cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of GX-188E DNA Therapeutic Vaccine Administered by Electroporation After Observation

This study is to follow up on the change of immune response by measuring HPV type 16/18 E6 and E7 specific T cell response and lesion condition in subjects who have administered in DNA-based therapeutic vaccine.

This is a follow-up study to investigate the change of immunogenicity and lesion condition in subjects with cervical intraepithelial neoplasia (CIN) 3 who have enrolled and completed GX-188E phase I study.

Subjects will make visits at week 48 (V1) to week 228 (V8) every 6 months after the final administration of GX-188E.

The endpoints are to evaluate the change of immune response, involved lesion and infection status compared to that of the final visit in phase I study.

Eligibility Criteria:
Inclusion Criteria:

* Female aged between 20 and 50 (inclusive)
* The subjects who have visited within 48 weeks after final injection of GX-188E
* Those who voluntarily signed informed consent form

Exclusion Criteria:

* Prior participation in any clinical trial within 30 days prior to the visit 1
* Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer

This randomized, open-label, two-arm, multi-center, Phase II study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab plus an aromatase inhibitor (AI) in first-line participants with HER2-positive and hormone receptor-positive advanced breast cancer. Participants will be randomized to one of two treatment arms; Arm A (pertuzumab in combination with trastuzumab plus an AI) or Arm B (trastuzumab plus an AI). Participants may also receive induction chemotherapy (a taxane, either docetaxel or paclitaxel) at the investigator's discretion in combination with the assigned treatment arm. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal of consent, or death whichever occurs first.


Eligibility Criteria:
Inclusion Criteria:

* Participants with HER2-positive and hormone receptor-positive advanced metastatic or locally advanced breast cancer
* Post-menopausal status over 1 year
* HER2-positive as assessed by local laboratory on primary or metastatic tumor
* Hormone-receptor positive defined as estrogen receptor-positive and/or progesterone receptor-positive
* At least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria In Solid Tumors Version 1.1

Exclusion Criteria:

* Previous systemic non-hormonal anticancer therapy in the metastatic or locally advanced breast cancer setting
* Previous treatment with anti-HER2 agents for breast cancer, except trastuzumab and/or lapatinib in the neoadjuvant or adjuvant setting
* Disease progression while receiving adjuvant trastuzumab and/or lapatinib treatment
* History of persistent Grade 2 or higher hematological toxicity according to National Cancer Institute-Common Toxicity Criteria Version 4.0
* Disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal treatment to recurrence of within 6 months
* Other malignancies within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
* Clinical or radiographic evidence of central nervous system metastases or significant cardiovascular disease
A Study to Assess the Tolerability of a Single Dose of STX107 in Adults With Fragile X Syndrome

The study will consist of a Screening period (up to 14 days), a Treatment period, and a Follow-Up period. Sixteen subjects will be enrolled into two sequential dose cohorts - 10 or 30 mg (or matching placebo) across four study centers.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects 18 to 50 years of age, inclusive.
* Molecular documentation of the full fragile X mutation.

Exclusion Criteria:

* Subjects with a history of seizure disorder who are, in the opinion of the Investigator and Medical Monitor, not currently considered to be well controlled.
* Subjects currently being treated with psychoactive medications (including stimulants and anxiolytics).
* Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. 4. Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
* Subjects who, in the Investigator's opinion, might not be suitable for the study
A Survey on NINLARO Risk Management Plan (RMP) Material Utilization Among Pharmacists in Japan

This is a survey among pharmacists who have instructed NINLARO therapy in ixazomib, lenalidomide and dexamethasone (IRD) dosing to patients with relapsed/refractory multiple myeloma (rrMM).

The main aims of the study are:

* To assess the frequency of pharmacists who have provided patients with the contents of the RMP material for patients.
* To assess the frequency of pharmacists who have obtained the RMP material for patients.
* To evaluate the depth of understanding of proper usage of NINLARO among pharmacists.

This is a prospective, non-interventional, observational web-based survey in pharmacists who have instructed the dosing of NINLARO (ixazomib) in combination with lenalidomide and dexamethasone therapy to patients with rrMM. The study will assess the effectiveness of distributed RMP material in prevention of ixazomib overdose in Japanese clinical practice.

The study will enroll approximately 300 pharmacists who belong to hospitals prescribing NINLARO. The data will be collected through a self-administered web-based survey with questionnaires provided in Japanese.

This web-based survey will be conducted in Japan.

Eligibility Criteria:
Inclusion criteria:

1. Who belong to hospitals prescribing NINLARO.
2. Who have instructed the dosing of NINLARO in IRD therapy to patients.

Exclusion criteria:

None
Development and Evaluation of a Medical Intervention for Early Childhood Caries

This study aimed to evaluate the effect of three forms of continuing medical education (CME) on provision of preventive dental services to Medicaid-enrolled children by medical personnel in primary care physician offices.

Practice-based, randomized controlled trial. Setting: 1,400 pediatric and family physician practices in North Carolina providing care to an estimated 240,000 Medicaid-eligible children aged 0-3 years. Interventions: Group A practices (n=39) received didactic training and course materials in oral health screening, referral, counseling and application of fluoride varnish. Group B practices (n=41) received the same as Group A and were offered weekly conference calls providing advice and support. Group C practices (n=41) received the same as Group B and were offered in-office visit providing hands-on advice and support. Outcome measures were computed from reimbursement claims submitted to NC Division of Medical Assistance. Primary outcome measure: rate of preventive dental services provision per 100 well-child visits. Secondary outcome measure: % of practices providing 20 or more preventive dental visits.

Eligibility Criteria:
Inclusion Criteria:

* pediatric or family physician Medicaid practice in North Carolina

Exclusion Criteria:

* participation in related pilot study
Choose Health: Food, Fun, and Fitness Curriculum Promotes Positive Behaviors in 3rd-5th Graders Compared to Control

The Choose Health: Food, Fun, and Fitness (CHFFF) curriculum was evaluated in 3rd-5th graders, hypothesizing that change pre- to post- CHFFF education would be greater than in the same child during a delayed intervention control period.

Choose Health: Food, Fun, and Fitness (CHFFF) is a Cornell curriculum for 3rd-6th graders targeting behaviors to prevent obesity and chronic disease risk: fewer sweetened drinks; more vegetables, fruits, and whole grains; fewer high-fat and high-sugar foods; and active play. The 6 lessons use experiential learning, food preparation, active games, goal setting, and a family newsletter. It was evaluated in 561 Expanded Food and Nutrition Education (EFNEP) participants in 27 after-school and 28 in-school groups in 5 NY counties in 2015 using a quasi-experimental design, with a delayed-intervention control period prior to CHFFF. Youth completed a self-reported survey 3 times: at initial enrollment, after a 6-week no-intervention control period, and after receiving the 6 weekly CHFFF lessons. Outcome measures included dietary intake scores created based on factor analysis, and related precursors. It was hypothesized that change pre- to post- CHFFF education would be greater than in the same child during the delayed intervention control period. Following CHFFF, youth improved significantly (p\<.05) compared to their control period in overall diet quality, vegetable intake, fruit intake, soda/fast food intake and choice, and the frequency with which they read nutrition facts labels, shared about healthy eating with their family, and tried a new food.

Eligibility Criteria:
Inclusion Criteria:

* Participants in EFNEP nutrition education in schools and in after-school programs in 5 counties in NY during the 2014-2015 school year

Exclusion Criteria:

* Younger than 3rd grade (n=3)
* Those with fewer than 4 lessons (n=9)
Retention of Bonded Amalgam Sealants Versus Resin-based Sealants

Dental caries, is one of the major public health problem in Pakistan. Dental sealants are known cost effective preventive measure of dental caries as compared to other preventive measures. Resin based sealants, is a proven treatment of pits and fissure sealants but retention is still problem. This trial will assess the use of amalgam sealants as an effective and retentive preventive measure in preventing dental caries in children as compared to the standard resin-based sealants. The findings of this randomized controlled trial will be used to raise awareness among the health care professionals, help them to choose amalgam sealants as an effective caries prevention method thereby reducing the burden of cost as amalgam is cheaper material compared to resin-based sealants.

The research question Is there any difference in the six months retention of bonded amalgam sealants compared to resin-based sealants among 12 to 16 years old children in Karachi

Objective:

To compare the six month retention of bonded amalgam sealants with that of resin-based sealants among 12 to 16 year old children in Karachi

Methods:

The study design will be parallel group, equivalence randomized controlled trial. Aim is to determine the equality of the Amalgam sealants retention compared to resin based sealants retention.

Outcome:

The primary outcome will be Retention, divided into Complete Retention, Partial Retention and Dislodgement of the sealant material.

Eligibility Criteria:
Inclusion Criteria:

* Children of aged 12 to 16 years (male and female) who will visit to the study site and fulfilled the eligibility criteria
* Teeth should be caries free at the time of sealants placement. As Dental sealant is a preventive treatment it is placed in a caries free surface. Incipient carious lesions will also be included.
* Teeth should be completely erupted, as incomplete eruption of teeth is highly correlates to the partial retention of sealants.
* Children who will give assent to participate in a study and their parents will give consent.

Exclusion Criteria:

* Special needs children (because they need special attention of parents)
* Children who have blood disorder like (leukemia, lymphoma, and thalassemia)
* Persons with impaired vision, speech and hearing (because either they may not be able to respond to questionnaire or conducting baseline dental training will be difficult).
Video Extradition of Continuous Positive Airway Pressure - Influence on Compliance

Confirming or denying it in the future is an opportunity for certain patient groups to have the option of video delivery. So that in calm circumstances and possibly. several times can review the video and equipment in the home and hopefully achieve the same or better compliance with the ongoing treatment.

Due to increasing age, BMI and increased focus on obstructive sleep apnea syndrome (OSAS) in the background population, an increasing number of obstructive sleep apnea (OSA) patients are expected to occur in the coming years. This is accompanied by a need for multiple deliveries of CPAP equipment, which is the recommended treatment. A large proportion of patients are young and healthy with their OSA. There is an increased focus on telemedicine and much of the control of patients has been transferred to ambuflex, where treatment effect or treatment problems can be more easily detected. Socioeconomically, the deliveries, together with the medical examination, are resource-intensive and they also take up a lot of the patient's time and often at distant times. The quality of disclosure and information varies greatly in both time and amount of information. The large amount of information can be difficult to remember for patients and relatives. Most investigations require more visits to the hospital and therefore potentially provide several days away from work.

A similar trial has never been made, but randomized studies have been made in the past where the delivery of CPAP or low compliance patients has been supported by a motivational video or teaching with good effect. Studies have also been conducted that have attempted to identify CPAP dropout and compliance based on gender, age, educational level and personality, with unemployment being the only contributing prognostic factor in the negative direction. It is well-studied that if patients suffer from insomnia, the onset of CPAP can be difficult and this patient group should be monitored more closely and possibly. have additional help for startup.

The video in this study provides a brief review of illness and treatment, instruction on assembling and adapting equipment, and answers to the most frequently asked questions. Both groups are given the same telephone numbers as usual, for questions and here it will be included in the study if there is a difference in the amount of contacts to the ambulatory. The video has been tested in the relevant setting before starting the project. M Gaglianos made in 1988 is a literature review showing that video teaching is good and more effective than traditional teaching methods, with effects on short-term but not long-term memory.

Eligibility Criteria:
Inclusion Criteria:

* candidate to CPAP
* over age of 18

Exclusion Criteria:

* Language issues
* sight or hearing handicap
* kognitive issues
* if drivers license is confiscated
Platelet-derived Factors for Treatment of Muscular Lesions

The purpose of this study is to demonstrate that platelet-derived repairing factors are effective and safe in the treatment of muscular lesion grade 2 or 3, a Phase II, open-label, single arm, single centre has been designed. Sample size will be 25.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* if woman, no pregnancy ongoing
* muscular lesion grade 2 or 3 in a lower limb muscular group

Exclusion Criteria:

* no hematological conditions
* no anticoagulation in the two preceding weeks
A Crossover Pilot Study of the Effect of Amiloride on Proteinuria

This cross-over study is designed to test the hypothesis that amiloride will reduce urinary protein excretion and protect the kidney from rapid progression in proteinuric kidney disease.

Patients with proteinuric kidney disease will be enrolled and receive either amiloride or triamterene first, a similar diuretic acting on epithelial sodium channel (ENaC) as amiloride, but not inhibiting urokinase plasminogen activator receptor (uPAR), will be used as a control. Then patients will cross over to receive another medication. We postulate that amiloride could be beneficial in the patients with proteinuric kidney diseases and could be used as an adjunct therapy to reduce proteinuria and to delay renal disease progression in this patient population.

Specific Aim 1: To examine the effects of amiloride on 24 hour urine protein excretion in patients with proteinuric kidney diseases.

Specific Aim 2: To study if the effect of amiloride on proteinuria reduction is mediated by suppressing soluble urokinase plasminogen activator receptor (suPAR) expression.

Study Design:

The study includes 3 phases. 30 patients will be recruited to this study. All patients need to be on an angiotensin converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) daily at least two month prior to the study.

Phase 1: Patients will be randomized to receive either amiloride 5mg twice daily or triamterene 50mg twice daily for 8 weeks. Serum potassium will be monitored one week before and one week after starting phase 1. If serum potassium remains equal to or less than 5.0mmol/L, amiloride or triamterene will be continued at same dose until the end of phase 1. If serum potassium is equal to or above 5.5 mmol/L, the patient will exit the study, and an adverse event will be reported. If serum potassium is between 5.1-5.4 mmol/L, it will be monitored again in one week. If serum potassium is above 5.5 mmol/L, the patient will exit the study, and an adverse event will be reported. If serum potassium remains in the same range, the patient will continue amiloride or triamterene at the same dose to complete phase 1.

Phase 2: the patients will discontinue amiloride or triamterene for a washout for 4 weeks, but continue with the ACE inhibitor or ARB.

Phase 3: the patients will cross over to triamterene or amiloride for 8 weeks. Use the protocol as described in phase 1.

Eligibility Criteria:
Inclusion Criteria:

* Patient with any type of proteinuric kidney diseases
* Aged 18-75
* Proteinuria ≥1g/day
* estimated glomerular filtration rate (eGFR) ≥ 30ml/min/1.73m2

Exclusion Criteria:

* Clinical evidences of lupus nephritis, or HIV associated nephropathy
* eGFR \<30ml/min/1.73m2
* Requirement for treatment with mineralocorticoid receptor antagonists (spironolactone, eplerenone)
* Status post kidney transplant
* Received glucocorticoid steroids within six months
* Serum K \>4.8 mmol/L
* Total carbon dioxide \<17 mmol/L
* Hemoglobin \<10 g/dl
* Contraindicated or allergic to loop diuretics or potassium sparing diuretics
* Abnormal liver function tests
Risk Prediction for Alzheimer Dementia With Brain Imaging and Genetics

The purpose of this study is to learn about how trauma, posttraumatic stress disorder (PTSD), and mild traumatic brain injury that can occur during deployment affect the brain. The investigators also want to learn how PTSD and mild traumatic brain injury can affect the chance of developing Alzheimer disease later in life. The investigators will study this by using magnetic resonance imaging and positron emission tomography scans to obtain pictures of the brain.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65
* Previously enrolled in studies of OEF/OIF veterans by the same investigators
* Free of implanted metal objects or mental shards in eyes
* Fluent in English and capable of consenting

Exclusion Criteria:

* Axis I disorders other than Major Depressive Disorder or PTSD
* Current substance abuse or lifetime substance dependence (other than nicotine)
* High risk for suicide
* Claustrophobia
* Neurological disorders
* Learning disability or developmental delay
* Major medical conditions
Efficacy and Safety of Phototherapy in the Treatment of Loss of Smell Post Acute Infection of Coronavirus 19

The aim of this study is to assess whether the use of a therapy combining olfactory training, corticoids, and phototherapy improves the PROMS compared to the use of olfactory training and corticosteroids only. To accomplish this goal the study will consist of 40 participants. The participants must present olfactory dysfunction for at least 4 weeks after a coronavirus-19 infection. Furthermore, to be eligible each participant will need a polymerase chain reaction test with positive results for coronavirus-19.

Standard Operating Procedures: Patients attending consult and calls for follow-up.

Plan for missing data: Missing data will be managed with statistical tests.

Statistical analysis: Categorical variables, whenever dichotomous or nominal, will be reported as frequencies and percentages. Normality will be assessed by the Kolmogorov Smirnov test. Descriptive statistics will be reported as mean (standard deviation) or median (interquartile range). To analyze the correlation between quantitative variables, the parametric Pearson test or the nonparametric Spearman's test will be used, subjected to their distribution. Differences between Diffusing capacity for carbon monoxide groups will be analyzed for statistical significance by the chi-square test for categorical variables and by a two-sample t-test or Wilcoxon rank-sum test for continuous variables as applicable. Statistical significance will be set at a P-value less than 0.05. Analyses will be performed using Statistical Package for the Social Sciences (V. 22.0) software.

Eligibility Criteria:
Inclusion Criteria:

* Positive coronavirus polymerase chain reaction patients who experience loss of smell for more than 4 weeks after symptoms begin will be included in the study but at time of the trial with a negative result from a polymerase chain reaction.
* Patients older than18 years.

Exclusion Criteria:

* Patients younger than 18 years.
* Pregnancy.
* Patients who do not have a positive real-time polymerase chain reaction for Coronavirus
* Patients who have contraindications for corticosteroid therapy such as:

  1. Pregnant patients
  2. Immunosuppressed
  3. Patients with peptic ulcer
  4. Diabetics
  5. Patients with glaucoma
Prevention and Reduction of Obesity Through Active Living

We will perform a randomized, controlled trial, the primary aim of which is to assess the effectiveness of a behavioral-based physical activity program in the prevention and treatment of obesity and related co-morbid conditions in a primary care setting. We hypothesize that the prevention and/or reduction of obesity and related co-morbidities in patients randomized to an individualized education and behavior counseling group will be greater by comparison to those randomized to a group that receives standard care alone.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between 25 and 65 years of age.
* Sedentary lifestyle (planned physical activity for the purpose of health one day per week or less).
* Abdominally obese (waist circumference greater than 88 and 102 cm for women and men respectively).
* Weight stable (± 2 kg) for 6 months prior to the beginning of the study.
* BMI between 25 and 34.9 kg/m2 (Because a lifestyle-based intervention alone for obesity reduction is ideal for persons with a BMI greater less than 35, and, that 94% of overweight and obese Canadian adults have a BMI between 25 and 34.9 kg/m2, subjects with a BMI 35 or greater will be excluded).

Exclusion Criteria:

* Physical impairment which would make the intervention very difficult, or unsafe according to the patient's physician including history of myocardial infarction, stroke, coronary bypass surgery or angioplasty in the last 6 months; peripheral artery disease, unstable angina or ischemia, uncontrolled or insulin dependent diabetes mellitus.
* Alcohol consumption \> 21 drinks per week.
* Plans to move from the area.
* Participating in another research study.
* Clinically judged to be unsuitable for participation or adherence
* Inability or unwillingness to provide informed consent.
* For women, planned pregnancy in the next 3 years.