cyrilzakka/clinical-trials huggingface dataset:
Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer

A research study on the diagnosis of spread of disease for children who have been diagnosed with solid tumors using a new whole body imaging technique and a new MR contrast agent (ferumoxytol). Standard tests that are used to determine the extent and possible spread of a child's disease include magnetic resonance (MR) imaging, computed tomography (CT), Positron Emission Tomography (PET) as well as bone scanning, and metaiodobenzylguanidine (MIBG) scanning. The purpose of this study is to determine if newer imaging tests referred to as whole body diffusion-weighted MR and whole body PET/MR can detect the extent and spread of the disease as accurately or even better as the standard tests (CT, MR and/or PET/CT). The advantage of the new imaging test is that it is associated with no or significantly reduced radiation exposure compared to standard CT and PET/CT imaging tests. The results of whole body MR and PET/MR will be compared with that of the conventional, standard imaging studies for tumor detecting.

Primary Objective: To compare the sensitivity, specificity and accuracy of WB-DW-MR scans (new technique) with 18F- FDG PET or 18F- FDG PET/CT or 18F- FDG PET/MR scans.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a solid extra-cranial tumor like malignant lymphoma or malignant sarcoma and
* Scheduled for or completed a 18F-FDG-PET or 18F-FDG-PET/CT tumor staging procedure.
* There will be no restrictions on prior treatment.
* Very young children who need sedation or anesthesia will be excluded from the study.
* In this pediatric \& adult study, the participant or parent/guardian is consented, and the patient when a minor is given an assent form and involved in the discussion as appropriate.

Exclusion Criteria:

* MR-incompatible metal implants,
* need of sedation or claustrophobia.
* Hemosiderosis/hemochromatosis (patients can still be included in 2nd branch without ferumoxytol)
* There will be restrictions regarding use of other Investigational Agents: Pt with iron-overload will not receive Ferumoxytol
* History of allergic reactions to similar compounds will be obtained and patients with a positive history of allergic reaction to iron compounds or other severe allergic reactions.will be excluded from the study.
* Pregnant women and fetuses.
24-hour Intraocular Pressure (IOP) Control With the Bimatoprost/Timolol Fixed Combination

The objective of this crossover, randomized, placebo controlled, double-masked study is to compare the short-term (12 weeks) mean 24-hour IOP control and safety of the new fixed combination (bimatoprost/timolol, BTFC) given PM with placebo once in the morning, versus BTFC given AM with placebo once in the evening versus bimatoprost given in the evening in patients with exfoliative glaucoma (XFG).

PRIMARY STUDY OBJECTIVES

* To show that the mean 24-hour IOP control obtained with BTFC (morning or evening) is statistically better to that with bimatoprost monotherapy given once on the evening.
* To demonstrate that the fixed combination will provide a significantly better IOP control in the morning when dosed in the evening.
* To test whether the mean 24-hour IOP control obtained with BTFC given once in the evening may be statistically better to that with BTFC given once in the morning.
* To show whether there will be less 24-hour fluctuation of IOP with the evening dosing of BTFC.

STUDY POPULATION

Consecutive newly-diagnosed, or suitably washed-out patients with exfoliative glaucoma (XFG) who exhibit a mean untreated IOP greater than 25 mm Hg at baseline (10:00).

Eligibility Criteria:
Inclusion Criteria:

* The patient is suffering from XFG (if the patient has bilateral XFG, both eyes will be treated, but the worse eye will be selected for the statistical analysis)
* Patient is older than 39 years and younger than 85 years
* Patient is able and willing to participate in the study for the whole duration of the follow up. Will sign the consent form.
* At screening the untreated IOP at 10:00 (± 1 hr) is greater than 25 mm Hg and lower than 40 mm Hg
* After bimatoprost run-in therapy the treated IOP at 10:00 (± 1 hr) is greater than 19 mm Hg
Effects of Portion Size and Energy Density of a Single Meal in Preschool Children

This study investigates the effect of varying both energy density and portion size of all foods at lunch on preschool children's intake. The foods used in this study are commercially-available, commonly-consumed foods with typical variations in energy density. The primary aim of the study is to investigate the independent and combined effects of energy density and portion size on preschool children's intake at a meal composed of foods typically served to this population.


Eligibility Criteria:
Inclusion Criteria:

* Children must be enrolled in participating childcare centers.

Exclusion Criteria:

* Allergy or intolerance to any of the foods or beverages served.
Clinical Evaluation of Resin Matrix Ceramic Posterior Crowns

The objectives of the present prospective randomized clinical study are to evaluate and to compare the survival and success rates, possible biological and technical complications, and the clinical performance of metal-ceramic, monolithic zirconia and resin-matrix posterior crowns.

The null hypothesis is that no differences would be found between the parameters studied for each type of restoration.

A total of 60 patients, in whom the placement of a crown in the posterior region of the maxilla or mandible was indicated, will be included in the study. The patients will be recruited from the Master of Buccofacial Prostheses and Occlusion (School of Dentistry; University Complutense of Madrid). Prior to treatment, patients will be informed regarding the aims of the study, the clinical procedure, the materials used, the risks and benefits of ceramic restorations and the alternatives to the proposed treatment. All the patients will be provided with a written informed consent for the inclusion in this study, Ninety posterior crowns will be produced and assigned in parallel and randomly to either resin-matrix ceramic, zirconia or metal-ceramic restorations. Three experienced prosthodontists will treat the patients. Abutment preparation will be performed in a standardized manner: circumferentially chamfer (1 mm in width), axial reduction of 1 mm, and an occlusal reduction of 1.5 to 2 mm. The tapering angle between the axial walls will be approximately 10- to 12- degrees. Full-arch digital impressions will be taken using an Intraoral Scanner. The restorations will be cemented with a resin cement. The restorations will be examined at one week (baseline), 1, 2, and 3 years, by two researchers who were not involved in the restorative treatment

Eligibility Criteria:
Inclusion Criteria:

* One posterior tooth (molar or premolar) to be crowned,
* Vital abutments or abutments with sufficient endodontic treatment
* Abutment not crowned previously
* Periodontally healthy abutments with no signs of bone resorption or periapical disease --
* Adequate occlusogingival height
* Stable occlusion, and the presence of natural dentition in the antagonist arch.

Exclusion Criteria:

* Patients who present reduced crown length (less than 3 mm occlusogingival height
* Poor oral hygiene, high caries activity, active periodontal disease or bruxism.
Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma

The purpose of the ALPHA study is to assess the safety, efficacy, cell kinetics and immunogenicity of ALLO-501 in adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of Large B-cell Lymphoma (LBCL) or Follicular Lymphoma.
* Relapse or refractory disease after at least 2 lines of chemotherapy
* At least 1 measurable lesion at time of screening.
* Eastern Cooperative Oncology Group Performance Status of 0 or 1.
* Adequate hematological, renal, liver, pulmonary, and cardiac functions.

Exclusion Criteria:

* Current or history of central nervous system (CNS) lymphoma.
* Clinically significant CNS dysfunction.
* ASCT within last 6 weeks or allogeneic HSCT within last 3 months prior to ALLO-647.
* Prior treatment with anti-CD19 therapy, any gene therapy, any genetically modified cell therapy or adoptive T cell therapy
* Systemic anticancer therapy within 2 weeks prior to study entry.
* On-going treatment with immunosuppressive agents.
* Active acute or chronic graft versus host disease (GvHD), or GvHD requiring immunosuppressive treatment within 4 weeks of enrollment.
* Any form of primary or acquired immunodeficiency (e.g., severe combined immunodeficiency disease).
* Current thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy.
* Patients unwilling to participate in an extended safety monitoring period
Diagnostic Equivalence of the Skin Prick Test Tape vs. Conventional Skin PrickTest

Testing of a new ready-to-use Tape in comparison to the currently used skin prick test for the diagnosis of allergies. Assessment of clinical equivalence of the SPT Tape for representative common inhalant allergens to conventional SPT in terms of wheal reaction positivity and overall safety. Tests are performed in patients who have a medical history of relevant allergic rhinitis to any of the tested allergens.

An open-label, single site bridging study. Subjects with a history of in-halation allergies will be tested in parallel with the SPT Tape and with the conventional SPT procedure using one forearm each.

In each patient, a panel of 8 allergens with the SPT Tape and with the conventional SPT is applied on the two forearms one time only.

The following Soluprick® allergens and control solutions will be evaluated:

Positive control, negative control, Phleum pratense, birch, Dermatophagoides pteronyssinus, D. farinae, dog dander, cat dander, mugwort, Alternaria sp. The allergens used for the SPT and the SPT Tape are identical Soluprick allergen solutions; allergens will be applied in the same location and order on both arms.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be included only, if

  1. they were informed about the nature, meaning, and scope of the study, and if they provided written consent to their participation
  2. they are at least 18 years of age,
  3. they have a history of allergic rhinitis due to grass and/or birch pollen, house dust mites, mugwort, cat and/or dog dander, and/or Alternaria since 2 years or more

Exclusion Criteria:

* Subjects may not be included, if

  1. they are impaired in understanding nature, meaning, and the scope of the study, or are incapable of giving written informed consent,
  2. they suffer from diseases, show other conditions, or take medications, which might impact the skin tests or might contradict the correct conduct and evaluation of the study. In particular this includes the following:

     1. acute allergy,
     2. history of systemic reactions or hypersensitivity to allergens, abuse of drugs or alcohol
     3. severe diseases,
     4. impaired reactivity of the skin (e.g. hyperkeratosis, ichthyosis, urticaria factitia) and acute chronic eczema in the skin test areas, skin infections,
     5. pregnancy or nursing,
     6. treatment with β-blockers,
     7. treatment with antihistamines or systemic glucocorticoids during the last 4 weeks, with astemizol during the last 12 weeks,
     8. treatment with tricyclic antidepressants benzodiazepines, and neuroleptic drugs which may have histamine-antagonistic effects during the last 2 weeks,
     9. participation in any other medication study at the study time
The Effects of Electronic Cigarettes on the Microcirculation of the Hand

Cigarette smoking is associated with poor wound healing and worse results after hand surgery. Nicotine and cigarette smoke has been shown to affect blood flow in blood vessels in the hand.

Patients are increasingly using electronic cigarettes (e-cigarettes) as a method of quitting smoking. E-cigarettes consist of a replaceable nicotine cartridge, a heating element and a battery source. They are able to deliver vaporised nicotine in the absence of other ingredients found in normal cigarettes such as tar and carbon monoxide.

Although e-cigarettes lack a lot of the harmful ingredients of regular cigarettes, nicotine still has toxic effects on the body. Nicotine causes the release of chemicals within the body that act to reduce blood flow in small blood vessels of the hand.

E-cigarettes remain a controversial topic among healthcare professionals due to the lack of research surrounding them. A recently published literature review identified only three significant studies into the effects of smoking e-cigarettes. All of these studies showed the harmful effects of e-cigarettes on the lungs but to date, there is no published research investigating the effects of e-cigarettes on the blood flow within the small blood vessels of the hand.

Currently, we advise patients to quit smoking after they sustain a hand injury to improve healing and recent research suggests that patients should be advised to quit smoking 4 weeks before routine hand surgery. However, there is no guidance on whether we should also advice patients to refrain from using e-cigarettes for this time period.

Our aims are to answer the following questions:

1. Do electronic cigarettes have any effect on the blood flow in the hand?
2. Do we need to give cessation advice to patients with hand injuries who smoke electronic cigarettes?


Eligibility Criteria:
Inclusion Criteria:

* Volunteers between 18-65yrs
* Volunteers with no co-morbidities
* Volunteers with no history of oral infections

Exclusion Criteria:

* Volunteers with ongoing co-morbidities requiring medical treatment
* Volunteers with a history of oral infections e.g Herpes Simplex Virus
* Volunteers who lack capacity to consent to the study
* Volunteers who are currently on nicotine replacement therapy
* Volunteers who have had use of a cigarette or nicotine containing product within 4 hours of beginning the study
* Volunteers who have previously quit smoking
Mechanisms of Diabetes Control After Weight Loss Surgery, Sub-study #1

Gastric bypass (GBP) and laparoscopic adjustable banding (AGB) are common procedures that can result in significant weight loss and significantly improve type 2 diabetes in 40-80% of cases. The mechanism and time course of these changes have not been well studied and are poorly understood. The primary aim of this study is to investigate the potential weight-independent mechanisms of diabetes remission after GBP, by comparing GBP and AGB subjects after similar weight loss.

All participants will be tested before and then after 10 and 20-30% weight loss after either GBP or AGB surgery. Subjects will undergo an oral glucose tolerance test (OGTT) an isoglycemic intravenous glucose test (IVGT) to assess the incretin effect, a measure of insulin sensitivity by an intravenous insulin sensitivity test (IVGTT) and body composition measurements.

Eligibility Criteria:
Inclusion Criteria:

* obese type 2 diabetes individuals scheduled to undergo bariatric surgery by either gastric banding or gastric bypass surgery
Aspirin or Rivaroxaban Thromboprophylaxis for Patients With Multiple Myeloma

The aim of this study is to evaluate the efficacy and safety of aspirin and rivaroxaban in thromboprophylaxis in Chinese MM patients at high risk for MM-associated VTE.

Venous thromboembolism (VTE) is one of the most common and dangerous complications of Multiple Myeloma (MM). The occurrence of VTE can disrupt treatment plans, compromise patients' quality of life, and even threaten their lives, presenting significant challenges in clinical management. Although several guidelines recommend risk-stratified thromboprophylaxis, there is a deficiency in prospective validation, and most initial studies were conducted in Western cohorts. This prospective, multicenter, open-label, randomized study aims to compare the efficacy and safety of aspirin or rivaroxaban in preventing VTE in Chinese MM patients who are at high risk for VTE.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed multiple myeloma (according to Guidelines for the diagnosis and management of multiple myeloma in China (2022 revision))
2. High risk of VTE (according to Expert consensus on the prevention and treatment of multiple myeloma related venous thromboembolism in China (2022))
3. Life expectancy exceeding 12 months
4. Gender: not specified, Age: 18-90 years
5. Serum HIV antigen or antibody negative
6. HCV antibody negative, or HCV antibody positive with HCV RNA negative
7. Echocardiogram shows a left ventricular ejection fraction of ≥50%
8. Ability to sign an informed consent form

Exclusion Criteria:

1. Pregnant women or women who are breastfeeding
2. Active gastrointestinal ulceration
3. Active bleeding
4. When initiating treatment, platelet count below 50 G/L, or with PT prolonged by more than 3 seconds, and APTT prolonged by more than 10 seconds.
5. Abnormal liver function (ALT or AST greater than 3 times the upper limit of normal, or total bilirubin greater than 2 times the upper limit of normal)
6. Abnormal renal function (creatinine clearance \< 30 mL/min)
7. Unable to cooperate in completing the clinical trial
8. Already enrolled in other clinical studies
9. Diagnosed with smoldering multiple myeloma or plasma cell leukemia
10. Patients already on antiplatelet therapy for other cardiovascular or cerebrovascular diseases.
Alzheimer's Family Caregiver Intervention in Vietnam

This is a single arm pilot study of 6-8 families to test the feasibility and acceptability of a Alzheimer's family caregiver intervention in Vietnam.

This is a single arm pilot study of 6-8 families to test the feasibility and acceptability of a modified version of the REACH-VA caregiver intervention in Vietnam. The REACH-VA caregiver intervention is an evidence-based intervention that has been shown to be effective in multicultural populations in the US. The model has been modified for use in Vietnam. This study will test the modified model in Vietnam. Participants in this study will be adult family caregivers of non-institutionalized persons with dementia who are living in Hanoi, Vietnam. They will receive 4-6 sessions delivered over the course of 2-3 months that will included the following components: 1) education about the nature of the disease, 2) risk assessment, 3) enhancing caregiver skills and problem-solving, and 4) caregiver stress reduction. The intervention will be delivered by a social worker or nurse using a Vietnamese language versions of the REACH-VA protocol and caregiver intervention notebook.

Eligibility Criteria:
Inclusion Criteria:

* Primary adult family caregiver of person with dementia

Exclusion Criteria:

* Caregivers of persons with dementia who are institutionalized
The Roles of IL-9/E-cadherin and Ferroptosis in Intestinal Mucosal Barrier Injury in Sepsis

The investigators aim to evaluate the roles of IL-9/E-cadheirin and ferroptosis in the intestinal mucosal barrier injury of sepsis. The results of this study would lay the foundation for revealing the mechanisms of EEN improving immune imbalance of sepsis and provide a new idea to the early treatment of sepsis.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of sepsis
2. Within 3 days of sepsis onset before ICU admission
3. No artificial nutrition (enteral or parenteral nutrition) were provided before ICU admission

Exclusion Criteria:

1. Ileus
2. Digestive tract hemorrhage
3. Inflammatory bowel disease
4. Cancer or chronic organ dysfunction (e.g., hepatic or renal dysfunction)
5. Malnutrition or immunodeficiency
6. Long-term use of hormones
Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer

The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed small cell lung cancer (SCLC)
* Subjects with either limited or extensive disease stage at the initial diagnosis
* Must have recurrence or progression after platinum-based first-line chemotherapy or chemoradiation therapy for the treatment of limited or extensive disease stage SCLC
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

* Untreated or symptomatic central nervous system (CNS) metastases
* Prior therapy with anti-PD-1, anti-PDL1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody
* Inadequate hematologic or hepatic function
Comparison of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-term Intensive Insulin Therapy

Primary Objective:

To test the hypothesis that basal insulin based treatment (G+) is noninferior to twice-daily premixed insulin (PM-2) in term of hemoglobin A1c (glycosylated hemoglobin, HbA1c) reduction from baseline to end of study. The test for superiority can be done if noninferiority is achieved.

Secondary Objectives:

* To assess efficacy in terms of percentage of patients achieving HbA1c \<7% and HbA1c \<7% without hypoglycemia.
* To assess efficacy in terms of percentage of patients achieving fasting plasma glucose (FPG) \<7 mmol/L and FPG \<7 mmol/L without hypoglycemia.
* To assess safety in term of occurrence of moderate/severe hypoglycemia.
* To assess daily blood glucose (BG) variation.
* To assess patient satisfaction.

The duration of study is approximately 21 months. Each patient will be followed for approximately 27 weeks from screening visit to end-of-study

Eligibility Criteria:
Inclusion criteria :

* Patients with age between 18 and 70 years.
* Hemoglobin A1c\>7.5%, and ≤11%.
* Fasting plasma glucose \>7 mmol/L.
* Fasting C peptide \>1 ng/mL.
* Type 2 diabetes (T2DM) patients with diabetes diagnosis between 2 and 10 years (World Health Organization 1999 T2DM diagnose criteria).
* Continuous treatment with stable doses of metformin (≥1 g/day) and 1 oral antihyperglycemic drug (at least half maximum dose) for more than 3 months prior to screening.
* Body mass index ≥21 kg/m2, and \<40 kg/m2.

Exclusion criteria:

* More than 7 consecutive days of insulin treatment within the 12 months except for acute disease or surgery.
* Diabetes other than T2DM (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake).
* History of hypoglycemia unawareness or recurrent hypoglycemia or severe hypoglycemia within the past 12 months.
* History of sensitivity to the study drugs or to drugs with a similar chemical structure.
* Pregnancy or planned pregnancy or current lactation (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method).
* Acute diabetic complications (diabetic ketoacidosis, lactic acidosis, hyperosmolar nonketotic diabetic coma) within the past 12 months.
* Significant diabetic complications and serious disease, e.g., symptomatic autonomic neuropathy, gastroparesis, unstable angina or active proliferative retinopathy.
* Acute infections which may affect BG control within the past 4 weeks.
* Active liver disease, alanine transaminase (ALT) and/or aspartate aminotransferase (AST) greater than two times the upper limit of the reference range at screening.
* Impaired renal function, defined as but not limited to, serum creatinine levels ≥1.5 mg/dL (132 μmol/L) for males and ≥1.4 mg/dL (123 μmol/L) for females or presence of macroproteinuria (\>2 g/day).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.