cyrilzakka/clinical-trials huggingface dataset:
Hospitalization at Home of Elderly Patients With Exacerbated COPD

Aim of the study was to evaluate the efficacy of hospital-at-home treatment compared with inpatient care in selected elderly patients with acute exacerbation of chronic obstructive pulmonary disease (COPD).

A total of 104 patients with an exacerbation of chronic obstructive pulmonary disease (COPD) selected from the Emergency Department (ED) of the hospital were randomized to home treatment from a Geriatric Home Hospitalization Service (GHHS) or to General Medical Ward (GMW).

The sample size estimation was performed according to the increasing 1-year (June 2002-May 2003) incidence of COPD exacerbation in hospital at home. On this basis, al least 100 patients needed to be included in the study to allow to detect a 20% difference in the endpoint hospital iatrogenic diseases, with a statistical significance  = 0.05 and a power 1-  = 0.8 using a two-sided test.

This study is considered a single-blind study because patients were aware of the treatment assignment while physicians and nurses evaluating patients were blinded to the patient's allocation.

In the ED all patients underwent baseline standard clinical evaluation; blood tests (blood cell count, routine biochemical tests and arterial blood gas tensions); pulse oximetry; 12-lead electrocardiography; chest radiographs and hand-held spirometry (SpirHOMEter, COSMED, Italy). Further investigations (including pneumologist's assessment) were performed when required, according to the clinical judgement of the ED physician. Only patients with a COPD exacerbation evaluated in ED for at least 12-24 hours and with stable clinical conditions were considered elegible to be included in the study.

Additional exclusion criteria were: 1) living outside the hospital catchment area; 2) absence of family and social support; 3) absence of informed consent; 4) necessity of intensive monitoring or mechanical ventilation; 5) history of dementia; 6) severe renal or hepatic failure; 7) cancer.

Patients fullfilling inclusion criteria were informed about the nature of the study and asked to give their informed consent. Extensive information was also provided to patients' relatives to obtain their collaboration. Patients fullfilling the inclusion criteria and having none of the criteria for exclusion were randomised, using a set of computer-generated random numbers, in a 1:1 ratio either to the treatment group (home-based hospitalization (GHHS)) or to the control group (conventional care (GMW)), using blinded sealed envelopes. Intention-to-treat analysis was used.

Eligibility Criteria:
Inclusion Criteria:

* Exacerbation of COPD
* Age \>= 75 years
* Living in hospital catchment area
* Informed consent
* Adequate social or familial support

Exclusion Criteria:

* Patients requiring assisted ventilation or intensive monitoring
* History of dementia
* Severe renal or hepatic failure
* Cancer
The Effects of Broccoli Sprout Extract on Obstructive Lung Disease

The purpose of this study is to examine whether broccoli sprout extract can effect lung function measurements in individuals with asthma and COPD.

Asthma afflicts 23 million people, results in nearly 13 million ambulatory physician encounters, and 440,000 hospitalizations annually. The economic burden for 2010 is estimated to run $20.7 billion.

Although steroids are the mainstay of treatment, they do not "cure" the disease. While inflammation may be the inciting factor, other mechanisms must play a crucial role in this process. Elevated oxidative stress could cause the kind of chronic inflammation associated with asthma, and could provide an explanation for recurrent asthma attacks. Cigarette smoke, both primary and secondary exposure, worsens the oxidative stress balance in the airways. Thus, the continuing focus on simply treating the inflammation is a barrier to progress. It is critical to examine other factors, such as abnormal oxidative stress through specific pathways that may affect airway inflammation and asthma attacks.

One compound, that repairs oxidative stress pathways, is sulforaphane, a food compound found in vegetables, including broccoli sprouts. Preliminary data demonstrate that broccoli sprout extract (BSE), rich in sulforaphane, improves airflow measures in asthmatics.

We plan to examine whether the airflow abnormalities in asthma, and the exacerbation from cigarette smoke, can be prevented by the administration of BSE, and determine the primary inflammatory and oxidative stress signaling pathways involved in the protection provided by BSE.

Eligibility Criteria:
Inclusion Criteria:

* asthma
* COPD

Exclusion Criteria:

* currently on chronic oral steroid medications
* current respiratory symptoms
* pregnant
* FEV1 less than 40% predicted at baseline
* extreme degrees of bronchial hyperreactivity
* recent respiratory infection (\<3 weeks)
* unstable symptoms in the prior month
* a history of intubation for respiratory symptoms within the past year
* any history of cardiac disease.
Burden of Respiratory Syncytial Virus (RSV) in the United Kingdom From 1995 to 2009

The study will assess the burden of RSV-attributable general practice consultations, hosptializations, and deaths by age and risk group in in United Kingdom from 1995 to 2009.

This epidemiological study is based on an already existing database of time series regression modeling outputs generated during the generated by EPI-FLU-018 BOD UK DB (116273) study, which estimated the burden of influenza in terms of General Practitioner (GP) consultations, hospitalizations, and deaths associated with various respiratory and non-respiratory outcomes.

Eligibility Criteria:
Inclusion Criteria:

• Included in the EPI-FLU-018 BOD UK DB BOD UK DB (eTrack: 116273) study database. The inclusion criterion for EPI-FLU-018 was registration with an acceptable flag in the CPRD, or registration in the HES database or the ONS mortality data with a flu-related event.

Exclusion Criteria:

• Not Applicable
A Study to Evaluate SGB-3403 in Healthy Volunteers and Subjects With Elevated Low-Density Lipoprotein Cholesterol (LDL-C)

This study is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending doses (MAD) of SGB-3403 when single administered subcutaneously to healthy volunteers and multiple administered subcutaneously to subjects with elevated LDL-C to evaluate the safety, tolerance, PK, and PD.

This study is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending doses (MAD) of SGB-3403 when single administered subcutaneously to healthy volunteers and multiple administered subcutaneously to subjects with elevated LDL-C. The study will be performed in 2 phases: SAD and MAD.

Eligibility Criteria:
Inclusion Criteria in SAD:

* Male and female subjects aged 18 to 55 years are included.
* Body mass index between 19 and 32 kg/m2, inclusive.
* Physical examination, vital signs, 12-lead electrocardiogram, and laboratory tests will be normal or slightly abnormal but not clinically significant according to the Investigator's judgment.
* Willing to comply with the protocol required visit schedule and visit requirements and provide written informed consent.

Exclusion Criteria in SAD:

* An underlying known disease or surgical or medical condition that, in the opinion of the Investigator, might interfere with the interpretation of the clinical study results.
* The positive result of hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus (HIV) antibody, or syphilis at screening.
* Alanine aminotransferase (ALT), total bilirubin (TBIL), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or gamma-glutamyl transferase (GGT) \> 1.5 × ULN (upper limit of normal).
* Serum creatinine exceeds the upper limit of normal at screening.
* History of multiple drug allergies or allergic reactions to an oligonucleotide or N acetylgalactosamine (GalNAc).
* History of intolerance to subcutaneous (SC) injection or relevant abdominal scarring (surgical, burns, etc.)
* Received an investigational agent within 28 days or 5 half-lives (whichever is longer) before the first dose of the study drug or are in another clinical study, received INCLISIRAN within 1 year.
* Use any Chinese herbs, vitamins, or supplements known to affect lipid metabolism (e.g., fish oil \> 1000 mg/ day, medicines, or health products containing red yeast rice) within 28 days before receiving the test drug.
* Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject's participation in or completion of the study.

Inclusion Criteria in MAD:

* Male and female subjects aged 18 to 65 years are included.
* Body mass index between 19 and 35 kg/m2, inclusive.
* Serum LDL-C ≥ 2.6mmol/L (≤ 100 mg/dL) and ≤ 4.9 mmol/L (≤ 190 mg/dL) at screening.
* Fasting triglyceride \< 4.52 mmol/L (\< 400 mg/dL) at screening.
Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy

Effects of VEGF Trap-Eye (aflibercept) in treatment-naive polypoidal choroidal vasculopathy (PCV) will be evaluated.

Efficacy of VEGF Trap-Eye (aflibercept, Eylea) for exudative age-related macular degeneration (AMD) was demonstrated in the phase III VIEW study. Polypoidal choroidal vasculopathy (PCV) is considered as a subtype of exudative AMD, however it is reportedly different from choroidal new vessels based on the histologic studies. The aim of this study is to evaluate effects of VEGF Trap-Eye in treatment of PCV, which was diagnosed using indocyanine green (ICG) angiography. VEGF Trap-Eye will be injected intravitreally bimonthly after 3 monthly loading dose for 12 months in treatment-naive PCV patients. The efficacy will be evaluated on preserving visual acuity and improving angiographic features at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Submacular PCV diagnosed using ICG angiography with no previous treatment (branching vascular network with or without polypoidal dilation in ICG angiography)
* Presence of signs of recent activity of PCV

  1. Visual acuity between 20/40 and 20/320
  2. Active leakage in fluorescein angiography
  3. Presence of any fluid in OCT(optical coherence tomography)-intraretinal, subretinal, sub-retinal pigment epithelial

Exclusion Criteria:

1. Extramacular PCV
2. Subretinal hemorrhage or other retinal lesions blocking angiographic characteristics in more than 50% area of PCV lesion.
3. Previous treatment of intravitreal injections (anti-VEGF, steroid or other agents)
4. Previous treatment of photodynamic therapy
5. Previous ocular surgery except cataract surgery before 3 or more months
6. Presence of exudative AMD in the other eyes requiring anti-VEGF treatment (Intravitreal bevacizumab was reported to affect the other eye.)
7. Presence of other ocular diseases which may affect visual acuity (glaucoma, cataract with opacity involving visual axis, etc)
8. Presence of uncontrolled systemic disease (diabetes mellitus, hypertension, ischemic heart disease, cerebral infarction, etc)
9. Patients who cannot understand or conform to the study protocol.
10. Patients who refuse to agree to the informed consent.
11. Patients with contraindication to aflibercept

    * Ocular or periocular infection
    * Active severe intraocular inflammation
    * Known hypersensitivity to aflibercept or to any of the excipients
Registry of Aortic Valve Bioprostheses Established by Catheter

The aim of this registry is to evaluate the overall survival up to 10 years of patients with aortic valve bioprostheses implanted via the transarterial or transapical route. Data from the register is enhanced by matching it with continuous data in the SNDS.

Mandated by the French health authorities, this registry must be maintained as part of the management of any patient undergoing transarterial or transapical aortic valve bioprosthesis implantation.

Participation in the registry is offered to all subjects eligible for bioprosthesis implantation.

Aortic valve stenosis is a serious chronic life-threatening in the short or medium term since the onset of functional symptoms. Aortic valve replacement surgery is currently the treatment of choice. It is done by surgery with sternotomy and extracorporeal circulation. However, despite the considerable improvement of the conditions of care per and post operative, this procedure is sometimes burdened with high mortality, especially in the population with severe co-morbidities and / or many. For this reason, some patients are considered against the indicated surgery or high surgical risk.

The recent development of aortic valve bioprostheses implanted with new approaches (pressure or transapical) can be considered for aortic valve replacement in a population that was previously excluded.

Based on very thorough evaluation of these valves test benches and animal as well as human settlements achieved through multiple studies and registries mono or multi patients challenged by cardiac surgeons or considered at high surgical risk, it is clear that the implementation of these valves could allow, under conditions of optimal implementation and monitoring, improve short-and long-term clinical status, quality of life and prognosis of patients.

FRANCE 2 registry, established in 2010, and whose inclusions ended 30 June 2012 has allowed an initial assessment of aortic valve bioprostheses implanted catheter The following registry France 2 has been requested by the highest authorities of health, FRANCE register TAVI is performed in continuity FRANCE 2. It takes account of the first data FRANCE 2. Data Report Form has been reduced, no new item has been added, it will be carried out in all centers authorized in France to implement this technique. The collection of data will TAVI France under the same conditions as those FRANCE 2, the database will be managed by the French Society of Cardiology

Eligibility Criteria:
Inclusion Criteria: Patients who have undergone transarterial or transapical aortic valve bioprosthesis implantation

Exclusion Criteria: Patient has not given consent
Allopurinol in Functional Impairment (ALFIE) Trial: 'Improving Muscle Strength'

Sarcopenia is defined as the presence of low muscle mass and either decreased muscle strength or function. It is increasingly becoming a significant cause of frailty, loss of independence and physical disability in ageing western populations. Recent experimental evidence has revealed that skeletal muscle is particularly susceptible to damaging molecules that result in oxidative stress and that oxidative stress plays a prominent role in the development and progression of sarcopenia. The investigators have previously shown that the xanthine oxidase inhibitor allopurinol is able to abolish vascular oxidative stress and improve endothelial function in cohorts such as optimally treated chronic heart failure and chronic kidney disease. Recently, the investigators have also shown that allopurinol improves exercise tolerance and time to ST-depression in optimally treated coronary artery disease, suggesting that allopurinol could also exert its effects through ATP and/or oxygen sparing mechanisms.

Therefore, we propose a randomised double blind placebo-controlled parallel group trial of allopurinol in patients with primary sarcopenia using MR-spectroscopy and Flow Mediated Dilatation to investigate the possible mechanisms that underlie this exciting possibility

this section will be completed once the study is officially recruiting

Eligibility Criteria:
Inclusion Criteria:

Age 65 and over 6-Minute Walk Distance \<400m

Exclusion Criteria:

Documented history of peripheral arterial disease. Pre-existing diagnosis of severe heart failure (LVEF\<35%). Malignancy under active treatment (excluding basal cell carcinoma). Severe COPD (Physician diagnosis). Intolerance to allopurinol. Individuals with Active Acute Gout currently taking allopurinol; or those who have stopped taking allopurinol ≤1month previously for this condition.

On long term high dose steroids (eq. Prednisolone\>10mg/day due to risk of steroid induced myopathy and osteoporosis).

Immobility that would render the patient incapable of doing the Short Physical Performance Battery Test (SPPB) or 6MWT.

Patients who have participated in any other clinical drug trial within the previous 30 days will be excluded.

Cognitive impairment precluding informed consent. Any other considered by a study physician to be inappropriate for inclusion.
A Safety and Efficacy Study of INC280 Alone, and in Combination With Erlotinib, Compared to Chemotherapy, in Advanced/Metastatic Non-small Cell Lung Cancer Patients With EGFR Mutation and cMET Amplification

The purpose of this study was to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) of INC280 in combination with erlotinib in the Phase Ib of this study, and to assess the anti-tumor activity and safety of INC280 alone, and in combination with erlotinib, versus platinum with pemetrexed in the Phase II of this study, in adult patients with EGFR mutated, cMET amplified, advanced/metastatic non-small cell lung cancer with acquired resistance to prior EGFR TKI.

The decision was taken to halt study enrollment with Cohort #3 in Phase Ib. Therefore, activities for the planned Phase II were not initiated.

This decision to stop further development of this combination was taken due to the challenge for enrollment in this very rare patient population along with the rapidly evolving disease landscape setting.

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic NSCLC
* EGFR mutation (L858R and /or ex19del)
* cMET amplification by FISH (GCN ≥ 6),
* Acquired resistance to EGFR TKI (1st or 2nd generation)
* ECOG performance status (PS) ≤ 1.

Exclusion Criteria:

* Prior treatment with 3rd generation TKI
* PhaseII : Prior treatment with any of the following agents:

  * Crizotinib, or any other cMET inhibitor or HGF-targeting inhibitor.
  * Concomitant EGFR TKI and platinum based chemotherapy as first line regimen.
  * Platinum-based chemotherapy as first line treatment
Desidustat in the Management of COVID-19 Patients

This study is a Phase 2b, Multicenter, Open-label, Randomized, Comparator- Controlled Study to Evaluate the Efficacy and Safety of Desidustat Tablet for the Management of mild, moderate and severe COVID-19 patients. 100 mg of Desidustat will be administered for a period of 14 days along with recommended standard care during the trial.

This is a phase 2b, multicenter, open-label, randomized, comparator-controlled clinical trial to evaluate the efficacy and safety of Desidustat for the management of COVID-19 patients. First 12 mild to moderate subjects (Test arm: Desidustat + Standard of care arm, 06 subjects and Reference arm: Standard of care, 06 subjects) will be enrolled in the study and after evaluation of safety of these 12 subjects by Data Monitoring Committee other 12 severe subjects (Test arm: Desidustat + Standard of care arm, 06 subjects and Reference arm: Standard of care arm, 06 subjects) will be enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to comprehend and willingness to sign a written ICF by the subject/impartial witness.
2. Male and Females, age ≥18 years at enrollment.
3. Understands and agrees to comply with planned study procedures.
4. Agrees to the collection of pharyngeal swabs and blood sample as per protocol.
5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen within one week.
6. Illness of any duration, and at least one of the following:

   1. Radiographic infiltrates by imaging (chest x-ray)
   2. Clinical assessment (evidence of rales/crackles or other clinical symptoms on exam).
7. Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site).

Exclusion Criteria:

1. ALT/AST \>5 times the upper limit of normal.
2. Stage V CKD (i.e. eGFR \<15 ml/min/1.73 m2 or requiring dialysis).
3. Pregnant or breast feeding.
4. Severe co-morbidity (e.g. uncontrolled hypertension and uncontrolled DM, systemic disease which affect the vital organs severity, immunocompromised patients etc.) as per investigator's assessment.
5. Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment.
6. Prolong QT interval (\>450 ms).
7. Patients on invasive mechanical ventilation.
Telephone Counseling or Standard Care in Patients Who Have Completed Treatment for Stages I, II, or III Cervical Cancer

RATIONALE: Telephone counseling after treatment may reduce stress and improve the well-being and quality of life of patients who have cervical cancer. Changes in quality of life may be related to changes in immune function and neuroendocrine function.

PURPOSE: This randomized phase I trial is studying how well telephone counseling works compared to standard care in reducing stress in patients who have completed treatment for stage I, stage II, or stage III cervical cancer.

OBJECTIVES:

* Compare quality of life (QOL) at baseline and changes in QOL, immune response, and neuroendocrine parameters over time in patients who have completed treatment for stage I-III cervical cancer receiving psychosocial telephone counseling vs usual care.
* Correlate psychosocial measures with immunologic stance.

OUTLINE: This is a randomized, controlled, parallel-group study. Patients are randomized to 1 of 2 intervention arms.

* Arm I: Patients undergo psychosocial telephone counseling comprising 5 weekly sessions and a 1-month follow-up session to learn strategies for reducing stress.
* Arm II: Patients undergo usual care for approximately 4 months. All patients complete questionnaires and Quality of life assessment at baseline and at 4 months. They also undergo saliva and blood sample collections at baseline and at 4 months for neuroimmune studies.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility Criteria:
INCLUSION CRITERIA

Disease Characteristics:

* Diagnosis of cervical cancer between the past 3-15 months

  * Stage I-III disease
* Completed therapy for cervical cancer ≥ 1 month ago

  * Not receiving ongoing treatment
* More than 4 weeks since prior immunotherapy
* More than 30 days since prior investigational drugs
* No prior biological response modifier
* No concurrent corticosteroids
* No concurrent immunosuppressive therapy

Patient Characteristics:

* Resident of Orange, San Diego, or Imperial County in California
* English or Spanish speaking
* No serious acute or chronic illness
* Has access to a telephone

EXCLUSION CRITERIA

Disease Characteristics:

* Stage IV cervical carcinoma
* Have undergone previous treatment with a biological response modifier (inferferons, interleukins) or prior immunotherapy within four weeks of study enrollment
* Used investigational drugs within 30 days of execution of the informed consent
* Required corticosteroids or were under immune suppression for any reason including an organ allograft or HIV infection
* Patients with metastatic disease or ongoing treatment
* Any acute or chronic illness, including autoimmune states, as judged clinically significant by the investigators

Patient Characteristics:

* Non-English or Spanish speakers