cyrilzakka/clinical-trials huggingface dataset:
Endoscopic Ultrasound-guided Versus Surgical Gastroenterostomy for Malignant Gastric Outlet Obstruction

Gastric outlet obstruction (GOO), defined by a mechanical obstruction of the duodenum, pylorus, or antrum, may result from various diseases. GOO was caused by underlying malignancy in up to 85% of patients, most of which could be attributed to pancreatic cancer. Malignant GOO may increase morbidity, reducing quality of life, and significantly influencing tolerability and efficacy of oncologic treatments. Before the advent of EUS-guided gastroenterostomy (EUS-GE), placement of enteral self-expandable metallic stents (SEMS) or surgical gastroenterostomy (SGE) are the standard of care for many years. The main shortcoming of enteral SEMS placement is recurrent GOO due to tumor ingrowth/overgrowth, which occurs in the majority of patients who survive longer than 6 months. On the other hand, the main limitation of SGE is its invasive nature, especially in such patients with advanced malignancies and poor nutritional status. In addition, SGE is associated with frequent complications, such as perioperative infections and gastroparesis.

EUS-guided gastroenterostomy (EUS-GE) is a novel procedure for palliation of malignant GOO. Several systematic reviews and meta-analysis demonstrated the feasibility, efficacy and safety of EUS-GE. Compared with laparoscopic GE (LGE), EUS-GE not only had almost identical technical and clinical success but also reduced time to oral intake, shorter median hospital stay, and lower rate of adverse events. However, data directly comparing EUS-GE to LGE are limited. We aimed to compare clinical outcomes between EUS-GE and LGE in the palliation of malignant GOO under a randomized setting.


Eligibility Criteria:
Inclusion Criteria:

1. Consecutive patients ≥ 20 years old
2. Confirmed unresectable distal gastric or duodenal or pancreatico-biliary malignancies
3. Suffering from gastric outlet obstruction with a gastric outlet obstruction score of ≤ 1
4. Performance status ECOG ≤3

Exclusion Criteria:

1. Unable to give informed consent
2. Prior duodenal metallic stent placement
3. Severe comorbidities precluding the endoscopic procedure or operation
4. Life expectancy of less than 1 month
5. History of gastric surgery
6. Linitus plastic
7. Multiple-level bowel obstruction confirmed on radiographic studies such as small bowel series or abdominal computed tomography
8. Coagulation disorders
9. Pregnancy
Rural Asthma Effectiveness Study

The investigators will test if their intervention, Asthma Self-Management for Adolescents (ASMA), an 8-week, high school-based intervention for teenagers, improves asthma in rural high school students with uncontrolled asthma when delivered by CHWs. The investigators will also test the cost-effectiveness of ASMA, and examine the barriers and facilitators of ASMA's widespread implementation.

Asthma, the most common pediatric chronic illness, has high prevalence and morbidity among adolescents. Despite this, there are few interventions for high school students, and none have been tested when delivered by Community Health Workers (CHWs) or in rural areas. This represents a significant limitation because the CHW model has been shown to be successful in clinic- and home-based interventions. Also, rural adolescents with asthma represent a very large population. Given the high prevalence of asthma in this group, this oversight is a significant public health concern. Cost effectiveness analyses and implementation research are also lacking in asthma intervention research. This study addresses these treatment and methodological gaps. The investigators developed and established the efficacy of Asthma Self-Management for Adolescents (ASMA), an 8-week, high school-based intervention, in urban Hispanic and African American adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents who are at least 13.0 at the time of consent
* Teenager reports having a prior asthma diagnosis, and in the last 12 months has: (a) used prescribed asthma medication and (b) uncontrolled asthma, defined as: (i) symptoms 3+ days a week; (ii) night awakenings 3+ nights per month; (iii) 2+ ED visits; or (iv) 1+ hospitalization for asthma; and
* Adolescents are English proficient

Exclusion Criteria:

• Co-morbid diseases that affect lung functioning.
Liver Transplantation Results in Hepatocellular Carcinoma Patients With Immunosuppression Without Steroids

The purpose of this study was to evaluate the safety and efficacy of a steroid-free immunosuppression protocol in Hepatocellular Carcinoma (HCC) patients.


Eligibility Criteria:
Inclusion Criteria:

* All liver transplantation patients with hepatocellular carcinoma in our center between Jan 2005 and Dec 2009 were potentially eligible for enrollment

Exclusion Criteria:

* the recipient pass away within 3 month following up liver transplantation
* Inability to provide written informed consent prior to study entry
* acute rejection are treated only with steroids
The Fate of Aortic Valve After SAS Surgery in Children

Aortic valve regurgitation (AR) is a common complication following surgery for subaortic stenosis (SAS), yet the long-term outcomes and risk factors for postoperative significant AR (SAR) remain poorly understood. This study aims to investigate the incidence and risk factors of SAR in SAS patients and evaluate the long-term postoperative outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age from 0-18
* Clinical diagnosis of subaortic stenosis and underwent surgery

Exclusion Criteria:

* Diagnosed with hypertrophic cardiomyopathy
* Underwent concomitant previous surgical repair for aortic valve or SAS
* Follow-up time less than 1 year or lack of detailed information.
Glucose Control in Severely Burned Patients

The central aim of this application is to determine whether improved outcomes with tight euglycemic control are due to insulin-specific responses. The investigators hypothesize that improving insulin resistance will lead to decreased inflammatory and hypermetabolic responses, as well as restored glucose metabolism, and so result in improved clinical outcome of severely burned patients.


Eligibility Criteria:
Inclusion Criteria:

* between 18 and 90 years of age
* \>20% TBSA
* Admitted to the burn unit within 120 hours following burn
* At least 1 surgical intervention necessary

Exclusion Criteria:

* death upon admission
* decision not to treat due to burn injury severity
* presence of anoxic brain injury that is not expected to result in complete recovery
* known history of AIDS, ARC, HIV, Hepatitis B-E
* history of cancer within 5 years of malignancy currently under treatment
* inability to obtain informed consent
* previous or existing renal dysfunction, liver disease, or hepatic dysfunction
* pre-existing type I diabetes mellitus
* pregnancy
* allergy to metformin
Diabetes in Pregnancy and Pregnancy Outcomes

To compare the clinical, glycemic profile and therapy as well as pregnancy complications and infant mortality among diabetic mothers in Indonesia.

Pregnancy is a diabetogenic state with increasing burden on the mother's metabolism. Insulin resistance is often found during pregnancy leading to a compensatory increase in pancreatic β-cell response and eventually hyperinsulinemia. Undiagnosed and untreated diabetes in pregnancy have been shown to be linked with numerous comorbidities and complications to both mother and foetus.

This study aims to compare the clinical, glycemic profile along with comorbidities, management and outcomes of diabetic mothers. Pregnant mothers with gestational and pregestational diabetes diagnosed under the ICD-10 coding of O24 were included in this study. The inclusion criteria was all patients with primary diagnosis of O24, have visited the clinic at least twice with a complete record of glycemic profile, management and fetal outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and laboratory diagnosis of Diabetes in Pregnancy (Gestational and Pregestational diabetes)
* Mothers must have visited the clinic at least twice throughout their pregnancy, at least one at the first trimester and one at the third trimester

Exclusion Criteria:

* Pregnancy is still undergoing
* Incomplete record of glycemic profile, management and fetal outcomes
ATAC - Arimidex, Tamoxifen Alone or in Combination

The aim of this study is to test whether Arimidex alone or in combination with Tamoxifen is beneficial in the treatment of breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven operable invasive breast cancer
* Patients who have completed all primary surgery and chemotherapy (if given), and are candidates to receive hormonal adjuvant therapy
* Women defined as post-menopausal

Exclusion Criteria:

* Patients in whom there is any clinical evidence of metastatic disease
* Patients who, for whatever reason (e.g. confusion, infirmity, alcoholism), are unlikely to comply with trial requirements
* Patients whose chemotherapy was started more than 8 weeks (ie 56 days) after completion of primary surgery or whose chemotherapy was completed more than 8 weeks (ie 56 days) before starting randomised treatment
Dietary Allowance of Methyl Donor Nutrients to Minimize Risks of Non-alcoholic Fatty Liver Progression

Investigate the methyl donors requirement of NAFLD patients to correct the malnutrition, lipid-toxicity, microbiota dysfunction, and metabolomics biomarkers.

Folate/choline/betaine, service as a methyl-donor nutrients, are essential nutrients involving in hepatic one-carbon and bioenergetic metabolism. Methyl-donor nutrients deficiency cause liver and muscle dysfunction as result of non-alcoholic fatty liver diseases (NAFLD) and its progressive lesions of steatohepatitis (NASH), fibrinogen cirrhosis and hepatoma. As methyl-donor nutrients intakes in Taiwanese population are highly insufficient, the dietary requirement of methyl-donor nutrients upon genetic, epigenetic and microbiota interaction to prevent or/and co-therapy of NAFLD progression is currently not known. In this study, we investigate whether intervention of methyl-donor nutrients improve or retard NAFLD progress. NAFLD patients are randomly divided into three groups and received placebo, folic acid, or choline, respectively. From first day to ten day, interventions are given double recommended daily intake dose of folic acid or double adequate Intakes dose of choline, then continuing with four times, and eight times dose for every 10 days. All supplements solve in cranberry juice. At the end of every ten days intervention prior, interventions are measurement of weight and body fat, and collection of blood and feces. The primary outcome measures are described to decreased body weight or body fat, improvement of liver function and fatty liver, and increasing methyl-donor nutrients levels.

Eligibility Criteria:
Inclusion Criteria:

* NAFLD/NASH patients
* Folate levels in plasma \< 6 ng/mL or choline levels in plasma \< 5 micromol per liter
* Folate intake \< estimated average requirement or choline intake \< 50% adequate Intakes
* Homocysteine levels in plasma \> 9 micromol per liter

Exclusion Criteria:

* Asymptomatic carrier of hepatitis B and C
* Liver disease except NAFLD
* Taking drugs that causes fatty liver
* Inflammation about stomach or intestines
* Pregnancy
* Cancer except liver cancer
* Heart disease, vascular disease, or psychosis
* Intake alcohol over 100 g or unaccessible intake alcohol
Evaluation of an Iris Dilatation Ring in Cataract Surgery (ADICC-ID)

During cataract surgery, it is necessary to dilate the iris in order to remove the crystalline lens and position the implant. The diameter of the optical implant being 6 mm, in case of capsulorhexis crystalline access 5.5 mm, the expansion should be at least 6 mm.

At pre-operative consultation, the iris is always dilated by instillation of eye drops and measured at the slitlamp. For patients with an inadequate dilation, the intervention requires the use of a mechanical dilatation device.

This study aims to assess the value of an alternative dilatation ring to Malyugin ring, which can be inserted and removed through an incision of less than 2 mm in diameter, due to its size smaller than that of the Malyugin ring.

Our hypothesis is that this Bhattacharjee ring ensures sufficient and stable iris dilation during surgery, enabling implant placement in good conditions.


Eligibility Criteria:
Inclusion Criteria:

* Patient with programmed cataract surgery under topical or local anesthesia
* Need to use a dilatation ring during operation, highlighted by iris dilatation ≤ 6 mm on slitlamp, after mydriatic solution and 10% phenylephrine eye drops instillation

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Patient's refusal to participate in the study
* Patient non covered by health insurance
* Complete iridectomy
* Tearing of iris sphincter
* Important posterior synechiae (when the iris is attached to the anterior surface of the implant)
* Anterior chamber very deep (depth of the anterior chamber lower than 1mm after injection of the viscous product)
Optimization of Therapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment

A phase IV study with the primary goal to optimize therapy of adult patients with acute lymphoblastic leukemia or lymphoblastic lymphoma (LBL) by dose and time intensive, pediatric based chemotherapy, risk adapted stem cell transplantation (SCT) and minimal residual disease (MRD) based individualised and intensified therapy. Study will further evaluate the role of asparaginase intensification, the extended use of rituximab and the use of nelarabine as consolidation therapy in T-ALL in a phase III-part of the study. Furthermore two randomisations will focus on the role of central nervous system (CNS) irradiation in combination with intrathecal therapy versus intrathecal therapy only in B-precursor ALL/LBL and the role of SCT in high-risk patients with molecular complete remission. Finally a new, dose reduced induction therapy in combination with Imatinib will be evaluated in Ph/BCR-ABL positive ALL.


Eligibility Criteria:
Inclusion Criteria:

* Acute lymphoblastic leukemia (pro-B, common, pre-B, early T, thymic T, mature T)
* Lymphoblastic lymphoma (B or T-lineage)
* Age 18-55 yrs
* Written informed consent
* Adequate contraception as specified per protocol

Exclusion Criteria:

* Severe comorbidity or leukemia associated complications
* Late relapse of pediatric ALL or ALL as second malignancy
* Cytostatic pre-treatment
* Pregnancy or breast feeding
* Severe psychiatric illness or other circumstances which may compromise cooperation of the patient
* Participation in other clinical trials interfering with the study therapy
A Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX in Subjects With Type 2 Diabetes Mellitus (T2DM)

A study to assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated Doses for 3 days in Subjects with Type 2 Diabetes Mellitus

A Single Centre, Double-blind, Randomised, Placebo-controlled, Cross-over Phase I Study to Assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated Doses for 3 days in Subjects with Type 2 Diabetes Mellitus

Eligibility Criteria:
Inclusion Criteria

* Provision of informed consent
* Male or female of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/tubal ligation) aged ≥18.
* Patients with HbA1c ≥7.5 but ≤11% at enrolment visit (Visit 1)
* ody mass index \>19 to \<38 kg/m2
* he fasting plasma glucose should be in the range of 3-14 mmol/L (54-252 mg/dL, nclusive) on the morning of Visit 1.
* Clinical diagnosis of type 2 diabetes mellitus
* Metformin as only anti-diabetic treatment, at least for the last 3 months

Exclusion Criteria:

* History or sign of any clinically significant disease or disorder which, in the opinion f the investigator, may either put the subject at risk because of participation in the sudy, or influence the results or the subject's ability to participate in the study
* Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) laboratory results \>3x upper level of normal range (ULN) Clinical diagnosis of Type 1 diabetes mellitus and/or history of diabetic ketoacidosis or positive Glutamic Acid Decarboxylase Autoantibodies test (GAD antibodies test).
* Patients treated with single Insulin therapy within the last 3 months
Novel Treatment for Diastolic Heart Failure in Women

The purpose of the study is to collect information about the potential benefit and safety of low dose spironolactone for a patient with diastolic heart failure (DHF) and to determine whether spironolactone can cause the patient's condition to improve.

Subjects with diastolic heart failure defined based on clinical symptoms, echocardiography diastology parameters and brain natriuretic peptide level will be randomized in a 1:1 fashion to either placebo or spironolactone 25mg daily for 6 months. They will be assessed over this 6 month period for improvement in exercise capacity, clinical symptoms, echocardiography diastology parameters, and biomarkers specific for heart failure. Safety of spironolactone in this patient population will also be assessed by recording adverse events and following electrolytes, blood urea nitrogen, and creatinine levels.

Eligibility Criteria:
Inclusion Criteria:

* Women who are 18 years of age or older.
* Women with clinical heart failure for \> 2 months.
* Women with left ventricular ejection fraction \> 50% within 2 months of screening.
* Women with New York Heart Association class II or III heart failure symptoms.
* Brain Natriuretic Peptide \> 62 pg/ml within 2 months of screening.
* Patient on angiotensin converting enzyme inhibitor or angiotensin receptor blocker therapy for at least 1 month.
* Blood Pressure no more than 150/95.
* Patient able to walk more than 50 meters at the time of enrollment.
* Signed informed consent.

Exclusion Criteria:

* Current treatment with spironolactone.
* Severe hepatic impairment.
* Creatinine \> 2.5 mg/dl
* Potassium \> 5.0 mEq/L
* Intolerance to spironolactone in the past.
* Significant valvular heart disease, pericardial disease, or severe chronic lung disease with cor pulmonale.
* Unstable angina or myocardial infarction within the past 4 weeks.
* Severe peripheral vascular disease or other physical conditions that would limit the walking distance.
* Pregnant or lactating females.
* Participation in any other drug trial within 30 days prior to randomization.
* Inability to provide informed consent.
Non-interventional Study With Pomalidomide (Imnovid®)

The purpose of this non-interventional study is to collect data on the efficiency and safety of pomalidomide in combination with dexamethasone in the routine application


Eligibility Criteria:
Inclusion Criteria:

* Patients with relapsed or refractory multiple myeloma Patients must have received at least two prior lines of treatment (induction therapy followed by stem cell transplantation ± maintenance therapy is considered one prior therapy) and must have progressed under the most recent therapy regimen
* Adult male and female patients (at least 18 years with no upper age limit)
* Written informed consent to data collection and pseudonymized data transfer
* The conditions of the Pregnancy Prevention Programme must be fulfilled for all patients unless there is reliable evidence that the patient does not have childbearing potential (see summary of product characteristics Imnovid®)
* Other criteria according to summary of product characteristics Imnovid®

Exclusion Criteria:

* Missing patient's informed consent
* Pregnant or breast-feeding women
* Male patients, not capable of complying the required preventive measures (see summary of product characteristics Imnovid®)
* Other criteria according to summary of product characteristics Imnovid®
Research of Anatomo-functional Biomarkers in Schizophrenia

To objectify UR biomarkers, we propose a longitudinal follow-up of resistant patients with schizophrenia, starting before the onset of clozapine and including a multimodal brain imaging assessment (T1 and T2 weighted sequences, DTI, ASL-Perfusion, fMRI- Rest) associated with clinical and biological monitoring. In order to correct the MRI signal of clozapine hemodynamic effects, we will develop a new MRI methodology based on the concomitant collection of physiological parameters (blood pressure, electrocardiogram and respiration).

The identification of biomarkers of ultra-resistance (UR) to treatment in schizophrenia would allow earlier, better adapted and more effective personalized management of these patients, which would improve their functional prognosis.

An early decrease in functional connectivity (FC) between some rest networks has recently been proposed as an UR biomarker by McNabb et al. Nevertheless, clozapine has, among its side effects, a direct cardiac action that profoundly modifies patient's hemodynamics. However, functional brain imaging techniques are based on BOLD effect which is dependent on these hemodynamic parameters. It is therefore not possible to say whether these differences in FC are inherent to the pathology or whether they are related to clozapine instauration which causes hemodynamic changes that may disturb BOLD signal.

To objectify UR biomarkers, investigators propose a longitudinal follow-up of resistant patients, starting before clozapine instauration and including a multimodal brain imaging assessment (T1 and T2 weighted sequences, DTI, ASL-Perfusion, fMRI- Rest) associated with clinical and biological monitoring. In order to correct the MRI signal of clozapine hemodynamic effects, investigators will develop a new MRI methodology based on the concomitant collection of physiological parameters (blood pressure, electrocardiogram and respiration).

Eligibility Criteria:
Inclusion Criteria:

* schizophrenia or schizoaffective disorder (DSM 5)
* drug resistance
* written patient approval
* social security number in France
* curator or tutor approval if needed

Exclusion Criteria:

* pregnancy
* other research participation
* neurological evolution disorder
* no MRI contraindication
Autologous Chondrocyte Implantation in the Patellofemoral Joint

The purpose of this study is to measure the outcomes of patients who have articular cartilage lesions in the patellofemoral joint and are treated with the Autologous Chondrocyte Implantation.

Cartilage restoration, in general, is a relatively new option for the treatment of articular cartilage lesions primarily of the knee. In the initial autologous cultured chondrocyte transplantation (ACT or, by others implantation, thus ACI) reported by Peterson et. al., the results of femoral lesions were favorable, while 5 of 7 patellofemoral treatments were poor. In the United States, the expedited FDA approval based on these results excluded the patella. As a result, in the United States, it has been difficult to further evaluate use of ACI at the patellofemoral joint in light of the exclusion of "off label" uses by many governmental and private insurance programs. Nevertheless, a growing body of knowledge is accumulating outside the United States that the use of ACI at the patella is a viable option and soon similar findings will be published in the US by Minas et. al. (accepted for publication)

Eligibility Criteria:
Inclusion Criteria:

* Carticel Implantation of the patella and/or trochlear lesion. Patients who have reached their two-year follow-up date. All patients included in sequential order.

Exclusion Criteria:

* Patients that have had a microfracture in the knee joint at the same time as Carticel Implantation.

Patients that have implantable lesions other than the patella and trochlea.