cyrilzakka/clinical-trials huggingface dataset:
Clinical and Radiographic Evaluation of Alkasite Restorative Material Versus Glass Ionomer Cement

To evaluate the clinical and radiographic performance of Alkasite restorative material versus glass ionomer in restoration of primary molars.

Restorations replacements are mostly caused by the existence of caries lesions surrounding the restorations, which are commonly referred to as secondary caries .

Secondary or recurrent caries is characterized as "lesions that occur at the edges of previously placed dental restorations" or "caries that develop in association with dental restorations or sealants" (CARS).Proper seal at the tooth surface restoration interface is essential . That's why the most frequently material used is (GIC) with the advantage of chemical adhesion to tooth structure, superior esthetics, and long-term fluoride release providing cariostatic effect, but it has the disadvantage of slow setting rate, low fracture toughness, susceptibility to moisture contamination, dehydration during initial phase of setting, and poor wear resistance.

Resin Modified Glass Ionomer and Composite have always been the preferred material for restoration although several modifications have been made recently to improve its properties, Cent ion N is one of the recent ones.

Cent ion N is a tooth-colored basic filling material for direct restoration. It belongs to the material of Alka sites, with high flexural strength. It also has calcium and fluoride releasing properties comparable to conventional GIC, besides it is quick and easy to use.

Eligibility Criteria:
Inclusion Criteria:

* 1. Children having carious primary molars without pulp exposure and normal radiograph.

  2. Children between age 5 and 7 years. 3. Both male and female are included. 4. Cooperative Children.

Exclusion Criteria:

* 1. Patients with systemic diseases. 2. Parent refuse to participate.
A Study in Male and Female Adolescent Participants With Severe Uncontrolled Asthma Starting Treatment With Dupilumab Injection (Dupixent®)

Primary objective:

- Describe the characteristics of enrolled severe asthma patients

Secondary objectives:

* Assess the control of asthma under dupilumab (Dupixent®) treatment until 1 year
* Assess the clinical objectives of the asthma care
* Assess comorbidities associated with Type 2 inflammation
* Assess safety during the year of treatment

52 weeks

Eligibility Criteria:
Inclusion Criteria:

* Adolescents, for whom initiation of dupilumab (Dupixent®) for the severe uncontrolled asthma indication was decided by the investigator before the inclusion in the study
* Adolescents ≥ 12 and \< 18 years of age at the time of the initiation of Dupixent® treatment

Exclusion Criteria:

- Adult participants ≥ 18 years of age

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Human Heterologous Liver Cells for Infusion in Children With Urea Cycle Disorders

Treatment with liver cell infusion for children with urea cycle disorders (UCD).

Urea cycle disorders are rare inherited diseases that generally have a poor outcome, especially with onset of the disease in the neonatal period. UCDs are caused by a deficiency of one of six enzymes responsible for removing ammonia from the bloodstream. Instead of being converted into urea which is removed from the body with the urine, ammonia accumulates in UCD patients leading to brain damage or death. In the light of a mortality rate of \> 50% at the age of 10 years the current pharmacological and dietary therapy is of modest success. Furthermore, mental retardation, cerebral palsy and other neurological sequelae are common among surviving patients.

In the last years, orthotopic liver transplantation (OLT) has become the best therapeutic option for UCD with long-term survival rates of about 90%. However, in the first weeks of life OLT still is technically demanding and prone to complications. With larger size of the recipient, the technical problems with OLT decrease considerably. The increased body weight usually achieved at the age of more than 8 weeks is related to a major reduction in transplantation related morbidity. Stabilization of metabolism until the patient can undergo OLT is essential.

In this study, young children with UCD will be treated by repetitive application of human liver cells. In the last consequence, the aim of this new therapy option is to supply a sufficient amount of healthy liver cells to compensate for the metabolic defect and to reduce the risk of neurological deterioration while awaiting OLT.

Eligibility Criteria:
Inclusion Criteria:

* Age: birth up to 5 years of age
* Ornithine transcarbamylase deficiency \[OTCD\], Carbamyl phosphate synthetase I deficiency \[CPSD\], Argininosuccinate synthetase deficiency \[ASSD, Citrullinaemia\]
* Written Informed Consent

Exclusion Criteria:

* Weight ≤ 3.5 kg
* Presence of acute infection at the time of inclusion
* Severe chronic or systemic disease other than study indication
* Structural liver disease (eg, cirrhosis, portal hypertension)
* Required valproate therapy
Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids

This multi-center center phase I/II study to establish the lowest possible recommended phase 2 dose (RP2D) of corticosteroids in conjunction with ruxolitinib and uhCG/EGF (a novel combination) for high-risk aGVHD.

This is a single arm study designed to determine the lowest dose of corticosteroids required (toxicity endpoint) without impairing GVHD complete response or partial response (CR/PR) at day 28 when given in conjunction with uhCG/EGF and ruxolitinib.

After completion of the corticosteroid dose finding, the final dose will be carried forward into a two-stage phase II extension trial to confirm safety and make a preliminary determination of efficacy of this novel drug combination for high-risk aGVHD.


Eligibility Criteria:
Inclusion Criteria:

HCT recipients over 12 years of age within the first 7 days of initial treatment of high-risk aGVHD, defined as:

* Newly diagnosed Minnesota high-risk aGVHD -OR-
* Newly diagnosed Minnesota standard risk aGVHD with plasma amphiregulin ≥ 33 pg/ml tested at the UMN Cytokine Reference Lab. For amphiregulin lab ordering information, see Fairview Lab Guide: http://labguide.fairview.org/showtest.asp?testid=6766\&format=long -OR-
* Newly diagnosed Minnesota standard risk aGVHD Ann Arbor 3 biomarkers tested by Viracor. For ordering information, see: https://www.viracor-eurofins.com/test-menu/403572p-agvhd-symptomatic- onset-algorithm/

  * Renal: Serum creatinine ≤2.5x upper limit of normal (ULN)
  * Cardiac: Left ventricular ejection fraction (LVEF) ≥ 35%
  * Voluntary written consent (adult or parent/guardian with minor assent for 12 through 17-year-olds).

Exclusion Criteria:

* Progressive malignancy
* Uncontrolled bacterial, fungal, parasitic, or viral infection at initiation of protocol treatment
* Unwilling or unable to stop supplemental sex hormone therapy (estrogen, progesterone, and/or testosterone preparations)
* Unwilling or unable to stop GnRH antagonists, aromatase inhibitors, or anti-androgens
* History of a hormone responsive malignancy
* Current thromboembolic disease requiring full-dose anticoagulation - patients receiving pharmacologic prophylaxis for thromboembolic disease will be eligible
* Active or recent (within prior 3 months) thrombus, irrespective of anticoagulation status
* Pregnancy
* Women or men of childbearing potential unwilling to take adequate precautions to avoid unintended pregnancy from the start of protocol treatment through 30 days after the last treatment
Microcurrent Versus Transcutaneous Electrical Nerve Stimulation on Pressure Ulcer

The purpose of the study was to evaluate which is more effective, microcurrent or transcutaneous electrical nerve stimulation, in treating pressure ulcers in elderly patients.

* Pressure sores are common problems in today's health care. A pressure sore leads to physiological as well as psychological suffering for the individual affected. The cost for the society, associated with prevention and treatment of pressure sores, is considerable
* Furthermore, the need for this study was developed from the lack of quantitative knowledge and information in the published studies about the effect of microcurrent and transcutaneous electrical nerve stimulation in treating pressure ulcers in elderly patients.
* This study will be carried out to provide guidelines about the effectiveness of microcurrent and transcutaneous electrical nerve stimulation in treating pressure ulcer and to assist in planning an ideal treatment regimen to increase healing of pressure ulcers in elderly patients.

Eligibility Criteria:
Inclusion Criteria:

Subject selection was done according to the following criteria:

* Age range between 40 and 60 years.
* Male and female patients will participate in the study.
* All patients enrolled in the study had their informed consent.
* Pressure ulcer grades were grade II and III.
* A relative or legal tutor provided consent when participants were incapable of making decisions.
* The trial complied with the ethical principles of the Helsinki Declaration for medical research in humans.
* Pressure ulcers were located in the sacral area

Exclusion Criteria:

* Age less than 40 years or more than 60 years
* A cardiac pacemaker or another implanted electric device.
* Cognitive problems or hearing loss.
* Pre-existing joint disorder before pressure ulcer.
* Patients who have co-morbidities such as diabetes mellitus, rheumatoid arthritis, hypertension, and cardiac and renal patients,
* Osteosynthesis implants near the ulcer, pressure ulcers in the occipital region, cancer, and osteomyelitis.
* Abnormal blood markers at baseline indicating limited healing potential (anemia, iron deficit, protein deficit, dehydration, non-controlled diabetes, or hypothyroidism).
* Allergy to the usual treatment for ulcer healing, systemic infection, and ulcer treatment with growth factor or vacuum-assisted closure in the 30 days before the Trial
Aliskiren Combined With Losartan in Proteinuric, Non-diabetic Chronic Kidney Disease

Study objective: To investigate the potential anti-proteinuric and renoprotective efficacy of aliskiren in addition to losartan in patients at risk of developing end-stage renal disease (ESRD)

Methods: This will be a randomized, double-blind study in which proteinuric, non-diabetic patients with chronic kidney disease (CKD) will be assigned in a 1:1 ratio to one of the following treatment groups for 3 years:

* Group A: Losartan (Control arm: conventional treatment)\*
* Group B: Aliskiren plus Losartan (Intervention arm)\*

  * With optional addition of other anti-hypertensive agents to achieve an optimal target blood pressure of \<130/80 mmHg.

Aliskiren is a direct renin inhibitor that has been shown to reduce proteinuria and retard renal deterioration in type 2 diabetic patients with overt nephropathy. However, it is not known if these therapeutic effects can be extended to nondiabetic chronic renal disease. The current study aims to explore this research question by randomly assigning patients with various stages of chronic renal disease to receive either aliskiren on top of losartan, or continuation of losartan.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 - 80 years of age
* Presence of nondiabetic CKD stages 3 to 4 as defined by estimated glomerular filtration rate (eGFR by 4-variable MDRD equation) as follows:

  * Stage 3: Moderate decrease in GFR 30-59 mL/min/1.73 sq.m
  * Stage 4: Severe decrease in GFR 15-29 mL/min/1.73 sq.m
  * CKD is defined as either kidney damage or GFR \<60 mL/min/1.73 m2 for \> 3 months with variations of less than 30% in the 3 months before screening
* Early-morning urinary protein-to-creatinine ratio of \>500 mg/g or 57 mg/mmol on at least 2 occasions four weeks apart
* Patients who are willing to give written, informed consent

Exclusion Criteria:

* eGFR \< 15 or \> 60 ml/min/1.73m2
* Early-morning urinary protein-to-creatinine ratio of \>5000 mg/g or 570 mg/mmol, or urinary protein-to-creatinine ratio of \<500 mg/g or 57 mg/mmol
* Serum K+ \> 5.2 mmol/L
* Presence of bilateral renal artery stenosis
* Known allergy to losartan or aliskiren
* Patients who are receiving angiotensin II receptor blocker / angiotensin converting enzyme inhibitor combination within 12 weeks of randomization
* Concurrent treatment with corticosteroids, nonsteroidal antiinflammatory drugs, or immunosuppressive agent
* Patients with connective tissue disease or obstructive uropathy
* Patients with concomitant malignancy or any such conditions that will severely limit life expectancy
* Female who are pregnant or intending to conceive
* Female of child-bearing age who are unwilling to practice effective contraception
* Patients who are unable to give informed consent
* Patients simultaneously participating in another study or who have participated in another study within the last 30 days of entry into this study
Computerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain

The purpose of this study is to investigate the efficacy and safety of the Occiflex device in the treatment of neck pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic neck pain: post-whiplash injury, myofacial pain, cervical facet joint disease and idiopathic chronic neck pain

Exclusion Criteria:

* Radiculopathy
* Myelopathy
* Cerebral vascular disease
* Malignancy
* Osteoporosis
* Cervical disc herniation
Anticholinergics for Cervical Edema in Labor

The purpose of this study is to is to determine the clinical effectiveness of a single dose of intravenous (IV) medication for the prevention of labor arrest and cesarean delivery in primiparous women undergoing trial of labor.


Eligibility Criteria:
Inclusion Criteria:

* Primiparous
* Viable single intrauterine pregnancy

  -≥ 34 weeks of gestation
* Ruptured membranes
* Category I tracing at time of inclusion
* Active phase of labor (\>=6 cm of cervix dilation)

Exclusion Criteria:

* Category II or III tracing
* Allergy to the study medication (IV Diphenhydramine)
Specific Clinical Experience Investigation for Long-term Use of Exenatide (Byetta Subcutaneous Injection)

The purpose of this investigation is to describe general safety profile of type II Diabetes Mellitus (DM) Japanese patients under exenatide therapy in real world medical practices

Specific Clinical Experience Investigation for long-term use of exenatide (Byetta subcutaneous injection).

Eligibility Criteria:
Inclusion Criteria:

- Patient diagnosed with Type 2 Diabetes Mellitus and who is naive patient with Byetta.
Comparison of 2 Ovarian Stimulation Protocols for Women With Low Ovarian Reserve

The purpose of this study is to determine whether minimal ovarian stimulation for in vitro fertilization is superior to high dose stimulation. Number of mature eggs, number of embryos as well as pregnancy rates will be compared.

A prospective randomized trial will be carried out. The Minimal stimulation (MS) protocol is based on low dose letrozole 2.5 mg over 5 days, starting from cycle day 2, overlapping with low dose gonadotropins, starting from day 3 of the letrozole at 150 units per day. GnRH antagonist wil be introduced to avoid premature LH surge when one or more of the growing follicles reached approximately 14 mm in size. The high dose stimulation protocol is based on high dose of gonadotropins (≥300 IU/day) throughout the cycle with the usage of gonadotropin-releasing hormone (GnRH) antagonist to avoid premature luteinizing hormone (LH) surge as described above.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of poor responder to ovarian stimulation

Exclusion Criteria:

* Patients undergoing pregestational diagnosis (PGD)
* Patients using donor eggs
Soft and Hard Tissues Evaluation Around Immediately Placed New Implant Design

patients were randomly divided into Maxi-Z plus dental implant group versus Maxi-Z implant group

after tooth extraction implants will be placed immediately and provisional restoration will be placed in both groups to detect the advantaged and drawbacks of newly designed Maxi-Z plus dental implant versus Maxi-Z dental implant

Eligibility Criteria:
Inclusion Criteria:

* good health
* unrestorable, periodontal healthy teeth

Exclusion Criteria:

* systemic disease
* periodontal disease
* presence of abscess
Laser Cell Therapy for Knee Cartilage Repair

Laser pulsed energy will be delivered over an optical fiber to create channels into damaged cartilage of the knee or knees. The channels have a diameter of approximately 100 microns or less and an approximate depth of 1 millimeter or less. Bone marrow aspirate will then be delivered into the damaged joint.

The creation of micro-channels into damaged knee cartilage will facilitate the movement of fluid into and out of the tissue to allow for more efficient nutrient diffusion. The addition of bone marrow aspirate will provide additional growth factor enriched nutrition to the tissue. The goal of this combination therapy is to facilitates the body's own reparative processes leading to improved patient well being.

Eligibility Criteria:
Inclusion Criteria:

Kellergren grading scale of 2 or 3 in at least one compartment of either or both knees with no compartment representing a stage 4 in either knee.

No significant MCL or LCL tear or laxity

No significant meniscal tear. ( i.e. bucket handle)

Exclusion Criteria:

* Injection with the past 6 weeks
* Stage 4 osteoarthritis in either knee
* Uncontrolled Diabetes or any other metabolic syndrome
* BMI greater than 28
* Significant lower extremity deformity
* Bilateral or tri compartmental Knee OA
* Adults unable to consent
* Individuals who are not yet adults (infants, children, and teenagers, age \< 18)
* pregnant women
* Prisoners
* Stage 4 osteoarthritis in either knee
* Subjects, who, in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
Comparing the Effect of Deep Neck Flexors Versus MCkenice Exercises on Cervical Functions

Physical Therapy rehabilitation programs could involve Manual procedures, stretching, traction, massage, electrotherapy, thermal agents, ultrasound, education and general exercise..In the recovery of patients with neck pain, exercise is one of the most commonly used modalities to gain muscle strength, endurance, and flexibility in order to recover damaged muscles and to maintain regular life activities.. Neck pain management exercise programs vary in terms of length, training frequency, intensity, and mode of exercise. .

This study will be a randomized controlled trial that involved sixty patients of both gender with chronic neck pain with duration of at least six weeks that will be recruited into the study. They will be recruited from the out patient clinic of Faculty of Physical Therapy, Egypt ,their age ranged from (30-50) years old with mean age, their height ranged from (152-182) cm and their weight ranged from (55-90) kg , Patients will be included if they had a localized chronic neck pain without any current arm pain or discomfort were included.Groups:

A: twenty patients will receive traditional Physical Therapy agents, Group B: twenty patients will receive traditional Physical Therapy agents plus isometric, stretching, scapulothoracic exercises and deep neck flexors exercises; and Group C: twenty patients will receive traditional Physical Therapy agents plus isometric, stretching, scapulothoracic exercises and Mckenzie technique.

Eligibility Criteria:
Inclusion Criteria:

1. age ranges from (30-50) years old with mean age,
2. height ranges from (152-182) cm and their weight ranged from (55-90) kg
3. Patients will be included if they have a localized chronic neck pain without any current arm pain or discomfort were included.

Exclusion Criteria:

1. history of cervical spine injury or surgery, if neck pain is secondary to other conditions (including neoplasm, neurological diseases or vascular diseases),
2. they have a radiculopathy presenting neurological deficit
3. they had infection or inflammatory arthritis in the cervical spine,
4. they have pain with any cause in or around the scapula, shoulder, upper extremities and lumbar spine that prevents stabilization of these structures.
Acute Mesenteric Ischemia, Reality in Catalonia

Acute mesenteric ischaemia (AMI) is a notorious disease with a high mortality, the diagnostic and management is truly multidisciplinary, but not very extended. The aim of this study is to analyse the results of the patients admited with an AMI in Catalonia.

Acute mesenteric ischaemia (AMI) is a notorious disease with a high mortality from 50 to 80%. Even though AMI is a relatively rare condition (1:1,000) the incidence rises exponentially with increasing age, in patients older than 75 years, the incidence of AMI has been reported higher than that of acute appendicitis. AMI patients benefit from early assessment in a surgical unit with capabilities to definitive management. The diagnosis and management of AMI are truly multidisciplinary, requiring high index of suspicion and awareness from emergency department physicians, preferably computed tomography angiography with precise interpretation, but usually this is not the truth reality and the diagnostic is delayed as well as the treatment, and the management is not multidisciplinary.

The aim of this study is to analyse the management and results of the patients admitted with an AMI in Catalonia from November 2024 to April 2026.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic of Acute Mesenteric Ischemia

Exclusion Criteria:

* Chronic Mesenteric Ischemia
* Ischemic Colitis
* Bowel obstruction strangulation
* Inflammatory bowel necrosis