louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05463939: Teclistamab Expanded Access Treatment Protocol for Relapsed or Refractory Multiple Myeloma Patients
Official title: Teclistamab US Expanded Access Treatment Protocol for Patients With Relapsed or Refractory Multiple Myeloma
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Relapsed or Refractory Multiple Myeloma
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-07-19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this expanded access treatment protocol is to provide patients access to teclistamab prior to market authorization. The program is limited to patients with relapsed or refractory multiple myeloma who have exhausted all treatment options available as local standard of care and who are not eligible for a teclistamab clinical trial.


Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with Relapsed or Refractory Multiple Myeloma
* Patient exhausted all commercially approved and clinically appropriate (not patient or physician preference) treatment options, and is ineligible for a clinical trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT00478439: Investigation of Macular Pigment Augmentation on Dark Adaptation
Official title: Investigation of Macular Pigment Augmentation on Dark Adaptation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Aging
Age-Related Macular Degeneration
Keywords: aging
age-related macular degeneration
macular pigment
dark adaptation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: ZeaVision, Inc.
First posted: 2007-05-24
Enrollment: 13
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The study will evaluate whether taking a nutritional supplement designed to increase macular pigment in the eye can improve a person's ability to adjust to darkness. Patients will be assigned to take either a placebo or nutritional supplement for 8 months. Vision will be assessed at baseline, 4 months, and 8 months.

Detailed description: The study design is a randomized, double-blinded, placebo-controlled intervention study that will evaluate whether macular pigment augmentation improves the speed of dark adaptation. Two groups of participants will be enrolled, old adults with normal vision and early age-related macular degeneration patients. Macular pigment will be augmented using EyePromise RESTORE (ZeaVision, Inc). EyePromise RESTORE is a nutritional supplement that has been found to increase macular pigment levels in some users. Macular pigment level and the speed of dark adaptation (how fast a person adjusts to the dark) will be assessed at baseline, 4-months, and 8-months. Fundus appearance will be assessed at baseline and 8-months follow-up.

Eligibility criteria: Inclusion Criteria:

* 60 to 80 years old
* \< +- 4.00 diopters spherical equivalent
* normal eye health or early age-related macular degeneration

Exclusion Criteria:

* neurological conditions that can impair vision
* diabetes

Primary outcomes:
measure: Dark Adaptation
timeFrame: Measured 3 times over 8 months
Secondary outcomes:
measure: Macular Pigment Density
timeFrame: Measured 3 times over 8 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB School of Optometry
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Leo P Semes, O.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00851539: Evaluating Post-test HIV Counseling Videos for Teens
Official title: Educational Effectiveness of an HIV Pretest Video for Adolescents: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
HIV Infections
Keywords: HIV
Teenagers
Adolescent
HIV Testing
HIV Seronegativity
Lead sponsor: North Bronx Healthcare Network
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2009-02-26
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The design of this randomized controlled trial (RCT) is to test the effectiveness of a post-test behavioral video in educating adolescents about HIV transmission and affecting their intentions to engage in risk-reduction behavior.

Detailed description: Adolescents are at risk for HIV because of their engagement in high risk sexual activity. This study seeks to determine effective ways to educate teens about HIV and how to protect themselves by use of multimedia. All eligible participants who agree to enroll in this trial will be randomized into two arms: the behavioral intervention video (intervention group) or meeting with an in-person counselor (control group) as they wait for their rapid HIV results. The goals of the RCT involve establishing the feasibility of using touch-screen technology for teenagers in the ED; establishing the receptivity of teens to HIV rapid testing in the ED; providing data on rates, and obtaining preliminary data on the effectiveness of the video in changing condom efficacy, condom outcome expectancies and condom use intention. Consenting to rapid HIV testing is a secondary outcome.

Eligibility criteria: Inclusion Criteria:

1. Youth who have had vaginal, anal or oral sex
2. 15-21 years of age
3. English speaking

Exclusion Criteria:

1. Clinically unstable secondary to pain or unstable vitals signs
2. Unable to understand the consent process for the study
3. Known HIV status or recent HIV test
4. Language other than English

Primary outcomes:
measure: Intention to use condoms
timeFrame: 5 months
Secondary outcomes:
measure: Consent to rapid HIV testing
timeFrame: Immediate
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
Study officials:
affiliation: Jacobi Medical Center/ Albert Einstein Medical College
name: Yvette Calderon, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Calderon Y, Cowan E, Leu CS, Brusalis C, Rhee JY, Nickerson J, Leider J, Bauman LJ. A human immunodeficiency virus posttest video to increase condom use among adolescent emergency department patients. J Adolesc Health. 2013 Jul;53(1):79-84. doi: 10.1016/j.jadohealth.2013.01.028. Epub 2013 Apr 9.
Clinical trial NCT00231439: Post-Poliosyndrome Treated With Intravenous Immunoglobulin (IvIg)
Official title: Post-Polio Syndrome Treated With Intravenous Immunoglobulin (IvIg)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Post-Polio Syndrome
Keywords: Post-polio syndrome
IvIg
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2005-10-04
Enrollment: 40
Sex: ALL
Minimum age (years): 0
Maximum age (years): 75
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Inflammatory cytokines in the cerebrospinal fluid may contribute to the new muscle weakness, fatigue and pain experienced by patients with post-polio syndrome. Intravenousimmunoglobulin (IvIg) reduces this inflammation. The purpose of this study is to investigate the clinical effect of IvIg in post-polio syndrome.

Detailed description: Post-polio syndrome (PPS) is characterised by new muscle weakness, pain, and fatigue several years after the attack of acute polio. This leads to increased disability, and up to now only supportive therapy is available.

Patients with PPS lose more motor neurons than expected and surviving neurons fail to maintain neurogenic supply to enlarged motor units. New data report an increased level of inflammatory cytokines in the cerebrospinal fluid (CSF). Immune modulating therapy like IvIg could be an option and this pilot study is the first to investigate the clinical effect of IvIg in PPS. In addition, levels of cytokines in CSF and serum before and after treatment will be investigated.

Eligibility criteria: Inclusion Criteria:

Post-polio syndrome diagnosed at Dept of Neurology, Haukeland University Hospital Walking ability -

Exclusion Criteria:

Other autoimmune disorders Other ongoing autoimmune therapy Severe cardiopulmonary disease IgA deficiency Previous treatment of IvIg Wheelchair dependence

Primary outcomes:
measure: Pain after three months
measure: Fatigue after 3 months
measure: Muscle strength after 3 months
Secondary outcomes:
measure: Pain, Fatigue, Muscle strength after 6 months. Changes in cytokine levels in CSF and serum
Other outcomes:
Locations:
Study officials:
affiliation: Stavanger University Hospital, Stavanger, Norway
name: Elisabeth Farbu, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02013739: Description of Insulin Resistance in Patients With Chronic Heart Failure
Official title: Description of Insulin Resistance and Explanatory Variables in Patients With Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Heart Failure
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2013-12-17
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with chronic heart failure

Brief summary: The purpose of this study is to describe insulin resistance in a general chronic heart failure population, in combination with muscle strength, body composition and cardiac function.

It is assumed that insulin resistance is increased in CHF patient, and that this is related to decreased muscle strength and decreased lean tissue mass.


Eligibility criteria: Inclusion Criteria:

* diagnosis of chronic heart failure for at least 6 months,
* clinically stable (not hospitalized) for more than 3 months prior to the onset of the study,

Exclusion Criteria:

* glucose lowering medical therapy

Primary outcomes:
measure: Glucose tolerance
timeFrame: day1
Secondary outcomes:
measure: HbA1c, blood lipids, BNP
timeFrame: day 1
measure: Muscle strength: maximal strength tested on a isokinetic dynamometer
timeFrame: Day 1
measure: Body composition: dual energy x-ray absorptiometry
timeFrame: Day 1
measure: cardiac function: echocardiography, retrospective from hospital files
timeFrame: retrospective
measure: Health-related quality of life: MLHFQ and Eq5d
timeFrame: Day 1
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Hasselt University
state: Limburg
Study officials:
affiliation: Hasselt University
name: Bert Op 't Eijnde, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06269939: Theory-Driven Manualized Approach to Improving New Learning and Memory in Healthy Aging and MCI
Official title: Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in Healthy Aging and Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aging
Keywords: memory
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to investigate the effectiveness of a memory enhancement technique in an aging population.

Detailed description: Memory enhancing techniques have been incorporated into an 8-session treatment protocol, Strategy Based Training to Enhance Memory (STEM), designed to teach participants about each of the techniques, train them on how to apply the techniques in daily life and practice their application to daily life memory demanding situations. The protocol includes teaching participants over age 60 how to restructure a memory demanding situation in order to make optimal use of the techniques.

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria:

  * read and speak English fluently

Exclusion Criteria:

* prior stroke or neurological injury/disease (i.e. traumatic brain injury, Multiple Sclerosis, or Stroke).
* history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis).
* significant alcohol or drug abuse history (inpatient treatment).
* Benzodiazepines and steroid use
* Diagnosis of dementia

Primary outcomes:
measure: Verbal Leaning task
timeFrame: Three points in time: pre-treatment, immediately following treatment, and 6- months after treatment is completed]
measure: Participation in Everyday life
timeFrame: Three points in time: pre-treatment, immediately following treatment, and 6- months after treatment is completed]
Secondary outcomes:
measure: Functional Neuroimaging
timeFrame: Two points in time: pre-treatment, immediately following treatment
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References:
Clinical trial NCT02980939: The Role of Hydration on Exercise Performance - ODIN
Official title: The Role of Hydration on Exercise Performance - ODIN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dehydration
Lead sponsor: University of Arkansas, Fayetteville
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: During exercise in the heat, there is a need to replenish fluids in order to avoid dehydration and decrease the risk for heat illness. What drives this urge to drink is the thirst mechanism. Following ingestion of fluids, there is an inhibition of thirst before there is a replenishing of fluids. However, there is little scientific evidence of where thirst is inhibited, if this thirst inhibition is augmented by exercise and how thirst itself influence exercise performance. Further, during rehydration studies, it is very difficult to successfully blind a subject to their drinking/hydration protocol. Previous studies that have blinded a subject to their drinking have used various methods such as intravenous fluid administration and/or nasogastric tubes. Therefore, the purpose of this research is to examine the mechanistic roles thirst inhibition plays while exercising in the heat while undergoing intravenous fluid administration. Specific attention will be directed to the cardiovascular and thermoregulatory function of the individuals. All blood, cardiovascular, thermoregulatory, and perceptual measures are shown in the diagram below.


Eligibility criteria: Inclusion Criteria:

* Cycling Racing History category 3 or higher USA cycling certification
* maximal oxygen uptake \>55 ml/kg/min

Exclusion Criteria:

* History of heat stroke
* Renal, cardiovascular, metabolic diseases
* Regular medication

Primary outcomes:
measure: 5km - Cycling Time Trial
timeFrame: 2hour
Secondary outcomes:
measure: Rectal Temperature
timeFrame: 2hour
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas - HPER
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Stavros A Kavouras, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04050839: Pain Neuroscience Education in Patients with Fibromyalgia
Official title: The Effectiveness of Pain Neuroscience Education in Patients with Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Fibromyalgia
Keywords: pain neuroscience education
patient education
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Many patients with fibromyalgia have little understanding of their condition, leading to maladaptive pain cognitions and coping strategies. Current research has suggested the use of physiotherapy and rehabilitation in addition to cognitive patient education in the treatment of fibromyalgia syndrome. This study aimed to explore the effectiveness of pain neuroscience education in patients with fibromyalgia.


Eligibility criteria: Inclusion Criteria:

* have fibromyalgia as defined by the criteria of the 1990 ACR
* have Turkish as their native language
* between 18 and 65 years of age

Exclusion Criteria:

* Having cognitive impairment
* Receiving psychotherapy
* Illiterate people
* Patients with significant hearing loss

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: Change from Baseline FIQ at 4th weeks
measure: Pressure pain thresholds (PPT)
timeFrame: Change from Baseline PPT at 4th weeks
measure: Tinel's Sign
timeFrame: Change from Baseline PPT at 4th weeks
Secondary outcomes:
measure: Tampa Scale of Kinesiophobia
timeFrame: Change from Baseline PPT at 4th weeks
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: KutahyaMSU
state: Kutahya Health Sciences University
Study officials:
References:
Clinical trial NCT01640639: THalidomide on Left ventricUlar Morphology aND Function in congEstive heaRt Failure
Official title: Effects of Thalidomide on Left Ventricular Morphology and Function in Patients With Congestive Heart Failure - The THUNDER Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Congestive Heart Failure
Keywords: left ventricular function
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2012-07-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Several studies have shown that inflammation and matrix degradation have pathogenic effects on the myocardium by influencing heart contractility, inducing hypertrophy, degrading the matrix, or enhancing fibrosis, thus contributing to the continuous myocardial remodeling process.

The sedative and antinausea drug thalidomide has been shown to have both anti-inflammatory and antioncogenic properties that could be of benefit in case of congestive heart failure (CHF).

Previous, small investigations have shown an improvement in left ventricular ejection fraction and a favorable cardiac remodeling during thalidomide therapy.

Detailed description: Purpose

Several studies have shown that inflammation and matrix degradation have pathogenic effects on the myocardium by influencing heart contractility, inducing hypertrophy, degrading the matrix, or enhancing fibrosis, thus contributing to the continuous myocardial remodeling process.

The sedative and antinausea drug thalidomide has been shown to have both anti-inflammatory and antioncogenic properties that could be of benefit in case of congestive heart failure (CHF).

Previous, small investigations have shown an improvement in left ventricular ejection fraction and a favorable cardiac remodeling during thalidomide therapy.

Purpose

The primary objective of this study is to carry out a double-blind, randomized, placebo-controlled study to assess the effects of oral thalidomide on left ventricular morphology and function in patients with CHF

Eligibility criteria: Inclusion Criteria:

* Left ventricular ejection fraction \< 50%
* Signs and symptoms of stable CHF
* NYHA III or IV functional class

Exclusion Criteria:

* Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
* Clinical instability

Primary outcomes:
measure: Changes in left ventricular ejection fraction
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Changes in NYHA functional class
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University La Sapienza
Study officials:
References:
Clinical trial NCT06518239: Establishing Optimal PEEP Setting for Obese Patients in the Steep Trendelenburg Position
Official title: Establishing Optimal PEEP Setting for Obese Patients in the Steep Trendelenburg Position: a Pilot Study.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Obesity
Keywords: obesity
steep trendelenburg
Trendelenburg
PEEP
positive end-expiratory pressure
EIT
electrical impedance tomography
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients will be monitored by the standard of care anesthesia machines intraoperatively. An EIT belt will be attached to the patient intraoperatively, and data from the belt will be compared to the anesthesia machines.
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether the Enlight 2100 electrical impedance tomography (EIT) belt can optimize positive end-expiratory pressure (PEEP) during surgery better than standard anesthesia machines.

Detailed description: Positive end-expiratory pressure (PEEP) is a measure taken intraoperatively to manage breathing during surgery. The Enlight 2100 is a device that uses electrical impedance tomography (EIT) to measure PEEP and provide a live image of the lungs while a patient is mechanically ventilated. In this study, the investigators will use the Enlight 2100 EIT belt to measure PEEP intraoperatively in order to better optimize PEEP settings for difficult cases.

Eligibility criteria: Inclusion Criteria:

1. BMI ≥ 40 kg/m2
2. Age \> 18 years
3. Scheduled for elective laparoscopic abdominal surgery in the steep Trendelenburg position.
4. Able to provide informed consent.

Exclusion Criteria:

1. Currently pregnant.
2. Presence of pacemaker, neurostimulator, spinal cord stimulator, or implantable cardioverter-defibrillator.
3. Skin ulcerations on upper torso near the belt placement.
4. Presence of phrenic nerve palsy or other diaphragm conditions.
5. Thoracic circumference \> 134 cm.
6. Tracheomalacia.
7. Inability to speak and understand English.

Primary outcomes:
measure: Optimal PEEP
timeFrame: From the time of consent to the end of surgery, assessed up to 24 hours.
Secondary outcomes:
measure: Difference between EIT and standard of care measured PEEP
timeFrame: From the time of consent to the end of surgery, assessed up to 24 hours.
measure: Delays in extubation
timeFrame: From the day of surgery to discharge, up to 1 week
measure: Incidence of extubation complications
timeFrame: From the day of surgery to discharge, up to 1 week
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University Hospital
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Tinashe Maduke, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: