louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01991509: Safety and Bioavailability of IV and SC LBR-101
Official title: A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study Assessing the Safety, Tolerability and Pharmacokinetics of Two Different Doses of LBR-101 Given Intravenously and Subcutaneously
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioavailability and Pharmacokinetics
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to assess the safety, tolerability and blood levels of LBR-101 when administered intravenously or subcutaneously to healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Generally Healthy, Signed Approved Informed Consent, BMI 17.5-34.5 kg/m2, Willing and able to comply with CRU rules regulations and study schedule

Exclusion Criteria:

* Clinically significant medical or psychiatric condition, Febrile illness within 5 days of dosing, Pregnant or Nursing Females. History of alcoholism, drug addiction or positive drug/alcohol screen, History of hypersensitivity to injected proteins or monoclonal antibodies, Unwilling or unable to comply with the protocol specified lifestyle guidelines, Investigational site staff members, Use of 3 or more prescription or non-prescription medications daily, Acetaminophen use in doses of higher than 1 g or more/day, Daily Aspirin use in higher than 325 mg/day, Treatment with an investigational drug within 30 days of dosing, Use of biologics within 6 months of screening, Any clinically significant abnormality in the 12-Lead ECG, Positive result for HIV, Hepatitis B, or Hepatitis C, Any clinically significant abnormalities in Blood Chemistry Hematology or Urinalysis, Positive Pregnancy Test.

Primary outcomes:
measure: Relative bioavailability of IV versus SC Administration of LBR-101
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Development
state: Texas
Study officials:
affiliation: Sponsor Chief Medical Officer
name: Marcelo Bigal, MD, PhD
role: STUDY_CHAIR
affiliation: Sponsor Clinical VP
name: Rafael Escandon, PhD MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT02915809: A Study to Evaluate Efficacy and Safety of GC3110B in Healthy Adults
Official title: A Randomized, Double-Blind, Multicenter Study to Compare the Immunological Efficacy and Safety of GC3110B With GCFLU Quadrivalent Inj. Administered Intramuscularly in Healthy Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Influenza, Human
Keywords: Influenza Vaccines
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2016-09-27
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate immunological efficacy and safety of GC3110B versus GCFLU Quadrivalent Inj. among healthy adults in 18 to 60 years of age.

Detailed description: Adults 18 to 60 years of age will be randomly assigned in a 1:1 ratio to receive either GC3110B or GCFLU Quadrivalent Inj.

Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 18 to 60 years
* Informed consent form has been signed and dated
* Able to comply with the requirements of the study

Exclusion Criteria:

* Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components
* Personal history of Guillain-Barré syndrome
* Subjects with severe chronic disease who are considered by investigator to be ineligible for the study
* Subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study
* Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy

Primary outcomes:
measure: Geometric Mean Titer Ratios of Antibodies to the GC3110B or GCFLU Quadrivalent Inj.
timeFrame: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Secondary outcomes:
measure: Percentage of Participants Achieving Pre-Defined Seroconversion Before and Following Vaccination
timeFrame: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
measure: Percentage of Participants Achieving Pre-Defined Seroprotection Before and Following Vaccination
timeFrame: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
measure: Number and Percentage of Participants Reporting Solicited Adverse Events Following Vaccination
timeFrame: Day 0 to Day 6
measure: Number and Percentage of Participants Reporting Unsolicited Adverse Events Following Vaccination
timeFrame: Day 0 to Day 21
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05609409: FlexED: A Digital, Gamified Early Intervention for Eating Disorders
Official title: FlexED: A Digital, Gamified Early Intervention for Eating Disorders
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Eating Disorders
Body Image
Keywords: Eating Disorders
Body Image Flexibility
Acceptance and Commitment Therapy
Psychological Flexibility
Online
Early Intervention
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of Cyprus
First posted: 2022-11-08
Enrollment: 24
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Noncurrent Multiple Baseline Experimental Design where subjects will serve as their own control.

Participants will be randomized to different baseline durations.
Primary purpose: TREATMENT

Brief summary: The goal of this multiple baseline experiment is to test the effect of a digital, gamified early intervention for eating disorders on body image flexibility and determine treatment dose. Twenty-four young women and girls (between the ages of 15-25) with eating disorder (ED) symptoms will be randomized to different baseline durations (varying between 2-6 weeks). Participants will complete eight 20-30 minute sessions of a multimedia application over 10 weeks using their home computer or mobile device. Body Image Flexibility (BIF) will be measured repeatedly using a multimodal assessment strategy (behavior, physiological and self-report) during baseline and treatment phases. The investigators will estimate the effect of the intervention on BIF and examine when change occurs and plateaus (with no discernable benefit for additional sessions) to determine treatment dose.


Eligibility criteria: Inclusion Criteria:

* Female identified 15-25 years old
* Weight Concerns Scale score of \>47
* Maladaptive weight control behaviors with onset \<3 years

Exclusion Criteria:

* Currently meets full diagnostic criteria anorexia or bulimia nervosa or has in the past.
* Psychosis, substance use disorder or current suicidal ideation or self-harm.
* Start or change in psychiatric medications within the past month.
* NonEnglish Speaking.
* Presents with other specified feeding or eating disorder (OSFED) that does not have weight/shape concerns as a primary feature (e.g., Avoidant Restrictive Food Intake Disorder).

Primary outcomes:
measure: Change in body image flexibility as indexed by the Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5)
timeFrame: Baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 weeks
measure: Change in High Frequency Heart Rate Variability (HF-HRV)
timeFrame: Baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 weeks
measure: Change in biased processing of body image stimuli relative to neutral stimuli
timeFrame: Baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
References:
Clinical trial NCT00092209: Antihypertensive Efficacy and Safety of Approved Drugs in Japanese Patients With Essential Hypertension (Banyu Study)(0954A-302)
Official title: A Randomized, Placebo-Controlled, Double-Blind, Parallel Study of the Anti-Hypertensive Efficacy and Safety of Losartan Monotherapy as Compared to HCTZ Monotherapy and to the Combination of Losartan and HCTZ in Japanese Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-24
Enrollment: 840
Sex: ALL
Minimum age (years): 25
Maximum age (years): 74
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 evaluate antihypertensive (lowering blood pressure) effectiveness of three combinations of approved study drugs compared to both study drugs being given alone.

Detailed description: The duration of treatment is 3.5 months.

Eligibility criteria: Inclusion Criteria:

* Japanese ancestry
* Stable high blood pressure defined by the study criteria

Exclusion Criteria:

* Pregnant or nursing
* Significant concurrent kidney, liver, blood, or other disease
* Recent heart attack or heart surgery
* History of stroke, severe hypertension (high blood pressure), significant heart failure or cardiac arrhythmias
* Significant lab abnormalities
* Uncontrolled blood sugar
* History of certain drug allergies

Primary outcomes:
measure: Mean trough SiDBP after 8 weeks of treatment
Secondary outcomes:
measure: Safety
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Saruta T, Ogihara T, Matsuoka H, Suzuki H, Toki M, Hirayama Y, Nonaka K, Takahashi K. Antihypertensive efficacy and safety of fixed-dose combination therapy with losartan plus hydrochlorothiazide in Japanese patients with essential hypertension. Hypertens Res. 2007 Aug;30(8):729-39. doi: 10.1291/hypres.30.729.
Clinical trial NCT00444509: Single Dose GW685698X Magnesium Stearate Study In Asthmatic Patients.
Official title: A Double-blind, Placebo-controlled, Crossover Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Dose Dry Powder GW685698X Containing Magnesium Stearate in Subjects With Mild to Moderate Asthmatic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: Asthmatic Patients
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-03-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a single centre, randomised, double blind, two-way crossover study, to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dry powder GW685698X (800?g) containing magnesium stearate. Magnesium stearate is an excipient added to improve the physical stability of inhaled dry powder formulations. Male and female patients with mild/moderate asthma will be randomised to determine which order they receive a single inhaled administration of GW685698X (800?g) with and without magnesium stearate. There will be a wash-out period of at least 5 days between doses.


Eligibility criteria: Inclusion criteria:

* Clinically stable persistent mild/moderate asthma within the 4 weeks preceding the screening visit,
* screening pre-bronchodilator FEV1 \>or=60 % predicted,demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of \>or= 12.0% over the max of the three screening measures and an absolute change of

  \>or= 200 mL within 30 minutes following a single 400 mcg salbutamol dose, male or female (of non child bearing potential or meet the contraception criteria),
* BMI 19-31 kg/m2,
* Non-smoker,
* refrains from use of prohibited medication within the specified timeframes

Exclusion criteria:

* Pregnant or nursing females
* History of life threatening asthma
* Subjects who are unable to stop taking protocol defined prohibited medication

Primary outcomes:
measure: Safety and tolerability: Vital signs: for 48 hours 12-lead ECG including QT, QTc, PR and QRS intervals for 48 hours PEFR, FEV1 for 48 hours Laboratory safety tests (clinical chemistry, haematology, urinalysis) at predose Adverse events for 46 days
timeFrame: Vital signs: for 48 hours
Secondary outcomes:
measure: Plasma GW685698X concentrations and pharmacokinetic parameters (AUC, Cmax, t1/2, tmax) following single inhaled doses in mild/moderate asthmatic patients for 48 hours. Weighted mean serum cortisol (0-24 h) on Day 1.
timeFrame: following single inhaled doses in mild/moderate asthmatic patients for 48 hours.
Other outcomes:
Locations:
city: Wellington
country: New Zealand
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: This study has not been published in the scientific literature.
Clinical trial NCT06962709: Studying Warmed Lidocaine for Increased Analgesic Effect During Intravitreal Injections
Official title: Comparing the Anesthetic Effect of Warmed Lidocaine to Room Temperature Lidocaine When Applied Topically for Intravitreal Injections
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pain Intensity Assessment
Pain Management
Keywords: warmed lidocaine
intravitreal injections
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Investigating whether warmed lidocaine increases analgesic effect for intravitreal injections


Eligibility criteria: Inclusion Criteria:

* Receiving intravitreal injection for any indication

Exclusion Criteria:

* Previous participant in study

Primary outcomes:
measure: Pain Rating
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University Hospital - Mason Eye Clinic
state: Missouri
Study officials:
References:
Clinical trial NCT00399009: Comparative Study of Circular Stapling Instruments
Official title: Comparative Study of Circular Stapling Instruments Concerning the Risk of Anastomotic Dehiscence After Anterior Resection for Rectal Cancer.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anastomotic Leak
Rectal Cancer
Keywords: Circular stapling devices
anastomotic leak
anastomotic dehiscence
rectal cancer
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2006-11-14
Enrollment: 880
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: After removing the rectum at surgery, bowel continuity can sometimes be restored by an anastomosis between the anus and the bowel. This anastomosis is most commonly created by the use of surgical circular stapling instruments. In a retrospective pilot study the risk of developing an acute leak in the anastomosis was increased with one of the most commonly used instruments in Sweden as compared to the other brand in use. In the current study the patient is randomized to either one of the instruments after a resection of the rectum for rectal cancer.


Eligibility criteria: Inclusion Criteria:

* Age over 18
* Anterior resection for Rectal Cancer
* Informed consent

Exclusion Criteria:

* Can not give informed consent
* Patient can not be followed

Primary outcomes:
measure: Clinical anastomotic leak
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University
name: Joakim Folkesson, M.D Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University
name: Lars Påhlman, Professor M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Folkesson J, Brown SS, Gunnarsson U, Pahlman L. Randomised multicentre trial of circular stapling devices. Int J Colorectal Dis. 2012 Feb;27(2):227-32. doi: 10.1007/s00384-011-1307-4. Epub 2011 Sep 10.
Clinical trial NCT01706809: Comparing of Different Biomarkers From Vena Rectalis Superior and Vena Cubiti in Patients Undergoing Low Anterior Resection for Rectum Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectal Cancer
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2012-10-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing open LAR for rectum cancer is subjected.

Brief summary: The primary aim of the present study is to investigate different biomarkers like VEGF, EVGF and others ability to predict time to recidive and progressions free survival.

Detailed description: Patients undergoing LAR for rectum cancer is subjected. Preoperative blood samples from vena rectalis superior and vena cubiti is collected, as well as biopsies from tumor. Preoperative and after 3 month peripheral blood samples is collected.

A total of 50 patients will be included in this study.

The study is approved by the local scientific ethical committee No. S-20100006

Eligibility criteria: Inclusion Criteria:

* Histological verified cancer
* The cancer must be located in rectum maximum of 15 cm.
* Age above 18

Exclusion Criteria:

* Disseminated cancer
* Perioperative radio-chemotherapy
* Laparoscopy surgery

Primary outcomes:
measure: The primary aim of the present study is to investigate different biomarkers like VEGF, EVGF and others ability to predict time to recidive and progressions free survival.
timeFrame: after the study is complete
Secondary outcomes:
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Vejle hospital
Study officials:
References:
Clinical trial NCT00036309: Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder
Official title: Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder
Keywords: Major Depressive Disorder
Diagnostic and Statistical Manual of Mental Disorders Fourth Edition-defined major depressive disorder without psychotic features
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2002-05-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if duloxetine is effective when compared to placebo in preventing recurrence of major depressive disorder in patients who have responded to open-label duloxetine treatment.


Eligibility criteria: Inclusion Criteria:

* Signed the informed consent
* Meet criteria for major depressive disorder without psychotic features.
* Have a level of understanding sufficient to provide informed consent and to communicate with the investigator and site personnel.
* Have had at least one other major depressive episode prior to the one being experienced at study entry.
* You are reliable and agree to keep all appointments for clinic visits, tests and procedures required by the protocol.

Exclusion Criteria:

* You have had treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry.
* Any women who are pregnant or breast feeding.
* If you have any serious medical illnesses other than major depressive disorder.
* If you have previously participated in a clinical trial for duloxetine.
* Any previous or current diagnosis of bipolar, schizophrenia, or other psychotic disorders.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
state: North Carolina
Study officials:
References:
citation: Hudson JI, Perahia DG, Gilaberte I, Wang F, Watkin JG, Detke MJ. Duloxetine in the treatment of major depressive disorder: an open-label study. BMC Psychiatry. 2007 Aug 28;7:43. doi: 10.1186/1471-244X-7-43.
Clinical trial NCT01128309: Stress Reduction and Anxiety: Effects on the Function and Structure of the Brain
Official title: Stress Reduction and Anxiety: Effects on the Function and Structure of the Brain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: European Commission
First posted: 2010-05-21
Enrollment: 29
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: TREATMENT

Brief summary: The aim of the study is to test whether Generalized Anxiety Disorder (GAD) patients that participate in a Stress Reduction Intervention show a brain activation pattern (assessed by MRI) indicative of improved emotion regulation compared to an active control intervention.


Eligibility criteria: Inclusion Criteria:

* participation in the study 'Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects" by Dr. Elizabeth Hoge

Exclusion Criteria:

* metallic implants
* left handed
* epileptic seizures
* head trauma
* weight over 350 pounds
* claustrophobia

Primary outcomes:
measure: brain activation and structure as assessed by MRI
timeFrame: Day 1 (within two weeks before the intervention)
measure: brain activation and structure as assessed by MRI
timeFrame: Day 2 (within two weeks after the intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Sara W Lazar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Britta K Holzel, PhD
role: PRINCIPAL_INVESTIGATOR
References: