cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Clinical Success of Bulk Fil Composite Versus Highly Viscous Glass Ionomer in Primary Class II Molars

evaluate the clinical performance of EQUIA Forte ® ( a HVGIC) and Plafique® Bulk Flow composite resin when placed in class II cavities in primary molars.

1. Thorough diagnosis of patients will be done by the primary investigator. Patients with class II carious primary molars with score 4 or 5 using the International Caries Detections and Assessment Criteria (ICDAS).
2. Pre-operative bitewing radiographs will be obtained to assess the depth of the cavity. Primary molars with score D1 or D2 according to the ADA will be included in the study.
3. Each patient will be assigned to one of the two groups.

   * Group I (n= 59): Plafique Bulk Flow Composite.
   * Group II (n=59): EQUIA Forte Group.
4. Class II carious primary molars are prepared using 330 burs. The cavity will be approximately with a depth of 0.5 mm in dentin and width of at least one-third of the occlusal table. Outline of the cavity will be determined by the extent of the carious lesion. No beveling will be done in any of the cavities.
5. Matrix is placed and secured in position.
6. One of the 2 restorative materials is placed in the cavity using the manufacturer's instructions.
7. Patients will be recalled at 3, 6, and 12 months to evaluate the restoration clinically using the FDI criteria.
8. Patients will receive oral health education on how to maintain a proper oral hygiene and proper diet consumption.
9. They will be given manual tooth brushes and tooth pastes to use during the study.

Eligibility Criteria:
Inclusion Criteria:

* Four to 8 years old children
* Cooperative children classified as class 3 or 4 based on Frankle et al. classification.
* Presence of deep bite or any type of malocclusion or parafunctional habits.
* Children who have at least one primary molar with active proximal caries (score 4 or 5 using ICDAS).

Exclusion Criteria:

* Refusal of the parents to sign the informed consent.
* Presence of deep bite or any type of malocclusion or parafunctional habits.
A Prospective Danish National Registry of PTRA in Patients With Renovascular Hypertension

A prospective Danish national registry of percutaneous transluminal renal angioplasty (PTRA) in high-risk patients with renal artery stenosis selected on the basis of common national criteria, and with a common follow-up protocol for all three Danish centres offering PTRA


Eligibility Criteria:
Eligibility criteria

1. True resistant hypertension (≥ 3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses) and uncontrolled blood pressure confirmed by 24-hour ambulatory blood pressure monitoring. The 24-hour ambulatory blood pressure monitoring is performed after nurse-administered medication and blood pressure measurements are performed hourly. If the average 24-hour ambulatory systolic blood pressure is ≥ 130 mmHg the patient can be evaluated for renal artery stenosis.
2. Hypertension and intolerance or side effects of the antihypertensive treatment. Hypertension is confirmed by 24-hour ambulatory blood pressure monitoring. The 24-hour ambulatory blood pressure monitoring is performed after nurse-administered medication and blood pressure measurements are performed hourly. If the average 24-hour ambulatory systolic blood pressure is ≥ 130 mmHg the patient can be evaluated for renal artery stenosis.
3. Progressive renal insufficiency (a reduction in eGFR \> 5 ml/min/1,73 m2 per year) in patients with bilateral renal artery stenosis or in patients with renal artery stenosis and only one kidney.
4. Recurrent heart failure/pulmonary edema and resistant hypertension (≥ 3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses) that may not be attributed to non-compliance, reduced left heart ventricular ejection fraction/heart valve disease or other obvious explanations (atrial fibrillation, fever, hyperthyroidism etc.). If the average 24-hour ambulatory systolic blood pressure is ≥ 130 mmHg after nurse-administered medication the patient can be evaluated for renal artery stenosis.
5. Younger patients (\< 40 years) with hypertension (24-hour ambulatory blood pressure monitoring ≥ 130/80 mmHg after nurse-administered medication )

Inclusion Criteria:

All of the following:

1. At least one of the above eligibility criteria
2. Duplex doppler ultrasonography or renography investigations consistent with hemodynamically significant renal artery stenosis
3. CT angiography or renal arteriography with angiographic renal artery stenosis of ≥ 70 % reduction of the luminal diameter in at least one projection

Exclusion Criteria:

1. If angiography/arteriography, ultrasonography or renography is consistent with bilateral significant renal artery stenosis and only one side is treated with PTRA
2. PTRA of a renal artery supplying a kidney which pre-PTRA handles ≤ 10% of the total kidney function (with no blockage of the renin-angiotensin system) and has a kidney size \< 7 cm (length)
A Study to Learn About the Study Medicine (Avelumab) in Japanese Patients With Urothelial Carcinoma That Has Spread

The purpose of this clinical trial is to learn about the current treatment patterns, safety, and effects of the study medicine (Avelumab) for the treatment of urothelial carcinoma.

This study is seeking Japanese participants who:

* have urothelial cancer that has spread
* are treated with Avelumab for maintenance

We will study the experiences of people receiving avelumab. This helps us learn the current treatment patterns, safety, and effects of avelumab. Participants will take part in this study up to 10 months. During this time, they will have no study visits.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with locally advanced or metastatic UC before receiving Avelumab 1L maintenance therapy.
2. Started treatment with avelumab for locally advanced or metastatic UC from 24 Feb 2021 (regulatory approval date) to 30 Nov 2021.
3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

(1) Written consent is not required for patients who were transferred to a hospital, and registration with verbal consent is acceptable.

(2) Opt-out enrollment is allowed for patients who have already died. 4)Deceased patients are also required to meet the inclusion criteria 1)-2).

Exclusion Criteria:

There are no exclusion criteria for this study.
Safety and Efficiency of Electrocautery De-Epithelization in Mammoplasty

The aim of this study is to evaluate safety and efficiency of electrocautery de-epithelization in mammoplasty.

Mammoplasty is the fifth most commonly performed by plastic surgeons worldwide to improve symptomatology resulting from macromastia.

One of the key stages in a breast reduction or augmentation surgery is the de-epithelization process. De-epithelialization is the first stage of reduction mammoplasty in techniques that use dermal, dermo-glandular pedicles. Traditional methods of de-epithelization include manual dissection or mechanical scraping as time-consuming and demanding by most surgeons, especially when the breasts are large and when there is no assistant available.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Patients undergoing mammoplasty.

Exclusion Criteria:

* Patients with active infections or open wounds at the surgical site.
* Individuals with known hypersensitivity or adverse reactions to electrocautery.
* Pregnant or lactating women.
* Patients with uncontrolled diabetes or coagulation disorders.
* History of psychiatric illness.
* Patients undergoing secondary or repeat breast reduction procedures.
A Multidisciplinary Weight Loss Program at AUB-MC

The current project aims at evaluating the feasibility and efficacy of a multi-disciplinary weight loss program, using an innovative and simple dietary intervention at the American University of Beirut Medical Center (AUB-MC). Such intervention is expected to enhance patients' compliance and adherence to lifestyle changes. In addition, the program includes supervised exercise sessions and behavioral therapy. Therefore, our project proposes an evidence based approach to close the obesity treatment gaps.


Eligibility Criteria:
Inclusion Criteria:

* Lebanese adult with obesity (≥18 years), obesity being defined as BMI ≥ 30 kg/m2
* Patients who can commit to frequent visit trials as per study protocol
* Patients not traveling outside Lebanon for at least the 6-month period of the trial
* Patients tolerating Metformin after a run-in period of 2 weeks

Exclusion Criteria:

* Patients who have taken other weight reducing drug therapy in the previous 6 months
* Patients who have undergone bariatric therapy or endoscopic procedure, or planning to do so in the near future (at \< 6 months)
* Patients with diabetes
* Patients working at AUB-MC, as we will not be able to assess the adherence to study visits nor the feasibility of such a program in the general population, presenting to AUB-MC only for clinical care
* A family member of a patient already enrolled in the study, as the participants will not be independent
* Pregnant obese patients
* Patients with pacemakers
* Patients known to have hypertension, cardiac, pulmonary, renal or liver disease, active cancer or psychiatric illnesses
* History of any surgery of less than 6 weeks duration
* Patients known to have disabling osteoarthritic or orthopedic problems
* Patients secondary uncontrolled endocrine disorders (thyroid disorders, polycystic ovary, Cushing disease), or drug induced obesity (such as anti-psychotic, steroids, hormonal therapy).
Melatonin in Adults With SMS

Sleep-Wake and behavioral disorders in Smith Magenis Syndrome (SMS) are strongly linked to an inversion of the nychtemeral secretion of melatonin. This inversion have been described in children with SMS. However its evolution during adulthood remains unknown. The aim of this study is to assess 24hours melatonin levels in 10 adults with SMS in order to optimize medication in adults with SMS

SMS is one of the rare syndromes in which the inversion of melatonin secretion is regular, which is an exceptional situation for the study of the influence of genetic factors on the regulation of sleep / wake rhythm. Recently, point mutations of the RAI1 gene (Retinoic Acid Induced 1) have been identified in individuals with the clinical features of SMS with a reversal of the secretion rate of melatonin ,highlighting the role of RAI1 in SMS sleep disorders.

Daytime secretion of melatonin is associated with significant drowsiness and plays a major role in diurnal behavior disorders, especially in younger people. Conversely, the absence of nocturnal melatonin is a causal factor in the shortening and fragmentation of nocturnal sleep .

Basically, little is known about the mechanisms that explain the inversion of the secretion rate of melatonin in SMS.

These aspects, and in particular the nycthemeral reversal of the melatonin cycle, have been described in a population of children and we do not know how these disturbances evolve in adulthood

Eligibility Criteria:
Inclusion Criteria:

* Patient with Smith Magenis Syndrome aged 18 years or older
* subject or guardian having signed the consent

Exclusion Criteria:

* Pregnant women
* Minor subject
* Diagnosis of Smith Magenis syndrome not certain
* Taking benzodiazepines or related substances
* Taking betablockers
* Major behavioral disorders versus indicating participation in this study
Personalized Therapy of Precursor Lymphoid Neoplasms

The primary goal of this study by The Polish Adult Leukemia Group (PALG) is to verify if individual therapeutic approach taking into account biological and phenotypic differences as well as response at the level of minimal residual disease is associated with improved outcome of adults with precursor lymphoid neoplasms

Between 1997-2010 the PALG run three prospective studies. In the most recent PLAG 5-2007 protocol attempts have been made to individualize treatment. In particular, stratification to high and standard risk group was based on both conventional clinical criteria and the level of MRD after induction and consolidation. Patients with unsatisfactory response were referred for allogeneic hematopoietic stem cell transplantation (alloHSCT). Interim analysis showed significant improvement compared to previous PALG 4-2002 protocol with regard to both overall survival and leukemia-free survival. The reasons of failure were relapses and non-relapse mortality (NRM) associated with alloHSCT.

In the current protocol we intend to further adjust the therapy for individual patients needs. We assume that this way we will be able to reduce the risk of relapse and NRM and improve the cure rate. All patients will receive multiagent induction and consolidation chemotherapy. The type and intensity of the therapy, as well as indications for allogeneic and autologous HSCT will depend on age, status of MRD, immunophenotype and the presence of BCR/ABL fusion gene.

Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of PLN according to WHO 2008 classification
* Age ≥18 years
* Biological status allowing administration of induction therapy
* Informed patient consent form signed

Exclusion Criteria:

* Pregnancy
* Psychiatric diseases
* History of other malignancies
* HIV infection
* Active hepatitis
* Hypersensitivity to drugs used in induction
Long Term Prospective Study Evaluating Effectiveness of Narrow Margins for Low-Risk Head and Neck Basal Cell Carcinomas

The purpose of this study is to determine the narrowest excision margin for head and neck Basal Cell Carcinoma (BCC) tumors satisfying the National Comprehensive Cancer Network® (NCCN) low-risk for recurrence clinical and histopathological criteria that gives an acceptable (95%) clinical cure-rate over a 3 year follow-up period. Margins of 1 and 2mm are evaluated.

Basal Cell Carcinoma (BCC) is the most common skin cancer in the US. Most are treated by surgical excision. Excision margins vary by tumor size, anatomic location, histological subtype, and surgeon preference. Published recommendations and follow up observation times vary. Current clinical practice supports the 4 mm excision margin; however, this can be a disservice to the patient by potentially excising additional normal tissue unnecessarily and yielding larger scars. Considering healthcare costs, both the excision and repair components are usually billed by size measurements. Determining the narrowest excision margin to give an acceptable clinical cure could feasibly reduce this expenditure.

Eligibility Criteria:
Inclusion Criteria:

* Patient has a BCC \<10mm on their cheeks, forehead, scalp \& neck or \<6mm on their central face, eyelids, eyebrows, periorbital, nose, lips, chin, mandible, preauricular \& postauricular, temple \& ear
* The BCC has well defined borders
* The BCC is primary
* The Patient is not immunosuppressed
* The BCC is not located at a site of prior radiation therapy
* The histologic subtype is nodular or superficial
* There is no perineural involvement

Exclusion Criteria:

* Patient has a BCC \>or=10mm on their cheeks, forehead, scalp \& neck or \>or=6mm on their central face, eyelids, eyebrows, periorbital, nose, lips, chin, mandible, preauricular \& postauricular, temple \& ear
* The BCC has poorly defined borders
* The BCC is recurrent
* The Patient is immunosuppressed
* The BCC is located at a site of prior radiation therapy
* The histologic subtype is aggressive
* There is perineural involvement
A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression

This study will evaluate the Safety, Pharmacokinetics and Efficacy of IV Administration of Ganaxolone in Women with Postpartum Depression

This study will explore whether ganaxolone is safe and well tolerated in women suffering from PPD. In addition, ganaxolone's efficacy in treating depressive symptoms will be assessed through a set of exploratory analyses. Plasma levels of ganaxolone will be determined through pharmacokinetic analysis. The study results will be used to select a ganaxolone dose and dosing regimen for further development in PPD.

Eligibility Criteria:
Inclusion Criteria:

* Participant experienced a Major Depressive Episode, which started between the start of the third trimester and 4 weeks following delivery. The Major Depressive Episode must be diagnosed according to Mini International Neuropsychiatric Interview (MINI) 7.0 interview
* Participant gave birth in the last 6 months
* Participant has a Hamilton Depression Rating Scale 17-item version (HAMD17) score of ≥ 26 at screening
* Participant must agree to stop breastfeeding from start of study treatment or must agree to temporarily cease giving breast milk to her infant(s)

Exclusion Criteria:

* Current or past history of any psychotic illness, including Major Depressive Episode with psychotic features
* History of suicide attempt within the past 3 years
* Active suicidal ideation
* History of bipolar I disorder
* History of seizure disorder
Breast Cancer Long-term Outcomes on Cardiac Functioning: a Longitudinal Study

Rationale: In addition to surgery, effective breast cancer (BC) treatment typically requires chemotherapy, radiotherapy, or both. However, it is still unclear whether patients with BC are at increased risk of long-term cardiac dysfunction due to the adverse effects of these therapies. In a cross-sectional study in primary care, a comparison on cardiac dysfunction between 350 BC survivors and 350 age- and general practitioner (GP)- matched controls without cancer was made. In that study, BC survivors were at increased risk of mild systolic cardiac dysfunction (left ventricle ejection fraction (LVEF)\< 54%). By contrast, there was no significant difference in an LVEF \< 50% or in diastolic dysfunction. To date it remains uncertain whether the mild or subclinical dysfunction we observed predicts further cardiac deterioration. Consequently, the translation of these results into guidelines for the daily practice of the GP is unclear.

Objective: The aim of the here proposed study is to clarify whether cardiac function in survivors of BC should be monitored by GPs, by assessing whether an unselected population of long-term BC survivors is at increased risk of developing cardiac dysfunction, whether in this group at-risk subgroups exists, and what factors are associated with the highest risk.

Study design: A new assessment of cardiac function among women included in the BLOC-I study. This produces a longitudinal matched cohort design consisting of two cohorts in primary care.

Study population: Survivors of BC, diagnosed ≥11 years ago who received chemotherapy and/or radiotherapy, and a matched reference population with no history of cancer. All participants participated in the Breast cancer Long-term Outcome of Cardiac function (BLOC-I) study.

Main study parameters/endpoints: Left ventricular systolic dysfunction. Systolic cardiac dysfunction is defined as a LVEF \<54/50/45%.


Eligibility Criteria:
Inclusion Criteria:

* Patients who previously took part in de BLOC-I study will be included. These criteria were:
* females diagnosed with stage I-III BC at least five years ago or local or locoregional recurrence of BC at least five years ago
* treatment with chemotherapy and/or radiotherapy.

Exclusion Criteria:

* Patients unfit to travel to the hospital due to severe mental or physical illness, based on assessment by their GP.

Exclusion criteria for the BC survivors in the BLOC-I study were:

* metastatic disease at the time of BC diagnosis;
* BC treatment after 80 years of age;
* history of treatment for other types of cancer.
Oral AZD8165 After Single Oral Ascending Doses in Healthy Male Subjects

The purpose of this study is to evaluate the safety and tolerability of AZD8165 and the pharmacokinetics of the metabolite AZ12971554 and plasma levels of the prodrug AZD8165 after escalating single oral low doses.


Eligibility Criteria:
Inclusion Criteria:

* Suitable veins for cannulation or repeated venipuncture
* Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and nor more than 100 kg

Exclusion Criteria:

* History of any clinically significancy disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms.
Influence of Various Healing Intervals on Alveolar Ridge Preservation Using Demineralized Dentin Graft: A Randomized Clinical Trial

Statement of the problem:

The alveolar ridge undergoes various remodeling processes following tooth extraction, but the ridge resorption continues over time, resulting in hard and soft tissue loss which complicates prosthodontic rehabilitation whether by dental implants or tooth supported prosthesis.

Aim of the study:

The aim of the study is to assess the influence of the different time intervals on the healing of the demineralized dentin graft in alveolar ridge preservation (ARP) procedures.

Materials and methods:

30 patients with hopeless teeth requiring extraction in maxillary non molar areas and requiring replacement with dental implants, will be enrolled and recruited from the outpatient clinic, faculty of dentistry, ain shams university according to the inclusion criteria. They will be randomly allocated into three equal groups. Group A (n=10) alveolar ridge preservation will be done with demineralized dentin graft and re-entry at 12 weeks, group B (n=10) alveolar ridge preservation will be done with demineralized dentin graft and re-entry at 18 weeks and group C (n=10) alveolar ridge preservation will be done with demineralized dentin graft and re-entry at 24 weeks. Radiographic assessment will be done using CBCT to the arch of interest and another cone beam will be done prior to the implant placement at 11, 17 and 23 weeks based on the study group and a volumetric assessment will be done with digital subtraction. At the respective times core biopsy will be taken for the histological assessment, and the implant placement will be done with the implant primary stability recorded using Ostell. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed. Data collected will be tabulated and statistically analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Systemically free patients (American Society of Anesthesiologists I; ASA I)
* Age range 20 - 50.
* Non-molar maxillary teeth indicated for extraction.
* Patients with extraction sockets having intact bony walls, or no more than one bony wall dehiscence not extending more than 50% of the total bone height

Exclusion Criteria:

* Teeth to be extracted or adjacent teeth associated with acute infections.
* Smokers.
* Patients with other conditions that may affect the treatment \[uncontrolled diabetes mellitus (HbA1c \>7.0), liver or kidney failure, any active oral or systemic acute infections, currently receiving chemo-or radiotherapy or a history of radiotherapy in the head and neck area, severe hematologic disorders\].
* Pregnant and lactating females.
* Patients with history of lack of compliance to dental visits and unwillingness or inability to sign the informed consent.