louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00357279: Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease
Official title: A Multi-Center, Double-Blind, Placebo-Controlled Randomized, Efficacy and Safety Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cystic Fibrosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-07-27
Enrollment: 352
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate the safety and effectiveness of a one dose strength of denufosol compared to placebo in patients with mild CF lung disease.


Eligibility criteria: Inclusion Criteria:

* Have confirmed diagnosis of cystic fibrosis
* Have FEV1 of greater than or equal to 75% of predicted normal for age, gender, and height
* Be able to reproducibly perform spirometry maneuvers
* Be clinically stable for at least 4 weeks prior to screening

Exclusion Criteria:

* Have abnormal renal or liver function
* Have chest x-ray at screening suggesting clinically significant active pulmonary disease
* Be colonized with Burkholderia cepacia
* Have had a lung transplant

Primary outcomes:
measure: Change in lung function
timeFrame: 48 weeks
Secondary outcomes:
measure: Pulmonary exacerbation
timeFrame: 48 weeks
measure: Requirements for concomitant CF medications
timeFrame: 48 weeks
measure: Quality of Life
timeFrame: 48 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Accurso FJ, Moss RB, Wilmott RW, Anbar RD, Schaberg AE, Durham TA, Ramsey BW; TIGER-1 Investigator Study Group. Denufosol tetrasodium in patients with cystic fibrosis and normal to mildly impaired lung function. Am J Respir Crit Care Med. 2011 Mar 1;183(5):627-34. doi: 10.1164/rccm.201008-1267OC. Epub 2010 Dec 17.
Clinical trial NCT02315079: Point of Care Testing of Inflammatory Markers in Tears
Official title: Point of Care Testing of Inflammatory Markers in Tears
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Syndrome
Keywords: Ocular Inflammation
Matrix Metalloproteinase 9
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-12-11
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18-90 years of age that present to our North Central Florida Tertiary Referral University Eye Clinics for evaluation. Patients with and without evidence of eye inflammation will be eligible for this study.

Brief summary: To evaluate the use of a point of care device to measure markers of inflammation in various eye conditions. In particular, matrix metalloproteinase-9 (MMP-9) will be measured. MMP-9 is an enzyme that plays a role in inflammation. The value obtained with the point of care device will be correlated with values obtained using gel electrophoresis to measure MMP-9 from the same sample. These data will be compared to clinical exam findings and questionnaires to help the investigators better understand the role of this marker of inflammation in eye diseases and possibly improve diagnostic abilities.

Detailed description: As a participant in the study a sample of tears will be collected in a non-invasive manner by sitting comfortably at the slit lamp (a slit lamp is the standard device used to examine the eye and merely requires the participant to sit upright and place their chin on a chin rest and their forehead up against the slit lamp apparatus). The participant will then be asked to look upwards and while gently lowering the lower eyelid, a sterile blunt glass pipette will be used to collect tears from the natural tear lake (the tear lake is a reservoir of tears that sits on the surface of the eye and above the lower eyelid). Collected tears will then be taken for analysis of inflammatory markers.

In addition, a survey to evaluate the symptoms and the symptoms impact daily life (Ocular Surface Disability Index Survey of National Eye Institute Visual Functioning Questionnaire- 25).

Eligibility criteria: Inclusion Criteria:

* Patients that present to clinic for evaluation. Patients with and without evidence of eye inflammation will be eligible for this study.

Exclusion Criteria:

* Patients outside the age limits will not be eligible for the study

Primary outcomes:
measure: Measurement of matrix metalloproteinase-9 in tears
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida, Department of Ophthalmology
state: Florida
Study officials:
affiliation: University of Florida, Department of Ophthalmology
name: Sonal Tuli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05425979: Mepivacaine Versus Bupivacaine Onset Time in Ultrasound-guided Ankle Blocks
Official title: Onset of Sensory Blockade in Ultrasound-Guided Ankle Block with Mepivacaine Versus Bupivacaine: a Randomized Non-Inferiority Clinical Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Ankle Block
Foot Surgery
Keywords: Ultrasound-Guided Ankle Block
Regional anesthesia
Local anesthesia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 50
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 research is to determine if both local anesthetics (mepivacaine and bupivacaine) are similar in their onset of sensory block to assess the efficiency of ultrasound-guided ankle blocks in our practice. Currently it is the standard of care to perform ankles blocks with both mepivacaine and bupivacaine. However, given similarity in their safety profile researchers would like to compare if one is non-inferior to the other in terms of onset time of ankle block.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years old.
* Patients who provide informed consent to participate.
* Patients undergoing foot surgery who require a peripheral nerve block of the ankle as primary anesthesia.
* ASA (American Society of Anesthesiology) Physical Status Classification I - III.

Exclusion Criteria:

* Inability to consent.
* Allergy to local anesthetic.
* Infection at site of injection.
* Pregnancy.
* Coagulopathy.
* Hepatic or renal failure.
* Preexisting neuropathy in operative limb.
* Planned spinal anesthetic or general anesthesia.

Primary outcomes:
measure: Onset of sensory Blockage
timeFrame: 20 minutes
Secondary outcomes:
measure: Block Failure
timeFrame: 20 minutes
measure: Pain Scores
timeFrame: Post-procedural, approximately 2-4 hours
measure: Total opioid received intra-operatively
timeFrame: Intra-operatively, approximately 4-6 hours
measure: Time to first opioid use
timeFrame: 24 hours
measure: Number of complications
timeFrame: 24 hour
measure: Total anesthesia-related time
timeFrame: 20 minutes
measure: Overall Benefit of Analgesia Score (OBAS)
timeFrame: 24 hours after discharge
measure: Total opioid use after discharge
timeFrame: 24 hours after discharge
measure: Duration of the ankle block
timeFrame: 24 hours after discharge
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Bridget Pulos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01754779: Treatment for Calcium Phosphate Kidney Stone Disease
Official title: Pharmacological Therapy for Calcium Phosphate Urolithiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Calcium Phosphate Kidney Stones
Keywords: calcium phosphate
urolithiasis
kidney stones
hypercalciuria
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-12-21
Enrollment: 13
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators will examine in two studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of Calcium Phosphate stone formers.

Detailed description: We will examine in two short-term placebo-controlled cross-over metabolic studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of CaP stone formers.

The first study will be conducted in hypocitraturic CaP stone formers without hypercalciuria, and will compare the effects of potassium citrate, citric acid and placebo.

The second study will be conducted in hypercalciuric CaP stone formers on a thiazide diuretic who require potassium supplementation, and will compare the effects of potassium chloride alone, potassium chloride + citric acid, and potassium citrate alone. Physicochemical assays will be applied in addition to computer-based stone risk prediction programs to assess risk of stone recurrence.

Eligibility criteria: Inclusion Criteria:

Aim 1

* Hypocitraturic CaP stone formers
* urine citrate \<320mg/d
* elevated pH as 24-hr urine pH above 6.40
* \>21 years

Aim 2

* Hypercalciuric CaP stone formers
* 24hr urine calcium \>250mg/d in women and \>300mg/d in men prior to indapamide use
* high pH as \>6.40 in the absence of urinary tract infection
* \>21 years

Primary outcomes:
measure: Urinary Calcium Phosphate Saturation
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Naim M Maalouf, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Doizi S, Poindexter JR, Pearle MS, Blanco F, Moe OW, Sakhaee K, Maalouf NM. Impact of Potassium Citrate vs Citric Acid on Urinary Stone Risk in Calcium Phosphate Stone Formers. J Urol. 2018 Dec;200(6):1278-1284. doi: 10.1016/j.juro.2018.07.039. Epub 2018 Jul 20.
Clinical trial NCT04268979: Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator
Official title: Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator Intervention for Neuro-Oncology Couples
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Brain Cancer
Keywords: Neuro Oncology
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 296
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to determine if family caregivers of neuro-oncology patients feel less burdened by utilizing the Electronic Social Network Assessment Program (eSNAP) + the Caregiver Navigator.


Eligibility criteria: Inclusion Criteria:

* English-speaking/reading/writing
* Able to complete questionnaires (including by proxy)
* Family Caregivers (FCGs) must self-identify as being a primary FCG of a patient with a primary brain tumor, secondary (metastatic) brain tumor, or leptomeningeal disease diagnosis. A primary caregiver is a family member, friend, or other unpaid person who provides at least some care for a patient at home.
* Patients must be diagnosed with new or recurrent primary brain tumor, a secondary (metastatic) brain tumor or leptominingeal disease within the last 9 months, receiving at least some evaluation and/or care at Moffitt (i.e. at least one appointment), have a prognosis of at least 9 months

Exclusion Criteria:

* Patients may not participate without a consenting FCG, but FCGs may participate without a consenting patient
* Patients and FCGs who are experiencing acute distress will be excluded from enrollment and referred directly to social work, per Moffitt policy.

Primary outcomes:
measure: Family Caregiver Well-Being Using GAD-7 Scale
timeFrame: 8 weeks per participant
measure: Family Caregiver Well-Being using PHQ-8 Scale
timeFrame: 8 weeks per participant
measure: Family Caregiver Well-Being Using Zarit Burden Interview
timeFrame: 8 weeks per participant
measure: Neuro Patients Well-Being Using GAD-7 Scale
timeFrame: 8 weeks per participant
measure: Neuro Patients Well-Being using PHQ-8 Scale
timeFrame: 8 weeks per participant
measure: Neuro Patients Well-Being using NeuroQol
timeFrame: 8 weeks per participant
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Margaret Byrne, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reblin M, Ketcher D, McCormick R, Barrios-Monroy V, Sutton SK, Zebrack B, Wells KJ, Sahebjam S, Forsyth P, Byrne MM. A randomized wait-list controlled trial of a social support intervention for caregivers of patients with primary malignant brain tumor. BMC Health Serv Res. 2021 Apr 17;21(1):360. doi: 10.1186/s12913-021-06372-w.
Clinical trial NCT05570279: PLAN-A Data- Bio- and Plan- Bank Collection for SCCA in Denmark
Official title: PLAN-A - Data- Bio-and Plan-bank Collection in Patients Treated With Radiotherapy for Squamous Cell Carcinoma of the Anus in Denmark - a DACG Cooperation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anal Cancer
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
name: Vejle Hospital
First posted: 2022-10-06
Enrollment: 314
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: All patients eligible for radiotherapy for SCCA in Denmark will be offered inclusion.

Brief summary: The study is a prospective registration of treatment related-, toxicity-, Quality of life- and outcome data from patients treated in Denmark with radiotherapy for squamous cell carcinoma of the anus (SCCA), as a cooperation within the Danish Anal Cancer Group (DACG).

Substudy one: A prospective biobank is collected with the purpose to identify predictive and prognostic markers for outcome.

Substudy two: MRI scans are performed to investigate the rate of pelvic insufficience fractures at one year post chemoradiotherapy.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Squamous cell carcinoma of the anus, and indication for curatively intended radiotherapy
* Written and oral consent

Exclusion Criteria:

* Contraindication to blood sampling or MRI scans (substudy 1 and 2)
* Other malignant disease within 5 years except from basal cell carcinomas

Primary outcomes:
measure: Complete clinical response
timeFrame: 3 years
Secondary outcomes:
measure: Early toxicity evaluation by CTCAE
timeFrame: 2 weeks after the last day of therapy
measure: Late toxicity evaluation by CTCAE
timeFrame: 1 and 3 years post treatment
measure: Quality of life assessed by the EORTC QoL questionaires
timeFrame: 2 weeks, 1 and 3 years post therapy
measure: Prognostic value of ctDNA
timeFrame: At time of treatment completion, an average of 30 days, 1 and 3 years post therapy
measure: Incidence of pelvis fractures
timeFrame: 1 and 3 years post therapy
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Vejle
country: Denmark
facility: Vejle Hospital
Study officials:
References:
Clinical trial NCT05874479: Reducing AIR Pollution Exposure to Lower Blood PRESSURE Among New York City Public Housing Residents
Official title: Reducing AIR Pollution Exposure to Lower Blood PRESSURE Among New York City Public Housing Residents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Pressure
Keywords: self-measured morning home systolic blood pressure (AM H-SBP)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-05-25
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Fine particulate matter \<2.5 µm (PM2.5) air pollution is the fifth leading risk factor for global mortality, with the largest portion of deaths due to cardiovascular disease (CVD). While several mechanisms are responsible, PM2.5-induced elevations in blood pressure (BP) may be relevant. Indoor portable air cleaners (PACs) are a novel approach to reduce exposure to PM2.5 and potentially lower blood pressure. The current study is being conducted to provide evidence that PACs reduce PM2.5 exposure and lower systolic blood pressure (SBP) in key patient populations.


Eligibility criteria: Inclusion Criteria:

* self-reported nonsmokers living in a nonsmoking household.
* adults living with hypertension (HTN) from NYC public housing.

Exclusion Criteria:

* History of major known arrhythmias (e.g. atrial flutter or fibrillation, ventricular tachycardia).
* Screening systolic BP ≥160 mm Hg or diastolic BP ≥100 mm Hg (i.e. severe hypertension by the 2017 ACC/AHA BP guideline).
* A change in drug regimen in the prior 2 weeks or a planned change in drug regimen during the first 30 days for those taking antihypertensive medication.
* Current smoking or living with an active smoker who smokes indoors
* Planned travel out of NYC for ≥2 weeks in next 6 months
* Incarcerated
* Pregnant
* Unable/unwilling to consent
* Established cardiovascular disease
* End-stage renal disease (chronic kidney disease stage IV or on dialysis)
* Barrier to technology use (e.g., visual or hearing impairment)
* Lung disease requiring oxygen
* Cancer receiving treatment

Primary outcomes:
measure: Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 30 Days
timeFrame: Up to Day 30
Secondary outcomes:
measure: Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 90 Days
timeFrame: Up to Day 90
measure: Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 180 Days
timeFrame: Up to Day 180
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jonathan Newman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01067079: Single Center, Open Label, Follow up Study in Subjects Who Previously Received Rabies Vaccine as Simulated Post-Exposure Regimen
Official title: A Phase III, Single Center, Open Label, Follow-up Immunogenicity Study in Subjects Who Previously Received Post-exposure Rabies Vaccine According to the Essen or 2:1:1 (Zagreb) Schedule
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rabies
Keywords: Rabies vaccine
Long-term Immunogenicity
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-02-11
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who received complete vaccine series in accordance to the designated vaccination schedule in the previous M49P8 study

Brief summary: This study will evaluate the immunogenicity of rabies vaccine at 13 months, 3 year and 5 years after initial vaccination, administered in two different post-exposure vaccination schedules


Eligibility criteria: Inclusion Criteria:

* Male and Female subjects who received complete vaccine series in accordance to the designated vaccination schedule in the previous M49P8 study

Exclusion Criteria:

* Any disease condition, that in the opinion of investigator may interfere with subjects ability to participate in the study.
* Receipt of additional doses of rabies vaccine after completion of initial vaccine series.
* For additional entry criteria please refer to protocol.

Primary outcomes:
measure: Rabies virus neutralizing antibody(RVNA) responses 13months, 3 years and 5 years after completion of initial vaccination series as evaluated by percentage of subjects with RVNA greater than or equal to 0.5 IU/mL
timeFrame: 13 months, 3 years and 5 years after initial vaccination
Secondary outcomes:
measure: Rabies virus neutralizing antibody(RVNA) responses 13months, 3 years and 5 years after completion of initial vaccination series as evaluated by geometric mean concentration
timeFrame: 13months, 3 years and 5years after initial vaccination
Other outcomes:
Locations:
city: Jizhou County
country: China
state: Hebei
Study officials:
References:
citation: Ma J, Wang H, Li J, Chang L, Xie Y, Liu Z, Zhao Y, Malerczyk C. A randomized open-labeled study to demonstrate the non-inferiority of purified chick-embryo cell rabies vaccine administered in the Zagreb regimen (2-1-1) compared with the Essen regimen in Chinese adults. Hum Vaccin Immunother. 2014;10(10):2805-12. doi: 10.4161/21645515.2014.972773.
Clinical trial NCT06888479: Optimal Timing of Hepatitis B Vaccination After Transplants
Official title: Optimal Timing of Hepatitis B Vaccination After Transplants: a Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Transplant-Related Disorder
Hepatitis B Virus Infection
Vaccine Reaction
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The investigators aim to perform a randomized clinical trial to determine the optimal timing of hepatitis B vaccination after hematopoietic cell transplantation (HCT) through evaluating the immunity effect of two different vaccination schedules (initiated at 3 or 6 months after transplantation) in patients with different immune reconstitution status.


Eligibility criteria: Inclusion Criteria:

1. Patients must be ≥ 16 years old;
2. Patients receiving hematopoietic cell transplantation;
3. Patients achieving complete molecular remission;
4. Patients or their guardians have to sign an informed consent form before the start of the research procedure.

Exclusion Criteria:

1. Multiple transplantations;
2. Donors' HBV-DNA or HBsAg are positive;
3. Patients' HBV-DNA or HBsAg are positive before transplantation or \< 3 months after transplantation;
4. Patients who are unable to comply with the research treatments and monitoring requirements due to mental or other medical conditions;
5. Patients who are ineligible for the study due to other reasons which would cause unacceptable risks to the patients.

Primary outcomes:
measure: Titer of hepatitis B surface antibodies (HBsAb).
timeFrame: One month after the completion of 3 doses of hepatitis B vaccine.
Secondary outcomes:
measure: HBV infection
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital
state: Tianjin
Study officials:
References: