louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00784602: Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes
Official title: Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Genital Prolapse
Keywords: prolapse
pelvic organ prolapse
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: William Beaumont Hospitals
First posted: 2008-11-04
Enrollment: 301
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with genital prolapse.

Brief summary: To prospectively observe the outcomes of surgical prolapse treatment in terms of urinary, bowel, and sexual function, quality of life, patient satisfaction, cost, and achieving patient determined treatment goals.

Detailed description: Patients meeting the inclusion/exclusion criteria will be identified by reviewing the hospital's surgical boarding list and contacted by phone to obtain informed consent. Once informed consent is obtained, chart review will be conducted here at William Beaumont Hospital and at the physician's office to collect patient information related to their prolapse condition. Prior to surgery, questionnaires will be mailed and completed by the participant and then again at 6 and 12 months after surgery, and then yearly. Questionnaires will assess urinary, bowel, and sexual function, and patient treatment goals, treatment satisfaction, and general health and wellbeing. Completion of the questionnaires will be voluntary, and participants will be followed in this manner until voluntary withdrawal, exclusionary criteria emerge, or death.

Eligibility criteria: Inclusion Criteria:

* Female
* Pelvic Organ Prolapse
* Able to provide informed consent
* Able to complete study assessments, per clinician judgment

Exclusion Criteria:

* Age \< 21 years
* Currently pregnant or \< 6 months post-partum

Primary outcomes:
measure: Changes in urinary, bowel, and sexual function as measured on the PFDI, PFIQ, and PISQ validated questionnaires
timeFrame: Ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Melissa Fischer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00650702: Safety and Efficacy of Punctum Plug Delivery System in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Official title: A Phase II, Randomized, Masked, Parallel-Group Study of Safety and Preliminary Efficacy of the Punctum Plug Delivery System in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma
Ocular Hypertension
Keywords: glaucoma, ocular hypertension, IOP
Lead sponsor: Mati Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-02
Enrollment: 36
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 the Punctum Plug Delivery System (PPDS) is safe and effective in controlling intraocular pressure in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Over 18 yrs with open-angle glaucoma or ocular hypertension
* Subjects who have a best-corrected visual acuity of 20/100 or better.

Exclusion Criteria:

* Uncontrolled medical conditions.
* Subjects who wear contact lenses.
* Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.
* Subjects who have a history of chronic or recurrent inflammatory eye disease.

Primary outcomes:
measure: IOP change from baseline
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Artesia
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Bel Air
country: United States
state: Maryland
city: Minneapolis
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: Lynbrook
country: United States
state: New York
city: High Point
country: United States
state: North Carolina
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03120702: Measurement of Total Hemoglobin by Pulse Oximetry in Neonatal Population
Official title: Measurement of Total Hemoglobin by Pulse Oximetry in Neonatal Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-19
Enrollment: 128
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Assess ability of Masimo SpHb sensor to demonstrate robust performance on various sensor application sites on neonates/infants


Eligibility criteria: Inclusion Criteria:

* Male or female newborn infants of any gestational age requiring at least one (1) blood draw as part of their routine care.
* Ages: Newborn infants less than 16 weeks postnatal age.
* Weight: Range from 500 g to 10 kg.
* Able to obtain written informed consent from parents or legal guardians

Exclusion Criteria:

* Neonatal patients with abnormalities at the planned application sites that would interfere with transilluminating the foot or hand like unusual deformities of limbs, absence of feet, severe edema, localized infections, and other.

Primary outcomes:
measure: Assess ability of Masimo SpHb sensor to demonstrate robust performance on various sensor application sites on neonates/infants
timeFrame: duration of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
Study officials:
References:
Clinical trial NCT05822102: Simultaneous quanTification of Elexacaftor/tezAcaftor/Ivacaftor Via Reverse Phase High Performance liquiD chromatographY
Official title: Simultaneous quanTification of Elexacaftor/tezAcaftor/Ivacaftor Via Reverse Phase High Performance liquiD chromatographY
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cystic Fibrosis
Keywords: trikafta
elexacaftor/tezacaftor/ivacaftor (ETI)
ETI
cystic fibrosis
Lead sponsor: National Jewish Health
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Up to 100 people with CF who attend the Adult CF Program of Colorado at National Jewish Health and are actively taking ETI hat has reached steady state dosing levels of ETI (defined as a continuous dosing regimen for a minimum of 14 days) will be recruited and enrolled.

Brief summary: The purpose of this study is to support the clinical validation of a new assay to measure the levels of ivacaftor, tezacaftor, and elexacaftor (the components of Trikafta) in the bloodstream in order to achieve greater understanding of the effectiveness of this medication in all people with cystic fibrosis. Blood will be drawn at 3.0, 4.5, and 6.0 hours after taking the medication in the morning.

Detailed description: Blood samples will be collected to measure steady state blood levels for participants who are being treated with elexacaftor/tezacaftor/ivacaftor (ETI). This study is being conducted to evaluate drug dosing in people with cystic fibrosis. The aim of this study is to support clinical validation of pharmacokinetics launch of the elexacaftor/tezacaftor/ivacaftor blood serum level assay to demonstrate instrument capabilities to pass ADx validation criteria.

Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained from subject
* Diagnosis of CF
* Aged 18 years and older
* Use of ETI that has reached steady state dosing levels of ETI, defined as a continuous dosing regimen for a minimum of 14 days.

Exclusion Criteria:

* A person with CF (pwCF) that is either not taking ETI or dose not follow a continuous dosing regimen for a minimum of 14 days.
* Use of prohibited medications as outlined by package insert
* Pregnant or lactating people with CF
* Acute, severe deterioration in health requiring intensive care unit admission

Primary outcomes:
measure: Number of patients with ETI in expected reference range
timeFrame: 3 hours, 4.5 hours and 6 hours after taking the medication
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Denver
country: United States
facility: St. Joseph Hospital
state: Colorado
Study officials:
affiliation: National Jewish Health
name: Jerry Nick, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01032902: Evaluation of the Performance of Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 Rapid Test
Official title: Study to Establish the Ability of the Chembio Diagnostics Systems, Inc. DPP HIV 1/2 Rapid Test to Qualitatively Detect the Presence of Antibodies Against HIV-1 in Oral Fluid, Whole Blood (Capillary and Venous), Serum and Plasma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Human immunodeficiency virus
Rapid Test
HIV
HIV Seronegativity
Lead sponsor: Chembio Diagnostic Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2009-12-16
Enrollment: 2808
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Point-of-care test sites including clinics and physician office settings

Brief summary: This study has been designed to evaluate the performance of the Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 rapid test. The device is intended to qualitatively detect the presence of antibodies against HIV-1/2 in oral fluid, whole blood (capillary and venous), serum or plasma. This study will assess the DPP® HIV 1/2 Screen assay's ability to detect HIV-1.


Eligibility criteria: Inclusion Criteria:

* Must be at least 2 years of age (no upper age limit).
* Must be willing and able to receive post-test counseling, if applicable.
* Must sign (and be given) a copy of the written Informed Consent form and or Assent form (if applicable).
* Must be able to sustain fingersticks and venipuncture from the arm or hand only.

Exclusion Criteria:

* Am in a life threatening condition at the time of enrollment
* Have a suppressed immune systems (i.e. transplant patients, individuals diagnosed with non-HIV immunosuppressive illness, etc.).
* Have participated or are participating in a clinical trial for an HIV vaccine.
* Have previously participated in this clinical trial.

Primary outcomes:
measure: The device detects HIV-1 antibodies in a variety of sample matrices: capillary whole blood, venous whole blood (with EDTA or heparin anticoagulant), oral fluid, serum and plasma (with EDTA or heparin anticoagulant).
timeFrame: 20 minutes
Secondary outcomes:
measure: The device provides a qualitative screen for the detection of antibodies to HIV-1 compared to an FDA approved HIV-1/2 EIA, with sensitivity and specificity equal to or greater than 98% at the lower 95% confidence interval boundary.
timeFrame: 20 minutes
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Univeristy of California, San Diego
state: California
city: Fort Lauderdale
country: United States
facility: Therafirst
state: Florida
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Philadelphia
country: United States
facility: St. Christopher's Hospital for Children/ Drexel University College of Medicine
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas HSC
state: Texas
Study officials:
References:
Clinical trial NCT05317702: The Duration of Effects of Massage in Healthy Participants
Official title: The Duration of Effects of Massage in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Pressure Pain Threshold
Massage
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Massage is a common rehabilitation treatment for musculoskeletal pain. Prior studies indicate massage applied with a deep pressure that induces a moderate amount of pain produces a lessening of pain sensitivity compared to light touch, pain free massage. The investigators now aim to investigate how long pain sensitivity changes last after 4 minutes of moderately painful massage and determine factors that help predict who displays a lessening of pain sensitivity.


Eligibility criteria: Inclusion Criteria:

• pain-free

Exclusion Criteria:

* Non-English speaking
* Systemic medical condition known to affect sensation (i.e. uncontrolled diabetes)
* Regular use of prescription pain medication
* Current or history of chronic pain condition
* Currently taking a blood-thinning medication
* Any blood clotting disorder, such as hemophilia
* Contraindications to the application of a blood pressure cuff to the arm, such as: lymphedema or arterial/venous lines
* Contraindications to elevating the arm above the head or exercising the arm with a light weight, such as a recent surgery or fracture
* Investigator is unable to locate myofascial trigger point in the upper trapezius during testing session

Primary outcomes:
measure: Change in Pressure Pain Threshold
timeFrame: PPT is applied between minutes 1, 2, 3, and 4 of massage. PPT is also applied at minutes 1,3,5,10,15 after massage. A higher PPT indicates a lessening of pain sensitivity.
Secondary outcomes:
measure: Temporal Summation
timeFrame: Applied before massage
measure: Conditioned Pain Modulation
timeFrame: Applied before massage
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: UCF
name: Abigail Wilson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06663202: Osseous Resective Surgery Vs Conservative Surgery with or Without Papilla Preservation Technique
Official title: Fibre-Retention Osseous Resective Surgery (FibReORS) Vs Conservative Surgery with or Without Papilla Preservation Technique for the Treatment of Residual Pockets: a 5-year Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Periodontitis
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of the study is to evaluate the efficacy of either fibre retention osseous resective surgery (FibReORS) or conservative surgery with or without PPT in the treatment of deep residual pockets ≥ 6 mm in stage III-IV periodontitis patients after cause related therapy (step II) in terms of endpoints of therapy and other secondary outcomes at different time intervals (1, 3 and 5 years). Moreover, the study aims to evaluate the stability of the results obtained for the different surgical approaches over a 5 years follow-up period.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of stage III/IV periodontitis.
* Completed steps I-II periodontal therapy at least 6 weeks before.
* Full Mouth Plaque Score less than 15% at re-evaluation.
* Full Mouth Bleeding Score less than 15% at re-evaluation.
* Posterior sextant with residual PPD ≥ 6 mm at ≥ 2 natural teeth (third molars excluded).
* Signed informed consent.

Exclusion Criteria:

* Compromised general health which contraindicates the study procedures (ASA III-VI patients).
* Systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives).
* Pregnant or nursing women.
* Presence of tooth mobility ≥ class 2.
* Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.
* Presence of deep infrabony defects (≥ 3 mm) at the involved sextant.

Primary outcomes:
measure: Pocket closure
timeFrame: 5 years
Secondary outcomes:
measure: Mean Probing Pocket Depth changes
timeFrame: 5 Years
measure: Mean Clinical Attachment Level changes
timeFrame: 5 years
measure: Mean recession changes
timeFrame: 5 years
measure: Tooth Retention
timeFrame: 5 years
measure: Number of instrumentation re-intervention
timeFrame: 5 years
Other outcomes:
measure: Pain after surgery
timeFrame: 14 days
measure: Discomfort during surgery
timeFrame: Immediately after surgery.
Locations:
Study officials:
References:
Clinical trial NCT01544621: Escape Smoke Project: Non-Intervention Non-Drug Multicenter Study on the Real-life Effectiveness of Smoking Cessation in General Practice in Denmark
Official title: Escape Smoke Project: Non-Intervention Multicenter Study On the Real-Life Effectiveness of Smoking Cessation in General Practice in Denmark
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking Cessation
Keywords: Real life smoking cessation. NON-drug NON-intervention study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Technical University of Denmark (DTU)
First posted: 2012-03-06
Enrollment: 544
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Active smokers who wish to quit

Brief summary: Real life smoking cessation rates after 24 weeks non-intervention design. Approximately 40 General Practice (GP) centers with 800 smokers will participate.

Detailed description: Active smokers who wish to quit seen at in primary care practices

Eligibility criteria: Inclusion Criteria:

* Smoking males or females aged 18 years or older.
* Subjects being motivated for and willing to quit smoking.
* Ability to read and understand Danish.

Exclusion Criteria:

* Not smoking.
* Aged below 18 years.
* Lack of motivation and willingness to quit smoking.
* Do not read and understand Danish.
* Is not willing to cooperate with the clinic staff.

Primary outcomes:
measure: Share of participants not smoking six months after the quit date. Intention-to-treat calculation, where participants lost to follow-up are included in as continued smokers
timeFrame: 6 months
Secondary outcomes:
measure: Share of participants not smoking six months after the quit date Per protocol calculation (participants lost to follow-up are excluded in the calculation of the quit rate)
timeFrame: 6 months
measure: Share of participants at six months not smoking the last 14 days Intention-to-treat calculation, where participants lost to follow-up are included in as continued smokers
timeFrame: 6 months
measure: Share of participants at six months not smoking the last 14 days Per protocol calculation (participants lost to follow-up are excluded in the calculation of the quit rate)
timeFrame: 6 months
measure: Share of participants not smoking at the last visit at the GP Intention-to-treat calculation, where participants lost to follow-up are included in as continued smokers
timeFrame: 6 months
measure: Share of participants not smoking at the last visit at the GP. Per protocol calculation (participants lost to follow-up are excluded in the calculation of the quit rate)
timeFrame: 6 months
measure: Share of participants still smoking at six months with a reduction in the use of tobacco and the resulting reduction in smoking Intention-to-treat calculation, where participants lost to follow-up are included in as continued
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04782921: Papillae Tunneling Techniques in the Treatment of Isolated Intrabony Defects
Official title: Clinical Outcomes of Papillae Tunneling Techniques in the Treatment of Isolated Intrabony Defects - a Prospective, Double Blind, Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis Complex
Xenograft Model
Lead sponsor: University of Ljubljana
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Papillae tunneling techniques (PTT) are a new approach toward regeneration of isolated intrabony defects. Compared to regular papillae preservation techniques, PTT rely on complete preservation of involved interdental papillae, providing optimal healing environment for periodontal wound. Surgical access is therefore gained either by vertical incision in vestibulum, or by short releasing incision on adjacent tooth. Interdental tissue is then carefully raised in a full thickness manner by tunneling instruments, root surface thoroughly cleaned by the ultrasound scaler or Gracey curettes and defect filled with the biomaterial of choice.

While the success and aesthetic results of non-incised papillae techniques are well documented, no paper so far compared clinical results of papillae preservation techniques with different biomaterials.

Therefore, the aim of our study is to compare gain of clinical attachment level (defined by sum of pocket probing depth and recession) to regular papillae preservation techniques, and to prove non-inferiority of Gel 40® (collagen matrix, loaded with micronized heterologous bone) to Gen-Os® (granulated cortico-cancellous heterologous bone mix).

Secondary objectives include analysis of aesthetic parameters - differences in recession and tip of the papillae location before and after the treatment.


Eligibility criteria: Inclusion Criteria:

* periodontitis stage III/IV
* at least one periodontal lesion with pocket probing depth \> 5 mm, limited by 2 or more bone walls and intrabony component \> 3 mm.
* good oral hygiene with plaque index and sulcular bleeding index \< 30%.
* systemically healthy
* smokers and non-smokers

Exclusion Criteria:

* systemic diseases that contraindicate the treatment,
* on medications that affects periodontal healing
* pregnant or lactating women
* one wall intrabony defects
* defects that involve buccal and lingual side of the tooth
* tooth with incorrect endodontic treatment or restoration

Primary outcomes:
measure: Clinical attachment level change (CALC)
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Wound closure (WC)
timeFrame: 1 week
measure: Tip of papillae
timeFrame: 6 and 12 months
Other outcomes:
measure: Probing pocket depth (PPD)
timeFrame: 6 and 12 months
Locations:
city: Ljubljana
country: Slovenia
facility: Faculty of Medicine
city: Ljubljana
country: Slovenia
facility: University Dental Clinic
Study officials:
References: