louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00634621: Effectiveness of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer
Official title: A Post-authorization, Observational Study to Assess the Impact of Blue Light Cystoscopy After Administration of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Keywords: Bladder
Cancer
Cystoscopy
Hexaminolevulinate
Hexvix
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2008-03-13
Enrollment: 283
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with documented or suspected bladder cancer.

Brief summary: The purpose of this study is to determine the effectiveness of hexaminolevulinate (Hexvix) in the diagnosis and treatment of patients with non-invasive bladder cancer and if it results in a change in patient management.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age.
* Patients of either sex.
* Patients with documented or highly suspected non-invasive bladder cancer.

Exclusion Criteria:

* Patients with hypersensitivity to the drug substance or any excipient of Hexvix.
* Patients with porphyry.
* Women of childbearing age.
* Patients at a high risk of suffering extensive bladder inflammation e.g. patients after intravesical BCG treatment, patients with moderate or severe leukocyturia or patients undergoing recent bladder surgery.

Primary outcomes:
measure: Detecting the Rate of Bladder Cancer Lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) With Hexvix® in the Overall Study Population by Comparison With the Diagnostic Gold Standard, i.e. Histological Examination of Lesions Biopsy.
timeFrame: Day 0 (Post contrast administration)
Secondary outcomes:
measure: Assess the Sensitivity of Standard White Light Cystoscopy (WLC) and Blue Light Cystoscopy (BLC) for Obtaining a Correct Diagnosis of Bladder Cancer at Individual Patient Level.
timeFrame: Day 0 (Post contrast administration)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: GE Healthcare
Study officials:
affiliation: Gregorio Marañón Hospital, Madrid
name: Dr. Carlos Hernández
role: PRINCIPAL_INVESTIGATOR
affiliation: Valencian Institute of Oncology, Valencia
name: Dr. Eduardo Solsona
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundación Puigvert, Barcelona
name: Dr. Joan Palou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00614484: Chemotherapy and Proton Radiation for the Treatment of Locally Advanced Lung Cancer
Official title: Phase I/II Study of Combined Chemotherapy and High Dose, Accelerated Proton Radiation for the Treatment of Locally Advanced Non-Small Cell Lung Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Locally Advanced Non-Small Cell Lung Cancer
Keywords: Proton
Radiation
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 28
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: The purpose of this study is to determine the effectiveness of proton beam radiotherapy combined with chemotherapy for treatment of locally advanced non-small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* Clinical stage 2, 3A or 3B (unresectable)
* Histologic evidence of non-small cell carcinoma
* Age \> 18 years
* Karnofsky performance status 70 or greater
* No prior radiation to the chest
* No previous chemotherapy

Exclusion Criteria:

* Clinical stage 1 or 4
* Previous malignancies except for non-melanoma skin cancer unless disease free for \> 3 years

Primary outcomes:
measure: Overall Survival.
timeFrame: Monthly for duration of participant lifespan. Average lifespan 1-2 years
Secondary outcomes:
measure: Treatment Related Toxicities.
timeFrame: Monthly for duration of participant lifespan. Average lifespan 1-2 years
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
affiliation: Loma Linda University Department of Radiation Medicine
name: David A. Bush, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Loma Linda University Department of Radiation Medicine
name: Jerry D. Slater, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05381402: Impact of COVID 19 on Psoriasis Patients
Official title: COVID 19 Impact on Psoriasis Patients, a Hospital Based Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: The Impact of COVID19 on Psoriasis Patients
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Psoriasis patients

Brief summary: The main objective of this work is to investigate the effect of COVID-19 pandemic on psoriasis patients.

This work is designed as a cross-sectional survey based on a questionnaire directed to Egyptian psoriasis patients.


Eligibility criteria: Inclusion Criteria:

* Psoriaisis patients

Exclusion Criteria:

* Children

Primary outcomes:
measure: Questionnaire
timeFrame: 2-4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01855984: Tocotrienols for School-going Children With ADHD
Official title: Tocotrienols Supplementation in School Going Children With Attention Deficit/Hyperactivity Disorder(ADHD) - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: ADHD
Children
Tocotrienol
Lead sponsor: RCSI & UCD Malaysia Campus
Sponsor class: OTHER
Collaborators: name: Penang Hospital, Malaysia
First posted: 2013-05-17
Enrollment: 160
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: The purpose of this study is to determine if tocotrienol supplementation given to school going children with ADHD will result in reduction of their ADHD symptoms.

Detailed description: The main objective of the study is to:

a. Determine if supplementation of tocotrienol compared to placebo has an effect on the symptoms of school going children with ADHD.

The secondary objective is to:

1. Determine if supplementation of tocotrienol compared to placebo has an effect on the dose of current medication used in school going children with ADHD.
2. Determine the safety of tocotrienol in the study population.
3. Determine if tocotrienol levels in children with ADHD correlate with their symptom scores.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with ADHD in accordance with the Diagnostic and Statistical Manual (DSM) IV criteria.
* Be able to swallow soft gel capsules.
* If already on medication for ADHD, the dose of the medication must be stable for the last 3months
* Be able to attend all follow up visits.
* Be agreeable to have their teacher score the National Initiative for Children's Healthcare Quality (NICHQ) Vanderbilt Assessment Scale - Teacher Informant
* Be willing to have their blood taken 3 times during the study.

Exclusion Criteria:

* ADHD caused by syndromes, inborn errors of metabolism, or structural brain lesions.
* Co-existing chronic liver disease
* Current use of anticoagulant or antiplatelet drugs.

Primary outcomes:
measure: ADHD symptom scores as measured by NICHQ Vanderbilt Parent and Teacher Assessment Scales
timeFrame: Change of total symptom scores from baseline at 6 months
Secondary outcomes:
measure: Change in the dose of current medication for ADHD
timeFrame: After 6 months intervention
measure: Number of participants with adverse reaction
timeFrame: 6 months
measure: Blood tocotrienol levels
timeFrame: 6 months
Other outcomes:
Locations:
city: Georgetown
country: Malaysia
facility: Child & Adolescent Psychiatry Unit, Hospital Pulau Pinang
state: Penang
Study officials:
affiliation: RCSI & UCD Malaysia Campus
name: May Loong Tan, MRCPCH(UK)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03956602: Effects of Snack Types on Acute Glucose and Insulin Response
Official title: Effects of Snack Types on Acute Glucose and Insulin Response
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Satiety
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of the present study was to determine the effects of different type of snack consumption on postprandial satiety, glucose, insulin, antioxidant capacity and anxiety in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* 18-55 years old

Exclusion Criteria:

* Smoker
* Pregnant woman
* Required dietary supplement use
* Required medication of metabolic disorders
* Allergy to nuts or gluten (wheat)

Primary outcomes:
measure: Change of Satiety
timeFrame: 0, 20, 40, 60, 90 and 120 minutes post snack consumption
measure: Change of glucose level
timeFrame: 0 and 40 minutes post snack consumption
measure: Change of insulin level
timeFrame: 0 and 40 minutes post snack consumption
measure: Change of anxiety feeling
timeFrame: 0 and 40 minutes post snack consumption
measure: Change of antioxidant level
timeFrame: 0 and 40 minutes post snack consumption
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: School of Exercise and Nutritional Sciences, SDSU
state: California
Study officials:
References:
Clinical trial NCT06847802: Delphi Process to Achieve Global Consensus on Gender Equity in Critical Care
Official title: Delphi Process to Achieve Global Consensus on Gender Equity in Critical Care
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Professional Role
Research Peer Review
Lead sponsor: Tata Memorial Centre
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers working in Intensive Care, Critical Care Practitioner, Scientists, or Researcher

Brief summary: Gender inequalities in healthcare, including among critical care professionals, have been widely recognized over the last decade. Significant gender disparities persist in areas including leadership, academia, research, workplace remuneration, and medical publication among critical care professionals. Furthermore, there remains a notable gap in knowledge and awareness regarding gender equity (all genders) and inclusivity among healthcare professionals.

Given the limited research and evidence on these issues, Investigator propose employing the Delphi methodology to generate consensus among global critical care practitioners on position statements aimed at addressing gender equity (all genders) in critical care.

Detailed description: To generate consensus among a diverse panel of critical care practitioners, scientists, and researchers on the strategic measures to achieve gender equity in critical care within healthcare institutions, professional societies, organizations, and boards in various professional domains.

Eligibility criteria: Inclusion Criteria:

* Professionals working in Intensive Care, Critical Care Practitioner, Scientists, or Researcher
* Any one of the following: having publications, engagement in advocacy related to gender equity, and currently or in the past holding an official leadership position in the Critical Care Society, Intensive care unit, or a healthcare institution
* Completed the Harvard Implicit Association Test (IAT)5

Exclusion Criteria:

* unwilling to participate

Primary outcomes:
measure: Gender equity among a diverse panel of critical care practitioners, scientists, and researchers in critical care
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00000102: Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Congenital Adrenal Hyperplasia
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 1999-11-04
Sex: ALL
Minimum age (years): 14
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the ability of extended release nifedipine (Procardia XL), a blood pressure medication, to permit a decrease in the dose of glucocorticoid medication children take to treat congenital adrenal hyperplasia (CAH).

Detailed description: This protocol is designed to assess both acute and chronic effects of the calcium channel antagonist, nifedipine, on the hypothalamic-pituitary-adrenal axis in patients with congenital adrenal hyperplasia. The multicenter trial is composed of two phases and will involve a double-blind, placebo-controlled parallel design. The goal of Phase I is to examine the ability of nifedipine vs. placebo to decrease adrenocorticotropic hormone (ACTH) levels, as well as to begin to assess the dose-dependency of nifedipine effects. The goal of Phase II is to evaluate the long-term effects of nifedipine; that is, can attenuation of ACTH release by nifedipine permit a decrease in the dosage of glucocorticoid needed to suppress the HPA axis? Such a decrease would, in turn, reduce the deleterious effects of glucocorticoid treatment in CAH.

Eligibility criteria: Inclusion Criteria:

* diagnosed with Congenital Adrenal Hyperplasia (CAH)
* normal ECG during baseline evaluation

Exclusion Criteria:

* history of liver disease, or elevated liver function tests
* history of cardiovascular disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT00856102: Exercise and Cognitive-psychosocial Functions in Men With Prostate Cancer Receiving Androgen Depletion Therapy
Official title: Efficacy of Exercise in Promotion Cognitive-psychosocial Functions in Men With Prostate Cancer Receiving Androgen Depletion Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Health Sciences Centre Foundation, Manitoba
First posted: 2009-03-05
Enrollment: 30
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the proposed research is to determine the efficacy of a home-based walking exercise program in promoting cognitive-psychosocial functions of men with prostate cancer receiving androgen depletion therapy (ADT). ADT is the mainstay treatment for men with advanced prostate cancer. However, ADT has a number of side effects including compromised cognitive function, depression and anxiety, which negatively impacts the quality of life of men with prostate cancer. The central question of the proposed research is to determine if exercise will have a positive impact on the quality of life of men with prostate cancer undergoing ADT.

Hypothesis:


Eligibility criteria: Inclusion Criteria:

* men aged 50 or older
* diagnosed with adenocarcinoma prostate cancer
* will initiate and receive continuous ADT (LHRH or combination of LHRH and anti-androgen for at least 6 months

Exclusion Criteria:

* severe cardiac disease (New York Heart Association class III or greater)
* angina
* severe osteoporosis
* uncontrolled hypertension
* orthostastic blood pressure drop \> 20mm Hg
* moderate to severe aortic stenosis
* acute illness or fever
* uncontrolled atrial or ventricular dysrhythmias
* uncontrolled sinus tachycardia (\> 120 beats per minute)
* uncontrolled congestive heart failure
* third-degree atrio-ventricular heart block
* active pericarditis or myocarditis
* recent embolism, thrombophlebitis
* deep vein thrombosis, resting ST displacement
* uncontrolled diabetes
* uncontrolled pain
* cognitive impairment
* history of falls due to balance impairment or lost of consciousness
* severe neuromusculoskeletal conditions that limit their ability to perform walking exercise

Primary outcomes:
measure: Cognitive-psychosocial functions
timeFrame: 3 and 6 months
Secondary outcomes:
measure: health-related quality of life
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
References:
citation: Lee CE, Kilgour A, Lau YK. Efficacy of walking exercise in promoting cognitive-psychosocial functions in men with prostate cancer receiving androgen deprivation therapy. BMC Cancer. 2012 Jul 30;12:324. doi: 10.1186/1471-2407-12-324.
Clinical trial NCT01220102: Efficacy of Epiduo and Treatment Adherence of Adolescent Patients With Inflammatory Acne
Official title: Efficacy of Epiduo and Adherence of Patients Between 12 to 20 Years Using This Drug First Time in the Monotherapy of Moderate Inflammatory Acne
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acne
Keywords: acne
Epiduo
adapalene/ benzoyl peroxide
Lead sponsor: Galderma Laboratorium GmbH
Sponsor class: INDUSTRY
First posted: 2010-10-13
Enrollment: 3113
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: About 2.700 patients with moderate inflammatory acne, aged 12 to 20 will be selected from about 324 dermatology practices

Brief summary: The purpose of this observational study is to assess the efficacy of Epiduo and patient adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years) with moderate inflammatory acne using this drug first time in topical monotherapy.

Detailed description: The objective of this observational study is to assess the efficacy of Epiduo and patient adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years) with moderate inflammatory acne using this drug first time in topical monotherapy. This non-interventional trial will include a larger population of teenaged acne patients in order to establish the practical contribution of a new mini-questionnaire to the evaluation of adherence for the physician in the daily clinical practice in general and in young adults topically treated with Epiduo in particular. In addition safety and local tolerability profile of Epiduo are to be assessed under marketed conditions.

Eligibility criteria: Inclusion Criteria:

* The patient has been diagnosed with moderate inflammatory acne
* Topical monotherapy of acne with Epiduo is indicated, the decision about treating the patient with Epiduo has been made independently from this study
* The patient is aged between 12 and 20 years

Exclusion Criteria:

* Pregnancy or breastfeeding
* Hypersensitivity to the medication or any of the ingredients
* Other contraindications mentioned in the Epiduo SPC

Primary outcomes:
measure: Severity of acne
timeFrame: at baseline and after 12 weeks of treatment
Secondary outcomes:
measure: local skin irritations
timeFrame: over 12 weeks
measure: treatment adherence
timeFrame: at final examination after 12 weeks of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Universitätsklinikum Magdeburg A.ö.R Klinik für Dermatologie und Venerologie
name: Harald PM Gollnick, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02405702: Importance of Patient Selection for Treatment of Infected Total Knee Prosthesis
Official title: Does the Selection of Patients Helps Healing the Infection After Change in One Step of a Knee Replacement?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Infection
Keywords: Infection
Knee
knee replacement
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-04-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years having surgery for the management of knee infection after change in one step of a knee replacement prothesis in the participating services between 2000 and 2010.

Brief summary: The infection of a total knee replacement often imposes changing implants. The change in two step is currently considered the gold standard. The change in one step is a much debated attitude: strictly contra-indicated for some professionals, but others agree to reserve these for favorable suspected cases selected. Several criteria have been proposed in the literature: age, condition, duration of infection, known bacterium responsible, not virulent and sensitive to antibiotics, no fistula, no significant bone destruction. But these criteria are poorly validated, standing over an experience of surgical teams rather than high-level scientific studies. Some authors have proposed to achieve change in one step systematically. The results of these cohorts on healing the infection does not seem very different from the changes in two steps. But it is most often single-center series, uncontrolled, with small numbers.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years
* Patient having surgery for the management of knee infection after change in one step of a knee replacement prothesis in the participating services between 2000 and 2010.

Exclusion Criteria:

* Patients under 18 years

Primary outcomes:
measure: Recovery from the infection measured visually
timeFrame: for the duration of hospital stay, up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Jean-Yves JENNY, MD
role: PRINCIPAL_INVESTIGATOR
References: