louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02028845: Loop-tipped Guidewire in Selective Biliary Cannulation
Official title: Loop-tipped Guidewire in Selective Biliary Cannulation: a Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Choledocholithiasis
Bile Duct Cancer
Pancreatic Cancer
Ampullary Tumor
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2014-01-07
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Background

   * Advanced guidewires with a U-shaped tip could effectively cross the long or multi-occlusive segment smoothly and go into the distal outflow vessel.
   * The guidewire looping technique is a safe and effective method for the recanalization of the occluded lesions in infrapopliteal vessels.
2. Objective - To compare the performance a loop-tipped guidewire with a straight-tipped guidewire in achieving successful deep biliary cannulation.
3. Design

   - Prospective randomized trial.
4. Setting:

   - Tertiary-care medical center
5. Patients

   - This study will involve 192 patients with biliary diseases which require endoscopic retrograde cholangiopancreatography.
6. Intervention - Cannulation of bile duct by using a loop-tipped guidewire or a straight-tipped guidewire
7. Main outcome measurements - Compare the cannulation success rate, the duration of the cannulation, immediate and late complications.


Eligibility criteria: Inclusion Criteria:

* age \> 19 and ability to consent
* no evidence of significant cardiopulmonary or medical comorbidities precluding participation

Exclusion Criteria:

* Known gastroduodenal anatomic abnormalities
* Coagulation disorders (international normalized ratio \> 1.5 or platelet count \< 50000 cells/cubic millimeter)
* Prior gastric surgery,endoscopic retrograde cholangiopancreatography
* Pregnancy

Primary outcomes:
measure: The cannulation success rate
timeFrame: Up to 9 months, The primary outcome measure will be assessed after the enrollment of patients (anticipated time: 2014/08/30).
Secondary outcomes:
measure: The duration of the cannulation, immediate and late complications.
timeFrame: Up to 9 months, The secondary outcome measure will be assessed after the enrollment of patients (anticipated time: 2014/08/30).
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Department of Gastroenterology, Ajou University School of Medicine
state: Gyeonggi
Study officials:
affiliation: Department of Gastroenterology, Ajou University School of Medicine
name: Byung Moo Yoo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00188045: Hemodynamic Effects of Chronic Administration of Spironolactone and/or Propranolol in Alcoholic Cirrhotic Patients
Official title: Hemodynamic Effects of Chronic Administration of Spironolactone, Propranolol and Their Association in Alcoholic Cirrhotic Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Alcoholic Cirrhosis
Keywords: Portal hypertension, alcoholic cirrhosis, Hepatic venous pressure gradient, hemodynamic, spironolactone, propranolol
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2005-09-16
Enrollment: 54
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: PREVENTION

Brief summary: The aim of this study was assesment of splanchnic and systemic hemodynamic effects of chronic administration (2 month) of spironolactone or propranolol, alone or in association in alcoholic cirrhotic patients. The patients were randomized in 4 groups (aldactone 150 mg/day, propranolol 160 mg/day, aldactone 150 mg/day + propranolol 160 mg/day, placebo). Systemic and splanchnic hemodynamic effect were evaluated by hepatic venous pressure gradient measurements before and after 2 month of treatment.


Eligibility criteria: Inclusion Criteria:

* Indication of transjugular hepatic biopsy
* alcoholic cirrhosis
* presence of oesophageal varices ≤ stade 2

Exclusion Criteria:

* renal insufficiency
* natremia ≤ 135 mmol/l
* vasoactive treatment in the last month before inclusion
* hepatocellular carcinoma
* positive HIV and HCV patients
* paracentesis in the last week before inclusion
* digestive bleeding in one last week
* oesophageal varices stade 3 or 2 with red signs

Primary outcomes:
measure: assessment of hepatic veinous pressure gradient changes after chronic treatment by spironolactone or propranolol alone or in association.
Secondary outcomes:
measure: Efficacy of spironolactone/propranolol association
Other outcomes:
Locations:
Study officials:
affiliation: UH Angers
name: Paul Cales, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02968745: Occupational Performance Problems in Individuals With Rheumatoid Arthritis
Official title: Occupational Performance Problems Frequently Reported by Individuals With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: RheumatoId Arthritis
Keywords: Rheumatoid arthritis
human activity
Canadian Occupational Performance Measure
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 81
Sex: ALL
Minimum age (years): 46
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: For this cross-sectional study, 81 patients treated between 2009 and August 2010 in clinical Hospital, at the Universidade Federal de Minas Gerais (UFMG) in Brazil werw recruited by convenience sampling

Brief summary: Aim: To identify the main occupational performance problems reported by individuals with rheumatoid arthritis and the relationship between these activities with work status of participants . Methods: the investigators conducted a cross-sectional study with 81 patients with RA. Individuals were interviewed the Canadian Occupational Performance Measure. Data was described in frequencies and percentages, and the Pearson's chi-square test was used to determine the asymptotic association between the occupational performance problems with work.

Detailed description: For this cross-sectional study, 81 patients were recruited by convenience at the Clinical Hospital (HC) of the Universidade Federal de Minas Gerais (UFMG), in Brazil.

COPM was applied to identify the main occupational performance problems reported by participants. The COPM is an individual measure of self-awareness about the problems faced when carrying out the activities. It identifies problems in the areas of self-care, productivity, and leisure, and measure the individual's performance and satisfaction regarding these activities

Eligibility criteria: Inclusion Criteria:

* over 46 years old;
* diagnosed with RA by rheumatologist (American College of Rheumatology);
* mental competency as assessed with the Mental State Mini-Examination;
* possessed the skills to understand the instructions study.

Exclusion Criteria

* had undergone surgery in the upper limbs.

Primary outcomes:
measure: Canadian Occupational Performance Measure
timeFrame: June 2009 to August 2010
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03968445: Neuroinflammation After Myocardial Infarction - Imaging Substudy
Official title: Neuroinflammation After Myocardial Infarction - Imaging Substudy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Myocardial Infarction
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to see if positron emission tomography and magnetic resonance imaging (PET/MRI) with an investigational drug called \[18F\]DPA-714 will show inflammation in the brain after a heart attack. This study may help physicians and researchers better understand the role of brain inflammation in heart disease and develop new treatments to protect the brain.

Detailed description: The primary objective of this study is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET ligand \[18F\]DPA-714 in individuals with recent AMI. The basic premise is that AMI leads to systemic inflammation that includes inflammation in the brain. The PET tracer \[18F\]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. The estimates of brain TSPO binding in patients with recent AMI will be compared to a matched group of patients who have undergone a recent elective PCI procedure.

Eligibility criteria: Inclusion Criteria:

1. Participation in UAB IRB protocol "Neuroinflammation After Acute Myocardial Infarction" (IRB-300002751, PI Lazar).
2. 21 years of age or older
3. . English speaking with at least 8th grade education
4. High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.
5. Admission to UAB Hospital for ST-elevation acute myocardial infarction (AMI) and treatment with percutaneous coronary intervention (PCI) OR Undergoing elective percutaneous coronary intervention (PCI)

Exclusion Criteria:

1. Contraindication to MRI
2. Pregnancy
3. Lactation
4. Serious medical co-morbidity that may interfere with participation
5. Prior myocardial infarction
6. Severe anemia
7. Prior coronary artery bypass grafting
8. Prior angioplasty and/or coronary artery stent placement (PCI group only)
9. History of traumatic head injury defined by a loss of consciousness ≥30 minutes or seizure at the time of injury
10. Diagnosis of major depression
11. Diagnosis of dementia
12. Low affinity binder for TSPO ligands based on genotyping for SNP rs6971.

Primary outcomes:
measure: TPSO-PET measurement of neuroinflammation after acute myocardial infarction
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Medical Center
state: Alabama
Study officials:
References:
Clinical trial NCT00951145: Medium and Long Term Outcome of Total Hip Arthroplasty Using Accolade TMZF Femoral Stem
Official title: Medium and Long Term Outcome of Total Hip Arthroplasty Using Accolade TMZF Femoral Stem
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis of the Hip
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
Collaborators: name: Stryker Orthopaedics
First posted: 2009-08-04
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: PROBABILITY_SAMPLE
Study population: All patients undergoing THA prior to 1/1/2003 using Accolade femoral stem

Brief summary: This is a retrospective/prospective study evaluating the clinical and radiographic outcome of total hip arthroplasty (THA) performed using Accolade femoral stem in a consecutive group of patients. All patients eligible for inclusion will be identified. The investigators hypothesize that the outcome of THA performed using Accolade femoral stem is equal or superior to historical survivorship of THA using other types of collarless, proximally coated, tapered stems.


Eligibility criteria: Inclusion Criteria:

1. All patients undergoing THA prior to 1/1/2003 using Accolade femoral stem.
2. Patients with hip fracture undergoing THA will also be included.
3. Patients willing and able to comply with follow-up requirements and self-evaluations.

Primary outcomes:
measure: The outcome of THA performed using Accolade femoral stem is equal or superior to historical survivorship of THA using other types of collarless, proximally coated, tapered stem
Secondary outcomes:
measure: Proximally coated tapered stems can be used for patients with various bone types, bone morphology, and underlying diagnosis
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
affiliation: Rothman Institute
name: Parvizi Javad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rothman Institute
name: Hozack William, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03094845: Safety and Clinical Tolerability of hdmASIT+TM Peptides Administered in HDM-induced Allergic Patients
Official title: Assessment of Safety and Clinical Tolerability of hdmASIT+TM Administered Subcutaneously in House Dust Mite-induced Allergic Rhinoconjunctivitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: House Dust Mite Allergy
Lead sponsor: ASIT Biotech S.A.
Sponsor class: INDUSTRY
First posted: 2017-03-29
Enrollment: 36
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: hdmASIT+TM product is based on highly purified allergen fragments from house dust mites. The purpose of this study is to assess the safety and clinical tolerability of subcutaneous immunotherapy with hdmASIT+TM in patients with house dust mite-induced allergic rhinoconjunctivitis compared to placebo.


Eligibility criteria: Inclusion Criteria:

* A medical history of moderate to severe allergic rhinoconjunctivitis for house dust mite for at least 12 months (definition of allergy severity according to ARIA (Bousquet et al., 2001))
* A positive skin prick test to house dust mite Dermatophagoides pteronyssinus
* Specific IgE against house dust mite Dermatophagoides pteronyssinus ≥ 0.7 kU/L
* Positive response to Conjunctival Provocation Test (CPT)
* Being treated with anti-allergic medication for at least 12 months prior to enrollment
* For asthmatic patients: confirmed diagnosis of controlled asthma according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2014), FEV1 ≥ 80% of the patient's reference value

Exclusion Criteria:

* Previous immunotherapy with house dust mite allergens within the last 5 years
* Ongoing immunotherapy with house dust mite allergens or any other allergens
* History of severe systemic reactions and/or anaphylaxis, including to food (e.g. peanut, marine animals) or to Hymenoptera venom (e.g. bee, wasp stings) or to medication (e.g. penicillin), etc.
* Partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014)
* Chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1) \< 80% of the patient's reference value (ECSC)
* History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening

Primary outcomes:
measure: Solicited adverse events
timeFrame: up to 7 weeks
Secondary outcomes:
measure: Unsolicited adverse events and serious adverse events (SAEs)
timeFrame: up to 12 weeks
measure: Physical examinations (body systems) and vital signs (heart rate, systolic and diastolic blood pressure)
timeFrame: up to 12 weeks
measure: Laboratory investigations (haematology, clinical biochemistry, immunological parameters)
timeFrame: up to 12 weeks
measure: Pulmonary functions (FEV1) for asthmatic patients
timeFrame: up to 7 weeks
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
Study officials:
References:
Clinical trial NCT01012245: Non-Interventional Study In Patients With Ocular Hypertension And Open Angle Glaucoma Treated With Xalatan And Xalacom
Official title: Project "XCHANGE" Non-Interventional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Ocular Hypertension
Keywords: Xchange
Xalatan
Xalacom
Betablocker
observational
longterm
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-11-13
Enrollment: 28812
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with glaucoma or ocular hypertension treated by office-based ophthalmologists

Brief summary: Non-interventional study to obtain real life data from the treatment with Xalatan and Xalacom in Germany and to assess the long-term efficacy and tolerability under routine conditions. Data were entered into an electronic case report form.


Eligibility criteria: Inclusion Criteria:

* patients with ocular hypertension or glaucoma, defined by SmPC

Exclusion Criteria:

* defined by SmPC

Primary outcomes:
measure: Change From Baseline in Intraocular Pressure (IOP)
timeFrame: Baseline, 1 year, 2 years, and 3 years
measure: Aulhorn Stage (Visual Field Defects)
timeFrame: Baseline, 1 year, 2 years, and 3 years
measure: Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio
timeFrame: Baseline, 1 year, 2 years, and 3 years
measure: Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio
timeFrame: Baseline, 1 year, 2 years, and 3 years
Secondary outcomes:
measure: Investigator Assessment of Xalatan® Efficacy
timeFrame: Baseline, 1 year, 2 years, and 3 years
measure: Subject Assessment of Satisfaction With Xalatan® Treatment
timeFrame: Baseline, 1 year, 2 years, and 3 years
measure: Visual Acuity (Visus)
timeFrame: Baseline, 1 year, 2 years, and 3 years
measure: Visual Impairment Due to Glaucoma
timeFrame: Baseline, 1 year, 2 years, and 3 years
measure: Subject Self-care: Application of Eye Drops
timeFrame: Baseline, 1 year, 2 years, and 3 years
measure: Reasons for Changes in Glaucoma Therapy
timeFrame: January 2000 through December 2008
measure: Investigator Assessment of Tolerability of Xalatan® Treatment
timeFrame: Baseline up to 3 years
measure: Reasons for Discontinuation From Study
timeFrame: January 2000 through December 2008
measure: Changes to the Color of the Iris During Xalatan® or Xalacom® Treatment
timeFrame: Baseline up to 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06006845: Time to Initiated Antitumor Therapy for Tumor Patients With COVID19 Infection
Official title: When to Initiation Antitumor Therapy for Tumor Patients With COVID19 Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tumor
COVID-19
Keywords: Tumor patients
COVID-19
antitumor therapy
Lead sponsor: The Seventh Affiliated Hospital of Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tumor patients infected with COVID-19 from December 1, 2022 to May 31, and received systemic antitumor therapy after infected with COVID-19.

Brief summary: The goal of this observational study is to study the safety of initiation of antitumor therapy early after nucleic acid test turn negativity in tumor patients infected with COVID-19. The main questions aims to answer are:

* Whether initiation of antitumor therapy early after nucleic acid test turn negativity in tumor patients infected with COVID-19 increases adverse events related to antitumor therapy.
* Whether initiation of antitumor therapy early after nucleic acid test turn negativity in tumor patients infected with COVID-19 increases risk of re-infection of COVID-19.
* How initiation of antitumor therapy early after nucleic acid test turn negativity in tumor patients infected with COVID-19 affects QoL of tumor patients

Participants will be asked to answer the question about:

* the severity and duration of COVID-19 symptoms
* the date of diagnosis of COVID-19
* the date of negative nucleic acid test
* the QoL of life before infection with COVID-19, during infection of COVID-19, after nucleic acid test negativity and receiving antitumor therapy


Eligibility criteria: Inclusion Criteria:

* Tumor patients diagnosed with COVID-19 infection at our center from December 1, 2022 to May 31.
* COVID-19 was confirmed by antigen testing or nucleic acid testing.
* Tumor was confirmed by pathology.
* Patients received systemic antitumor therapy after infected with COVID-19.

Exclusion Criteria:

* COVID-19 was not confirmed by antigen testing or nucleic acid testing
* Tumor was not confirmed by pathology
* Patients did not receive systemic antitumor therapy
* Patients died before receiving systemic antitumor therapy

Primary outcomes:
measure: Incidence of adverse events after antitumor therapy
timeFrame: 28 days after antitumor therapy
measure: Re-infection of COVID-19
timeFrame: 28 days after antitumor therapy
Secondary outcomes:
measure: Clinical manifestations of COVID-19 in tumor patients
timeFrame: Until nucleic acid testing turn negative
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Seventh Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The Seventh Affiliated Hospital of Sun Yat-sen University
name: Bo Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03025945: Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo
Official title: Pseudophakic Cystoid Macular Edema Prevention and Risk Factors; Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystoid Macular Edema
Lead sponsor: Intuor Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-20
Enrollment: 662
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: Prospective, randomized, double-masked, placebo-controlled clinical study to define the effective use of a topical non-steroidal anti-inflammatory drug added to topical steroid use after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular edema.


Eligibility criteria: Inclusion Criteria:

* Subjects, 18 and older subjects with visually significant cataracts and were to undergo phacoemulsification with implantation of an intracapsular positioned intraocular lens.

Exclusion Criteria:

* previous uveitis (\<1 year) previous anterior segment intraocular surgery hypersensitivity or allergy to NSAIDs

Primary outcomes:
measure: Post-operative Clinical Findings of Cystoid Macular Edema
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Arizona Eye Consultants
name: Sean McCafferty, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCafferty S, Harris A, Kew C, Kassm T, Lane L, Levine J, Raven M. Pseudophakic cystoid macular edema prevention and risk factors; prospective study with adjunctive once daily topical nepafenac 0.3% versus placebo. BMC Ophthalmol. 2017 Feb 20;17(1):16. doi: 10.1186/s12886-017-0405-7.