cyrilzakka/clinical-trials huggingface dataset:
Study For Patients With Untreated Gastric Cancer Who Will Receive Capecitabine And Lapatinib

The study will determine if changes in expression of markers involved in the 5-FU pathways are associated with response to treatment with the combination of lapatinib and capecitabine independent of tumor erbB2 status.


Eligibility Criteria:
Inclusion Criteria:

* Has signed inform consent
* Untreated, newly diagnosed, advanced metastatic or unresectable gastric cancer, including the gastro-esophageal junction
* Tumor accessible to and patient consent for endoscopic biopsy at study start and after 7 days of single agent Lapatinib
* Measurable disease according to RECIST criteria
* Male or female \> or = 18 years of age
* Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram
* must have adequate organ function as defined by baseline laboratory values

Exclusion Criteria:

* Gastric carcinoid, sarcomas, or squamous cell cancer
* Pregnant or lactating females
* Intractable nausea, vomiting, or gastro intestinal obstruction requiring decompression and drainage with a gastric tube or nasogastric suction.
* patients who require continuous enteral feeding
* Malabsorption syndrome or uncontrolled inflammatory GI disease (Crohn's or ulcerative colitis
* Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure
A Study of RAY1225 in Participants With Type 2 Diabetes

The main purpose of this study is to learn more about the Tolerability of RAY1225 in participants with type 2 diabetes mellitus. The study will also explore the efficacy of RAY1225. The study will last about six months for each participant.


Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes had been diagnosed for at least 12 weeks prior to screening and one of the following conditions:

   1. have T2DM controlled with diet and exercise alone;
   2. are stable in dose and type on a single or in a combination of oral antidiabetic medication, metformin, α-glucosidase inhibitors or SGLT-2 inhibitors only ,within 12 weeks before screening;
2. BMI ≥ 20 kg/m²；
3. Fasting blood-glucose（FPG）\<15 mmol/L;
4. Weight change \< 5% in the 12 weeks before screening;
5. Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.

Exclusion Criteria:

1. have type 1 diabetes mellitus；
2. Severe diabetic complications, including proliferative retinopathy or maculopathy, severe diabetic neuropathy (e.g., urinary retention, urinary incontinence, and painful peripheral neuropathy), resting tachycardia, orthostatic hypotension, intermittent claudication, or diabetic foot;
3. Two or more episodes of ketoacidosis, lactic acidosis, or hyperosmolar state leading to hospitalization within 24 weeks before screening;
4. had grade 3 hypoglycemic events within 12 months before screening,
5. Three or more grade 2 hypoglycemic events occurred within 3 months before screening;
6. Have symptoms related to hypoglycemia at screening;
7. Within 6 weeks before screening, serious trauma, serious infection, or surgery that may have affected glycemic control was reported;
8. Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome type 2 or with thyroid nodules of unknown etiology found at screening and considered clinically significant by the investigator.
9. Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed \>1 year prior to screening)
THE IMMUNOLOGICAL EFFECTS AND METABOLIC TOLERANCE OF LIPID INFUSION IN PATIENTS WITH CIRRHOSIS.

The study will be an experimental pre-post trial in which patients with ethanol related liver disease (both severe alcoholic hepatitis and decompensated ) admitted in our institute from Jun 2013-Dec 2014 will be enrolled in the study. Those on ryle's tube feeding would receive polymeric blenderized kitchen based liquid diet while those tolerating orally would receive soft/ solid diet as tolerated as per requirement. All the patients would receive same amount of calories i.e., 30-35 kcal/kg ideal body weight/ day and 1-1.2 gm/kg protein. 35-40% of non protein calorie would be provided as fats and rest of the calories will be provided as carbohydrates. All patients will be transfused 250ml of 20% intra lipid per day for 3 consecutive days, over and above the feed provided to them to be taken enterally (orally or through Ryle's Tube). Patients will undergo tests prior to infusion and 72 hours after infusion.


Eligibility Criteria:
'Inclusion Criteria:

* Subjects aged ≥ 18 years.
* Patients with alcohol related liver disease (severe alcoholic hepatitis and decompensated cirrhosis)
* Patients tolerating enteral nutrition.

Exclusion Criteria:

* Active ongoing Gastrointestinal bleed.
* Unresolved sepsis
* Allergy to soya oil, eggs, peanuts or other ingredients of intralipid.
* Co-morbidities like Diabetes mellitus, hyperlipidemia, Coronary Artery Disease (CAD) and hypothyroidism.
* Renal failure (S.creatinine \> 1.5mg %)
* Pregnancy
* Patients on high inotropic support (requiring more than 1 inotropic support)
* Refusal to participate in the study
Automated Postoperative Sedation After Cardiac Surgery

This study compares automated administration of propofol and remifentanil guided by the Bispectral index (BIS) versus manual administration for sedation after cardiac surgery.

Automated sedation has the potential to improve patient care after cardiac surgery by adjusting drug doses to the minimum required for efficacy. Indeed, automated and continuous titration may avoid overdosing, improve hemodynamic stability and also decrease the mean time to tracheal extubation.

Medsteer SAS developed a controller, EasyTiva device, allowing the closed-loop coadministration of propofol and remifentanil, guided by a Bispectral Index (BIS) monitor.

Automated sedation is so facilitated by the BIS which permits continuous monitoring of electrocortical activity.

This randomized monocentric trial compares the automated administration with manual intravenous administration of propofol-remifentanil for maintaining adequate depth of hypnosis (BIS 55-75) during sedation after cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgical procedure requiring postoperative sedation
* Low operative risk : EuroSCORE 2 ≤ 5%
* Consent for participation
* Affiliation to the social security system

Exclusion Criteria:

* Pregnant or breastfeeding women
* Neurological or muscular disorder
* Pacemaker
* Hypersensitivity to propofol or remifentanil
* Communication difficulties or neuropsychiatric disorder
Recurrent Glomerulonephritis After Renal Transplantation

Glomerulonephritis (GN) is the leading cause of end-stage renal disease in 30% to 50% of patients who receive a renal transplant. The exact prevalence of either recurrent or de novo GN is unknown since a considerable number of patients never undergo allograft biopsy, leaving GN underdiagnosed. The aim of this study is to evaluate the effects of recurrent GN on the prevalence, risk factors, clinicopathological features, and outcome of renal transplant recipients.

Glomerulonephritis is the leading cause of end-stage renal disease in 30% to 50% of patients who receive a renal transplant. Even though recurrent or de novo posttransplant primary GN is the third most frequent cause of renal allograft loss after renal transplantation, different recurrence rates have been reported in different patient series worldwide. With the implementation of diverse and improved immunosuppressive treatment regimens and prolongation of graft survival, renal allograft loss caused by recurrent or de novo GN will be more important than ever. Data obtained from comparing patients who have recurrent primary GN against patients with non-recurrent GN and renal transplant recipients with non-GN etiology shall bring new approaches to the daily practice of managing patients with GN and renal failure, assessing them as transplant candidates and applying new therapies.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent a renal transplantation because of an end-stage renal disease caused by primary glomerulonephritis and have biopsy-proven recurrent primary glomerulonephritis (Recurrent GN group)
* Patients who underwent a renal transplantation because of an end-stage renal disease caused by primary glomerulonephritis and have no signs of recurrence (Non-recurrent GN group)
* Patients who underwent a renal transplantation because of an end-stage renal disease linked to an etiology other than primary glomerulonephritis (Non-GN group)

Exclusion Criteria:

* Patients who are unwilling or unable to consent
Comparison of Two Protocols for Patellofemoral Pain Syndrome

The patellofemoral pain syndrome (PFPS) is defined as a painful complaint in the anterior aspect of the knee, although peripatellar pain and / or retropatellar are also common. In general, conservative treatment is the initial option of choice for patients with PFPS, however, the lack of a specific causal factor makes it difficult to choose the best treatment so early. This way, the purpose of this study is investigate the effects of the quadriceps femoris strengthening versus hamstring stretching in patients with pattellofemoral pain.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of anterior knee pain for at least 1 moth;
* Average pain level of 3 or more on a 10-cm visual analogue scale during stepping up and down a 25-cm height;
* Anterior or retropatellar knee pain on at least 2 of the following activities: prolonged sitting, climbing stairs, squatting, running, kneeling, and hopping/jumping;
* Presence of 2 of the following clinical criteria on assessment: pain during apprehension test, pain during the patellar compression test, and crepitation during the compression test.

Exclusion Criteria:

* Previous knee surgery or arthritis;
* History of patellar dislocation or subluxation, malalignment, or ligament laxity;
* Patellar tendon pathology or chondral damage;
* Spinal referred pain;
* History of other abnormalities such as leg length inequalities (\>2 cm);
* Medication as a part of the treatment;
* Previous physical therapy or acupuncture treatment for the knee within the previous 30 days.
Non-invasive Evaluation of Lymphoma Patients Based on Artificial Intelligence and PET/MRI

18F-FDG PET/MR imaging protocol integrating advanced MR vascular imaging sequences, along with computerized quantitative methods for data analysis, is expected to serve as an objective tool for assessment of lymphoma patients. The aim of this prospective study is to develop an automatic artificial intelligence-based tool for the assessment of early response to treatment and evaluation of residual masses in patients with lymphoma. Specific objectives are:

1. To evaluate the added value of 18F-FDG PET/MRI compared with PET/CT in imaging lymphoma.
2. To optimize PET/MR imaging protocol for lymphoma assessment.
3. To develop an automated tool for staging patients with lymphoma.
4. To develop an automated method for early prediction of response to therapy and prognosis in patients with lymphoma.
5. To develop an automated non-invasive tool for discriminating benign from active residual masses at end of treatment in patients with lymphoma.


Eligibility Criteria:
Inclusion Criteria:

1. patients with newly diagnosed hodgkin's, aggressive non-hodgkin's and follicular lymphoma (for whom the PET/CT is the imaging modality of choice)/
2. Patients aged 18 years or older of both sexes.
3. Patients treated at Tel-Aviv Sourasky Medical center.

Exclusion Criteria:

1. pregnancy,
2. contraindication to MRI or to intravenous gadolinium injection.
Phase I-II Study With Tumor Molecular Pharmacodynamic (MPD) Evaluation and Pharmacokinetics of PD-0332991 in Patients Suffering Metastatic Melanoma

An open label multicentre, phase I-II study with tumour molecular pharmacodynamics (MPD) evaluation and pharmacokinetics of PD-0332991 added to vemurafenib in patients suffering metastatic melanoma with BR.

The main objective is to establish the Maximum Tolerated Dose (MTD) of PD-0332991 when added to standard vemurafenib therapy (960 mg BID). The estimated MTD is defined as the dose of PD-0332991 combined with vemurafenib that will be associated with a prespecified proportion of patients experiencing a Dose-Limiting Toxicity (DLT), ie, 1/3.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Stage IV or un-resectable stage III melanoma
* Presence of BRAF V600E/K mutation and CDNKN2A loss and expression of Rb using immunohistochemistry in a recent metastatic sample (\< 6 months)
* A previous exposure to BRAF inhibitor or combination of BRAF and MEK inhibitors therapy is allowed unless it has been stopped more than 3 months before study enrolment(This will defined the two strata of the trial)
* No previous therapy by MEK inhibitor unless associated with BRAF inhibitors
* No previous therapy with the AKT/PI3K pathway inhibitor
* Patients should have a tumour available for repeated biopsies for pharmacodynamics evaluation
* Life expectancy of \> 3 months
* ECOG performance status \<2
* Signed informed consent
* Patient with health insurance coverage
* No patient under guardianship or curators

Exclusion Criteria:

* Inadequate hepatic function defined as serum bilirubin\>25 μmol/l, transaminases \> 3.0 times the upper limit of normal (ULN) or 5ULN in cases of liver metastases;
* Inadequate bone marrow function defined as absolute neutrophil count\<1500/mcl, platelets\<150000/mcl and haemoglobin\<8g/dL
* Inadequate renal function with serum creatinine\>2.0mg/dl) and /or creatinine clearance\< 60 ml/min
* Untreated brain metastases : Patients with brain metastases will be eligible if they have completed treatment 1 months prior to the start of study medication, have discontinued corticosteroid treatment for these metastases for at least 5 days, and are neurologically asymptomatic
* Myocardial infarct or unstable angina within the past 6 months
* Concomitant take of drugs known to be strong inhibitor or inducers of CYP314
* HIV positive.
* Chemotherapy, immunotherapy within 4 weeks
* Drugs interfering with PD-0332991 and vemurafenib metabolism
* Malabsorption syndrome or other condition that would interfere with enteral absorption
* Congenital long QT syndrome or screening QTc \> 470 msec
* Need for chronic corticosteroid therapy of ≥10 mg of prednisone per day
Does Access to an EHR Patient Portal Influence Chronic Disease Outcomes?

The purpose of this study is to determine if patients with congestive heart failure, diabetes or secondary cardiovascular diseases, who access HealthMedia's online tailored behavior change programs on the electronic health record patient portal have better clinical and behavioral change outcomes.

The specific aims of the study are to determine if e-portal interventions influence:

* Measures of patient activation, patient self-management, treatment adherence, patient satisfaction with care, and disease specific knowledge.
* Process measures relevant to appropriate care for CVD, CHF, and DM.
* Clinical markers of cardiovascular or diabetes morbidity and risk.

These aims will be evaluated in one-year prospective study. Patients who use the portal will be randomized to control (i.e., access to routine portal-related information) and intervention groups (i.e., targeted and periodic messages designed to capture data relevant to self-management; to improve knowledge of their specific disease, tests, and risks; to devise time-dependent goals; and to motivate self-efficacy). Outcomes including activation, satisfaction, and adherence will be measured by telephone interview prior to and one year after intervention, and by lab and clinical measures and data available from the EHR. We will also evaluate potential selection issues among those who sign on to the e-portal by administering the same baseline interview to a matched (by disease and by age) random sample of patients who do not sign on to the e-portal.

Patients with chronic diseases are likely to experience particular benefit from online e-health resources as they have greater information needs and participate in self-management.(Camer, 2000) Unlike traditional office visits, online interactions eliminate the need to travel, are always available and give the patient access to a broad range of information, helping them actively participate in their own care.(Brown, 1999) There is growing evidence that patient education and engagement using e-health applications results in improved patient outcomes in the care of chronic illnesses, improved patient-physician communication, and reduction of anxiety for caregivers.(Brennan et al., 2001; Bronson et al., 1986; Bronson \& O'Meara, 1986; Ross et al., 2003a, 2003b) We anticipate demonstrating clinically meaningful improvements in chronic disease health status, using evidence-based science delivered in behaviorally-validated ways.

Eligibility Criteria:
Inclusion Criteria:

* Adult age 18 years or older
* Have medical records in the Geisinger Electronic Health Record
* Have congestive heart failure and/or Diabetes and/or cardiovascular disease
Comparing the Efficacy of an Online Gambling Intervention to a no Intervention Control Condition

Online interventions for gambling problems hold a strong potential to help people with gambling concerns. However, there are no trials, to-date, that have been able to demonstrate the effectiveness of such an intervention. The current trial will compare participants provided access to an online gambling intervention to those assigned by chance to a no intervention condition in order to test the efficacy of one such Internet intervention for gambling.

Participants will be recruited through Amazon's MTurk crowdsourcing platform. Potential participants identified as problem gamblers who are interested in quitting or reducing their gambling in the next 6 months, or often think about it, based on an initial survey will be invited to complete additional surveys at 6 weeks and 6 months. Those who then agree to be followed up will be randomized to access an online intervention for gambling or a no-intervention website. These participants will then be contacted again at 6 weeks and 6 months to ask about their gambling, and their impressions of the online intervention. The primary hypothesis to be tested is that participants receiving access to the online gambling intervention will report a greater reduction in number of days gambling and in NODS scores at 6-month follow-up than participants in the no intervention control condition.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or over
* A score of 5 or over on the Problem Gambling Severity Index (PGSI)
* Thinking about cutting down or quitting their gambling (in next 6 months, or state that they are thinking about it most or almost all of the time)
* Willingness to complete a 6-week and 6-month follow-up survey
Juvenile Postlumbar Puncture Headache After Puncture With Needles With Quincke Tip or With Sprotte Tip

The purpose of this study is to compare postlumbar puncture complaints as headache or backache after lumbar puncture with needles with Quincke design or with Sprotte design in children and adolescents.

After lumbar puncture patients may develop complaints as position dependent headache, other headache or backache. Several though not all studies in adults showed that the frequency of complaints can be reduced by using non-traumatic Sprotte-design needles instead of cutting Quincke-design needles. In children and adolescents there are no comparable data published. In most pediatric hospitals in Germany Quincke needles are used.

Comparison: Children and adolescents from 4 to 18 years of age who have to undergo a lumbar puncture are randomly attributed to puncture with Quincke needle or with Sprotte needle. During the following days headache (main criterium), position-dependent headache, backache, vomitus, and malaise are noted. Pain is measured with a visual analogue scale/faces scale.

Eligibility Criteria:
Inclusion Criteria:

* lumbar puncture necessary for diagnostic reasons

Exclusion Criteria:

* intrathecal instillation at lumbar puncture
* patients in whom severity of disease make it impossible to judge endpoint criteria
Hypermetabolism in ALS Using Six REE Formulas

Introduction: About 50-60% of Amyotrophic Lateral Sclerosis (ALS) is characterized by hypermetabolism, defined as 10% or more excess resting energy expenditure (REE) compared to theoretical values. Harris and Benedict's (HB) formula is the equation mainly used to predict REE, but others are also applied in current practice. The present study aimed to assess REE in ALS patients compared to control populations and to compare six formulas commonly used to predict REE.

Nutritional assessments were performed in ALS patients and in two control populations without hypermetabolism: healthy elderly people (control 1) and patients with non-restrictive-eating disorders (control 2). Weight, height and body composition (by bioimpedance analysis) were assessed.

EE was measured (mREE) by indirect calorimetry and calculated (cREE) using HB 1919 and 1984, World Schofield, De Lorenzo, Johnstone and Mifflin formulas. Mann-Whitney and Chi2 tests were used to compare the equations.


Eligibility Criteria:
Inclusion Criteria:

* ALS patients
* 18 years old or more
* IC and nutritional assessment within 1.5 months
* delay between diagnosis and IC \< 12 months

Exclusion Criteria:

-