louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02293629: A Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Target Engagement of BMS-986147 in Healthy Subjects
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Target Engagement of BMS-986147 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Subjects
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-11-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This is the first clinical study with the BMS-986147 compound in healthy subjects. The purpose of this study is to guide the dose range and dose frequency for future studies with BMS-986147 and will provide guidelines for selection of a potentially effective dose in patients.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy men and women, ages 18 to 45 years
* Subjects must not have clinically significant deviation from normal: medical history, physical examination, ECGs and laboratory evaluations
* Women of child bearing potential are eligible for enrollment.
* Women must have a negative pregnancy test

Exclusion Criteria:

* Evidence of organ dysfunction
* Any significant acute or chronic medical illness
* Inability to: tolerate oral medications, be venipunctured

Primary outcomes:
measure: Safety and tolerability of single oral dose of BMS-986147 based on incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, and physical examinations
timeFrame: Up to 30 days post last dose of study drug
measure: Safety and tolerability of multiple oral dose of BMS-986147 based on incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, and physical examinations
timeFrame: Up to 30 days post last dose of study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Wcct Global, Llc
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00017329: PS-341 in Treating Patients With Metastatic Kidney Cancer
Official title: Phase II Trial of PS341 (NSC 681239) in Patients With Advanced Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Cancer
Keywords: stage IV renal cell cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic kidney cancer.

Detailed description: OBJECTIVES:

* Determine the efficacy of PS-341 in patients with metastatic renal cell carcinoma.
* Determine the safety of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive PS-341 IV over 3-5 seconds twice weekly for 2 weeks. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-19 months.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed renal cell carcinoma

  * Metastatic disease
* Unidimensionally measurable disease
* No brain metastases

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* Karnofsky 70-100%

Life expectancy:

* More than 3 months

Hematopoietic:

* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 mg/dL
* ALT/AST no greater than 2.5 times upper limit of normal (ULN)

Renal:

* Creatinine no greater than 1.5 times ULN

Other:

* No pre-existing neuropathy of grade 1 or greater
* No other malignancy within the past 5 years, except completely resected basal cell skin cancer, unless treated with potentially curative therapy or at low risk for recurrence
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 4 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior biologic therapy and recovered
* No concurrent biologic therapy

Chemotherapy:

* No prior cytotoxic therapy
* No concurrent cytotoxic therapy

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy

Surgery:

* At least 4 weeks since prior major surgery

Other:

* No other concurrent anticancer therapy

Primary outcomes:
Secondary outcomes:
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: Beverly Drucker, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02887729: Analysis of Clinical and Molecular Genetic Data Influencing the Evolution and Response to Therapy of ADPKD Patients (Autosomal Dominant Polycystic Kidney Disease)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autosomal Dominant Polycystic Kidney Disease
Keywords: Polycystic disease
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 4000
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: ADPKD patients followed in Nephrology centers in the West of France

Brief summary: Genkyst is a regional cohort involving up to nephrologists working in private and public nephrology centers in the West of France. It registers clinical and molecular genetic data of all consenting patients with ADPKD from this area.


Eligibility criteria: Inclusion Criteria:

* ADPKD patients followed in Nephrology centers in the West of France
* Age \>17

Exclusion Criteria:

* None

Primary outcomes:
measure: Clinical description of the patient
timeFrame: at the inclusion day
Secondary outcomes:
measure: Genetic analysis
timeFrame: at the inclusion day
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Brest
country: France
facility: AUB Brest
city: Brest
country: France
facility: CHU Brest
city: Brest
country: France
facility: Centre Nephrologie et Dialyse d Armorique
city: La Roche sur Yon
country: France
facility: CH La Roche Sur Yon
city: Le Mans
country: France
facility: ECHO dialyse
city: Le Mans
country: France
facility: CH Le Mans
city: Lorient
country: France
facility: AUB Lorient
city: Lorient
country: France
facility: CH Bretagne Sud
city: Morlaix
country: France
facility: AUB Morlaix
city: Nantes
country: France
facility: CHU Nantes
city: Niort
country: France
facility: CH Niort
city: Poitiers
country: France
facility: CHU Poitiers
city: Pontivy
country: France
facility: CH Centre Bretagne
city: Quimper
country: France
facility: AUB Quimper
city: Quimper
country: France
facility: CHI de Cournouaille
city: Rennes
country: France
facility: CHU Rennes
city: Reze
country: France
facility: ECHO Confluent
city: Roscoff
country: France
facility: Centre Heliomarin de Roscoff
city: Saint Brieuc
country: France
facility: CH Yves LE FOLL
city: Saint Herblain
country: France
facility: ECHO Centre Ambulatoire
city: Saint Malo
country: France
facility: CH Saint Malo
city: Saint Nazaire
country: France
facility: CH de Saint Nazaire
city: Tours
country: France
facility: CHU Tours
city: Vannes
country: France
facility: CH Bretagne Atlantique
city: Vannes
country: France
facility: ECHO Vannes
Study officials:
affiliation: University Hospital, Brest
name: Yannick Le Meur, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01277029: Study of Psychiatric Aspects in Women With Lower Urinary Tract Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychiatric Aspects in Women With Lower Urinary Tract Symptoms
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2011-01-14
Enrollment: 702
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with low urinary tract symptoms

Brief summary: To identify the differences in psychopathology, personality traits among different female LUTS subtypes.


Eligibility criteria: Inclusion Criteria:

* all cases with lower urinary tract symptoms

Exclusion Criteria:

* nil

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Far Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT06740929: Hormonal Management of Heavy Menstrual Bleeding in Adolescents
Official title: Hormonal Management of Heavy Menstrual Bleeding in Adolescents and Young Adults with and Without a Bleeding Disorder: a Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heavy Menstrual Bleeding
Bleeding Disorder
Keywords: heavy menstrual bleeding
bleeding disorder
adolescent
contraception
menstrual management
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 163
Sex: FEMALE
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents and young adults presenting to the gynecology consultation at HUG.

Brief summary: The goal of this study is to evaluate whether hormonal medications (such as contraceptive pill, patch, injectable progestins and hormonal intra-uterine device) have similar efficacy at managing heavy menstrual bleeding in adolescents with a bleeding disorder compared to those without. We also aim to assess the quality of life and hemoglobin and iron levels in this population.

Detailed description: Adolescents with heavy menstrual bleeding and willing to start a hormonal medication to reduce menstrual flow are included. At baseline and during the study period, questionnaires and blood tests are performed. Adolescents with a bleeding disorder are compared to those without. Follow-up is 1 year.

Eligibility criteria: Inclusion Criteria:

* Adolescents and young adults aged \< 26yo
* Presenting to the gynecology consultation at HUG
* Diagnosed with heavy menstrual bleeding (PBAC \> 100)
* Willing to initiate a hormonal medication to manage heavy menstrual bleeding

Exclusion Criteria:

* Pregnancy or planning to become pregnant during the study period
* Already using hormonal medication for menstrual management and/or contraception
* Known anatomical uterine pathology
* Using anticoagulant or antiaggregant agents

Primary outcomes:
measure: Percentage of reduction in menstrual blood loss
timeFrame: 6 months after hormonal medication initiation
Secondary outcomes:
measure: Percentage of reduction in menstrual blood loss
timeFrame: 3 months following hormonal medication initiation
measure: Percentage of reduction in menstrual blood loss
timeFrame: 12 months after hormonal medication initiation
measure: Quality of life
timeFrame: at baseline, 3 months, 6 months and 12 months
measure: Hemoglobin and ferritin levels changes
timeFrame: at baseline, 6 months and 12 months
measure: Changes in thrombin generation markers
timeFrame: at baseline and 6 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
References:
Clinical trial NCT05327829: Stimulating After Recovery From Traumatic Brain Injury
Official title: Stimulating After Recovery From Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: TBI (Traumatic Brain Injury)
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Uniformed Services University of the Health Sciences
First posted: 2022-04-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Block design
Primary purpose: OTHER

Brief summary: This is a preliminary, prospective interventional study to investigate the feasibility of using transcutaneous alternating current stimulation (TACS) after a traumatic brain injury (TBI) to improve cognitive function and decision-making.

Detailed description: All participants engaged in the study will participate once weekly for six weeks at Hennepin Healthcare Systems, Inc. (HHS). Each participant will be randomized into the block design of sham or tACS during the first three appointments or the last three appointments. While participating, both the tACS will be applied in accordance with the manufacturer's suggested use. Participants will complete computer-based tasks, while taking part in either the sham or tACS stimulation. The study is investigating the use of neuromodulation after Traumatic Brain Injury (TBI) for improved cognitive function.

Eligibility criteria: Inclusion Criteria:

* Adults 18 years and older
* Diagnosis of a mild to moderate TBI (GCS \> 8 on admission)
* Able to perform a computerized assessment
* Willing to attend all scheduled appointments
* Able to undergo the informed consent process

Healthy participants:

* Adults 18 years and older
* Able to perform a computerized assessment
* Willing to attend all scheduled appointments
* Able to undergo the informed consent process

Exclusion Criteria:

* Open wound on scalp
* Severe TBI diagnosis or GCS of less than 8 on admission
* Non-English speaking
* Incarcerated
* Implanted defibrillator or pacemaker
* Visual impairment that hinders ability to complete computerized assessments

Healthy subject exclusion criteria:

* Less than 18 years of age
* Open wound on scalp
* TBI diagnosis
* Non-English speaking
* Incarcerated
* Implanted defibrillator or pacemaker
* Visual impairment that hinders ability to complete computerized assessments

Primary outcomes:
measure: Feasibility of using non-invasive stimulation to improve Cognitive Flexibility after TBI
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: David Darrow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02118129: Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.
Official title: Knowledge, Attitudes, Intake and Blood Levels of Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: Vitamin D
Intervention
Behaviour
Mobile app
Lead sponsor: University of Guelph
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Vitamin D Society
First posted: 2014-04-21
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to examine whether a behavioural intervention changes attitudes, knowledge, intake or blood levels of vitamin D in young adults. The hypothesis is that an educational component and use of a mobile smartphone 'app' will increase knowledge and/or intake of vitamin D.


Eligibility criteria: Inclusion Criteria:

* Men or women aged 18-25 years
* Must be fluent in English
* Must be currently living in Canada
* Must own iPhone, iPad or iPod Touch running iOS 7.0 or higher (handheld 'app' used in intervention is only available in Apple Store; not available for Android or Blackberry platforms at this time)

Exclusion Criteria:

* Outside age group
* Not fluent in English
* Not living in Canada
* Does not own the specified Apple device

Primary outcomes:
measure: Vitamin D blood levels
timeFrame: 12 weeks
measure: Vitamin D Intake
timeFrame: 12 weeks
Secondary outcomes:
measure: Knowledge & attitudes regarding vitamin D
timeFrame: 12 weeks
Other outcomes:
measure: Vitamin D app recordings
timeFrame: 12 weeks
Locations:
city: Guelph
country: Canada
facility: University of Guelph
state: Ontario
Study officials:
affiliation: University of Guelph
name: Kelly A Meckling, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Guelph
name: Samantha E Goodman, MSc
role: STUDY_DIRECTOR
affiliation: University of Guelph
name: Barbara A Morrongiello, PhD
role: STUDY_DIRECTOR
References:
citation: Goodman S, Morrongiello B, Meckling K. A randomized, controlled trial evaluating the efficacy of an online intervention targeting vitamin D intake, knowledge and status among young adults. Int J Behav Nutr Phys Act. 2016 Nov 11;13(1):116. doi: 10.1186/s12966-016-0443-1.
Clinical trial NCT03038529: Variable Approaches of Intradiscal O3-O2 Injection
Official title: Variable Approaches of Intradiscal O3-O2 Injection for Management of Low Back Pain: Could it Make a Difference? a Prospective Double Blind Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain , Ozone
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cost Intradiscal injection of ozone-oxygen mixture (O3-O2) which offers a rapid onset amelioration of symptoms, with a sustained duration pain relief in low back pain.

Does change of injection approach make a difference?

Detailed description: Low back pain (LBP) mostly is induced by disc herniation (DH), or degeneration and has a burden upon social and economic aspects of life. Medical and or surgical interventions have been used to resolve this problem, but one of the newly introduced is the minimally invasive low cost Intradiscal injection of ozone-oxygen mixture (O3-O2) which offers a rapid onset amelioration of symptoms, with a sustained duration pain relief.

A lot of injection approaches are available, but which offers the best results, is the question.

Eligibility criteria: Inclusion Criteria:

* radicular leg pain
* low back pain
* non-responsive to conservative treatment

Exclusion Criteria:

* patient refusal
* infection at injection site
* coagulopathy
* uncontrolled or degenerative spine disease
* pregnancy
* multilevel disk involvement

Primary outcomes:
measure: Quality of pain alleviation (visual analog scale)
timeFrame: one year
Secondary outcomes:
measure: Analgesia reduction (percent)
timeFrame: one year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Emad Zarief Kamel Said
Study officials:
affiliation: Assiut University
name: Abdelraheem Alawaamy, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00273429: Cosopt Versus Xalatan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: Pharmaceutical Research Network
Sponsor class: OTHER
First posted: 2006-01-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the 24-hour efficacy and safety, measured every three hours, of the dorzolamide/timolol fixed combination given twice daily versus latanoprost and placebo each given once daily.


Eligibility criteria: Inclusion Criteria:

* adults with primary open-angle, pigmentary, or exfoliation glaucoma, or ocular hypertenstion
* intraocular pressure should be 22 to 30 mm Hg inclusive on timolol BID at the 08:00 H
* ETDRS visual acuity must be 1.0 or better in both eyes

Exclusion Criteria:

* any contraindications to study medications
* any anticipated change in systemic hypertensive therapy during the trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lakeland
country: United States
facility: Central Florida Eye Associates
state: Florida
city: Bourbonnais
country: United States
facility: Midwest Eye Center SC
state: Illinois
Study officials:
affiliation: Pharmaceutical Research Network, LLC
name: William C. Stewart, MD
role: STUDY_DIRECTOR
affiliation: Central Florida Eye Associates
name: Jay Mulaney, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Midwest Eye Center SC
name: Sriram Sonty, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00707629: Long Term Effects of Diabetes of Very Young Children
Official title: Long Term Effects of Diabetes of Very Young Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes
neurocognitive measures
behavioral measures
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2008-07-01
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children between ages 6 and 10. Diagnosed with type 1 diabetes prior to the age of 5 years.

Brief summary: To investigate neurocognitive and behavioral measures in 25 children aged 6-10 years diagnosed with diabetes for \> 5 years who have received long-term insulin pump therapy (\> 3 years) compared to a group of children matched for age, sex, glycemic control, and diabetes duration treated with insulin injections. Outcome measures will assess: clinical variables, cognitive status (intelligence, neuropsychological functioning), academic achievement, behavior, parenting stress, and quality of life.

It is hypothesized that long term insulin pump therapy initiated during early childhood can delay the progression of neurocognitive complications of diabetes, decrease parental stress, and improve school performance and quality of life, as compared to insulin injections.


Eligibility criteria: Inclusion Criteria:

* Subjects must have type 1 diabetes for at least 5 years, diagnosed prior to the age of 5 years
* Children recruited on pumps must have used pump therapy for at least 3 years
* Parents/guardians must be understand the protocol and be able to give consent, with assent obtained from all children over the age of 7 years.

Exclusion Criteria:

* Children will be excluded if they have additional medical problems requiring treatment with agents known to affect blood glucose such as steroids or L-asparaginase.
* Children must not have any other chronic illness in addition to diabetes with the exception of treated autoimmune hypothyroidism.

Primary outcomes:
measure: Diabetes Control
timeFrame: Data Collected at each study visit
measure: Ease of Injections versus Insulin pump Therapy
timeFrame: Conclusion of study
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
Study officials:
affiliation: Indiana University/Riley Hospital for Children
name: Linda A DiMeglio, MD
role: PRINCIPAL_INVESTIGATOR
References: