditions: Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)

Summary: the purpose of the study is to evaluate the efficacy of bedaquiline (bdq) compared with rifamycin when administered as part of a treatment regimen with clarithromycin (cam) and ethambutol (eb) in adult participants with treatment-refractory mycobacterium avium complex-lung disease (mac-ld) at week 24 for microbiological assessment in mycobacteria growth indicator tube (mgit).


Eligibility criteria:
inclusion criteria: * has body weight greater than or equal to (\>=) 40 kilograms (kg) at screening and on day 1 * has radiological evidence consistent with nontuberculous mycobacterial lung disease (ntm-ld) based on a chest computed tomography (ct) scan taken within 6 months prior to screening or at screening * has at least 2 positive sputum cultures of mycobacterium avium complex (mac) (sputum cultures to be taken at least 4 weeks apart): one obtained within 12 months prior to screening, which was documented while being treated for mycobacterium avium complex lung disease (mac-ld) for a total of at least 6 months; and one at screening (by central microbiology laboratory) * received at least 6 months of consecutive mac-ld treatment (at least 2 antibiotics for mac, including a macrolide), that is either ongoing or has stopped within 12 months prior to screening * no presence of cognitive dysfunction that would impact the completion of the patient reported outcome (pro) assessments exclusion criteria: * had previous exposure to bedaquiline (bdq) * has active tuberculosis (tb) disease * has cystic fibrosis, medically unstable respiratory disease (for example, chronic obstructive pulmonary disease, bronchiectasis, asthma) * has one or more cavities \>=2 centimeter (cm) in diameter on a chest ct scan taken within 6 months prior to screening or at screening * treatment already includes an injectable/inhaled aminoglycoside within 3 months prior to screening or the investigator deems the participant to be a candidate for an injectable/inhaled aminoglycoside during screening period or at day 1
further lipid-lowering with pcsk9 inhibitors for cardiovascular outcomes in high-risk coronary plaques assessed by ct angiography

Conditions: Coronary Artery Disease; CT Angiography; PCSK9; Cardiovascular Events

Summary: the primary objective was to evaluate the effect of pcsk9 inhibitors in addition to the background lipid-modifying therapy (lmt), compared with placebo plus background lmt in terms of clinical outcomes in patients with coronary ct angiography (ccta)-detected high-risk plaques.

ccta is an accurate, noninvasive alternative to invasive coronary angiography. ccta can provide detailed information about the characteristics of coronary artery plaques, such as their composition, morphology, and distribution. various ccta-detected plaque characteristics indicative of plaque quantity and quality have been identified as high-risk features independently predicting clinical events, including the presence of positive remodeling, low attenuation plaque, spotty calcification, and napkin ring sign. currently, the treatment for ccta-detected high-risk plaque has been receiving increasing interest. the current study aimed to prove the efficacy of pcsk9 inhibitors in addition to the background lmt, as compared with placebo plus background lmt in patients with ccta-detected high-risk plaques. hypothesis: pcsk9 inhibitors in addition to background lmt will show a superior event rate, compared with placebo plus background lmt, in terms of major adverse cardiac and cerebrovascular events (macces) at 24 months after the last patient's randomization in patients with high-risk coronary plaques assessed by ct angiography.

Eligibility criteria:
inclusion criteria: 1. subject must be ≥ 18 years. 2. patients with at least one target lesion meet ccta-detected plaque features of the following: 1. degree of stenosis ≥ 50% 2. at least 2 of the following high-risk plaque features: i. low-attenuation plaque ii. positive remodeling iii. napkin-ring sign iv. spotty calcium 3. the target lesion is located at the proximal or mid segment of left anterior descending artery, left circumflex artery or right coronary artery. 4. subject is able to confirm his/her understanding of the risks, benefits, and treatment alternatives of receiving study-related treatment. he/she or his/her legally authorized representative provides written informed consent prior to any study-related procedure. exclusion criteria: 1. target lesions underwent or planned to revascularization. 2. patients with acute coronary syndrome. 3. new york heart association class iii or iv, or last known left ventricular ejection fraction \< 30%. 4. uncontrolled or recurrent ventricular tachycardia. 5. homozygous familial hypercholesterolemia. 6. active liver disease or hepatic dysfunction. 7. failed ccta plaque analysis. 8. non-cardiac co-morbid conditions with life expectancy \< 2 years. 9. pregnant and/or lactating women. 10. known hypersensitivity or contraindication to statin or pcsk9 inhibitors.

Keywords: pcsk9 inhibitors lipid-lowering therapy high-risk coronary plaques coronary ct angiography
fluoxetine for refractory constipation

Conditions: Refractory Constipation

Summary: the goal of this clinical trial is to learn if fluoxetine works to treat refractory constipation . it will also learn about the safety of fluoxetine. the main questions it aims to answer are: does fluoxetine increase the number of completely spontaneous bowel movements (csbms) per week? what medical problems do participants have when taking fluoxetine? does fluoxetine improve psychological symptoms such as anxiety and depression in participants with refractory constipation? researchers will compare fluoxetine to polyethylene glycol (peg, a commonly used laxative) to see if fluoxetine works to treat refractory constipation. participants will: take fluoxetine (40 mg/day) or polyethylene glycol (once daily) for 6 months. visit the clinic at baseline, and at 1 month, 3 months, and 6 months for checkups and tests. record their bowel movements and any changes in symptoms, including anxiety, depression, and side effects.


Eligibility criteria:
inclusion criteria: 1. individuals aged 18 to 70 years; 2. patients meeting the rome iv diagnostic criteria for chronic constipation, defined by at least two symptoms: straining, lumpy or hard stools (bristol stool scale types 1-2), incomplete evacuation, anorectal obstruction, need for manual maneuvers, or spontaneous bowel movements occurring less than three times per week. these symptoms must have persisted for a minimum of six months, with the diagnostic criteria being met for at least the past three months; 3. refractory constipation, defined as the use of at least three medications (including osmotic agents, laxatives, prokinetics, biofeedback and probiotics, surgery) for more than three months, with unsatisfactory treatment outcomes; 4. patients present indications for fluoxetine, such as comorbid depression; 5. patients who voluntarily provided informed consent prior to enrollment. exclusion criteria: 1. women who are pregnant or lactating; 2. presence of cardiovascular conditions, organ dysfunction, immune disorders, or infections; 3. concurrent gastrointestinal organic conditions such as tuberculosis, polyps, crohn's disease, tumors, etc.; 4. prior abdominal surgeries; 5. use of psychotropic medications; 6) diagnosis of hypothyroidism or parkinson's disease.