cyrilzakka/clinical-trials huggingface dataset:
Treatment of Early Systemic Sclerosis by Bosentan

Systemic sclerosis (ssc) is characterised by extensive tissue fibrosis. Using drugs that are capable of inhibiting fibroblast activity may be beneficial if administrered early in the disease course. Thirty adult patients with early SSc will be treated with the endothelin-1 antagonist bosentan for 6 months.Disease progression will be assessed.

Systemic sclerosis (SSc) is characterised by obliterative vasculopathy and extensive fibrosis. The accumulation of extracellular components in the extracellular matrix is mostly due to increased activity og tissue fibroblasts. The proliferation and hyperactivity of the fibroblasts may be caused by enhanced production of several cytokins, among them endothelin-1.The activity of endothelin-1 has been shown to be increased both in the circulation and within skin lesions. Endothelin-1 has several distinct properties, among them profibrotic activity, inflammatory and vasoconstriction.Thus, the actions induced by endothelin-1 may be a potensial target for the therapy of SSc.

Thirty patients with early SSc, that is of less than 12 months duration will be offered six months of treatment with the oral dual endothelin-1 antagonist bosentan. Assessment of disease progression will be performed at 3, 6, 9. 12 and 24 months using clinical, histological and immunohistochemical methods.

Eligibility Criteria:
Inclusion Criteria:

* Early systemic sclerosis

Exclusion Criteria:

* Age \> 70 or \< 18
* Pregnancy
* Nursing
* HIV
* Hb \< 8.5 g/l
* Systolic blood pressure \< 85 mmHg
* Lack of compliance
* Liver disease
* Hypersensitivity to bosentan
* Concurrent us of glibenclamide, ciclosporine A or tacrolimus -
Risk of Acute Kidney Injury Among Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatments

The purpose of this study is to compare the incidence of hospitalization for acute kidney injury among patients with type 2 diabetes who are new initiators of Saxagliptin and those who are new initiators of other oral antidiabetic drugs in classes other than Dipeptidyl peptidase IV (DPP4) inhibitors.

Prospectively designed retrospective database study. This study will be conducted using administrative claims data and electronic medical records that are collected as part of routine clinical practice.

This will be a prospectively-designed database cohort study comparing hospitalizations for acute kidney injury among new initiators of Saxagliptin compared to those who are new initiators of OADs in classes other than DPP4 inhibitors. The study time frame will be from 2009 through 2014.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Newly prescribed Saxagliptin or an OAD in a class other than DPP4 inhibitors
* Enrolled in the respective database for at least 180 days prior to the first prescription of new OAD

Exclusion Criteria:

* Patients identified with a diagnostic code for acute kidney injury within the 180-day baseline period
* Patients with DPP4 inhibitor exposure during the baseline period
* Patients currently using Exenatide or Insulin
Comparison of Customized and Standard Total Ankle Prostheses

The objective of this study is to compare primary total ankle replacement (TAR) performed with a customized procedure (prostheses customized for each patient based on his or her ankle morphology reconstructed from tomographic scans, and implanted via cutting guides customized for the patient) with standard primary TARs, considering: objective radiological results, subjective patient outcomes, and overall costs of both procedures


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects older than 40 years and younger than 75 years (≥ 40 age ≤ 75 years) with arthrosis at the unilateral tibio-tarsal joint who are candidates for primary total ankle replacement.
* Consenting patients and able to complete scheduled study procedures and follow-up evaluations.
* Patients who have signed the "informed consent" approved by the Ethics Committee.

Exclusion Criteria:

* Social conditions (homeless patients, with restrictions on personal freedom)
* ASA 3 and 4
* Deep venous insufficiency Lower limbs
* History of Erisipelas lower limbs
* Neurological or psychocognitive disorders
* neurological diseases
* Axial deformities of ankle \>15°
* Personal or family history of DVT or EP
* Prosthetic and/or arthrodesis surgeries at another lower extremity joint except that candidate for ankle prosthesis)
* Pregnant women
* Patients with rheumatic diseases
* Patients that requires ancillary surgical procedures
Growth Hormone Deficiency in Chronic Heart Failure: an Observational Study

Aim of this study is to define the possible detrimental effect of a lack of growth hormone, on the well-being and life expectation of patients affected by heart failure.

Growth hormone and its main effector IGF-1 have well-documented roles in the regulation of cardiac and circulatory function. Evidence suggests that GH/IGF-1 exert a beneficial effect on cardiac load, cardiac growth and remodeling, despite their hypertrophying action. Several studies in the last years have demonstrated worse cardiovascular outcomes in adult patients with GH deficiency and/or low levels of IGF-1.

A wide range of alterations in the GH/IGF-1 axis have been described to date in patients with chronic heart failure (CHF): reductions in GH levels, reductions in IGF-1 and a pattern of peripheral resistance to GH, in particular in patients with severe heart failure and cardiac cachexia. Our study hypothesis is that an actual status of GH deficiency coexists with CHF in a large percent of patients, and that it may represent a predictor of worse functional status and possibly of a worse prognosis. Aim of this study is to explore the latter hypothesis, comparing the clinical and functional evolution of patients with CHF and GHD with that of a general CHF population.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Heart Failure: NYHA class II to IV, ACC/AHA stage C/D
* Left ventricular end diastolic diameter \>60 mm
* Left ventricular ejection fraction \< 40%
* Clinical stability, guideline-oriented top pharmacological therapy
* Informed consent

Exclusion Criteria:

* Active Myocarditis
* Hypertrophic Cardiomyopathy
* Active endocarditis
* Active malignancy
* End stage renal disease
* Severe liver disease (Child B-C)
Induced Physiological Ketosis in Asthenia and\or Decreased Tolerance to Physical and\or Mental Exertion

The purpose of this study is evaluating of efficacy of innovative dietary strategy -stimulation of physiological ketosis with Liquid Technology Formula PanTrek, in patients with asthenia and or decreased tolerance to physical and\\or mental exertion. PanTrek is a liquid formula of potassium and magnesium salts of beta-oxibutiric acid, ginsenosides and rosmarinic acid.

It will be double-blind, placebo-controlled study in 88 patients of both sex, aged from 18 to 65. Patients will be randomly assigned to one of two groups: placebo or IP group in 1:1 proportion. Study instruments: D-Fis, MoCA, TMT, VAS, assessment of blood keton concentration before and after first and last administration per os of 25 ml of placebo or PanTrek. PanTrek will be served in ampuls, 25 ml per ampule.

The duration of the study will be 15 days of treatment and 15 days of follow-up observation.

Patients will be assessed at screening/baseline, after 15 days and after 30 days.

The dose regimen: the shot of PanTrek, 25 ml, will be administered per os, twice per day, in the morning and in the evening, per se or deluted in 100 ml of water one hour before or after meal.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* diagnosis of astenia and/or decreased tolerance to physical and\\or mental exertion
* ability of patients to understand assessment procedures

Exclusion Criteria:

* intollerance of components of PanTrek
* participation in other trials
Factors Affecting Surgical Recovery in Hospital Patients

The objective of this observational study is to elucidate the factors influencing adverse postoperative outcomes in hospitalized surgical patients. The primary questions addressed are:

What factors contribute to the occurrence of adverse outcomes following surgery? How can the risks be mitigated to achieve improved postoperative outcomes?


Eligibility Criteria:
Inclusion Criteria:

* The study population consisted of all patients who had undergone surgery, with no instances of severe data missingness.

Exclusion Criteria:

* Missing data were identified where the rate of missingness was greater than 20%
An Observational Study to Describe in Routine Clinical Practice the Treatment Patterns of Usage of Biological DMARDs in RA Patients.

This observational study will describe the treatment patterns of usage of biological DMARDs in routine clinical practice and the demographics and RA disease characteristics in patients suffering from rheumatoid arthritis. Patients will be recruited and examined the same day when recruited. There will be no follow up visit or treatment period only one visit in this study.


Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years of age.
* Patients with a diagnosis of RA according to the revised ACR criteria.
* Patients receiving treatment of launched biological DMARDs.

Exclusion Criteria:

* Patients who received biological DMARDs due to clinical trials or biologics not launched.
* Patients who are considered not appropriate for study due to other reasons at physicians' discretion.
A Comparison of Two Daily Disposable Soft Contact Lenses

Approximately 120 subjects will be comparing two soft contact lenses for one week each.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must read, understand, and sign the Statement of Informed Consent, and receive a fully executed copy of the form.
2. The subject must be appear able and willing to adhere to instruction set forth in this clinical protocol.
3. The subject be between (and including) 18 and 39 years of age.
4. The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day worn for at least 30 days immediately preceding the study.
5. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 to -6.00 D in each eye.
6. The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

1. Currently pregnant or breastfeeding (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any autoimmune disease or use of any medication, which may interfere with contact lens wear.
4. Entropoin, Ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
5. Any previous, or planned ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
6. Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related inflammatory event (e.g. past peripheral ulcer or round scar), or any other ocular abnormality that may contraindicate contact lens wear.
7. Any ocular infection.
8. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
9. Monovision, multifocal, toric, or extended wear contact lens correction.
10. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
11. History of binocular vision abnormality or strabismus.
12. Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV) by self-report.
Therapeutic Literacy Evaluation in Liver Transplanted Patients

Health literacy is a new concept in therapeutic patient education. Health Literacy has been defined as the cognitive and social skills which determine the motivation and ability of individuals to gain access to, understand and use information in ways which promote and maintain good health. Health literacy seems predictive of adherence 's patients to treatment or positive health behavior.

Liver transplanted patients need to modify their lifestyle and to perform new behaviors in order to improve their survival and their quality of life. Health literacy evaluation in these patients is necessary to know what they understand and to improve their intake.

The Aim of the study is to evaluate health literacy among liver transplanted patient and to perform liver transplanted patient profiles related to their own health literacy.

The second aim is to study the impact of health literacy on medication adherence and iatrogenic hospitalizations It is a monocentric non-randomized study. During the hepatologist consultation, the HLQ Health Literacy Questionnaire is performed to explore patient health understanding and perception. Then the pharmacist interviews the patient to explore motivations and brakes for their own healthcare; Furthermore, a cognitive and precarity evaluation is performed in order to analyze psychological or social factors which can influence health literacy.

Tests performed:

* Health Literacy Questionnaire: HLQ
* Montreal Cognitive Evaluation Assessment: MoCA
* EPICES: precarity test validated in French
* A qualitative interview

Eligibility Criteria:
Inclusion Criteria:

* Adult patient \> 18 years
* Liver transplanted patient \> 1 year at the start of the study
* patient who are followed-up by an hepatologist in the center
* patient who understands and speaks French

Exclusion Criteria:

* patient not yet liver transplanted (on the waiting-list)
* patient who has not come back home yet
* patient who does not speak or understand French
* patient refusal to participate
* patient under supervision or guardianship
Bone Marrow Aspirate Concentrate in Treating Mandibular Cystic Defects

Mandibular cystic defect healing is a complex process. Various methods have been developed to shorten the bone regeneration time and improve its quality. Autogenous grafting is the gold standard for filling cystic defects due to the osteogenesis property provided by the viable cells but is related to donor site morbidity. Allografts and Xenografts are used for the same purpose. However, the increased cost is their main disadvantage. Bone marrow aspirate concentrate is now used to enhance the healing and regeneration process in many areas of the body with no morbidity and low cost.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from mandibular cystic defect.
* Cystic defect width of 4-8 cm that requires removal under general anesthesia.

Exclusion Criteria:

* Medically compromised patients contradicting operation.
* Previously enucleated lesions.
* Previous surgery, tumor, infection to the pelvis affecting the anterior iliac crest.
* Infected Cysts
Prognostic Role of Minimal Residual Disease in Acute Myeloid Leukemia

Study purpose is to assess the prognostic role of Minimal Residual Disease (defined as medullary expression of WT1 gene), performed at Baseline and during treatment according to clinical practice. MRD results will be relate to treatment outcome and survival analysis variables (Overall Survival, Disease Free Survival, Cumulative Incidence of Relapse)


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Acute Myeloid Leukemia
* Age \> 18 years
* Intensive chemotherapy as first line curative treatment
* Observation period: March 2004 - September 2014
* Bone marrow WT1 expression and Immunophenotyping by multi-parametric flow cytometry performed at baseline
* Written informed consent

Exclusion Criteria:

* Diagnosis of Acute Promyelocytic Leukemia
* Bone marrow WT1 expression and Immunophenotyping by multi-parametric flow cytometry NOT performed at baseline
* Patient ineligible to intensive chemotherapy
Intracutaneous Delivery of Varied Dose Volumes of Saline

This study will evaluate intracutaneous delivery of 0.1, 0.25 and 0.5 milliliter volumes of saline from the FLUGEN 101.2 investigational microneedle-based device.

An intracutaneous delivery device will be evaluated for ability to inject various volumes of saline into subjects skin.

Eligibility Criteria:
Inclusion Criteria:

* Able to read and/or understand and sign the Informed Consent form

Exclusion Criteria:

* Medical history of acute or chronic skin disease
* Active skin allergy or acute skin infection, presence of tattoo(s), scars, sunburn or skin abnormalities at any prospective injection site
* Hirsute at any prospective injection site
* Diabetes
* High levels of anxiety or depression or history of psychosis
* Abuse of alcohol or use of other drugs of abuse including tobacco
* Pregnant or breastfeeding women
* Any medical condition that may interfere with study protocol adherence including completion of study activities
* Foreseeable inability to complete the study as scheduled.
Erlotinib Re-Challenge for Recurrent EGFR-mutant Lung Cancer in Patients Who Previously Received Adjuvant Erlotinib or Gefitinib

The purpose of this study is to measure the ability of erlotinib to effectively treat recurrent lung cancer which carries an EGFR mutation lung cancer after prior treatment with erlotinib or gefitinib received in the post-surgical or post-radiation setting.


Eligibility Criteria:
Inclusion Criteria:

* A history of stage I-IIIB NSCLC
* Previously underdone definitive surgery or radiation
* Received prior adjuvant treatment or neoadjuvant with erlotinib or gefitinib for a total of at least 3 months at any time
* Stopped adjuvant erlotinib or neoadjuvant at least 2 months prior to date of first imaging demonstrating recurrence
* Pathologic evidence of recurrent lung cancer, confirmed at MSKCC EGFR sensitizing mutation (point mutation in exons 18 or 21, or deletion in exon 19) must be documented in the primary or recurrent tumor
* Tissue from their recurrent tumor must be submitted for EGFR mutation testing, and to evaluate for the presence of the T790M mutation (results do not need to have been reported to be eligible)
* Measurable disease by RECIST; if received prior irradiation, then must have a target lesion outside the irradiated field
* Signed informed consent
* Age \> or = to 21 years old
* Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped

Exclusion Criteria:

* Prior progressive disease while receiving erlotinib or gefitinib therapy
* Patients with known pre-existing interstitial lung disease
* Total bilirubin greater than 1.8 mg/dl, excepting patients known to have Gilbert's syndrome
* AST or ALT greater than five times the upper limit of normal
* Pregnant or lactating women
* Medically unfit for erlotinib therapy as determined by treating oncologist
Contactless Detection of Sleep Apnea

In this study the inestigators aim to validate the performance of Sleepiz One+ for sleep apnea detection during routine diagnostic sleep studies. Patients who are prescribed polysomnography study will be asked to participate and undergo a simultaneous sleep recording with radar sensor-based device.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18years
* Ability and consent to undergo electrophysiological routine assessment
* Patients suspected to suffer from sleep apnea or any other sleep related disorder

Exclusion Criteria:

* Previous enrollment into the current study,
* Enrollment of the investigator, his/her family members and other dependent persons
* Cardiac pacemaker or another implanted electrical device
* Women who are pregnant or breastfeeding
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, delirium etc. of the participant
Diet and Physical Activity Program for Type 2 Diabetes Mellitus

An individualized educational intervention are going to be developed. Its based on the COM-B model, designed and applied by Primary Care nursing professionals for patients with type 2 diabetes mellitus. Its expected that participants, after a 6 month intervention, face to face and telephone, will improve their adherence to healthy behaviors related to diet and physical activity, their quality of life and the glycosylated hemoglobin figures.


Eligibility Criteria:
Inclusion Criteria:

* Be cared for by one of the nurses participating in the research team
* Ability to complete the questionnaire
* Sign the informed consent
* Keep the Primary care health center during till the end of the research
Improving Followup of Abnormal Colon Cancer Screening Tests

The purpose of this study is to determine whether direct mailings to patients with positive fecal occult blood tests can increase rates of performing followup colonoscopy.

Screening programs using the fecal occult blood test (FOBT) have demonstrated a significant reduction in colorectal cancer mortality, although only when accompanied by a complete diagnostic evaluation of the colon in the setting of a positive result. 90% of patients with a positive FOBT result have completed a subsequent colonoscopy within Harvard Vanguard Medical Associates. This project will use a pre-post study design to increase the rate of followup colonoscopy in the setting of positive FOBT results. Patients in the intervention group will receive a personalized mailing highlighting their positive result and need for colonoscopy, followed by telephone outreach from a centralized gastroenterology scheduling office. The primary outcome will be the performance of colonoscopy, however we will also perform chart reviews to identify predictors of completing appropriate followup.

Eligibility Criteria:
Inclusion Criteria:

* Patients with positive fecal occult blood test during 2004, 2005, and 2006; and no colonoscopy following this test result

Exclusion Criteria:

* Patients with active cardiopulmonary disease or limited life expectancy due to severe illness such as malignancy
* Colonoscopy within 5 years prior to positive fecal occult blood test
* Age \> 80 years
Tysabri Observational Program

The primary objective of this study is to assess the long-term safety and impact on disease activity and progression of Tysabri in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.

TOP is an epidemiological observational study of participants receiving natalizumab, with each participant to be followed for up to 15 years. This study is designed to address the long-term safety profile and the long-term impact on disease activity and progression of Tysabri with marketed use, and the impact of treatment on disability in particular by comparing the results with prospectively determined controls from established databases.

Eligibility Criteria:
Key Inclusion Criteria:

* Documented diagnosis of Relapsing Remitting Multiple Sclerosis
* The decision to treat with Tysabri must precede enrollment
* Patient must be a new Tysabri user, and must not have had more than 3 Tysabri infusions prior to enrollment
* Must have had at least one relapse in the previous year, and must satisfy locally approved therapeutic indications for Tysabri

Key Exclusion Criteria:

* History of Progressive Multifocal Leukoencephalopathy or other opportunistic infections, or an increased risk of opportunistic infections
* History of positive anti-Tysabri antibodies
* Concomitant Immunomodulatory or immunosuppressive therapy during therapy with Tysabri
* Patient immunocompromised at the time of enrollment
* Known active malignancy
* Women must not be breast feeding or pregnant, or planning to become pregnant (must use birth control unless surgically sterile)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.