cyrilzakka/clinical-trials huggingface dataset:
An Open Label Study to Assess the Effect of Euryco-10® Oral Dietary Supplement in Senior Men

To evaluate the effect and support the tolerance of orally ingested formulation containing Eurycoma longifolia dietary supplement (Euryco-10) on a cohort of senior men.

This is a single-center, single arm, open label study in senior men. This study will investigate the effect and tolerance of oral ingestion of Euryco-10. Subjects meeting all inclusion and none of the exclusion criteria will be enrolled and provided with study dietary supplement. Subjects will be instructed to take 2 capsules per day for 35 days. Administration and any adverse events will be recorded in the subject diary. At each clinic visit (Day 0, Day 21 and Day 35) the Subject will complete the AMS Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

Male ≥ 55 years of age

Exclusion Criteria:

Severe lower urinary tract symptoms.

Current use of any herbal and/or nutritional supplements that can interfere with testosterone.

A history of cancer except melanoma skin cancer.

Currently receiving treatment with cancer chemotherapy or antiandrogens.

Chronic use of systemic glucocorticoids (use within \>14 days up to the 3months prior to screening); use of non-testosterone anabolic steroids within12 months prior to screening.

History of frequent opioid use \>1 time/week during any week within 30 days prior to screening.

Have a history of known angina.

Have a history of severe liver disease or clinical evidence of hepatic impairment at screening.

Untreated severe obstructive sleep apnea.

Allergies to any of the ingredients in Euryco-10® or BioPerine.

Any condition which would interfere with the subject's ability to provide informed consent, to comply with study instructions, or which might confound the interpretation of the study results
Efficacy of Faslodex in Treatment of SLE Clinical, Serologic, and Molecular Studies

SLE(Systemic Lupus Erythematosus) is an autoimmune disese that primarily occurs in women(9:1 compared to men). The disease is activated by genetic and environmental factors, yet the female gender is the strongest risk factor. The sex hormone estrogen has been proven in the past to be an enhancer of the immune response. Estrogen serves as a ligand for two specific receptor proteins. Lab studies that we have already done have shown estrogen significantly increases these two ligands in the T cells from SLE females, but not in T cells from normal women. These estrogen-dependent increases are blocked by the estrogen receptor antagonist ICI 182,780. The objective of this research is to investigate if ICI 182,780 alters disease progression and/or activity in females with SLE and may provide a new treatment for women with SLE. This is based on previous work we have done.

This is a double-blind study, involving (goal) 20 women with SLE. All will be premenopausal with regular menstrual cycles. Patients will meet at least four of the criteria of the American Colleges of Rheumatology for classification of SLE. Disease activity will be determined by SLE disease activity index called SLEDAI scores. Patients can take meds to control their disease, but none will be able to take birth control pills/patches, or hormone replacement at the time of the study. The pharmacy will be in control of the blind and 10 will get ICI 182,780 (Faslodex) and 10 will get placebo. Lab will be drawn before each injection and a bone density will be done on injection 1 and 12, the injections will be monthly, depending on the female's cycle. A visit will be done at month 15 to evaluate SLEDAI, and draw lab as well. Each vs will have a SLEDAI done with the clinical evaluation. The injection is 250mg/5cc, which is divided into 2 injections of 2.5cc each, given IM, on day 4-10 of each cycle.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women with SLE
* Without life-threatening manifestations
* With regular menstrual cyles not on hormones of any kind

Exclusion Criteria:

For any of the following:

* Increase of SLEDAI greater than 12
* If life-threatening manifestations occur
* If menstruation ceases
Vitamin D Serum Levels in Monosymptomatic Enuretic and Non Enuretic Children

We are group of researchers interested in causes and management of nocturnal enuresis, we embarked on this research on 2020 and we reached promising results regarding the role of vitamin D serum level in etiology and management of monosymptomatic enuresis.

this research was conducted as a comparative study regarding serum vitamin D levels in monosymptomatic enuretic and non enuretic children, also we compared urine osmolality and nocturnal polyuria in both groups and we found that low vitamin D levels are correlated with low nocturnal urine osmolality and increased incidence of nocturnal polyuria

Eligibility Criteria:
Inclusion Criteria:

* Patients with PMNE.
* which was defined as bedwetting frequency of 3 or more nights per week for at least 2 weeks of observation.
* Didn't receive any previous treatment for enuresis.

Exclusion Criteria:

* Patients with non-monosymptomatic enuresis (associated with storage and/or voiding symptoms). -Patients with anatomical abnormalities (Meatal stenosis, Hypospadias, Epispadias, etc.).
* Patients with neurological diseases.
* Patients with Renal impairment.
* Patient with previous pelvic, urological or brain and spinal cord surgery.
* Patients with chronic constipation and irritable bowel habits.
* Patients with active urinary tract infection.
* Patients who are on vitamin D supplements.
Impact of Self-monitoring of Blood Pressure and Self-titration of Medication in the Control of Hypertension (ADAMPA)

The ADAMPA study is a pragmatic randomized clinical trial which aims to evaluate the effectiveness of an intervention based on self-monitoring and self-titration of medication in poorly controlled hypertensive patients 40 years and older. The total duration of the study is 3 years, with 6 months of enrolment and 1 year of follow-up to measure the primary endpoint (Difference in mean systolic blood pressure, in mmHg, between the intervention and control groups).

ADAMPA study. Objectives: To evaluate the comparative effectiveness of an intervention that includes educational components, self-monitoring of blood pressure and self-titration of antihypertensive medication in the improvement of control of hypertension compared to usual care in a poorly controlled population of hypertensive patients.

Design: Pragmatic, controlled, randomized, non-masked clinical trial with two parallel arms.

Disease related to the study: Hypertension.

Main outcome measure: Difference in mean systolic blood pressure, in mmHg. At 12 months of follow-up between the intervention and control groups, determined at physicians' practice with a validated automatic electronic sphygmomanometer

Study population: Patients assigned to the Valencia Clinic-La Malvarrosa Health Department. Total number of patients to be randomized: 458 (229 per arm).

Duration of intervention: 12 months (also, a pragmatic extension with passive follow-up is planned for 24 months, collecting a reduced set of outcome variables, as secondary variables)

Calendar and expected completion date: The trial will take place over 3 years (6 months of recruitment, 12 months of follow-up for the main analysis of results, 12 months of pragmatic follow-up at 24 months, and finally 6 months for reporting results). Estimated Completion Date: 2020.

Eligibility Criteria:
Inclusion Criteria:

* 40 years or older
* Diagnosis of hypertension of any origin
* Systolic blood pressure (SBP) \> 145 or diastolic blood pressure (DBP) \> 90 mm Hg at baseline
* Voluntarily participation in the study and having signed the corresponding informed consent.

Exclusion Criteria:

* Inability to understand and/or perform self-adjustment of the medication, including dementia or significant cognitive impairment (at the discretion of the investigator performing the recruitment).
* History of orthostatic hypotension (fall\> 20 mm Hg in SBP after adopting the orthostatic position).
* SBP\> 200 or DBP\> 100 mm Hg on the baseline examination
* Being on treatment with more than 4 antihypertensive drugs
* Participation in another study on high blood pressure or in a clinical trial
* Presence of tremor or neurological disease that makes it difficult to perform BP self-measurement.
* Presence of arrhythmia
* Presence of terminal illness
* Chronic disability impeding to leave home
* History of acute cardiovascular event in the last 3 months
* Hypertension managed directly by specialist physicians outside the primary care setting.
* Spouse selected for the study
* Non-resident or transient patients
* Pregnancy
ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study

Primary objective is to demonstrate that data collected from ShuntCheck-Micro-Pumper (SCMP) testing results can be used in conjunction with imaging to diagnose shunt patency or obstruction in pediatric/adolescent subjects presenting to an Emergency Department or Neurosurgery Clinic (ED/NC). SCMP results and SCMP results combined with other diagnostic methods, including the Attending Physician's and the Neurosurgeon's clinical judgment will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females, older than 35 months and less than 20 years of age.
2. Parent/guardian or alert subject (age 18 or over) capable of giving consent; subject less than 18 and of assent age must give assent to participate if appropriate and required by the institution. If the subjects are incapable of giving assent, then only parent/guardian consent is required.
3. Possess an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle.
4. Suspicion of shunt obstruction is great enough to warrant the performance of any diagnostic test for this condition
5. Will be available for follow-up for up to 7 days

Exclusion Criteria:

1. Inability or unwillingness of the parent/guardian or alert subject to give informed consent/assent (when appropriate) as required by the Institutional Review Board.
2. Presence of multiple shunts or known non-functioning shunts crossing the clavicle.
3. Evaluating staff rule out shunt obstruction on the basis of a physical/clinical examination.
4. SCMP test would interfere with emergent subject care or if the subject is scheduled to go the OR in short order.
5. Presence of an interfering open wound or edema over the shunt.
6. Likelihood, in the judgment of the investigator, of the subject being lost to follow-up as a result of subject unavailability or clinical outcome being unobtainable.
7. Any other condition that would preclude or bias the results of the study according to the judgment of the investigator.
8. Judgment of the investigator that participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject.
Clinical Study of the InQB8 TTVR System

Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.

The study is a multi-center, prospective, single-arm study to assess safety and performance of the inQB8 Medical Technologies MonarQ Tricuspid Valve Replacement System.

Eligibility Criteria:
Inclusion Criteria:

* Anatomically suitable for the MonarQ TTVR System
* Symptomatic, tricuspid regurgitation (TR) that is severe or greater
* Adequately treated for heart failure based upon medical standards
* Hemodynamically stable

Exclusion Criteria:

* Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365 days), or any planned percutaneous cardiac procedure within the next 90 days
* Refractory Heart Failure (HF) that requires or required advanced intervention
* Any condition, in the opinion of the investigator, making it unlikely the patient will be able to complete all protocol procedures and follow-up.
* Currently participating in another investigational biologic, drug or device study
A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Heart Failure

The aim of present study is to evaluate the efficacy and safety of Extended-Release Carvedilol Sulfate versus Sustained-release Metoprolol Succinate in Patients With Mild or Moderate Chronic Heart Failure.


Eligibility Criteria:
Inclusion Criteria:

* Males or Females
* Aged from 18 to 75 years
* New York Heart Association(NYHA) classification Ⅱ-Ⅲ
* At screening, subject has an LVEF\<0.45
* Have received optimal therapy with an Angiotensin converting enzyme inhibitors or angiotensin receptor blocker for 4 weeks before enrollment
* Subjects with symptoms of Stable heart failure do not need intravenous injection diuretics,cardiac inotropes or vasodilators
* Willing to provide written informed consent

Exclusion Criteria:

* Current treatment on any Class I or III antiarrhythmic, except amiodarone or beta-blockers
* Current treatment on calcium antagonists except for long-acting dihydropyridine agents
* Have a history of acute coronary syndrome,cerebral apoplexy or transient ischemic attack with 3 months
* Have a history of cardio-vascular surgery or other vessel operations with 3 months
* Have a history of sustained ventricular tachycardia or ventricular fibrillation with 3 months
* Have a plan to receive coronary revascularization or heart transplantation
* Uncontrolled ventricular arrhythmias (not controlled with antiarrhythmic therapy or an implantable defibrillator)
* Subjects with uncorrected primary obstructive or severe regurgitative valvular disease，nondilated (restrictive) or hypertrophic cardiomyopathy
* Sitting systolic blood pressure≤90mmHg (based on an average of 3 readings)
* Current decompensated heart failure
* Second or third degree heart block，or sick sinus syndrome，a pacemaker is not placed
* Contraindication to vasodilators
* Have a history of cardiac resynchronization therapy or
* Have received cardioverter defibrillator or pacemaker with 1 month
* Resting heart rate\<50 beats per minute(based on the average of 3 readings)
* Elevated liver enzymes (alanine aminotransferase or aspartate aminotransferase levels greater than 3 times upper limit of normal)
* Serum creatinine levels greater than 2 times upper limit of normal
* Current clinical evidence of obstructive pulmonary disease (e.g., asthma or bronchitis) requiring inhaled or oral bronchodilator or steroid therapy
* History of drug sensitivity or allergic reaction to alpha or beta-blockers
* Contraindication or intolerance to beta-blockers
* Pregnant or lactating women and women planning to become pregnant
* Has any systemic disease, including cancer, with reduced life expectancy (\<12 months)
* Use of an investigational drug within 30 days of enrollment
* Participation in an investigational device trial within 30 days of enrollment
* Known drug or alcohol abuse 1 year prior to enrollment
* Has a history of psychological illness/condition that interferes with ability to understand or complete requirements of the study
* In the opinion of the investigator the subject is known to be noncompliant with prescribed medication regimen
A Retrospective Study of the Feasibility of Ambulatory Appendicectomy for Acute Appendicitis (Based on Data From the PMSI French National Hospital Information System) in the Adults Hospitalized Between December 2013 and December 2014

Acute appendicitis is a frequent surgical emergency, with an estimated incidence of about 80,000 cases a year (in France). It mainly affects young adults but is associated with a low complication rate and a short stay in hospital. Ambulatory treatment is an innovative type of care in which the patient is hospitalized for less than 12 hours and does not stay overnight in hospital.

Ambulatory care is based on the guidelines issued by three French learned societies (the SFCD, the ACHBT and the AFCA) and has been defined by the French government as a national priority.

The literature data show that 20% of patients undergoing appendicectomy for acute appendicitis can be treated on an ambulatory basis. However, the success factors for short-stay care (hospitalization \<24 hours) or ambulatory care (hospitalization \<12 hours) have yet to be identified.

The investigators thus intend to perform a retrospective study of data from the PMSI French national hospital information system, in order to identify factors that are predictive of a length of hospital stay below 24 hours in patients having undergone appendicectomy for acute appendicitis during 2013 in France. The objective is to define the population of patients that could potentially benefit from ambulatory care.


Eligibility Criteria:
Inclusion Criteria:

Medical criteria:

* Patients operated on for acute appendicitis between December 2013 and December 2014

Sociodemographic criteria:

* Adult patients (aged between 18 and 75, inclusive)
* Social security coverage

Exclusion Criteria:

Sociodemographic criteria:

* Patients under the age of 18
* Pregnancy or breastfeeding
* Legal guardianship or incarceration
Primary Tumor Sidedness Associated With Clinical Characteristic and Postoperative Outcomes in Colon Cancer: a Propensity Score Matching Study

Background: Recent investigations have suggested that sidedness is associated with the prognosis of colon cancer patients. The role of sidedness in surgical outcome is unclear. The aim of this study was to investigate the different clinical characteristics and associated postoperative outcomes of sidedness in colon cancer.

Materials and methods: This is a retrospective study using the multi-institutional, nationally validated database of the American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP) from 2009 to 2013. Sidedness groups including right sided and left sided colon cancer were created according to the associated diagnosis and procedure codes. Postoperative mortality, morbidity, overall complication, and length of total hospital stay were analyzed after using a propensity score matching method.


Eligibility Criteria:
Inclusion Criteria:

* colon cancer S/P colectomy

Exclusion Criteria:

-
Post-Market Clinical Investigation of the Clareon® IOL

The primary purpose of this study is to evaluate the long-term (3 years) visual acuity and adverse event outcomes for the Clareon® Intraocular Lens (IOL). A comparison to historical safety and performance endpoint (SPE) rates as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014 will be conducted at one year. The secondary purpose of this study is to evaluate the visual acuity outcomes with the Clareon IOL at Years 2 and 3.

Subjects will attend a total of 12 study visits over a period of approximately 36 months: One preoperative screening visit, two operative visits, and nine post-implantation visits. Both eyes will be implanted, with the second eye implantation to occur 2-21 days after the first. Primary endpoint data will be collected at the Year 1 visit (Day 330-420 post-implantation from second eye surgery).

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosed with bilateral cataracts
* Planned small incision cataract removal surgery
* Able to comprehend and willing to sign a statement of informed consent and complete all required post-implantation visits

Key Exclusion Criteria:

* Subjects who may reasonably be expected to require ocular surgical treatment or refractive surgical procedures at any time during the study
* Certain eye conditions, as specified in the protocol, including but not limited to glaucoma, diabetic retinopathy, diabetic macular edema, and macular degeneration
* Pregnant or lactating, current or planned during the course of the study

Other protocol-defined inclusion/exclusion criteria may apply.
Efficacy of Nanoparticle-incorporated Bonding Agent on Post-restorative Sensitivity

Type of study: Randomized Clinical trial To compare post-restorative sensitivity between titania nanoparticle reinforced bonding agent and bonding agent without nanoparticles in posterior composite restorations.

Participants aged 18 years and above with Class-I and Class-II Carious lesions are allocated in two groups. Group A will undergo composite restoration with Nanoparticles incorporated in bonding agent. Group B will undergo restoration without nanoparticles in bonding agent.

In this study Novel titania nanoparticle reinforced bonding agent will be evaluated for post-restorative sensitivity in composite restorations. Participants following the Inclusion criteria will be allocated in this study by Consecutive non-random sampling technique. Participants will be divided into two groups A and B. After rubber dam isolation, carious lesion will be excavated. In group A, titania nanoparticle reinforced bonding agent will be used for restorative treatment while in group B, Bonding agent without nanoparticles will be used. Post-restorative sensitivity record will be taken at 24 hours, after one week and after one month. Sensitivity will be assessed using Visual analog scale (VAS) mean score.

Eligibility Criteria:
Inclusion Criteria:

* Participants with good general health
* Selected teeth should be vital and periodontally healthy
* Class-I and II with minimal cavity depth of 3mm, not exceeding 5mm
* Defective previous restorations in need of replacement (secondary caries/fractures)
* Selected teeth should be in occlusion with natural or prosthetic antagonist and adjacent teeth

Exclusion Criteria:

* Patients with Temporomandibular disorders
* Extremely poor oral hygiene status
* Teeth with very deep carious lesions
* Teeth with periapical or periodontal pathology
* Patients taking anti-inflammatory, analgesics or psychotropic drugs
* History of spontaneous pain
* Previously root canal treated teeth
Assessment of Safety and Performances of HYPE SCS Stem Associated to NOVAE Sunfit TH Acetabular Cup in Hip Arthroplasty

Total hip arthroplasty is the preferred treatment for hip disease (primary or secondary osteoarthritis, osteonecrosis, for example) and femoral neck fractures.

HYPE SCS stems are intended to be used for primary total hip arthroplasties to reduce pain and restore joint mobility of the hip.

Clinical data for HYPE SCS available are not deemed sufficient to support performance and benefits claimed on the whole lifetime of the product.

Thus, in order to maintain compliance with the EU regulation (2017/745) relating to medical devices and following MEDDEV 2.7.1.guidelines, SERF has set up post-market clinical follow-ups (PMCF). This PMCF study aims to generate clinical data in order to confirm these performance of HYPE SCS Stem associated to NOVAE Sunfit TH acetabular cup. In the meantime, through complications faced over the entire period of the study, risks related to the implantation of HYPE SCS stems will be assessed at medium term (5 years). It should be noted that this patient cohort reflects the usual medical care of Hospital Center "J. Monod" of Flers.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old.
* Patients covered by health insurance system
* Patients requiring a total hip arthroplasty, implanted swith a femoral stem SCS associated to NOVAE Sunfit TH acetabular cup

Exclusion Criteria:

* Patient who expressed opposition to participation in the study and to the use of his personal data
* Patient unable to understand surgeon's instructions and meet follow-ups requirements
* Patient presenting a contraindication indicated in the IFU of both implantsw
* Patient presenting a contraindication to have an X-ray
* Patients implanted with a femoral stem SCS associated to NOVAE Sunfit TH acetabular cup, in context of off-label use