cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease

The purpose of this study is to evaluate the effect of MEDI8968 on the rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult subjects with symptomatic, moderate to very severe COPD (Global Initiative for Chronic Obstructive Lung Disease - GOLD stage II-IV) receiving standard maintenance therapy for the underlying disease condition.

A Phase 2 double-blind, placebo-controlled study to evaluate the efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease. The study will have a screening phase of 23 days, treatment phase from Week 1 to 53 and follow-up phase from Week 53 to 69. Participants will receive either MEDI8968 600 milligram (mg) as intravenous (IV) infusion on Day 1 followed by 300 mg injection subcutaneously (SC) every 4 weeks up to Week 53 or matching placebo in the same fashion. Participants will primarily be assessed for incidence rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Age 45 through 75 years
* Predicted (Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] stage II, III, and IV) at Screening
* History of previous acute exacerbations of chronic obstructive pulmonary disease (AECOPD) 12 months prior to Screening
* Clinically stable and free from an AECOPD for 8 weeks prior to Day 1
* Current smoker or ex-smoker with a tobacco history of more than or equal to (\>=) 10 pack-years.

Exclusion Criteria:

* Past or present disease or disorder,
* Significant or unstable ischemic heart disease etc
* Known history of allergy or reaction to any component of the investigational manufacturing product (IMP)
* Past or current malignancy within the past 5 years
* Subjects have had a chest x-ray or Computed Tomography (CT) scan suggestive of malignancy or tuberculosis (TB).
* Use of immunosuppressive medication receipt of any biologic agent.
A Phase IIb Study to Investigate the Efficacy and Tolerability of Cinaciguat (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)

A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant, non-lactating female subjects, age \>/= 18 years of age; or women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovarectomy, and women with a hysterectomy
* Subjects must have the clinical diagnosis of congestive heart failure (CHF) made at least three months prior to enrollment
* Subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study: dyspnea and clinical evidence of volume overload

Exclusion Criteria:

* Acute de-novo heart failure
* Acute myocardial infarction and/or myocardial infarction within 30 days
* Valvular heart disease requiring surgical intervention during the course of the study
* Heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease
* Primary hypertrophic cardiomyopathy
* Acute inflammatory heart disease, eg, acute myocarditis
* Unstable angina requiring angiography
Improving Metabolic Control in Diabetic Young Children

: Although intervention or prevention with young children with T1DM may help ameliorate problems or forestall later problems in metabolic control, a number of potential barriers to research have constrained the development of such interventions. To assess the feasibility of intervening with young children and their families, we propose to conduct an exploratory pilot study of a behavioral intervention for young children (ages 7 to 11) newly diagnosed with T1DM. The intervention, derived from the pediatric prevention work of Seligman and his colleagues, seeks to apply positive psychology principles to enhance optimism, self-efficacy, and parent-child collaboration in diabetes management, in order to improve quality of life, adherence, and metabolic control. This exploratory study will allow us to evaluate the feasibility of intervening with young children and their caretakers and to estimate intervention effect sizes in preparation for a randomized controlled clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 7 to 11
* Recently diagnosed with T1DM
* Treated at Mount Sinai or at North General Hospital

Exclusion Criteria:

* Children below age 7 and above age 11
* Individual with diminished mental capacity, such that they would not be able to either complete the assessments or comprehend the materials presented in the intervention, will be excluded.
* Individuals without sufficient command of the English language to permit participation (due to the verbal nature of the intervention and the assessment package, and the linguistic limitations of the study team).
A 10-12 Week Study to Evaluate the Safety and Efficacy of 320 mg Valsartan and 80 mg Simvastatin in Combination and as Monotherapies in Treating Hypertension and Hypercholesterolemia

This 10-12 week study will provide data on the safety and efficacy of using 320 valsartan and 80 mg simvastatin together compared to using either one alone in lowering blood pressure and LDL cholesterol. After discontinuing current drug therapies for hypertension and hypercholesterolemia, patients will be given 320mg valsartan+80mg simvastatin, 320mg valsartan+placebo, or 80mg simvastatin+placebo..


Eligibility Criteria:
Inclusion Criteria:

* ESSENTIAL HYPERTENSION
* ELEVATED LDL-C CHOLESTEROL
* USING STABLE DOSE OF HMG CoA REDUCTASE INHIBITOR (STATIN) FOR 3+ MONTHS

Exclusion Criteria:

* SEVERE HYPERTENSION
* EVIDENCE OF HISTORY OR CURRENT HEART DISEASE
* HISTORY OF STROKE OR MYOCARDIAL INFARCTION
* DISLIPIDEMIA OR HYPERTENSION DUE TO SECONDARY CAUSES
* UNCONTROLLED DIABETES OR INSULIN

Other protocol-defined exclusion criteria may apply.
Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)

Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and simvastatin in patients with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hypercholesterolemia who satisfy the following criteria:

  * Patients who have used any of the following HMG-CoA reductase inhibitors (hereinafter referred to as "statins") for 4 weeks or longer before the start of the observation period and whose LDL-cholesterol level during the treatment had not reached lipid management target indicated below
  * Age: 20 years of age or older (at the time of obtaining informed consent)
  * Sex: both males and females
  * Inpatient/outpatient: Out-patients

Exclusion Criteria:

* Patients for whom any of the following is applicable:

  * Patients whose fasted triglyceride level measured at the start of the observation period or the treatment period exceeds 500 mg/dL
  * Patients with homozygous familial hypercholesterolemia
  * Patients with creatine phosphokinase (CPK) \> 2x upper limit of normal (ULN) measured at the start of the observation period or the treatment period.
  * Patients with serious hepatic disorder, or patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2x ULN measured at the start of the observation period or the treatment period.
  * Patients with a history of hypersensitivity to any ingredient of ezetimibe tablets or simvastatin tablets
  * Pregnant, nursing women, women who may be pregnant, or patients wishing to be pregnant during the study.
  * Patients who have discontinued use of serum lipid lowering agents for less than 4 weeks at the start of the treatment period (8 weeks in the case of probucol). (However, if the patient had taken a serum lipid lowering agent before the test conducted at the start of the observation period, a period of discontinuation of 27 days, or 55 days in the case of probucol, is allowed.)
  * Patients who are using cyclosporine from after the start of the observation period
  * Patients who are using any of the following drug from after the start of the observation period: itraconazole, miconazole, atazanavir, saquinavir mesilate
  * Patients with a history of ezetimibe use
  * Patients with hyperlipidemia associated with the following diseases:

    * Hypothyroidism
    * Obstructive gall bladder or biliary disease
    * Chronic renal failure
    * Pancreatitis
  * Patients with hyperlipidemia associated with concomitant use of drugs having adverse effect on serum lipids, etc
  * Patients who have received an investigational drug within 4 weeks of the start of the observation period
  * Other patients deemed not appropriate for study entry by the investigator
Human Fibrinogen Concentrate in Pediatric Cardiac Surgery

The goal of the study is to determine whether the use of Human Fibrinogen Concentrate (RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and infants undergoing cardiopulmonary bypass.

The goal of the study is to determine whether the use of Human Fibrinogen Concentrate (RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and infants undergoing cardiopulmonary bypass. RiaSTAP will be administered after termination of Cardiopulmonary Bypass (CPB) at a dose of 70 mg/kg, in a prospective, randomized, controlled study. We hypothesize that the administration of RiaSTAP in this manner will reduce peri-operative bleeding and transfusion requirements.

Eligibility Criteria:
Inclusion Criteria:

* Neonatal and infant cardiac patients presenting for open-heart surgery at Nicklaus Children's Hospital will be eligible for enrollment in the study.

Exclusion Criteria:

* Patients who fall outside of the age range for the study will be excluded. Patients known to have had an anaphylactic or severe reaction to the drug or its components will not be enrolled. At the time of the rewarming ROTEM, any patient with a FIBTEM MCF \> 15mm, will be excluded.
GLS4/RTV and TAF Drug-drug Interaction

The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of GLS4/RTV combined with TAF in healthy subjects.

This is a 2-part study with each part is an open-label study in healthy adult subjects.

Total 28 subjects will be enrolled into the study and divided into 2 part (Part A and Part B), 14 subjects in each part. With each part, the subject will be receive study drug per the defined treatment periods.

Eligibility Criteria:
Inclusion Criteria:

* Males or females, of any race, between 18 and 50 years of age, inclusive, at Screening;
* Body mass index between 18.0 and 28.0 kg/m2, inclusive, at Screening;
* Females of childbearing potential and male subjects will agree to use contraception from screening to the 6 months after the last administration.

Exclusion Criteria:

* In the 12 months prior to screening, observing clinical significance of the following diseases, including but not limited to, gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental, or cardio-cerebrovascular diseases;
* Allergic constitution (multiple drug and food allergies);
* A history of alcoholism;
* Take any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days of screening;
* Any drug that changes the liver enzyme activity, such as barbiturates and Rifampicin, was taken within 30 days before screening;
* P-GP, BCRP, OATP1B1, OATP1B3, OAT1, OAT3 or MRP4 inhibitors or inducers, such as azithromycin, pantoprazole or St. John's herb, etc., was taken within 30 days before screening;
* Female subjects are lactating or have positive blood pregnancy results during the screening period;
The Effect of Probiotics on Gingivitis

The aim of the study is to assess the effect of oral probiotics containing Streptococcus salivarius M18 on gingivitis and oral hygiene in young adults.

This will be a double-blind, randomized, placebo-controlled two-arm parallel-group study of the effect of oral probiotics containing Streptococcus salivarius M18 on gingivitis and oral hygiene. The groups will include young adults with gingivitis diagnosed clinically. To assess the effect of oral probiotics, the following parameters will be used: gingival index, GI; gingival bleeding index, GBI and oral hygiene level (the Turesky Modification of the Quigley-Hein Plaque Index, TMQHPI).

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-25 years
* Permanent bite;
* Presence of more than 20 teeth;
* Absence of systemic and chronic diseases;
* The diagnosis of gingivitis stated clinically.

Exclusion Criteria:

* Presence of mild, moderate or severe chronic periodontitis;
* Refusal to sign informed consent;
* Taking supplements and medication containing probiotics or prebiotics 1 months before the study;
* Taking antibiotics (within 3 months before the study);
* Allergy to the components of the drugs used in the study;
* Presence of immunodeficiency, taking immunosuppressants.
* Use of other hygiene products, immunostimulants and antibacterials, probiotics, prebiotics during the study;
* Refusal to take a given medication;
* Failure to attend check-ups.
A Naturalistic Prospective Study of Treatment Effectiveness for Attention-Deficit/Hyperactivity Disorder (ADHD)

To determine if there is a clinically and statistically significant difference between OROS-MPH and IR MPH in ADHA and ODD symptoms by the parent completed SNAP-IV. It is hypothesized that OROS-MPH is superior in improving symptom outcomes overall, remission rate, functional improvement, quality of life and persistence with medication over time.

This one-year prospective observational study is designed to evaluate and compare outcomes effectiveness between OROS-MPH and IR MPH in ADHA and ODD symptoms at the ADHD Clinic of the British Columbia Children's and Women's Health Centre. A practical clinical trial is valuable because it has the potential to provide us the information which represents the actual outcomes in real settings.

The primary objective of this study is to analyze the treatment outcomes of ADHD patients under conditions of routine clinical practice. Patients will, therefore, be treated according to the current practice of each participating physician, with the exception of several additional rating scales which are SNAP-IV, Strengths and Difficulties Questionnaire, WEISS Functional Impairment Rating Scale (WFIRS)-Parent, Child Health and Illness Profile (CHIP), EQ-5D, Parent/Caregiver Questionnaire, ADHD Side Effect Checklist, Adolescent Diversion Questionnaire, Adaptive Behavior Assessment System-Second Edition (ABAS-2) and Clinic Global Impressions. Patients will be assessed at baseline and 12 months regardless of whether the original treatment is continued. If a patient terminates the study early, all assessments that are normally collected at the end of the study will be collected at the time of termination. Only patients with pre and post data will be included in the analysis.

Results of this study are expected to make breakthrough on the treatment of ADHD in practice; and, particularly, information which come out from this study is not currently available from other researches.

Eligibility Criteria:
Inclusion Criteria:

1. Patients between the ages of 6 and 18.
2. Enrolled in school with at least 1 school year remaining before completion of high school.
3. Current drug therapy with either a IR MPH or OROS MPH.

Exclusion Criteria:

1. Parent/caregiver unable or unwilling to provide written informed consent.
2. Child unable or unwilling to provide assent (for children aged 7 years).
3. Parent/caregiver unable or unwilling to complete questionnaires.
4. Child unable or unwilling to complete questionnaires ADHD is considered by the clinician to be secondary to another more serious disorder such as personality disorder, substance abuse, bipolar disorder, autism, or mental handicap.
5. Participation in another treatment study.
Prospective Evaluation of a New Covered Metal Stent for Malignant Lesions of the Esophagus

In this study, a newly designed and FDA approved fully covered metal stents will be used to palliate 20 patients with malignant lesion of the esophagus. Dysphagia score will be assessed before and after treatment to confirm efficacy

The incidence of esophageal cancer is increasing, and despite advances in treatment, the prognosis is still very poor \[1-4\]. At presentation, between 50-60 % of patients have unresectable disease \[5,6\]. For these patients, palliation is the goal with a particular focus on the relief of dysphagia, which is the major etiology of morbidity \[5,6\]. Presently, Self expanding metal stent (SEMS) have become the treatment of choice for dysphagia associated with unresectable esophageal and GE junction malignancies.

In this study, a newly designed and FDA approved fully covered metal stents will be used to palliate 20 patients with malignant lesion of the esophagus. Dysphagia score will be assessed before and after treatment to confirm efficacy

The objectives are:

1. To evaluate if the newly fully covered metal stent , HANAROSTENT can provide adequate palliation of cancerous lesions of the esophagus;
2. To determine whether it is non-inferior in efficacy and safety to the esophageal stents currently available at UVa with minimal complications and improvement of symptoms

Eligibility Criteria:
Inclusion Criteria:

* Inoperable malignant obstruction of the esophageal or gastric cardia
* Malignant fistula between the esophagus ans respiratory tree
* Recurrent cancer after prior radiation

Exclusion Criteria:

* Patient unstable for endoscopic procedure
* Previous esophageal stenting
* Tumor growth within 2 cm of the upper esophageal sphincter
* Pregnant women (self reported, no pregnancy test will be done per protocol)
Impact of Visceral Fat on the Pathogenesis of Age-related Macular Degeneration

The purpose of this study is to determine the relationship among the body fat distribution, especially the visceral fat, in patients with age-related macular degeneration in comparison to patients with a normal fundus.

In this study the investigators want to examine the relationship among visceral fat, serum leptin levels, and high-sensitive CRP (hsCRP), Tnf-alpha, Amyloid alpha and Amyloid Beta serum levels in patients with age-related macular degeneration in comparison to patients with a normal fundus.

Eligibility Criteria:
Inclusion Criteria:

* man and women over 18 years old
* filled informed consent
* diagnosis of age-related macular degeneration

Exclusion Criteria:

* inherited retinal disease
* other acquired retinal macular disease
* missing informed consent
Skin Denervation in Systemic Lupus Erythematosus

To address the issues of skin denervation and its clinical and pathological correlations in systemic lupus erythematosus

To address the issues of skin denervation and its clinical and pathological correlations in lupus, we will study a systemic lupus erythematosus (SLE) cohort by evaluating the extent of cutaneous innervation. Patients are recruited from the rheumatologic clinic, and various neuropsychiatric syndromes are diagnosed based on clinical judgement following detailed history taking and neurological examinations. Skin biopsy with PGP 9.5 immunohistochemistry will be performed following established procedures after informed consent is obtained, and punches of 3 mm in diameter will be taken from the lateral side of the distal leg, 10 cm above the lateral malleolus. Intraepidermal nerve fibre densities will be compared with results of immunological, pathological, psychophysical, and electrophysical studies to understand the pathogenesis of peripheral neuropathy in SLE.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of systemic lupus erythematosus based on the consensus criteria

Exclusion Criteria:

* Conditions known to be associated with peripheral neuropathy, such as diabetes, uremia, alcoholism, and the administration of potentially neurotoxic agents, such as alkylating agents, methotrexate, cyclosporine, and antibiotics.
Efficacy, Safety, and Tolerability of Nerispirdine in Patients With Multiple Sclerosis

The primary objective is to assess the activity of nerispirdine in improving the ability to walk, in patients with multiple sclerosis (MS).

Secondary objectives:

* To assess other measures of walking ability, tiredness, and lower limb muscular strength, spasticity, clinical assessment by subject and clinical assessment of change by the Study Investigator
* To assess the safety and tolerance of nerispirdine
* To evaluate the pharmacokinetics (PK) parameters of nerispirdine

Total duration per patient is approximately 19 weeks in total, comprising a 3-week screening period inclusive of a 2-week placebo run-in period, a 14-week treatment period, and a 2-week placebo run-out (follow-up) period

Eligibility Criteria:
Inclusion Criteria:

* Clinically definite MS (according to McDonald criteria),

Exclusion Criteria:

* Multiple sclerosis exacerbation or clinical relapse within 6-month prior to the screening visit.
* Subject who is not able to complete two trials of a timed 25 foot walk, with or without an assisted device,
* Patients without valid V1, V2, and V4 T25-FW measurements are not eligible for randomization.
* Female patients who are either pregnant or breastfeeding.

Other protocol-defined inclusion/exclusion criteria may apply.