louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02809794: CPAP In-home Assessment Australia
Official title: CPAP In-home Assessment Australia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2016-06-22
Enrollment: 50
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: The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.

Detailed description: Existing and Naïve CPAP users will be recruited into a 6 month in-home study Participants will attend 5 study visits at day 0, 7, 30, 60 and 180. Outcome of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires.

Eligibility criteria: Inclusion Criteria:

* Aged 18 and over.
* Diagnosed with OSA by a practicing physician and prescribed Positive Airway Pressure (PAP) therapy.

Exclusion Criteria:

* Persons contraindicated for Continuous Positive Airway Pressure (CPAP) therapy.
* Persons with other significant sleep disorder(s) (e.g. periodic leg movements, insomnia, central sleep apnea).
* Persons with obesity hypoventilation syndrome or congestive heart failure.
* Persons that require supplemental oxygen with their CPAP device.
* Persons with implanted electronic medical devices (e.g. cardiac pacemakers).
* Persons who are pregnant or think they might be pregnant.
* Persons whose primary language is other than English.
* Persons in existing dependent or unequal relationships with any member of the research team, the researcher(s) and/or the person undertaking the recruitment/consent process.
* Persons highly dependent on medical care.
* People with cognitive impairment, an intellectual disability or a mental illness

Primary outcomes:
measure: Apnea Hypopnea Index (AHI), measured as number of events/hour
timeFrame: 6 months
measure: Log of safety-related events, measured as number of safety-related faults
timeFrame: 6 months
measure: Machine reported faults, measured as number of machine faults
timeFrame: 6 months
measure: Participant reported faults, measured as number of participant complaints
timeFrame: 6 months
Secondary outcomes:
measure: Perception of the device, measured through questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Bulleen
country: Australia
facility: Sleep Matters
state: Victoria
city: Bunbury
country: Australia
facility: Sleep & Snore Solutions
state: Western Australia
city: Midland
country: Australia
facility: St John of God Midland Public Hospital
state: Western Australia
Study officials:
References:
Clinical trial NCT02084160: Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation
Official title: The Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation; a Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Liver Disease
Lead sponsor: Meridian Bioscience, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-11
Enrollment: 579
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic liver disease subjects from previous Exalenz trial "HIS-EX-408"

Brief summary: The objectives of this study are:

* To evaluate the ability of the Methacetin Breath Test (MBT) to detect hepatic decompensation events
* To evaluate the relationship between liver Biopsy and clinical outcome and show that the MBT has a better predictive ability of clinical outcome than liver biopsy.
* To evaluate the ability of the MBT to predict each of the individual liver related complications.

Detailed description: Exalenz has previously gathered information in a previous study on patients with chronic liver disease including the methacetin breath test. Several years later, the company wishes to investigate this group of subjects and see retrospectively if the breath test was a predictor of complications related to their liver disease.

Eligibility criteria: Inclusion Criteria:

All subjects that aere enrolled in the previous Exalenz trial HIS-EX-408 or PLT-BID-1108

Exclusion Criteria:

None

Primary outcomes:
measure: Hepatic Decompensation Event
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Jerusalem
country: Israel
facility: Hadassah Medical Origanzation
Study officials:
affiliation: Hadassah Medical Organization
name: Taufick Chori, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00563160: Study of Efficacy of Induction Chemotherapy With Gemcitabine and Carboplatin for Operable Non-small-cell Lung Cancer Before Surgery
Official title: Phase II Study of the Response Rate of Induction Chemotherapy With Gemcitabine and Carboplatin for Operable Non-small Cell Lung Cancer Before Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung Neoplasms
Keywords: lung cancer
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
Collaborators: name: Eli Lilly and Company
First posted: 2007-11-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To study the activity of chemotherapy with Gemzar-carboplatin in the preoperative setting for operable stages of non-small-cell lung cancer and to identify novel molecular markers correlated with chemosensitivity and prognosis


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically proven, newly diagnosed primary bronchogenic non-small cell lung cancer
* Measurable or evaluable tumour on chest X-ray or CT scan.
* No multiple ipsilateral or contralateral parenchymal tumours
* Stage I(exceptT1N0),II,IIIa disease as shown by PET-CT

Primary outcomes:
measure: pathological response rate
timeFrame: 12 months
Secondary outcomes:
measure: progression-free survival
timeFrame: 18 months
measure: overall survival
timeFrame: 18 months
measure: quality of life measurements
timeFrame: 18 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Elizabeth Hospital
Study officials:
affiliation: Department of Clinical Oncology, Queen Elizabeth Hospital
name: Siu Kie Au, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05676060: X-ray Guided Facet Block in Chronic Low Back Pain
Official title: X-ray Guided Facet Block in Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Back Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: individual

Brief summary: Review outcome of injection of facet joint in chronic low back pain

Detailed description: Low back pain is a common problem that most people may experience. the incidence of low back pain is highest in the third decade and increases with age until the 60-65 year age group.

In the USA the prevalence of Low back pain is between 15 and 45%. Facet joint is the primary cause of pain in 10-15% of young adult patients with chronic low back pain.

Probable risk factors include genetic factors, age, smoking, heavy physical work, static work postures, lifting, vibration, obesity, and psychosocial factors.(2) Other Causes of low back pain include muscle and ligament strain, bulging or ruptured disc, arthritis, osteoporosis Treatment of chronic low back pain include pharmacological treatment, ,epidural steroid injection ,facet joint block and back surgery The facet joints are a set of plane types of synovial joints between the articular processes of two adjacent vertebrae, The lumbar facet joint is innervated by the medial branch from the posterior ramus of the lumbar spinal nerve.

Lumbar facet joint injections are performed by various techniques, including fluoroscopic-guided technique indications of diagnostic and therapeutic facet joint interventions

1. Average pain levels \> 5 on a scale of 0 to 10.
2. Contraindications or inability to undergo physical therapy or inability to tolerate oral medications.

Complications from facet joint injections in the lumbar spine are rare and mostly related to the needle placement and/or reactions to injected drugs.(3)

Eligibility criteria: Inclusion criteria:1-strong clinical suspicion of the facet syndrome,

2-Focal tenderness over the facet joints

3-Low back pain with normal radiological findings,

4-Post-laminectomy syndrome with no evidence of arachnoiditis or recurrent disc disease,

5-Persistent low back pain after lumbar spinal 6- Failed conservative treatment, including physical therapy with exercises, chiropractic management, and pharmacologic therapy

Exclusion Criteria:

- 1- Low back pain with abnormal radiological findings,

2-Post-laminectomy syndrome with evidence of arachnoiditis or recurrent disc disease,

Primary outcomes:
measure: Visual analogue scale
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01223560: Collection of Information-Rich Type 1 Diabetes Data
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Artificial pancreas
Model predictive control
Virtual patient
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: The Danish Council for Strategic Research
name: Technical University of Denmark
name: Novo Nordisk A/S
First posted: 2010-10-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this clinical study was to obtain type 1 diabetes data to identify models for glucose prediction and control and to construct a physiological pharmaco-kinetic/pharmaco-dynamic computer model of a type 1 diabetic person.


Eligibility criteria: Inclusion Criteria:

* diabetes duration \> 5 years
* HbA1c \< or = 7.2%
* CSII treated for \> 3 months
* Capable of being moderately, physically active for 20 minutes

Exclusion Criteria:

* symptoms of diabetic late complications except simplex retinopathy
* pregnancy or nursing

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
References:
Clinical trial NCT01123460: Biomarkers Predicting Response in Patients With Non-Small Cell Lung Cancer Previously Treated With Erlotinib Hydrochloride
Official title: Measurement of Potential Biomarkers Predicting Erlotinib Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: non-small cell lung cancer
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-05-14
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples submitted for research from patients enrolled on E3503

Brief summary: RATIONALE: Studying samples of blood in the laboratory from patients receiving erlotinib hydrochloride may help doctors learn more about the effects of erlotinib hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research study is studying biomarkers predicting response in patients with non-small cell lung cancer previously treated with erlotinib hydrochloride.

Detailed description: OBJECTIVES:

* To evaluate whether serum NGAL, MMP-9, NGAL/MMP-9 complex, and soluble E-cadherin can be utilized as biomarkers to predict response in patients with non-small cell lung cancer treated with erlotinib hydrochloride.

OUTLINE: Serum samples are analyzed for NGAL, MMP-9, NGAL/MMP-9, and soluble E-cadherin by ELISA and Luminex assays.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of non-small cell lung cancer
* Received erlotinib hydrochloride on clinical trial ECOG-E3503

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Baseline serum NGAL, MMP-9, NGAL/MMP-9 complex, and soluble E-cadherin levels as predictors of erlotinib hydrochloride response
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Steven M. Dubinett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03798860: Monitoring of Donor-specific Antibodies After Treatment with Immunoglobulins, Plasmapheresis and Rituximab in Lung Transplantation
Official title: Monitoring of Donor-specific Antibodies (DSA) After Combined Treatment with Immunoglobulin a and Immunoglobulin M-enriched Intravenous Human Immunoglobulins and Plasmapheresis and Rituximab in Lung Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Transplantation
Donor-specific Anti-human Leukocyte Antigen(HLA) Antibodies
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients after lung transplantation with detection of donor-specific antibodies

Brief summary: Single-arm, prospective observational study

Detailed description: This is an observational study to monitor the treatment of donor-specific antibodies in lung transplant recipients with detection of donor-specific antibodies. All consented subjects will be approached for participation. The study will evaluate the effectiveness of the treatment protocol of donor-specific antibodies with Immunoglobulins or combined treatment with Immunoglobulins, Plasmapheresis and Rituximab after lung transplantation.

Eligibility criteria: Inclusion Criteria:

* all patients after lung transplantation with detection of donor-specific antibodies

Exclusion Criteria:

* none

Primary outcomes:
measure: Donor-specific Antibodies Clearance
timeFrame: 6, 12, 18, 24 months
Secondary outcomes:
measure: Graft survival
timeFrame: 1, 3, 5 years
measure: Incidence of acute cellular and humoral rejections and chronic lung allograft dysfunction (CLAD)
timeFrame: 1, 3, 5 years
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery
Study officials:
affiliation: Hannover Medical School
name: Fabio Ius, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05429060: A Prospective Evaluation of Hemorrhoidal Surgery Outcome in Istanbul
Official title: A Prospective Assessment of Surgical Treatments in Hemorrhoidal Disease: Real-life Practice and Early Outcome in Terms of Patient-reported Symptoms and Quality of Life
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemorrhoids
Quality of Life
Complication of Treatment
Indication, Unlabeled
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who underwent any interventional treatment other than medical therapy under local and/or general anesthesia will be eligible.

Brief summary: This study aims to evaluate the effect of surgical treatments on the quality of life in hemorrhoidal disease. All available treatment methods will be included in this 1-year cohort which is going to collect data from a big metropol.


Eligibility criteria: Inclusion Criteria:

* Surgical interventions under local and/or general anesthesia
* Elective or emergency interventions (including thrombectomy)
* Surgical interventions in operation room or office
* Any kind of excision, sclerotherapy, ligation, suturation, ablation, mucopexy

Exclusion Criteria:

* Any accompanying perianal disease (anal fistula, anal fissure, perianal abscess, anal condyloma extending into the anal canal)
* Previous surgery for hemorrhoids (any intervention other than medical treatment)
* Previous perianal surgery (internal sphincterotomy, fistula surgery)
* Pelvic and/or perineal radiotherapy
* Previous obstetric or perianal injury and/or sphincter repair
* Previous rectal surgery (distal colectomy for benign or malignant etiology)

Primary outcomes:
measure: Improvement in Short Health Scale-HD score at 1 year after hemorrhoidal surgery
timeFrame: 1 year
measure: Hemorrhoidal Disease Symptom Score at 1 year after hemorrhoidal surgery
timeFrame: 1 year
Secondary outcomes:
measure: Recurrence
timeFrame: 1 year
measure: Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medipol University Bahcelievler Hospital
state: Bahcelievler
Study officials:
affiliation: Medipol University
name: Naciye Cigdem Arslan, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01540760: A Study of MCAF5352A in Healthy Volunteers
Official title: A Phase Ib, Single-Center, Randomized, Placebo-Controlled, Double-Blind Multiple Ascending-Dose Study to Investigate the Safety, Pharmacokinetics, and Immunogenicity of Subcutaneous MCAF5352A in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2012-02-29
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This single-center, randomized, placebo-controlled, double-blind, multiple ascending dose study will evaluate the safety, pharmacokinetics and immunogenicity of MCAF5352A in healthy volunteers. Subjects will be randomized to receive either MCAF5352A or placebo on Days 1, 15 and 29.


Eligibility criteria: Inclusion Criteria:

* Healthy males and females, 18 - 55 years of age
* Subjects in good health as determined by screening medical history, physical examination, vital signs, 12-lead ECG and laboratory tests
* Body weight between 45 kg and 110 kg
* Female subjects must be willing to use two effective methods of contraception from screening to a minimum of 4 months after the last dose of study drug

Exclusion Criteria:

* Pregnant or lactating women
* Positive for hepatitis B, hepatitis C or HIV infection
* History of significant chronic or recurrent infections
* History of clinically significant drug allergy and/or a known hypersensitivity to protein therapeutics or formulation components or a related drug
* History of alcohol or drug abuse within 12 months prior to Day 1, or evidence of such abuse
* Subjects who have previously received the study drug
* Participation in a clinical trial within 4 weeks prior to Day 1 or use of any experimental or biologic therapy within 12 weeks prior to Day 1 or within 5 half-lives of the product, whichever is greater

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: approximately 5 months
Secondary outcomes:
measure: Pharmacokinetics: Area under the concentration-time curve
timeFrame: Pre-dose and 5 time points up to 14 days post-dose
measure: Immunogenicity: Serum MCAF5252A antibodies
timeFrame: Days 1, 29, 50, 78, 106 and 134
Other outcomes:
Locations:
city: Quebec
country: Canada
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03056560: Evaluating a Video Bystander Program for First-Year College Students
Official title: TakeCARE: A Video Bystander Program to Prevent Sexual Violence on College Campuses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bystander Behavior
Lead sponsor: Southern Methodist University
Sponsor class: OTHER
First posted: 2017-02-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate an innovative video bystander program, which has the potential to be implemented broadly and cost-effectively across college campuses. Half of the participants will receive the video bystander program, and the other half will not.

Detailed description: Sexual violence, which includes both sexual coercion and assault, is a significant problem on college campuses due to its high prevalence and adverse consequences. This research will evaluate an innovative video bystander program, which has the potential to be implemented broadly and cost-effectively across college campuses. We will recruit first-year college students from each of 4 college campuses (Southern Methodist University, Marquette University, William Paterson University, and Stony Brook University).

The video bystander program (TakeCARE) starts with a narrator acknowledging the various demands placed on students in attempting to balance adult responsibilities with the social opportunities of college, as well as the importance of keeping safe while engaging in these social activities. The program describes how likely it is that people they know may become a victim of sexual violence and how they can help "take care of their friends" to help prevent victimization. TakeCARE includes 3 video vignettes that demonstrate ways that students can intervene when they see sexual coercion, relationship violence, or other situations that might result in harm.

After a baseline assessment, students will be randomly assigned to view one of two video programs: TakeCARE (the video bystander program) or a control video program. A post-treatment assessment will be completed within a week of viewing the video program, and follow-up assessments will be completed 2 months and 6 months after baseline.

Eligibility criteria: Inclusion Criteria:

* first-year college students

Exclusion Criteria:

-

Primary outcomes:
measure: Change in bystander behavior
timeFrame: Baseline and 2 months
Secondary outcomes:
measure: Change in bystander behavior
timeFrame: Baseline and 2 months
measure: Change in bystander efficacy
timeFrame: Baseline and 2 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Southern Methodist University
state: Texas
Study officials:
affiliation: Southern Methodist University
name: Ernest Jouriles, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: