cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Two Treatment Regimens of 0.5 mg Ranibizumab Intravitreal Injections Guided by Functional and/or Anatomical Criteria, in Patients With Neovascular Age-related Macular Degeneration

This study will evaluate and compare two individualized ranibizumab treatment regimens in patients with neovascular (wet) AMD aiming to achieve and to maintain a maximum visual function benefit, while aiming to avoid unnecessary intravitreal injections.

The results will be used to generate further recommendations on functional and anatomical monitoring of the disease and timing of treatment administration for patients with neovascular AMD. In this context, the study will investigate the utility of optical coherence tomography (OCT) to aid retreatment decisions with ranibizumab.

During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.

Eligibility Criteria:
Inclusion Criteria:

* Visual impairment predominantly due to neovascular age-related macular degeneration AMD
* Active, newly diagnosed, untreated CNV due to AMD
* CNV involving the center of the retina
* A qualifying vision score at study entry

Exclusion Criteria:

* Stroke or myocardial infarction less than 3 Months prior to study entry
* Active injection or inflammation of either eye at the time of study entry
Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial

The purpose of this study is to evaluate the safety and efficacy of S-1 and Cisplatin compared to 5-FU and Cisplatin in treatment of patients with metastatic diffuse gastric and gastro-esophageal junction cancer previously untreated with chemotherapy.

This is an open-label, international, Phase 3 study evaluating the efficacy and safety of the S-1/cisplatin regimen versus the 5-FU/cisplatin regimen in chemotherapy-naïve patients with metastatic diffuse gastric carcinoma including carcinoma of the gastro-esophageal junction. Patients will be randomly assigned to S-1/cisplatin (experimental regimen, Arm A) or 5-FU/cisplatin (control regimen, Arm B).

Eligibility Criteria:
Inclusion Criteria:

* Has given written Informed Consent.
* Histologically confirmed, unresectable, metastatic diffuse gastric cancer including carcinoma of the gastro-esophageal junction.
* No prior chemotherapy for gastric cancer except adjuvant and/or neo-adjuvant chemotherapy more than 12 months ago.
* Life expectancy of at least 3 months.
* Able to take medications orally.
* Eastern Cooperative Oncology Group performance status 0 to 1.
* Adequate organ function (bone marrow, kidney and liver).

Exclusion Criteria:

* Certain type(s) of non-measurable lesion(s), if the only one(s).
* Certain serious illness or medical condition(s).
* Lost greater than or equal to 10% of body weight in the 3 months proceeding signing the Informed Consent Form.
* Treatment with drugs interacting with S-1, 5-FU, or cisplatin.
* Pregnant or lactating female.
* Known hypersensitivity to fluoropyrimidines or cisplatin.

Other protocol-defined inclusion/exclusion criteria may apply.
Managing Frailty Through Mobilization in Males and Female Inpatients with Cardiovascular Disease

Frailty describes the overall health of a person. Inpatients with cardiovascular problems have a higher risk for frailty - or the sick are more likely to get sicker - causing longer hospital stays, hospital readmission, and death. Females are particularly vulnerable to these problems, generally displaying higher frailty levels than males. In hospital, patients spend almost all their time in bed, and this lack of movement worsens cardiovascular and musculoskeletal health, sometimes lengthening patients' hospital stay and priming them for another cardiovascular event. Prolonged sedentary time may be more detrimental on frailty among females than males. The proposed pilot project will test if an in-hospital General Medicine mobilization program reduces frailty (measure of overall health) in male and female inpatients with cardiovascular disease. A Kinesiologist will provide daily check-ins and promote daily movement (e.g., standing more, resistance bands, physical activity promotion, etc.). The investigators expect both males and females will lower their frailty levels, but given their higher frailty levels in general and because females are typically less active than males, the investigators expect the intervention's effects to be greatest among females. Sixty patients (30 females) will be recruited. Patients with a major heart problem, projected to be in-hospital for at least 3-days, and can independently provide consent. Frailty will be measured using a validated questionnaire. Participants will also be equipped with activity monitors for 24h/d continuous wear to measure amount of time spent stepping, sitting, and lying. Hospital records will be used for length of stay and readmissions. The investigators will compare the outcomes (activity and frailty) between males and females to determine if the intervention impacted each sex differently. This work will guide improved care plans to decrease frailty and improve health outcomes in both male and female patients with heart problems.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are admitted to unit 4C at the Vitalité Health Network
* Patients who have a cardiovascular disease (e.g., heart failure)
* Those who are projected to be in-hospital for at least 3-days
* Patients who are not in a shared room with another study participant
* Patients who are able to independently provide consent or have a caregiver provide consent
* Can communication in French or English

Exclusion Criteria:

-Patients enrolled in other clinical trials or interventions that might confound the results of the study.
Endoscopic Tri-Modal Imaging in Patients With Barrett's Esophagus

This study is being done to determine if a new endoscope will help doctors identify pre-cancer or early cancer lesions in patients who have Barrett's esophagus. This new endoscope allows the doctor to look at the lining of the esophagus in 3 different ways by modifying light.

Patients with Barrett's esophagus are advised to undergo periodic endoscopic surveillance with random biopsies in an attempt to identify high-grade dysplasia (HGD) or early adenocarcinoma (ACA) at a time when intervention can be curative. This approach, however, can be time-consuming and is hindered by low sampling yield and random sampling error. Endoscopic Tri-Modal Imaging (ETMI) is a novel diagnostic modality that encompasses three advanced imaging features in one system: high-resolution endoscopy (HRE), autofluorescence imaging (AFI) and narrow-band imaging (NBI). HRE and AFI provide a bird's-eye view of 'red flag' areas which are then assessed by NBI for focused and more specific tissue characterization. The aim of this prospective, multi-center study is to compare the diagnostic performance of ETMI with that of standard white-light endoscopy (WLE) for identifying high-grade dysplasia (HGD) and early adenocarcinoma (ACA) in BE. A total of 84 BE patients will be recruited for the study and they will undergo both ETMI and WLE examinations in a randomized, crossover fashion. Standard surveillance biopsies and ETMI-targeted biopsies will be performed. The primary outcome will compare the number of patients and lesions with HGD or early ACA detected with WLE and ETMI. It is anticipated that ETMI will enhance the detection of high-grade Barrett's lesions relative to WLE.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Prior diagnosis of BE, defined as the presence of columnar-lined epithelium in the distal tubular esophagus with specialised intestinal metaplasia on histological investigation
3. Prior diagnosis of HGD or early ACA that was endoscopically inconspicuous according to the referring source
4. A minimum Barrett's length of C\>2M\>2 or C\<2M\>4 according to the Prague C\&M classification for the endoscopic appearance of BE
5. Ability to provide written informed consent

Exclusion Criteria:

1. Description of a visibly suspicious lesion within the Barrett's segment according to the referring source
2. Presence of a type 0-I or type 0-III lesion, or a lesion that, according to the discretion of the endoscopist, does not allow delay in intervention for a period of 6 weeks (minimum interval between the two crossover endoscopies)
3. Prior endoscopic therapy for Barrett's lesions, such as photodynamic therapy or endoscopic mucosal resection (EMR)
4. Presence of esophagitis \> Los Angeles grade A classification
5. Presence of conditions precluding histological sampling of the esophagus (e.g., esophageal varices, coagulation disorders, anticoagulant therapy)
6. Pregnancy
Enhancing Renal Graft Function During Donor Anesthesia

Renal transplantation is now recognized as the treatment of choice for patients with end-stage renal disease. An optimum anesthetic regimen should enhance the function and perfusion of the transplanted kidney. The aim of this study is to assess \& compare the effectiveness of 3 different modalities in this respect: Mannitol, Dopamine and adequate hydration.


Eligibility Criteria:
Inclusion Criteria:

* end-stage renal disease, for living-donor kidney transplantation

Exclusion Criteria:

* severe cardiac or hepatic dysfunction
* coagulopathy
Study of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Acupuncture for Insomnia and Related Distress Among Cancer Caregivers

The other aim of this study is to determine which of those two treatments (acupuncture or cognitive behavioral therapy) works better for treating insomnia in Informal Caregivers of cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* As per self report, age 18 and older
* As per self report, identifying as an informal caregiver to MSKCC patients of any site or stage of cancer
* Score greater than 7 on the Insomnia Severity Index and meet the criteria for Insomnia Disorder as defined by the Diagnostic and Statistical Manual of Mental disorders, 5th Edition (DSM-5) (56) as assessed by the Insomnia Interview Schedule
* In the judgment of the investigators and/or consenting professional, able to read and comprehend English
* In the judgment of the consenting professional cognitively able to provide informed consent

Exclusion Criteria:

* As per self report, participant has another sleep disorder provided that it is not adequately treated (e.g., sleep apnea without CPAP treatment)
* As per self report, participant has major depressive disorder, alcohol or drug dependence and
* As per self report, heavy drinker (regularly having more than 14 alcoholic beverages per week)
* As per self report, engaging in night shift work
* To not obscure cortisol assessment, regular smokers per self report (daily use) will be excluded.
* As per self report significant needle phobia as to prevent participation in acupuncture
Effects of Six Months of Moderate Resistance- Versus Endurance-Training on Muscle ATP Synthesis in First-Degree Relatives of Patients With Type 2 Diabetes

Life style intervention including diet and exercise is the recommended strategy for prevention of type 2 diabetes mellitus (T2DM). First-degree relatives of patients with type 2 diabetes mellitus have an increased risk of insulin resistance and a lifetime risk of developing type 2 diabetes of 40%- 80%. Poor physical fitness is a strong indicator of an increased risk of developing diabetes.

Long-term endurance exercise training has been shown to increase insulin sensitivity in sedentary young and elderly individuals, first degree relatives of patients with Type 2 diabetes, glucose intolerant obese, or Type 2 diabetic humans. In type 2 diabetic patients, non-diabetic individuals with IGT and sedentary adults after exercise training of different intensity, different duration and different frequency an increase of insulin sensitivity was found.

However, despite the vast knowledge concerning beneficial effects physical activity for the prevention of T2DM (and many other chronic metabolic disorders) to date wide ranging strategies have not been realized satisfactory. Regardless of age, ethnicity, sex or health status the lack of time is the primary reason for the failure to exercise on a regular basis (or is stated as primary reason). Therefore the investigators aimed at investigating whether a controlled endurance/resistance training twice a week over 6 month might be beneficial for healthy, non obese, first degree relatives with T2DM. Therefore the investigators measure parameters associated with the prevention of T2DM like insulin sensitivity, flux through fATPase and fCK, intramyocellular and hepatocellular lipids.


Eligibility Criteria:
Inclusion Criteria:

* First degree relatives of type 2 diabetic patients
* Age: 18-50 years
* BMI \<30 kg/m2 (due to limited MR diameter)
* Normal routine lab tests (blood cell count, kidney, liver, pancreas, thyroid and neuromuscular function)
* Availability within the local area throughout the study
* Ability to understand and sign the consent forms

Exclusion Criteria:

* Current smoking
* Present drug treatment
* Regular exercise training
* Contraindications for MRS studies: claustrophobia and metalliferous implants
* Pregnancy
* HIV or Hepatitis
* Acute disease 2 weeks previous to the examination
* Heart disease
* Hypertension (RR\>140/95)
* Liver disease
* Kidney disease
* Pulmonary disease
* Thyroid disease
Urethral Stricture After Transurethral Resection of the Prostate/Bladder: a Prospective Study of Risk Factors

There is currently no prognostic or predictive risk marker for this urethral stricture disease.

The most conservative standard treatment for urethral stricture (internal urethrotomy) has a very high recurrence rate (greater than 75%) and, on many occasions, reconstructive urologists have to choose within a great variety of further complex interventions. Knowing risk and predictive markers of this disease could help to optimize both the need and the approach for these surgeries and may offer a more individualized management to patients.

The pathophysiological mechanisms that influence the development of urethral stricture are not established. In developed countries, the most common etiology of urethral stricture is idiopathic (41%) followed by iatrogenic (35%).

Serum testosterone is important in urethral development, in the integrity of the corpora cavernosa and has been shown to play a fundamental role in the development of genital structures. Recently, hypoandrogenism (HA) has been associated with a decrease in urethral androgen receptors and periurethral vascularization. Furthermore, low serum testosterone levels appear to be implicated in an increased risk of urethral atrophy.

In recent years it has been proven that coagulation, in addition to influencing the formation of the provisional matrix, participates in mechanisms of tissue injury through the activation of PARs. As a result, the coagulation cascade directly influences several key aspects of the wound healing response, from platelet aggregation and vasoconstriction, but also inflammation and scar formation. Although it is strictly regulated under normal conditions, an imbalance in favor of a procoagulant state as occurs in many pathologies of other organs (liver, lung, kidney) has the potential to deregulate inflammatory and tissue repair mechanisms and culminate in fibrosis.

In general, it is accepted that the probability of developing a urethral stricture after endoscopic treatment is around 2-10% of cases. However, this complication has never been studied in depth and the true incidence of urethral stricture, and its consequences in quality of life, after a transurethral procedure is unknown.

The aim of this study is to analyze the potential role of serum hormonal status and coagulation disorders as risk factors for the development of urethral stricture after transurethral surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing transurethral resection of the prostate or bladder (TUR P/B) at our department.

Exclusion Criteria:

* Patients not giving their informed consent
* Patients with urethral catheter at the moment of TUR P/B
* Patients with any type of urethral stricture at the moment of TUR P/B
* Patients under hormonal treatments (testosterone, thyroxine...) 1 year before the TUR P/B.
* Patients with already known coagulation disorders or undergoing anticoagulation treatments at the moment of the blood test.
Prevention of Ectopic Bone Related Pain and Disability After Hip Replacement Surgery With Peri-Operative Ibuprofen

The primary aim of this randomised trial is to determine the effects of a short peri-operative course of treatment with a non-steroidal anti-inflammatory drug (NSAID), ibuprofen, on the long-term consequences of ectopic bone formation in patients undergoing elective total hip replacement surgery. The specific hypotheses to be tested at that 6 to 12 months after surgery, patients assigned post-operative ibuprofen will have less self-reported pain and physical disability, greater health-related quality of life and reduced ectopic bone formation compared with those assigned placebo.

Methodology:

The study is a multicentre, randomised, double blind, placebo-controlled trial. 1000 patients undergoing elective total hip replacement surgery from 20 orthopaedic centres in Australia and New Zealand will be assigned to receive either ibuprofen (1200mg daily) or matching placebo in 3 divided doses for 14 days. Study treatment will be started postoperatively on the day of surgery. Patient should not receive any other NSAIDs, apart from low dose aspirin, during the 14-day treatment period, unless such treatment becomes definitely indicated, in which case the study treatment should be withdrawn and open label treatment provided. There will be no other changes to standard care.

Participants:

All patient scheduled for elective total hip replacement surgery, or revision thereof, are potentially eligible unless there is a definite indication for or contraindication to treatment with a NSAID during the 14-day treatment period.

Randomisation:

Randomisation will be performed centrally using a computer-based system that can be accessed 24 hours a day by a toll-free telephone call. A minimisation program will stratify treatment allocation by centre.

Outcomes:

The primary outcome are self-reported pain and physical function, 6 to 12 months after randomisation. Secondary outcomes include health-related quality of life, patients' global assessment, radiographic evidence of ectopic bone.

Eligibility Criteria:
Inclusion Criteria: Patient undergoing elective total hip replacement surgery, or revision thereof -

Exclusion Criteria: A definite indication or contra-indication for treatment with a NSAID during the 14-day study treatment period, in the opinion of the treating clinician.

-
Clinical Evaluation of the IONA Test for Non-invasive Pre Natal Screening in Twin Pregnancies

The purpose of this study is to evaluate the performance of the IONA® test which is a non-invasive prenatal test (NIPT) for Down's syndrome and other chromosomal abnormalities in twin pregnancies, from a maternal blood sample.

350 low risk and 150 high risk women with twin pregnancies will be recruited to produce a large cohort evaluation the use of the IONA test in twin pregnancies for Downs, Edwards and Patau syndrome. Reserve samples will also be used to further develop the test for other chromosomal abnormalities.

Eligibility Criteria:
Inclusion Criteria:

* Currently pregnant with twin foetuses at time of entry to study
* Have had or are about to have a conventional screening test (combined/quad test, ultrasound scan or other NIPT)
* If identified as high risk, intend to undergo prenatal invasive diagnosis and/or undergoing invasive prenatal therapy such as laser treatment for TTTS where a sample of amniotic fluid is taken for karyotyping.

Exclusion Criteria:

* Participant herself has down syndrome or other chromosomal abnormality
Predictive Clinical and Biological Parameters in Acute Leukemia, Myelodysplastic Syndromes and Myeloproliferative Disorders-HEMATO-BIO-IPC-2013-015

HEMATO-BIO-IPC-2013-015 is a monocenter prospective longitudinal study. Our aim is to define predictive clinical and biological factors in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by using genomics, genetics and epigenetics, in vitro and in vivo drug sensitivity studies,and translational immonulogy and immunomonitoring studies.

HEMATO-BIO primary outcome measure is to identify molecular, genomic and epigenetic, pharmacologic and immunophenotypic alteration in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by collecting, at diagnosis and/or complete remission and/or relapse:

* tumor samples: marrow aspiration, blood sampling.
* non-tumor samples: skin biopsy, buccal swab . from 650 patients treated at our cancer center.


Eligibility Criteria:
Inclusion Criteria:

* acute leukemia, myelodysplastic syndrome or myeloproliferative disease
* age \> 18
* affiliated to the French Social Security Systm
* signed informed consent

Exclusion Criteria:

* emergency
* patients deprived of liberty or placed under the authority of a tutor
Diabetes-Specific Nutritional Formulas Versus Oatmeal

Diabetes-specific nutritional formulas (DSNFs) are frequently used as part of medical nutrition therapy for patients with type 2 diabetes in order to improve glycemic control and enhance weight reduction. The mechanism through which DSNFs improve postprandial (PP) plasma glucose is not yet known.

The aim of this study is to compare the effects of 2 DSNFs versus oatmeal on PP plasma glucose, serum insulin and serum active glucagon-like peptide-1 (GLP-1), serum free fatty acids (FFA) and serum triglycerides (TG).


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes treated with oral diabetes medications

Exclusion Criteria:

* Type 1 diabetes