cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Calcium and Vitamin D Supplementation During Marine Corps Training

The primary objective of this randomized, double-blind, placebo-controlled trial is to determine the efficacy and effectiveness of Ca and vitamin D supplementation provided daily throughout Marine Corps recruit training on maintenance of PTH and indices of bone strength in Marine Corps recruits. The investigators hypothesize that Ca+D will prevent elevations in PTH and result in greater increases in indices of bone strength compared to placebo.

Military recruits undergoing initial military training (IMT) are 17 times more likely to develop stress fractures compared to active duty service members. Up to 800 male and female recruits will be enrolled at the MCRD, Parris Island, SC over two seasons (summer/fall and winter/spring) in order to account for seasonal variation in vitamin D status. Ca (2000 mg/d) and vitamin D (1000 IU/d) will be supplied as either capsules or a fortified food product daily throughout training. This study will provide novel data for the military, medical and scientific communities regarding the relationship between Ca and vitamin D supplementation and biomarkers of immune function, and the requirements for calcium and vitamin D to support bone health during IMT.

Eligibility Criteria:
Inclusion Criteria:

* Male or female Marine Corps recruit at least 17 years of age.

Exclusion Criteria:

* Pregnant or breastfeeding
* History of kidney stones or kidney disease
* History of endocrine disorders
* Allergies to any component of the food product bar
Registration and Informed Consent Study for the Childhood Cancer Research Network

RATIONALE: Collecting informed consent from parents of children with cancer to register with the Childhood Cancer Research Network may help the study of cancer in the future.

PURPOSE: This study is collecting informed consent to register younger patients with cancer into the Childhood Cancer Research Network.

OBJECTIVES:

* Obtain informed consent from parents (and the child, when appropriate) of children diagnosed with cancer (who are under 21 years of age) to register their child's name and address with the Childhood Cancer Research Network.
* Obtain informed consent from parents (and the child, when appropriate) of children diagnosed with cancer (who are under 21 years of age) to be contacted in the future for possible participation in non-therapeutic research studies involving the parents and/or child.
* Facilitate the systematic registration of pediatric and adolescent patients diagnosed with cancer into the Childhood Cancer Research Network.

OUTLINE: Consent is obtained from parents (and pediatric patients, where applicable) to register the patient's and parent's names and addresses with the Childhood Cancer Research Network, provide a copy of the pathology report to the Network, and contact parents in the future for possible non-therapeutic research studies involving the parents and/or child.

Information provided will be held in strict confidence.

PROJECTED ACCRUAL: Not specified

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Child (\< 21 years of age) with newly diagnosed cancer

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
A Study to Evaluate Preventive Treatments for Talquetamab-related Oral Toxicity

The purpose of this study is to identify preventive treatments that can minimize the occurrence, severity, and duration of talquetamab-related taste changes (dysgeusia), during the prophylaxis (preventive) treatment phase, and to better characterize the signs or symptoms of talquetamab-related taste changes.


Eligibility Criteria:
Inclusion Criteria:

* Multiple myeloma (MM) according to IMWG diagnostic criteria
* Were triple-class exposed (received prior treatment with a PI, an IMiD, and anti CD38 mAb)
* Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
* Have an Eastern Cooperative Oncology Group-performance status (ECOG-PS) of 0 or 1 at screening. Participants with ECOG-PS 2 or 3 are eligible for the study if the ECOG-PS score is related to stable physical limitations (e.g., wheelchair-bound due to prior spinal cord injury) and not related to multiple myeloma or associated therapy
* Be willing and able to adhere to the lifestyle restrictions specified in the protocol

Exclusion Criteria:

* Contraindications or life-threatening known allergies, hypersensitivity, or intolerance to any study drug or its excipients
* Stroke, transient ischemic attack, or seizure within 6 months prior to screening
* Any of the following within 6 months prior to the first dose of study treatment: severe or unstable angina, myocardial infarction; major thromboembolytic event (e.g., pulmonary embolism, cerebrovascular accident), clinically significant ventricular arrythmia or heart failure New York Heart Association functional classification Class III or IV. Uncomplicated deep vein thrombosis is not considered exclusionary
* Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of talquetamab, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment
* A WETT score suggesting severe dysgeusia at screening. Also unresolved/severe dysgeusia referred by the participant or a finding in the physical examination/oral cavity inspection. Some examples include leukoplakia, prior mouth cancers, extensive dental caries, severe periodontitis, active oral infections, candidiasis, parotic gland removal, or radiotherapy with resultant xerostomia
Palliative Care in Maternity and Neonatology

Palliative care is now an accepted principle in most maternity and neonatology wards, however not much is known about its psychological and social consequences on families. Some children continue their life after a palliative care decision has been taken. In France, quality of life and the neuro-developmental evolution of newborns who continue their life after a palliative care decision has been taken, have never been studied.


Eligibility Criteria:
Inclusion Criteria:

* Father and/or Mother of a child, who is alive or not, for whom a decision of palliative care has been made in the neonatal period
* Under the care of one of the Level 3 Maternity Centers in the North and Pas-de-Calais departments (Arras, Lens, Lille, Valenciennes) since 2018
* Written consent of the two legal guardians of the child allowing the collection of data concerning the child
* Written consent of the parent(s) participating to this study by completing the parental questionnaires

Exclusion Criteria:

* Medico-legal complaint underway
* Parents who do not understand French
* Parents or children who are under legal protection (guardianship, curatorship)
* Parents or children who are not Social Security beneficiaries
Evaluation of a Simplified Strategy for the Long-term Management of HIV Infection (Simpl'HIV)

The purpose of this study is to evaluate whether maintenance antiretroviral therapy could be simplified to DTG + FTC dual therapy and/or patient-centered monitoring once virological suppression is achieved. Using a factorial design, the study aims to assess the efficacy of DTG + FTC dual therapy to maintain virological suppression through 48 weeks of follow-up as well as the costs of a patient-centered ART laboratory monitoring.

This is a pragmatic multicentre, 2x2 factorial randomized controlled trial with 1:1:1:1 randomization to switching to DTG-based maintenance dual therapy in association with FTC or continuation of cART, and to patient-centered monitoring or continuation of standard monitoring.

Patients will be followed during 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent as documented by signature;
2. Documented HIV-1 infection;
3. Enrolled in the Swiss HIV Cohorte Study (SHCS) or receiving care from a medical doctor of the SHCS network;
4. ≥ 18 years of age;
5. HIV-RNA \<50 copies/mL at screening and for at least 24 weeks before screening on effective suppressive cART, one blip with less than 200 copies/mL being allowed during this period if followed by at least 2 results \< 50 copies/mL.
6. On standard cART at the time of inclusion, i.e.:

   * 2 NRTIs + either 1 NNRTI, 1 boosted PI or 1 INSTI;
   * NRTI-sparing triple ARV regimen (e.g. 1 NRTI + 1 NNRTI + 1 InSTI);
   * Dual therapy with protease inhibitor.

Exclusion Criteria:

1. HIV-2 infection;
2. Previous ART change for unsatisfactory virological response, i.e. slow initial virological suppression, incomplete suppression or rebound. Change of drug or drug class for convenience or toxic effect prevention or management is allowed.

   Note: patients with documented genotype(s) presenting only a M184V mutation remain eligible;
3. Creatinine clearance \< 50ml/min;
4. ASAT or ALAT \>2.5x upper limit of the norm;
5. Known hypersensitivity, intolerance or allergy to DTG or FTC;
6. Known or suspected non-adherence (defined as \<80% adherence, i.e. missed doses \> 1x/week) to current treatment in the last 6 months;
7. Concomitant use of drugs that decrease DTG blood concentrations including carbamazepine, oxcarbamazepine, phenytoin, phenobarbital, St John's wort and rifampicin;
8. Women who are pregnant or breast-feeding;
9. a. Presence of any INSTI-resistance. Non-availability of INSTI resistance testing is NOT an exclusion criteria.

   b. Non availability of previous routine resistance test, at least for reverse transcriptase and protease genes.

   Note: Subjects remain eligible in the absence of any previous resistance test only if they are on their first-line antiretroviral regimen;
10. Evidence of acute or chronic hepatitis B virus infection based on results of serology testing.
(-)- Epicatechin Becker Muscular Dystrophy

This is a 48-week open-label extension of our initial proof-of-concept study (UCD0113) in patients with Becker muscular dystrophy who participated in the earlier trial. This single center study will enroll up to 10 adults who will receive the purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks. After screening visits, participants will be enrolled in the study if they meet all inclusion criteria. They will be evaluated at screening, baseline, and weeks 4, 8, 12, 24, 16 and 48. The main criterion for success of the study will be presence of one or more biologic or strength and performance outcome measures that yield a response magnitude that allows for sufficient power in a Phase II B study with a sample size of 30 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Prior participation in UCD0113 BMD epicatechin pilot study
* Male
* Age 18 years to 70 years
* Average to low daily physical activity
* Ability to ambulate for 75 meters without assistive devices
* Diagnosis of BMD confirmed by at least one the following:
* Dystrophin immunofluorescence and/or immunoblot showing partial dystrophin deficiency, and clinical picture consistent with typical BMD, or
* Gene deletions test positive (missing one or more exons) of the dystrophin gene, where reading frame can be predicted as 'in-frame', and clinical picture consistent with typical BMD, or
* Complete dystrophin gene sequencing showing an alteration (point mutation, duplication, or other mutation resulting in a stop codon mutation) that can be definitely associated with BMD, with a typical clinical picture of BMD, or
* Positive family history of BMD confirmed by one of the criteria listed above in a sibling or maternal uncle, and clinical picture typical of BMD.
* Hematology profile within normal range
* Baseline laboratory safety chemistry profile within normal range
* No plan to change exercise regimen during study participation
* Nutritional, herbal and antioxidant supplements taken with the intent of maintaining or improving skeletal muscle strength or functional mobility have been discontinued at least 2 weeks prior to screening (daily multivitamin use is acceptable).

Exclusion Criteria:

* Currently enrolled in another treatment clinical trial.
* History of significant concomitant illness or significant impairment of renal or hepatic function.
* Use of regular daily aspirin or other medication with antiplatelet effects within 3 weeks of first dose of study medication.
* Regular participation in vigorous exercise.
* Symptomatic heart failure with cardiac ejection fraction \<25%
Mobile Application Using the PRO-CTCAE to Improve Patients' Participation in Symptom Management During Treatment.

This study aims to evaluate the effect of a mobile application system using the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to improve patients' participation in symptom management during cancer treatment. Our hypothesis is that patients who use a mobile application using the PRO-CTCAE will more likely to recognize symptoms due to cancer treatment and report them better to their clinicians than patients who do not use the mobile application.

This is a randomized controlled trial to evaluate the effect of a mobile application system using the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to improve patients' participation in symptom management during cancer treatment. Breast, lung, head and neck, esophagus, and gynecologic cancer patients who will begin new lines of chemotherapy or radiation therapy will be randomly assigned into the intervention and control groups (2:1 ratio). The intervention group will have the mobile application installed on their smart phones which they could record symptoms and adverse events due to cancer treatments using the pre-specified PRO-CTCAE questions for different types of cancer. The control group will have usual care. Primary endpoint is patients' participation/engagement of reporting symptoms and it will be evaluated at 8 weeks after the intervention using a questionnaire developed by the research team. Secondary end points are unexpected hospital visits during treatment during 8 weeks after the beginning of the treatment and quality of life at 8 weeks after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to have chemotherapy or radiation therapy.
* Patients who own a smartphone (Android) and who can use mobile applications.
* Patients who understand the purpose of this study and agree to participate in the study
* Patients age over 18 years old (no age limit, but if necessary informed consent of the caregivers will be obtained for the patients whose age are over 70 years old)

Exclusion Criteria:

* Patients whose life expectancy is less than 6 months (hospice)
* Patients who would any physical or mental problems that would make them difficult to use the applications
A Prospective Study of Pharmacogenetic Factors and Gene Expression Profile

This study is a parallel translational study of a Randomized Phase III trial Investigating the Role of Oxaliplatin duration (6 Cycles Versus 12 Cycles) in modified FOLFOX-6 Regimen as Adjuvant Therapy for Patients with Stage II/III Colon Cancer (MIDAS trial: protocol NCCCTS-467) . Patients participating in the trial will be provided with the informed consent of this parallel study, and peripheral blood and tumor tissue of those who signed the consent will be collected for germline polymorphism analysis and gene expression profile study .


Eligibility Criteria:
Inclusion Criteria:

* Curatively resected, histologically confirmed colon adenocarcinoma (presence of the inferior pole of the tumor above the peritoneal reflection)
* AJCC/UICC high-risk stage II, stage III colon cancer Stage II patient with high risk of relapse, if they fulfill one or more of the following criteria:(T4 tumors,bowel obstruction or perforation,vascular or lymphatic or perineural invasion)
* Patients who are participating in the randomized phase II trial of FOLFOX 6 or 12 cycles
* Patients should sign a written informed consent for this translational study before or during participating in a randomized phase III study investigating the role of oxaliplatin duration (6 cycles versus 12 cycles) in modified FOLFOX-6 regimen as adjuvant therapy for patients with stage II/III colon cancer

Exclusion Criteria:

* Patients who do not agree with sampling of peripheral blood for genetic analysis
* Patients who are considered not to be suitable for this study at investigator's discretion
The Efficacy of Minayo Iron-rich Yeast Drink With SOD on Female Nutritional Anemia, Skin Condition and Qi-blood Deficiency Syndrome

The goal of this single arm, open-label study is to learn about the efficacy of Minayo Iron-rich Yeast Drink with SOD on females who are aged 18-35 and suffer nutritional Anemia, skin condition and Qi-blood deficiency syndrome. The main question it aims to answer is:

- whether the serum ferritin level in blood is improved after the intervention

14 qualified participants will be enrolled to drink the product "Minayo Iron-rich Yeast Drink with SOD" for four weeks, once a day. Four site visits will be made for each participant so that all relevant clinical data will be captured and recorded for data analysis and reporting.

Researchers will compare the final blood test result (hemoglobin concentration level, Glutathione (GSH), Superoxide Dismutase (SOD)) against the baseline to conclude whether the product will be effective in improving Anemia and skin conditions.


Eligibility Criteria:
Inclusion Criteria:

* Female, aged 18 to 35;
* Hemoglobin concentration level below 110g/L based on WHO diagnostic criteria for anemia;
* Agree not to take any drugs, supplements, or other dairy products during the trial;
* Agree not to take any other medications or supplements containing iron during the trial;
* Willing to refrain from participating in other interventional clinical studies during the trial period;
* Be able to fully understand the purpose, benefits and potential risks including side effects of the research;
* Willing to obey all test requirements and procedures;
* Informed consent signed.

Exclusion Criteria:

* Anemia caused by organic diseases;
* Subject who is in the treatment of gastrointestinal symptoms;
* Lactose intolerance;
* Subject who is currently presence of other organic diseases affecting intestinal function, such as history of gastrointestinal resection, colon or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, congenital megacolon, scleroderma, anorexia nervosa, etc.;
* Controlling diet, exercising, or taking medications to control weight or affect appetite in the last 3 months;
* Subject who has any of the following medical history or clinical findings that may affect the evaluation of the trial effect: significant gastrointestinal disorders, liver, kidney, endocrine, hematological, respiratory and cardiovascular diseases;
* Abuse alcohol or other drugs, supplement or OTC drugs currently or n the past may cause bowel dysfunction or can affect test result evaluation;
* Frequently use of medications that may affect gastrointestinal function or the immune system according to investigator's judgment;
* Take laxatives or other substances that promote digestion 2 weeks before the trail start;
* Subject who used drugs or supplements of iron agent 10 days before the beginning of the trial;
* Pregnant or lactating women or those planning to become pregnant during the trial;
* PI deems that subjects could not fully cooperate with trial arrangements.
A Multi-center Study of Low-dose Decitabine for the Treatment of Immune Thrombocytopenia

Decitabine has been reported to have a clinically significant, often long lasting effect on the platelet count in myelodysplastic syndromes(MDS). It is also reported that decitabine could increase platelet counts by enhancing megakaryocyte maturation and platelet release. Immune thrombocytopenia(ITP) is known as an immune-mediated acquired disease characterized by transient or persistent decrease of the platelet count. However, refractory ITP is lacking of effective treatments and the efficacy of decitabine in ITP remains poorly understood. Data from this study may provide some idea of decitabine in the treatment of ITP.

The investigators are undertaking a multicenter, single-arm study of primary ITP adult patients from 9 medical centers in China. All the participants are selected to receive low-dose of decitabine treatment (given intravenously at a dose of 3.5mg/m2 for 3 days per cycle for 3 cycles). Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with the diagnosis of ITP according to the International Working Group (IWG) guidelines
* failure to splenectomy or at least four standard ITP-specific treatments, but not necessarily undergone splenectomye
* baseline peripheral platelet count less than 30,000/uL or the presence of bleeding symptoms
* need of treatment(s) (including, but not limited to, low dose of corticosteroids) to minimize the risk of clinically significant bleeding. Need of on-demand or

Exclusion Criteria:

* secondary ITP
* pregnancy
* hypertension
* cardiovascular disease
* diabetes
* liver and kidney function impairment
* HCV, HIV, HBsAg seropositive status
* patients with systemic lupus erythematosus and/or antiphospholipid syndrome
Clinical Audit on the Use of Upper Endoscopy in Assist University Children Hospital

this protocol aides to evaluate:( 1)whether upper gastrointestinal endoscopy (UGE) is used appropriately according to the Guideline on pediatric GI endoscopy \[1\] commissioned by the European Society for Paediatric Gastroenterology Hepatology and Nutrition(ESPGHAN) and the European Society of Gastrointestinal Endoscopy(ESGE). In our hospital setting and(2) whether there is any relationship between appropriateness of gastrointestinal endoscopy and the presence of lesions detected by endoscopy.

gastrointestinal endoscopy is a safe and effective procedure. However,complications do exist and procedure-related costs are significant The rapid escalation of the cost of medical care, in the face of limited resources, is making the appropriateness of indications more and more essential to the rational utilization of such resources.Upper Gastrointestinal (UGI) endoscopy in the pediatric population has evolved during the last 30 years with an increasing number of diagnostic and therapeutic applications.

years with an increasing number of diagnostic and therapeutic Technological improvements and endoscopic devices have contributed to the evolution This prospective study is to determine whether upper gastrointestinal endoscopy is used appropriately in our hospital setting according to, the Guideline on pediatric GI endoscopy \[1\] commissioned by the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) and the European Society of Gastrointestinal Endoscopy (ESGE). and whether the appropriateness of use Predicts the probability of detecting significant lesions by endoscopy

Eligibility Criteria:
Inclusion Criteria:

* Weight loss,

failure to thrive

Unexplained anemia

Abdominal pain with suspicion of an organic disease

Dysphagia or odynophagia

Caustic ingestion

Recurrent vomiting exclusion criteria

patients with perforated viscous