louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05219786: Online Field Test of an Appendicitis Decision Support Tool
Official title: Online Field Test of an Appendicitis Decision Support Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis Acute
Keywords: decision support
decision aid
decisional conflict
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Patient-Centered Outcomes Research Institute
First posted: 2022-02-02
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: After the recent publication of the CODA Trial comparing antibiotics and surgery for acute appendicitis, the investigators developed a comprehensive decision support tool. This tool will help patients understand the risks and benefits of each treatment and make a treatment decision. This study is an online randomized field test comparing the decision support tool to a control infographic and assessing it's affect on decisional outcomes, such as decisional conflict.


Eligibility criteria: Inclusion Criteria: who live in the United States and who have not previously had appendicitis.

* Workers on Amazons Mechanical Turk Platform with an approval rating of 95% or higher
* Workers on Amazons Mechanical Turk Platform who live in the United States
* Workers on Amazons Mechanical Turn Platform who have not previously had appendicitis

Exclusion Criteria:

* Employees or relatives of employees of the University of Washington

Primary outcomes:
measure: Decisional Conflict Pre vs. Post Intervention
timeFrame: At time of enrollment
Secondary outcomes:
measure: Decisional Conflict Between Arms
timeFrame: At time of enrollment
measure: Acceptability
timeFrame: At time of enrollment
measure: Trust and Accuracy of Information
timeFrame: At time of enrollment
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: David R Flum, MD, MPH
role: STUDY_DIRECTOR
References:
citation: CODA Collaborative; Flum DR, Davidson GH, Monsell SE, Shapiro NI, Odom SR, Sanchez SE, Drake FT, Fischkoff K, Johnson J, Patton JH, Evans H, Cuschieri J, Sabbatini AK, Faine BA, Skeete DA, Liang MK, Sohn V, McGrane K, Kutcher ME, Chung B, Carter DW, Ayoung-Chee P, Chiang W, Rushing A, Steinberg S, Foster CS, Schaetzel SM, Price TP, Mandell KA, Ferrigno L, Salzberg M, DeUgarte DA, Kaji AH, Moran GJ, Saltzman D, Alam HB, Park PK, Kao LS, Thompson CM, Self WH, Yu JT, Wiebusch A, Winchell RJ, Clark S, Krishnadasan A, Fannon E, Lavallee DC, Comstock BA, Bizzell B, Heagerty PJ, Kessler LG, Talan DA. A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis. N Engl J Med. 2020 Nov 12;383(20):1907-1919. doi: 10.1056/NEJMoa2014320. Epub 2020 Oct 5.
Clinical trial NCT04760886: Paediatric Rural vs Urban Trauma
Official title: Comparing Paediatric Trauma Presentations in a Rural District General Hospital and an Urban Major Trauma Centre: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paediatric Trauma
Keywords: Paediatric trauma
Lead sponsor: NHS Highland
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 100
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: age 0-16yr olds with paediatric trauma, treated operatively.

Brief summary: Retrospective cohort study examining paediatric trauma admission over 1 year in a rural hospital vs urban centre

Detailed description: As above. All patient data was anonymised.

Eligibility criteria: Inclusion Criteria:

* All paediatric trauma in each centre over the above time frame, treated operatively, seen on an acute orthopaedic take

Exclusion Criteria:

* Adults, non-operative trauma

Primary outcomes:
measure: Type of operation performed
timeFrame: 1st April 2019- 1st April 2020
measure: Distribution of type of paediatric trauma
timeFrame: 1st April 2019- 1st April2020
Secondary outcomes:
measure: Seasonality of trauma
timeFrame: 1st April 2019- 1st April 2020
Other outcomes:
Locations:
city: Inverness
country: United Kingdom
facility: Jennifer Dunn, Raigmore hospital orthopaedic department
state: Scotland
Study officials:
affiliation: NHS Highland
name: Jennifer Dunn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05529186: Causes of Mortality in Kidney Transplant Recipients
Official title: Causes of Mortality in Kidney Transplant Recipients, a Paradigm Shift
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Disease
Keywords: renal disease
kidney transplant
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 7000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subject (≥18 years old) with transplantation performed between 01/01/2008 and 31/12/2014

Brief summary: The causes of mortality in kidney transplant patients and the risk factors for mortality have been widely published. However, there is a high variability according to geographical areas and time. Recent studies suggest that the classical hierarchy of causes of mortality, i.e. the predominance of cardiovascular causes of death, could be overturned by the increase in infectious and cancer-related deaths. Investigators will try to highlight this paradigm shift and the related risk factors by studying two large French transplantation databases.


Eligibility criteria: Inclusion criteria:

* Adult subject (≥18 years old) during transplantation
* Transplantation performed between 01/01/2008 and 31/12/2014
* Kidney transplant subject, double transplants kidney + pancreas, or kidney + islets of Langherans
* Subject previously transplanted other organs
* Subject not objecting, after being informed, to the reuse of their data for the purposes of this research

Exclusion criteria:

* Subject who expressed their opposition to participating in the study
* Subject having received a double transplant during the same operation: kidney + heart, kidney + liver, kidney + lungs

Primary outcomes:
measure: Distribution of the causes of death of kidney transplant recipients presented in the form of percentage
timeFrame: Six months of starting dialysis
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Néphrologie-Dialyse-Transplantation - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT01063686: The Cervical Cap in the Diagnosis of Rupture of Membranes in the Second Trimester
Official title: Use of a Cervical Cap as an Aid in Uncertain Rupture of Membranes in the Second Trimester
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Fetal Membranes, Premature Rupture
Ultrasonography
Keywords: Pregnancy
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2010-02-05
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Early preterm premature rupture of membranes (PPROM) complicates 0.7% of pregnancies. When PPROM occurs before the 24th week,the risk of fetal and neonatal death is 70%. There is also a high risk of neonatal and maternal morbidity. When the diagnosis of PPROM is uncertain by physical examination, additional tests are needed. These tests have false positive and false negative rates. The gold standard for diagnosing PPROM is amniocentesis and dye test. This procedure has a risk of infection and abortion.Our hypothesis is that by using a cervical cap for 6 hours and repeated ultrasound exams we can diagnose or rule out PPROM in cases which are uncertain. Our study group will be pregnant women gestational age 14-23, suspected of having PPROM.


Eligibility criteria: Inclusion Criteria:

* Gestational age 14-23
* Single fetus
* Suspected rupture of membranes
* Oligohydramnios

Exclusion Criteria:

* Vaginal bleeding
* Suspected chorioamnionitis

Primary outcomes:
measure: Changes in amniotic fluid index and single vertical pocket before and after placement of the cervical cap/
timeFrame: the parameters will be measured before placement, 6 hours after placement, 1 hour after displacement
Secondary outcomes:
measure: chorioamnionitis and abortion
timeFrame: one week from the start of the study
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Department of Ob/Gyn Rabin Medical Center, Israel
name: David Danon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01590186: Examination and Treatment of Pain in Front Foot
Official title: Examination and Treatment of Pain in Front Foot
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Pain
Front foot
Flat foot
Metatarsalgia
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
name: Aalborg University
First posted: 2012-05-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Examination and treatment of pain in front foot

Brief summary: Tibial flat foot deformity is the most common reason for metatarsalgia. Flat foot deformity is a sign of degenerated problems such as weakness in ligament or fractures. Furthermore, metatarsalgia can be a sign of excessive load caused by sport activities or at work. The condition is very common at diabetics and patients with rheumatism.

The purpose of the study is to examine the load under the front foot at health people and patients with metatarsalgia. Furthermore, the researchers aim at being able to assess the best treatment of the flat foot deformity at each patient.


Eligibility criteria: Inclusion Criteria:

* Examination and treatment of pain in front foot

Exclusion Criteria:

* Normal gait
* No pains

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Northern Orthopaedic Division, Clinic Aalborg
state: Northern Jutland
Study officials:
affiliation: Northern Orthopaedic Division
name: Mogens B Laursen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00911586: Pharmacokinetic Study to Determine Time to Steady-state
Official title: Pharmacokinetic Study to Determine Time to Steady-state of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Male Hypogonadism
Primary Hypogonadism
Secondary Hypogonadism
Lead sponsor: Clarus Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-02
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.

Detailed description: Serum testosterone levels will be obtained in hypogonadal (serum testosterone \<300 ng/dL) males receiving testosterone undecanoate capsules administered twice daily. Serum samples will be obtained consecutively in the morning on several days during one month of open-label treatment to confirm the time at which steady-state is reached.

Eligibility criteria: Inclusion Criteria:

* Male, age 18-75
* Morning serum testosterone (T) \<300 ng/dL on two occasions
* Naive to androgen-replacement therapy or willing to wash-out from current T therapy

Exclusion Criteria:

* Significant intercurrent disease
* Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score \>15 or history of prostate cancer.
* Serum transaminases \>2 times upper limit of normal
* Serum bilirubin \>2.0 mg/dL
* Hematocrit \<35% or \>50%
* BMI \>36
* Untreated, obstructive sleep apnea.

Primary outcomes:
measure: Serum T Concentration at Steady State
timeFrame: pre-dose on Days 1, 3, 5, 6, and 7
measure: Serum T Concentration at Steady-State
timeFrame: pre-dose on Days 10, 14, 17, 21, 24, 27, and 28
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
Study officials:
affiliation: Alabama Clinical Therapeutics
name: Gregory Flippo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yin AY, Htun M, Swerdloff RS, Diaz-Arjonilla M, Dudley RE, Faulkner S, Bross R, Leung A, Baravarian S, Hull L, Longstreth JA, Kulback S, Flippo G, Wang C. Reexamination of pharmacokinetics of oral testosterone undecanoate in hypogonadal men with a new self-emulsifying formulation. J Androl. 2012 Mar-Apr;33(2):190-201. doi: 10.2164/jandrol.111.013169. Epub 2011 Apr 7.
Clinical trial NCT04798963: The Evaluation of Functional Parenchymal Volume and Split Renal Function Before and After Partial Nephrectomy
Official title: 3D Assessment of Functional Parenchymal Volume and Split Renal Function Before and After Partial Nephrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Cell Carcinoma
Keywords: kidney cancer
partial nephrectomy
split renal function
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to compare pre- and postoperative 3D renal function results of patients who underwent on-clamp and off-clamp partial nephrectomy.


Eligibility criteria: Inclusion Criteria:

1. Men and women \>18 years; 2. Diagnosis of unilateral renal cell carcinoma (stage T1-T3aN0M0); 3. Planned surgery: retroperitoneoscopic/laparoscopic/robotic partial nephrectomy; 4. Patients with CT of the kidneys with contrast enhancement performed according to the required protocol.

-

Exclusion Criteria:

1. Age \< 18 years old or ASA\> 3;
2. Solitary kidney;
3. Bilateral kidney
4. The presence of concomitant systemic pathology (DM, AH), as well as kidney disease (glomerulonephritis), which can change the state of the renal parenchyma;
5. Obstructive nephropathy
6. Systemic intake of nephrotoxic drugs;
7. Pregnancy. -

Primary outcomes:
measure: GFR after the surgery
timeFrame: 6 months
Secondary outcomes:
measure: Complication rate (Clavien-Dindo)
timeFrame: 3 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sechenov University.
Study officials:
References:
Clinical trial NCT00087763: Pegaptanib Sodium on Foveal Thickening in Patients With Exudative Subfoveal Age-Related Macular Degeneration (AMD)
Official title: A Phase II Prospective, Randomized, Double-Masked, Sham-Controlled, Dose-Ranging, Multi-Center Trial to Assess the Effect of Pegaptanib Sodium on Foveal Thickening in Patients With Exudative Subfoveal Age-Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Macular Degeneration
Keywords: AMD
Age Related Macular Degeneration
Exudative Subfoveal Age Related Macular Degeneration with Subfoveal Choroidal Neovascularization
Lead sponsor: Eyetech Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2004-07-16
Enrollment: 135
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if Macugen™ reduces foveal thickness and improves vision in patients with wet AMD.

Detailed description: This will be a randomized, double-masked, controlled, dose-ranging, multi-center comparative trial, in parallel groups. Patients will be stratified by clinical center and foveal thickness to be treated either Macugen or a sham injection. After 24 weeks, all patients will treated with Macugen until the end of the study at 54 weeks.

Eligibility criteria: Inclusion Criteria:

* Best corrected visual acuity in the study eye between 20/40 and 20/320 and better or equal to 20/800 in the fellow eye.
* Foveal thickness \<= 300 um (measured by OCT center point thickness).
* Subfoveal choroidal neovascularization secondary to age-related macular degeneration, with a total lesion size (including blood, scar/atrophy \& neovascularization) of \<= 12 disc areas, of which at least 50% must be active CNV.

Exclusion Criteria:

* Previous subfoveal thermal laser therapy.
* Any subfoveal atrophy or scarring, blood over the fovea, or fibrosis. Additionally no more than 25% of the total lesion size may be made up of scarring or atrophy.
* Previous photodynamic therapy with Visudyne (PDT) in the study eye. Eyes with predominantly classic lesions (as classified by fluorescein angiographic appearance) may be enrolled in the trial if, in the clinical judgment of the investigator, PDT can be deferred for at least 54 weeks after the first study treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01976663: A Safety and Effectiveness Study of JUVÉDERM VOLIFT® XC Versus Control for Moderate to Severe Nasolabial Folds
Official title: A Prospective, Multicenter, Within-subject Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLIFT® XC Versus Control for the Correction of Moderate to Severe Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moderate to Severe Nasolabial Folds
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-11-06
Enrollment: 126
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: A prospective, multicenter, within-subject controlled study of the safety and effectiveness of JUVÉDERM VOLIFT® XC versus Control for the correction of moderate to severe nasolabial folds (NLFs).


Eligibility criteria: Inclusion Criteria:

* 2 visible moderate to severe nasolabial folds
* Agree to refrain from undergoing other anti-wrinkle/volumizing treatments in the lower two-thirds of the face for the duration of the study

Exclusion Criteria:

* Undergone facial tissue augmentation with dermal fillers in the lower two-thirds of the face within the past 12 months
* Undergone facial tissue augmentation with fat injections, botulinum toxin injections in the lower two-thirds of the face, mesotherapy, or cosmetic facial procedures in the face or neck within the past 6 months
* Received semi-permanent fillers or permanent facial implants anywhere in the lower face

Primary outcomes:
measure: Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS)
timeFrame: Baseline, Month 6
measure: Percentage of Nasolabial Folds With ≥1-Point Improvement
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Percentage of Nasolabial Folds With ≥1-Point Improvement
timeFrame: Baseline, Month 12
measure: Mean Change From Baseline in Overall Nasolabial Folds FACE-Q Score
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center P.C.
state: Alabama
city: Los Angeles
country: United States
facility: Vitiligo and Pigmentation Institute of Southern California
state: California
city: San Francisco
country: United States
state: California
city: Coral Gables
country: United States
facility: Dermatology Research Institute, LLC
state: Florida
city: Coral Gables
country: United States
facility: Skin Research Institute
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
Study officials:
References:
citation: Monheit G, Beer K, Hardas B, Grimes PE, Weichman BM, Lin V, Murphy DK. Safety and Effectiveness of the Hyaluronic Acid Dermal Filler VYC-17.5L for Nasolabial Folds: Results of a Randomized, Controlled Study. Dermatol Surg. 2018 May;44(5):670-678. doi: 10.1097/DSS.0000000000001529.
Clinical trial NCT01547663: A Comparison of Pain Scales in Patients With Disorder of Consciousness Following Craniotomy
Official title: A Comparison of Pain Scales in Patients With Disorder of Consciousness Following Craniotomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain, Postoperative
Keywords: pain scale
craniotomy
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with disorder of consciousness within 48 hours following craniotomy

Brief summary: This study aims to test validity, reliability and practicality of translated NCS, CNPI and FLACC in unconscious patients in 48 hour following craniotomy.

Detailed description: This study aims to test predictive validity (sensitivity and specificity), content validity, concurrent validity, construct validity, inter-rater reliability and practicality of translated Nociception Coma Scale (NCS) , Checklist of Non Verbal Pain Indicator (CNPI) and the Faces, Legs, Activity, Cry, Consolability Observation Tool (FLACC) in unconscious patients in 48 hour following craniotomy.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years old
2. Preoperative intracranial lesion which predicts delayed recovery
3. Disorder of consciousness within 48 hours after craniotomy assessed by using Coma Recovery Scale-Revised (CRS-R) 17
4. Not received postoperative sedation or muscle relaxants

Exclusion Criteria:

1. Documented history of prior brain injury
2. History of delayed development
3. Prior psychiatric illness
4. Prior neurological illness
5. Superior limb contusion, fracture, paralysis -cannot move
6. Thalamic hemorrhage -cannot express feeling

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Mahidol University
Study officials:
References: