cyrilzakka/clinical-trials huggingface dataset:
Surgical Treatment in Diabetic Patients With Grade 1 Obesity

Surgical Treatment in Diabetic Patients With Grade 1 Obesity

There will be a randomized clinical trial, non-blind, 1-arm treatment (Duodenal Ileal Interposition with Sleeve Gastrectomy and Selective Intra-Abdominal Denervation for Type 2 Diabetes Mellitus), including 40 research subjects with type 2 diabetes mellitus and obesity class I. In order to analise the effect on weight loss and glycemic control after 2 years of follow up

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of type 2 diabetes mellitus
* Both sexes were treated with oral antidiabetic agents and / or insulin except the current treatment with Glucagon-like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase 4 inhibitors
* Stable antidiabetic medication within the last 8 weeks prior to randomization (V2), if therapy includes insulin, the average daily dose should not have changed by more than 10% in the past 8 weeks
* HbA1c\> 8.0%
* Age\> 20 years and \<60 years
* Body mass index (BMI) of 30 35 kg / m²
* Agree to sign the consent form

Exclusion Criteria:

* Type 1 diabetes mellitus (positive for anti-GAD), or GAD negative anti anti body with low β cell function (C-peptide after stimulation \<0.5 ng / ml)
* Current treatment with GLP-1 receptor agonist and / or dipeptidyl peptidase 4 inhibitors
* Recent vascular event (myocardial infarction, coronary angioplasty or stroke in the past 6 months)
* Malignant neoplasm
* Portal hypertension
* Inability to cooperate with segment
* Low capacity of understanding surgery
* Unrealistic expectations of the outcome
* Cognitive impairment
* Current pregnancy
* Moderate or severe mood disorder; severe anxiety; eating disorders (based on Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria)
* Chemical dependency or alcoholism (based on DSM-V criteria).
Microwave Ablation of Resectable Liver Tumors

The purpose of this protocol is to pathologically evaluate the destruction by microwave ablation of primary and metastatic liver tumors. The primary aim is to measure tissue destruction with the MedWaves Microwave Ablation/ Coagulation Ablation System.

Minimally invasive surgical alternatives are becoming more attractive for the treatment of malignancy.The goal is to reduce morbidity and mortality and increase the ability to treat patients in the outpatient setting. Image-guided ablation is becoming an attractive alternative because of its relative low cost, its ability to provide large regions of coagulative necrosis in a controlled fashion, and its relatively low toxicity. Although image-guided ablative techniques have been extensively investigated for the treatment of liver tumors, there has been limited experience with microwave ablation (MWA) in the liver. This study will evaluate the treatment effect of MWA in liver tumors. Patients undergoing planned surgical removal of liver tumors will have the tumors intra-operatively treated with MWA. The histological changes will be evaluated upon removal of the specimen.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary or metastatic liver cancer for which surgery is planned
* All participants need to be fully able to give informed consent

Exclusion Criteria:

* Mental or legal incompetence
* Impaired decision-making capacity
* Pregnant women may not participate
Comparison of Effect of Repeated Exposure, Flavor-Flavor and Flavor-Nutrient Learning on Vegetable Acceptance in Infants

This study aims at comparing learning mechanisms to increase vegetable acceptance in infants at complementary feeding, namely repeated exposure (RE), flavor-flavor learning (FFL) and flavor-nutrient learning (FNL); measuring the stability of the learning effect; and examining the impact of infants' feeding history on vegetable acceptance.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants, aged between 4 and 8 months old, not yet introduced to complementary foods

Exclusion Criteria:

* Infants with food allergies, with chronic health problem, or born before 36 weeks of gestational age
Using Real-Time Functional Brain Imaging to Enhance Recovery From TBI

In this randomized, controlled clinical trial, we will evaluate the effects of (1) a brain-training program that uses real-time neurofeedback in functional magnetic resonance imaging (fMRI) to allow people to learn how to gain voluntary control over activity in targeted brain regions and/or (2) 8 weeks of computer-based cognitive training using a software program (Cognitive Remediation for Brain Injury (CRBI)) versus control training tasks on cognitive learning and symptoms. In addition, the investigators will measure brain function (active and resting functional magnetic resonance imaging) and structure (high resolution magnetic resonance imaging) before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Mild TBI: PTA/confusion≤1 hour immediately after injury; or LOC \<30 min \[69\] confirmed by the Ohio confirmed by the Ohio State University TBI Identification Method-Short Form (OSU TBI-ID-SF).
* Age 18-45 years
* Right handed \[70\].
* Minimum of 4 months and within 36 months post-injury
* Can participate in fMRI and outcome assessment
* Adequate visual, auditory, sensory-motor function for training program.
* Fluent in English
* Persistent cognitive dysfunction confirmed by an objective measure

Exclusion Criteria:

* History of hypoxic event
* Pre-existing significant neurological (e.g. MS) or psychiatric (e.g. schizophrenia, bi-polar) disorders.
* Current illicit drug use or ETOH abuse
* Contraindications to MRI (metal, pregnant, pacemaker, claustrophobia, etc.).
* Unwilling or unable (e.g. language barrier) to participate
* Hospitalization during study
* Current Med Board for discharge, Litigation/ + malingering test \[71\]
* Use of medications to enhance cognitive function (e.g. Ritalin)
* Initial Glascow Coma Score \<13 or penetrating head injury
* Subjects must not show suicidal ideation as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS; 111). Subjects with a score of 4 or 5 (as recommended by the FDA for treatment trials) will be excluded and referred for appropriate treatment.
* Subjects should not be enrolled in a concurrent TBI clinical trial.
Exploratory Safety and Effectiveness Evaluation of Pulsed Field Ablation (PFA) by Balloon Catheter With TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)

The purpose of this study is to explore preliminary safety and acute effectiveness of pulsed field ablation by the ablation system (pulsed field ablation balloon catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causes abnormal blood flow.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with symptomatic Paroxysmal Atrial Fibrillation (PAF) defined as AF that terminates spontaneously or with intervention within 7 days of onset. This PAF is considered to be symptomatic if symptoms related to AF are experienced by the participant
* Selected for AF ablation procedure by pulmonary vein isolation (PVI)
* Willing and capable of providing consent
* Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion Criteria:

* Previously known AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity \[body mass index more than {\>} 40 kilogram per square meter {kg/m\^2}\], renal insufficiency \[with an estimated creatinine clearance less than {\<}30 milliliter {mL}/minute {min}/1.73 meter {m}\^2\])
* Previous left atrium (LA) ablation or surgery
* Participants known to require ablation outside the pulmonary vein (PV) region (example, atrioventricular reentrant tachycardia, atrioventricular nodal re-entry tachycardia, atrial tachycardia, ventricular tachycardia and Wolff-Parkinson-White)
* Previously diagnosed with persistent AF (\>7 days in duration)
* Severe dilatation of the LA (left anterior descending artery \[LAD\] \>50 millimetre \[mm\] antero-posterior diameter or left atrium volume index \[LAVi\] \>48 \[mL/m\^2\] in case of transthoracic echocardiography \[TTE\])
Enhancing the Outcome of Skills Training for People With Schizophrenia

This study will determine the effectiveness of skills training in people with schizophrenia and the applicability of the acquired skills in the "real world."

People with schizophrenia have a large number of social and symptom management training programs available to them. Studies suggest that these training programs are effective, but their generalizability and effectiveness in outpatient settings has not been thoroughly examined. This study will examine the treatment outcomes of a skills training approach in schizophrenic individuals taking antipsychotic medication.

Participants taking stable doses of risperidone, olanzapine, or quetiapine will be randomly assigned to receive either intensive symptom management and social skills training or group therapy for 12 months. A verbal memory test will be used to stratify the randomization procedure and to control for neurocognitive functioning.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder for \> 5 years
* Use of stable dose risperidone, olanzapine, or quetiapine for at least 1 month with no planned medication changes
* Social Behavior Scale (SBS) score \> 45
* Willing and able to provide informed consent

Exclusion Criteria:

* Intelligence Quotient \< 70
* Use of more than one antipsychotic medication
* Use of benzodiazepines, tricyclic antidepressants, or anticholinergic medication commonly used to treat extrapyramidal symptoms
* Diagnostic and Statistical Manual (DSM)-IV criteria for alcohol or other substance dependence
* History of any traumatic brain injury leading to loss of consciousness for \> 30 minutes
* Diagnosis of a comorbid medical condition that could interfere with antipsychotic medication treatment or the ability to complete the study
Efficacy of Low Dose hCG on Oocyte Maturity in Poor Responder Women Undergoing Intracytoplasmic Sperm Injection

This study is a prospective, randomized, parallel, controlled trial to assess the efficacy of the late follicular phase administration of low dose hCG on oocyte maturity for ovarian stimulation in 73 poor respond patients undergoing intracytoplasmic sperm injection (ICSI) treatment.

In this study all eligible patients were randomly allocated into three study groups by a permuted block randomization method: group A (control group) received only recombinant FSH, group B received rFSH supplemented by 100IU hCG in the late follicular phase. Group C received rFSH supplemented by 200IU hCG in the late follicular phase.

All of the patients underwent a standard long protocol and received GnRH-a (Suprefact), 0.5cc subcutaneous, started from the day 17 of the preceding cycle and ovulation induction was started 14 days thereafter.

Patients were categorized according to the following stimulation protocols:

Group A (control group): which 300 IU r-FSH was administered for the first 5 days of the stimulation cycle. Then the first ultrasound scan was performed to monitor response. At this stage the dose of rFSH adjusted according to the ovarian response and continued until the day of ovulatory hCG administration.

Group B: rFSH supplemented with daily administration of 100 IU hCG in the late follicular phase based on the follicle size (14mm).

Group C: rFSH supplemented with daily administration of 200 IU hCG in the late follicular phase based on the follicle size (14mm).

To assess the pregnancy outcomes, serum hCG was measured 2 weeks after embryo transfer. Clinical pregnancy was defined by the observation of sac with fetal heart rate on ultrasonography 4 weeks after embryo transfer.

Eligibility Criteria:
Inclusion Criteria:

1. Poor ovarian response to ovulation induction according to the ESHRE definition\[20\] and presence of at least 2 of the criteria needed to define poor responders including advanced maternal age, history of low ovarian response in previous IVF/ICSI treatments and abnormal ovarian reserve test(Antral Follicle number \< 5)
2. indication for ICSI treatment, second or third cycle
3. Age 37 to 43 years
4. Body mass index (BMI) ≤ 30 kg/m2
5. The presence of two functional ovaries and no previous ovarian surgery
6. The presence of normal uterine cavity and 2 normal tubes base on recent hysterosalpingographic or hysteroscopic evaluation
7. Basal (day 2 or 3) serum FSH levels ≤13 IU/L
8. Normal semen analysis
9. No history or signs of endometriosis
10. No untreated endocrinologic disease
The Efficacy of Precision Treatment for Gastric Cancer Guided by Molecular Profiling

Gastric cancer (GC) is one of the most common and lethal cancers worldwide, especially in China, and the median overall survival for patients with advanced, metastatic GC remains only about 1 year. Several molecular profiling studies have demonstrated that a proportion of gastric cancer harbour actionable molecular alterations which shows a predictive benefit from a specific therapy (in any cancer type). In the current study, the efficacy of precision treatment for gastric cancer guided by multidimensional molecular biology profiling will be observed. The analysis focused on the overall survival outcomes for patients whose tumours harboured actionable molecular alterations and who received appropriately matched therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female. Age: 18-80 years.
2. Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy.
3. Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, assessed using imaging techniques (CT or MRI).
4. Multidimensional molecular biology profiling has been conducted using tumor or blood sample.
5. ECOG Performance status 0-1.
6. Life expectancy of at least 3 months.
7. Signed informed consent.

Exclusion Criteria:

1. The quality of NGS reports does not fit the requirement.
2. History of documented congestive heart failure; angina pectoris requiring medication; evidence of transmural myocardial infarction on ECG; poorly controlled hypertension (systolic BP \> 180 mmHg or diastolic BP \> 100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias.
3. Baseline LVEF \< 50% (measured by echocardiography or MUGA).
4. Patients with dyspnea at rest due to complications of advanced malignancy or other disease, or who require supportive oxygen therapy.
5. Patients receiving chronic or high dose corticosteroid therapy. (Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed).
6. Known dihydropyrimidine dehydrogenase (DPD) deficiency.
7. History or clinical evidence of brain metastases.
8. Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.
9. Positive serum pregnancy test in women of childbearing potential.
10. Subjects with reproductive potential not willing to use an effective method of contraception.
11. Major surgery within 4 weeks of start of study treatment, without complete recovery.
12. Patients with known active infection with HIV, HBV, or HCV.
Furosemide Stress Test as a Predictor of Tubular Function in Chronic Kidney Disease

In kidney diseases, tubule-interstitium has become much more relevant, as formerly only the glomerulus was considered to have the main importance. Kidney's tubular atrophy and interstitital fibrosis is now recognized as long term prognostic value. We aim to evaluate the function of the kidney's tubule-interstitium through furosemide excretion after intravenous administration of this drug, and correlate the rate of excretion of furosemide with interstitial fibrosis findings in scheduled kidney biopsy for patients with chronic kidney disease.

All patients scheduled for kidney biopsy will be invited to participate in a standard isovolemic furosemide stress test before the biopsy procedure. The latter will consist in 1.5 miligrams per kilogram of weight of intravenous furosemide administration, with urinary output follow up and measurement. The urinary output will be replaced intravenously with normal saline to avoid dehydration and/or hypotension. A standard 5ml sample of blood will be taken before the test and aliquots of urine before and after furosemide administration will be frozen.

After completion of the formely mentioned test, patients will proceed to their scheduled kidney biopsy along with interventions considered appropiate by their attending physician.

Kidney biopsy sample will be examined by histopathology service and the degree of interstitial fibrosis will be described. The degree of fibrosis will be correlated with the degree furosemide excretion and urinary output.

Eligibility Criteria:
Inclusion Criteria:

* Accept to participate (informed consent)
* Legal age or older
* An estimated glomerular filtration rate greater than 15ml/min/1.73m2, calculated by CKD-EPI.

Exclusion Criteria:

* Known Alergic reaction to furosemide
* Contraindication to kidney biopsy
* Patient already in renal replacement therapy
Evaluation of Rheumatoid Arthritis Disease Education Literature

Rheumatoid arthritis is an inflammatory disease that results in joint inflammation, pain and swelling. It may progress to advance stages that render patients unable to carry out their daily activities. It also results in joints deformity and is a leading cause of disability globally.

Patient education plays an important role in the management of disease. Adequate patient knowledge and awareness about disease may help in incorporating the ailment in daily life. The purpose of this study is to evaluate the benefit of a disease education literature in Urdu language and with culturally relevant illustration for rheumatoid arthritis patients.


Eligibility Criteria:
Inclusion Criteria:

1. Out-patients with established diagnosis of rheumatoid arthritis over 3 months.
2. Participants who are willing to participate in the study.

Exclusion Criteria:

1. Patients with no rheumatoid arthritis.
2. Patients currently undergoing surgery or had previous history of surgery.
3. Patients who are not willing to participate.
4. In-patients.
Study of AZD9829 in CD123+ Hematological Malignancies

This is a modular, multicentre, open-label, Phase I/II, dose-setting study. AZD9829 will be administered intravenously as monotherapy or in combination in participants with CD123 positive hematological malignancies.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age;
* CD123+ hematologic malignancy based on flow cytometry or immunohistochemistry by local laboratory;

  * R/R AML (except APL);
  * R/R HR-MDS with ≥5% bone marrow blast at time of inclusion;
* Had at least 1 prior line of therapy at currents histology, and have no available treatment options;
* ECOG performance status of ≤ 2.

The above is a summary, other inclusion criteria details may apply.

Exclusion Criteria:

* Active CNS leukemia;
* Previous treatment with any CD123 targeting therapy;
* Prior allogeneic HSCT, within 90 or cell therapy within 60 of start of therapy;
* Active GVHD that requires immunosuppressive treatment within 4 weeks prior to start of AZD9829;
* History of other malignancy(with certain exceptions);
* Active and uncontrolled infections;
* Unresolved AEs ≥2 Grade, from prior therapies.

The above is a summary, other exclusion criteria details may apply.
A Trial of Neoadjuvant TS-1 and Cisplatin for Type 4 and Large Type 3 Gastric Cancer

The aim of this study is to evaluate survival benefit of TS-1 plus cisplatin as a neoadjuvant chemotherapy in gastric cancer patient with resectable type 4 (linitis plastica type) and large type 3 tumor in comparison with surgery alone.

A randomized phase III study is going to started in Japan to compare TS-1 plus cisplatin as a neoadjuvant chemotherapy with surgery alone in patient with type 4 and large type 3 gastric cancer.A total of 300 patients will be accrued for this study from 35 institutions within five years. The primary endpoint is overall survival. The secondary endpoints are progression free survival (PFS), response rate, proportion of protocol achievement, proportion of curative resection, and adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. histologically proven adenocarcinoma of stomach
2. Borrmann type 4 or large (\>=8 cm) type 3
3. no evidence of distant metastasis including liver(M0)
4. no evidence of para-aortic and/or retropancreatic lymph node metastasis(N0-2)
5. no peritoneal metastasis and negative peritoneal lavage cytology (PLS) with laparoscopic confirmation
6. no involvement of the esophagus with \> 3cm
7. an age of 20-75 years
8. an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
9. no prior chemotherapy, radiotherapy for any malignancy
10. no prior surgery for gastric cancer except for endoscopic membrane resection (EMR)
11. no breeding from primary tumor or gastrointestinal stenosis
12. sufficient oral intake
13. adequate organ function
14. written informed consent

Exclusion Criteria:

1. synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
2. pregnant or breast-feeding women
3. severe mental disease
4. systemic administration of corticosteroids, flucytosine, phenytoin or warfarin
5. other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease
6. myocardial infarction within six disease-free months