cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Health Promoting Community Center Network (HPCCN) Innovation.

The purpose of this research study is to design, implement and evaluate the setting for a "Healthy Community Center". This is a program review of a program which will be planned in a community based participatory level, based on the socioecological model. A pre-post design will be utilized where all community centers in the study will be exposed to the intervention components. It is hypothesized that community centers who will receive the intervention will have better skills at building sustainable participatory effective health promotion projects and will provide a healthy setting for the community within its juristiction.

The purpose of this research study is to design, implement and evaluate the setting for a "Healthy Community Center". This is a program review of a program which will be planned in a community based participatory level, based on the socioecological model. A pre-post design will be utilized where all community centers in the study will be exposed to the intervention components. All community centers (n=15) will be evaluated by pre intervention questionairres and focus groups of community center Managers and health promotion professionals. The network will be designed upon the foundation of the "Healthy Cities network" with adaptations made in the process of participatory planning and designing according to the results of the focus groups. Intervention will include a a 12 week training session for designated "Health Coordinator" from each community center, Planning and implementing a personolized Health promtion Project in each community centre .It is hypothesized that community centers who will receive the intervention will have better skills at building sustainable participatory effective health promotion projects and will provide a healthy setting for the community within its juristiction.

Eligibility Criteria:
Inclusion Criteria:

* People who live within the geographical area of the community centers

Exclusion Criteria:

* Children under the age of 6 People who do not reside within the geographical area of the community centers
An Open-label Study of Poly-l-lactic Acid for Correction of Wrinkles in the décolletage Area

This is a prospective open-label study to evaluate safety and effectiveness of two different reconstitution volumes of poly-l-lactic acid (PLLA) for correction of wrinkles in the décolletage area.

A challenge for wrinkle correction of the decolletage/chest and other non-facial areas is that larger surface areas typically need to be treated than for facial indications, for which reason the Sponsor is investigating a larger reconstitution volume compared to the approved label. In this study, the total volume of 18mL, including 1mL of 2% lidocaine, is being explored and compared with results from the current labeled volume of 9mL, including lidocaine, to assess if the larger volume is well-tolerated for treatment for wrinkles in the decolletage area.

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant, non-breastfeeding females over the age of 22
* subjects seeking treatment for the décolletage
* subjects with moderate (Grade 2) or severe (Grade 3) on the Galderma Décolletage Scale
* subjects willing to abstain from any other surgical or cosmetic procedures in the décolletage area for the duration of the study.

Exclusion Criteria:

* Known/previous allergy or hypersensitivity to Sculptra
* Previous tissue augmenting therapy, contouring or revitalization treatment in the décolletage prior to baseline
* Any plastic surgery or permanent surgical implant in the treatment area
* Previous treatment/procedure in the treatment area in the previous 6 months that would interfere with study injections or study assessments
A RCT of the Efficacy of Vonoprazan 20mg QD in the Treatment of Helicobacter Pylori Infection

The treatment of helicobacter pylori is very important. The routine treatment is quadruple therapy. In recent years, double therapy has appeared and the curative effect is fair. However, antacid generally uses proton pump inhibitor. The proton pump inhibitor needs double dose to achieve good antacid curative effect. The effect of vonoprazan used for inhibiting gastric acid is better than proton pump inhibitor. At present, many studies use vonoprazan instead of common proton pump inhibitor, but almost all use double dose of vonoprazan. In the previous study, we found that the effect of double dose of proton pump inhibitor can be achieved with 20mg QD of vonoprazan. Therefore, in this study, 20mg QD of vonoprazan was used to replace the double dose of proton pump inhibitor to observe the antibacterial effect of vonoprazan on Helicobacter pylori.

The treatment of helicobacter pylori is very important. The routine treatment is quadruple therapy. In recent years, double therapy has appeared and the curative effect is fair. However, antacid generally uses proton pump inhibitor. The proton pump inhibitor needs double dose to achieve good antacid curative effect. The effect of vonoprazan used for inhibiting gastric acid is better than proton pump inhibitor. At present, many studies use vonoprazan instead of common proton pump inhibitor, but almost all use double dose of vonoprazan. In the previous study, we found that the effect of double dose of proton pump inhibitor can be achieved with 20mg QD of vonoprazan. Therefore, in this study, 20mg QD of vonoprazan was used to replace the double dose of proton pump inhibitor to observe the antibacterial effect of vonoprazan on Helicobacter pylori.

Eligibility Criteria:
Patients aged ≥18 years with Hp-positive first sterilization were included in this study. Before treatment, the existence of Helicobacter pylori can be confirmed by one or more of the following methods: rapid urease test, Hp culture, 13C urea breath test, 14C urea breath test and stool Hp antigen test.

The main exclusion criteria include acute upper gastrointestinal bleeding, active gastric or duodenal ulcer, acute gastric or duodenal mucosal lesions, previous eradication treatment of Helicobacter pylori, penicillin/furazolidone allergy, surgery that may affect gastric acid secretion (upper gastrointestinal resection or vagotomy), Zollinger-Ellison syndrome or other hypergastric acid secretion diseases, severe neurological, cardiovascular, pulmonary, liver, renal, metabolic, gastrointestinal, urological, etc. Any fertile woman must use proper contraception. All subjects provided written informed consent before participating in the study.
Virtual Reality as a Dietary Education Adjunct for Pediatric Patients With Obesity

Childhood obesity is a national crisis, effecting up to 1 in 5 of children in the US. In the Lucile Packard Children's Hospital Pediatric Weight Management Clinic, the investigators educate parents and caregivers about the importance of dietary modification. In addition to physician guidance, the investigators partner with registered dieticians to counsel families during an hour-long interview. However, traditional methods of education are limited by long-term recall. A typical person only recalls 2- 3% of didactic content after a period of 30 days. In order to improve recall and increase involvement of our pediatric patients in their own dietary modifications, the investigators propose a pragmatic, randomized pilot study investigating the effectiveness of Virtual Reality (VR) in changing dietary choices and improving recall.


Eligibility Criteria:
Inclusion Criteria:

* Ages 6-18 years of age
* Able to consent or have parental consent
* Diagnosis of Obesity Grade 1, 2 and 3 at LPCH/SHC facilities

Exclusion Criteria:

* People who do not consent
* Significant Cognitive Impairment
* History of Severe Motion Sickness
* Visual Problems
Safety of Bosentan in Type II Diabetic Patients

This study evaluates the safety of topical Bosentan in Type II Diabetes patients

The study is a Phase I, masked, placebo controlled clinical trial to assess safety of topical Bosentan in Type II Diabetes patients with no diabetes retinopathy

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent;
* Type II Diabetes Mellitus;
* 18 or more years old

Exclusion Criteria:

* Pregnant or breastfeeding Women
* Known allergy or intolerance to investigational product or any of its excipients
* Severe corneal abnormalities
* Any relevant ocular / ophthalmic pathology that may put study results at risk in the opinion of Principal Investigator
* Any sign or symptom of Diabetes Retinopathy
* Any ocular surgery in the 6 previous months to study inclusion
* Uncontrolled diabetes in the previous 3 months to inclusion or HbA1c levels ≥ 9% at baseline.
* Oxford Scale or OSDI scores compatible with study failure at inclusion visit. (Oxford ≥ 5 or OSTDI ≥ 13)
* Previous hepatopathy history or signs of hepatopathy at baseline.
* Contact lens use
* Actual treatment with the commercially available presentation
CT-2584 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Previous Therapy

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. CT-2584 may stop the growth of prostate cancer by stopping blood flow to the tumor.

PURPOSE: Randomized phase II trial to study the effectiveness of CT-2584 in treating patients who have metastatic prostate cancer that has not responded to previous therapy.

OBJECTIVES: I. Compare the efficacy, safety, and pharmacokinetics of 2 different treatment schedules of CT-2584 in patients with hormone refractory, metastatic adenocarcinoma of the prostate.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive CT-2584 IV over 6 hours daily for 3 days every 3 weeks. Arm II: Patients receive CT-2584 IV over 6 hours once every 7 days for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 80 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven metastatic adenocarcinoma of the prostate Refractory to hormonal therapy Failed at least 1 nonhormonal therapy (prior radiotherapy allowed, but does not constitute nonhormonal therapy) No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 60-100% Life expectancy: Not specified Hematopoietic: No known or suspected red blood cell disorder (e.g., hereditary spherocytosis, paroxysmal nocturnal hematuria, sickle cell trait, autoimmune hemolytic disorder) Hepatic: Bilirubin no greater than 1.5 mg/dL No severe liver dysfunction, particularly, no impaired hepatic synthetic functions as evidenced by prolonged prothrombin time or otherwise unexplained serum albumin less than 3 g/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No evidence of congestive heart failure No clinically significant cardiac arrhythmia No prior or concurrent symptoms of acute coronary artery disease No significant cardiac valve disease (e.g., aortic stenosis, valve prosthesis) Pulmonary: No prior asthma during adulthood that required therapy Other: No prior seizures or drug related anaphylactic reactions No history of microangiopathy (e.g., cavenous hemangioma, prior thrombotic thrombocytopenic purpura)

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior systemic biologic therapy for prostate cancer and recovered Chemotherapy: At least 4 weeks since prior chemotherapy (12 weeks for strontium-89 and 6 weeks for bicalutamide) and recovered Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: At least 3 weeks since prior major thoracic or abdominal surgery Other: At least 4 weeks since other prior investigational drugs (except bisphosphonates) and recovered
Ultrasound Visceral Slide Test for Prediction of Periumblical Adhesions Before Gynecologic Laparoscopic Surgery

Ultrasound visceral slide test for prediction of periumbilical adhesions before gynecologic laparoscopic surgery: a prospective cohort study.

The investigators are planning to conduct a prospective study to evaluate if there is an effect of abdominal wall thickness and body mass index on slide distance of visceral organ during ultrasound examination.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective laparoscopic surgery for any gynecologic indication.

Exclusion Criteria:

* Emergency laparoscopic surgery
* Patients under age 18
Occupational Cataracts and Lens Opacities in Interventional Cardiology : the O'CLOC Study

The purpose of this study is to test the existence of an increased risk of cataracts among interventional cardiologists as compared to cardiologists not exposed to X-rays.

This cross-sectional study includes cardiologists aged \> 40 years: a group of interventional cardiologists (coronary interventionists and electrophysiologists) and a group of unexposed workers (including cardiologists). Individual information, including risk factors of cataracts (age, diabetes, myopia, etc. ...), are collected during a telephone interview. For the exposed group, a specific section of the questionnaire is focused on the occupational history, the description of the procedures (type, frequency, radiation protection tool) and will be used for the classification into "comparable exposure level" groups according to estimates of cumulative dose. For all participants, eye examinations are performed to specifically detect cataracts even in the early stages (lens opacities, LOCS III according to the international standard classification).

Eligibility Criteria:
Inclusion Criteria:

* aged at least 40 yrs old
* for interventional cardiologists: cumulated number of procedures \> 2000

Exclusion Criteria:

* previous history of medical radiation exposure for radiotherapy or brain scans
* for non-interventional cardiologists: occupational history of interventional cardiologist
Minimal Invasive Volar Plating Versus Cast Immobilization for Treatment of Stable Non-displaced Distal Radial Fractures.

Nondisplaced distal radial fractures are nowadays treated by plaster cast immobilization. In this study, the investigators challenge this classical standard treatment with a surgical solution: minimal invasive volar plating with pronatus quadratus sparing approach. Potential benefits of this surgical treatment are higher cost effectiveness, economical benefit, earlier recuperation of professional and recreational activities, earlier functional recuperation by faster clinical recovery (range of motion, grip strength) and decreased risk of secondary fracture displacement. Potential drawbacks are surgical risks and complications.

Randomized controlled trial Number still to be determined by power analysis on economical outcome measurement Similar study number = 90 Randomization by computer.

RZ Tienen, Dr Goorens Level 4 hand surgeon

Inclusion criteria:

* Stable distal radial fractures (volar tilt \<10° dorsal tilt, \<2mm impaction, \<2mm articular depression)
* 18 - 65 years, professional active

Exclusion criteria:

* associated lesions, open fractures, unstable, displaced fractures
* neurological disorder affecting the upper limb, history of wrist lesion involving the same wrist, dementia, substance abuse, severe psychiatric disorder and previous injured contralateral wrist

Treatment

1. Cast treatment: 6 weeks with 1 plaster exchange of after 2 weeks
2. Minimal invasive plating: no cast

Followup 2 weeks, 6 weeks, 3 months, 6 months, 1 year

Primary PROM:

* Cost effectiveness: QALY SF-36
* Direct costs: surgery, hospitalisation, follow-up consultations, imaging, medication, wound care, nurse cost, physiotherapy cost
* Indirect costs: loss of productivity (SF-HLQ)
* Health insurances costs
* Confounding factors

  * Independent vs servant
  * Insurance?
  * Work type?
  * Age, sex, dominance
* Work absence, professional recuperation
* Recreational sport resumption

Secondary PROM

* ROM (F/E/RD/UD/P/S)
* Grip strength (Jamar)
* Pain (VAS)
* DASH scare, PRWE score
* Satisfaction (VAS), would you do it again?
* RX ulna variance, radial tilt
* complications

Eligibility Criteria:
Inclusion Criteria:

* Stable distal radial fractures (volar tilt \<10° dorsal tilt, \<2mm impaction, \<2mm articular depression)
* 18 - 65 years, professional active

Exclusion Criteria:

* associated lesions, open fractures, unstable, displaced fractures
* neurological disorder affecting the upper limb, history of wrist lesion involving the same wrist, dementia, substance abuse, severe psychiatric disorder and previous injured contralateral wrist
Impact of Immune Checkpoint Inhibitor Therapy on Type 2 Inflammation

The primary objective of this study is to determine the impact of anti-checkpoint immunotherapy on type 2 inflammation via a retrospective analysis of % eosinophilia.


Eligibility Criteria:
Inclusion Criteria:

* Electronic patient file "DxCare" at the University Hospitals of Montpellier
* Patient has received anti-PD-1 immunotherapy --AND/OR -- anti-PD-L1 immunotherapy according to central pharmacy records

Exclusion Criteria:

* No mention of % eosinophilia in the patient file
Substrate Metabolism and Insulin Sensitivity in Patients With Hyperprolactinemia Before and After Treatment

The purpose of this study is to investigate the effects of chronic elevated levels of Prolactin on metabolism and insulin sensitivity by studying patients with hyperprolactinemia before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Written consent
* Age between 18 and 70
* At diagnose a serum prolactin \> 200 microgram/l (10 U/l)

Exclusion Criteria:

* Hypothyroidism
* Use of any medication
* Pregnancy
Micronutrient Supplementation and Incidence of Common Cold

This study investigates the effects of a dietary supplement - a cocktail of vitamins and minerals - on the incidence of common cold in a cohort of middle management employees.The primary outcome is defined as the number of duty days lost due to common cold/flu. Further, immune parameters and markers of redox biology/oxidative stress will be determined. The wellbeing in the cohort will be evaluated via questionnaires.

randomized, double-blinded, placebo controlled trial 82 Subjects, men and women, 25 - 50 yrs, non-smokers, employees of middle management, 24 weeks of supplementation/placebo, 4 wk wash-out of all supplements and dietetic products, undersupply of fruit, vegetables (\< 4 portions/day) and whole grain food (\< 5x/wk)

Eligibility Criteria:
Inclusion Criteria:

* pre or peri-menopausal
* non-smokers
* sedentary or moderately trained
* BMI: \>20 and \< 35kg/m2
* undersupply of fruits, vegetables and whole grain food, fibres
* contraceptives
* wash-out

Exclusion Criteria:

* post-menopausal
* smokers
* trained people
* BMI out of inclusion range
* adequate intake of vegetables, fruits and whole grain food, fibres
* no adherence to wash-out
Study of an Investigational Drug, ASP3026, in Patients With Solid Tumors

A study to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced malignancies (solid tumors).

This study will be conducted using a traditional 3 + 3 dose escalation study design. Enrollment of at least 3 subjects is planned for each dosing cohort. The decision to expand a cohort or dose escalate will be based on the occurrence of dose limiting toxicities (DLTs) in Cycle 1 that are considered by the Investigator to be related (possibly or probably) to ASP3026. The Safety Data Review Committee may elect to enroll additional subjects in a cohort to further evaluate the dose level. Each cycle will include 28 days of continuous dosing with ASP3026. Treatment with ASP3026 may continue until one of the discontinuation criteria is met.

The maximum tolerated dose (MTD) is defined as the highest dose of ASP3026 on a dosing schedule at which \< 33% of subjects experience a DLT during Cycle 1. The MTD or lower dose, as determined by the Safety Data Review Committee, will be the recommended Phase 2 dose (RP2D). Twelve additional patients will be treated at the RP2D to further evaluate safety and tolerability.

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status \< 2.
* Histologically or cytologically confirmed diagnosis of a relapsed/refractory solid tumor
* Patient meets at least 1 of the following criteria:

  * Disease progression despite standard therapies
  * No standard therapies are available or such therapies are not anticipated to result in a durable response
  * Standard therapies are considered unsuitable or have been refused
* Life expectancy \> 12 weeks
* Able to be hospitalized from 1 day prior to the initial dosing until day 15 of the dosing, and from day 27 until day 29 of the dosing

Exclusion Criteria:

* Patient exhibits persistent subjective and objective findings of toxicity ≥ Grade 2 (CTCAE v4.0-JCOG) from the previous cancer treatment with antitumor effect (except of alopecias)
* Received previous treatment with antitumor effect within 21 days prior to the scheduled initial dosing
* Patient had a major surgical procedure within 21 days prior to the scheduled initial dosing or a major surgical procedure scheduled during the course of the study
* Use of an investigational drug or device within 21 days prior to the scheduled initial dosing
* Use of blood transfusion or hematopoietic growth factors within 14 days prior to the scheduled initial dosing
* A positive test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV)
* Known history of a positive test for human immunodeficiency virus (HIV) infection
* Patient has central nervous system (CNS) or leptomeningeal involvement with clinical symptoms
Reconstructive Ear Surgery in Pediatrics

The aim of the study is

1. Evaluation of preoperative degree of hearing loss in pediatric population.
2. Evaluation of types and prevalence's of ossicular disruptions due to chronic otitis media and trauma.
3. Assessment of best candidates for hearing restoration surgeries.
4. Comparing different surgical techniques for hearing restoration in various ossicular disorders .
5. Evaluation of degree of surgical restoration of the sound transmitting mechanism of the middle ear in pediatric population.

Conductive hearing loss (CHL) results from impaired transmission of sound from the external auditory canal across the middle ear structures to the cochlea of the inner ear. A variety of disorders can affect the sound transmission pathway at the level of the ear canal, tympanic membrane, and ossicles prior to reaching the hearing organ.

Ossiculoplasty is the surgical restoration of the sound transmitting mechanism of the middle ear. Ossiculoplasty has been performed as early as the 1950s.A myriad of prosthetics and surgical techniques have been described over the last half-century, with no overall consensus on the ideal method of treatment.

Pediatric population are commonly known to develop conductive hearing loss secondary to various conditions such as chronic otitis media, otitis media with effusion, atelectatic otitis media and head trauma. Various methods have been fashioned to restore hearing in such patients however no consensus to the most optimum method for hearing restoration has been well established

Eligibility Criteria:
Inclusion Criteria:

1. patients aged ≤ 18years with CHL.
2. patients who are candidate for ossiculoplasty as surgical treatment for them.

Exclusion Criteria:

1. Patients with preoperative sensory neural hearing loss (SNHL).
2. Patient with intra operative complications.
3. Patients with intracranial and intratemporal complications.
4. Patients with stapes foot plate fixation, broken graft and missed patients.
5. Patients \>18years.
6. Patients who unfit for surgery.