cyrilzakka/clinical-trials huggingface dataset:
How Much Vitamin D is Needed in Milk Products to Support Vitamin D Intake and Bone Health in Children?

The study is a parallel interventional randomized dose-response trial designed to improve vitamin D intakes through food in a group of healthy 2 - 7.9 year old children. Subjects will be recruited from the general population in the greater Montreal area. The study will be conducted at the Mary Emily Clinical Nutrition Research Unit of McGill University. Children will be required to attend two study visits. Some information will be collected through monthly telephone survey to the parents. The investigators will add vitamin D to cheese and yogurt for daily consumption at home over a three month period. All products will be provided to the parents in the form of coded containers that do not contain any labels aside from the group and expiration date. Ingredient lists will be provided upon consenting to the study. To better understand vitamin D status; dietary intake, hematology, serum biochemistry including 25(OH)D, growth, and body composition will be measured at the beginning and end of the three month study period. In addition, bone mass at baseline will be assessed. Sun exposure will be documented and a skin pigmentation test will be used to more objectively assess chronic sun exposure. The investigators will also investigate the association between vitamin D intake and status with immune function.


Eligibility Criteria:
Inclusion Criteria:

* Children will be pre-pubertal
* Healthy
* Regularly consume milk and milk products
* Healthy weights

All races will be studied.

Exclusion Criteria:

* Chronic diseases (including asthma) or medications known to affect vitamin D, infections or the immune system; known anaemia, small size at birth or preterm birth \<37 wk gestation
* No milk allergy or lactose intolerance, no nutritional supplements Less than 1/3rd of preschool age children take a supplement based on our work; it will thus not be a limitation for recruitment to exclude supplement users. We will not study obese children since the response to exogenous vitamin D intervention is reduced.
Prospective S&E Study of Wavefront-guided PRK for Myopia With iDesign Advanced Wavescan Studio™ System and Star S4 IR™

Prospective, multicenter, bilaterally-treated, open-label, non-randomized clinical trial.


Eligibility Criteria:
NOTE: Enrollment open only to military personnel

Inclusion Criteria:

* Signed informed consent and HIPAA authorization.
* Refractive error, based on the iDesign displayed refraction must be myopia with or without astigmatism with sphere up to -8.00 D, and cylinder between 0.00 D and -4.00 D with maximum SE of -10.00 D.
* Anticipated residual stromal bed thickness of at least 250 microns as calculated by the iDesign system.
* Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
* BSCVA ≥2 lines (≥10 letters) better than distance Uncorrected Visual Acuity (UCVA).
* Less than or equal to 0.75 D difference between cycloplegic and manifest refraction sphere.
* Stable refractive error as defined by a change of ≤1.00 D in MRSE over at least a 12 month time period.
* Any subject eye with a history of contact lens wear within the last 4 weeks must demonstrate refractive stability
* Agreement between manifest refraction (adjusted for optical infinity) and iDesign System refraction chosen for treatment.
* Willing and capable of complying with follow-up examinations for the duration of the study.

Exclusion Criteria:

* Women who are pregnant, breast-feeding, or intend to become pregnant, or not using an adequate method of birth control.
* Concurrent use of systemic (including inhaled) medications that may impair healing.
* History of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
* Subjects with a cardiac pacemaker, implanted defibrillator or other implanted electronic device.
* History of prior intraocular or corneal surgery, active ophthalmic disease or abnormality, retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma, corneal opacity within the central 9 mm and visible on topography, at risk for developing strabismus, or with evidence of glaucoma or propensity for narrow angle glaucoma.
* Evidence of keratoconus, corneal dystrophy or irregularity, or abnormal topography
* Known sensitivity or inappropriate responsiveness to any of the medications used in this study.
* If either eye does not meet all inclusion criteria
* Desire to have monovision.
* Participation in any other clinical study, with the exception of the fellow eye in this study.
Blood Transfusion Education Using Blended Virtual Reality and Simulation for Nursing Undergraduate Students

Nurse-administered blood transfusion (BT) is a common form of medical treatment, but nursing students are often excluded from participating in and observing BTs during clinical placements. To address clinical placement limitations, nursing educators have increasingly adopted technology-guided simulation pedagogies, including virtual reality (VR) simulation, for nursing students' clinical skills education.


Eligibility Criteria:
Inclusion Criteria:

* All undergraduate nursing students enrolled in the 'Nursing of Adults' course in a pre-licensure program at a Hong Kong university.

Exclusion Criteria:

* Students who had vision impairment to watch VR videos;
* Students who had neck pain/ injury to move their head, or open wound to wear the VR headset;
* Students who experienced nausea and dizziness when watching VR videos;
* Students who had epileptic symptoms
Study Comparing Best Medical Practice With or Without VNS Therapy in Pharmacoresistant Partial Epilepsy Patients

This is a post-market medical device study. This study will compare best medical practice with or without adjunctive VNS Therapy in patients who are 16 years and older with pharmacoresistant partial epilepsy.

This is a post-market medical device study. This study will compare best medical practice with or without adjunctive VNS Therapy in patients who are 16 years and older with pharmaco-resistant partial epilepsy. The Sponsor, Cyberonics, provides funding for this study. Patients are followed for 26 months, 24 of those months are following the initiation of treatment. No study sites will be permitted to enroll study subjects until Institutional Review Board (IRB)/Ethics Committee (EC) approval has been received.

Eligibility Criteria:
Inclusion Criteria:

* Patient has confirmed partial onset seizures.
* Seizure activity is not adequately controlled by patient's current AED regimen.
* Patient is between 16 and 75 years of age.
* Patient is able to give accurate seizure counts and health outcomes information. Patient is able to complete study instruments with minimal assistance.
* Patient has previously failed at least 3 AEDs in single or combination use.
* During baseline evaluation period, patient should take at least 1 AED.
* Patient should have confirmed epilepsy for a minimum of 2 years.
* Patient's AED regimen is stable for at least 1 month prior to enrolment.
* Patient has at least 1 objective partial onset seizure per month during the 2 months prior to enrolment.
* Patient or legal guardian understands study procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies.

Exclusion Criteria:

* Patient has pseudoseizures or a history of pseudoseizures.
* Patient has idiopathic generalised epilepsy or unclassified epilepsy.
* Patient has ever received direct brain stimulation (cerebella or thalamic) for treatment of epilepsy.
* Patient has had a unilateral or bilateral cervical vagotomy.
* Patient has a history of non-compliance with the completion of a seizure diary.
* Patient has taken an investigational drug within a period of 3 months prior to inclusion.
* Patient is currently using another investigational medical device.
* Patient has a significant cardiac or pulmonary condition currently under treatment.
* Patient has previously undergone brain surgery.
* Patient has a demand cardiac pacemaker, implantable defibrillator, or other implantable stimulator.
* Patient currently lives more than 2 hours from the study site or plans to relocate to a location more than 2 hours from the study site within one year of enrolment in the Study.
A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

The main objective of this study is to assess safety, tolerability, and pharmacokinetics (PK) of ABBV-368 plus tilsotolimod; ABBV-368 plus tilsotolimod and nab-paclitaxel; and ABBV-368 plus tilsotolimod, nab-paclitaxel, and ABBV-181 in participants with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).


Eligibility Criteria:
Inclusion Criteria:

* Participants should weigh at least 35 kg.
* Eastern Cooperative Oncology Group performance status of 0 or 1 and a life expectancy of \>= 3 months.
* Participant have \>= 1 lesion accessible for intratumoral injection.
* Histologically or cytologically confirmed R/M HNSCC (of the following 4 subsites: oral cavity, oropharynx, larynx, and hypopharynx) who previously progressed either during or after \<= 3 prior treatment regimens administered in the recurrent or metastatic setting.

  * Must have received 1 immunotherapy regimen which included a PD-(L)1 inhibitor.
  * Must have received platinum-based therapy, or be considered ineligible for platinum-based therapy by the investigator.

Exclusion Criteria:

* Uncontrolled metastases to the central nervous system (CNS).

  * Participants with brain metastases are eligible provided that evidence of clinical and radiographic stable disease for at least 4 weeks after definitive therapy is given and participants have not used prohibited levels of steroids for at least 4 weeks prior to first dose of the study.
* Received prior treatment with OX40 or toll-like receptor (TLR) agonists (excluding topical agents).
Limited Versus No-limited Shoulder Movement in Breast Cancer Surgery

Randomized clinical trial that will include women aged 18 or older, submitted a curative surgery for breast cancer at Hospital do Câncer III (HCIII-INCA). Patients will be allocated into two groups: Intervention (upper limbs no-limited movement with amplitude above 90º for flexion and abduction of shoulder) and Control (upper limbs limited movement at maximum 90º amplitude flexion and abduction of shoulder, until withdrawal surgical points). Sociodemographic and clinical data will be collected through interviews, questionnaires and electronic and physical records. The outcomes will be incidence of operative wound complications, like edema, joint restraint, winged scapula, pain, axillary web syndrome through the physical examination, performed by the nursing and physiotherapy team throughout the intervention period, ending in the 30-day post-operatory.

Breast cancer treatment has been accompanying advances in technology, surgeries are more conservative, however postoperative complications are still observed. At early postoperative period, the most common operative wound complications are seroma, infection and necrosis. Shoulder dysfunctions are a frequent complication and difficult women to return to their activities. There is no consensus regarding the onset and type of exercise in postoperative period. Thus, the objective of this study is to compare the active no-limited mobilization with limited mobilization in the immediate post operatory at the incidence of wound complications in women submitted to surgery for the treatment of breast cancer.

It's a randomized clinical trial that will include women aged 18 years or older, submitted a curative surgery for breast cancer at Hospital do Câncer III (HCIII-INCA) located in Rio de Janeiro. All patients admitted for surgical treatment at the institution and during the study period will be evaluated for eligibility criteria. Those considered eligible for the study will be clarified regarding the objectives, treatment groups, adverse effects and non-compulsory participation of the study. Upon acceptance to participate, they will be allocated to the respective intervention groups. Group 1 - upper limbs no-limited movement with amplitude above 90º for flexion and abduction of shoulder; Group 2 - upper limbs limited movement at maximum 90º amplitude flexion and abduction of shoulder, until withdrawal surgical points.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 and over;
* Indication of curative surgical treatment for breast cancer axillary approach at Hospital do Câncer III / INCA.

Exclusion Criteria:

* Bilateral breast cancer;
* Surgical treatment and / or previous radiotherapy for breast cancer;
* Reconstruction surgery;
* Functional alteration in upper limbs prior to diagnosis of breast cancer;
* Illiterate women who are not able to read and complete the protocol of adhesion;
* Women who are not able to answer questions clearly;
* Age over 80.
Evaluation of Safety and Immunogenicity of Meningococcal B and Meningococcal ACWY Vaccine in at Risk Population

This study aims to evaluate the immunogenicity, safety and tolerability of co-administration of vaccinations for meningitis B (Bexsero®) and meningitis ACWY (Menveo®) in adults and children aged 10-45 years living with HIV. All participants will be vaccinated with both Menveo® and Bexsero® on days 0 and 30. Immunogenicity will be determined on venous blood sampled at days 0 and 60. Adverse effects will be recorded to evaluate safety.


Eligibility Criteria:
Inclusion Criteria:

* Any 10-45-year old male or female patients with confirmed HIV infection where they (or someone with parental responsibility) can sign fully informed consent and are able to comply with study requirements.

Exclusion Criteria:

* Pregnancy or breast feeding,
* History of MenACWY (Menveo® or Nimenrix®) and 4CMenB (Bexsero®) vaccination in the previous 2 years,
* Receipt of other non-live vaccines within 2 weeks and live vaccines within 4 weeks of first dose, planned receipt of vaccine within 2 weeks of study visits,
* Current active malignancy,
* Known latex allergy
* Known or suspected hypersensitivity to any components of the vaccines or history of severe allergic reaction after previous vaccination
* Bleeding disorder preventing IM vaccination,
* Any acute or chronic illness which according to the investigators judgement would prevent patients to receive the vaccines or participate in the study
* Participation in clinical trials concerning investigational medical product within 0 days or before completion of the study
* Children in care
Simple Verbal Intervention for Adequately Collecting Sputum

simple verbal intervention with figure of lung and upper respiratory tract will be helpful to adequately collecting sputum.

and in the acceptable specimen based on Gram stain, positivity for AFB stain and culture rate will be higher.

suspicious patients for pulmonary tuberculosis are randomized to control or education group. patients in education group will be educated with the brochure that contains figure of lung/upper respiratory tract and methods of collecting sputum.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* 2009.7\~2010.7 patients with suspicious pulmonary tuberculosis who visited Boramae Hospital

Exclusion Criteria:

* on medication for tuberculosis
* patients who medicated with fluoroquinolone within 1month
* patients without consciousness or patients who cannot expectorate sputum
* hemoptysis over 50cc per day
* patients who don't consent on the study
Different Surgical Modalities in the Management of Pelvi-ureteric Junction Obstruction

The study compared open pyeloplasty (OP) and laparoscopic pyeloplasty (LP) for treating Pelvi-ureteric Junction Obstruction (PUJO) in 40 patients.


Eligibility Criteria:
Inclusion Criteria:

* Age between 7 months and 60 years. Diagnosed with Pelvi-ureteric Junction Obstruction (PUJO). Glomerular Filtration Rate (GFR) greater than 10 ml/min. Open to both genders.

Exclusion Criteria:

* Active infection. GFR less than 10 ml/min. Presence of a single kidney. Patients with kidney or multiple congenital anomalies. Pregnancy.
The Women's Healthy Lifestyle Study

This study aims to determine if a motivational interviewing counseling style can help women eat a healthy diet and exercise during breast cancer treatment and beyond.

Women receiving chemotherapy for early stage breast cancer often gain weight and body fat, and this contributes to the health burden that cancer survivors face. Weight gain is a concern not only for overall health status, but also as a possible factor for risk of cancer recurrence. Unfortunately achieving weight loss, after a gain has occurred, is difficult, and there are no satisfactory methods for maintenance of weight loss. This study proposes to design and test a novel telephone-based intervention for preventing weight gain during treatment for breast cancer in a pilot, randomized study. The 12-month intervention will target maintenance of current weight and prevention of body fat gain using counseling for moderate exercise and a low-fat, high fruit-vegetable diet. The counseling approach will be based on motivational interviewing techniques and will be delivered through telephone appointments. Motivational interviewing is a client-centered type of counseling that elicits active participation of the patient. By taking a more active role, patients may be more likely to follow through with the recommended lifestyle changes. Study endpoints will include blood markers of dietary compliance, pedometer steps, self-monitoring logs, questionnaires (including quality of life) and anthropometric measures (including body fat by DEXA). An important goal of the study is to establish recruitment methods and demonstrate recruitment rates in newly diagnosed stage I-IIIA breast cancer patients. The study data also will demonstrate implementation of the counseling approach and provide a basis for sample size estimates for a larger trial. This type of intervention, namely a combination of exercise and diet, has been indicated to have good potential for prevention of recurrence. It is therefore necessary to develop effective methods for eliciting these behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Adult female, age 18 and older
* Stage I, II, or IIIA breast cancer
* Scheduled for chemotherapy and completed no more than two weeks of chemotherapy
* Body mass index 25-45 kg/m2
* Stable body weight within 5 pounds in the past 2 months
* Physician approval for participating in a weight control program
* Willing and able to follow advice for exercise and diet quality

Exclusion Criteria:

* Previous invasive cancers, excluding basal cell carcinoma, in the past 10 years
* Following a medically-prescribed diet
* Currently participating in a formal weight loss program
* Medical conditions that preclude safe exercise
Gastric Bypass Stent Small-Sample-Size Study For Nonalcoholic Fatty Liver Disease

Evaluate the preliminary effectiveness and safety of the Gastric Bypass Stent System in treating nonalcoholic fatty liver disease.

The Gastric Bypass Stent System is intended to be used in Patients with Diagnosis of nonalcoholic fatty liver disease， Proton density fat fraction measured by magnetic resonance imaging (MRI-PDFF) ≥8%. In this pivotal, prospective, single-arm clinical investigation the Sponsor seeks to demonstrate the safety and performance of the Gastric Bypass Stent System in Treatment of Patients with Nonalcoholic Fatty Liver Disease

Eligibility Criteria:
Inclusion Criteria:

（ - ） Males or females with age between 18 and 65 years old;

（ - ） Diagnosis of nonalcoholic fatty liver disease;

（ - ） Proton density fat fraction measured by magnetic resonance imaging (MRI-PDFF) ≥8%;

（ - ） BMI≥24;

Patients who understand the objective of the study; voluntarily participate in the study and have signed the informed consent form; and are able and willing to comply with all requirements, including follow up and evaluations.

Exclusion Criteria:

（ - ） History of excessive alcohol consumption (alcohol consumption equivalent to ethanol \> 30 g/d for males and \> 20 g/d for females);

（ - ） End-stage liver disease (e.g. hepatic cirrhosis or hepatic cancer) or other conditions which may lead to fatty liver;

（ - ） Unable to cooperate to complete MR examination;

（ - ） Subjects who have used any nonsteroidal anti-inflammatory drug or corticosteroid in the past month;

（ - ） Patients with iron deficiency or iron deficiency anemia;

（ - ） ALT or AST increased to 8 × upper limit of normal (ULN), and bilirubin increased to 2×ULN;

（ - ） Patients with coagulation disorder or haemorrhagic diathesis (platelets \<100×109/L);

（ - ） Patients with duodenal ulcer, or previous or existing pancreatitis;

（ - ） History of liver abscess;

（ - ） History of gallstones (symptomatic or presenting of any stone with a diameter greater than 20mm);

（ - ） Patients with gastrointestinal hemorrhage or potential hemorrhage;

（ - ） Gastrointestinal tract anomalies, such as gastrointestinal tract atresia or any or other conditions that would result in failed placement in the gastrointestinal tract;

（ - ） Patients with history of intestinal obstruction or related disease in the past year;

（ - ） Drug abusers or patients with uncontrollable psychiatric disorders;

（ - ） Patients with any contraindication to endoscopy based on the investigator's judgment;

（ - ） Pregnancy or lactating women;

（ - ） Patients who are participating in any other drug or medical device clinical study;

（ - ） Patients with any other conditions evaluated by the investigators as unsuitable for participating in the trial;
Achieving Medication Safety During Acute Kidney Injury

The utilization of clinical decision support (CDS) is increasing among healthcare facilities which have implemented computerized physician order entry or electronic medical records. Formal prospective evaluation of CDS implementations occurs rarely, and misuse or flaws in system design are often unrecognized. Retrospective review can identify failures but is too late to make critical corrections or initiate redesign efforts. A real-time surveillance dashboard for high-alert medications integrates externalized CDS interactions with relevant medication ordering, administration, and therapeutic monitoring data. The surveillance view of the dashboard displays all currently admitted, eligible patients and provides brief demographics with triggering order, laboratory, and CDS failure data to allow prioritization of high-risk scenarios. The patient detail view displays a detailed timeline of orders, order administrations, laboratory values, and CDS interactions for an individual patient and allows users to understand provider actions and patient condition changes occurring in conjunction with CDS failures. Clinical pharmacists' use of the dashboard for patient monitoring and intervention aims to increase the rate and timeliness of intercepted medication errors compared to CPOE-based CDS in the setting of acute kidney injury, which affects patients at various points across all hospital units and services and has numerous opportunities for intervention.


Eligibility Criteria:
Inclusion Criteria:

* 0.5 mg/dl increase or decrease in serum creatinine within 48 hours
* Active, recurring order for targeted renally cleared or nephrotoxic medication

Exclusion Criteria:

* Chronic dialysis
* Transplant patients