louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00728039: Quality of Life (QOL), Coping and Psychological Symptoms in Children and Adolescents With Cyclic Vomiting Syndrome
Official title: Quality of Life, Coping and Psychological Symptoms in Children and Adolescents With Cyclic Vomiting Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vomiting Syndrome
Keywords: Youth
Consensus
Criteria
CVS
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Children's Hospital and Health System Foundation, Wisconsin
First posted: 2008-08-05
Enrollment: 61
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged 9-10 will complete 5 questionnaires Adolescents aged 11-18 will complete 6 questionnaires Youth aged 11-18 will fill out an additional questionnaire that asks how they cope with stress related to CVS symptoms Parents will complete 4 questionnaires

Brief summary: 1. Characterize the quality of life of young children with CVS (i.e., psychological, social, physical, school functioning) and the impact of the child's illness on the parent's and family's quality of life (i.e., emotional, social, cognitive functioning, communication, worry, daily activities and family relationships).
2. Assess symptoms of depression, anxiety, ADHD and behavioral problems in what our preliminary data suggests is a psychiatrically vulnerable population.
3. Evaluate the associations between quality of life and psychiatric symptoms and the frequency and intensity of CVS attacks.
4. Use the data generated from this study to develop a psychosocial intervention targeted at young children with CVS and their families who evidence risk for functional disability, with the aim of intervening as early as possible to limit the psychological and social morbidity experienced by children with CVS and their and families.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of CVS

Exclusion Criteria:

* Children and parents who are not English speaking
* Youth with significant developmental delay, mental retardation, psychotic symptoms, or other significant mental impairments and those with other major medical disorders such as IDDM, congenital heart disease, cystic fibrosis, etc.

Primary outcomes:
measure: Characterize the quality of life of youth with CVS as well as the strategies they use to cope with stress, their strengths and vulnerabilities, and to assess symptoms of depression and anxiety in these at risk youth.
timeFrame: Two years
Secondary outcomes:
measure: Evaluate the associations among coping strategies the frequency and intensity of CVS attacks to determine if particular coping styles and personal characteristics are associated illness severity, psychiatric co-morbidity and quality of life.
timeFrame: Two years
Other outcomes:
Locations:
Study officials:
affiliation: Medical College of Wiconsin
name: Sally E Tarbell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01527539: Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes
Official title: A Multi-centre, Non-comparative, Open-labelled, Extension Trial to Assess the Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes (Extension to BIAsp-1237)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-02-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in North America. The aim of this trial is asses the long term safety and efficacy of biphasic insulin aspart 30 in Canadian subjects with type 2 diabetes who had participated in the BIAsp-1237 trial.


Eligibility criteria: Inclusion Criteria:

* Completed the BIAsp-1237 trial

Primary outcomes:
measure: HbA1c
Secondary outcomes:
measure: Occurrence of adverse events
measure: Occurence of hypoglycaemic episodes
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Novo Nordisk Investigational Site
state: Nova Scotia
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Edmonton
country: Canada
facility: Novo Nordisk Investigational Site
city: Windsor
country: Canada
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03495739: Clinical Trial to Assess the Safety and Pharmacokinetics of RDG-17012 Capsule and Pradaxa® Capsule in Healthy Male Volunteers
Official title: A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of RDG-17012(Dabigatran Etexilate Tosylate) With Pradaxa® Capsule(Dabigatran Etexilate Mesylate) in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Huons Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-04-12
Enrollment: 64
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, single-dosing, 2x2 crossover study, the safety and pharmacokinetics of RDG-17012 with Pradaxa® in healthy male volunteers


Eligibility criteria: Inclusion Criteria:

* Age between 19 to 45, healthy male subjects(at screening)
* Subject without a hereditary problems, chronic disease and morbid symptom
* Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress

Exclusion Criteria:

* Volunteer who has past or present history of any diseases following below.(liver, kidney,digestive system, pulmonary,hematooncology, endocrine, urinary,neurology,mental disorder, skeletomuscular, immunology, otolaryngology,cardiovascular)
* Exceed 2 times the normal range of AST, ALT, Total Bilirubin at screening test
* History of drug abuse, or a positive urine drug screen
* Regular alcohol consumption(over 21 units/week, 1unit=10g of pure alcohol) or volunteers who cannot abstain from drinking during the study
* Any condition that, in the view of the investigator, would interfere with study participation

Primary outcomes:
measure: Area Under Curve(AUC) last of Total dabigatran and Free dabigatran
timeFrame: (Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2
measure: Maximum of concentration(Cmax) of Total dabigatran and Free dabigatran
timeFrame: (Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2
Secondary outcomes:
measure: Area Under Curve(AUC)inf of Total dabigatran and Free dabigatran
timeFrame: (Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Huons
state: Seongnam-si
Study officials:
References:
Clinical trial NCT01137539: TVT-SECUR as an Office-based Procedure
Official title: TVT-SECUR as an Office-based Procedure - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Stress Urinary Incontinence
Keywords: urinary incontinence
stress urinary incontinence
mid-urethral slings
Tension-free vaginal taping
TVT
Lead sponsor: Michigan Institution of Women's Health PC
Sponsor class: OTHER
Collaborators: name: Ethicon, Inc.
First posted: 2010-06-04
Enrollment: 50
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study to assess the feasibility and success of performing the TVT-Secur in the office setting. Endpoints would be success, complications, and patient and physician acceptance of the procedure. Success would be assessed by validated questionnaires.

This is a prospective single arm study of 50 patients who will have the TVT-Secur procedure done in the office under local anesthesia. They will be followed for a period of 3 years.

Detailed description: The study will include 50 patients who would meet the inclusion/exclusion criteria and who sign the informed consent. Subjects are diagnosed with Stress urinary incontinence resulting from urethral hypermobility with no prior urinary incontinence surgery. Subjects are women who no longer intend to bear children and who do not require any other concomitant surgery.

Eligibility criteria: Inclusion Criteria:

* Stress urinary incontinence with hypermobility of the UV junction
* ASA I or II
* Age 21-89

Exclusion Criteria:

* Prior anti-incontinence surgery
* Not completed childbearing
* ASA III or higher
* Need concomitant surgery
* Poor compliance for office based approach

Primary outcomes:
measure: Treatment Success Based on Patient Report on Validated Questionnaire
timeFrame: 24 months
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 12 months
Other outcomes:
Locations:
city: Dearborn
country: United States
facility: Advanced Urogynecology of Michigan PC
state: Michigan
Study officials:
affiliation: Michigan Institute of Women's Health PC
name: Salil S Khandwala, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03685539: DECT in Imaging Patients With Solid Organ Cancer With Intracranial Metastasis
Official title: Advanced CT Imaging Optimization for the Detection of Intracranial Metastasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Neoplasm
Metastatic Malignant Neoplasm in the Brain
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-09-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This trial studies how well dual energy computed tomography (DECT) works in imaging patients with solid organ cancer that has spread to the brain. Imaging techniques, such as DECT, may help find and diagnose tumor cells and find out how far the tumor cells have spread in the brain.

Detailed description: PRIMARY OBJECTIVES:

I. To optimize two major parameters of computed tomography (CT) imaging for optimal detection of intracranial metastatic lesions.

Ia. Virtual monochromatic image reconstruction. Ib. Contrast bolus timing. II. To measure the detection accuracy of CT compared to the diagnostic standard of care gadolinium-based "Gamma Knife (GK)" protocol magnetic resonance imaging (MRI).

OUTLINE:

Within 7 days before the standard Gamma Knife MRI, patients undergo DECT scan over 6 seconds at 1.5, 5, 10, and 20 minutes after receiving the contrast agent.

Eligibility criteria: Inclusion Criteria:

* Adult patient with pathology-proven solid organ cancer
* MRI of the brain with contrast, positive for two or more metastatic lesions

  * One lesion with a single greatest diameter on contrast-enhanced MRI of 1 cm or greater
* Planned treatment with stereotactic radiosurgery

Exclusion Criteria:

* Known allergy to iodine-based contrast agents
* Patients with glomerular filtration rate (GFR) less than 30 or use of hemodialysis
* If prior nephrectomy, GFR less than 60
* Prior central nervous system malignancy
* Prior brain radiation
* Pregnant women are excluded

Primary outcomes:
measure: Best diagnostic performance of computed tomography (CT) reconstruction parameters
timeFrame: Up to 2 years
measure: Accuracy of CT
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jason M Johnson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04644939: Impact of Telephone Call on Bowel Preparation Quality in Colonoscopies
Official title: Impact of Telephone Call for Patient Education on Bowel Preparation Quality in Outpatient Colonoscopies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonoscopy
Lead sponsor: Makassed General Hospital
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Bowel preparation regimens typically incorporate dietary modifications along with oral cathartics. Inadequate bowel preparation can result in failed detection of prevalent neoplastic lesions and has been linked to an increased risk of procedural adverse events. Previous studies have suggested that patient compliance is important to ensure proper bowel cleansing. Patient counseling along with written instructions that are simple and easy to follow and in their native language should be provided to patients.

Thus, interventions that improve the quality of bowel preparation could have a great benefit regarding colonoscopy results. Little in the literature that studies the impact of enhanced patient education on bowel preparation quality.

In this study we aim to determine the impact of patient education using telephone call one day prior to outpatient colonoscopy on bowel preparation quality.


Eligibility criteria: Inclusion Criteria:

* patients undergoing outpatient colonoscopy

Exclusion Criteria:

* History of previous inadequate bowel preparation
* History of colorectal surgeries
* Patient who did not sign the consent
* Patients with dementia
* Patients with Swallowing difficulties

Primary outcomes:
measure: Bowel preparation quality
timeFrame: Directly after colonoscopy
Secondary outcomes:
measure: Colonic polyps rate
timeFrame: Directly after colonoscopy
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Makassed General Hospital
Study officials:
affiliation: Makassed General Hospital
name: Walid Nassreddine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05592639: VideoEndoscopic Radical Inguinal Lymphadenectomy for Penile Cancer
Official title: Videoendoscopic Radical Inguinal Lymphadenectomy Versus Open Radical Inguinal Lymphadenectomy in Patients With Penile Cancer: a Feasibility Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Penile Cancer
Inguinal Lymphadenopathy
Melanoma
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: The Christie NHS Foundation Trust
name: St George's University Hospitals NHS Foundation Trust
name: Norfolk and Norwich University Hospitals NHS Foundation Trust
First posted: 2022-10-25
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Assess the feasibility of performing a RCT comparing videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in men diagnosed with genital cancer requiring inguinal lymphadenectomy, and determine the design of such an RCT.

Detailed description: There is increasing interest in using videoendoscopic inguinal lymph node dissection (ILND) as an alternative to open ILND. Videoendoscopic inguinal lymphadenectomy (VEIL) may decrease complications compared to open ILND and provide equivalent short-term oncological outcomes.

As yet, there have been no randomised-controlled trials (RCTs) comparing these procedures.

VELRAD aims to assess the feasibility of performing a RCT comparing VEIL and open ILND. This will be measured by recruitment rate, the acceptability of the trial design and intervention to clinical stage and patients. Investigators will also collect qualitative data on why patients did or did not agree to be randomised

Eligibility criteria: Inclusion Criteria:

1. People requiring inguinal lymphadenectomy i.e.

   1. Patients with squamous cell carcinoma or mucosal melanoma of the penis \> T1bG2 or patients with male genital cancer requiring inguinal lymphadenectomy
   2. Patients unsuitable for dynamic sentinel node biopsy (DSNB) with impalpable nodes: previous penectomy or non-visualisation at previous DSNB
   3. Previous DSNB with metastatic inguinal nodes on histology or FNA positive nodes on cytology who require a completion radical inguinal lymphadenectomy
   4. Small volume palpable inguinal lymph nodes (\< 2 cm on CT) not fixed to skin
2. Age \> 18 years

Exclusion Criteria:

1. Unfit for surgery
2. People unlikely to benefit from lymphadenectomy because of advanced cancer
3. Those with palpable inguinal lymph nodes fixed to skin or adjacent structures
4. Does not want to participate in the trial or unable to provide informed consent

Primary outcomes:
measure: Ability to recruit patients
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London
Study officials:
affiliation: University College, London
name: Asif Muneer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05024539: Real-World Effectiveness of Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma
Official title: Real-World Effectiveness of Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma-A Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
regorafenib
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Henan Cancer Hospital
First posted: 2021-08-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pathologically proven Hepatocellular Carcinoma whose disease progressed after two lines of antitumor therapy were treated with regorafenib alone or in combination.

Brief summary: Real-World Effectiveness of Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma

Detailed description: To analyze the real-world usage pattern, effectiveness and factors associated with the effectiveness of regorafenib in the treatment of patients with Hepatocellular Carcinoma. This retrospective, observational study included clinicopathological and follow-up data of patients with Hepatocellular Carcinoma who were treated with regorafenib from June 2017 to September 2020. Patients with incomplete data were excluded. Overall survival (OS) stratified by combination therapy with programmed cell death ligand-1 (PD-L1) inhibitors, chemotherapy and regorafenib dose was calculated by Kaplan Meier method and log rank test. R software version 4.0 was used for the analysis.

Eligibility criteria: 1. Inclusion Criteria:

   1. Must be a pathologically proven Hepatocellular Carcinoma
   2. Must have been treated with regorafenib
   3. Regorafenib must be used after two lines of standard antitumor therapy
2. Exclusion Criteria:

   1. Application is less than one course of treatment with regorafenib
   2. First - or second-line treatment with regorafenib
   3. Patients with multiple primary cancers

Primary outcomes:
measure: The difference in overall survival between the two groups calculated by Kaplan-Meier
timeFrame: 2021.7-2021.12
measure: The difference of overall survival in patients receiving different doses of regorafenib
timeFrame: 2021.11-2021.12
measure: Regorafenib in combination with other drugs
timeFrame: 2021.7-2021.10
Secondary outcomes:
measure: Survival differences among the patients with different clinical phenotypes and genotypes
timeFrame: 2021.7-2021.10
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan cancer hosiptal
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Shujun Yang
role: STUDY_DIRECTOR
References:
Clinical trial NCT01883739: Randomised Controlled Trial to Investigate the Effect of Parental Presence at Intensive Care Unit to Ward Transfer Bedside Rounds on Parental Anxiety and Children's Safety
Official title: Randomised Controlled Trial to Investigate the Effect of Parental Presence at Intensive Care Unit to Ward Transfer Bedside Rounds on Parental Anxiety and Children's Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parental Anxiety
Children's Safety
Keywords: Parental anxiety
Children's safety
Family Centered Care
Bedside Transfer Rounds
Pediatric Cardiac Intensive Care
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Canadian Medical Protective Association
First posted: 2013-06-21
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators shall conduct a randomized controlled trial to investigate the effect of parental presence at transfer rounds on parental anxiety and patient safety following transfer from the Pediatric Cardiac Intensive Care Unit (PCICU) to the ward. The investigators plan to test the hypothesis that parental involvement in the child's transfer, with the option of peer support, will result in measurable reductions in medication errors, unplanned nutritional and feeding management, and parental anxiety after transfer as compared to the control group. The investigators goal is to improve continuity of care by implementing multidisciplinary transfer rounds at the child's bedside in which patients and family share in the control of the management plan when a cardiac child is discharged from PCICU to the ward.


Eligibility criteria: Inclusion Criteria:

* Parents of cardiac children aged 1 day to 17 years admitted to PCICU
* Written informed consent and assent when appropriate
* Planned discharge from the PCICU to the ward.

Exclusion Criteria:

* Parents with less than grade 6 reading skills as they will not be able to independently take the Spielberger's State -Trait Anxiety Inventory (STAI).
* Parents who are not willing to be randomized to the control group in which they cannot be present for transfer rounds.
* Neonates being discharged from PCICU to NICU or neonates being discharged from NICU to wards.

Primary outcomes:
measure: Change from baseline in parental STAI score
timeFrame: 2 to 4 hours post transfer
Secondary outcomes:
measure: Rate of unplanned changes in medication and nutrition management
timeFrame: 48 hours post transfer
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Pediatric Cardiac ICU, Stollery Children's Hospital
state: Alberta
Study officials:
affiliation: Stollery Children's Hospital, University of Alberta
name: Ian Adatia, MBChB, MRCP, FRCP(C)
role: PRINCIPAL_INVESTIGATOR
References: