louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06145815: Machine Learning Predictive Model for Rotator Cuff Repair Failure
Official title: Predictive Model for Minimal Important Change After Rotator Cuff Repair Using Machine Learning Methods: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tears
Keywords: Artificial intelligence
Machine Learning
Minimal Important Change
Lead sponsor: La Tour Hospital
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 4789
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients who were primarily treated for rotator cuff tears by partial or complete surgical repair with a planned arthroscopic procedure were included in study.

Brief summary: There is little overall evidence behind clinical practice guidelines for diagnosis and treatment of rotator cuff repair. The purpose of this study was to compare the performance of different machine learning models that use pre-operative data from an international and multicentric database to predict if a patient that underwent rotator cuff repair could achieve the minimal important change (MIC) for single assessment numeric evaluation (SANE) at one year follow-up.


Eligibility criteria: Inclusion Criteria:

* Primarily treated for rotator cuff tears by partial or complete surgical repair with a planned arthroscopic procedure
* Reparable tears
* No language barrier hindering questionnaire completion or legal incompetence were not included

Exclusion Criteria:

* missing pre- or post-operative single-assessment numeric evaluation (SANE)

Primary outcomes:
measure: SANE score
timeFrame: At 12 post-operative months
Secondary outcomes:
Other outcomes:
Locations:
city: Meyrin
country: Switzerland
facility: La Tour hospital
state: Geneva
Study officials:
affiliation: La Tour hospital, Meyrin (1217) Geneva, Switzerland
name: Alexandre Lädermann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00884715: Pharmacokinetics, Efficacy and Safety of an Octreotide Implant in Patients With Carcinoid Syndrome
Official title: Open Label Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Two Doses of an Octreotide Implant in Patients With Carcinoid Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Carcinoid Syndrome
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-04-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the pharmacokinetics, safety and efficacy of an octreotide implant for the treatment of the symptoms of carcinoid syndrome.

Detailed description: This study will evaluate a longer acting octreotide formulation. A subcutaneous implant at 2 doses will be evaluated for pharmacodynamics, efficacy and safety for a period of 9 months.

Eligibility criteria: Inclusion Criteria:

* histologically confirmed tumor
* documented evidence of carcinoid syndrome
* life expectancy of at least 6 months
* previous positive octreotide scan
* received stable doses of octreotide injections
* performance status of 0-2 on the ECOG performance scale

Exclusion Criteria:

* poorly differentiated or high grade neuroendocrine tumor
* significant cv, hepatic, renal or other disease

Primary outcomes:
measure: Assess the effects of 1 or 2 implants on carcinoid syndrome symptoms of flushing and diarrhea
timeFrame: 9 months
Secondary outcomes:
measure: safety and tolerability of the implants
timeFrame: 9 months
Other outcomes:
Locations:
city: Iowa
country: United States
state: Iowa
city: Boston
country: United States
state: Massachusetts
city: Burlington
country: United States
state: Massachusetts
Study officials:
References:
Clinical trial NCT02739685: Bioresorbable Vascular Scaffolds Versus Stents in Patients With Chronic Total Occlusion
Official title: Everolimus-eluting Bioresorbable Vascular Scaffolds Versus Everolimus-eluting Stents in Patients With Chronic Total Occlusion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 17
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 current study is to demonstrate non-inferiority of everolimus-eluting bioresorbable vascular scaffold to everolimus-eluting stents in patients with chronic total occlusion regarding the antirestenotic efficacy at 8 to 10-month angiographic follow-up.


Eligibility criteria: Inclusion Criteria:

Clinical inclusion criteria:

* Age ≥18 years
* Angina pectoris, equivalent symptoms, and/or positive stress test
* Viable myocardium subtended by chronic total occlusion
* Negative pregnancy test in women with childbearing potential

Angiographic inclusion criteria:

* Chronic total occlusion defined as Thrombolysis in Myocardial Infarction flow 0 with an estimated duration ≥3 months
* Successful wire passage and assumption of successful stent/scaffold deployment
* Target reference vessel diameter 2.5 - 4.0 mm

Exclusion Criteria:

Clinical exclusion criteria:

* Limited long-term prognosis with a life-expectancy \<12 months
* Contraindications to antiplatelet therapy
* Known allergy against cobalt chrome, everolimus, or polylactic acid

Angiographic exclusion criteria:

* Target lesion located in the left main trunk
* Target lesion located in a coronary bypass graft
* Bifurcation lesion with planned two-stent strategy
* Indication for coronary artery bypass grafting

Primary outcomes:
measure: In-stent late lumen loss assessed by angiography
timeFrame: 8-10 months after the index procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: University of Luebeck
Study officials:
References:
Clinical trial NCT02076685: NAT2 Genotyping in Re-challenge Protocol of INH Titration in Patients With Anti-TB Medications-induced Hepatitis
Official title: The Application of the N-acetyltransferase 2 (NAT2) Genotyping in Re-challenge Protocol of Isoniazid (INH) Titration in Patients With Anti-TB Medications-induced Hepatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatotoxicity
Keywords: pharmacogenetics
anti-tuberculosis drug
genetic polymorphism
isoniazid
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-03-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To improve the treatment outcome in patients with tuberculosis and integrate the pharmacogenetics into clinical practice, the information of NAT2 genotyping was used in re-challenge protocol for isoniazid (INH) titration in patients with anti-tuberculosis medication-induced hepatitis.


Eligibility criteria: Inclusion Criteria:

1. \>= 18 years.
2. Take INH for at least a week.
3. abnormal liver function (ALT (alanine, transaminase) increased by more than three times the upper limit of normal, or ALT higher than twice the upper limit of normal and total bilirubin higher than 2.0 mg / dL

Exclusion Criteria:

1.Taking INH before liver function abnormalities. 2.

Primary outcomes:
measure: successful re-use of isoniazid for TB treatment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Nationa Taiwan University Hospital
name: Shen Li Jiuan, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02213185: EMLA and Sterile Water Injections - Pain From Injections
Official title: Effect of EMLA® Patches for Reducing Pain Associated With Sterile Water Injections - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Sterile water injections
Pain
VAS
Complementary method
Lead sponsor: University of Skövde
Sponsor class: OTHER
First posted: 2014-08-11
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to study the effect of local anaesthesia (EMLA®) on pain associated with sterile water injections.

Detailed description: Sterile Water Injection (SWI) was previously shown to give good pain relief for lower-back pain during childbirth, chronic neck pain and ureterolithiasis. However, the pain associated with the injections remains problematic, and therefore it is important to find a less painful injection technique.

Eligibility criteria: Inclusion Criteria

* Woman
* Age 18-45 years
* Healthy
* Ability to understand information and instructions

Exclusion Criteria:

* Pregnancy
* Previous experience of SWI
* On-going pain
* Use of medication for depression, pain, or sleeping disorder 24 hours prior to the experiment
* Smoking, snuffing, physical activity, and intake of caffeinated beverages (coffee, tea, or energy drink (e.g., Red Bull) 2 hours prior to the experiment

Primary outcomes:
measure: Self reported experience of injection pain measured by Visual Analogue Scale following Sterile Water Injections
timeFrame: 15 minutes
Secondary outcomes:
measure: Self reported (questionnaire descriptive via email), self-reported experiences of side effects following Sterile Water injections
timeFrame: 24 hours
Other outcomes:
Locations:
city: Skövde
country: Sweden
facility: School of Health Sciences, University of Skövde
Study officials:
affiliation: University of Skövde
name: Lena B Mårtensson, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martensson LB, Gunnarsson BM, Karlsson S, Lee N, Bergh I. Effect of topical local anaesthesia on injection pain associated with administration of sterile water injections - a randomized controlled trial. BMC Anesthesiol. 2022 Feb 1;22(1):35. doi: 10.1186/s12871-022-01573-0.
Clinical trial NCT02127385: The Type of Hepatoglobin in IUGR
Official title: The Type of Hepatoglobin in IUGR
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Haptoglobin Type
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-04-30
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients adimitted with IUGR

Brief summary: Intra Uterine Growth Restriction is associated with increased oxidative stress. Haptoglobin (Hp) is an abundant plasma glycoprotein produced in the liver. The function of Hp is as anti oxidant agent, it binds free hemoglobin (Hb) released from red blood cells to decrease oxidative tissue damage. There are 3 differenet genotype of haptoglobin Hp 1-1 Hp 1-2 and Hp 2-2 with different anti oxidant properties and different prevalence ( Hp 1-1, Hp 1-2 and Hp 2-2approximately 16%, 48% and 36% respectively) . we hypotheise that IUGR will be more common and severe in the Hp 2-2 genotype with the less anti oxidant properties.


Eligibility criteria: Inclusion Criteria: Pregnancies complicated with IUGR -

Exclusion Criteria: NOT INTERESTED DO PARTICIPATE

-

Primary outcomes:
measure: type of haptoglobin
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: HILLEL YAFFE MEDICAL CENTER- TECHNION
name: RON BELOOSESKY, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01435785: Performance Evaluation of Four Pharmacokinetic-Pharmacodynamic(PKPD) Models of Propofol in Elderly Patients
Official title: Derivation and Prospective Validation of Four Pharmacokinetic-Pharmacodynamic Models of Propofol in Elderly Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Propofol Overdose of Undetermined Intent
Keywords: PKPD
Propofol
TCI
Elderly patients
Lead sponsor: Universidad del Desarrollo
Sponsor class: OTHER
Collaborators: name: Pontificia Universidad Catolica de Chile
First posted: 2011-09-19
Enrollment: 14
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients older than 65 years, ASA 1,2 programed for elective sugery

Brief summary: Despite the wide use of propofol target-controlled infusion (TCI) in elderly patients, pharmacokinetic (PK) and pharmacodynamic (PD) models performance has not been prospectively assessed in this population. The aims of this study are to derive four PKPD models using previously published PK parameters sets, and to prospectively assess their performance in elderly people. With the obtained data we propose to build a specific PKPD model for this population.

Detailed description: After BIS® and routine monitors were placed, 14 ASA I-II elderly patients (\>65 yr) will be anesthetized with plasma TCI of propofol based on Schnider model. After partial recovery from a bolus dose a remifentanil infusion was started and continued throughout surgery. All BIS and TCI data will be continuously record. Arterial blood samples for propofol assays were collected at 1, 2, 3, 5, 10, 20, 40 and 60 min post-induction, and at 0, 1, 3, 5, and 10 min after stopping the infusion. A three compartment effect site model linked to a Sigmoidal Emax PD model, will be used to fit all the data simultaneously in NONMEM. Median performance errors(MDPE), and median absolute performance errors(MDAPE) were calculated to measure bias and accuracy of each model. Comparisons between models will be performed.

Eligibility criteria: Inclusion Criteria:

* Patients older than 65 years, ASA 1,2

Exclusion Criteria:

* Included less than 70% or more than 130% of ideal body weight
* Neurologic disorder
* Use of psychoactive medication, including alcohol intake during the last 48 hours

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Clinica Alemana de Santiago
city: Santiago
country: Chile
facility: Clinica Alemana Santiago
Study officials:
affiliation: Clinica Alemana Universidad del Desarrollo
name: Pablo O Sepulveda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01986985: Comparison of 18F FDG PET/CT TO PET MRI
Official title: Comparison of 18F FDG PET/CT TO PET MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Any Condition With a Clinical Indication for PET/CT Exam
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2013-11-19
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The objective of this study is to gather image and associated data to of a pre-market PET/MRI scanner and to use the data for regulatory submission and future product development and marketing. Clinical data is required in order to test the MR attenuation correction of PET data. These aims can only be accomplished through a clinical study.


Eligibility criteria: Inclusion criteria

1. Subject must have a clinical indication for a PET/CT exam
2. Subject must be at least eighteen (18) years of age
3. Female subjects that are determined to be non-pregnant by a physician investigator or are demonstrated non-pregnant by negative urine pregnancy test administered within the 24 hour period before PET/CT imaging
4. Subject must be able to hear and understand instructions without assistive devices
5. Subject must provide written informed consent
6. Subject has the necessary mental capacity to understand instructions, and is able to comply with protocol requirements
7. Subject is able to remain still for duration of imaging procedure (approximately 60 minutes total for PET/MRI); and
8. Subject must be able to participate in a PET/MR imaging session within 1 hour of concluding their PET/CT exam.

Exclusion criteria

1. Subjects who have any axial diameter larger than 55 cm
2. Subjects with a weight greater than 499 lbs
3. Subjects that have metallic/conductive or electrically/magnetically active implants without MR Safe or MR Conditional labeling, with the exception of dental devices/fillings, surgical clips, and surgical staples determined to be safe for MRI scanning by a physician investigator
4. Subjects that have implants with MR Unsafe labeling;
5. Subjects that have implants labeled as MR Conditional by the manufacturer for which the allowable conditions are not expected to be achieved by the MR/PET environment or scan protocol;
6. Subjects who have a contraindication to MRI per the screening policy of the participating site.

Primary outcomes:
measure: PET/MR Images Clinical Usefulness
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: GE Healthcare
name: Roee Lazebnik, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03738085: Previous Abdominal Surgery and Obesity Does Not Affect Unfavorably the Outcome of Total Laparoscopic Hysterectomy
Official title: Previous Abdominal Surgery and Obesity Does Not Affect Unfavorably the Outcome of Total Laparoscopic Hysterectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laparoscopic Surgical Procedure
Obesity
Surgery--Complications
Keywords: Complication
Previous surgery
Total laparoscopic hysterectomy
Obesity
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 380
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All women who underwent TLH for benign conditions

Brief summary: Previous surgery and obesity has disputed as an unfavorable factor during Total Laparoscopic Hysterectomy. The aim of the investigator's study was to assess the effects of previous abdominal surgery and obesity on intra-operative and post-operative outcomes of TLH.

Detailed description: Abstract:

Objective: To assess the effects of previous abdominal surgery and obesity on the intra-operative and post-operative outcomes of total laparoscopic hysterectomy (TLH).

Method: In this retrospective cohort study, women who underwent TLH for benign conditions between January 2011 and December 2016 in tertiary academic center were included. Patients were grouped according to previous abdominal surgery. The study group consisted of patients who had at least one previous abdominal surgery and the control group consisted of patients with no previous abdominal surgery. In a further analysis, a subgroup of obese patients with BMI (body mass index) ≥30 kg/m2 was evaluated. For this analysis, the obese patients who underwent TLH were picked up and the results were compared to the results of obese patients who underwent total abdominal hysterectomy (TAH) during the same time period. The main outcome parameters were duration of hospital stay and major complication rate.

Eligibility criteria: Inclusion Criteria:

* all women who underwent TLH for benign conditions during study period
* all obese ≥30 kg/m2 women who underwent TAH for benign conditions during study period

Exclusion Criteria:

* No

Primary outcomes:
measure: Complication rate
timeFrame: Up to one week
measure: Hospital stay difference
timeFrame: Up to one week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ankara University
name: Batuhan Turgay
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara University
name: Bulent Berker, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00603785: Effects of Anti-IgE Antibody Omalizumab on Patients With Chronic Sinusitis
Official title: Effects of Anti-IgE Antibody Omalizumab (Xolair) on Patients With Chronic Sinusitis and a Positive Allergen Test
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Chronic Sinusitis
Keywords: Chronic sinusitis
Xolair
Nasal Discharge
Nasal Obstruction
Facial Pain
Hyposmia
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Chicago
First posted: 2008-01-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We propose to study the effects of Xolair on patients with chronic sinusitis with or without nasal polyps. Because of the similarities between the inflammatory processes found in asthmas and rhinitis to those found in chronic sinusitis, we hypothesize that sinusitis should respond to Xolair, just as asthma.

Detailed description: We propose to study the effects of Xolair on patients with chronic sinusitis with or without nasal polyps. Since Xolair has been shown to be effective in asthmatic subjects with evidence of atopy and elevated IgE, we will limit our study to patients with chronic sinusitis and these parameters. The primary objective is to determine if Xolair decreases mucosal thickness on CT scan after 6 months of treatment.

Eligibility criteria: Inclusion Criteria:

* Males and females between 18 and 75 years of age
* Chronic sinusitis as defined by symptoms for greater than 12 weeks despite treatment.
* Paranasal sinus CT scan showing evidence of chronic sinusitis.
* Positive skin or RAST test to an inhalant allergen.
* Serum total IgE between 30 and 700 International Units/ml.
* Body weight less than 150kg.
* Impaired quality of life as measured by the Rhinosinusitis Disability Index (RSDI).

Exclusion Criteria:

* Women of childbearing potential not using the contraception method(s) (Birth control pills, depo Provera, double barrier) as well as women who are breastfeeding.
* Known sensitivity to Xolair
* Patients with severe medical conditions that in the view of the investigator prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease).
* Use of any other investigational agent in the last 30 days.
* No measurable disability on the RSDI.
* Immunocompromised patients or patients with ciliary disorders.

Primary outcomes:
measure: Subjects will have QOL measures (RSDI, SNOT 20, SF-36), NPIF, and nasal lavage repeated. Exacerbations of sinusitis requiring additional treatments will be recorded. Paranasal sinus CT scans will be obtained at the screening and final visits
timeFrame: At entry and every 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Andrew Goldberg, MD
role: PRINCIPAL_INVESTIGATOR
References: