louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03134001: Evaluation of Oral PCA Device - PCoA™ Acute
Official title: Evaluation of Oral Patient-Controlled Analgesia (PCA) Device - PCoA™ Acute , for Hospitalized Patients With Post-operative Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Dosentrx Ltd.
Sponsor class: INDUSTRY
First posted: 2017-04-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Study includes 2 groups: test group comprised patients receiving oral analgesics via the PCoA™ Acute and control group of nurse providing analgesics.
Primary purpose: TREATMENT

Brief summary: Randomized, open label, controlled pilot clinical study comprised hospitalized post operative patients receiving oral analgesics. The study aims to evaluate the safety, efficacy and usability of a novel pill dispensing system - PCoA™ Acute and compare it to the conventional procedure of nurse providing analgesics.


Eligibility criteria: Inclusion Criteria:

1. Operative procedure with at least 3 days' hospital stay.
2. Planned post-operative pain therapy with oral medication using a strong opioid.
3. No contra-indication for opioid therapy.
4. No contra-indication for oral pain therapy.
5. Patient was able to understand and complete the questionnaire.
6. Patient signed an informed consent form.

Exclusion Criteria:

1. Opioid or drug addiction. 2. Opioid intolerance. 3. Pain therapy using IV PCA or infusion. 4. Rejection of opioid therapy. 5. Not able to swallow medicine.

-

Primary outcomes:
measure: PCoA™ Acute safety
timeFrame: 48 hr
measure: PCoA™ Acute efficacy
timeFrame: 48hr
measure: PCoA™ Acute usability
timeFrame: 48hr
Secondary outcomes:
measure: Number of pill intakes during the study
timeFrame: 48hr
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01835301: Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation
Official title: Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: In-stent Coronary Artery Restenosis
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2013-04-18
Enrollment: 40
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: A total of 40 subjects will be enrolled in the study, with 20 patients who previously received BMS \> 3 years ago and 20 patients who previously received DES \> 3 years ago

Brief summary: This study aims to test the hypothesis that plaque composition differs within a stent between bare metal stents and drug eluting stents (DES). It is possible that a difference in plaque composition seen within a stent may be contributory to the late thrombotic events seen more frequently with DES.


Eligibility criteria: Inclusion Criteria:

* Subject \> 18 years of age;
* Subject, male or female, who underwent DES or BMS implantation in a native coronary vessel more than 3 year ago;
* Subject is scheduled for a diagnostic coronary or interventional procedure;
* Subject is willing to sign the informed consent.

Exclusion Criteria:

* Subject requires emergency catheterization;
* Subject has an acute myocardial infarction defined as anginal symptoms with ST-elevation on the EKG or creatine kinase-MB elevation \>3times the upper limit of normal;
* Angiographic evidence of ≥ 70% stenosis within the target stent (visual estimate);
* Subject presented with cardiogenic shock;
* Subject has angiographically confirmed thrombus in the target coronary artery;
* Subject has a complex lesion not amenable to the IVUS/VH catheters and/or OCT catheters passing the stented segment;
* Subject has a contraindication to angiography/IVUS/OCT;
* Female subject is pregnant or lactating;
* Subject has life threatening comorbid conditions for which the investigator feels the subject should not be enrolled

Primary outcomes:
measure: Plaque composition
timeFrame: During hospital stay, about 2 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Ron Waksman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00185601: Internet Diabetes Self-Management Workshop
Official title: Internet Diabetes Self-Management Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2005-09-16
Enrollment: 761
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine of the effectiveness of an Internet based Diabetes Self-Management workshop for people with type II diabetes. Half of the people who complete the workshop will be invited to continue their education by participating in a email discussion group. Thus, we will be able to learn both the efficacy of the original program as well as its efficacy when reinforced by the discussion group.

Diabetes is a disease that must be managed day by day by the individual with the disease. Although we know a great deal about the self-management of type II diabetes, most self-management is less than optimal. In addition, most people with diabetes do not have an opportunity to participate in formal diabetes education. This study will determine if an Internet delivered educational workshop will help people with diabetes manage their disease. Thus we will be measuring changes in behaviors, changes in symptoms and changes in HbA1c, blood pressure, cholesterol, and weight. If successful the workshop will serve as a prototype for Internet diabetes education.


Eligibility criteria: Inclusion Criteria::- Diabetes type 2

* Have internet access and email address
* Live in the United States
* 18 years of age or older Exclusion Criteria:- Previous participation in similar online or community-based self-management program
* Active treatment for cancer
* Pregnant

Primary outcomes:
measure: HbA1c
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Outcome Measure: Health-related quality of life
timeFrame: 6 and 12 months
measure: Outcome Measure: Health behaviors
timeFrame: 6 and 12 months
measure: Health care utilization
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Kate R Lorig
role: PRINCIPAL_INVESTIGATOR
References:
citation: Case S, Jernigan V, Gardner A, Ritter P, Heaney CA, Lorig KR. Content and frequency of writing on diabetes bulletin boards: does race make a difference? J Med Internet Res. 2009 Jun 24;11(2):e22. doi: 10.2196/jmir.1153.
Clinical trial NCT01148901: Effectiveness and Safety of Early Treatment With Infliximab for Hip Arthritis Associated With Ankylosing Spondylitis (AS) (P06451)
Official title: Hip Arthritis Associated With AS Efficacy and Safety of Early Treatment With Infliximab (Remicade®)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing spondylitis
Hip arthritis
Infliximab
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Hospital Universitario Reina Sofia de Cordoba
name: Dr. Jose María Martos Becerra (Central Radiological Assessment) - Hospital de Alta Resolución, Puente Genil (Spain)
First posted: 2010-06-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is designed to measure improvement of hip involvement in patients with ankylosing spondylitis (AS) after receiving 4 doses of infliximab. Participants will receive infliximab 5 mg/kg (as an intravenous perfusion over a period of 2 hours) at Weeks 0, 2, 6, and 14, consistent with the approved dosing regimen described in the label. Participants will be evaluated for hip pain, functional capacity and stiffness before and after 14 weeks (4 doses) of treatment. Further treatment after 4 doses is based on standard clinical practice as determined by the trial site.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Ankylosing spondylitis (AS) diagnosis
* Have all 3 of the following:
* Presence of hip pain (nocturnal inflammatory pain)
* Limitation of hip mobility
* Patient's Global Assessment Visual Analog Scale (0-10 cm) ≥4 cm.
* Inadequate response or intolerance to non-steroidal anti-inflammatory drugs (NSAIDs)
* Eligible to be treated with Infliximab (Remicade®)

Exclusion Criteria:

* Causes of coaxalgia other than coxitis of AS, demonstrated by images or laboratory tests
* Women who are pregnant or nursing or plan to nurse or become pregnant
* Serious infections like sepsis, abscesses.
* History of or current certain infections
* History of or current certain medical conditions

Primary outcomes:
measure: Number of participants with clinical improvement assessed by the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire
timeFrame: Baseline and Week 15
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03719001: Effect of Changing Physiological Conditions on Myogenic Oscillations: Pilot Study
Official title: A Pilot Study to Evaluate the Effect of Changing Physiological Conditions on the Amplitude and/or Frequency of Myogenic Oscillations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Vascular Diseases
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Spontaneous myogenic oscillations will be studied under general anesthesia using finger photoplethysmography. This pilot study will explore potential physiological conditions that will effect the amplitude and/or frequency of myogenic oscillations.

Detailed description: This is a single center, nonrandomized, nonblinded, interventional clinical pilot research study that plans to enroll 40 patients.

Study will be conducted while subjects are under general anesthesia.

Myogenic oscillations will be measured using finger photoplethysmography. Changes in the amplitude and/or frequency of these oscillations will be analyzed in response to the interventions. Arterial blood pressure will be recorded to verify the efficacy of the interventions.

Six different interventions that will either lower or increase blood pressure will be applied to the subjects. Each subject will receive 1 or 2 of the six interventions. Each of the 6 interventions will be applied to 8 subject.

The interventions that the subject will not be randomized. They will be determined by the subjects blood pressure immediately before the intervention to guarantee that the blood pressure manipulations are within a safe range.

Data will be analyzed offline using Matlab.

Eligibility criteria: Inclusion Criteria:

1. Over 18 yrs of age
2. Undergoing surgery in Moffitt-Long operating rooms
3. Receiving general anesthesia
4. Will have an intra-arterial catheter for clinical purposes
5. Able to consent in english

Exclusion Criteria:

1. Under 18 years of age
2. unable to provide informed consent
3. Pregnancy

Primary outcomes:
measure: myogenic oscillations
timeFrame: up to 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Pekka Talke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02261701: Rehabilitation After Rotator Cuff Repair
Official title: Rehabilitation After Rotator Cuff Repair a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Injury
Keywords: shoulder surgery
rotator cuff injury
rehabilitation
function
pain
quality of life
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2014-10-10
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A new postoperative regimen with a new bandage technique after surgery results in a better shoulder function and quality of life after surgery - than traditional postoperative regimen with shoulder lock and abductor cushion.

Detailed description: A new postoperative regimen , with a new bandage technique with shorter immobilization time and without shoulder lock, is supposed to results in a better shoulder function 6 and 12 months after surgery. Function is measured by Constant score, pain with VAS and quality of life with EQ5D, 3 and 12 months after surgery. The two treatment groups are compared.

Eligibility criteria: Inclusion Criteria:

* planned shoulder surgery, rotator cuff repair

Exclusion Criteria:

* not swedish speaking
* reoperation

Primary outcomes:
measure: Shoulder function
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Pain
timeFrame: 6 months after surgery
Other outcomes:
measure: EQ-5D
timeFrame: 6 months after surgery
measure: Quality of life shoulder specific
timeFrame: 6 months after surgery
measure: Pain
timeFrame: 12 months after surgery
measure: Euro quality of Life 5D
timeFrame: 12 months after surgery
measure: Quality of life shoulder specific
timeFrame: 12 months after surgery
Locations:
city: Västerås
country: Sweden
facility: Department of Orthopaedic surgery, Physiotherapy
state: Västmanland
Study officials:
affiliation: Center for Clinical Research County Västmanland, Sweden
name: Ann Christin Johansson, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00807001: Double-Blind, Dose-Escalation Study of IDX184 in Chronic Hepatitis C Treatment-Naïve Subjects
Official title: A Phase I/II, Double-Blind, Dose-Escalation Study to Evaluate the Safety and Antiviral Activity of IDX184 in Treatment-Naïve Subjects Infected With Genotype 1 Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Hepatitis C (HCV)
Keywords: Hepatitis C, HCV, treatment-naive
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-12-11
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a proof-of-concept study which will provide data about the safety and antiviral activity of several doses of the investigational drug IDX184 given for 3 days in treatment-naive HCV genotype 1-infected subjects so that optimal doses can be chosen for testing in later studies.


Eligibility criteria: Inclusion criteria:

1. 18-65 years old
2. Subject of childbearing potential must agree to use a consistent form of an acceptable double-barrier method of birth control.
3. Plasma HCV RNA ≥ 5 log10 IU/mL
4. HCV genotype 1

Exclusion criteria:

1. Received prior antiviral treatment for hepatitis C infection
2. Subject is pregnant or breastfeeding
3. Body Mass Index (BMI) \> 32
4. Currently abusing alcohol or illicit drugs
5. Currently receiving methadone, buprenorphine or other drugs for the treatment of opioid addiction
6. Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV)

Primary outcomes:
measure: Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events
timeFrame: 17 days
Secondary outcomes:
measure: Antiviral Activity at Day 4. Change in Plasma HCV RNA (Hepatitis C Virus Ribonucleic Acid)
timeFrame: Baseline to 4 days
Other outcomes:
Locations:
Study officials:
References:
citation: Lalezari J, Asmuth D, Casiro A, Vargas H, Lawrence S, Dubuc-Patrick G, Chen J, McCarville J, Pietropaolo K, Zhou XJ, Sullivan-Bolyai J, Mayers D. Short-term monotherapy with IDX184, a liver-targeted nucleotide polymerase inhibitor, in patients with chronic hepatitis C virus infection. Antimicrob Agents Chemother. 2012 Dec;56(12):6372-8. doi: 10.1128/AAC.01521-12. Epub 2012 Oct 15.
Clinical trial NCT02359201: Assessment of V0018 1.5 mg Effect on Craving
Official title: Double-blind, Randomized, Placebo-controlled, Cross-over Study of the Effect of a 1.5 mg Nicotine Lozenge on Smoking Craving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking
Keywords: Nicotine replacement therapy
craving
Healthy moderately dependant smokers
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2015-02-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the reduction of craving after administration of V0018 1.5 mg compared to placebo in healthy moderately dependent smokers.


Eligibility criteria: Inclusion Criteria:

* Male and female aged 18 to 64 years
* Smoking ≥ 10 cigarettes/day and \< 20 cigarettes/day continuously for the last two years
* With a first cigarette smoked within 30 min after waking
* Not currently in the process of quitting smoking

Exclusion Criteria:

Related to pathologies

* Current or recurrent buccal lesions which, in the opinion of the investigator, would interfere with the assessment of the different parameters
* Hyposalivation or asialia
* Intolerance to lactose, or any pathology that could cause endogenous production of Carbon Monoxide (CO)

Related to treatments

* Use of antidepressants within the last three months
* Use of sedatives, hypnotics, tranquilizers or any other addictive agents within the last 3 months
* Routine use of tobacco other than cigarettes
* Regular use for more than one week of any treatment for smoking cessation (gum, patch, inhaler, lozenge, tablet, bupropion, varenicline) and other smokeless tobacco products (including e-cigarettes) within three months
* History of hypersensitivity to nicotine, peanut, soya or to any of the excipients of study treatment
* Intolerance to fructose
* History of phenylketonuria (aspartame)

For women of childbearing potential:

* Is pregnant or in post-partum period or a nursing mother

Primary outcomes:
measure: Questionnaire for Smoking Urges Brief (QSU-Brief) (10 items)
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Gieres
country: France
Study officials:
affiliation: Pierre Fabre Medicament
name: Françoise MD TONNER
role: STUDY_DIRECTOR
References:
Clinical trial NCT00583401: PFO ACCESS Registry
Official title: Patent Foramen Ovale Closure With the AMPLATZER PFO OCCLUDER in Patients With Recurrent Cryptogenic Stroke Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale Who Have Failed Conventional Drug Therapy
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Patent Foramen Ovale
Stroke
Keywords: PFO
stroke
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2007-12-31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Closure of Patent Foramen Ovale with the AMPLATZER® PFO OCCLUDER in patients with at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional therapy.

Detailed description: The primary objective of the PFO Access Registry is to allow access to the AMPLATZER PFO Occluder in subjects with a PFO who have already experienced at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional drug therapy.

Eligibility criteria: Inclusion Criteria:

Patent foramen ovale (PFO); recurrent cryptogenic stroke; failed antiplatelet/anticoagulant therapy

Exclusion Criteria:

International normalized ration (INR) outside of 2-3; intracardiac thrombus (subjects may be enrolled after resolution of thrombus)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05475301: Incidence, Risk Factor, Treatment and Overall Survival of Locally Recurrent Rectal Cancer
Official title: Incidence, Risk Factor, Treatment and Overall Survival of Locally Recurrent Rectal Cancer: a Retrospective, Population-based Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Neoplasms
Neoplasm Recurrence, Local
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 1431
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed with stage I-III primary rectal cancer in the first half of 2015.

Brief summary: Data on disease recurrence was collected for all primary rectal cancer patients diagnosed in the Netherlands over the first six months of 2015. Three-year cumulative incidence, risk factors, treatment and three-year OS of locally recurrent rectal cancer were determined.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed stage I-III primary rectal carcinoma;
* Diagnosed between January 1st and June 30th of 2015;
* TME resection of primary rectal carcinoma.

Exclusion Criteria:

* Neuroendocrine tumor morphology;

Primary outcomes:
measure: Cumulative incidence of patients with locally recurrent rectal cancer in curatively treated primary rectal cancer patients
timeFrame: Three years
measure: Risk factors for development of locally recurrent rectal cancer in curatively treated primary rectal cancer patients
timeFrame: Three years
measure: Proportions of treatment given to patients with locally recurrent rectal cancer
timeFrame: Three years
measure: Overall survival of patients with locally recurrent rectal cancer
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: