louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00579631: Adolescent Survivors of Cancer or Similar Illnesses
Official title: Health Behaviors in Adolescent Survivors of Cancer or Similar Illnesses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescent Cancer Survivors
Pediatric Cancer Survivors
Keywords: survivors
adolescent
pediatric
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 148
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Memorial Sloan-Kettering Cancer Center's Department of Pediatrics

Brief summary: The purpose of this study is to examine the health behaviors of young adults who have been treated for cancer, leukemia, or similar illnesses. We will also ask you some questions about your family members' and friends' health behaviors. We plan to use the findings from this study to design new programs to help teenage cancer survivors resist doing things that might harm their health.

Detailed description: This study proposes to explore cancer-risk behaviors and future behavioral intentions among adolescent cancer survivors (i.e., 14-19 years old) and compare them to their "healthy" peers using population-based normative data. Additionally, it seeks to determine the significant theory-driven covariates related to adolescent survivors' health behaviors, which will aid in the design of future behavioral interventions.

Eligibility criteria: Inclusion Criteria:

* Current age at enrollment between 14 and 19;
* A diagnosis of cancer between the ages of 8 and 14;
* At least 12 months post-treatment and no evidence of disease (NED) at the time of assessment;
* Can be reached by mail or telephone;
* Fluent in English;
* Parent or legal guardian able to provide informed consent;
* Able to provide informed assent.

Exclusion Criteria:

* Major psychopathology or cognitive impairment likely in the judgment of the investigator to interfere with participation and compliance with the protocol.
* Currently receiving therapy for cancer treatment

Primary outcomes:
measure: To describe the patterns of cancer-risk behaviors for adolescent cancer survivors as compared to population-based normative data of "healthy" adolescents, and to describe relevant theory-driven covariates for adolescent cancer survivors.
timeFrame: conclusion of study
Secondary outcomes:
measure: To examine the role and relative utility of sociodemographics, medical characteristics, theory-driven variables in explaining adolescent cancer survivors' health behaviors.
timeFrame: conclusion of study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Marie Barnett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05051631: BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity
Official title: BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
mammogram
screening
risk assessment
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 1072
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stepped-Wedge Trial. 10 clinics will be assigned to 5 arms to receive the intervention at sequential times. The time at which each arm receives the intervention will be randomized.
Primary purpose: SCREENING

Brief summary: The central goal of this study is to test strategies to implement evidence-based breast cancer risk assessment in healthcare clinics in Tennessee. The BRAVE Strategy (Breast cancer Risk Assessment - achieVing Equity) study aims to assess the feasibility, reach, acceptability, and appropriateness of select customized strategies to increase uptake of breast cancer risk assessment. The investigators will achieve these aims through a conducting a stepped-wedge trial conducted in 10 healthcare clinics in the state of Tennessee. The primary outcome is the proportion of women age 25-49 having risk assessment. Secondary outcomes include the numbers of 1) women identified as high-risk; 2) pursuing risk-adherent screening; and 3) diagnosed with breast cancer.


Eligibility criteria: Inclusion Criteria:

* ages 25-49

Exclusion Criteria:

* personal history of breast cancer

Primary outcomes:
measure: Proportion of eligible women who receive breast cancer risk assessment
timeFrame: baseline to 18 months
Secondary outcomes:
measure: Number of women identified as high risk for breast cancer
timeFrame: baseline to 18 months
measure: Number of high risk women who received screening
timeFrame: baseline to 24 months
measure: Number of cancers detected in high risk women
timeFrame: baseline to 24 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Lucy B Spalluto, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01511731: Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions
Official title: Open-label, Randomized, 2-way Crossover Study to Compare the Bioavailability of Reddy Cheminor and Merck &Co, Pepcid Famotidine Tablets 40 mg Under Fasting Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
famotidine
Crossover
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2012-01-19
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to compare the single-dose relative bioavailability of Reddy Cheminor and Merck \&Co, pepcid 40 mg famotidine tablets under fasting conditions.

Detailed description: Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 30 healthy adult male volunteers. A total of 30 subjects completed the clinical phase of the study. Single oral 40 mg doses were separated by a washout period of 7 days.

Eligibility criteria: Inclusion Criteria:

Exclusion Criteria:

History or presence of significant:

• cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.

In addition, history or presence of:

* alcoholism or drug abuse within the past year;
* hypersensitivity or idiosyncratic reaction to famotidine or any other histamine H2-receptor antagonist; Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.

Subjects who, through completion of the study, would have donated in excess of:

* 500 mL of blood in 14 days, or
* 500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator),
* 1000 mL of blood in 90 days,
* 1250 mL of blood in 120 days,
* 1500 mL of blood in 180 days,
* 2000 mL of blood in 270 days,
* 2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days of study start.

Primary outcomes:
measure: Area Under Curve (AUC)
timeFrame: predose,0. 5, 1, 1. 33, 1. 67, 2, 2. 33, 2.67, 3, 3. 33, 3. 67, 4, 4. 5, 5, 6, 8, 10, 12, 16 and 24 hours post-dose.
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Phoenix Clinical Research Center
Study officials:
affiliation: Phoenix Clinical Research Center
name: Samuel Serfaty, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05804331: The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study
Official title: The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer of Stomach
Oesophageal Cancer
Gastric Cancer
Gastric Adenocarcinoma
GI Cancer
GIST
Neuroendocrine Tumors
Gastric Neoplasm
Esophageal Neoplasms
Lead sponsor: Western Sydney Local Health District
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to tertiary centre for endoscopic resection of gastrointestinal neoplasm

Brief summary: To determine the long term outcomes of Endoscopic Submucosal Dissection (ESD), Endoscopic Full Thickness Resection (EFTR) and Submucosal-Tunnelling Endoscopic Resection (STER) for upper gastrointestinal neoplastic lesions

Detailed description: To collect prospective observational data on patients undergoing ESD, EFTR or STER for UGI neoplastic lesions

* Lesion characteristics including histology
* Procedural outcomes
* Safety Outcomes
* Efficacy outcomes

Eligibility criteria: Inclusion Criteria:

* UGI neoplastic lesions \> 10mm

  * Lesions for ESD limited to the mucosal and/or submucosal layer OR
  * Lesions for EFTR limited to the muscularis propria layer OR
  * Lesions for STER limited to the submucosal and/or muscularis propria layer
* Aged 18 years or older

Exclusion Criteria:

* Age less than 18
* Unable to give informed consent
* Pregnant or lactating patients
* Patients with bleeding diathesis or who cannot discontinue ADP blockers (e.g. clopidogrel, prasugrel) or antithrombotics (e.g. warfarin, dabigatran) periprocedurally

Primary outcomes:
measure: Effectiveness of endoscopic resection of UGI neoplastic lesions: completeness of resection
timeFrame: 2 weeks
measure: Safety: intra and post procedural; bleeding; perforation; anaesthetic
timeFrame: 30 day
measure: Long term outcomes: recurrent and residual disease
timeFrame: 3 years
Secondary outcomes:
measure: Endoscopic sessions, procedure time (in minutes) and overall time (in weeks) needed to achieve the primary objectives
timeFrame: 6 months
measure: Need for more than one endoscopic therapy
timeFrame: 3 years
measure: Need for surgery
timeFrame: 2 months
measure: Post ESD, EFTR, STER defect features
timeFrame: 1 day
measure: Patient interviews/questionnaires
timeFrame: 3 years
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Westmead Hospital
state: New South Wales
Study officials:
affiliation: WSLHD
name: Michael Bourke
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02943031: The Effect of Individualized Precision Therapy Programs in Patients With BTC
Official title: The Effect of Individualized Precision Therapy Programs in Patients With Biliary Tract Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Biliary Tract Neoplasms
Keywords: bile duct tumor
individualized precise treatment programs
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2016-10-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective cohort study. Patients who meet the inclusion criteria will be enrolled in this study. The samples of biliary tract tumors will be collected. Genome sequencing, mini-PDX and PDX will be performed according to the requirement of individualized precision therapy programs. Suitable drugs will be chose according to drug screening results. OS and PFS will be compared with traditional chemotherapy to evaluate the effect of individualized precision therapy programs.

Detailed description: In this prospective cohort study, patients who are eligible for inclusion criteria will enroll in the study. After bile duct tumor samples were collected, whole genome sequencing, drug screening ( including Mini-PDX and PDX) will conduct. Suitable drugs will be decided according to the different genomics classification, and then to develop individualized precise treatment programs.

The investigators hope to achieve the following objectives:

① Through the establishment of Individualized Precision Therapy Programs to improve the overall survival of bile duct malignancy (BTC)；

② To study the molecular typing of the prognosis of biliary malignancy;

③ To construct a database of BTC gene bank, as well as for drug screening information.

Eligibility criteria: Inclusion Criteria:

* Pathological diagnosis of biliary malignancies
* The expected survival time is longer than 3 months
* PKS score\> 60 points
* Willing to take part in the study

Exclusion Criteria:

* Can not or refuse to collect tumor samples
* Refused to accept the relevant treatment method

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Study officials:
affiliation: Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
name: JIAN WANG, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00619931: A Multiple-Dose Study to Assess the Safety, Tolerability, and Steady State Pharmacokinetics of APD791 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy adult volunteers
Lead sponsor: Arena Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The APD791-002 study is designed primarily to evaluate the safety, tolerability, and pharmacokinetics of APD791 when administered for 7 days to healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy adult men and women, ages 19-45
* Non smokers

Exclusion Criteria:

* History of a bleeding disorder
* Use of any drug known to have an effect on coagulation or clotting or any anti-platelet therapy within 2 weeks of the screening
* Recently donated blood or had significant blood loss
* Current use of a prescription medication
* Pregnant females

Primary outcomes:
measure: Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters
timeFrame: Throughout study duration
Secondary outcomes:
measure: Pharmacokinetic assessments
timeFrame: Throughout study duration
measure: Pharmacodynamic assessments (e.g., platelet function)
timeFrame: Throughout study duration
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: MDS Pharma Services
state: Nebraska
Study officials:
affiliation: MDS Pharma Services
name: James Kisicki, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arena Pharmaceuticals
name: Christen M Anderson, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05970731: Directed Topical Drug Delivery for Treatment for PASC Hyposmia
Official title: Directed Topical Drug Delivery for Treatment for PASC Hyposmia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post Acute Sequelae Covid-19 Hyposmia
Keywords: Covid-19
smell loss
hyposmia
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase II randomized, double-blinded, placebo-controlled study to evaluate the efficacy of topical intranasal treatment of beclomethasone vs. placebo for improved olfactory function.

Detailed description: Eligible participants are randomized to receive either Beclomethasone or placebo intranasally via a microsponge twice on day 1 and day 14. Study duration is three months and includes 4 in-person study visits: 2 visits for drug administration at Baseline and Week 2, and 2 follow-up visits at Week 6 and Week 18. Participants will be expected to complete the Smell Identification Test (SIT) and Questionnaire on Olfactory Disorders (QOD) at baseline, Week 6, and Week 18. The investigator hypothesizes that the application of beclomethasone directly in the nasal cavity will result in improved olfactory function.

Eligibility criteria: Inclusion Criteria:

* Post-COVID hyposmia lasting greater than 3 months following COVID19 by history
* Male or female, aged 18 years or older

Exclusion Criteria:

* Pregnancy or lactation
* Known allergic reactions to components of microsponge (including shellfish) or to beclomethasone
* Known diagnosis of glaucoma
* Febrile illness within 1 week
* Treatment with another investigational drug or other intervention within 3 months
* Active sinonasal disease by nasal exam, i.e. rhinosinusitis, nasal polyps
* Adults unable to consent
* Prisoners, employees or subordinates
* Individuals who are not yet adults (infants, children, teenagers)

Primary outcomes:
measure: Change in olfactory function as measured by the Smell Identification Test (SIT)
timeFrame: Baseline, 6 weeks, 18 weeks
Secondary outcomes:
measure: Change in olfactory quality of life (QOL) measured by the Questionnaire on Olfactory Disorders (QOD)
timeFrame: Baseline, 6 weeks, 18 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Bradley Goldstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06051331: The Effect of Simulation-Based Breast Health Education on Breast Cancer Awareness and Breast Self-Examination Practices
Official title: The Effect of Simulation-Based Breast Health Education on Breast Cancer Awareness and Breast Self-Examination Practices of Afgan Refugee Women: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Health Knowledge, Attitudes, Practice
Keywords: Afghan
Breast Cancer
Awareness
Health Education
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 64
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aimed to evaluate the effect of simulation-based breast health education on breast cancer awareness and breast self-examination practices of Afghan refugee women. The study hypothesized that simulation-based breast health education would have an effect on breast cancer awareness and breast self-examination practices scores among Afghan refugee women.

Detailed description: Purpose: The aim of the research is to examine the effects of simulation-based breast health education on breast cancer awareness and breast self-examination practices of Afghan refugee women.

Methods: The study will conduct with 64 (32 in the intervention group, and 32 in the control group) Afghan. The study population consisted of Afghan women. The simulation-based breast health education will applied to the intervention group once a week for 8 weeks.

No intervention will offer to the control group. Data will collected by a socio-demographic questionnaire, Breast Cancer Awareness Measure (BCAM) and breast self-examination practices checklist.

Eligibility criteria: Inclusion Criteria:

* 20-65 years,
* must be able to speak Turkish or Dari.

Exclusion Criteria:

* breast cancer

Primary outcomes:
measure: The Breast Cancer Awareness Measure Score
timeFrame: up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT06754631: Efficacy and Safety of Continuous Versus Intermittent Nebulization of Salbutamol in Acute Severe Asthma in Children Under 12 Years of Age
Official title: Efficacy and Safety of Continuous Versus Intermittent Nebulization of Salbutamol in Acute Severe Asthma in Children Under 12 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Lead sponsor: RESnTEC, Institute of Research
Sponsor class: OTHER
Collaborators: name: Nishtar Medical University
First posted: 2025-01-01
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Asthma affects around 260 million people globally, causing around 0.5 million deaths annually. Pediatric asthma remains a major global public health challenge, significantly affecting the quality of life for many children. Therefore, this study was planned to compare the effects of continuous versus intermittent nebulization of salbutamol in the treatment of acute severe asthma (ASA) in children visiting the emergency department of a tertiary childcare hospital in South Punjab, Pakistan.


Eligibility criteria: Inclusion Criteria:

* Children of either gender
* Aged 2 to 12 years
* Diagnosed with moderate exacerbation of acute asthma according to British Guidelines on the Management of Asthma, with a clinical asthma score of 8 or more

Exclusion Criteria:

* Children who were prescribed with other first-line therapy, such as adrenaline or 3% NaCl nebulization
* Presented at imminent risk of respiratory arrest
* Congenital heart disease
* Chronic respiratory disease
* Neurological disorders
* Children referred from any other hospital with no data available on emergency treatment

Primary outcomes:
measure: Discharge
timeFrame: 4 hours
Secondary outcomes:
measure: Hospital stay
timeFrame: 24 hours
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: Nishtar Hospital
state: Punjab
city: Multan
country: Pakistan
facility: The Children's Hospital and The Institute of Child Health
state: Punjab
Study officials:
affiliation: Children's Hospital and institute of Child Health Multan, Punjab, Pakistan
name: Arif Zulqarnain, FCPS
role: STUDY_DIRECTOR
affiliation: Children's Hospital and institute of Child Health Multan, Punjab, Pakistan
name: Muhammad Salman, FCPS
role: PRINCIPAL_INVESTIGATOR
References: