louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04147364: Patterns of Injury and Mortality in Free-fall Trauma Patients
Official title: Patterns of Injury and Mortality in Free-fall Trauma Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trauma
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patterns of injury and mortality after free-falls in a Taiwan level one trauma center.

Brief summary: In this study, the investigator aimed to analyze the demographic characteristics, patterns of injury and mortality after free fall in a Taiwan level one trauma center.

Detailed description: Falls from height is the leading cause of accidental deaths. The mechanism of free-fall injury is abrupt vertical deceleration and the severity is dependent on the height, body weight, posture and contact area...etc. Most victims presented to emergency department with major trauma, so initial evaluation and timely management are crucial for the survival. The knowledge of unique pattern of injuries helps clinicians to facilitate the diagnosis. In this study, the investigator aimed to analyze the demographic characteristics, patterns of injury and mortality after free fall in a Taiwan level one trauma center.

Eligibility criteria: Inclusion Criteria:

* adult patients with free-fall trauma

Exclusion Criteria:

* adult patients with free-fall trauma, not relating with traffic accidents

Primary outcomes:
measure: patterns of injury and causes of mortality
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital Emergency Department
Study officials:
affiliation: National Taiwan University Hospital
name: Wan-Ching Lien, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01451164: A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia
Official title: A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-10-13
Enrollment: 459
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: To investigate the efficacy and safety of OPC-34712 in comparison with placebo in patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Patients age 18 years or older to less than 65 years (at time of informed consent) diagnosed with schizophrenia based on DSM-IV-TR diagnostic criteria
* Patients who are hospitalized, or judged to required hospitalization, for acute relapse of schizophrenia at time of informed consent
* Patients who are experiencing acute exacerbation of psychotic symptoms

Exclusion Criteria:

* Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product
* Patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator
* Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis Ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)

Primary outcomes:
measure: Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
Secondary outcomes:
measure: Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
measure: Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
measure: Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness (CGI-S)
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
measure: Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6.
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
Other outcomes:
Locations:
city: Kanto Region
country: Japan
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: kyoji Imaoka, Operating Officer
role: STUDY_DIRECTOR
References:
Clinical trial NCT05013164: Role of Folinic Acid in Improving the Adaptive Skills and Language Impairment in Children With Autism Spectrum Disorder
Official title: Role of Folinic Acid in Improving the Adaptive Skills and Language Impairment in Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism Spectrum Disorder
Lead sponsor: Nishtar Medical University
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 44
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: No such study has been conducted in Pakistan so the primary objective of this study was to determine the role of folinic acid in improving the speech and adaptive skills while secondary objective was improvement of stereotype movements and hyperactivity in ASD among children aged 3 to 14 years.


Eligibility criteria: Inclusion Criteria:

* Children of both genders aged 3 to 14 years with diagnosis of autism spectrum disorder established by DSM-5 Criteria, Childhood Autism Rating Scale (CARS) scoring and clinical examination along with documentation of Language Impairment

Exclusion Criteria:

* All children having autism with seizure disorder, autism with serious medical illness within last 6 months or those with autism with well-defined genetic syndrome.

Primary outcomes:
measure: To determine the role of folinic acid in improving the speech and adaptive skills among children with autism spectrum disorders
timeFrame: 12 weeks
Secondary outcomes:
measure: To dertermine improvement of stereotype movements and hyperactivity in children with autism spectrum disorders
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: Children's Hospital and Institute of Child Health
state: Punjab
Study officials:
affiliation: ICH Multan, Pakistan
name: Fawwad Saleem, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00620464: A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(P05720)
Official title: A Randomized, Double-Blind, Parallel Group, Bioequivalence Study of IMPLANON and Radiopaque IMPLANON
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and Radiopaque IMPLANON.


Eligibility criteria: Inclusion Criteria:

* At least 18 but not older than 40 years of age at the time of screening
* Good physical and mental health
* Regular cycles with a usual length between 24 and 35 days
* Body mass index ≥ 18 and ≤ 29
* Willing to give informed consent in writing

Exclusion Criteria:

* Contraindications:

  * known or suspected pregnancy
  * active venous thromboembolic disorder (e.g. deep vein thrombosis,pulmonary embolism)
  * presence or history of severe hepatic disease as long as liver function values have not returned to normal
  * malignancy or pre-malignancy, if sex -steroid-influenced
  * undiagnosed vaginal bleeding
  * hypersensitivity to any of the components of Implanon/Radiopaque Implanon
* Hypertension, i.e. systolic blood pressure \>140 mmHg and/or diastolic blood pressure \> 90 mmHg.
* A history during pregnancy or during previous use of sex steroids of: jaundice and/or severe pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss
* Present use or use during 2 months prior to the start of Implanon/Radiopaque Implanon of one of the following drugs: phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, nelfinavir, griseofulvin or the herbal remedy St John's wort.
* Administration of investigational drugs within 2 months prior to the start of Implanon/Radiopaque Implanon

Primary outcomes:
measure: Bioequivalence of Implanon® and Radiopaque Implanon.
timeFrame: 3 years
measure: Bioequivalence of Implanon® and Radiopaque Implanon
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Schnabel P, Merki-Feld GS, Malvy A, Duijkers I, Mommers E, van den Heuvel MW. Bioequivalence and x-ray visibility of a radiopaque etonogestrel implant versus a non-radiopaque implant: a 3-year, randomized, double-blind study. Clin Drug Investig. 2012 Jun 1;32(6):413-22. doi: 10.2165/11631930-000000000-00000.
Clinical trial NCT02210364: Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC).
Official title: Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Unresectable Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Breast Cancer
Pancreatic Cancer
Metastatic Colorectal Cancer
Lead sponsor: PharmaMar
Sponsor class: INDUSTRY
First posted: 2014-08-06
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination with Capecitabine in Patients with Unresectable Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC) to determine the recommended dose (RD) of PM01183 in combination with capecitabine, to characterize the safety profile, to explore the feasibility of PM01183 dose optimization, to characterize the pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity of this combination and to conduct an exploratory pharmacogenomic (PGx) analysis.


Eligibility criteria: Inclusion Criteria:

* Voluntarily signed and dated written informed consent (IC)
* Age between 18 and 75 years
* Women of childbearing potential must have pregnancy excluded by appropriate testing before study entry.
* Life expectancy ≥ 3 months.
* Patients with a histologically/cytologically confirmed diagnosis of unresectable Metastatic Breast Cancer, Pancreatic Cancer or metastatic Colorectal Cancer.

Exclusion Criteria:

* Three or more prior chemotherapy-containing lines for advanced disease.
* Prior treatment with PM01183 or with capecitabine containing therapy for advanced disease.
* History within the last year or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically relevant valvular heart disease or symptomatic arrhythmia or any asymptomatic ventricular arrhythmia requiring ongoing treatment.
* Ongoing chronic hepatopathy of any origin.
* Active uncontrolled infection.
* Patients with dyspnea who are requiring any ongoing oxygen support.
* Known human immunodeficiency virus (HIV) infection.
* Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
* Men or women of childbearing potential who are not using an effective method of contraception

Primary outcomes:
measure: Recommended dose of PM01183 in combination with capecitabine
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
city: Barcelona
country: Spain
Study officials:
References:
Clinical trial NCT01540864: A Safety and Efficacy Study of HPP404 on Weight Loss in Overweight or Obese Subjects
Official title: A 26 Week Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Safety and Efficacy of Various Doses of HPP404 on Weight Loss in Overweight or Obese Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Obesity
Overweight
Keywords: Obesity
Overweight
Body Mass Index
Lead sponsor: High Point Pharmaceuticals, LLC.
Sponsor class: INDUSTRY
First posted: 2012-02-29
Enrollment: 126
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: The purpose of this study is to compare the safety and effect of HPP404 versus placebo on body weight in overweight or obese subjects.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) from 30.0 to 39.9 kg/m2, for subjects with no additional co morbidities;
* BMI from 27 to 39.9 kg/m2, for subjects with co morbidities (i.e. dyslipidemia defined as high LDL (≥ 160 mg/dL) or high total cholesterol (≥ 240 mg/dL), or subjects with hypertension)

Exclusion Criteria:

* Systolic blood pressure \> 160 mmHg and/or diastolic pressure \> 90 mmHg at the Screening Visit without treatment
* History of use of tobacco or nicotine-containing products 180 days prior to Screening visit
* Subjects with type 2 diabetes or fasting blood glucose concentration ≥ 126 mg/dL
* History of appetite or weight modifying surgeries/procedures

Primary outcomes:
measure: Percent weight loss
timeFrame: Day 1 to Day 182
Secondary outcomes:
measure: Number of subjects attaining a 5% or more weight loss
timeFrame: Day 1 to Day 182
measure: Absolute and percent change in Body Mass Index (BMI)
timeFrame: Day 1 to Day 182
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Site 11
state: Georgia
city: Valparaiso
country: United States
facility: Site 3
state: Indiana
city: Louisville
country: United States
facility: Site 12
state: Kentucky
city: Hyannis
country: United States
facility: Site 9
state: Massachusetts
city: Saint Paul
country: United States
facility: Site 10
state: Minnesota
city: New York
country: United States
facility: Site 2
state: New York
city: Charlotte
country: United States
facility: Site 1
state: North Carolina
city: High Point
country: United States
facility: Site 5
state: North Carolina
city: Norfolk
country: United States
facility: Site 7
state: Virginia
city: Richmond
country: United States
facility: Site 6
state: Virginia
Study officials:
affiliation: High Point Pharmaceuticals, LLC.
name: Enrikas Vainorius, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02825264: STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program
Official title: STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program in a Real-World Patient Population
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Open Angle Glaucoma
Keywords: Glaucoma Drainage Device
STARflo
Lead sponsor: iSTAR Medical
Sponsor class: INDUSTRY
First posted: 2016-07-07
Enrollment: 70
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: Patients suffering from open angle glaucoma or some case of narrow angle glaucoma who have been implanted with STARflo.

Brief summary: STARflo is a novel suprachoroidal Glaucoma Drainage Device (GDD), bleb-free, exhibiting anti-fibrotic properties. Release of this CE Marked implant has been limited to leading Glaucoma Centers in Europe.

Detailed description: This Clinical Experience Program is being initiated to expand the surgical and clinical practice knowledge about the use of STARflo for reducing intraocular pression (IOP) in patients suffering from open angle glaucoma in a real world population of patients.

This program is designed to be an international multicenter observational study.

Patient data may be collected retrospectively and/or prospectively for up to 5 years after surgery.

The aim of this program is to document the patient's benefit following implantation of the STARflo implant in a real-word patient population, to learn about surgical practices and to collect data to support future cost-effectiveness analysis.

Eligibility criteria: Inclusion criteria:

* Patients suffering from open angle glaucoma or some case of narrow angle glaucoma who have been implanted with STARflo implant from 2011
* Patients who have signed a Data Release form

Exclusion criteria:

* Patients who did not sign a Data Release form

Primary outcomes:
measure: Reduction of intraocular pressure (IOP)
timeFrame: at 12 Months
Secondary outcomes:
measure: Occurence of Ocular Adverse Events
timeFrame: up to 60 Months after surgery
measure: Reduction of intraocular pressure (IOP) over time
timeFrame: at 6, 24, 36, 48 and 60 Months
measure: Reduction of IOP lowering medication
timeFrame: at 6, 12, 24, 36, 48 and 60 Months
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Bât. BC-3 OPHTALMOLOGIE - POLICLINIQUE C.H.U.
city: Lyon
country: France
facility: Hospital de la Croix-Rousse
city: Paris
country: France
facility: CHNO des Quinze-Vingts
city: Dortmund
country: Germany
facility: St. Johannes Hospital Dortmund
city: Heidelberg
country: Germany
facility: Universitäts-Augenklinik Heidelberg
city: München
country: Germany
facility: Klinikum der Universität München
city: Rostock
country: Germany
facility: Augenklinik Universitätsmedizin Rostock
city: Sopron
country: Hungary
facility: Elisabeth Academic Hospital
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
Study officials:
affiliation: Sponsor Representative
name: Zubair Hussain, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03954964: Increasing Awareness of Opioid Disposal in the Orthopedic Patient Population
Official title: Increasing Awareness of Opioid Disposal in the Orthopedic Patient Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Total Joint Replacement
Hip Total Joint Replacement
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-05-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Researchers are trying to determine if providing education on proper disposal of unused opioid medications to the orthopedic patient undergoing a planned hip or knee total joint replacement will increase the percentage of patients who properly dispose of unused opioids.


Eligibility criteria: Inclusion Criteria:

* Adult 18 + years
* Planned total hip or knee replacement surgery
* English speaking

Exclusion Criteria:

* Pediatric patients 17 and younger
* Non-English speaking patients
* Total joint replacement surgery other than Hip and Knee

Primary outcomes:
measure: Disposal of unused prescription pain medication
timeFrame: 12 weeks post operative
measure: Use of medication deactivation bag
timeFrame: 12 weeks post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Christine Aliory, APRN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04686864: A Virtual Parent-led Support Group for Parents of Children and Youth With Eating Disorders: A Mixed Methods Feasibility Study Examining Acceptability, Cost and Parent Outcomes
Official title: A Virtual Parent-led Support Group for Parents of Children and Youth With Eating Disorders: A Mixed Methods Feasibility Study Examining Acceptability, Cost and Parent Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Eating Disorders
Keywords: eating disorder
parent support group
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: We studied the implementation of a virtual parent-led peer support group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: There is a gap in the literature about the feasibility and implementation of parent-led support groups for parents who have children or adolescents with eating disorders. In this study, we will be observing the experiences of 40 parents in Ontario who will virtually participate in one of 3 parent-led support groups for parents of children and youth with eating disorders. Parents will be expected to attend the virtual sessions twice a month over the course of six months. We hope to evaluate the acceptability, cost, and parental outcomes of the parent-led support groups via surveys before, during, and after the study, as well as using a post-study interview.


Eligibility criteria: Inclusion Criteria:

* have the capacity to write, speak and understand English, in order to participate in the sessions
* have access to the internet/computer to participate in the sessions
* must have a child or adolescent with an eating disorder.

Exclusion Criteria:

* don't have the capacity to write, speak and understand English
* don't have access to the internet/computer
* don't have a child or adolescent with an eating disorder

Primary outcomes:
measure: Change in number of parents who remain in the support group
timeFrame: Baseline and 6 months later
measure: Number of support groups each parent attends
timeFrame: 6 months after baseline
measure: Cost
timeFrame: 12 months after baseline
Secondary outcomes:
measure: Change in Carer Burden
timeFrame: Baseline, 3 months, 6 months
measure: Change in Carer Needs
timeFrame: Baseline, 3 months, 6 months
measure: Change in Parental Self Efficacy and Collaboration
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Jennifer Couturier, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: