cyrilzakka/clinical-trials huggingface dataset:
Study Assessing Safety, Pharmacokinetics and Efficacy of CC-223 With Either Erlotinib or Oral Azacitidine in Advanced Non-Small Cell Lung Cancer

The main purpose of this first study combining an investigational dual mTOR inhibitor, CC-223, with other agents (erlotinib or the investigational agent, oral azacitidine) is to establish a maximum tolerated dose level for each combination in order to evaluate their effects in future clinical trials for advanced non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women, 18 years or older, with histologically or cytologically-confirmed, Stage IIIB/IV Non-Small Cell Lung Cancer with tumor progression following at least one prior treatment regimen (either chemotherapy or an Epidermal Growth Factor Receptor inhibitor) for advanced disease. There is no restriction on the number of prior treatment regimens allowed.
2. Eastern Cooperative Oncology Group Performance Score of 0 to 1.
3. Adequate organ function.
4. Adequate contraception (if appropriate).
5. Consent to retrieve archival tumor tissue.
6. Consent to repeated tumor biopsy (dose expansion phase).

Exclusion Criteria:

1. Prior systemic cancer-directed treatments or investigational drugs within 4 weeks or 5 half lives, whichever is shorter except erlotinib which may be continued with intervention in subjects allocated in Arm A.
2. Symptomatic central nervous system metastases.
3. Acute or chronic pancreatitis.
4. Persistent diarrhea or malabsorption \> Grade 2, despite medical management.
5. Impaired cardiac function or significant cardiac disease.
6. Diabetes on active treatment, fasting blood glucose \> 126 mg/dL, HbA1c \> 6.5%.
7. Known Human Immunodeficiency Virus, chronic hepatitis B or C infection.
8. Prior treatment with an investigational dual TORC1/TORC2, PI3K, or Akt inhibitor. Prior treatment with rapalogs is allowed.
9. Major surgery \< 2 weeks prior to starting study drugs. No specific wash out is required for radiotherapy. Subjects must have recovered from any effects of recent therapy that might confound the safety evaluation of study drug.
10. Pregnant or breastfeeding, inadequate contraception.
11. History of concurrent second malignancies requiring ongoing systemic treatment.
to Evaluate Effect of Multi Doses Flibans 100 mg Film-c Tablets on Single Dose PK of Digoxin 0.5 mg, Healthy Volunteers

The aim of this trial is to investigate the effect of multiple doses of flibanserin on the single dose pharmacokinetics of digoxin in healthy female and male volunteers. Digoxin is a narrow therapeutic index drug for which a large number of relevant drug-drug interactions are known. Flibanserin is now under evaluation in postmenopausal women which increases the likelihood that flibanserin and digoxin will be administered together in the clinical setting.


Eligibility Criteria:
Inclusion criteria:

healthy male and female subjects
Procalcitonin-guided Antibiotic Therapy During Severe Exacerbation of COPD

This study assess whether a procalcitonin guided antibiotic therapy can reduce significantly unnecessary antibiotic prescription during severe exacerbation of COPD requiring mechanical ventilation without compromising patients' outcome. The first group of patients will receive systematically empiric antibiotic therapy and the second group will receive antibiotics only if procalcitonin value is at or greater than 0.25 ng/ml.

Recently, procalcitonin gained interest as the most reliable biomarker in predicting bacterial origin in low respiratory tract infections and sepsis.

Procalcitonin was shown to be non-inferior to standard guidelines in guiding antibiotic therapy during COPD exacerbation, without worsening patients' outcomes, and with a significant reduction in antibiotic exposure.

Its use to guide antibiotic treatment during COPD exacerbation may be more challenging because of the frequent colonization of the airways in patients with COPD, and thus it needs further evaluation.

Additionally, until today, no interventional studies evaluating procalcitonin protocol have been conducted in ventilated COPD patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 40 years old who consent to the study protocol
* COPD diagnosis based on GOLD guidelines

Exclusion Criteria:

* Patients who did not consent
* Asthma
* Malignancy
* Immunocompromised
* Survival for at least 1 year is unlikely
* Patients already enrolled in this study
The Iliac Arterio-venous Fistula for Treatment of Neurally Mediated Syncope Study

The purpose of the study is to investigate the efficacy of the ROX coupler in treating patients with tilt test proven Neurally mediated syncope.

Neurally mediated syncope (NMS) is a debilitating condition, with no proven therapeutic measures. The ROX coupler is a device used to create an Iliac arterio-venous anastamosis which allows a shunt of 0.8 litres per minute. The haemodynamic changes following creation of an arterio-venous anastomosis at the iliac level leads to an increase in cardiac preload, reversing finding thought to induce NMS.

This a randomised controlled study to evaluate the effect of Iliac arterio-venous anastamosis in patients with neurally mediated syncope. The Head up tilt test is used as an objective measure to evaluate the effect of the arterio-venous anastamosis in patients with NMS. Participants with tilt test proven NMS will be eligible for the study ( if they satisfy all other eligibility criteria). Participants will be randomised to ROX coupler intervention or standard therapy. The primary outcome measure will be absence of loss consciousness on tilt table testing at 3 months post intervention.

Eligibility Criteria:
Inclusion Criteria:

* Absence of transient loss of consciousness associated with reflex bradycardia or hypotension on tilt testing at 3 months following randomised intervention

Exclusion Criteria:

* Time to first episode of syncope after randomised intervention
* Number of syncopal episodes in the first 3 months after randomised intervention.
* Tilt table response at 6 months following randomised intervention i.e. 3 months after unblinding
* Number of syncopal episodes at 6 months after intervention i.e. 3 months after unblinding
Effects of ELAVl and CDOA vs Upper Thoracic Mobilization on Forward Head Posture in Upper Cross Syndrome

This randomized controlled study will examine the patient of forward head posture who suffering with upper cross syndrome. There will be comparison of two treatment methods 1st one is elongation longitudinaux articular vertebral and columnar decoaption osteo-articulaire also known as ELDOA and 2nd is upper thoracic mobilization .

This study includes 42 participants, both male and female, age between 20 to 45. ELDOA target the cervical and upper thoracic spine to improve range of motion, restore normal cervical and thoracic spine alignment and reduce muscle tension. Upper thoracic mobilization improve thoracic spine mobility and enhance cervical spine alignment.

Eligibility Criteria:
Inclusion Criteria:

* Adult between (20 to 45 year) with upper cross syndrome
* CVA angle less than 48-50 degrees.
* No history of spinal injury and fracture
* limited cervical range of motion

Exclusion Criteria:

* Severe spinal degeneration or deformity
* Injury or surgery
* Cervical radiculopathy
* Severe osteoporosis
* Malignancy of upper extremity of thorax
* Obesity
Colonic Glucose vs. Saline Infusion

The distal ileum and proximal colon, where the glucagon-like peptide 1 (GLP-1) releasing cells predominate, are important organs in mediating glycemic control. The proximal colon is not easy to access and the correspond in vivo research remains to be difficult. The investigators intend to recruit subjects who underwent rectal surgery with simultaneous protective ileostomy and evaluate hormone secretion and glycemic excursions via ileostomy glucose or saline infusion, and quantify the glucose absorption rate within the proximal colon.


Eligibility Criteria:
Inclusion Criteria:

* Male and postmenopausal females aged 18 - 75 years
* Body mass index (BMI) 20 - 35 kg/m2
* With protective ileostomy due to benign or malignant rectal surgery

Exclusion Criteria:

* History of postoperative adjuvant chemotherapy
* Other significant illness, including epilepsy, cardiovascular or respiratory disease
* Impaired renal or liver function (as assessed by calculated creatinine clearance \< 90 mL/min or abnormal liver function tests (\> 2 times upper limit of normal range))
* Donation of blood within the previous 3 months
* Participation in any other research studies within the previous 3 months
* Females who are pre-menopausal
* Inability to give informed consent
* Vegetarians
The Evaluation of Nitric Oxide Generating Lozenges on Outcome in Newly Diagnosed COVID-19 Patient of African American and Hispanic Origin

This study is a multi-center, randomized, double blinded, prospective, placebo controlled study. Patients upon diagnosis of COVID-19 (Corona Virus Disease-19) will be eligible to participate in the study. The purpose of this study is to find out the side effects and ability to take the study drug, Nitric Oxide (NO) lozenges when taken twice daily by mouth. If this study shows that the drug has no or few, acceptable side effects, it will then include up to 840 participants to find out if the drug can reduce bad outcomes of COVID-19 infection (hospitalization, ICU admission, death). In each part of the study, half of the subjects will receive the study drug and the other half will be given a placebo (inactive pill).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female of 50-85 years of age
2. Subjects with recent COVID-19 diagnosis (within 72 hours), that are symptomatic (fever, cough, SOB, weakness, or other flu-like symptoms).
3. Agrees to comply with study procedures (diary, oximeter readings, telephone follow up).
4. Has given voluntary, written, informed consent to participate in the study.
5. Identifies as African American or Hispanic Origin
6. Patients must have at least 1 risk factor (history of hypertension (BP\> 140/99) CHF, angina, prior MI, coronary angiography with one significantly occluded vessel, diabetes mellitus, obesity, or smoking, (for at least 5 years).

Exclusion Criteria:

1. Females who are pregnant, breastfeeding or planning to become pregnant during the course of the study.
2. Patients unresponsive or unable to take anything by mouth (NPO).
3. Individuals who are cognitively impaired and/or who are unable to give informed consent.
4. Blood pressure below 110 mmHg systolic and 60 mmHg diastolic on entry into study.
5. History of syncope or other symptoms of orthostatic hypotension.
6. History of methemoglobinemia.
7. Severe case of G6PD deficiency
PAtient-CenTric Chronic Pancreatitis Registry (PACT-CP)

The main objective of this study is to generate real-world evidence reflecting the experience of individuals with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP). Efforts will be directed toward understanding the unmet need and therapeutic burden to identify the most critical factors that influence treatment choices/prescribing patterns, quality of life, and healthcare utilization outcomes in standard of care for individuals with EPI due to CP.

Study participants will be followed prospectively, and data from study participants will be collected at 3-month intervals via Electronic Data Capture (EDC) portal. Investigators will complete assessments approximately every 6 months at the time of routine clinical encounters. Adverse Events (AEs) will be collected as part of the study data collection forms. Serious Adverse Events (SAEs) are to be reported within 24 hours (1 business day) of awareness, whether or not the site learns of the event at the time of a registry follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

To be eligible for enrollment, a study participant must meet the inclusion criteria below:

1. At least 18 years of age (or age of majority)
2. Willing to provide consent to participate
3. Meet one (1) of the following at the time of enrollment:

   1. Diagnosis of chronic pancreatitis (CP)
   2. Diagnosis of recurrent acute pancreatitis (RAP)
4. Suspected or confirmed diagnosis of EPI made by a healthcare provider
5. On Pancreatic Enzyme Replacement Therapy (PERT), either prior to the Enrollment Visit or newly prescribed at the time of the Enrollment Visit.

To be eligible for enrollment into the registry, a study participant must not have any of the criteria below:

1. Currently participating in or planning to participate in a double-blind randomized trial and/or open-label Phase 3b/4 on CP or EPI
2. Diagnosed with any of the following conditions at the time of enrollment:

   1. Cystic fibrosis
   2. Fibrosing colonopathy
   3. A history of or current diagnosis of pancreatic cancer, main duct papillary mucinous neoplasms (IPMNs), and other pancreatic malignancies
   4. Allergy to pork or other porcine pancreatic enzyme products (PEPs)
   5. Any condition that would, in the investigator's opinion, limit the individual's ability to complete the study.

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      Exclusion Criteria:

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Efficacy of 2% Chlorhexidine Gluconate in 70% Alcohol Compare 10% Povidone Iodine in Blood Culture in Children

To evaluate the efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine in reducing blood culture contamination in pediatric patients.

This is a prospective study of pediatric patients between 0-15 years of age who were admitted in three pediatric wards: general pediatric ward aged \<5 years, general pediatric ward aged \>5 years, and pediatric intensive care unit at a tertiary-care teaching hospital. Patients who needed percutaneous blood cultures were eligible for enrollment and were classified into two groups according to antiseptic used: 10% povidone iodine in odd months and 2% chlorhexidine gluconate in 70% alcohol in even months. Blood cultures were taken primarily by ward nurses using standard technique. The blood cultures were analysed and monitored for 5 days. Isolated organisms and their antimicrobial susceptibilities were determined using standard microbiologic techniques.

Blood culture isolates were categorized into two groups including a true pathogen and a contaminant by clinical criteria combined with laboratory data. A blood culture was classified as contaminated if common skin flora such as Coagulase negative staphylococci, Corynebacterium spp., Micrococcus spp., or Bacillus spp. were isolated from one of the blood culture samples without isolation of the same organism from another potential infection site (for example, intravenous catheter), or a common skin flora was isolated in a patient with incompatible clinical features and improved without specific treatment for that organism.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients between 0-15 years of age who were admitted in three pediatric wards: general pediatric ward aged \<5 years, general pediatric ward aged \>5 years, and pediatric intensive care unit. Patients who needed percutaneous blood cultures were eligible for enrollment.

Exclusion Criteria:

* Preterm infant
* Patient who had skin infection at site of venepuncture
* Patient who had history allergy to 2% Chlorhexidine gluconate in 70% alcohol or 10% povidone-iodine
Musculoskeletal Pain in Long-term Dizziness

This project is aimed at patients with dizziness believed to be due to conditions in the balance organ in the inner ear (vestibular diseases). Dizziness can be bothersome and influence postural control negatively, and can cause secondary musculoskeletal disorders. Dizziness can also result in reduced work capacity. The purpose of the project is to strengthen the knowledge base regarding symptom burden, prognosis and treatment of prolonged dizziness. The hypothesis is that musculoskeletal pain at baseline is a prognostic factor for prolonged dizziness.

Patients referred to an tertiary otorhinolarynglogical clinic due to dizziness will be invited to participate in the study. The aims are to examine the prevalence, extent and distribution of musculoskeletal pain in patients with prolonged dizziness, and to investigate the associations between musculoskeletal pain, dizziness symptoms, psychological and physical function and health-related quality of life.

Furthermore, the aim is to monitor the natural course of the dizziness symptoms and functional status in these patients, and examine risk factors for prolonged disability after 6 and 12 months. The hypothesis is that muscle pain and distress at baseline may be independently associated with prolonged complaints at follow-up.

Finally, patients who still are dizzy and have pain after 12 months will be invited to participate in one of two group interventions a) modified vestibular rehabilitation and b) virtual reality / exergaming. The interventions will be feasibility studies with a pre-post design.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to an otorhinolaryngological university clinic due to suspected vestibular disorders (dizziness)
* Patients must be bothered with dizziness at the time of consultation

Exclusion Criteria:

* Patients uable to fill in questionnaires due language barriers
* Patients not able to undergo diagnostic and testing procedures
* Patients with vestibular Schwannoma
* Patients with diving-related inner ear injuries
Evaluation of the Retinal Health Monitoring System Thickness Module

Evaluate the ability and accuracy of the Retinal Health Monitoring System - Retinal Thickness Module (RHMS - RTM).

Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in subjects with normal macular thickness and subjects with center-involving macular edema.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥50.
2. Corrected visual acuity (VA) of 20/125 or better, in the study eye(s)
3. Media clarity, undilated pupil size, and subject cooperation sufficient to obtain adequate OCT B-scans in the study eye(s)
4. Able to perform self-testing of retinal thickness with the RHMS-RTM after training
5. Able and willing to provide written informed consent before undergoing any study-related procedures
6. Group 1: Macula with normal thickness \[central subfield thickness (CST): \<305μm in women, and \<320μm in men as measured by Heidelberg Spectralis SD-OCT in at least one eye. Patients diagnosed with dry AMD are eligible for enrollment into Group 1. No history of wAMD, DR, or RVO in either eye
7. Group 2 and Group 3, in at least one and the same eye: History of center-involving macular edema due to wAMD (Group 2); or DR or RVO (Group 3); Macular edema on SD-OCT with CST ≥305 μm in women, and ≥320μm in men as measured by Heidelberg Spectralis SD-OCT.

Exclusion Criteria:

1. History of corneal refractive surgery \[e.g., laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), radial keratotomy (RK)\] in the study eye(s)
2. History of epiretinal membrane, vitreomacular traction, or macular hole in the study eye(s)
3. Participation in any study using an investigational drug within 30 days of screening or an investigational device within 60 days of screening
4. Refractive error within defined limits
5. History of photocoagulation laser scar or other retinal scar in the central 3 mm of the macula, in the study eye(s)
GDM Screening During COVID Pandemic. IADPSG vs WHO '99 Criteria

All pregnant women who performed an OGTT following Italian Guidelines and then delivered at our University Hospital from march 2020 to march 2021 were prospectively enrolled in this study. Primary outcome of the study was the number of women to whom was diagnosed GDM with only the fasting glucose value (≥ 92 mg/dl), following Italian Diabetes Societies recommendations for COVID 19 pandemic period. In the same time, we prospectively collected the data of women who became diabetic following the criteria of WHO 1999 (fast glucose value ≥ 120 mg/dl, 2 hours later ≥ 140 mg/dl) still in use in some large countries like India. From the clinical charts, we reported the distribution of risk factors for GDM (maternal age ≥ 35 years, family history for diabetes type 2, ethnia, BMI ≥ 25, previous GDM) and clinical outcomes such as hypertensive disorders, preterm birth, macrosomia, intrauterine growth restriction and Caesarean section in emergency.

These data will be compared between the 2 groups consisting in those diagnosed with only IADPSG criteria versus those diagnosed with only WHO '99 criteria.


Eligibility Criteria:
Inclusion Criteria: Pregnant women who perform GDM screening -

Exclusion Criteria: Twin pregnancies

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Evaluation of Quality of Life and Its Influencing Factors After VA-ECMO in Refractory Cardiac Arrest Based on SF-36 Score : A Grenoble Cohort Study From 2006 Through 2018

If the ExtraCorporeal Membrane Oxygenation (ECMO) improves survival in the management of refractory cardiac arrest (RCA), this technique is still an invasive technique, not devoid of complications and requiring intensive care that can have serious consequences for patients. If the studies so far show an acceptable quality of life post ECMO in refractory cardiac arrest, the study looks about the quality of life of our patients in Grenoble who survived a refractory cardiac arrest between 2006 and 2018 at the hospital university Grenoble Alps and the factors influencing this quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Adult \>18 years
* Admission to intensive care unit after a Refractory Cardiac Arrest
* Hemodynamic instability after resumption of spontaneous cardiac activity.
* Non-opposition of the patient or his relatives
* Admission to intensive care unit From 2006 Through 2018

Exclusion Criteria:

* ECMO for hypothermia or drug intoxication.
* Comorbidity contraindicated the ECMO
* Patients dead before hospital discharge
Epidermal Cells Delivery and Acute Burns

The aim of the study is to compare results obtained with epidermal cell spray and classic skin grafting for epidermal replacement in acute burns

Comparing the impact in terms of cicatrisation duration and costs between 2 treatments of deep 2nd and 3rd degree burns.

Determine if the costs of the innovating treatment RECELL®, a priori more expensive, are counterbalanced by a shorter cicatrisation duration and an improved evolution versus a conventional strategy.

Give an information about efficiency improvement of RECELL® with additional costs

Eligibility Criteria:
Inclusion Criteria:

* Thermal burns requiring surgical debridement
* Area involved \< 1260cm²

Exclusion Criteria:

* local or systemic infection
* conditions that would interfere with wound healing (diabetes, hypertension, inflammatory diseases treated by corticoids)
* hypersensitivity to trypsin