cyrilzakka/clinical-trials huggingface dataset:
Chinese Medicine Treatment of Obesity With Type 2 Diabetes, Dyslipidemia

With metformin for the control, evaluate the safety and efficacy of Jiangtangtiaozhi decoction in treatment of obesity with type 2 diabetes, dyslipidemia

Waist circumference, body mass index, triglycerides, glycosylated hemoglobin, blood glucose were evaluated; liver function, kidney function, blood, urine, stool, adverse event recording, evaluation of low blood sugar event log security.

Eligibility Criteria:
Inclusion Criteria:

1. signed informed consent;
2. waistline male ≥ 90cm, female ≥ 80cm;
3. According to the 1999 WHO standards, meet diagnostic criteria for type 2 diabetes onset and untreated patients, after a screening period (diet + exercise therapy 4 weeks) after the fasting plasma glucose ≥ 7.0mmol • L-1, but fasting blood glucose \<13.9mmol • L-1, or 2h postprandial blood glucose ≥ 11.1mmol • L-1; and glycated hemoglobin ≥ 7.0%;
4. After a screening period (diet + exercise therapy 4 weeks) after the triglyceride (TG) ≥ 1.7mmol / L, and TG \<5.65mmol / L;
5. TCM for the heat of the gastrointestinal;
6. Age 30-65 years old.

Exclusion Criteria:

1. Patients has been used insulin therapy; previously had a continuous period of 3 months or longer treatment of diabetes(including other Chinese and Western medicine, physical therapy, psychological therapy and health food, etc.) ; enrolled within 1 month before the use of blood glucose and lipids drug treatment;
2. Patients with diabetic complications; or a serious heart, lung, liver, kidney, brain and other serious complications or associated with other primary diseases;
3. Patients with uncontrolled blood pressure control, the systolic blood pressure ≥ 160mmHg or (and) diastolic blood pressure ≥ 100mmHg persons;
4. Patients have diabetic ketoacidosis in the last month, diabetic ketoacidosis and severe infections;
5. Patients with mental illness;
6. Pregnancy, pregnancy or breast-feeding women to prepare;
7. Patients with Chinese medicine allergies; and allergy;
8. Patients with had participated in this study within 1 month have participated or are participating in other clinical studies;
9. In the past five years, patients with alcohol and / or psychoactive substances, drug abuse and dependence;
10. According to the researchers to determine, with the possibility of lower income group or the other into a complex set of diseases or conditions, such as work environment, frequent changes in unstable living environment, the situation could easily lead to lost;
11. Patients taking the dose and type of antihypertensive drugs can not remain stable;
12. Patients taking drugs that affect the quality of the body or health food.
13. Patients with liver, impaired renal function (ALT, AST greater than 2 times the upper limit of normal; serum creatinine greater than the upper limit of normal);
14. Patients are known to lower blood sugar for those who are asymptomatic.
Bronchoreversibility and Radiologic Morphology of Emphysema

To assess response to bronchodilation with tiotropium plus salbutamol in patients with severe emphysema and analyze relationships between bronchoreversibility response and semiquantitative computed-tomography based emphysema severity measures.


Eligibility Criteria:
Inclusion Criteria:

* Radiologic evidence of severe heterogeneous emphysema
* GOLD COPD class III-IV
* No other significant pulmonary comorbidity
* Quit smoking since at least 4 months
XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan

The objectives of this post-marketing surveillance, conducted in Japan, is to know the frequency, type and degree of device malfunction, to assure the safety of the medical device, and to collect information on evaluation of the efficacy and safety.

The surveillance is to be conducted in accordance with the Japanese Ministerial Ordinance concerning the Standards for Postmarketing Surveillance and Tests of Medical Devices.

Eligibility Criteria:
Inclusion Criteria:

* Only XIENCE V stent(s)or PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure.

Exclusion Criteria:

* Neither XIENCE V stent(s) nor PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure.
Three Techniques in Bioceramic Apexification for Necrotic Immature Incisors

The goal of this randomized clinical trial is to find the most effective Bioceramic-based apexification procedures in children with immature necrotic maxillary incisors. The main questions they aims to answer are:

* What is the best Bioceramic apexification technique regarding the post-operative pain and the periapical healing ?
* What is the best Bioceramic apexification technique regarding the bioceramics extrusion and the required time ? Participants will under gone Bioceramic apexification procedures which root canal preparing, disinfecting, filling, and restoring. Then, the patient will asked to come to follow-up appointments for clinical and radiological evaluations If there is a comparison group: Researchers will compare Bioceramic Putty Apical Plugs, Single Cone Gutta-percha with Bioceramic Sealer, and Combination of Bioceramic putty and sealer technique to find the best effective technique.


Eligibility Criteria:
Inclusion Criteria:

* Patients with one or more maxillary incisors with an open apex root (defined as root which root canal size equal or larger than #80 K-file) and presented with pulp necrosis and radiographic evidence of chronic apical periodontitis and periapical radiolucency greater than 3 mm.

Exclusion Criteria:

* Children with systemic diseases that compromised their general immune status.
* Uncooperative (definitely negative on the Frankl's behavioral scale).
* unrestorable incisors.
Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents

The main objective of this research is to demonstrate the possible use of erythroferrone (ERFE) as a potential marker of recombinant human erythropoietin (rHuEpo) use to be included in the Athlete Biological Passport (PBA) developed by the World Anti-Doping Agency (WADA).


Eligibility Criteria:
Inclusion Criteria:

* Man between 18 and 49 years old
* Beneficiary of a social protection scheme
* Able to sign informed consent

Exclusion Criteria:

* Hematocrite\>50% or Hemoglobin\> 17d/dl or Ferritin\<30 ug/l
* Hypersensitivity to the active substance or to any of the excipients ofEPREX
* Erythroblastopenia already reported following treatment with erythropoietin
* Uncontrolled hypertension
* Any medication taken as part of a chronic treatment
* Absence of stable or evolutionary pathology without treatment
* History of convulsion or epilepsy
* History of thrombotic vascular events
* Large blood loss due to an accident, pathological condition or other similar situation.
* Donation of blood or blood transfusion within three months prior to inclusion in the protocol.
Prevention of pneumonIA in Nursing hOme

Infections in nursing home are associated with high morbidity and mortality. Pulmonary infections are known to be the most problematic. In our INCUR observational study of 773 residents, 20.13% of residents had pneumonia during the year of follow-up. On average, the extra cost of pneumopathies was 4,467 euros / patient for the long-term care facility and 3,044 euros for the hospital.

The pneumopathies in nursing home are the main cause of hospitalization of residents. Depending on the series, 9 to 50% of residents with pneumonia should be transferred. This reflects the difficulties faced by nursing home care teams in these situations. The respiratory symptomatology of nursing home residents is difficult to grasp and the prescribed antibiotic therapy is often considered inappropriate (25% to 75% of cases). Prevention of resident pneumonia, such as vaccination against pneumococcus remains poorly practiced, influenza vaccination teams or vitamin D supplementation.

In addition to the risk of mortality, lung diseases are often the cause of a rapid functional decline. Preventing pneumonia in nursing homes is therefore an important issue in the prevention of dependence, the quality of life, the health care system (use of hospitalization and transfer to emergencies) and health expenditure. In this vulnerable population, a prevention intervention seems particularly relevant.

In this research project, the investigators hypothesize that a multi-domain prevention intervention for pneumonia carried out by nursing teams in nursing homes can reduce the incidence of pneumonia. They also believe that this action would reduce emergency transfers and health expenditures.

Eligibility Criteria:
Inclusion Criteria:

* Living in a nursing home for at least 30 days at the start of inclusions,
* Having received information concerning the study and having not expressed opposition to participate,
* For which an agreement in principle of the attending physician has been obtained.

Exclusion Criteria:

* Refusal of the resident (or of his legal representative) or of his treating physician after given information,
* Resident at the end of life (life expectancy evaluated within one month by the coordinating physician),
* Resident whose attending physician is already involved in the PIANO study under a resident of another nursing home.
A Study of TNFerade™ Biologic With Concomitant Radiotherapy, Fluorouracil, and Hydroxyurea (TNF-FHX) in Patients With Head and Neck Cancer

The primary objective of the first phase is to determine the safety, the maximum tolerated dose (MTD) and dose-limiting toxicity of TNFerade in combination with the previously studied combination of Fluorouracil (5FU), Hydroxyurea (HU) and standard daily radiotherapy in patients with recurrent head and neck cancer (RHNC). All chemoradiotherapy is administered on a "week-on/week-off" schedule. The primary objective of the second phase II is to determine the locoregional control rate at 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Head and neck cancer
* Patients must have a locoregional tumor amenable to reirradiation with curative intent.
* disease, or the majority of disease, should be accessible to injection via direct intratumoral injection
* Life expectancy of greater than 12 weeks
* Age \> 18 years
* ECOG performance status 0-1

Exclusion Criteria:

* Metastatic disease
* History of malignancy (other than head and neck cancer) in the last 2 years except carcinoma in situ of the cervix or bladder, non-melanomatous skin cancer, or localized early stage prostate cancer, with patients continually disease free, or cancers that are not felt to influence treatment for head and neck cancer and life expectancy of patient
* Patients may not be receiving any other investigational agents currently or within the 4 weeks prior to study Day 1
* Active infection of any type
* Chronic treatment for greater than 6 months with steroids
* Pregnant or lactating women
* Patients with known history of cerebral vascular disease; stroke or TIA within the last 6 months
* Patients with history of documented thrombosis (PE or DVT), or known coagulopathy or thrombophilia, or evidence of DVT / thromboembolic event upon enrollment
* Patients receiving hormone replacement therapy or hormonal contraceptives within two weeks of day 1
* Patients who have undergone surgery within the last 1 month prior to day 1
* Patients with active carotid artery involvement or status post carotid artery graft / stenting
The mCME Project:Delivering Continuing Medical Education for Community Health Workers Via SMS Text Messages

Community health workers (CHWs) provide essential basic medical care to hundreds of millions of people across the globe. CHWs offer a myriad of services including community sanitation, breast feeding counseling, family planning, management of febrile children, and malaria control and prevention, to name but a few. In fact, CHWs are often the only source of primary health care available to some of the most disadvantaged populations in the world. However, to be effective, CHWs must be trained - and retrained - at regular intervals, and the costs for such trainings can be substantial. In the US, clinicians are required to stay current and maintain their competence through continuing medical education (CME). Increasingly, CME activities are delivered via internet-based, self-teaching modules. A typical example would be a set of topical readings followed by multiple-choice questions, with the answers, and CME credit, provided to the user upon satisfactory completion of the module. This content is typically delivered over the Internet. However, there is no intrinsic reason why this approach could not be adapted so that CME activities are delivered using standard cell phones via SMS text messaging. This would significantly expand professional training opportunities to a far greater range of CHWs than possible through computer/tablet/smart phone platforms, and would be particularly valuable in poorer countries with limited training budgets. In the mCME project, the investigators propose to test the effectiveness and cost effectiveness of a mobile phone-based CME delivery strategy among Vietnamese community-based physician assistants (CBPAs), a cadre of CHW mandated to provide primary health care to rural and disadvantaged populations. The investigators hypothesize that providing CME activities over a mobile platform will significantly improve their professional knowledge, and may also improve their job satisfaction and self-efficacy.


Eligibility Criteria:
Inclusion Criteria:

1. Graduated from a CBPA training program
2. Possesses their own cell phone
3. Phone able to send/receive text messages
4. Aged 18 years or older

Exclusion Criteria:

1. Unwilling to sign informed consent
2. Lives/operates in an area without cellular coverage
3. Unwilling to be randomized
4. Unwilling to adhere to study procedures
Targeting Default Mode Network Dysfunction in Persons At Risk of Alzheimer's Disease with Non-invasive Techniques

Default mode network (DMN) dysfunction is a well-established feature of Alzheimer's Disease (AD) and is already present in preclinical stages and in subjects at risk for AD, thus offering a potential target for early intervention. Non-invasive stimulation techniques are candidate approaches to modulate network dysfunction, however interventions specifically targeting subjects at risk for AD are lacking. This project will test a non-invasive intervention to modulate the DMN in cognitively healthy older adults carrying the main genetic risk factor for AD, the APOE e4 allele. The proposal will non-invasively stimulate the DMN in at risk subjects and will assess the neuronal-cognitive effect of this approach with multimodal neuroimaging and neurophysiological techniques.

Sixty-four participants will be enrolled (n=32 APOE e4 carriers, 32 non-carriers as reference group) and will undergo rTMS stimulation, TMS with concurrent electroencephalography (TMS-EEG), multimodal imaging (resting-state and task functional MRI, and diffusion tensor imaging) and cognitive assessment at baseline, after the intervention (week 1) and after 2 months. Participants will be randomized to 2 groups: active DMN stimulation (real-rTMS) or placebo (sham-rTMS). Each subject will undergo a rs-fMRI scan before the intervention to derive individualized DMN stimulation targets. rTMS will be applied over the left inferior parietal lobule node of the DMN.

Eligibility Criteria:
Inclusion Criteria:

* Age: 60 years and older
* MMSE score \> 24

Exclusion Criteria:

* Pathological scores in at least two standardized cognitive tests
* Participation in other interventional studies
* Known carriers of an autosomal dominant genetic mutation associated to AD
* Neurological, psychiatric or medical conditions not compatible with the study

Exclusion Criteria for MRI and rTMS:

* metal implants, pace-makers, prosthetic heart valves
* claustrophobia
* history of epilepsy
* pregnancy
Effects of Two Different Physical Therapy Protocols After an Endodontic Intervention

The purpose of this study was to evaluate the clinical results produced by a manual therapy treatment combined with dry needling (MT+DN) and a manual therapy treatment (TM) versus a control (C), to normalize the altered cervico-mandibular variables after a session of root canal therapy.


Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old and requiring an endodontic intervention.

Exclusion Criteria:

* Have received TMJ or cervical treatment during the last month, presented any red flag, neurological or cognitive impairment (inability to understand the questionnaires or examination).
Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar: The AGTP II Trial

The purpose of this trial is to evaluate the efficacy of a pericardial adipose graft transposition (Adipose Graft Trasposition Procedure, AGTP) for the improvement of cardiac function in patients with a chronic myocardial infarction. Preclinical studies in the porcine model of myocardial infarction have shown that the AGTP reduces infarct area and improves cardiac function. A first-in-man clinical (NCT01473433) trial showed that the AGTP is safe in patients.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age, capable of giving informed consent.
* Q wave in the ECG
* Myocardial infarct \>=50% transmularity by NMR non revascularizable (for transmurality or bad vessel).
* Candidate to bypass for other myocardial areas

Exclusion Criteria:

* Severe non cardiac co-morbidity with a reduction of life expectancy of less than 1 year
* Severe valvular disease candidate for surgical restoration
* Candidate to ventricular remodeling
* Contraindication for NMR
* Severe renal or hepatic failure
* Abnoraml laboratory tests (no explanation at inclusion)
* Previous cardiac intervention
* Pregnant or breast feeding women
Conventional vs Ultrasound Guided Arteria Cannulation.

The aim of the project is to compare two methods for arterial cannulation. The traditional method with ultrasound guided cannulation. The investigators goal is to improve this procedure to reduce pain and complications.

The practice of placing vascular catheters is used many times every day at almost every hospital. It is a safe procedure which generally does not imply problems. Though the procedural optimum aren't reached. The procedure still fails some times and induce complications. When the catheter is placed using the traditional method the pulse is palpated by the operator's fingers. This is only to be done near the hand wrist. In this position the catheter steadiness is fragile but because the pulse can't be sensed more proximal the operator is forced to choose this position. This it though a problem that can be solved by non invasive visualization technology. Ultrasound-guidance for central vascular access is already well-established. However, in recent years ultrasound-guidance for peripheral vascular access has gained popularity too. The evidence of multiple studies demonstrates increased success rate and reduced complication rate with ultrasound compared to blind landmark technique for vascular catheter placement.

In recent years there have been both procedural technique and technology improvements in the field of ultrasound. This has led to the improvement of procedural catheterisation techniques that now can be done by novices with higher attempt success rate than traditional method. One technique that is gaining success is the short-axis-out-of-plane technique (SAX-OOP) with dynamic-needle-tip-tracking (DNTT).Using the ultrasound machine the needle can be placed in a more proximal direction on the forearm and the investigators believe that by the help of the exposed procedure on the monitor many complications can be reduced.

It has been shown that inexperienced trainees lear the technique SAX-OOP and DNTT very quickly.

First investigators hypothesize that the number of attempts, the number of withdrawals, the time spend and the number of utilized catheters will be decreased using ultrasound vs. the traditional method. Secondly investigators hypothesize that the pain induced by the conventional method inclusive preoperational lidocaine injection will be the same or more intense than using DNTT with local anesthesia. Thirdly investigators claim that the best anatomical place to put the catheter isn't always corresponding with the spot chosen by palpation, which increase the number of failures. Fourthly investigators hypothesize that the use of ultrasound will increase the operator's subjective feeling of having accomplished a successful procedure.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-90 years
* Fulfill the criteria of an operation
* Routine need of an arterial needle

Exclusion Criteria:

* Lack of patient consent
* Ultrasound identified plaques in the radial artery or ultrasound verified compromised flow in either the radial or ulnar artery.
A Community-based Intervention Among Active Drug Users in Montpellier

The study aims to assess the effectiveness of a community-based model of HCV mass screening associated with an immediate HCV treatment on the cascade of care among active drug users (DUs) in the city of Montpellier, France.

Active DUs will be recruited using a Respondent-Driven Sampling (RDS) method. Hosted in the temporary community care facility (the research site), located outside the existing care facilities in the city, participants will benefit from HCV/HIV/HBV screening, on-site measurement of HCV-RNA and liver fibrosis, early treatment, treatment follow-up and risk and harm reduction tools related to their risk practices. Peers will be present in this unique structure and will accompany participants throughout their treatment. Participants will be referred during treatment to existing care facilities but followed up in the research up to 44 to 48 weeks after initiation of treatment to assess the rate of re-infection. The number of active DUs in the population will be estimated by using a capture/recapture method nested in the RDS survey

Secondary objectives of the research are:

* To estimate the seroprevalence of hepatitis C in active DUs in Montpellier;
* To estimate the size of the active DUs population in the city of Montpellier using a capture/recapture method;
* To estimate HCV care cascade steps in active DUs in Montpellier;
* To identify the factors associated with HCV treatment failure;
* To determine the proportion of treated and cured HCV patients who re-infect within months after end of treatment;
* To estimate the seroprevalence of hepatitis B and HIV infection in active DUs in Montpellier.

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years
* Be an active drug user defined by:

  1. Report current and regular (Last uptake no more than 3 days ago and at least 10 times a month) use of illicit psychoactive substances other than cannabis (heroin, amphetamines, cocaine, MDMA/ecstasy, cathinones) or misused medications (methadone, buprenorphine, opiate drugs, methylphenidate, ketamine) AND
  2. Positive urine test for a psychoactive substance other than cannabis (Heroin, amphetamines, cocaine, MDMA/ecstasy, cathinones) or a misused medication (methadone, buprenorphine, opiate drugs, methylphenidate, ketamine).

Exclusion Criteria:

* Inability to understand the study
* Be under guardianship, curatorship or future protection mandate
* Lack of informed consent