cyrilzakka/clinical-trials huggingface dataset:
Drug Interaction Study To Investigate The Potential Effect Of Proton Pump Inhibitor On The Pharmacokinetics Of Palbociclib (PD-0332991)

Fixed sequence, 2-period crossover study to compare the pharmacokinetic profiles of Palbociclib in absence and presence of prior administration of proton pump inhibitor Rabeprazole. The increased gastric pH achieved by the treatment with multiple doses of Rabeprazole might affect the absorption process of Palbociclib.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects of non-childbearing potential; Healthy subjects identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory test.

Exclusion Criteria:

* A positive urine drug screen, urine cotinine test or alcohol breath test.
* Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication.
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives prior to the first dose of study medication. All antacid agents must be discontinued 28 days prior to the first dose of study medication.
Effect of Empowerment Program on Children's Knowledge, Attitude, Self-Efficacy, and Practice of Nail Biting.

The study aims to evaluate the effect of an empowerment program based on the BASNEF model on children's knowledge, attitude, self-efficacy, and practice of nail biting.

Research Hypothesis H1: The application of an empowerment program based on the BASNEF model has a positive impact on children's knowledge, attitude, self-efficacy, and practice of nail biting.

Nail-biting or onychophagia is a common phenomenon affecting children where excessive nail-biting is associated with several adverse consequences beyond mere appearance. The aim is to evaluate the effect of an empowerment program based on the BASNEF model on children's knowledge, attitude, self-efficacy, and practice of nail biting.

A quasi-experimental study was conducted in the pediatric wards of Menoufia University Hospital and Benha University Hospital. A convenience sample of 135 children aged 6 to 18 was randomly assigned to two groups. The study group attended four empowerment sessions based on the BANSEF model, emphasizing age-appropriate information, fostering a positive attitude towards quitting nail-biting, discovering the subjective norms that influence nail-biting behaviors, and equipping children with enabling factors to quit. The control group received routine health education.

Eligibility Criteria:
Inclusion Criteria:

* Had nail-biting habits
* Willing to attend the educational sessions

Exclusion Criteria:

* Had history of mental illness
Long Term Predictors of Graft Patency After Coronary Artery Bypass Graft Surgery (Multi-slice CT Coronary Angiography Study Validated by Coronary Angiography)

To detect and evaluate the predictors of graft patency after coronary artery bypass graft surgery as assessed by multi-slice CT coronary angiography validated by coronary angiography

Coronary artery bypass grafting (CABG) is an effective treatment of complex, multi-vessel coronary artery disease(1) .The majority of these patients receive left internal mammary artery (IMA) grafts to the left anterior descending (LAD) coronary artery and saphenous vein grafts (SVGs) or other conduits to the remaining vessels. Based on small studies of selected groups of patients, it is generally believed that SVGs have a 40% to 50% 10-year patency and that the LIMA has a 90% to 95% 10-year patency The success of coronary artery bypass grafting (CABG) is dependent on the long-term patency of the arterial and venous grafts.(2) Graft failure is a surrogate marker for future cardiac events, including repeat revascularization, myocardial infarction ,and death(3)(4). Vein graft occlusion in the perioperative period is due to thrombosis resulting from technical problems. Vein graft occlusion within the first year is attributed to intimal proliferation, although after 1 year, atherosclerosis is thought to be the dominant factor (5) . LIMA graft failure was defined as diffuse and \>95% conduit narrowing ("string sign" When IMA graft failure occurs, technical error is the most common cause in the early postoperative period, while late (and rare) IMA failure include progressive fibro-intimal proliferation and atherosclerosis either in the IMA graft or in the native LAD vessel)(6) Traditionally, graft patency has been evaluated with coronary angiography (ICA) but, since the advent of multi-detector computed tomography (MDCT), the temptation to use a noninvasive and widely available technique to study coronary artery bypass graft (CABG) patients has been stronger. The introduction of scanners like 64-slice and 128-slice upwards-along with new scan protocols opens new perspectives in non-invasive assessment of graft patency.(7) The pooled sensitivity and specificity of detecting complete graft occlusions - according to( Barbero et al ,2016) ,was 99% and 99% respectively as compared to the standard of coronary angiography. (8) Computed tomographic angiography, labeled as Appropriate test for evaluation of bypass grafts and coronary anatomy (9)

Eligibility Criteria:
Inclusion Criteria:

* All patients underwent coronary artery bypass graft surgery more than one year ago complaining of chest pain are included in the study from September 2017 to September 2018
* Written consent, free and informed

Exclusion Criteria:

* • Renal insufficiency (serum creatinine \>1.6 mg/dl).

  * Contrast hypersensitivity.
  * Irregular heart rhythm (e.g. Atrial fibrillation).
  * Inability to hold breath for at least 10 seconds
Study Comparing the Gastro-intestinal Tolerability and Absorption Profile of Vortioxetine After Administration of Modified-release Formulations and Immediate-release Formulation in Healthy Women

The purpose of this study is to evaluate the gastro-intestinal tolerability (nausea, vomiting, diarrhoea, abdominal discomfort, and abdominal pain) of vortioxetine following single oral doses of three modified-release (MR) capsules with differently coated multiple particles compared to one immediate-release (IR) tablet.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women ≥18 and ≤45 years of age with a body mass index (BMI) of \>18.5 and \<30.0 kg/m2.
* Women will be of child-bearing potential with a confirmed non-pregnant and non-lactating status.

Other protocol-defined Inclusion and Exclusion Criteria may apply.
Intensive Sequential Chemotherapy With Adriamycin Taxol and Cytoxan in the Treatment of Locally Advanced Breast Cancer

Intensive sequential chemotherapy with Adriamycin Taxol and Cytoxan in the treatment of locally advanced breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced breast cancer
Evaluation of Position-induced Cyclorotation Between Wavefront Measurement and Refractive Surgery by the Iris Registration Method

Cyclorotation of eyes may be affected by motion and orientation of the head and body. An automated alignment method with the technique of iris recognition was used to assess the amount and orientation of position-induced cyclorotation between preoperative wavefront measurement and laser refractive surgery.

Ninety-three consecutive patients undergoing bilateral wavefront-guided laser refractive surgery in the Department of Ophthalmology of the National Taiwan University Hospital between September 2004 and December 2007 were enrolled in this retrospective study. Before laser refractive surgery, all patients were seated in front of the Zyoptix 100 system platform (Bausch \& Lomb, salt lake city, UT, USA) and received Zywave aberrometer measurement on both eyes. When patients were in the supine position for refractive surgery, an infrared camera mounted on the laser system (Technolas 217z100 excimer laser system, Bausch \& Lomb)obtained iris images on undilated pupils before laser ablation. Overall cyclorotation was detected by a comparison between iris images of undilated pupils in the supine position and dilated pupils in the seated position before laser treatment. The degree and direction of position-induced cyclorotation were assessed.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing bilateral wavefront-guided laser refractive surgery

Exclusion Criteria:

* patients with strabismus, extraocular muscle palsy, muscle restriction or other diseases interfering normal ocular movement.
Chemotherapy Resistance in Osteogenic Sarcoma and Other Solid Tumors

The purpose of this study is to investigate tumors in the laboratory to determine how and why they respond, or fail to respond to different drug therapies. This study will also investigate why high pressure develops within tumors and how this affects how well drugs work. We will also take blood samples before and/or after your procedure to measure biochemical factors that may help us predict the behavior of osteogenic sarcoma and other solid tumors.

When tumor tissue known or presumed to be a primary or secondary bone cancer or solid tumor with known elevated intra-tumoral pressure such as retinoblastoma is being removed or has been removed for diagnostic or therapeutic reasons a small sample of it will be obtained for this study. The tumor samples will be used to study in vitro, determinants of chemotherapy resistance and oncogenesis. These determinants will be correlated with histologic response to preoperative chemotherapy and clinical outcome (event free survival). In addition, blood samples (20ml) may be obtained before or after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* All patients with a presumed or known diagnosis of a primary or secondary bone cancer or other solid tumor who are having or have had a biopsy or surgery to remove tumor for diagnostic or therapeutic reasons. No tumors will be obtained solely for research purposes.
* All adult patients (\> or = to 18 yrs.) will have given written informed consent.
* All minor patients (\<18 yrs.) will have given assent to the best of their ability to understand, and their parent or guardian will have given written informed consent

Exclusion Criteria:

* N/A
Vasoactive Intestinal Peptide in COPD

This study, a new immunomodulatory therapy of COPD with vasoactive intestinal peptide (VIP) was evaluated. Based on preliminary unpublished clinical and experimental results, the course of disease under VIP treatment and the molecular mechanisms involved were assessed.

34 patients with severe COPD were treated either with VIP inhalation in addition to conventional therapy or inhalation of placebo plus conventional therapy for a period of 3 months. The trial was conducted as a double blind, comparative study with two parallel groups.

Chronic obstructive bronchitis is a chronic inflammatory disease of the airways, which affects as many as 8% of individuals in industrialized nations. There is an increase in the number of woman and men suffering from COPD. Pulmonary hypertension and cor pulmonale are common sequelae of chronic airflow obstruction, but the precise mechanisms of increased vascular resistance are unclear. Potential causes of pulmo-nary hypertension in COPD include emphysematous destruction of the capillary bed, remodeling of pulmonary vessels and hypoxic pulmonary vasoconstriction. This proposal, a new immunomodulatory therapy of COPD with vasoactive intestinal peptide (VIP) was evaluated. Based on preliminary unpublished clinical and experimental results, the course of disease under VIP treatment and the molecular mechanisms involved were assessed.

34 patients with severe COPD were treated either with VIP inhalation in addition to conventional therapy or inhalation of placebo plus conventional therapy for a period of 3 months. The trial was conducted as a double blind, comparative study with two parallel groups.

In the absence of acute infection or acute worsening of the disease due to other conditions, 2 transbronchial biopsies were collected before treatment, and after 3 months of treat¬ment for assessment of the regulation of a) the immune response, b) the extracellular matrix and c) the epithelial growth. This assessment will be performed in fully equipped and experienced laboratories at the University of Vienna.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed moderate to severe COPD with or without pulmonary hypertension
* Male and female patients.
* Aged 18 - 75 years.
* Written consent.
* Adequate contraception in female patients of childbearing age.
* Negative pregnancy test (four-weekly test repetition).

Exclusion Criteria:

* Lack of consent
* Pregnancy (four-weekly tests)
* Lactation
* Presumed non-cooperativeness
* Patients outside the stipulated age range
* Myocardial infarction within the last 12 months
* Stroke within the last 12 months
* Malignant diseases in anamnesis
* Legal incapacity
* Parallel participation in a clinical trial
* Parallel participation in a clinical trial within the last 4 weeks
A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)

The purpose of this study was to assess efficacy, safety, tolerability, and pharmacokinetics of ABBV-8E12 in participants with progressive supranuclear palsy (PSP).

This was a Phase 2, randomized, double-blind, placebo-controlled, multiple dose, multicenter study consisting of a screening period of up to 8 weeks (56 days), a 52-week double-blind treatment period, and a post-treatment follow-up period of approximately 20 weeks following last study drug administration (for those participants who prematurely discontinued from treatment, declined to participate in or did not qualify for participation in a long term extension \[LTE\] study). At the end of the treatment period, extended treatment was available for eligible participants who completed the 52-week treatment period and entered the separate long-term extension study (NCT03391765; Study M15-563). There were 3 cohorts in the study (Cohort 1, Cohort J1, and Cohort 2). Cohort 1 had augmented safety and pharmacokinetic (PK) assessments in the first 30 participants enrolled into the global study from countries other than Japan. Cohort J1 had augmented safety and PK assessments in the first 9 participants enrolled into the study from Japan. Cohort 2 consisted of all other participants enrolled in the global study not participating in Cohort 1 or Cohort J1.

This study was prematurely discontinued because the program for progressive supranuclear palsy was discontinued due to lack of efficacy of study drug.

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female participant with age 40 years or greater at the time of signed consent
* Meets the criteria for possible or probable progressive supranuclear palsy (PSP; Steele-Richardson-Olszewski Syndrome)
* Presence of PSP symptoms for less than 5 years
* Participant is able to walk 5 steps with minimal assistance (stabilization of one arm or use of cane/walker)
* Participant has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend)

Key Exclusion Criteria:

* Participants who weigh less than 44 kg (97 lbs) at screening
* Mini-Mental State Examination (MMSE) score less than 15 at screening
* Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)
* Participant resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period
* Evidence of any clinically significant neurological disorder other than PSP
* The participant has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) or International Classification of Diseases (ICD-10) criteria
* Participant has had a significant illness or infection requiring medical intervention in the past 30 days
Phase 2 Study of Rituximab-ABVD in Classical Hodgkin Lymphoma

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with newly diagnosed stage II, stage III, or stage IV Hodgkin's lymphoma.

OBJECTIVES:

Primary

* Investigate plasma DNA biomarkers, including plasma clonal immunoglobulin DNA, tumor suppressor gene methylation, and Epstein-Barr virus DNA, in patients receiving rituximab and doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine (ABVD) for newly diagnosed stage II-IV classical Hodgkin's lymphoma.
* Characterize the impact of rituximab on these markers.
* Characterize the relationship between marker detection and clinical outcome.

Secondary

* Estimate the event-free survival of patients with newly diagnosed Hodgkin's lymphoma treated with rituximab and ABVD.
* Assess the presence of Hodgkin's lymphoma stem cells in peripheral blood mononuclear cells at baseline, after treatment with rituximab, and after treatment with ABVD.
* Assess whether plasma DNA biomarkers add information to fludeoxyglucose F 18 positron emission tomography (FDG-PET) in assessing tumor response.

OUTLINE: Patients receive doxorubicin hydrochloride IV, vinblastine IV, bleomycin IV, and dacarbazine IV (ABVD) on days 1 and 15 of all courses. Patients also receive rituximab IV on days -6, 1, 8, 15, and 22 of ABVD course 1 and on day 1 only of ABVD courses 2, 4, and 6. Treatment repeats every 28 days for 6-8 courses in the absence of disease progression or unacceptable toxicity.

Patients with bulky disease may undergo radiotherapy.

Plasma samples are obtained during treatment for investigation of tumor markers (e.g., immunoglobulin rearrangement, patterns of DNA methylation, and the presence of Epstein-Barr virus DNA). Patients undergo fludeoxyglucose F18 positron emission tomography periodically during the study.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed classical Hodgkin's lymphoma

  * No lymphocyte-predominant histology
  * Stage II, III, or IV disease
  * Newly diagnosed disease

PATIENT CHARACTERISTICS:

* Performance status 0-2
* Creatinine \< 2.0 mg/dL
* Bilirubin \< 5 mg/dL
* Not pregnant or nursing
* No HIV positivity
* Hepatitis B surface antigen negative
* No active concurrent malignancy except for superficial nonmelanoma skin cancer or cervical carcinoma in situ

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy or radiotherapy for Hodgkin's lymphoma
* Steroids allowed if medically required before chemotherapy initiation
The Effect of VOXX/eSmartr High Performance Technology on Sports Vision Ability

This study is designed to compare the effect of Voxx/eSmartr technology on common measures of sports vision performance including (Hand-Eye Coordination/Reaction time, visual concentration and basic visual functions of size detection and contrast sensitivity). The study will be a randomized, prospective, double-blind design in order to determine the effect of this technology on a subject's sports vision ability.


Eligibility Criteria:
Inclusion Criteria.

* Female or Male age 18-45 years of age
* Exercises at least once a week by self-report
* Physically able to complete the HEC/RT test (e.g. no shoulder or arm discomfort or limitation

Exclusion Criteria.

* Member of a vulnerable population
* Visual or physical condition which precludes performing the physical or visual testing (e.g. strabismus, double vision, shoulder or arm pain or injury)
* Previous training in hand-eye coordination/reaction time or visual concentration
* History of double vision or strabismus
* Insufficient vision to drive an automobile in NY State
Investigation of the Efficacy and Tolerability of a Cosmetic Product With Onabotulinumtoxin A in the Treatment of Facial Lines

This randomized, multi-center, double-blinded, placebo-controlled, split-face clinical trial was conducted to evaluate the procedure-pairing of OnabotulinumtoxinA with a peptide anti-aging serum to improve facial lines and wrinkles, as well as overall skin texture and radiance of the face after 12 weeks of twice-daily use in female subjects ages 35 - 60 as compared to placebo. A total of 29 subjects completed study participation.

This randomized, multi-center, double-blinded, placebo-controlled, split-face clinical trial was conducted to evaluate procedure pairing of a peptide anti-aging serum with Onabotulinumtoxin A in the treatment of periorbital facial wrinkles when used over the course of 12 weeks by women with moderate to severe crow's feet wrinkles and fine lines, and mild to moderate photoaging.

Efficacy and tolerability will be assessed through clinical grading at baseline, weeks 4, 8 and 12. Efficacy evaluation for wrinkles, fine lines, and skin appearance will be graded at rest and at maximum smile for each side. Investigator and subject tolerability, self-assessment questionnaire and VISIA photography will be completed at baseline, weeks 4, 8 and 12.

A total of 29 subjects completed study participation.

Eligibility Criteria:
Inclusion Criteria:

1. Female subjects must be between 35-60 years of age.
2. Female subjects of childbearing potential must be willing to use a form of birth control during the study.
3. Subjects with Fitzpatrick I-VI photo skin type.
4. Subjects must have moderate to severe crow's feet facial wrinkles (score 4-7 on 0-9 scale) using modified Griffith's 10-point scale.
5. Subjects must have moderate to severe crow's feet fine lines (score 4-7 on 0-9 scale) using modified Griffith's 10-point scale.
6. Subjects may have mild to moderate photo-aging (score 3-6 on 0-9 scale) secondary to physiologic aging, hormonal influences, and environmental stressors.
7. Subjects must have no skin disease in the facial area being evaluated.
8. Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
9. Subjects must be willing to provide verbal understanding and written informed consent

Exclusion Criteria:

1. Female subjects who are pregnant, breast feeding, or planning a pregnancy.
2. Subjects with severe overall photo damage (score 7-9 on 0-9 scale) as determined by the Investigator.
3. Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products or to the botulinum toxin.
4. Subjects who are unwilling or unable to comply with the requirements of the protocol.