louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03222427: A Study of LY3314814 in Healthy Participants
Official title: An Absolute Bioavailability Study of LY3314814 in Healthy Subjects Using an Intravenous Tracer Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2017-07-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to measure how much LY3314814 gets into the bloodstream when it is given as a single dose by mouth and as an intravenous (IV) infusion over two hours. The study will last at least two weeks for each participant, not including screening.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy males or females
* Have venous access sufficient to allow for blood sampling and intravenous (IV) administration of the investigational product

Exclusion Criteria:

* Have a history of significant ophthalmic disease
* Have vitiligo or any other clinically significant disorder of skin pigmentation
* Have a history of use of antipsychotic drugs, or chronic use of antidepressant or anxiolytic drugs, prescribed as well as non-prescribed

Primary outcomes:
measure: Absolute Bioavailability of LY3314814
timeFrame: Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose
Secondary outcomes:
measure: Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814
timeFrame: Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
state: West Yorkshire
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02998827: Thalidomide Results in Diminished Ovarian Reserve in Reproductive Age Female IBD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn Disease
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 90
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The effectiveness of thalidomide in treating inflammatory bowel disease has been widely recognized. Meanwhile, many serious adverse drug reactions were notified， but no reports on ovarian reserve function.Therefore, this study was to investigate the influence of thalidomide on function of ovarian reserve.

Detailed description: It will be divided two groups of patients according to the treatment itself . One group was treated by thalidomide, the other was other treatment excluding. It will detect the function of ovarian reserve before and after treatment in both two groups, to investigate the influence of thalidomide on function of ovarian reserve.

Eligibility criteria: Inclusion Criteria:

* Age 18-50 years old Diagnosis of patients with CD

Exclusion Criteria:

* Pregnancy or lactation Period of women have fertility program during the study Treatment not foot eight weeks after last IFX Central or peripheral nerve disease Abnormal in liver and renal function Heart function failure Malignant tumor Active tuberculosis

Primary outcomes:
measure: difference AMH between thalidomide group and other treatment group
timeFrame: 1 year
measure: difference AFC between thalidomide group and other treatment group
timeFrame: 1 year
measure: difference E2 between thalidomide group and other treatment group
timeFrame: 1 year
measure: difference FSH between thalidomide group and other treatment group
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04353427: Improving Physical, Mental, and Spiritual Health in Faith-Based Settings Through Creating a Healthy Culture in Bronx, NY
Official title: Improving Physical, Mental, and Spiritual Health in Faith-Based Settings Through Creating a Healthy Culture in Bronx, NY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The proposed study "Improving Physical, Mental, and Spiritual Health in Faith- Based Settings through Creating a Healthy Culture in Bronx, NY" aims to assess the efficacy of a holistic health intervention that seeks to integrate physical, mental, spiritual, and community engagement processes into faith-based settings, compared to usual care in Bronx, NY. Briefly, the intervention involves a seven-session faith-based small group education program conducted by trained lay educators. A health ministry at each partner religious institution will be developed and sustained

Detailed description: The purpose of this research study is test a holistic health intervention that combines physical, mental, spiritual, and community processes into faith-based settings in Bronx, NY. The program involves a seven-session faith-based small group education sessions to be conducted by lay educators.

Eligibility criteria: Intervention study participants

Inclusion Criteria:

* Age 18 and over
* Self-identify as a member of the religious institution for at least three months
* Able to read and speak in English, Vietnamese, or Khmer

Exclusion Criteria:

* Any serious health issue that may interfere with the study procedures

Key informants participants

Inclusion Criteria:

* Age 18 and over
* Must be a study implementation partner, a health ministry member, or lay educator

Exclusion Criteria:

* None

Focus group participants

Inclusion Criteria:

* Must be a participant in the intervention
* Attended at least 3 out of the 7 group education sessions as an intervention participant;

Exclusion Criteria:

* None

Primary outcomes:
measure: Changes in sociodemographic characteristics of participants
timeFrame: baseline and 6 months visit
Secondary outcomes:
measure: Facilitators and Barriers in intervention process by Focus Group participants
timeFrame: 6 months
measure: Facilitators and Barriers in intervention process by Key informants
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone
state: New York
Study officials:
affiliation: NYU Langone Health
name: Sahnah Lim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05195827: Effect of PRM-125 on Ambulatory Blood Pressure
Official title: Evaluation of Once-Daily PRM125 On Ambulatory Blood Pressure in Adults With Hypertension
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: PRM Pharma, LLC
Sponsor class: INDUSTRY
First posted: 2022-01-19
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of Once-Daily PRM125 On Ambulatory Blood Pressure in Adults with Hypertension

Detailed description: Approximately 60 subjects with primary hypertension are treated for 8 weeks with PRM125 to determine if Ambulatory Blood Pressure is changed.

Eligibility criteria: Inclusion Criteria:

* primary hypertension

Exclusion Criteria:

* medical conditions that preclude evaluation and/or adversely effect subject safety

Primary outcomes:
measure: Change in 24 hour Systolic Blood Pressure
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in 24 hour Diastolic Blood Pressure
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: AMR
state: Florida
Study officials:
References:
Clinical trial NCT03313427: Early Physical Therapy Intervention in Preterm Infants
Official title: Early Physical Therapy Intervention in Preterm Infants During the Stay in the Neonatal Intensive Care Unit and at Home to Promote Motor Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infant
Physical Therapy
Early Intervention
NICU
Home
Motor Development
Lead sponsor: University of Vic - Central University of Catalonia
Sponsor class: OTHER
Collaborators: name: Hospital Sant Joan de Deu
First posted: 2017-10-18
Enrollment: 48
Sex: ALL
Minimum age (years): 28
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The hypothesis of this study is that early physical therapy intervention, initiated during the NICU stay and up to 2 months corrected age, based on the family-centered model, could promote preterm infants motor development in short-term (2 months corrected age) and long-term (8 months corrected age).

There is a high evidence level of different systematic reviews, which support the effectivity of early intervention with preterm infants.

The principal aim of this randomized controlled trial is to evaluate the effectiveness of early physiotherapy intervention to promote motor development in preterm infants at 2 and 8 months corrected age.

The secondary purpose is to study the motor development of those preterm infants who received early physical therapy intervention.


Eligibility criteria: Inclusion Criteria:

* Preterm infants, gestational age between 28-34 weeks
* Families with ability to take care of the child, without chronic or mental illness
* Long-term parental presence in the hospital (at least 10h/day)

Exclusion Criteria:

* Children diagnosed with congenital disease or brain injury (LPV, HIV), before or during the study
* Children undergoing major surgery (cardiac intervention, Ductus, thoracic intervention)
* Children with musculoskeletal deformities

Primary outcomes:
measure: Motor development.
timeFrame: 2 months corrected age and 8 months corrected age
Secondary outcomes:
measure: Movement quality.
timeFrame: 40 weeks postmenstrual age and 2 months corrected age
measure: Gross motor and fine motor function.
timeFrame: 8 months corrected age
measure: Development and risk of development delay.
timeFrame: 1 months corrected age and 8 months corrected age
measure: Mothers' stress index.
timeFrame: after the intervention, 3 months corrected age
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Deu
Study officials:
References:
citation: Ochandorena-Acha M, Terradas-Monllor M, Lopez Sala L, Cazorla Sanchez ME, Fornaguera Marti M, Munoz Perez I, Agut-Quijano T, Iriondo M, Casas-Baroy JC. Early Physiotherapy Intervention Program for Preterm Infants and Parents: A Randomized, Single-Blind Clinical Trial. Children (Basel). 2022 Jun 15;9(6):895. doi: 10.3390/children9060895.
Clinical trial NCT00869427: Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured
Official title: Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Urinary Tract Infection
Spinal Cord Injury
Keywords: UVI
Spinal cord injury
Prevention
Vitamin C
Lead sponsor: Sunnaas Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Dentsply Sirona Implants and Consumables
First posted: 2009-03-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: After spinal cord injury, patients have frequent urinary tract infections (UVI). Vitamin C is usually prescribed to prevent such infection, but the efficacy of the treatment is poorly documented. In the study, patients will be randomised either to receive vitamin C daily, or not, for one year, and clinical episodes of UVI will be registered. The null hypothesis is that vitamin C will not reduce the number of UVI episodes by 30%.

Detailed description: The study is an investigator-blind randomised parallel study on the efficacy of vitamin C to prevent urinary tract infections in stable, ambulatory spinal cord-injured patients. To be included, patients should have had at least 3 previous UVI episodes over the last two years. 40 patients are included. Patients are randomised to receive either 1 g vitamin C b.i.d. over 1 year, or no vitamin C. The main outcome is the number of clinical UVIs that have been treated with antibiotics.

Eligibility criteria: Inclusion Criteria:

* spinal cord injury
* 3 or more episodes of UVI over previous 2 years

Exclusion Criteria:

* pregnancy
* age \<18
* continuous use of antibiotics, hippuric acid or crane berry juice

Primary outcomes:
measure: Clinical episodes of UVI treated by antibiotics
timeFrame: one year
Secondary outcomes:
measure: Silent bacteriuria
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Sunnaas Rehabilitation Hospital
name: Nils Hjeltnes, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05461027: Percutaneous Cryoablation of Central Kidney Tumours With Temporary Renal Artery Occlusion
Official title: Percutaneous Cryoablation of Central Kidney Tumours With Temporary Renal Artery Occlusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Cancer
Keywords: Kidney Cancer
Central Kidney Tumours
Renal Artery Occlusion
cryoablation
Urological surgery
T1a tumours
Cold sink effect
Endovascular balloon clamping
Renal hilum
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subject (≥18 years) who has undergone cryoablation of a central kidney tumour with temporary occlusion of the renal artery by an endovascular balloon at the HUS during the period 01/01/2018 to 30/12/2021

Brief summary: Percutaneous cryoablation is an alternative to urological surgery for T1a tumours, whose oncological efficacy decreases for the most central tumours due to a cold sink effect.


Eligibility criteria: Inclusion criteria:

* Adult subject (≥18 years)
* Subject who has undergone cryoablation of a central kidney tumour with temporary occlusion of the renal artery by an endovascular balloon at the HUS during the period 01/01/2018 to 30/12/2021
* Subject who has not expressed his/her opposition, after information, to the re-use of his/her data for the purpose of this research.

Exclusion criteria :

* Subject having expressed his/her opposition to participate in the study
* Subject under legal protection, guardianship or curatorship

Primary outcomes:
measure: Description of the technique of percutaneous cryoablation of central renal tumours with temporary balloon obliteration of the renal artery
timeFrame: Files analysed retrospectively from January 01, 2018 to December 31, 2021 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Imagerie Interventionnelle - CHU de Strasbourg - France
Study officials:
affiliation: Service d'Imagerie Interventionnelle - CHU de Strasbourg - France
name: Pierre-Alexis AUTRUSSEAU, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04635527: A Study on the Safety and Effectiveness of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma
Official title: A Phase Ib Study to Evaluate the Safety and Efficacy of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this phase Ib study is to assess the safety, tolerability and effectiveness of IBI318 in combination with conventional TACE (cTACE) in patients with potentially resected hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

1. Aged ≥ 18 years and ≤ 75 years at the time of consent.
2. Hepatocellular carcinoma confirmed by histology/cytology.
3. Lesions with measurable disease at baseline by mRECIST.
4. Barcelona Clinic Liver Cancer stage A or B for hepatocellular carcinoma exceeding Milan criteria.
5. Child-Pugh: \<=6
6. Adequate organ and bone marrow function.

Exclusion Criteria:

1. With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
2. Having previously received standard systemic therapy, ablative therapy, interventional therapy and surgical treatment for hepatocellular carcinoma.
3. Potential liver transplant candidates
4. Have a history of hepatic encephalopathy or have a history of liver transplantation.
5. With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.

Primary outcomes:
measure: Number of participants experiencing clinical and laboratory adverse events (AEs)
timeFrame: Up to 90 days post last dose
Secondary outcomes:
measure: The percentage of subjects with pathological Complete Response (pCR) after liver resection
timeFrame: 3 years
measure: The percentage of subjects with major pathological response (MPR) after liver resection
timeFrame: 3 years
measure: The percentage of subjects with R0 resection
timeFrame: 3 years
measure: Objective response rate (ORR) in two arms based on mRECIST by investigator
timeFrame: 3 years
measure: Disease-free survival (DFS) in two arms based on mRECIST by investigator
timeFrame: 3 years
measure: Overall survival (OS) in two arms
timeFrame: 3 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT01021527: A Study to Assess the Effects of Exenatide on Insulin Secretion Rates Using a Graded Infusion of Intravenous Glucose (0000-099)(COMPLETED)
Official title: A Randomized, 4-Period Study to Assess the Effects of Exenatide on Insulin Secretion Rates Using a Graded Infusion of Intravenous Glucose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-11-30
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A four-period study to evaluate if the grade glucose infusion procedure will be able to detect an increase in beta-cell glucose sensitivity from exenatide compared to no treatment in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Subject is in good health
* Subject is a non-smoker

Exclusion Criteria:

* Subject has irritable bowel disease
* Subject has a history of cancer
* Subject has a history of hypertension requiring treatment
* Subject is unable to refrain from the use of any prescription or non-prescription medication
* Subject consumes excessive amounts of alcohol or caffeine
* Subject has had major surgery, donated blood or participated in another investigational study in the past 4 weeks

Primary outcomes:
measure: beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose)
timeFrame: 0-160 minutes after start of infusion
Secondary outcomes:
measure: safety and tolerability of a graded glucose infusion procedure measured by the number of clinical adverse experiences
timeFrame: 11 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01642927: Pulse Wave Analysis in Advanced Heart Failure
Official title: Pulse Wave Analysis in Advanced Heart Failure Patients Before and After Ventricular Assist Device
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Left Ventricular Assist Device
Heart Failure
Intra-aortic Balloon Pump
LVAD Clot
LVAD-related GI Bleed
Keywords: LVAD
IABP
Heart Failure
Thrombosis
Hemorrhage
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2012-07-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced heart failure patients, eligible for or currently treated with LVAD, outpatient cardiology clinic or inpatient heart failure service patients

Brief summary: A comparison of pulse wave characteristics, as measured by peripheral tonometry, in pre and post Left Ventricular Assist Device (LVAD) patients.

Detailed description: Pulse waveforms, especially central pressure waveforms, are predictive of cardiovascular events. Peripheral waveforms have been correlated to central waveforms. Peripheral waveforms can be easily measured through applanation tonometry. In this study the investigators hypothesize:

1. That previously established peripheral tonometry techniques would apply to patients with advanced heart failure, including continuous flow LVADs and facilitate serial evaluation of central hemodynamics without invasive monitoring.
2. That temporary changes in LVAD speed will be evident in frequency spectrum analysis of peripheral, non-invasive waveforms.
3. That clinical events involving LVAD will have characteristic frequency spectra.

Eligibility criteria: Inclusion Criteria:

1)18 years of age or older

2)Advanced heart failure as defined by need for IABP or LVAD

3)One or more of the following:

* Current inpatient heart failure treatment with intra-aortic balloon pump (IABP)-IABP Group

  •≤ 1 week post-LVAD implantation with current IABP support-IABP/LVAD Group

  •≥ 3 mo post-LVAD placement and scheduled for LVAD speed optimization with echocardiography.-Post-LVAD Group
* Post-LVAD placement with suspected GI hemorrhage or LVAD thrombosis-LVAD Event Group

  4)Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Exclusion Criteria:

1. Clinical status will not permit pause of IABP (IABP and IABP/LVAD Groups)
2. Unable to undergo echo or oversewn or patched aortic valve (Post-LVAD Group)

Primary outcomes:
measure: Observation of pulse wave signatures in LVAD patients
timeFrame: ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Univeristy of Minnesota Lillehei Heart Institute
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Peter Eckman, MD
role: PRINCIPAL_INVESTIGATOR
References: