louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00139022: Home Diagnosis and Treatment of Obstructive Sleep Apnea
Official title: Can Obstructive Sleep Apnea be Diagnosed at Home? A Randomised Trial of Home vs.in-Lab Diagnosis and Treatment of OSA.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: sleep apnea, home monitoring, CPAP
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2005-08-30
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: Obstructive Sleep Apnea (OSA) is a common and underrecognised condition. The diagnosis of OSA is typically made after an in-lab polysomnography (PSG) which requires an overnight stay in a sleep laboratory. Many sleep laboratories have long waiting lists for PSG. There are a number of portable devices which may be useful in home diagnosis of OSA, however there is limited data on outcomes of OSA diagnosed and treated at home. In this study we propose to compare diagnostic accuracy of a home monitoring device with a PSG and outcomes of OSA therapy when implemented at home vs in the sleep laboratory.

Detailed description: We will randomise patients suspected to have OSA to either home evaluation and treatment (using a portable monitor and auto-CPAP) or in-lab evaluation with a PSG and manually-titrated CPAP. We will obtain sleep, sleepiness and quality of life questionnaires, vigilance testing and blood pressure at baseline and after 1, 2, 4 and 12 weeks of therapy. We will also assess and compare compliance with CPAP therapy in each arm of the study.

Eligibility criteria: Inclusion Criteria:

* adult ( age \> 18)
* suspected OSA
* no coexisting heart or lung disease
* not in a safety-sensitive occupation

Exclusion Criteria:

-

Primary outcomes:
measure: Sleepiness score
Secondary outcomes:
measure: Quality of life
measure: Vigilance tests
measure: Sleep quality
measure: CPAP compliance
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Sleep Disorders Center, Royal Univerisity Hospital
state: Saskatchewan
Study officials:
affiliation: Univerisity of Saskatchewan
name: Robert P Skomro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skomro RP, Gjevre J, Reid J, McNab B, Ghosh S, Stiles M, Jokic R, Ward H, Cotton D. Outcomes of home-based diagnosis and treatment of obstructive sleep apnea. Chest. 2010 Aug;138(2):257-63. doi: 10.1378/chest.09-0577. Epub 2010 Feb 19.
Clinical trial NCT01333722: Acute Pain Study Following Bunionectomy
Official title: A Randomized, Multicenter Study Comparing the Analgesic Efficacy and Safety of Hydrocodone / Acetaminophen Extended Release to Placebo in Subjects With Acute Pain Following Bunionectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in the treatment of moderate to severe pain following bunionectomy.

Detailed description: The bunionectomy was performed under regional anesthesia and propofol sedation. Perioperative anesthesia was standardized for all participants. Upon completion of surgery, designated study personnel ensured continued eligibility per the selection criteria of the protocol.

After an appropriate period of time following bunionectomy, participants who had a pain intensity score of ≥ 40 mm on a 100 mm visual analog scale (VAS) and moderate or severe pain intensity per the categorical pain intensity scale were eligible for randomization, in equal numbers, into 1 of 2 treatment arms: hydrocodone/acetaminophen extended release or placebo.

Eligibility criteria: Inclusion Criteria:

Subjects who were in general good health, experiencing moderate to severe pain following bunionectomy

Exclusion Criteria:

* Subjects who underwent Base wedge osteotomy and / or Long-Z Hart bunionectomy procedures
* Drug allergies to hydrocodone, acetaminophen
* Clinically significant or uncontrolled medical disorders or illness - history of drug or alcohol abuse / addiction

Primary outcomes:
measure: Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)
timeFrame: From time of first study drug administration to 12 hours following first study drug administration
Secondary outcomes:
measure: TOTPAR (Total Pain Relief)
timeFrame: From time of first study drug administration to 12 hours following first study drug administration
measure: SPRID (Pain Relief and Pain Intensity Difference)
timeFrame: From time of first study drug administration to 12 hours following first study drug administration
measure: Time to Perceptible and Meaningful Pain Relief
timeFrame: From time of first study drug administration to 12 hours following first study drug administration
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Site Reference ID/Investigator# 51464
state: California
city: Austin
country: United States
facility: Site Reference ID/Investigator# 51602
state: Texas
city: Salt Lake City
country: United States
facility: Site Reference ID/Investigator# 51344
state: Utah
Study officials:
affiliation: AbbVie
name: Pedro Quintana Diez, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04148222: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Lyme Disease
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Lyme Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lyme Disease
Lyme Disease, Chronic
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of Lyme Disease

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Lyme Disease

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Lyme Disease

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female patients of any age (interest is given to children to compare with mothers)
3. Diagnosis of Lyme Disease

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Primary outcomes:
measure: Correlation of Microbiome to Lyme Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: One year
Secondary outcomes:
measure: Validation of Sequencing Methods
timeFrame: One year
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00233922: Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant
Official title: Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Orbital Trauma
Orbital Fractures
Keywords: orbit
orbital
trauma
fractures
facial
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: National Healthcare Group, Singapore
First posted: 2005-10-06
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with orbital injuries are entered into the trial. Age: 20 - 70. After obtaining appropriate consent, they are entered into either a control arm where reconstruction of the orbit is done with a titanium mesh (established practice) or the experimental arm where reconstruction is by a bioresorbable implant made of polycaprolactone. Patients are followuped at 1 week, 1 month, 3 months, 6 months \& 12 months. CT scan of the orbits are performed preop, 6 months \& 12 months. End point is the 12 month follow-up appointment. Visual acuity, range of motion, enophthalmos \& diplopia are assessed in follow-up.

Detailed description: Patients with orbital injuries are entered into the trial. Age: 20 - 70. After obtaining appropriate consent, they are entered into either a control arm where reconstruction of the orbit is done with a titanium mesh (established practice) or the experimental arm where reconstruction is by a bioresorbable implant made of polycaprolactone. Patients are followuped at 1 week, 1 month, 3 months, 6 months \& 12 months. CT scan of the orbits are performed preop, 6 months \& 12 months. End point is the 12 month follow-up appointment. Visual acuity, range of motion, enophthalmos \& diplopia are assessed in follow-up.

Eligibility criteria: Inclusion Criteria:

* age: 20 - 70 years facial trauma with orbital fractures

Exclusion Criteria:

* No other coexistent conditions eg. diabetes, heart disease, etc

Primary outcomes:
measure: visual acuity
measure: Enophthalmos
measure: Diplopia
measure: Cosmetic appearance
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Thiam-Chye Lim, MBBS, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01363622: Vaspin Levels Compared With Serum Insulin and Blood Glucose Levels in Neonates
Official title: Zekai Tahir Burak Maternity Teaching Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Insulin Sensitivity
Keywords: Vaspin
LGA
SGA
Insulin
Blood glucose
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2011-06-01
Enrollment: 82
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: SGA infant LGA infant AGA infant

Brief summary: The aim of this study was to investigate circulating concentrations of vaspin in fetal and neonatal samples from SGA, AGA and LGA with the respective insulin concentrations. Serum vaspin concentrations were determined by enzyme immunoassay in 22 SGA and 30 LGA and 30 AGA singleton full-term fetuses and neonates on cord blood and postnatal day 5.


Eligibility criteria: Inclusion Criteria:

* Full term healthy infant

Exclusion Criteria:

* sepsis
* congenital anomaly
* sick infant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching Hospital
Study officials:
References:
Clinical trial NCT01189422: Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes
Official title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Subcutaneously Administered Teplizumab (MGA031) in Adults With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 Diabetes Mellitus
T1DM
Lead sponsor: MacroGenics
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2010-08-26
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of subcutaneously administered teplizumab in adults with relatively recent onset T1DM, greater than 12 weeks and less than 52 weeks of presentation of first signs and symptoms of disease to a physician prior to randomization.


Eligibility criteria: Inclusion Criteria:

* Randomization after 12 weeks but within 12 months from first doctor visit for symptoms or signs of diabetes
* Diagnosis of type 1 diabetes mellitus
* Currently receiving insulin therapy
* Detectable fasting or stimulated C-peptide level at screening
* One positive autoantibody test result at screening: Islet-cell autoantibodies (ICA512)/islet antigen-2 (IA-2),Glutamic acid decarboxylase (GAD) autoantibodies, or Insulin autoantibodies

Exclusion Criteria:

* Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
* Previous treatment with monoclonal antibody
* Current treatment with oral antidiabetic agents
* Evidence of active infection

Primary outcomes:
measure: Dose regimen
timeFrame: 91 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00729222: Hemodynamic Effects of Rolofylline in the Treatment of Patients With Heart Failure (7418-503)
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Hemodynamic Effects of Rolofylline Injectable Emulsion in the Treatment of Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: NovaCardia, Inc.
First posted: 2008-08-07
Enrollment: 60
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 study will estimate the effects of rolofylline, alone and in addition to loop diuretic therapy on pulmonary capillary wedge pressure and other hemodynamic parameters, in patients with heart failure and renal impairment.


Eligibility criteria: Inclusion Criteria:

* Patients with heart failure and renal impairment, currently using furosemide, with systolic blood pressure \>95 mm Hg

Exclusion Criteria:

* Patient has active infection, use of diuretic within 3 hours of screening visit, has acute tubular necrosis or severe pulmonary disease, any heart problems within the last two weeks

Primary outcomes:
measure: change in pulmonary capillary wedge pressure
timeFrame: from baseline to 4 and 8 hours
Secondary outcomes:
measure: Change in cardiac output, systemic vascular resistance, pulmonary vascular resistance, pulmonary pressure and right atrial pressure
timeFrame: from baseline to 4 and 8 hours
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Ponikowski P, Mitrovic V, O'Connor CM, Dittrich H, Cotter G, Massie BM, Givertz MM, Chen E, Murray M, Weatherley BD, Fujita KP, Metra M. Haemodynamic effects of rolofylline in the treatment of patients with heart failure and impaired renal function. Eur J Heart Fail. 2010 Nov;12(11):1238-46. doi: 10.1093/eurjhf/hfq137. Epub 2010 Sep 7.
Clinical trial NCT01595022: FR01 and FR20 IUS (Intrauterine System) Wearing Study
Official title: A Multi-center, Single-blinded, Randomized, Controlled, Parallel-group Study to Evaluate the Wearing Comfort of Two Different Placebo Intrauterine Systems FR01 and FR20 Compared to a Placebo T-frame Intrauterine System for 3 Cycles in Healthy Women Aged 18-40 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-05-09
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to evaluate two different placebo intrauterine systems, placebo FR01 and FR20 with different types of inserters, for wearing comfort, insertion/removal ease and pain compared to a placebo T-frame intrauterine system.


Eligibility criteria: Inclusion Criteria:

* Healthy Female subject
* Age 18-40 years (inclusive)
* History of regular cyclic menstrual periods at baseline (cycle length 21 to 35 days)
* Women using any COC (combined oral contraceptive) for contraception with a monthly regimen before the study entry.
* Confirmed uterine sound depth of 6 to 10 cm

Exclusion Criteria:

* Pregnancy or lactation
* Sterilized
* Nulliparous
* Congenital or acquired uterine anomaly
* Vaginal or cesarean delivery within 8 weeks prior to insertion

Primary outcomes:
measure: Pelvic pain during the IUS wearing period (wearing comfort) measured by 5-point Likert scale (no pain/mild/moderate/severe/very severe pain)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
city: Kuopio
country: Finland
city: Tampere
country: Finland
city: Turku
country: Finland
city: Den Helder
country: Netherlands
city: Heerlen
country: Netherlands
city: Zwijndrecht
country: Netherlands
city: Stockholm
country: Sweden
city: Uppsala
country: Sweden
city: Örebro
country: Sweden
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06171022: The Effect of Cherry Seed Pillow on Fibromyalgia
Official title: The Effect of Cherry Seed Pillow on Pain and Quality of Life in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the effects of 4-week Cherry seed pillow application on pain and quality of life in individuals diagnosed with fibromyalgia will be examined.


Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Diagnosis of Fibromyalgia according to ACR classification criteria
* Neuromuscular system examination is normal
* Pain (vas-visual anologous scale) level of at least 5 points
* No communication problems
* Willingness to participate in the practice of using cherry seed cushion
* To be capable of answering the data collection tools to be used in the research
* Not having made hot, cold etc. applications at home

Exclusion Criteria:

* -No diagnosis of Fibromyalgia according to ACR classification criteria
* Normal examination of the neuromuscular system
* Pain (vas-visual anologous scale) level between 0-5
* Communication problems
* Failure to accept the practice of using cherry seed cushion and failure to finish the implementation process
* Having a musculoskeletal disorder other than fibromyalgia
* Pregnant or lactating
* To be capable of answering the data collection tools to be used in the research
* Having made hot, cold etc. applications at home

Primary outcomes:
measure: Change from baseline in pain at 4 weeks
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Change from baseline in function at 4 weeks
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay University
state: Karatay
Study officials:
References:
Clinical trial NCT03693222: Quadratus Lumborum Block in Pediatric Patients
Official title: Effect of Quadratus Lumborum Block on Postoperative Analgesic Requirements in Pediatric Patients: A Randomized Controlled Double Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Quadratus lumborum block, abdominal trunk block
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2018-10-02
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients included in the study were randomly divided into 2 groups. Cases were assessed as intravenous opioid with 1 mg/kg tramadol HCl (Group O, n=20) or ultrasonography-guided quadratus lumborum block (Group B, n=20).
Primary purpose: OTHER

Brief summary: Quadratus lumborum block (QLB) is a newly-defined trunk block performed with local anesthetic injection by imaging the abdominal muscles with ultrasonography (US) guidance; thus, analgesia is expected to be ensured from the T7-L1 dermatomal segment level.

In the study, the aim was to compare the postoperative analgesic effect of quadratus lumborum block in pediatric patients undergoing lower abdominal surgery

Detailed description: Patients included in the study were randomly divided into 2 groups. Cases were assessed as intravenous opioid with 1 mg/kg tramadol HCl (Group O, n=20) or ultrasonography-guided quadratus lumborum block (Group B, n=20).

Total analgesic amounts in 24 hours and first analgesic requirement times recorded.

Eligibility criteria: Inclusion Criteria:

* The study included 40 cases undergoing lower abdominal surgery aged from 3 to 16 years with ASA (American Society of Anesthesiologist) I-II level.

Exclusion Criteria:

* Cases with ASA III-IV health level and those with a history of allergy to local anesthetic medications were not included in the study.

Primary outcomes:
measure: postoperative total analgesic amounts in 24 hours
timeFrame: how many times in 24 hours
Secondary outcomes:
measure: first analgesic requirement times
timeFrame: in 24 hours
Other outcomes:
Locations:
Study officials:
References: