Kornimate/medical-research-clean huggingface dataset:
study evaluating the safety, efficacy, and pharmacokinetics of miricorilant in participants with presumed nonalcoholic steatohepatitis (nash)

Conditions: Nonalcoholic Steatohepatitis (NASH)

Summary: this phase 2, double blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant (cort118335) in patients with presumed nonalcoholic steatohepatitis (nash).

this is a randomized, double-blind, placebo-controlled study that assessed the safety efficacy and pharmacokinetics (pk) of miricorilant in patients with presumed nonalcoholic steatohepatitis (nash). patients who meet the criteria for study cort118335-860 were randomized on day 1 to receive 900 mg miricorilant, 600 mg miricorilant, or placebo for 12 weeks. due to observations related to safety, the study was terminated prior to completion and study objectives, endpoints, and procedures were modified as specified in the protocol.

Eligibility criteria:
inclusion criteria: * have a diagnosis of nash based on a biopsy obtained within the last year or * have a diagnosis of presumed nash based on blood tests and scans exclusion criteria: * have participated in another clinical trial within the last year and received active treatment for nash * have participated in another clinical trial for any other indication within the last 3 months * are pregnant or lactating women * have a bmi \<18 kg/m\^2 * have had liver transplantation or plan to have liver transplantation during the study * have type 1 diabetes or poorly controlled type 2 diabetes.

Keywords: nonalcoholic steatohepatitis nash nonalcoholic fatty liver disease
safety, tolerability and pharmacodynamics of qax028 compared to open-label tiotropium bromide and placebo in mild-to-moderate chronic obstructive pulmonary disease (copd) patients.

Conditions: COPD

Summary: this will be a single dose proof-of-concept study in mild-to-moderate copd patients. the study will investigate the safety and tolerability of qax028 as well as the bronchodilatory effects of qax028 compared to tiotropium and placebo in mild-to-moderate copd patients.


Eligibility criteria:
inclusion criteria: * male or female patients aged 40-75 years with diagnosis of mild or moderate copd * current or x-smokers with a smoking history of \>10 pack-years. * screening ipratropium post-bronchodilation fev1 at 1 h post-dose will be greater than 50% of the normal predicted fev1 value. exclusion criteria: * patients who can not comply with the following washout periods for standard copd treatments as follows should be excluded: * short-acting bronchodilators * long-acting bronchodilators * inhaled steroids other protocol-defined inclusion/exclusion criteria may apply.

Keywords: copd/tiotropium/qax028
zanubrutinib-rituximab(zr) in patients with newly diagnosed untreated mantle cell lymphoma

Conditions: Untreated Mantle Cell Lymphoma

Summary: the proposed study is a prospective, single-center, single-arm and open-ended phase ii study in patients over the age of 18 with previously untreated mantle cell lymphoma(mcl). the primary objective of this study is to explore the safety and efficacy of a new chemo-free treatment pattern zanubrutinib-rituximab(zr) in newly diagnosed mcl.

the study will start with an initial 28-days of induction immunotherapy with zr and 4 cycles of consolidation immunotherapy with zr，following imaging examinations to evaluate response rates. patients who are evaluated as sd and pd will be withdrawn from the trial,while those who achieve pr and cr will be further stratified according to their age and physical status. the older or frail patients who are ineligible for asct will take zanubrutinib orally until intolerable toxicity or disease progression. patients who are young and fit for transplantation will receive asct consolidation. after asct, patients with cr will end therapy and enter the follow-up stage, while patients with pr will continue to take zanubrutinib orally until intolerable toxicity or disease progression.

Eligibility criteria:
inclusion criteria: 1. histopathologically or cytologically confirmed mantle cell lymphoma(excluding indolent mantle cell lymphoma) by the 2008 world health organization (who) classification of diseases; 2. initial untreated patients; 3. age ≥ 18 years; 4. ecog score 0-2; 5. women must not be pregnant or breastfeeding and agree to avoid pregnancy prior to study entry, for the duration of study participation, and for 12 months thereafter. male patients must agree that their spouses will not become pregnant during the study period and for 12 months thereafter; 6. patients must have measurable disease (i.e., ≥ 1.0 cm in lymph nodes diameter; or skin lesions assessed by physical examination); 7. written informed consent obtained from the subject. exclusion criteria: 1. indolent mantle cell lymphoma; 2. patients with severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine \> 3 times the upper limit of normal) 3. uncontrolled active infection, with the exception of tumor-related b symptom fever; 4. patients with organic heart disease with clinical symptoms or cardiac dysfunction (nyha grade ≥2); 5. co-existence of other tumors; 6. any other psychological conditions that prevent patients from participating in the study or signing the informed consent form.

Keywords: mantle cell lymphoma; zanubrutinib; rituximab; asct
study evaluating the efficacy of enbrel (etanercept) in subjects in japan

Conditions: Rheumatoid Arthritis

Summary: the objective of this surveillance is to determine the following items in all patients receiving enbrel for a certain period after marketing: 1) unlabeled adverse events, 2) onset (frequency, severity and other details) of adverse events, 3) factors considered to affect the safety, and 4) the efficacy of enbrel. moreover, the onset (frequency, severity and other details) of the followings will be key issues of this surveillance:infection (tuberculosis, opportunistic infection, etc.), autoimmune diseases, cardiac failure, malignant tumor, interstitial pneumonia, demyelinating disorders, pancytopenia, aplastic anemia and application site reactions.


Eligibility criteria:
inclusion criteria · patients with rheumatoid arthritis \[only those refractory to the previous treatment\]
lung ultrasound in comparison with c.t in covid-19

Conditions: COVID-19

Summary: investigate the diagnostic ability of thoracic ultrasound in suspicious covid-19 infection and/or covid-19 pneumonia. also, to compare its findings to ct and follow up these findings.

ultrasound and c.t will be assessed in acute presentation of covid 19 patients and then those patients will be reassessed again after 1 month by lung ultrasound and c.t and if ultrasound will show the same efficacy of diagnosis or not

Eligibility criteria:
inclusion criteria: * all cases of covid 19 patients exclusion criteria: * all other causes of consolidation ,ground glass fibrosis or collapse findings of c.t and ultrasound
ce-u and mre to predict the efficacy of anti-tnf therapy in crohn's disease

Conditions: Crohn's Disease

Summary: the value of anti-tnf therapy in intestinal strictures related to crohn's disease (cd) has not been clearly demonstrated. the results reported by some teams suggest no beneficial effect or even an increased risk of bowel obstruction in the case of stricture, while other publications indicate a favourable action of anti-tnf in this setting. the efficacy of anti-tnf in patients with intestinal stricture related to crohn's disease could depend on the lesions responsible for the stricture, as anti-tnf agents are probably effective in inflammatory forms and useless or even potentially harmful in fibrotic forms. in practice, the decision is currently empirical and a trial of anti-tnf therapy is often proposed. in view of the high incidence of intestinal strictures in cd and the need for a treatment as effective as anti-tnf in this setting, it is important to more clearly define the indications of these treatments guided by the information provided by modern imaging. the aim of this prospective study is to determine whether certain signs detected by mr enterography and contrast-enhanced ultrasonography can help to predict failure of anti-tnf therapy in patients with cd presenting a symptomatic stricture of the small bowel and scheduled to receive this treatment.


Eligibility criteria:
inclusion criteria: * crohn's disease defined according to the usual endoscopic, histological, and radiological criteria * small bowel (jejunum or ileum) stricture identified by radiography or endoscopy * obstructive symptoms greater than or equal to 3 on a scale from 0 to 6 evaluated over the last 8 weeks * failure of corticosteroids and/or immunosuppressives and indication for anti-tnf therapy exclusion criteria: * nonresolving complete bowel obstruction * previous anti-tnf therapy * contraindication to anti-tnf therapy: * intra-abdominal, intra-mural or extramural abscess * active infection * severe infection during the previous 2 months * nontreated latent tuberculosis * heart failure * active malignancy during the previous 5 years * demyelinating neurological disease * modification of the treatment of crohn's disease during the previous two months: azathioprine, mercaptopurine, methotrexate, thalidomide * contraindication to mr enterography or contrast-enhanced ultrasonography

Keywords: stricture anti-tnf ileal crohn'disease patients with ileal crohn's disease complicated by symptomatic stricture after failure of corticosteroids and/or immunosuppressives
effects of anti-hiv therapy on nervous system function

Conditions: HIV Infections

Summary: the purpose of this study is to observe the way two different anti-hiv treatment strategies affect nerve and brain function in adults with hiv.

aids dementia complex (adc) is a condition characterized by cognitive impairment, psychomotor slowing, and behavioral change. a milder form of adc, called hiv minor cognitive/motor disorder (mcmd), is characterized by similar symptoms but has less of an impact on daily functioning. the neurocognitive impairment that results from adc and mcmd carries an increased risk of poor drug adherence, morbidity, and mortality. it is unclear if highly active antiretroviral therapy (haart) is effective in preserving neurocognitive function or in preventing or treating neurocognitive impairment. distal symmetric sensory polyneuropathy (dspn) and nucleoside-related neuropathy are two other serious conditions that hiv patients are at high risk for. dspn is thought to be caused by active hiv infection; nucleoside-related neuropathy is thought to be caused by mitochondrial toxicity related to the use of certain antiretrovirals. these 2 conditions may lead to severe pain and discomfort in the feet. it is unknown what connection, if any, there is between dspn and nucleoside-related neuropathy and the use of haart. more data are needed on the natural history of these conditions. this trial is a substudy of a study of management of antiretroviral therapy (smart). in the smart study, patients will participate in one of two strategies: a drug conservation (dc) strategy and a viral suppression (vs) strategy. participants in the dc group will stop or defer haart, then receive episodic haart treatment for the minimum time needed to maintain a cd4 cell count of at least 250 cells/mm3. participants in the vs group will receive haart to maintain a viral load as low as possible, regardless of cd4 count. the purpose of this study is to compare changes in neurocognitive functioning and peripheral neuropathy symptoms between the 2 strategies of the smart study. patients will participate in this substudy and the main smart study at the same time. within 45 days prior to randomization into the main smart study, participants will have baseline data collected for this substudy. this data will include peripheral neuropathy assessments, treatments for symptoms of peripheral neuropathy. at selected study sites, additional measures will assess neurocognitive function, depression, alcohol and drug use, and education. at 6 months, 12 months, and every 12 months thereafter, peripheral neuropathy symptoms and treatment for the symptoms will be assessed; a pain questionnaire will also be completed. participants will be followed until the smart study ends.

Eligibility criteria:
inclusion criteria: * coenrollment in the smart study exclusion criteria: * unable to comply with all study requirements

Keywords: treatment experienced hiv antiretroviral therapy, highly active
pet imaging of cancer patients using 68ga-dota-siglec-9

Conditions: Acute Myeloid Leukemia; Melanoma; Non Small Cell Lung Cancer

Summary: this is a scientific study to determine expression of vascular adhesion protein 1 (vap-1) in cancer patients by 68ga-dota-siglec-9 positron emission tomography/computed tomography (pet/ct) before and after cancer treatment.

the purpose of this study is to evaluate expression of vascular adhesion protein 1 (vap-1) in bone marrow and cancerous lesions before and after therapy using 68ga-dota-siglec-9 positron emission tomography/computed tomography (pet/ct). patients with acute myeloid leukemia (aml) that undergo bone marrow transplantation and patients with melanoma and lung cancer that undergo chemotherapy will be studied. in addition, imaging results will be compared with clinical data and research data from blood samples. the study is of great clinical importance as other methods do not provide such comprehensive information on the presence of the vap-1 molecule in the body, especially in the bone marrow and cancer tissue before and after cancer treatment. research is also important for drug development targeting vap-1.

Eligibility criteria:
inclusion criteria: * diagnosis of acute myeloid leukemia (aml) and fit for allogeneic hematopoietic stem cell transplantation (allohsct), as assessed in the standard operating procedures. * diagnosis of metastatic melanoma and fit for immune checkpoint inhibitors or braf- and mek inhibitors. * diagnosis of metastatic non-small cell lung cancer (nsclc) (stage iv) and fit for immune checkpoint inhibitors and/or chemotherapy. * able and willing to give written informed consent and to comply with the study protocol. exclusion criteria: * unsuitable for allohsct (aml), checkpoint inhibitors or braf- and mek inhibitors (melanoma or checkpoint inhibitors and/or chemotherapy (nsclc) according to the standard operating procedures. * unable or unwilling to comply with the study protocol for any reason. * evidence of significant uncontrolled concomitant diseases such as neurological, renal, hepatic, endocrine, or gastrointestinal disorders which, in the opinion of the investigator, would preclude patient participation
the impact of epigenetic mmrd in endometrial carcinomas-a real world study

Conditions: Endometrial Neoplasms

Summary: in recent years, the incidence of endometrial carcinoma (ec) has increased significantly and patients tends to be younger. in addition to known risk factors such as obesity, hypertension and diabetes, genetic factors also play an important role in the occurrence and development of ec. among them, mismatch repair defect (mmr) can produce mutant phenotypes, leading to cancer susceptibility. although some articles indicated that epigenetic mmrd, one type of mmrd, predicted poor prognosis among endometrial carcinoma patients, hitherto, the clinicopathological significance and prognosis of epigenetic mmrd has not been determined. to date, there are no relevant large-sample data to investigate the prevalence of epigenetic mmrd in chinese population, as well as the impact on the prognosis of endometrial cancer. in this setting, the purpose of this study was to investigate the prevalence of epigenetic mmrd and its impact on clinicopathology and prognosis on endometrial cancer among chinese patients.

we conducted a retrospective real-world study of all endometrial carcinoma cases from 2019 to 2022. the inclusion criterion is all patients diagnosed with endometrial cancer in our hospital from 2019 to 2022 and exclusion criteria are those without histological specimens in our hospital. after immunohistochemistry and mlh1-promoter methylation testing, tumors were classified into 3 groups according to status of mismatch repair defects. tumors with mmr abnormalities by ihc and mlh1 methylation were classified as epigenetic mmr deficiency while those without mlh1 methylation were classified as probable mmr mutations, and those without mmrd were classified as mmr proficient. the first outcome is the prevalence of epigenetic mmrd in endometrial cancer, and the second outcome is whether the clinicopathological features and prognosis of endometrioid adenocarcinoma differ between the epigenetic mmrd population, mmr proficient population and the lynch/ lynch-like population.

Eligibility criteria:
inclusion criteria: * all patients diagnosed with endometrial cancer in our hospital from 2019 to 2022 exclusion criteria: * those without histological specimens in our hospital
the primordial dwarfisms: diagnosis, identification of the molecular basis of seckel syndrome and microcephalic osteodysplastic primordial dwarfism type ii

Conditions: Microcephalic Osteodysplastic Primordial Dwarfism Type II; Seckel Syndrome

Summary: the purpose of this study si to define morphological and epidemiological parameters and identify new symptoms in french patients with seckel syndrome (sckl) or microcephalic osteodysplastic primordial dwarfism type ii (mopdii).

multicentre study, aiming to determine morphological and epidemiological parameters and identify new symptoms in french patients with sckl or mopdii. at pre-inclusion visit: realization of the photographs of: the face, entire body and the extremities (hands and feet) that will be serve for the collegiate decision of the inclusion or not of patients. patients are seen at inclusion v1 , a second visit v2 at 6-10 months after v1 and an annual follow-up visit. at inclusion: * full clinical examination, specialized consultations (otorhinolaryngology, stomatology, orthopedics, ophthalmology) * results of x-ray examinations and biological tests * assessment of the patients competencies and initiation of appropriate care ( orthophony and psychomotricity...) * assessment of intelligence and cognitive ability according the wisc-iv scale * blood testing for diagnosis and research. visit 2: * full clinical examination * cerebral angiography-mri for all patients * programming a neurosurgery / neurovascular consultation based on mri results * immuno-hematology and hepato-gastroenterology consultation if anomaly during the visit v1 annual follow-up visit: * assessment of the complications of the disease and its clinical care * full clinical examination * skeletal x-ray and systematic orthopedic consultation * blood check * prescription of tests if necessary depending to the complications identified of the disease * reevaluation of the care according to the detected symptoms

Eligibility criteria:
inclusion criteria: patients aged from 2 months to 50 years must present all of the following criteria: * symmetrical intrauterine growth restriction (iugr) \< - 2 ds, birth size \<-2 ds and cranial perimeter of birth \<-2 ds * postnatal growth restriction (size \<-4ds) * microcephaly \<-4ds * clinical diagnosis of seckel syndrome or microcephalic osteodysplastic primordial dwarfism type ii (mopdii) by a geneticist * having given free and informed consent exclusion criteria: * refutation of the diagnosis * parents' refusal to participate in genetic studies once the diagnosis of sckl or mopdii has been establish for the patient (major or minor) * allergy to gadolinium, contraindicating the realization of an angio-mri * absence of affiliation to a social security scheme or universal health coverage.

Keywords: seckel syndrome microcephalic osteodysplastic primordial dwarfism type ii
pet detection of ccr2 in human atherosclerosis

Conditions: Carotid Atherosclerosis

Summary: : use of novel radio-pharmaceutical 64cudota-ecl1i to evaluate arterial atherosclrosis

using 64cudota-ecl1i to evaluate arterial atherosclrosis in normal volunteers and patients with carotid or femoral arterial atherosclerosis..

Eligibility criteria:
inclusion criteria: normal volunteers: 18-40 years of age, non smoker, no history of diabetes, hypertension, or hyperlipidemia. patients: 50-89 years of age, adequate nutritional status, with or without smoking history, diabetes, hypertension, and hyperlipidema. both asymptomatic and symptomatic patients with known carotid artery atherosclrosis \>70% and scheduled to undergo surgery. advanced peripheral artery disease. - exclusion criteria:inability to receive and sign informed consent. currently enrolled in another study. patients who have type 1 diabetes or are in septic shock, receiving steroid therapy, recent history of heavy alcohol consumption, (male \>2 drinks per day, and female \> 1 drink per day. following extreme diets like atkins or south beach diet or with stage 4 chronic renal failure. patients with unstable clinical condition that in the opinion of the pi precludes participation in the study. inability to tolerate 60 minutes in a supine position with arms down at sides. contraindications to mr imaging, (pacemaker, brain aneurysm clips, shrapnel, etc. positive pregnancy test or lactating. have another conditions such as cancer or autoimmune/inflammatory diseases, e.g. rheumatoid arthritis or multiple sclerosis that are known to have increased expression of ccr2. -
3-month discontinuation of dual antiplatelet therapy after ultimaster sirolimus-eluting stent implantation

Conditions: Coronary Artery Disease

Summary: to evaluate safety of reduction of dual antiplatelet therapy period to three months after implantation of ultimaster sirolimus-eluting stent (u-ses). additionally to investigate appropriateness of thienopyridine monotherapy with discontinuation of aspirin.


Eligibility criteria:
inclusion criteria: * patients with coronary artery lesion who received percutaneous coronary intervention using ultimaster sirolimus-eluting stent. * patients considered appropriate to discontinue dual antiplatelet therapy at 3 months after stent implantation. * patients who have provided written informed consent. exclusion criteria: * patients previously experienced stent thrombosis. * patients who are unable to clinical follow-up procedure specified in the protocal for the present study. * patients who are enrolled or planned to participate in another clinical trials of antiplatelet therapy.

Keywords: drug-eluting stent
idiopathic esophagogastric junction outflow obstruction

Conditions: Esophagogastric Junction Disorder

Summary: this study compares two treatments for idiopathic esophagogastric junction outflow obstruction: pneumatic dilation compared with expectant management, on symptoms and liquid barium emptying exams.

the objectives of this study are to address these gaps in knowledge by: performing a randomized controlled trial in patients with idiopathic egjoo that compares treatment outcomes after pneumatic dilation versus expectant management (disease controls) (expectant management). and, determining rational physiological and objective measures of treatment response.

Eligibility criteria:
inclusion criteria: * initial hrim consistent with the diagnosis of egjoo and mechanical esophageal obstruction has been excluded by prior upper endoscopy. * egjoo patients with a retained liquid barium column on tbe ≥5cm in height at 1 minute * patients must have symptomatic dysphagia exclusion criteria: * diseases that potentially could cause mechanical obstruction such as gastroesophageal reflux disease with erosive esophagitis, peptic stricture, cancer, eosinophilic esophagitis, prior fundoplication, adjustable gastric band surgery and hiatal hernias. patients with any identifiable anatomic esophageal or gastric obstruction will be excluded from the study * patients with previous surgery on the esophagus or stomach * previous history of per oral endoscopic myotomy or prior pneumatic dilation * history of gastroparesis

Keywords: idiopathic esophagogastric junction outflow obstruction esophageal sphincter function esophagogastric junction pneumatic dilation