cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study of Metformin Treatment in Patients With Well-differentiated Neuroendocrine Tumors

Neuroendocrine tumors are rare but recent data showed a relevant increase in its incidence. The Mammalian Target of Rapamycin (mTOR), one of most important area of research, has demonstrated be a therapeutic target in these tumors. The metformin has demonstrate in preclinical studies having an antineoplastic action by inhibiting the mTOR pathway, and may be an alternative treatment for this disease.

Eligible patients for this study should have metastatic gastroenteropancreatic neuroendocrine tumors well differentiated (grade 1 or grade 2) and will be treated with metformin 850 mg every 12 hours, and each cycle will consist of 30 days. After 180 days of treatment the efficacy of metformin under the control of disease progression will be evaluated. As a secondary outcome the investigator will check the patient adherence to the treatment, the control of patient symptoms with functioning neuroendocrine tumor, and disease free survival. Also will be performed an analysis of immunohistochemical expression of mTOR pathway proteins of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic well-differentiated neuroendocrine tumor grade 1 or 2 with histological confirmation;
* Performance status according to Eastern Cooperative Oncology Group (ECOG) 0 to 2;
* Able to take pills;
* Age ≥ 16 years;
* Ability to Provide Written Informed Consent;
* Adequate organ function;

Exclusion Criteria:

* Patient with out of control severe hormonal syndrome;
* Diabetic patients under metformin treatment, or those who have received treatment with metformin within 3 months;
* Patient with hypersensitivity to biguanides, kidney or liver failure, or other conditions that predispose to lactic acidosis;
* History of severe clinical or psychiatric illness, that would prevent participation in the study by clinical judgment;
* Patients who participate in other protocol with experimental drugs;
* Patients under any kind of active infection;
* Patients who have received chemotherapy within 3 weeks;
* Patients pregnant or lactating;
* Diabetic patients who require higher dose of metformin 850mg x 2 daily;
Research of Molecular and Metabolic Markers in Oligodendrogliomas Comparatively to Other Brain Tumours

At present, diagnosis of oligodendroglioma is made on histological and radiographic criteria in the French Mayo-Ste Anne classification. The less frequent grade A oligodendrogliomas are characterized by no vascular contrast on RMN evaluation comparatively to grade B forms. This benign histological subtype relapses in few cases with a more aggressive histology. To determine these relapsed cases at diagnosis, a collection of tumour begun in February 2004. Then, our study was designed to identify diagnostic molecular and metabolic markers that could eventually be used as a signature characterising grade A versus grade B oligodendrogliomas. The molecular analysis will use genomic techniques like allelotyping study, quantitative real-time PCR, gene sequencing , serial analysis of genomic expression and immunohistochemistry, since the metabolic study will be the spectroscopic examination of in vivo tumour. This study will include paediatric and adult patients followed for oligodendrogliomas, medulloblastomas and gliomas to compare the different tumour signatures. All these results will be correlated to survival and clinical features.


Eligibility Criteria:
Inclusion Criteria:

* Paediatric and adult patients (\> 1 year of age)
* Patient with oligodendroglioma or medulloblastoma or glioma
* Possibility of 3 year follow-up
* Patient consent obtained

Exclusion Criteria:

-
The Effectiveness of Resistance Exercise for Glycemic Control in Type 2 Diabetes Mellitus Patients

Resistance exercise is effective in improving glycemic control in diabetes patients. The effectiveness of a home-based resistance exercise program has not been establish.

Exercise play an important role in diabetes control. The American Diabetes Association (ADA) approved of resistive exercise as an effective method in controlling blood sugar of type 2 diabetes patients. Few community-based intervention has been establish. So the authors developed the low-cost community based resistance exercise program to promote exercise in of type 2 diabetes patients.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes was diagnosed by physician using fasting plasma glucose not less than 126 mg/dl and/or HbA1c not less than 7 %.
* Type 2 diabetes was diagnosed at least 6 months previously.
* The subject was ongoing treatment in primary care unit of prince of Songkla University.

Exclusion Criteria:

* Gestational diabetes and type 1 diabetes patients
* History of cardiovascular disease within the pass 6 months or any unstable chronic condition including dementia, proliferative diabetic retinopathy, retinal hemorrhage or detachment, dialysis and diabetic foot patients.
Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC

This study is aimed at patients with unresectable NSCLC who take nintedanib during sequential radiotherapy to explore the incidence of radiation pneumonitis above grade 2 in the nintedanib combined with radiotherapy mode and observe safety. And will further explore the progression-free survival (PFS) and overall survival (OS) of patients treated with nintedanib in combination with radiotherapy and immunotherapy.

Primary objective: To evaluate the safety of nintedanib combined with sequential radiotherapy in patients with unresectable NSCLC and the incidence of radiation pneumonitis above grade 2. Secondary objective: To evaluate the changes in lung function, progression-free survival (PFS) and overall survival (OS) in patients with unresectable NSCLC after nintedanib combined with sequential radiotherapy.

Patients need to receive induction therapy, chemotherapy and/or immunotherapy for at least one cycle. Then they will receive sequential radiotherapy and nintedanib for 6 months. Finally, they will receive immunotherapy maintenance therapy for 16 cycles.


Eligibility Criteria:
Inclusion Criteria:

* 1) Men or women who are over 18 years old (including 18 years old) when signing the informed consent form;
* 2) Non-small cell lung cancer was confirmed by histology and could not be resected, and EGFR/ALK driver gene was confirmed negative by gene mutation examination;
* 3) At least one measurable lesion with imaging examination (according to RECIST1.1) is examined by spiral CT or MR, and the length and diameter of the lesion are ≥ 10 mm;
* 4) within 3 days before treatment, the score according to ECOG is 0 \~ 1;
* 5) Life expectancy ≥3 months;
* 6)The vital organs function well,
* 7)The subjects volunteered to join the study and signed the informed consent form, with good compliance and cooperation with the follow-up.

Exclusion Criteria:

* 1) Complicated with severe respiratory diseases: pulmonary fibrosis, active tuberculosis, etc.
* 2)Persons with mental disorder, blood system diseases, autoimmune diseases and serious primary diseases of heart, brain, liver and kidney;
* 3) Hemorrhagic events that require blood transfusion, invasive intervention or hospitalization occur within 3 months before the first administration, or there are bleeding symptoms and need intervention treatment (such as hemoptysis, hematuria and bloody stool), or high-risk factors with bleeding risk (such as tumor surrounding or invading important blood vessels, obvious necrosis or cavity around tumor, esophageal varices, etc.);
* 4) Thrombosis or embolic diseases, abnormal blood coagulation function and bleeding tendency;
* 5) Known or suspected to be allergic to the study drug and its auxiliary materials;
* 6) The baseline pregnancy test of pregnant and lactating women or fertile women is positive.
* 7) According to the researcher's judgment, the subjects have other factors that may lead to the forced termination of this study.
Prospective Clinical and Biologic Study of Secondary Cutaneous Effects in Targeted Cancer Therapies

The aim of the study is to do a descriptive analysis of the cutaneous toxicity observed in patients treated using targeted therapies in order to have a better understanding of the skin pathophysiology.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cancer beginning a targeted therapy
* Patients able to follow the protocol
* Age \>/= 18 years old
* Signed inform consent

Exclusion Criteria:

* Patient unable to follow the protocol, having a non cooperative behavior or unable to come to follow up visits or unable to complete the study
* Pregnant or breastfeeding woman
Cholesterol Lowering Treatment With Psyllium Husks and Isolated Soy Protein in Hypercholesterolemia

Despite improved treatment, cardiovascular disease remains one of the most common diseases and causes of death in the Western world. Hypercholesterolemia is a well known risk factor for developing cardiovascular disease. Prevention and treatment are based in part on lowering LDL cholesterol. Dietary and lifestyle changes always play an important part of the treatment and preventive effort, and conversion to a heart-healthy diet reduces LDL cholesterol by a mean 10%. Further lowering of LDL cholesterol by means of food supplements have been demonstrated in numerous studies. Cholesterol lowering food supplements include isolated soy protein and water soluble dietary fibre such as psyllium husks. Postulated mechanisms of action responsible for the cholesterol lowering in these two food supplements are different, so there is a reason to expect an additive cholesterol lowering effect during concomitant treatment with both substances. The investigators want to investigate whether concomitant treatment with psyllium husks and isolated soy protein in addition to a heart-healthy diet results in a significantly greater reduction of LDL cholesterol in hypercholesterolemia, than single treatment with each of the substances.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18,5 - 35 kg/m2
* LDL cholesterol \> 3,5 mmol/l

Exclusion Criteria:

* Triglycerides \> 5,0 mmol/l
* Use of phytosterols, food supplements containing soy protein or water soluble fiber supplements
* Cardiovascular disease
* Diabetes mellitus
* Gastrointestinal disease
* Liver- og kidney disease
* Electrolyte imbalance
* Orlistat treatment
* Alcohol abuse
* Hypersensitivity to the interventional substances
* Pregnancy and nursing
Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Participants With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Non-Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) and/or Anti-tumor Necrosis Factor (Anti-TNF) Therapy

This observational study will evaluate the safety, tolerability and efficacy of tocilizumab in participants with moderate to severe RA who have an inadequate response to current non-biologic DMARD and/or anti-TNF therapy. Data will be collected from each participant during tocilizumab therapy and on follow-up for a total of 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe active RA with an inadequate response to existing therapies (DMARDs and/or anti-TNFs)
* Considered eligible for tocilizumab therapy by the treating physician as per routine clinical practice

Exclusion Criteria:

* Pregnant or breastfeeding females
* Immunization with live/attenuated vaccine within 4 weeks prior to baseline
* Participants with clinically significant raised liver enzyme, abnormal lipid profile, platelet count, hemoglobin, white blood cell and neutrophil count
* History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
* Participants with active tuberculosis (TB). Participants with latent TB should be treated with standard anti-mycobacterial therapy before initiating tocilizumab and have a negative chest x ray for active TB at enrolment
* History of diverticulitis, chronic ulcerative lower GI disease such as Crohn's disease, ulcerative colitis or other symptomatic lower GI conditions that might predispose to perforations then the benefit risk ratio should be considered by treating physician
* Know active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infection
* History of or currently active primary or secondary immunodeficiency or known human immunodeficiency virus (HIV) positive status
* Any other condition which puts the participant to undue risk for tocilizumab therapy as per local prescribing information or Investigator's judgement
Comparison of NPH Insulin and Insulin Detemir in Children and Adolescents With Type 1 Diabetes

This trial is conducted in Europe.

The aim of this research is to compare the efficacy and safety of treatment with NPH insulin and insulin detemir. You will be treated with either insulin detemir or NPH insulin once or twice daily as basal insulin. Additionally you will receive insulin aspart as bolus insulin


Eligibility Criteria:
Inclusion Criteria:

* Insulin detemir naive
* Type 1 diabetes for at least 12 months
* HbA1c lesser than or equal to 11.0%

Exclusion Criteria:

* Significant concomitant diseases
CONSERVE Plus Post-Approval Study (PAS)

The objective of this post-approval study is to provide scientifically valid and reliable evidence that supports claims of longer term safety and effectiveness with regard to Month 120 device survivorship rates.

This study will evaluate the performance of CONSERVE Plus Hip Resurfacing System under actual conditions of use. Additionally, this study will evaluate the performance of the device in the post approval environment to see if there are any significant changes in device performance as compared to the pre-market IDE Study

Eligibility Criteria:
Inclusion Criteria:

1. Was previously enrolled in the CONSERVE® Plus IDE as part of the All Enrolled Audited Cohort (N=1366 procedures (1206 patients)) and received the "Original Shell".
2. Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.

Exclusion Criteria:

1. Patient is mentally incompetent.
2. Patient is a prisoner.
3. Patient is an alcohol and/or drug abuser
4. Patient has undergone device revision or removal
A Pilot Feasibility Study in Recovered Heart Failure

One third of patients diagnosed with heart failure demonstrate left ventricular reverse remodelling and recovery of cardiac function following a period of medical therapy. These patients have an excellent long-term prognosis. Whether they need to remain on long-term medical therapy is not clear. The investigators will investigate the safety of therapy withdrawal in patients with a previous diagnosis of heart failure and recovered cardiac function, in a randomised controlled trial.

Patients with a previous diagnosis of heart failure, who have recovered cardiac function, without symptoms, normal serum biomarker concentrations and who are currently still taking heart failure medications, will be recruited. Participants will be randomised to withdrawal of therapy and control arms and will undergo imaging investigations and cardiopulmonary exercise tests at baseline along with serum biomarker tests. Those participants randomised to withdrawal of therapy will have a gradual, supervised reduction of medications. If, at anytime, there are signs of recurring heart failure, medications will be restarted. Participants in the control arm will continue their medical therapy as usual.

Participants will be followed up with further biomarker testing, cardiopulmonary exercise testing and imaging investigations at 6 months.

The primary end-point will be a relapse in heart failure, defined by adverse remodelling, increase in left ventricular size, rise in serum biomarkers or clinical evidence of heart failure as judged by the clinical team.

Eligibility Criteria:
Inclusion Criteria:

1. Have an index diagnosis of heart failure confirmed by 2 independent operators based on clinical details.
2. Be currently taking at least 1 of the following medications loop diuretic, betablocker, angiotension converting enzyme inhibitor/angiotensin receptor blocker and mineralocorticoid receptor antagonist.
3. Have demonstrated evidence of left ventricular reverse remodelling following the initial diagnosis with subsequent improvement in ejection fraction to \>50% and normalisation of left ventricular (LV) volumes.
4. Have no symptoms of heart failure (NYHA Class 1).
5. Low plasma NTproBNP.

Exclusion Criteria:

1. Uncontrolled hypertension.
2. More than moderate valvular disease.
3. Estimated glomerular filtration rate \<30mls/min.
4. Atrial/supraventricular/ventricular arrhythmia requiring beta-blockade.
5. Pregnancy.
6. Unstable angina.
7. Age \<16 years
Clinical Study to Evaluate the Possible Efficacy of Metformin in Patients With Parkinson's Disease

Parkinson's disease (PD) is one of the most common neurodegenerative diseases characterized by the progressive loss of dopaminergic (DA) neurons in the substantia nigra compacta (SNc) and aggregation of Lewy bodies in neurons. Although aging, oxidative damage and neuroinflammation have been recognized to play crucial roles in the pathogenesis of PD, the precise etiology remains obscure. Emerging evidence suggests PD is a systemic metabolic disease, and metabolic abnormality correlates with functional alternations in PD


Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception. Diagnosed Parkinson's disease patient taking Levodopa

Exclusion Criteria:

Secondary causes of Parkinsonism Diabetic patients Patients taking anti-inflammatory drugs Atypical parkinsonian syndromes Prior stereotaxic surgery for Parkinson's disease Pregnancy and lactation Suffering from active malignancy Addiction to alcohol and/or drugs Known allergy to the studied medications
Effectiveness and Safety of Edaravone Dexborneol in Acute Ischemic Stroke

This study is a multicenter, prospective, cohort study to observe the clinical efficacy and safety of edaravone dextrol in patients with acute ischemic stroke in a real-world setting.

The study lasts a total of 90 days and includes three phases: screening, treatment, and follow-up. Treatment period: patients are divided into exposure group and non-exposed group based on the use of edaravone dextrol after ischemic stroke. The exposure group: edaravone dextrol is used according to reference to clinical practice, without specific restrictions. The non-exposed group: edaravone dextrol is not used, and concomitant therapy is at the clinician's discretion. Follow-up period: All patients continue to be followed up to 90 days after stroke onset.

Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years old；
* Clinically diagnosed as acute ischemic stroke；
* Time from symptom onset to admission≤14 days (symptom onset time is defined as last known well time)；
* Pre-stroke mRS ≤1；
* Have been informed of the content of the informed consent form and agree to participate.

Exclusion Criteria:

* Acute intracranial hemorrhagic diseases confirmed by images: parenchymal hemorrhage, epidural hematoma, subdural hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.
* Patients who are pregnant or lactating and who are planned to become pregnant within 90 days;
* Patients with severe renal failure (eGFR\<30ml/min);
* Patients with concurrent malignancy or severe systemic disease with an estimated survival of less than 90 days;
* Patients with severe mental disorders or unable to complete the informed consent and follow-up due to dementia;
* Patients who are judged unsuitable for participation in the study.
Surgical Management of Placenta Accreta

purpose of this study was to report our experience for surgical management of suspected placenta accreta cases encountered in King Hussein medical center

was a retrospective study of all patients who underwent planned deliveries for placenta accreta at King Hussein Medical Centre (KHMC) from August 2011 to October 2014.Demographic characteristics were recorded. Ultrasound (U/S) and magnetic resonance imaging (MRI) were used for the diagnosis. Surgery for all patients were performed by multidisciplinary teams. All information were obtained from patient's files.

Eligibility Criteria:
Inclusion Criteria:

* all placenta previa accreta cases encountered in our institution over three year period

Exclusion Criteria:

-
The Effect of a Weight Management Program During Treatment With Olanzapine

The study is a prospective, randomized, open-label study.

The principal objective of this trial is to investigate the effect of a comprehensive behavioural treatment program on weight gain in schizophrenic patients under olanzapine treatment, and on subjective well-being.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia
* Ages between 18 and 65
* Informed consent
* Weight gain of at least 1.5 kg in the first 4 weeks
* A sufficient understanding to participate adequately in the weight management program
* Patients must agree to cooperate with all tests and examinations required by the protocol.
* Each patient must understand the nature of the study and must sign an informed consent document.

Exclusion Criteria:

* Serious, unstable somatic illnesses
* Illnesses associated with weight gain including renal and endocrine diseases
* Weight change greater than 3 kg in the preceding three months
* Weight gain less than 1.5 kg in the first 4 weeks
The Effects of DPPIs on Cognitive Function of Diabetic Patients

This is a single-center, randomized controlled clinical trial with a parallel-group design conducted at Minia University hospital.

All patients admitted to Diabetes clinics of Minia University Hospital, will be screened for the eligibility criteria.

diabetic patients (aged above 50 years) with uncontrolled diabetes on oral hypoglycemic drugs. 105 patients will be enrolled and randomized into three groups.

Group I=35 T2DM patients given DPP4Is Group II=35 T2DM patients given DPP4Is and metformin. Group III=35 patients will be given placebo (only adjust their drugs to control blood glucose level)

Eligibility Criteria:
Inclusion Criteria:

Type-2 diabetic adult subjects (above 50 years old) who had uncontrolled (A1c=8-9 %) blood glucose levels with an oral hypoglycemic drug at the screening visit were eligible to participate.

Exclusion Criteria:

Those with type1 diabetes or ketoacidosis, end organ failure as chronic renal failure (estimated serum creatinine level ≥ 1.5mg/dl in male and ≥ 1.4mg/dl in female), liver cell failure (elevated alanine transaminase (ALT) and aspartate transaminase (AST) ≥ 2 folds), and heart failure, previous history of pancreatitis, and pregnant or lactating females were excluded from the study.