cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib

The purpose of this study is to evaluate the efficacy and safety of fixed-Dose combination of Pitavastatin/Ezetimibe under the real-world condition


Eligibility Criteria:
Inclusion Criteria:

* Those who taking statins or statins and ezetimibe in addition to dietary and exercise therapy for primary hypercholesterolemia or mixed hyperlipidemia
* Those who are judged to need administration of a fixed-dose combination of pitavastatin/ezetimibe for change of statin's formulation or change of statin's dose, addition of ezetimibe

Exclusion Criteria:

* Those who are taking a fixed-dose combination of pitavastatin/ezetimibe at study enrollment
* Those with hypersensitivity reactions or relevant medical history to pitavastatin or ezetimibe
* Those who have been administered an investigational product within 12 weeks of the enrollment date or are planning to participate in another clinical trial during this study participation period.
Socket Preservation Using Dentin Graft Autogenous Dentin Graft With Collagen Sponge on Dental Implant Stability AUTOGENOUS TOOTH GRAFT WITH COLLAGEN SPONGE ON DENTAL IMPLANT STABILITY

The present study was performed to evaluate socket preservation using collagen sponge with autogenous dentin graft versus collagen sponge with de-mineralised freez-dried bone graft on dental implant stability

in our study we made socket preservation using two different grafts in two groups.

before grafting we took CBCT

we used autogenous dentin graft covered by collagen sponge in one group and demineralized freeze - dried allograft covered with collagen sponge in the other group.

after 6 months we Took another CBCT to assist the dimensional changes and bone density in the alveolar socket after grafting We inserted the implant and during insertion we took a core biopsy with trephine bur with external diameter 3 mm for histological analysis.

After implant insertion we assisted the stability using RFA.

Eligibility Criteria:
Inclusion Criteria:

* Patients are free from any systemic diseases.
* Patients with good oral hygiene.
* Age range from 25-50 years.
* Adequate inter arch space .

Exclusion Criteria:

* Medications that may affect bone turnover, and bone metabolic diseases.
* Smoker patients and alcoholics.
* Patients with parafunctional habits.
* Patients with active acute infection related to tooth of interest.
* Patients with a lack of compliance, and serious mental or psychological problems.
* Pregnant females.
Evaluation of Antioxidant and Skin Beauty Effects of Cherry Collagen Drink

To assess cherry collagen drink on skin condition improvement


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged above 20 years old

Exclusion Criteria:

* Subject who is not willing to participate in this study.
* Patients with diseases of the skin, liver, kidney.
* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
* Female who is pregnant or nursing or planning to become pregnant during the course of the study.
* Received facial laser therapy, chemical peeling or UV overexposure (\> 3 hr/week) in the past 4 weeks.
* Constant drug use
* Students who are currently taking courses taught by the principal investigator of this trial.
* Body weight \< 50 kg.
Value of Patch Testing in Direct Diet Therapy for Eosinophilic Esophagitis

This study is being done to see if allergy patch testing (APT) can help predict effective dietary therapy in patients with eosinophilic esophagitis.

Patients are referred to Mayo Clinic Rochester with an establish diagnosis of EoE and are nonresponsive to proton pump inhibitor (PPI) medical therapy. Eligible patients will then meet with one of three investigators complete the Mayo Dysphagia Questionaire-30 Day (MDQ-30) following which a standardized Allergy Patch testing (APT) will be conducted. Thereafter, a standard clinically indicated Six Food Elimination Diet treatment completed. Patients will follow up with one of three investigators following the elimination diet who will be blinded to the results of the APT. During this visit responders and nonresponders will be identified and nonresponders will complete a directed elimination diet based on APT results.

Eligibility Criteria:
Inclusion criteria:

* Adults ages 18-90
* Patients with EoE, defined as dysphagia with histologic finding of greater than or equal to 15 eosinophils per high powered field (eos per HPF) on index esophageal biopsy
* Persistent symptoms and/or greater than or equal to 10 eos per HPF on esophageal biopsy after at least 8 weeks of twice daily PPI therapy

Exclusion criteria:

* Patients with conditions known to be associated with esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome
* Topical swallowed steroids within 8 weeks of study enrollment
* Dermatologic conditions precluding application of Finn chambers to the skin for APT
* Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
A Clinical Decision Support System and Patient Portal for Preventing Medication-related Falls in Older Patients

Falls in older adults represents a growing public health challenge. The use of certain medication is recognized as an important modifiable risk factor for falls. Research indicates fall-risk increasing drug (FRID) deprescribing is effective in reducing falls but difficult to initiate and to sustain over longer periods of follow-up. A clinical decision support system (CDSS) and patient portal for communicating medication-related fall risk to fall clinic patients may improve joint medication management between patients and physicians and consequently reduce the incidence of injurious falls.

This study investigates the effectiveness and cost-effectiveness of the concurrent use of a CDSS and a patient portal for personalized FRID deprescribing, and will be assessed through a multicenter cluster-randomized controlled trial among new fall clinic patients, aged 65 years or older. The main study parameter is the time to first injurious fall. The primary objective of the ADFICE_IT study is to investigate the effects of a CDSS and accompanying patient portal for optimizing FRID deprescribing on injurious falls. This study has three secondary objectives. First, the effect of the CDSS and patient portal on a number of secondary outcomes will be investigated. Second, a process evaluation to evaluate the implementation of the CDSS and patient portal will be conducted. Third, the cost-effectiveness of the CDSS and patient portal will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* History of at least one fall in the past year;
* A Mini-Mental State Examination (MMSE) score of 21 points or higher or equivalently a Montreal Cognitive Assessment (MOCA) Dutch score of 16 points or higher;
* Use of at least one fall-risk increasing drug (FRID); and
* Sufficient command of the Dutch language in speech and writing.

Exclusion Criteria:

* Active participation in another study;
* Life expectancy of less than one year: and/or
* Suffering from severe mobility impairment (i.e. bedridden, e.g. inability to walk short distances with assistance of a walking aid).
Development of a Molecular Diagnostic Tool for Endometrial Cancer.

WomEC is an in vitro diagnostic test for Endometrial Cancer (EC) based on the detection of the expression level of a combination of 5 proteins in the soluble fraction of a pipelle biopsy specimen. The aim of the study consists in validating WomEC's ELISA test, creating and freezing an algorithm to rule out EC in post-menopausal women with abnormal uterine bleeding (AUB).


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women (≥1 year without menstruation) with AUB who present with:

  1. Endometrium \> 3mm by transvaginal ultrasound, OR
  2. Endometrium ≤ 3mm who meet at least one of the following criteria:

  i. Persistent symptoms (more than one episode of metrorrhagia) ii. Heterogenous endometrium on transvaginal ultrasonography iii. Risk factors (BMI ≥ 30, use of tamoxifen, hormone replacement therapy (HRT), Lynch syndrome, BRCA mutation.
* Obtaining written informed consent

Exclusion Criteria:

* Women with an active pelvic infection.
* Women who have had viral infections with evidence of active and latent disease such as Hepatitis B, Hepatitis C, and HIV infection. Patients who have had Hepatitis C in the past but who have been successfully treated and in whom viral replication has not been observed in the last year will be included.
SIB-Norwegian Version, Validation and Reliability Study

The purpose of this study is to validate and to test interrater reliability for the Norwgian version of Severe Impairment Battery (SIB).

The study will include 60 persons with mild to severe dementia. To test the validation of SIB, we will interview the included persons with Severe Impairment Battery (SIB) and compare the results with Clinical Dementia Rating (CDV)reported by their nurses. To test interrater reliability 30 of the included persons will be interviewed with SIB by two different raters, and the two raters results will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Dementia, mild to severe.
* Nursing Home resident

Exclusion Criteria:

* No ability to write or read.
* Physical handicapped, unable to use hands.
VMAT for Dominant Intraprostatic Lesion

The aim of this study was to determine the efficacy and safety of the implementation of a program of " image-guided focal Intensification dose to intraprostatic dominant lesion " in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy in the Department of Radiation Oncology of HUP (Hospital Universitario de La Princesa), within the established dose escalation protocol with intensity modulated image-guided radiotherapy (IMRT / IGRT).

The aim of this study was to determine the efficacy and safety of the implementation of a program of " image-guided focal Intensification dose to intraprostatic dominant lesion " in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy in the Department of Radiation Oncology of HUP (Hospital Universitario de La Princesa), within the established dose escalation protocol with intensity modulated image-guided radiotherapy (IMRT / IGRT).

Eligibility Criteria:
Inclusion Criteria:

* Male \> 18 years old with histologic diagnostic of prostate adenocarcinoma
* Clinical stage cT2a-T3b N0-1 M0 (AJCC 7 th edition)
* PSA (prostate-specific antigen) \< 100 ng/ml
* Gleason score 6-10
* Life expectancy \> 5 years
* Patients who accept the radiotherapy treatment
* Patients provided written informed consent before participating in the trial

Exclusion Criteria:

* Transurethral resection of the prostate or prior prostate surgery
* Previous pelvic radiotherapy
* Urethral stenosis with or without prior dilations
* IPSS\>15
* Rectal diverticuli or rectal vascular malformations
* Metastatic disease
* Severe psychiatric or medical conditions that could hamper both treatment and follow-up
Prospective Validation of the Prognostic Value of Long Non-coding MFI2-AS1 RNA in Localized Clear Cell Kidney Cancers

An exploratory analysis of the expression of MFI2-AS1 will be performed at the plasma level with the objective of comparing this expression with tumor tissue. The objective would be to be able to use long non-coding RNA as a biomarker for diagnosis before tissue analysis and for patient follow-up. In addition, correlations will be made between tumor expression of MFI2-AS1 and genetic and immune alterations in tumors in order to better clarify the link between the expression of this long non-coding RNA and the characteristics of the tumor and of the tumor. tumor microenvironment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Localized kidney tumors\> T1a
* Patient having signed an informed consent
* Patient affiliated to a health insurance plan
* Subject having signed a consent form to participate in research and the constitution of a collection and genetic analyzes

Exclusion Criteria:

* Metastatic carcinoma from the outset
* Contraindication to performing a TAP CT with injection of contrast product
* Inability to provide informed information about the subject (subject in an emergency situation, difficulties in understanding, etc.)
* Subject under legal protection
* Subject under tutorship or curatorship
* Pregnancy
* Feeding with milk
Individualized Positive End-expiratory Pressure Evaluation Using the Intratidal Compliance-volume Profile in Children

The investigators assess the changes in respiratory compliance according to different levels of positive end expiratory pressure (PEEP) in children under general anesthesia. In addition, the investigators evaluate the intratidal compliance-volume profile at each PEEP level and determine the optimal PEEP level during anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Children undergoing surgery more than 1 hour under general anesthesia
* American Society Anesthesiologist physical status I, II

Exclusion Criteria:

* History of lung resection
* History of bronchopulmonary dysplasia or respiratory distress syndrome
* Abnormalities in chest radiography
* Laparoscopic surgery
* Abdominal surgery
Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer

This randomized phase 2 open-label study will evaluate the safety and efficacy of zimberelimab (AB122) monotherapy, domvanalimab (AB154) in combination with zimberelimab, and domvanalimab in combination with zimberelimab and etrumadenant (AB928) in front-line, PD-L1 positive, metastatic non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants; age ≥ 18 years
* Histologically confirmed, treatment naïve, metastatic squamous or non-squamous NSCLC with documented high PD-L1 expression, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Must have at least 1 measurable lesion per RECIST v1.1
* Adequate organ and marrow function

Exclusion Criteria:

* Use of any live vaccines against infectious diseases within 28 days of first dose of investigational medicinal products (IMPs)
* Any gastrointestinal condition that would preclude the use of oral medications (eg, difficulty swallowing, nausea, vomiting, or malabsorption)
* History of trauma or major surgery within 28 days prior to the first dose of IMP
* Concurrent medical condition requiring the use of supra-physiologic doses of corticosteroids (\> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications
* Positive test results for Hepatitis B surface antigen, Hepatitis C virus antibody with presence of Hepatitis C qualitative RNA or human immunodeficiency virus (HIV-1 and/or HIV-2) antibody at screening
* Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy.
* Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer
Oxidative Stress and Cardiovascular Morbidity in Sleep Apnea-Hypopnea Syndrome (SAHS)

The purpose of this study is to compare the levels of 8-isoprostane and other oxidative stress biomarkers in plasma and condensed exhaled air between patients with SAHS and cardiovascular complications, patients with SAHS without cardiovascular complications and control subjects. To evaluate the effect of three months of treatment with CPAP on the oxidative stress biomarkers.

Aim: To compare the levels of 8-isoprostane and other oxidative stress biomarkers in plasma and condensed exhaled air between patients with SAHS and cardiovascular complications, patients with SAHS without cardiovascular complications and control subjects. To evaluate the effect of three months of treatment with CPAP on the oxidative stress biomarkers.

Design: randomized, double blind, of parallel groups and controlled with placebo study.

Study subjects: 53 patients with SAHS (23 with cardiovascular complications and 30 without cardiovascular complications), 23 patients with cardiovascular diseases without SAHS and 23 control subjects.

Interventions: Three months of treatment with therapeutic CPAP or with sham CPAP (placebo).

Determinations: clinical (cardiovascular morbidity) and anthropometric data. Fat free corporal mass, echocardiography, spirometry, ambulatory monitoring of the arterial pressure, endothelial reactivity. Oxidative stress biomarkers (8-isoprostane, homocysteine, HIF-1, NFkB, AP-1, VEGF, ET-1, TNF-alpha, IL-1, IL-6, ICAM-1, VCAM-1, nitrates and nitrites) in plasma and condensed exhaled air.Peripheral sensitivity to hypoxia. Urinary excretion of catecholamines.

Eligibility Criteria:
Inclusion Criteria:

* Sleep apnea-hypopnea syndrome (AHI \> 5)
* Excessive sleepiness (ESS \> 11)
* No previous CPAP treatment

Exclusion Criteria:

* Blood pressure \> 180/120 mmHg.
* Secondary hypertension
* Professional driver
* COPD, asthma, bronchiectasis, lung cancer, restrictive lung disorder, chest wall disease
* Neuromuscular disease or thyroid function abnormalities
* Morbid obesity (BMI \> 40 Kg/m2).
* Respiratory infection in the 2 last months.
* Anemia (Hb \< 10 g/dl) or polyglobulia (Hct \> 55%).
* Diurnal hypercapnia (PaCO2 \> 45 mmHg) or moderate hypoxemia (PaO2 \< 70 mmHg).
Pre-operative Sonographic Assessment of The Median Nerve in Carpal Tunnel Syndrome. Does it Affect The Operative Procedure?

Sonographic Assessment of The Median Nerve in Carpal Tunnel Syndrome to assess the surgical importance and added value of superficial ultrasonography in assessment of the median nerve in CTS.

Abstract Objective: To assess the surgical importance and added value of superficial ultrasonography in assessment of the median nerve in CTS.

Methods: The study was conducted on thirty patients with CTS with electrophysiological confirmation; twelve males and eighteen females with mean age 43.93±4.51 (range 35-52y), and another thirty normal subjects; fifteen males and fifteen females, with their mean age 36.7±4.86 (range 29-45y). The cross sectional area (CSA) and flattening ratio (FR) at different levels were measured on both groups. Data from the study and control groups were compared. The accuracy of the ultrasonographic diagnostic criteria for CTS was evaluated using receiver operating characteristic (ROC) analysis. All the patients had surgical carpal tunnel release and the operative details were correlated with the ultrasonographic data.

Eligibility Criteria:
Inclusion Criteria:

* Carpal tunnel syndrome

Exclusion Criteria:

* bifid median nerve, carpal tunnel mass lesions, persistent median artery
Ruxolitinib as add-on Therapy in Steroid-refractory Graft-vs-host Disease

Steroid-refractory graft-vs-host disease (SR-GVHD) is a major cause of mortality after allogeneic hematopoietic stem cell transplantation (HSCT). We sought to evaluate the effect and safety of ruxolitinib (RUX) add-on in the treatment of patients with SR-GVHD.

Nowadays, second-line treatment for SR-GVHD differs between centers and depends on the physician's experience. The agents commonly used as second and further lines of therapy include anti-thymocyte globulin, mycophenolate mofetil, calcineurin inhibitor, or extracorporeal photopheresis. However, the response varied. This study highlighted that corticosteroid (CS) is not a panacea for treating GVHD, and some patients with remission still experience further relapse. Additionally, the identification of multiple infections adds complexity.

Hope was supposed to come in 2019 after the Food and Drug Administration (FDA) approved RUX for the therapy of SR-GVHD in adult and pediatric patients \> 12 years. RUX add-on should be withheld as the risks outweigh the benefits, especially for patients who developed scleroderma and bronchiolitis obliterans. RUX can be added on as needed for the treatment of GVHD, especially in patients receiving DLI as relapse therapy with the conversion from mixed chimerism to complete chimerism. Despite some studies showing the efficacy of RUX across affected organs, some other data bring the opposite results. Thus we conducted this study to reinforce the efficacy of RUX as an add-on therapy for SR-GVHD.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with hematologic disorder

Exclusion Criteria:

* Those who are not applicable of receiving Ruxolitinib as immunodeficiency-modulation therapy
* Those who are actively encountering acute infectious illness
The Management of Postoperative Craniotomy Pain in Pediatric Patients

The purpose of this prospective, clinical observational trial is to assess the incidence of pain (and analgesia), methods of pain assessment (and by whom), prescribed analgesics, methods of analgesic delivery, and patient/parent satisfaction in patients undergoing craniotomy surgery at three major children's hospitals (Boston Children's Hospital, Children's Hospital of Philadelphia, The Children's Center Johns Hopkins Hospital) in the United States.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients 0-18 years, who are scheduled to undergo craniotomy surgery for any reason (e.g., brain tumor, epilepsy surgery, craniofacial reconstruction) at either the Boston Children's Hospital, the Children's Hospital of Philadelphia, or the Children's Center of the Johns Hopkins Hospital will be eligible for enrollment.

Exclusion Criteria:

* Patients who remain intubated after surgery. Additionally, we will exclude patients who are allergic to opioids or who have a history of substance abuse