louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06257862: Translation, Cross-cultural Validity and Reliability of a Danish Version of the Anterior Knee Pain Scale
Official title: Translation, Cross-cultural Validity and Reliability of a Danish Version of the Anterior Knee Pain Scale (Kujala-DK)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patella Subluxation
Patellofemoral Pain Syndrome
Keywords: MPFL
KUJALA
PAIN
Questionnaire
TRANSLATION
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 130
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MPFL-reconstructed patients.

Brief summary: The Anterior Knee Pain Scale (Kujala) is a questionnaire designed to assess adults with patellofemoral disorders and is widely used in both anterior knee pain and patellar dislocation patients.The questionnaire is a patient-reported outcome measure (PROM), that was developed in 1993 and has been translated and validated into most major languages (e.g. French, Italian, Chinese, German, and Spanish) and has gained wide international acceptance. In a recent systematic review, the Kujala was among the eight most commonly used PROMS for patients with patellofemoral pain. In addition, the Kujala was used in almost 80% of studies of patellofemoral instability/dislocation.

The Kujala has been widely used in Denmark during the last 15 years, but surprisingly it has not been translated and validated in Danish according to international guidelines. The translation of the Kujala into Danish will stimulate to more valid and precise results of the Kujala questionnaire in both patients with anterior knee pain and patients with patellar dislocation

The aim of this study is to cross-cultural translate and adapt the Kujala into a Danish Kujala-DK. Secondarily to determine validity and reliability of the Kujala-DK in two consecutive Danish populations of patients with either anterior knee pain or patellar dislocation.


Eligibility criteria: Inclusion Criteria:

* Danish speaking
* MPFL-reconstructed

Exclusion Criteria:

-

Primary outcomes:
measure: Kujala (Anterior Knee Pain Scale)
timeFrame: Baseline, after 6-8 days
measure: Victorian Institute of Sports Assessment - Patella questionnaire (VISA-P)
timeFrame: Baseline
measure: International knee documentation committee (IKDC)
timeFrame: Baseline
measure: Banff patella instability instrument (BPII 2.0)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Division of Sports Trauma, Palle Juul-Jensens Boulevard 99
Study officials:
References:
Clinical trial NCT00589862: Clinical Management of Antiplatelet Drug Resistance in Patients With Drug Eluting Coronary Stents
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Drug Eluting Stents
Clopidogrel Resistance
Aspirin Resistance
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2008-01-10
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is recommended that patients who have drug-eluting stents placed in their coronary arteries take aspirin and Plavix (Clopidogrel) for at least a year. Patients who stop taking these antiplatelet drugs or who have resistance to the antiplatelet effects of these drugs are at a higher risk of clots occurring inside the stents which may result in a heart attack. At the present time, it is unknown if increasing the doses of the antiplatelet agents is effective in overcoming this resistance. The purpose of this project is to identify patients with antiplatelet drug resistance and to test whether an increase in the Plavix (Clopidogrel) dose overcomes antiplatelet drug resistance.


Eligibility criteria: Inclusion Criteria:

* Required Coronary Artery Angioplasty with a drug-eluting stent deployment

Exclusion Criteria:

* The last drug-eluting stent placed greater than 2 weeks prior
* Aspirin or Plavix (Clopidogrel) allergy or contraindication

Primary outcomes:
measure: to evaluate the frequency of aspirin and Plavix (Clopidogrel) resistance (as measured by a percent inhibition of platelet aggregation) in patients undergoing coronary drug-eluting stent deployment
timeFrame: 3 month intervals up to 12 months
Secondary outcomes:
measure: to assess if a Plavix (Clopidogrel) dose increase in patients with resistance to both aspirin and Plavix (Clopidogrel) is effective in overcoming antiplatelet drug resistance
timeFrame: 3 month intervals up to 12 months
measure: to evaluate the frequency of major adverse cardiovascular events in patients with and without antiplatelet resistance and following a dose increase in Plavix (Clopidogrel).
timeFrame: 3 month intervals up to 12 months
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
Study officials:
affiliation: Creighton University
name: Daniel Hilleman, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00956462: Steroids Versus Non-steroidal Anti-inflammatory Drugs Following Glaucoma Surgery
Official title: Topical Steroids Versus Topical Non-steroidal Anti-inflammatory Drugs Following Ahmed Valve Glaucoma Drainage Device Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Keywords: intraocular pressure
Ahmed valve
NSAIDS
steroids
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the eye pressure response to non-steroidal anti-inflammatory eye drops as compared to steroid eye drops following glaucoma surgery.

Detailed description: Glaucoma is a chronic disease of the eye which results in gradual loss of nerve fibres, resulting in visual loss. The mainstay of treatment is reduction of intraocular pressure (IOP), which has been shown to preserve vision, and glaucoma surgery aims to achieve this. One type of surgery involves insertion of a glaucoma drainage device (GDD). Following surgery steroid eye drops are commonly used in order to reduce the inflammation that occurs as a result of the surgery. However, a common side effect of steroid eye drops is a rise in eye pressure. Non-steroidal anti-inflammatory drugs (NSAID) eye drops do not have this side effect and are used as an alternative to steroids following other types of eye surgery. Use of NSAID drops following GDD surgery may result in improved eye pressure. This study aims to evaluate the eye pressure response to NSAID eye drops following GDD surgery.

Eligibility criteria: Inclusion Criteria:

1. 18 - 85 years of age
2. Undergoing glaucoma drainage device surgery

Exclusion criteria

1. Unable to consent
2. Undergoing combined GDD and cataract surgery
3. Patients with conditions requiring additional anti-inflammatory medications e.g., uveitic glaucoma, previous corneal transplant
4. Patients with prior history of corneal ulceration
5. Breast-feeding (nursing) mothers
6. Pregnant or planning to become pregnant during the trial period
7. Allergic to Ketorolac Tromethamine, or had an allergic-type reaction to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs used for pain relief or arthritis

Primary outcomes:
measure: Intraocular pressure
timeFrame: Six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Graham Trope
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Graham Trope, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02582762: Pilot Study of Efficacy of Nail Gel in Finger Nail Surface Abnormality
Official title: Pilot Study of Efficacy of Nail Gel Containing Artemisia Abrotanum Extract and Glycerin in Finger Nail Surface Abnormality
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nail Abnormalities
Keywords: Nail gel
Nail surface abnormality
Efficacy
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 20
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: Nail surface abnormalities is any conditions that affect the nail matrix or nail bed which cause nail plates grow defectively. Common nail surface abnormalities are pitting nails, longitudinal ridging, and transverse ridging/Beau's line. Aging nails usually have nail surface abnormalities as well.

Nail gels are artificial nails used widely for aesthetic purposes. Although, their cosmetic use is increasing with day by day, their usefulness in conditions such as nail biting, brittle nails, and ingrown toe nails has been reported. Moreover, a previous study reported the benefits of nail gels in terms of improving nail surface abnormalities like pitting nails, trachyonychia, and onychoschizia.

This study was conducted to evaluate the efficacy of nail gel containing Glycerin which has humectant effect and Artemisia Abrotanum extract which has anti-fungal/bacterial activities in finger nail surface abnormalities.

Detailed description: Evaluation of nail surface abnormality can be done by using Visiometer® (bioengineering measurement) and dermoscope. Both techniques are non-invasive.

Artemisia Abrotanum extract has been used as ingredient in cosmetic products and its safety has been declared. Undesirable events from external using products containing this substance have never been reported yet. Nail gel product in this study has been approved as a cosmetic product by Food and Drug Administration of Thailand (Thai FDA).

Eligibility criteria: Inclusion Criteria:

1. Age 18 years old or above
2. Being diagnosed nail surface abnormalities stably more than 3 months

Exclusion Criteria:

1. Having severe or uncontrolled concomitant diseases
2. Having nail infection
3. History of manicure within the last 1 month
4. Use of Biotin or other nail modifying drugs within the previous 3 months
5. Pregnancy or lactation

Primary outcomes:
measure: Improvement overall nail surface abnormalities
timeFrame: 2 weeks and 8 weeks
Secondary outcomes:
measure: Improvement roughness of nail surface abnormalities
timeFrame: 2 weeks, and 8 weeks
measure: Increase nail hydration
timeFrame: 2 weeks, and 8 weeks
measure: Patients's satisfaction
timeFrame: 2 weeks and 8 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Mahidol University
state: Bangkoknoi
Study officials:
affiliation: Siriraj Hospital, Mahiidol University
name: Sumanas Bunyaratavej, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01271062: Restoration of Beta Cell Function and Cardiovascular Parameters in Relation to Adipoinsular and Enteroinsular Axes After Gastric Bypass Surgery
Official title: Restoration of Beta Cell Function and Cardiovascular Parameters in Relation to Adipoinsular and Enteroinsular Axes After Gastric Bypass Surgery in Severely Obese Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Bariatric Surgery Candidate
Keywords: Resolvment of Diabetes Mellitus, Type 2
gastric bypass
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
Collaborators: name: European Foundation for the Study of Diabetes
name: Medical University of Graz
First posted: 2011-01-06
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Bariatric operations such as the gastric bypass procedure provide a unique in vivo model of improvement of pathological beta cell function. The presented double-centre study aims to comprehensively investigate different aspects of beta cell function in patients with type 2 diabetes (T2DM) with a wide range of disease duration after gastric bypass. In parallel, our project will address the aspects of changes in enteroinsular and adipoinsular axes as well as the early and late changes of other defined parameters after gastric bypass surgery.


Eligibility criteria: Inclusion Criteria:

* \> 18 years
* indication forbariatric surgery or non-bariatric abdominal surgery

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Acute insulin response (AIR) to glucose during IVGTT will be used as a primary variable characterizing the beta cell function
timeFrame: 10 days after gastric bypass
Secondary outcomes:
measure: OGTT calculations and modelling describing beta cell response to oral glucose load; Insulin and C-peptide areas under the curve (AUCs) during OGTT quantifying the incretin effect.
timeFrame: 10 days after gastric bypass
measure: • Plasma concentrations and adipose tissue expression of selected adipokines and inflammatory cytokines characterizing the adipoinsular axis
timeFrame: 10 days after gastric bypass
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Division of Endocrinology and Nuclear Medicine, Department of Internal Medicine, MEdical University of Graz, Austria
city: St. Gallen
country: Switzerland
facility: Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Switzerland
Study officials:
affiliation: Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Switerland
name: Bernd Schultes, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Endocrinology and Nuclear Medicine, Department of Internal Medicine, Medical University of Graz, Austria
name: Thomas Pieber, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06172062: Establishment and Application of an Artificial Intelligence Algorithm for Automatic Identification of Intraoperative Bleeding During Laparoscopic Pancreaticoduodenectomy
Official title: Establishment and Application of an Artificial Intelligence Algorithm for Automatic Identification of Intraoperative Bleeding During Laparoscopic Pancreaticoduodenectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Laparoscopic Pancreaticoduodenectomy
Keywords: laparoscopic pancreaticoduodenectomy
surgical videos
artificial intelligence
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients underwent laparoscopic pancreaticoduodenectomy for benign and malignant diseases. Besides, the surgical videos had been recorded.

Brief summary: Surgeons will label surgical videos of laparoscopic pancreaticoduodenectomy with bleeding information from multicenter. The labeled surgical video will be used as training material to train the algorithmic model so as to build an artificial intelligence algorithm that can automatically identify intraoperative bleeding in this surgery. Then, we will test the performance capability of the algorithm.


Eligibility criteria: Inclusion Criteria:

1. surgical videos that recorded complete laparoscopic pancreaticoduodenectomy including resection and reconstruction phases.

Exclusion Criteria:

1.surgical videos that recorded laparoscopic pancreaticoduodenectomy combined with resection and reconstruction of mesentericoportal vein.

Primary outcomes:
measure: performance of artifical intelligence algorithm
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT01320462: Smoking Cessation Program in the Preadmission Clinic
Official title: Smoking Cessation Program in the Preadmission Clinic:The Combination of Counseling, Pharmacotherapy and Quit Line
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Smoking
quit
surgery
anesthesia
champix
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2011-03-22
Enrollment: 296
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: Main Hypothesis: The multifaceted intervention (preoperative counseling, pharmacotherapy by varenicline and follow up by quit line) in the preoperative clinic is more effective than the simple preoperative smoking intervention (brief advice and provision of information about the quit lines ) in terms of short-term and long-term quit rates

Objectives: To evaluate the effectiveness and feasibility of a multifaceted intervention (preoperative counseling, pharmacotherapy by varenicline and follow up by the quit line) in the preoperative clinic to help surgical patients quit smoking perioperatively and for the long-term.


Eligibility criteria: Inclusion Criteria:

* Patients who smoke more than 10 cigarettes per day for more than 1 year
* And had no period of smoking abstinence longer than 3 months in the past year.
* Patients who are scheduled to have any elective surgery next 7 to 60 days. Patients \> 18 years of age

Exclusion Criteria:

* Patients unwilling or unable to give informed consent
* Patients who are pregnant and breast feeding
* Patients with any psychiatric disorder
* Patients who used nicotine replacement / bupropion within previous 3 months
* Cardiovascular disease within the past 6 months
* Any serious or unstable disease within the past 6 months
* Drug or alcohol abuse within the past year.

Primary outcomes:
measure: pre-surgery counseling for quit smoking
timeFrame: 1 year after surgery
Secondary outcomes:
measure: perioperative complications
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital, Department of Aneshtesia
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital, Department of Anesthesia
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Frances Chung, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01753362: Liraglutide In Overweight Patients With Type 1 Diabetes
Official title: LIRAGLUTIDE IN OVERWEIGHT PATIENTS WITH TYPE 1 DIABETES
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes
Lead sponsor: University at Buffalo
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2012-12-20
Enrollment: 84
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: The purpose of this study is to examine the effects of liraglutide (a drug used to treat type 2 diabetes) on glucose (sugar) control over the 26 week study period when used in addition to insulin.


Eligibility criteria: Inclusion Criteria:

1) Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII; also known as insulin pump) or multiple (four or more) injections of insulin per day. 2) Using a continuous glucose monitoring device (CGM) or regularly measuring their blood sugars four times daily. 3) HbA1c of less than 8.5%. 4) Well versed with carbohydrate counting. 5) Age 18-75 years 6) BMI≥ 25kg/m2 7) Age at diagnosis of type 1 diabetes should be \<30 years. 8) evidence of auto-immunity to beta cells (GAD-65 and islet cell antibody screen)

Exclusion Criteria:

1)Type 1 diabetes for less than 6 months; 2)Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks; 3)Hepatic disease (transaminase \> 3 times normal) or cirrhosis; 4)Renal impairment (serum eGFR \<30ml/min/1.73m2); 5)HIV or Hepatitis B or C positive status; 6)Participation in any other concurrent clinical trial; 7)Any other life-threatening, non-cardiac disease; 8)Use of an investigational agent or therapeutic regimen within 30 days of study. 9) history of pancreatitis 10) pregnancy 11) inability to give informed consent 12) history of gastroparesis 13)history of medullary thyroid carcinoma or MEN 2 syndrome. 14) Smokers will be advised not to change their amount of smoking for the duration of the study; 15) Use of any agent other than insulin for treatment of diabetes (metformin, pramlintide or thiazolidinediones.

Primary outcomes:
measure: HbA1c
timeFrame: 26 weeks
Secondary outcomes:
measure: Glucose Concentrations
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: diabetes endocrinology center of WNY
state: New York
city: Buffalo
country: United States
facility: Diabetes Endocrinology Research Center of WNY
state: New York
Study officials:
affiliation: SUNY UB
name: Paresh Dandona, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02019862: TRJ Post Market Clinical Follow Up
Official title: TRJ PMCF Köln: 2-years Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Hip Arthroplasty
Keywords: Total hip arthroplasty
TRJ
PMCF
Hip stem
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2013-12-24
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: specialist clinical centre

Brief summary: Clinical and radiological 2 years results of TRJ® Hip Stem.


Eligibility criteria: Inclusion:

* TRJ® implantation performed
* patient consent available for participation in the study

Exclusion:

* permanent cortisone therapy
* alcohol or drug abuse

Primary outcomes:
measure: Implant Survival
timeFrame: 24 months
Secondary outcomes:
measure: Clinical Outcome
timeFrame: 24 months
measure: Osteolysis
timeFrame: 24 months
measure: Ossification
timeFrame: 24 months
measure: Migration
timeFrame: 24 months
measure: TRJ® Implant Position
timeFrame: 24 months
Other outcomes:
Locations:
city: Köln
country: Germany
facility: Dreifaltigkeitskrankenhaus Köln
Study officials:
References: