louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05804279: Pharmacokinetics of BPDO-1603 or BPDO-16031 and BPDO-16033 Administration in Healthy Adults
Official title: Pharmacokinetics and Safety of BPDO-1603 or BPDO-16031 and BPDO-16033 Administration in Healthy Adults. Randomized, Open-label, Single-dose, Cross-over, Phase 1 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Alzheimer's disease, Dementia
Lead sponsor: Hyundai Pharm
Sponsor class: INDUSTRY
First posted: 2023-04-07
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pharmacokinetics and safety of BPDO-1603 or BPDO-16031 and BPDO-16033 administration in healthy adults. Randomized, open-label, single-dose, cross-over, Phase 1 study


Eligibility criteria: Inclusion Criteria:

1. Healthy adults aged 19 or older and 55 or less at the time of screening tests
2. Men weigh 55 kg or more and women weigh 50 kg or more
3. Those with a body mass index of 18.5 kg/m2 or more and less than 27.0 kg/m2

Exclusion Criteria:

1. Clinically significant active chronic diseases, hepatometer (severe liver disorder, etc.), kidney (severe kidney disorder, etc.), and nervous system (hepatorespiratory tract patients). Parkinson's disease, immune system, respiratory system (asthenia, obstructive pulmonary disease, etc.), urinary system, digestive system (digestive ulcer, etc.), endocrine system, blood/tumor, cardiovascular system (cardiac infarction, heart failure, uncontrolled hypertension, atrioventricular junction disorder, etc.), or have a history.
2. A person who has a serious urinary tract infection due to renal tubular acidosis, etc. or has a history of history
3. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

Primary outcomes:
measure: Cmax of memantine and donpezil
timeFrame: from baseline to day 10
Secondary outcomes:
measure: AUClast of memantine and donpezil
timeFrame: from baseline to day 10
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hyundaipharm
Study officials:
References:
Clinical trial NCT03215979: Use of Platelet-enriched Plasma During Auricular Reconstruction
Official title: Use of Platelet-enriched Plasma to Improve the Percentage of Integration of the Cutaneous Graft During Second Stage of Auricular Reconstruction in Children Aged 8-12 Years; A Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ear Cartilage
Platelets
Microtia-Anotia
Lead sponsor: Hospital General Dr. Manuel Gea González
Sponsor class: OTHER_GOV
First posted: 2017-07-12
Enrollment: 36
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study investigators are trying to determine the benefits of using platelet enriched plasma during the second stage of auricular reconstruction. The intervention will be blinded to the surgeon and the surgical team. The main outcome will be the evaluation of the integration rate of the skin full thickness graft used to coat the auricular frame.


Eligibility criteria: Inclusion Criteria:

* Microtia Tanzer II-A
* patients aged 8-12 years
* Haemoglobin \> 10 gr/dL
* History of first stage of auricular reconstruction

Exclusion Criteria:

* associated endocrinopathies
* desnutrition (\<2.5 gr/ dL)

Primary outcomes:
measure: Integration rate (in percentage) of the full thickness split graft sued during the second stage of auricular reconstruction.
timeFrame: evaluation will be at day 10
Secondary outcomes:
measure: Complication
timeFrame: evaluation will be at day 10
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: Hospital General "Dr. Manuel Gea González"
Study officials:
References:
Clinical trial NCT01995279: Ear Acupuncture Reducing Pain and Improving Balance
Official title: The Effects of a Single Session of Ear Acupuncture in Pain Sensation and Body Balance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: low back pain
French Auriculotherapy
postural control
balance
posture
Lead sponsor: Universidade Cruzeiro do Sul
Sponsor class: OTHER
First posted: 2013-11-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present project is to examine the effects of single session of French ear acupuncture on pain sensation and on postural control in individuals with chronic low back pain.

We hypothesize that:

I) The application of French ear acupuncture at specific points to reduce low back pain would decrease pain intensity in patients with chronic low back pain.

II) The pain reduction would be greater for those individuals with low back pain who receive application of French ear acupuncture at specific points to reduce low back pain compared with patients who receive placebo treatment.

III) The application of French ear acupuncture at specific points to reduce back pain will have positive effect on the performance of the postural control system.


Eligibility criteria: Inclusion Criteria:

* Complaints of back pain lasting more than 12 weeks
* Pain referred larger than 4 according to the 11-points pain scale

Exclusion Criteria:

* No other musculoskeletal injury,
* Individuals diagnosed with structural damage
* Individuals who performed a spine surgery
* Individuals who have sensory abnormalities or dizziness.
* Individuals may not be in physical therapy for reducing low back pain.
* Painkillers or anti-inflammatories use 24 hours before the experimental procedure.

Primary outcomes:
measure: 11-point Short Pain Scale (SPS-11)
timeFrame: 20 minute
Secondary outcomes:
measure: Center of pressure sway area
timeFrame: 20 minute
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Laboratório de Análise do Movimento, Universidade Cruzeiro do Sul
state: SP
Study officials:
affiliation: Associate Professor, Universidade Cruzeiro do Sul
name: Paulo B de Freitas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ushinohama A, Cunha BP, Costa LO, Barela AM, Freitas PB. Effect of a single session of ear acupuncture on pain intensity and postural control in individuals with chronic low back pain: a randomized controlled trial. Braz J Phys Ther. 2016 Jul-Aug;20(4):328-35. doi: 10.1590/bjpt-rbf.2014.0158. Epub 2016 Jun 16.
Clinical trial NCT02220179: Resilience for Children and Young People in Foster Care and Residential Care in Denmark
Official title: Resilience for Children and Young People
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Children and Adolescents in Foster Care and Residential Care
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: TRYG Foundation
First posted: 2014-08-19
Enrollment: 9000
Sex: ALL
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this project we invite 9.000 children and young persons in Denmark and their foster parents and staff at the residential institutions to participate in a cluster randomized controlled intervention study where we aim to test the effectiveness of a web based knowledge and inspiration program about resilience for children, adolescents and adults (called myresilience.org). The complete CONSORT trial protocol is available at http://myresilience.org/ at the subsite 'about us'.

Detailed description: The complete CONSORT trial protocol is available at http://myresilience.org/ at the subsite 'about us'.

Eligibility criteria: Inclusion Criteria:

* All children and adolescents registered in foster care in Denmark on august 11th 2014.
* All children and adolescents registered in residential care in Denmark on august 11th 2014.

Exclusion Criteria:

• Request for legal protection against contacts from researchers.

Primary outcomes:
measure: National Test in Danish Reading
timeFrame: Outcome data will be collected on the average 2 years after intervention
Secondary outcomes:
measure: The frequency of Care collapse
timeFrame: Outcome data will be collected on the average 2 years after intervention
Other outcomes:
measure: Questionnaire data
timeFrame: data collected august 2015
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
Study officials:
affiliation: University of Aarhus
name: Poul L Bak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02781779: Comparison of Outcomes Between the Use of Silverlon® Dressing and AQUACEL® AG Dressing Post Cardiac Device Implant
Official title: Comparison of Outcomes Between the Use of Silverlon® Dressing and AQUACEL® AG Dressing Post Cardiac Device Implant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infections
Wounds and Injuries
Keywords: Cardiac Implantable Electronic Device
Implant
Lead sponsor: Kansas City Heart Rhythm Institute
Sponsor class: OTHER
First posted: 2016-05-24
Enrollment: 147
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: The purpose of this study is to learn how effective each of the two dressings, Silverlon® and AQUACEL® AG, are in preventing post cardiac implantable electronic devices (CIED) procedure wound infections.

Detailed description: This is a single center, prospective, 2-arm randomized, non-blinded study. A total of 100 participants will be assigned to the Silverlon arm and 100 to the AQUACEL AG arm.

The number of procedures to implant CIED has risen in recent years. With this rise has also brought a rise in post-procedure infections. Infections will happen and there is a continued need to improve all aspects of the surgery and post-operative care. Wound coverage with appropriate dressings is one aspect that needs to be studied in CIED implant patients. Silverlon and AQUACEL AG are two options of dressings available for these patients. This study will look to see if one of the two is a better option for post-operative CIED implant patients.

Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled for a CIED implant, generator change, or upgrade at the University of Kansas Hospital
* Able to give informed consent

Exclusion Criteria:

* Patients who are already on antibiotics for another reasons
* Immunocompromised patients such as those on immunosuppressant's and HIV positive patients
* Patients who are post device explant for lead infection
* Patients with an allergy to adhesive, silver or an allergy to the dressing(s) or their components

Primary outcomes:
measure: Pocket Hematoma, Moderate-Severe
timeFrame: 7-10 days post implant
Secondary outcomes:
measure: Wound Drainage
timeFrame: At time of dressing removal, up to 10 days post operative
measure: Pocket Dehiscence
timeFrame: At time of dressing removal, up to 10 days post operative
measure: Rash After Removal
timeFrame: At time of dressing removal, up to 10 days post operative
measure: Site Itching/Burning
timeFrame: At time of dressing removal, up to 10 days post operative
measure: Skin Erythema
timeFrame: At time of dressing removal, up to 10 days post operative
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Dhanunjaya Lakkireddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00120679: Treatment for Patients With Non-Small Cell Lung Cancer Who Developed Anemia Due to Chemotherapy
Official title: An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Patient With Non-Small Cell Lung Cancer Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Anemia
Keywords: non-small cell lung cancer
darbepoetin alfa
Amgen
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-07-19
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 validate a Patient Satisfaction Questionnaire for Anemia Treatment (PSQ-AT) in non small cell lung cancer patients treated with darbepoetin alfa or recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.


Eligibility criteria: Inclusion Criteria: - Subjects receiving multi-cycle chemotherapy for non-small cell lung cancer - Anemia due to chemotherapy (hgb less than or equal to 11.0 g/dL) - Expected to receive greater than or equal to 8 additional weeks of chemotherapy as part of their planned treatment - Karnofsky Performance Scale (KPS) greater than or equal to 50% - Adequate renal function - Adequate liver function Exclusion Criteria: - Iron deficiency - Unstable cardiac disease - Known positive test for human immunodeficiency virus (HIV) infection

Primary outcomes:
measure: Anemia correction
Secondary outcomes:
measure: Patient preference
measure: Activities of daily living
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Schwartzberg LS, Yee LK, Senecal FM, Charu V, Tomita D, Wallace J, Rossi G. A randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia in patients with breast, lung, or gynecologic cancer. Oncologist. 2004;9(6):696-707. doi: 10.1634/theoncologist.9-6-696.
Clinical trial NCT02510079: Emergent Expanded Access for ahSC Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury.
Official title: Emergent Expanded Access to Use Autologous Human Schwann Cell Augmentation of Nerve Autograft Repair in a Single Patient With Severe Peripheral Nerve Injury
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Sciatic Nerve Injury
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: The Miami Project to Cure Paralysis
First posted: 2015-07-28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT

Brief summary: The primary purpose of this research study is to determine the safety of injecting ones own Schwann cells to augment sural nerve autografts after a severe, non-lacerating injury to the sciatic nerve has occurred.

Detailed description: The secondary purpose of this research project is to evaluate whether transplanted Schwann cells can enhance recovery of sensory and motor function. Emergency expanded access for a single patient was granted, as the patient was an ideal candidate for sural nerve repair augmented by autologous Schwann cells which could be harvested from a relatively small segment of sensory nerve. The cells were expanded using cell culture techniques and placed along with the sural nerve grafts wrapped by an FDA approved collagen matrix (Duragen). This study is being conducted at the Jackson Memorial and the University of Miami health systems. As a research subject the patient will be in this study for a total of 5 years from the date receiving Schwann cell transplant augmentation of sural nerve autografts.

Eligibility criteria: Single patient with severe sciatic nerve injury enrolled under emergency request

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: W. Dalton Dietrich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00215579: Determining the Effects of Risperdal Consta in Patients With Psychotic Disorders and Incomplete Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Janssen, LP
First posted: 2005-09-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: As many as 75 percent of patients with schizophrenia have difficulty taking their oral medication on a regular basis. This may lead to worsening of symptoms. Clinicians commonly respond to these problems by adding adjunctive medications, despite the absence of systematic studies that support such practices. It is possible, however, that in many of these cases, the unstable course and/or unsatisfactory treatment response reflects incomplete adherence with the originally prescribed oral antipsychotic, rather than a need for adjunctive medications. This study will examine whether switching patients who demonstrate an unstable course and/or an unsatisfactory clinical response to a long-acting injectable preparation as the primary antipsychotic may enhance medication adherence and improve outcomes.


Eligibility criteria: Inclusion Criteria:

* Eligible patients will be male or female
* Between 18-65 years of age and will meet DSM-IV criteria for schizophrenia or schizoaffective disorder.
* The subject must have, in their physicians opinion, an unstable course and must have been treated with an oral antipsychotic.

Exclusion Criteria:

* Pregnant and breast feeding females will be excluded.
* Because fluoxetine is known to change the plasma level of CONSTA, subjects taking fluoxetine within two weeks of starting the study will be excluded.
* Patients who are known to have a hypersensitivity to oral Risperdal will be excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Butner
country: United States
facility: John Umstead Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: William H Wilson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02412579: Genetic Profiling of Liver Cancer in Patients Undergoing Liver Transplantation
Official title: Circulating MicroRNA Isoforms as Biomarkers in Hepatocellular Carcinoma and Associated Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: HCC
Liver Cancer
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2015-04-09
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: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hepatocellular Carcinoma Clinic Pre-Liver Transplant Clinic

Brief summary: The purpose of this study is to determine whether genetic markers unique to liver cancer are present and to assess usefulness as a diagnostic tool.

Detailed description: Hepatocellular carcinoma (HCC) is the most common form of liver cancer and a growing trend worldwide. Decision-making regarding treatment for patients is limited by the lack of clinically actionable biomarkers. This is pronounced in the case for determining and monitoring liver transplant recipients. In an effort to improve diagnosis, the use of circulating serum-based microRNA isoforms (isomiRs) can serve as non-invasive, screening biomarkers in HCC patients pre- and post-transplantation of the liver.

Eligibility criteria: Inclusion Criteria:

* Patients with the diagnosis of HCC who are on the wait list for liver transplantation
* Patients with the diagnosis of HCC who have been admitted to hospital, scheduled to undergo liver transplantation within the following 24 hours.
* Age Range: 18 to 75 years old

Exclusion Criteria:

* Patients with metastatic HCC and patients with the diagnosis of HCC who are not on the wait list for liver transplantation.
* Patients older than 75 years old and younger than 18 years old.
* Patients who are unable to consent.
* Pregnant patients.

Primary outcomes:
measure: Using next-generation sequencing methods to detect isomiRs across different HCC cohorts at all stages undergoing liver transplantation.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
affiliation: Annette C. & Harold C. Simmons Transplant Institute
name: Peter Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00885079: Confirmatory Study of OPC-12759 Ophthalmic Suspension
Official title: Confirmatory Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-04-21
Enrollment: 188
Sex: ALL
Minimum age (years): 20
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 verify whether OPC-12759 ophthalmic suspension is effective compared with active control in dry eye patients.


Eligibility criteria: Inclusion Criteria:

1. Out patient
2. Subjective complaint of dry eye that has been present for minimum 20 months
3. Ocular discomfort severity is moderate to severe
4. Corneal - conjunctival damage is moderate to severe
5. Unanesthetized Schirmer's test score of 5mm/5minutes or less
6. Best corrected visual acuity of 0.2 or better in both eyes

Exclusion Criteria:

1. Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca
2. Ocular hypertension patient or glaucoma patient with ophthalmic solution
3. Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study
4. Anticipated use of contact lens during the study
5. Patient with punctal plug
6. Any history of ocular surgery within 12 months
7. Female patients who are pregnant,possibly pregnant or breast feeding
8. Known hypersensitivity to any component of the study drug or procedural medications
9. Receipt of any investigational product within 4 months.

Primary outcomes:
measure: Change in Fluorescein Corneal Staining (FCS) Score From Baseline
timeFrame: Baseline, Weeks4
measure: Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline
timeFrame: Baseline, Weeks4
Secondary outcomes:
Other outcomes:
Locations:
city: Kagoshima
country: Japan
facility: Kyushu region
city: Matsuyama
country: Japan
facility: Chushikoku region
city: Nagoya
country: Japan
facility: Tokai region
city: Osaka
country: Japan
facility: Kansai region
city: Tokyo
country: Japan
facility: Kanto region
Study officials:
affiliation: OPCJ-DDO
name: Eiji Murakami
role: STUDY_CHAIR
References: