louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01902303: Evaluation of Cold Sore Treatments on Ultra Violet (UV) Induced Cold Sores
Official title: Evaluation of Cold Sore Treatments on UV Induced Cold Sores
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Herpes Simplex
Keywords: Herpes Labialis
Herpes Simplex
Herpes
Ultra Violet (UV) Induced
Lead sponsor: Beech Tree Labs, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Norwich Clinical Research Associates Ltd.
name: Hill Top Research
First posted: 2013-07-18
Enrollment: 303
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: The purpose of this study is to determine if a new drug treatment is effective to block the development of a cold sore lesion following Ultra Violet (UV) exposure.

Detailed description: This was a multi-center, randomized, evaluator and subject-blind, placebo controlled study design

The objective of this study was to evaluate the ability of the test articles to block the development of a cold sore lesion from progressing beyond the prodromal stage following a UV-induced process.

The primary efficacy endpoint of this study was to determine if a recurrent oral herpes episode initiated with prodromal symptoms was aborted before progressing to a lesion (vesicle) via assessing lesion stages by a trained evaluator.

The secondary efficacy endpoints included: a) subject self-assessments and b) test article weights and diaries to track treatment compliance.

Eligibility criteria: Inclusion Criteria:

* Clinical history of recurrent cold sores averaging 2 or more episodes per year
* UV exposure is known to cause a cold sore outbreak

Exclusion Criteria:

* History of abnormal reactions to sunlight
* Used antiviral therapy directly prior to entering study
* Any other condition which in the opinion of the Investigator may affect the results or place the subject at undue risk.

Primary outcomes:
measure: Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by a Trained Evaluator
timeFrame: Day 0- Day 7
Secondary outcomes:
measure: Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by the Participant
timeFrame: 0 -7 days
Other outcomes:
Locations:
city: St. Petersburg
country: United States
facility: Hill Top Research
state: Florida
city: Cincinnati
country: United States
facility: Hill Top Research
state: Ohio
city: Mt. Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
Study officials:
affiliation: President, Beech Tree Labs, Inc.
name: John McMichael, PhD
role: STUDY_DIRECTOR
References:
citation: Mamber SW, Hatch T, Miller CS, Murray JV, Strout C, McMichael J. Low-dose Oral Thimerosal for the Treatment of Oral Herpes: Clinical Trial Results and Improved Outcome After Post-hoc Analysis. J Evid Based Integr Med. 2022 Jan-Dec;27:2515690X221078004. doi: 10.1177/2515690X221078004.
Clinical trial NCT01539603: Comparison of Drug Eluting Balloon and Drug Eluting Stent
Official title: Comparison of Drug-Eluting Balloon First and Then Bare Metal Stent With Drug-eluting Stent for Treatment of de Novo Lesions (DEB First): A Randomized Controlled Single Center Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Stable Angina
Unstable Angina
NSTEMI
Keywords: drug eluting balloon
bare metal stent
drug eluting stent
coronary artery disease
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2012-02-27
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of Drug-Eluting Balloon first and then bare metal stent compared with drug-eluting stent for treatment of de novo lesions (DEB first).

Detailed description: A recent trial to test premount bare metal stent on drug-eluting balloon failed to demonstrate non-inferiority and safety compared to drug-eluting stent alone for treatment of coronary artery stenosis.

We think that inappropriate drug delivery to diseased vessel due to stent strut might affect the efficacy of drug-eluting balloon. Therefore, we design a clinical study with a different protocol, that is, drug-eluting balloon first and then bare metal stent implantation in comparison to drug-eluting stent.

Eligibility criteria: Inclusion Criteria:

* De novo lesion
* 2.5mm =\< Reference diameter =\< 4mm
* Lesion length =\< 28mm
* Type A, B1/B2 lesion

Exclusion Criteria:

* ST-segment elevation MI
* Reference diameter \< 2.5mm or \> 4mm
* Bifurcation lesion
* Type C lesion
* history of AMI or stroke within 1 year F. chronic renal disease (Cr \> 2mg/dL)

Primary outcomes:
measure: in-segment late loss
timeFrame: 9 month
Secondary outcomes:
measure: stent thrombosis
timeFrame: 9 month
measure: angiographic and procedure success
timeFrame: 9 month
measure: MACE
timeFrame: 9 month
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National Universtiy Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: In-Ho Chae, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chae IH, Yoon CH, Park JJ, Oh IY, Suh JW, Cho YS, Youn TJ, Choi DJ. Comparison of Drug-Eluting Balloon Followed by Bare Metal Stent with Drug-Eluting Stent for Treatment of de Novo Lesions: Randomized, Controlled, Single-Center Clinical Trial. J Korean Med Sci. 2017 Jun;32(6):933-941. doi: 10.3346/jkms.2017.32.6.933.
citation: Park SD, Yoon CH, Oh IY, Suh JW, Cho YS, Youn TJ, Choi DJ, Chae IH. Comparison of a drug-eluting balloon first and then bare metal stent with a drug-eluting stent for treatment of de novo lesions: study protocol of a randomized controlled trial. Trials. 2013 Feb 8;14:38. doi: 10.1186/1745-6215-14-38.
Clinical trial NCT00974103: Persistent Low Back and Pelvic Pain 3-6 Months Post Partum
Official title: Persistent Low Back Pain and Pelvic Pain 3-6 Months Post Partum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Girdle Pain Post Partum
Low Back Pain Post Partum
Keywords: low back pain
pelvic pain
pelvic girdle pain
post partum
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: University of Stavanger
First posted: 2009-09-10
Enrollment: 13
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to identify how many females have persistent low back pain and/or pelvic pain 3-6 months post partum. The females that have persistent pelvic pain can continue in the study and be examined by a chiropractor. They will then divide the females into Hanne Alberts 5 subgroups of pelvic pain. The females that have one-sided pelvic pain will be invited to participate in a randomised controlled study where chiropractic intervention is compared to exercises.

Detailed description: The study is a follow up study to "Prevalence of low back pain and pelvic pain in the pregnant population in Stavanger".

Eligibility criteria: Inclusion Criteria:

* Low back and\\or pelvic girdle pain during pregnancy
* Fluent understanding of spoken and written Norwegian

Exclusion Criteria:

* hospitalisation due to pain or complications post partum

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: 20 weeks after the initial assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger university hospital
Study officials:
affiliation: Helse Stavanger HF
name: Jan P Larsen, MD Dr med
role: STUDY_DIRECTOR
References:
Clinical trial NCT04358003: Plasma Adsorption in Patients With Confirmed COVID-19
Official title: Plasma Adsorption in Patients With Confirmed COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
ARDS
Keywords: SARS-CoV-2
COVID-19
Spectra Optia Apheresis System
D2000 Cartridge
Terumo BCT
Marker Therapeutics
Lead sponsor: Marker Therapeutics AG
Sponsor class: INDUSTRY
Collaborators: name: Terumo BCT
First posted: 2020-04-22
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To characterize the ability of the D2000 Cartridge in combination with the Optia SPD Protocol to reduce the morbidity and mortality associated with SARS-CoV-2 infection in patients admitted to the ICU.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Admitted to ICU
* Diagnosis of SARS-CoV-2 with any one of the following conditions:

  1. Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or
  2. Severe disease, defined as:

     1. dyspnea,
     2. respiratory frequency ≥ 30/min
     3. blood oxygen saturation ≤ 93%
     4. partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, and/or
     5. lung infiltrates \> 50% within 24 to 48 hours; or
  3. Life-threatening disease, defined as:

     1. respiratory failure,
     2. septic shock, and/or
     3. multiple organ dysfunction or failure.
* Patient fact sheet is provided to the subject.
* Subject or legal representative is able and willing to give informed consent. If authorized by the IRB, emergent plasma adsorption with the D2000 cartridge may be initiated prior to consent.

Exclusion Criteria:

* Treatment limitation or a do not attempt to resuscitate in place
* Pregnancy
* Significant or uncontrolled bleeding
* In the opinion of the investigator, any other condition that precludes plasma adsorption with the D2000

Primary outcomes:
measure: All-cause mortality
timeFrame: Day 28
Secondary outcomes:
measure: Change in Sequential Organ Failure Assessment [SOFA] scores
timeFrame: Day 28
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences (UAMS)
state: Arkansas
city: Albuquerque
country: United States
facility: UNM Health Science Center
state: New Mexico
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: West Reading
country: United States
facility: Reading Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern/Clements Hospital
state: Texas
city: Galveston
country: United States
facility: UTMB
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Medical Campus
state: Virginia
Study officials:
References:
Clinical trial NCT04403503: The Influence of Tissue Adhesive to Palatal Donor Site Healing.
Official title: The Influence of Tissue Adhesive to Palatal Donor Site Healing. A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Donor Site Complication
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: CTG was harvested from 21 patients in each group. Donor site was treated with either GS (control) or GS+CY (test). Palatal tissue thickness, graft dimensions, working time (WT) and primary bleeding time were recorded intraoperatively. The data of pain perception (PP) will be measured using visual analog scale, quantity of analgesics (QA), secondary bleeding (SB), epithelization level (EL), and color match (CM) will be assessed prospectively. these outcomes will be evaluated in the first 7 days and 14th, 21th, and 28th days. Patient reported outcomes will be recorded using OHIB 14 questionnaire.


Eligibility criteria: Inclusion Criteria:

* age ≥18;
* PPS indication that needs CTG in anterior mandible;
* stable periodontium after phase I therapy;
* full-mouth plaque and bleeding scores \<15%

Exclusion Criteria:

* previous palatal harvesting history;
* unstable endodontic conditions;
* tooth mobility at surgical site;
* systemic disease;
* pregnancy;
* use of medications with potential adverse effects to periodontal tissues

Primary outcomes:
measure: Donor site pain perception (PP)
timeFrame: first week
Secondary outcomes:
measure: Primary bleeding time (PBT)
timeFrame: during surgery
measure: Graft height (GH)
timeFrame: during surgery
measure: Graft width (GW)
timeFrame: during surgery
measure: Graft thickness (GT)
timeFrame: during surgery
measure: Working time (WT)
timeFrame: during surgery
measure: Quantity of analgesics (QA)
timeFrame: first week
measure: Secondary bleeding (SB)
timeFrame: first week
measure: Sensation loss (SL)
timeFrame: first week, second week , third week, fourth week.
measure: Color match (CM)
timeFrame: first week, second week, third week, fourth week.
measure: Epithelization level (EL)
timeFrame: first week, second week, third week, fourth week.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT03190590: Neurophysiological and Functional Mechanisms of Motor Control and Learning
Official title: Neurophysiological and Functional Mechanisms of Motor Control and Learning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transcranial Direct Current Stimulation
Keywords: transcranial magnetic stimulation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Noninvasive stimulation of the central nervous system, including transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), has been increasingly used in the investigation of cortical plasticity. The purpose of our study is to understand mechanistically-at the neurophysiological and systems levels-how the brain learns new motor skills. We propose to study the acquisition, consolidation, and retention of motor skill learning in healthy subjects. At the behavioral level, we will use movement kinematics to quantify and characterize movement, which allow us to infer functional strategies used by the brain to reduce movement errors. At a neurophysiological level, we will use TMS to document changes in cortical circuitry, which will allow us to infer neuroplastic changes possibly subserving these strategies. At a systems level, we will enhance motor system excitability using tDCS, which will enable us to infer the contribution of the stimulated area to the motor system's ability to learn new skills.


Eligibility criteria: Inclusion Criteria:

* Right-handed dominance
* Ability to give informed consent

Exclusion Criteria:

* active and/or chronic neurological, psychiatric (including depression), or medical conditions
* psychoactive medication use
* active drug/alcohol dependence or abuse history
* homelessness or other social situation that would preclude consistent visits
* history of head injury (including neurosurgery)
* history of seizure
* inability to comprehend or participate in the procedures involved
* metal in the head (besides in mouth), such as implanted electrodes or devices, shrapnel, surgical clips, or fragments from welding/metalwork
* implanted devices (such as cardiac pacemakers, medical pumps, or intracardiac lines) in the thorax

Primary outcomes:
measure: Motor skill gain from day 1 to day 5
timeFrame: 5 Days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Heidi Schambra-Griesemer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01885390: Registry to Evaluate the ROX COUPLER in Patients With Resistant or Uncontrolled Hypertension
Official title: ROX CONTROL HTN Registry: To Evaluate the ROX Coupler in Patients With Resistant or Uncontrolled Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Blood Pressure, High
Blood Pressure, Resistant
Blood Pressure, Uncontrolled
Keywords: Hypertension
High blood pressure
Resistant blood pressure
Uncontrolled blood pressure
Lead sponsor: ROX Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-25
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this registry is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant or uncontrolled hypertension.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of resistant or uncontrolled hypertension must be made on the basis of current findings, medical history, and physical examination.

Exclusion Criteria:

* Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the registry, comply with follow-up requirements, or impact the scientific integrity of the study.

Primary outcomes:
measure: Change in ambulatory daytime mean systolic blood pressure
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in ambulatory daytime mean diastolic blood pressure
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: ZNA Cardio Middelheim
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Eastbourne
country: United Kingdom
facility: East Sussex Healthcare NHS Trust
city: London
country: United Kingdom
facility: Queen Mary University of London
Study officials:
affiliation: Queen Mary University of London
name: Mel Lobo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04624490: Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease
Official title: Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Asthma
COPD
Interstitial Lung Disease
Cystic Fibrosis
Pulmonary Hypertension
Pulmonary Infection
Other Lung Disease
Keywords: Hyperpolarized 129Xe MRI
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 260
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to develop and evaluate the usefulness of hyperpolarized (HP) 129Xe gas MRI for regional assessment of pulmonary function.

Detailed description: This is an unblinded, open-label study with \~160 subjects with diagnosed pulmonary disease and \~100 healthy controls. Subjects to be enrolled will include males and females 18-80 years old. Evaluation will be on an outpatient basis. Imaging will be done on a single day and will involve administration of up to four 1-liter doses of HP 129Xe plus one 129Xe calibration dose (\~300-400mL HP 129Xe). In addition to 129Xe MRI, a series of anatomical conventional 1H MR images will be collected including a localizer scan, breath-hold spin echo image, and breath-hold steady-state free precession image to highlight the vasculature. All subjects will be evaluated at one center: The University of Kansas Medical Center, KS USA.

Eligibility criteria: Inclusion Criteria:

Healthy Volunteers:

* Subject has no diagnosed pulmonary conditions
* Ability to read and understand English or Spanish

Subjects with Lung Disease:

* Subject has a diagnosis of pulmonary dysfunction made by a physician
* No acute worsening of pulmonary function in the past 30 days
* Ability to read and understand English or Spanish

Exclusion Criteria:

* MRI is contraindicated based on responses to MRI screening questionnaire
* Subject is pregnant or lactating
* Subject does not fit into 129Xe vest coil used for MRI
* Subject cannot hold his/her breath for 15-16 seconds
* Subject deemed unlikely to be able to comply with instructions during imaging
* Oxygen saturation \<88% on room air or with supplemental oxygen
* Cognitive deficits that preclude ability to provide consent
* Institutionalization

Primary outcomes:
measure: RBC/Barrier Ratio
timeFrame: Day 1
Secondary outcomes:
measure: ADC
timeFrame: Day 1
measure: Ventilation Defect Percentage
timeFrame: Day 1
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Peter Niedbalski, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01579890: Compassionate Use of Pennsaid Topical Lotion (Diclofenac) in Osteo or Rheumatoid Arthritis
Official title: A Non-blinded, Non-placebo Controlled, Compassionate Use, Open Treatment, Open-ended Program of the Safety of Pennsaid Topical Lotion (Diclofenac) in the Treatment of Osteo or Rheumatoid Arthritis
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Osteoarthritis of the Hand
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
Collaborators: name: Nuvo Research Inc.
First posted: 2012-04-18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This was a compassionate use, open treatment safety study of Pennsaid topical lotion (diclofenac) for osteo or rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* diagnosed osteo or rheumatoid arthritis
* Oral NSAIDs were not deemed appropriate treatment
* Completed diclofenac sensitivity patch test with negative result
* Signed informed consent form

Exclusion Criteria:

* At the discretion of the physician and HPB

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: