louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03402243: Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use
Official title: Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-01-18
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In this pilot study, menthol cigarette smokers will be randomized to one of three experimental marketplaces: 1) a condition simulating a ban on menthol cigarettes but not menthol e-cigarettes (condition A); 2) a condition simulating a ban on both menthol cigarettes and menthol e-cigarettes (Condition B); and 3) a condition in which menthol is not banned for either product (Condition C - the control condition). All conditions would have medicinal nicotine available if subjects decide to quit tobacco products entirely. At visits occurring every two weeks over a 6 week period, subjects will receive "credits" that they could exchange for any product available in their randomized marketplace condition. Outcomes include the amount of each tobacco product used.


Eligibility criteria: Inclusion Criteria:

* Be between the ages of 18 and 64
* Purchase exclusively menthol cigarettes
* Not currently motivated to quit smoking
* Smoking a minimum number of cigarettes per day

Exclusion Criteria:

* Report a serious, unstable medical or psychiatric condition
* Use any medications that might interfere with measures to be studied (for example, medications known to affect smoking)
* Have used any smoking cessation therapy during the past month
* Regularly use any form of tobacco other than cigarettes
* Are pregnant or breast feeding or planning to become pregnant or breast feed during the study

Primary outcomes:
measure: Amount of Tobacco Product Used
timeFrame: 6 weeks
Secondary outcomes:
measure: How Much of Each Product is Obtained From the "Experimental Marketplace"
timeFrame: 6 weeks
measure: Motivation to Quit Smoking Cigarettes
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Clinical and Translational Sciences Institute
state: Minnesota
Study officials:
References:
citation: Kotlyar M, Shanley R, Dufresne SR, Corcoran GA, Hatsukami DK. Effect on Tobacco Use and Subjective Measures of Including E-cigarettes in a Simulated Ban of Menthol in Combustible Cigarettes. Nicotine Tob Res. 2022 Aug 6;24(9):1448-1457. doi: 10.1093/ntr/ntac107.
Clinical trial NCT03055143: Study of Doxorubicin in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer
Official title: A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study Of Doxorubicin Hydrochloride Liposome Injection, 2 mg/ml (50 mg/m2 Dose) of Sun Pharma Advanced Research Company Limited, India, And Caelyx® (Doxorubicin Hydrochloride) Liposome Injection, 2 mg/ml (50 mg/m2 Dose) of Schering-Plough, Belgium, in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer, Under Fed (Normal Breakfast) Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer and Ovarian Cancer
Lead sponsor: Sun Pharma Advanced Research Company Limited
Sponsor class: INDUSTRY
First posted: 2017-02-16
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This was a randomized, multi centre, open label, two treatment, two period, two sequence, single dose, crossover study, with at least 28 days washout between doses, conducted under fed (normal breakfast) conditions.


Eligibility criteria: Inclusion Criteria:

1. Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
2. Patients with metastatic breast cancer/advanced ovarian cancer having age within the range of between 18-55 years.
3. Subjects who had no evidence of underlying disease
4. Subjects who had signed written consent form

Exclusion Criteria:

1. Females who were pregnant, breastfeeding, or are likely to become pregnant
2. Subjects who had any medical condition (except metastatic breast cancer/advanced ovarian cancer) that could jeopardize their health or prejudice the results
3. Subjects deemed uncooperative or noncompliant
4. Smoking or consumption of any nicotine products

Primary outcomes:
measure: Maximum measured plasma concentration
timeFrame: 336 hours
Secondary outcomes:
measure: The area under the plasma concentration versus time curve from time 0 to infinity
timeFrame: 336 hours
Other outcomes:
Locations:
Study officials:
References:
citation: Bhowmik S, Bhowmick S, Maiti K, Chakra A, Shahi P, Jain D, Rajamannar T. Two multicenter Phase I randomized trials to compare the bioequivalence and safety of a generic doxorubicin hydrochloride liposome injection with Doxil(R) or Caelyx(R) in advanced ovarian cancer. Cancer Chemother Pharmacol. 2018 Sep;82(3):521-532. doi: 10.1007/s00280-018-3643-3. Epub 2018 Jul 11.
Clinical trial NCT02464943: Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissections
Official title: Zenith® Dissection Endovascular System in the Treatment of Patients With Acute, Complicated Type B Aortic Dissections
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Aortic Dissection
Keywords: Aorta
Thoracic
Aortic dissection
Type B
DeBakey type III
Endovascular
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2015-06-08
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The Zenith® Dissection extended study is to collect confirmatory safety and effectiveness data on the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type B aortic dissection.


Eligibility criteria: Exclusion Criteria:

* \< 18 years of age
* Other medical condition(e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., \< 2 years)
* Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
* Unwilling to unable to comply with the follow-up schedule
* Inability or refusal to give informed consent
* Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
Study officials:
References:
Clinical trial NCT00559143: Biventricular Alternative Pacing
Official title: Better Pacing - Biventricular Pacing as Alternative Method in Patients With Disturbances of AV Conduction and Preserved LV Function
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Atrioventricular Block
Keywords: AV conduction disturbances
LV function
Biventricular Pacing
Conductance Catheters
Lead sponsor: Medtronic Hellas Medical Devices ΑEE
Sponsor class: INDUSTRY
First posted: 2007-11-16
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Aim of present study is to examine the short and long-term results of pacing from right ventricular apex and to compare them with those of biventricular pacing.

Detailed description: In this study all subjects to be studied will have atrioventricular conduction disturbances that require permanent artificial pacing. In all subjects a biventricular pacemaker will be implanted. Moreover the subjects will be randomized in a biventricular or conventional pacing mode and will be observed for a long term period.

Eligibility criteria: Inclusion Criteria:

* Subjects between the age of 18 to 75 years with classic indication for permanent artificial pacing in which it is expected very high percentage of ventricular pacing, (pacing systoles constitute the 80% and more of the total).
* Physiologic or mildly affected systolic function of left ventricle, LVEF\> 40%.
* Subject is willing and able to comply with the Clinical Investigational Plan and to remain available for follow-up visits, through study closure.
* Subject (or if allowed by local law/regulations: subject's legally authorised representative) is willing and able to sign and date the study Informed Consent.

Exclusion Criteria:

* Subjects with classic indication for Biventricular Pacing - (European Guidelines 2007).
* Permanent atrial fibrillation.
* Cardiovascular surgery within the last three months prior to enrollment.
* Myocardial infarction within the last three months prior to enrollment.

Primary outcomes:
measure: Change in End Diastolic Diameter of Left Ventricle with the two different ways of pacing (DDD(R)-RV & DDD(R)-BiV)
timeFrame: two years
Secondary outcomes:
measure: Tolerance in the cardiopulmonary stress test, quality of life, LV function and changes of BNP, TNF, interleukin-6, interleukin-12 and oxidant stress.
timeFrame: two years
measure: Assessment of the operation of Left Ventricle at the different pacing types using conductance catheters in a subgroup of patients that will perform a programmed coronary angiography due to investigation of possible coronary artery disease.
timeFrame: two years
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University Hospital of Crete
state: Crete
Study officials:
affiliation: University Hospital of Crete
name: Emmanuel Simantirakis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Crete
name: Panagiotis Vardas, MD, Cardiology Professor
role: STUDY_CHAIR
References:
Clinical trial NCT06416943: 3D Port-A Catheter Model for New Staff
Official title: Effects of a 3D-Printed Port-A Catheter Model Training Course for New Staff
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Personal Satisfaction
Cancer
Keywords: 3D printed model
port-a catheter
nursing skill education
Lead sponsor: Fu Jen Catholic University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to develop a highly realistic 3D-printed Port-A catheter upper body model to enhance the effectiveness of training new nursing staff in Port-A catheter placement and care skills.

Detailed description: Background： Cancer patients often require long-term administration of chemotherapy drugs, nutritional supplementation, and blood transfusions. During these treatments, an implantable central venous access (port-a catheter) is often utilized to avoid the inconvenience of repeated needle insertions for treatment and to minimize the risk of medication leakage. Port-A catheters are considered a safer clinical measure. However, poor care and maintenance of the catheter can lead to complications such as infection, catheter damage, and leakage, which can even result in death. Proper care and maintenance are crucial for the successful use of Port-A catheters. For nursing staff, acquiring professional knowledge in Port-A catheter care is essential for improving the quality of cancer patient care. Insufficient education and training in Port-A catheter care can lead to clinical errors that endanger patients' lives.

Methods： This study involves providing training to participants and assessing their performance and effectiveness. It employs a prospective quasi-experimental design with a single group and pre- and post-test evaluations. The study includes 50 newly recruited nursing staff.

Effect： The investigators anticipate that the use of a 3D-printed upper body Port-A catheter model will yield better results in the training of newly recruited nursing staff.

Eligibility criteria: Inclusion Criteria:

* New nursing staff joined Fu Jen Catholic University Hospital.

Exclusion Criteria:

* Refused to participate in the study.

Primary outcomes:
measure: Examination score of pre-intervention
timeFrame: pre-intervention
measure: Examination score of post-intervention
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University Hospital, Fu Jen Catholic University
Study officials:
affiliation: Fu Jen Catholic University Hospital
name: Ke-Yun Chao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01513343: Promoting The Self-Regulation Of Energy Intake
Official title: Promoting The Self-Regulation Of Energy Intake In Latino Preschoolers: A Family Focused Obesity Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Washington State University
name: University of Colorado, Denver
First posted: 2012-01-20
Enrollment: 255
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to develop and test the efficacy of a scientifically-based, culturally competent seven-session parent directed, obesity prevention program focused on parental feeding strategies that support young children's self-regulation of intake.

Detailed description: The intervention program was developed and piloted. Expected outcomes: At the end of the intervention program, it is expected that parents in the intervention group will: 1) use more child-centered (e.g., repeated presentation of new foods, involvement in food preparation) and less parent-centered feeding directives; 2) be less likely to show an indulgent and more likely to show an authoritative feeding style (feeding responsiveness); 3) show lower scores on restriction and pressure to eat and higher scores on monitoring; and 4) demonstrate higher levels of food knowledge (e.g., best feeding practices, reduced feeding misconceptions). Children in the intervention group are expected to: 1) show more willingness to try new foods, and 2) show increased self-regulation of energy intake. At the end of the interventions, children are expected to show greater consumption of fruits and vegetables (including consuming a wider variety of fruits and vegetables). All effects are expected to continue through the 6- and 12-month follow-ups, although the effects sizes will diminish. Although we do not expect effects on BMI after 6 weeks, we expect to see decreases in children's BMI percentiles by the 6- and 12-month follow-ups for the intervention group-especially for the top 25% of the BMI percentile range. No parental BMI effects are expected.

Eligibility criteria: Inclusion Criteria:

* Parents whose children attend Head Start with the sample of children equally split on gender and ethnicity,
* with representation from ages 3 to 6 years.

Exclusion Criteria:

* Parents and children who have any kind of food allergies or diabetes or are on special diets will be excluded from the study.

Primary outcomes:
measure: Children's BMI Percentiles
timeFrame: 12-month follow-up
Secondary outcomes:
measure: Parental Feeding Behaviors
timeFrame: 12-month follow-up
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Pullman
country: United States
facility: Thomas G. Power
state: Washington
Study officials:
affiliation: Baylor College of Medicine
name: Sheryl O Hughes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06524843: Fracture Risk Evaluation of Bone Metastases Derived From Carcinoma
Official title: Generation of Synthetic Patient Data (RAW) for Risk Evaluation of Bone Metastases Derived From Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone Metastases
Keywords: Bone metastases
Prediction model
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female adult patients, affected by bone metastases derived from carcinoma, treated at Rizzoli Ortopaedic institute from 01/01/2010 to 31/12/2022.

Brief summary: From the archives of the Rizzoli institute all patients (approximately 750) treated for bone metastases from 01/01/2010 to 31/12/2022.

A review will be made from the medical records, radiological imaging, and histological data of these patients


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of bone metastasis from carcinoma, regardless of the type of carcinoma, and of the number and location of the metastases
* Availability of imaging and clinical data
* Availability of at least one follow-up during the last 12 months form diagnosis

Exclusion Criteria:

* At least one inclusion creteria not met

Primary outcomes:
measure: Creation a dataset of clinical data and diagnostic images
timeFrame: At baseline (Day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
state: Emilia-Romagna
Study officials:
References:
citation: Mirels H. Metastatic disease in long bones: A proposed scoring system for diagnosing impending pathologic fractures. 1989. Clin Orthop Relat Res. 2003 Oct;(415 Suppl):S4-13. doi: 10.1097/01.blo.0000093045.56370.dd.
citation: Coleman RE. Clinical features of metastatic bone disease and risk of skeletal morbidity. Clin Cancer Res. 2006 Oct 15;12(20 Pt 2):6243s-6249s. doi: 10.1158/1078-0432.CCR-06-0931.
Clinical trial NCT00314938: A Single Dose Study to Evaluate the PK-PD Response and Safety of PHA-794428 in Children With Growth Hormone Deficiency
Official title: A Double Blind, Single Dose Study To Explore The Safety, Pharmacokinetics And Pharmacodynamics Of PHA-794428 In Pediatric Patients With Growth Hormone Deficiency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Growth Hormone Deficiency
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-04-17
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be the first clinical study of the development of PHA-794428 in a pediatric population. Since differences in PK and/or PD response may occur between adult and pediatric subjects, it is deemed appropriate to first conduct an exploratory single dose study in pediatric patients to assess safety and tolerability in this patient population. In addition this will add pediatric data to facilitate the prediction of the optimal therapeutic dose to be tested in repeated dose phase 2b trials in children, using PK/PD modeling

Detailed description: The study terminated on 10-Dec-2007. Pfizer's decision to terminate the program was due to cases of injection-site lipoatrophy that were reported in the clinical Phase 2 studies after a single injection of PHA 794428.

Eligibility criteria: Inclusion Criteria:

* 1.Male and female children with a minimum age of 6 years
* 2. Prepubertal as defined by Tanner staging
* 3. Growth hormone deficiency

Exclusion Criteria:

* 1. PGHD patients with uncontrolled pituitary tumor growth
* 2. Tumors within 3 mm of the optic chiasm
* 3. Serum ALT and/or AST \>= 1.5 times the upper limit of normal range

Primary outcomes:
measure: PK, IGF-1 and safety measurements up to 2 weeks after dosing
Secondary outcomes:
measure: Antibody and IGFBP-3 measurements
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Edegem
country: Belgium
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Erlangen
country: Germany
facility: Pfizer Investigational Site
city: Petach Tikva
country: Israel
facility: Pfizer Investigational Site
city: Cardiff
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04305938: A Human Clinical Study to Collect Calibration and Performance Data for the RBA-1 and KBS-1
Official title: A Human Clinical Study to Collect Calibration and Performance Data for the RBA-1 and KBS-1
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Calibration and Validation of Analyte Testing System
Lead sponsor: Kaligia Biosciences, LLC
Sponsor class: INDUSTRY
First posted: 2020-03-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The research subjects subjected to the test articles used in this study will be hospital patients with doctor-prescribed blood tests as standard of care.

Brief summary: The purpose of the Kaligia Biosciences KBS Systems 1.0(b) analyte monitoring device is to measure the blood analyte levels in patients. The KBS Systems 1.0(b) device avoids the common practice of accessing the vein to draw blood for conventional laboratory analysis. Instead, the KBS Systems 1.0(b) device uses Raman Spectroscopy to acheive the measurement of various blood analytes through the use of only approximately 40µl of blood. Such a small volume of blood can be sampled via a finger prick procedure rather than needing a larger volume of blood sampled via a venipuncture. The spectra contain information of all the molecules present in the blood (RBCs, hemoglobin, glucose, sodium, potassium, etc.). From these spectra, the system is able to analyze the blood and provide results in a matter of minutes, rather than hours or even, in some cases, days.


Eligibility criteria: Inclusion Criteria:

* Adults \> 18 yrs of age.
* Willingness and ability to provide informed consent
* Hospital patients with a physician-prescribed laboratory blood test

Exclusion Criteria:

1. People with clotting factor disorders and/or currently taking anticoagulation medication.
2. Has any other medical condition that, in the opinion of the Investigator, would interfere with the person's participation in this study (i.e. double arm amputee).
3. Any skin abnormalities or tattoos located on the palm(s) of the hand(s). The left palm is preferred for this study; however, the right palm can be used if the left palm is excluded.
4. Parkinson's disease, dyskinesia, tremors, or similar that may make it challenging for said person to hold their hand on the device in a still and stable manner.

Primary outcomes:
measure: Analyte validation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
Study officials:
References: