cyrilzakka/clinical-trials huggingface dataset:
Caries Risk Assessment in Egyptian Children in Mixed Dentition Stage

This study aim to assess the validity of ADA caries risk assessment tool on the Egyptian Children in mixed dentition stage .

Dental caries is the most common chronic disease of childhood that causes health problems such as pain and infection in children reducing their quality of life.

Risk for caries includes physical, biological, environmental, behavioral, and lifestyle-related factors as insufficient fluoride exposure, poor oral hygiene,inappropriate methods of feeding infants, and poorness .

Risk is a probability that an event will occur. Caries Risk Assessment (CRA) is "prediction of future caries based on the diagnosis of current disease by evaluation of risk and protective factors for making evidence-based clinical decisions. Individual risk assessment constitutes the cornerstone of the treatment plan for the management of early childhood caries for pediatric patients. Caries risk assessment should be included in the treatment plan to facilitate The decision-making process concerning preventive care (both home and office) treatment, recall appointments.

An ideal risk assessment model should be inexpensive, easy to use and time efficient with a high degree of accuracy in caries predictive value.

American Dental Association (ADA) is a tool for caries risk assessment and Management , that when modified to meet the needs of an environment Will be of tremendous use in caries risk assessment. The ADA's mission is to help dentists succeed and support the advancement of the health of the public.

Eligibility Criteria:
Inclusion Criteria:

* Children age range from 6 to 12 years.
* Apparently healthy children.
* Children affected by dental caries.
* Parents acceptance for their children's participation in the study.

Exclusion Criteria:

* Children on long-term medication.
Nutritional Supplement and Bone Health in Post-Menopausal Women

The process of bone remodeling exhibits pronounced diurnal pattern that is important for bone health. A balanced rate of bone resorption is required to maintain bone health, a balance that can be disturbed during the lifecycle to effect net rate of formation (as occurs during growth and development to adulthood) or net resorption (as occurs, for example, during the menopause).The research to be undertaken investigates the pluripotent effect of dairy-based products on the regulation of the diurnal process of bone metabolism in post-menopausal women at risk of osteoporosis.

Study Design: A block randomised, cross-over design of 24h rates of bone turnover in healthy, post-menopausal women with osteopenia receiving either a milk-based protein supplement (MBPS) or isoenergetic placebo control (PLACEBO).

Participants: 16 Post-menopausal women with osteopenia as determined by site-specific bone mineral density BMD (DXA) diagnosed and screened by a clinician and for dietary intake of calcium and Vit D by a clinical dietitian.

Subject screening (clinical examination) and dietary intake of calcium and Vit D (by food frequency questionnaire) will precede the experimental protocol.

Experimental protocol and data collection:

Subjects will attend for a 2 day and 2 night (overnight) residence equipped to conduct residential human trials.

The subjects' programmed protocol is as follows;

1. Arrive @ 17:00h with overnight bag;
2. Empty bladder and then provide and retain urine samples for the duration of the stay (assisted collection by researchers);
3. Consume a standardised evening meal (pre-prepared by the research dietitian) and then relax reading/watching films etc;
4. At 20:00h a research nurse will insert a cannula into a superficial arm vein and a blood draw (5ml) will be taken and processed for later analysis;
5. Further blood draws (5ml) will be taken at 22:00h, 2300h, 2400h,0100h and 0200h and the cannula withdrawn;
6. At 22:00h consume either placebo control (PLACEBO) (day 1) OR supplement (MBPM)(day 2) - or vice versa - in randomised order.
7. Retire to bedroom;
8. Consume a standardised breakfast and lunch (pre-prepared by the research dietitian) whilst living in and around the University grounds (i.e. in close proximity to ensure 24h urine collection is complete);
9. Repeat from 2 above to end of 2nd day.

Eligibility Criteria:
Inclusion Criteria:

Post-menopausal women aged 50-70y. Assessed by site-specific BMD to be osteopenic. Assessed by clinical screen to be otherwise healthy and free from other illness or current medication likely to influence the study outcome.

Exclusion Criteria:

Intolerance to dairy-based food products
The Efficacy of 5-fluorouracil/Mitomycin for the Patients With Pulmonary Metastasis of Hepatocellular Carcinoma

The aim of this study is to evaluate the efficacy of 5-fluorouracil + Mitomycin for the patients with pulmonary metastasis of hepatocellular carcinoma who had progressive disease with sorafenib.

Extrahepatic metastasis of hepatocellular carcinoma has recently been paradoxically increasing due to increased survival with effective locoregional therapies. Sorafenib is the first systemic agent that has demonstrated a significant survival benefit in patients with advanced HCC; however, the modest improvement of 3 months is far from satisfactory. There is no convincing evidence, to date, that systemic chemotherapy when tumor progresses after sorafenib therapy improves overall survival. The combination of anticancer agents is important to achieve favourable clinical results. For patients with metastatic liver cancer or HCC, some studies have discussed the effectiveness of 5-fluorouracil/mitomycin(FM). However, few studies have examined the actual FM regimen for HCC.

The aim of this study is to evaluate the efficacy of 5-fluorouracil/mitomycin for the patients with pulmonary metastasis of hepatocellular carcinoma who had progressive disease with sorafenib.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have received previous local therapy treatments for the intrahepatic hepatocellular carcinoma (RFA, PEI, cryoablation, surgery, resection) and who don't have any viable intrahepatic tumor within 3 months of imaging (dynamic liver CT or liver MRI) after the locoregional therapy
* Patients who have measurable lung metastasis
* Patients who have received their last dose of sorafenib more than 14 days before and who had progressive disease of lung metastasis with sorafenib
* Patients who have risk factors of hepatocellular carcinoma (chronic hepatitis B, chronic hepatitis C, liver cirrhosis)
* Age : 18 years to 80 years
* ECOG Performance Status of 0 to 2
* Child-Pugh class A,B (Child-Pugh score 5-9)
* Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:

  * WBC count \> 1,000/mm3
  * Absolute neutrophil count \> 500/mm3
  * Hb \> 7.0 g/dL
  * Platelet count \> 50,000 /mm3
  * Bilirubin \< 3 mg/dL
  * Adequate clotting function: INR \< 2.3 or \< 6sec

Exclusion Criteria:

* Child-Pugh score \> 10
* ECOG Performance Status \> 3
* History of organ allograft
* Patients with uncontrolled co-morbidity which needs treatment
* Patients who have received prior systemic chemotherapy except sorafenib
Network-based Approach in Type 2 Diabetes and Its Cardiovascular Risk

PIRAMIDE study design will test the hypothesis that simultaneous interactions between DNA methylation and microRNAs may hit T2D candidate genes and predict the development of T2D-related cardiovascular complications.


Eligibility Criteria:
Exclusion Criteria:

* Clinical Diagnosis of Type 2 Diabetes. In according to current guidelines, diabetes is diagnosed by evidence of impairing fast glucose (IFG) \> 7.0 mmol/L (\>125 mg/dl), post prandial glycemia \> 11.1 mmol/L (\>200 mg/dl), and evidence of glycated hemoglobin (HbA1c) \> 6.6%. Clinical and demographic characteristics of study population will be avaiable from datasets generated by physicians.
* Clinical Diagnosis of macrovascular dysfunction.

Exclusion Criteria:

• Patients with known history of cancer, malignancy disorders, active infections, and chronic or immune-mediated diseases.
A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of LBAL compared to Humira® in subjects with active Rheumatoid Arthritis despite Methotrexate therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female patients from 20 years to 75 years of age when signing Informed Consent.
* Diagnosed as having RA (Rheumatoid Arthritis) according to the revised 1987 ACR (American College of Rheumatology) criteria for at least 3 months prior to screening
* Patients who have inadequate response to MTX administered for at least 12 weeks before the beginning of screening period and on a stable dose.

Exclusion Criteria:

* patients with active tuberculosis or latent tuberculosis based on current clinical symptoms, chest X-ray test and IFN-γ release assay at screening
* patients with any of the following concomitant diseases and/or history within 24 weeks before the first administration of investigational products in this study; Serious infectious disease, Opportunistic infection, Chronic or recurrent infectious disease
* patients with any seropositive result for hepatitis B or hepatitis C or HIV
* patients who have any of the following diseases; Sepsis, Demyelinating disorders, Lymphoproliferative disease, Infection with prosthetic joint, Autoimmune diseases other than rheumatoid arthritis
Safety, Tolerability and Activity Study of Multiple Doses of ISIS-SGLT2Rx in Healthy Volunteers

The primary purpose of this trial is to assess the safety and tolerability of ISIS-SGLT2Rx when given at increasing single doses and to assess the safety and tolerability of the same doses when given multiple times.

To evaluate the safety and tolerability of a single subcutaneous injection of ISIS-SGLT2Rx administered at four increasing dose levels (50, 100, 200, 400 mg) and to evaluate the safety and tolerability of multiple doses of ISIS 388626 administered subcutaneously of either 6 or 13 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years
* Male or female gender although females must be post-menopausal or surgically sterile (hysterectomy, oophorectomy or tubal ligation)
* Give written informed consent to participate in the study and availability for all study requirements
* Fasting plasma glucose \</= the upper limit of the laboratory's reference range (ULN)
* HbA1c \</= ULN
* BMI \< 30 kg/m²
* Agree to maintain steady hydration throughout study participation and agree not to fluid restrict

Exclusion Criteria:

* Pregnant women, nursing mothers or women of childbearing potential
* Clinically significant abnormalities in medical history or physical examination
* Clinically significant abnormalities in laboratory examination (including ALT \> ULN, AST \> ULN, bilirubin \> ULN, creatinine \> ULN, urine protein positive by urine dipstick, platelets \< lower limit of normal and any other clinically significant laboratory findings)
* Estimated GFR \< 60 mL/min per 1.73m²
* History of clinically significant abnormalities in coagulation parameters
* Positive test result for HIV, hepatitis B virus, and/or hepatitis C virus
* Active infection requiring antiviral or antimicrobial therapy
* Subjects on chronic or acute prescription medication may be permitted after discussion with the Isis Medical Monitor
* Malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for \> 1 year)
* Any other concurrent condition which, in the opinion of the Investigator, would preclude participation in this study or interfere with compliance
* Past and present history of alcohol or drug abuse (defined as \> 3 units daily)
* Undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days prior to Screening
* Blood donation within three months of Screening
Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

This is a post-marketing single arm, phase IV trial in which patients with high-risk early-stage HR+HER2- breast cancer will receive adjuvant abemaciclib in combination with endocrine therapy (ET) After study intervention, participants will remain on combination abemaciclib + ET at the discretion of their treating providers

Dose escalation (DE) was shown to minimize the rates of Grade 3 diarrhea in the setting for HER2+ breast cancer. DE can improve tolerability for drugs such as abemaciclib. This is a post-marketing single arm, phase IV trial in which patients with high-risk early-stage HR+HER2- breast cancer will receive adjuvant abemaciclib in combination with endocrine therapy (ET) After study intervention, participants will remain on combination abemaciclib + ET at the discretion of their treating providers

In this study, the investigators we will test the hypothesis that gradual up-titration of abemaciclib dose over a course of 2-3 weeks will decrease the rate of G3 or worse diarrhea, permitting more patients to remain at the intended dose when evaluated at day 84

Eligibility Criteria:
Inclusion Criteria:

* ECOG 0-2
* Histologically confirmed early-stage HR+HER2- breast cancer documented by biopsy who are prescribed adjuvant abemaciclib
* Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization.
* Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.
* As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.

Exclusion Criteria:

* Chronic history of diarrhea
* Active infection requiring systemic therapy
* Uncontrolled HIV/AIDS or active viral hepatitis
* Pregnant or nursing
* Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.
* Other major comorbidity as determined by study PI
Functional Performance of the Journey Deuce Bicompartmental Versus the Genesis II Total Knee System

The objectives of this study are to assess the safety and effectiveness of the Journey Deuce Bicompartmental Knee System at 4-6 weeks, 4 months, 1 year, and 2 years when compared to total knee replacement using the Genesis II Total Knee System. The hypothesis is that the Journey Deuce Bicompartmental Knee System is as safe and effective as the Genesis II Total Knee System at the 2-year. The null hypothesis is that there is no difference between the groups.


Eligibility Criteria:
Inclusion Criteria:

* Patient presents with non-inflammatory degenerative joint disease of the medial and patellofemoral compartments requiring a unilateral knee replacement.
* Patient is 30 to 65 years of age, inclusive.
* Patient is willing to consent to participate in the study by signing and dating an IRB-approved consent form.
* Patient plans to be available for follow-up through 2 years postoperative.

Exclusion Criteria:

* Patient is known to have insufficient femoral or tibial bone stock resulting from conditions such as cancer, distal femoral/proximal tibial osteotomy, significant osteoporosis or metabolic bone disorders.
* Patient is immunosuppressed, has an autoimmune disorder, or an immunosuppressive disorder (i.e. chronic condition characterized by markedly inhibited ability to respond to antigenic stimuli.) Examples of such conditions include patients who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses) or patients with acquired immunodeficiency syndrome (AIDS).
* Patient has inflammatory arthritis (e.g. rheumatoid arthritis)
* Patient has BMI \> 35.
* Patient has had major knee surgery in the past i.e. HTO, unicondylar knee replacement, failed fracture fixation.
* Patient has an active infection, local or systemic.
* Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up (e.g.: drug or alcohol abuse, serious mental illness, or general neurological conditions such as Parkinson, Multiple sclerosis, etc.).
* Patient has ACL deficiency in the study knee.
* Patient has hip arthritis and/or replacement.
* Patient has lateral compartment disease.
* Patient is pregnant or plans to become pregnant during the course of the study.
* Patient is on workman's compensation.
* Patient has a known sensitivity to materials in the device.
Pain Self-management Program for Older Adults

It is well documented that severe pain is more common in older adults than it is younger persons. Of concern, older adults may not have access to traditional face-to-face self-management programs, which are recognized to be valuable in chronic pain management. Access to effective self-management approaches is particularly important for older adults who may have mobility limitations or live in remote areas, or have difficulty accessing health care services. The development of effective pain self-management programs for older adults who cannot access traditional psychological interventions is of significant importance. Internet self-management programs have the potential to address pain undermanagement. As technology advances, the digital divide between the older and younger demographic continues to progress. Given the known difficulties with treatment access, the purpose of this study is to explore the efficacy and acceptability of a remotely-delivered chronic pain self-management program tailored to older adults, the Pain Course, when delivered in online and workbook formats. The program was previously shown to be effective among younger persons but has not been tested with older adults.

The program is delivered through a secure platform administered by the Online Therapy Unit for Service Education and Research at the University of Regina. Using a patient preference randomized control trial (RCT) design, participants (n = 120) will be enrolled in either the online group or workbook group, or to a wait list control group. The content of both programs will be identical and contain 5 core lessons, which participants will be encouraged to work through over an 8-week period. By exploring the efficacy of an online vs. workbook group, the results from this study may serve as a stepping-stone for improved self-management of chronic pain in older adults.

A patient preference randomized controlled trial (RCT) was chosen for this study. The goal is to have most participants accept randomization by emphasizing they are equally acceptable, so only those with a very strong preference or no access to Internet aren't randomized. According to the preliminary power analysis, a total of 120 participants will be randomly assigned to be enrolled in the online group or workbook group, or be placed on a twelve-week wait list control, which will serve as a control group to control for the influence of time on symptom change between groups.

Eligibility Criteria:
Inclusion Criteria:

* are residents of Canada
* are 65 years of age or older
* report experiencing pain for more than three months
* are not experiencing very severe symptoms of depression or anxiety
* have regular access to a computer and the internet
* are proficient in writing and speaking the English language

Exclusion Criteria:

* high suicide risk
* concerns about online therapy
* not present in the country during treatment
* are younger than 65 years of age
Efficacy and Safety of Memantine and Sodium Oligomannate in Patients With Moderate to Severe Alzheimer's Disease

Alzheimer's disease (AD) is the main cause of dementia. At present, AD is incurable. Memantine is recommended for the treatment of moderate and severe AD patients. Sodium oligomannate (GV-971) is a marine-derived oligosaccharide. It is proposed that it can reconstitute the gut microbiota, and inhibit neuroinflammation in the brain as observed in animal models. It reduces Aβ deposition in the brain of Aβ-transgenic mice. The reduction in both Aβ deposition and neuroinflammation may synergistically contribute to the improvement of cognitive impairment and delay the progress of the disease. China Food and Drug Administration（CFDA）approved it for the treatment of mild to moderate AD in 2019. Due to the different mechanism of memantine and GV-971, theoretically, they may synergistically improve cognitive function and delay disease progression. However, there is a lack of data on their effectiveness and safety. Therefore, the purpose of this study is to compare the efficacy and safety of memantine and GV-971 monotherapy and combination therapy in patients with moderate to severe AD, which is of great significance for guiding the treatment of moderate and severe AD.


Eligibility Criteria:
Inclusion Criteria:

* age of 50-80 years old , either sex;
* met the diagnostic criteria for suspected AD;
* moderate to severe AD patients(5 points ≤Mini-Mental State Examination total score≤14 points);
* total Hachinski ischemic scale (HIS) score ≤4 points;
* memory loss for at least 12 months, with a progressive deterioration;
* brain MRI scan suggesting a significant possibility of AD;
* no obvious physical signs during nervous system examination;
* stable and reliable caregivers;
* elementary school or higher education level;
* signed an informed consent form.

Exclusion Criteria:

* previous nervous system diseases ;
* mental illness;
* unstable or severe heart, lung, liver, kidney, or hematopoietic diseases;
* uncorrectable visual and auditory disorders;
* simultaneous use of cholinesterase inhibitors, memantine or GV-971.
On the Safety, Tolerability, and Efficacy of UTAA09 Injection in the Treatment of Lymphoma

The main research objective is to evaluate the safety, tolerability, and pharmacokinetic characteristics of UTAA09 cell preparation in the treatment of relapsed/refractory B-cell non Hodgkin's lymphoma patients. The secondary research objective is to explore the clinical efficacy of UTAA09 injection after administration and to explore the content of CD19 positive B cells in peripheral blood after UTAA09 injection administration.

Single dose, single arm trial, exploring the initial 28 day safety and efficacy of the investigational drug.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects voluntarily participate in clinical studies;
2. ECOG score 0-1 points;
3. Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and inert lymphoma transformed into diffuse large B-cell lymphoma; CD19 and/or CD20 positivity;
4. At least one measurable tumor lesion determined according to Lugano's criteria: the longest diameter of intranodal lesions\>1.5cm, and the longest diameter of extranodal lesions\>1.0cm.

Exclusion Criteria:

1. Received other chimeric antigen receptor therapy or gene modified cell therapy before screening;
2. Subjects who were undergoing systemic steroid therapy during screening and were determined by the researchers to require long-term use of systemic steroid therapy during the treatment period (excluding inhalation or local use);
3. Any unstable heart disease, including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \[NYHA\] classification ≥ III), and severe arrhythmia.