cyrilzakka/clinical-trials huggingface dataset:
Weekly Paclitaxel and Cyclophosphamide in Metronomic Administration : Dose Escalation Study of Weekly Paclitaxel

The aim of the study is to determine the MTD of Paclitaxel in association with metronomic Cyclophosphamide.

The aim of the study is to determine the MTD of Paclitaxel in association with metronomic Cyclophosphamide for cancer which present no therapeutic solution

Eligibility Criteria:
Inclusion Criteria:

* Patient with cancer histologically proved
* No other therapeutic proposal after discussion in multidisciplinary consultation
* Radiological evidence of the evolving nature of the disease
* Measurable disease with at least one measurable lesion according to the criteria RECIST 1.1
* At least 28 days since prior treatment(systemic treatment or major surgery)
* Patient who have recovered from any previous toxicity
* Man or woman de ≥ 18 years and ≤ 65 years
* Performance Status (ECOG) ≤ 2 within 7 days before inclusion
* Polynuclear neutrophils ≥ 1500/mm3, platelets ≥ 100 000/mm3, Hemoglobin ≥ 9 g/dl
* Serum Albumin ≥ 36 g/l and lymphocytes ≥ 700/mm3
* Total bilirubin and SGPT/ALT and SGOT/AST ≤ 3 ULN(≤ 5 ULN if liver metastases)
* Creatinine in normal ranges and Creatinine clairance \> 60 ml/min (Cockroft formulae)
* Central venous access
* Negative pregnancy test for women who may be pregnant within 7 days before inclusion
* Effective contraceptive during the treatment period and up to 6 months after the end of treatment (for patients of both sexes during their reproductive and child-bearing age and their partners)
* Patient covered by government health insurance
* Informed consent signed by the patient before any specific study procedure

Exclusion Criteria:

* Prior treatment by Paclitaxel
* Oral treatment impossible
* Known dysphagia, malabsorption or maldigestion
* Pre-existing neuropathy clinically symptomatic
* Known leptomeningeal brain metastases
* Known allergy to Cremophor, to Paclitaxel or one of its excipients (especially polyoxyethylene castor oil), to Cyclophosphamide or one of its excipients (lactose, sucrose)
* Active and uncontrolled infection
* Acute urinary tract infection, pre-existing hemorrhagic cystitis
* Diabetes insipidus
* History or progressive psychiatric illness
* Persons under guardianship or detainees
* Unable for medical follow-up (geographic, social or mental reasons)
* Pregnant, or likely to be or breastfeeding women
* Absence of effective contraception for the duration of treatment and 6 months after completion of therapy (for patients of both sexes in childbearing or reproductive age and their partners)
The Effect of Phosphatidylserine on Time Trial Performance in Trained Male Cyclists

Phosphatidylserine is a phospholipid found in high concentrations in the brain and nervous tissues along with naturally occurring in many foods. It has been extensively studied for its effects on improving cognitive function, learning, memory and alleviating stress. However, more recently it has been proposed that phosphatidylserine could improve exercise capacity. The mechanisms of proposed action are difficult to distinguish because of the limited research and therefore the purpose of this study is to identify the proposed mechanism of action of phosphatidylserine supplementation and to establish whether these mechanisms will have an effect on time trial performance in trained male cyclists.


Eligibility Criteria:
Inclusion Criteria:

* Cyclists
* Maximum oxygen uptake of at least 55 mL/kg/min

Exclusion Criteria:
Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis

The study is a randomised control trial to assess the visual and clinical outcomes of collagen cross linking in fungal keratitis. Fungal keratitis is a major cause of corneal blindness in India and the therapeutic options available are minimal to handle the advanced complications and sequalae caused by the disease.The antimicrobial and tissue remodeling role of corneal cross linking was demonstrated by several studies earlier,we anted to specifically assess the role of corneal cross linking in non resolving fungal keratitis in prevention of perforation and enhancement of healing process.

Patients with culture positive deep stromal fungal keratitis not responding to appropriate medical therapy for a period of two weeks were randomized to receive or not receive adjuvant CXL. The medical therapy was continued in both the groups and were followed up for 6 weeks after randomization. Healing of the ulcer was taken as successful outcome, while perforation and increase in ulcer size of more than 2 sq.mm from the baseline was considered as treatment failure.

Eligibility Criteria:
Inclusion Criteria:

* Ulcer size more than 5 mm
* Ulcer depth upto 70% of stromal depth
* Corneal thickness of 400 microns and above

Exclusion Criteria:

* Corneal thickness of below 400 microns
* Ulcers involving the limbus
* Pregnant women
* Children below the age of 18 years
Resect and Discard Strategy in Clinical Practice

Nowadays, post-polypectomy surveillance intervals are determined by combining endoscopic and pathologic data. Real-time imaging technologies, have shown promising results in discriminating adenomatous from non-adenomatous polyps.

The "resect and discard strategy" for small polyps (based on real-time assessment of the histology and on the endoscopic resection without pathological examination) has been shown to be cost-effective in simulation models. No data exist about the impact of this strategy in clinical practice.

The aim of present study was to assess whether the systematic use, in the everyday clinical practice, of the "resect and discard strategy" allows to correctly manage patients with small colonic polyps.


Eligibility Criteria:
Inclusion Criteria:

* consecutive adult outpatients undergoing colonoscopy for routine clinical indications

Exclusion Criteria:

* surveillance interval was not necessarily directed by endoscopic findings (history of colorectal cancer, inflammatory bowel disease, hereditary polyposis syndromes, hereditary non-polyposis colorectal cancer)
* colonoscopy was performed without NBI technology
* at least one lesion \> 10 mm or \< 10 mm but with morphologic features suspect for malignancy (depressed or ulcerated lesions) was detected
* bowel preparation was inadequate
* caecal intubation was not accomplished
* polyps could not be resected for concomitant anticoagulation treatment, 7) polyps were resected but not retrieved for pathology.
Efficacy of Traumatic Memory Modification Using Memory Reconsolidation and Propranolol Among Adolescents With PTSD

The aim of this study is to demonstrate the effectiveness of propranolol in blocking reconsolidation by reducing PTSD symptoms in the short and long term in adolescents with PTSD for more than 3 months.


Eligibility Criteria:
Inclusion Criteria:

* - Adolescents aged 12 to 18 years;
* Exposed to a single traumatic event or to events circumscribed in time, including sexual abuse in the absence of reminders in the environment;
* Fluent in French;
* Positive diagnosis of PTSD with the SCID-5;
* Disorders evolving for at least three months;
* Heart rate ≥ 55 bpm;
* Systolic blood pressure ≥ 100 mmHg;
* Written parental or legal guardian consent;
* Written agreement by the adolescent;
* Adolescents affiliated, via their parents, to the French social security body.

Exclusion Criteria:

* - Medical condition contraindicating administration of propranolol (COPD, asthma, cardio-vascular insufficiency, heart failure as second- and third-degree atrioventricular blocks, Prinzmetal angor, pheochromocytoma, Raynaud disease, history of an anaphylactic reaction, sinus node disease, hypoglycemia, AV blocks)
* Known chronic renal or hepatic insufficiency
* Schizophrenia;
* Mental retardation;
* Autism spectrum disorder;
* Acute severe suicidal ideation
* Traumatic brain injury (loss of consciousness \> 10 minutes);
* Currently treated for substance or alcohol dependence;
* Currently treated for Attention Deficit Hyperactivity Disorder;
* Currently treated with a drug that can interfere with propranolol and that can represent a danger according to medical advice if it's suspended more than 24 hours.
* Currently treated with a bradycardic drug;
* Concurrent psychotropic medication with the exception of cyamemazine (suspended 48 hours before session)
* Concurrent trauma-focused psychotherapy in progress or stopped less than 1 month ago;
* Pregnancy or breast feeding.
* Current use of "recreative" toxic drugs
* Concurrent participation to another interventional study
Post-marketing Surveillance Study of Ex-intravenous Drug Abusers With Chronic Hepatitis C Treated With PegIntron Plus Rebetol (P04408/MK-4031-261)

Previous intravenous drug abusers with chronic hepatitis C who are under substitution therapy (buprenorphine, methadone) will be treated with PegIntron and Rebetol according to the approved European labeling. The study will assess the tolerability, safety and efficacy of the treatment with PegIntron plus Rebetol in this study population. The objective of the study is to collect data on the prevalence of the hepatitis C infections in drug-substituted patients. The study will also compare the feasibility of HCV (Hepatitis C Virus) treatment in patients receiving Subutex® vs other drug substitution pharmacotherapies.


Eligibility Criteria:
Inclusion Criteria:

* Treatment-naïve participants or relapsers to interferon monotherapy
* Participants with chronic hepatitis C infection
* At least 18 years of age
* Must meet the following laboratory criteria:

  * Platelets \>=100,000/mm\^3
  * Neutrophil count \>=1,500/mm\^3
  * TSH (thyroid stimulating hormone) within normal limits
  * Hemoglobin \>=12 g/dL (females); \>=13 g/dL (males)
* Ex-intravenous drug abusers who are under stable substitution therapy
* Women of childbearing potential must practice adequate contraception and have a routine pregnancy test performed monthly during treatment and for 7 months post-treatment.
* Sexually-active participants must be practicing acceptable methods of contraception during the treatment and for 7 months post-treatment

Exclusion Criteria:

* Any contraindications specified in the SPC (Summary of Product Characteristics) and approved European labeling
* Hypersensitivity to the active substance or to any interferons or to any of the excipients
* Pregnant women
* Women who are breast-feeding
* Existence of or history of severe psychiatric condition, in particular severe depression, suicidal ideation or suicide attempt
* A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous 6 months
* Severe debilitating medical conditions, including participants with chronic renal failure or creatinine clearance \<50 mL/min
* Coinfection with HIV (Human Immunodeficiency Virus)
* Autoimmune hepatitis or history of autoimmune disease
* Severe hepatic dysfunction or decompensated cirrhosis of the liver
* Pre-existing thyroid disease unless it can be controlled with conventional therapy
* Epilepsy and/or compromised central nervous system function
Intraocular Pressure Control After Anterior Segment Laser - Comparison Between 2 Drugs

The purpose of this study is to compare the intra-ocular (IOP) control efficacy between brimonidine 0.1% vs. 0.2% after laser peripheral iridotomy (LPI).

Postoperative IOP elevation is one of the most common complications after LPI.Previous studies showed that brimonidine 0.2% is effective in blunting IOP spikes after LPI.This prospective randomized double-masked interventional study will include patients with bilateral narrow angles, defined by irido-trabecular contact in \>180o on gonioscopy.Pilocarpine 1% will be used in both eyes, and 30 minutes later, brimonidine 0.1% randomly used in one eye and brimonidine 0.2% in the contra-lateral eye. LPI with Nd:YAG laser is performed 30 minutes later in both eyes by a single glaucoma specialist. IOP measurements are assessed before the use of any eyedrop (basal IOP), 30 minutes after pilocarpine (pre-brimonidine), and 30, 60, 120, 180 minutes after LPI. Pachymetry, ultrasonic biometry, gonioscopy, and total YAG laser energy are recorded. Non-parametric test will be used for analysis.

Eligibility Criteria:
Inclusion Criteria:

* bilateral narrow angles, defined by irido-trabecular contact in \>180o on gonioscopy

Exclusion Criteria:

* previous cataract surgery
Study of Retinal and Choriocapillary Vascular Changes in Patients Undergoing Tadalafil 20mg

This study evaluates the retinal and choriocapillary vascular features in patients under the effects of Tadalafil 20mg using optical coherence tomography angiography.

Tadalafil is a an inhibitor of the enzyme phosphodiesterase and it works by increasing blood flow to the penis thus promoting the erection.

This drug represents an treatment for erectile dysfunction in patients after radical prostatectomy.

The optical coherence tomography angiography represents a novel and non-invasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features.

The study evaluates the changes in optical coherence tomography angiography parameters at baseline and after 1, 3, 6 months after the somministration of Tadalafil 20 mg orally.

Eligibility Criteria:
Inclusion Criteria:

* age older than 45 years
* diagnosis of erectile dysfunction due to surgery of radical prostatectomy
* treatment-naïve with Tadalafil for erectile dysfunction
* absence of vitreoretinal and vascular retinal diseases
* absence of diabetes

Exclusion Criteria:

* age younger than 45 years
* diagnosis of erectile dysfunction due to other causes
* previous treatments before Tadalafil for erectile dysfunction
* presence of vitreoretinal and vascular retinal diseases
* presence of diabetes.
Evaluation of the Effectiveness of Montelukast in Children With Recurrent Obstructive Bronchitis

The aim of the study was to evaluate the effectiveness of montelukast sodium in the treatment and prevention of recurrent obstructive bronchitis in children. The investigators examined 80 children aged 1 to 7 years with recurrent obstructive bronchitis, who were randomly divided into 2 groups.

The aim of the study was to evaluate the effectiveness of montelukast sodium in the treatment and prevention of recurrent obstructive bronchitis in children. The investigators examined 80 children aged 1 to 7 years with recurrent obstructive bronchitis, who were randomly divided into 2 groups. Group I (control) included 40 patients who received standard therapy and placebo. Group II (main) included 40 patients who received standart therapy and oral montelukast sodium.

Eligibility Criteria:
Inclusion Criteria:

* RDA score=6 points
* E:I index score \>1.40
* ineffective treatment at home for ≥48 hours
* adverse comorbidities

Exclusion Criteria:

* chronic or congenital diseases of the Central nervous, cardiovascular and bronchopulmonary systems
Safety and Efficacy of the GlucoMe APP in Patients With Uncontrolled Diabetes Treated With MDI

The study will evaluate the safety and efficacy of computerized GlucoMe App in patients with uncontrolled diabetes treated with MDI.

GlucoMe is an interactive system, which provides glucose management tools to both the patient and health care team (HCT). The system includes a decision support system to be used by the HCT aiming to aid clinical decision making with mathematical models. The system does not intend to replace clinical judgement and all recommendations are to be approved by the HCT.

Forty (40) diabetic patients on multiple daily insulin injection (MDI) with abnormal HbA1c and identified as potential end users of the device will be recruited to the study and screened according to the study inclusion and exclusion criteria. Patient's daily blood glucose will be measured and the GlucoMe App will give its recommendations for change in insulin dose, as well as recommendations for pre and post-meal carbohydrate and exercise. Patient's daily blood glucose levels will be followed by the HCT biweekly for 12 weeks and patients will be instructed to change their insulin doses according to the decision of the treating physician. At the end of the study, the HCT's recommendations for treatment adjustment will be compared to those of the system for both safety and efficacy. Study subjects and the HCT will be asked to complete a questionnaire regarding the GlucoMe system usability.

Eligibility Criteria:
Inclusion Criteria:

1. Both type 1 and type 2 diabetes
2. HbA1c 7-11%
3. Treated with MDI for at least 3 months
4. Ability to use the system at home, mobile phone

Exclusion Criteria:

1. Active CAD, CVA during last 6 months
2. Treatment with steroids or other glucose modifying drugs
3. Chronic infection/cancer/other severe disease
Comparing Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 Versus Placebo for the Preventive Treatment of Chronic Migraine

The study is being conducted to evaluate two doses of TEV-48125 in adult patients with chronic migraine


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18 to 70 years, inclusive, with migraine onset at ≤50 years of age
* Patient signs and dates the informed consent document
* Patient has history of migraine according to International Classification of Headache Disorders, or clinical judgment suggests a migraine diagnosis
* 85% e-diary compliance
* Total body weight between 99 and 250 lbs, inclusive

  * Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* Clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease, at the discretion of the investigator
* Evidence or medical history of clinically significant psychiatric issues, including any suicide attempt in the past, or suicidal ideation with a specific plan in the past 2 years
* History of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological \[eg, cerebral ischemia\], peripheral extremity ischemia, or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events), such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism
* Known infection or history of human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection
* Past or current history of cancer in the last 5 years, except for appropriately treated nonmelanoma skin carcinoma
* Pregnant or nursing females
* History of hypersensitivity reactions to injected proteins, including monoclonal antibodies
* Participation in a clinical study of a new chemical entity or a prescription medicine within 2 months prior to study drug administration or 5 half-lives, whichever is longer

  * Additional criteria apply, please contact the investigator for more information
Improving Asthma Outcomes Through Spirometry Distance Learning

Spirometry is a recommended component of asthma diagnosis and treatment in the primary care setting, yet few providers report its routine use for children with asthma. Misclassification of asthma severity occurs when assessment is based on symptoms alone. This misclassification can lead to inadequate treatment, increased morbidity, and increased healthcare utilization/cost.

The goal of this study is to test the effectiveness of a distance learning quality improvement program called Spirometry 360 developed by the interactive Medical Training Resources (iMTR) group at the University of Washington Child Health Institute. The Spirometry 360 program aims to improve care for children with asthma by enhancing provider knowledge and self-efficacy related to the use and interpretation of office-based spirometry.

The Spirometry 360 program includes:

1. "Spirometry Fundamentals™: A basic guide to lung function testing," a computer-based training program that teaches primary care providers how to coach patients to produce high-quality spirometry tests and accurately interpret spirometric data;
2. Spirometry Learning Lab: Case-based teaching of spirometry in practice guides test administrators and interpreters through clinical examples in an interactive virtual classroom setting. These sessions are led by expert clinical faculty and are archived for future reference and review;
3. Spirometry Feedback: Tailored analysis of providers' spirometry testing sessions offers monthly individualized feedback reports by clinical experts on spirometry tests performed in the clinic.

This is a cluster randomized controlled trial to test the effectiveness of the Spirometry 360 program. The Spirometry 360 program will be provided to 25 primary care pediatric practices from two practice-based research networks. A separate group of 25 matched control practices recruited from these same networks will receive standard training from the equipment vendor during the study and the Spirometry 360 training program at the end of the study.

Eligibility Criteria:
Inclusion Criteria (Parent):

* Parents must have a child who has had at least one visit for asthma with a participating provider during the 12 months before the study start date
* Must have monthly access to email and the Internet
* Must have child aged 5-16 years

Inclusion Criteria (Child):

* Aged 5-16 years
* Must have access to email and the Internet

Exclusion Criteria (Parents):

* Parents with children who are outside our target age range of 5-16 years old
* Parents with children who haven't had a clinic visit for asthma care in the last year
* Parents without monthly access to the Internet

Exclusion Criteria (Child):

* Children who are outside our target age range of 5-16 years
* Children without monthly access to email and the Internet
Effect of Anaesthesia on ER Stress in Cancer Patients

Investigate the change in endoplasmic reticulum stress after cancer surgery according to different anaesthetics including propofol and sevoflurane.

We hypothesize propofol and sevoflurane based anesthesia would show different pattern of endoplasmic reticulum stress after cancer surgery in patients with cancer

Eligibility Criteria:
Inclusion Criteria:

- patients with cancer

Exclusion Criteria:

* age under 19 years old
* allergy history to propofol or sevoflurane
* history of previous cancer