louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00483002: Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets
Official title: Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking Cessation
Keywords: A prospective and observational program to monitor use in real practice including efficacy of Varenicline in Korea.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-06
Enrollment: 3719
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy smokers

Brief summary: To monitor use in real practice including safety and efficacy of Champix tablets 0.5mg, 1mg medication for 12 weeks in smokers

Detailed description: No sampling method will be applied to this study.

Eligibility criteria: Inclusion Criteria:

* Subjects selected for this study are those who would have been prescribed Champix tablets by the physician according to the subject's condition in usual clinical practice.

Exclusion Criteria:

* None

Primary outcomes:
measure: Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than Week 7
timeFrame: Week 3 through Week 7
measure: Percentage of Participants With 7-day Point Prevalence From Week 7 to Less Than Week 11
timeFrame: Week 7 through Week 11
measure: Percentage of Participants With 7-day Point Prevalence for at Least Week 11
timeFrame: At least Week 11
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Ock M, Shin JS, Ra SW. Safety and Effectiveness of Varenicline in Korean Smokers: A Nationwide Post-Marketing Surveillance Study. Patient Prefer Adherence. 2022 Feb 15;16:413-426. doi: 10.2147/PPA.S344757. eCollection 2022.
Clinical trial NCT04505202: Effect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications
Official title: Effect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications in Patients With Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Associated Pneumonia
Tracheobronchitis
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ventilator-associated pneumonia and ventilator-associated treakeabronchitis in respiratory tract infections associated with ventilator are common infections in intensive care unit and cause significant morbidity, mortality and health expenditures in nosocomial infections. Adequate and effective oral care by nurses in intensive care patients, possible complications, intensive care unit stay in the intensive care unit and is very important in terms of mortality.

Detailed description: The aim of this study will (1) evaluate the effect of 0.12% chlorhexidine gluconate on ventilator-associated pneumonia, ventilator-associated treakeabronchitis, (2) determine the effect of preventing microorganism colonization, and (3) assess the mortality rate for each patient and the cost-effectiveness in the health expenditures.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Admission in critical care with in 24 hours
* Having an endotracheal tube

Exclusion Criteria:

* History of chlorhexidine allergy
* Duration of mechanichal ventilation less than 48 h
* Confirmed diagnosis of pneumonitis before admission in the ICU
* Transfer from another ICU
* Receiving chemotherapy or radiotherapy
* Patients with immunodeficiency
* Patients with tracheostomies
* Required specific oral hygiene procedures
* Facio-maxillary or dental trauma/surgery
* Being pregnant

Primary outcomes:
measure: Pathogen colonization change
timeFrame: change from baseline pathogen colonization at Day 3
measure: Oral assessment guide score change
timeFrame: at the time of admission into the study (day 0), at study day 2 and at day 3
measure: Clinical pulmonary infection score change
timeFrame: at the time of admission into the study (day 0), at study day 2 and at day 3
measure: rate of tracheobronchitis change
timeFrame: change from baseline the rate of tracheobronchitis at Day 3
Secondary outcomes:
measure: cost effectiveness
timeFrame: Day 30
measure: Mortality
timeFrame: Day 7 and Day 28
Other outcomes:
Locations:
city: Karabük
country: Turkey
facility: Karabük University Training and Research Hospital
state: Karabuk
Study officials:
References:
Clinical trial NCT02754102: Human Phototoxicity Test
Official title: Human Phototoxicity Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-04-28
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To determine the phototoxic potential of a topically applied article in human subjects.


Eligibility criteria: Inclusion Criteria:

* be male or female between the ages of 18 and 60 inclusive;
* be lightly pigmented (Fitzpatrick Skin Type I, II, III);
* have read and signed the written Informed Consent Form and have completed a HIPAA (Health Insurance Portability and Accountability Act) Authorization Form in conformance with 45CFR (Code of Federal Regulations ) Parts 160 and 164;
* be in general good health as determined by the subject's medical history and in the discretion of the investigator.

Exclusion Criteria:

* have a visible sunburn;
* have a history of sun hypersensitivity/photosensitivity or photosensitive dermatosis;
* must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product.
* have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products.

Primary outcomes:
measure: Intensity of skin reactions will be evaluated using the 5 point grading scale
timeFrame: Up to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05017402: Higher Dose of Alglucosidase Alpha for Pompe Disease
Official title: Higher Dose of Alglucosidase Alpha for Pompe Disease: Long-term Follow-up Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Glycogen Storage Disease Type II
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2021-08-23
Enrollment: 36
Sex: ALL
Minimum age (years): 0
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The observational population included patients of Pompe disease who were diagnosed and treated in our series.

Brief summary: This study is aimed to investigate that whether the higher dose ERT improve safety and clinical outcomes of Pompe disease patients. Also, wish to develop a new therapeutic recommendation and hope that it could improve the long-term outcomes of Pompe diesease patients.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Pompe disease
2. Currently receiving ERT with regular clinic visits
3. Agree to sign informed consent

Exclusion Criteria:

1. Lost follow-up for clinical visits
2. Allergy to Myozyme
3. Refuse to sign informed consent

Primary outcomes:
measure: Forced vital capacity
timeFrame: For patient older than 3-year-old, first test before study, then every six months, up to 2-years.
measure: Peak expiratory flow
timeFrame: For patient older than 3-year-old, first test before study, then every six months, up to 2-years.
measure: Polysomnography
timeFrame: For patient older than 6-month-old, first test before study, then every six months, up to 2-years.
Secondary outcomes:
measure: uGLC4
timeFrame: uGLC4 will be tested before the treatment, then every three months, up to 2-years.
measure: CK
timeFrame: CK will be tested before the treatment, then every three months, up to 2-years.
measure: AST
timeFrame: AST will be tested before the treatment, then every three months, up to 2-years.
measure: ALT
timeFrame: ALT will be tested before the treatment, then every three months, up to 2-years.
measure: Body weight
timeFrame: The body weight will be monitored before the treatment, then every two weeks, up to 2-years.
measure: Body height
timeFrame: The body height will be monitored before the treatment, then every two weeks, up to 2-years.
measure: Antibody titers
timeFrame: First test will be one month later after first ERT, then every six months, up to 2-years.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02889302: An Additional Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Official title: An Additional Phase III Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinocerebellar Degeneration
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-09-05
Enrollment: 203
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 investigate the superiority of KPS-0373 to placebo, and evaluate the safety of KPS-0373 in SCD patients.


Eligibility criteria: Inclusion Criteria:

* Japanese SCD patients with mild to moderate ataxia

Exclusion Criteria:

* Patients with secondary ataxia
* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Primary outcomes:
measure: SARA (Scale for the Assessment and Rating of Ataxia)
timeFrame: 24 weeks
Secondary outcomes:
measure: SF-8(QOL)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
name: Nobuo Kanai
role: STUDY_DIRECTOR
References:
citation: Nishizawa M, Onodera O, Hirakawa A, Shimizu Y, Yamada M; Rovatirelin Study Group. Effect of rovatirelin in patients with cerebellar ataxia: two randomised double-blind placebo-controlled phase 3 trials. J Neurol Neurosurg Psychiatry. 2020 Mar;91(3):254-262. doi: 10.1136/jnnp-2019-322168. Epub 2020 Jan 14.
Clinical trial NCT02048202: Medical Clowning in the NICU (Neonatal Intensive Care Unit and Their Effects on Parents and Staff
Official title: Effects of Medical Clowning (Dream Doctors) on the Development of the Nervous System and the Relationship Between Preterm Premature Baby Parents and NICU Staff
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature Neonate
Keywords: clown
neonate
premature
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
Collaborators: name: University of Haifa
First posted: 2014-01-29
Enrollment: 60
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature neonates 32 weeks gestation

Brief summary: The study will compare intervention by Infant Aquatics to infant massage. The intervention in both methods will start at 36 weeks gestational age for 3 months and will consist of sessions with a therapist every 2 weeks. Development will be assessed and compared at 3, 8 and 18 months using Infant Motor Pattern method, Griffith developmental scales and Vineland adaptive behavior scales.

Detailed description: Preterm infants, a continuously growing population, are at high risk for neurodevelopment impairments ranging from minor neurological dysfunction (MND) to cerebral palsy (CP), mainly due to developmental brain injury. Infant Aquatics have been found to benefit and promote infant development. The support and sensory stimulation of the water may improve the development the sensory, motor, as well as, autonomic system of preterm infants.

Eligibility criteria: Inclusion Criteria:

* neonates wherein their parents have expressed consent to participate in trail
* neonates with parents who are able to understand and fill in questioners
* neonates with no chromosomal deficiencies and no genetic deficiency

Exclusion Criteria:

* neonates with parents who are unable to understand and fill in questioners
* neonates with intraventricular bleeding IVH/PVH
* neonates with periventricular hemorrhage
* neonates with known chromosomal deficiencies or genetic deficiency

Primary outcomes:
measure: ◦Developmental assessment - a composite of several measures
timeFrame: ◦Time Frame: 3 month
Secondary outcomes:
measure: Developmental assessment - a composite of several measures
timeFrame: ◦◦Time Frame: 18 month
Other outcomes:
Locations:
city: Tiberias
country: Israel
facility: The Baruch Padeh Medical Center - Poria
Study officials:
affiliation: The Baruch Padeh Medical Center - Poria
name: Shay Barak, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Baruch Padeh Medical Center - Poria
name: Amir Kushnir, MD
role: STUDY_CHAIR
affiliation: University of Haifa
name: Hagit Friedman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03580902: CBT4CBT for Office Based Buprenorphine
Official title: A Method to Increase Buprenorphine Treatment Capacity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Opioid-use Disorder
Lead sponsor: CBT4CBT, LLC
Sponsor class: INDUSTRY
First posted: 2018-07-10
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: In this Phase II SBIR/STTR project, our Specific Aim will be to determine if the use of CBT4CBT-Buprenorphine leads to clinically significant improved outcomes and increased retention for buprenorphine maintenance patients in a larger and diverse population of individuals seeking buprenorphine treatment in primary care (N=100).

Detailed description: In this phase, 100 individuals entering buprenorphine maintenance at the primary care clinic (Central Medical Unit, CMU) will be randomized to either (1) standard buprenorphine maintenance in which counseling is offered on site, or (2) standard buprenorphine maintenance with CBT4CBT-Buprenorphine substituting for on-site counseling. This will be a 12-week trial.

Eligibility criteria: Inclusion Criteria:

* Meets current Diagnostic Statistical Manual (DSM-5) criteria for opioid use disorder
* Requesting buprenorphine maintenance treatment at Central Medical Unit of the APT Foundation

Exclusion Criteria:

* Unstabilized psychotic disorder
* Currently suicidal or homicidal
* Current cocaine, benzodiazepine, or alcohol use disorder.
* Any history of PCP (phencyclidine) use.
* Pregnant or lactating
* Any other physical or mental condition that would contraindicate office-based buprenorphine maintenance treatment.

Primary outcomes:
measure: Percent of urine toxicology screens that are negative for opioids by group.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Central Medical Unit of the APT Foundation
state: Connecticut
Study officials:
affiliation: APT Foundation, Inc.
name: Julia Shi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04284202: PD-1 Combined With Dasatinib for as Third-line Treatment for ARID1A Mutation Advanced NSCLC
Official title: PD-1 Combined With Dasatinib for as Third-line Treatment for ARID1A Mutation Advanced NSCLC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: NSCLC Stage IV
ARID1A
PD-1
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evalute the efficacy and safety of PD-1 antibody combined with Dasatinib as third-line therapy for NSCLC patients with ARID1A mutation until disease progression or intolerable toxicity or patients withdrawal of consent. The target sample size is 30+individuals. The primary endpoint of this study is PFS、ORR、OS and the secondary endpoint is toxicity.


Eligibility criteria: Inclusion Criteria:

- 1. Provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures 2. over 18 years old 3. Metastatic (stage IV) NSCLCwith ARID1A mutation underwent 2 lines of prior treatment.

4. World Health Organization (WHO) performance status 0-2 5. Adequate bone marrow reserve and organ function as demonstrated by complete blood count, biochemistry in blood and urine at baseline 6. ECG recording at baseline showing absence of any cardiac abnormality as per exclusion criterion #5 7. Female patients of childbearing potential must be using adequate contraceptive measures must not be breast feeding, and must have a negative pregnancy test prior to start of dosing.

Exclusion Criteria:

- 1. Subjects with known EGFR and ALK mutations are excluded. 2. Subjects with untreated CNS metastases are excluded 3. Subjects with an active, known or suspected autoimmune disease. 4. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody or any other antibody targeting T cell co-regulatory pathways.

5. Prior therapy with Dasatinib 6. Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results.

Primary outcomes:
measure: Progression Free Survival
timeFrame: Event driven, an expected average of 6 months
Secondary outcomes:
measure: Overall survival(OS)
timeFrame: An expected average of 24months
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
Study officials:
References:
Clinical trial NCT01686802: Post-operative Oral Morphine Versus Ibuprofen
Official title: Oral Morphine Versus Ibuprofen for Post-operative Pain Management in Children: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-operative Pain
Keywords: oral morphine
ibuprofen
post-operative pain
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 132
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children 5-17 years of age who have undergo orthopedic day surgical procedures for definitive management of fractures, tendon release, etc. will be randomized to receive either ibuprofen or oral morphine as needed for pain relief for 48 hours post-operatively at home. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We hypothesize that oral morphine will result in significantly lower pain scores on the Faces Pain Scale Revised (FPS-R) compared to ibuprofen. It is hoped that the results of this trial will create a new option for post-operative pain management in children.


Eligibility criteria: Inclusion Criteria:

* all children aged 5-17 years who undergo an elective orthopedic or fracture-related surgical procedure at the Children's Hospital in London, Ontario and have a same-day discharge.

Exclusion Criteria:

* known hypersensitivity to either ibuprofen or morphine
* chronic users of NSAIDS or opioids
* cognitive impairment
* poor English fluency
* pregnancy
* acute or chronic renal insufficiency
* bleeding disorder
* obstructive sleep apnea

Primary outcomes:
measure: Change in faces pain score pre and post intervention
timeFrame: 48 hours from the time of discharge from hospital.
Secondary outcomes:
measure: Change in faces pain score pre and post intervention
timeFrame: 48 hours from the time of discharge from hospital
measure: Adverse effects
timeFrame: 96 hours from first dose of intervention
measure: Number of participants requiring acetaminophen for breakthrough pain
timeFrame: 48 hours from first dose of intervention
measure: Unscheduled visits to a health care provider for pain
timeFrame: 96 hours from first dose of intervention
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Science Center
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Naveen Poonai, MSc MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Poonai N, Datoo N, Ali S, Cashin M, Drendel AL, Zhu R, Lepore N, Greff M, Rieder M, Bartley D. Oral morphine versus ibuprofen administered at home for postoperative orthopedic pain in children: a randomized controlled trial. CMAJ. 2017 Oct 10;189(40):E1252-E1258. doi: 10.1503/cmaj.170017.