cyrilzakka/clinical-trials huggingface dataset:
Non-invasive Improvement of Buttocks With Magnetic Device

This study will evaluate the clinical safety and patient satisfaction with the high power magnet system for the aesthetic improvement of buttocks. The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and three follow-up visits - 1 month, 3 months and 12 months after the final treatment. Study will be conducted at several study sites.

At the baseline visit, subject's weight will be recorded.

The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the gluteal area. Visible contractions will be induced by the device.

At the last therapy visit, the subject's weight will be recorded. In addition, subjects will receive Subject Satisfaction Questionnaire to fill in.

Safety measures will include documentation of adverse events (AE) including subject's experience of pain or discomfort after the procedure. Following each treatment administration and at the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment.

Post-procedure evaluation (follow-up visits) will be conducted 1 month, 3 months and 12 months after the final treatment. A weight measure will be conducted. Also, subject's satisfaction will be noted.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily signed informed consent form
* BMI ≤ 30 kg/m2
* Women of child-bearing potential are required to use birth control measures during the whole duration of the study
* Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
* Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation

Exclusion Criteria:

* Cardiac pacemakers
* Electronic implants
* Pulmonary insufficiency
* Metal implants
* Drug pumps
* Haemorrhagic conditions
* Anticoagulation therapy
* Heart disorders
* Malignant tumor
* Fever
* Pregnancy
* Breastfeeding
* Following recent surgical procedures when muscle contraction may disrupt the healing process
* Application over menstruating uterus
* Application over areas of the skin which lack normal sensation
* Scars, open lesions and wounds at the treatment area
* Unrepaired abdominal hernia
Epidemiology of Vascular Inflammation & Atherosclerosis

To investigate the relationship of vascular cell phenotypes to atherosclerosis.

BACKGROUND:

Currently, the predominant hypothesis regarding atherosclerosis is that it is in major part driven by two independent pathways: hyperlipidemia (the "stimulation") and inflammation (the "response"). Although vascular cells mediate the influence of inflammation on atherosclerosis, very little is known about vascular cell epidemiology and the relationship of vascular cell phenotypes to atherosclerosis. The main hypothesis tested in this study is that variation in vascular cell biology is related to the population variation in atherosclerosis.

DESIGN NARRATIVE:

The cross-sectional study will be nested within a large cohort study, the Multiethnic Study of Atherosclerosis (MESA). A partial sample of 1,000 individuals who have undergone other special laboratory analyses will be identified and new measures collected as part of their upcoming site visit. A number of novel cellular phenotypes describing the innate immune response (monocyte activation, natural killer and T cell counts), the adaptive immune response (TH1 and TH2 helper cells, and memory T cells), and vessel integrity (circulating endothelial progenitor cells) will be measured in these participants. Plasma constituents will also be measured that relate to the cellular phenotypes. The overall goal is to test the hypothesis that these novel phenotypes are associated with subclinical atherosclerosis in the coronary and carotid arteries assessed by quantification of coronary calcification (CAC) and B-mode ultrasound (CIMT), in addition to the other subclinical measures available from the MESA cohort.

Eligibility Criteria:
No eligibility criteria
GCWB1176 Evaluates the Effectiveness and Safety of Immune Function

This human application test was planned to evaluate the effectiveness and safety of immunodefinition compared to the placebo when the GCWB1176 was consumed for those whose white blood cell level was normal or somewhat decreased.


Eligibility Criteria:
Inclusion Criteria:

1. At the time of screening, 19 or 75 years
2. A person with a peripheral blood leukocyte level measured in Visit 1, 3x10\^3 cells/μl or more, 8x10\^3 cells/μl
3. Those who are more than one of the following standards

   * Those who had more than twice within one year of visiting 1 year.

     * {Common cold, acute tonsillitis, acute pharyngitis, acute laryngitis, acute rhinitis, etc.

       * Those who have stomatitis more than twice within 1 year of visit

         * Those who had Herpes Zoster infection within 1 year of visit
4. Those with a stress awareness scale (PSS) 16 or more
5. A person who agrees to participate in this human application test before the start of the human test and writes a written consent form

Exclusion Criteria:

1. Those who are currently treating drugs due to underlying disease, etc.
2. Hypertension patients (systolic blood pressure 140 mmHg or higher or dichotomous blood pressure 90 mmHg or higher, human application test target 10 minutes stabilized)
3. Patients with diabetes with an fasting blood sugar at least 126 mg/dL or administering urine disease (oral blood sugar, insulin, etc.)
4. Those who are 0.1 UIU/mL or less, or 10 UIU/mL or more
5. Those who have vaccinated vaccines (influenza, corona, shingles that can affect immunity) within 3 months of visiting 1
6. A disease that can affect immune responses such as adult -like and rhinitis
7. AST (GOT) or ALT (GPT) is three times more than the normal upper limit of the embodiment
8. Those who are 1.5 times more than the normal upper limit of Creatinine
9. Those who administered steroids, antibiotics, immunosuppressants, and gastric acid inhibitors within 1 month of visit.
10. Visit 1 person who consumes vitamins, health functional foods that can affect immunity within 2 weeks of visiting
11. A person who has administered or consumed lactic acid bacteria products (4 or more times a week) within 2 weeks of visiting within 2 weeks of visit.
12. Those who complain of severe gastrointestinal symptoms such as heartburn and indigestion
13. Those who are pregnant or have a planning plan for lactation or this human application period
14. Those who have participated in other interventional clinical trials (including human application test) within 8 weeks of visit, or plan to participate in other interventional clinical trials (including human application tests) after the beginning of this human application test
15. Those who are sensitive or allergic to food ingredients for this human application
16. Those who have a BMI (body mass index) of 30 kg/m2 or more
17. A person who consumed alcohol within 1 month (30 days) based on 1 visit (man\> 210 g/week, woman\> 140 g/week)
18. Those who judge that the test person is inadequate for other reasons
Pharmacokinetic Drug Interaction Between YH4808 and Diclofenac

The objective of this study is to compare pharmacokinetics after single oral administration of YH4808 and Diclofenac each separately versus coadministration of YH4808 and Diclofenac in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* healthy male age 20 to 45 over 55kg with Ideal body weight(IBW)
* No clinically important abnormal physical findings at the screening examination
* Subject who has no congential, chronic disease and disease symptoms in medical examination result
* Subject who is judged to be eligible by principal inverstigator or sub-investigator according to various reasons includiong ther abnorminal test results(clinical laboratory test, 12-lead GCG etc)
* Ability to communicate well with the inverstigator and to comply with the requremetns of the entire study
* Willingness to give written informed consent(prior to any study-related procedures beinging performed) and to be able to adhere to the study restrictions and examination schedule

Exclusion Criteria:

* Suject who has history or presence of clinically significant diseases in liver, kidney, gastrointestinal tract, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, urinary system, and mental disorder
* Subject who is hypersensitive to components contained in YH4808 or declofenac or related drug(ex. rebamipide, revaprazan, NSID etc)
* Medical history of gastrointestinal disease or acid restraining surgery, gastric/ esophagus surgery(excluding appendectomy, hernia surgery)
* Subject who has history of drug dependence or using that drug
* Subject who had taken usual dose of any prescription durgs within 14 days before the treatment or who had used usual dose of OTC drugs within 7 days before the treatment
* Subject who participated in antoher clinical trial within 2 monthes before enrolling in this study
* subject who donated whole blood within 2 months or component blood within 1 month before the treatment
* Subject who drank over 21unit/week(1 unit= 10g of alcohol) or were not able to refrain from drinking alcohol during study days
* Subject who stopped smoking within 3 months before the treatment or detected cotinine in urine test
* Subject with clinically significant observations considered as unsuitable based on medical judgment by the investigators
Osteopathic Manipulative Treatment in Individuals With Temporomandibular Disorder Who Make Use of Occlusal Splints

This study aim to contribute with the investigation of the therapeutic effect of osteopathic manipulative treatment in pain intensity and Quality of Life in individuals diagnosed with temporomandibular disorder who make use of occlusal splints.

Objective:

It is known the multifactorial etiology of Temporomandibular Disorders(TMD) which raises the need of a multidisciplinary approach for its treatment. Studies have presented good results about the use of occlusal splints along with other therapies. The Osteopathic Manipulative Treatment(OMT) has as characteristic the philosophy of global approach and precise functional diagnosis. Based on a lack of randomized blind trials about this subject, This study aim to contribute with the investigation of the therapeutic effect OMT in pain intensity and Quality of Life in participants diagnosed with TMD making use of occlusal splints.

Methodology:

This study is a randomized blind trial, with sample composed by 18 participants referred to the occlusion clinic of Fluminense Federal University (UFF), diagnosed by the team of dentists and interns of occlusion clinic through the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). The participants will complete the Short Form 36 Health Survey(SF-36) to measure the quality of life, and pain intensity diagram with Numeric Rating Scale (NRS) to measure the pain intensity. The sample will be randomized into 2 groups (9 individuals for each): Test Group (TG) - patients subject to Clinical Treatment with splints (CT) offered at the Occlusion Clinic unit along with Osteopathic Manipulative Treatment - OMT. Control Group (CG) - patients subject only to CT and will receive a sham treatment that simulate the OMT to blind these participants. After the treatment, patients will be re-evaluated in 8 weeks' time.

Statistical analysis:

The SF-36 and the pain intensity and the most intense pain evaluation diagram with Numeric Rating Scale (NRS) will be performed by the Wilcoxon's non parametric test.

Eligibility Criteria:
Inclusion Criteria:

* individuals who has diagnosis of Temporomandibular disorder.

Exclusion Criteria:

* individuals who already has subjected to osteopathic manipulative treatment to temporomandibular disorder.
Levels of the Stat4 Alpha and Stat4 Beta Isoforms in PBMCs From Patients With Crohn's Disease and Ulcerative Colitis

The goal in these studies will be to assess the relative levels of the Stat4 alpha and Stat4 beta isoforms in PBMCs from patients with Crohn's Disease, ulcerative colitis, celiac disease or from control patients. We hypothesize that the beta to alpha ratio will be higher in patients with active disease and that there will be a correlation between the ratio and the severity of disease.


Eligibility Criteria:
Inclusion Criteria:

* Children with a new diagnosis of Crohn's Disease and whose physician has not yet initiated corticosteroid treatment (10 Subjects):
* Clinical diagnosis within the previous 21 days
* Above age 7 and younger than age 18
* Signed informed consent statement and assent statement.
* Children with a new diagnosis of Ulcerative Colitis and whose physician has not yet initiated corticosteroid treatment (10 Subjects):
* Clinical diagnosis within the previous 21 days
* Above age 7 and younger than age 18
* Signed informed consent statement and assent statement.
* Children with Crohn's Disease whose physician has initiated Infliximab treatment for the first time (10 Subjects):
* Clinical diagnosis of Crohn's Disease
* Above age 7 and younger that age 18
* Signed informed consent statement and assent statement.
* Children with Ulcerative Colitis whose physician has initiated Infliximab treatment for the first time (10 Subjects):
* Clinical diagnosis of Ulcerative Colitis
* Above age 7 and younger than age 18
* Signed informed consent statement and assent statement.
* Healthy Controls (10 Subjects):
* Above age 7 and younger than age 18
* otherwise healthy, with no intercurrent illness as determined by a member of the study team using the eligibility checklist
* controls will be gender and age (± 2 years) matched to the patient groups described above
* Signed informed consent statement and assent statement

Exclusion Criteria:

* unwilling to give consent for this study.
* child with prior prescription and administration of Infliximab
A Pharmacokinetic Study of the Effect of Itraconazole Exposure to Orvepitant in Healthy Volunteers

A Phase 1 study to assess the effect of itraconazole, a strong inhibitor of CYP3A and P-glycoprotein, on the pharmacokinetics (PK) of orvepitant in healthy male volunteers.

Subjects will receive two single doses of 20mg orvepitant, once alone and once in combination with repeat doses of itraconazole. All subjects will follow the same sequence - orvepitant alone followed by orvepitant in combination with itraconazole.


Eligibility Criteria:
Key Inclusion Criteria:

* male volunteers
* judged to be in good health, based on the results of medical history, physical examination, vital signs, 12 lead ECG, and clinical laboratory findings
* body weight greater than 50 kg and body mass index (BMI) within the range 18 to 30 kg/m2 (inclusive)

Key Exclusion Criteria:

* clinically significant findings on physical examination
* relevant medical history
* history of or considered at high risk of seizures (except febrile fits in childhood), including history of significant head injury
* positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV) or human immunodeficiency virus (HIV)
* serum biochemistry and full blood count considered by the Investigator to be of clinical significance
* systolic blood pressure \<100 or \>140 mmHg or diastolic BP \<50 or ˃90 mmHg, measured prior to the first dose of orvepitant
* abnormal 12 lead electrocardiogram (ECG)
* has donated one or more units (approximately 450 mL) of blood or acute loss of an equivalent amount of blood within 90 days prior to study intervention administration
Exploratory Study to Assess the Short Term Intratumoural and Peripheral Effects of BN83495 in Postmenopausal Women With Newly Diagnosed Breast Cancer

This trial will assess the intratumoural pharmacological activity of BN83495 by changes in intratumoural levels of sex hormones and associated inhibition of steroid sulphatase (STS) activity.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects 55 to 80 years with histologically or cytologically documented primary intraductal or lobular invasive breast cancer that meets the following criteria:
* T2, N0 or N1, M0.
* Primary tumour clinically determined to be 2 to 5 cm in the greatest dimension.
* Laboratory documentation of positive oestrogen receptor (ER+) status in at least 10% of the tumour cells.
* Laboratory documentation of HER-2 negative status.

Postmenopausal defined as

* no spontaneous menses for a total of 2 years
* amenorrheic for at least 12 months with serum oestrogen level \<30 pg/mL, and both luteinising hormone (LH)/follicle stimulating hormone (FSH) \>20 IU/L, chemotherapy-induced amenorrhoea for at least 12 months
* bilateral oophorectomy, or radiation castration and amenorrhoeic for at least 3 months.

Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

Exclusion Criteria:

* Has locally advanced breast cancer that is considered non-operable without neoadjuvant therapy.
* Has evidence of metastatic disease
* as a diagnosis of inflammatory breast cancer
* Has ductal carcinoma in situ
Antitetanus Vaccination for People Older Than 65 Years.

In the last ten years, more than one hundred generalized tetanus cases were declared in France. Most of them were affecting people older than 70 years with an important mortality (around 28%). It is know that the only way to protect ourselves from this disease is the vaccination. In France tetanus vaccination is mandatory since 1940.

Nowaday none study looked specifically for the vaccination of people older than 65 years. The hypothesis is: there is a difference in the tetanus vaccination coverage for people older than 65 years depending on the demographic and medical practice of their general practitioner.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 65 years consulting their attending physician in and who agreed to participate in the study.
* The doctors included are general practitioners located in a liberal office in the "Auvergne Rhône Alpes" region for which the URPS ("Union régional des Professionnels de Santé") has an email address.

Exclusion Criteria:

* None
Evaluate the Safety of agenT-797 in Participants With Moderate to Severe Difficulty Breathing Secondary to SARS-CoV-2

A Phase 1/2 study of agenT-797 to treat moderate to severe acute respiratory distress syndrome (ARDS) secondary to acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or influenza.

This is a Phase 1/2 study to evaluate the safety and potential efficacy of agenT-797, an unmodified, allogeneic invariant natural killer T (iNKT) cell therapy, in participants with moderate to severe ARDS secondary to SARS-CoV-2 or influenza, either with intubation or at high risk to be intubated, as determined using Berlin definition(s).

Part 1 will employ a standard 3+3 dose escalation design of agenT-797. All participants will receive a single infusion of agenT-797. Participants will also receive other treatments and supportive care per discretion of the investigator. Once the maximum tolerated dose of agenT-797 has been cleared in Part 1, an Expansion Cohort will be opened.

A safety monitoring committee will be established to assess safety and decide on escalation to next cohort and expansion dose, as well as any protocol modification to include less severe cases.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily agree to participate and can provide informed consent or have a duly appointed health care proxy establish which/who has the authority to consent on behalf of the participant
2. Inpatient hospitalization
3. Evidence of SARS-CoV-2 infection with the diagnosis of moderate to severe ARDS secondary to SARS-CoV-2 or influenza per Berlin definition (ARDS 2012)
4. Participants, or study participant's duly appointed health care proxy with the authority to consent on behalf of the participant, must consent to placement of a central venous access line for the administration of agenT-797

Exclusion Criteria:

1. Currently participating and receiving study therapy of an investigational agent that is not registered for any other indication
2. Clinically significant cardiomyopathy
3. Pre-existing respiratory disease, such as significant chronic obstructive pulmonary disease requiring home oxygen, hospitalization, or systemic steroid use during the past year
4. "Significant" pulmonary hypertension, defined as mean pulmonary artery pressure ≥ 20 millimeters of mercury and evidence of right ventricular dysfunction or enlargement
5. Receipt of vaccines containing live virus within 4 weeks prior to first dose of study treatment
6. Known hypersensitivity to donor-derived cell therapy or their preservation solution
7. Active systemic bacterial or fungal infection or viral co-infection
8. Pregnant or lactating women
9. Presence of multiorgan dysfunction syndrome; no organ failure should be seen other than the organ of interest, which is the lung
Mild Hypofractionation With Proton Therapy or Intensity Modulated Radiation Therapy (IMRT) for Intermediate-Risk Prostate Cancer

This is a study to first establish feasibility of the study and then to register the treatment data of adult patients with a diagnosis of intermediate risk of prostate cancer presenting for definitive radiation treatment with either proton radiotherapy or Intensity Modulated Radiation Therapy (IMRT). The investigators propose to employ a hypofractionated strategy with our image guided treatment to further improve cancer control and decrease toxicity.

This study will be done in two phases, first, a feasibility study and then a registration study. In the first, feasibility will be established using the primary objectives set below. The second phase will begin no earlier than 30 days after the last patient in the initial phase has completed treatment and once safety and feasibility has been verified. The secondary objectives will serve as the objectives for the second phase of the study.

Eligibility Criteria:
Inclusion Criteria

* Histologically confirmed prostate adenocarcinoma within 365 days of registration.
* Clinical stages T1a-T2c N0 M0 (AJCC Criteria 6th Ed). For any suspicious pelvic lymph node \> 1.5cm (as exhibited on pelvic imaging), biopsy of the lymph node is suggested.
* Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range 2-7. Biopsy with \> 6 cores is strongly recommended. (The highest Gleason Score in any core reported on the pathology report will be used for determining inclusion.)
* PSA values \<20 ng/ml within 90 days prior to registration, and done either prior to prostate biopsy, or at least 21 days after prostate biopsy.
* Zubrod (ECOG) status 0-1 documented within 90 days of registration.
* Androgen deprivation is at the discretion of the treating radiation oncologist.
* Subjects must give IRB-approved study-specific informed consent. Subjects must complete all required tests within the specified time frames.
* Subjects must be at least 18 years old.
* Members of all races and ethnic groups are eligible for this trial.

Exclusion Criteria

* Clinical stages T3 or greater (AJCC Criteria 6th Ed).
* PSA of 20 ng/ml or greater.
* Gleason score 8 or higher.
* Evidence of distant metastasis. (Determined by CT scan, MRI, and/or bone scan prior to the simulation appointment; imaging results from UPHS will supercede results from similar scans from an outside facility.)
* Evidence of lymph node involvement.
* Previous prostate cancer surgery to include: prostatectomy, hyperthermia, and cryosurgery.
* Previous pelvic radiation for prostate cancer.
* Active rectal diverticulitis, Crohn's disease, or ulcerative colitis.
* Prior systemic chemotherapy for prostate cancer.
* History of proximal urethral stricture requiring dilatation.