cyrilzakka/clinical-trials huggingface dataset:
The Next Generation Longitudinal Birth Cohort Diabetes Study

The overall aim of this project is to understand the independent roles of maternal factors, intrauterine exposures, genetic factors, and postnatal environment on the development of obesity and youth-onset type 2 diabetes (T2D) in childhood.

Our primary objective for the study is to clinically and metabolically phenotype parents and their offspring to identify risk factors for obesity, T2D, and cardiometabolic risk in childhood and adolescence in a prospective birth cohort by reporting:

1. Maternal and/or paternal factors including anthropometrics, metabolic parameters, HNF1a genotype, lifestyle (diet and physical activity), and socioeconomic environment.
2. Infant factors including anthropometrics, early infant nutrition, and metabolism.

Secondary Objectives:

1. To evaluate if children born to mothers with T2D prior o pregnancy are at increased risk of obesity and T2D.
2. To determine the modifiable risk factors which contribute to the increased risk of obesity and T2D.
3. To evaluate the differential risk between mothers and fathers with T2D in terms of somatic and genetic contributions to risk compared to intrauterine environmental contributions to risk.
4. To plan a large-scale, randomized, controlled community-based breastfeeding intervention with intensive breastfeeding counseling and support for the prevention of T2D development in offspring of mothers or fathers with youth onset T2D.
5. To explore potential new research questions and feasibility studies for epigenetic studies using cord blood under the umbrella of the new research theme on T2D at the Children's Hospital Research Institute of Manitoba.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with type 2 diabetes, gestational diabetes, or no diabetes.
* From self-identified Indigenous heritage (e.g., Cree, Oji-Cree, Métis, Anishinaabe, etc.).
* Are delivering and residing in Manitoba.
* Mother/Father and children must be biological family members.

Exclusion Criteria:

* Mothers or children with type 1 diabetes.
* Residing outside of Manitoba.
Effects on Physical Fitness, Immunity, and Quality of Life of Yoga Training in Breast Cancer Survivors.

This study wants to prove that Yoga Training can improve physical Fitness, immunity, and quality of Life of in Breast Cancer Survivors. In summary, our findings show potential benefits of yoga for people with cancer in improvements of psychological health. Because of the small number of studies having been conducted and the methodological limitations, the results should be regarded as preliminary and treated with caution. Our preliminary findings also provide practitioners with important information that yoga may be a possible adjunctive therapy for cancer patients to help manage psychological distress and to improve quality of life.


Eligibility Criteria:
Inclusion Criteria:

* breast cancer with stage1 or stage2, Sedentary life style, no orthopaedic disease and medical disease

Exclusion criteria

* recurrent or metastasis, medical or current psychiatric illness which would make compliance with the study protocol difficult or dangerous, medications which would alter training response
ChEmo-Genomics Based Treatment of Acute Myeloid Leukemia

Adult acute myeloid leukemia (AML) is a heterogeneous hematologic malignancy associated with poor prognosis, especially after relapse. High-throughput genomic studies have highlighted the importance of molecular alteration in the pathophysiology, clinical evolution and treatment response of AML. In addition, identification of specific gene mutation can be targeted by specific inhibitors, opening the way to personalized treatments. However, only a limited number of gene mutations are druggable or actionable, highlighting the need for additional information to guide treatment choices. Among them, new Drug Screening Tests (DST) allow for the screening of library of hundreds of drugs to ex-vivo patient-derived AML cells. Combination of genomic and pharmacologic approaches might therefore improve prediction of drug effects. There is an urgent need to bring these approaches into the clinic but feasibility trials are necessary before incorporating them into treatments strategies.The proposed study is a prospective multicentre feasibility study of a combined "chemo-genomic" approach in patients with advanced AML.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Diagnosis of acute myeloid leukemia according to WHO classification
* Refractory or relapsed disease
* ECOG performance status of \<3
* Life expectancy \>3 months
* Written informed consent
* Affiliation to the French Social Security System.

Exclusion Criteria:

* Diagnosis of Acute Promyelocytic Leukemia.
* Patients deprived of liberty or placed under the authority of a tutor.
Immunity to Measles Virus in the Thai Population Age 18-30 Years and Predictive Factors

Prevalence of participants who have protective immunity to measles virus is less than ninety percent.

Predictor of adequate measles antibody levels include the following :

* History of measles infection
* History of complete measles primary immunization( 2 doses with at least 1 month interval after age of 9 months)
* History of measles exposure

Predictor of inadequate measles antibody levels include the following :

* Born outside Thailand
* History of staying outside Thailand for long time in childhood
* Living in the rural area for a long period in childhood
* Fail to participate school system on time


Eligibility Criteria:
Inclusion Criteria:

* Age 18-30 years old

Exclusion Criteria:

* Last measles vaccination less than 10 years of age
* Immunocompromised host including congenital immune defect, splenectomy or splenic dysfunction, history of suspect HIV exposure, taking immunosuppressant
* Receiving blood or blood product within 3 months
* Receiving others vaccinations or immunoglobulins or any medication that possibly decrease immune response
NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study

The purpose of the Pipeline™ Vantage Embolization Device with Shield Technology™ Post Approval Study (PAS) ("Pipeline™ Vantage PAS") is to collect safety and effectiveness data in patients undergoing treatment for intracranial aneurysms (IA) using the Pipeline™ Vantage Embolization Device with Shield Technology™ ("Pipeline™ Vantage Device") in a post approval setting.

The INSPIRE Pipeline™ Vantage Post Approval Study is a, prospective, multi-center, single-arm clinical study to collect safety and effectiveness data in patients undergoing treatment for intracranial aneurysms using the Pipeline™ Vantage Embolization Device with Shield Technology™.

This study is a sub-study to the Neurovascular Product Surveillance Registry (NCT02988128).

Eligibility Criteria:
Inclusion Criteria:

1. Patient or legally authorized representative (LAR) has provided written informed consent using the Ethics Board and Medtronic approved Informed Consent Form and agrees to comply with the protocol requirements. HIPAA/data protection authorization has been provided and signed by the patient (or patient's LAR) as applicable per local law.
2. Patient has an intracranial aneurysm intended to be treated with the Pipeline™ Vantage Embolization Device with Shield Technology™.
3. Patient is an adult per local law at time of consent.

Exclusion Criteria:

1. Patient with any contraindications for the device or procedure per the Pipeline™ Vantage Device local geography IFU.
2. Patient who may be unable to complete the study follow-up.
3. The Investigator determined that the health of the patient may be compromised by the patient's enrollment.
4. Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.
5. Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results.
Evaluating a Chronic Pain Treatment Program

This interventional study seeks to evaluate the overall outcomes of a novel, emotional awareness intervention for people with chronic musculoskeletal pain and determine which patients benefit the most from this intervention. The investigators also are evaluating the effects of brief emotional communication technique embedded in the pre-treatment assessment.


Eligibility Criteria:
Inclusion Criteria:

* Adults with chronic musculoskeletal pain, not accounted for by disease or tissue pathology, who are seeking or referred for this psychological treatment program

Exclusion Criteria:

* Autoimmune diseases
* Cancer pain
* Illiterate
* Cognitively impaired
* Too medically ill
A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis

This is a 2 year clinical study to compare 5-grass mix SLIT-drops with placebo in relieving grass pollen-induced rhinoconjunctivitis symptoms and in use of symptom-relieving medication during the second grass pollen season (peak grass pollen season, PGPS)

The study will collect health-related quality of life data in the groups treated with 5-grass mix SLIT-drops or with placebo during the first and second PGPS.

The trial medication used is already approved to treat allergic rhinitis caused by grass pollen in adults in several countries.

This trial is a 2 year, parallel-group, double-blind, placebo-controlled phase III trial to evaluate efficacy and safety of the 5-grass mix SLIT-drops in adults with grass pollen-induced rhinoconjunctivitis with or without asthma. Approximately 440 adults will be enrolled in the trial and will receive the 5-grass mix SLIT-drops or placebo. The trial is conducted in several European countries.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged ≥18 years on the day informed consent is obtained
2. A clinical history of grass pollen-induced allergic rhinoconjunctivitis for two years or more with or without asthma
3. A clinical history of severe allergic rhinoconjunctivitis symptoms (interfering with usual daily activities or sleep) induced by grass pollen, which remain troublesome despite symptomatic treatment with antihistamines, nasal steroids or eye drops during the previous grass pollen season
4. Positive specific immunoglobulin E (IgE) (defined as ≥class 2, ≥0.70 kU/l) against grass: Phleum pratense
5. Positive skin prick test to Phleum pratense at screening

Exclusion Criteria:

1. Has a clinically relevant history of symptomatic seasonal and/or perennial allergic rhinoconjunctivitis and/or asthma caused by an allergen other than grass pollen, to which the subject is exposed, which could potentially overlap with the efficacy assessment periods
2. Within the last 3 months before the randomisation visit, has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids
3. SLIT treatment with any grass pollen AIT for more than 1 month within the last 5 years. In addition, any SLIT treatment with grass pollen AIT within the previous 12 months
4. SCIT treatment with any grass AIT reaching the maintenance dose within the last 5 years. In addition, any SCIT treatment with grass AIT within the previous 12 months
5. Ongoing treatment with any allergy immunotherapy product
6. Uncontrolled or severe asthma requiring daily use of more than 800 mcg budesonide or equivalent at screening
Morphine for the Treatment of Pain in Patients With Breast Cancer

RATIONALE: Morphine helps to relieve the pain associated with cancer surgery. Giving morphine in different ways may offer more pain relief.

PURPOSE: This randomized clinical trial is studying how well morphine injected directly into the underarm area works compared with morphine injected into the back of the shoulder in treating pain in patients who have breast cancer and who are undergoing axillary lymph node dissection.

OBJECTIVES: I. Determine whether morphine injected at the site of surgery can control pain from surgery.

OUTLINE: This is a prospective, double blind, randomized study. Patients are randomized into 3 groups with 6 patients in each group. Group 1 receives morphine diluted in normal saline (NS), which is administered in the axillary region at the completion of surgery before surgical closure. The area is flooded and the solution is allowed to remain in the wound for 5 minutes. Group 2 (control group) receives NS only, administered in the same fashion as group 1. Group 3 receives morphine subcutaneously in the deltoid area, ipsilateral to the site of surgery, at the beginning of wound closure. Postoperatively, patients self-administer IV fentanyl analgesia through a patient controlled analgesia pump. Comparisons of daily IV fentanyl utilization is done among the three groups. Quality of pain is assessed via visual analog pain scores four times a day at 2, 4, 6, and 24 hours postoperatively.

PROJECTED ACCRUAL: A total of 18 patients will be accrued over a period of 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Patients with breast cancer who are scheduled to undergo axillary node dissection

PATIENT CHARACTERISTICS: See General Eligibility Criteria

PRIOR CONCURRENT THERAPY: No oral-equivalent doses of morphine greater than 10 mg a day -- Patient Characteristics-- Age: Not specified Sex: Not specified Other: Not allergic to morphine
Quantitative Coronary Angiography Versus Intravascular Ultrasound GUIDancE for Drug-Eluting Stent Implantation

The purpose of this study is to compare clinical outcomes between quantitative coronary angiography -guided and Intravascular ultrasound -guided strategy in patients with significant coronary artery disease undergoing sirolimus-eluting Orsiro/Orsiro mission stent implantation.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women at least 19years of age
2. Typical chest pain or objective evidence of myocardial ischemia suitable for elective PCI
3. Significant coronary artery lesions suitable for sirolimus-eluting Orsiro/Orsiro mission stent implantation
4. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

1. Angiographic exclusion criteria: any of the followings 1)Bypass graft lesions 2)Impaired delivery of IVUS is expected:

   * Extreme angulation (≥90°) proximal to or within the target lesion.
   * Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
   * Heavy calcification proximal to or within the target lesion.
2. Previous percutaneous coronary intervention within 6 months before the index procedure
3. Previous BVS (bioresorbable vascular scaffold) implantation
4. Left ventricular ejection fraction (LVEF) \< 30%
5. Hypersensitivity or contraindication to device material and its degradants and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated.
6. Persistent thrombocytopenia (platelet count \<100,000/µl)
7. Any history of hemorrhagic stroke or intracranial hemorrhage, Transient ischemic attack or ischemic stroke within the past 6 months
8. A known intolerance to antiplatelet agents (aspirin, clopidogrel, prasugrel or ticagrelor)
9. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure.
10. A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.
11. Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
12. Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \> 3 times upper limit of normal).
13. Life expectancy \< 1 years for any non-cardiac or cardiac causes
14. Unwillingness or inability to comply with the procedures described in this protocol.
15. Patient's pregnant or breast-feeding or child-bearing potential.
Development of a New Method for Steady-State Measurement of NO Lung Diffusing Capacity in Healthy Subjects

Using a rapidly responding nitric oxide analyzer in a new developed modular lung-function-setup we are going to measure steady-state NO diffusing capacity in 107 healthy subjects (age 6-45 years). The results will be compared to those measured by using carbon monoxide single-breath estimates. We like to show that the new method is sufficient to measure exactly lung diffusion capacity in this collective.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Lung function testing possible
* Written consent

Exclusion Criteria:

* Pulmonary, neuromuscular, cardiovascular, endocrinological illness
* Pregnancy
* Abuse of nicotine, alcohol, drugs during the last two years
In-Vivo Response of P. Falciparum to Antimalarial Treatment in HIV-Infected and HIV-Uninfected Adults

Plasmodium falciparum malaria and HIV are among the most important infectious diseases in sub-Saharan Africa. Approximately two-thirds of the estimated 35 million HIV infected persons live in sub-Saharan Africa. Of the 300-500 million annual cases of malaria infection occurring worldwide, about 90% of P. falciparum infections occur in sub-Saharan Africa, resulting in approximately 1 million deaths, mostly in children under five years of age. It is clear that HIV and malaria are responsible for substantial disease, suffering, and an enormous economic burden on the people who can least afford it. Although a study in 1993 in Tanzania showed significantly higher prevalence of malaria infections in HIV-positive compared to HIV negative adults, until recently there have been few studies showing any association between the two infections.

We conducted a study to measure the efficacy of the then-first line antimalarial drug (sulfadoxine-pyrimethamine) among patients in three study arms: those who were HIV negative, those who were HIV infected with CD4 cell counts \< 200, and among HIV infected patients with CD4 cell counts \>= 200. Our hypothesis is that patients with HIV infection and low CD4 cell count will not respond to antimalarial therapy as well as patients who are HIV infected with higher CD4 cell counts or who are HIV negative.

The study was conducted at Siaya District Hospital, in Nyanza Province, Kenya. Non-pregnant adults who provided consent to participate, who were found to have pure Plasmodium falciparum malaria parasitemia with at least 500 asexual parasites per microliter, and who agreed to undergo HIV counseling and testing were eligible for participation. Clients were then followed with repeat physical examinations and blood smears on day 1,2,3,4,7,14,21 and 28 and any non-scheduled day when they were sick. Those that failed therapy were treated with quinine to clear parasitemia. Samples were also taken to measure reinfection vs. recrudescence, pharmacokinetics, and antifolate resistance markers.

Eligibility Criteria:
Inclusion Criteria:

18 years of age or older, not pregnant. Are able to make all follow-up visits. Are able to understand and give informed consent. Have a history of fever in past 24hrs or current axillary temperature of ³ 37.5C.

Have an unmixed infection with P. falciparum of at least 500 asexual parasites/mm3 as determined by microscopic examination of thick and/or thin peripheral blood smears.

Do not have any evidence of severe or complicated malaria (e.g., cerebral malaria, Hb \< 5 g/dL, signs and symptoms of congestive heart failure) that would require hospitalisation for treatment.

Have no reported allergy to sulfa drugs. Agree to HIV testing and receiving the results.

Exclusion Criteria:

Less than 18 yrs old. Pregnant. History of allergic reactions to sulfa drugs. Have severe or complicated malaria. No history of fever. Plan to leave Siaya in next month. Do not agree to HIV testing.
Detecting Respiratory Viruses in Upper and Lower Respiratory Tract Samples

Background:

- Bronchoalveolar lavage (BAL) is a procedure where a tube is passed through the mouth or nose into the lungs. Fluid is squirted through the tube into a part of the lung and then collected for examination. It is used to detect respiratory viruses. BAL is a relatively invasive procedure, and researchers want to test the accuracy of other procedures that do not involve collecting fluid from the lungs. The nasopharynx is the area of the upper throat that lies behind the nose. Researchers want to see if a swab taken from this area is as accurate as a BAL sample.

Objectives:

- To see if a nasopharynx swab can be used to detect respiratory viruses as well as BAL samples.

Eligibility:

- Individuals at least 12 years of age who will have a bronchoscopy to collect a BAL sample to test for respiratory viruses.

Design:

* Participants will be screened with a physical exam and medical history.
* Participants will have a BAL sample collected.
* Participants will then have a nasopharynx swab. The swab will be inserted into the nose, left in place for up to 10 seconds, and then removed

Bronchoalveolar lavage (BAL) specimens can be used for the detection of respiratory viruses. Although bronchoscopy is relatively safe, it still has inherent risks to the subject. Nasopharyngeal (NP) swab specimens are easy to collect and are minimally invasive for the subject. We will use a rapid multiplex polymerase chain reaction (PCR) to detect respiratory viruses in paired BAL and NP specimens to determine if either specimen is more likely to be positive. The study population will include all patients undergoing bronchoscopy for clinical indications at the Clinical Center. This is a prospective observational study.

Eligibility Criteria:
* INCLUSION CRITERIA:
* Age 12 years or above
* Scheduled for clinically indicated bronchoscopy for the collection of a BAL specimen and will have respiratory virus PCR ordered on the BAL specimen as part of their ongoing care at the NIH Clinical Center.
* Must agree to allow the storage of their samples (BAL and NP) for use in future research.

EXCLUSION CRITERIA:

None
The Internal Thoracic Artery Skeletonization Study: A Paired, Within-Patient Comparison

The purpose of this study is to determine whether skeletonization of the internal thoracic artery leads to improved flow, increased length, improved sternal perfusion, and decreased pain and dysesthesia in patients undergoing coronary artery bypass surgery

Traditional harvesting of the internal thoracic artery (ITA) for use as a conduit in coronary bypass surgery involves the dissection of a rim of tissue surrounding the artery on either side. Although the benefits of ITA use are well established, there are certain limitations to its routine use. Recent studies, primarily observational, have suggested that skeletonization of the ITA (i.e. harvesting of the ITA alone) may overcome some of these limitations by improving conduit flow, increasing length, and reducing the risk of deep sternal infection in high risk patients. Furthermore, skeletonization of the ITA can potentially preserve intercostal nerves and reduce post-operative pain and dysesthesias associated with ITA harvesting. In order to assess the effects of ITA skeletonization, this is a prospective, randomized, within-patient study design in patients undergoing coronary artery bypass grafting.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing bilateral internal thoracic artery harvest for coronary artery bypass surgery

Exclusion Criteria:

* Inability to speak English or French
* Inability to complete follow-up visits