louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00052104: Telephone-Based Support for Caregivers of Patients With Dementia
Official title: A Telephone Intervention for Dementia Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dementia
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-01-23
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to develop an effective, low-cost, telephone-based intervention to reduce anxiety, depression, and feelings of burden and stress in caregivers of patients with dementia. This study will also determine whether the intervention can alter the course of dementia.

Detailed description: Caregivers are randomized to receive either telephone-based intervention or standard medical care. Both groups receive a resource packet containing information about caring for someone with dementia and a list of local resources. Caregivers in the intervention group also receive a series of telephone calls over 12 months, during which education, emotional support, and training in problem-solving skills are provided by trained therapists. Caregivers in the standard care group receive no additional psychosocial intervention. Participants are assessed pre-treatment, mid-treatment (6 months), post-treatment, and at a 3-month follow-up.

Eligibility criteria: Patient Inclusion Criteria:

* DSM-IV diagnosis of dementia (vascular, mixed, or associated with Alzheimer's disease)
* Lives in the community, including senior/retirement centers, but excluding nursing homes and assisted living centers
* 50 years old or older
* Resides in Southeastern New England

Caregiver Inclusion Criteria:

* Living with a person with dementia
* Provides care for at least 6 months for at least 4 hours a day
* English as primary language
* Telephone access
* Resides in Southeastern New England

Patient Exclusion Criteria:

* Major acute medical condition affecting independent functioning

Caregiver Exclusion Criteria:

* Acute medical illness
* Cognitive impairment as defined by an MMSE score \< 25

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT00407004: Elimination of Albumin-Bound Substances by MARS and Prometheus
Official title: Effect of Extracorporeal Liver Support by MARS and Prometheus on Albumin-Bound Substances in Acute-on-Chronic Liver Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Failure
Keywords: acute-on-chronic liver failure, MARS, Prometheus, bilirubin, bile acids, cytokines
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Fresenius Medical Care North America
First posted: 2006-12-04
Enrollment: 10
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: This trial compares the efficacy of two artificial liver support systems, MARS (Molecular Adsorbents Recirculating System) and Prometheus (FPSA, Fractionated Plasma Separation and Adsorption), in removing albumin-bound substances such as bilirubin, bile acids, and cytokines.


Eligibility criteria: Inclusion Criteria:

* consecutive patients with acute-on-chronic liver failure (severe deterioration of chronic liver disease) unresponsive to standard medical treatment for \>=48 hours

Exclusion Criteria:

* arterial hypotension
* extrahepatic malignancy

Primary outcomes:
measure: serum levels of albumin-bound substances
Secondary outcomes:
measure: plasma clearance of albumin-bound substances
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz
name: Rudolf E. Stauber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Graz
name: Peter Krisper, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krisper P, Haditsch B, Stauber R, Jung A, Stadlbauer V, Trauner M, Holzer H, Schneditz D. In vivo quantification of liver dialysis: comparison of albumin dialysis and fractionated plasma separation. J Hepatol. 2005 Sep;43(3):451-7. doi: 10.1016/j.jhep.2005.02.038.
citation: Jung A, Krisper P, Haditsch B, Stauber RE, Trauner M, Holzer H, Schneditz D. Bilirubin kinetic modeling for quantification of extracorporeal liver support. Blood Purif. 2006;24(4):413-22. doi: 10.1159/000094575. Epub 2006 Jul 14.
Clinical trial NCT03319004: Validation of Phase Lag Entropy(PLE) as an Indicator of Depth of Sedation in Patients Undergoing Spinal Anesthesia
Official title: Validation of Phase Lag Entropy(PLE) as an Indicator of Depth of Sedation in Patients Undergoing Spinal Anesthesia: Comparative Analysis With Bispectral Index
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgery Requiring Spinal Anesthesia
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: For verifying the phase lag entropy as the tool for measurement of level of consciousness, the investigators compared phase lag entropy to bispectral index. Using Target-Controlled Infusion pump, propofol was infused for sedation during the spinal anesthesia. The investigators measured Observer's Assessment of Alertness/Sedation Scale as the propofol concentration rises. At the same time, The investigators observed phase lag entropy score and bispectral index score.


Eligibility criteria: Inclusion Criteria:

* patients who require sedation during the spinal anesthesia

Exclusion Criteria:

* dementia, CVA patients, patients have problems with communication

Primary outcomes:
measure: phase lag entropy score
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
References:
Clinical trial NCT00277472: Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With Hypertension
Official title: A 28-week, Multicenter Study to Evaluate the Effects of Valsartan/Hydrochlorothiazide (160/12.5 mg) in Comparison With Hydrochlorothiazide (25 mg) Monotherapy, for the Treatment of Patients With Hypertension, Uncontrolled by Hydrochlorothiazide (12.5 mg) Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
High blood pressure
diuretics
valsartan
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-01-16
Enrollment: 300
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: This study will assess the efficacy and safety of valsartan/hydrochlorothiazide combination therapy in patients with hypertension not controlled with hydrochlorothiazide monotherapy.


Eligibility criteria: Inclusion Criteria:

* Male or female 18 years of age and older
* Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but \< 180 mm Hg and mean seated diastolic blood pressure ≥ 95 mm Hg and \<110 mm Hg

Exclusion Criteria:

* - Patients with sever hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg
* Diabetes with fasting glucose \> 126 mg/dl or on existing anti-diabetic medication
* History of stroke, transient ischemic attack, or myocardial infarction within the last 6 months, or diagnosed with congestive heart failure.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Blood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 4 weeks
measure: Blood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 2 weeks and 20 weeks
Secondary outcomes:
measure: Change from baseline in systolic blood pressure after 2 weeks and 4 weeks
measure: Change from baseline in diastolic blood pressure after 2 weeks and 4 weeks
measure: Change in systolic blood pressure at 20 weeks compared to 4 weeks
measure: Change in diastolic blood pressure at 20 weeks compared to 4 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis
name: Novartis 862-778-8300 Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06553404: Myoslow Lens Study to Control Myopia in Children
Official title: A Prospective, Randomized, Controlled Double Masked Trial to Assess the Performance of Myoslow Lens in Slowing Myopia Progression in Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Myopia
Lead sponsor: Crystal Optic
Sponsor class: INDUSTRY
First posted: 2024-08-14
Enrollment: 125
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief summary: A Prospective, randomized, controlled double masked trial to assess the performance of Myoslow lens in slowing myopia progression in children.

The following study measures will be assessed:

* Demographics and medical history
* Current spectacles
* Best Corrected Visual Acuity (BCVA) assessed by Measurement and Summation (M\&S) system
* Biometry
* Cover test
* Stereopsis
* Ocular Motility
* Pupil responses
* Cycloplegic refraction
* Fundus Examination
* Vision related quality of life using the questionnaire Pediatric Refractive Error Profile (PREP)2
* Adverse Events


Eligibility criteria: Inclusion Criteria:

* Children, 6-12 years old
* Spherical Equivalence Refraction (SER): -1.00 to -5.00 Diopter (D).
* Astigmatism and anisometropia of 1.50 D or less.
* Best Corrected Visual Acuity (BCVA) (6 / 7.5) or higher.

Exclusion Criteria:

* Eye and systemic disorders.
* Previously treated for myopia

Primary outcomes:
measure: spherical equivalent error
timeFrame: 24 months
Secondary outcomes:
measure: Axial length
timeFrame: 24 months
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba MC
Study officials:
affiliation: Crystal Optic
name: Haim Stolovitch, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00369304: Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate
Official title: A Randomized, Open Label, 2-Period Crossover Study to Determine the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Health
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is an open-label, randomized, 2-period crossover, inpatient study to be performed in healthy subjects. The study will consist of 2 treatment periods: There will be 2 parallel cohorts of 12 subjects each who will be enrolled to receive single doses of tolbutamide or AGG-523 plus tolbutamide in periods 1 and 2 in a crossover design. Doses of test article will be administered after an overnight fast of at least 10 hours.


Eligibility criteria: 1. Men and women, aged 18 to 50 years. Women of non-childbearing potential may be included.
2. Body mass index in the range of 18 to 30 kg/meter squared and body weight equal to or greater than 50 kg.
3. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12 lead electrocardiogram (graphic trace of the pattern of your heart beat).
4. Non-smoker or smoker of fewer than 10 cigarettes (half a pack) per day as determined by history. Must abstain from smoking during inpatient stay.
5. Have a high probability for compliance with and completion of the study.

Primary outcomes:
measure: To evaluate the effects of a single oral dose of AGG-523 on the pharmacokinetic profile of a single oral dose of tolbutamide in healthy subjects.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00001904: Assessment of a B-Mode Ultrasound Technique for the Measurement of Carotid Artery Intima-Media Thickness
Official title: Assessment of a B-Mode Ultrasound Technique for the Measurement of Carotid Artery Intima-Media Thickness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Myocardial Infarction
Keywords: Atherosclerosis
Cardiovascular Disease
Computerized Edge Reader
Myocardial Infarction
Risk Factor
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: This minimal risk protocol is designed to assess the reproducibility of B-mode ultrasound measurements of carotid intima media thickness (IMT) when the scans are performed in CC Radiology and read using a computerized edge reader. Up to 20 volunteers will have two ultrasounds performed within a 6-month period. IMT thickness is used as a surrogate marker for atherosclerosis and may be of value in clinical trials.

Detailed description: This minimal risk protocol is designed to assess the reproducibility of B-mode ultrasound measurements of carotid intima-media thickness (IMT) when the scans are performed in CC Radiology and read using a computerized edge reader. Up to 50 volunteers will have two ultrasounds performed within a 6-month period. IMT thickness is used as a surrogate marker for atherosclerosis and may be of value in clinical trials.

Eligibility criteria: Adult (age 18 or older).

Desire to participate in the study; willing and able to provide informed consent.

No history of stroke or carotid disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Allergy and Infectious Diseases (NIAID)
state: Maryland
Study officials:
References:
citation: Tan GH, Gharib H. Thyroid incidentalomas: management approaches to nonpalpable nodules discovered incidentally on thyroid imaging. Ann Intern Med. 1997 Feb 1;126(3):226-31. doi: 10.7326/0003-4819-126-3-199702010-00009.
citation: Mercuri M. Noninvasive imaging protocols to detect and monitor carotid atherosclerosis progression. Am J Hypertens. 1994 Jul;7(7 Pt 2):23S-29S. doi: 10.1093/ajh/7.7.23s.
Clinical trial NCT03758404: Gene Therapy for Achromatopsia (CNGA3)
Official title: An Open Label, Multi-centre, Phase I/II Dose Escalation Trial of a Recombinant Adeno-associated Virus Vector (AAV2/8-hG1.7p.coCNGA3) for Gene Therapy of Children and Adults With Achromatopsia Owing to Defects in CNGA3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Achromatopsia
Lead sponsor: MeiraGTx UK II Ltd
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2018-11-29
Enrollment: 11
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A clinical trial of adeno-associated virus vector (AAV) CNGA3 retinal gene therapy for patients with achromatopsia

Detailed description: CNGA3 retinal gene therapy for patients with achromatopsia

Eligibility criteria: Inclusion Criteria:

* Are aged years or over
* Have achromatopsia confirmed by a retinal specialist investigator

Exclusion Criteria:

* Are females who are pregnant or breastfeeding
* Have participated in another research study involving an investigational medicinal therapy for ocular disease within the last 6 months
* Have any other condition that the investigator considers makes them inappropriate for entry into the trial

Primary outcomes:
measure: Number of Participants Meeting the Primary Outcome Defined as Any of the Below Events Occurring During the 6 Weeks Following Administration, at Least Possibly Related to the Advanced Therapy Investigational Medicinal Products (ATIMP), Not Surgery Alone.
timeFrame: 6 Weeks
Secondary outcomes:
measure: Improvements in Visual Function as Assessed by Visual Acuity
timeFrame: 6 Months
measure: Improvements in Retinal Function as Assessed by Static Perimetry
timeFrame: 6 Months
measure: Quality of Life Measured by QoL Questionnaires in Children and Adolescents
timeFrame: 6 Months
measure: Quality of Life Measured by QoL Questionnaires in Adults
timeFrame: 6 Months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Kellogg Eye Center
state: Michigan
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
Study officials:
affiliation: Chief Investigator
name: James Bainbridge
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000804: A Randomized Trial of L-735,524, An Inhibitor of the HIV Protease Enzyme, and Interleukin-2 in Persons Infected With HIV (NOTE: Only For Patients Who Previously Completed NIAID 93 CC-113)
Official title: A Randomized Trial of L-735,524, An Inhibitor of the HIV Protease Enzyme, and Interleukin-2 in Persons Infected With HIV (NOTE: Only For Patients Who Previously Completed NIAID 93 CC-113)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: HIV Infections
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to study L-735,524, which is an inhibitor of the HIV protease enzyme. It will be used with interleukin-2 in patients infected with HIV.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04958304: Moderna COVID-19 Vaccine mRNA-1273 Observational Pregnancy Outcome Study
Official title: Moderna mRNA-1273 Observational Pregnancy Outcome Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: SARS-CoV-2
Keywords: mRNA-1273
mRNA-1273 vaccine
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Virus Diseases
Messenger RNA
COVID-19
COVID-19 Vaccine
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who have been exposed the Moderna COVID-19 vaccine during the 28 days prior to their LMP or at any time during pregnancy are eligible for this exposed cohort.

Brief summary: The main goal of this study is to evaluate the outcomes of pregnancy in females exposed to the Moderna COVID-19 vaccine (mRNA-1273) during pregnancy.

Detailed description: The Moderna COVID-19 Vaccine Pregnancy Registry will collect and analyze information on the potential impact of exposure to the Moderna COVID-19 vaccine on pregnancy and birth outcomes.

Eligibility criteria: Inclusion Criteria:

* Currently pregnant
* The outcome of pregnancy (that is, pregnancy loss or live birth) must not be known at entry.
* Agrees to electronically sign the release of medical information form permitting the study to contact her HCPs (for example, primary care provider \[PCP\], obstetrician, nurse midwife) and the infant's HCP (for example, pediatrician) for medical information.
* Received the Moderna COVID-19 vaccine at any point from 28 days prior to last menstrual period (LMP) throughout pregnancy.

Exclusion Criteria:

* Participant has received any other COVID-19 vaccines at any point from 28 days prior to LMP throughout pregnancy.
* Women currently participating in another investigational device or drug study, currently taking an investigational medicinal product, or having taken an investigational product within 28 days prior to LMP or during pregnancy.

Primary outcomes:
measure: Number of Participants Having Infants With Suspected Major and Minor Congenital Malformations
timeFrame: Up to 1 year of infant age
measure: Number of Participants With Any Pregnancy Complications
timeFrame: From end of first trimester (approximately 14 weeks) up to mid-third trimester (approximately 34 weeks)
measure: Number of Participants With Any Pregnancy Outcomes
timeFrame: Approximately 4 weeks after expected date of delivery (EDD)
measure: Number of Participants With Infant Outcomes
timeFrame: Up to 1 year of infant age
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: IQVIA Call Center for United States and Canada
state: North Carolina
Study officials:
References: