cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Safety and Tolerability of Different Doses of PF-05402536 and PF-06413367 in Healthy Adult Smokers.

The purpose of this study is to determine the safety and tolerability of multiple doses of PF-05402536 and PF-06413367 in healthy adult smokers.


Eligibility Criteria:
Inclusion Criteria:

* Current cigarette smokers
* Males or females of non-child bearing potential, who are between the minimum legal age for smoking (approximately 18 or 19 years, depending on local jurisdiction) and 55 years, inclusive, and who are motivated to stop smoking.
* Subjects must have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the prescreening assessment for entry, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, or neurologic disease that may compromise their ability to safely participate in the study.
* Active suicidal ideation or history of suicidal behaviors within the past 5 years prior to the screening visit.
Maestro 1.1 Post-Market Registry

The objective of the study is to observe the real-life usage of the Maestro Platform for surgical assistance in laparoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be adults aged ≥ 18 years scheduled for laparoscopic surgery.

Exclusion Criteria:

* Participants might be excluded based on the investigator's discretion.
Exploring Vancomycin Disposition in Neonates

Vancomycin is already used for decades in neonates. However, there are remaining questions concerning vancomycin disposition in this population. The purpose of this study is first of all to perform a paired analysis of serum vancomycin concentrations using an immunoassay versus a reference liquid chromatography-tandem mass spectrometry method. Secondly, we aim to determine vancomycin protein binding and its covariates in neonates.

Exploration of vancomycin disposition in neonates:

Objective 1: Paired analysis of (total) serum vancomycin concentrations in neonates using the currently available immunoassay (Cobas c702) versus a reference liquid chromatography-tandem mass spectrometry method (LC-MS/MS).

Objective 2: The determination of vancomycin protein binding and its covariates in neonates.

Eligibility Criteria:
Inclusion Criteria:

* Neonates, admitted to the Neonatal Intensive Care Unit to whom vancomycin is administered for medical reasons, can be included in the study after informed consent of the parents.

Exclusion Criteria:

* No vancomycin therapy
* No signed informed consent available
Family Weight Management Study

The purpose of this study is to address the Healthy People 2010 obesity prevention objective. This study will test the effects of a comprehensive family weight management program on the BMI z-score of 7-12 year-old children with a BMI \> 85th percentile who receive primary care in a large municipal Bronx hospital. The intervention framework will draw on social marketing theory and the transtheoretical model of behavioral change to incorporate successful obesity prevention strategies. A two-arm randomized controlled clinical trial (RCT), which will enroll (n =506) 7-12 year old children with a \> 85th BMI percentile, will compare the Experimental Intensive Intervention to a Standard (Control) Intervention. The Standard Intervention will receive: 1) an initial consult, which includes an overview of lifestyle goals, 2)quarterly follow-up, 3) and a monthly newsletter. The Intensive Intervention will add: 1)12 core group modules for parents (to address roles and skills) and for children (to enhance motivation and skills and to provide physical activity), 3) Tailored support using a "toolbox" approach from community health workers as extensions of the Family Weight Management professional education staff, and 4) monthly after-core follow-up groups. The study will determine if children randomized to the Experimental Intensive Intervention will have greater improvement in BMI change (z-scores) than those randomized to the Control Standard Intervention. The study will also evaluate the effects on the Experimental Intervention on lifestyle variables and assess intervention costs. The RE-AIM evaluation will address: Reach: How many of the eligible children/ families were referred and how many of those referred actually enrolled? We will use BMI data in the computerized medical records to evaluate the proportion and the appropriateness of the referrals. Efficacy/Effectiveness: How did the Experimental intervention affect BMI (changes in z-score), and key biomarkers when followed as planned? Adoption: How acceptable were the intervention(s) to the primary care medical team and the children/families in the pediatric clinics etc? (from process measures and post intervention surveys) Implementation: How many of the intervention activities were provided as planned? Quality control measures will be used to evaluate the integrity of the intervention(s). Maintenance: How much of the intervention effect is sustainable? Individual effects will be evaluated based on the 24 month follow data. Institutional effects evaluation will include the potential to maintain services using third-party coverage.


Eligibility Criteria:
Inclusion Criteria:

BMI greater than 85th percentile for sex, age 7-12 years

Exclusion Criteria:

health or condition that would interfere with study participation, unwilling or inability to provide parent/guardian consent or child ascent, intention to move from area

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A Phase 1 Study of Single Agent Veliparib in Japanese Subjects With Advanced Solid Tumors

This is a Phase 1 study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of single agent Veliparib in Japanese subjects with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed malignant solid tumor, and any of the following: \* Subjects with recurrent high grade serous ovarian cancer who completed or discontinued platinum based therapy; \* Subjects with BRCA-mutated breast cancer who have received prior chemotherapy with anthracycline and/or taxanes; \* Subjects with deleterious mutations of BRCA with advanced solid tumors who have received available standard therapies.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Life expectancy of greater than 12 weeks.
* Adequate organ and marrow function· Measurable or non-measurable disease.

Exclusion Criteria:

* Major surgery and/or radiation within (\<) 4 weeks prior to study enrollment.
* Chemotherapy or hormone therapy within (\<) 4 weeks prior to study enrollment except for mitomycin C and nitrosoureas, in which case it is 6 weeks.
* Any investigational agents within (\<) 4 weeks prior to study enrollment.
* Any anti-cancer Chinese medicine/herbal remedies within 14 days prior to study enrollment.
* Toxicities (with the exception of alopecia) from prior major surgery, radiation, or systemic chemotherapy have not recovered to less than grade 2.
Acceptability of Palliative Care in Parkinson Disease Care

This study will assess the feasibility of using specific criteria to standardize the referral of individuals with Parkinson disease to a group of medical providers known as palliative care specialists. Palliative care specialists provide supportive care to individuals living with serious illnesses. The specialty focuses on providing relief from the symptoms and stress of serious illness.


Eligibility Criteria:
Subjects with Parkinson disease:

Inclusion Criteria:

* Diagnosis of idiopathic PD confirmed as most likely diagnosis with participant's treating provider
* 18 years of age or older
* Participant or care partner able to provide informed consent
* Presence of one or more of the following:

Uncontrolled symptoms (over prior week):

* Depression
* Pain
* Fatigue

Critical events (over prior 6 months):

* ≥3 falls
* Unintended weight loss
* Wheelchair dependence (\>50% of time)

Exclusion Criteria:

* Diagnosis of atypical or secondary parkinsonism
* Outpatient palliative care visit scheduled or within the prior 6 months of the screening visit

Subjects who are care partners:

Inclusion Criteria:

* Care partner of enrolled participant in the study
* 18 years of age or older
* Able to provide informed consent

Exclusion Criteria:

• No care partner specific exclusion criteria
Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients

This study will assess the pharmacokinetics and safety following single dose of valsartan in Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome

Exclusion Criteria:

* GFR \< 30 mL/min/1.73 m2
* Inability to safely tolerate the temporary discontinuation of concomitant antihypertensive medications (expect amlodipine or atenolol) from 24 hours prior to study drug administration to study completion.
* Inability to safely tolerate the temporary discontinuation of any drug known or suspected to effect hepatic or renal clearance capacity from 24 hours prior to study drug administration to study completion (this includes drugs that are known to cause induction or inhibition of hepatic enzymes).

Other protocol-defined inclusion/exclusion criteria may apply
An Extension Study to Determine the Safety and Anti-Leukemic Effects of Imatinib Mesylate in Adult Participants With Ph+ Leukemia

The objectives of Part 1 of the study were:

* To determine the rate of hematologic response (HR) lasting ≥4 weeks in participants with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the accelerated phase (AP).
* To evaluate duration of HR, overall survival, cytogenetic response (CyR), time to blast crisis in CML participants in the AP, improvement of symptomatic parameters, tolerability and safety of STI571 treatment.

The objective of the extension (Part 2) was:

-To enable participants to have access to study drug and continue study treatment and to decrease data collection to include only overall survival and serious adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants, aged ≥18 years, with a histologically confirmed diagnosis of Ph+ leukemia of one of the following types:

  * Accelerated phase chronic myeloid/myelogenous leukemia (CML).
  * Acute lymphoid/lymphoblastic leukemia (ALL) or acute myeloid/myelogenous leukemia (AML) in first or subsequent relapse after either standard chemotherapy, autologous or allogeneic bone marrow transplantation, or high-dose treatment with peripheral blood stem cell support, or
  * ALL or AML refractory to standard chemotherapy (no complete remission achieved after two courses of conventional induction chemotherapy).
  * Lymphoid blastic phase of CML in first or subsequent relapse or refractory to standard chemotherapy.
* With serum serum glutamate oxaloacetate transaminase (aspartate aminotransferase) and serum glutamate pyruvate transaminase (alanine aminotransferase) not more than 3 x upper limit of normal (ULN) (or not more than 5xULN if clinically suspected leukemic involvement of the liver), serum creatinine concentration not more than 2xULN, and total serum bilirubin level not more than 3xULN (bilirubin limit was 1.5xULN before protocol amendment 1)

Exclusion Criteria:

* Participants who had an Eastern Cooperative Oncology Group (ECOG) performance status score ≥3.
* Participants with known leukemic involvement of the central nervous system (CNS).
* Participants who had received treatment with any of the following agents: interferon-alpha within 48 hours, hydroxyurea within 24 hours, homoharringtonine within 14 days, low-dose, moderate dose or high dose cytosine arabinoside within 7, 14 or 28 days respectively, 6-mercaptopurine, vinca alkaloids or steroids within 7 days, anthracyclines, mitoxantrone, etoposide, methotrexate, cyclophosphamide within 21 days, or busulfan within 6 weeks.
* Participants who had undergone hematopoietic stem cell transplantation within six weeks of Day 1, or who had not achieved full hematopoietic recovery following the transplant.
* Participants with grade 3/4 cardiac disease or any serious, concomitant, medical condition.
* Participants with a history of non-compliance to medical regimens or who were considered potentially unreliable.

Other protocol-defined inclusion/exclusion criteria may apply.
Ambulatory Physical Exercise Program in Hematopoietic Stem Cell Transplantation Recipients

The proposed study in an inception cohort of patients with hematological malignancies treated with PBSCT is designed to evaluate the effects of a physical exercise intervention on muscular-skeletal, physical activity and quality of life outcomes.

Peripheral Stem Cell Transplantation is a frequently used therapy option to increase survival in hematological and lymphatic malignancies. These malignancies and their treatment are associated with numerous physical and psychological symptoms and severe side effects. Physical exercise has been proposed as a promising strategy for the treatment of some of these physical and psychological complaints, and various exercise interventions are currently available after cancer treatment. To date, promising preliminary results concerning exercise programs in PBSCT recipients were published with limited sample size populations. Results of musculoskeletal outcomes in PBSCT recipients after cancer treatment are lacking.

Eligibility Criteria:
Inclusion Criteria:

* Status after high-dose chemotherapy following Hematopoietic Stem Cell Transplantation
* Willing to enter a physical exercise program
* Good understanding of the German language
* Written informed consent

Exclusion Criteria:

* Uncontrolled cardiovascular disease and myocardial infarction in the previous six months
* Uncontrolled hypertension
* Uncontrolled thyroid disease
* Uncontrolled diabetes
* Diagnosis of depression before entering the study.
Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein

To assess parental perceptions on infant feeding behavior and enjoyment with a goat milk formula compared to a cow milk formula

This is a feasibility study to determine the utility of two new standardized psychometric tools for paediatricians to assess and manage feeding difficulties in formula fed infants. Baby Eating Behaviour Questionnaire (BEBQ) and Montreal Children's Hospital Feeding Scale (MCH-Feeding Scale) will be used in this study.

The secondary objectives are to determine if these tools can then measure the changes in behaviour after introducing two formula that differ in the sources of protein, ie formula made from whole goat milk compared to a conventional formula made from cow milk proteins. The quality of life and general health outcomes of these infants will also be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Healthy infants aged 2-3 months, predominantly formula fed

Exclusion Criteria:

* Infants born less than 37GA
* Confirmed or suspected cow milk protein allergy
* Predominantly breast fed
* Infants suffering from chronic disease
Surgically Resected Crohn's Disease Patients: Prognostic Factors for Re-operation and New Score Building

The project will consist of a multicentre, prospective, observational study with a total duration of 24 months. Clinical, endoscopic and ultrasound data will be collected in a dedicated database (on IG-IBD Register), which will be used to identify potential clinical, endoscopic and ultrasound risk factors of re-operation. These data could be merged into a shared score, to stratify patients according to the risk of post-surgical re- operation and to define an optimal therapeutic management in the post- operative period. Approximately 220 adult patients, with a defined diagnosis of CD, who underwent a surgery for CD in the previous 6 months will be enrolled.

Patients will be consecutively enrolled in this prospective cross-sectional study, during the first 12 months, and then followed for 12 (minimum) up to 24(maximum) months, depending on date of patients' enrolment (total study length: 2 years). Patients will be stratified according to risk factors and type of treatment carried out in that year

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18 to 65 years, inclusive
* Diagnosis of Crohn's Disease (CD) for at least 6 months prior to enrolment, by clinical, endoscopic and histopathologic evidence
* First surgery for CD performed less than 6 months before enrolment (no second surgery allowed)
* Ability to provide written informed consent and to be compliant with the schedule of protocol assessments

Exclusion Criteria:

* Diagnosis of ulcerative colitis or indeterminate colitis
* Crohn's disease isolated at stomach, duodenum, jejunum, or perianal region, without ileo-colonic involvement
* More than one surgery for luminal CD
* Current stoma or need for ileostomy or colostomy
* Clinically relevant diseases making interpretation of the trial difficult or that would put the patient at risk of severe complications, in the opinion of the investigator
* Inability to provide written informed consent and poor compliance with the schedule of protocol assessments
Assessment of Volume Status by Bedside Ultrasound in Children With Acute Gastroenteritis

The purpose of the study is assessment of volume status by bedside ultrasound in children with acute gastroenteritis

The research will be conducted of emergency medicine department in the Derince Training and Research Hospital. Patients referred to acute gastroenteritis will be included to the study. After initial evaluation, the clinician will inform the principal investigator about the patient. The principal investigator will record the patient's demographic data, contact information, vital signs, history, physical examination findings, and weight. Than expirium and inspirium diameters of vena cava inferior will be measured with the bedside ultrasound and caval index will be calculated. An investigator who have had an ultrasound certification by Emergency Medicine Association of Turkey for six years will make the measurements. After 1 week the patient will called up for re-evaluation. Applicants' weights will be measured again with the same weighing machine. The differences between initial and after one week weight measurement will be accepted as the gold standard method for volume loss. The weight loss of the patient, the dehydration findings detected on physical examination and the caval index will be compared.

Data will be collected on predesigned data sheets, by an investigator and subsequently will be entered into a spreadsheet (Excel 2007; Microsoft, Redmond, WA). All recorded data will be checked by an another investigator to identify possible errors. Results will be submitted at least every two months.

Linear regression will be performed with dehydration as the dependent variable and the caval index as the independent variable.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 6 months and 18 years of age who presented to the Emergency Department with gastroenteritis

Exclusion Criteria:

* congenital heart disease
* chronic liver disease
* chronic renal disease
* patients or parents who doesn't want to enroll the study
Exploring Cultural Acceptability of Community Breast Cancer Risk Assessment Among Hispanic Women in Maricopa County

This study explores the cultural acceptability of community breast cancer risk assessment among Hispanic women in Maricopa county.

PRIMARY OBJECTIVES:

I. Examine the association between perceived risk and mammography screening behavior and differences in perceived risk by patient characteristics in Hispanic women screened at Mountain Park Health Center (MPHC).

II. Characterize attitudes, beliefs, and barriers towards mammography screening and cultural acceptability of BRCA models in community settings using focus group and interview data from under- and uninsured Hispanic women in Maricopa County.

OUTLINE: This is an observational study.

Participants attend an interview or participate in a focus group on study.

Eligibility Criteria:
Inclusion Criteria:

* AIM 1:

  * Completed a baseline survey for the Latinas Learning about Density (LLEAD) study
  * Self-identify as Hispanic
  * Between 40-65 years of age
* AIM 2:

  * Between the ages of 45 and 65
  * Self-identify as Hispanic
  * Current residence in Maricopa County
  * Be under- (e.g. Arizona Health Care Cost Containment System) or uninsured at the time of enrollment
  * Can read and speak English or Spanish well enough to understand and complete the informed consent process and take part in either a focus group or individual interview

Exclusion Criteria:

* AIM I:

  * Women with a history of breast cancer
* AIM 2:

  * Women with a history of breast cancer
Efficacy of Arm Training in COPD Patients

Recent guidelines on pulmonary rehabilitation (PR) recommend upper extremity exercise training (UEET) in patients with chronic obstructive pulmonary disease (COPD).

The theory supporting the inclusion of upper extremity exercise training in the pulmonary rehabilitation for these patients, is based on the profound understanding of the activity of the accessory respiratory muscles, which are competitively involved in both the support of the upper extremities during activities and the ventilation. However, a systematic review of the literature carried out by our staff reveals that the clinical trials carried out up to now to verify the effectiveness of UEET are of poor methodological quality and the investigators cannot corroborate the recommendation recently made on the basis of the results of the investigators' review.

Therefore the investigators began this randomized, parallel groups, controlled clinical trial with the purpose of determining the short-term effect of unsupported UEET on the performance of the upper extremities and on symptoms perceived during activities by patients with COPD.

We recruited inpatients with stable, moderate or severe COPD referred to the PR program at the regional centre of Villa Pineta Hospital.

Patients were randomized into two groups: control and intervention. Patients randomized to the control group undertook an inpatient comprehensive PR that complied with the recommendations made by the ATS/ERS and included a minimum of 15 daily sessions of specific training for lower extremities.

Patients randomized to the intervention group undertook an experimental program consisting of 15 additional daily sessions of unsupported UEET over and above the same PR program used for control patients.

Measurements of upper extremity performance and symptoms perceived were taken in both groups at baseline (T0) and at the completion of the interventions (Tend) by one physiotherapist unaware to the patient's group allocation. To verify if the experimental training leads to long-term results on the functional arm exercise capacity, some measurements were repeated at 6-months as the latest follow-up (T6months).

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of COPD
* a degree of COPD severity equal or above grade 2 (moderate) on the basis of the GOLD classification
* clinical stability for a minimum of 4 weeks
* degree of chronic dyspnea ≥ grade 2 on the Medical Research Council Dyspnea Scale

Exclusion Criteria:

* muscular-skeletal abnormalities limiting the shoulder girdle functionality
* cognitive impairment limiting participation
* previous inclusion in UEET programmes within the last 3 years
* malignancies