louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03767907: Online Cognitive Behavioural Therapy for Addiction: Efficacy and Cost-Effectiveness in a Pragmatic Clinical Trial
Official title: Online Cognitive Behavioural Therapy for Addiction: Efficacy and Cost-Effectiveness in a Pragmatic Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Dependence
Keywords: cognitive behavioural therapy
online treatment
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and cost-effectiveness of a Computer-based Training for Cognitive Behavioural Therapy (CBT4CBT) to treatment as usual in outpatients seeking treatment for substance use disorder.

Detailed description: Fifty-two adult outpatients seeking treatment for substance use disorder from the Centre for Addiction and Mental Health Addictions Program will be randomized to receive either a computer-based training for cognitive behavioural therapy or treatment as usual for eight weeks. Participants will complete interviews, questionnaires, and other assessments (urine toxicology and physiological assessments) at week 0, at week 8, and at 6 month follow-up). Measures will assess alcohol and drug consumption, substance use disorder symptoms and associated features, quality of life, and healthcare costs.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Fluency in English
3. Understanding and willingness to comply with study requirements
4. Meet diagnostic criteria for current substance use disorder
5. Have used substance in the past 30 days
6. Treatment-seeking for substance misuse

Exclusion Criteria:

1. Unable to read at sixth grade level
2. Untreated or unstable severe psychiatric or medical disorder
3. Acute suicidal or homicidal ideation

Primary outcomes:
measure: Timeline Follow-Back (TLFB)
timeFrame: 30 days
Secondary outcomes:
measure: Urine Toxicology Screen
timeFrame: 30 days
measure: Addiction Severity Index (ASI)
timeFrame: 30 days
measure: WHO Quality of Life (WHOQOL-BREF)
timeFrame: 4 weeks
measure: Program and Client Costs-Substance Abuse Treatment (PACC-SAT)
timeFrame: 7 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Campbell Family Mental Health Research Institute, CAMH
state: Ontario
Study officials:
affiliation: Campbell Family Mental Health Research Institute, CAMH
name: Lena C. Quilty, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01522807: A Study Of Three PF-05190457 Formulations In Healthy Volunteers
Official title: A Phase I, Cross-Over, Single Dose, Double-Blind Study To Estimate The Relative Bioavailability Of Three Different Formulations Of PF-05190457 In Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: Phase 1
Single Doses
Biocomparison
Pharmacokinetics
Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-02-01
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to evaluate the plasma drug concentrations of three formulations of PF-05190457 after administration of single doses to healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy males and females of non-childbearing potential between ages of 21 and 55 years, BMI of 17.5 to 30.5 kg/m\^2, and weight above 50 kg.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.

Primary outcomes:
measure: The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameters of Area Under the Curve (AUC) and its ratio between formulations as data permit.
timeFrame: 0 - 48 hours post dose
measure: The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameters of Maximum Concentration (Cmax) and its ratio between formulations as data permit.
timeFrame: 0 - 48 hours post dose
measure: The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameter of Time of Maximum concentration (Tmax) as data permit.
timeFrame: 0 - 48 hours post dose
measure: The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameter of Elimination of half-life (t ½ ) as data permit.
timeFrame: 0 - 48 hours post dose
Secondary outcomes:
measure: The ratio of fasted to fed single dose pharmacokinetics of PF-05190457 in two test formulations will be described by estimating parameters of Area Under the Curve (AUC) and its ratio between fed states as data permit.
timeFrame: 0 - 48 hours post dose
measure: The ratio of fasted to fed single dose pharmacokinetics of PF-05190457 in two test formulations will be described by estimating parameters of Maximum Concentration (Cmax) and its ratio between fed states as data permit.
timeFrame: 0 - 48 hours post dose
measure: Changes in plasma glucose and insulin due to single doses of three formulations of PF-05190457 will be estimated.
timeFrame: 0 - 24 hours post dose
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04346407: Dronabinol for Post-operative Pain After Lumbar Fusion
Official title: Impact of Dronabinol on Post-operative Pain After Lumbar Fusion for Degenerative Disorders of the Spine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Post-operative Pain
Keywords: Lumbar Fusion
Post-operative Opioid Consumption
Post-operative Pain
Lead sponsor: Norton Leatherman Spine Center
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind Placebo controlled
Primary purpose: TREATMENT

Brief summary: Impact of 2.5mg of oral Dronabinol daily versus placebo on post-operative opioid consumption on patients aged 18 to 65 years old undergoing 1 to 3 level posterolateral fusion

Detailed description: This is a randomized double-blind clinical trial comparing 2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery versus placebo for patients aged 18 to 65 years old undergoing 1 to 3 level posterolateral fusion. The outcome of interest is post-operative opioid consumption defined as cumulative Morphine Milligram Equivalents at 72 hours after surgery.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 65 years old
* Patients undergoing 1 to 3 level posterolateral fusion
* Opioid naïve or not
* No prior spine fusion
* Willing and able to sign an Informed Consent

Exclusion Criteria:

* Indication for surgery is fracture, tumor or infection
* Comorbid psychiatric diagnosis requiring therapy and/or medication
* Comorbid chronic pain syndrome (reflex sympathetic dystrophy, fibromyalgia)
* Has hepatic disease
* On workers compensation/disability/litigation
* Known adverse reaction to medications to be administered
* History of alcohol and drug abuse
* On long-acting narcotic pain medication (including extended release narcotic pain medications and methadone)

Primary outcomes:
measure: Cumulative Morphine Milligrams at 72 hours post-operative
timeFrame: 72 hours post-operative
Secondary outcomes:
measure: Cumulative Morphine Milligrams at 24 hours post-operative
timeFrame: 24 hours post-operative
measure: Cumulative Morphine Milligrams at 48 hours post-operative
timeFrame: 48 hours post-operative
measure: Worst pain in past 24 hours post-operative
timeFrame: 24 hours post-operative
measure: Worst pain in past 48 hours post-operative
timeFrame: 48 hours post-operative
measure: Worst pain in past 72 hours post-operative
timeFrame: 72 hours post-operative
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
Study officials:
affiliation: Norton Healthcare
name: Jeffrey L Gum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04155307: Is the Evaluation of Anal Distensibility by Endoflip® Technique Useful for the Diagnosis of Anismus?
Official title: Is the Evaluation of Anal Distensibility by Endoflip® Technique Useful for the Diagnosis of Anismus?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anismus
Distal Constipation
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Terminal constipation affects 13 to 20% of the french population. Anismus is defined by an absence of relaxation or a paradoxical contraction of the striated anal sphincter muscle during defecation.

Anismus is one of the main causes of terminal constipation. Anismus diagnosis is retained if 2 out of 3 examinations (manometry, electromyogram, defecography) are positive.

EndoFLIP® is a new medical device developed to measure distensibility of a hollow organ. Anal EndoFLIP® l could be a more sensitive and specific tool for detecting anismus in patients with distal constipation.

60 patients suffering from distal constipation will be included in order to perform, in addition to the usual examinations, an anal EndoFlip in order to test the sensitivity and specificity of this method for the diagnosis of anismus.


Eligibility criteria: Inclusion Criteria:

* patient older than 18 years
* patient with distal constipation defined according to the Rome IV criteria, for at least 3 months and verified by a transit time study showing a predominant slowing of markers at the recto-sigmoid level.
* patient who read and signed the informed consent form

Exclusion Criteria:

* Patients with a predominant right of left colonic constipation;
* Pregnant woman or woman with no effective contraception and of childbearing age
* Patient with inflammatory bowel disease, ischemic colitis, history of colon or rectal cancer, infectious colitis or proctologic disease.
* Patient with anorectal malformation
* Patient with an history of pelvic floor radiotherapy
* Patient with a digestive stoma
* Insertion of the probe impossible or painful
* Patient who has participated to a clinical trial within 30 days prior to the inclusion visit
* Patient not understanding or reading French
* Patients under guardianship, curatorship, safeguard of justice
* Patient without liberty by administrative or judicial decision

Primary outcomes:
measure: Sensitivity of the anal distensibility evaluated with the EndoFLIP® technique for the diagnosis of anismus
timeFrame: 30 min
measure: Specificity of the anal distensibility evaluated with the EndoFLIP® technique for the diagnosis of anismus
timeFrame: 30 min
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Laura BRIL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03344107: Stent-related Symptoms Comparison: Polaris Loop vs Vortek Double-J Stents
Official title: Comparison Between Symptoms Related to Polaris Loop Stent Versus Vortek Double J Stent After Uncomplicated Flexible Ureterorenoscopy for Renal Stones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptoms and Signs
Pain
Renal Calculi
Keywords: Symptoms and Signs
Pain
Renal Calculi
Ureteral Stent
Ureteroscopy
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 68
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: Prospective randomized controlled single-blind parallel-group trial in order to compare symptoms related to loop-tail (Polaris Loop) stents versus conventional double J (Vortek) stents after uncomplicated flexible URS.

Detailed description: Patients undergoing RIRS for a single renal stone \< 2 cm are asked to participate in a prospective randomized controlled single-blind parallel-group study. Ureteral stent is always placed after flexible URS. Patients are prospectively randomized into two groups with a 1:1 allocation: group LT receive loop-tail stents (Polaris ™ Loop - Boston Scientific, Natick, USA), while group DJ receive conventional double J stents (Vortek ® - Coloplast, Humlebaek, DK). Stent removal is planned 4 weeks after the procedure.

Participants are asked to fill in the Italian validated version of the Ureteral Stent Symptoms Questionnaire (USSQ) 2 days and 4 weeks after surgery. The USSQ is further submitted 4 weeks after stent removal (8 weeks after surgery) and these results are used as baseline evaluation, on the assumption that SRS persist for a few days after removal.

Eligibility criteria: Inclusion Criteria:

* patients undergoing flexible ureteroscopy and laser lithotripsy for kidney stones \< 2 cm
* given informed consent
* WHO PS 0-2

Exclusion Criteria:

* significant residual fragments at the end of the procedure
* intraoperative complications (i.e. ureteral damage or ureteral stricture)
* urinary tract infections
* anatomic abnormalities
* chronic diseases or medications potentially influencing pain perception and urinary symptoms (i.e. alpha blockers and antimuscarinics)
* preoperative ureteral stenting.

Primary outcomes:
measure: USSQ Urinary symptoms scores
timeFrame: 4 weeks
Secondary outcomes:
measure: USSQ domains scores
timeFrame: 4 weeks
measure: USSQ domains scores
timeFrame: 2 days
measure: USSQ domains' scores adjusted for baseline
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza
Study officials:
affiliation: AOU Città della Salute e della Scienza, Torino
name: Andrea Bosio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01730807: IntellaTip MiFi XP Ablation Catheter Trial
Official title: IntellaTip MiFi XP Ablation Catheters First in Human Use Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Flutter
Keywords: Atrial Flutter
Ablation
Type I Atrial Flutter
Atrial Arrhythmia
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 10
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: A study to assess the performance of a new catheter design for the treatment of Atrial Flutter.

Detailed description: A prospective, non-blinded, single arm, single center study designed to assess the performance of the IntellaTip MiFi XP Ablation Catheter for the treatment of recurrent or sustained type I atrial Flutter.

Eligibility criteria: Inclusion Criteria:

* 18 or older
* indicated for ablation for Atrial Flutter

Exclusion Criteria:

* Thrombus
* Recent MI/cardiac revascularization
* Prosthetic Valves
* recent ablation for atrial flutter
* atrial flutter with reversible cause
* Class IV HF

Primary outcomes:
measure: Acute Procedural Success
timeFrame: one day
Secondary outcomes:
measure: Complication Rate at procedure
timeFrame: 7 days
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
Study officials:
affiliation: Royal Adelaide Hospital
name: Prashanthan Sanders, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01944007: Evaluation of Cross-Linked Polyelectrolyte (CLP) in Healthy Volunteers
Official title: Open-label Phase 1 Multiple Dose Escalation Trial to Assess the Safety, Tolerability, and Efficacy of Capsules Containing Cross-linked Polyelectrolyte (CLP) Given to Normal Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Basic Science: Safety, Tolerability, Efficacy of CLP
Keywords: CLP
Lead sponsor: Sorbent Therapeutics
Sponsor class: INDUSTRY
First posted: 2013-09-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a dose-escalation study to determine the effect of CLP in normal healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy males or females between the ages of 18 and 70 years
* Body mass index (BMI) between 18 and 32 kg/m\^2, inclusive
* Females could not be pregnant or breast feeding and had to be using birth control

Exclusion Criteria:

* Positive drug screen for substances of abuse
* Positive results for HIV, hepatitis B, or hepatitis C
* Screening 12-lead ECG demonstrating QTc interval \>430 msec for males and \>450 msec for females, or any cardiac rhythm disorder considered by the Investigator to be clinically relevant

Primary outcomes:
measure: Net Sodium Balance
timeFrame: Days 5 - 9
Secondary outcomes:
measure: Total Fecal Weight
timeFrame: Days 1-9
measure: Net Balance of Potassium, Magnesium, Calcium, and Phosphorous
timeFrame: Days 5-9
measure: Fecal content and concentration of sodium, potassium, magnesium, calcium, phosphorous, iron, zinc, and copper
timeFrame: Days 5-9
measure: Urine content and concentration of sodium, potassium, magnesium, calcium, and phosphorous
timeFrame: Days 5-9
measure: Serum concentrations of sodium, potassium, magnesium, calcium, and phosphorous
timeFrame: Days 5-9
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Jasper Clinic, Inc.
state: Michigan
Study officials:
affiliation: Jasper Clinic, Inc.
name: Thomas Blok, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Henderson LW, Dittrich HC, Strickland A, Blok TM, Newman R, Oliphant T, Albrecht D. A Phase 1 dose-ranging study examining the effects of a superabsorbent polymer (CLP) on fluid, sodium and potassium excretion in healthy subjects. BMC Pharmacol Toxicol. 2014 Jan 25;15:2. doi: 10.1186/2050-6511-15-2.
Clinical trial NCT06871007: Nivolumab and DA-EPOCH-R in Pediatric Primary Mediastinal (Thymic) Large B-cell Lymphoma
Official title: Nivolumab and DA-EPOCH-R in Pediatric Primary Mediastinal (Thymic) Large B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
PHASE2
Conditions: Primary Mediastinal (Thymic) Large B-cell Lymphoma
Children
Nivolumab
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 22
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Addition of nivolumab (immune checkpoint inhibitor) to standard chemotherapy (DA-EPOCH-R) may improve outcome in children with primary mediastinal large B-cell lymphoma

Detailed description: A total of 6 blocks of Nivolumab+DA-EPOCH-R are planned for all patients regardless of stage and other risk factors. Nivolumab 40 mg (Day 2), Rituximab 375 mg/m2 (Day 1) and Prednisolone 60 mg/m2 (Days 1-5) are administered at constant unchangeable doses. Other drugs are administered at starting doses (Etoposide 50 mg/m2 (Days 1-4), Doxorubicin 10 mg/m2 (Days 1-4), Vincristine 0,4 mg/m2 (Days 1-4) and Cyclophosphamide 750 mg/m2 (Day 5). These starting doses are adjusted further according to standard principles of DA-EPOCH-R.

Eligibility criteria: Inclusion Criteria:

* Age from 0 years to 17 years 11 months

  * Established on the basis of histological and immunohistochemical studies, the diagnosis of PMLBL (the presence of programmed death-ligand on tumor cells is not necessary)
  * Lack of specific therapy for lymphoma
  * Signed informed consent

Exclusion Criteria:

* Age \>18

  * History of specific therapy for lymphomas.
  * Drug intolerance

Primary outcomes:
measure: Event free survival
timeFrame: 5 year
Secondary outcomes:
measure: Overall survival
timeFrame: 5 year
measure: Progression free survival
timeFrame: 5 year
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Dmitry Rogachev National Research Center
city: Saint-Petersburg
country: Russian Federation
facility: Pavlov University, RM Gorbacheva Research Institute
Study officials:
affiliation: Dmitry Rogachev National Research Center
name: Natalya Myakova
role: PRINCIPAL_INVESTIGATOR
affiliation: Pavlov University, R.M. Gorbacheva Research Institute
name: Ludmila Zubarovskaya
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02218307: The Use of Antibiotic Sinonasal Rinse After Sinus Surgery
Official title: The Use of Antibiotic Sinonasal Rinse After Sinus Surgery: A Randomized Double-Blind Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Rhinosinusitis
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Double blind placebo controlled trial to evaluate whether the routine use of nasal irrigation with mupirocin is more effective than saline irrigations alone in reducing symptoms of chronic rhinosinusitis in the early postoperative period.


Eligibility criteria: Inclusion Criteria:

* Chronic Rhinosinusitis
* Undergoing endoscopic sinus surgery

Exclusion Criteria:

* Age under 18
* Documented adverse reaction to mupirocin

Primary outcomes:
measure: Quality of Life in Chronic Rhinosinusitis Patients
timeFrame: 3 months
Secondary outcomes:
measure: Quality of Life in Chronic Rhinosinusitis Patients
timeFrame: 3 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine, ENT Dept
state: Florida
Study officials:
References: