cyrilzakka/clinical-trials huggingface dataset:
A Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris

Open-label study will evaluate the safety of an approximate 1.5 mg/kg/day dose of oral sarecycline in the long-term treatment of participants with moderate to severe facial acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Successfully completed participation in Phase 3 study of sarecycline (SC1401 or SC1402)
* Signed informed consent or assent form
* Body weight between 33 kg and 136 kg, inclusive
* Negative urine pregnancy test for females of childbearing potential
* Agrees to use effective method of contraception throughout study, if applicable.
* Able to fulfill protocol requirements, indicated willingness to participate in study and agrees to all study procedures by providing written informed consent/assent and authorization to disclose (personal health information)

Exclusion Criteria:

* Currently participating in another clinical study, unless it is a pharmacokinetic sarecycline study and participation approved by medical monitor; has received investigational medication (except sarecycline) within 30 days of enrollment.
* Discontinued participation in a Phase 3 study with sarecycline for any reason
* Had poor compliance wtih study requirements/study drug dosing in a Phase 3 study with sarecycline
* Is receiving/planning to receive any systemic acne medication, systemic retinoids, systemic corticosteroids or any androgen/anti-androgenic therapy (eg, testosterone, spironolactone)
* Is pregnant, lactating or planning a pregnancy during the study period
* Has a significant intercurrent illness (including clinically significant abnormality in clinical laboratory tests), psychiatric disorder, or other factors that, in the opinion of the Investigator or Medical Monitor, precludes participation in the study
* Is judged by the Investigator to be unsuitable for any reason
PREVACT : Preventive REversal of Vitamine K Antagonist in Minor Craniocerebral Trauma

The occurence of a minor craniocerebral trauma in patients receiving vitamine K antagonist treatment leads to a high risk of bleeding.

Current guidelines recommend to perform a CT scan, and, in case of intracranial bleeding, to reverse anticoagulation with concomitant administration of prothrombin complex concentrates (PCCs) and vitamin K.

However, even if a reversion is performed, the prognostic of post-traumatic intracranial bleeding remain bad.

The investigators hypothesize that, for patients admitted in an emergency department after a minor head trauma and receiving anticoagulant treatment, a systematic preventive reversion with PCCs can lead to a significant reduction of intracranial haemorrhage and can also improve the neurological prognostic of patients versus the current strategy.

PREVACT will test this hypothesis, in an open label, randomized, multicentre, clinical trial involving 400 patients.


Eligibility Criteria:
Inclusion Criteria:

* Admission in an emergency departement for a recent and isolated minor head trauma with at least one of the following characteristic : a period of alteration in the level of consciousness, a period of loss of consciousness (\< 30 min), a posttraumatic amnesia, persistant posttraumatic headache, repeated vomitting (at least 2 episodes) or any other neurological sign such a convulsion or a localised neurological sign, wound of the scalp or the face testifying of the importance of the cranial trauma...
* Subject receiving anticoagulant treatment with anti-vitamin K for the treatment of atrial fibrillation (AF)
* Initial ED Glasgow Coma Scale (GCS) score of ≥13
* Achievable follow up
* Informed consent form signed by the patient or if he/she isn't able an emergency inclusion can be realised.

Exclusion Criteria:

* Delay between the minor head trauma and the possible preventive PCC's administration \> 6h
* Subject receiving anticoagulant treatment other than anti vitamin K (heparin, fondaparinux, dabigatran, rivaroxaban, apixaban...)
* Subject receiving anticoagulant treatment for other reason than a AF
* Subject on antiplatelet treatment (except the use of low dose of aspirin (≤ 100 mg/day)
* Delocalised biology INR in capillary blood \< 1.5 if it's available (only in departement where this analyse is a usual practice)
* Haemorrhage or suspected haemorrhage other than intracranial which could led to a reversion of the anticoagulation
* Head trauma associated with one or further potential haemorrhagic traumatic lesions
* Subject who reject the use of products derived from human blood
* Women who are pregnant
* Subject with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study
* Subject without social security registered
Phase I Trial of BAY1251152 for Advanced Blood Cancers

The purpose of this study is to identify the most appropriate dose that can be safely administered and that can have an effect on blood cancer cells. Once that safe dose is identified, additional patients will be asked to join the study to further evaluate the safety and effectiveness of the study drug. The study will also investigate the pharmacokinetics (study of what the body does to the drug), as well as pharmacodynamics (study of what the drug does to the body), which may provide information about the effects of BAY 1251152. The study will also measure some biological markers (markers of biological activity in your body) that can be used to predict the response and safety of the proposed treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged ≥18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and Life expectancy of at least 12 weeks
* Patients are able and willing to provide bone marrow biopsies/aspirates as requested by the protocol
* Patients with confirmed advanced hematological malignancies
* Negative serum pregnancy test
* Women and men of reproductive potential must agree to use highly effective contraception when sexually active.
* Ability to understand and the willingness to sign a written informed consent.
* Patients must have adequate coagulation (international normalized ratio (INR) or prothrombin time (PT), partial thromboplastin time (PTT) ≤1.5 times ULN)
* Adequate liver function (total bilirubin ≤ 1.5 times the ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN

Exclusion Criteria:

* Presence of active/uncontrolled central nervous system involvement
* History of clinically significant cardiac disease; uncontrolled hypertension
* Left ventricular ejection fraction (LVEF) \< 45%
* Allogeneic stem cell transplant within 100 days before first dose of study drug
* Known history of human immunodeficiency virus (HIV) infection
* Chronic or active hepatitis B or C, requiring antiviral therapy
* Evidence of history of bleeding disorder, dialysis, or coexisting cancer that is distinct in primary site or histology from the cancer evaluated in this study
* Serious, uncontrolled infection
* Unresolved chronic toxicity \> grade 1 from prior therapy
* Use of strong CYP3A4 inhibitors or strong inducers within 7 days prior to the start of study treatment and for the duration of the study
Epidemiology of Congenital Heart Disease in France

Congenital heart disease (CHD) is the leading cause of birth defects, with an incidence of 0.8%. Since the 1980s, France has been a pioneer in neonatal CHD surgery (Pr. Fontan, Pr. Lecomte, Pr. Serraf, etc.), in prenatal diagnosis, and in interventional cardiac catheterization.

Actually, first children operated for complex CHD have reached adulthood and a new epidemiology of CHD is emerging. Currently, one of the public health challenges is the need to maintain appropriate follow-up and to avoid disruption of care during the transition from adolescence to adulthood. Thus, the national health authorities (DGOS) recently certified a national network of expert centers for complex CHD (M3C).

In addition, under the leadership of the French Society of Cardiology, the sub-specialty of Pediatric and Congenital Cardiology has been recognized.

However, while North American and North European countries have published their updated data on the main indicators of CHD morbidity and mortality, no study has reported epidemiology of CHD in France.

Currently, available data are approximate, estimating that 200,000 children and 250,000 adults would be living in France with a CHD. Nevertheless, no information is available on hospitalizations, type of CHD, their follow-up, possible disruption in care, and morbidity and mortality in patients with CHD in France. This epidemiological study will use the national health insurance hospital database to answer these questions.

Retrospective epidemiological study based on the national health insurance hospital database from 2010 to 2020 (10 years):

Main objective:

• To assess the prevalence of patients with CHD hospitalized in France over 10 years.

Secondary objectives: asess over the same period:

* Overall mortality rate according to the CHD classification and the geographic area
* Overall morbidity rate, according to the CHD classification and the geographic area
* Overall cardiac surgery-related mortality rate (cardiac surgery and other surgery), according to the CHD classification (adjusted for the severity of the CHD and the surgical procedure) and to geographic area
* Overall cardiac catheter-related mortality rate, according to the CHD classification (adjusted for the severity of the CHD and the catheterization procedure) and to geographic area
* CHD follow-up within and outside the national M3C network
* Periods of loss of cardiological follow-up (within or outside the M3C network, in hospital or in town)
* Obstetrical data for women (parity, pregnancy)
* The existence of a prenatal diagnosis (yes / no and the term of pregnancy at the time of diagnosis of CHD)

Eligibility Criteria:
Inclusion criteria:

- Patient (of any age) with a CHD as defined by the international ACC-CHD classification and listed in the ICD10 classification, hospitalized from 01/01/2010 to 12/31/2019 in a French tertiary care hospital from the M3C network.

Exclusion criteria:

- Patient with non-malformative genetic heart disease (cardiomyopathy, hereditary rhythmic disease).
Efficacy and Safety Study of DHA-O in Adults With Hypertriglyceridemia

The purpose of this study is to investigate the efficacy and safety of DHA-O to lower elevated triglyceride levels in healthy adults with hypertriglyceridemia.


Eligibility Criteria:
Inclusion Criteria:

* ages 18-79
* fasting TG levels, 150-499 mg/dL
* baseline DHA intake \<200mg/d
* active and in good health

Exclusion Criteria:

* recent diagnosis of CHD or history of revascularization within 6mos of study
* use of lipid altering medications (other than stable statins)
* use of anticoagulants
* use of omega-3 products within 4 weeks of screening
* serum AST/ALT \>1.5x ULN and/or creatinine \>1.5 mg/dL at screening
* lipid altering foods or supplements
* women who are pregnant or of childbearing potential not using adequate birth control
* current use or history of drug or alcohol abuse
* inability to swallow capsules
The Effect of a Liraglutide on IVF in Obese PCOS

The aim of this study was to evaluate the impact of low dose liraglutide in combination with metformin compared to metformin alone on IVF pregnancy rate (PR) and cumulatively PR (IVF and spontaneous) in infertile obese women with PCOS who had been previously poor responders regarding weight reduction with lifestyle modification and resistant to first line reproductive treatments.

Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility, in particular when PCOS is linked to obesity. Obese PCOS has poor IVF outcomes associated with impaired oocyte and embryo parameters and morphology. The purpose of this pilot prospective study was to investigate the effect of the novel medical therapy (combination of metformin and liraglutide (COMBI)) in the specific infertile obese PCOS population. GLP-1 has been investigated in regulation of reproductive system in animal models. Current observations suggest that it directly regulates kisspeptin and GnRH expression and that ovaries express GLP-1 mRNA. In obese PCOS, GLP-1 receptor agonist liraglutide provided positive effects on weight reduction and glucose homeostasis

Eligibility Criteria:
Inclusion Criteria:

* 18 years old to 38 years old
* polycystic ovary syndrome (rotterdam criteria)
* BMI of 30 kg/m² or higher
* Infertility
* Before IVF

Exclusion Criteria:

* type 1 or type 2 diabetes mellitus

  * history of carcinoma
  * Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
  * personal or family history of MEN 2
  * significant cardiovascular, kidney or hepatic disease
  * the use of medications known or suspected to affect reproductive or metabolic functions
  * the use of statins, within 90 days prior to study entry no other ovarian pathology normal male semen
Magnetic Resonance Lung Function Imaging Study of Pulmonary Fibrosis Combined With Emphysema Syndrome

This study intends to use magnetic resonance pulmonary function imaging technology to explore imaging markers for early diagnosis of patients with CPFE. Through baseline, 6-month and 12-month follow-up examinations, the changes in magnetic resonance pulmonary function in patients with CPFE and their correlation with disease progression were explored.


Eligibility Criteria:
Inclusion Criteria:

* (1) Chest HRCT shows emphysema mainly distributed in the upper lung field, manifesting as wallless or thin-walled (wall thickness \<1 mm) low-transmittance areas with clear boundaries with normal tissue, or multiple bullae (diameter \> 1 cm), and the emphysema area/total lung volume is ≥10%; (2) interstitial pulmonary fibrosis mainly distributed in the lower lung field and subpleura, manifesting as honeycomb shadow or grid shadow, and the lung structure is destroyed , may be accompanied by traction bronchiectasis, ground glass opacities and consolidation opacities.

Exclusion Criteria:

* (1) Refusal to sign the informed consent form; (2) MRI contraindications (implanted pacemaker/defibrillator, claustrophobia, or any clinical condition that prohibits longer MRI examinations).
Endoscopic Metabolic and Bariatric Therapies

This is a prospective collection of data from adult patients who have had an endoscopic metabolic and bariatric endoscopy procedure (EMBT) for primary or revision surgical procedures for obesity.

The Investigators will be collecting data on bariatric patients post-bariatric surgery, post-endoscopic revision of bariatric surgical complications and post-endoscopic metabolic and bariatric therapies (including but not limited to roux-en-y gastric bypass, sleeve gastrectomy, laparoscopic adjustable gastric banding, gastroplasty with endoscopic myotomy (GEM), endoscopic sleeve gastroplasty (ESG), transoral outlet reduction (TORe), primary obesity surgery endoluminal (POSE), restorative obesity surgery endoluminal (ROSE), intragastric balloons (IGB), aspiration therapy and pylorus sparing antral myotomy) to review demographics, adverse events, medications, radiology, procedure time, cost, comorbidity resolution and resource utilization.

Eligibility Criteria:
Inclusion Criteria:

* patients from Mass General Brigham
* any patient having an endoscopic primary obesity procedure
* any patient having an endoscopic post-bariatric surgical revision procedure
* any patient having a bariatric surgical procedure

Exclusion Criteria:

* patients without past surgical and medical history medical records in the Mass General Brigham system
* patients unwilling to allow for medical record review at Mass General Brigham
Source Profiling of Biohazardous Aerosols in Hospitals

To characterise the physical parameters (number concentration, size distribution and their trajectories) of aerosols (droplets) generated in high risk procedures.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (\>18 years old) that can give valid consent
2. URTI: with symptoms such as coryza, sore throat, nasal discharge, cough and sputum +/- fever. Amongst these, cough should be a major complaint.
3. LRTI (CAP): acute lower respiratory illness of no other known cause which is usually associated with fever, symptoms and signs of the chest and abnormalities on the CXR. (BTS 1993).

Exclusion Criteria:

1. Pneumonia developed at or after 48 hours, or history of hospital admissions within 1 month of the present admission (to exclude hospital-acquired infections)
2. Patients who are unable to cooperate with the study protocols (such as mentally confused, dementia) or are physically unable to sit or stand independently to carry out the tests optimally.
3. Patients with TOCC associations with infections such Avian Flu or SARS (travel to endemic areas, at-risk occupations, close contacts with index cases, especially with compatible clinical features) or NPA revealed positivity of influenza A/B
4. Patients who are clinically or haemodynamically unstable, such as the need for inotropes, oxygen supplement of \>2L/min, any types of shock, etc.
5. Underlying diseases that might affect the coughing effort (such as musculoskeletal diseases, or severe kyphoscoliosis)
Multi-Nutrient Supplement for Radio-Protection

Exposure to radiation, such as during routine CTs, bone scans, or X-rays, causes oxidative stress which can damage the DNA (your genetic material) within your white blood cells. While the amount of DNA damage that may occur from one scan is not harmful to your overall health, there could be concerning damage in patients who are constantly exposed to this radiation. Currently, there is no way to prevent DNA damage during a medical scan. One potential way to fight the oxidative stress caused by radiation is to take an antioxidant before a scan. The purpose of this study is to see if a combination of antioxidants can protect someone from the damage that radiation causes to the DNA of their white blood cells.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 76 years.
* Scheduled for bone scan procedure at the Juravinski Hospital.

Exclusion Criteria:

* History of smoking within six months prior to study enrollment.
* Known hypersensitivity reactions to any of the ingredients in the MNSRP.
* Chemotherapy or radiation therapy within six months prior or one month following study enrollment.
* Individuals currently taking vitamin or mineral supplements that contain antioxidants will be considered on a case-by-case basis but will be asked to refrain from intake for at least two weeks prior to partaking in this study.
Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients

The objective is to compare the efficacy and safety of masitinib in combination with riluzole versus matched placebo in combination with riluzole for the treatment of Amyotrophic Lateral Sclerosis (ALS).

Masitinib is a selective, oral tyrosine kinase inhibitor with neuroprotective capability demonstrated via numerous preclinical studies. Two of masitinib's main cellular targets are the mast cell and microglia cell. It is well-established that mast cells play a prominent role in neuroinflammatory processes. Microglia, resident immune cells of the central nervous system (CNS), also constitute an important source of neuroinflammatory mediators and may have fundamental roles in numerous neurodegenerative disorders. The development of masitinib in ALS is therefore based on the pharmacological action of masitinib in microglia cells and mast cells, thereby slowing microglial-related disease progression, reducing neuro-inflammation, and modulating the neuronal microenvironment in both central and peripheral nervous systems. This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group (two ascending dose titrations of masitinib and matching placebo), comparative study of oral masitinib in the treatment of patients with amyotrophic lateral sclerosis (ALS).

Eligibility Criteria:
Main inclusion criteria include:

* Patients diagnosed with laboratory supported probable, clinically probable or definite ALS according to the World Federation of Neurology Revised El Escorial criteria
* Patient with a familial or sporadic ALS
* ALS disease duration from diagnosis no longer than 24 months at the screening visit
* Patient treated with a stable dose of riluzole (100 mg/day) for at least 12 weeks days prior to the baseline visit
* Patient with an ALSFRS-R score progression between onset of the disease and screening of \> 0.3 per month, confirmed with an ALSFRS-R score progression of ≥ 1 point during a 12-week run-in period between screening and randomization.
* Patient with a score, at screening, of at least 26 overall, including a score of at least 3 on item #3 and at least 2 on each of the 12 ALSFRS-R individual component items and with a score, at randomization, of at least 2 on each of the 12 ALSFRS-R individual component items

Main exclusion criteria include:

* Patient with dementia or significant neurological, psychiatric, systemic or organic disease, uncontrolled or that may interfere with the conduct of the trial or its results
* Patient with a FVC \< 60% predicted normal value for gender, height, and age at screening and baseline
* Pregnant, or nursing female patient
Epidemiology of Impaired Coagulant Balance in Diabetes

To determine the nature, extent and molecular mechanisms responsible for impaired fibrinolysis in White, Black, Hispanic and American Indian populations with respect to the presence or absence of diabetes. The overall objective is to determine whether impairments of fibrinolysis underlie subclinical and clinical vascular disease in diabetes in specific populations with and without accelerated microvascular disease.

BACKGROUND:

The results of this project should clarify the extent to which results obtained in experimental animals pertain directly to diabetes in human subjects. The study will also assist in the interpretation of results from clinical studies and from platelet activation experiments.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Combination Nicotine Replacement for Alcoholic Smokers

The overall objective of the study is to develop recommendations for treatment programs to help alcoholic smokers to stop smoking. A sample of 175 alcohol dependent cigarette smokers will be recruited from the community and treated in a 6-month outpatient alcohol and tobacco treatment program. The 175 patients will be divided into two groups. One group will receive an active nicotine patch and active nicotine gum. The other group will receive an active nicotine patch and placebo nicotine gum. Followup assessments will be conducted for 1-year from the beginning of treatment.


Eligibility Criteria:
Inclusion criteria:

* Males and females at least 18 years old.
* English speaking.
* Meets criteria for alcohol dependence or alcohol abuse.
* Must complete an alcohol detoxification program prior to entering the study.
* Currently smoking 15 or more cigarettes per day and have at least a 3 year history of smoking.
* Have a current desire to stop smoking and stop drinking.
* Willing to complete followup assessments up to 12 months after treatment.
* Willing to provide names of 2 people who can help locate the subject at followup and the name of one person who can verify information about alcohol and tobacco use.
* One person per household.

Exclusion Criteria:

* Allergy to nicotine patch or nicotine gum.
* Weigh less than 100 pounds.
* Use other nicotine products, such as cigars, pipes or smokeless tobacco.
* Severe skin disorder.
* Active peptic ulcer.
* Active joint disease.
* Heart attack within 3 months prior to entering the study.
* Pregnant or breastfeeding female who are not on birth control.
* Currently taking medication to treat alcoholism or smoking, such as naltrexone, disulfiram or bupropion.
* Poor vision or hearing that would interfere with using a cell phone.
* Lack of transportation to the treatment site or live at least one hour from the treatment site.
* Homeless.