louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05624502: Improvement in Postoperative Pain Outcomes
Official title: Mprovement in Postoperative Pain Outcome: Pain Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Post Operative Pain
Keywords: acute postoperative pain
orthopedic surgery
general surgery
obs/gyn surgery
Neurosurgery
Bariatric surgery
Thoracic surgery
opioids
NSAIDs
Regional analgesia
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute postoperative pain patients after different surgical procedures

Brief summary: This is an observational study project aims at improving postoperative pain outcomes by evaluating the current status of postoperative pain managements in the institution. Then the investigators will compare the results by internal and external benchmarking. Then they will suggest recommendations to improve the current situation of postoperative pain management.

Detailed description: At least half of the patients suffer from moderate to severe post-operative pain. The price of poorly managed pain is high: pain impedes recovery, causes suffering and prolongs the hospital stay. PAIN OUT provides tools for measurement, feedback and benchmarking of pain treatment quality in order to improve patient care. A research project that aims at improving postoperative pain treatment outcomes by evaluating the current status of postoperative pain managements in our institution. Then the investigators compare the results by internal and external benchmarking. Then suggest recommendations to improve the current situation of postoperative pain management.

parameters include" Patient's data Pain assessments by using the visual analogue score of 11 point (from "0" no pain - "10" worst pain) will be evaluated as the following: Worst pain since surgery, Least pain since surgery, Pain score at rest. Pain score during movements in bed, Pain score during deep breathing and coughing, How often the severe pain since surgery (%), Does the pain interfere with sleeping pattern, and the side effects.

Eligibility criteria: Inclusion Criteria:

* Postoperative patients during the first 24 hours of surgery (day 1)
* Male and Females
* Adults

Exclusion Criteria:

* Patient refusal
* Drug abusers and addicts
* Major significant systemic diseases
* Language barriers

Primary outcomes:
measure: postoperative pain scores
timeFrame: first 3 days postoperative
measure: time in severe pain
timeFrame: during the first 24 hours
measure: dynamic and static pain
timeFrame: during the first 24 hours
Secondary outcomes:
measure: worst and least pain
timeFrame: during the first 24 hours
measure: time to first request of analgesia
timeFrame: during the first 24 hours
measure: total analgesic consumption
timeFrame: during the first 24 hours
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Salah N. El-Tallawy
Study officials:
References:
Clinical trial NCT00906802: Benefit of Roux-en-Y (R-Y) Reconstruction After Pancreaticoduodenectomy
Official title: Benefit of R-Y Reconstruction After Pancreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Keywords: pancreaticoduodenectomy
reconstruction
Lead sponsor: Kochi University
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: One of the most common complications of pancreaticoduodenectomy (PD) is delayed gastric emptying (DGE), otherwise known as "gastroparesis," which is not fatal but results in prolonged hospital stay and increased hospital costs. Delayed gastric emptying is defined as nasogastric decompression after postoperative day (POD) 10 or a failure to tolerate a regular diet after POD 14. The incidence of DGE has been reported to range from 5% to 72%.

Detailed description: We hypothesized that the hand-sewn, two-layered, or continuous suture, could induce anastomotic edema to indeed the afferent peristalsis, which is one of the causes of DGE.

Eligibility criteria: Inclusion Criteria:

* These patients were to undergo elective pancreatic head resection for the treatment of periampullary mass

Exclusion Criteria:

* A body weight loss greater than 10% during the six months prior to surgery
* The presence of distant metastases
* Seriously impaired function of vital organs due to respiratory, renal or heart disease

Primary outcomes:
measure: the incidence of DGE
timeFrame: 3-6 months
Secondary outcomes:
measure: the incidence of other complication associated with reconstruction
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Nankoku
country: Japan
facility: Kochi Medical School
state: Kochi
Study officials:
affiliation: Kochi University
name: Kazuhiro Hanazaki, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT02878902: Impact of the Implementation of CKD Coordination Function on Dialysis Initiation Frequency in Emergency
Official title: Impact of the Implementation of a Chronic Kidney Disease (CKD) Coordination Function on Dialysis Initiation Frequency in Emergency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: emergency
coordination
dialysis
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with chronic kidney disease in our center

Brief summary: Kidney failure is a major public health problem. REIN registry shows that 33% of patients treated in renal replacement therapy for ESRD start dialysis in emergency. Unscheduled care is associated with an increased risk of morbidity and mortality, with less access to off dialysis center and kidney transplant. In addition, the emergency management has an impact on the organization of health structures. The High Authority of Health in 2012 issued a "care pathway Guide" aimed "to report in this process of the multidisciplinary nature of the management and coordination of principles and procedures for the Chronic Renal failure and cooperation between professionals involved. " A function of coordinator of the Chronic Renal Disease was set up in service since May 2013. Investigators propose to carry out a study to value its impact on the start of the dialysis in emergency and hypothesize that this feature innovative in France improves the patient pathway and thus reduce support emergency frequency of ESRD.

The objective of this study is to show the improvement of the quality of care for terminally chronic renal failure patients.

This is to evaluate an experiment aimed to facilitate a complex care path. If this experiment is successful, it could form part of "advanced practice".


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years with terminal chronic renal failure enrolled in the course of care

Exclusion Criteria:

* Patients under 18 years
* Patient Off Course
* Patient beginning dialysis with a method of transition

Primary outcomes:
measure: Percentage of emergency dialysis patients beginner
timeFrame: Change of this percentage from baseline at 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03600402: Effects and Dose-response of Manual Therapy in the ROM of the Ankle in Older People
Official title: Effects and Dose-response of Manual Therapy in the ROM of the Ankle in Older People: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging Problems
Keywords: ROM
Manual Therapy
Mobilization
Ankle
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 38
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Limitations of the joint range of the ankle in elderly people is usually common. One of the ways to treat this limitation is through manual therapy, although the effects it produces in dose-response terms are still not well understood. Because of this, this work on the one hand aims to determine the effects and effectiveness of manual therapy and, on the other hand, determine the dose-response necessary for the range of motion of the ankle to improve when applying techniques of manual therapy on the ankle in the older adult.


Eligibility criteria: Inclusion Criteria:

* Age
* Ankle dorsiflexion limitation

Exclusion Criteria:

* Do not sign the consent
* No injuries in the foot
* No acute pathology (3 months) in lower limb

Primary outcomes:
measure: Active ankle range of movement
timeFrame: Change from baseline to day 1, 3, 5, 8, 10, 12, 19 and 48
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
affiliation: Study Principal Investigator
name: David Hernández, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hernandez-Guillen D, Blasco JM. A Randomized Controlled Trial Assessing the Evolution of the Weight-Bearing Ankle Dorsiflexion Range of Motion Over 6 Sessions of Talus Mobilizations in Older Adults. Phys Ther. 2020 Apr 17;100(4):645-652. doi: 10.1093/ptj/pzaa003.
Clinical trial NCT00137202: Post Burn Pruritus Study in Patients Undergoing Wound Healing
Official title: A Pilot Study to Determine the Pruritic Benefits of Ondansetron Versus Diphenhydramine in Burn Patients Undergoing Wound Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Itching
Keywords: pruritus
burn wound
Lead sponsor: United States Army Institute of Surgical Research
Sponsor class: FED
First posted: 2005-08-29
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if a drug called ondansetron (Zofran) controls itching from healing burn wounds as well or better than the usual drug used, diphenhydramine (Benadryl).

Detailed description: A clear mechanism or cause for pruritus in patients recovering from burn has not been delineated.

While the exact mechanisms/pathways for itching are currently unclear, histamine antagonism appears to be the most popular treatment. Whether histamine antagonism works predominantly via peripheral inhibition or central sedation is uncertain. By treating another intermediary in the pruritus cascade, it may be possible that an alternate treatment could be used while eliminating some of the unwanted side effects of antihistamine at the same time.

Eligibility criteria: Inclusion Criteria:

* Males or females; 18 years or older.
* Seen in the United States Army Institute of Surgical Research (USAISR) Burn Clinic with healing burn wounds of any percent (%) of total body surface area (TBSA) causing pruritus
* Stable medical condition
* Negative pregnancy test and not nursing
* Able to indicate status of pruritus on a numeric scale
* Able to understand and read English

Exclusion Criteria:

* Unstable medical condition as determined by attending burn surgeon
* Prisoner
* History of allergic reaction to serotonin inhibitors or diphenhydramine
* Pregnant or lactating
* Unable to verbalize pruritus intensity scale
* Unable to understand or read English

Primary outcomes:
measure: Ondansetron will have a greater ability to control pruritus in burn patients who are undergoing wound healing when compared to the standard of care, diphenhydramine.
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: US Army Institute of Surgical Research
state: Texas
Study officials:
affiliation: Wilford Hall Medical Center, Lackland AFB, San Antonio, TX
name: Stuart Gross, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: US Army Institute of Surgical Research, Fort Sam Houston, TX
name: Steven E Wolf, MD
role: STUDY_DIRECTOR
References:
citation: Matheson JD, Clayton J, Muller MJ. The reduction of itch during burn wound healing. J Burn Care Rehabil. 2001 Jan-Feb;22(1):76-81; discussion 75. doi: 10.1097/00004630-200101000-00017.
Clinical trial NCT02527902: Autonomic Nervous System (ANS) and Renal Function in Immunoglobin A (IgA) Nephropathy
Official title: Autonomic Nervous System (ANS) Analysis According to Different Renal Function Stage in Immunoglobin A (IgA) Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IGA Glomerulonephritis
Keywords: IGA Glomerulonephritis
Autonomic nervous system
ANS
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The estimation of the cardiovascular risk in the general population must take into account small renal disturbances, as the microalbuminuria. Conversely certain parameters of the cardiovascular risk influence the evolution of renal diseases, for example the arterial high blood pressure.

The measure of the activity of the autonomous nervous system, and especially the quantification of its variability, is a means to estimate the cardiovascular risk. The investigators formulate the hypothesis that the variability of the autonomous nervous system is an additional clinical element for the evaluation of the evolutionary risk of renal diseases.

The aim of this study is to compare the variability of the autonomous nervous system during the various evolutionary stages of the renal disease.

The renal disease studied will be IgA nephropathy (IgNA). IgNA is a histologically defined glomerulonephritis (rela biopsy) by the presence of deposits immunoglobulin A (IgA) in the renal mesangium (at list 1+) by immunofluorescence.


Eligibility criteria: Inclusion Criteria:

* diagnosis of IgNA biopsy-proven free, informed, express and written

Exclusion Criteria:

* IgNA secondary to Henoch-Schonlein purpura (HSP) or Systemic Lupus Erythematosus or alcoholic cirrhosis
* current kidney transplantation
* Hypertension treated or not,
* Diseases interfering with ANS analysis: cardiac arrhythmia, beta-blocker therapy
* diabetes

Primary outcomes:
measure: Standard deviation of all R-R intervals (SDNN)
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Eric Alamartine, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03486002: EFFEXTS OF THE CLEANSWEEP SUCTION CATHETER
Official title: EFFECTS OF TELEFLEX CATHETER (CLEANSWEEP) ON VENTILATOR MECHANICS
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Endotracheal Tube Clearance
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Teleflex
First posted: 2018-04-03
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is designed to compare the effectiveness of a closed suction system with an inflatable balloon on the catheter (Cleansweep system) to that of a standard closed suction system in terms of reducing the interior resistance of endotracheal tubes. Subjects who require frequent suctioning ( \> every 2.5 hours) and who have stable cardiovascular systems will be randomized to receive suctioning either through the Cleansweep system or standard system initially followed by the corresponding system. The subjects will be suctioned every two hours for eight hours ( the first 2 suction procedures with one system followed by 2 with the other system). After each suction procedure measurements of resistance will be made using peak and plateau pressures.

Analysis: For each patient, data for both procedures on each catheter system will be pooled and mean differences between the standard system and the Cleansweep system will be calculated. For all 20 patients the mean (+/- SD) of these differences will be calculated and significance will be sought using appropriate statistical tests. The study will be unblinded and randomization determines merely which system will used initially for the first 2 procedures.


Eligibility criteria: Inclusion Criteria:

* Intubated, mechanically ventilated patients who require suctioning more often than every 2.5 hours

Exclusion Criteria:

* Unstable cardiovascular system (significant arrythmias, blood pressure support requiring \> 2 pressors
* refractory hypoxemia (P/F ratio \< 80)

Primary outcomes:
measure: Change in endotracheal tube resistance during mechanical ventilation after 4 suction procedures
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: Neil MacIntyre
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02397902: Destiffening and Hypotensive Effects of Whole Milk and Full-fat Dairy Products
Official title: Destiffening and Hypotensive Effects of Whole Milk and Full-fat Dairy Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Prehypertension
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Dairy Management Inc.
First posted: 2015-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The specific aim of the proposed study is to address the efficacy of conventional full-fat dairy products as part of the normal routine diet for improving vascular function and reducing blood pressure in middle-aged and older adults with elevated blood pressure. The investigators hypothesize that dietary intervention including whole milk and full-fat milk products will induce significant decreases in systolic blood pressure and arterial stiffness. The investigators also test the hypothesis that the reductions in blood pressure will be associated with the corresponding decreases in arterial stiffness and/or increases in endothelial vasodilatory function as well as improvements in arterial baroreflex sensitivity. If our hypotheses are supported by the results, the information could be used as a basis for recommendations for the use of whole milk and full-fat milk products in the secondary prevention of elevated blood pressure and vascular dysfunction.


Eligibility criteria: Inclusion Criteria:

* Prehypertension or stage-1 hypertension

Exclusion Criteria:

* Consume \> 3 servings of dairy or fruit per day
* Strenuous physical activity \> 3 time per week
* Lactose intolerance, pregnancy, lactation, and/or alcohol abuse
* Taking cardiovascular-acting drugs
* Overt cardiovascular disease, metabolic disease, GI disorders and/or renal disease

Primary outcomes:
measure: Seated blood pressure
timeFrame: 4 weeks
Secondary outcomes:
measure: 24-hour ambulatory blood pressure
timeFrame: 4 weeks
measure: Carotid arterial compliance as measured by arterial pressure and corresponding cross-sectional area by ultrasound
timeFrame: 4 weeks
measure: Arterial stiffness as measured by pulse wave velocity between the aortic arch and femoral artery
timeFrame: 4 weeks
measure: Flow mediated dilation
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
Study officials:
affiliation: The University of Texas at Austin
name: Tanaka Hirofumi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas at Austin
name: Stephen J Roy, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03252002: Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single and Multiple Oral BAY1101042 Tablet Doses in Healthy Male Subjects
Official title: Single/Multiple Dose Escalation Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAY1101042 Given as 5 mg MR Tablet After Single Oral Dosing Followed by Once Daily Dosing for 7 Days in 12 Healthy Male Subjects Per Dose Step in a Randomized, Placebo Controlled, Single Blind, Group Comparison Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Chronic kidney disease
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-08-16
Enrollment: 96
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To investigate the safety, tolerability, pharmacokinetics and effects of BAY1101042 in healthy male subjects after a single oral dose and multiple once daily dosing for 7 days


Eligibility criteria: Inclusion Criteria:

* The informed consent must be signed before any study specific tests or procedures are done.
* Healthy male subject.
* Age: 18 to 45 years (inclusive) at the screening.
* Body mass index (BMI): above/equal 18 and below/equal 29.9 kg/m2.
* Ability to understand and follow study-related instructions.

Exclusion Criteria:

* Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
* Subjects with thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) levels outside the normal reference range at screening.
* Regular use of medicines.
* Smoking more than 10 cigarettes daily.
* Systolic blood pressure below 100 or above 145 mmHg (at screening).
* Diastolic blood pressure below 50 or above 90 mmHg (at screening).
* Heart rate below 50 or above 90 beats/ min (at screening).

Primary outcomes:
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: Approximately 19 days
Secondary outcomes:
measure: AUC(0-24) of BAY1101042
timeFrame: At day 1
measure: AUC(0-24)/D of BAY1101042
timeFrame: At day 1
measure: Cmax of BAY1101042
timeFrame: At day 1
measure: Cmax/D of BAY1101042
timeFrame: At day 1
measure: AUCτ,md of BAY1101042
timeFrame: At day 9
measure: AUCτ,md/D of BAY1101042
timeFrame: At day 9
measure: Cmax,md of BAY1101042
timeFrame: At day 9
measure: Cmax,md/D of BAY1101042
timeFrame: At day 9
Other outcomes:
Locations:
city: Mönchengladbach
country: Germany
facility: CRS Clinical-Research-Services Mönchengladbach GmbH
state: Nordrhein-Westfalen
city: Wuppertal
country: Germany
facility: CRS Clinical Research Services Wuppertal GmbH
state: Nordrhein-Westfalen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: