louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00656474: Efficacy Study of GLYC-101 to Evaluate Outcomes After Post-laser Ablation
Official title: Double-blind, Randomized, Placebo-controlled Phase 2 Pilot Study to Investigate the Safety and Clinical Outcomes of 1.0 % Topically Applied GLYC-101, Compared to Placebo, in Healthy Subjects Undergoing Retro-auricular Carbon Dioxide Laser Skin Resurfacing.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Wounds
Keywords: burn wounds
wound healing
Lead sponsor: TR Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-04-11
Enrollment: 12
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study is intended to evaluate safety and efficacy parameters in patients treated with GLYC-101 gel or placebo after laser ablation.

Detailed description: The proposed pilot-study will document feasibility, safety and efficacy of topically applied Glucoprime gel (GLYC-101 gel 1.0 %) in promoting wound healing in healthy volunteer subjects undergoing retro-auricular Carbon Dioxide Laser Skin Resurfacing (CO2 LSR). The study will observe the effects of the topical agent over the course of 1 month following the treatment. as a preparation for study GLYC-101-1b (Double-blind, randomized, placebo-controlled Phase 2 Pilot Study to investigate the safety and efficacy of 1.0 % topically applied GLYC 101 compared to placebo, in patients undergoing Carbon Dioxide Laser Skin Resurfacing).

Eligibility criteria: Inclusion Criteria:

Subjects meeting all of the following criteria will be considered for admission to the study:

* Patients giving informed consent for retro-auricular laser ablation between 25 and 55 years old.
* Retro-auricular area is free of any irritation, scars or dermatologic conditions which might interfere with the study.
* Willing and able to participate in the study and follow all study directions.
* Able to read, understand and sign the consent form.

Exclusion Criteria:

* Pregnant, nursing, or planning a pregnancy during the course of the study, as determined by the interview and a urine pregnancy test.
* Systemic or cutaneous disease that may interfere with the study results.
* Presence of irritation or dermatologic skin conditions in the retro-auricular area.
* Known allergies to materials within the test formulations.
* Systemic or cutaneous therapy with medication that impacts wound healing (steroids, immune modulators, immune suppressants).

Primary outcomes:
measure: Time to Complete Wound Closure (Epithelialization)
timeFrame: Over the course of 1 month following the initial treatment.
Secondary outcomes:
measure: Percentage of Wound Epithelialized
timeFrame: Day 15 post laser ablation.
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: CLINICAL TESTING CENTER of BEVERLY HILLS
state: California
Study officials:
affiliation: CLINICAL TESTING CENTER of BEVERLY HILLS
name: John Joseph, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01965574: Preload Dependence During Prone Position In ARDS Patients
Official title: Evaluation of Performance Diagnosis of Hemodynamic Parameters of Preload Dependence in ARDS Patients During Prone Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARDS PATIENTS WITH HEMODYNAMIC INSTABILITY
Keywords: ARDS - FLUID LOADING - PRELOAD DEPENDENCE
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-10-18
Enrollment: 33
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: Preload dependence assessment is difficult during prone position, and to date, no hemodynamic parameters have been validated to rationalize fluid loading in that position. This study aims to validate several hemodynamic parameters, using continuous cardiac output by pulse contour analysis and transpulmonary thermodilution.


Eligibility criteria: Inclusion Criteria:

* ARDS patient
* mechanically ventilated in prone position
* sedated and paralyzed
* with continuous cardiac output monitoring by transpulmonary thermodilution and pulse contour analysis
* fluid loading as indicated by attending physician

Exclusion Criteria:

* Age below 18
* no affiliation to social security
* Vena cava obstruction
* previous inclusion in protocol

Primary outcomes:
measure: Area under ROC curve of the variation in continuous cardiac output during Trendelenburg position, to detect preload dependence
timeFrame: 1 minute after Trendelenburg position onset.
Secondary outcomes:
measure: Area under ROC curve of the variation in continuous cardiac output during end-expiratory occlusion to detect preload dependence
timeFrame: 15 seconds after the onset of end-expiratory occlusion
measure: Area under ROC curve of the respiratory variation in pulse pressure to detect preload dependence
timeFrame: 1 minute after tidal volume increase to 8 ml/kg
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Jean Christophe RICHARD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yonis H, Bitker L, Aublanc M, Perinel Ragey S, Riad Z, Lissonde F, Louf-Durier A, Debord S, Gobert F, Tapponnier R, Guerin C, Richard JC. Change in cardiac output during Trendelenburg maneuver is a reliable predictor of fluid responsiveness in patients with acute respiratory distress syndrome in the prone position under protective ventilation. Crit Care. 2017 Dec 5;21(1):295. doi: 10.1186/s13054-017-1881-0.
Clinical trial NCT00908674: Androcur Effects on Quality of Life
Official title: Measure of Androcur Effects on Quality of Life at Prostate Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-05-27
Enrollment: 245
Sex: MALE
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 advanced prostate cancer

Brief summary: Androcur is an antiandrogenic drug, which blocks the action of male sex hormones. Androcur is used for treatment of advanced prostate cancer. This study investigates the effect of Androcur on quality of life of prostate cancer patients who are taking the drug for 12 months


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* Inoperable prostate tumor or progradiated after surgery/ irradiation therapy
* Locally advanced tumor or distant metastases is present

Exclusion Criteria:

* Patient not fulfil the recruitment criteria
* Liver disease; Dubin-Johnson syndrome; Rotor syndrome; previous or existing liver tumours (in carcinoma of the prostate only if these are not due to metastases); wasting diseases (with the exception of carcinoma of the prostate); depression; previous or existing thromboembolic processes; diabetes with vascular changes; sickle-cell anaemia.
* As regards patients with prostatic carcinoma who have a history of thromboembolic processes and/or an existing sickle-cell anaemia, or diabetes with vascular changes, the risk:benefit ratio must be considered carefully in each individual case before the use of Androcur

Primary outcomes:
measure: Quality of life change measured by SF-35 questionnaire
timeFrame: Baseline, after 3, 6 and 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Many Locations
country: Hungary
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05374174: Validation of a Spasticity Measurement Tool
Official title: Validation of a Spasticity Measurement Tool
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stroke
Keywords: Spasticity
Hyperreflexia
Clonus
Hypertonia
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons who have experienced a unilateral stroke

Brief summary: The objective of this project is to investigate the validity of a handheld spasticity measurement tool against standard clinical measurements of spasticity. We propose the testing apparatus will accurately provide an equivalent clinical measure of spasticity while also providing a more precise estimation of spastic response in persons with stroke.

Detailed description: An ongoing conversation amongst clinicians exists on how to properly define, measure, and manage spasticity. The standard measurement tools are the Modified Ashworth Scale (MAS) and the Tardieu scale, although both of these lack reliability and specificity, causing variability between clinicians and a lack of accurate spasticity measurement. In addition, some have concerns about whether the MAS measures true spasticity at all. Due to this lack of trust in these scales, clinicians often use them as a communication tool to identify the presence of spasticity, rather than as reliable quantifiable outcome measurements.

The MAS and Tardieu function mainly on the principal of catch, a limb is moved slowly by a clinician through the available range of motion, and then quickly. Hyperactive muscles are sensitive to velocity dependent stretch and will activate a reflex if quickly perturbed. In both the MAS and Tardieu, the catch location is noted and translated into a score. In MAS the catch location is only noted in three distinct ranges; with the Tardieu Scale the catch angle is remembered by the clinician and recorded after the movement with a standard goniometer.

Here we will test a new handheld spasticity measurement tool MITSS (Modified Intelligent Tardieu Scale for Spasticity), which is essentially a 3-DOF digital goniometer, to quantify the catch angle as well as general forces at the joint.

Eligibility criteria: Inclusion Criteria:

* Age 18-75
* Able to provide informed consent
* History of unilateral stroke

Exclusion Criteria:

* Orthopedic injuries or surgeries that would impact arm function

Primary outcomes:
measure: Catch angle
timeFrame: Baseline
Secondary outcomes:
measure: Modified ashworth score
timeFrame: Baseline
measure: Tardieu Spasticity Score
timeFrame: Baseline
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Director, Single Motor Unit Laboratory
name: William Z Rymer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04026074: Concepts for Analgosedation During Placement of Regional Anaesthesia Before Operations.
Official title: Randomized Controlled Doubleblind Pilot Study Comparing Analgosedation Concepts During Placement of Regional Anaesthesia With Either Fentanyl, Remifentanil, Clonidine, EMLA-Patch or Placebo in Regard of Pain Reduction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Arthropathy
Hip Arthritis
Fractures, Closed
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 50
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: Aim of the study is to specify the best analgosedation technique during placement of regional anaesthesia from the patients' view.

In this double blind randomized trial the investigators will be testing the application of drugs administered intravenously (fentanyl-bolus, remifentanil-infusion, clonidine-bolus) or transcutaneously (EMLA salve) or placebo (NaCl 0,9% i.v. and skin protection salve).

Detailed description: In this doubleblind randomized pilot trial, patients will receive one of five possible combinations to assess which medication leads to the best medication during placement of regional anaesthesia. This assessement includes NRS, patients' satisfaction and wellbeing. The tested substances will be administered intravenously (fentanyl-bolus, remifentanil-infusion, clonidine-bolus) or transcutaneously (EMLA salve). The fifth combination will be the control group with only placebo medication. We expected to get first information for objectifying analgosedation during placement of regional anaesthesia for the conduction of further studies in this field.

Eligibility criteria: Inclusion Criteria:

* Adult patients planed electively for orthopedic surgery

Exclusion Criteria:

* Missing patient's consent
* Intolerance against study medication

Primary outcomes:
measure: Pain intensity during placement of the regional anaesthesia
timeFrame: 1 day
Secondary outcomes:
measure: Patients' wellbeing
timeFrame: 1 day
measure: Complication rate (delirium, allergic reactions, cardiopulmonary decompensation)
timeFrame: Through study completion, an average of 1 day
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Hospital LKH Graz
Study officials:
affiliation: Medical University of Graz
name: Gregor A Schittek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03485274: Substance Misuse To Psychiatric Disorders for Cannabis
Official title: Substance Misuse To Psychiatric Disorders for Cannabis (SToP-C)--an Early Assertive Pharmacotherapy Intervention Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cannabis Use Disorder
Depressive State
Anxiety State
Depression
Anxiety Disorders
Pharmacotherapy
Keywords: Cannabis
depression
anxiety
medication
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Queen Mary Hospital, Hong Kong
First posted: 2018-04-02
Enrollment: 37
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomised single-blinded
Primary purpose: TREATMENT

Brief summary: With the recent availability of vortioxetine, and the surging phenomenon of cannabis misuses amongst young abusers, it is a timely opportunity to conduct an early pharmacotherapy intervention study to offer an evidence-based strategy aiming to stop individuals with cannabis use disorders with depressive or anxiety symptoms, to develop into a more chronic disabling dependence or co-morbid state.


Eligibility criteria: Inclusion Criteria:

• Cannabis use disorder with anxiety or depressive symptoms or disorders; or positive cannabis test results in 1 month with anxiety or depressive symptoms

Exclusion Criteria:

* Age \<16 years old
* Unable to read English or Chinese
* Unable to give informed consent
* Had been diagnosed to have Intellectual Disabilities (DSM-5) or Mental Retardation
* Had history of primary psychotic episode
* Had been diagnosed to have substance-induced mood disorder, other than cannabis
* Had been diagnosed to have mood disorders or anxiety disorders
* Had been taking maintenance therapeutic dose of antidepressant continuously \>= 6 months AND with depressive symptom or anxiety symptom being in remission
* Had known hypersensitivity to vortioxetine
* Had known history of serotonin syndrome
* Pregnant
* Mother currently breast-feeding
* Currently taking warfarin and/or having poorly controlled bleeding disorder
* Had history of prolonged QTc ≥500ms and/or known unstable or untreated cardiology disease

Primary outcomes:
measure: change in severity of Cannabis Use Disorder (CUD)
timeFrame: 6 months
Secondary outcomes:
measure: prevalence of Cannabis induced mood disorder
timeFrame: 6 months
measure: Change in Hamilton anxiety (HAM-A) rating scale
timeFrame: 6 months
measure: Change in Hamilton depression (HAM-D) rating scale
timeFrame: 6 months
measure: Change in cognitive outcome
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Albert KK Chung, MBBS(HK)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02538874: A Study of BMS-986171 in Healthy People to Assess Safety, to Measure Blood Levels of Drug, and to Find Out What the Drug Does to the Body
Official title: A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986171 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Liver Fibrosis/NASH
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-09-02
Enrollment: 275
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess safety, to measure blood levels of drug, and to find out what the drug does to the body.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Age 21 to 55 years (Part A,B, and C)
* BMI 30-40 (Part A or Part B); BMI 20-35 (Part C). BMI = weight (kg)/ \[height (m)\]

Exclusion Criteria:

* Any significant medical illness
* Cannot tolerate subcutaneous injections, or having blood samples taken
* Smoking more than 10 cigarettes/day
* History of allergy to pegylated compounds or of hypersensitivity to protein based therapeutics.
* HIV, Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection.
* Pregnancy

Primary outcomes:
measure: Safety and tolerability of single dose of BMS-986171 will be measured by number of incidence of AEs, serious AEs, and events of special interest including injection site assessment, AEs leading to discontinuation
timeFrame: up to 30 days after the last dose
measure: Safety and tolerability of multiple subcutaneous doses of BMS-986171 will be measured by number of incidence of AEs, serious AEs, and events of special interest including injection site assessment, AEs leading to discontinuation
timeFrame: up to 30 days after the last dose
measure: Safety and tolerability of single dose of BMS-986171 will be measured by number of incidence of Death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations
timeFrame: up to 30 days after the last dose
measure: Safety and tolerability of multiple subcutaneous doses of BMS-986171 will be measured by number of incidence of Death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations
timeFrame: up to 30 days after the last dose
Secondary outcomes:
measure: Immunogenicity based on antibody responses
timeFrame: 6 months following study discharge.
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Profil Institute For Clinical Research, Inc.
state: California
city: Cypress
country: United States
facility: Wcct Global, Llc
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03131674: The Effect of Cervical Physical Therapy Treatment in Patients With Somatic Tinnitus
Official title: The Effect of Cervical Physical Therapy Treatment in Patients With Somatic Tinnitus
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tinnitus, Subjective
Keywords: Somatic tinnitus
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
First posted: 2017-04-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We use a delayed treatment design, where both groups receive the same treatment.

One group receives the treatment immediately after the inclusion. The other group receives the treatment after a 9-weeks delay.
Primary purpose: TREATMENT

Brief summary: This study investigates the effect of cervical physical therapy on tinnitus annoyance in patients with somatic tinnitus. This study specifically enrolls patients with co-varying tinnitus and neck complaints, with low-pitched tinnitus or patients who's tinnitus can be influenced by neck movements or positions.

These inclusion criteria were chosen, since a prior study showed that these factors were good prognostic indicators for a positive treatment effect.


Eligibility criteria: Inclusion Criteria:

* Patients with subjective tinnitus (Tinnitus Functional Index between 25 and 90 point) in combination with self-reported neck complaints (Neck Bournemouth Questionnaire \> 13 points) are included in case one of the following is present:

  * Tinnitus and neck complaints increase and decrease together
  * Tinnitus is low-pitched and increases during inadequate neck postures

Exclusion Criteria:

* Tinnitus related to Ménière's disease, clear otological or neurological causes
* Serious depression
* Contra-indications for cervical spine treatment
* Patient already received cervical physical therapy in the past 2 months

Primary outcomes:
measure: Tinnitus Questionnaire
timeFrame: Baseline, 9 weeks, 18 weeks
Secondary outcomes:
measure: Tinnitus Functional Index
timeFrame: Baseline, 9 weeks, 18 weeks
measure: Neck Bournemouth Questionnaire
timeFrame: Baseline, 9 weeks, 18 weeks
measure: Change in Auditory evoked potentials
timeFrame: Baseline, 9 weeks
measure: Change in Manual Rotation test
timeFrame: Baseline, 9 weeks
measure: change in adapted Spurling test
timeFrame: baseline, 9 weeks
measure: change in presence of active triggerpoints
timeFrame: baseline, 9 weeks
measure: change in Craniocervical flexion test
timeFrame: baseline, 9 weeks
measure: change in Coordination and strength test of cervical extensor muscles
timeFrame: baseline, 9 weeks
measure: change in Speech in noise test
timeFrame: baseline, 9 weeks
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital of Antwerp
state: Antwerp
Study officials:
References: