cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Written Information Delivered by the General Practitioner of the Patients Presenting to the Emergency Room for an Aggravation of Asthma

Asthma is a common pathology (prevalence 6.4% in 2018, in France), currently managed by the general practitioner in general practice. It is a chronic disease at risk of exacerbation, which can lead to the use of care. The treatment of asthma is based on a basic treatment, to be taken every day, the purpose of which is to avoid acute exacerbations and lead a normal life. There is also an emergency treatment, to be taken in case of sudden worsening of the respiratory state. The asthmatic patient is the first actor in his care. He must be able to react in case of emergency. A good knowledge of the disease and its treatment as well as training in self-management of crises are thus fundamental and must be part of its medical care. The existence of an exacerbation represents a criterion of non-control of the disease, thus a failure of the long-term care of the patient. The optimization of this care includes individual issues aimed at improving the quality of life and collective by reducing the avoidable use of care and thus the expenses related to this disease. It relies on therapeutic education sessions as well as the provision of written information, clear and detailed by the doctor. This information consists of the writing of a detailed medication prescription as well as the dispensing of a written action plan.

The action plan must describe the actions to be taken by the patient in case of exacerbation of his asthma, to regain control. Regarding the format, it can be coupled to the prescription drug (action plan and prescription on the same prescription) or distinct from the prescription drug (a prescription for drugs and a prescription for the action plan). In some countries, "ready-to-use" action plans have been validated by learned societies, which is not the case today in France. In Canada, a study demonstrated in 2006 that 46% of asthmatic patients followed in hospital had an action plan, while the national average was estimated at about 10% in 2010. There is little data in France on the proportion of patients with asthma action plans.

Unlike the action plan, which is little distributed to the patient, the prescription drug for asthma is always given to the patient at the end of the consultation and specifies the procedures for taking treatments.

As part of this work, the investigators are interested in evaluating the written information given to the adult asthmatic patient by their general practitioner: the action plan but also the prescription medication.


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age is ≥ 18 years
* Asthma patient
* Emergency Patient Counselor for GHPSJ for management of worsening asthma
* Patient followed for his asthma in town by a general practitioner
* Francophone patient

Exclusion Criteria:

* Patient opposing his participation in the study
* Patient under tutorship or curatorship
* Patient deprived of liberty
* Patient under safeguard of justice
Neoadjuvant Rapamycin in Patients Undergoing Radical Cystectomy

This study aims to evaluate the effects of rapamycin directly on bladder tumors and the effects of rapamycin on the immune system of patients with bladder cancer.

This is a presurgical clinical trial which aims to understand the biologic activity of TORC1 inhibition and safety in patients with bladder cancer. In this presurgical setting, paired PMBCs and tumor tissue is evaluated before and after exposure to rapamycin to address target specificity, drug delivery, physiologic effects on tumor growth and apoptosis, and correlation of biomarkers with clinical activity.

Eligibility Criteria:
Inclusion Criteria:

1. Have invasive (≥T1) bladder cancer
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
3. In their treating physician's opinion is a good candidate for radical cystectomy
4. In their treating physician's opinion does not need neoadjuvant chemotherapy prior to cystectomy
5. Be able to give informed consent
6. Be age 18 or older
7. Have adequate marrow function (defined as granulocytes greater than 1,500 cells/mm3 hemoglobin \>9.5 gm/dl or platelets more than 100,000 cells/mm3).
8. Have adequate end-organ function (GFR \>30, bilirubin \<1.5, SGOT \< 3x ULN)
9. Have a life expectancy \> one year
10. Not have a prior history of non-bladder cancer unless the cancer is clinically stable and not requiring active treatment
11. Not have received chemotherapy or radiotherapy in the prior 30 days

Exclusion Criteria:

1. Immunosuppressed state (e.g. HIV, use of chronic steroids)
2. Fixed disease (clinical T4)
3. Active, uncontrolled infections
4. Hepatic impairment (SGOT \>3x ULN)
5. Unhealed wounds
6. Patients at risk of pregnancy who are unwilling or unable to take effective contraception before rapamycin therapy, during therapy, and for 12 weeks after discontinuation of therapy.
Pulmonary Physiologic Assessment of Patients on Veno-arterial Extracorporeal Membrane Oxygenation (VA ECMO)

There is limited data on the respiratory system mechanics and ideal mode of ventilation for patients on veno-arterial extra-corporeal membrane oxygenation (VA ECMO) post cardiac arrest. In this observational study, the investigators will review and/or obtain laboratory, hemodynamic, respiratory system mechanical, and clinical data from patients on VA ECMO. The specific aims of this study are as follows:

Aim 1: To characterize the lung ventilation strategy employed in patients on VA ECMO and its success.

Aim 2: To characterize respiratory system mechanics while on ECMO using esophageal manometry and Electrical Impedance Tomography (EIT).

Aim 3: To characterize right heart function and pulmonary vascular hemodynamics on the employed ventilation strategy.

The overarching hypothesis is that fine-tuned individualized ventilation might be superior to an algorithm that does not account for cardiac and pulmonary functions. Therefore, the aims of this study are to identify areas in which the ventilation strategy may theoretically be suboptimal, which will guide future interventional studies investigating alternatives methods of ventilation which may reduce time on the ventilator after cardiac arrest, time in the intensive care unit, and need for veno-venous ECMO.


Eligibility Criteria:
Inclusion Criteria:

* On VA ECMO after cardiac arrest
* Between 18 and 85 years of age
* Has an orogastric or nasogastric tube with esophageal balloon capabilities in place

Exclusion Criteria:

* Known pre-existing significant pulmonary pathology
* Pacemaker or implanted cardiac defibrillator
Efficacy and Safety of Pregabalin vs Placebo for Generalized Anxiety Disorder (GAD) Symptoms in Subjects Discontinuing Benzodiazepine Treatment and Remaining 6 Weeks on Study Medication, Free From Benzodiazepine Use.

GAD subjects maintained on a stable dose of alprazolam for at least four weeks who meet eligibility criteria will be randomized to receive pregabalin vs matching placebo while simultaneously tapering off of alprazolam over 6 weeks. Subjects return weekly for assessment of safety/tolerability of pregabalin vs placebo as well as for assessment of anxiety and benzodiazepine withdrawal symptoms. Subjects successfully able to discontinue alprazolam, will continue 6 weeks of treatment with pregabalin vs placebo (free of benzodiazepine use). The efficacy and safety of pregabalin vs placebo for anxiety symptoms and ability to discontinue/remain free of alprazolam will be compared among pregabalin and placebo treated groups. Hypothesis is that a greater proportion of subjects will be successful in discontinuing and remaining free from benzodiazepines who were treated with pregabalin as compared to subjects treated with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent
* 18-65 years old
* male and female
* A primary lifetime diagnosis of DSM-IV-TR (2000) GAD (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition)

Exclusion Criteria:

* Pregnant or lactating women
* History of non-response to alprazolam, other benzodiazepines, gabapentin or pregabalin given for the treatment of anxiety as indicated by a (screening or baseline) Hamilton Anxiety Scale (HAM-A) score \> 18
Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone (MNTX) in Subjects With Impaired Renal Function

This study is evaluating the Pharmacokinetics of MNTX in healthy control subjects and in patients with mild, moderate, or severe renal impairment who do not require hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

1. Body weight \>100 lbs. (\> 45 kg), and body mass index (BMI) between 18-38 kg/m2, inclusive (BMI 18-30 for the matched reference group)
2. For patients/subjects requiring pharmacotherapy, a stable drug regimen, defined as not having started a new drug or changed dosage within three (3) days or five (5) half-lives (whichever was longer) prior to administration of MNTX concomitant medication must either have conformed to the list of approved drugs and dosage or have been approved by the sponsor.
3. Patients with normal renal function, demographically comparable to the patients with impaired renal function weights and ages were within the range of chronic kidney disease (CKD) group and the average for the matched reference group was within 10 years and 10 kg of the average for the CKD
4. Patients with impaired renal function, good general health except for those illnesses associated with CKD.

Exclusion Criteria:

1. Subjects/patients with any conditions possibly affecting drug absorption (eg. Gastrectomy or clinically significant diabetic gastroenteropathy)
2. Methadone use
3. Consumption of grapefruit or grapefruit juice within seven (7) days prior to administration of study medication.
4. Patients requiring hemodialysis.
Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children

OBJECTIVES:

Compare growth of lead-poisoned children receiving succimer (dimercaptosuccinic acid; DMSA) plus standard treatment to those receiving standard treatment only.

PROTOCOL OUTLINE: This is randomized study. Patients are randomized to receive succimer in addition to standard treatment (arm I) or standard treatment only (arm II).

Succimer is administered orally 3 times a day for 7 days, then twice daily for 19 days. Patients may receive up to 3 courses.

Standard treatment consists of a medical history and physical examination, environmental assessment with modification to reduce lead exposure, dietary modifications to decrease lead absorption, the use of a daily multivitamin and mineral supplement with iron, developmental screening and intervention, and frequent follow up of lead levels.

If blood lead level rises above 45 mcg/dL, patient receives succimer regardless of treatment arm originally assigned.

Patients are followed every 3-4 weeks for 2 months, then every 3 months for 6 months, and then every 6 months thereafter.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Asymptomatic children with confirmed venous blood lead of at least 20 mcg/dL and less than 45 mcg/dL Children with blood lead of 45 mcg/dL or greater are not randomized in this study since they probably will receive succimer regardless of being enrolled in this study --Patient Characteristics-- Other: No contraindications to the use of succimer (i.e., allergy or a lack of lead safe environment in which to live during chelation)
Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease

The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751 in Parkinson's disease patients at early stage of the disease.

The B7601011 study has a randomized, double-blind, placebo-controlled parallel group design. Approximately 88 subjects will be randomized to 2 treatment groups. Each subject will participate in the study for approximately 23 weeks including a 30 day screening period, 15 week double blind treatment period, and an approximately 28 day follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Females of non-childbearing potential and/or male subjects
* Clinical diagnosis of Parkinson's disease.
* Parkinson's Disease Hoehn \& Yahr Stage I-III inclusive
* Treatment naïve or history of prior incidental treatment with dopaminergic agents for no more than 28 days
* Able to refrain from any Parkinson's disease medication not permitted by the protocol.

Exclusion Criteria:

* History or presence of atypical Parkinsonian syndrome.
* Severe acute or chronic medical or psychiatric condition or cognitive impairment or laboratory abnormality.
* Any condition possibly affecting drug absorption.
* Participation in other studies involving investigational drug(s), or treatment with any investigational drug within 30 days.
Galactose - the Ideal Carbohydrate Supplement for Exercise in Type 1 Diabetes

In this study, 14 subjects with type 1 diabetes are studied in a randomized crossover study in which the subjects cycle at a fixed intensity at 60% of their maximum oxygen capacity (VO2 max) for 1 hour. Thirty minutes before each cycling test, participants consume a 200 ml beverage, consisting of either: 1) dextrose (20 g), 2) galactose (20 g), 3) lactose (20 g) or 4) water (sweetened). If blood sugar drops below 3.9 mmol/l, glucose infusion is given and blood sugar is kept just above 5 mmol/L.

The trial days take place at least 4 days apart.

On study days, a catheter is placed in two antecubital veins for regular blood sampling and for glucose infusion (if needed). The participant will rest in a bed, when not performing the 1-hour bicycle ergometer test.

Thirty minutes before the leg-cycle ergometer test, the participants consume a 300 ml beverage containing either: 1) dextrose (20 g), 2) galactose (20 g) 3) lactose (20 g) or 4) water (sweetened). At t=0, the ergometer test is started and continued for 1 hour (fixed intensity cycling at 60% of VO2-max). If blood glucose drops below 3.9 mmol/l, glucose infusion (5 % glucose) will be administered, and blood glucose is kept just above 5 mmol/l and infused volume is registered.

Blood samples are collected at t= -40, 0, 30, 60, 90, 120 for measurement of plasma lactate, non-esterified fatty acids (NEFA), plasma triglyceride and hormonal concentrations (epinephrine, norepinephrine, cortisol, and glucagon). Plasma blood glucose measurements are performed at t = -40 and every 10-15 minutes until the end of the study day.

Respiratory exchange ratio is measured by indirect calorimetry (collection of respiratory gasses VO2 and VCO2) pre-exercise, at the end of the exercise bout, and 30 minutes post-exercise. Protein oxidation rate is estimated from urinary urea excretion, and net lipid and glucose oxidation rates are calculated from indirect calorimetry measurements with correction for protein oxidation. Therefor a urine sample will also be collected at the end of the study day.

The bicycle ergometer test is discontinued after 1 hour of bicycling and the participant is observed until 2 hour post exercise where the study day is ended.

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes for at least 2 years
* age between 18 and 65 years
* HbA1c less than 70 mmol/mol
* Physically active (at least 150 minutes of moderate-to-vigorous intensity activity weekly)
* Insulin pen and pump treatment
* Men and women are eligible, but women will have to perform study days in the mid-cycle phase of the menstrual cycle.

Exclusion Criteria:

* - Diabetic nephropathy, neuropathy, and proliferative retinopathy
* Hypoglycemia unawareness
* Lactose intolerance
* Heart disease and other conditions which may be negatively affected by the VO2 max test and 1-hour cycling on study days
Effectiveness of Aquamin® in Mitigating Halitosis

The purpose of this study is to assess whether Aquamin®, a multi-mineral natural product from red marine algae, can help reduce halitosis when taken for 90 days.

This is a sub-study to the ongoing clinical trial entitled: Aquamin®, a multi-mineral natural product from red marine algae, as an adjuvant intervention for mild ulcerative colitis and ulcerative colitis in remission (HUM00156676) NCT# NCT03869905.

However, the Food and Drug Administration (FDA) indicated that no Investigational New Drug Application (IND) was required.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to give written informed consent
* Willing to follow study procedures of no eating, drinking, toothbrushing, smoking or using mouth rinse 60 minutes before study visits
* Willing to not scrape their tongue with a toothbrush, oral hygiene aid, or other utensil during the study participation
* Periodontally stable
* Self-reported halitosis
* A negative pregnancy test for pre-menopausal women with intact female reproductive organs, and subject must agree to use appropriate birth control over the study period.

Exclusion Criteria:

* Pregnant or lactating women
* Participating in any other interventional trials using an investigational drug
* Diagnosed with any stomach or intestinal bleeding disorders (gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin secreting tumors) or active gastric / duodenal ulcers - peptic ulcer disease (in last 3 months) or with severe symptoms of ulcerative colitis or Crohn's disease
* Any gastrointestinal or colonic malignancy- Kidney disease, including kidney "stones" or hypercalcemia
* Coagulopathy/hereditary hemorrhagic disorders/or receiving therapeutic doses of Coumadin or heparin
* Presence of one or more cavitated carious lesions, untreated dental abscesses (endodontic or periodontal), untreated periodontitis (gum disease), or oral pathologies that may contribute to oral malodor (e.g., candidiasis, erosive gingival conditions)
* Taking any of the following within 30 days (will be eligible after completing 30 days of wash out period):

Calcium; Vitamin D, including multivitamins that have low amounts of calcium/Vitamin D supplements; Oral steroids; Non-steroidal anti-inflammatory medications (NSAIDS); Antibiotics.
Evaluation of Immunohistochemical Expression of Heparanase in Helicobacter Pylori-Associated Chronic Gastritis

Treatment of H.pylori may not be achieved in many patients with chronic gastritis. Termination of the inflammatory respose produced by h.pylori may be useful in management of difficult cases. Heparanase is a pro-inflammatory mediator. Blocking of heparanase may relief the symptoms of chronic gastritis.

Chronic gastritis (CG) is a very common disease. The incidence of CG is not accurately known. However, it is clear that the incidence of CG is increasing by advancing age. CG is divided into two main types; type A or immune and type B or non-immune gastritis. Both types of CG share the same histological features. However, type A is less common, usually affects the gastric fundus in a diffuse manner and separates the antrum. on the contrary; type B or non-immune CG, which is by far more common, inevitably develops in the antrum and progresses proximally. H. pylori-induced CG usually requires antibiotic therapy to eradicate the causative organism and subsequently terminate the inflammatory response and the symptoms of gastritis. However, eradication of H. pylori is difficult to be achieved in many patients. Previous studies established that there is a vicious circle between H. pylori-infected gastric epithelial cells and the gastric mucosal inflammatory cells. Heparanase (HPSE) is a mammalian ᵦ-endoglucoronidase. HPSE plays a critical role in multiple inflammatory processes by degrading and remodeling heparan sulfate polysaccharide chains in the extracellular matrix (ECM). This leads to release of multiple cytokines and chemokines which are located in the ECM. HPSE is a drug target, three inhibitors of this enzyme have been tested in early stage clinical trials. Many studies reported that the expression of HPSE is up-regulated in a variety of inflammatory conditions as ulcerative colitis, acute pancreatitis, acute vasculitis and sepsis. The aim of this work is to evaluate the role of heparanase (HPSE) in chronic gastritis (CG) by correlating the expression of HPSE to different histological features of CG as presence of H. pylori, chronic inflammatory infiltrate, gastric atrophy, intestinal metaplasia and neutrophil infiltrate (activity), to detect new treatment modalities in CG.

Eligibility Criteria:
Inclusion Criteria:

* patients with symptomatic chronic gastritis who underwent upper endoscopy.

Exclusion Criteria:

* patients with gastric carcinoma.
Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers

The purpose of this study is to determine whether SYL1001 is safe for the prevention and treatment of ocular pain and dry eye syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must provide signed inform consent prior to participation.
* BMI between 19,5 y 29 kg/m2.
* Normal ocular test in both eyes: IOP \</=21 mmHg. BCVAof \>/=0,8 (20/25)Snellen scale, or \</=0.1 LogMar.
* Normal fluorescein Clearance Test in both eyes.
* Normal funduscopy in both eyes.

Exclusion Criteria:

* Pregnant or breastfeeding females or those with a positive pregnancy test or who will not use a medically acceptable contraceptive method from selection and during the study.
* Current relevant disease.
* Previous chronic processes or with rebound characteristics that could interfere with study according investigator's judgment.
* Volunteers who have received pharmacological treatment, including medicinal plants, during the four weeks previous to beginning the study.
* Having used corticoids sporadically in the last 30 days whichever the route aof administration, or any med by ocular or nasal administration route.
* Case history of hypersensitivity to meds or any other allergic process.
* Visual alterations: previous eye surgery, glaucoma, use of lenses, uveitis or ocular surface pathology (dry eye, blepharitis).
* Volunteers with visual alteration with more than 3 dioptres in either eye.
* Volunteers who has participated in a clinical trial during the past fout months before study entry.
* Blood or derivate transfusion during the six previous months to study entry.
* Case history of drug or alcohol abuse or dependence.
* Positive result in test drug abuse during selection period.
* positive serology results to hepatitis B virus(HbsAg), virus C o VIH.
* Analytic alterations medically relevant, at investigator's judgement.