Kornimate/medical-research-clean huggingface dataset:
safety, tolerability, pk, pd and preliminary efficacy of ono-4685

Conditions: Plaque Psoriasis

Summary: this is an early phase study to assess the safety and tolerability of ono-4685 in patients with psoriasis. in addition, the study will assess how the drug is distributed and eliminated by the body (pharmacokinetics) and how the drug affects the body (pharmacodynamics). this will be done by measuring the amount of drug in the blood and measuring other markers in the body that might have been affected by ono-4685. the study will also look at preliminary information on whether ono-4685 might be effective in treating psoriasis. the study will be split into three parts. part a will assess a single dose of ono-4685 in small groups of patients, each group planned to receive a higher dose than the last group. in part b and c, patients will receive multiple doses of ono-4685 over a period of 4 weeks.


Eligibility criteria:
inclusion criteria * subjects must be willing and able to participate in the study * a diagnosis of plaque-type psoriasis for ≥6 months. * plaque-type psoriasis involving ≥3% of body surface area (bsa) (parts b and c). * willing to provide skin biopsies (parts b and c). * subjects in good health, as judged by medical history, medical examination, vital signs, ecg and clinical laboratory tests. * subjects willing to comply with the contraception and sperm and ova donation requirements of the protocol. exclusion criteria * subjects with any clinically significant abnormality in screening tests. * guttate, erythrodermic or pustular psoriasis as sole or predominant form of the psoriasis, or other skin condition (eg eczema). * presence or history of alcohol or drugs abuse. * heavy smokers (more than 20 cigarettes or use more than ½ ounce (12.5 grams) of tobacco each day). * subjects have had any 'live' vaccines (excluding covid-19 vaccine) during the 3 months before the first dose of study medicine. * subjects have had a first covid-19 vaccine within 6 weeks or second and booster covid-19 vaccinations within 2 weeks before the first dose of study medicine. * subjects have had any clinically significant disease or infection, including tuberculosis. * presence or history of malignancy (cancer) including lymphoproliferative disorders. * subject is pregnant, lactating, or breastfeeding. * subjects have received treatment with biologics in the last 3 months, immunosuppressant medicine or prescription medicine for psoriasis within 4 weeks before admission to the ward; have used phototherapy from 2 weeks before admission to the ward; have used highly potent or potent topical steroids within 2 weeks before admission to the ward. * subjects have used topical corticosteroids or vitamin d analogues within 7 days before admission to the ward (parts b and c).

Keywords: psoriasis ono-4685 pd-1 bi-specific antibody pd-1 receptor pd-1 agonist
comparing rectus sheath catheter to epidural post cystectomy

Conditions: Bladder Cancer; Postoperative Pain

Summary: this is a prospective randomised controlled trial that will compare the outcomes of rectus sheath catheters to epidurals in patients who have undergone a cystectomy, via a lower midline abdominal incision for bladder cancer.

this study will compare the outcomes of two different pain control techniques, used as standard of care, following major abdominal surgery for bladder removal. rectus sheath catheters are small tubes that are positioned into a specific area of the cut abdominal wall at the end of surgery; whereas an epidural is a tube that is positioned into the back. both allow administration of local anaesthetic for pain control. the current gold standard is an epidural. this study will aim to evaluate this and show the comparative efficacy of the rectus sheath catheter, which anecdotally the investigators have found superior in practice.

Eligibility criteria:
inclusion criteria: * patients over or equal to the age of 19 years old who can understand the study protocol and are able to give consent * patients with an american society of anaesthesiology (asa) classification 1 to 3 * patients must have a preoperative oral 24 hour opioid consumption of less than or equal to 30mg morphine equivalents * patients must be able to understand and be able to use patient controlled analgesia * patients must be undergoing a cystectomy with an infra-umbilical midline incision exclusion criteria: * patients with bmi greater than 40 * patients with an allergy to local anaesthetics * patients who are contraindicated to having an epidural (e.g. coagulopathic, distorted anatomy, patient refusal, infection at the site of proposed insertion) * patients with previous spinal surgery at the proposed site of epidural * patients with neurodegenerative disorders or spinal cord injury * patients with known anatomy that would not permit placement of the rectus sheath catheters e.g. prune belly syndrome * patients undergoing another complex abdominal procedure in addition to cystectomy and reconstruction requiring extension of the abdominal incision above the umbilicus.

Keywords: bladder cancer-cystectomy rectus sheath catheter epidural
investigation of efficiency of breathing with different breathing patterns

Conditions: Respiratory Physiology; Respiratory Insufficiency; Breathing Patterns

Summary: our aim in this study is to investigate the efficiency of the breathing with different breathing patterns. ten volunteers and twenty patients having respiratory problems will be coached on their breathing through specific masks which will provide four different breathing patterns. these patterns will be 1) breathing in through the nose only and out through the mouth only 2) breathing in through the mouth only and out through the nose only 3) breathing in and out through the nose only 4) breathing in and out through the mouth only the data obtained from volunteers and patients will be compared within and between the groups.


Eligibility criteria:
inclusion criteria: * for healthy subjects: 1. ten healthy adult (\> 18 years of age) volunteers will be recruited from the mgh main campus through intra-hospital e-mail broadcasting. subjects with the following issues will be excluded from the study. * for patients with respiratory insufficiency: 1. twenty adult (\> 18 years of age) patients will be recruited. these patients will be either patients in acute respiratory failure resulting from copd exacerbation breathing spontaneously only receiving nasal oxygen admitted to the medical floors of the mgh; or patients with diagnosed stable copd on home oxygen therapy seen by pulmonary physicians in the outpatient clinics or coming to the mgh as study subjects. exclusion criteria: * for healthy volunteers: 1. subjects with facial deformity, heavy beard or moustache which prevents good seal between the mask and the face; 2. subjects who have claustrophobia and cannot wear the mask. * for patients with respiratory insufficiency: 1. patients with facial deformity, heavy beard or moustache which prevents a good seal between the mask and the face; 2. patients who have claustrophobia and cannot wear the mask. 3. patients who are hemodynamically unstable. 4. patients requiring continuous noninvasive positive pressure ventilation or endotracheal intubation.

Keywords: breathing patterns, unidirectional breathing, mask ventilation, respiratory physiology
endoscopic diagnosis and treatment of acute nonvariceal upper gastrointestinal bleeding

Conditions: Acute Upper Gastrointestinal Non Variceal Hemorrhage

Summary: acute nonvariceal upper gastrointestinal bleeding (anvugib) is a common critical disease in gastroenterology. due to the development of modern medical technology, the incidence rate of anvugib has been decreasing in recent years, but its mortality within 30 days is still 11%. endoscopic hemostasis and drug therapy are the first choice for the treatment of anvugib. after endoscopic hemostasis, it is very important to treat peptic ulcer bleeding with strong acid suppression therapy to maintain gastric ph above 6.0. this study is to study the effect of endoscopic and drug treatment of anvugib.

acute nonvariceal upper gastrointestinal bleeding (anvugib) is a common critical disease in gastroenterology. it refers to the bleeding caused by the non varicose diseases above the ligament of flexor, including the bleeding of pancreaticobiliary tract and the bleeding caused by the diseases near the anastomotic stoma after gastrojejunostomy. due to the development of modern medical technology, the incidence rate of anvugib has been decreasing in recent years. a us study shows that the incidence rate of anvugib dropped from 78/10 to 61/10 10000 \[1\] from 2001 to 2009. however, the mortality within 30 days of anvugib is still as high as 11% \[2\]. peptic ulcer bleeding is the most common cause of bleeding in anvugib. the annual incidence rate is 19.4-57/10 million, and the rate of rebleeding within 7 days is 13.9%, and the mortality rate is 30 in 30 days. a study in china shows that compared with the 1990s, the detection rate of high-risk ulcer has increased, but the overall mortality has not decreased significantly \[4\]. endoscopic hemostasis is the first choice for the treatment of peptic ulcer. the latest guidelines of our country recommend that patients with upper gastrointestinal bleeding with stable hemodynamics should try their best to have emergency gastroscopy within 24 hours after bleeding, and emergency endoscopic hemostasis is feasible for bleeding lesions \[5\]. after endoscopic hemostasis, it is very important to give strong acid suppression therapy to maintain gastric ph above 6.0 in the treatment of peptic ulcer bleeding \[6-9\]. this study is to analyze the effect of endoscopic and drug treatment of anvugib.

Eligibility criteria:
inclusion criteria: * from january 2014 to february 2021, patients with acute nonvariceal upper gastrointestinal bleeding underwent emergency endoscopic hemostasis in our hospital. exclusion criteria: * 1. the age is less than or equal to 18 years old and greater than or equal to 85 years old; 2. forrest grade iic and iii; 3. complicated with severe cardiovascular and cerebrovascular diseases or severe liver and kidney diseases (such as heart failure, liver failure, renal failure, etc.); 4. the records of the cases were incomplete.

Keywords: acute upper gastrointestinal non variceal hemorrhage peptic ulcer dieulafoy's lesion gastric ulcer bleeding endoscopic hemostasis
effectiveness of percutaneous electrolysis in the treatment of lateral epicondylalgia. a single-blind randomized controlled trial.

Conditions: Epicondylitis

Summary: the concept of epicondylitis refers to the manifestation of pain ni the area of insertation of the epicondile muscles, and that it is accompained by limitation funcional.a tendinopathy is characterized as a process of degenaration, with fibroblast proliferation and disorganization of the fibers of collagen. this tendon pathology especially affects the epicondyle extensors and especially the first and second radial and short extensor carpal.

eccentric exercises of the epicondyle muscles were performed in 3 sets of 10 repetitions. participants were asked to perform the exercise program on an individual basis twice every day for 4 weeks. the eccentric program consisted of 3 exercises, focusing on the epicondyle muscles. participants were asked to do a normal flexion extension (concentric phase) and a slow return to the initial position (eccentric phase) included first the concentric phase, and the eccentric phase was slowly conducted. the exercise program was taught by a physiotherapist in the first session and monitored in the subsequent sessions.

Eligibility criteria:
inclusion criteria: - patients of both sexes, aged between 18 and 60 years, in an active state of pain and with a diagnosis of one month of evolution. exclusion criteria: - patients who are pregnant, have pacemakers and those surgically operated patients who have been treated with epte a month earlier

Keywords: tendinopathy electrolysis exercise dry needing
hearts of athletes

Conditions: Cardiac Involvement With COVID-19

Summary: the hearts of athletes study is being conducted to determine the heart involvement with covid-19 in athletes. this study aims to enroll any adult (18 years of age or greater) • athlete is defined as ncaa collegiate athlete, professional athlete, military, or olympic athlete will be eligible for the study. with covid-19 • covid-19 diagnosed via an rt-pcr (nasal or throat swab test) prior to enrollment or without covid-19 • identified as a local control participant (similar sport) to a participant with covid-19, who is willing to undergo a standard cardiovascular evaluation participants with and without covid-19 will use their mobile devices to provide health information, like symptoms, by answering survey questions daily for 30 days. also, participants will allow their de-identified cardiac images to be sent to the duke heart center for blinded analysis. no physical risks are associated with this study. one possible risk, although minimal, is loss of confidentiality.


Eligibility criteria:
inclusion criteria: * any adult athlete (defined as ncaa collegiate athlete, professional athlete, or olympic athlete) will be eligible for the study. * covid-19 diagnosed via an rt-pcr, or history of covid-19 antibodies at least 10 days and less than 6 months prior to consent * no longer requiring quarantine per local health recommendations, prior to cardiovascular evaluation. * identification as a control participant (similar sport) to a participant without covid-19 willing to undergo cardiovascular evaluation exclusion criteria: * anyone with known cardiovascular disease - defined as known myocardial disease, valvular heart disease, or known coronary heart disease * anyone without the ability to provide informed consent * anyone with a known contraindication to cardiac magnetic resonance (metallic implant)

Keywords: athletes
a prospective study of cadonilimab in hepatocellular carcinoma after radical surgery with high risk of recurrence

Conditions: Hepatocellular Carcinoma (HCC)

Summary: this study aims to compare the safety and tolerability of cadonilimab applied after curative hepatectomy for hepatocellular carcinoma combined with high - risk recurrent factors.

hepatectomy and local ablation are the main curative treatment methods for hepatocellular carcinoma, but the 5-year recurrence rate after surgery is as high as 70%, which is the main bottleneck problem affecting the long-term prognosis of patients. this study aims to investigate the safety and tolerability of cadonilimab (pd-1/cytotoxic t lymphocyte antigen-4 (ctla-4) bispecific antibody) applied after curative hepatectomy for hepatocellular carcinoma combined with high - risk recurrence factors.

Eligibility criteria:
inclusion criteria: * sign a written informed consent before the implementation of any trial-related procedures. * male or female, aged ≥18 years and ≤70 years. * ecog ps score is 0 - 1 point. * subjects diagnosed with hepatocellular carcinoma by imaging criteria and/or pathology and who have received curative resection. * the definition of curative resection complies with the definition of curativeness in the 2024 edition of the chinese guidelines for primary liver cancer (cnlc). * the postoperative recurrence risk stratification conforms to the high - risk group in the erasl - pre or erasl - post formula. * no prior systemic antitumor treatment for hepatocellular carcinoma has been received. * child - pugh liver function score of grade a or b7. * expected survival time \> 6 months. exclusion criteria: * previously diagnosed by histology/cytology, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc. * subjects with other malignant tumors within 5 years before enrollment, except for hcc. subjects with other malignant tumors that have been cured by local treatment are not excluded, such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix or breast. * history of hepatic encephalopathy or liver transplantation. * portal vein trunk or mesenteric superior vein, inferior vena cava tumor thrombus.

Keywords: hepatocellular carcinoma hepatectomy adjuvant cadonilimab
the modified "pills-in-the-pocket" strategy

Conditions: Atrial Fibrillation (AF)

Summary: this is a multicentre, prospective, randomised controlled study of 328 patients with non-paroxysmal af (within 5 years of first diagnosis of af) with recurrent atrial arrhythmias after first catheter ablation, randomly divided in a 1:1 ratio into a study group treated with triple aads (amiodarone + bisoprolol + digoxin) and a control group treated with conventional aads (amiodarone + bisoprolol + digoxin). the study group was treated with triple aads (amiodarone + bisoprolol) and the control group was treated with conventional aads (amiodarone + bisoprolol) with the aim of comparing the efficacy and safety of the two groups in terms of reversion of sr, which may provide an effective option of pocket drug reversion for patients with recurrence of sr after af catheter ablation. translated with deepl.com (free version)


Eligibility criteria:
inclusion criteria:(1) age ≥18 years; (2) non-valvular, non-paroxysmal af (within 5 years of the first diagnosis of af) with recurrent atrial arrhythmia lasting for more than 24 hours after the first catheter ablation and not self-terminating; (3) patients who are not taking aads such as amiodarone, dronedarone, propafenone, etc. after the procedure, and who agree to receive aads without contraindications to aads; or patients who are taking aads such as amiodarone, dronedarone, propafenone, etc. after the procedure, but have been off of them for more than 1 month. - exclusion criteria:(1) previous cardiac surgery, such as cardiac bypass grafting, mechanical valve or prosthetic valve replacement; (2) combined cardiomyopathy (e.g. hypertrophic cardiomyopathy, dilated cardiomyopathy, ischaemic cardiomyopathy, etc.); (3) cardiac ultrasound suggests that the diameter of the left atrium is ≥50mm or there are valvular changes in rheumatic heart disease; (4) previous history of abnormal thyroid function; (5) severe hepatic or renal insufficiency (egfr \<15, child class 3), or history of renal dialysis; (6) heart rate \<60 beats/minute, any degree of atrioventricular block, two-branch or three-branch block at the time of resumption of sr after catheter ablation; (7) left ventricular ejection fraction \<40% or new york heart association (nyha) class iii-iv after catheter ablation; (8) participation in a clinical trial of another drug or device during the same period; (9) abnormalities or diseases that, in the opinion of the investigator, should be excluded from enrolment in this study. -

Keywords: atrial fibrillation af
efficacy and safety of tetrabenazine in chorea

Conditions: Huntington's Disease

Summary: the primary objective of this study was to establish the absolute reduction of chorea in participants with huntington's disease(hd) treated with tetrabenazine or placebo


Eligibility criteria:
inclusion criteria: * 18 years of age or older * suffer from manifest hd as confirmed by genetic testing * meet chorea and total functional capacity scores on unified huntington's disease rating scale * meet criteria on hamilton depression rating scale, unified parkinson's disease rating scale dysphagia and dysarthria scale * independently ambulatory exclusion criteria * previous treatment with tetrabenazine * unstable or serious medical or psychiatric illness * concomitant use identified drugs * untreated depression * lack of caregiver
a drug-drug interaction study evaluating the combination of idx320 and idx184 in healthy participants (mk-6844-002)

Conditions: Chronic Hepatitis C

Summary: this study is designed to evaluate the potential for a pharmacokinetic (pk) drug-drug interaction between idx320 and idx184 and to assess the safety and tolerability when the two drugs are administered in combination in healthy participants.


Eligibility criteria:
inclusion criteria: to participate in the study, participants must meet the following requirements: 1. must be a healthy male or female between 19 and 65 years of age with body mass index (bmi) between 18 and 35 kg/m2. 2. must be a non-smoker. 3. must agree to use an acceptable double-barrier method of birth control. 4. must provide written informed consent after the study has been fully explained. exclusion criteria: participants are not eligible if they meet any of the following: 1. pregnant or breastfeeding. 2. history of clinically significant diseases, as determined by the investigator. 3. safety laboratory abnormalities at screening which are clinically significant. 4. positive screening test for hepatitis b virus, hepatitis c virus or human immunodeficiency virus (hiv). 5. use of chronic prescription medications within 3 months, acute prescription medications within 14 days, or systemic over-the-counter (otc) medications within 7 days of the starting the study. 6. current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding two years.

Keywords: hcv hepatitis c
chemotherapy plus surgery in treating children at risk of or with stage i wilms' tumor

Conditions: Kidney Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. it is not yet known which regimen of chemotherapy is more effective for stage i wilms' tumor. purpose: randomized phase iii trial to study the effectiveness of chemotherapy and surgery in treating children who are at risk of or who have stage i wilms' tumor.

objectives: i. determine the initial extension of disease, surgical procedures, gross and histological morphology, treatments, clinical outcome, and late consequences of therapy after treatment with neoadjuvant chemotherapy, surgery, and adjuvant chemotherapy with or without maintenance chemotherapy in patients with intermediate risk or anaplastic stage i wilms' tumor. ii. determine the safety and effectiveness of reduced chemotherapy in these patients. outline: this is a randomized, multicenter study. patients receive dactinomycin iv on days 1-3 and 15-17 and vincristine iv on days 1, 8, 15, and 22. patients then undergo surgery about a week after completion of chemotherapy. after surgery, patients receive vincristine iv on days 1, 8, 15, and 22 and dactinomycin iv on days 8-12. patients are then randomized to one of two treatment arms after week 9. arm i: patients receive dactinomycin iv on days 1-5 of week 10 and vincristine iv on day 1 of both weeks 10 and 11. this course is repeated during weeks 17 and 18. arm ii: patients receive no further treatment. patients are followed every 3 months for 3 years, then annually thereafter. peer reviewed and funded or endorsed by cancer research uk projected accrual: a total of 350 patients (175 per treatment arm) will be accrued for this study within 7-8 years.

Eligibility criteria:
disease characteristics: initial diagnosis of a unilateral tumor with clinical and radiological characteristics of a nephroblastoma histologically proven stage i wilms' tumor after neoadjuvant treatment and surgery intermediate risk or anaplastic no detectable distant metastases 4 weeks after adjuvant chemotherapy patient characteristics: age: 0.5 to 17 performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified prior concurrent therapy: see disease characteristics

Keywords: stage i wilms tumor