cyrilzakka/clinical-trials huggingface dataset:
Biomechanical Properties of Keratoconic Eyes

In keratoconus (KC) corneal thinning and protrusion can cause myopia and irregular astigmatism, affecting vision. The biomechanical properties of the cornea is maintained by an intricate collagen network, which is responsible for its shape and function. In KC this collagen network is disrupted resulting in the cornea losing its shape and function. Keratoconic changes are focal and localised to certain regions of the cornea and the early detection of these changes is challenging. Screening methods include corneal topography (evaluation of anterior corneal surface curvature), tomography (assessing the morphological features of the anterior segment) and aberrometry (measuring the optical aberrations of the eye). More recent research suggests that the biomechanical destabilization of the cornea may precede topographic and tomographic evidence of KC. Management of KC depends on disease severity with severe cases being treated with keratoplasty and less severe cases with cornealcollagencrosslinking (CXL). CXL is an emerging technique, which aims to increase the biomechanical strength of the keratoconic cornea. Despite strong evidence of changes in the biomechanical properties in human corneas following CXL, there is a significant need for accurate measures of biomechanical changes in vivo pre and post CXL. Until recently technical limitations have restricted the ability to assess the biomechanical properties of the whole cornea in vivo. With the introduction of the CorvisST (Oculus) it is now possible to assess regional biomechanical behaviour of the cornea. The output from the device provides a variety of parameters to indicate the cornea's biomechanical strength. To date, the association between the deflection behaviours in various regions of the cornea in keratoconic eyes preand post CXL has not been studied. In order to effectively assess the clinical benefits of CXL such information is vital. The primary goal of this investigation is to investigate regional biomechanical properties of the keratoconic eye before and after CXL.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects over the age of 18 with keratoconus who are enrolled for collagen crosslinking treatment

Exclusion Criteria:

* Any patient who has had surgical complications will also be excluded from participation in the study.

Determination during enrolment:

* Pregnancy or breastfeeding during the study
* Any kind of systemic disease which affect collagen and the body water regulation system (Marfan syndrome, osteogenesis imperfect, pseudozanthoma elasticum, EhlersDanlos, diabetes, rosacea, acne, cardiovascular disease, thyroid disease)
Success of Zirconia and Stainless Steel Crowns for Permanent Molars

The purpose of this study is to evaluate and compare the clinical and radiographic performance of zirconia and stainless steel crowns on permanent molar

Zirconia and stainless steel crowns will be placed on at least two permanent molars, in a split mouth design. 100 patients will be included in the study. The teeth will be randomized into two groups according to the crown type.

Group 1: Zirconia crown 2: Stainless steel crown. Plaque index, gingival index, crown retention, presence of restoration failure, gingival margin extension and pulpal health of the teeth will be clinically evaluated at baseline and 1., 6., 12., 18., 24. months. The restorations will be evaluated radiographically at 6., 12. and 18. months. Intra-oral photos will be taken directly after treatment and at control appointments.

The data will be analysed statistically using Fisher's Exact Test and pearson's chi-square test; and Log-rank and the Kaplan-Meier will be used to estimate survival percentages.

Eligibility Criteria:
Inclusion Criteria:

* Patients and parent of the patients who accept to participate and sign the informed consent
* Patients who have at least two permanent molars with caries that require crown restoration
* Patients that have good cooperation to the procedure

Exclusion Criteria:

* Patients and parent of the patients who don't accept to participate and sign the informed consent
* Teeth that doesn't have opposing permanent molars
* Patients who have bruxism or deep-bite
* Patient who are allergic to nickel
Cardiotoxicity in Breast Cancer Patients Treated with Proton or Photon Radiotherapy: a RadComp Companion Study

This is a companion study to the "Pragmatic Randomized Trial of Proton vs Photon Therapy for Patients with non-Metastatic Breast Cancer Receiving Comprehensive Nodal Radiation: A Radiotherapy Comparative Effectiveness (RadComp) Consortium Trial" (NCT02603341). The investigators will collect cardiovascular (CV) biomarkers and echocardiograms prior to, during, and for up to 1 year following radiation for a subset of patients enrolled on RadComp and to evaluate the impact of proton vs photon radiation therapy (RT) on CV function and structure.

The study population of the companion study will consist of newly enrolled RadComp trial participants. Patients on this ancillary will be consented prior to RadComp randomization to decrease the bias secondary to RT type and enhance internal validity. The study will define the early changes in biomarkers, imaging measures, and RT dose volume metrics and long-term (5-10 year) CV clinical outcomes using the RadComp parent study's infrastructure for clinical data collection and long-term follow-up. Blood samples, echocardiograms, and questionnaires are obtained at baseline (between end of chemotherapy and start of RT), immediately after the end of RT, and at 6 months and 12 months after the end of RT. An additional blood sample will be collected at 4 weeks after the start of RT. Clinical, demographic, and patient reported outcomes data are collected as part of the RadComp parent study. In addition to data collected by RadComp, we will collect a limited set of clinical data and two additional quality of life instruments for the companion study.

Eligibility Criteria:
Inclusion Criteria:

* Consented to RadComp
* Willing and able to provide written consent

Exclusion Criteria:

* Knowledge of randomization on RadComp prior to enrollment on companion study
* Non-diagnostic echocardiography windows as assessed on local read.
Implementation of the HELIOSTARTM in Real-world Clinical Practice at a High-volume Center

The HELIOSTARTM catheter (Biosense Webster) is a new technology for pulmonary vein isolation (PVI) in atrial fibrillation (AF), combining radiofrequency (RF)-ablation and 3D-mapping visualization with the concept of "single-shot"-ablation device. This study evaluates the operator learning curve und procedural outcome during implementation of the HELIOSTARTM.

The first patients undergoing PVI by HELIOSTARTM at Heidelberg University Hospital are included in this prospective study. Procedures are performed by an operator proficient in CB-ablation. Procedural outcome was analyzed over the course of increasing experience with the device and in comparison to a previous cohort investigated during implementation of the Arctic FrontTM-cryoballoon (Medtronic).

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years, ability to provide informed consent and at least one episode of documented paroxysmal or persistent AF

Exclusion Criteria:

* history of prior AF ablation, left atrial thrombus, suspected irregular PV-anatomy in pre-procedural transesophageal echocardiography (TOE) or contraindication for peri-procedural anticoagulation therapy
New Periodontal Classification

A new classification system of periodontal and peri-implant diseases and conditions was proposed by consensus of world experts in 2017. Since then there has been ongoing debates among periodontists regarding the application of the new classification. This study aims to shed light on the current understanding of the new classification among Egyptian periodontists.

This study was approved by the Research Ethics Committee of Faculty of Dentistry Beni-Suef University (ID #FDBSUREC/27022019/AM) and was conducted in full accordance with the World Medical Association Declaration of Helsinki 1975, revised in 2003. The questionnaire was anonymous with no personal identification data. Completion and submission of the questionnaire was considered an approved informed consent to participate in the study by the Research Ethic Committee.

The questionnaire was designed by the authors and pilot tested among a group of 12 periodontists for validation. Afterwards, adjustments were made to ensure a clear and comprehensive version of the questionnaire. The questionnaire had a cover letter explaining the nature and purpose of the survey and comprised 15 questions. The first six statements of the questionnaire were descriptive in nature addressing the participant's demographics, and the seventh was a question whether the participant is aware of the new PDL classification or not. Only those who were aware of it were asked to proceed to 13 multiple choice questions using Likert scale; ranging from strongly disagree to strongly agree or from excellent to poor, in addition to "I don't know" option (8). There were also three open ended questions for further comments at the end of the questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* periodontists

Exclusion Criteria:

* non periodontists
Sintilimab Versus Pembrolizumab for Advanced-stage Non-Small-Cell Lung Cancer

This study is a single-center, randomized controlled, phase II clinical trial, aiming at giving a comparison of Sintilimab and Pembrolizumab in stage IIIB-IV NSCLC patients at first-line treatment setting.

This trial has been set up with two arms. Screened patients would be included into one of the arms based on tumor PD-L1 expression. The purpose of this study is to compare the efficacy of the approved checkpoint inhibitor pembrolizumab and home-made drug Sintilimab in patients with advanced NSCLC whose tumor have high PD-L1 expression and low or negative expression.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years. Signed Informed Consent Form.
2. Stage IV NSCLC confirmed by histology/ cytology or Stage IIIB-IIIC NSCLC that could not be treated with radical radiation therapy (8th edition of IASLC Lung Cancer Staging System).
3. Fresh tumor tissue or paraffin tissue within 6 months is adequate for PD-L1 expression (TPS) testing in the central laboratory.
4. Tumor tissue without EGFR mutation or ALK rearrangement must be confirmed.
5. Per RECIST 1.1 the efficacy evaluation criteria for solid tumors, at least one radiologically measurable lesion which was not treated with radiotherapy or had obvious disease progression after radiotherapy.
6. Patients who received no systemic chemotherapy or any other systemic treatment for advanced NSCLC. For patients who received preoperative neoadjuvant chemotherapy or postoperative adjuvant chemotherapy or radical chemoradiotherapy, if the disease progresses occurred one six months after the last treatment, they can be enrolled. Patients who received targeted therapy or immunotherapy can not be enrolled.

Exclusion Criteria:

1. Active hepatitis B. Active hepatitis B is defined as HBsAg positive and the detected HBV-DNA copy number is larger than the upper limit of normal value in the laboratory of the study site.
2. Currently or prior clinically active interstitial lung disease. Currently active pneumonia. Current radiation pneumonitis for which corticosteroid treatment is required.
3. Known HIV antibody positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
4. Fever and the body temperature is above 38°C or clinically significant infection within 1 week prior to the enrollment.
5. Active tuberculosis. Evidence of severe or uncontrollable systemic diseases (such as severe mental, neurological diseases, seizure, or dementia, unstable or non-compensatory respiratory, cardiovascular, hepatic or renal diseases, and uncontrolled hypertension \[CTCAE Grade 2 hypertension or above after drug treatment\]).
6. Patients with active bleeding or new thrombotic diseases who are orally taking with anticoagulant drugs or have bleeding tendency.
Early Postoperative Fitting of the Air- Limb Prosthesis for Transtibial Amputees

The aim of the study is to check whether an early adjustment of the Air-Limb prosthesis to Transtibial amputees due to vascular diseases, will shorten the healing time of the stump and the process of rehabilitation.

The method of immediate adjustment of a temporary Prosthesis has been developed in the past, aiming to reduce the healing time of the stump and the process of rehabilitation. According to this method, a temporary Prosthesis is being adjusted immediately after amputation, or during the first week after it. Rehabilitation starts with the patient's standing while partial weight bearing on the Prosthesis.

In spite of many experiments and trials to adopt this process of rehabilitation, it is not universally adopted, because of the bad adjustment and damages to the stump caused by the Plaster of Paris. At present, with the improvement of materials and research experiments are being renewed, to check the efficiency of the process, using the Air- Limb a temporary Prosthesis.

Eligibility Criteria:
Inclusion Criteria:

* Transtibial amputees due to vascular diseases.

Exclusion Criteria:

* Bilateral amputation.
* Upper extremity can't bear weight.
* The sound leg can't bear weight.
* Amputee that needs Dialysis treatment.
* Cognitive impairment.
Study of Sleep Inertia in Major Depressive Disorder by the Psychomotor Vigilance Task

The study population comprises three groups of 30 analyzable participants: Patients with sleep inertia and Major Depressive Disorder, patients with Major Depressive Disorder but without sleep inertia, and controls without mood disorders or sleep inertia. Controls will be patients referred to the Sleep Disorders and Acupuncture Unit for polysomnography as part of the screening process for a sleep disorder. Only controls presenting an apnea-hypopnea index \< 15/h, a periodic leg movements index during sleep \< 15/h and a total sleep time ≥ 6 hours on the video-polysomnography will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* Ability to understand, write and read French Inclusion criteria for patients with major depression
* Diagnosis of depression according to DSM-5 criteria
* Suspicion of a sleep disorder requiring polysomnographic screening
* Score for IHSS items 3 and 4

  * Score ≥ 1 for group with sleep inertia
  * Score = 0 for the group without sleep inertia Inclusion criteria for controls
* No complaints of sleep inertia (score = 0 on IHSS items 3 and 4)
* No excessive daytime sleepiness (Epworth Sleepiness Scale score ≤10),
* No depressive symptoms (Hospital Anxiety Depression Scale score \< 8 on items 2, 4, 6, 8, 10, 12, 14).

Exclusion Criteria:

* The patient is participating in an interventional study
* The patient is under safeguard of justice or state guardianship
* Unweaned from the following medications for at least 5 half-lives prior to inclusion: wake-promoting or psychostimulant drugs (modafinil, methylphenidate, mazindol, amphetamine, pitolisant, solriamfetol, sodium oxybate), neuroleptics, hypnotics, antidepressants, anxiolytics, antiepileptics, budipine, dopamine agonist and antagonist antiemetics (except domperidone), opiates, gabapentin, pregabalin, benzodiazepines, Z-hypnotics (zolpidem and zopiclone), monoamine oxidase inhibitors, catechol-O-methyltransferase or sedative antihistamines.
* Patients with central nervous system diseases: Parkinson's disease, mild cognitive impairment and dementia, progressive supranuclear palsy, multisystem atrophy, Huntington's chorea, amyotrophic lateral sclerosis, epilepsy, history of head trauma with loss of consciousness.
* Patients with a malignant neoplastic disease requiring therapeutic treatment in the 12months prior to the screening visit
* Other medical or psychiatric illnesses (with the exception of depression in he depression group) which, in the investigator's opinion, could interfere with the study.
* History of suicide attempt (including failed attempt), or suicidal ideation in the past month
* Chronic alcohol consumption or drug abuse in the previous 6 months
* Sleep-wake circadian rhythm disorders and presence of sleep insufficiency according to ICSD-3 criteria
* Pregnant, parturient or breast-feeding women.
Protein Requirements in Adults With Phenylketonuria (PKU)

Phenylketonuria (PKU) is an inherited inborn error of phenylalanine (PHE) metabolism caused by decreased activity of phenylalanine hydroxylase (PAH) enzyme. Therefore, PHE accumulates in plasma leading to mental problems. Treatment is a phenylalanine-restricted diet with sufficient protein. However, the optimum protein requirements are still unknown and compliance with diet is not satisfactory in PKU adults. A Previously established technique called indicator amino acid oxidation (IAAO) will be used to determine protein requirements from amino acid based formula vs. glycomacropeptide (GMP) in adults with PKU (≥ 19y). This study will help treat adults with enough protein ensuring maintenance of health.


Eligibility Criteria:
Inclusion Criteria:

-Adults more than 19 years of age who are diagnosed with PKU and clinically stable with no acute illness

Exclusion Criteria:

* Adults with PKU under age 19 year
* Adults diagnosed with PKU but are currently ill with a fever or cold
Efficacy, Safety, Tolerability of Neramexane in Patients With Subjective Tinnitus

The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.


Eligibility Criteria:
Main Inclusion Criteria:

* Patients aged between 18 and 75 years with a clinical diagnosis of first onset, persistent (i.e., tinnitus should never be absent for \> 24 hours in a row), subjective, uni- or bilateral subacute tinnitus

Main Exclusion Criteria:

* Clinical diagnosis of intermittent or pulsatile tinnitus
* Patients who have tinnitus as a concomitant symptom of an otological/neurological disease (such as otitis media, Menière's disease, otosclerosis, etc)
Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients

The investigators hypothesize that adjuvant metformin use in breast cancer patients with overweight or pre-diabetes mellitus (DM) may improve their body condition including weight loss.

In this study, the investigators aim to test the efficacy and safety of adjuvant metformin for operable breast cancer patients with overweight or pre-DM.


Eligibility Criteria:
Inclusion Criteria:

* Operable Breast cancer patients with BMI ≥ 23 or 100 ≤ FBS \< 126
* From 6 month to 2 years since breast cancer operation and at least 4 weeks since chemotherapy or radiotherapy
* No drug use except Tamoxifen
* Normal OTPT \& Serum creatinine (\<=ULN)
* ECOG performance status 0-2 or Karnofsky PS 60-100%
* Life expectancy \> 12
* Absolute neutrophil count ≥ 1.5 x 10\^9/L
* Platelets ≥ 100 x 10\^9/L
* Pregnancy(-) \& without plan for pregnancy
* Sign a written informed consent form

Exclusion Criteria:

* Type I or II DM or concurrent use of DM control agents
* Prior use of Metformin
* Hypoglycemia (FBS\< 70 with clinical symptom)
* Concurrent investigational or commercial agents
* Other diet or drug intervention for weight loss
* Concurrent use of steroid
* Abnormal liver and/or renal function
* Symptomatic congestive heart failure / Cardiac arrhythmia / Angina pectoris
* Ongoing or active infection
* lactic acidosis
* Pregnancy or ongoing breast feeding
* Anorexia, bulimia, nausea due to other disease for longer than 1 month
* Allergies or allergic reactions attributed to oral medications
* Inability to swallow or digest oral medications
* Physical or psychiatric illness that would limit compliance with study protocol
* Participants in other clinical trial
Cell Proliferation in Pulmonary Hypertension. FDG-PET Comparison Between Patients and Healthy Subjects

Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) are serious diseases with poor prognosis despite recent advances. Currently, pulmonary hypertension (PH) is considered a cell proliferative disorder, which has not been adequately characterized due to the lack of markers. A better understanding of the mechanisms that regulate this proliferative disorder will allow the identification of new therapeutic targets for HP.

The objective of the project is to identify cell proliferative processes in severe forms of PH. Patients with PAH (n=20), CTEPH (n=20) and healthy controls (n=20) will undergo characterization of microRNAs (miRNAs) contained within circulating microparticles (MPs) analysis and mitochondrial functionality and FDG-PET to compare cell metabolism in the lungs and the right ventricle between patients and controls.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with PAH:

   * Hemodynamic diagnosis of precapillary pulmonary hypertension: PAPm ≥25 mmHg, PCWP ≤15 mmHg
   * Exclusion of group 2,3,4 or 5
2. Patients with CTEPH:

   * Hemodynamic diagnosis of precapillary pulmonary hypertension: PAPm ≥25 mmHg, PCWP ≤15 mmHg
   * Persistence of thrombotic perfusion defects on pulmonary scintigraphy or angioCT, after 3 months or more of correct anticoagulant therapy
3. Healthy subjects

   * No known disease or condition
   * Normal lung function, chest x-ray, EKG and blood chemistry and haematology

Exclusion Criteria:

* Severe comorbidity.
* Pulmonary, pleural or rib cage disease interfering with FDG-PET acquisition
* Malignancy with exception of basocellular carcinoma
* Current smoker or former smoker (last 10 years or more than 10-year-pack).
* Pregnant or lactating women Hyperglycemia (fasting above 200 mg/dL)
* Hypersensitivity to the product or its excipients
Return to Work and Living Healthy After Head and Neck Cancer

Based on a randomized controlled trial, the manualized group intervention Return to work and living healthy after head and neck cancer (RELIANCE) for head and neck cancer survivors will be tested against a non-manualized control intervention (social counseling) in order to evaluate the efficacy of the RELIANCE intervention compared to the control condition. The study design includes two phases, the initial study phase (pilot study) and the intervention study (RCT). The aim of the pilot study is to implement and ensure the necessary standardized procedures for the implementation of patient recruitment and interventions. In the randomized controlled trial, potential participants are assigned to the intervention group or to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of laryngea, hypopharyngeal, oropharyngeal, tonsil or base of the tongue cancer within the last six months
* Curative treatment
* Completion of primary and follow-up Treatment
* Fluency in German
* Written informed and voluntary consent
* Psychological distress (Distress Thermometer score \> 4)
* Self-perceived prognosis of employment (SPE score ≥ 1)

Exclusion Criteria:

* Alcohol dependency with physical withdrawal symptoms (CAGE score ≥ 3 and current use of alcohol)
* Acute suicidal tendencies
* Receiving old-age pension or will receive old-age pension within the next 12 months
* Cognitive impairment indicated in the medical records or by the attending doctor
* Being in psychotherapy