cyrilzakka/clinical-trials huggingface dataset:
Baricitinib, Methotrexate as Monotherapy or Combination in the Treatment of Rheumatoid Arthritis - an Open Label Randomized Clinical Trial

The goal of this open-label randomized clinical trial is to assess the efficacy of baricitinib 2 mg in comparison to methotrexate 25 mg as monotherapy followed by baricitinib 4 mg in comparison to methotrexate 10 mg and baricitinib 2 mg combination in patients with rheumatoid arthritis with moderate to severe disease activity. The main question it aims to answer:

• Is there any difference in the efficacy of baricitinib as monotherapy in comparison to methotrexate monotherapy or methotrexate-baricitinib combination in the treatment of rheumatoid arthritis

This open-label randomized clinical trial will be conducted in the department of rheumatology, BSMMU. The rheumatoid arthritis patients with moderate to high disease activity at baseline, disease activity score (DAS28ESR\>3.2) will be considered as primary entry criteria for this study. Consecutive sampling method will be applied. The study will be done in 2 phases, duration of each phase 24 weeks. Considering inclusion and exclusion criteria, total 132 patients are randomized into group A and group B following block randomization. Each group will be consisting of 66 patients. In phase 1 Group A will be put on baricitinib 2 mg once daily and Group B will be put on methotrexate 25 mg weekly. The patients who fail to achieve remission or low disease activity by 24 weeks eligible for entry into phase 2 where group A will be put on baricitinib 4 mg and group B will be put on baricitinib 2 mg in combination with methotrexate 10 mg. Follow-up will be done at the 4th, 12th and 24th week in phase 1 and 28th, 36th and 48th week in phase 2. Response to treatment will be evaluated by DAS 28 ESR. At the end of 24th week endpoint for efficacy will be assessed at by DAS 28ESR. Adverse effects will be assessed by history, physical examinations and investigations.

Results will be compared among two groups with a 95% confidence interval and a p-value of \< 0.05. The degrees of statistical significance between groups will be analyzed by unpaired t-test and/or Mann-Whitney U test. Qualitative data in between groups will be analyzed by the chi-square test. Probabilities of associations will be assessed by calculating Spearman´s rank correlation coefficient

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients more than 18 years of age 2. Patients fulfill the ACR/EULAR 2010 classification criteria for Rheumatoid arthritis 3. Patients with DAS 28 ESR\> 3.2

Exclusion Criteria:

* 1. Recent or concurrent infection including active tuberculosis 2. Haemoglobin (Hb) \< 9 gm/dl 3. Total WBC count \< 4000 / µL 4. Neutrophil count \< 1200 / µL 5. Lymphocyte count \< 750 / µL 6. AST/ALT \> three times the upper limit of normal 7. Estimated glomerular filtration rate \< 60 ml/minute/1.73 m2 8. Co-morbid illness- e.g., Malignancy 9 . Pregnant or breast feeding woman
Interactive Studies of Endstage Diabetic Dialysis Patients

The purpose of this study is to document relevant and related clinical changes associated with different hemoglobin concentrations in diabetic hemodialysis patients.

Hypothesis: The expansile capacity of blood vessels is affected by different hemoglobin concentrations in diabetic hemodialysis patients.

Vascular disease is an important cause of morbidity and mortality in patients with chronic kidney disease (CKD), of which a large proportion is diabetic. Diabetics have complex and multiple reasons for vascular disease, and there is accumulating evidence of associated poor endothelial cell function, particularly in those with kidney disease. One important mechanism through which this might occur relates to changes in shear rate and stress resulting from different viscosity levels. Such fluctuations are increasingly recognized to affect endothelial cell function and hence vessel-wall adaptability in both the short and long term.

Little is known of the consequence of different shear effects on endothelial cell function at various hemoglobin levels in kidney disease. There is some evidence to suggest however that, in the presence of micro-vascular disease, a relative anemia, with associated lower viscosity and shear stress, may be of benefit compared to higher hemoglobin levels.

Diabetics account for almost 40% of dialysis patients worldwide, and are the fastest growing component of the epidemic of CKD. Thus, an understanding of optimal treatment targets for anemia therapy, and the impact of different target levels of hemoglobin on vascular wall function is imperative.

Eligibility Criteria:
Inclusion Criteria:

* Diabetics and non-diabetics on hemodialysis
* On erythropoietin and iron
* On a statin

Exclusion Criteria:

* Uncontrolled blood pressure (BP)
* Ulcers
* Amputations
* Unstable cardiac function
* Malignancy
* Planned operations
Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 in Healthy Volunteers

The primary aim of this study is to investigate the safety and tolerability of AZD2423 single doses in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Have a body mass index (BMI) between ≥18 and ≤30 kg/m2, as calculated by the investigator, and weigh at least 50 kg and no more than 100 kg
* Healthy male and non-fertile female volunteers with suitable veins for cannulation or repeated venipuncture

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study,or influence the results or the subject's ability to participate in the study
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Any clinically significant illness/infection or medical/surgical procedure or trauma,as judged by the Principal Investigator, within 3 months of the first administration of investigational product
CT Imaging for Guiding PA-TACE for HCC

Postoperative adjuvant transarterial chemoembolization (PA-TACE) may improve survival outcomes in a subset of patients with resected hepatocellular carcinoma (HCC), reliable biomarkers for the criterion for the selection of candidates are lacking. The present study aimed to evaluate whether CT imaging can provide more value for predicting benefit from PA-TACE.


Eligibility Criteria:
Inclusion Criteria:

* CT scans acquired no more than one month before surgery
* Confirmation of HCC diagnosis by pathological examination
* Curative surgical resection

Exclusion Criteria:

* Prior antitumor treatment
* Macrovascular thrombosis or metastasis
* Perioperative mortality
* Unqualified image artifacts
* Tumor rupture
* MVI status not reported
Liraglutide in Newly Onset Type 1 Diabetes.

The purpose of this study is to investigate the effect and safety of liraglutide 1.8 mg once daily compared to placebo for 52 weeks on change in beta-cell function in patients with newly diagnosed type 1 diabetes as an adjunctive therapy to insulin treatment.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes according to WHO criteria diagnosed ≤ 6 weeks before visit 0
* Age 18 - 40 years - both inclusive
* Postprandial C-peptide \> 0.2 nmol/l following sustacal meal test
* Able to understand the written patient information and to give informed consent

Exclusion Criteria:

* Type 2 diabetes
* Body mass index \<20 kg/m2
* Pregnancy or unwillingness to use safe contraceptives
* Compromised kidney function (eGFR \< 60 ml/min/1,73m2), dialysis or kidney transplantation at visit 0
* Liver disease with elevated plasma alanine aminotransferase (ALT) \> three times the upper limit of normal at visit 0
Sexual Function in High-risk Pregnant Women

Our aim with this study is to evaluate the sexual functions of pregnant women whose pregnancies are defined as high-risk pregnancies and whose pregnancies are followed by perinatology specialists.


Eligibility Criteria:
Inclusion Criteria: - Pregnant women over 18 years old, -Pregnant women 39 years old and under, -Pregnant women in their 3rd trimester.

Exclusion Criteria: - Pregnant women under 18 years old, -Pregnant women over 40 years old, -Pregnant women in their 1st or 2nd trimester.
Effects of Sleep Deprivation on Diaphragm Command During an Inspiratory Endurance Trial in Healthy Volunteers.

The purpose of this study is to assess the impact of sleep deprivation on subjective inspiratory endurance in healthy subjects.

Sleep in intensive care unit is altered and few studies have suggested that sleep deprivation (SD) could impact respiratory muscle endurance. A lack of inspiratory endurance could lengthen weaning from invasive ventilation. The purpose of this study is to confirm whether SD alters inspiratory endurance and to identify brain mechanisms involved in SD-induced decreased endurance. A group of 20 male healthy subjects will perform an inspiratory load trial after a normal sleep night and after a sleepless night. Electrophysiological parameters (EEG, motor evoked potentials) of the inspiratory motor command and sensory perceptions will be assessed before, during and after each trial.

Eligibility Criteria:
Inclusion Criteria:

* Male adult volunteers
* Aged 25 to 45 years
* Regularly sleeping more than 6 hours per night
* Not excessive coffee consumers (\< 3 expressos / day)
* Non smokers
* Absence of respiratory, cardiac, muscular or neurological disease or diabetes
* With a neutral Horne \& Ostberg score

Exclusion Criteria:

* Previous history of respiratory disease or otorhinolaryngological (asthma, respiratory allergies, swallowing disorders, oropharyngeal malformations)
* History of epilepsy or syncope during sleep deprivation
* Taking medications that interfere with sleep (antidepressants, benzodiazepines...)
Study to Evaluate the Safety, Tolerability of BCX9930 in Participants With Either Complement 3 Glomerulopathy (C3G), Immunoglobulin A Nephropathy (IgAN), or Primary Membranous Nephropathy (PMN)

The objective of this study was to determine the safety and therapeutic potential of BCX9930 in participants with C3G, IgAN, or PMN.


Eligibility Criteria:
Inclusion Criteria:

* Body weight ≥ 40 kilograms (kg)
* Primary diagnosis of C3G, IgAN, or PMN confirmed by central pathology review
* An estimated glomerular filtration rate (eGFR) ≥ 50 milliter per minute per 1.73 meter square (mL/min/1.73 m\^2) (or ≥ 30 mL/min/1.73 m\^2 after Data Monitoring Committee \[DMC\] recommendation)
* Receiving treatment with a stable, maximum recommended or maximum tolerated dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 60 days prior to the Day 1 Visit
* Documentation of current vaccinations against Neisseria meningitidis and Streptococcus pneumoniae or willingness to start vaccination series

Exclusion Criteria:

* Known congenital deficiency of C1s, C1r, C1q, C2, or C4
* History of hematopoietic cell transplant or solid organ transplant or anticipated candidate for transplantation
* Myocardial infarction or cerebrovascular accident within 30 days prior to screening, or current and uncontrolled clinically significant cardiovascular or cerebrovascular condition
* History of malignancy within 5 years prior to the screening visit
* Active serious bacterial, viral, or fungal infection or any other serious infection within 14 days of screening
* Treatment with any systemic immunosuppressive or immunomodulatory therapy within 90 days OR anti-CD20 antibody therapies (eg, rituximab) within 180 days prior to the screening visit
* Treatment with renin inhibitors (eg, aliskiren) or sodium-glucose-cotransporter 2 (SGLT2) inhibitors within 60 days prior to Day 1
Chlorhexidine Vaginal Cleansing Versus Iodine Prior to C-section and the Rate of Postoperative Infection

Background: Women undergoing cesarean delivery have 5 to 20 fold greater risk for infection and infectious morbidity compared with those undergoing vaginal birth. Endometritis, febrile morbidity, and wound infection are the most frequent complications of post cesarean infections. Endometritis accounts for 6-27% followed by clinically significant fever, which was reported about 5-24%,while the incidence of wound infection is about 2-9%.Previous studies evaluated whether vaginal cleansing can reduce the incidence of postoperative infectious morbidity. In most of the studies, povidone iodine was used as intervention.

Objectives: The aim of this study is to test the hypothesis that preoperative vaginal cleansing with chlorhexidine would be superior to iodine for the prevention of maternal infectious morbidities including endometritis, fever and wound complications.

Methods: This prospective randomized single blinded controlled trial will be conducted at Makassed General Hospital between February 2018 and January 2019. Total of 300 patients, 150 in each group, will be enrolled. Group 1 patients will receive chlorhexidine vaginal cleansing while group 2 patients will receive iodine prior to C-section. Adverse post infectious morbidities such as endometritis, febrile illness and wound infections will be observed within 30 days of C-section.

This prospective randomized single blinded controlled trial will be conducted at Makassed General Hospital between February 2018 and January 2019. All pregnant women who will undergo cesarean delivery and willing to sign the informed consent will be included. Total of 300 patients, 150 in each group, will be enrolled. Group 1 patients will receive chlorhexidine vaginal cleansing while group 2 patients will receive iodine prior to C-section. Adverse post infectious morbidities such as endometritis, febrile illness and wound infections will be observed d within 30 days of C-section.

Vaginal cleansing will be performed in conjunction with the abdominal preparation with foam sponge that contains either chlorhexidine or iodine, sponge will be inserted into the vagina and rotated 360 degrees in the vaginal cavity for about 30 sec. All participants will receive a single body mass index (BMI) based antibiotic dose of cefazolin within 30 minutes prior to the incision.

Eligibility Criteria:
Inclusion Criteria:

* all pregnant women who will undergo cesarean delivery
* and willing to sign the informed consent.

Exclusion Criteria:

* Known allergy to the antiseptics used
* Infection diagnosis on admission
* Age ≤ 17 years
Renal Effects of Melatonin Trial in Chronic Kidney Disease

This will be a prospective, double blinded, randomized, controlled pilot study to determine if there is any correlation between melatonin administration and proteinuria.

Investigators plan to enroll up to 100 eligible participants in this pilot trial with 50 participants randomized to receive melatonin and 50 patients randomized to receive a placebo. Participants will be randomized on a rolling basis; meaning, once participants agree to enroll in the study, the participant will be placed randomly into either group.

Eligibility Criteria:
Inclusion Criteria:

* Are between ages 18 and up with chronic kidney disease (CKD) I-III (stage 3 kidney disease, kidney dysfunction)
* Random urine microalbumin of 30 mcg or greater (protein in the urine)
* Have ability to complete a sleep survey
* Currently not on melatonin therapy.

Exclusion Criteria:

* End Stage Renal Disease
* CKD Stage IV (stage 4 with severe kidney dysfunction)
* Severe liver disease
* Chronic dialysis therapy
Genetic Mechanisms Underlying SARS-CoV-2 Infection and the Impact of COVID-19 on Cognitive Function

There is a considerable variation in the disease behavior in terms of contracting the infection, manifesting none to a range of symptoms and severity of the infection among individuals exposed to or infected with SARS-CoV-2 virus, the causative organism of COVID-19. Although the respiratory system appears to be the primary target of this virus infection, emerging evidences suggests involvement of extra-pulmonary organs including central nervous system. We aim to compare the genetic profile of individuals with vs without COVID-19 after being exposed to infected cases. Additionally, we will assess the cognitive function in covid-19 positive cases with vs. without neurological symptoms at the time of infection and 1-month follow-up using the Montreal Cognitive Assessment (MoCA) questionnaire.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female over 18 years of age at the time of enrollment
2. Have symptoms of COVID-19 (with or without hospitalization) or contact history
3. Willing to undergo nasopharyngeal swab test for viral-RNA at baseline (in non-hospitalized cases) and the MoCA survey at baseline and 1-month follow-up

Exclusion Criteria:

1. Unwilling to provide informed consent
2. MoCA score ≤17 at baseline
3. Patients with clinical diagnosis of dementia
4. Impaired consciousness
Effect of Propofol on Cardioprotective Role of Remote Ischemic Preconditioning (RIPC)

This study involves research using human subjects (cardiac surgical patients) to evaluate the effect of remote ischemic preconditioning (RIPC) on cardioprotective outcomes. RIPC applied to upper or lower extremities has been shown cardioprotective role by lowering release of cardiac troponin in patients with cardiac diseases. However, it is not clear whether anesthetics, such as propofol or sevoflurane, may impair the cardioprotective effect of RIPC in cardiac surgical patients. Therefore, the purpose of the study is to compare the effects of anesthetics on cardioprotection of RIPC in patients undergoing cardiac surgery.

Patients undergoing cardiac surgery using cardiopulmonary bypass will be randomized to control, propofol, or sevoflurane group. Patients in the control group will receive remote ischemic preconditioning (RIPC) on their upper arms before anesthetic induction. Patients in the propofol or sevoflurane groups will receive RIPC after anesthetic induction using propofol or sevoflurane, respectively. In all patients, arterial blood samples will be obtained before and after each RIPC. From the samples, human dialysate will be obtained and perfused to rat heart through Langendorff apparatus before ischemia-reperfusion injury to the rat heart. Infarct size of the sectioned rat heart will be compared among the three - control, propofol, and sevoflurane - groups.

Eligibility Criteria:
Inclusion Criteria:

* ASA class I\~III patients undergoing cardiac surgery using cardiopulmonary bypass

Exclusion Criteria:

* Cardiac surgery without using cardiopulmonary bypass
* Descending thoracic aortic surgery
* Strenuous exercise, excessive alcohol or caffeine intake 24 hours before remote ischemic preconditioning
* Left ventricular ejection fraction \< 30%
* Uncontrolled hypertension or diabetes mellitus
* Severe renal or hepatic dysfunction
* Patients on hemodialysis
* Patients with arterio-venous fistula on arms or any reason to protect arms
* Peripheral vascular or nerve disease, bleeding tendency
* Preoperative use of IABP, ECMO, or ventricular assist devices
* Emergency operation, redo operation
* Refuse to enroll
* Pregnancy
* Preoperative use of beta-blockers
An Italian Study of the Efficacy of Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Oppositional Defiant Disorder (ODD).

The study is a phase IIIb multicentre, randomised, placebo controlled, trial in paediatric patients with Attention-Deficit/Hyperactivity (ADHD) and Oppositional Defiant Disorder (ODD). The primary aim of the study is to evaluate the efficacy of atomoxetine in improving ADHD and ODD symptoms in patients non responders to a previous psychological intervention with parent support. Moreover, the potential role of atomoxetine in treating other psychiatric comorbid conditions associated with ADHD and ODD will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Child or adolescent patients, male or female outpatients, who are at least 6 years of age, but must not yet have reached their 16th birthday prior to Visit 1, when informed consent is obtained.
* Patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnostic criteria for ADHD (any subtype) and ODD and score at least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder (SNAP-IV ADHD) Subscale score at both Visit 1 and 2.
* They must also have a SNAP-IV ODD subscale score of at least 15 at both Visit 1 and Visit 2.
* Other comorbid conditions, are allowed but the diagnosis of ADHD and ODD must be the patient's primary diagnosis.
* Patients must be of normal intelligence in the judgment of the investigator (that is, without a general impairment of intelligence and likely, in the investigator's judgement, to achieve a score of greater than or equal to 70 on an Intelligence Quotient (IQ) test). The administration of a formal IQ test is not an entry requirement for the study. Specific learning disabilities are not considered general impairment of intelligence.

Exclusion Criteria:

* Patients who weigh less than 20 kilograms (kg) at study entry (Visit 1).
* Patients who have a documented history of Bipolar I or II disorder, any history of psychosis or pervasive development disorder.
* Patients with a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control are not eligible to participate.
* Patients at serious suicidal risk as assessed by the investigator.
* Patients who, in the investigator's judgment, are likely to need psychotropic medications apart from the drug under the study, including health-food supplements that the investigator feels have central nervous system activity (for example, St. John's Wort, melatonin).
Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone

The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
* Eastern Cooperative Oncology Group (ECOG) of 0 or 1

Exclusion Criteria:

* Prior systemic therapy for lung cancer
* Symptomatic Central Nervous System (CNS) metastases
* History of autoimmune disease