Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of td-1473 in crohn's disease

Conditions: Crohn's Disease

Summary: a phase 2 study to evaluate the efficacy, safety and tolerability of td-1473 in subjects with moderately-to-severely active crohn's disease with up to 48 weeks of treatment.

a phase 2 multi-center, randomized, double blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 12 weeks of induction therapy with td˗1473 in subjects with moderately-to-severely active crohn's disease. this study includes 3 phases: screening, induction, and active treatment extension (ate). the induction phase of the study is a randomized, double blind, placebo controlled, parallel group study evaluating 2 oral dose levels of td-1473 compared to placebo for 12 weeks in subjects with moderately to-severely active cd. subjects who complete induction will continue to receive td-1473 in the ate, for up to 48 additional weeks.

Eligibility criteria:
inclusion criteria: * is at least 18 years of age at screening * males and females with clinical evidence of crohn's disease for at least 3 months duration at screening * moderately-to-severely active crohn's disease at baseline, as defined by a crohn's disease activity index (cdai) score of 220-450 inclusive * ses-cd score of ≥ 3 with ulceration (corresponding to a score of 1) in at least 1 of the 5 ileocolonic segments on the ulcerated surface subscore of the ses-cd\] * is corticosteroid-dependent or has demonstrated inadequate response, or intolerance to conventional therapy (aminosalicylates, corticosteroids and immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate) or biologics (e.g., anti-tnf therapy, anti-il-12/23 (anti-interleukin), anti-integrin). * additional inclusion criteria apply exclusion criteria: * is currently receiving biologic (anti-tnf, anti-integrin, or anti-il12/23) therapy * has a current bacterial, parasitic, fungal, or viral infection * has clinically significant abnormalities in laboratory evaluations * prior exposure or potential exposure to a jak inhibitor that was stopped due to intolerance or lack of efficacy * subject has participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening or 5x the half-life of the investigational drug, whichever is longer, or is currently participating in another trial of an investigational drug (or medical device) * subject has failed ≥ 3 biologic agents of 3 different mechanisms of action (i.e., anti-tnf, anti-integrin, and anti-il12/23) * additional exclusion criteria apply

Keywords: td-1473 janus kinase inhibitor jak inhibitor inflammatory bowel disease ibd crohn's disease intestinal restriction
trial of mycophenolic acid versus azathioprine in the treatment of corticosteroid-refractory myasthenia gravis

Conditions: Myasthenia Gravis

Summary: this is an randomized, double-blind, double-dummy trial, and the objective is to compare the efficacy and safety of mycophenolic acid (ma) and azathioprine (aza), immunosuppressive drugs, in myasthenia gravis patients. this prospective study will enroll 40 myasthenia gravis (mg) patients who are poor controlled under prior steroid therapy. all subjects should be randomly assigned to ma group and aza group that will receive routine pyridostigmine and prednisolone in combination with ma or aza.

this will be a double-dummy study to keep the blinded quality. * ma group: 1 tablet aza placebo and 4 tables ma (180 mg/tab,720 mg/day) twice daily. * aza group: 1 tablet aza (50mg/tab) and 4 tables ma placebo twice daily. * when patients achieve minimal manifestation (mm, i.e. complete remission), which lead to normal daily routine, the dose of pyridostigmine should reduce to 240 mg/day (4 tablets) or less. the dose of steroid should be stepped down by 10 mg qod (every other day) for every 2 weeks until the dose achieves 40 mg qod. after that, the dose should be stepped down by 5 mg qod for every month. * when disease progresses and is no longer maintaining minimal manifestation, the dose of steroid will be stepped up by 10 mg qod for every 2 weeks until achieve clinical stable remission. the taper rule of steroid could start again 1 month after stabilization. * every patient will be treated for 1 year. if the patient could not achieve mm within 1 year, the blind of individual patient will be opened and the patients will be crossed over to another medical treatment. the efficacy and safety of second medication will be observed openly until the end of study. * when the muscle weakness worsens under established study schedule, plasmapheresis could be conducted to improve the condition rapidly.

Eligibility criteria:
inclusion criteria: * male or female age between 20-70 (including 20 and 70 years old). * osserman ii and iii myasthenia gravis. * positive serum anti-acetylcholine receptor antibodies. * poor control of disease with daily dose of prednisone ≥ 30 mg or 0.5 mg/kg at 3 months before enrollment. * without immunosuppressive therapy other than steroid. exclusion criteria: * ocular mg or minimal clinical syndrome that would not require the therapy of steroids. * negative serum anti-acetylcholine receptor antibodies. * use immunosuppressants other than steroids in the preceding year. * previous use other investigational medication within 3 months or current participate other clinical study. * poor renal function: serum creatinine \> 3.0 mg/dl or estimated creatinine clearance \< 30 ml/min * females who are pregnancy or breast-feeding. * recent history, within 5 years, of malignancy * unwilling or unable to participate the necessary continuous visits and examinations.
safety and tolerability of dmt in healthy adults

Conditions: Safety Issues; Healthy Volunteers

Summary: this study aims to evaluate the acute and subacute effects of an inhaled n, n-dimethyltryptamine (dmt) in healthy individuals.

this is a double-blind, randomized, placebo-controlled crossover design. 25 participants will be evaluated, who will undergo two dosing sessions on the same day: with dmt (60 mg, inhaled) and with placebo (1 mg dmt, inhaled). each session will last approximately 2 hours; the substance order will be randomized.

Eligibility criteria:
inclusion criteria: * previous experience with dmt * be right-handed * healthy volunteers exclusion criteria: * heart failure * liver failure * kidney failure * uncontrolled high blood pressure * history of heart rhythm disorders * history of valvular heart disease * history of chronic obstructive pulmonary disease (copd) * active or in treatment for bronchial asthma * severe obesity * coagulation disorders * clinical evidence or history of increased intracranial * clinical evidence or history of cerebrospinal pressure * history or reports of epilepsy * severe neurological disease, * pregnancy * reported or clinically recognized thyroid disorders * diagnosis or family suspicion of genetic monoamine deficiency oxidase * previous adverse response to psychedelic substances * symptoms or family members with a present or past psychotic disorder * dissociative identity disorder * bipolar affective disorder * prodromal symptoms of schizophrenia * problematic use or abuse of alcohol or other psychoactive substances (except tobacco) * acute or subacute risk of suicide * acute flu symptoms * symptoms of airway infection * contact with a confirmed case of covid-19 (sars-cov-2) in the last 7 days

Keywords: n,n-dmt n,n-dimethyltryptamine dmt placebo psychedelic
prevalence of malignant and premalignant lesions in the head & neck in patients with chronic obstructive pulmonary disease

Conditions: COPD, HEAD&NECK CANCER,SCREENING

Summary: head and neck cancers usually occur in patients who have a history of long tobacco use. chronic obstructive pulmonary disease (copd) is a chronic progressive disease of the airways and lung parenchyma that is also associated with exposure to tobacco. copd and head \& neck cancer share a common environmental risk factor in cigarette smoke exposure. the investigators hypothesize that patients with chronic lung disease related to smoking have a higher risk to develop cancer in the head and neck. the investigators designed a study to assess the prevalence of cancer and pre-cancer disease in the head \& neck in patients with chronic lung disease. the investigators will examine patients with and without a history of smoking and chronic lung disease in order to determine the prevalence of head and neck cancer in the different groups. the patients who will be included in the study will undergo comprehensive evaluation of their lung function and voice performance. this study is a joint effort of the pulmonology institute and the department of otolaryngology, head \& neck surgery in israel and the netherlands.


Eligibility criteria:
inclusion criteria: 1. group of adult copd patients. 2. adult patients with smoking history and no clinical manifestation of copd who will be recruited form the institute of pulmonary medicine and the otolaryngology outpatient clinic. 3. adult patients with lung disease unrelated to smoking, i.e. bronchial asthma who will be recruited from the institute of pulmonary medicine exclusion criteria: 1. patients with an acute disease or copd exacerbation 2. pregnant patients 3. patients who were intubated ≤3 months prior to inclusion 4. patients with a medical history of surgical intervention in the upper airway 5. patients with a medical history of malignant disease in the upper airway 6. patients who underwent radiotherapy of head and neck
a study to explore the efficacy of jnj-89495120 in the treatment of major depressive disorder

Conditions: Depressive Disorder, Major

Summary: the purpose of this study is to evaluate how well jnj-89495120 works (anti-depressant effects) and how well it is tolerated as compared to placebo on reducing the symptoms of depression in participants with major depressive disorder (mdd).


Eligibility criteria:
inclusion criteria: * primary psychiatric diagnosis of recurrent major depressive disorder, without psychotic features, based on clinical assessment using diagnostic and statistical manual of mental disorders (dsm)-5 criteria and confirmed with the mini international neuropsychiatric interview (mini) * participant had to have at least one previous major depressive disorder (mdd) episode prior to their current episode * were first diagnosed with depression before the age of 55 * are in a current episode of depression: episode length must be at least 2 months but not longer than 24 months * have taken 0, 1, or 2 treatments for depression in your current episode * body mass index (bmi) within the range 18 to 35 kilograms per square meter (kg/m\^2) at screening exclusion criteria: * treatment with vagus nerve stimulation (vns), electroconvulsive therapy (ect), transcranial magnetic stimulation (tms), deep brain stimulation (dbs), or ketamine/esketamine within the current or past major depressive episodes * current or past dsm-5 diagnosis of bipolar disorder, psychotic disorders, borderline personality disorder, antisocial personality disorder, or current obsessive-compulsive disorder * post-traumatic stress disorder within the past three years of screening * dementia, any dementing disease, intellectual disability, or neurocognitive disorder * history of alcohol and substance use disorders within 6 months of screening, with the exclusion of nicotine, caffeine, and mild cannabis use disorder, according to the mini and clinical assessment * known allergies, hypersensitivity, or intolerance to jnj-89495120 or its excipients
efficacy of dexamethasone added to ramosetron for preventing postoperative nausea and vomiting in highly susceptible patients following spine surgery

Conditions: Nausea; Vomiting

Summary: the purpose of this study is to study the efficacy of dexamethasone added to ramosetron for preventing postoperative nausea and vomiting in highly susceptible patients following spine surgery.


Eligibility criteria:
inclusion criteria: * females * ages 18 to 65 years old exclusion criteria: * patients who is taking steroid or who had been treated for the gastrointestinal disease * patients who have troubles with the kidney or liver * patients transferring to the icu after the surgery * overfat patients * patients who had taken antiemetics within 24 hours before the surgery

Keywords: highly susceptible patients following spine surgery
intraoperative hypotension predicted by mean arterial pressure

Conditions: Wedge Resection; Lobectomy by Video-thoracoscopies

Summary: during general anesthesia, intraoperative hypotension (ioh) is associated with increased morbidity and mortality. mean arterial pressure (map) \< 65mmhg is the most common definition of hypotension. in order to reduce ioh, a complex method using machine learning called hypotensive prediction index (hpi) was shown to be superior to changes in map (δmap) to predict hypotension (map between 65 and 75 excluded). linear extrapolation of map (lepmap) is also very simple and could be a better approach than δmap. the main objective of the present study was to investigate whether lepmap could predict ioh during anesthesia 1, 2 or 5 minutes before. hypothesis : the area under the roc curves (roc area under curves) at 1, 2 and 5 minutes of lepmap would be superior to δmap


Eligibility criteria:
inclusion criteria: * all lobectomy including for another study (vatofa study) with continuous invasive blood pressure monitoring per arterial line * all pancreaticoduodenectomy or hepatectomy including for another study (carbodav study) with continuous invasive blood pressure monitoring per arterial line * age 18 or over exclusion criteria: * complex hemodynamic cases (heart, lung and liver transplantation) * using extracorporeal membrane oxygenation. * patient who object to take part of the study.

Keywords: wedge resection lobectomy video-thoracoscopies
breath analysis based disease biomarkers

Conditions: Liver Diseases; Liver Cancer; COVID19

Summary: the purpose of the study is to develop a clinical test based on breath analysis that can be used for disease diagnosis or prognosis.

the study will seek to collect and analyze breath samples from a broad range of patients to develop reference ranges and to refine the testing methods. protocols for breath sample collection and algorithms for analysis will be developed. samples will be collected from normal volunteers, persons with documented liver disease, organ transplant or with known covid-19 test results.

Eligibility criteria:
inclusion criteria: * able to provide informed consent exclusion criteria: * none
magnetic resonance imaging (mri ) versus ultrasound in placenta accreta diagnosis

Conditions: Placenta Accreta, Third Trimester

Summary: this study aim to assess the accuracy of magnetic resonance imaging (mri) compared to gray-scale and colour doppler ultrasound (us) for the prenatal diagnosis of placenta accreta.

placenta accreta occurs when the chorionic villi abnormally invade the myometrium. based on histopathology it is divided into three grades: placenta accreta (the chorionic villi are in contact with the myometrium), placenta increta (the chorionic villi invade the myometrium), and placenta percreta where the chorionic villi penetrate the uterine serosa. with increasing rate of cesarean delivery, the incidence of both placenta praevia and placenta accreta is steadily increasing in frequency. prenatal diagnosis of invasive placentation is associated with a reduced risk of maternal complications as it allows a preplanned treatment of the condition . gray-scale and colour doppler ultrasound (us) are valuable tools in the prenatal diagnosis of placenta accreta .however, if the ultrasound ( us ) findings suggest possible percreta or are inconclusive or negative in an at-risk woman, magnetic resonance imaging (mri) can be useful. multiple sonographic findings are seen with placenta accreta such as decrease in myometrial thickness, placenta previa, placental lacunae, abnormal pattern of color doppler, loss of the retroplacental clear zone and placenta percreta irregularities in wall of urinary bladder ( ub ) have been detected . the most magnetic resonance imaging characteristic findings seen in placenta accreta are nodular thickening in the dark zone of placenta-uterine interface together with extensions of dark bands through the placenta, outer uterine bulge causing from the mass effect of the placenta and heterogeneous signal intensity of placenta on the t2-weighted haste sequences due to large placental lakes and vessels.

Eligibility criteria:
inclusion criteria: * haemodynamically stable pregnant women who have the following risk factors for placenta accreta : persistent anterior placenta previa, prior uterine surgery (such as a previous cesarean section, uterine curettage, or myomectomy). * maternal age : 20-40 years old. * bmi : 18-29.9 kg/m2. exclusion criteria: * exclusion criteria will be mri contraindications, cardiac pacemaker, metal objects in the body, and patient's refusal for mri evaluation. * haemodynamically unstable patients.
study evaluating pantoprazole sodium enteric-coated spheroid suspension in infants with presumed gerd

Conditions: Gastroesophageal Reflux

Summary: the purpose of this study is to characterize the pharmacokinetic (pk) and pharmacodynamic (pd) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.


Eligibility criteria:
inclusion criteria: * greater than 44 weeks beyond neonatal period but less than 12 months * presumptive diagnosis of gerd * weight greater than 2.5 kg but less than 15 kg exclusion criteria: * history of gastrointestinal (gi) disorders, ie, unrepaired tracheal esophageal fistula, gi malabsorption * clinically significant medical or surgical abnormalities

Keywords: gerd infant
emotion regulation individual therapy for adolescents with nssi - an open pilot study

Conditions: Nonsuicidal Self-Injury

Summary: the primary aim is to investigate the effectiveness of emotion regulation individual therapy for adolescents (erita) who self-harm.


Eligibility criteria:
inclusion criteria: * a primary diagnosis of nssi as defined by dsm-5 section 3 * \< 1 nssi episode during the past month * at least one parent needs to commit to participate in the parent program exclusion criteria: * bipolar disorder i or primary psychosis * severe suicidal ideation * ongoing substance dependence * insertion/withdrawal of psychopharmacological substances within two months prior to the treatment * other acute primary axis i diagnosis (e.g. anorexia nervosa) that demand treatment in first hand * current life circumstances that would hinder the treatment (i.e. ongoing domestic abuse) * insufficient swedish language skills * cocurrent treatment with mentalization based therapy (mbt) or dialectical behavioral therapy (dbt)
interventional treatment of refractory pneumothorax by bronchoscope

Conditions: Pneumothorax

Summary: the purpose of this study is to determine whether injecting autologous blood or putting bronchial plug through bronchoscope is effective in the treatment of refractory pneumothorax.

this is a multi-site, controlled, randomized study. refractory pneumothorax is a challenge for respiratory physicians. many patients present recurrent pneumothorax. thoracic closed drainage is a basic and effective treatment to pneumothorax. chronic obstructive pulmonary disease(copd)is one of the main causes of spontaneous pneumothorax. many patients precluded the performance of surgery for poor pulmonary function. in china, economical load is another reason for patients who are unwilling to surgery. so we want to seek a cheap, effective and safe method for refractory pneumothorax. we will adopt three methods in this study. conventional thoracic closed drainage was continuously used in the control group, autologous blood was perfused to the target pulmonary segment in the treatment a group and self-made silicone bronchial plug was placed to the target pulmonary segment in the treatment b group. the leak position was detected by biliary lithotomy balloon. main outcome measures: duration of continuous leakage. secondary end-points included the lung reexpanded, hospital costs and hospital stays etc.

Eligibility criteria:
inclusion criteria: * spontaneous pneumothorax has been treating with thoracic closed drainage for 7 days, the patient has still persistent air leakage; * patients informed consent to participate in this study and can complete the requirements of the follow-up visit exclusion criteria: * patients with severe abnormal gas exchange are defined as paco2\>50mmhg(6.6kpa) or pao2\<45mmhg(6.0kpa) ; * patients have systemic disease or cancer which affect the survival time ; * patients have other serious diseases (the researchers think patient is not an appropriate candidate) which affect the evaluation or follow-up in research; * patients are not suitable for or unable to tolerate bronchoscopy procedures; * patients have active tuberculosis; * patients have any disease or condition that interferes with completion of initial or follow-up assessments of the effectiveness endpoints including interference test of nerves or skeletal muscle disease; * patients have demonstrated unwillingness or inability to complete screening or baseline data collection procedures; * patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study, or is currently participating in another clinical study; * female patient of childbearing potential has a positive result from a pregnancy test.

Keywords: interventional treatment refractory pneumothorax bronchoscope