cyrilzakka/clinical-trials huggingface dataset:
Comparison of Efficacy and Safety of Insulin Detemir and NPH Insulin in Children and Adolescents With Type 1 Diabetes

The trial is conducted in Europe and Middle East. The aim of the trial is to compare the use of Insulin Detemir once or twice daily combined with mealtime Insulin Aspart against that of NPH Insulin once or twice daily combined with mealtime Insulin Aspart. The trial involves children and adolescents with Type 1 Diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for at least 12 months
* Informed consent obtained
* BMI: 6-7 years: less than or equal to 19 kg/m2, 8-9 years: less than or equal to 20 kg/m2, 10-11 years: less than or equal to 22 kg/m2, 12-13 years: less than or equal to 24 kg/m2 and 14-17 years: less than or equal to 27 kg/m2.
* HbA1c equal to or less than 12.0%

Exclusion Criteria:

* Proliferate retinopathy or maculopathy
* Total daily insulin dose greater than 2.00 IU/kg
* Any condition or disease that rule out trial participation according to the judgement of the investigator.
* Mental incapacity, unwillingness or language barriers precluding understanding or cooperation.
* A life-style incompatible with trial participation
Patient-Provider Tools to Improve the Transition to Adult Care in Sickle Cell Disease

The purpose of the study is to develop patient-provider clinical support tools to improve clinical practice, patient self-management, and disease outcomes in sickle cell disease during transition to adult care. The investigators hypothesize that these clinical support tools (patient tool, provider tool, and patient/parent web-based portal) will be feasible, user friendly, and beneficial. The investigators hypothesize that participants will demonstrate better disease self-efficacy at the end of the 6 week intervention and maintain these gains during the follow-up period (up to 1 year post-intervention).

The purpose of the study is to develop patient-provider clinical support tools to improve clinical practice, patient self-management, and disease outcomes in sickle cell disease during transition to adult care.

Eligibility Criteria:
Inclusion Criteria:

* Have sickle cell disease (SCD)
* Between the ages of 13 and 24
* Receive care at Cincinnati Children's Hospital Medical Center, University Hospital, University of Cincinnati Med Peds Practice, a practice in the Ohio Valley SCD Network, or another local provider
* Parent/caregiver of a patient with SCD age 13-24 years

Exclusion Criteria:

* Below age 13
* Have significant health complication(s) that would interfere with completion of the intervention (by physician report)
* Have significant cognitive or developmental disabilities (by parent or physician report) due to high demand on participants to understand questions
* Are not a patient at Cincinnati Children's Hospital Medical Center, University Hospital, University of Cincinnati Med Peds Practice, a practice in the Ohio Valley SCD Network, or another local provider
* Are not a parent/caregiver of a patient with SCD age 13-24 years
Evaluation of the Safety and Efficacy of the AnapnoGuard 100 System

The purpose of this study is to evaluate the safety of using the AnapnoGuard 100 system during the course of mechanical ventilation and intubation of critical care patients in Intensive Care Unit.


Eligibility Criteria:
Inclusion Criteria:

* Age above 21 (men and women);
* Patient is admitted to ICU and expected to receive mechanical ventilation for more than 12 hours
* Absence of clear signs of pneumonia and lung contusion on chest X ray;
* For study patients, connection of the ETT to the AnapnoGuard system less than 6 hours from intubation initiation;
* No fever or fever from a known non chest/lung origin;

Exclusion Criteria:

* Patients who had been treated with mechanical ventilation during the last 3 months;
* Patients with facial, oropharyngeal or neck trauma
* BMI \> 40
* Pregnant women
* Patients ventilated in prone position
* Difficult intubation (defined as more than 3 intubation attempts)
E-health Interventions to Promote Physical Activity Among Inactive Adults

The project addresses physical inactivity as a global health issue. Physical inactivity is the fourth leading risk factor for global mortality. Moreover, inactive adults have a higher risk to develop lifestyle diseases. To date, there is preliminary evidence of the efficacy in the use of certain strategies including fitness technologies and digital interventions for physical activity (PA) promotion. Intervention studies are needed to test the effectiveness of PA promotion strategies.

A Hybrid Type I effectiveness-implementation randomised controlled trial (RCT) will investigate the effects of 1) fitness trackers, 2) home-based online training, and 3) peer support via social media among inactive adults. The design will allow testing the study outcomes while gathering information on implementation in a real-world situation. The study will produce evidence on whether these interventions increase the levels of PA among inactive adults and improve health outcomes. Increased PA will also result in better primary prevention of lifestyle diseases.


Eligibility Criteria:
Inclusion Criteria:

* young (18-40 years) or middle aged (40-55 years) healthy adults, both men and women;
* inactive (undertaking less than 150 min of moderate-intensity PA per week) in the last 3 months;
* living in the Troms and Finnmark county;
* current owner of a smartphone;
* able to understand training instructions in English language.

Exclusion Criteria:

* presence of disabilities which might reduce the ability to perform exercise;
* presence of conditions which might prevent from safely exercise;
* lack of Internet connection at home;
* lack of space to exercise safely at home (recommended 4 sqm).
Safety and Antiviral Study of ACH126, 433 (b-L-Fd4C) in Adults With Lamivudine-resistant Chronic Hepatitis B

The purpose of this study was to determine the safety and antiviral hepatitis B virus (HBV) activity of ACH126, 433 in the treatment of adults with lamivudine-resistant chronic hepatitis B.

Evaluation of the safety and antiviral activity of 3 dose levels of ACH126, 433 over a 12-week treatment in the population is described.

Eligibility Criteria:
Inclusion Criteria

* Chronic HBV infection, known to be hepatitis B surface antigen (HbsAg) positive ≥ 6 months
* On lamivudine, either 100 or 150 milligrams daily for the treatment of chronic hepatitis B infection and exhibit a 2-3 log decrease in HBV deoxyribonucleic acid (DNA) levels followed by a rebound of at least 1.5 log HBV DNA or

  * Achieved an HBV DNA level of \< 10,000 copies/milliliter (mL) HBV DNA on at least 2 occasions and have rebounded to \> 100,000 copies/mL HBV DNA, or
  * Have a demonstrable lamivudine -resistant genotype regardless of treatment history.
* Hepatitis B e-antigen positive.
* Human immunodeficiency virus (HIV) negative.
* Serum alanine aminotransferase ≥ 1.5 and ≤ 10x times the upper limit of normal (ULN).
* Hemoglobin ≥ 10 grams/deciliter or hematocrit ≥ 30% (in the absence of blood transfusions or erythropoietin treatment in the preceding 2 weeks).
* Platelet count \>75,000/cubic millimeters (in the absence of ongoing granulocyte colony-stimulating factor therapy).
* Serum creatinine \< 1.1x the ULN.
* Negative radiologic screening test (ultrasound, computerized tomography scan, or magnetic resonance imaging) for hepatocellular carcinoma within 6 months prior to entry.
* Prothrombin time/international normalize ratio \< 2.
* Participants of reproductive capability must utilize an approved form of birth control.
* All women of child-bearing capability must have a negative serum or urine pregnancy test (minimum sensitivity of 24 international units/liter of beta human chorionic gonadotropin) within 72 hours prior to the start of study medication.
* Participants must be able to provide written informed consent.
* Participant must be available for follow-up for a period of 20 weeks.

Exclusion Criteria

* HIV infection.
* Hepatitis C co-infection.
* Alcohol abuse.
* Pregnancy or breast-feeding.
* Inability to tolerate oral medication.
* Any clinical condition or prior therapy that, in the Investigator's opinion, would make the participant unsuitable for the study or unable to comply with the dosing requirements.
* Use of any investigational drug.
* Participants with decompensated liver disease.
* Use of any concomitant herbal treatments.
Virtual Surgery of the Upper Airways

Obstructive sleep apnea (OSA) is a sleep related breathing disorder caused by repetitive collapses of the upper airways resulting in impaired breathing, oxygen desaturation and sleep disturbances. OSA has a massive impact on global health contributing directly to cardiovascular diseases, insulin resistance, metabolic syndrome and daytime fatigue and is repeatedly associated with an increase in motor vehicle accidents.

The mainstay of treatment is still the use of positive airway pressure or surgery of the upper airways, but the success rate is persistently low. Surgery may be of help, but there is a lack of patient-specific options in both diagnostics and treatment.

Mathematical and computational modeling is expected to provide significant insight into the airway function and onset of OSA.

This study is part of a project that will rely on biomedical engineering to obtain the required insight to produce software tools for computer-aided diagnostics and treatment of OSA.

This study is the clinical part of a project that contains 4 work packages (WP 1-4). The clinical study (work WP 1) will ensure the inclusion of up to 30 patients with verified sleep apnea that will be in need of either structural nasal surgery, pharyngeal surgery or orthognathic surgery. Studies of nasal airflow and pressure as well as a detailed ConeBeam CT scans of the upper airways will be performed before and after surgery.

WP 2, 3 and 4 deals with the mathematical modeling, structural mechanic modeling and the patient-specific airflow modeling.

Eligibility Criteria:
Inclusion Criteria:

* Obstructive sleep apnea
* need either functional septorhinoplasty or oropharyngeal/orthognathic surgery in order to establish adequate airway patency
* have undergone sleep registration using polysomnography and ultrawideband radar
* on the subsequent clinical evaluation presenting either 1) intranasal obstruction, due to malalignment of the nasal septal cartilage or the nasal outer framework; and/or 2) oropharyngeal obstruction or retrognathia.

Exclusion Criteria:

* previous nasal or oropharyngeal surgery
* previous use of nasal decongestant or nasal topical steroids over the last 3 months
Infant Formula and Toddler Drink Feeding Study

The purpose of this study is to evaluate the growth and development outcomes of infants fed a new infant formula and toddler drink through 24 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Participant is judged to be in good health as determined from participant's medical history
* Participant is a singleton from a full-term birth with a gestational age of 37 - 42 weeks by parent report
* Participant's birth weight was ≥ 2490 g (\~5 lbs. 8 oz.)
* Parent(s) confirm their intention to feed their infant the study product as the sole source of feeding from Study Visit 1 to 6 months of age, and as the sole milk beverage during the first 12 months of life
* Parent(s) confirm their intention to feed the infant the assigned toddler drink from 12 months of life to 24 months of life as the primary milk beverage
* Parent(s) confirm their intention not to administer vitamin or mineral supplements,(except for vitamin D supplements if instructed by their healthcare professional) from enrollment through the duration of the study
* Parent(s) confirm their intention not to administer solid foods or juices to the infant from enrollment through 6 months of age unless recommended by the participant's HCP
* Participant's parent(s) has voluntarily signed and dated an informed consent form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study
* If parent(s) elect to feed the participant human milk, they confirm that their infant was fed human milk since birth and confirm their intention to exclusively feed human milk as the sole source of feeding through 6 months of age.
* If parent(s) of human milk fed participant elect to supplement or wean, they confirm their intention to use the experimental supplemental/weaning formula and experimental toddler drink as the primary milk beverage.

Exclusion Criteria:

* An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development
* Awareness of a positive drug screen (including but not limited to cocaine, heroin, or methamphetamine) in the mother or participant
* Suspected maternal substance abuse including alcohol
* Participant is taking and plans to continue medications (including over the counter (OTC), such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations, prebiotics or probiotics, or rehydration fluids that might affect GI tolerance
* Participant is in another study that has not been approved as a concomitant study by AN
* Participant has been treated with antibiotics (except for topical antibiotics, eye drops) prior to enrollment
* Participant has been treated with other medications (besides antibiotics) that in the opinion of the PI may affect growth, GI tolerance and/or development, prior to enrollment
LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin

To prospectively evaluate the utility of enoxaparin vs. oral warfarin in reduction of echocardiographic indices of LV mural thrombus. The primary outcome is the presence of LV mural thrombus at 3.5 months. The secondary outcome is cost analysis comparing the two arms.

Patients with anterior Q-wave MIs and ejection fractions\<=40% will be enrolled within the first 4 days of infarction. Patients will be randomized to receive either enoxaparin 1mg/kg (maximum 100mg) subcutaneously every 12 hours for one month or heparin followed by oral warfarin for 3 months.

Clinical and safety evaluations, 2-D echocardiograms at baseline and at 3.5 months and cost analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80
* Anterior myocardial infarction with:

  1. Pathological Q-waves in at least 3 contiguous anterior precordial leads, assumed to be new
  2. CK peak\>5 times the upper limit of normal with positive MB bands
* Ejection fraction \<=40% or anterior dyskinesis or documented LV Thrombus
* MI onset \< 7 days from randomization

Exclusion Criteria:

* Inability to give written informed consent
* Medical conditions that would prohibit discharge within 48 hours with the exception of need for anticoagulation
* Cardiogenic shock, rest angina unresponsive to medical therapy or serious ventricular arrhythmia in the 24 hours prior to randomization
* Patients scheduled for surgical procedure in the next 4 months that would prevent use of enoxaparin or warfarin
* Anemia: Baseline Hgb\<=9 gm for women, \<=10 gm for men or platelet count\<100,000
* Renal insufficiency (creatinine \>2.0 mg/dl)
* Serious liver disease as reflected by INR\>1.3
* Stroke within past 6 months or a prior documented intracranial or subarachnoid hemorrhage
* Active bleeding or major surgery within 2 weeks prohibiting the use of anticoagulants
* Acute pericarditis
* Women of childbearing potential unless pregnancy test negative
* Cardiac or non-cardiac condition with expected survival\< 6 months
* Severe peripheral vascular disease
* Patients who undergo cardiac surgery, including CABG, as a result of their index myocardial infarction
* Allergy to aspirin, heparin or warfarin, pork or pork products
* History of recurrent thromboembolic disease or a history of Protein C, Protein S, antithrombin III deficiency or known bleeding disorder.
* Current use of warfarin or need for chronic anticoagulation
* Current participation in other trials using investigational drugs or devices
* Prior enrollment in this trial
A Study of MK-8527 in Healthy Adult Participants (MK-8527-013)

The goal of this study is to learn how \[14C\]MK-8527 moves through a healthy person's body over time. Researchers will study how \[14C\]MK-8527 is absorbed by the body, broken down by the body, and how it leaves the body.


Eligibility Criteria:
Inclusion Criteria:

* Is in good health
* Has a body mass index (BMI) of 18 to 32 kg/m\^2

Exclusion Criteria:

* Has a history of cancer
* Has positive tests for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus
HPV Vaccine Communication ECHO for Primary Care Clinics

The safe, highly-effective human papillomavirus (HPV) vaccine remains underused in the US; only 51% of 13- to 17-year-old girls and boys were up-to-date by 2018. The Announcement Approach Training is effective in increasing HPV vaccine uptake during the clinic visit by training providers to make strong vaccine recommendations and answer parents' common questions. Systems communication like recall notifications also improve vaccination by reducing missed clinical opportunities. Although never tested to support HPV vaccination, the ECHO (Extension for Community Healthcare Outcomes) Model is a proven implementation strategy to promote capacity exchange between health care experts at academic centers and primary care providers at the front line of rural community health care. The trial will test the effectiveness of two ECHO-delivered HPV vaccination communication interventions versus control: HPV ECHO will provide Announcement Approach training, and HPV ECHO+ will provide training plus recall notices to communicate with parents who initially decline vaccination.

The investigators will recruit 36 primary care clinics (family medicine and pediatric) in Pennsylvania. Eligible clinics will have at least 100 active patients, ages 11-14, in their electronic health record systems. Recruitment will target clinics in Central Pennsylvania, where most counties are designated as rural. Clinics will be randomized to one of three arms: ECHO-delivered HPV vaccine communication training using the Announcement Approach (HPV ECHO); HPV ECHO plus systems follow-up communication for parents who initially decline vaccination (HPV ECHO+); or control. Covariate-constrained randomization will be used to ensure balance among the three arms with respect to clinic size (adolescent patient population), clinic type (academic vs. non-academic), rurality, and historic adolescent HPV vaccination rates.

Eligibility Criteria:
Clinics in cluster RCT (main study)

Inclusion Criteria:

* Family medicine or pediatric clinic in Pennsylvania
* Having at least 100 active patients, ages 11-14.

Exclusion Criteria:

* Primary care clinic outside Pennsylvania
* Participated in HPV vaccine communication or quality improvement research either through Penn State or another institution in the last 12 months.

Parents in nested study survey

Inclusion criteria:

* Parent or guardian of an adolescent ages 11-17
* Adolescent has not yet started HPV vaccination
* Adolescent receive primary care at participating clinic

Exclusion criteria:

* Not the parent or guardian of an adolescent ages 11-17
* Adolescent already initiated HPV vaccination
* Adolescent does not receive primary care at participating clinic
Human Papilloma Viruses (HPV) Vaccine Adherence Community Clinic Study

There has been very limited research that has looked at electronic reminders (text messages) and its effectiveness in adherence to vaccination among low-income minority populations. Results have shown that text messages, among low-income parents and adolescents who were identified as having a cellphone, is an effective strategy to increase the likelihood of adolescent vaccination adherence. Hard copy and electronic messaging reminders have also been proven to be effective when coupled with other prevention strategies for immunizations for influenza and pneumococcal pneumonia and screening for colon, breast, and cervical cancer in adults. Additionally, Merck and Co. recommend electronic reminders in their patient compliance program as a key strategy for adherence. To our knowledge, this community-based pilot intervention study will be the first to assess electronic reminders and HPV vaccine initiation and adherence among rural uninsured and Medicaid populations. The investigators hypothesize that adolescent whose parents who receive the intervention will be more likely to initiate HPV vaccination and be compliant at 3 months and at 7 months as compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Parent/Caretaker has Medicaid or is Uninsured
* Parent/Caretaker has a child between 11- 18 y/o
* Parent/Caretaker should be able to read English or Spanish
* Parent/Caretaker should have a phone and/or email address to provide for the study

Exclusion Criteria:

* Parents who have children younger than 11 or older than 18 years of age
* Parents who are not currently uninsured or enrolled in Medicaid/Medicare.
* Parent/Caretaker's child who received the 1st dose of HPV vaccine before enrolling in study
Evaluation of the Accuracy of Percutaneous Biopsy by Vacuum-assisted Biopsy (VAB) to Assess Pathological Complete Response in Patients With Clinical and Radiological Complete Response After Neoadjuvant Chemotherapy (NeoVAB)

Breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death in females in the world. Neoadjuvant chemotherapy (NAC) is increasingly used in patients with operable breast cancer to enhance the likelihood of breast conservation. New generation of treatments or combinations lead to a high rate of pathological complete responses (pCR) in patients with human epidermal growth factor receptor 2 positive (HER2) and triple negative tumours. Safe omission of surgery in patients who receive NAC and achieve radiologic complete response depends on the ability to accurately estimate pCR preoperatively.

If pathological complete response after NAC could be accurately assessed by VAB, surgery could be avoided. In the context of new treatments or combinations with an increased pCR rate, this new strategy could induce major changes in clinical practice, leading to breast surgery de-escalation.

A total of 66 patients will be submitted to percutaneous vacuum-assisted biopsy (VAB), followed by breast surgery. The primary endpoint of the study is the false negative rate of VAB procedure. This rate will be calculated by comparing the detection of invasive or in situ carcinoma on surgical specimen versus VAB samples. The secondary endpoints of the study are feasibility, VAB procedure technical complications and safety.

Eligibility Criteria:
Inclusion Criteria:

1. Patient aged 18 years or older.
2. Written informed consent provided.
3. Triple negative or HER2-positive / ER-negative or HER2-positive / ER-positive breast tumours.
4. Patients eligible for breast conservation after NAC.
5. Patients with T2-T3 N0 invasive breast cancer initially treated by NAC to allow breast conservation, who have received a minimum of 6 cycles of adequate NAC +/- anti-HER2.
6. Clinical complete response after NAC.
7. Radiological (mammography, breast US, breast MRI) complete response after NAC.
8. Patients predicted to be node-negative at treatment initiation.

Exclusion Criteria:

1. Patient younger than 18 years old.
2. Pregnant or breastfeeding women.
3. Proven metastatic axillary or internal mammary chain lymph node involvement before NAC proven by biopsy or cytology.
4. Bilateral breast cancer.
5. Contraindication to MRI.
6. Contraindication to breast conservation
7. Patients with a BRCA mutation or other autosomal dominant high-penetrance genetic predisposition to breast cancer.
8. Patients with limitation of freedom or under guardianship
9. Inability for psychological reasons
10. Hypersensitivity to local anaesthesia
11. Initial imaging showing ACR6 micro calcifications and/or ACR6 non-mass enhancement associated to the index lesion