cyrilzakka/clinical-trials huggingface dataset:
Resin Infiltrate As Pit and Fissure Sealant in Permanent Molars

The aim of this study is to evaluate and compare the clinical effectiveness of ICON resin Infiltration versus conventional sealant and the microleakage and penetration depth of the two sealant materials.

Using the resin infiltration technique as a different approach for sealing pits and fissures creates a diffusion barrier as resin infiltrate tends to inhibit enamel pores that serve as diffusion channels for acids and dissolved minerals within the lesion body. A low-viscosity resin that can penetrate into caries lesions, which is referred to as resin infiltration technique. The mechanisms associated with this method depend on the infiltration of subsurface lesions with low-viscosity light-curing resins after eroding the highly mineralized surface layer and increasing penetration depth. This method is believed to overcome the limitations of sealant applications and is considered to be a better alternative for the treatment of initial caries lesions.

Eligibility Criteria:
Inclusion Criteria:

1. Age of the children from 6 to 8 years.
2. Healthy children free from any systemic disease.
3. Show bilaterally sound fully erupted lower first permanent molars with deep narrow central fissures and supplemental grooves.
4. The eruption time of these molars should not exceed 3 years.
5. No sign of pain or active periodontal disease in the selected teeth.

Exclusion Criteria:

1. Children with fillings or sealants in the selected teeth.
2. Children with clinical evidence of caries in the selected teeth either white spot lesions or cavities.
3. Children with an allergy to any drug, such as resin restorative material.
4. Children with Extremely poor oral hygiene.
5. Hypoplastic teeth.
6. Children with bruxism.
The Predictive Value of TMPRSS2-ERG Fusion in High Risk Prostate Cancer Patient

The objective of this study is to evaluate the predictive value of TMPRSS2-ERG gene fusion in patients with prostate cancer treated with radiation and hormonal therapy.

The objective of this study is to evaluate the predictive value of TMPRSS2-ERG gene fusion in prostate patients who have been treated with hormonal and radiation treatment after biochemical failure

Original biopsy slides of 65 patients will be collected and reviewed. A tissue used to test and map DNA fragments will be constructed from patients who underwent radiation therapy. RNA and DNA will be extracted from each slide. This study, if positive, will establish the predictive value of TMPRSS2-ERG gene fusion in prostate cancer patients. It can lead to believe that high-risk prostate cancer patients will benefit from a more aggressive treatment.

An endpoint of this study is to evaluate the relation between the Gleason score and the TMPRSS2-ERG gene fusion. Another is to evaluate the relation between the T-stage and TMPRSS2-ERG gene fusion.

Eligibility Criteria:
Inclusion Criteria: One of the following

* T3a +
* PSA \> 20
* Gleason 8 or higher
* Karnofsky performance status ≥ 70.
* Signed study-specific informed consent
Post-COntrast 3D SE T1 Versus Coronal SE T1-WI MRI in Detecting Optic Neuritis (COCON)

3D FLAIR, 3D T1 FAT SAT, coronal T2 and coronal T1 dixon sequences were usually used to assess visual deficits in MRI. Optic nerve examination is preferably performed using a coronal T2 sequence in order to detect a hypersignal suggestive of inflammation whereas brain examination is preferably performed using a 3D T1 sequence to highlight signs of spatial dissemination and lesions suggestive of multiple slerosis (MS). No study has yet investigated the detection capabilities of 3D T1 for the detection of optic nerve inflammation. The objective of this retrospective study was to determine whether a single 3D T1 sequence allows simultaneous exploration of the optic nerve and the brain for the positive diagnosis of optic neuropathy and/or MS.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Decrease in visual acuity explored in MRI between january 2018 and january 2020

Exclusion Criteria:

* Past history of episode of Optic neuritis
Efficacy Study of Strattera for Treating Attention Disorders in Traumatic Brain Injury (TBI)

Atomoxetine is the only medication that is currently approved by the FDA for the treatment of attention deficit hyperactivity disorder in adults. It has gained recent interest as an alternative medication for treating attentional problems related to traumatic brain injury (TBI), but it's effectiveness in this population has not been studied. There are a number of advantages of Atomoxetine over traditional neuro-stimulant medications currently used for attentional disorders after traumatic brain injury. This study will use a randomized double-blind placebo-controlled crossover design to investigate the efficacy of atomoxetine to improve attention, behavioral function, and depression in adults with TBI


Eligibility Criteria:
Inclusion Criteria:

* History of TBI
* Moderate to severe TBI as indicated by Glasgow Coma Score (GCS) score of 12 or less; or Post Traumatic Amnesia (PTA) of seven days or more
* at least one year post injury
* between the ages of 18-65 (inclusive)
* symptoms consistent with attentional dysfunction
* consent to participate in study

Exclusion Criteria:

* history of any conditions that would prohibit standard neuropsychological testing
* non-English speaking (to the extent that would limit ability to complete study measures)
* prior history of significant psychiatric illness requiring hospitalization
* epilepsy
* cardiovascular disease or risks including: dysrhythmias, angina, myocardial infarction, uncontrolled hypertension, valvular heart disease including mitral valve prolapse
* use of any monoamine oxidase inhibitor or any other drug affecting brain monoamine concentrations
* severe renal or hepatic impairment
* pregnant or lactating
Patients Suffering From Emotional Dysregulation

Emotional dysregulation (ED) is a common syndrome in psychiatric disorders. It is characterized by intense emotions, easily triggered, and with significant psychological impact: explosions of anger, irritability, impulsivity, emotional lability, etc. It is systematic in borderline personality disorder, and observed in a majority of patients with bipolar disorder. (even in the interictal period), adult ADHD, or addictions. ED is a cause of psychological distress, suicidal behavior or non-suicidal self-injury, and impaired quality of life. Pharmacological treatments only very partially improve these symptoms. Psychotherapies aimed at reducing ED are poorly developed in France. Dialectical behavioral therapy is a therapy that has shown its effectiveness in ED of BPD.

This is why the psychiatry and addiction center of the University Hospitals of Strasbourg has set up groups using this psychotherapeutic approach based on this technique for almost 3 years. This technique being very little practiced in France, and even less studied, we want to see if it is adapted to a French population not accustomed to this type of practice.


Eligibility Criteria:
Inclusion Criteria:

* Major subject (≥18 years old)
* Having participated in the first session of a GREMO group, which is a behavioral and dialectical therapy protocol from January 1, 2018 to December 31, 2023,
* Subject not opposing the reuse of their data for scientific research purposes.

Exclusion Criteria:

* Subject having expressed their opposition to the reuse of their personal data for scientific research purposes.
Molecular and Hormonal Responses to Diet-Induced Insulin Resistance

This study determined the effect of 7 days of high-fat overfeeding on whole-body glycaemic control, glucose kinetics, skeletal muscle insulin signalling, and markers of skeletal muscle microvascular function in 15 healthy young individuals.

Fifteen healthy, young individuals underwent metabolic testing before and after 7 days of high-fat overfeeding. We determined whole-body glycaemic control, glucose kinetics, skeletal muscle insulin signalling, and markers of skeletal muscle microvascular function. Stable isotope tracers were used to assess the rate of appearance of glucose from the gut, liver glucose output and whole-body glucose disposal. Insulin signalling was determined by Western blotting of skeletal muscle tissue. Microvascular function was assessed through the use of quantitative immunofluorescence microscopy. These measurements were performed both postabsorptively and following the ingestion of 50 grams of glucose + 15 grams of protein.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 40 years
* Physically active
* Non-smoker
* Not taking any medication known to interfere with the study
* No history of cardiovascular disease or diabetes
* Weight stable for the last 6 months

Exclusion Criteria:

* Outside of age range
* Sedentary
* Smoker
* Taking medication known to interfere with the study
* History of cardiovascular disease or diabetes
* Unstable weight within last 6 months
Changes of Intra Abdominal Pressure During Surgeries in Prone Position as a Marker of Renal Damage

Background: Patients undergoing surgical operations in prone position do not have a measure of intra abdominal pressure as a standard procedure. Many of them could have elevated values of this parameter and could be exposed to possible renal damage due to a stiffening of the abdominal muscles while being positioned prone.

Purpose of study: Intraoperative intrabdominal pressure measurement and evaluation of correlation with possible postsurgical complications.

Methodology: Electronic device able to measure intra abdominal pressure is connected between a Foley catheter and a urinary collecting bag. During the procedure, values of the intra abdominal pressure are displayed on a monitor next to anaesthetic machine in real time. The numbers representing the pressure in mmHG are assessed and recorded.

Discussion: Possible correlation between intra abdominal hypertension and postsurgical complications in patients operated in prone position could be a foundation to further clinical trials and presurgical assessment of intraabdominal pressure.


Eligibility Criteria:
Inclusion Criteria:

* Consent to participate in the study
* Patients qualified for surgical stabilization of the spine in prone position

Exclusion Criteria:

* No consent to participate in the study or inability to obtain consent
* The inability to insert a urinary catheter
* No indication for urinary catheter
* Patients undergoing palliative treatment
* Patients with advanced liver and kidney disease
Herbal Therapy in Treating Women With Metastatic Breast Cancer

RATIONALE: The Chinese herb Scutellaria barbata contains ingredients that may slow the growth of cancer cells and may be an effective treatment for metastatic breast cancer.

PURPOSE: Phase I/II trial to study the effectiveness of Scutellaria barbata in treating women who have metastatic breast cancer.

OBJECTIVES:

* Determine the efficacy of Scutellaria barbata (Chinese herbal extract) in terms of tumor response in women with metastatic breast cancer.
* Determine the safety and toxicity of this therapy in these patients.
* Determine the feasibility of this therapy in these patients.
* Determine the time to progression, overall survival, and resource utilization of patients treated with this therapy.
* Determine the quality of life of patients treated with this therapy.
* Determine the bioavailability and pharmacokinetics of this therapy in these patients.

OUTLINE: Patients receive oral Scutellaria barbata (Chinese herbal extract) twice daily for 12 months in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed breast cancer (may include original primary cancer diagnosis)
* Measurable disease
* Metastatic involvement with minimal or no symptoms

  * Solitary metastases require histological confirmation
* No extensive liver involvement (more than 50% of liver parenchyma)
* No lymphangitic pulmonary involvement
* CNS involvement or spinal cord compression allowed if stabilized by therapy for more than 3 months
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Sex:

* Female

Menopausal status:

* Not specified

Performance status:

* ECOG 0-1

Life expectancy:

* More than 6 months

Hematopoietic:

* WBC at least 2,500/mm\^3
* Platelet count at least 75,000/mm\^3

Hepatic:

* See Disease Characteristics
* Bilirubin no greater than 1.7 mg/dL

Renal:

* Creatinine no greater than 2.0 mg/dL

Other:

* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No history of multiple or severe food or medicine allergies

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 1 week since prior biologic therapy
* No concurrent anticancer biologic therapy

Chemotherapy:

* At least 1 week since prior chemotherapy
* No concurrent anticancer chemotherapy

Endocrine therapy:

* At least 1 week since prior hormonal therapy
* No concurrent anticancer hormonal therapy

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* Recovered from prior anticancer therapy
* At least 1 week since prior investigational agents
* At least 1 week since prior herbal medications
* No other concurrent anticancer therapy
* No other concurrent investigational agents
* Concurrent pamidronate allowed
* Concurrent acupuncture or other nonherbal therapy allowed
* Concurrent nutritional vitamin supplementation (up to 5 times recommended daily allowance) allowed
Electrical Stimulation in Patients With Unipolar Major Depression

Double Blinded Randomized Trial of eTNS as adjuvant treatment for Major Unipolar Depressive Disorder. The primary objective is to assess the safety and tolerability of eTNS (external trigeminal nerve stimulation) of the V1 branch of the trigeminal nerve as an adjunctive treatment for adult patients with the diagnosis of unipolar MDD (Major Depressive Disorder).


Eligibility Criteria:
Inclusion Criteria:

* Outpatients with non-psychotic, unipolar Major Depressive Disorder assessed via the MINI structured interview and legally capacitated to sign the informed consent for participation in the study;
* A score of ≥ 14 on the HAM-D17 with Item 1 (depressed mood) ≥ 2;
* A history of treatment failure with at least 3 adequate trials antidepressants over the previous 6 weeks and less than 6 medications, with no change in antidepressant medication or dose within the previous 6 weeks, and ongoing use of at least one antidepressant (which will continue during participation in the study);
* Patients with suicidal ideation are eligible only if the thoughts of death or of life not being worth living are not accompanied by a plan or intention for self-harm and lack of self-harming attempt in the past 6 months;
* Patients with appropriate support to be compliant with the study protocol.

Exclusion Criteria:

* Patient is mentally or legally incapacitated, unable to give informed consent;
* Patients with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime); bipolar disorder (lifetime); dementia (lifetime); delirium or any substance abuse disorder within the past 6 months; eating disorder within the past year; obsessive-compulsive disorder (lifetime); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. Patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudo-dementia of depression) will be excluded;
* Patients currently receiving more than six medications for treatment of MDD;
* Patients with exposure to ECT or rTMS or any investigational treatment (for any disorder) within the past 6 months;
* Prior VNS and/or DBS therapy (lifetime);
* Past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke, CVA, or TIAs; cerebral aneurysm; Parkinson's or Huntington's disease; or Multiple Sclerosis.
* Current pregnancy, breast feeding, plans to become pregnant during the study, or not using a medically accepted means of contraception;
* Other medical conditions that would increase the risk of infection or surgical related morbidity and/or would affect compliance with the study protocol.
Comparison of Daily Home Hemodialysis (HD) With Conventional in Center HD in Terms of Patients Quality of Life and Clinical Outcomes

The objective of this study is to describe the characteristics of patients on daily home hemodialysis and to confirm in real practice in France the effectiveness shown in studies, mainly American, both in terms of clinical outcomes and quality of life. Due to the few studies available in this population, the focus will be particularly on physical activity.

Primary objective :

The main objective of this study is to evaluate the physical activity in the daily life of patients in daily hemodialysis in comparison with patients treated 3 times a week (conventional hemodialysis) others objectives are also:

1. To describe the characteristics of daily hemodialysis patients;
2. To describe the prescription procedures of the home daily HD;
3. To compare the evolution of the blood pressure between the 2 modalities of hemodialysis;
4. To compare the frequency of hospitalizations, duration and hospitalization reasons between the 2 hemodialysis modalities;
5. To compare the quality of life of the patients between the 2 modalities ;
6. To evaluate the quality of the sleep of the patients between the 2 modalities ;
7. Compare the percentage of patients with restless leg syndrome (RLS) and the severity of RLS between the two modalities;
8. Compare the evolution of drug intake between the two modalities;
9. Evaluate the number of abandoning subjects and causes of discontinuation of HQD;

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18 years or over
2. Patient who dated and signed the consent form
3. Patient (s) affiliated to a Social Security scheme
4. Interventional arm: patient who begins or will begin daily hemodialysis training (5, 6 or 7 times per week) at home.
5. Comparator arm: prevalent or incident patient treated by conventional hemodialysis (3 times per week) and fitting with the matching criteria of an interventional patient included in the center

Exclusion Criteria:

1. Patient with needs any help to walk (wheelchair, crutch, walker, cane ...)
2. Patient with active neoplasia;
3. Patient with predicted life expectancy of less than one year;
4. Patient with significant reading or writing difficulties;
5. Patient participating in a clinical trial or other interventional study; 6. Patient with history of mental instability, major cognitive impairment in the previous 5 years, or major psychiatric condition not adequately controlled or stable under pharmacological treatment
The Effects of a Ficus Carica in Subjects With Functional Constipation

The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Fig paste on functional constipation. The investigators measured colon transit time, frequency of defecation, defecation time, stool type, and abdominal discomfort.


Eligibility Criteria:
Inclusion Criteria:

* age between 19 and 39 years,
* diagnosis of functional constipation by ROME III criteria,
* Colon transit time (CTT) ≥ 36 h,
* subjects giving written informed consent

Exclusion Criteria:

* allergic or hypersensitive response to any of the ingredients in the test products,
* having previous history or current disease of digestive system, cardiovascular system, endocrine system and neurological disorder,
* diagnosis of irritable bowel syndrome by ROME III criteria, etc,.
A Study of MK-2214 in Adults With Mild Cognitive Impairment or Mild-to-Moderate Alzheimer's Disease (MK-2214-002)

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of MK-2214 in adults with mild cognitive impairment (MCI) or mild-to-moderate Alzheimer's Disease (AD). The primary hypothesis (Part 1) is that at a generally well tolerated dose level, the true geometric mean concentration at Day 85 of MK-2214 in cerebrospinal fluid is \>0.3 nanomolar (nM).


Eligibility Criteria:
Inclusion Criteria:

* Participant is in overall good health based on medical history and laboratory safety tests
* BMI between 18.5 and 35 kg/m\^2

Part 1 (MCI and Mild to Moderate AD) Only:

* History of cognitive and functional decline with gradual onset and slow progression for at least one year before Screening
* Have an Mini-Mental State Examination (MMSE) \>12 at the prestudy visit
* Modified Hachinski Ischemic Score (MHIS) score \<4 at the prestudy visit

Exclusion Criteria:

* Based on clinical interview and Columbia-Suicide Severity Rating Scale (C-SSRS), has reported suicidal ideation with intent, with or without a plan or method
* History of unstable or poorly controlled endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, renal, respiratory, or genitourinary abnormalities or diseases
* History of clinically significant active neurological disease (except for AD or MCI for participants in Part 1)
* History of clinically significant active autoimmune disease requiring ongoing systemic immunosuppressant therapy
* History of cancer (malignancy)
* History of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food
* Positive test(s) for Hepatitis B Surface Antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)
* Has had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy visit
* Has a contraindication to lumbar dural puncture, such as coagulopathy, concomitant anticoagulation beyond low dose aspirin, thrombocytopenia, or other factors that could preclude safe lumbar puncture
* Currently receiving or has received aducanumab or another anti-amyloid therapy within the last 6 months
* Has a history of receiving biological therapy within 3 months or 5 half-lives (whichever is longer) or any human immunoglobulin preparation within the last year
* Has received any non-live vaccine starting from 14 days prior to first study intervention or is scheduled to receive any non-live vaccine through 14 days following the final dose of study intervention. Exception: COVID-19 and influenza vaccines may be administered
* Is receiving systemic immunosuppression, including corticosteroids exceeding physiologic replacement doses