Kornimate/medical-research-clean huggingface dataset:
retinoblastoma survivor study: assessment of general health and quality of life

Conditions: Retinoblastoma

Summary: the purpose of this study is to find out about the quality of life and health in a group of adults who had retinoblastoma when they were children. by quality of life, we mean how you are feeling about being satisfied with things in your life, including your physical health, your emotional health, and your ability to carry out daily activities. we hope that this information will help us provide better care to future children with retinoblastoma and better follow-up care for survivors of retinoblastoma.


Eligibility criteria:
inclusion criteria: * patient diagnosed with retinoblastoma at any age * at least five years from completion of all retinoblastoma-directed therapy * able to provide informed consent and/or assent, if indicated

Keywords: survivor quality of life eye
adjunctive sirolimus and oseltamivir versus oseltamivir alone for treatment of influenza

Conditions: Influenza

Summary: seasonal influenza epidemics are important causes of mortality and morbidity. cytokine dysregulation, with high levels of pro-inflammatory cytokines, occurs in patients with severe influenza a(h1n1)pdm09 virus infection, a(h5n1) infection, and a(h7n9) infection. we aim to investigate the effects of adjunctive sirolimus in adults hospitalized with influenza a or b infections involving the lower respiratory tract.

the investigators aim to investigate the effects of adjunctive sirolimus in adults hospitalized with influenza a or b infections involving the lower respiratory tract. patients will be randomized to either oseltamivir and adjunctive sirolimus or oseltamivir alone and assessed with reference to normalization of respiratory status (sao2 ≥93% or respiratory rate ≤20/min on room air) as the primary endpoint,10 cytokines/chemokines and pro-inflammatory mediator changes, viral clearance, symptom resolution, icu admission/death, day 28 mortality; safety profiles will also be assessed. the investigators hypothesize that addition of sirolimus to oseltamivir would improve respiratory status and other endpoints more effectively than oseltamivir alone through reduction of inflammatory responses without affecting viral clearance.

Eligibility criteria:
inclusion criteria: * influenza a and b virus infections confirmed by pcr and/or immunofluorescence assays, hospitalized for the management of severe manifestations of influenza, initiation of oseltamivir, clinical evidence of lower respiratory tract infection (e.g. shortness of breath, tachypnea, oxygen desaturation, crepitations on auscultation, infiltrations or consolidations on chest radiograph) and written informed consent (by the subjects, or from their next of kin if the subjects are unable to provide written consent at the time of enrollment) exclusion criteria: * use of other immunosuppressants (e.g. post-chemotherapy, post-transplant, autoimmune diseases) other than systemic corticosteroids * patients with known immuno-compromised conditions (e.g. active haematological malignancies, hiv/aids patients who are on antiretroviral therapy and cd4 cell count \< 200) * pregnancy/lactation * hepatic failure * patients with surgery done/planned within 1 month * patients who have received macrolide antibiotics and nsaid for 1 week prior to enrolment due to their immuno-modulating effects * patients on drugs that may interact and alter sirolimus level (rifampicin, azole antifungals, phenytoin, diltiazem, verapamil, nicardipine, metoclopramide, phenobarbital, carbamazepine) will be excluded for safety purposes * use of investigational anti-influenza antivirals and blood products

Keywords: respiratory mortality cytokines chemokines
the clinical trial of teicoplanin for injection

Conditions: Infectious Disease

Summary: 1. primary study endpoint security effectiveness 2. secondary study endpoint extensive use of population characteristics clinical drug characteristics appropriate crowd characteristics adverse reactions susceptible population characteristics reveal rare, new, unanticipated and long-term adverse drug reactions bacterial resistance explore the advantages of teicoplanin in combination with other antimicrobial agents explore the opportunistic use of teicoplanin for injection

research purposes 1. to explore the safety and efficacy of different doses of teicoplanin for injection in the real world 2. to explore the characteristics of different doses of teicoplanin for injection, the clinical characteristics of drug use and repeated use of bacterial resistance; 3. reveal rare or even very rare, new, unanticipated, and adverse drug reactions associated with long-term use; 4. to explore the advantages of different doses of teicoplanin in combination with other antimicrobial agents; 5. to explore the use of teicoplanin in the treatment of infectious diseases on the rational use of drugs time; 6. to reveal the risk factors of adverse reactions and susceptibility to people, to identify the characteristics of the crowd; 7. to investigate the clinical use of teicoplanin injection for the real situation, for further risk management, to expand the indications and expert consensus dose study to provide clinical clues and basis; 8. to provide reference for revision of clinical guidelines and consensus, clinical pathway design; 9. to further enhance the level of safe use of teicoplanin injection, basic medical support and market vitality. research design 1. national, large-scale, standardized, standardized, real-world research; 2. prospective, single - arm open, non - interventional, registration, multi - center clinical study; 3. in the hospitals using teicoplanin for injection, 200 were selected on the basis of voluntary principles; 4. registration of teicoplanin in patients with injection; 5. target sample size of 100,000 cases; 6. exemption from informed consent for ethical review applications; 7. study of teicoplanin and large-scale data on the safety and effectiveness of antibiotics.

Eligibility criteria:
inclusion criteria: * prescription for teicoplanin in patients exclusion criteria: * no
treatment of tnnt1-myopathy with l-tyrosine.

Conditions: Nemaline Myopathy

Summary: the purpose of the study is to investigate if treatment with l-tyrosine improves selected outcome measures of tnnt1 myopathy.


Eligibility criteria:
inclusion criteria: * male or female patients * any age with tnnt1-related myopathy exclusion criteria: * patients who are non-cooperative or parents/ legal guardians who are unwilling to sign consent form
trilaciclib vs placebo in patients with extensive stage small cell lung cancer (es-sclc) receiving topotecan

Conditions: Extensive-stage Small-cell Lung Cancer

Summary: this is a multicenter, randomized, double-blind, placebo-controlled study to assess whether trilaciclib administered prior to topotecan is non-inferior to placebo administered prior to topotecan with regard to overall survival.

the study will include 3 study phases: screening phase, treatment phase, and survival follow-up phase. patients randomized in this study will receive trilaciclib/placebo + topotecan 1.5 mg/m2 until disease progression, unacceptable toxicity, withdrawal of consent, investigator decision to discontinue treatment, or the end of the trial, whichever comes first. trilaciclib was approved by the united states (us) food and drug administration (fda) as a treatment to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for es-sclc. as a post-marketing requirement, the fda asked the sponsor to conduct a study in patients with es-sclc undergoing chemotherapy to evaluate survival and disease progression following trilaciclib administration in patients treated with a platinum/etoposide-containing regimen or topotecan-containing regimen with at least 2 years of follow-up. this study is designed to fulfill this requirement.

Eligibility criteria:
inclusion criteria: 1. es-sclc with confirmed diagnosis of sclc by histology or cytology 2. progression during or after prior first or second line chemotherapy. first-line regimen must have been a platinum-containing combination. 3. measurable or evaluable disease as defined by recist v1.1 exclusion criteria: 1. history of topotecan (or other topoisomerase i inhibitor) or trilaciclib treatment for sclc 2. any chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment within 3 weeks, except for adjuvant hormonal therapy for breast cancer and prostate cancer 3. presence of brain metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids 4. radiotherapy within 2 weeks 5. history of ild/pneumonitis 6. history of other malignancies, except for curatively treated solid tumors with no evidence of disease for ≥ 2 years or other ncs cancers

Keywords: myelosuppression es-sclc chemotherapy-induced myelosuppression chemotherapy-induced neutropenia chemotherapy-induced anemia myeloprotection
non-invasive mechanical ventilation as a rescue therapy to relieve dyspnea in patients with stable severe copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to determine whether non-invasive mechanical ventilation(niv), playing the role as a rescue therapy , are effective in relieving exertional dyspnea in stable severe copd patients.

chronic obstructive pulmonary disease(copd) is a preventable and treatable illness, which is clinically characterized by persistent airflow limitation that is usually progressive. it's well known that airflow limitation lead to air trapping particularly during exercise, resulting in increased dyspnea and limitation of exercise capacity. thus, copd patients often unconsciously adopt a sedentary lifestyle, probably due to distressing exertional dyspnea. the sedentarism results in physical deconditioning and alterations of the peripheral muscles, and the latter one causes more exertional dyspnea and fatigue, which in turn leads to much more sedentarism, forming the vicious cycle of sedentarism, dyspnea/fatigue and more sedentarism. thereby, measures should be taken to interrupt this vicious cycle. some previous studies suggested that niv acting as an add-on therapy could help unloading the inspiratory muscle, reducing the dynamic compression of the airway, diminishing the dynamic hyperinflation,to some extent, relieved dyspnea during exercise in copd patients. however,those measures were taken during exercise, acting as an add-on therapy. whether niv can play a role as a rescue therapy to relieve exertional dyspnea while the patients are already undergoing optimal treatment with bronchodilator and anti-inflammatory medication is still not quite clear. therefore, we hypothesize that niv as a rescue-therapy has the same effect on relieving dyspnea in stable severe copd patients just like the add-on therapy.

Eligibility criteria:
inclusion criteria: * severe copd (post bronchodilator fev1/fvc \< 70% and fev1 \< 50% predicted) * stable clinical condition(no exacerbation in the 4 weeks prior to study participation with no change in medications) * dyspnea as a main symptom that limited daily activities exclusion criteria: * obvious pulmonary bullae demonstrated by chest ct scan or x-ray examination * facial trauma/malformation; recent facial, upper airway or upper gastrointestinal tract surgery * oxygen saturation(spo2) \< 88% at rest with a fraction of inspired oxygen(fio2) ≥ 0.5 * systolic blood pressure \> 160mmhg or diastolic blood pressure \> 100mmhg at rest * unstable angina or a myocardial infarct in the previous four weeks * resting sinus tachycardia ( \> 120 beats/min) * patients with musculoskeletal or neurological disorders * patients who are unable to give informed consent

Keywords: copd dyspnea exercise noninvasive ventilation
profiling of original cellular and humoral biomarkers of type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the "lymphoscreen" study aims to characterize precisely (phenotypes/cytokines/functions) cd8+ t cell responses in type 1 diabetes to identify biomarkers of the disease. such markers are needed for refine type 1 diabetes diagnosis/prognostic, and to design new therapeutic approaches targeting autoreactive cd8+ t cells. an original approach using dna immunization of humanized mice allowed us to identify relevant cd8 epitopes derived from gad65 and ia-2 beta cell autoantigens. the aims are: (i) identifying exhaustively epitopes recognized by autoreactive cd8+ t lymphocytes in type 1 diabetes and following islet or pancreas graft in humans; (ii) identifying pathogenic cd8+ t cell patterns or profiles related to type 1 diabetes pathogenesis and evolution; (iii) correlating cd8+ autoreactive t cell responses and autoantibody responses to new cellular (such as cd4+ t cells or peripheral cell mirna) or humoral markers of the disease (such as serum mirna).


Eligibility criteria:
inclusion criteria: * at least, 50 patients with "recent" type 1 diabetes, * 30 patients with long-term type 1 diabetes, * 10 patients with latent autoimmune diabetes, * 10 subjects with a risk for diabetes, * 20 type 1 diabetic patients with pancreatic graft or langerhans islet graft. * 50 healthy subjects paired to hla class i and to the age those subjects have to respect the following criteria : * age from 7 to 70 -caucasian * affiliated to a national insurance scheme * written informed consent obtained for children, written informed consent is required from the two parents. non-inclusion criteria : * age strictly inferior to 7 or strictly superior to 70 years old * pregnancy * secondary diabetes * no written informed consent
investigate the effect of food on the pharmacokinetic of jlp-1207 in healthy male volunteers

Conditions: LUTS; Benign Prostatic Hyperplasia; Overactive Bladder

Summary: the purpose of this study is to investigate the pharmacokinetic drug interaction between solifenacin and tamsulosin in healthy male volunteers.

a randomized, open-label, single dose, two-way crossover study

Eligibility criteria:
inclusion criteria: * 19\~45 years healthy male * body weight is over 55kg, bmi measurement 18.0kg/m\^2\~ 27.0kg/m\^2 * signed informed consent form from to participate voluntarily and to comply with the trial requirements. * researchers determined suitable volunteers through physical examination, laboratory tests exclusion criteria: * history of clinically significant liver, kidneys, nervous system, immune system, respiratory, endocrine disorders or tumor or blood disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.) * sitting sbp\>150mmhg or \ 100mmhg or \<60mmhg, after 3 minutes break * an impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason. * have a gastrointestinal disease history that can affect drug absorption (crohn's disease ulcers, etc) or surgery (except simple appendectomy or hernia surgery) * history of drug abuse * positive urine drug screening * administrated investigational product in a previous clinical trial within 90 days of the first administration day in this study. * donated blood within 60 days prior to the first administration day in this study.

Keywords: α1-blockers antimuscarinic agent
vortioxetine intravenous infusion at initiation of oral treatment with vortioxetine in patients with depression

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to evaluate the efficacy and safety of vortioxetine given as a single intravenous dose of 25 mg at initiation of an oral vortioxetine regimen of 10 mg/day for 7 days

the study consists of a 7-day double-blind treatment period (day 0 to day 6)

Eligibility criteria:
inclusion criteria: * the patient has recurrent mdd, diagnosed according to dsm-5® and confirmed using the mini-international neuropsychiatric interview (mini). * the patient has a madrs total score ≥ 30 at the screening visit. * as part of standard of care treatment, the patient is to be admitted to hospital due to the severity of the depressive symptoms and is willing to remain hospitalized for the duration of the study treatment period. * the patient has had the current mde for ≥3 months but less than 12 months. * the patient has received treatment for the current episode with an ssri/snri monotherapy (citalopram, escitalopram, paroxetine, duloxetine, venlafaxine, sertraline) at an approved dose for at least 6 weeks. exclusion criteria: -the patient has any current psychiatric disorder or axis i disorder (dsm-5® criteria), established as the primary diagnosis, other than mdd, as assessed using the mini or another diagnostic interview other in- and exclusion criteria may apply
ketofol versus propofol in urgent ercp for acute cholangitis

Conditions: Conscious Sedation Failure During Procedure

Summary: endoscopic retrograde cholangiopancreatography (ercp) is a lengthy and uncomfortable procedure that requires adequate sedation. propofol is the commonly used sedative during ercp. however, dose dependent cardiac and respiratory depression may occur. hypotension usually occurs in severe cholangitis which necessitate the use of alternative sedative. the aim is to study the efficacy and safety of ketofol as a sedative during urgent ercp for severe cholangitis.

this randomized controlled trial was carried out on 96 patients undergoing urgent ercp for severe cholangitis. patients were allocated into two groups; group 1: received ketofol and group 2: received propofol. demographic data, ercp duration, recovery time, heart rate (hr), mean arterial pressure (map), peripheral oxygen saturation, ramsey sedation scale (rss), pain numerical rating scale (nrs), propofol requirement, adverse events, endoscopists and patients satisfaction were recorded

Eligibility criteria:
inclusion criteria: * severe acute cholangitis of either sex * aged between 21-70 years * undergoing urgent therapeutic ercp for severe cholangitis with american society of anaesthesiologist (asa) grade ii - iii. exclusion criteria: * patients who had asa physical status grade vi, * baseline spo2 \<90%, * patients who had difficulty in communication, * patients allergic to the studied medications, * morbidly obese patients, * patients with chronic obstructive pulmonary disease, * complicated airway, * pregnant patients.
relative levels of bms-986036 in blood plasma in healthy, overweight, and obese participants following subcutaneous administration via auto-injector versus pre-filled syringe

Conditions: Healthy Participants

Summary: the purpose of this study is to develop an auto-injector (ai) device for the bms-986036 subcutaneous formulation that can be self-administered conveniently by participants.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * healthy, overweight, obese, male and female participants, as determined by normal in medical history, physical examination (pe), electrocardiograms (ecgs), and clinical laboratory determinations * body mass index (bmi) of 25.0 kg/m2 to 40.0 kg/m2, inclusive i) approximately 25% of participants will be overweight and have a bmi between 25 kg/m2 and 30 kg/m2, inclusive ii) approximately 75% of participants will be obese and have a bmi \> 30 kg/m2 to ≤ 40 kg/m2 * women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial exclusion criteria: * women who are pregnant or breastfeeding * inability to tolerate subcutaneous (sc) injections * inability to be venipunctured and/or tolerate venous access * any sound medical, psychiatric, and/or social reason as determined by the investigator other protocol-defined inclusion/exclusion criteria apply
reproducibility study of transcranial doppler

Conditions: Stroke

Summary: hardening of the neck vessels (carotid arteries) caused by fatty deposits called 'plaques' is a common cause of strokes. over time plaques can burst or may lead to a severe narrowing (stenosis) of the neck artery. when plaques burst, small clots or fatty particles (called microemboli) break off, block brain vessels and lead to a stroke. researchers have an incomplete understanding of the processes that cause hardening of the arteries, development of small clots and are unable to predict who will have a stroke. at present, the only ultrasound scan that evaluates circulation in the head and detects these small clots is called the transcranial doppler ultrasound. the aim of the study is to test this simple ultrasound technique to see if it can detect signals that may correspond to these small clots or fatty particles. the other objective is to see how repeatable the ultrasound technique is. this may help to identify patients with hardened neck arteries who are at higher risk of a recurrent stroke. this could also potentially improve patients selection to a targeted surgical or future novel pharmacological therapy.


Eligibility criteria:
inclusion criteria: * healthy volunteers with no previous history of cerebrovascular disease and aged over 18 years old. * patients with symptomatic cerebrovascular event (stroke, transient ischaemic attack or amaurosis fugax) and image confirmed carotid artery stenosis of \>30%. this will include patients scheduled for carotid endarterectomy (\>50% for men and \>70% for women, by north american symptomatic carotid endarterectomy trial criteria) or treated conservatively with an optimal medical therapy (if patient declined surgical intervention or is outside surgical criteria for carotid endarterectomy). exclusion criteria: * subjects unable to comply with the study procedures such as a severe disabling stroke. * inadequate temporal window for transcranial doppler assessment. * adults with incapacity.

Keywords: microemboli