louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00633243: Effective Treatment of Hepatitis C in Substance Users
Official title: Effective Treatment of Hepatitis C in Substance Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Opiate Dependence
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-03-11
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: We hypothesize that integrating Hepatitis C into methadone and buprenorphine treatment will improve Hepatitis C outcomes as well as drug treatment outcomes in patients who are addicted to opiates. We will test this hypothesis by randomly assigning patients to receive integrated or separated care. The first group will receive Hepatitis C treatment and substance abuse treatment contemporaneously at the South Central Rehabilitation Center (SCRC). They will take both methadone or buprenorphine and Hepatitis C medications under the daily (methadone) or weekly (buprenorphine) observation of a health care provider. The second group will receive substance abuse treatment at SCRC, and go to another facility to receive Hepatitis C treatment services. These participants will take their medications on their own (without observation).

We will look at outcomes such as Hepatitis C viral loads, adherence to medications, and drug treatment outcomes such as receipt of buprenorphine and methadone and urine toxicology testing.


Eligibility criteria: Inclusion Criteria:

* Subjects with a DSM IV diagnosis of opioid dependence who are currently enrolled in methadone or buprenorphine maintenance at South Central Rehabilitation Center in good standing (opiate free urine with positive methadone or buprenorphine, respectively) for at least 30 days.
* Hepatitis C infection as evidenced by a positive HCV antibody and a detectable HCV RNA.

Exclusion Criteria:

* Suicidal or homicidal ideation
* Psychiatric condition that is not stable
* Pregnancy (RBV is a Class C drug during pregnancy)
* Pending court case or warrant which would interrupt treatment
* Decompensated cirrhosis (Child's Class B or C) or presence of hepatocellular carcinoma
* HIV+ with CD4\<200 or CD4\>200 and VL\>5,000 copies/mL
* Platelet count \< 75,000 /mL
* Hemoglobin \< 10 mg/dL
* Absolute neutrophil count \<1500 cells/mL

Primary outcomes:
measure: Number of Participants With a Sustained Virologic Response (SVR)
timeFrame: 24 weeks (end of treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: South Central Rehabilitation Agency
state: Connecticut
Study officials:
affiliation: Yale University
name: R. Douglas Bruce, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04552938: LVA on Serum Profiling in Patients With Lymphedema
Official title: The Impact of Lymphaticovenous Anastomosis on Serum Profiling in Patients With Lymphedema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphedema
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Written informed consent was obtained from all patients. Between June 2018 and May 2019, 26 patients with lower limb lymphedema confirmed with lymphoscintigraphy were recruited. Patients with upper limb and bilateral lower limb lymphedema were excluded.

Brief summary: The correlation between oxidative stress and increased lymphedematous limb volume lacks supporting evidence. Lymphedema patients are prone to cellulitis. This study aims to investigate the link between oxidative stress, limb volume, and cellulitis after supermicrosurgical lymphaticovenous anastomosis (LVA).

Detailed description: In this study, we focused on the changes in serum antioxidant biomarkers before and after LVA, detected by isobaric tags for relative and absolute quantitation (iTRAQ)-based quantitative proteomic analysis, enzyme-linked immunosorbent assay (ELISA), and Oxidative Stress Panel Kit. For clinical correlation, magnetic resonance (MR) volumetry was implemented for precise lymphedematous limb volume measurements. Correlations were made between changes in oxidative stress, limb volume, and cellulitis before and after LVA.

Eligibility criteria: Inclusion Criteria:

* patients with lower limb lymphedema confirmed with lymphoscintigraphy
* unilateral lower limb lymphedema
* lymphedema duration \> 2 years
* no active infection
* no prophylactic antibiotic use for at least one month before LVA
* no tumor recurrence or metastasis
* no consumption of antioxidants, such as vitamin E or ascorbic acid

Exclusion Criteria:

* Patients with upper limb and bilateral lower limb lymphedema

Primary outcomes:
measure: the correlation between post-LVA volume reduction
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT01484938: Lens Wearing Experience and Biocompatibility of a Marketed Multi-Purpose Disinfecting Solution in Silicone Hydrogel and Soft Contact Lens Wearers
Official title: Lens Wearing Experience and Biocompatibility of a Marketed Multi-Purpose Disinfecting Solution in Silicone Hydrogel and Soft Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Keywords: Soft contact lenses
Multi-purpose solution
Corneal staining
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-12-05
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study was to describe mean differences in corneal staining (type and area) for OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS) at Day 30 compared to Baseline (Day 0).


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Soft contact lens wear on a daily wear basis
* Able to wear contact lenses for at least 8 hours
* Generally healthy and have normal ocular health
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* No use of additional lens cleaners
* No known sensitivities to any ingredient in the test article
* No history of ocular surgery/trauma within the last six months
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30
timeFrame: Baseline (Day 0), Day 30
measure: Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30
timeFrame: Baseline (Day 0), Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon Research
name: Jami R Kern
role: STUDY_DIRECTOR
References:
Clinical trial NCT03938038: Guidance of Ultrasound in Intensive Care to Direct Euvolemia
Official title: Guidance of Ultrasound in Intensive Care to Direct Euvolemia: A Cluster Randomized Crossover Comparative Effectiveness Trial (GUIDE Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 415
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomization will not occur at the individual patient level. Instead, assessment techniques (US-guided versus usual care) will be randomly assigned to care team clusters. Because teams change each month, the assignment will be to US-guided care during the first half or the second half of the month.
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess the effectiveness of routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation in reducing acute kidney injury (AKI) incidence and duration in trauma patients in a teaching institution.


Eligibility criteria: Inclusion Criteria:

* Injured patients that are admitted to the trauma ICU

Exclusion Criteria:

* Incarceration
* Pregnancy

Primary outcomes:
measure: Number of Acute Kidney Injury (AKI)-Free Days
timeFrame: within 7 days of injury
measure: Number of Participants Who Receive 3 or More Ultrasound Volume Assessments
timeFrame: within 24 hours of ICU admission
Secondary outcomes:
measure: Number of Participants With Acute Kidney Injury (AKI)
timeFrame: within the first 7 days of ICU admission
measure: Stage of Acute Kidney Injury (AKI)
timeFrame: within the first 7 days of ICU admission
measure: Number of Participants With Need for Renal Replacement Therapy
timeFrame: within the first 30 days of ICU admission
measure: Quantity of Fluids Administered
timeFrame: 24 hours
measure: Quantity of Fluids Administered
timeFrame: 48 hours
measure: Type of Fluids Administered
timeFrame: 24 hours
measure: Type of Fluids Administered
timeFrame: 48 hours
measure: Quantity of Diuretics Administered
timeFrame: 24 hours
measure: Quantity of Diuretics Administered
timeFrame: 48 hours
measure: Time to Lactate Normalization
timeFrame: within the first 7 days of ICU admission
measure: Time to Creatinine Concentration <1.5 mg/dL or to Prehospital Baseline
timeFrame: within the first 7 days of ICU admission
measure: Time to Base Excess Normalization
timeFrame: within the first 7 days of ICU admission
measure: Number of Ventilator-free Days
timeFrame: within first 30 days after injury
measure: Number of ICU-free Days
timeFrame: within first 30 days after injury
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Gabrielle Hatton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06214338: Blood Bioavailability of Two Different Doses of a β-alanine Supplement (BIo-β)
Official title: Blood Bioavailability of Two Different Doses of a β-alanine Supplement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bioavailability
Keywords: β-alanine
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to To study the blood bioavailability of a sustained-release β-alanine granulated supplement of two different doses (10 g and 20 g).

Detailed description: Subjects will consume 10 g of β-alanine one day by 4 ingestions of 2.5 g separated by 1 hour and 15 min. While on another day 20 g of β-alanine by 4 ingestions of 5 g separated by 1 hour and 15 minutes, with a washout period of 15 days between the two doses. Subsequently, the amino acid levels in blood will be analyzed after the product intake and during a period of 8 hours.

Each day of visit the paresthesias (moment of appearance, intensity and sensations) will be studied at different times.

Eligibility criteria: Inclusion Criteria:

* Men between 18 and 60 years old.
* Cyclists with more than two years of cycling experience.
* Bicycle training at least twice a week.

Exclusion Criteria:

* Suffer a lasting injury that prevents you from training in the month prior to surgery.
* Subjects with a chronic illness.
* Having consumed in the three months prior to the start of the study any β-alanine supplement.
* Making changes in diet or exercise during the study.
* Inability to understand the informed consent form.
* Consumption of other supplements that could alter the results of the study.

Primary outcomes:
measure: Aminoacids in plasma
timeFrame: After the first intake of the product, samples will be taken at 15, 30, 45, 60 and 75 minutes. After the fourth and last product intake, samples will be taken at 15, 30, 45, 60, 75, 90, 120, 180 and 240 minutes.
Secondary outcomes:
measure: Paresthesia
timeFrame: After the first intake of the product, samples will be taken at 15, 30, 45, 60 and 75 minutes. After the fourth and last product intake, samples will be taken at 15, 30, 45, 60, 75, 90, 120, 180 and 240 minutes.
measure: symptomatology - qualitative question
timeFrame: After the first intake of the product, samples will be taken at 15, 30, 45, 60 and 75 minutes. After the fourth and last product intake, samples will be taken at 15, 30, 45, 60, 75, 90, 120, 180 and 240 minutes.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References:
Clinical trial NCT06426238: Self-reported and Experimental Pain in Patients Undergoing Orthodontic Treatment
Official title: Comparison of Self-reported and Experimental Pain Outcomes Between Clear Aligners and Fixed Appliances in Patients Undergoing Orthodontic Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Pressure pain threshold
Clear aligners
Orthodontic appliance
Adolescents
Self-reported pain
Lead sponsor: Midwestern University
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 38
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients starting an orthodontic treatment (clear aligners or fixed braces) at the Multispecialty Clinic of Midwestern University

Brief summary: Pressure Pain Threshold (PPT) is defined as the minimum force applied to an area that is perceived as pain. PPT is considered an objective measurement tool to assess pain levels. Studies have assessed the difference in pain levels between clear aligners and fixed appliances using subjective pain scales. No study has utilized PPT to evaluate the difference in pain between aligners and fixed braces at different time points. This study will aim to compare the self- reported and experimental pain perception between the clear aligner and fixed appliance therapies during the phase of crown alignment and to assess how long pain is perceived in the following five days from the adjustment of the appliance.


Eligibility criteria: Inclusion Criteria:

* consecutive consented patients (\> 14 years old) beginning an orthodontic treatment on both arches, either with aligners or fixed appliance at the Midwestern University, Multidisciplinary Clinic;
* patients in possession of an email address and Internet connection.

Exclusion Criteria:

* patients with generalized systemic conditions known to affect the overall body pain and pressure pain threshold assessment (e.g., fibromyalgia, autoimmune conditions such as multiple sclerosis, rheumatoid arthritis),
* untreated dental caries.

Primary outcomes:
measure: Self-reported pain intensity
timeFrame: At three timepoints through study completion: at baseline, at 4-6 weeks, and at 8-12 weeks
measure: Pressure Pain Threshold
timeFrame: At three timepoints through study completion: at baseline, at 4-6 weeks, and at 8-12 weeks
Secondary outcomes:
measure: Anxiety and depression symptoms
timeFrame: At two timepoints through study completion: at baseline, and at 8-12 weeks
measure: Pain catastrophizing
timeFrame: At two timepoints through study completion: at baseline, and at 8-12 weeks
measure: Past pain experience
timeFrame: At T0: Baseline (pre-intervention)
Other outcomes:
Locations:
city: Downers Grove
country: United States
facility: Midwestern University
state: Illinois
Study officials:
References:
Clinical trial NCT06116838: Transcutaneous Spinal Cord Stimulation in Healthy Adults
Official title: Effect of Varying Transcutaneous Spinal Cord Stimulation Parameters and Location on Lower Extremity Motor Responses and Comfort
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy Adults
Keywords: Transcutaneous spinal cord stimulation
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The purpose of these visits is to determine the optimal waveform and stimulation location. In order to make this determination, we will first determine what stimulation waveform allows us to reach Resting Motor Threshold (RMT) with the lowest intensity but it is the most comfortable when walking at higher intensities. We will use a test-retest design comparing neurophysiologic measures while participants receive various combinations of stimulation waveforms, modulation frequencies, and stimulation locations.
Primary purpose: OTHER

Brief summary: The goal of this study is to understand how transcutaneous spinal cord stimulation (tSCS) waveform, modulation frequency, and stimulation location impact lower extremity muscle activation and participant comfort in adults without neurologic conditions.

Detailed description: Investigators will use a test-retest design comparing neurophysiologic measures while receiving various combinations of stimulation waveforms, modulation frequencies, and stimulation locations to determine the settings which lead to the highest participant tolerance with the lowest lower extremity resting motor thresholds (RMTs).

Eligibility criteria: Inclusion Criteria:

* Age 18-75 years old
* Able and willing to give written consent and comply with study procedures

Exclusion Criteria:

* History of stroke or neurologic pathologies (such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, etc.)
* Pregnant or nursing
* Skin allergies or irritation; open wounds
* Utilizing a powered, implanted cardiac device for monitoring or supporting heart function (i.e. pacemaker, defibrillator, or LVAD)
* History of seizures or epilepsy
* Active cancer or cancer in remission less than 5 years
* Metal implants in the back or spine
* Painful musculoskeletal dysfunction due to injury or infection
* Unstable cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension, uncontrolled diabetes, or chronic emphysema)

Primary outcomes:
measure: Resting motor threshold
timeFrame: All study visits (1-10), over the course of up to 5 weeks
measure: Continuous stimulation tolerance
timeFrame: All study visits (1-10), over the course of up to 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Arun Jayarman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01179438: Effect of Dexmedetomidine on Microcirculation in Patients Undergoing Extracorporeal Shock Wave Lithotripsy
Official title: Effect of Dexmedetomidine on Microcirculation in Patients Undergoing Extracorporeal Shock Wave Lithotripsy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Microcirculation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2010-08-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Dexmedetomidine administration for minor procedure, such as extracorporeal shock wave lithotripsy, provides good quality of sedation and analgesia. Dexmedetomidine is a highly selective α2-adrenergic receptor agonist which causes sedative effects and reduces opioid requirements in the perioperative period. Extracorporeal shock wave lithotripsy may cause pain and result in tachycardia and vasoconstriction-related hypertension. Surgical or procedural stress may induce inflammation and it may cause further microthrombosis. Both vasoconstriction and microthrombosis will alter the microcirculatory status. Dysfunction of microcirculation may impair tissue perfusion and result in organ dysfunction. Dexmedetomidine may induce vasodilation by slow intravenous infusion for sedation. Dexmedetomidine may also reduce inflammation. After reviewing the literature, the investigators found that the effect of dexmedetomidine on microcirculation was not well investigated. By application of the non-invasive technique of sidestream dark field imaging, the investigators can investigate the vessel density, percentage of perfused vessels, and microvascular flow index on sublingual vessels.

The goal of this study is to identify the effect of dexmedetomidine on sublingual microcirculation in patient undergoing extracorporeal shock wave lithotripsy.


Eligibility criteria: Inclusion Criteria:

* Patient who is older than 18 years old and less than 75 years old
* Patient who receive extraproporeal shock wave lithotripsy with ASA class I or II
* Patient who has understood the inform consent and agree to participate this study

Exclusion Criteria:

* Patient's hemodynamic status is unstable in spite of adequate management or presence of signs of shock
* Patient who has a past history of allergy to s dexmedetomidine
* Patient who has history of cardiovascular, renal or hepatic dysfunction
* Patient who has participated in any other investigational study of other drugs currently
* Female patient who is pregnant or considers breast feeding currently
* Patient who has suspected full stomach

Primary outcomes:
measure: Microcirculation status
timeFrame: 120min
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital, anesthesiology department
Study officials:
References: