louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01768988: Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study
Official title: Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pancreatic Cancer
Visceral Pain
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2013-01-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double blind controlled, parallel arms trial, aimed to assess the efficacy of pregabalin on pancreatic cancer induced abdominal pain. The goals of this study include (1) assessing the analgesic effect of pregabalin in comparison to placebo; assessing the presence of central sensitization and its potential reversion by Pregabalin; (3) assessing quality of life of patients treated with pregabalin in comparison to placebo; (4) to compare adverse effects in patients treated with Pregabalin in comparison to placebo; (5) to compare anxiety and depression in patients treated with pregabalin in comparison to placebo.


Eligibility criteria: Inclusion Criteria:

* 1. Patients \> 18 years old recently diagnosed of pancreatic cancer (\<3 months).
* 2. Personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
* 3. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.

Exclusion Criteria:

* 1. Patients with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
* 2. Patients with previously diagnosed moderate to severe renal impairment. Those with a Clearance of Creatinine (CLcr) \< 60mL/min should be excluded.
* 3. Patients treated with anticonvulsants during the previous 4 months.

Primary outcomes:
measure: Pain intensity (Visual Analogue Scale; VAS Score)
timeFrame: From baseline to day 90.
Secondary outcomes:
measure: Quality of life
timeFrame: From baseline to day 90.
measure: Performance status
timeFrame: From baseline until to day 90.
measure: Anxiety and depression
timeFrame: From baseline to day 90.
measure: Neuropathic Pain
timeFrame: From baseline to day 90.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
References:
Clinical trial NCT05063188: Connective Tissue Massage With Fibromyalgia
Official title: Is Connective Tissue Massage Effective In Individuals With Fibromyalgia?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 32
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study was to examine the effectiveness of clinical pilates exercises and connective tissue massage in individuals with Fibromyalgia (FM). 32 women were randomly divided into two groups as intervention (n=15, mean age=48.80±7.48) and control (n=17, mean age=55.64±7.87). While connective tissue massage and clinical pilates exercises were applied to the intervention group, control group were applied only clinical pilates exercises.According to our results, connective tissue massage increased the effectiveness of clinical pilates exercises in individuals with FM.


Eligibility criteria: Inclusion Criteria:(a) having FM diagnosis according to American College of Rheumatology 2016 criteria, (b) being a women, (c) aged 20-65. (d) being stable in drug use for at least 6 months or more. (e) being volunteer to participate in this study.

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Exclusion Criteria:(a) have been exercising regularly for the past three months, (b) the presence of uncontrolled cardiopulmonary disease, (c) the presence of orthopedic, neurological or mental problems that may prevent exercise, (d) having undergone any surgery in the last six months for both groups, (e) pregnancy, (f) presence of malignancy, (g) not being able to participate in at least 75% of the training.

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Primary outcomes:
measure: Pain Location Inventory
timeFrame: 10 min
measure: Fibromyalgia Impact Questionnaire
timeFrame: 15 min
measure: Health Assessment Questionnaire
timeFrame: 10 min
measure: Beck Anxiety Inventory
timeFrame: 10 min
measure: Short Form-36
timeFrame: 10 min
measure: Biopsychosocial Questionnaire
timeFrame: 15 min
Secondary outcomes:
Other outcomes:
Locations:
city: Pamukkale
country: Turkey
facility: Pamukkale University
state: Denizli
Study officials:
References:
Clinical trial NCT01811888: Painful Knee Prosthesis. Relationship Between Endogenous Analgesia and Persistent Post Surgical Pain.
Official title: Painful Knee Prosthesis. Relationship Between Endogenous Analgesia and Persistent Post Surgical Pain.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2013-03-15
Enrollment: 180
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 with knee osteoarthritis scheduled for total knee artheroplasty.

Brief summary: This is a prospective, observational study, aimed to establish the relationship between an inefficient endogenous pain modulation before surgery (total knee arthroplasty; TKA) and the probability to develop chronic pain after surgery (persistent post surgical pain). Endogenous analgesia efficiency will be measured during the month previous to surgery using quantitative sensory testing (QST). Persistent post surgical pain will be defined as presence of pain in movement greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after surgery.


Eligibility criteria: Inclusion Criteria:

* Older than 18 patients
* Scheduled for primary total knee arthroplasty
* Disposition to visits and scheduled tests

Exclusion Criteria:

* Previous surgery on knee to be operated
* Documented peripheral neuropathy
* Severe disease or condition that could potentially interfere with interpretation of tests.

Primary outcomes:
measure: Presence of pain in the operated knee, 6 months after surgery.
timeFrame: Presence of pain greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after surgery.
Secondary outcomes:
measure: Endogenous Analgesia efficiency measured with QST (Quantitative sensory testing) techniques.
timeFrame: From start of recruitment untill day 180.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Servicio d'Anestesia i Reanimació, Hospital del Mar
Study officials:
References:
citation: Dursteler C, Salazar Y, Rodriguez U, Pelfort X, Verdie LP. Conditioned pain modulation predicts persistent pain after knee replacement surgery. Pain Rep. 2021 Mar 29;6(1):e910. doi: 10.1097/PR9.0000000000000910. eCollection 2021 Jan-Feb.
Clinical trial NCT03612388: Combined Use of a Novel Cardioplegic Formula With Myocardial Protection System (MPS)® Versus Cardioplexol ® in Isolated Coronary Artery Bypass Grafting (CABG) Using MiECC;
Official title: Combined Use of a Novel Cardioplegic Formula With MPS® Versus Cardioplexol ® in Isolated CABG Using MiECC (Minimal Extracorporeal Circulation System)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Extracorporeal Circulation
Complication of Coronary Artery Bypass Graft
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 211
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation system) at the department of cardial surgery University Hospital Basel Switzerland

Brief summary: Combined use of a novel cardioplegic formula with MPS® (Myocardial protection system) versus Cardioplexol ® (colloid solution with Procaine, magnesium and potassium) in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation system).


Eligibility criteria: Inclusion Criteria:

* CABG using MPS® or Cardioplexol ®

Exclusion Criteria:

* use of other colloid solution than Cardioplexol ® or MPS®
* other inventions than CABG
* myocardial infarction \<7 days before CABG
* patients denial of data use

Primary outcomes:
measure: Change in lab values for cardial biomarkers
timeFrame: perioperative during hospital stay for CABG
Secondary outcomes:
measure: mortality
timeFrame: 30 days after CABG
measure: need for intensive care unit
timeFrame: perioperative during hospital stay for CABG
measure: dysrhythmia
timeFrame: perioperative during hospital stay for CABG
measure: bleeding
timeFrame: perioperative during hospital stay for CABG
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Klinik für Herzchirurgie, Universitätsspital Basel
Study officials:
affiliation: University Hospital Basel, CH-4031 Basel
name: Oliver Reuthebuch, PD MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02329288: Retrobulbar Triamcinolone Acetonide Injection in the Treatment of NA-AION
Official title: Retrobulbar Triamcinolone Acetonide Injection in the Treatment of Nonarteritic Anterior Ischemic Optic Neuropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Triamcinolone Acetonide
Optic Neuropathy, Ischemic
Lead sponsor: Second Military Medical University
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: NAION produces an ischemic insult in the optic nerve head presumably due to the hypoperfusion of the short ciliary arteries that supply it.

Intravenous injection of glucocorticoid have proven to be effective in treatment of Nonarteritic Anterior Ischemic Optic Neuropathy,but have some side effects. the investigators believe that offering them Retrobulbar Triamcinolone Acetonide Injection that might halt the progression of the visual acuity and visual field loss if our hypothesis is correct, would greatly improve their chances of avoiding blindness.


Eligibility criteria: Inclusion Criteria:

Sudden mono ocular vision loss associated with optic disc edema and positive Marcus Gunn (\<30 days)

Exclusion Criteria:

Any eye disease except NAION(Nonarteritic Anterior Ischemic Optic Neuropathy) Neurologic defect Abnormal ESR, CRP, any history of retina or vitreal surgery Severe corneal opacity which makes retina examination impossible

Primary outcomes:
measure: Changes of Best corrected visual acuity(BCVA)
timeFrame: baseline and 1month, 3month
Secondary outcomes:
measure: Changes of Visual Field
timeFrame: baseline and 1month, 3month
Other outcomes:
Locations:
Study officials:
affiliation: department of ophthalmology
name: shihong zhao
role: STUDY_DIRECTOR
References:
Clinical trial NCT01076088: Safety and Efficacy of Co-Administration of Sitagliptin and Metformin in China (MK-0431-121)
Official title: A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial in China to Study the Safety and Efficacy of Co-administration of Sitagliptin and Metformin in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-02-25
Enrollment: 744
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy and safety of initial treatment with sitagliptin and metformin in patients with type 2 diabetes mellitus in China. The primary hypothesis is that after 24 weeks, initial co-administration treatment with sitagliptin and metformin provided greater reduction in hemoglobin A1C (A1C) compared to initial treatment with sitagliptin alone and with metformin alone.


Eligibility criteria: Inclusion Criteria:

* has type 2 diabetes mellitus
* is male, a female who cannot have children, or a female who agrees to use birth control during the study
* is not on an antihyperglycemic agent (AHA) (hemoglobin A1c \[A1C\] 7.5-11.0%) or on oral single AHA (A1C 7.0-10.5%) or low-dose AHA combination therapy (A1C 7.0-10.0%)

Exclusion Criteria:

* Patient has type 1 diabetes mellitus or ketoacidosis
* Patient is taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin)
* Patient is on a weight loss program not in the maintenance phase or on a weight loss medication
* Patient has a history of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer
* Patient is HIV positive
* Patient is pregnant

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1C (A1C) at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Ji L, Han P, Wang X, Liu J, Zheng S, Jou YM, O'Neill EA, Golm GT, Engel SS, Kaufman KD, Shankar RR. Randomized clinical trial of the safety and efficacy of sitagliptin and metformin co-administered to Chinese patients with type 2 diabetes mellitus. J Diabetes Investig. 2016 Sep;7(5):727-36. doi: 10.1111/jdi.12511. Epub 2016 May 19.
Clinical trial NCT01801488: Genome-wide Analysis of Single Nucleotide Polymorphisms of Brain Arteriovenous Malformations and Cerebral Aneurysm
Official title: Genome-wide Analysis of Single Nucleotide Polymorphisms of Brain Arteriovenous Malformations and Cerebral Aneurysm
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arteriovenous Malformations
Intracranial Aneurysm
Subarachnoid Hemorrhage
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2013-02-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to University Hospital.

Brief summary: Test single nucleotide polymorphisms (SNP's) in ruptured and unruptured aneurysm tissue to identify a genetic difference between the two types of aneurysms; and to test SNP's in arteriovenous malformation tissue to identify a genetic link.


Eligibility criteria: Inclusion Criteria:

* All adult patients between the ages of 18 and 89 that are having open surgical resection of an AVM or clipping of an aneurysm will be included

Exclusion Criteria:

Primary outcomes:
measure: Risk gene expression
timeFrame: Within one week of sample collection.
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
affiliation: SUNY Upstate Medical University Neurosurgery
name: Eric M Deshaies, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04043988: Management of Diverticulitis in the Emergency Department
Official title: Management of Diverticulitis in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diverticulitis
Lead sponsor: Olive View-UCLA Education & Research Institute
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2019-08-02
Enrollment: 718
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the emergency departments at EMERGEncy ID NET sites will be screened for study eligibility by study coordinators or treating clinicians.

Brief summary: This study aims to describe current treatment practices in the US for managing acute uncomplicated diverticulitis. In addition, we will identify clinical factors associated with the decision to discharge versus hospitalize patients with uncomplicated diverticulitis with the goal of informing clinical decision-making and providing a foundation for diagnostic algorithms to guide clinical practice.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Emergency department presumptive or confirmed final diagnosis of acute diverticulitis
* Verbal or written consent provided in English (or Spanish depending on study site)

Exclusion Criteria:

* None

Primary outcomes:
measure: Rates of hospital admission
timeFrame: Day 1
measure: Rate of Imaging
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Sylmar
country: United States
facility: Olive View-UCLA Medical Center
state: California
Study officials:
References:
Clinical trial NCT04742088: Assessment of the Safety and Performance of a Compression Ankle Support in the Prevention of Injuries During Sports Practice
Official title: Assessment of the Safety and Performance of a Compression Ankle Support in the Prevention of Injuries During Sports Practice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Chronic Instability of Ankle Joint
Lead sponsor: Decathlon SE
Sponsor class: INDUSTRY
Collaborators: name: EFOR, France
First posted: 2021-02-05
Enrollment: 30
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: Decathlon has developed ankleSOFT100 product which is medical device designed to reduce pain and joint instability during sport practice. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon ankleSOFT100 product to demonstrate safety and performance of this device in a real-world setting.


Eligibility criteria: Inclusion Criteria:

* Subject is aged ≥18 years old
* Subject has chronic pain AND / OR chronic ankle instability
* The current condition of his/her ankle allows the subject to pursue a usual physical activity
* Subject has been informed and is willing to sign an informed consent form
* Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (6 weeks)
* Subject is affiliated to the French social security regime

Non-inclusion Criteria:

* Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent
* Subject has worn a support (ankle brace or articulated orthosis) during sports sessions during the last month
* Subject has any medical condition that could impact the study at investigator's discretion
* Subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastodiene, elastane, polyester, synthetic rubber)
* Adult subject to a legal protection measure

Primary outcomes:
measure: Functional score
timeFrame: At baseline and 6 weeks of follow-up
Secondary outcomes:
measure: Confidence level
timeFrame: At baseline and 6 weeks of follow-up
measure: Ankle instability
timeFrame: At 2 weeks and 6 weeks of follow-up
measure: Ankle pain
timeFrame: At 2 weeks and 6 weeks of follow-up
measure: Safety (adverse events)
timeFrame: 6 weeks of follow-up
Other outcomes:
Locations:
city: Faches-Thumesnil
country: France
facility: Centre de rééducation et de balnéothérapie Kinés Faches
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
city: Paris
country: France
facility: Cabinet de kinésithérapie du Belvédère
city: Paris
country: France
facility: KOSS Paris 8
Study officials:
affiliation: Centre Hospitalier Universitaire de Lille
name: Valérie WIECZOREK
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06697288: Evaluation of Efficacy of Anthelios Sunscreen on Face Versus Usual Routine on Signs of Aging
Official title: Evaluation of the Efficacy of the UVMune 400 Fluid Sunscreen on the Face Versus Usual Photoprotection Routine on Visible and Measurable Signs of Aging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Keywords: skin aging
Anthelios UVMUNE 400 Oil Control Fluid SPF 50+
preventive effect
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2024-11-20
Enrollment: 260
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This experimental, randomized study aims at evaluating the preventative effect of a Sun Protection Factor (SPF) 50+ sunscreen (Anthelios UVMUNE 400 Fluid SPF 50+) with high Ultraviolet A (UVA) protection on clinical signs of skin aging.

Detailed description: The study will be conducted in compliance with the protocol, current internal procedures and in the spirit of the International Council on Harmonisation (ICH) Topic E6(R2)5 ref: EMA/CHMP/ICH/135/1995, ICH Good Clinical Practice (GCP) Addendum Nov 2016 and applicable regulatory requirement.

Statistical plan: Tx represents the values observed at Time x, for each parameter and by subgroup. Quantitative variables, or those that can reasonably be treated as such, will be summarized using the minimum, maximum, measures of central tendency such as the mean and median \& measures of dispersion such as the standard deviation (SD). Qualitative variables will be summarized in the form of counts and percentages.

For each parameter, a graphical representation of the means ±95% Confidence Interval (CI) will be produced to visually assess the evolution across time, by treatment group.

Eligibility criteria: Inclusion Criteria:

* Subjects with signs of photo aging (Global score of at least 14)
* All skin types

Exclusion Criteria:

* Any history of significant dermatological/ophthalmological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site
* Pregnant or breastfeeding women
* Subject with known allergy to cosmetic products or to any ingredient of the sunscreen product

Primary outcomes:
measure: Change in the dermatological assessment of skin signs on the face (Global score)
timeFrame: Day0; Day84; Day168; Day252; Day336
Secondary outcomes:
measure: Dermatological assessment of skin signs on the face - Atlas Bazin, Flament (Global score)
timeFrame: Day0; Day84; Day168; Day252; Day336
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: CIDP
Study officials:
affiliation: Centre International de Développement Pharmaceutique
name: Renato Moura
role: PRINCIPAL_INVESTIGATOR
References: