louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04418388: Pharmacokinetics and Safety of PBK-1801 After Single Oral Administration in Healthy Korean Women
Official title: A Single Center, Open-label Clinical Trial to Evaluate Pharmacokinetic Characteristics and Safety of PBK-1801 After Single Oral Administration in Healthy Korean Women Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Pharmbio Korea Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-05
Enrollment: 36
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the pharmacokinetic characteristics after a single dose of oral PBK-1801 in healthy Korean women for preparing the bridging data for Koreans.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) between 19 and 30 kg/m²
* Subjects are to be in good general health according to medical history, physical examination, electrocardiograph (ECG) recording and clinical laboratory assessments showing no signs clinically significant pathology (A subject with a clinically insignificant abnormality may be included by the discretion of the investigator)
* Subjects are to have given their written informed consent to participate in the study and to abide by study restrictions

Exclusion Criteria:

* History or evidence of clinically significant cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, psychiatric or other major disease
* Subjects who have any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract other than uncomplicated appendectomy, inflammatory bowel disease).
* History or current alcohol abuse or drug addiction
* Subjects who for any reason, are deemed by the Investigator to be inappropriate for this study

Primary outcomes:
measure: Cmax
timeFrame: 5 days
measure: AUClast
timeFrame: 5 days
measure: AUCinf
timeFrame: 5 days
measure: Tmax
timeFrame: 5 days
measure: T1/2
timeFrame: 5 days
measure: CL/F
timeFrame: 5 days
measure: Vd/F
timeFrame: 5 days
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 30 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: SeungHwan Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02819388: Evaluation of a Contraceptive Counseling Intervention in Deprived Neighborhoods: SIRIAN Randomized Controlled Trial
Official title: Evaluation of a Counseling Intervention to Improve Contraceptive Use in Deprived Neighborhoods: SIRIAN Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: randomized control trial; contraception; inequalities
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 500
Sex: ALL
Minimum age (years): 14
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the effects of a community-based counseling intervention to improve contraception among residents in two deprived neighborhoods in Barcelona (Spain). Half of the participants received contraceptive counseling at the community setting, while the other half acted as a control group.

Detailed description: To evaluate the effects of a community-based counseling intervention to improve contraception among residents in deprived neighborhoods a randomized controlled trial is performed. Women aged 14-49 years and men aged 14-39 years from two low income neighborhoods in Barcelona (Catalonia, Spain) who had not undergone an irreversible contraceptive method and aren't planning a pregnancy have been recruited in 2011-13. The intervention consists of a culturally developed and theoretically-based brief counseling in community settings. The primary outcome is the consistent use of very effective contraceptive methods (optimal use). Secondary outcomes analyzed are the incorrect use of very effective contraceptive methods and use of less effective methods stratified by sex and migrant status. Differences within subgroups from baseline to 3 months - follow up are analyzed and intervention effects are assessed with adjusted robust Poisson regressions.

Eligibility criteria: Inclusion Criteria:

* Women living in the selected neighbourhoods aged 14-49 years
* Men living in the selected neighbourhoods aged 14-39 years

Exclusion Criteria:

* Having undergone an irreversible contraceptive method
* Whishing or planning a pregnancy in the next year

Primary outcomes:
measure: Number of participants using consistently effective contraceptive methods (optimal use) assessed by questionnaire
timeFrame: Three months after the baseline
Secondary outcomes:
measure: Number of participants inconsistently using effective methods assessed by questionnaire
timeFrame: Three months after the baseline
measure: Number of participants using less effective methods (withdrawal and periodic abstinence) assessed by questionnaire
timeFrame: Three months after the baseline
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Agència de Salut Pública de Barcelona
state: Catalonia
Study officials:
affiliation: Agència de Salut Pública de Barcelona - Barcelna Public Health Agency
name: Elia Diez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04567888: Testing a Digital Intervention for Adolescents
Official title: Testing a Digital Intervention for Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rumination
Stress, Psychological
Lead sponsor: Happify Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-29
Enrollment: 353
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.
Primary purpose: OTHER

Brief summary: Teen participants (ages 13-17) will be randomly assigned to either an experimental (the Happify Teens digital platform), or a waitlist control group. The study includes an 8-week intervention period and a 1-month follow up period.

Detailed description: Teen participants (ages 13-17) will be randomly assigned to either the experimental group in which participants receive access to Happify Teens, a digital platform rooted in several therapeutic traditions that aims to improve wellbeing, or a waitlist control group. Both group conditions last 8 weeks. Participants assigned to the Happify Teens platform will have full access to the intervention, with featured tracks that focus on dealing with stress, worries and building skills for greater happiness. Participants assigned to the waitlist (control) condition will not have access to the Happify Teens platform for the full study period (12 weeks total). Participants in the waitlist control will receive access to Happify Teens after the full study period is complete (12 weeks). Perceived stress, rumination, and optimism will be assessed via self-report at baseline, end of the 8-week intervention, and at 1 month post intervention.

Eligibility criteria: Inclusion Criteria:

* 13-17 years of age
* US resident
* Perceived Stress Scale Score ≥ 10
* Ruminative Responses Scale Score ≥ 14
* Ability and willingness to complete study activities
* Willingness and access to using a digital intervention via mobile application or web browser

Exclusion Criteria:

* Current or past user of any Happify platform
* Non-US Resident
* Perceived Stress Scale Score \< 10
* Ruminative Responses Scale Score \< 14

Primary outcomes:
measure: Change in Perceived Stress [Perceived Stress Scale (PSS)]
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes:
measure: Change in Rumination [Ruminative Responses Scale (RRS)-Short Form-Brooding Subscale]
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Happify (an online platform -- study is entirely online)
state: New York
Study officials:
affiliation: Happify Inc.
name: Eliane Boucher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boucher EM, Ward HE, Stafford JL, Parks AC. Effects of a Digital Mental Health Program on Perceived Stress in Adolescents Aged 13-17 Years: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Apr 19;10(4):e25545. doi: 10.2196/25545.
Clinical trial NCT02769078: Replication Of An Early Evaluation Of 30-Day Readmissions Among Nonvalvular Atrial Fibrillation Patients Treated With Dabigatran, Rivaroxaban, Apixaban, or Warfarin In The U.S
Official title: Replication Of An Early Evaluation Of 30-Day Readmissions Among Nonvalvular Atrial Fibrillation Patients Treated With Dabigatran, Rivaroxaban, Apixaban, or Warfarin In The U.S
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Anticoagulation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-05-11
Enrollment: 14201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received any of the NOACs, dabigatran, rivaroxaban, apixaban, or warfarin during any time of the hospitalization (from admission to discharge)

Brief summary: The overall objective of this proposal is to execute a real-world database analysis to evaluate hospital readmissions among hospitalized nonvalvular atrial fibrillation (NVAF) patients in the U.S.


Eligibility criteria: Inclusion Criteria:

* Have a primary or secondary diagnosis of AF identified by International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes from the Cerner Health Facts hospital database between January 1, 2012 and August 31, 2014
* Age 18 years or older as of initial hospitalization with AF diagnosis

Exclusion Criteria:

* Have any primary or secondary diagnosis code or procedure code for valvular disease during the study period. This exclusion criterion is consistent with that used in other previous BMS Health Economics and Outcomes Research (HEOR) studies and is used to ensure that the study populations are NVAF patients
* Received multiple types of NOACs during the index hospitalization. Preliminary analysis showed that very few patients receive multiple types of NOACs during the same hospitalization. This exclusion criterion will allow to cleanly group patients into the different New oral anticoagulant (NOAC) usage groups

Primary outcomes:
measure: Proportion of NVAF patients with bleeding-related hospital readmissions from inpatient hospitalization records collected from the Cerner Health Facts hospital database
timeFrame: January 1, 2012 to August 31, 2014
Secondary outcomes:
measure: Cost associated with bleeding-related hospital readmissions from inpatient hospitalization records collected from the Cerner Health Facts hospital database
timeFrame: January 1, 2012 to August 31, 2014
measure: Proportion of NVAF patients with all cause hospital readmissions and the associated costs from inpatient hospitalization records collected from the Cerner Health Facts hospital database
timeFrame: January 1, 2012 to August 31, 2014
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01842178: Endometrial Scratching in In Vitro Fertilization Cycles With Oocyte Donation
Official title: Randomized Prospective Study of Endometrial Injury in In Vitro Fertilization Cycles With Oocyte Donation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Subfertility
Lead sponsor: Centro de Infertilidad y Reproducción Humana
Sponsor class: OTHER
First posted: 2013-04-29
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the potential benefit in pregnancy rates produced by an endometrial scratching made in an IVF cycle prior to embryo transfer in patients with donated oocytes.

Detailed description: This is a randomized, comparative, prospective, double Blind study.

The First stage of this study consists of revising the patients medical records to identify possible candidates. Patients indicated are randomized into two groups: experimental and control. They are followed up to 12 week of pregnancy.

Eligibility criteria: Inclusion Criteria:

* Do IVF cycle with donor eggs
* Will adjust to protocol for the study.
* Have signed informed consent

Exclusion Criteria:

* Clinically significant systemic disease, hypothalamic or pituitary tumors
* ovarian, uterine or breast cancer
* hormonal abnormalities and / or medical , biochemistry, hematology pathology, which might interfere with gonadotropin treatment.
* known positivity for human immunodeficiency virus (HIV), hepatitis C or B virus (HCV / HBV) of the candidate or her partner.
* Uterine Factor(submucosal fibroids, intramural fibroids\> 4 cm)
* Hydrosalpinx
* Patients receiving immune treatment
* Positive Diagnosis Thrombophilia
* preimplantation genetic diagnosis needed
* In case of using marital sperm are excluded the following patients:Altered male karyotype, Altered Meiosis in testicular biopsy, Altered FISH, sperm Fragmentation\> 45%
* Pregnancy contraindication
* Known allergy to preparations containing estrogens or any of its excipients.
* Simultaneous participation in another clinical trial with medication.
* Do not want or can not adjust to study protocol.

Primary outcomes:
measure: biochemical pregnancy
timeFrame: 14-16 days post-follicular punction
Secondary outcomes:
measure: Clinical pregnancy
timeFrame: 6 pregnancy weeks
Other outcomes:
measure: Evolutionary pregnancy
timeFrame: 12 weeks of pregnancy
measure: abortion
timeFrame: 6-12 week of pregnancy
Locations:
city: Barcelona
country: Spain
facility: Centro de Infertilidad y Reproducción Humana
Study officials:
affiliation: Centro de Infertilidad y Reproducción Humana
name: miguel angel checa, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03441178: A Prospective, Multi-Center Evaluation of the ENSEAL X1 Large Jaw Tissue Sealer
Official title: A Prospective, Multi-Center Evaluation of the ENSEAL X1 Large Jaw Tissue Sealer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colectomy; Gynecological; Thoracic
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2018-02-22
Enrollment: 101
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: This prospective, single-arm, multi-center, evaluation will collect clinical data in a post-market setting. The three types of procedures studied will be colectomy, gynecological, and thoracic. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ENSEAL X1 instructions for use.

Detailed description: The primary objective of this study is to prospectively generate device specific clinical data related to hemostasis in a post-market setting using the ENSEAL X1 per its instructions for use. There will be no blinding or planned interim analysis in this study.

Eligibility criteria: Inclusion Criteria:

1. Elective procedure (colectomy, gynecological, or thoracic) where at least one vessel is planned to be transected by the ENSEAL X1 device per its instructions for use;
2. Willingness to give consent and comply with all study-related evaluations and treatment schedule; and
3. At least 18 years of age.

Exclusion Criteria:

1. Physical or psychological condition which would impair study participation; or
2. Enrollment in a concurrent clinical study.

Primary outcomes:
measure: Percent of Vessels Where Hemostasis (<= Grade 3) is Achieved Using ENSEAL X1
timeFrame: Intraoperative, after vessel has been transected
Secondary outcomes:
measure: Hemostasis Grading Assessment for Each Vessel Transection
timeFrame: Intraoperative, after vessel has been transected
measure: Number of Grade 3 Vessels Needing ENSEAL X1 Touch-up
timeFrame: Intraoperative, after vessel has been transected
measure: Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used
timeFrame: Intraoperative, after vessel has been transected
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital
Study officials:
affiliation: Indiana University
name: Bruce Robb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03931278: Sonification Embodied Associations
Official title: Investigating Auditory Sonification (Melodic and Single Tones) and Visual Real-time Feedback as a Tool for Embodied Associations, and Its Effects on Learning and Balance in Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: University Ghent
name: Revalidatie & MS Centrum Overpelt
name: National MS Center Melsbroek
First posted: 2019-04-30
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this study to investigate, if learning and recall of a sequence of body movements (steps that realize a pattern on the ground) can be improved by self-produced music (having particular melodic-structures in relation to the pattern), compared to the same sound (a single tone) for each pattern in persons with multiple sclerosis compared to age and gender matched controls


Eligibility criteria: Inclusion Criteria:

* Time up and Go (TUG) test: 8 sec -- \> 21 sec

Exclusion Criteria:

* cognitive impairment hindering the understanding and execution of the experimental procedures,
* pregnancy,
* hearing impairment,
* amusia
* beat deafness,
* colour blindness.

Primary outcomes:
measure: accuracy
timeFrame: week 1
measure: precision
timeFrame: week 1
Secondary outcomes:
measure: Inter Step intervals
timeFrame: week 1
measure: Inter Stride intervals
timeFrame: week 1
measure: step duration on the tile
timeFrame: week 1
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Ghent
city: Melsbroek
country: Belgium
facility: National MS Center Melsbroek
city: Overpelt
country: Belgium
facility: Revalidatie en MS Centrum Overpelt
Study officials:
affiliation: Hasselt University
name: peter Feys, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: lousin Moumdjian
role: STUDY_CHAIR
References:
Clinical trial NCT02091778: Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU When Using Fast Gelling Dressing as Intended.
Official title: Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU When Using Fast Gelling Dressing as Intended.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcers
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2014-03-19
Enrollment: 21
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 primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of fast gelling dressing when used as intended in Diabetic Foot Ulcer (DFU).

The primary endpoint will be Changes from baseline in the condition of the peri-wound skin measured by the following variables; maceration, redness/irritation, rash/eczema, blistering, dermatitis, skin stripping, trauma to wound edges and product degradation on the skin


Eligibility criteria: Inclusion Criteria:

1. Both gender ≥18 years old.
2. Subjects with type 1 or 2 diabetes mellitus.
3. Texas Grade A1 or 2, C1 or 2
4. Exuding diabetic foot ulcer
5. Ulcer localisation; below the ankle
6. Signed Informed Consent.

Exclusion Criteria:

1. Known allergy/hypersensitivity to the dressing.
2. HbA1c ≥ 10% (86 mmol/mol) (most recent value within 3 months)
3. Wound infection requiring systemic treatment
4. Subjects who will have problems following the protocol.
5. Subjects included in other ongoing clinical investigation at present or during the past 30 days.
6. Toe pressure less than 70 mmHg
7. Clinical suspicion of osteomyelitis (based on probe to bone/radiological changes)
8. Dry wounds

Primary outcomes:
measure: Change in Peri-wound Skin
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Salford
country: United Kingdom
facility: Salford Royal Hospital (NHS) Foundation Trust
Study officials:
References:
Clinical trial NCT02072278: Electroencephalography Study Investigating the Effects of Vortioxetine in Healthy Male Subjects
Official title: Interventional, Randomised, Double-blind, Placebo-controlled, Active Comparator, Four-way Crossover Electroencephalography Study Investigating the Effects of Vortioxetine (Lu AA21004) in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Men
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2014-02-26
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To explore a neurophysiological marker (electroencephalography) of cognitive effect of vortioxetine


Eligibility criteria: Inclusion Criteria:

* The subject has a normal resting EEG at screening visit
* The subject is able to perform tasks with an auditory stimulus
* The subject is not visually impaired - normal prescription glasses are accepted
* The subject has a normal circadian rhythm, defined as a person who usually wakes between 6:00 and 9:00 a.m. and goes to sleep between 9:00 pm and midnight.

Exclusion Criteria:

* The subject has worked shifts, including night duty, or has travelled across \>3 time zones \<2 weeks prior to the first dose of IMP.

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Battery of EEG measurements
timeFrame: The EEG task battery will be conducted on Days -1 and starting 6 hours post-dose on Days 1 and 3 of each treatment period.
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: FR801
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: