louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01606059: Phase 1 Study of DW-0919 & DW-0920 in Healthy Male Volunteers Under Fasting Condition
Official title: A Randomized, Open Label, 2-treatment, 2-sequence, Cross-over Study to Compare the Safety and Pharmacokinetics of DW-0919 and DW-0920 After Single Oral Administration in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Chungnam National University Hospital
First posted: 2012-05-25
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate safety and pharmacokinetics of DW-0919 and DW-0920 in healthy male volunteers under fasting condition.


Eligibility criteria: Inclusion Criteria:

* Adult males aged 20 to 55 years at screening.
* No significant congenital/chronic disease.
* No symptoms in physical examination.
* Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
* Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion Criteria:

* History of Hyperreactivity with drug ingredients(acetaminophen, tramadol) or opioids.
* History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
* History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.

Primary outcomes:
measure: AUC of DW-0919(Acetaminophen, Tramadol)
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36
measure: Cmax of DW-0919(Acetaminophen, Tramadol)
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36
measure: AUC of DW-0920(Acetaminophen, Tramadol)
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36
measure: Cmax of DW-0920(Acetaminophen, Tramadol)
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36
Secondary outcomes:
Other outcomes:
Locations:
city: DaeJeon
country: Korea, Republic of
facility: Chungnam National University Hospital
Study officials:
References:
citation: Kim HC, Yoon DY, Lee S, Jang IJ, Hong JH, Kim J. Comparative pharmacokinetics between two tablets of tramadol 37.5 mg/acetaminophen 325 mg and one tablet of tramadol 75 mg/acetaminophen 650 mg for extended-release fixed-dose combination. Transl Clin Pharmacol. 2022 Jun;30(2):112-119. doi: 10.12793/tcp.2022.30.e12. Epub 2022 Jun 27.
Clinical trial NCT01932359: Rapidly Absorbable Versus Non-absorbable Sutures for Mohs Surgery Repair on the Face: a Randomized Controlled Split-scar Study
Official title: Rapidly Absorbable Versus Non-absorbable Sutures for Mohs Surgery Repair on the Face: a Randomized Controlled Split-scar Study (RAVNAS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scars
Keywords: Scar outcome
Mohs surgery
face
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 105
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: This study aims to compare scar outcomes between rapidly absorbable and non-absorbable sutures (stitches) for the closure of wounds after skin cancer removal on the face.


Eligibility criteria: Inclusion Criteria:

* Mohs surgical wound on the face
* Wound greater than or equal to 4 cm in length
* Subject is willing and capable of cooperating to the extent and degree required by the protocol and will be able to come for follow-up assessments
* Subject has read and signed Subject Information and Informed Consent Form

Exclusion Criteria:

* Surgical wound less than 4 cm in length
* Surgical site outside of face
* Subject to be be treated with radiation therapy after surgery
* Subject is not willing or able to attend for follow-up assessments

Primary outcomes:
measure: Stony Brook Scar Evaluation Scale (SBSES) score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Department of Dermatology and Skin Science, UBC, Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: David Zloty, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00559559: PAtient NOtifier Feature for Reduction of Anxiety
Official title: PAtient NOtifier Feature for Reduction of Anxiety: A Multicenter ICD Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tachycardia, Ventricular
Keywords: Primary and secondary prevention for ventricular tachycardia
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2007-11-16
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is intended to look at the effect of the SJM vibrating Patient Notifier™ system, which will warn the patient of possible failures of the implanted system, on reducing patient device related anxiety


Eligibility criteria: Inclusion Criteria:

* Patient has recently (min. 2 weeks - max. 14 weeks) been implanted with an SJM ICD with the Patient Notifier™ feature;
* Patient is willing and able to independently comprehend and complete the study-related questionnaires;
* Patient has signed the study specific informed consent form.

Exclusion Criteria:

* have already had a Patient Notifier™ alert since implant;
* had a prior device implant (PM or ICD);
* have not been discharged from the hospital since device implant;
* have evidence of psychosis, dementia or cognitive impairment as documented in the patients' hospital records;
* cannot commit to the follow-up schedule;
* have a life expectancy of less than 1 year;
* are on a waiting list for a heart transplant;
* are less than 18 years old;
* are pregnant;

Primary outcomes:
measure: Reduction in device related anxiety, related to battery depletion, as assessed by the Duru Questionnaire (question 9) Reduction in device related anxiety, related to device malfunction, as assessed by the Duru Questionnaire (question 10)
timeFrame: 12months
Secondary outcomes:
measure: Reduction in general anxiety Evolution over time in anxiety for the different personality types Cross-overs Sensitivity and Specificity of the Patient Notifier™ Number of appropriate/inappropriate ICD therapies Hospitalizations Mortality
timeFrame: 1year
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich
Study officials:
affiliation: Universitätsspital Zürich
name: Firat Duru, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duru F, Dorian P, Favale S, Perings C, Pedersen SS, Willems V; PAtient NOtifier Feature for Reduction of Anxiety: A Multicenter ICD Study investigators. Effects of an alert system on implantable cardioverter defibrillator-related anxiety: rationale, design, and endpoints of the PANORAMIC multicentre trial. Europace. 2010 May;12(5):726-30. doi: 10.1093/europace/euq026. Epub 2010 Mar 5.
Clinical trial NCT01001559: Combination Deplin® and Antidepressant Therapy for a Major Depressive Episode (MDE)- a Retrospective Analysis
Official title: Combination Deplin® and Antidepressant Therapy Compared to Antidepressant Therapy Alone for an Episode of Major Depression- a Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Keywords: Depression
Combination therapy
antidepressant
Deplin
folate
methylfolate
Lead sponsor: Pamlab, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Red Oak Psychiatry Associates, PA
name: Baylor Health Care System
First posted: 2009-10-26
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults ages 18-70 experiencing an episode of major depression

Brief summary: This is a retrospective chart review study to determine if Deplin® 7.5mg-15mg combined with an antidepressant is better than an antidepressant alone in adults with major depression.


Eligibility criteria: Inclusion Criteria:

* Males or females age 18-70
* The active arm (Arm #1) includes randomly selected 100-125 charts of patients with a primary diagnosis of major depression and a CGI-S of ≥4 who began Deplin and SSRI or SNRI therapy at the same time beginning in January 2007 to the present; and, Control group (Arm #2) includes randomly selected 125-150 charts of patients with a primary diagnosis of major depression who began SSRI or SNRI therapy matched in severity (CGI-S of ≥4)

Exclusion Criteria:

* Folic acid \>400 mcg taken at any time during the study
* Psychotic features in the current episode or a history of psychotic features
* Any bipolar disorder (current or past) or any psychotic disorder (current or past)
* Current or past treatment with vagus nerve stimulation, ECT, or transcranial magnetic stimulation
* Antipsychotic therapy in conjunction with their antidepressant currently or in past 4 weeks

Primary outcomes:
measure: Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline
timeFrame: 60 days
Secondary outcomes:
measure: Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale
timeFrame: 60 days
measure: Number of Hospitalizations Due to MDD
timeFrame: 60 days
measure: Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications
timeFrame: 60 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, PA
state: Texas
Study officials:
affiliation: Red Oak Psychiatry Associates, PA
name: Lawrence D Ginsberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ginsberg LD, Oubre AY, Daoud YA. L-methylfolate Plus SSRI or SNRI from Treatment Initiation Compared to SSRI or SNRI Monotherapy in a Major Depressive Episode. Innov Clin Neurosci. 2011 Jan;8(1):19-28.
Clinical trial NCT03686059: Outcome of Omega 3 FA and Punctal Plugs on Ocular Surface Disease
Official title: Outcome of Concomitant Use of Punctal Plugs and Omeg 3 Fatty Acids on Ocular Surface Disease in Patients Using Systemic Isotretinoin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ocular Surface Disease
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ocular surface disease is a common adverse effect of systemic isotretinoin therapy.

The investigators consider that punctal plugs and Omega 3 is a good line for treatment of ocular surface disease associated with systemic isotretinoin therapy

Detailed description: Subjective and objective evaluation of ocular surface disease was done at baseline ,1 and 3 months of the study .

Eligibility criteria: Inclusion Criteria:

* systemic isotretinoin therapy

Exclusion Criteria:

* systemic or ocular diseases ,previous ocular surgery, corneal pathology and contact lens wearer

Primary outcomes:
measure: Change in Break up Time at baseline and during the study
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: ACDS
Study officials:
References:
Clinical trial NCT01710059: Using Mobile Phones to Improve Adherence to Inhaled Steroids
Official title: Refined ADEPT: Human Augmentics for Sustained Wellbeing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Health Status Disparities
Minority Health
Pediatrics
Behavioral Intervention
Cellular Phone
Peer Group
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: GlaxoSmithKline
First posted: 2012-10-18
Enrollment: 12
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study has two main goals. The first goal is to test whether a mobile phone intervention can increase adherence to daily inhaled steroid medications in African American adolescents prescribed this type of medication by his/her asthma doctor. The second goal is to use a mobile phone intervention to better understand real life patterns of use of quick-relief (beta2-adrenergic agonist) asthma medication in this population.


Eligibility criteria: Inclusion Criteria:

* 11-16 years of age
* self-identify as African American
* have persistent asthma
* be on a prescription daily inhaled corticosteroid medication for asthma
* be on a prescription inhaled beta2-adrenergic agonist medication for asthma

Exclusion Criteria:

* candidate refusal
* the presence of other co-morbidities that could interfere wtih study participation
* \> 60% adherence to inhaled corticosteroid medication, measured by the electronic dose counter, during the run-in period

Primary outcomes:
measure: Adherence to inhaled corticosteroids, measured objectively using an electronic dose counter
timeFrame: 10 weeks
Secondary outcomes:
measure: To understand patterns of use of quick-relief medication for asthma
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Giselle S. Mosnaim, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02111759: The Effect of Knee Flexion Angle for Graft Fixation During Single-Bundle Anterior Cruciate Ligament Reconstruction
Official title: The Effect of Knee Flexion Angle for Graft Fixation During Single-Bundle Anterior Cruciate Ligament Reconstruction - A Multicentre, Patient and Assessor Blinded, Stratified, Two-arm Parallel Group Superiority Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Injury
Lead sponsor: University of Toronto Orthopaedic Sports Medicine
Sponsor class: OTHER
Collaborators: name: Arthroscopy Association of North America
First posted: 2014-04-11
Enrollment: 204
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct a randomized controlled trial to determine if the knee flexion angle (KFA) during anterior cruciate ligament reconstruction (ACLR) graft fixation has an effect on postoperative outcomes. The specific research questions are: what is the effect of the KFA on 1) patient-reported outcomes; 2) postoperative extension loss; 3) antero-posterior (AP) knee stability; 4) rate of re-operation.


Eligibility criteria: Inclusion Criteria:

* Male and female patients older than 16 years old with an isolated anterior cruciate ligament injury as diagnosed by clinical examination and MRI
* No pre-existing arthritis as defined by the Kellgren-Lawrence radiographic rating system
* Patients treated with an initial period of rehabilitation to eliminate swelling, optimize quadriceps strength and restore range of motion
* surgical management with a transtibial or anteromedial portal single-bundle ACLR with bone patella tendon bone (BPTB) autograft by a fellowship-trained sports medicine surgeon.

Exclusion Criteria:

* Acute ACL injuries that have not undergone an initial period of physical therapy in order to restore the aforementioned parameters
* Associated grade III injury to the MCL (medial opening \>10mm at 30 degrees of knee flexion or any medial opening in extension)
* Presence of a PCL or posterolateral corner injury
* Lack of informed consent.

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 24 months postoperatively
Secondary outcomes:
measure: KOOS scores
timeFrame: 3, 6, and 12 months
measure: Marx Activity Score (MAS)
timeFrame: 3, 6, 12, 24 months
measure: the degree of extension loss in the affected knee (vs. contralateral knee)
timeFrame: 3, 6, 12, and 24 months
measure: Side to side differences in anterior-posterior (AP) stability
timeFrame: 3, 6, 12, and 24 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: University of Toronto Orthopaedic Sports Medicine
name: Jaskarndip Chahal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05465759: Frequency of SARS COVID-19 Infection Among Malignant Patients at South Egypt Cancer Institute
Official title: Frequency of SARS COV-2 Infection Among Malignant Patients at South Egypt Cancer Institute
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients at south Egypt cancer institute

Brief summary: Assessment the frequency of SARS COV-2 infection among malignant patients at south Egypt Cancer institute

Detailed description: Coronavirus disease (COVID-19) is an infectious disease caused by the SARS-CoV-2 virus Most people infected with the virus will experience mild to moderate respiratory illness and recover without requiring special treatment. However, some will become seriously ill and require medical attention. Older people and those with underlying medical conditions like cardiovascular disease, diabetes, chronic respiratory disease, or cancer are more likely to develop serious illness. Anyone can get sick with COVID-19 and become seriously ill or die at any age Cancer is one of the most common examples of immunocompromised states

Eligibility criteria: Inclusion Criteria:

* Malignant patients.
* PCR positive for covid-19

Exclusion Criteria:

* PCR negative for covid-19

Primary outcomes:
measure: calculate the frequency of SARS-CoV-2 infection among patients with malignant data collection during the study period
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06175559: Embedded Narrative in Interactive Game Design for Improving Medication Adherence of Schizophrenia
Official title: Embedded Narrative in Interactive Game Design for Improving Medication Adherence of Schizophrenia：Exploratory Research
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Schizophrenia and Related Disorders
Medication Adherence
Mental Health Issue
Gamification
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study explores the potential of an interactive narrative game to enhance medication adherence among stable schizophrenia patients. Employing participatory design methods, game's development and testing process actively involved patients and individuals closely connected to their daily lives. Artificial Intelligence-Generated Content (AIGC) facilitated swift iterations in game's visual style and content. During game therapy, patients are tasked with making decisions based on presented situations, which influence the course of the narrative.

Detailed description: Our game design is inspired by Cognitive Behavioral Therapy (CBT), specifically the autonomic engagement and emotion regulation for the treatment of stable schizophrenic patients. This design aims to motivate patients to practice the basic principles of CBT in a virtual environment with the aim of producing positive psychological and behavioral changes in real life.

To ensure that the interactive design in the game can effectively promote cognitive reconstruction and emotional regulation in patients, the investigators used the following game interaction strategies:

1. Situational simulation: By simulating real-life situations, patients face challenges and make decisions in the game that are similar to those in real life, so as to train their cognitive and emotional regulation.
2. Immediate feedback: Provide patients with immediate feedback during the game so that they can understand the impact of their decisions on the outcome of the game, thus encouraging them to make more positive decisions in real life.
3. Role-imitation: Encourage patients to take an in-depth look at their thoughts and behaviors from a third-person perspective by having them take on the role of a therapy practitioner.

Eligibility criteria: Inclusion Criteria:

* Stable Phase Schizophrenia
* on long-term medication
* medication adherence was problematic

Exclusion Criteria:

* Serious Schizophrenia
* Lack of basic cognitive abilities

Primary outcomes:
measure: 8-item Morisky Medication Adherence Scale , MMAS-8
timeFrame: 10 minutes
measure: the In-Game Core Scale (iGEQ)
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Zhao Liu, Prof
role: STUDY_DIRECTOR
References: