cyrilzakka/clinical-trials huggingface dataset:
Effect of Fiber Supplementation in Children With Type 1 Diabetes

High fiber foods are recommended as a preferential source of carbohydrate by the Nutrition Study Group of the European Association for the Study of Diabetes. Dietary fibers may delay glucose absorption and reduce postprandial glycemic excursion. They also appear to have a beneficial effect on cholesterol levels. It has been shown, in few short term adult studies, that high fiber foods reduce postprandial blood glucose levels. The American Diabetes Association feels that there is little evidence confirming the positive effect of high fiber foods on blood glucose control. It is not clear whether a high fiber diet can improve glycemic control and/or reduce the risk of hypoglycemic events. Our hypothesis is that children with type 1 diabetes will benefit from having added fibers in their diet. The investigators plan to study blood glucose values using a continuous blood glucose monitor before and after dietary fibers are introduced. This will help us determine whether a diet rich in fiber should be recommended in all children with type 1 diabetes mellitus


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria are: Diagnosis of type I diabetes for at least two years prior to enrollment, the ability tolerate wearing the continuous blood glucose monitoring device for a total of 6 days, and the ability to follow a prescribed meal plan.

Exclusion Criteria:

* The exclusion criteria are: Medical conditions that could potentially affect the absorption of nutrients such as celiac disease of inflammatory bowel disease and the use of any fiber supplements at home.
Immunogenicity and Safety of NBP608 Compared to Varivax in Healthy Children 12 Months to 12 Years of Age

This study assesses non-inferiority by comparing seroconversion rate of NBP608 to Varivax which are indicated for active immunization for prevention of varicella. Total of 488 subjects (244 subjects per treatment arm) of 12 months to 12 years of age are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned.

This is a multi-national, multi-center, randomized, double blinded, parallel-group study to assess the Immunogenicity and safety of NBP608 compared to varivax which are indicated for active immunization for the prevention of varicella. Total of 488 subjects of 12 months to 12 years of age are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned in 1:1 ratio. Stratified randomization for age group is used to achieve the balance of treatment assignment within age strata.

Total of four visits are scheduled including two visits via telephone contact. Blood sampling is conducted for immunogenicity assessment before and 6 weeks after vaccination at Visit 1 and Visit 3 respectively. Safety is monitored 1 week, 6 weeks and 26 weeks after vaccination through Visit 2\*, Visit 3 and Visit 4\* (\* telephone contact)

Eligibility Criteria:
Inclusion Criteria:

* Healthy children aged between 12 months and 12 years old who are available for the follow-up during the study period
* After menarche females who are confirmed to be negative in a pregnancy test on the day of vaccination and agree to practice birth control for 3 months after the vaccination

Exclusion Criteria:

* Those with hypersensitivity to any component of the IPs(Investigational Products), such as gelatin or neomycin
* Those who have received a varicella vaccine previously
* Those with a history of hypersensitivity to vaccination, such as Guillain-Barre syndrome
* Those with congenital or acquired immunodeficiency
* Those with active untreated tuberculosis
* Those who have received or are expected to receive salicylates from 14 days prior to IP(Investigational Product) vaccination to Visit 3
* Those who have received or are expected to receive other vaccines from 1 month prior to IP(Investigational Product) vaccination to Visit 3
* Those who have received or are expected to receive other IPs(Investigational Products) in another clinical study from 1 month prior to IP(Investigational Product) vaccination to Visit 3
Comparison of Vibratory Perineal Stimulus With Transvaginal Electrical Stimulation

Aim: To compare the effects of Vibratory Perineal Stimulus with transvaginal electrical stimulation to the pelvic floor muscles functionality in women with urinary incontinence and who are unable to voluntarily contract their pelvic floor muscles.

Study Design: Randomized controlled trial

* The purpose of this study is to find out the effect of vibratory perineal stimulus compared to transvaginal electrical stimulation on the functionality of pelvic floor muscles in women with urinary incontinence who are unable to perform voluntary contraction of this musculature.
* Study Design: Randomized controlled trial
* Search location: The data will collected at the Ambulatory of Urogynecology and Obstetrics of Porto Alegre Clinical Hospital (HCPA), where the activities of Pelvic Physiotherapy are performed.and in the Clinical Research Center of the same hospital.
* Inclusion criteria: women with urinary incontinence with zero or one strength degree of pelvic floor muscle contraction by the Modified Oxford Scale.
* Main outcome: Improvement the functionality of pelvic floor muscles
* Secondary outcome: Improvement of urinary loss
* First protocol: patients will be referred by the medical team and will undergo physiotherapeutic evaluation to collect personal data, check the symptoms of urinary incontinence, apply a quality of life questionnaire and measure pelvic floor muscles strength. If patient has zero or one degree of pelvic floor muscle strength, will be referred to the second phase.
* Second protocol: Patients will be randomized into two groups - Vibratory stimulus group or electrical stimulation group. Both will follow a 6-week treatment protocol with intervention once a week. Both are intravaginal devices applied for 20 minutes, with on cycle of 8 seconds and off cycle of 16 seconds.
* Final protocol: patients will repeat the initial evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of urinary incontinence;
* To be unable to perform a voluntarily contraction of pelvic floor muscles;
* Understand the instruments used in the research;

Exclusion Criteria:

* Allergy to latex;
* Individual or group pelvic floor muscle training in the last 6 months.
Miodural Bridge Stretching in Posture Modification in Professional Footballers

Fatigue influences the kinematics of the knee. Decreasing the tone of the suboccipital musculature may decrease the tone of the knee flexors. Inhibition of the suboccipital musculature is used to improve ischiosural muscle tension.

The main objective of the study is to evaluate the effectiveness of the stretching of the miodural bridge in the modification of the posture in professional soccer players of 3rd division.

Randomized clinical trial. 30 players will be randomized to the two study groups: experimental (technique of stretching technique of the miodural bridge) and control (without intervention). A blinded evaluator will perform three evaluations: pretreatment, post-treatment and follow-up. The study variables will be: modification of posture and weight distribution (plantar pressure platform). The sample distribution will be calculated using a Kolmogórov-Smirnov analysis. The changes after each evaluation will be analyzed with the t-student test of related samples and through an ANOVA of repeated measures the intra and intersubject effect will be observed. The effect size will be calculated using Cohen's formula.

After stretching the miodural bridge, it is expected to see improvement in posture changes.


Eligibility Criteria:
Inclusion Criteria:

* Football players
* Male
* From 18 to 23 years old
* That have a federation file in 3rd division in the Region of Murcia
* That you don't have any acute lesions at the time of the study.

Exclusion Criteria:

* Subjects that: present some relevant subacute or chronic pathology that may have a direct impact on the processes or structures related to the study who have neurological problems or related to the vestibular system
* That receive a specific Physiotherapy training on any of the study regions
* Not sign the informed consent document
DART: Diagnostic-CT-Enabled Planning: A Randomized Trial in Palliative Radiation Therapy

The objective of this trial is to assess the efficacy, acceptability, and scalability of diagnostic-CT-enabled planning, compared to conventional CT simulation planning.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Able to provide informed consent
* Patient has consented to PRT to bone/soft tissue metastases or primary targets in the thorax, abdomen, or pelvis and RO will use simple planning techniques (i.e. parallel-opposed pair or direct field beam arrangement)
* Patient will be scheduled for same-day simulation and treatment (if randomized to Arm 1)
* Patient has a pre-existing and recent (i.e. within 4 weeks of time of enrollment) diagnostic CT or CT-fused scan with full visualization of the region-of-interest which has been acquired from an approved diagnostic scanner
* Patient positioning scan is deemed acceptable and reproducible (e.g., patient is lying supine and relatively flat, there is no/minimal motion blur, ect.)
* Intravenous (IV)/oral contrast in the region-of-interest is permitted as long as it does not create artifact which obscured the target volume (density override calculations may be required)

Exclusion Criteria:

* Any contraindication to receiving radiation
* Oncologic emergencies and/or on-call cases
* Pregnant or lactating women
* Cases requiring composite dosimetric planning to account for previous radiotherapy or extended distance set-up
The Food Intake, Satiety and Blood Glucose After Ingestion of Potato Chips Produced From Three Potato Cultivars

Potato is one of the world's most popular foods and is widely accepted as a staple food. The objective of this study is to determine the effect of consuming potato chips from different cultivars on blood glucose, subjective appetite and food intake. It is hypothesized that the chips produced from various potato cultivars will differ in their effect on blood glucose, satiety and food intake.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men with a body mass index (kg/m2) of 20-24.9

Exclusion Criteria:

* smocking, medication, breakfast skipping, restrained eating
Acupressure and Fistula Needle Insert Pain Management

Introduction: This study was conducted to determine the effectiveness of acupressure application on Hegu (LI4) point on the severity of acute pain caused by fistula needle in patients with brescia-cimino, snuff-box and antecubital fistula.

Methods: This study was randomized control study which was conducted with 66 intervention and 65 control participants. The participants in the intervention group were divided into 3 groups according to the fistula area. Data were collected using Descriptive Information Form and pain scale.

This study is determined that finger acupuncture at L14 point reduces the severity of pain felt by the patient during fistula needle insertion. Acute pain during puncture of arteriovenous fistula is a common problem in hemodialysis patients. Moreover, patients experience this acute pain three times a week. Accordingly, acupressure applied to the L4 acupuncture point can be considered as an effective, simple and low-cost non-pharmacological method to reduce acute pain during needle insertion in patients. Since this application is non-invasive and does not carry the risk of complications, it can be taught to patients and/or nurses to contribute to the management of acute pain. In addition, in this article, we examined the effect of acupressure applied only to the LI4 acupuncture point on pain intensity during fistula needle insertion, therefore, we suggest designing different studies with different acupuncture points (effective in reducing pain).

Eligibility Criteria:
Inclusion Criteria

18 years or older have brescia-cimino, snuff-box or antecubital fistula speak Turkish have hemodialysis(HD) treatment three times a week have not used analgesics in the last 6 hours had no pain who volunteered to participate in the study.

Exclusion Criteria With aneurysmatic fistula had soft tissue damage infection in extremities has coagulations and bleeding problems.
Low-cost Imaging Technology for Global Prevention of Cervical Cancer

Cervical cancer remains the first or second leading cause of cancer death among women in many low-and middle-income countries. Cervical cancer prevention programs in low-resource settings are hampered by a lack of personnel with appropriate clinical expertise, lack of pathology services, and lack of associated infrastructure. There is an urgent need for appropriate diagnostic tools to enable accurate screening and diagnosis in low-resource settings. The purpose of this study is to develop and validate a low-cost Multimodal Mobile Colposcope (MMC) for global cervical cancer prevention programs. This new device will combine the imaging capabilities of a mobile colposcope with the microscopic imaging capabilities of a fiber-optic confocal imaging probe.


Eligibility Criteria:
Inclusion Criteria:

* Women \>25 years of age;
* Women undergoing colposcopy due to abnormal cervical screening or follow-up for a history of dysplasia;
* Women of childbearing potential must have a negative urine or blood pregnancy test;
* Ability to understand and willingness to provide informed consent by signing specific Informed Consent Document.

Exclusion Criteria:

* Women under 25 years of age;
* Women who have undergone hysterectomy with removal of the cervix;
* Women with known allergy to proflavine or acriflavine;
* Women who are pregnant or nursing at the time of enrollment;
* Incapacitated women or in vulnerable situations or who are not willing to give consent;
Safety and Efficacy Study of Salvage Chemotherapy (R-ESHAP) to Treat Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma

Aggressive non-Hodgkin's lymphoma is difficult to handle once it relapses or becomes refractory to chemotherapy. Various second or third line chemotherapies, which are called salvage chemotherapy, were developed without promising results. Improvement in efficacy by adding relatively new agent, rituximab, to chemotherapy is now widely accepted in non-Hodgkin's lymphoma. This study will test the safety and efficacy of adding rituximab to existing salvage chemotherapy, ESHAP (R-ESHAP). Our aim is also to proceed to high-dose chemotherapy with autologous hematopoietic stem cell transplantation after successful R-ESHAP therapy.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of aggressive non-Hodgkin's lymphoma
* Refractory to the first line chemotherapy or relapsed
* Expression of CD20 on lymphoma cells
* Measurable lesions on imaging studies

Exclusion Criteria:

* Blood cell counts not reaching to 3,000/microliter for white blood cells, 7 g/dl for hemoglobin, and 50,000/microliter for platelets without transfusion at the time of registration
* Circulating lymphoma cells equal to or more than 25,000/microliter
* Hepatic dysfunction
* Renal insufficiency
* Cardiac dysfunction or arrhythmia
* Sever infection (bacterial, viral)
* CNS involvement
* Other malignancies
* Pregnancy or breast feeding
Orkambi Treatment in 2 to 5 Year Old Children With CF

The purpose of this observational research study is to determine the effects of clinically prescribed Orkambi treatment on 2 to 5 year old children homozygous for the F508del Mutations in the Cystic fibrosis transmembrane conductance regulator (CFTR) gene on sleeping energy expenditure, growth status and gut health and function.

Orkambi is a novel FDA approved (August, 2018) therapy for use in patients with cystic fibrosis (CF) who are 2 to 5 years of age and homozygous for F508del mutations in the CFTR gene. It is a combination of lumacaftor and ivacaftor that addresses both the processing and gating defects of the F508del mutation. This investigator-initiated study is designed to evaluate the nutritional, growth and GI impact of Orkambi treatment for this unique younger (2 to 5 years) patient cohort. This proposal extends previous highly informative nutrition and weight gain investigation of ivacaftor treatment in people with CF gating mutations to another CFTR modulator treatment (Orkambi) in people homozygous for F508del mutations. The primary aims of the study are to evaluate the impact of 24 weeks of Orkambi treatment in 2 to 5 year old subjects with CF homozygous for F508del mutations on sleeping or resting energy expenditure, growth status and gut health and function in n=32 children ages 2.0 to 5.9 years of age. Protocol evaluations will occur at baseline (pre-treatment) and 12 and 24 weeks after clinically prescribed Orkambi treatment has begun. Other outcomes of significant clinical interest in young subjects with CF will be explored. All subjects will be evaluated as outpatient at The Children's Hospital of Philadelphia, and will be recruited both regionally and nationally to ensure timely enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis and homozygous for F508del mutations, approved for treatment
* Age: 2.0 to 5.9 years
* In usual state of good health
* A clinical decision has been made for subject to begin Orkambi treatment
* Family committed to the 6 to 8 month study protocol with visits to the Children's Hospital of Philadelphia (CHOP) that will last 2-3 days for the baseline visit (Visit 1) prior to Orkambi and the 24 week visit (Visit 3) after clinically prescribed Orkambi treatment has begun, and will last up to 2 days for the 12 week visit (Visit 2) after Orkambi treatment has begun.

Exclusion Criteria:

* On parenteral nutrition
* Use of any medications that inhibit or induce cytochrome P450 (CYP) 3A
* Liver function tests elevated above 3x the reference range for age and sex
* Lung disease considered severe based on clinical impression by home CF center.
* Other illness affecting growth or nutritional status
* Other contraindications described for Orkambi therapy
An Observational, Retrospective, UK & Ireland Audit of Patient Adherence to Rebif® Injections Using the RebiSmart™ Injection Device

This is an observational, retrospective, UK \& Ireland audit measuring patient adherence to Rebif® injections with the RebiSmart™ injection device. Data will be collected from Multiple Sclerosis (MS) patients who have been prescribed Rebif® and have been using the RebiSmart™ device for injection for a minimum of 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Relapsing Multiple Sclerosis (Relapsing Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis with relapses) according to the Association of British Neurologists criteria (30) in the UK and the revised 2005 McDonald criteria (31) in Ireland
* Prescribed Rebif® (22mcg or 44mcg) using the RebiSmart™ injection device
* Have been using RebiSmart™ for 24 months and be due a device replacement as part of their standard routine of care
* Registered with Bupa Home Healthcare (UK) or SENSE nurse (Ireland)
* Be willing to give consent for their adherence data to be captured in the audit

Exclusion Criteria:

Patients who do not fulfill entirely the inclusion criteria as well as the following:

* Discontinued Rebif before 24 months of treatment
* Unable or unwilling to give consent for their adherence data to be captured in the audit
A Culturally Adapted, Social Support-Based, Physical Activity Interventions for South Asian Indian Women in the United States

The purpose of this study is to assess the feasibility and acceptability of a peer-based dyadic social support health coaching physical activity (PA) intervention in inactive South Asian Indian (SAI) and to explore preliminary effects of the intervention on intermediate outcomes: self-reported and objective moderate-to-vigorous physical activity (MVPA), social support, and self-efficacy .


Eligibility Criteria:
Inclusion Criteria:

* inactive SAI (Physical activity (PA) \<150 minutes/week)
* physically able to engage in moderate PA
* speak and read English; able to enroll with an eligible adult female partner who does not live in the same household
* willing to use the Fitbit app/device
* own a smartphone that is compatible with Fitbit software (up to 223.3 MB on iPhone or 165 MB on Android) 9)
* able and willing to send and receive text messages
* Blood pressure reading \<160/100 mm Hg, or with medical clearance.

Exclusion Criteria:

* SAI women with a current/planned pregnancy
* cannot speak and read English
* those participating in a PA or weight loss program
* those diagnosed with a physical disability that interferes with their ability to be physically active.
* not living in Houston, Texas
A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome

A 14-Week clinical research study to compare the effectiveness and safety of ropinirole and placebo (an inactive sugar pill) in the treatment of patients with Restless Legs Syndrome (RLS) in the United States.


Eligibility Criteria:
Inclusion criteria:

* Patients diagnosed with Restless Legs Syndrome (RLS) with symptoms such as: uncomfortable or "creepy-crawly" sensations in your legs, overwhelming urge to move your legs to relieve these sensations, sensations go away when you move your legs, or trouble falling asleep or staying asleep because of these symptoms.
* Patients must give written informed consent prior to any specific study procedures.

Exclusion criteria:

* Patients who suffer from narcolepsy, sleep terror disorder, sleepwalking disorder, or a breathing related sleep disorder.
* Patients diagnosed with renal failure (end-stage renal disease) iron deficient anemia or pregnancy.
* Patients suffering from other movement disorders (i.e. Parkinson's Disease).
* Patients who have medical conditions such as diabetes, peripheral neuropathy, rheumatoid arthritis, or fibromyalgia syndrome.
* Participation in any clinical drug or device trial in the last three months.

Other inclusion or exclusion criteria to be evaluated by the physician.
A Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product and U-200 Product in Healthy Volunteers

This is a double-blinded, randomised, single-centre phase I pilot trial for exploring the feasibility of a pivotal clinical trial establishing bioequivalence between BioChaperone insulin lispro U-200 and BioChaperone insulin lispro U-100 in healthy subjects.

Each subject will be randomly allocated to a sequence of four treatments, i.e. two single doses of BioChaperone insulin lispro U-200 of 0.2 U·kg BW-1 and two single doses of BioChaperone insulin lispro U-100 of 0.2 U·kg BW-1 on four separate dosing visits.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
* Age ≥ 18 and ≤ 64 years, both inclusive.
* Body Mass Index (BMI) between 18.5 and 28.0 kg∙m-2, both inclusive.
* Fasting Plasma Glucose (FPG) ≤ 5.6 mmol/L (100 mg/dL).
* Signed and dated informed consent obtained before any trial-related activities, i.e. any procedures that would not have been performed during normal management of the subject).

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products.
* Receipt of any investigational medicinal product within 3 months before randomisation in this trial.