cyrilzakka/clinical-trials huggingface dataset:
A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)

The purpose of this study is to evaluate the efficacy and the safety of two doses of CHF6001 (Tanimilast) as add-on to maintenance triple therapy in the target patient population.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥ 40 years, with COPD and with chronic bronchitis.
* Current smokers or ex-smokers (history of ≥10 pack years).
* Post-bronchodilator FEV1 \<50% of the patient predicted normal value and FEV1/FVC ratio \< 0.7.
* At least, one moderate or severe COPD exacerbation in the previous year.
* CAT score ≥10.
* Subjects on regular maintenance triple therapy for at least 12 months prior to screening and receiving regular maintenance triple therapy for at least 3 months prior to screening visit.

Exclusion Criteria:

* Subjects with current asthma.
* Subjects with moderate or severe COPD exacerbation 4 weeks before study entry and randomisation
* Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD.
* Subjects with primary diagnosis of emphysema not related to COPD.
* Subjects with known respiratory disorders other than COPD.
* Subjects with lung volume reduction surgery.
* Subjects with active cancer or a history of lung cancer.
* Subjects under Roflumilast treatment within 6 months before study entry.
* Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation.
* Subjects with clinically significant cardiovascular condition.
* Subjects with neurological disease.
* Subjects with clinically significant laboratory abnormalities.
* Subjects with moderate or severe hepatic impairment.
Early Treatment of ARNI on Myocardial Remodeling and Progress

Myocardial remodeling following myocardial infarction (MI) is an important prognostic factor for heart function and adverse cardiovascular events, especially are intimately linked with heart failure. MI often causes deleterious changes in ventricular size, shape, and function. This adverse remodeling and progress is mediated by neurohormonal and hemodynamic alterations. The angiotensin receptor neprilysin inhibitor (ARNI) sacubitril/valsartan was shown to be superior to an ACE inhibitor in patients with heart failure with reduced ejection fraction (HF-REF), reduce the risk of both death (from cardiovascular and all-causes) and heart failure hospitalization, may be a new approach to the treatment of heart failure. However, the impact of early treatment of ARNI on myocardial remodeling and progress, and aerobic exercise capacity in patients with prior MI has yet to be assessed. The aim of this study is to evaluate the efficacy and the safety of early treatment of ARNI on myocardial remodeling and progress, and aerobic exercise capacity in patients following MI.

Myocardial remodeling following myocardial infarction (MI) is an important prognostic factor for heart function and adverse cardiovascular events. The angiotensin receptor neprilysin inhibitor (ARNI) sacubitril/valsartan was shown to reduce the risk of both death (from cardiovascular and all-causes) and heart failure hospitalization. However, whether early treatment of ARNI following post-MI could alter myocardial remodeling or aerobic exercise capacity has yet to be assessed. The patients with MI within one month were enrolled in the treatment of ARNI group or ACEI group. The study proposes to perform serial Cardiopulmonary Exercise Tests (CPET) to prospectively measure changes in aerobic exercise capacity in patients with prior myocardial infarction (MI), echocardiographic measures of LV end-diastolic/ systolic volumes, LV ejection fraction (LVEF), BNP and protein plasma levels, symptomatic heart failure, and life quality.

Eligibility Criteria:
Inclusion Criteria:

1. Acute myocardial infarction (AMI) within 1 months prior to recruitment;
2. Aged 18 years or over and under 80 years;
3. Randomized patients will have been hemodynamically stable, SBP ≥100mmHg, no symptomatic hypotension;
4. NYHA Class Ⅱ-Ⅳ, HFrEF or HFpEF;
5. Elevated NT-proBNP or BNP at the time of screening;
6. Peak VO2/kg\<16 ml/kg/min by CPET

Exclusion Criteria:

1. Inability to complete a CPET;
2. Symptomatic hypotension and/or systolic blood pressure \<100mmHg;
3. eGFR \< 30 mL/min/1.73m2 and/or serum potassium \>5.2mmol/L;
4. History of hypersensitivity or allergy to ACE-inhibitors/ARB
5. History of angioedema;
6. Pregnancy, planning pregnancy, or breast feeding;
7. Life-threatening diseases with limited life expectancy \<1 year
Infracyanine Green vs Brilliant Blue G in Macular Hole Inverted Flap Surgery: A Swept Source OCT Analysis.

This study will compare by swept-source optical coherence tomography (SS-OCT) the retinal morphology after inverted internal limiting membrane (I-ILM) flap vitreoretinal surgery for medium-to-large macular holes using infracyanine green (IFCG) vs brilliant blue G (BBG) dyeing. It is a single-center prospective, randomized study. One group of patients will undergo I-ILM vitrectomy with IFCG staining, the other vitrectomy with BBG staining. Postoperative twelve-month corrected distance visual acuity, macular hole closure rate, and SS-OCT parameters will be compared and statistically analyzed. The aim of the study is to verify if these parameters can be negatively affected by toxicity related to the use of one of the two dyes.

The purpose of this study is to compare by swept-source optical coherence tomography (SS-OCT) the retinal morphology after inverted internal limiting membrane flap (I-ILM) surgery for medium-to-large macular holes (FTMHs) using infracyanine green (IFCG) vs brilliant blue G (BBG). This prospective randomized study include 40 eyes with ≥ 400 µ idiopathic FTMH undergoing IFCG or BBG-stained I-ILM technique. Just before surgery, randomization is performed using the sealed-envelope technique, based on the patients' surgical chart number. The random allocation sequence is generated by the trial statistician pulling 41 standard-sized pieces of paper out of a hat. Twenty pieces of paper are marked with the Letter I, for IFCG, and 21 with the Letter B, for BBG. The trial statistician then sequentially puts each piece of paper into 41 sealed opaque envelopes. These envelopes are numbered 1 to 41 and given to the surgeons. Patients are numbered randomly from 1 to 41 based on a surgical chart number related to the baseline testing session and intervention period. Clinical data collection and measurement of outcome variables are performed by personnel masked to the randomization process and not been directly involved in the patients' surgery.

Eligibility Criteria:
Inclusion Criteria:

* Phakic or pseudophakic patients affected with medium to large idiopathic full thickness macular hole (FTMH), with a minimum preoperative diameter of 400 µ

Exclusion Criteria:

* Patients with chorioretinal diseases except FTMH, myopia \> 5 D, history of glaucoma, previous trauma or ocular surgery other than cataract extraction, or conditions affecting visual acuity except cataract.
Home Treatment of Patients With Pulmonary Embolism Based on Pro-Brain Natriuretic Peptide (BNP) Levels

The aim of this study is to investigate the safety of treatment of pulmonary embolism in an outpatient setting based on normal pro-BNP levels. The mortality rate and the incidence of hemodynamic instability as well as major bleeding and recurrent venous thromboembolism (VTE) in the outpatient group will be studied.

Pulmonary embolism is a major health problem. Because of risk for early hemodynamic instability and mortality, all patients with a recently diagnosed pulmonary embolism are treated in hospital. The clinical course of most patients is without complications. In practice most of the patients are only waiting in hospital in a good, clinical stable condition until their INR range is stable.

This prospective management study is to investigate the safety of treatment of pulmonary embolism in an outpatient setting based on normal pro-BNP levels (\< 500 pg/ml). The incidence of complications due to the pulmonary embolism or its treatment will be followed during the first ten days of treatment.

Eligibility Criteria:
Inclusion Criteria:

* outpatient with a pulmonary embolism, confirmed by locally approved guidelines
* aged 18 years and above
* written informed consent

Exclusion Criteria:

* hemodynamic or respiratory instability defined as one of the following; hypotension RR systolic\< 90 mmHg,pulse rate\> 100 bpm, need for oxygen therapy to maintain oxygen saturation above 90 %, collapse
* illness unrelated to PE for which the patient would require hospitalization
* pain requiring intravenous narcotics
* thrombolysis
* active bleeding or thrombopathy
* pregnancy
* in hospital patients
* physical or psychiatric inability for home treatment
* no support system at home renal insufficiency
A Study Evaluating Veliparib as a Single Agent or in Combination With Chemotherapy in Subjects With Solid Tumors

This is an extension study to evaluate the safety of Veliparib monotherapy or in combination with Carboplatin plus Paclitaxel or modified Folinic Acid/Fluorouracil/Irinotecan (FOLFIRI) in subjects with solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Must have confirmed solid malignancy that is metastatic, and standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective.
* For Veliparib monotherapy (must have tumor with defects in DNA repair mechanisms (BRCA mutation or high grade ovarian cancer or solid tumors for combination therapy.
* If the subject has known brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of Central Nervous System (CNS) disease progression as determined by comparing a computed tomography (CT) scan or magnetic resonance imaging (MRI) scan performed during screening to a prior scan performed at least 4 weeks earlier and provided that the subject is asymptomatic, has no evidence of cavitation or hemorrhage, and does not require corticosteroids (must have discontinued steroids at least 3 months prior to study drug administration).
* Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range.

Exclusion Criteria:

* Subject has a clinically significant and uncontrolled major medical condition(s) including but not limited to:
* Uncontrolled seizure disorder, including focal or generalized seizure within the last 12 months;
* Uncontrolled nausea/vomiting/diarrhea;
* Active uncontrolled infection;
* Symptomatic congestive heart failure;
* Unstable angina pectoris or cardiac arrhythmia;
* Psychiatric illness/social situation that would limit compliance with study requirements;
* Any medical condition, which in the opinion of the study investigator, places the subject at an unacceptably high risk for toxicities.
* Subjects who have hypersensitivity to Carboplatin, Paclitaxel or Cremophor should be excluded from arm B.
* Subject has received any of the following anti-cancer therapies 21 days prior to the first dose of study drug or a biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drug.
* Subject who requires parenteral nutrition, tube feeding or has evidence of a partial bowel obstruction or perforation within 28 days prior to study drug.
* The subject has had another active malignancy within the past 3 years except for any cancer in situ that the Principal Investigator considers to be cured.
Evaluation of Sarcopenia-Related Malnutrition in Older Adults

Sarcopenia and malnutrition are two geriatric syndromes that are frequently seen in the elderly and have multifactorial etiology and severe clinical effects. However, the results vary widely due to the many methods and criteria used in the diagnosis and prevalence rates of both syndromes. In this study, it is aimed to investigate the relationship between the GLIM (Global Leadership Initiative on Malnutrition) criteria and various sarcopenia levels, which are newly defined worldwide and have the widest spectrum so far in describing malnutrition.


Eligibility Criteria:
Inclusion Criteria:

* To get a score of 21 and above in the Mini-Mental State Examination
* To be able to walk independently or with the help of a device (cane, etc.)

Exclusion Criteria:

* Individuals with a serious orthopedic (advanced hip or knee arthrosis, etc.) or neurologic conditions that may affect ambulation
A Study to Investigate the Effect of Concord Grape Juice on Cognitive Function in Mums of Preteen Children

There is some evidence that polyphenols can affect cognitive function. Therefore, consumption of polyphenols has the potential to prevent cognitive impairment or even enhance cognitive performance. The objective of this study is to investigate the effect of polyphenol consumption served in the form of Concord Grape Juice (CGJ) on cognitive performance and driving performance in Mums.

The study design will be a repeated measures, double-blind, randomised, placebo controlled, crossover study. There will be 2 conditions; CGJ and a placebo drink. 20 participants will undergo two 12 week dietary interventions which will entail daily consumption of a 12oz serving of CGJ or placebo in a counterbalanced manner. There will be a 4 week washout period between conditions. At baseline, 6, and 12 weeks of each 12-week treatment arm cognitive performance and driving performance will be assessed (using the driving simulator at the Institute for Transport Studies). CGJ is a common ingredient in commercially available products.

Mums will be defined as mothers of pre-teen children (aged under 13 years) who are aged 40-50. This population generally have hectic and stressful lifestyles and therefore there is potential for this population to receive cognitive benefit from polyphenol consumption.


Eligibility Criteria:
Inclusion Criteria:

* BMI within normal/overweight range (18 - 29 kg/m2)
* Non-smokers or given up more than 6 months ago
* Working 80% of a full time week (at least 30 hours/week)
* Ability to adequately understand verbal and written information in English
* Full Driving Licence held for at least 5 years
* Mothers of pre-teen children (must have child aged \<13 years)
* Willing to abstain from drinking red wine and dark fruit juices (e.g. other grape juices, cranberry, raspberry and pomegranate juices) during the study

Exclusion Criteria:

* Menopausal
* diabetes or known impaired glucose tolerance
* taking any regular medication e.g. for hypertension
* Food allergies to ingredients and food colouring of the drinks to be consumed within the study
* Night shift work
* Pregnant or planning a pregnancy within the next year
* Having been pregnant or lactating within the previous 6 months
* Vegetarian
* No history of, or current eating disorders
* Epilepsy (driving SIM exclusion criterion)
* Claustrophobia (driving SIM exclusion criterion)
Study on Gut Microbiota in Chronic HBV Infected Patients

Hepatitis B Virus(HBV) infection is a common infectious disease affecting up to 2 billion people worldwide. Around 650 thousand people died of liver failure, cirrhosis and primary liver cancer caused by chronic hepatitis B every year. Age is the main factor affecting the chronicity of hepatitis B, while 90% and 25% to 30% of hepatitis b virus(HBV) infection in perinatal and infant period will develop into chronic infection respectively. Whereas the proportion in patients above 5 years old is only 5% to 10%. Intestinal microbiota plays an important role in maintaining nomal physiological function of the intestine and the immune function of the body. It has been found that the disorder of intestinal microbiota is associated with numerous intestinal and parenteral diseases. Recently, the relationship between immune response and intestinal microbiota has been claimed. In a previous study using IMT to treat HBeAg positive chronic hepatits B patients combined with antiviral theraopy, 80% of them has reached HBeAg clearance. Increasing evidence suggests that the gut microbiota has evolved as a new important player in the pathogenesis of hepatitis B virus-induced chronic liver disease. However, the composition and structure alteration of the gut microbiota associated with the stage and progression of HBV infection remains unknown. Hence, we proposed a trial to detected gut microbiota of chronic HBV infected patients high-throughput 16S rRNA gene sequencing to elucidate the microbial influence which contribute to the microbial shift of patient in different stage.


Eligibility Criteria:
Inclusion Criteria:

1. Alcohol free history or alcohol consumption \<140g per week in male, \<70g per week in female
2. smooth and soft stool like sausage or snake
3. Voluntary participate in this study

Exclusion Criteria:

1. Syptom of digestive system disorder such as hematochezia, constipation, Abdominal distention, abdominal pain, diarrhea and jaundice within 1 month
2. Abormal results of several tests including: fecal routine, fecal occult blood test
3. Be diagnosed as enteritis within 1 month
4. Chronic obstructive pulmonary disease, renal insufficiency and other systemic diseases.
5. Autoimmune disease
6. Chronic fatigue syndrome and neuropsychic disease
7. A history of antibiotics, microecological preparation, gastrointestinal motility medicine, laxative, weight loss drug, Glucose lowering, blood fat regulation, glucocorticoid or immunosuppressor treatment within 1 month
8. History of organic diseases in digestive system such as gastrointestinal polyposis, ulcers, malignancies, etc.
9. History of gastrointestinal surgery
PET/MRI in the Diagnosis of Pediatric Chronic Pain

\[18F\]FTC-146 is a sigma-1 receptor detector and is an experimental radiotracer. Several studies have implicated involvement of sigma-1 receptors in generation and perpetuation of chronic pain conditions, while others are investigating anti sigma-1 receptor drugs for treatment of chronic pain. Using \[18F\]-FTC-146 and PET/MRI, we hope to learn what is the best approach to identify the source of pain generation and characterize the disease in pediatric patients with chronic pain.

It is estimated that 20% to 35% of children and adolescents worldwide are affected by chronic pain. As a result of chronic pain, children may miss school, withdraw from social activities, and develop internalizing behaviors. Therefore, accurately identifying the cause of a child's pain is important for both proper treatment of the pain and to prevent problems secondary to the chronic pain. Evidence in the literature points strongly toward an involvement of the sigma-1 receptor in neurogenic inflammation, which is known to be an important pathophysiological mechanism for maintenance and perpetuation of chronic neuropathic pain. The investigators hope to image and identify activated pain pathways in pediatric pain paitents using a radiolabeled biomarker for increased S1R expression. By localizing and quantifying areas of increased S1R expression to sites of augmented nociceptive activity using hybrid molecular/anatomic imaging techniques, we will objectively identify sites of neurogenic inflammatory activity and pain generation. The ability to image the changes associated with chronic pain generating pathologies provides us with a tool to identify and measure the intensity of the pathology. Imaging S1R expression in chronic pain states in pediatric patients would be both novel in its application and extremely powerful in better characterizing pediatric pain.

Eligibility Criteria:
Inclusion Criteria:

* 11-18 years old.
* Chronic pain (nociceptive, neuropathic or mixed pain) lasting at least 2 months.
* Pain level of at least 4/10 on a 0-10 Comparative Pain Scale (reported at time of screening).
* Covid Vaccination status: Vaccinated or unvaccinated subjects who received a negative test result from the Covid test within 72 hours of the scan.

Exclusion Criteria:

* MRI incompatible
* Pregnant or nursing
* Non-English speaker
* Claustrophobic
National Survey of Symptoms of People Aged 70 and Overs Diagnosed With COVID-19

Cross-sectional study based on a French national survey aimed to described and identify the most frequent symptoms of COVID-19 older patients.

This cross-sectional survey was initiated and conducted by the French Society of Geriatrics and Gerontology. A standardized questionnaire was emailed to 1600 geriatrician members of the French Society of Geriatrics and Gerontology throughout France between March 22, 2020 and April 5, 2020. Geriatricians were asked to complete the survey for their last 10 patients infected by the SARS-CoV-2. The study was declared to the Commission Nationale de l'Informatique et des Libertés (CNIL) under the number ar20-0031v1.

For each patient, demographic characteristics (age, gender, residence place, care place, autonomy according to the Groupe Iso Ressource (GIR)), medical history (presence of major neurocognitive disorder, hypertension, diabetes, asthma or chronic obstructive pulmonary disease (COPD), heart pathology, severe renal failure with a clearance of creatinine under 30ml/min, solid or liquid cancer) were collected. The symptoms within de 72 hours of the actual disease were also collected for each patient including geriatric syndromes (fall, hypoactive or hyperactive delirium, altered general status, altered conscience), general symptoms (temperature, blood pressure), respiratory symptoms (cough, polypnea), ear nose and throat (ENT) symptoms (rhinorrhea, odynophagia, otalgia, conjunctivitis, ageusia or dysgeusia, anosmia), digestive symptoms (diarrhea, nausea or vomiting), and blood formula modification (leucopenia (with count if available), lymphopenia (with count if available), thrombopenia (with count if available).

Procedure Data were collected by the physician who was in charge of the patient between March 22, 2020 and April 5, 2020.

Given the main objective of the study was only descriptive, no calculation was required concerning the number of subjects to include in the study.

Eligibility Criteria:
Inclusion Criteria:

* confirmed COVID-19 defined by a positive RT-PCR to SARS-CoV-2

Exclusion Criteria:

* none