cyrilzakka/clinical-trials huggingface dataset:
Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors

Many cancer survivors are at risk for cardiovascular disease (CVD); it is therefore important to identify patients at increased risk for cardiotoxicity, especially in the setting of CVRF or pre-existing CVD, and to design personalized interventions to prevent cardiovascular morbidity. In this background, cardio-oncology rehabilitation frameworks for specific cancer patients have been proposed. Given potential beneficial effects of exercise among cancer patients (including those at higher risk of CVD), data pertaining to optimal program designs are of paramount contemporary importance.

Thus, the aim of this study is to compare the impact of a Cardiac Rehabilitation Program (CRP) model versus a community-based exercise intervention plus usual care on cardiorespiratory fitness (CRF), physical function domains and CVRF control in adult cancer survivors who have been exposed to cardiotoxic cancer treatment and/or with cardiovascular medical background. Study outcomes will be assessed at baseline (M0) and after an 8 weeks-intervention (M1), comprising maximal aerobic capacity (peak oxygen uptake), muscular strength, neuromuscular function, single CVRF control including physical activity measurements and psychosocial parameters, health-related quality of life, fatigue, health literacy, inflammatory response and feasibility metrics; an economic evaluation will provide quantitative comparison, for a cost-effectiveness analysis


Eligibility Criteria:
Inclusion criteria:

* Age \>18 years
* Cancer survivors exposed to the following therapies:

  * high-dose anthracycline or high dose radiotherapy in thoracic wall
  * low-dose anthracycline or anti-human Epidermal growth factor Receptor-type 2 drugs (anti-HER2) alone plus ≥ 2 CVRF and / or age ≥ 60 years at cancer treatment
  * low-dose anthracycline followed by anti-HER2;
* Cancer survivors with medical background of

  * coronary artery disease
  * moderate valvular disease
  * LVEF \<50%
* Follow up after primary treatment with curative intent
* Conclusion of primary treatment at least 2 months before the inclusion

Exclusion criteria:

* Previous participation in a CRP
* Contraindications to exercise training:

  * musculoskeletal or neurologic disorders, cognitive impairment
  * unstable angor pectoris, decompensated HF, active myocarditis, acute endocarditis, acute pulmonary thromboembolism, complex ventricular arrhythmias
* Active cancer
* Considered unsuitable as per principal investigator judgment (namely due to expected inability to fulfill proposed schedule)
Digital Community to Improve Health in Rural Areas

The study is a cluster randomized controlled trial developed in counties located in Appalachia and the Midwest. We will prioritize counties from states with high risk for HIV and HCV infection associated with injection drug use.

The study will randomize clusters with groups of participants to an intervention or a standard of care condition.

Eligibility Criteria:
Inclusion Criteria:

* Lives in target zip codes
* Half not using illicit substances (not including marijuana) currently or in the past
* Half using illicit substances (not including marijuana) currently or in the past

Exclusion Criteria:

* Under the age of 18
* Not in target zip codes
Successful Extubation and Noninvasive Ventilation in Preterm ≤ 1500g Terms

Noninvasive ventilation has been used in preterm newborn with respiratory distress syndrome in an attempt to assist failure extubation. The investigators investigated failure extubation in infants gestational age less than or equal to 34 weeks and weights less than or equal to 1500 grams. Neonates were randomized to noninvasive modalities support. 101 newborns were included in this study in three groups , group 1: Nasal Intermittent Positive Pressure Ventilation (NIPPV) (n=36), group 2: Nasal Continuous Positive Airway Pressure Bubble (NCPAP bubble) (n=33) and group 3: Nasal Continuous Positive Airway Pressure Bubble Ventilator (NCPAP ventilator) (n=32)

The infants were randomly allocated after extubation used a list of computer-generated randomization in NIPPV modes (with the following settings: positive inspiratory pressure (PIP) \< 16 centimeters of water (cm H2O), positive end-expiratory pressure (PEEP) 4-5 centimeters of water (cm H2O, backup respiratory rate (RR) \< 18 cycles per minute flow 6-7 liters per minute (L / min) and inspiratory time (TI) according to the time constant for idae (0.30 to 0.34 seconds), and respirator seal to NCPAP water tower was adjusted to 4-5 centimeters of water (cm H2O) PEEP, flow 6-7 liters per minute (L / Min.) oxygen for both was adjusted to maintain arterial oxygen saturation between 85-95%

The criteria for extubation were defined using a protocol by the clinic staff, confirmed by arterial blood gases and chest X-ray, as well as adjustments of the ventilator settings.

Vital signs, blood gas parameters and noninvasive brackets were recorded before, immediately, 15, 30, 45 minutes, 1(hour) h, 2h, 12h, 24h and 48 h after extubation were documented.

Neonatal morbidities were documented until discharge, among these are: patent ductus arterious, necrotizing enterocolitis, retinopathy of prematurity, intracranial hemorrhage and pneumothorax.

Data on achievement of prenatal, antenatal steroids and surfactant administration were documented. All newborns were natural porcine surfactant Curosurf®.

The total duration of mechanical ventilation and oxygen were documented from birth until discharge or death. The supplemental oxygen or mechanical ventilation days was defined as daily requirement of fraction of inspired oxygen (FiO 2)\> 0.21 or ventilation \> 12 hours, respectively.

The newborns were followed for all interaction until discharge (about 5 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Were eligible for the study
* Newborn (NB) ≤ 34 weeks and 500g to the weight of ≤ 1500 grams with a diagnosis of respiratory distress syndrome (RDS) who had their first elective extubation.

Exclusion Criteria:

* Excluded patients with cardiorespiratory system malformations
* Genetic disorders
* Neuromuscular disease and malformations of the central nervous system.
Evaluate the Safety, Tolerability, and Efficacy of ICP-490 in Patients with Relapsed or Refractory Non-Hodgkin Lymphoma

This is a multi-center, non-randomized and open-label phase I/IIa clinical study to evaluate the safety, tolerability, and efficacy of ICP-490 in patients with relapsed or refractory non-hodgkin lymphoma.


Eligibility Criteria:
Inclusion Criteria

1. Aged ≥ 18 years old.
2. Diagnosed as relapsed or refractory non-hodgkin lymphoma .
3. The patient must have measurable diseases.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.
5. Patients must have adequate organ function.
6. Expected survival time ≥ 3 months.
7. All toxicities caused by prior anticancer therapy must have recovered to Grade ≤ 1 (based on CTCAE v5.0) except alopecia and fatigue.
8. Female patients of childbearing potential should have a negative blood pregnancy test result within 48 h prior to the first dose of investigational drug.
9. Male or Female of reproductive age must use contraception from 28 days before the first dose until at least 6 months after the last dose of the study drug.

Exclusion Criteria

1. Known active central nervous system (CNS) involvement Lymphoma.
2. Excludes other active malignancies within 3 years before first dose, except locally curable cancers after radical treatment.
3. Uncontrolled or severe cardiovascular disorders.
4. Presence or history of clinically significant CNS diseases.
5. Any active infection requiring intravenous infusion for systemic treatment within 14 days prior to the first dose of the study drug.
6. Presence or history existence of diseases restricted by the protocol.
7. Major surgery within 28 days before first dose.
8. Any serious or uncontrolled systemic disease that the investigator believes may increase the risk associated with participating in the study or the administration of the study drug, or may affect the patient's ability to receive the study drug.
9. Patients who have received medications or foods with strong inhibitory or inductive effects on cytochrome P450 CYP3A, and proton pump inhibitors within 2 weeks prior to the first dose of investigational drug, or who are planning to receive proton pump inhibitors during the study.
10. Patients with a history of intolerance to thalidomide, lenalidomide, or any component contained in the formulation of the investigational drug.
Feasibility Study of Renal Denervation for the Treatment of Resistant Hypertension

The aim of this study is to assess the potential therapeutic benefit of catheter-based renal sympathetic denervation using therapeutic unfocussed ultrasound in a single-arm feasibility trial.


Eligibility Criteria:
Inclusion Criteria:

* Uncontrolled hypertension (defined as SBP ≥ 140 mmHg during 24Hr Ambulatory BP monitoring)
* Current treatment with ≥ 3 anti-hypertensive drugs (including at least one diuretic)
* Renal artery diameter ≥5mm by digital angiography
* Accessibility of renal vasculature

Exclusion Criteria:

* Estimated GFR \< 45
* Type 1 Diabetes
* Known renovascular abnormalities (eg, renal artery stenosis, previous renal artery stenting or angioplasty)
The Effects of tDCS on Illness Awareness in Schizophrenia

This is a novel study that seeks to explore the clinical and functional imaging effects of transcranial direct current stimulation (tDCS) on illness awareness or anosognosia in schizophrenia, arguably the most treatment-resistant manifestation of the disorder.

Transcranial DCS is a novel, non-invasive and non-convulsive technique for altering brain function. To our knowledge, no research has investigated the functional and behavioural effects of tDCS on anosognosia in schizophrenia. As such, we aim to improve impaired illness awareness in schizophrenia with tDCS by inhibiting left hemisphere regions (i.e. temporoparietooccipital cortex) shown by our group to be activated during illness denial.

Positive results will demonstrate that impaired illness awareness in schizophrenia involves a similar brain network to impaired illness awareness in patients with brain lesions and can be similarly modulated with non-invasive techniques, such as tDCS. If proven effective, this easy to administer, safe, non-invasive intervention would have the potential to alter individuals' attitude towards their illness and medication, leading ultimately to an improvement in individuals' capacity for illness recognition and treatment engagement, which would undoubtedly have a significant impact on the management of this devastating mental disorder.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female inpatients or outpatients ≥ 18 years of age
2. Having a DSM-IV diagnosis of schizophrenia or schizoaffective disorder
3. Voluntary and capable of consenting to participation in the research study
4. Fluent in English
5. Moderate-to-severe lack of illness awareness (≥3 on PANSS G12 Insight and Judgment item)
6. On a stable dose of antipsychotic and other concomitant medications, and unlikely to undergo changes in dose during the study

Exclusion Criteria:

1. Serious unstable medical illness or any concomitant major medical or neurological illness, including a history of seizures or a first degree relative with a history of a seizure disorder
2. Acute suicidal and/or homicidal ideation
3. Formal thought disorder rating of over 2 on the (Scale for Assessment of Positive Symptoms) SAPS.
4. DSM-IV substance dependence (except caffeine and nicotine) within one month prior to entering the study
5. Pregnant women
6. Mild lack of insight to good illness awareness (\<3 on PANSS G12 Insight and Judgment item).
7. Positive urine drug screen for drugs of abuse
8. Currently taking antiepileptics
9. Any contraindications to MRI (eg., metal implants that would preclude an MRI, claustrophobia)
10. Score \< 32 on the Wide Range Achievement Test-III (WRAT III)
Study of Biostate® in Children With Hemophilia A

The objective of this study is to assess the efficacy and safety of a Von Willebrand Factor/Factor VIII (VWF/FVIII), Biostate, and to investigate the pharmacokinetics of Biostate in children with haemophilia A.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects between 0 and \<12 years of age.
* Diagnosed with severe haemophilia A (FVIII:C \<1%), and pre-treated for a minimum of 20 to 50 exposure days.
* Have evidence of vaccination against hepatitis A and B (or presence of antibodies against hepatitis A and B due to either a previous infection or prior immunisation), as documented in the medical notes at enrolment.
* The subject and/or legal guardian understand(s) the nature of the study and has/have given written informed consent to participate in the study and is/are willing to comply with the protocol.

Exclusion Criteria:

* For all subjects at Day 1: Are actively bleeding.
* Have received an infusion of any FVIII product, cryoprecipitate, whole blood, plasma or desmopressin acetate in the 4 days prior to their dosing within the PK component.
* Have a known history of, or who are suspected of having FVIII inhibitors.
* Have received aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) within 7 days of administration of the IMP.
* Have an impaired liver function ie, bilirubin \>1.5 x upper limit of normal (ULN) and/or aspartate/alanine aminotransferase (AST/ALT) \>2.5 x ULN (referring to limits of the laboratory that performs the determination) at Screening.
* Are human immunodeficiency virus \[HIV\]-1/-2 antibody positive with a viral load of \>200/µL.
* Suffer from an acute or chronic medical condition, other than haemophilia A, which may, in the opinion of the Investigator, affect the conduct of the study.
* Suffering from von Willebrand disease (VWD) with von Willebrand factor: ristocetin cofactor (VWF:RCo) level \<50 IU/dL at Screening.
* Have a known or suspected hypersensitivity or previous evidence of severe side effects to a plasma-derived FVIII product or to human albumin.
* Have participated in a clinical study or used an investigational compound in another study (eg, a new chemical entity not registered for clinical use) in the 3 months preceding the first day of IMP administration, or are planning to enter such a study during the study period.
* Unwillingness and/or inability to comply with the study requirements.
Role of Fexofenadine in Diabetic Kidney Disease

* This study will that will be conducted on 60 outpatients previously diagnosed with type 2 diabetes mellitus.
* Patients will be recruited from Internal Medicine Department, Tanta University Hospital, Tanta, Egypt.

This study will be randomized, controlled, parallel, prospective clinical study. Accepted patients will be randomized into 2 groups as the following

* Group 1 (Control group): 30 patients will receive maximum tolerated dose of ACEI for six months
* Group 2 (Fexofenadine group): 30 patients will receive maximum tolerated dose of ACEI plus fexofenadine tablets 60 mg once daily for six months

The primary end point will be the change in Urinary albumin to creatinine ratio (UACR) after six months of treatment


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged ≥ 18 years
* Confirmed diagnosis of Type 2 diabetes mellitus at least 6 months prior to screening
* Stage 2 and 3 diabetic nephropathy (persistent micro- or macroalbuminuria with urinary albumin creatinine ratio (UACR) \>30mg/g) despite treatment with maximum tolerated dose of ACE inhibitors for at least 8 weeks prior to the screening
* Hemoglobin A1c \> 6.5 % with regular use of insulin and/or oral glucose lowering agents

Exclusion Criteria:

* Type 1 diabetes mellitus
* Severe renal impairment (eGFR\< 30 mL/min/1.73 m2 at screening)
* Pregnant or lactating women
* Chronic heart failure
* Malignancy
* Inflammatory or autoimmune disease
* History of kidney disease other than diabetic nephropathy
Safety and Efficacy Study of Retreated Clevudine in Chronic HBV Patients Who Received Clevudine in L-FMAU-201

The purpose of this study is to determine the safety and antiviral activity of Clevudine, when retreated to patients previously treated with Clevudine


Eligibility Criteria:
Inclusion Criteria:

1. Patients who received clevudine in L-FMAU-201 clinical trial (phase IIb)
2. Female of childbearing potential must have a negative serum ( b-HCG) pregnancy test within 14 days of starting therapy.
3. Patient is able to give written informed consent prior to study start and to comply with the study requirements.
4. Patients who met the following criteria after completion of the Week 48 visit were to have additional follow-up visits at Weeks 54 and 60: 1) had received no additional therapy since completion of 24-week treatment of clevudine and 2)experienced a \> 1 log10 decrease from baseline in HBV DNA at Week 48

Exclusion Criteria:

1. HBV DNA negative (\< 4,700 copies/mL) consistently at the last 2 visit (at least 2 consecutive visits, at one month interval)
2. Patient is currently receiving antiviral immunomodulatory or corticosteroid therapy.
3. Patients previously treated with lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection after cessation of treatment in L-FMAU-201 study.
4. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
5. Patient is coinfected with HCV, HDV or HIV.
6. Patient with clinical evidence of cirrhosis or hepatocellular carcinoma (®-Fetoprotein) Evaluation will be based on alpha-fetoprotein primarily. If alpha-fetoprotein level is suggestive of cirrhosis or hepatocellular carcinoma, confirmation will be made with sonography etc.
7. Patient is pregnant or breast-feeding.
8. Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases. For males, condoms should be used. Females must be surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal or using at least a medically acceptable barrier method of contraception (i.e., IUD, barrier methods with spermicide or abstinence)
9. Patient has a clinically relevant history of abuse of alcohol or drugs.
10. Patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.
11. Patient has creatinine clearance less than 60mL/min as estimated by the following formula:

(140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo in 1 to 5 Year Old Patients With Persistent Asthma

The primary objective of this trial is to evaluate the safety and efficacy of two doses of tiotropium inhalation solution delivered via the Respimat® inhaler once daily in the afternoon in patients (1 to 5 years old) with persistent asthma on top of inhaled corticosteroid (ICS) treatment.


Eligibility Criteria:
Inclusion criteria:

1. All patients' parents (or legal guardians) must sign and date an informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in the trial. Where appropriate, participants should assent to enroll in the study.
2. Male or female patients between 1 and 5 years of age.
3. By a physician documented (at least 6 month) history of persistent asthma symptoms, including (but not limited to) wheezing, cough, and/or shortness of breath. (persistent = need for inhalation corticosteroid maintenance therapy to control asthma symptoms)
4. For patients aged 5 years and capable of performing technically acceptable Pulmonary Function tests (PFTs): documented impaired lung function (i.e. pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) is smaller or equal to 90% of predicted normal).
5. All patients must have been on maintenance treatment with an inhaled corticosteroid at stable dose, either as mono treatment or in combination with another controller medication, for at least 4 weeks before Visit 1.
6. All patients must be symptomatic (partly controlled) as defined by the Global Initiative for Asthma (GINA) guideline for children aged 5 years and younger in the week prior to Visit 1 (screening) and in the week prior to randomisation (Visit 2).

Further inclusion criteria apply.

Exclusion criteria:

1. Patients with a significant disease other than asthma.
2. Patients with clinically relevant abnormal screening haematology or blood chemistry will be excluded if the abnormality defines a significant disease as defined in exclusion criterion 1.
3. Patients with a history of congenital or acquired heart disease, or patients who have been hospitalised for cardiac syncope or failure during the past year.
4. Patients with any unstable or life-threatening cardiac arrhythmia, including cardiac arrhythmia requiring intervention (e.g. pacemaker implantation) or a change in drug therapy within the past year.
5. Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy.
6. Patients with clinically significant lung diseases other than asthma.
7. Alternative causes (other causes than asthma) that can lead to respiratory symptoms of wheeze, cough and shortness of breath.
8. Patients with known active tuberculosis.
9. Patients who have undergone thoracotomy with pulmonary resection.
10. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit (Visit 1).

Further exclusion criteria apply.