Kornimate/medical-research-clean huggingface dataset:
clinical trial to evaluate cerc-002 in adults with covid-19 pneumonia and acute lung injury

Conditions: COVID-19 Pneumonia; Acute Lung Injury; ARDS

Summary: the study is a prospective, randomized, placebo-controlled, double-blind phase 2 clinical study of the efficacy and safety of cerc-002, a potent inhibitor of light (lymphotoxin-like, exhibits inducible expression, and competes with herpes virus glycoprotein d for herpesvirus entry mediator, a receptor expressed by t lymphocytes), for the treatment of patients with 2019 novel coronavirus disease (covid-19) pneumonia who have mild to moderate acute respiratory distress syndrome (ards). light is a cytokine in the tumor necrosis factor super family (tnfsf14) which drives inflammation and induces many other cytokines including il-1, il-6 and gm-csf. light levels have been shown to be elevated in covid-19 infected patients and inhibiting light is hypothesized to ameliorate the cytokine storm which has shown to be a major factor in progression of ards. the study will assess the efficacy and safety of cerc-002 in patients with severe covid-19 over a 28 day period as single dose on top of standard of care.


Eligibility criteria:
inclusion criteria: 1. subject/legally authorized representative (lar) is able to understand and provide written informed consent, and assent (as applicable) to participate in this study. 2. subject is ≥18 years of age at the time of informed consent and assent (as applicable). 3. subject is male or non-pregnant, non-lactating female, who if of childbearing potential agrees to comply with any applicable contraceptive requirements if. discharged from the hospital prior to completing the study. 4. subject has a diagnosis of covid-19 infection through an approved testing method. 5. subject has been hospitalized due to clinical diagnosis of pneumonia with acute lung injury defined as diffuse bilateral radiographic infiltrates with partial pressure of arterial oxygen/percentage of inspired oxygen (pao2/fio2) \>100 and \<300. 6. subject's oxygen saturation at rest in ambient air \<93% exclusion criteria: 1. subject is intubated. 2. subject is currently taking immunomodulators or anti-rejection drugs. 3. subject has been administered an immunomodulating biologic drug within 60 days of baseline. 4. subject is in septic shock defined as persistent hypotension requiring vasopressors to maintain mean arterial pressure (map) of 65 mm hg or higher and a serum lactate level greater than 2 mmol/l (18 mg/dl) despite adequate volume resuscitation. 5. subject has received any live attenuated vaccine, such as varicella-zoster, oral polio, or rubella, within 3 months prior to the baseline visit.
pilot study: active video gaming to facilitate physical activity and quality of life in kidney transplant recipients

Conditions: Quality of Life

Summary: background: renal transplant recipients have a greater risk of morbidity and mortality primarily due to cardiovascular disease when compared to the general population. cardiovascular disease is responsible for 50% to 60% percent of deaths amongst renal transplant population and death from cardiovascular disease is a leading cause of functioning graft loss. physical activity is an effective form of secondary prevention in existing cardiovascular disease reducing all-cause mortality by 25%-30% and has demonstrated positive effects overall on quality of life and well-being. transplant patients who participated in regular cardiovascular exercise have significant more positive scores on the sf-36 health status questionnaire in comparison to inactive transplant recipients. active video gaming is evolving as an innovative method to increase physical activity. active video gaming has supported physical activity in children and youth. there is however a paucity of literature examining interactive games as a means to facilitate physical activity and its impact on cvd and quality of life in the adult population nor any literature examining avg and its impact on an adult surgical population. this pilot study is designed to determine if active video gaming is feasible and is able to lead to behavioral modifications and quality of life improvement. subject selection: this is a pilot study during which 10 patients who have undergone renal transplant will be selected to exercise with active video gaming for a duration of 3 months. the program activity will begin 6 months post surgery.


Eligibility criteria:
inclusion criteria: * renal transplant patient who want and are able to take part in this study exclusion criteria: * cardiac or pulmonary dysfunction diagnosed through preoperative assessment. * any surgical complication incurred with transplantation. * peripheral vascular disease.
doppler ultrasound following unicondylar knee replacement to determine the incidence of postoperative dvt

Conditions: Number of Deep Venous Thrombosis (DVT)

Summary: purpose of this study is to determine the incidence of deep venous thrombosis after partial knee replacement.

doppler ultrasound will be performed 2-6 weeks after surgery.

Eligibility criteria:
inclusion criteria: * unilateral partial knee replacement * postoperative anticoagulation with aspirin 325 twice daily * regional anesthesia * inflatable garments worn during hospitalization exclusion criteria: -bilateral partial knee replacement

Keywords: dvt
study on the predictive value of high-sensitivity cardiac troponin i, n-terminal pro-b-natriuretic peptide, and soluble suppression of tumorigenesis-2 for mortality and the development of cardiovascular events in patients with type 2 diabetes (diabetes-cv)

Conditions: Type 2 Diabetes; Cardiovascular Complication

Summary: the diabetes-cv study is an observational study designed to assess the prognostic value of serum cardiac damage markers high-sensitivity cardiac troponin i (hs-ctni), n-terminal pro-b-natriuretic peptide (nt-probnp), and soluble suppression of tumorigenesis-2 (sst2) in predicting mortality, major adverse cardiovascular events, and diabetic complications in patients with type 2 diabetes.

this single-center, investigator-initiated, prospective observational study aims to evaluate the prognostic value of serum cardiac damage markers such as high-sensitivity cardiac troponin i (hs-ctni), n-terminal pro-b-natriuretic peptide (nt-probnp) and soluble suppression of tumorigenesis-2 (sst2) in subjects with type 2 diabetes. the study will utilize clinical and laboratory data from patients attending the diabetology unit at the irccs inrca hospital in ancona (italy), including both study-specific data and information extracted from routine outpatient medical records.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * patients attending the outpatient services exclusion criteria: * type 1 diabetes * patients with active cancer or cancer in remission for less than 5 years * any medical or other reason that leads the investigator to consider the subject ineligible for the study.

Keywords: type 2 diabetes high-sensitivity cardiac troponin i n-terminal pro-b-natriuretic peptide soluble suppression of tumorigenesis-2 mortality risk diabetes complications
shanghai st-segment elevation myocardial infarction cohort

Conditions: ST Elevation Myocardial Infarction

Summary: st-segment elevation myocardial infarction(stemi) remains a major cause of morbidity and mortality worldwide, despite of the early reperfusion therapy, including fibrinolysis, primary percutaneous coronary intervention (pci),and standardized medical treatment.to improve the prognosis of stemi patients, the management in their hospitalization should be optimized, including improvements in risk stratification, more widespread use of an invasive strategy, implementation of care delivery systems prioritising immediate revascularisation through pci (or fibrinolysis), advances in antiplatelet agents and anticoagulants, and greater use of secondary prevention strategies such as lipid-lowering therapy. this study aims to standardized the management of stemi patients and improve the prognosis of the stemi patients.

this study is a prospective cohort study. it aims to standardized the management of stemi patients and improve the prognosis of the stemi patients.

Eligibility criteria:
inclusion criteria: * st elevation myocardial infarction * coronary angiography and percutaneous coronary intervention within 12 hours of symptom onset * capable and willing to provide informed conset and capable of completing study visits exclusion criteria: * cardiovascular shock at admission * severe physical disability * active malignant tumors * active autoimmune diseases

Keywords: acute myocardial infarction cardiac remodelling heart failure
a pivotal safety and efficacy study of ocs-01 eye drops in participants with diabetic macular edema (diamond 2)

Conditions: Diabetic Macular Edema

Summary: the primary objective of this study is to evaluate the efficacy and safety of the topical ophthalmic administration of ocs 01 as compared to vehicle in participants with diabetic macular edema (dme).

a phase 3 pivotal double-masked, randomized, vehicle-controlled, multicenter study of the efficacy and safety of ocs 01 eye drops in participants with diabetic macular edema

Eligibility criteria:
inclusion criteria (selection): 1. have a signed informed consent form before any study-specific procedures are performed. 2. have dme with presence of intraretinal and/or subretinal fluid in the study eye, with cst of ≥310 µm by sd-oct at screening (visit 1) (as assessed by an independent reading center). 3. have a documented diagnosis of type 1 or type 2 diabetes mellitus prior to screening (visit 1). exclusion criteria (selection): 1. have macular edema considered to be because of a cause other than dme. 2. have a decrease in bcva because of causes other than dme. 3. have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.

Keywords: topical ophthalmic suspension eye drop
a study to assess safety and tolerability of cc-486 (onureg®, oral azacitidine) in combination therapy in participants with acute myeloid leukemia (aml)

Conditions: Leukemia, Myeloid, Acute

Summary: the purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of cc-486 (onureg®) in combination with venetoclax in relapsed and/or refractory acute myeloid leukemia (aml) and newly diagnosed aml.


Eligibility criteria:
inclusion criteria: * confirmation of the following for acute myeloid leukemia (aml) * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2. ecog 3 is allowed if participants are 18 to 74 years old with comorbidities * agree to serial bone marrow aspirate/biopsies exclusion criteria: * suspected or proven to have acute promyelocytic leukemia based on morphology, immunophenotype, molecular assay, or karyotype * received prior hypomethylating agent (hma) therapy for myelodysplastic syndromes/chronic myelomonocytic leukemia then develop aml within 4 months of discontinuing the hma therapy * prior history of malignancy unless the participant has been free of the disease for ≥ 1 year prior to the start of study treatment other protocol-defined inclusion/exclusion criteria apply

Keywords: acute myeloid leukemia cc-486 onureg oral azacitidine venetoclax venclexta venclyxto
nitrous oxide in the treatment of acute suicidal ideation

Conditions: Suicidality; EEG; Suicidal Ideation; Nitrous Oxide; Biomarkers / Blood; Biomarkers / Hair

Summary: the primary aim of the nitos study is to investigate the potential rapid antisuicidal effects of n2o in the transdiagnostic treatment of suicidal ideation. on day 1, patients will receive either nitrous oxide (50% n2o balanced with oxygen) or placebo (50% oxygen balanced with air). seven days after the first inhalation, a second inhalation will be performed. all patients will receive n2o at least once during this trial. while the first inhalation will be double-blind, only the patients but not the raters will be blinded to the second inhalation (day 8). for mechanism of action and prediction, a nested biomarker substudy will employ multimodal techniques including analysis of hair and blood samples, and eeg.


Eligibility criteria:
inclusion criteria: * ability to give written informed consent * moderate to severe suicidal ideation defined as a score ≥3 on the montgomery-asberg depression rating scale (madrs; schmidtke et al., 1985) suicide item (item #10) as well as a self-report beck scale for suicide ideation (bss; kliem et al., 2017) items #4 plus #5 score ≥ 2 * plasma homocysteine level ≤ 14 µmol/l exclusion criteria: * organic, including symptomatic, mental disorders (f00-f09; lifetime diagnosis) * schizophrenia, schizotypal and delusional disorders (f20-f29; lifetime diagnosis) * mental and behavioral disorders due to psychoactive substance use. nicotine and cannabis will be ignored (f10-f19) * non-medical (i.e., recreational) use of inhalational n2o during the last 12 months * past intolerance or hypersensitivity to n2o * critical illness * severe cardiac disease * pregnancy or breastfeeding * pulmonary hypertension * chronic cobalamin or folate deficiency unless treated with folic acid and/or vitamin b12 * history or evidence of any other medical or neurological condition that would expose the subject to an undue risk of a significant adverse event as determined by the clinical judgment of the investigator * treatment with ketamine/esketamine during the last 4 weeks * treatment with opioid medications during the last 3 months * treatment with vagus nerve stimulation (vns) or electroconvulsive therapy (ect) within the last 3 months * recent (within the last 4 weeks) or current use of benzodiazepines in excess of 5 mg lorazepam or equivalent per day * finally, any other factors that, in the investigator's judgment, would unduly impact patient safety or compliance during the study.

Keywords: suicidality nitrous oxide suicidal ideation depression
effectiveness of art therapy on reducing pain and anxiety in children receiving venipuncture

Conditions: Venipuncture; Pain; Anxiety; Fear

Summary: venipuncture is one of the most common stressful procedures in children. managing pain and fear of venipuncture procedure recommended strongly because it may change children's memory for procedural pain and the subsequent acceptance of later health care painful interventions. prior painful experiences can reduce the acceptance of later health care, hence making it more difficult for both patients and nurses. there was clear evidence that the distraction method is the most performed as a psychological technique performed to decrease venipuncture-related pain and distress and supporting its efficacy in children. the aim of this study to investigate the effectiveness of tick-b on children's pain and anxiety during venipuncture procedure.

note: the first registration number for the protocol of ph.d. was approved as 10092019-6 on 10th september 2019 it approved the grant to publish the result as 20072020-3 on 23, august,

Eligibility criteria:
inclusion criteria: * being between 6-12 years old, * a physician order was placed for the blood sample, exclusion criteria: * chronic medical condition. * those whose parent not participated, * neurodevelopmental delayed, verbal difficulties, difficulties in hearing or visual, * unconsciousness. * take a medication analgesic in the past 6 hrs. * history of syncope.
a first-in-human study of xstem-oa in patients with knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: the aim of the study is to assess safety, tolerability and preliminary efficacy of xstem-oa when administered as a single intra-articular injection to patients with symptomatic knee osteoarthritis. the study is divided into two parts; a dose escalation (part a) and an optional dose expansion part (part: b). three dose levels are planned to be evaluated in part a and selected dose level(s) may be further expanded in part b.


Eligibility criteria:
major inclusion criteria: * aged ≥40 and ≤75 years at screening * radiological evidence of predominantly medial osteoarthritis in the knee, uni- or bilateral, of kl grade ii to iii * moderate to severe pain associated with osteoarthritis in the knee as measured by a vas pain score of ≥35 and ≤90 mm major exclusion criteria: * body mass index (bmi) of ≥35 at screening * ongoing signs or symptoms of systemic or local infection * known knee infection in the study knee within 6 months of screening * history of clinically relevant concomitant joint disease, clinically-relevant knee deformities, or any clinically significant medical history of the ligament, or realignment surgery or joint replacement surgery * medical history of any autoimmune disease * history of surgery in the study knee that occured within 6 months of screening * treatment with immunosuppressive therapy (systemic or local) or any medication affecting the bone or cartilage metabolism within 6 months of screening * patients who are immunocompromised as caused by a disease
transplantation of anaerobic cultured human intestinal microbiota in irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: patients with irritable bowel syndrome (ibs) are treated with microbiota from a human intestinal anaerobic sample cultured for decades. patients are recruited consecutively with symptoms of ibs and serve as their own controls. after an observation time of 4 weeks, patients are recruited for a 1-week run-in and then given the cultured fecal microbiota by the duodenal route via gastroscopy. two treatments are given within a 1-week interval. assessment of symptoms are made before and 4 weeks after the last treatment (at 6 weeks). additionally, fecal samples are collected for bacterial 16s ribosomal ribonucleic acid (rrna) analysis and bacterial functional parameters (microflora-associated characteristics).

diarrhea-dominated irritable bowel syndrome (ibs-d) is studied in subjects by treatment with an anaerobic human intestinal microbiota cultured for 15 years and quality controlled with a specified content of bacterial species regularly over the years. inclusion criteria is: diarrheal disease since at least 4 weeks, 18-80 years of age, previously unsuccessful treatment with no symptomatic relief of antidiarrheals or resins, and signed informed consent. primary outcome was irritable bowel syndrome-symptom severity scale (ibs-sss). secondary outcome was bristol stool scale (bss). secondary outcome: changes in fecal microflora distribution and multiplicity as shown by the 16s ribosomal ribonucleic acid (rrna) analysis of feces. once eligible for the study, patients were monitored for a run-in period of one week with the ibs-sss and the bss plus fecal samples for analysis of bacterial species using the bacterial specific 16s rrna differentiation. then, the anaerobic cultured human intestinal microflora (achim) was given twice with an interval of 1 week. thereafter, patients were further monitored over 4 weeks as regards ibs-sss and bss. another feces sample was also collected for bacterial 16s rrna analysis to evaluate the microbiota diversity. the study will be evaluated using eligible subjects as their own controls by means of wilcoxon's matched-pairs test, alternatively t-test for matched pairs. power analysis show that 40 subjects are needed to study in order to achieve a power of 80%.

Eligibility criteria:
inclusion criteria: * ibs according to the rome iii criteria exclusion criteria: * pregnancy * antibiotic and probiotics within 8 weeks before inclusion * unable to give informed consent * immunodeficiency (drug- och disease-related)

Keywords: ibs microbiota
a study to evaluate the efficacy and safety of serplulimab in combination with chemotherapy and concurrent radiotherapy in patients with limited-stage small cell lung cancer

Conditions: Limited-Stage Small Cell Lung Cancer

Summary: this study is a randomized, double-blind, multicenter, phase iii clinical study to compare the clinical efficacy and safety of serplulimab + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with limited-stage small cell lung cancer.

eligible subjects in this study will be randomized to arm a or arm b at 1:1 ratio. arm a (serplulimab arm): serplulimab + chemotherapy(carboplatin/cisplatin-etoposide)+concurrent radiotherapy; arm b (placebo arm): placebo + chemotherapy(carboplatin/cisplatin-etoposide)+concurrent radiotherapy; the 4 stratification factors for randomization include: ecog ps (0 or 1), staging (i/ii or iii), radiation fraction (bid or qd), and region (asia or non-asia).

Eligibility criteria:
inclusion criteria: 1. male or female, aged ≥18 years when signing the icf. 2. histologically diagnosed with sclc. 3. diagnosed with ls-sclc (stage ⅰ-ⅲ of the ajcc 8th edition of the cancer staging), which can be safely treated with curative radiation doses. 4. major organs are functioning well. exclusion criteria: 1. histologically or cytologically confirmed mixed sclc. 2. subjects suitable for surgery. subjects who are suitable for surgery but refuse surgical treatment can be included. 3. patients who have previously received systematic anti-tumor treatments for small cell lung cancer, including but not limited to radiotherapy, chemotherapy, and immunotherapy. 4. patients with other active malignancies within 5 years or at the same time. 5. subjects with known history of severe allergy to any monoclonal antibody. 6. subjects with known anaphylaxis to carboplatin/cisplatin or etoposide. 7. in the judgment of the investigator, subjects who have any other factors that may lead to a premature discontinuation.

Keywords: limited-stage small cell lung cancer serplulimab
evaluation of efficacy and safety of an anti-allergy drug with a contact lens in allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to evaluate the efficacy and safety of an anti-allergy drug with a contact lens compared to placebo in preventing ocular itching associated with allergic conjunctivitis


Eligibility criteria:
inclusion criteria: * history of ocular allergies and a positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months; successful soft contact lens wearer who has frequently worn contact lenses for at least one month or more exclusion criteria: * active ocular infection; clinically significant blepharitis; follicular conjunctivitis; pterygium; narrow angle glaucoma; dry eye syndrome; ocular surgery within past 6 months; pregnancy or lactation

Keywords: allergic conjunctivitis, ophthalmology, multicenter, controlled