cyrilzakka/clinical-trials huggingface dataset:
A Study To InvestigateThe Safety, Tolerability And Efficacy Of Nebulised Curosurf® In Preterm Neonates With Respiratory Distress Syndrome (RDS)

The present study will mainly aim at investigating the safety, tolerability and efficacy of different escalating single doses administration of nebulised Curosurf®, in preterm neonates with RDS (Respiratory Distress Syndrome) during nCPAP.

The study will be conducted in spontaneously breathing preterm neonates with mild to moderate RDS and will consist of two parts:

Part I, with the objective to assess the safety and tolerability of single ascending doses of nebulised Curosurf® ; Part II, with the objective to compare the efficacy of nebulised Curosurf®, administered at two selected doses from part I, during nCPAP, versus nCPAP alone in terms of incidence of respiratory failure in the first 72 hours of life.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained by parents/legal representative (according to local regulation) prior to or after birth
2. Inborn neonates from 28+0 to 32+6 weeks of gestational age (GA), spontaneously breathing and stabilised on nCPAP
3. Clinical course consistent with RDS.
4. Receiving CPAP pressure 5-8 centimeter of water (cm H2O) and fraction of inspired oxygen (FiO2) between 0.25 and 0.40 to maintain saturation of peripheral oxygen (SpO2) between 88% and 95% for at least 30 minutes. Randomization should occur between 60 minutes and 12 hours after birth.

Exclusion Criteria:

1. Early need for endotracheal intubation for cardiopulmonary resuscitation in delivery room or within 1 hour from birth because of severe RDS
2. Respiratory Distress not secondary to surfactant deficiency
3. Use of surfactant prior to study entry and need for endotracheal administration of any other treatment.
4. Major congenital anomalies.
5. Evidence of severe birth asphyxia
6. Mothers with prolonged rupture of the membranes
7. Presence of air leaks.
8. Presence of IVH (intraventricular hemorrhage ) ≥ III.
9. Hypotension or evidence of hemodynamic instability.
10. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk.
11. Participation in another clinical trial
Comparison of INVOS and FORE SIGHT Cerebral Oximeter

Cerebral oxygenation can be monitored using near infrared spectroscopy. Different devices are available to assess cerebral oxygenation noninvasively. Beach chair position is assumed to influence cerebral oxygenation. Litte is known about the influence of prone position and head down position on cerebral oxygenation. The investigators hypothesize that these positions influence cerebral oxygenation. Further the investigators presume that the two cerebral oximeters INVOS and ForeSight provide comparable oxygenation data.


Eligibility Criteria:
Inclusion Criteria:

age \>18 and \<80 years written informed consent

Exclusion Criteria:

cerebrovascular disease coronary heart disease severe organ failure hemoglobin \< 10mg/dl injury of forehead pregnancy
Support for People Undergoing Chemotherapy

Chemotherapy adversely affects quality of life in cancer patients. Both stress management training and exercise training have been shown to improve quality of life. These two types of training have not been directly compared for chemotherapy patients.

This study seeks to evaluate the separate and combined effects of stress management training and exercise training on quality of life during chemotherapy treatment. Participants receive either a home-based, self-administered program in 1 of 3 types (stress management, exercise, or stress management + exercise) or usual care (reading materials). It is hypothesized that the combined program (stress management + exercise) will be significantly associated with better quality of life than the usual care group, the exercise only group, and the stress management only group. All participants are assessed at 3 timepoints: before they begin chemotherapy, 6 weeks after their first chemotherapy infusion, and 12 weeks after their first infusion.


Eligibility Criteria:
Inclusion Criteria: participants must:

* Be diagnosed with cancer
* Be scheduled to receive cytotoxic chemotherapy for at least 14 weeks
* Be ≥18 years of age or older
* Have an ECOG performance status of 0, 1, or 2
* Be capable of speaking and reading English
* Be able to provide informed consent

Exclusion Criteria:

* ECOG of 3 or greater
* Presence of contraindications to participating in moderate intensity exercise including:

  1. . metastases to weight-bearing sites (spine, pelvis, lower extremities)
  2. . active infections
  3. . cardiomyopathy or congestive heart failure
  4. . severe pulmonary or ventilatory disease (FEV 1.0\<50%)
  5. . large pleural effusions or pericardial effusions
  6. . anemia (Hgb \<8g/dL)
  7. . neutropenia (absolute neutrophil count \< 0.05 x 10(9th)/L)
  8. . severe osteoporosis (\> 2.5 SD below age and gender norms)
  9. . thrombocytopenia (platelets \< 20 x 10(9th)/L)
  10. . hyponatremia (Na+ \< 130 mmol/L)
  11. . hypokalemia (K+ ≤ 3.0 mmol/L)
  12. . hypercalcemia (Ca++ \> 6.5 mmol/L)
  13. . abnormal ECG
  14. . sensorimotor deficits sufficient to impede unassisted walking
* Receipt of intravenous chemotherapy administration in the past 2 months
* Prescription for chronotropic, sympathomimetic, or inotropic/vasoactive medications
* Presence of other contraindications as determined by the attending oncologist and research staff
Care Companion Diabetes

Digital health interventions have the potential to help patients with diabetes effectively manage their disease at home. Many digital health studies provide patients with educational materials and self-care recommendations. The digital health interventions allow patients to conveniently access these materials on their phones or computers, and enable care teams to provide essential knowledge for diabetes management. Digital health based education intervention is a reasonably inexpensive method that offers high coverage and motivational encouragement to help patients improve their health at home.This study aims to provide patients with timely education for diabetes management and has the potential to improve clinical outcomes for patients with diabetes.

This study is a prospective, randomized control, pragmatic trial of patients with diabetes, including patients newly diagnosed with diabetes and patients with uncontrolled diabetes. This study focuses on delivering educational materials through the MyChart Care Companion pathway to conduct timely educations and assess patient medication adherence level and activity level. This is a minimal risk study without intervention procedures.

There are two Type 2 Diabetes subjects groups uncontrolled diabetes and new diabetics. Each group will be randomized 1 to 1 to either the Care Companion program or control group which receives a one-page document on diabetic care. The Care Companion program is a digital interactive weekly program that includes modules on health and nutrition education and weekly activity and medication adherence check-ins. There are weekly modules that are completed over 16 weeks.

The objective is to provide timely education to patients with type 2 diabetes through MyChart Care Companion pathway, with the aim of improving patient's self management knowledge. We will also evaluate patient experience and acceptance of the MyChart Care Companion features.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a new type 2 diabetes diagnosis within 1 year at time of enrollment and has an A1c level over 6.5%, or patients with a type 2 diabetes diagnosis over an year and has an A1c level over 8% at time of enrollment
* Patient able to speak and understand English
* Patient is at least 18 years of age

Exclusion Criteria:

* Patient has cognitive limitations that, in the opinion of their provider, limit the patient's ability to understand study requirements
Lactate Clearance in Hospital-acquired Pneumonia

There is no clear consensus on the use of pneumonia severity index (PSI) developed for community-acquired pneumonia in hospital-acquired pneumonia cases. In another aspect, PSI is a relatively difficult scoring system that includes many parameters. This study evaluated whether lactate clearance could be used as a mortality marker instead of PSI in hospital-acquired pneumonia. As a result, lactate clearance was lower in the mortal group and when the diagnostic statistics were evaluated, it was seen that the sensitivity and specificity rates were significantly higher. In conclusion, lactate clearance has been evaluated as a strong predictor of mortality in hospital-acquired pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* 18 and over age, hospital-acquired pneumonia, emergency department admissions

Exclusion Criteria:

* Patients who are pregnant or lactating, under 18 years of age, in the healthcare-associated pneumonia group, had mechanical ventilation at the last hospitalization, whose lactate level could not be studied for any reason at admission and 6th hour, had missing data used in pneumonia severity index calculation and/or who did not accept to participate in the study
Azilect + Antidepressant Chart Review

To identify the occurrence of serotonin toxicity in Parkinson's Disease (PD) patients receiving antidepressant therapy and rasagiline, compared to those receiving rasagiline without antidepressant medications and compared to PD patients receiving antidepressants, but not rasagiline.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients with a diagnosis of PD
2. Rasagiline treatment as mono- or adjunct therapy for PD with concomitant antidepressant medication (SSRIs, SNRIs, St. John's wort and/or TCAs) at any time during the specified review period, OR Rasagiline treatment as mono- or adjunct therapy for PD without concomitant antidepressant medication (SSRIs, SNRIs, St. John's wort and/or TCAs) at any time during the specified review period. OR Antidepressant therapy (SSRIs, SNRIs, St. John's wort and/or TCAs) and any other dopaminergic anti-PD treatment besides rasagiline or selegiline at any time during the specified review period
3. Willing to consent to review of office chart and to review of records of ER visits and/or hospitalizations corresponding to the review window, if required
4. Patients previously participating in a rasagiline clinical trial (and their follow-up protocols) are eligible, provided that they did not receive antidepressant therapy during trial participation.
5. In addition to the above criteria, each group has specific inclusion criteria stated below:

   * Group R+AD: Enrollment in this group requires that patients must have taken rasagiline and an antidepressant (SSRIs, SNRIs, St. John's wort and/or TCAs, regardless of indication) within 14 days of each other (or five weeks, if fluoxetine preceded rasagiline).
   * Group R: Enrollment in this group requires patients must have at least 2 months of rasagiline use.
   * Group AD: Patients must be taking an approved dopaminergic medication for PD. Enrollment in this group requires that patients must have at least 2 months of treatment with an antidepressant medication.

Exclusion Criteria:

1. Use of rasagiline for any indication other than PD
2. Patients taking a monoamine oxidase inhibitor (MAOI) antidepressant and/or selegiline
3. Inability or unwillingness to request records of ER visits and/or hospitalizations corresponding to the review period.
Risperidone and Suicidality in Major Depressive Disorder

The purpose of this trial is to investigate the efficacy of risperidone as an adjunct to an antidepressant treatment in the acute management of suicidality during an episode of major depressive disorder.

Using a double blind, placebo-controlled design, subjects diagnosed with a current episode of major depressive disorder (defined by DSM-IV criteria and supported by the Mini International Neuropsychiatric Interview), severe with suicidality despite currently taking an antidepressant, will be enrolled in the eight-week study. The treatment will be initiated by randomizing patients to receive risperidone or placebo in addition to the antidepressant that the patient is already taking. The clinical efficacy will be evaluated after 4 days, weekly for 4 weeks, then every other week for 4 weeks with the efficacy measures. During the eight-week study, treatment with risperidone or placebo will continue at the highest effective dosage (up to 2 mg per day). The dose of the antidepressant will not be changed during the study.

Eligibility Criteria:
Inclusion Criteria:

1. 19-60 years of age
2. Diagnosis of major depressive disorder, currently severe with suicidality
3. A total score of Montgomery-Asberg Depression Rating Scale (MADRS) =/\> 25 with the suicide sub-score =/\> 4
4. Currently is taking an antidepressant at a therapeutic dose for longer than 3 weeks
5. In good physical health

Exclusion Criteria:

1. Depression without suicidality
2. Presence of major psychiatric conditions other than major depressive disorder, such as bipolar disorder, schizophrenia, or anxiety disorders (except for generalized anxiety disorder)
3. Depressive symptoms induced by alcohol or substance abuse
4. Psychotic features which are predominant at the initial evaluation
5. Unstable major medical illness, such as cardiac disease or diabetes
6. Female subjects who are pregnant, breastfeeding, or, if of child-bearing potential, unwilling to use adequate birth control measures
CTL019 Out of Specification MAP for ALL or DLBCL Patients

Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release.

The purpose of this Managed Access Program (MAP) Treatment Plan is to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release where no overwhelming safety concerns has been identified for manufacture and release of the out of specification product.

Eligibility Criteria:
Inclusion Criteria:

Patients eligible for inclusion in this Treatment Plan have to meet all of the following criteria:

1. Patients must be treated at a healthcare facility that has been certified /qualified by Novartis to dispense and administer tisagenlecleucel in line with the tisagenlecleucel Risk Evaluation and Mitigation Strategy (REMS) in the United States (US) or the local Risk Management Plan (RMP).

   - Note that tisagenlecleucel treatment should be initiated under the direction of and supervised by a HCP experienced in the treatment of hematological malignancies and trained for administration and management of patients treated with tisagenlecleucel. The healthcare facility must have tocilizumab for use in the event of cytokine release syndrome and emergency equipment per patient prior to infusion on site and ensure timely access to additional doses of tocilizumab; for detailed requirements refer to the approved local label.
2. Patients must be prescribed tisagenlecleucel in line with the locally approved indications (for the precise indication statements see approved local product label). These may include:

   * pediatric and young adult patients up to and (including) 25 years of age with refractory/relapsed (r/r) acute lymphoblastic leukemia (B-ALL)
   * adult patients with r/r diffuse large B-cell lymphoma (DLBCL)
3. Informed consent must be obtained prior to treatment
4. The incoming apheresis material and/or the final manufactured product is out of specification due to failure to meet acceptance or release specifications

Exclusion Criteria:

Patients eligible for this Treatment Plan must not meet any of the following criteria:

1. Contraindications as per the approved local label or the IB.
Comparison of Cardiac Index and Cardiac Output Effect During Maintenance Hemodialysis Between Acetate-Free and Acetate-Based Online Hemodiafiltration

The purpose of this study is to detemine whether effect of Acetate-free solution on cardiac index and cardiac output measured by saline dilution techniques compares with Acetate-based solution in online-hemodiafiltration


Eligibility Criteria:
Inclusion Criteria:

* End-stage renal disease patients with age over 20 years and stable clinical status
* Dialytic age \> 6 months
* Maintenance hemodialysis with online-hemodiafiltration mode at King Chulalongkorn Memorial Hospital
* Use arteriovenous fistula or arteriovenous graft as vascular access for hemodialysis
* No vascular access recirculation
* No liver impairment
* No severe, intractable metabolic acidosis or alkalosis (HCO3 \<15, \>30)
* No pre-existing severe, intractable hypocalcemia (Ca \< 7.5) or clinical of hypocalcemia

Exclusion Criteria:

* On hemodialysis via tunnel catheter
* Vascular access recirculation
* Liver dysfunction
* Severe, intractable metabolic acidosis or alkalosis (HCO3 \<15, \>30)
* Pre-existing severe, intractable hypocalcemia (Ca \< 7.5) or clinical of hypocalcemia
* Acute or recent myocardial ischemia or congestive heart failure (within 1 months)
* Threatening arrhythmia (VT, VF, sustained SVT, AF with rapid ventricular response)
* Patients affected by acute or chronic infections, malignant tumor
Implantable Cardioverter Defibrillator (ICD Registry)

The ICD Registry™ is a nationwide quality program that helps participating hospitals measure and improve care for patients receiving implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices with defibrillator (CRT-Ds). The ICD Registry captures the characteristics, treatments, and outcomes of patients receiving (ICDs). Patient-level data is submitted by participating hospitals on a quarterly basis to the American College of Cardiology Foundation's (ACCF) National Cardiovascular Data Registry (NCDR) which then produces an Outcomes Report of the hospital's data, with comparison to both a volume peer group (number of ICD patients submitted annually) and the entire ICD registry data set.

In January 2005 the Centers for Medicare and Medicaid Services (CMS) expanded the covered indications for primary prevention implantable cardioverter defibrillators (ICDs) to incorporate the findings from the Sudden Cardiac Death Heart Failure Trial (SCDHeFT) and the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II). As part of this expansion, CMS mandated that a national registry be formed to compile data on Medicare patients implanted with primary prevention ICDs to confirm the appropriateness of ICD utilization in this patient population.

Responding to this mandate, a collaborative effort of the Heart Rhythm Society (HRS)and the American College of Cardiology Foundation (ACCF), utilizing the expertise of the National Cardiovascular Data Registry (NCDR®), developed the ICD Registry™. Enrollment opened on June 1, 2005. CMS selected the NCDR ICD Registry as the mandated national registry in October 2005.

Eligibility Criteria:
All U.S and International patients.

Inclusion Criteria:

* All patients who receive an ICD/CRT-D (initial or generator change) for primary or secondary prevention purposes.
* All patients with an ICD/CRT-D undergoing a Lead Only procedure.
* U.S. populations must submit all patients who receive an ICD/CRT-D (initial or generator change) for primary prevention purposes who are insured by Medicare.

Exclusion Criteria:

None
Efficacy of PJS-539 for Adult Patients With COVID-19.

The PJS-539 is a multicentre, phase 2, randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of PJS-539 in the viral load of patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

COVID-19, a disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) became a pandemic in March 2020. Clinically, the coronavirus disease 2019 (COVID-19) ranges from asymptomatic disease in some to severe forms. However, until now, only the use of corticosteroids in selected patients has been shown to improve clinical outcomes in patients with COVID-19.

PJS-539 has been demonstrated to inhibit viral uptake and replication of SARS-CoV-2.

The objective of this Phase II trial is to assess the effect of PJS-539 in the viral load of patients with mild to moderate COVID-19 symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (age ≥ 18 years);
2. COVID-19 diagnosis confirmed by:

   1. Detection of SARS-CoV-2 by reverse transcription polymerase chain reaction (RT-PCR), or
   2. Rapid genetic or antigen tests validated by Brazilian National Health Surveillance Agency (ANVISA);
3. Mild or moderate symptoms without indication for hospitalization;
4. Symptoms started seven days ago or less;
5. Be able to access the study's online questionnaire.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Known allergy or hypersensitivity to the study drug;
3. Patients at high risk of bleeding, defined by:

   1. Previous Intracranial hemorrhage,
   2. Ischemic stroke in the last 3 months,
   3. Anatomical vascular alteration of the central nervous system known, such as aneurysms or arteriovenous malformations,
   4. Malignant neoplasm of the central nervous system known,
   5. Metastatic solid neoplasia,
   6. Significant closed head or facial trauma in the last 3 months (defined as any trauma that required medical evaluation or hospitalization),
   7. Known intracranial abnormalities not listed as absolute contraindications (e.g., benign intracranial tumor),
   8. Bleeding in the last 2 to 4 weeks (excluding menstrual bleeding),
   9. Surgical procedure in the last 3 weeks,
   10. Current use of full-dose anticoagulants (warfarin, enoxaparin or new anticoagulants) or dual antiplatelet therapy,
   11. Thrombocytopenia (\<100,000/mL) or international normalized ratio (INR) \> 1.3;
4. Renal failure, defined as glomerular filtration rate (GFR) estimated by the formulas Modification of Diet in Renal Disease (MDRD) or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) \<30 mL/min/1.73m2;
5. Previous participation in the study;
6. History of liver disease (cirrhosis) reported by the patient or in medical records, presence of esophageal varices or presence of ascites;
7. Decompensated heart failure, defined by the presence of dyspnea attributed to cardiac cause, edema of the lower limbs, crackles on pulmonary auscultation or pathological jugular turgency.
8. Participation in other clinical trials with antivirals in COVID-19
A Phase III Clinical Trail to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection

The goal of this clinical trial is to compare the efficacy and safety of GR2001 injection with Human Tetanus Immunoglobulin(HTIG) in tetanus prophylaxis. Patients will receive either GR2001 injection or HTIG on study D0.


Eligibility Criteria:
Inclusion Criteria:

1. Chinese male or female adults aged ≥ 18 years；
2. Participants with suspected tetanus exposure (due to dirty or contaminated wounds from various injuries);
3. Participants who provide signed written informed consent form.

Exclusion Criteria:

1. Participants known to be allergic to the investigational medicinal product or those suffering from severe allergic conditions；
2. Suspect or diagnosed as tetanus;
3. Previously diagnosed as Immunoglobulin A (IgA) deficiency with anti-IgA antibodies；
4. Prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine;
5. Females who are pregnant or with pregnancy test positive.