cyrilzakka/clinical-trials huggingface dataset:
Brain Plasticity Following Aerobic Exercise in Patient With Mild Cognitive Impairment: Neuroimaging Study

The proposed study aims to explore brain mechanisms mediating the cognitive benefits of aerobic exercise in patients with mild cognitive impairment- a prodromal stage of Alzheimer disease. We will perform FMRI experiments, as well as laboratory and behavioral tests that will advance our knowledge about the nature of these mechanisms. Participants will participate in individual- tailored aerobic training program. Pre and post evaluation will identify brain changes following the training using advanced techniques of brain imaging. Cognitive performance will be assessed prior and at the end of the program, as well as endocrine markers reflecting improvement in learning abilities. Moreover, demonstrating cortical plasticity in subjects with aMCI has tremendous practical significance for these subjects .

Mild cognitive impairment (MCI), a prodromal stage of Alzheimer disease (AD), refers to a transitional state between the cognition of normal aging and dementia such AD. To date, therapeutic approaches to AD are symptomatic and of modest efficacy. Nontheless, recent studies in animal models or healthy subjects, have shown that aerobic exercise affect brain plasticity. The current proposal aims at exploring the brain mechanisms mediating the cognitive benefits of aerobic exercise in patients with amnestic MCI (aMCI),in compare to a control group of subjects with aMCI receiving stretching exercise. More specifically, we aim to perform two fMRI experiments, that will advance our knowledge about the nature of mechanism of the cognitive benefit resulting of aerobic exercise. Our preleminary results suggest that subjects with aMCI show different hierarchy of reliable responses when processing long time scales in auditory task. Therefore, in the first experiment, we will evaluate how these patterns of temporal hierarchy of language processing are affected by aerobic exercise. Next, we will explore whether aerobic exercise affect memory enocoding task, which rely on areas in the medial temporal lobe who bear a heavy neuropathological burden in MCI. The insights gained from the study may have important clinical implications for patients who are at the early stages of Alzheimer's disease

Eligibility Criteria:
Inclusion Criteria:

* Only patients at the age of 60-90 who have met criteria for a diagnosis of MCI will be included.
* Participants will be both men and women, and this factor is not specifically addressed.

Exclusion Criteria:

* Patients with any significant medical (i.e. cardiac), neurological (other than MCI) illness will be excluded from the study.
* Medical and neurological illnesses will be ruled out by physical and neurological examinations, reports of the patients' treating physicians and medical records.
* The experiments will be undertaken in compliance with the safety guidelines for MRI research. Based on initial fMRI screening questionnaires, subjects will be excluded if they indicate any risk factor on these questionnaires.
Glufast On Insulin Glargine Trial in Type 2 DM

We will evaluate the efficacy and safety of combination therapy of 10 mg mitiglinide or 0.2mg voglibose with insulin glargine for 16 weeks after single administration of insulin glargine for 4 weeks in type 2 diabetic patients whose glycemic control were not enough despite administration of oral antidiabetic drug or insulin glargine.


Eligibility Criteria:
Inclusion Criteria:

* The type 2 diabetic patients aged between 30 and 70
* The patients whose Hb1Ac is over 7.0% despite administration of two or more oral antidiabetic drugs over 6 months or only insulin glargine over 3 months before registration
* Outpatients whose BMI is between 21 and 40 kg/㎡
* The patients who consented to participate in the clinical study in writing

Exclusion Criteria:

* The patients who have been using insulin formulation except insulin glargine
* The patients whose fasting blood glucose is over 270 mg/dL
* The patients whose C-peptide is under 1ng/ml on an empty stomach
* The patients who was surgically operated of gastrointestinal tract
* The patients who need additional treatment or who underwent operation within 3 months for severe complication such as diabetic foot ulcer, retinopathy and neuropathy
* The patients with severe hepatic dysfunction : uncompensated hepatic cirrhosis, or the case where aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is over 2.5 times higher than the normal limit ( ≥ 2.5 x normal ranges)
* The patients with unstable angina or acute myocardial infarction occurred within 3months
* The patients with renal failure or severe hypertension : diastolic blood pressure is over 110mmHg despite drug treatment
* The patients who have a life-threatening disease such as cancer or severe infection
* The patients with a history of drug allergy
* Pregnant or breast feeding or the women who are likely to be pregnant
* The patients who need oral or parenteral corticosteroids
* The patients who were judged to be unsuitable to the clinical study by other reasons
Postoperative Effects of TAP Block Versus QLB Type 2 Block

This study compares analgesic effectiveness of transversus abdominis plane block and quadratus lumborum block type 2 in open hernia repair surgery. All of the patients will receive routine intravenous analgesic regimen. In addition to that one-third of the patients will receive transversus abdominis plane block, one-third will receive quadratus lumborum block type 2. One-third of the patients will not receive any blocks and will constitute the control group


Eligibility Criteria:
Inclusion Criteria:

* Patients who are over 18 years of age
* Patients who are scheduled for elective unilateral open hernia repair with tension free mesh techniques
* Patients who are in ASA's physical status score group 1 or 2

Exclusion Criteria:

* Patients who are younger than 18 years of age
* Patients who have severe stenotic heart diseases
* Patients who have bleeding diathesis
* Patients who have true allergies to local anesthetics
* Patients who have neurologic deficits corresponding to effect site of the anesthetic techniques
Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer

Feasibility and efficacy of combined modality intervention using chemotherapeutic agent gemcitabine with anti-angiogenic peptide vaccination targeting VRGFR1 should be determined in case of advanced/inoperable or therapy-resistant pancreatic cancer patients.

Gemcitabine 1,000mg/m2 BSA will be administered on day1, day8, day15, day29, day36, day43, respectively.

HLA-A\*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084; SYGVLLWEI) emulsified with Montanide ISA51 will be subcutaneously injected twice weekly for 8weeks (total 16 doses).

HLA-A\*2402-restricted cytotoxic T lymphocyte (CTL) clones were obtained from healthy volunteer donor peripheral blood.

These CTL clones showed potent cytotoxicities selectively against VEGFR1-expressing target cells in HLA-class I-restricted manner.

Eligibility Criteria:
Inclusion Criteria:

* Heterozygote or homozygote of HLA-A\*2402 allele
* Inoperable or recurrent pancreatic cancer with or without any prior therapy
* Difficult to continue the prior therapy due to treatment-related toxicities
* ECOG performance status 0-2
* Evaluable primary or metastatic lesion with RECIST criteria
* Clearance period from prior therapy more than 4 weeks
* Life expectancy more than 3 months
* Laboratory values as follows 2,000/μL\<WBC\<15,000/μL Platelet count\>100,000/μL AST\<150IU/L ALT\<150IU/L Total bilirubin\<3.0mg/dl Serum creatinine\<3.0mg/dl

Exclusion Criteria:

* Pregnancy (refusal or inability to use effective contraceptives)
* Breastfeeding
* Active or uncontrolled infection
* Systemic use of corticosteroids or immunosuppressants
* Uncontrollable brain metastasis and/or meningeal infiltration
* Unhealed external wound
* Possibilities of complicated paralytic ileus or interstitial pneumonitis
* Decision of not eligible determined by principal investigator or attending doctor
(18)F-FDG PET Database of Adult Healthy Individuals

Epilepsy is the most common chronic neurological disorder in the world, affecting more than 50 million people worldwide.

Approximately 35% of patients with epilepsy are refractory to all available antiepileptic drugs. Focal Hypometabolism on interictal \[18F\]-FDG PET is a hallmark of the Seizure Onset Zone as well as surrounding areas. Using \[18F\]-FDG PET is thus particularly useful to determine the seizure onset zone of epileptic patients and thus to guide surgical treatment when antiepileptic drugs fail.

Interpretation of PET images primarily relies on standard visual analysis, but statistical analysis, with the widely used Statistical Parametric Mapping (SPM) software improves the diagnostic yield of PET. Over the past years, some authors have thus reported that the use of SPM can result in greater sensitivity and specificity of PET imaging in patients with partial epilepsy.

In order to perform statistical analysis of PET images to compare brain metabolism of epileptic patients and healthy controls, it is necessary to collect a normative database of \[18F\]-FDG PET images in healthy controls.

The purpose of this study is (i) collect a normative database of \[18F\]-FDG PET images in healthy adults controls to evaluate rigorously the diagnostic value of multimodal imaging for non-invasive localization of the EZ and (ii) to evaluate the test-retest reliability of \[18F\]-FDG PET scanning.


Eligibility Criteria:
Inclusion Criteria:

* healthy adult controls
* Age 20-65 years
* Signed informed consent form.

Exclusion Criteria:

* Contraindication to the MRI
* Known neurological disease
* Adult subject to legal protection measure.
* Women of childbearing age who do not have effective contraception
Evaluation of Glycemic Control Using Adjunctive Continuous Glucose Monitoring With the Dexcom G4 System

This is a prospective, non-randomized, observational study conducted in the United States.Up to sixty (60) subjects will be enrolled. The purpose of the study is to evaluate long-term utility and usability of Dexcom G4 Continuous Glucose Monitoring (CGM) System. Subjects will be followed monthly over a period of one year.


Eligibility Criteria:
Inclusion Criteria:

* Require intensive insulin therapy, defined as use of Continuous Subcutaneous Insulin Infusion (CSII) i.e. insulin pumps or multiple daily injections (MDI.
* Willing to refrain from use of any acetaminophen - containing (ACT) medication during the study, up to 24-hours before the initial sensor insertion.

Exclusion Criteria:

* Have extensive skin changes/ diseases that preclude wearing the device.
* Dialysis.
Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED)

The primary purpose of the study is to determine if GARDASIL (V501) with four components is able to prevent cervical cancer, cervical dysplasia, including Cervical Intraepithelial Neoplasia (CIN)(Any Grade) and Adenocarcinoma In Situ (AIS), and genital warts.


Eligibility Criteria:
Inclusion Criteria:

* Female with an intact uterus with lifetime history of 0-4 sexual partners

Exclusion Criteria:

* Prior Human Papillomavirus (HPV) vaccination
* Prior abnormal paps
* History of genital warts
Effectiveness of Plasma Transfusions in Critical Care Patients

Measuring the effectiveness of plasma transfusions in critical care

Measuring the effectiveness of plasma transfusions in critical care

Eligibility Criteria:
Inclusion Criteria:

* ICU Admission
* INR \> 1.2
* Require FFP for active bleeding and/or prior to an invasive procedure
* Are able to provide consent or proxy consent

Exclusion Criteria:

* Congenital or acquired coagulation factor deficiency
* Platelet count \< 50 x 109 /L and have NOT received subsequent platelet transfusion
* Consumptive coagulopathy (bleeding ≥ 3 sites and ↓ plts, ↓ fib, ↑ d dimer)
* Uncontrolled bleeding (6 or more units of blood in the last 6 hours)
* Receiving therapeutic doses of heparin/heparinoid (must be off for at least 6 hours)
* Have received clotting factor concentrates in the previous 24 hours
* Are expected to require surgery in the next 48 hours
* Survival expected to be less than 48 hours
* Currently enrolled in another study with a similar outcome
* Previous enrollment in this study
A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney Disease

Primary Objectives

* To assess the safety and tolerability of RGLS8429
* To assess the impact of RGLS8429 on ADPKD biomarkers

Secondary Objectives

* To assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV)
* To characterize the pharmacokinetic (PK) properties of RGLS8429
* To assess the impact of RGLS8429 on renal function

This is a randomized, double-blind, placebo-controlled multiple ascending dose and an open-label fixed-dose Phase 1b study consisting of two parts, Part A and Part B. In Part A, multiple ascending doses of RGLS8429 or placebo will be administered via subcutaneous injection to subjects with ADPKD to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of RGLS8429. In Part B, a fixed-dose of RGLS8429 will be administered via subcutaneous injection to subjects with ADPKD to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of RGLS8429.

Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female ADPKD patients, 18 to 70 years old
2. Class 1C, 1D, or 1E Mayo Imaging Classification of ADPKD (based upon either the MRI obtained during screening, or a prior MRI obtained within 5 years of screening with documented Mayo classification)
3. eGFR between 30 to 90 mL/min/1.73 m2
4. Body mass index (BMI) 18 to 35 kg/m2
5. Must understand and consent to the study procedures explained in the ICF and be willing and able to comply with the protocol

Key Exclusion Criteria:

1. Administration of tolvaptan in the 28 days before randomization
2. Subject is mentally incapacitated or has significant emotional problems
3. Any medical condition or social circumstance that, in the opinion of the Investigator, may make the subject unlikely to complete the study or comply with study procedures and requirements; or may pose a risk to the subject's safety
4. History or presence of alcoholism or drug abuse within the past 2 years prior to screening
5. Only one kidney or kidney transplant recipient
6. Participation in another clinical trial and/or exposure to any investigational drug or approved therapy for investigational use within 28 days or 5 half-lives of the investigational drug's dosing, whichever is longer, prior to dosing. The 28-day or 5-half-life windows will be calculated from the date of the last dosing in the previous study to Day 1 of the current study.
A 24-52-week Study to Evaluate the Long-term Efficacy and Safety of Saredutant in Patients With Depression (MAGENTA)

The purpose of the study is to evaluate the long-term efficacy and safety of Saredutant in patients with depression. The primary objective is to evaluate the efficacy and safety of Saredutant 100 mg once daily compared to placebo in the prevention of relapse of depressive symptoms in outpatients with major depressive disorder who achieved an initial response to 12 weeks of open-label treatment with Saredutant.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depressive disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI), recurrent episode.

Exclusion Criteria:

* Total score of 28 or less on the Montgomery and Asberg Depression Rating Scale (MADRS).
* Clinical Global Impression (CGI) severity score of less than 4.
* Duration of the current depressive episode less than 2 months or greater than 2 years.
* Elderly patients with a Mini-Mental State Examination (MMSE) total score \<25.
* Patients with a history or presence of bipolar disorders or psychotic disorders.
* Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
* Benzodiazepine or sedative-hypnotic use greater than 2 days per week during the month prior to entry into the Acute Phase.
* Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, fluoxetine within 1 month, Monoamine oxidase inhibitors (MAOIs) within 2 weeks, other antidepressant or mood-stabilizer (lithium, anticonvulsants) within 1 week.

The investigator will evaluate whether there are other reasons why a patient may not participate.
Comparison of Two Laser Therapy Methods for PDR

Proliferative diabetic retinopathy (PDR) is treated with conventional pan retinal photocoagulation (PRP) which can improve the visual prognosis in this complication significantly. However , the treatment may also resulting adverse effects such as blurring of central vision, visual field constriction and disturbance in dark adaptation and contrast vision. Extended targeted retinal coagulation (TRP) to the ischemic areas may cause regression of the neovascularization while minimizing some of the risks and complication associated of treatment of PDR with these two methods.


Eligibility Criteria:
Inclusion Criteria:

* patients with PDR condidate for photocoagulation teraphy
* Pupil with dilatasion≥6mm
* without privious treatment with anti VEGF drugs 3months before study
* without privious vitroretinal sugery
* without privoius lasertraphy

Exclusion Criteria:

* To have NVI cricteria with increase of inraocular pressure
* to have cataract or vitrus leakage which prevent lasertraphy
* pupil smaller that 6mm
* traditional retinal detachment
* privious treatment with anti VEGF drugs 3months before study
* privious PRP
* patient unable to get wide field FAG
A New Method to Treat Hereditary Cerebellar Ataxia - Umbilical Cord Mesenchymal Stem Cells Transplantation

Hereditary cerebellar ataxia is a type of autosomal dominant genetic disease, lesions mainly involving the cerebellum, but the spinal cord and cranial nerves may also be some involvement. A total of 20 molecularly diagnosed SCA1 patients divided in two groups. One group accepted for the treatment of stem cell transplantation,the other group will be the control. Purpose of this project to prove that allogeneic umbilical cord mesenchymal stem cells are applied to clinical safely, and in the treatment of hereditary cerebellar ataxia is valid.

After admission the patients accepted transplantation would receive physical examination, blood and urine tests, electrocardiogram, electrophysiologic study;evaluation of SCA1 symptoms (balance, walking, dexterity, tremor, memory, mood and concentration),then stem cell therapy：after stem cell prepared, the patients accepted 4 times stem cell transplantations through lumbar puncture, the time is 3-5days between two treatments. The control only receive evaluation of SCA1 symptoms .

Eligibility Criteria:
Inclusion Criteria:

1. 18-65 years of age
2. Molecularly diagnosed SCA1

Exclusion Criteria:

1. Cognitively impaired individuals
2. Schizophrenics
3. Patients with severe kidney and liver disease, epilepsy, heart disease, pulmonary disease, cardiac arrhythmia, diabetes insipidus, leukemia and some other central neural disease (such as Parkinson disease, accidence of brain vascular et al)
4. Age less than 18 years, age greater than 65 years
Lot-to-lot Consistency of 23-valent Pneumococcal Polysaccharide Vaccine

This study is a randomized, double-blind phase Ⅳ clinical trial of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the consistency of three consecutive lots, immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine of commercial scale in participants aged 40-65 years.

This study is a randomized, double-blind phase Ⅳ clinical trial in subjects aged 40-65 years to evaluate the lot-to-lot consistency,immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine of commercial scale.The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd.A total of 1800 subjects will be enrolled.The subjects will be randomly divided into three groups in a ratio of 1:1:1 to received one dose of vaccine on day 0.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 40-65 years in stable health;
* The subjects can understand and voluntarily sign the informed consent form;
* Proven legal identity.

Exclusion Criteria:

* Have received any pneumococcal vaccine;
* History bacterial pneumonia or invasive pneumococcal infectious diseases caused by pneumococci and confirmed by culture;
* Women of childbearing age (menarche to premenopause) are pregnant (including positive urine pregnancy test), breastfeeding or planning pregnancy within 1 month;
* History of asthma, allergy to vaccines or vaccine components, and serious adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema;
* Severe chronic diseases,such as severe cardiovascular diseases, hypertension(Systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc.;
* Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
* Autoimmune disease or immune deficiency/immunosuppression;
* Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
* Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
* A long history of alcohol or drug abuse;
* Receipt of blood products within in the past 3 months;
* Receipt of other investigational drugs within 30 days prior to receiving the investigational vaccine;
* Receipt of attenuated live vaccines or COVID-19 vaccines in the past 14 days;
* Receipt of inactivated or subunit vaccines in the past 7 days;
* Onset of various acute or chronic diseases within 7 days prior to the study;
* Underarm body temperature before vaccination\>37.0°C;
* The subjects participated in other clinical trials during the follow-up period or will be planned to participate other clinical trials within 1 months;
* According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.