louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01421654: Evaluation of Acclimate Feature for Positive Airway Pressure (PAP) Therapy
Official title: Evaluation of Positive Airway Pressure (PAP) Feature to Improve Patient Adherence to Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: OSA
Sleep Apnea
PAP
positive airway pressure
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2011-08-23
Enrollment: 20
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 the study is to evaluate if using the Acclimate feature at the beginning of Positive Airway Pressure (PAP) therapy results in patients using their PAP therapy at least as long as they would standard therapy. Additionally, the Acclimate feature will be evaluated with regard to patient comfort, ease of acceptance of PAP therapy, leak events, and respiratory events.

Detailed description: Acclimate has been designed as a comfort feature for patients starting PAP therapy. The feature allows acclimatization to the targeted positive airway pressure setting. Using the Acclimate feature, the pressure increases incrementally over a period of time. The feature can be only be used for a set period of time, afterwards which the device initiates the therapeutic session at the prescribed pressure.

Eligibility criteria: Inclusion Criteria:

* Subjects ≥18 years of age.
* Recent diagnosis of moderate to severe OSA where fixed PAP is clinically indicated.
* Naïve to PAP therapy.

Exclusion Criteria:

* Patients requiring supplemental oxygen.
* Patients with a history of pneumothorax, pneumomediastinum, cavities or cysts in the lung.
* Previous surgery to the brain, middle or inner ear, pituitary gland or sinuses.
* Middle ear infection or perforated ear drum.
* Ongoing sinus infection/sinusitis.
* Clinically significant epistaxis.
* Predominant central sleep apneas in the subject's PSG.

Primary outcomes:
measure: Hours Used
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Sleep Insights
state: New York
Study officials:
affiliation: Sleep Insights
name: Ken Plotkin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04574154: Regional Anesthesia in THR - Comparing the Analgesic Efficacy of Fascia Iliaca Block and Erector Spinae Plane Block
Official title: Regional Anesthesia in THR - Comparing Analgesic Efficacy of Fascia Iliaca Block and Erector Spinae Plane Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Papa Giovanni XXIII Hospital
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized trial
Primary purpose: TREATMENT

Brief summary: THR (Total Hip Replacement) can be very painful and regional anesthesia is very effective in reducing postoperative pain. Fascia Iliaca Block (FIB) and Erector Spinae Plane Block (ESPB) are indirect approaches to the lumbar plexus that resulted to be very promising for THR. However, no studies investigated the analgesic superiority of either FIB or ESPB. In our study the investigators compare FIB and ESPB in terms of pain relief expressed as morphine consumption in the first 24 hours after primary THR.


Eligibility criteria: Inclusion Criteria:

* primary THR
* informed consent

Exclusion Criteria:

* allergies to study drugs
* spinal anesthesia contraindicated
* kidney failure
* epilepsy, psychiatric disease, neurologic deficits
* revision surgery
* neuropathies in the lumbar area
* no informed consent
* pregnancy
* alcohol/opioid abuse
* emergency surgery/intensive care

Primary outcomes:
measure: morphine
timeFrame: 24 hours
Secondary outcomes:
measure: perceived postoperative pain: Numeric Rating Scale (NRS)
timeFrame: 24 hs
measure: perceived postoperative pain: Numeric Rating Scale (NRS)
timeFrame: 48 hours
measure: side effects
timeFrame: 48 hours
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Aast Papa Giovanni Xxiii
Study officials:
References:
Clinical trial NCT00984997: Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors
Official title: Phase II Study of Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: Superior Sulcus Tumor
Lung Cancer
Non-Small Cell
Multimodality Treatment
Surgery
Segmentectomy
Lobectomy
Cisplatin
CDDP
Etoposide
VP-16
VePesid
Radiation Therapy
Radiotherapy
Chest Irradiation
Prophylactic Cranial Irradiation
PCI
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2009-09-25
Enrollment: 38
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: TREATMENT

Brief summary: 1. To determine the outcome of patients with potentially resectable superior sulcus tumors of non-small cell histology treated by surgery followed by accelerated radiation therapy and chemotherapy.
2. To evaluate toxicity, the initial local-regional control rate, sites of and time to local and distant failures.

Detailed description: Eligible (surgically resectable and medically operable) patients will have surgery followed by radiation therapy, given twice daily, for 5 weeks if margins are negative and for 5-1/2 weeks for positive margins. Grossly positive margins can be treated by brachytherapy followed by external radiotherapy.

Concomitant chemotherapy consisting of cisplatin given intravenously on days 1 and 8, and etoposide taken by mouth 30-60 minutes prior to each radiotherapy treatment x the first 10 days. The cycle will be repeated start day 29.

If the patients are considered to have no evidence of disease in one month after completion of chemotherapy, optional prophylactic radiotherapy to the brain will be give in 10 fractions once daily for 2 weeks.

Eligibility criteria: Inclusion Criteria:

1. No previous treatment.
2. Tumor must be resectable.
3. \>/= 18 and \</= 70 years of age.
4. Zubrod performance status \</= or higher performance status if based only on pain.
5. Must have adequate bone marrow, liver and renal function as defined in 3.6.

Exclusion Criteria:

1. Cytological or histological proof of N3 disease.
2. Evidence of metastatic disease to distant sites.
3. Patients with impending cord compression will be ineligible.

Primary outcomes:
measure: Rates of Locoregional control (LRC) [Response] Following Surgery and Accelerated Radiation Therapy/Chemotherapy
timeFrame: Assessed from one month after completion of chemotherapy to year 10
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ritsuko Komaki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03235297: Effects of Altitude on Single-Breath Diffusing Capacity for Carbon Monoxide
Official title: Effects of Altitude on Single-Breath Diffusing Capacity for Carbon Monoxide in Normal Subjects and Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: Altitude
Diffusing capacity for carbon monoxide
COPD
Pulmonary function testing
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: University of Utah
First posted: 2017-08-01
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women, ages 20-80, both healthy subjects and those with a diagnosis of COPD.

Brief summary: The purpose of this study is to further understand the effects of altitude on the physiology of gas exchange in the pulmonary microcirculation in normal subjects and in people with chronic obstructive pulmonary disease (COPD) measured as the single-breath diffusing capacity for carbon monoxide (DLCOsb). The study will determine a mathematical formula to allow for altitude corrections in both study populations to be used clinically in pulmonary labs.

Detailed description: The DLCOsb is one of the most common and widely tests clinically used across the world in pulmonary function laboratories to assess gas exchange from the lung to hemoglobin in the pulmonary circulation. This test is used in the differential diagnosis of respiratory related symptoms, to grade the degree of severity in lung disease, and to objectively monitor the progression of disease or the response to therapies. Therefore, it is important to have standard methods of performing and interpreting this test.This is a prospective study, collecting data from subjects at different simulated altitudes. The study hypothesis is that increasing altitude will increase the DLCOsb in a predictable manner that will allow for mathematical corrections to be applied for uniform interpretation in pulmonary labs at differing altitudes.

Eligibility criteria: Inclusion Criteria:

* Ages 20- 80 years
* Subjects must be either healthy or have been diagnosed with COPD

Exclusion Criteria:

* Anemia (hemoglobin \< 10.0 g/dL)
* Carboxyhemoglobin \> 3%
* Active smoking
* Heart disease or heart failure
* Pulmonary hypertension
* COPD exacerbation
* Pneumothroax within 6 months
* Bullous emphysema on chest imaging (Chest X-ray or CT)
* Supplemental oxygen use
* Diabetes mellitus
* Alcohol dependence
* Non-English speaking

Primary outcomes:
measure: Effect of altitude on measured diffusing capacity for carbon monoxide
timeFrame: 3 weeks
Secondary outcomes:
measure: Comparison of a novel inert gas technique for measuring alveolar volume with body plethysmography
timeFrame: 4 months
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Matt Hegewald, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06802497: Comparison of Postoperative Outcomes of Laparoscopic Lateral Suspension and V-NOTES Lateral Suspension With the Salman Ketenci Gencer Technique
Official title: Comparison of Early Postoperative Outcomes of Patients Undergoing Laparoscopic Lateral Suspension and V-NOTES Lateral Suspension With the Salman Ketenci Gencer Technique
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pelvic Organ Prolapse
Keywords: laparoscopy
v-notes lateral suspension
pelvic organ prolapse
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2025-01-31
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study planned to include 84 patients with pelvic organ prolapse.

Brief summary: Comparison of Early Postoperative Outcomes of Patients Undergoing Laparoscopic Lateral Suspension and V-NOTES Lateral Suspension with the Salman Ketenci Gencer Technique


Eligibility criteria: Inclusion Criteria:

* Patients with stage 3 or 4 pelvic organ prolapse Sexually active patients

Exclusion Criteria:

* Cervical pathology History of loop electrosurgical excision procedure (LEEP) or conization Presence of vaginal, pelvic, or adnexal mass Suspicious abdominal malignancy Morbid obesity Any pelvic infection Signs of pregnancy

Primary outcomes:
measure: Postoperative Improvement in Pelvic Organ Prolapse (POP) Severity by POP-Q Score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpaşa Training and Research Hospital
Study officials:
References:
Clinical trial NCT00601497: Effects of Electrical Stimulation on Osteoarthritis of the Knee
Official title: Effects of Electrical Stimulation on Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2008-01-28
Enrollment: 39
Sex: ALL
Minimum age (years): 50
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 find out whether electrical stimulation can reduce knee pain and increase function in people with osteoarthritis of the knee.


Eligibility criteria: Inclusion Criteria:

* 50 years of age or older
* Diagnosis of primary osteoarthritis of the knee (as defined by American College of Rheumatology criteria)
* Knee pain of at least six months duration
* Moderate or greater knee pain (defined as a score of 3 or greater on an 11 point numeric pain rating scale) for most days in the last month
* Willing to abide by protocol and treatment schedule.

Exclusion Criteria:

* Implants, such as pacemaker, TENS, or insulin pump, incompatible with electrical stimulation
* Uncontrolled concomitant disease affecting the knee, such as: rheumatoid arthritis, systemic lupus erythema, psoriatic arthritis
* Pregnant or breast-feeding
* Intra-articular corticosteroid or hyaluronic acid injection into the knee within 3 months preceding study
* Arthroscopy of the knee within the past year
* Significant injury to the knee within the past 6 months
* Use of assistive devices other than a cane or knee brace
* Disease of spine or other lower extremity joints of sufficient degree to affect assessment of the knee

Primary outcomes:
measure: Knee Pain
timeFrame: Baseline, Week 4, Week 8, and Week 12
Secondary outcomes:
measure: Knee function
timeFrame: Baseline, Week 4, Week 8, and Week 12
measure: Knee stiffness
timeFrame: Baseline, Week 4, Week 8, and Week 12
measure: Patient global assessment
timeFrame: Baseline, Week 4, Week 8, and Week 12
measure: Health-related quality of life
timeFrame: Baseline, Week 4, Week 8, and Week 12
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Ann G Taylor, RN, EdD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03415997: Dosing Iodinated Contrast Media According to Lean vs. Total Body Weight
Official title: Dosing Iodinated Contrast Media According to Lean vs. Total Body Weight at Abdominal CT: a North American Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contrast Media Dosing
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the effect of dosing iodinated contrast media according to a patient's total body weight vs. lean body weight. Participants will be randomized into 2 groups based on contrast dosing technique, and solid organ enhancement at uniphasic abdominal CT will be measured.


Eligibility criteria: Inclusion Criteria:

* outpatients only
* patients scanned on modern Siemens scanners at our institution

Exclusion Criteria:

* self-reported history of chronic kidney, heart or liver disease
* allergy to iodinated contrast
* acute illness
* outside maximum threshold limit for weight-based contrast dosing
* pregnancy
* image degradation

Primary outcomes:
measure: Mean hepatic enhancement (MHE): difference in liver attenuation on computed tomography images acquired before and after administration of contrast (in portal venous phase), as measured in Hounsfield units (HU)
timeFrame: 1 hour
Secondary outcomes:
measure: Standard deviation in mean hepatic enhancement (sigma MHE): standard deviation in the difference in liver attenuation on CT acquired before and after administration of contrast (in portal venous phase), as measured in Hounsfield units (HU)
timeFrame: 1 hour
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Andreu Costa, Md FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Costa AF, Peet K, Abdolell M. Dosing Iodinated Contrast Media According to Lean Versus Total Body Weight at Abdominal CT: A Stratified Randomized Controlled Trial. Acad Radiol. 2020 Jun;27(6):833-840. doi: 10.1016/j.acra.2019.07.014. Epub 2019 Aug 19.
Clinical trial NCT00136097: Study on the Infection Risk of Long Dwell Period Catheters in High Risk Intensive Care Unit (ICU) Patients
Official title: Study on the Infection Risk of Long Dwell Period Catheters in High Risk ICU Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Burns
Keywords: colonisation of the catheter
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2005-08-26
Enrollment: 142
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an evaluation of the use of silver impregnated catheters in burn patients to reduce catheter colonisation compared to the standard central venous catheter without antiseptic activity.


Eligibility criteria: Inclusion Criteria:

* Burn patient
* Placement of a new trilumen central venous catheter

Primary outcomes:
measure: Degree of colonisation of the central venous catheter at the moment of removal
Secondary outcomes:
measure: Incidence of a catheter related blood stream infection during the presence of the catheter
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Kirsten Colpaert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01576497: Optimal Number of To-and-fro Motion in EUS-guided Fine Needle Aspiration for Pancreatic Masses
Official title: Optimal Number of To-and-fro Motion in EUS-guided Fine Needle Aspiration for Pancreatic Masses in Terms of Suction or Without Suction: Prospective Randomized Single Blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Masses
Keywords: EUS, EUS-FNA, Pancreatic masses
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2012-04-12
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: EUS-FNA is the standard of care for diagnosing pancreatic masses. According to the operator's preference, EUS-FNA with suction or without suction technique has been used. To date, little is known about optimal number of to-and-fro motion during each needle pass. As usual 10-15 to-and-fro motions was used for EUS-FNA with suction technique. Theoretically, more number of to-and-fro motions may be required in EUS-FNA without suction. In this circumstance, the contamination of blood in specimen and possible adverse event may occur. To determine optimal number of to-and-fro motion in EUS-guided FNA for pancreatic masses in terms of with suction or without suction, this prospective single-blinded randomized trial was conducted.

Detailed description: For this prospective single-blinded randomized trial, two 10cc syringes was prepared. Two syringe was provided as same performance. However, one syringe is falsely made as suction syringe (fake one). During EUS-FNA, two syringe is randomly assigned and loaded by a nurse. Thus, operator was blinded which syringe is with suction or without suction.

First hypothesis: There is difference in the diagnostic accuracy of pancreatic masses according to EUS-FNA with suction or without suction/ different number of to-and-fro motion.

Second hypothesis: There is difference in the amount of blood in samples obtained by EUS-FNA with suction or without suction/ different number of to-and-fro motion.

Eligibility criteria: Inclusion Criteria:

* Age \> 19 years Solid pancreatic mass lesions

Exclusion Criteria:

* Age \< 19 years Coagulopathy Unable to consent

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 1 year
Secondary outcomes:
measure: Blood contamination in each sample
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Do Hyun Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06504797: The Effect of Automatic Massage Applied to Healthcare Workers on Pain, Fatigue and Psychological Well-being
Official title: The Effect of Automatic Massage Applied to Healthcare Workers on Pain, Fatigue and Psychological Well-being
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Massage
Pain, Back
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determine the effect of automatic massage applied to healthcare workers on pain, fatigue and psychological well-being. This research is planned as a pretest-posttest type study. It will be held in the Osmaniye State Hospital maternity ward. The application will be applied by one person in the rest room. Data will be collected using the Introductory Information Form, Psychological Well-Being Scale, Perceived Stress Scale (ASÖ/PSÖ-14), State-Trait Anxiety Inventory (STAI), and Piper Fatigue Scale.


Eligibility criteria: Inclusion Criteria:

* Working in the delivery room

Exclusion Criteria:

* Being receiving psychiatric treatment (Pharmacotherapy or psychotherapy),
* having a wound on the waist and back that prevents the application.

Primary outcomes:
measure: pain perception
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: