cyrilzakka/clinical-trials huggingface dataset:
Research on Mechanism of Massage Therapy on Energy Metabolism Disorder of Simple Obesity

This project is to penetrate and consummate the research mechanism of massage therapy on simple obesity. Latest researches indicate that the energy regulation network system of hypothalamus and metabolic disorders on adipocyte may be the pathological bases which result in obesity. The research group have firstly conducted effect studies of massage therapy on model of simple obesity rats and observed some neurobiological mechanism (whole effect mechanism), meanwhile, the team have discussed influences on the development of preadipocyte and function of endocrine with dynamic mechanical stimulation in vitro (local effect mechanism). This research aims at centering on the hypothesis that massage therapy can act on energy regulation network system of hypothalamus specifically, thus regulating the energy metabolic disorders. Then applying functional magnetic resonance imaging (fMRI) to explore whether patients with simple obesity exist abnormality on energy regulation network system of hypothalamus, ascertain mechanisms how massage therapy treat energy metabolism disorders of simple obesity, deepen mechanism study on how massage therapy prevent and treat obesity and enrich the clinical application's scientific connotation that massage therapy treat simple obesity.

This project will divide in two groups,healthy volunteers and obesity group.Healthy volunteers do not accept any treatment while obesity group need accept massage therapy three times a week,18 times in total.And two groups will be checked by functional magnetic resonance imaging (fMRI), Healthy volunteers for once and obesity group for twice(before treatment, obesity group's image of fMRI will compare with Healthy volunteers' and the image which is taken after treatment)

Eligibility Criteria:
Inclusion Criteria:

1.above 20% of the normal weight;BMI≥25.0；F%≥30%;

2.18-60 years old；

3.Patients agreeing and signing the Informed Consent for the study．

Exclusion Criteria:

1. The individuals do not adhere to the treatment or are with other treatments.
2. Secondary obesity, eg:pituitary diseases, hypothalamic disorder, hypothyroidism, pancreatic diseases，hyperadrenocorticism, postmenopausal obesity etc.
3. Having therapy for obesity in the last two weeks.
4. The individuals with server cardiovascular and cerebrovascular diseases and cancer.
5. Critical patients or patients combined with liver and kidney damage.
6. Individuals with psychosis.
7. Female individuals with pregnancy, lactation and planning a pregnancy in the two months.
ETSF for Latinx Young Adults with Alcohol Use Disorder

The goal of this clinical trial is to learn if the eTSF intervention is feasible among Latinx young adults with alcohol use disorder. The main questions it aims to answer are:

* Is eTSF feasible?
* Is eTSF effective in reducing alcohol use and increasing 12-step engagement compared to the control condition? The control condition will receive educational materials on drinking problems and a list of local/online AA meetings Participants will
* Be randomly assigned to either the eTSF condition or the control condition.
* Fill out the baseline online survey.
* Go through the eTSF app/control materials.
* And at 3 months post-baseline, fill out the follow-up online survey.


Eligibility Criteria:
Inclusion Criteria:

* YAs age 18-29
* Identify as Latinx
* Meet the Diagnostic \& Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnostic criteria for alcohol use disorder
* Are at least minimally motivated to change their drinking (i.e., scoring ≥3 on the University of Rhode Island Change Assessment Scale's contemplation, action, or maintenance subscales and ≤3 on the precontemplation subscale)
* Be able to provide at least one contact person to assist in tracking them for follow-up assessment

Exclusion Criteria:

* Attending any 12-step program (≥2 meetings in the past month)
* Experiencing psychotic symptoms or cognitive impairment
* In alcohol or drug treatment programs
* Taking addiction treatment medications
* Experiencing, expecting to experience, or had a history of severe/complicated withdrawal
Lipofilling Versus Conservative Treatment in Fingertips Injuries Sequelae

The purpose of this study is to evaluate the contribution of autologous graft reinjection (lipofilling) in the treatment of dysaesthesic pulp.


Eligibility Criteria:
Inclusion Criteria:

* Major patient (18 years old) and ≤ 75 years old
* Patient with unidigital trauma downstream of distal interphalangeal joint
* Treated by directed healing OR covered by a flap
* Presenting troublesome pulpal dysesthesia evolving for more than 6 months AND less than 24 months
* The discomfort must be objectified by a DN4 score greater than or equal to 4/10 (neuropathic pain)
* Patient does not have any allergy to the substances used, in particular anesthetic: xylocaine, adrenaline

Exclusion Criteria:

* Patient with cutaneous sepsis, or amputation upstream of distal interphalangeal, or reimplantation, or dysesthesia that has been in progress for more than 24 months, or multi-digital traumatism
* Refusal of the patient to integrate the protocol Or incapacity to consent
* Pregnant or breastfeeding woman
* Tumor history of the amputated finger
Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine

The purpose of the study is to evaluate the safety and immunogenicity of an investigational hepatitis B vaccine (HEPLISAV) in adults 18 to 70 years of age.


Eligibility Criteria:
A subject must meet all of the following criteria to be eligible for the trial:

Inclusion Criteria:

* Be 18-70 years of age, inclusive
* Able to comprehend and follow all required study procedures and be available for all visits scheduled in the study
* If a woman is of childbearing potential, she must consistently use an acceptable method of contraception or confirm in writing she will abstain from sexual activity from the Screening Visit through Week 28.
* Able and willing to provide informed consent

A subject with any one of the following criteria is not eligible for the trial:

Exclusion Criteria:

* Previous receipt of any hepatitis B vaccine
* History of hepatitis B or human immunodeficiency virus (HIV) infection or positive test for HBsAg, anti-HBs, antibody to hepatitis B core antigen (anti-HBc), or antibody to HIV
* History of autoimmune disorder
* History of sensitivity to any component of study vaccines
* Has received the following prior to the first injection:

  1. Within 28 days:

     * Any vaccine
     * Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication
     * Granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF)
     * Any other investigational medicinal agent
  2. Within 90 days: Blood products or immunoglobulin
  3. At any time: An injection of DNA plasmids or oligonucleotide
* If female: Pregnant, nursing, or planning to become pregnant during the trial
* Is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin
* Any other medical condition considered by the investigator likely to interfere with the subject's compliance or the interpretation of study assessments
Evaluation of Intermediate Care Clinics for Diabetes

The aim of this trial is to assess the effectiveness of intermediate care clinics for diabetes, compared to usual care.

Intermediate care clinics (ICC) are suggested as one method of improving care for people with type 2 diabetes, but their effectiveness and cost effectiveness is not known. Their aim is to provide a multidisciplinary community based service to support general practices in achieving good control of their patients. Two local PCTs (Leicester City and Warwickshire) have agreed to establish intermediate care clinics as part of a cluster randomised trial of their effectiveness.

Patients with type 2 diabetes in participating practices will be invited to take part. Those that agree will attend a baseline assessment by a study nurse. This will include measurement of HbA1C, body mass index, waist circumference, blood pressure, urine and lipids, as well as questionnaires about quality of life, satisfaction with current services and continuity of care. Practices will then be randomised to either usual care or intervention arms, the latter having access to the new clinics. Participating patients will be asked to attend a follow up assessment 18-24 months after the baseline assessments, when the same measurements will be repeated. We expect about 30% of patients in the intervention arm will have been referred to the ICC.

The primary outcome will be the percentage of patients achieving adequate control of HbA1, blood pressure and cholesterol, comparing all participants in the intervention and control arms, whether or not those in the intervention arm attended ICC. The study is powered to detect a 10% difference in this outcome, and will include 51 practices and 5100 patients. We will also examine the effect of the intervention on process measures, such as the number of contacts in hospital and general practice. In the intervention arm we will document in detail the inputs provided by ICC, so that if successful the model can be adopted elsewhere.

The economic evaluation will be undertaken from a societal perspective. A costing study will measure intervention and treatment costs in both groups. A comparative assessment of the marginal costs and outcomes of the intervention will be undertaken, to include cost-effectiveness ratios and cost-utility analysis. All findings will be subject to sensitivity analysis.

Additionally we will explore the views of patients in the intervention arm who attended ICC using semi-structures interviews to identify positive and negative aspects of the patients' experiences. We will also hold focus groups to explore views of professional stakeholders.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes from participating practices across NHS Leicester, Warwickshire and Coventry.

Exclusion Criteria:

* Patients unable to give informed consent,
* Terminal cancer, OR
* Pregnant.
Influence of Probiotics on Clinical Parameters, the Oral Microbiome and the Immune System During an Orthodontic Treatment

Orthodontic treatment with fixed appliances can be necessary to correct malocclusions in adolescence or adulthood. It its known that orthodontic treatment induces aseptic pseudo-inflammatory reactions. However, studies could show that an increase of certain inflammatory cytokines during orthodontic treatment correlated with a higher risk of root resorption. Moreover, it has been shown that orthodontic treatment leads to a dysbiosis of the oral microbiome especially during the first 3 months of the orthodontic treatment. This could be a potential risk factor as the inflammation of periodontitis during an orthodontic treatment could favor root resorption and progressive destruction of the periodontal apparatus.

Probiotics are already used successfully as an adjuvant therapy in the treatment of periodontitis to improve clinical parameters and to reduce local inflammation. However, there are only a few studies that investigated the influence of probiotics during an orthodontic treatment.

Therefore, the aim of the study is to investigate if the daily intake of lozenges containing probiotics versus placebo lozenges during the first 3 months of orthodontic treatment with fixed appliances can improve clinical parameters, reduce local inflammation and prevent a dysbiosis of the oral microbiome.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents from age 12 to 17 with fixed appliances undergoing orthodontic treatment
* Signed declaration of consent by the patient and the parent or legal guardian for adolescent patients

Exclusion Criteria:

* Systemic or metabolic disease that are related to gingivitis or (e.g. diabetes) or could possibly influence the oral microbiome
* obesity:

  -adolescents: body mass index \> + 2 standard deviations (SD) over the average value given by the World Health Organisation (weight and height will be measured)
* Eating disorder or underweight

  -adolescents: BMI \> -2 SD under the average value given by the WHO (weight and height will be measured)
* Above-average consumption of milk products: \> 3 portions/day = \>1,2 liters of milk or 1200g yoghurt/day (daily dose recommended by the german society for nutrition = 1-3 portions of milk products)
* allergy to ingredients of the lozenges
* intake of antibiotics or dietary supplementation (probiotics, vitamin C/D) in the last 6 months or during the study
* regular use of antibacterial mouth wash
* pregnancy
* smoking
* retraction of the declaration of consent by the patient and the parent or legal guardian for adolescent patients
Effectiveness of Pedialink CEASE Module

The study involves the testing of a Pedialink module through parent exit interviews in one intervention practice and one control practice. Pedialink is the American Academy of Pediatrics' online home for continuous professional development. The intervention site will complete the Pedialink module and the control site will be given routine tobacco control materials.

We will measure changes in practice patterns in the two pediatric practices following the implementation of the online training. At each of these practices, the parents or guardians of children seen by the practice will be surveyed for a one week period before, and a one week period six weeks after either using the online training module (intervention) or being given routine tobacco materials (control).

A follow-up telephone survey will be given to some parents at 3-months. Those given the telephone survey are parents or guardians who smoke or parents or guardians who live with a smoker and are surveyed at the second time-point.

We hypothesize that intervention practices will have higher rates of screening for home and car no-smoking rules and higher rates of advising for home and car no-smoking rules.

This study will involve developing an online training and dissemination system to train pediatricians to address the secondhand smoke exposure of children. We will gather pediatric staff responses to the specific components of the online training and refine this training for a range of outpatient pediatric office settings. We will test the feasibility and efficacy of implementing the online training and dissemination system within the pediatric office setting. We will also gather parental responses to specific components of the pediatric visit, which will be impacted by the online training for pediatric offices.

The following hypotheses will be tested:

Primary Hypothesis

H1. The following measures of physician behavior, as assessed by exit interviews, 3 month follow up telephone interviews of parents or guardians who smoke or parents or guardians who live with a smoker and chart review of 20 charts, will increase more in the intervention practice than in the control practice:

* Screening for home no-smoking rule
* Screening for car no-smoking rule
* Advising parents about the need for a strictly enforced no-smoking in the home rule
* Advising parents about the need for a strictly enforced no-smoking in the car rule.

Secondary Hypothesis H2. Compared to the control practice, the intervention practice will have a greater increase in the summary scores that measure the key processes of practice implementation shown to predict successful practice change. This implementation process will be measured by administering previously validated surveys to physicians and key practice staff before and following the implementation of the office system.

Eligibility Criteria:
Inclusion Criteria:

* Parent or guardian of child seen by the practice.
* Smoke or live with a smoker.
* Speak English or Spanish.

Exclusion Criteria:

* Under 18
* Cannot be reached by telephone
Relation Between Bioelectrical Impedance Analysis (BIA) and CT-scan Analysis in the ICU

Aim of the present study is to determine whether muscle mass as assessed by bioelectrical impedance analysis correlates with and corresponds to muscle mass as assessed by CT scan analysis in critically patients admitted to the intensive care unit.

BIA measurements are performed in critically ill patients admitted to the ICU or MC, within 72 hours before or after CT scanning.

The BIA measurements are taken with the BIA 101 ASE, manufactured by Akern, Florence-7 Italy. This device is phase sensitive and injects an alternating current of 400 µA at 50 kHz. Measurements were performed while patients lay in supine position with a pillow supporting the head. The resistance, reactance, body weight and length are entered in the BIA algorithm, using BodyGram PRO. This algorithm calculated the body composition, with muscle mass being reported in kilogram (kg).

Abdominal CT scans are analyzed using the computer program SliceOmatic® version 4.3 and 5.0 (TomoVision, Montreal, QC, Canada) at the level of the third lumbar vertebra (L3). The muscle tissue was identified by using boundaries in Hounsfield Units (grayscale) set of -29 to +150(23). The program computes muscle surface area in cm2, by multiplying the pixel area by the amount of pixels identified as muscle.

For a direct comparison with the BIA-derived muscle mass, the CT-derived muscle area is converted to kg. This is done by following two steps. Firstly, the Shen equation is used for the conversion to litres.Secondly, the muscle volume is multiplied by its density, resulting in muscle mass expressed in kg.

Eligibility Criteria:
Inclusion Criteria:

* Abdominal CT-scan made for diagnostic reasons

Exclusion Criteria:

* CT-scan not analysable
* Internal or external metal devices
* active pacemaker
Comparison Between aPDT and Systemic Doxycycline on Non-surgical Periodontal Therapy in Type 2 Diabetics

The objective of this study is to evaluate Photodynamic Therapy (PDT) as adjunct on non surgical periodontal therapy in patients with type 2 diabetes. A total of 40 individuals will be selected and divided in two groups. On the treatment stage, the control group (Group C) will receive standard non surgical periodontal treatment. The Test Group (Group T) will be treated with PDT as an adjunct to non surgical periodontal treatment. The treatment will be repeated 4 times in two weeks, followed by dental prophylaxis every 15 days until accomplish 3 months. The follow-up will be done for 6 months. The clinical parameters measured will be: plaque index, pocket depth, bleeding on probing, relative clinical insertion level and suppuration. In addition, the evaluation of crevicular fluid volume and the levels of IL-1, TNF-α, subgingival microbiota by the hybridization DNA-DNA Checkerboard technique. The investigators expect to find identical or better results for the test group.


Eligibility Criteria:
Inclusion Criteria:

* Poorly Controlled Type 2 Diabetes (HbA1c \> 7%)
* Advanced Chronic Periodontitis
* Presence of 15 teeth

Exclusion Criteria:

* Use on antiinflammatory drugs
* Use of antibiotics less then 6 months before therapy
* Smokers
* Positive for HIV
* Periodontal treatment less then 6 months before therapy
* Advanced complications of Diabetes
A Study of JNJ-75229414 for Metastatic Castration-resistant Prostate Cancer Participants

The purpose of this study is to determine recommended Phase 2 dose (RP2D) regimen(s) of JNJ-75229414 in Part 1 (Dose Escalation and to determine safety at the RP2D regimen(s) in Part 2 (Dose Expansion).


Eligibility Criteria:
Inclusion Criteria:

* Histology: Metastatic CRPC (mCRPC) with histologic confirmation of adenocarcinoma. Metastatic CRPC with neuroendocrine features or mixed histology is excluded
* Prior Therapy: Prior treatment with at least 1 prior novel androgen receptor AR-targeted therapy (that is, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or at least 1 prior chemotherapy (example, docetaxel)
* Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1
* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or detectable prostate-specific antigen (PSA) levels based on local laboratory results
* Fertile participants must use a condom with spermicide during any sexual contact with a woman of childbearing potential, including pregnant women, from the time of signing the ICF until 1 year after receiving a JNJ-75229414 infusion. Vasectomized participants must agree to use a condom to protect any sexual partner from exposure to semen for 1 year after receiving the last dose of study drug. Contraceptive (birth control) use should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies

Exclusion Criteria:

* Prior Grade 4 Cytokine release syndrome (CRS) or Grade 3 or Grade 4 neurotoxicity related to any T cell redirection (Bispecific cluster of differentiation \[CD 3\])
* Prior Kallikrein 2 (KLK2)-targeted therapy
* Prior chimeric antigen receptor T cell (CAR-T) therapy
* Receiving systemic treatment less than or equal to (\<=) 6 months prior to signing informed consent) for any invasive malignancy other than prostate cancer unless approved by the sponsor. Bisphosphonates initiated greater than or equal to (\>=) 6 weeks prior signing informed consent are allowed
* Less than 2 weeks between last administration anti-androgen agents (example, abiraterone or enzalutamide), poly adenosine diphosphate-ribose polymerase (PARP) inhibitors (example, olaparib) or radiotherapy, and less than 3 weeks between last administration of cytotoxic chemotherapy (example, docetaxel), radionuclides (example, radium-223, lutetium-177-Prostate-specific membrane antigen \[PSMA\]-617) or an investigational agent, and apheresis
First Approach for Aspirin Misuse Objective Screening

prospective interventional study. The aim is to analyse the effect of usual ongoing treatments over the microvascular cutaneous response to galvanic current application (Current induced vasodilation ; CIV) on the forearm of subjects referred for ultrasound investigations due to suspicion of peripheral artery disease. Hypothesis is that the use of aspirin (even at low dose) abolishes the response .

At admission eligible patients are proposed to participate. Written consent is signed after complete oral and written explanation of the protocol is signed.

No register of non-included patients will be kept. In included patients, in parallel to the routine ultrasound investigation for which the patient is referred, microvascular investigation will be performed as explained later in arm description.

Usual ongoing treatments are obtained by history and recorded. The end of the visit is the end of the participation of the subjects.

Eligibility Criteria:
Inclusion Criteria:

* subjects referred for investigation of peripheral arterial disease.
* Affiliation to the French National healthcare system
* French speaking patients
* Ability to stand still for half a minute.

Exclusion Criteria:

* pregnancy
* inability to understand the study goal
* Patients protected by decision of law