louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00824824: Effect of Cosopt Versus Combigan on Retinal Vascular Autoregulation in Primary Open Angle Glaucoma (POAG)
Official title: Effect of Cosopt Versus Combigan on Retinal Vascular Autoregulation in Primary Open Angle Glaucoma (POAG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Retinal Vascular Autoregulation
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2009-01-19
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: We have completed a study in which we examined the response of the retinal circulation to changes in posture from sitting to lying down in patients with primary open angle glaucoma (POAG). This alteration in position produces changes in the local blood pressure at the entrance to the retinal vasculature. In a healthy retina, the vasculature adapts by dilating and constricting in order to maintain a steady blood flow rate. In an eye with POAG, this often does not occur. As a result, there are large fluctuations in blood flow which may produce the retinal neuronal damage associated with glaucoma.

The purpose of this study is to demonstrate that topical anti-glaucoma treatments with agents that have vasoactive as well as IOP-lowering effects can have a beneficial effect on maintaining a steady retinal blood flow rate even when there are changes in local blood pressure.


Eligibility criteria: Inclusion Criteria:

* POAG
* Age 40 to 80 years
* Untreated IOP greater than 21 mm Hg

Exclusion Criteria:

* More than two IOP lowering medications
* Exfoliation or pigment dispersion syndrome
* Diabetic retinopathy
* History of ocular surgery

Primary outcomes:
measure: Presence of Retinal Vascular Dysregulation (RVD)
timeFrame: 6 weeks post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
Study officials:
affiliation: Mass Eye and Ear Infirmary
name: Louis Pasquale
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feke GT, Pasquale LR. Retinal blood flow response to posture change in glaucoma patients compared with healthy subjects. Ophthalmology. 2008 Feb;115(2):246-52. doi: 10.1016/j.ophtha.2007.04.055. Epub 2007 Aug 8.
Clinical trial NCT05928624: A Pilot Trial to Test the Feasibility of Utilizing Home Blood Pressure Monitoring to Optimize the Administration of Midodrine Among Decompensated Cirrhosis Patients
Official title: Wireless Automated Tracking in Cirrhosis Patients at Home (WATCH) Trial: A Randomized Single Blind Trial Testing the Use of Home Monitoring Among Decompensated Cirrhosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis, Liver
Portal Hypertension
Ascites Hepatic
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a randomized single-blind feasibility trial to test the utilization of home blood pressure devices to improve the clinical management of decompensated cirrhosis patients.

Detailed description: This is a feasibility trial to determine the feasibility of using home monitoring devices (e.g. blood pressure cuffs) to improve outcomes for cirrhosis patients.

Eligibility criteria: Inclusion Criteria:

* Patients will need to have decompensated cirrhosis defined as a Child Pugh Score ≥ 7

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in Mean Arterial Pressure
timeFrame: Baseline and 24 Weeks
Secondary outcomes:
measure: Change in Ascites Burden
timeFrame: Baseline and 24 Weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Giuseppe Cullaro, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00804024: ClearWay™ RX Registry Trial
Official title: Multi-center, Registry Trial of ClearWay™ RX Local Therapeutic Infusion Catheter for All Indications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Diseases
Vascular Diseases
Keywords: Heart Diseases. Vascular Diseases.
Lead sponsor: Atrium Medical Corporation
Sponsor class: INDUSTRY
First posted: 2008-12-08
Enrollment: 102
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: The ClearWay Rx Registry enrolled subjects who required the use of the ClearWay Rx Local Therapeutic Infusion Catheter.

Brief summary: The primary goal of this registry is to collect data regarding the use of the ClearWay RX Local Therapeutic Infusion Catheter for all indications.

Detailed description: The registry will collect de-identified data regarding the indication for use, ease of use, drug perfusion, catheterization procedure details, success for intended use, and overall operator performance evaluation.

Eligibility criteria: Inclusion Criteria:

* Subject required the use of the ClearWay Rx Local Therapeutic Infusion Catheter.

Exclusion Criteria:

* Subject not meeting the above inclusion criterion

Primary outcomes:
measure: use, easy of use, drug perfusion, catheterization procedure details, success for intended use, and overall operator performance evaluation.
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Escondido
country: United States
facility: Escondido Cardiology Associates
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Winter Haven
country: United States
facility: Winter Haven Florida
state: Florida
city: Macon
country: United States
facility: The Georgia Heart Center
state: Georgia
city: Indianapolis
country: United States
facility: Clarian Health Partners Methodist Research Institute
state: Indiana
city: Paducah
country: United States
facility: Western Baptist Hospital
state: Kentucky
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
city: St.Joseph
country: United States
facility: Great Lakes Heart & Vascular Institute
state: Michigan
city: Duluth
country: United States
facility: St.Mary's Duluth Clinic Health System
state: Minnesota
city: Charlotte
country: United States
facility: Presbyterian Hospital Mid-Carolina Cardiology
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center-Cardiovascular Research
state: North Carolina
city: Lebanon
country: United States
facility: Good Samaritan Hospital
state: Pennsylvania
city: Richmond
country: United States
facility: Virginia Cardiovascular Specialists
state: Virginia
Study officials:
affiliation: Medstar Health Research Institute
name: Ron Waksman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00768924: CopiOs(TM) Bone Void Filler in the Post-Harvest Iliac Crest
Official title: CopiOs(TM) Bone Void Filler in the Post-Harvest Iliac Crest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Fusions
Keywords: Bone Void Filler
Post-Harvest Iliac Crest
Ability of CopiOs to fill the post-harvest iliac crest bone void created by a surgeon during spinal fusion.
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-10-08
Enrollment: 35
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: CopiOs will be used to fill the bony deficit as a result of iliac crest autograft harvest during spinal fusion surgery.

Brief summary: The CopiOs Bone Void Filler (BVF) is a synthetic bone graft material consisting of calcium phosphate dehydrate within lyophilized type I bovine collagen that has been formed into pads of various sizes for surgical implantation. Pre-clinical animal studies suggest that the bone healing strength of CopiOs to be equivalent to autograft.

Detailed description: Purpose of the study is to evaluate the in-vivo use of CopiOs bone void filler in a single site trial, providing pre and post-operative evaluations of subjects undergoing spinal fusion with autogenous bone graft, in whom the CopiOs has been used as a bone void filler in the post-harvest iliac crest.

Eligibility criteria: Inclusion Criteria:

* Patient is 18 years and older
* Patient must be an appropriate candidate for iliac crest bone harvesting during a spinal fusion.
* Patient must be skeletally mature.
* Patient has signed an IRB approved Informed Consent and HIPAA compliant waiver.

Exclusion Criteria:

* Patient is suffering from any co-morbidities that would excessively increase the risk of surgery, including but not limited to pulmonary or cardiac conditions.
* Patient is pregnant.
* Patient has a severe degenerative bone disease.
* Patient has systemic conditions which would affect bone or wound healing.
* Patient is unwilling or unable to follow postoperative instructions or cooperate in a follow-up program.
* Patient is suffering from mental illness, alcohol abuse or drug abuse.
* Patient has known allergies to bovine collagen.
* Patient has a history of multiple allergies.
* Patient has infection at the surgical site.
* Significantly impaired vascularity proximal to surgical site.
* Sites are in direct contact with articular space.
* Sites where stresses on void will exceed the load strength of fixation hardware.
* Patient has hypercalcemia.

Primary outcomes:
measure: Data obtained by this study will provide valuable insight on the ability of CopiOs to fill the post-harvest iliac crest bone void created by a surgeon during spinal fusion.
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: South Texas Spine Clinic
state: Texas
Study officials:
References:
Clinical trial NCT06446024: Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan
Official title: Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Limb Ischemia
Arterial Occlusion Mesenteric Artery Superior
Acute DVT of Lower Extremity
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-06
Enrollment: 500
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: The INDIGO System is intended for use in patients with acute lower limb artery occlusion, acute superior mesenteric artery occlusion, or severe acute deep vein thrombosis who require immediate treatment and for whom it is difficult to perform surgical thrombectomy or who are expected to have no effective therapeutic effect.

Brief summary: This study aims to confirm the safety and effectiveness of the INDIGO Aspiration System in patients requiring immediate treatment for acute lower extremity artery occlusion, acute superior mesenteric artery occlusion, or severe acute deep vein thrombosis. Primary objective of the study is to collect predetermined data on use, safety and effectiveness, including clinical and technical performance of the INDIGO System in Japan.


Eligibility criteria: Inclusion Criteria:

Patients who meet Appropriate Use Criteria per local Japanese requirements for acute lower limb artery, acute upper mesentery artery occlusions, or severe acute deep vein thrombosis.

Exclusion Criteria:

Patients who do not meet Appropriate Use Criteria per local Japanese requirements for acute lower limb artery, acute upper mesentery artery occlusions, or severe acute deep vein thrombosis.

Primary outcomes:
measure: ALI: Target Limb Salvage
timeFrame: 30 days post-treatment and 6 months post-treatment
measure: ALI: Technical Success
timeFrame: Intraoperative
measure: ALI: Major device-related bleeding in ALI patients
timeFrame: Periprocedural
measure: SMA: Technical success
timeFrame: Intraoperative
measure: SMA: Device-related Distal Embolization
timeFrame: Intraoperative
measure: DVT: Technical success
timeFrame: Intraoperative
measure: DVT: Major Device-Related Bleeding
timeFrame: Periprocedural
measure: DVT: New Symptomatic Pulmonary Embolism (PE)
timeFrame: 30 days post-treatment
measure: DVT: Clinically significant re-thrombosis of the target venous segment
timeFrame: 30 days post-treatment
measure: All Disease States: Device-related Serious adverse effects (SAE) and mortality
timeFrame: 6 months post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Nara
country: Japan
facility: Nara City Hospital
Study officials:
References:
Clinical trial NCT06074224: Sleep Assessment: The Benefits of Identifying Sleep Disturbance Using a Sleep Questionnaire
Official title: Sleep Assessment: The Benefits of Identifying Sleep Disturbance Using a Sleep Questionnaire
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Disturbance
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators are interested in measuring the influence of addressing sleep in the orthopedic setting. This includes assessing patient experience measures (satisfaction with the visit, perceived empathy, communication effectiveness) as well as greater engagement in their healthcare (patient activation). The investigators will also see what factors might be associated with sleep disturbance and if addressing sleep leads to an intervention such as cognitive behavioral therapy.

Detailed description: All adult (18+ years old) new patients seeing a musculoskeletal specialist will be invited to enroll. For the purposes of this trial, The investigators will include people with lesser degrees of sleep disturbance including anyone with a score greater than 3. For people that are enrolled in the trial, the researcher will record the PSQI score and enter at the first page of survey filled out by the patient after meeting. P The patients in the intervention group will include those for whom their clinician was given their sleep questionnaire result before the visit. The control group will include patients whose clinicians do not view the results, simulating usual care. Patients in both groups will fill out a survey entailing demographics, sleep quality, JSPPPE.

Eligibility criteria: Inclusion criteria:

1. Adult patients (18+)
2. Orthopedic new visit
3. Sleep disturbance score \> 3

Exclusion criteria:

1. Inability to read.
2. Diminished cognition preventing completion of the questionnaires.

Primary outcomes:
measure: Jefferson Scale of Patient's Perceptions of Physician Empathy
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas Health Austin (UTHA)
state: Texas
city: Austin
country: United States
facility: University of Texas Health Austin
state: Texas
Study officials:
affiliation: Professor of orthopedic surgery at The university of Texas at Austin
name: David Ring, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02172924: A Phase 2 Study Using Placenta Derived Decidual Stromal Cells for Graft Versus Host Disease
Official title: A Phase 2 Study Using Placenta Derived Decidual Stromal Cells for Graft Versus Host Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Graft vs Host Disease
Keywords: Stem Cell Transplantation
Decidual Stromal Cells
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2014-06-24
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy using decidual stromal cell therapy for graft versus host disease after allogeneic hematopoietic stem cell transplantation. The hypothesis to be tested is that the cells are safe to infuse and that they have a positive clinical effect.

Detailed description: Patients with GVHD grade 2-4, will receive decidual stromal cells at approximately 1x10\^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response.

Eligibility criteria: Inclusion Criteria:

* Acute graft versus host disease grade 2-4 or therapy resistant chronic graft versus host disease.
* Are on calcineurin inhibitor and high dose corticosteroids.

Exclusion Criteria:

* Terminally ill patients

Primary outcomes:
measure: Actuarial survival at one year after onset of graft versus host disease
timeFrame: 12 months after inclusion
Secondary outcomes:
measure: Response at 28 days after onset of graft versus host disease
timeFrame: 28 days after inclusion
measure: Side effects
timeFrame: Up to 6 months after inclusion
measure: Incidence of severe infections
timeFrame: Up to 12 months after inclusion
measure: Disease free survival
timeFrame: 12 months after inclusion
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Olle Ringdén, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00904124: The Effect of Different Types of Dietary Fiber on Satiation
Official title: Determination of the Effect of Different Types of Isolated Dietary Fiber on ad Libitum Food Intake in Healthy Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Dietary fiber
guar gum
alginate
cellulose
food intake
eating behaviour
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2009-05-19
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: It has been suggested that dietary fibers can affect food intake and satiation. Satiation, or meal termination, can be induced by sensory properties and energy density of fiber-rich food products, but also by the chemical/physical/rheological behavior of the fibers in the stomach and/or intestine. It is not clear which properties are the key regulators of satiation by fiber sources. There are many types of dietary fiber, which have diverse sensory and chemical properties, thus these might have different effects on satiation.


Eligibility criteria: Inclusion Criteria:

* Age: 18-50 years
* BMI: 18-25 kg/m2
* Healthy: as judged by the participant

Exclusion Criteria:

* Weight loss or weight gain of more than 5 kg during the last 2 months
* Using an energy restricted diet during the last 2 months
* Lack of appetite for any (unknown) reason
* Having problems with chewing and swallowing
* Having problems with digestion
* Restrained eater
* Hypersensitivity for gluten or other ingredients of chocolate cookies
* Hypersensitivity for one of the fibers

Primary outcomes:
measure: Ad libitum intake
timeFrame: 1 hour and 2 hours
Secondary outcomes:
measure: eating rate
timeFrame: 1 hour and 2 hours
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University
Study officials:
affiliation: Wageningen University
name: Edith Feskens, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wanders AJ, Jonathan MC, van den Borne JJ, Mars M, Schols HA, Feskens EJ, de Graaf C. The effects of bulking, viscous and gel-forming dietary fibres on satiation. Br J Nutr. 2013 Apr 14;109(7):1330-7. doi: 10.1017/S0007114512003145. Epub 2012 Jul 31.
Clinical trial NCT05550324: IPSC Repository of Pediatric Cardiovascular Disease
Official title: IPSC Repository of Pediatric Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Heart Disease
Heart Diseases
Keywords: iPSC
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any individual with or without pediatric cardiovascular disease

Brief summary: Obtain blood samples for generation and maintenance of induced pluripotent stem cells (iPSCs) and genomic/DNA sequencing for biomedical research that will improve the understanding and treatment of pediatric cardiovascular disease

Detailed description: Human induced pluripotent stem cells (iPSCs) are a type of pluripotent stem cell which can be generated from easily accessible patient cells, such as peripheral blood mononuclear cells and skin fibroblasts. As iPSCs are epigenetically reprogrammed from somatic cells, they retain all genetic information of the affected patients, thus providing an ideal model for studying the contribution of genetic variation to pediatric cardiovascular disease. In addition, human iPSCs can be differentiated into cardiomyocytes, endothelial cells, smooth muscle cells and cardiac fibroblasts, which are major affected cell types in the heart responsible for cardiovascular disease. Therefore, patient-specific iPSCs possess great promise in modeling pediatric cardiovascular disease, discovering novel drugs and prospective cell regeneration therapy.

The DNA from these patients will be analyzed for point mutations, rare sequence variations, single nucleotide polymorphisms in known cardiac development genes or for chromosomal copy number changes by using state of the art genetic approaches.

Eligibility criteria: Inclusion Criteria:

1. The subjects must have the diagnosis of cardiovascular disease
2. The subject must have a syndrome associated with cardiovascular disease
3. The subject must be related to an individual in cohort 1 or 2
4. The subject is considered a control and does not fall into any of the other cohorts

Exclusion Criteria:

N/A

Primary outcomes:
measure: improve the understanding and treatment of pediatric cardiovascular disease
timeFrame: up to 10 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References: