louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00591188: Capecitabine and Interferon-Alpha in Metastatic Renal Cell Carcinoma Patients With Failure on Interleukin-2 Based Regimens
Official title: Phase II Study of Capecitabine and Interferon-Alpha in Metastatic Renal Cell Carcinoma Patients With Failure on Interleukin-2 Based Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Keywords: kidney cancer, capecitabine, interferon
Lead sponsor: Kidney Cancer Research Bureau
Sponsor class: OTHER
First posted: 2008-01-11
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine preliminary efficacy of capecitabine and interferon-alpha in second-line after interleukin-2 based regimens in patients with MRCC


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed renal carcinoma
* CT-confirmed metastatic sites
* Must have measurable disease, defined as ≥ 1 unidimensionally measurable lesion measured as ≥ 20 mm with conventional techniques OR as ≥ 10 mm with spiral CT scan
* Disease progression after IL-2
* Age 18 or older
* ECOG performance status 1-3
* Life expectancy ≥ 2 months
* WBC ≥ 3,000/mm3
* Platelet count ≥ 100,000/mm3
* Hemoglobin ≥ 7.5 g/dL
* Creatinine ≤ 1.5 mg/dL (2.0 mg/dL in post-nephrectomy patients)
* Total bilirubin ≤ 1.5 mg/dL
* AST ≤ 3.0 times normal
* Alkaline phosphatase ≤ 2.5 times normal (10 times ULN in presence of bone metastases)
* Not pregnant or nursing
* No history of autoimmune
* No history of serious cardiac arrhythmia, congestive heart failure, angina pectoris, or other severe cardiovascular disease (i.e., New York Heart Association class III or IV)
* No CNS metastases by neurologic exam and/or MRI
* No history of seizure disorders
* No local and/or systemic infections requiring antibiotics within 28 days prior to study entry
* No other malignancy
* Written informed consent

Primary outcomes:
measure: Evaluate progression-free survival with capecitabine and interferon treatment in metastatic renal cell carcinoma (MRCC) patients (pts) with IL-2 failure in first-line
timeFrame: one year
Secondary outcomes:
measure: Evaluate the safety and tolerability of the capecitabine and interferon combination
timeFrame: one year
measure: Evaluate response rate and overall survival with the capecitabine and interferon combination in MRCC pts with progression on IL-2 based regimens
timeFrame: one year
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: N.N. Blokhin Russian Cancer Research Center
Study officials:
affiliation: Kidney Cancer Research Bureau
name: Ilya V. Tsimafeyeu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: N.N. Blokhin Russian Cancer Research Bureau
name: Lev V. Demidov, MD, DSc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00298688: A Study of IRESSA in Relapsed and Refractory Small Cell Lung Cancer
Official title: Phase II Study of Iressa in Relapsed and Refractory Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-03-03
Enrollment: 56
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: The purpose of this study is to determine the disease control rate at trial closure and after the first stage of the study in patients with relapsed or refractory SCLC and measurable disease treated with gefitinib


Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent
* Histologically confirmed, relapsed or refractory SCLCr
* Aged 18 or over and a life expectancy of more than 2 months

Exclusion Criteria:

* Any evidence of clinically active interstitial lung disease
* Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ.

Primary outcomes:
measure: To determine the disease control rate in these patients
Secondary outcomes:
measure: To determine the objective response rate at trail closure in these patients
measure: To determine the time to progression-or-death in these patients
measure: To determine overall survival in these patients
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Research Site
city: Herlev
country: Denmark
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Iressa Medical Science Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03923088: Comparison Between Jacobson's Progressive Muscle Relaxation Technique and Audio-visual Distraction Technique in Reducing Dental Anxiety in Children During Dental Visit
Official title: Comparison Between Jacobson's Progressive Muscle Relaxation Technique and Audio-visual Distraction Technique in Reducing Dental Anxiety in Children During Dental Visit ; Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Anxiety
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dental anxiety is fear associated with the thought of visiting the dentist for preventive care and dental procedures. Children with dental anxiety characterized by crying before dental checkup, tachycardia and aggressively clinging to the accompanying parent. It has been cited as the fifthmost common cause of anxiety by Agras et al. Dental anxiety may have major and long-lasting implications for the child and their family. Cohen et al reported that dental anxiety affects an individual's life in multiple ways. The physiological impacts included signs and symptoms of the fright response and feelings of exhaustion after a dental appointment, while the cognitive impacts included an array of negative thoughts, beliefs, and fears. Dental anxiety in children could remain a problem in adulthood if not handled properly thus it will affect oral health and psycho-social condition. This research is conducted to deliver different concepts in psychological and behavioral techniques in management of anxious pediatric dental patients.


Eligibility criteria: Inclusion Criteria:

* Children: 6 to 9 years old children. Teeth: tooth requiring dental treatment

Exclusion Criteria:

* Children having allergy to local anaesthesia or systemic problem. Refusal of participation Mentally ill or mentally retarded children

Primary outcomes:
measure: cooperation measured by modified venham rating scale
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01311388: Construction of the "Patient-Centered"Molecular Pathology Diagnostic Center
Official title: Construction of the "Patient-Centered"Molecular Pathology Diagnostic Center
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: cancer
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2011-03-09
Enrollment: 1500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cancer patients

Brief summary: The investigators want to achieve the goal of diagnosis in early phase, accurate treatment and existence for a long period in order to screen in early phase, diagnose in clinical trial, choose treatment and evaluate prognosis of cancers by establishing molecular pathology tools.

Detailed description: This research is going to discuss the biomarker expression of common malignant neoplasm (tumor)among Taiwanese, such as large intestine rectal cancer, breast cancer, prostate gland cancer, lung cancer, oral cancer, gastric cancer, liver cancer, cervical cancer, cancer of the womb, ovarian cancer, carcinoma of urinary bladder, kidney cancer and so on.

The investigators hope to find the biomarker of common tumors among Taiwanese in order to develop the tools of tumor screening, diagnosis, treatment methods and prediction prognosis

Eligibility criteria: Inclusion Criteria:

* above 20 years old
* all kinds of cancer patients

Exclusion Criteria:

* under 20 years old
* none cancer patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: TMU-CECR
Study officials:
affiliation: TMU-CECR
name: Wen-Ta Chiu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01235988: Meta-analysis - Eltrombopag
Official title: Systematic Review of the Clinical and Cost Effectiveness of Treatments for Idiopathic (Immune) Thrombocytopenic Purpura (ITP): Direct Meta Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombocytopaenia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-11-07
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Meta-analysis: A systematic review was conducted to obtain all relevant evidence relating to eltrombopag and relevant studies were selected

Brief summary: The purpose of the meta-analysis was to explore the efficacy of eltrombopag versus placebo (standard of care)

Detailed description: Meta-analysis of three studies: Bussell 2007 \& Bussell 2009 \& RAISE (TRA102537).

Eligibility criteria: Inclusion Criteria:

* Adults with ITP
* Received a pre-specified treatment
* Prospective clinical studies with at least 10 patients

Exclusion Criteria:

* Subjects with ITP due to other causes

Primary outcomes:
measure: >=50 Gi/L platelet count to <400 Gi/L
timeFrame: 43 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00848588: A Survey of Factors Associated With the Successful Recognition of Agonal Breathing and Cardiac Arrest.
Official title: A Survey of Factors Associated With the Successful Recognition of Agonal Breathing and Cardiac Arrest by 9-1-1 Call Takers.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Keywords: agonal breathing
cardiac arrest
9-1-1 call taker
survey
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
First posted: 2009-02-20
Enrollment: 404
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The survey will be sent to all full-time and part-time 9-1-1 call takers employed in the Canadian provinces of Ontario, Nova Scotia and New Brunswick, as well as the city of Montreal, Quebec, Canada.

Brief summary: The overall goal of this pilot study is to design and conduct a survey of 9-1-1 call takers in the province of Ontario, Canada to better understand the factors associated with the successful identification of cardiac arrest (including victims with agonal breathing) over the phone. Specific objectives are:

1. To conduct iterative semi-structured interviews to identify behavioural factors influencing identification of cardiac arrest by 9-1-1 call takers;
2. To develop a survey instrument about behavioural factors influencing the ability of 9-1-1 call takers to identify cardiac arrest based on a systematic review of the literature, the results of the semi-structured interviews, and theoretical constructs from the Theory of Planned Behaviour; and
3. To conduct a survey among Ontario 9-1-1 call takers using the survey instrument, and to identify factors and strategies that might be targeted by Knowledge Translation interventions.


Eligibility criteria: Inclusion Criteria:

* 9-1-1 call-takers, male or female, full or part-time, employed in an eligible Ambulance Communication Centre

Exclusion Criteria:

* Ambulance Communication Centre Managers, support staff or administrative staff

Primary outcomes:
measure: Intention to Give CPR Instructions
timeFrame: During a call with a victim potentially in cardiac arrest
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Christian Vaillancourt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vaillancourt C, Jensen JL, Grimshaw J, Brehaut JC, Charette M, Kasaboski A, Osmond M, Wells GA, Stiell IG. A survey of factors associated with the successful recognition of agonal breathing and cardiac arrest by 9-1-1 call takers: design and methodology. BMC Emerg Med. 2009 Jul 31;9:14. doi: 10.1186/1471-227X-9-14.
Clinical trial NCT05276388: Establishment of a Biological Biobank of Subjects Vaccinated Against SARS-CoV-2 Infection (COVID-19)
Official title: Establishment of a Biological Biobank of Subjects Vaccinated Against SARS-Cov-2 Infection (COVID-BioVac)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronavirus Infections
Keywords: Biobank
SARS-CoV-2
COVID-19
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Employees, fellows, collaborators of the San Raffaele Hospital and other subjects who will be deemed suitable

Brief summary: Establishment of a biological bank of subjects vaccinated against SARS-Cov-2 infection (COVID-BioVac)

Detailed description: The purpose of the COVID-BioVac study is to establish a biobank of biological samples from subjects who have received the anti-SARS-CoV-2 vaccine, with the ultimate aim (following approval by the EC of specific substudies) to study and characterize the antiviral immune response generated following anti-SARS-CoV-2 vaccination. To this end, the COVID-BioVac Biobank will be officially established for the collection and storage of human biological material, non-profit, to support research activities aimed at advancing scientific knowledge, including in the genetic field, on the immune response. vaccination-induced anti-SARS-CoV-2.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Who have vaccinated for SARS-CoV-2 with Pfizer-BioNTech vaccine or others
* Signing of informed consent from January to March 2021

Exclusion Criteria:

* none

Primary outcomes:
measure: COVID-19 vaccines response
timeFrame: from Day 1 of first vaccination up to 1 years after the last vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
state: Milano
Study officials:
affiliation: IRCCS Ospedale San Raffaele
name: Patrizia Rovere Querini, MD
role: STUDY_CHAIR
affiliation: IRCCS Ospedale San Raffaele
name: Massimo Locatelli, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03429088: Exercise Promotion in Primary Care
Official title: Exercise Promotion in Primary Care: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
PreDiabetes
Diabetes
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators conducted a pilot study to determine if telephone counseling, in a health care setting that routinely assesses physical activity of its members, is a feasible approach to improve physical activity among patients with diabetes and prediabetes. The investigators built on an existing innovation at Kaiser Permanente, in which physical activity is assessed at every outpatient visit. The primary aims were to (1) pilot study elements, including database identification of patients; recruitment, training and engagement of health care providers; patient recruitment; data collection procedures; and a 24-week intervention, and (2) to assess feasibility and obtain feedback from key stakeholders on the approach.


Eligibility criteria: Inclusion Criteria:

* prediabetes or diabetes not prescribed insulin
* less than 30 min of physical activity per week
* cleared to increase physical activity by primary care provider

Exclusion Criteria:

* health condition that may limit unsupervised physical activity
* height and weight that were combined and resulted in a BMI \> 40 kg/m2
* disabling rheumatoid or osteoarthritis
* ongoing treatment for cancer
* unstable coronary heart disease

Primary outcomes:
measure: Feasibility of identifying and recruiting sufficient number of participants into a telephone-based physical activity intervention.
timeFrame: The intervention lasted 24 weeks.
Secondary outcomes:
measure: Moderate to Vigorous Physical Activity
timeFrame: Assessments were made a baseline and approximately 24 weeks after baseline assessments.
measure: Motivation for Physical Activity
timeFrame: Participants completed the survey at baseline and approximately 24 weeks after baseline assessments.
measure: Physical Activity Self-Regulation
timeFrame: Participants completed the survey at baseline and approximately 24 weeks after baseline.
Other outcomes:
Locations:
Study officials:
References:
citation: Young DR, Nguyen MK, Yamamoto A, Pomichowski M, Cornejo M, Paz S, Coleman KJ, Sallis RE, Fortmann SP. Telephone-based motivational interviewing versus usual care in primary care to increase physical activity: a randomized pilot study. Pilot Feasibility Stud. 2019 Jan 15;5:6. doi: 10.1186/s40814-019-0390-0. eCollection 2019.
Clinical trial NCT04190888: Sickle Cell Uric Acid (SCUA) - Cohort Repository
Official title: Sickle Cell Uric Acid (SCUA) - Cohort Repository
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Sickle Cell Disease
Keywords: Uric acid
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 78
Sex: ALL
Minimum age (years): 5
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants currently receiving medical care from the pediatric or adult hematology comprehensive sickle cell centers.

Brief summary: The purpose of this research is to study the causes of Sickle Cell kidney disease, as well as to collect and store samples and information about people with Sickle Cell Disease.

Detailed description: Sickle Cell Disease causes kidney injury over time, but it is not clear why some individuals have very significant chronic kidney disease and why some do not. The purpose of this research is to study whether having high levels of 'uric acid,' which is a naturally occurring molecule in the body that may increase kidney injury and systemic inflammation, accelerates the progression of chronic kidney disease over time. Researchers will measure the number of participants that have high uric acid levels at the beginning of the study, as well as the number of participants that develop new high levels throughout the study. The study will also try to determine what causes the high uric acid levels in some patients but not others. The results of this study could help understand kidney injury and uric acid in sickle cell disease better.

Eligibility criteria: Inclusion Criteria:

* Age 5-29 years
* Sickle cell disease as diagnosed by hemoglobin electrophoresis, or by newborn screen per standard of care
* Currently receiving comprehensive sickle cell care at the Children's Hospital of Richmond at VCU or in the adult Internal Medicine sickle cell care clinic at VCU.

Exclusion Criteria:

* Those who have received organ, stem cell, or bone marrow transplantation. - Those who require chronic dialysis

Primary outcomes:
measure: Percentage of participants in the sample with hyperuricemia
timeFrame: Baseline
measure: Incidence rate of hyperuricemia per year
timeFrame: Baseline to year 5
measure: The mean rate of change of estimated glomerular filtration rate (eGFR) per year in those with hyperuricemia and those with normouricemia
timeFrame: Baseline to year 5
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Cristin Kaspar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03951688: Multi-modal Exercise Program in Older Adults
Official title: Effects of a Multi-modal Exercise Program in Community-dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community-dwelling Older Adults
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 110
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Aim: To evaluate the short-term effects of a multi-modal exercise program on physical performance variables in older adults.

Detailed description: * Aim: To evaluate the short-term effects of a 16 weeks home-based multi-modal exercise program on physical performance variables in community-dwelling older adults.
* Design: randomized controlled trial.
* Setting: home-based intervention.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 65 years
* Community-dwelling

Exclusion Criteria:

* Unable to ambulate independently
* Mini-mental state examination score \< 24
* Barthel Index score \< 80
* Unstable cardiovascular disease
* Neurological disorder that could compromise exercising
* Upper or lower-extremity fracture in the past year

Primary outcomes:
measure: Timed 'Up-and-Go' test (TUG)
timeFrame: 16 weeks
Secondary outcomes:
measure: Repeated chair stand test (STS-5)
timeFrame: 16 weeks
measure: One-Leg Stand test (OLS)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Moncada
country: Spain
facility: Universidad CEU Cardenal Herrera
state: Valencia
Study officials:
affiliation: Cardenal Herrera University
name: JF Lisón, PhD
role: PRINCIPAL_INVESTIGATOR
References: