cyrilzakka/clinical-trials huggingface dataset:
Vestibular Dysfunction and Glucose Metabolism

Introduction: the global sugar consumption has increased in the past 50 years and their abusive intake is responsible for the insulin resistance and causes the metabolic syndrome - obesity, diabetes mellitus, hypertension and coronary heart disease. Objective: To evaluate the effect of scheduled diet without glucose as treatment of labyrinthine disorders associated with glucose-insulin index. Study Design: A prospective randomized controlled trial. Patients and Methods: A study conducted at the University of São Paulo with 51 patients divided into two groups: Diet Group (DG) that comprises subjects treated with fractionated diet with glucose restriction and control group (CG) where individuals were not counseled regarding diet. Patients underwent computerized dynamic posturography - sensory organization test (CDP - SOT) and Visual Analog Scale (VAS) in the first and thirtieth days of the study.

51 patientes with dizziness and glucose intolerance diagnosed by the glucose tolerance test were selected.

The subjects were submited to CDP SOT conditions and a visual analogue scale to measure his self perception about dizziness.

Then, they were randomized in two groups: with and without fractioned diet without glucose during 30 days.

The CDP was repeated in order to verify a statistical difference of SOT condition 5 that reflects the individual hability to maintain the own posture with the vestibule solely and CS - that represents the final balance situation.

The VAS was repeated too in order to verify the self perception of the dizziness after diet.

Eligibility Criteria:
Inclusion Criteria:

* dizziness related to fasting or glucose intake
* alterations of glucose tolerance test

Exclusion Criteria:

* dizziness not related to vestibular problems
* ortopedical or neurological diseases
* diabetes mellitus
Comparison of Berberine and Metformin for the Treatment for MS in Schizophrenia Patients

Berberine is an isoquinoline alkaloid extracted from medicinal herbs, has been demonstrated to produce beneficial effects on diabetes and hyperlipidemia, fewer study reported its modification on lipid metabolism in schizophrenia. Metformin, have been used for metabolic abnormalities in schizophrenia, findings from these studies indicated that they did have some effect,which are still in experimental stage.This study is aim to compare the efficacy and safety of berberine and metformin for preventing metabolic dysfunction in schizophrenia patients.


Eligibility Criteria:
Inclusion Criteria:

* 1) In accordance with criteria set out in the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV )Axis I Disorders, Clinical Version;
* 2)Meet metabolic syndrome based on Guidelines for Prevention and Treatment of Blood Lipid Abnormality in Chinese Adults(2007);
* 3)Have taken stable dose of the current single antipsychotic drug for at least one month;
* 4) Female subjects will be enrolled to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods during the study.

Exclusion Criteria:

* 1)Individuals who refuse to provide informed consent;
* 2)Currently substance abuse or psychiatrically unstable per treating clinician's judgment;
* 3)One with significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases also not suitable for this trial;
* 4)Currently on anti-inflammatory or immunosuppressant medication including oral steroids and history of chronic infection (including tuberculosis, HIV and hepatitis), malignancy, organ transplantation, blood dyscrasia, central nervous system demyelinating disorder, and any other known autoimmune or inflammatory condition pregnancy or breastfeeding.
Endometrial Effects of Daily Progesterone s.c. 25 and 50 Mg Aqueous Formulation to Female Healthy Volunteers

This is a multiple dose, observer blind, randomised, parallel groups pharmacodynamic and pharmacokinetic study to assess the endometrial effects (predecidual changes) of a new aqueous progesterone formulation administered s.c. at the dose of 25 and 50 mg/day.

This study is designed in order to assess the efficacy of the investigational product (Progesterone acqueous s.c. formulation) when it is administered at the dose of 25 and 50 mg. The induced predecidual changes will be evaluated through endometrial bioptic samplings, performed on day 11 and will be compared between the two treatment groups.

The pharmacokinetic evaluation was designed according to internationally recognised guidelines for PK studies.

Eligibility Criteria:
Inclusion Criteria:

* BMI: 19\</=BMI\</=25 kg/m2;
* Proper estrogen priming; absence of progesterone exposure prior to exogenous progesterone administration;
* normal pelvic ultrasound;
* absence of active follicular growth following initiation of E2 treatment;
* Complete suppression of ovarian function;
* Vital signs: SBP 100-139 mmHg, DBP 50-89, HR 50-90 bpm;
* Full comprehension of the nature and purpose of the study and possible risks and side effects;
* signed written informed consent prior to inclusion in the study

Exclusion Criteria:

* pregnant or lactating women;
* ECG: clinically relevant abnormalities;
* clinical relevant abnormal physical findings which could interfere with the objectives of the study;
* clinical relevant abnormal laboratory values indicative of physical illness, ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients;
* history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study;
* history of uterine pathologies (fibroids, polyps, adenomyosis, etc), history of dysfunctional bleeding, relevant history of renal, hepatic, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, history of neoplasias (genital apparatus, breast, liver or hormone-dependent cancer) severe liver failure, acute or chronic liver dysfunction, cholestatic jaundice, hypertension, thrombo-phlebitis, thrombo-embolism, cerebro-vascular insult or severe depression; medication, including OTC, during 2 weeks before the start of the study;
* participation in the evaluation of any drug within 1 month prior to the start of the study;
* blood donations during the 1 month prior to this study;
* history of drug, alcohol \[\>1 drink/day defined according to USDA Dietary Guidelines 2005 (18)\] caffeine (\>5 cups/ day of coffee or tea) or tobacco abuse (≥10 cigarettes/day);
* Abnormal diets (\<1600 or \>3500 kcal/day) or substantial changes in eating habits within the past 4 weeks.
Oscillating PEP vs Autogenic Drainage in People With Bronchiectasis

In this study, investigating two modes of chest physiotherapy on lung clearance index (LCI), 50 patients with bronchiectasis will be randomized to either oPEP or autogenic drainage.

One of the fundamental treatments in the management of bronchiectasis is airway clearance, which effectively rids the airways of mucus to prevent secondary infection and inflammation. While effective airway clearance is widely accepted as a first line treatment, the choice of airway clearance method is complicated by lacking evidence base. One of the obstacles to establishing evidence of efficacy of an airway clearance technique or device is the limitations in the choice of endpoints.

Aerobika (Trudell medical international, Canada) is an oscillating positive expiratory pressure (oPEP) device, designed and developed for the effective clearance of secretions in people with suppurative lung diseases. It has been tested and found safe and effective in chronic obstructive pulmonary disease (COPD) - chronic bronchitis.

The lung clearance index (LCI) measured by multiple breath washout (MBW) is a measure of ventilation inhomogeneity and has been shown to be a sensitive lung function test in early lung disease. Its usefulness has been demonstrated in cystic fibrosis (CF), particularly in children and adults with mild disease. LCI has been assessed in bronchiectasis and has been found to be significantly different from normal subjects, and to correlate with Forced Expiratory Volume in 1 second (FEV1).

The aim of this study is to test the long term effect of daily lung clearance on LCI, quality of life and exacerbations using the Aerobika oPEP device versus autogenic drainage (AD) in people with bronchiectasis.

50 patients with confirmed bronchiectasis will be enrolled in this study. Participants will be randomized to daily physiotherapy with either Aerobika or Autogenic drainage. Change in LCI, measured before and after one month, will be the primary endpoint of this study.

Eligibility Criteria:
Inclusion Criteria:

1. High Resolution chest computerized tomography (HRCT) during stable disease imaging bronchiectasis in at least 2 lung lobes
2. Sputum production during most days of the year
3. Stable chronic therapy during last 4 weeks
4. FEV1 = 70% predicted or higher on spirometry
5. Able to give informed consent or assent
6. Age: 18- 80 years

Exclusion Criteria:

1. An exacerbation during last 4 weeks before randomization
2. Any change in respiratory medications during the past 4 weeks before randomization
3. A diagnosis of cystic fibrosis
4. A diagnosis of primary ciliary dyskinesia
Safety Margin Assessment After RFA Using the Registration of Pre-ablation MRI and Post-ablation CT

Magnetic resonance imaging (MRI) has been widely used for small liver lesion detection and characterization. In patients who undergo RFA, MRI is often performed before RFA, whereas immediate technical success is usually assessed by CT. Conventional visual assessment of two modalities may be more challenging than being anticipated, because acquisition position, respiration, and spatial resolution differ between the two. Therefore, the study purpose is to evaluate the results of software-assisted ablative margin assessment using registration of different pre-and post-RFA modalities compared with the conventional method of side-by-side MRI-CT comparison in patients with HCCs.


Eligibility Criteria:
Inclusion Criteria:

* patients (≥ 18 years) who were referred to our radiology department for liver tumor RFA
* patients who had liver MR images of sufficient quality for pre-RFA evaluation within 30 days before RFA
* patients with 1-3 tumors (\<5 cm)

Exclusion Criteria:

* Child-Pugh class C
* any uncorrected coagulopathy
* hypersensitivity to iodine or other reasons that prevented the performance of post-RFA contrast-enhanced CT
IPACK Versus Popliteal Sciatic Nerve Block in ACL Reconstruction

This is a prospective study comparing femoral nerve block plus sciatic nerve block to femoral nerve block plus infiltration of the posterior knee capsule (IPACK) in patients undergoing arthroscopic anterior cruciate ligament reconstruction. Femoral nerve block via the adductor canal (FNB-AC) with IPACK may provide effective analgesia while avoiding the motor block involved with sciatic nerve block. The lack of motor block is important to facilitate postoperative ambulation and physical therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients less than 21 years of age
* American Society of Anesthesiologists physical status I and II
* Undergoing elective anterior cruciate ligament reconstruction

Exclusion Criteria:

* They are unable or unwilling to take part in the study
* History of allergy to any of the medications administered for the nerve block
* Contraindication to peripheral nerve block
* Patients who are unable to understand instructions or questions related to the study or the families required language interpretation
* Patients who consume opioid medications for more than three days per week for more than a month prior to surgery
Analysis of Chilblains pROfile During coVID-19 Epidemic (ACROVID)

Cases of chilblains have been reported with an unusual frequency in France in the context of the COronaVirus Infectious Disease 2019 (COVID-19) epidemic. Some of these cases have been linked to a virological status in favour of a recent Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) infection. Chilblains are acral inflammatory lesion typically reactive to cold (primary form). There are secondary forms acquired during autoimmune connectivitis such as lupus chilblain or hereditary forms related to type I Interferonopathy. An interferon type I signature has been described in these secondary forms of frostbite but also during the cytokine storm of severe forms of CoV-2 SARS infection. If cases of frostbite are indeed secondary to an SARS-CoV-2 infection, comparative analysis of their immunopathological profiles could provide a better understanding of the inflammatory mechanisms during COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Patient over the age of majority or a minor over 12 years of age accompanied by his/her legal representative
* Benefiting from a Social Security scheme
* Informed consent signed by the patient (if major) or by his legal representative (if minor) after clear, fair and appropriate information about the study.
* Red and swollen lesions of the hands and/or feet evolving for more than 24 hours in the context of a COVID-19 epidemic.
* PCR SARS-CoV-2 PCR on nasopharyngeal swab with results available, prior to the inclusion visit.
* Absence of fever or respiratory signs suggestive of COVID-19 for at least 14 days

Exclusion Criteria:

* A person who does not benefit from a Social Security scheme or who does not benefit from it through a third party.
* Patient who is subject to a judicial safeguard measure
* Allergy to local anaesthetic products
* Fever or respiratory signs suggestive of COVID-19 within 14 days
Comparison of Alogliptin Versus Alogliptin and Pioglitazone on Insulin Resistance of Metformin Treated Women With PCOS

The purpose of this study was to determine whether dual treatment with metformin and alogliptin is more effective than treatment with metformin, alogliptin and pioglitazone in the treatment of obese women with polycystic ovary syndrome (PCOS) regarding insulin resistance and beta cell function.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old to menopause
* polycystic ovary syndrome (NICHD criteria)
* BMI of 30 kg/m² or higher

Exclusion Criteria:

* type 1 or type 2 diabetes mellitus
* history of carcinoma
* Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
* personal or family history of MEN 2
* significant cardiovascular, kidney or hepatic disease
Gene Therapy With GX-12 in Combination With HAART for the HIV-1 Infected Patients

The purpose of this study is to assess the safety of GX-12 gene therapy combined with HAART in the HIV-1 infected patients and to investigate the efficacy with the value of plasma viral load and with CD4 counts and HIV-1 specific IFN-gamma expressed T-lymphocytes

Currently, management of HIV infection and AIDS is mainly done by antiviral chemotherapy which inhibits reverse transcriptase or proteolytic enzyme. The HAART (highly active antiretroviral therapy) has indeed succeeded extraordinary in decrease of the mortality and in increase of the life expediency of AIDS patients. However, there have been some significant limitations of them (for example, treatment fatigues, the side effects, the emergency of resistant, high medical costs, etc.).

Recently, there has been a number of bioresearch for immunotherapy to overcome these limitations of current medications. GX-12 is a genetic using a naked DNA with human IL-12 mutant as immune adjuvant. GX-12 is designed to vaccinate the individuals with HIV antigens, which is to result in enhancing the HIV specific immunity and to expand broadly the immune responses nonspecifically.

In this study, the safety and efficacy of GX-12 will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 50 years
* HIV-1 type B infected but asymptomatic patient
* Patient who has received HAART less than 6 months according to the standard management guidelines and reached to aviremia
* Patient with appropriate immunity (i.e., CD4 counts\>=400cells/ul and SI\>3 by CD4+ T-cell proliferation in vitro assay)
* Patient with negative HBV and HCV
* Woman who is not childbearing or who has used any contraceptive at least for 3 months before study entry
* Patients given a written consent

Exclusion Criteria:

* Patient who has received other investigational drug or who participated into other study within 30 days before this study
* Patient who had an experience of hypersensitivity to same drug (for example: a plasmid DNA, etc)
* Patient who has received an immunosuppressant
* Patient who has received other HIV vaccine
* Patient who has received other interleukin(s)
* Patient who experienced an opportunistic infection defined as AIDS before this study
* Patient with any severe recurrent diarrhea or vomiting
* Patient with clinically significant acute or chronic liver dysfunction, kidney dysfunction, hematological disorder, endocrine disorder, immune disorder, heart disease, infection, etc.
* Patient with malignant tumor(s)
* Patient with alcohol or drug abuse
* Patient of potential harm due to drug interactions by HAART
* Woman of pregnancy (positive pregnancy test) or beast feeding
* Patient who is not appropriate at investigator's discretion, not specified in above
Radiofrequency Ablation for Hepatocellular Carcinoma Using Octopus MP Electrodes

This study is to investigate the therapeutic effect and treatment results of radiofrequency ablation using the Octopus MP electrode capable of temperature monitoring and drug injection and a variable-length electrode for treatment of small hepatocellular carcinomas (≤ 3cm).


Eligibility Criteria:
Inclusion Criteria:

* Child-Pugh Class A or B
* chronic hepatitis B or chronic hepatitis C or liver cirrhosis
* presence of hepatocellular carcinoma (HCC) after confirmed by pathology or imaging studies including contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) according to the Korean Liver Cancer Study Group (KLCSG)-National Cancer Center (NCC) Korea practice guidelines.
* up to 3 lesions, each greater than less than or equal to 3 cm at the time of locoregional treatment.

Exclusion Criteria:

* number of recurrent HCCs, more than 3
* largest HCC size over 3 cm
* presence of vascular invasion by HCC
* platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50%
* presence of extrahepatic metastasis
Copeptin in Childhood Epilepsy

In many fields of medicine, except seizure disorders, blood biomarkers have captured an integrated part of diagnostic decision making, including copeptin, the surrogate marker of vasopressin release. There are strong arguments to hypothesize circulating copeptin is elevated in epilepsy, especially in generalized seizures such as fever seizures (FS), and that copeptin is predictive for complexity and relapse at least in FS. Although long-term morbidity and mortality are both low in FS, there is high anxiety among parents because of a lack of criterions to identify children at risk for relapse. Copeptin may fill this gap by adding important diagnostic and prognostic information. Eventually, less children may receive needlessly over years fever drugs or anti-epileptic drugs.

Background:

Copeptin is a surrogate marker of the pituitary-secreted nonapeptide arginine-vasopressin (AVP) and has gradually replaced AVP in several clinical studies largely due to its structural and methodological advantages. Copeptin is a marker of non-specific stress response, and has been suggested to have clinical implications in a variety of cardiovascular and non-cardiovascular conditions. However, up to now there are no data available on copeptin in seizure disorders, neither in adults nor in children.

Working hypotheses:

1. Circulating copeptin concentrations are increased after generalized seizures, including FS.
2. Copeptin is predictive for complexity and relapse in FS.

Specific aims:

1. to determine copeptin concentrations in children below six years after generalized seizures, either unrelated or related to fever (FS), and in control children below six years without seizures.
2. to compare copeptin concentrations with blood-gas parameters (including hydrogen ion concentration (pH), base deficiency, and carbon dioxide), lactate, sodium, chloride, C reactive protein (CRP), and prolactin.

Eligibility Criteria:
Inclusion Criteria epilepsy-cohort:

* All kind of seizures leading to presentation
* Age below 6 years

Inclusion Criteria control-cohort:

* Fever without seizures caused by banal infections
* Age below 6 years

Exclusion Criteria:

* No blood required for medical reasons
Target Gene Sequencing for Advanced Stage, Relapsed or Refractory Natural Killer/T-cell Lymphoma

Although modern radiation techniques combined with chemotherapy has greatly improved the local control and long-term survivals for patients with early-stage NKTCL, relapse and systemic dissemination are common for localized patients. Relapsed/refractory diseases together with advanced stage NKTCLs uaually progress rapidly with poor prognosis (5-year overall survival rate, 0-20%). According to published studies, some recurrent genetic alternations have been identified in NKTCL, including oncogene/tumor suppressive gene abberants, epigenetic changes, cellular signaling pathways abnormalities, cellular apoptosis related genes and so forth. However, the gene profiling techniques and materials vary in different studies, no consensus has been reached on the gene abnormalities of advanced, or relapsed/refractory NKTCL up to now. Additionally, gene sequencing using ctDNA of peripheral blood has been unexploited in NKTCL patients.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of NKTCL with typical morphology and immunophenotype, according to the 2008 World Health Organization classification of lymphomas;
2. stage III/IV disease; or relapsed or refractory disease after at least one line prior teratment;
3. age ≥ 18 years;
4. ECOG performance status 0-2;
5. at least one measurable lesion;
6. adequate hematological, hepatic, and renal functions;
7. life expectancy of more than 3 months.

Exclusion Criteria:

1. Previously untreated stage I/II disease;
2. with no adequate tumour tissue;
3. any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.