cyrilzakka/clinical-trials huggingface dataset:
Obtain a Good Blood Glucose Control With the Paradigm Real Time System

In this study, subjects with insufficient metabolic control despite optimized basal-bolus injection regimens were randomily assigned to either the Mini- Med Paradigm REAL-Time insulin pump (PRT), an insulin pump that can receive and display CGM data from a separate subcutaneous glucose sensor, or conventional CSII, and compared glycemic outcomes after 6 months.

The long-term clinical benefit of tight glycemic control in people with diabetes is well known . HbA1c generally assesses the average/long term quality of glycemic control, it has been clearly demonstrated that a target of HbA1c at 7.0% or less has benefits for diabetic patients

Eligibility Criteria:
Inclusion Criteria:

* Patient has signed informed consent form prior to study entry.
* Patients have been diagnosed with Type 1 DM at least 12 months prior to inclusion.
* Patients should have been received diabetes care from the investigator of each center at least 3 months prior to inclusion.
* Patients have been treated with multiple daily injections and use rapid Insulin Analog for their meal prior to study entry.
* Have an HbA1c value ≥ 8 %.
* Pediatric patients must be aged between 2 and 18 years old and adult patients be aged between 19 and 65 years old.
* Patients must perform at least 3 self-monitoring blood glucose finger-sticks daily.
* Patients from PRT group must be willing to wear sensors and transmitter connected to the pump Paradigm® Real-Time for up to 24 weeks and to change sensors, insulin infusion sets and reservoirs every 3 days (\~60 times during the study period ).
* Patients from CSII group must be willing to wear an insulin pump, change insulin infusion sets, and reservoirs every 3 days (\~60 times during the study period ).
* Patient is required to use the Paradigm® Real-Time system at least 70% of the time during the study period.
* Patients in both groups are required to wear at the beginning and the end of the study a CGMS for 3 days. and to perform 6 self-monitoring blood glucose finger-sticks daily during the 3 days.
* Patients must be willing to undergo all study procedures, to receive a technical training to understand how to use the Paradigm® Real-Time System or the Insulin Pump depending of the randomization.
* Patients must agree to receive a training on how to adapt their insulin doses to their meals, how to calculate and apply corrective treatment.

Exclusion Criteria:

* Hearing or vision impairment so that alarms cannot be recognized.
* Alcohol or drug abuses other than nicotine.
* Allergy to sensor or components of the sensor.
* Allergy to insulin infusion set or components of the insulin infusion set.
* Patient is pregnant or of child-bearing potential during the study.
* Patient does not have a reliable support person or the patient is unwilling to comply with the provisions of the protocol.
* Patients suffering from cancer, heart failure, kidney disease and other chronic debilitating conditions.
* Patients participating in other device or drug studies will be excluded.
* Patients may participate in this study only once.
Telehealth-based Symptom Management for Veterans Treated With Selinexor

The purpose of this study is to find out if continued monitoring of side effects from Selinexor and prescribed medication to prevent side effects helps improve symptoms, quality of life, and ability to continue the treatment longer.

The primary objective of this study is to evaluate control of treatment-related and cancer-associated symptoms over the first three months of therapy with selinexor in Veterans who participate in a telehealth symptom management intervention.

The secondary objectives are:

* To describe characteristics of patients treated with selinexor.
* To describe adherence with the telehealth intervention.
* To define the type and frequency of adverse events that patients experience while taking selinexor.
* To describe the duration of selinexor therapy and evaluate adherence and dose intensity of selinexor in VA cancer patients receiving a telehealth symptom management intervention.
* To describe concomitant medication usage in patients treated with selinexor.
* To assess quality of life in patients treated with selinexor in the VA.
* To estimate progression-free survival in VA cancer patients treated with selinexor.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of B-cell malignancy: either relapsed or refractory multiple myeloma or diffuse large B-cell lymphoma, meeting the FDA-approved indication for Selinexor treatment.
* Requiring therapy as assessed by the treating oncology provider.
* Prior authorization drug request for selinexor approved by VA oncology pharmacist.
* Subject age 18 years or older.
* Subject willing and able to perform video or telephone research visits.
* Subjects must be able to read and comprehend English.
* Subject must be a Veteran receiving cancer care from a VA facility affiliated with the National Teleoncology Program.
* Patients must be enrolled prior to starting Selinexor.

Exclusion Criteria:

* Any prior or current therapy with selinexor.
* Any medical, psychiatric, or cognitive issue that the principal investigator or the subject's oncologists believes would prevent participation or completion of the study.
* Individuals who are vulnerable to coercion or undue influence.
* Any individuals or populations that may temporarily or permanently require additional considerations include such as those susceptible to coercion or undue influence (e.g., patients with limited or no treatment options, socially and economically disadvantaged persons).
* Current selinexor therapy that is part of an investigational clinical trial.
Emotional Processes in VR Exposure Treatment for Flight Phobia

This study will assess emotional processes and their relation to treatment outcomes during Virtual reality exposure therapy for Flight Phobia. The researchers hypothesize treatment outcomes will be associated with positive changes in emotional constructs

Emotional constructs and emotion regulation capacities play a central role in the severity of anxiety disorders and are directly related to treatment outcomes in different anxiety disorders. In this study we will examine the relation between positive and negative affect, emotion regulation, emotional instability, emotional differentiation, experiential avoidance and therapy outcomes in participants undergoing Virtual Reality Exposure Therapy for Flight Phobia. We assume that treatment outcomes will be positively related to changes in the regulation, management and experience of emotions.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Flight phobia based on a structured interview
* possession of a smartphone with an active data plan

Exclusion Criteria:

* cardiovascular disease
* neurological disorders and history of epilepsy
* psychosis
* major depression
* suicidal behavior
* substance abuse.
Prednisone in Cystic Fibrosis Pulmonary Exacerbations

This will be a 5 year randomized, double blind, placebo controlled trial of 7 days of oral prednisone in cystic fibrosis (CF) patients receiving intravenous (IV) antibiotic treatment for a pulmonary exacerbation at the Hospital for Sick Children and other study sub-sites across Canada. The intervention will be oral prednisone 2 mg/kg/day (max 60 mg) divided twice daily for 7 days as an adjunctive therapy for pulmonary exacerbations in CF patients who have not recovered their baseline forced expiratory volume in 1 second (FEV1) after 7 days of IV antibiotic treatment. The primary outcome will be the proportion of subjects who achieve \>90% of their baseline FEV1 % predicted at day 14 of IV antibiotic treatment for a pulmonary exacerbation in each treatment arm.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of CF by newborn screening or at least one clinical feature of CF, AND either (a) or (b) as follows:
2. A documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis
3. A genotype with two identifiable CF-causing mutations
4. Age \> 6 years old.
5. Acute pulmonary exacerbation treated with IV antibiotics as previously defined 10% relative drop in FEV1 from baseline at the time of exacerbation
6. Informed consent by patient or parent/legal guardian
7. Ability to reproducibly perform pulmonary function testing
8. Ability to comply with medication use including the ability to take capsules, study visits and study procedures as judged by the site investigator

Exclusion Criteria:

1. A respiratory tract culture positive for Burkholderia cenocepacia in the 12 months prior to enrollment
2. A respiratory tract culture positive for Mycobacterium abscessus in the 12 months prior to enrollment
3. Treatment with IV or oral corticosteroids within 2 weeks of enrollment or from Day 0-Day 7 of the pulmonary exacerbation
4. Active allergic bronchopulmonary aspergillosis (ABPA) at the time of enrollment as determined by treating physician
5. Asthma related exacerbation at enrollment as defined by the treating physician based on clinically compatible symptoms (eg. wheeze)
6. History of avascular necrosis or pathologic bone fracture
7. Uncontrolled hypertension with end organ damage
8. Active gastrointestinal bleeding
9. Status post lung or other organ transplantation
10. Pregnancy
11. Lactose intolerance (contained in placebo)
12. On Lumacaftor-Ivacaftor (Orkambi) at the time of exacerbation
13. Investigational drug use within 30 days prior to enrollment visit
14. Physical findings that would compromise the safety of the subject or the quality of the study data as determined by site investigator
NAD Supplementation to Prevent Progressive Neurological Disease in Ataxia Telangiectasia

The study investigates the effect of dietary supplementation of nicotinamide ribonucleoside (NR) in children with ataxia telangiectasia (AT), with main focus on neurological symptoms.

Ataxia Telangiectasia (AT) is a genetic disease, where patients are born with mutations in the Ataxia- Telangiectasia Mutated (ATM) gene. The gene codes for the ATM kinase, which is required for repair of DNA double-stranded breaks and DNA damage response signalling.

There is no treatment available for the neurological manifestations of AT.

The study investigates the effects of NR (300 mg/day) during 2 years.

Eligibility Criteria:
Inclusion Criteria:

* clinically and molecular verified classical A-T disease

Exclusion Criteria:

* less than 2 years of age
* participation in other on-going study
* pregnancy
* liver failure
* other severe medical conditions considered to set patient at risk
Assessment of Masticatory Performance in Periodontitis

The loss of periodontal attachment contributes to reduced masticatory performance and has a negative impact on general health.This clinical trial aims to assess the status of masticatory performance among patients with stage I, stage II, stage III and stage IV periodontitis, along with those with healthy periodontium.

Periodontal disease manifestations include gingival bleeding, halitosis, tooth mobility and loss of teeth in advanced cases. The loss of periodontal attachment contributes to reduced masticatory performance and has a negative impact on general health. Loss of periodontium leads to reduced ability of tooth to withstand masticatory loads. Thus, biting abilities of subjects with healthy periodontium are significantly greater than those of chronic periodontitis patients. Even though the new periodontitis classification includes masticatory dysfunction in stage 4, but clinical periodontal parameters do start influencing objective masticatory efficiency in early stages. Since the masticatory function is an important point for the classification of periodontitis, standardized procedures with corresponding reference values are needed to consider these parameters in the assessment of periodontitis and to be able to make specific therapy recommendations.

This clinical trial aims to assess the changes in masticatory performance among periodontitis patients of all stages and healthy individuals using test methods easily applicable in daily practice.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients with age group 30-50 years diagnosed with generalized periodontitis
2. Presence of minimum 20 teeth (Eichner group A1, A2, A3) excluding third molars.

Exclusion Criteria:

* Systemic diseases that may affect periodontal disease progression or outcome of treatment (diabetes, autoimmune diseases)
* Systemic diseases that may affect masticatory ability of the patient (sarcopenia, TMJ disorders, Xerostomia, Acute Pulpitis)
* Grade C periodontitis (evaluated indirectly by radiographic bone loss/age criteria)
* Smoking or substance abuse
* Pregnant and lactating women
Acid Production in Dental Plaque After Exposure to Probiotic Bacteria

The increasing interest in probiotic lactobacilli in health maintenance has raised the question of potential risks. One possible side effect could be an increased acidogenicity in dental plaque. The aim of this study was to investigate the effect of probiotic lactobacilli on plaque lactic acid (LA) production in vitro and in vivo.

Methods. subjects (n=18) were given lozenges with probiotic lactobacilli (L. reuteri DSM 17938 and ATCC PTA 5289) or placebo for two weeks in a double-blinded, randomized cross-over trial. The concentration of LA in supragingival plaque samples was determined at baseline and after 2 weeks. Salivary counts of mutans streptococci (MS) and lactobacilli were estimated with chair-side methods.


Eligibility Criteria:
Inclusion Criteria:

* moderate to high counts of salivary mutans streptococci (\>104 CFU) as estimated with the Dentocult SM chair-side test,
* no visible open caries lesions or periodontal disease,

Exclusion Criteria:

* smokers,
* ingestion of probiotic bacteria within the last two months,
* ingestion of antibiotics within the last two months
Real World Study of the Effectiveness and Safety of Conbercept Ophthalmic Injection in the Treatment of Retinopathy of Prematurity - Multicenter, Retrospective and Observational Study Based on Real World Data

This study is a retrospective, multi-center real world study. The real world data comes from the electronic medical record system and disease database of the research centers .The patient's demographic information, disease information, clinical treatment status, efficacy evaluation and adverse events and so on will be collected and evaluated by applicability of the data, generated an analysis data set. Use the causal inference method of statistical analysis to observe the effectiveness and safety of intravitreal injection of Conbercept, and explore the effectiveness and safety of different doses in the treatment of retinopathy of prematurity.


Eligibility Criteria:
Inclusion criteria:

1. Patient who are diagnosed as retinopathy of prematurity using clinical fundus screening;
2. Patients at the initial stage of treatment whose one eye at least has the following condition: Stage 1+, Stage 2+, Stage 3, Stage 3+ in Zone 1; or Stage 2+, Stage 3+ in Zone 2; or those with AP-ROP according to the international ROP classification,;
3. Patient for whom the first treatment is laser therapy, intravitreal injection of Conbercept or ranibizumab;

Exclusion criteria:

1. Patients with neurological diseases that seriously affect visual function;
2. Patient or his mother (during pregnancy) has received intravitreal or systemic anti-VEGF drug therapy for other diseases;

Elimination criteria:

1. Patients with insufficient data on treatment or medication;
2. Patients who are followed up for less than 3 months after treatment.
A New Radiation Therapy Planning System in Patients Undergoing Radiation Therapy for Cancer

RATIONALE: A new radiation therapy planning system may help doctors plan better treatment for patients with cancer.

PURPOSE: This clinical trial is studying a new radiation therapy planning system in patients undergoing radiation therapy for extracranial cancer.

OBJECTIVES:

* Determine the ability of the Radionics Body System™ to immobilize and re-localize patients receiving radiotherapy to extra-cranial sites of cancer.
* Determine the accuracy of radiation dose calculations for extra-cranial sites of cancer when using the XPLAN™-intensity modulated radiation therapy (XPLAN™/IMRT) integrated software in this system.

OUTLINE: Patients receiving radiotherapy have a Body Localizer cast constructed and undergo a CT scan while immobilized in the Body Localizer. Patients undergo another CT scan in the treatment position using the standard alpha cradle. The XPLAN™-intensity modulated radiation therapy (XPLAN™/IMRT)-generated treatment plan is compared to the standard treatment plan to verify that the calculated dose is within 2-3 percent of the planned dose using standard technique. Patients undergo sets of CT scans 3 additional times over the next few weeks for a total of 8 CT scans Patients may undergo additional CT scans before and after radiotherapy treatments for a maximum of 5 CT scans per week performed over the course of radiotherapy.

PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Cancer for which a course of radiotherapy to an extra-cranial site is required

  * Head and neck sites excluded
* Initial treatment field (or cone down field) must be no greater than 12 X 10 cm

PATIENT CHARACTERISTICS:

Age

* Not specified

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Cardiovascular

* No right heart insufficiency

Other

* Not pregnant or nursing
* Fertile patients must use effective contraception
* Weight must not exceed 150 kilograms (330 pounds)

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics

Surgery

* Not specified
Human Genes and Microbiota in Early Life

The long-term goal of the Human Genes and Microbiota in Early Life (HuGME) is to explore the short- and long-term effects of maternal microbiota during pregnancy and the microbiota colonization of their offspring early in life and their interaction with the host on maternal-offspring health consequences in later life in the born in Guangzhou cohort study in China. Identification of the effect of microbiota in early life, as well as environmental factors and microbe-host interaction, will lead to a better understanding of disease pathogenesis and provide a foundation for targeted mechanistic investigation into the consequences of microbial-host crosstalk for long-term health. It also can result in new strategies to predict and prevent diseases in later life.

Prenatal and early postnatal life represent critical windows for growth and cognitive and immune system development. In addition to genetics and host biology, the environment plays a critical role in the health of a child. One key player in this process is the maternal and infant gut microbiomes. The establishment and progression of the intestinal microbiota from birth to childhood are dependent on a range of factors, including maternal microbiota, diet, environment, and medical exposures. The host-microbial crosstalk during this time is thought to be involved in the pathobiology of later-life diseases, such as allergic disease, obesity, and neurodevelopmental delay. Although the microbiome and its importance for health have been extensively studied, it remains unclear how maternal microbiota-fetal interaction, the establishment, and progression of microbiota in infant adaptation to postnatal environmental exposures, and microbial-host crosstalk affect the health of the children in later life.

Hypotheses:

1. Maternal microbiota-fetal interaction has an essential effect on fetal immune system development and adverse pregnancy outcomes.
2. Host genes can shape infant gut microbial assembly and metabolism.
3. Early-life interactions between host genes and microbiota have an impact on immune system development and atopic disease in later life.
4. Co-metabolism of the gut microbiome and metabolites in the host affects childhood obesity
5. Early-life interactions between the host and microbiota have an impact on the neurodevelopment of the children.
6. Maternal microbiota influence the metabolism of the mother during pregnancy and postpartum.

Eligibility Criteria:
Inclusion Criteria:

Pregnant women with \< 20 weeks of gestation Pregnant women intended to eventually deliver in Guangzhou Women and Children's medical center Permanent residengts of families intended to remain in Guangzhou with their child for ≥3 years

Exclusion Criteria:

Refuses to have blood and stool samples stored at Born in Guangzhou cohort study Biobank.
An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

This observational, prospective, open-label, multi-center study will evaluate the effectiveness in disease reduction and the safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected for 11 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>/=18 years of age
* Patients with rheumatoid arthritis eligible for RoActemra

Exclusion Criteria:

* Hypersensitivity to RoActemra
* Active, severe infections
Serum Erythropoietin Level in Perinatal Asphyxia

This study is to evaluate brain and kidney injuries in full-term neonates with perinatal asphyxia by detecting specific biomarker in blood (Erythropoietin).

Perinatal hypoxic-ischemic encephalopathy (HIE) is an important cause of brain injury in the newborn and can result in long-term devastating consequences. Acute kidney injury (AKI) occurs in (50 - 72%) among asphyxiated term infants. The kidney cells that make erythropoietin are sensitive to low oxygen levels in the blood that travels through the kidney. These cells make and release erythropoietin when the oxygen level is too low.

Eligibility Criteria:
Inclusion Criteria:

Cases group:

1. The presence of a sentinel hypoxic event immediately before or during delivery
2. History of fetal distress (bradycardia, late decelerations, absence of heart rate variability).
3. Need for neonatal resuscitation at delivery
4. One-min Apgar score \<3 or 5-minApgar score\<7
5. Metabolic acidosis (BE \> 10 in cord blood)
6. Cardiocirculatory instability (CCI), clinical indications of hypoxic-ischemic encephalopathy (HIE) and multiple organ involvement (MOI).

Control group:

Newborns who were delivered normally after uncomplicated pregnancy. None of them have clinical nor biochemical signs of asphyxia.

Exclusion Criteria:

* Newborns who do not fulfill the above criteria.
* Newborns with congenital heart diseases and perinatal hemolytic anemia or congenital liver affection.
* Whose parents refuse to participate in the study.
* Cases above 4 days old.
* Preterm neonates (less than 37 weeks).
An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia

The primary purpose of this study is to assess the safety and efficacy of repeated subcutaneous (SC) injections of KRN23 in adult subjects with X-Linked Hypophosphatemia (XLH).


Eligibility Criteria:
Inclusion Criteria:

1. Satisfactory completion of KKP's sponsored KRN23-INT-001 clinical trial
2. eGFR ≥ 60 mL/min
3. Corrected Ca \< 10.8 mg/dL
4. For female of child-bearing potential, a negative serum pregnancy test
5. A willingness to utilize adequate contraception and not become pregnant \[or to have their partner(s) become pregnant\] during the study
6. Additional inclusion criteria apply

Exclusion Criteria:

1. Subject experienced a safety-related event in the KRN23-INT-001 study
2. Pregnant or lactating female subject or pregnant or female planning to become pregnant during the study
3. Receipt of a live (attenuated) vaccine (except for influenza vaccines) during the course of the KRN23-INT-001 study and/or of this study
4. Condition which could present a concern for either the subject's safety or difficulty with data interpretation
5. Additional exclusion criteria apply