louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04847024: Parecoxib vs. Dexketoprofen for the Management of Pain After Cesarean Section.
Official title: Parecoxib vs. Dexketoprofen in Combination With Acetaminophen as Additional Analgesia in Patients With Neuraxial Morphine for the Management of Pain After Cesarean Section. A Randomized, Double Blind, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caesarean Section; Pain
Keywords: Caesarean section
Pain
Parecoxib
Dexketoprofen
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 380
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parecoxib + acetaminophen vs Dexketoprofen + acetaminophen in patient receiving neuraxial analgesia for pain after caesarean section.
Primary purpose: TREATMENT

Brief summary: Although it is known that parecoxib and dexketoprofen are commonly used in successful post-operative pain relief, there are very few studies that compare these two agents in their individual applications and/or combined with neuraxial analgesia with opioids and even less in post-cesarean section pain, as well as the evaluation of the side effects and their impact on the patient's functionality. For this reason, in order to approach this answer, we sought to perform this study in patients undergoing elective or emergency cesarean section in our institution, who meet the inclusion criteria, using the Visual Analog Pain Scale at 12 hrs and 24 hrs post surgery and evaluating the aforementioned side effects, comparing in one arm of the study Parecoxib + acetaminophen vs Dexketoprofen + acetaminophen in the other arm, randomizing the patients in both groups using a double-blind configuration.


Eligibility criteria: Inclusion Criteria:

* Pregnancy 32w or more.
* Emergency or elective caesarean section.

Exclusion Criteria:

* Allergy to Parecoxib.
* Allergy to dexketoprofen.
* Allergy to acetaminophen.
* General anesthesia.

Primary outcomes:
measure: Pain at 12 hours
timeFrame: 12 hours
measure: Pain at 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Side effects
timeFrame: 24 hours
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas H
Study officials:
References:
Clinical trial NCT03868124: Clinical Study Comparing Two Models of a Travoprost Intraocular Implant
Official title: Prospective, Randomized Phase III Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2019-03-08
Enrollment: 560
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: Phase III study to compare the safety and efficacy of intraocular implants containing Travoprost at two different elution rates versus Timolol Maleate Ophthalmic Solution, 0.5% (Timolol) in reducing elevated intraocular pressure in subjects with open angle glaucoma (OAG) or ocular hypertension (OHT)

Detailed description: This is a prospective, randomized, double-masked, active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of the Model G2TR-063 Travoprost Intraocular Implant and the Model G2TR-125 Travoprost Intraocular Implant to topical Timolol in subjects with OAG or OHT. The staff who record key efficacy measures and the study subjects will remain masked to study treatment.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with open-angle glaucoma or ocular hypertension
* C/D ratio ≤ 0.8
* Zero to two preoperative ocular hypotensive medications

Exclusion Criteria:

* Active corneal inflammation or edema
* Retinal disorders not associated with glaucoma

Primary outcomes:
measure: Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative
timeFrame: 3 Months
Secondary outcomes:
measure: Mean IOP (Control Group vs. Each Implant Group) Through 12 Months Postoperative
timeFrame: 12 Months
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Center for Sight
state: Nevada
Study officials:
affiliation: Glaukos Corporation
name: Kerry Stephens, OD
role: STUDY_CHAIR
References:
Clinical trial NCT06565624: Evaluation of Reflex Tear Production
Official title: Evaluation of Reflex Tear Production
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dry Eye Disease
Keywords: Reflex Tear Production
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2024-08-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate reflex tear production following cotton swab nasal stimulation in subjects with dry eye disease (DED).

Detailed description: The primary analysis will assess the change from baseline (pre- versus immediately post-cotton swab nasal stimulation) in tear meniscus height (TMH) using optical coherence tomography (OCT). This study will consist of one visit on a single day.

Eligibility criteria: Key Inclusion Criteria:

* Within the last 12 months, have a previous history of dry eye disease, either clinician diagnosed or patient reported.
* Within the last 6 months, have used, or desired to use artificial tears for dry eye symptoms.
* Corrected Visual Acuity (Snellen) 20/200 or better in both eyes.
* Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history.
* Able, as assessed by the investigator, and willing to follow study instructions.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Current evidence of any clinically significant ophthalmic disease other than dry eye (for example, glaucoma or macular degeneration).
* Use of artificial tears within 2 hours of the Study Visit.
* History of ocular surgery within 1 year of the Study Visit.
* Use of contact lenses in either eye within 7 days of the Study Visit.
* Use of lid hygiene (all forms of lid care) or heat masks within 7 days of the Study Visit.
* Use of any topical ocular anti-inflammatory medications, any topical ocular corticosteroid, or any non-steroidal-anti-inflammatory agents within 30 days of the Study Visit.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline in TMH immediately following stimulation
timeFrame: Day 1 pre-stimulation (Baseline); Day 1 immediately post-stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Pharma
role: STUDY_DIRECTOR
References:
Clinical trial NCT01006824: Trial of Wireless Capsule Endoscopy in the Evaluation of Obscure Gastrointestinal Bleeding
Official title: Randomized Controlled Trial of Wireless Capsule Endoscopy in the Evaluation of Obscure Gastrointestinal Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obscure Gastrointestinal Bleeding (Occult or Overt)
Keywords: Capsule endoscopy
gastrointestinal hemorrhage
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2009-11-03
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study compares wireless capsule endoscopy (patients swallow a pill-size camera that sends pictures of the intestine to a recorder worn on their belt) to an x-ray study (called dedicated small bowel contrast radiography) in patients who have bleeding from the gastrointestinal tract without a source of the bleeding identified on routine endoscopic examinations of the esophagus (food pipe), stomach, small intestine, and large intestine.

The investigators hope to determine if the capsule is a better test in terms of decreasing further bleeding, decreasing the need for further diagnostic testing, and decreasing the need for blood transfusions and time spent in the hospital.


Eligibility criteria: Inclusion Criteria:

1. Iron deficiency anemia in men or post-menopausal women and positive fecal occult blood test in pre-menopausal women with nondiagnostic upper endoscopy, colonoscopy, and push enteroscopy.
2. Persistent or recurrent melena or hematochezia with nondiagnostic upper endoscopy, colonoscopy, and push enteroscopy.

Exclusion Criteria:

1. Known or suspected GI tract obstruction
2. Severe motility disorders (e.g., achalasia, gastroparesis, pseudoobstruction)
3. Pregnancy
4. Cardiac pacemaker or implanted electro-medical devices

Primary outcomes:
measure: Further bleeding
timeFrame: 1 year
Secondary outcomes:
measure: Diagnostic yield
timeFrame: 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: L.A. County + U.S.C. Medical Center
state: California
Study officials:
affiliation: University of Southern California
name: Loren Laine, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Laine L, Sahota A, Shah A. Does capsule endoscopy improve outcomes in obscure gastrointestinal bleeding? Randomized trial versus dedicated small bowel radiography. Gastroenterology. 2010 May;138(5):1673-1680.e1; quiz e11-2. doi: 10.1053/j.gastro.2010.01.047. Epub 2010 Feb 2.
Clinical trial NCT04440124: Does the Incremental Shuttle Walk Test Predict the Development of a Hospital Acquired Pneumonia in Patients Undergoing Elective Oesophagectomy: A Prospective Cohort Study
Official title: Does the Incremental Shuttle Walk Test Predict the Development of a Hospital Acquired Pneumonia in Patients Undergoing Elective Oesophagectomy: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oesophageal Cancer
Keywords: physiotherapy
shuttle walk test
hospital acquired pneumonia
outcomes
oesophagectomy
Lead sponsor: University Hospital Birmingham NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing oesophagectomy

Brief summary: The purpose of this study was to assess the predictive value of the incremental shuttle walk test on rates of hospital acquired pneumonia for patients undergoing oesophagectomy.

Detailed description: Field tests to objectively measure functional capacity are becoming of greater importance when looking to assess an individual's fitness for surgery. One such field test is the incremental shuttle walk test (ISWT). An externally paced, maximal excursion test, the ISWT is a simple and easily reproducible test that is widely used within cardiac and pulmonary populations and shown to correlate well with Vo2 mas on a cardiopulmonary exercise test. Previous studies looking at the benefit of the ISWT in predicting post-operative outcomes within the oesophagastric population have demonstrated that walking less than 350 meters has been associated with significantly higher rates of mortality at 30 days and 3 years. No correlation between ISWT and postoperative respiratory complications in this surgical population has been previously reported.

This study aims to assess whether walking \<350 meters on an ISWT predicts the development of hospital acquired pneumonias following an elective oesophagectomy

Eligibility criteria: Inclusion Criteria:

* Consecutive patients with a diagnosis of oesophagogastric cancer listed for an elective oesophagectomy at a large UK tertiary hospital

Exclusion Criteria:

* Patients who were unable to complete the walking test
* patients deemed not fit for surgery
* patients with a significant neurological event peri or post operatively

Primary outcomes:
measure: Hospital acquired pneumonia
timeFrame: during hospital stay, on average 14 days
Secondary outcomes:
measure: 30 day Mortality
timeFrame: 30 days after date of surgery
measure: 90 day Mortality
timeFrame: 90 days following date of surgery
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: UHB NHS Foundation Trust
Study officials:
References:
Clinical trial NCT05542524: Oral Care of Patients Treated With Anti-RANK-ligand Antibodies for a Giant Cell Tumour
Official title: Oral Care of Patients Treated With Anti-RANK-ligand Antibodies for a Giant Cell Tumour: Retrospective Study at the University Hospitals of Strasbourg
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Giant Cell Tumors
Keywords: Giant Cell Tumors
Anti-RANK-ligand antibodies
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult subject, having presented a giant cell tumor treated with adjuvant or neoadjuvant denosumab at the HUS from 01/01/2014 to 08/31/2022.

Brief summary: Giant cell tumors are mostly benign tomoral processes, most often responsible for areas of osteolysis in the metaphysoepiphyseal area of long bones, representing 5-6% of primary bone tumors. The bone weakening induced by these beaches leads to pain and risk of fracture, and this is what leads the patient to consult.

These tumors are found particularly in the young adult population between 20 and 40 years old, are locally aggressive, but malignant transformations and metastases (pulmonary) are quite rare.

In this study, the investigators wish to retrospectively study the oral care of patients who presented with a giant cell tumor and were treated with Denosumab at the University Hospital of Strasbourg and their associated oral follow-up


Eligibility criteria: Inclusion criteria:

* Adult subject, having presented a giant cell tumor treated with adjuvant or neoadjuvant denosumab at the HUS from 01/01/2014 to 08/31/2022.
* Subjects who have not expressed their opposition to the reuse of their data for scientific research purposes.

Exclusion criteria:

* Subject having expressed their opposition to the retrospective reuse of their data for scientific research purposes
* Pathology finally labeled other than giant cell tumour.
* Treatment with denosumab was not initiated because of death, change in treatment protocol, etc.
* Absence of oral follow-up element.

Primary outcomes:
measure: Number of Decayed, Missing, and Filled Permanent Teeth (DMFT)
timeFrame: Files analysed retrospectively from from January 01, 2014 to August 31, 2022 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Médecine et Chirurgie Bucco-Dentaires - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT04843124: Remote Hearing Aid Adjustment for New Hearing Aid Users; a Randomised Controlled Trial (RCT)
Official title: Remote Hearing Aid Adjustment for New Hearing Aid Users; a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Aids
Lead sponsor: Sodra Alvsborgs Hospital
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many hearing aid users experience substantial communication difficulties that may affect their participation in daily life situations negatively. One of the reasons for experiencing remaining problems could be due to unrealistic expectations, another reason could be that the hearing aid is not well adjusted or that the hearing aid user didn't got sufficient support and follow-up from the audiologist.

The purpose of this project is to offer remote hearing aid adjustment as an additional support for new hearing aid users.


Eligibility criteria: Inclusion Criteria:

* \>18 yr of age
* new hearing aid user

Exclusion Criteria:

* \<18 yr of age
* experienced hearing aid users

Primary outcomes:
measure: Hearing Handicap Inventory for the Elderly/Adults (HHIE/A)
timeFrame: Change" is being assessed: at baseline, directly after completed rehabilitation, 6 months post and 1 year post.
Secondary outcomes:
measure: The Abbreviated Profile of Hearing Aid Benefit (APHAB)
timeFrame: Change" is being assessed: at baseline, directly after completed rehabilitation, 6 months post and 1 year post.
Other outcomes:
Locations:
city: Boras
country: Sweden
facility: Hearing Clinic, Hearing Organization
state: Vastra Gotalandsregion
Study officials:
References:
Clinical trial NCT01994434: Ulnar Nerve Deep Branch Compression by a Ganglion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Guyon's Canal
Nerve Compression
Keywords: Deep branch of the ulnar nerve
Distal ulnar nerve compression
Lead sponsor: The Second Hospital of Tangshan
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
First posted: 2013-11-25
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ulnar nerve compression is common at the elbow, but less common at the wrist. The purposes of this study are to report a series of 9 patients with pure ulnar nerve deep branch compression by a ganglion and to evaluate the outcome following a surgical treatment. According modified Bishop's scoring system, the investigators would evaluate postoperative results of this uncommon nerve lesion.

Detailed description: Pre- and post-operative physical examination include assessment of tenderness and strength (grip and pinch). Grip strength and tip pinch strength between the thumb and index finger are measured using the E-LINK system. According Bishop's scoring system, the investigators redesign a questionnaire for comprehensive assessment of this uncommon nerve lesion.

Eligibility criteria: Inclusion Criteria:

Ulnar nerve deep branch compression by a ganglion -

Exclusion Criteria:

Ulnar nerve deep branch compression caused by other reasons

-

Primary outcomes:
measure: Grip strength
timeFrame: 18-24 months
measure: Tip pinch strength
timeFrame: 18-24 months
Secondary outcomes:
measure: Modified Bishop's scoring system
timeFrame: 18-24 months
Other outcomes:
Locations:
city: Tangshan
country: China
facility: The Second Hospital of Tangshan
state: Hebei
Study officials:
References:
citation: Almeida V, de Carvalho M. Lesion of the deep palmar branch of the ulnar nerve: causes and clinical outcome. Neurophysiol Clin. 2010 Jun;40(3):159-64. doi: 10.1016/j.neucli.2010.01.005. Epub 2010 Feb 17.
Clinical trial NCT00747734: A Study of MNRP1685A in Patients With Locally Advanced or Metastatic Solid Tumors
Official title: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of MNRP1685A, a Human IgG1 Antibody, Administered Intravenously in Patients With Locally Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Cancers
Keywords: Neuropilin-1
NRP1
anti-NRP1
anti-angiogenic
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-05
Enrollment: 35
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: This is a Phase I, first-in-human, open-label, dose-escalation study of MNRP1685A administered by IV infusion every 3 weeks in patients with locally advanced or metastatic solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable. This study will be conducted at up to three study centers in the United States.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Incurable, locally advanced, or metastatic solid malignancy that has progressed on, or failed to respond to, at least one prior regimen
* Evaluable or measurable disease per RECIST (in certain circumstances, prostate or ovarian cancer patients with non-measurable disease)

Exclusion Criteria:

* Inadequate hematologic or organ function
* Anti-cancer therapy within 4 weeks prior to initiation of study treatment
* Recent history of or current clinically significant gastrointestinal, cardiovascular or pulmonary disorders
* Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytics, or a filter of the inferior vena cava
* Active infection or autoimmune disease
* Known human immunodeficiency virus (HIV) infection
* Pregnancy or breast feeding

Primary outcomes:
measure: Incidence and nature of dose-limiting toxicities (DLTs)
timeFrame: Length of study
Secondary outcomes:
measure: Total exposure (AUC)
timeFrame: Length of study
measure: Maximum and minimum serum concentrations
timeFrame: Length of study
measure: Clearance
timeFrame: Length of study
measure: Volume of distribution
timeFrame: Length of study
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Rainer Brachmann, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05798234: Factors Associated With Failure of HFNO in COVID-19 ICU Patients
Official title: Factors Associated With Failure of HFNO in COVID-19 ICU Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Pneumonia
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients

Brief summary: To determine the factors associated with OHD failure in COVID-19 patients admitted to an Intensive Care Unit

Detailed description: Patients admitted into 1 participating ICU for acute hypoxemic respiratory failure due to COVID-19 between 02/01/2020 and 06/01/2022 will be assessed for OHD failure

Eligibility criteria: Inclusion Criteria:

* Patients admitted in ICU for COVID-19 pneumonia

Exclusion Criteria:

* under immediate ECMO
* secondary transferred from another ICU
* readmission in the ICU
* initial limitation of care

Primary outcomes:
measure: High flow oxygen failure
timeFrame: icu stay duration
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Service de Réanimation Médicale, Hôpital Central
Study officials:
References: