louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03350373: Clinical Pharmacology of FYU-981 (Final Formulation)
Official title: Clinical Pharmacology Study of Final Formulation of FYU-981 Administered to Healthy Male Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Mochida Pharmaceutical Company, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Fuji Yakuhin Co., Ltd.
First posted: 2017-11-22
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a randomized, open-label, 2-period crossover study. The purpose of this study is to assess the pharmacokinetics and safety after single oral administration of final formulation of FYU-981 to healthy male adults in fasted and fed conditions. Participants are randomized to fasted (n=6) or fed conditions (n=6) in each step. The effect of food to pharmacokinetics of FYU-981 is also investigated.


Eligibility criteria: Inclusion Criteria:

* Japanese healthy adult subjects
* Body mass index: \>=18.5 and \<25.0

Exclusion Criteria:

* Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study

Primary outcomes:
measure: Pharmacokinetics (Cmax: Maximum plasma concentration)
timeFrame: 48 hours
measure: Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
timeFrame: 48 hours
measure: Pharmacokinetics
timeFrame: 48 hours
measure: Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
timeFrame: 48 hours
measure: Pharmacokinetics (CLtot/F: Total clearance/Fraction of dose absorbed)
timeFrame: 48 hours
measure: Pharmacokinetics (kel: Elimination rate constant)
timeFrame: 48 hours
measure: Pharmacokinetics (Vd/F: Distribution volume/Fraction of dose absorbed)
timeFrame: 48 hours
measure: Pharmacokinetics (MRT: Mean residence time)
timeFrame: 48 hours
measure: Safety (Incidence of treatment-emergent adverse events)
timeFrame: 13 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hachiōji
country: Japan
facility: P-One Clinic
state: Tokyo
Study officials:
affiliation: Clinical Research Department
name: Katsuaki Nagasawa
role: STUDY_DIRECTOR
References:
Clinical trial NCT00968773: Rebound Hernia Repair Device Mesh Trial
Official title: Rebound Hernia Repair Device Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Inguinal Hernia
Keywords: inguinal hernia
mesh
hernia repair device
Lead sponsor: Minnesota Medical Development, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Kentucky
name: Ohio State University
First posted: 2009-08-31
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a post-market study of the Rebound Hernia Repair Device to further establish the safety, efficacy, and utility of the Rebound Hernia Repair Device in a controlled population. The Rebound Hernia Repair Device will be used for its approved indication in comparison to "standard" hernia mesh. Two-way students t-tests, Chi squared analysis and ANOVA will be used to detect differences in variables. The study is sufficiently powered to detect a 25% difference.

The study data will include quality of life assessments, visual analogue scale , SF-36, Carolinas Comfort Scale), recurrence of hernia (technical failure), use of medications (pain) and complications/adverse events.


Eligibility criteria: Inclusion Criteria:

* 18 to 80 years of age
* Unilateral or bilateral inguinal hernia (moderate in size), primary in nature

Exclusion Criteria:

* Unable to provide informed consent
* Assessed as ASA 3 or 4
* Renal failure;creatinine greater than 2.0mg percent
* Ascites as determined by clinical suspicion/ultrasound confirmation
* Known pregnancy
* Femoral hernias
* Diabetes requiring injectable insulin
* Prior lower abdominal surgery through lower midline or Pfannenstiel incision
* TAPP approach
* Requiring anticoagulants during surgery
* Participation in another study involving another device or drug
* Emergent procedures for hernia incarceration and strangulation
* Recurrent inguinal hernias

Primary outcomes:
measure: Presence of hernia recurrence
timeFrame: 2 years
Secondary outcomes:
measure: Pain and discomfort to patients using VAS
timeFrame: 2 years
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Dept. Of Surgery
state: Kentucky
city: Columbus
country: United States
facility: The Ohio State Medical Center, Dept. of Surgery
state: Ohio
Study officials:
affiliation: University of Kentucky
name: John S Roth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Jeffrey W Hazey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01926873: A Screening Study To Assess The Cognition Status in Healthy Volunteers
Official title: MULTI-CENTER COGNITION ASSESSMENT IN HEALTHY SUBJECTS TO COLLECT REFERENCE DATA FOR COMPARISON TO PATIENTS WITH DEPRESSION
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-08-21
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: This multi-center screening study will conduct a cognition assessment to collect reference data for comparison to patients with depression in healthy volunteers. Data will be collected for 6 weeks.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers, 18 to 65 years of age, inclusive
* Healthy volunteers with a stable chronic disease that is not associated with cognitive deficits (e.g. asthma) and does not require any treatment known to affect cognition have to be discussed with the medical monitor before enrollment
* A body mass index between 18 to 30 kg/m2 inclusive
* Able to participate and willing to give written informed consent and to comply with the study restrictions
* At least second generation resident in the country of origin

Exclusion Criteria:

* Current or past history of a psychiatric disorder
* Family history of psychiatric disorders
* Suspicion or evidence of regular consumption of drugs of abuse or a positive drug test at the screening visit
* Acute or chronic disorder which is not stable or may affect cognition or needs treatment affecting cognition
* Change of smoking behavior or smoking cessation therapy within 30 days before screening visit
* Positive result on hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) 1 and 2
* Systolic blood pressure greater than 140 or less than 90 mm Hg, and diastolic blood pressure greater than 100 or less than 50 mm Hg
* Resting Pulse Rate greater than 100 or less than 45 beats per minute
* Clinically significant abnormalities in laboratory test results or in ECG assessment at screening visit
* Participation in an investigational drug study within 1 month prior to baseline

Primary outcomes:
measure: Cognitive status of volunteers
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
city: Atlanta
country: United States
state: Georgia
city: Oak Brook
country: United States
state: Illinois
city: Cedarhurst
country: United States
state: New York
city: Salt Lake City
country: United States
state: Utah
city: Freiburg
country: Germany
city: Mainz
country: Germany
city: Mannheim
country: Germany
city: Schwerin, Mecklenburg-Vorpommern
country: Germany
city: Bialystok
country: Poland
city: Choroszcz
country: Poland
city: Tuszyn
country: Poland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00296673: Reactive Neuromuscular Training Effects on Side Bridge Endurance Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance
Keywords: Rehabilitation, Side Bridge test, Muscular endurance
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2006-02-27
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of reactive neuromuscular training on muscular endurance test.


Eligibility criteria: Inclusion Criteria:

Healthy participants with no history of balance problems, ages 20 - 40.

Exclusion Criteria:

1. Lower extremity injury, surgery, visual, or vestibular condition that would effect balance?
2. Unstable joints of the lower extremity infections, injuries or other malignancies affecting the lower extremity?

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan College of Chiropractic
state: Missouri
Study officials:
affiliation: Logan College of Chiropractic
name: Dennis E. Enix, DC
role: PRINCIPAL_INVESTIGATOR
affiliation: Logan College of Chiropractic
name: Rodger E. Tepe, PhD
role: STUDY_DIRECTOR
References:
citation: Visser JE, Bloem BR. Role of the basal ganglia in balance control. Neural Plast. 2005;12(2-3):161-74; discussion 263-72. doi: 10.1155/NP.2005.161.
citation: Delecluse C, Roelants M, Verschueren S. Strength increase after whole-body vibration compared with resistance training. Med Sci Sports Exerc. 2003 Jun;35(6):1033-41. doi: 10.1249/01.MSS.0000069752.96438.B0.
citation: Jemmett RS, Macdonald DA, Agur AM. Anatomical relationships between selected segmental muscles of the lumbar spine in the context of multi-planar segmental motion: a preliminary investigation. Man Ther. 2004 Nov;9(4):203-10. doi: 10.1016/j.math.2004.07.006.
citation: Chiang J, Potvin JR. The in vivo dynamic response of the human spine to rapid lateral bend perturbation: effects of preload and step input magnitude. Spine (Phila Pa 1976). 2001 Jul 1;26(13):1457-64. doi: 10.1097/00007632-200107010-00016.
citation: Shiavi RG, Champion SA, Freeman FR, Bugel HJ. Efficacy of myofeedback therapy in regaining control of lower extremity musculature following stroke. Am J Phys Med. 1979 Aug;58(4):185-94.
Clinical trial NCT05481073: UV Sensor in Patients With Actinic Keratosis
Official title: Pilot Feasibility Study of Using UV Sensor in Patients With Actinic Keratosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratosis, Actinic
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2022-08-01
Enrollment: 10
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-hospitalized patients routinely seen in dermatology outpatient clinics who meet the inclusion criteria will be offered the possibility of participating in the study.

Brief summary: To validate the use of Ultraviolet (UV) radiation sensor in patients with actinic keratosis, to identify barriers to its use in prospective longitudinal studies.

Detailed description: To prevent both acute and chronic damage from exposure to UV A and UV B radiation. Personal UV exposure can be assessed by portable sensors. Having an accurate awareness of one's own behavior (assessed by the accuracy of the UV sensor), can motivate and engage with skin protection.

Eligibility criteria: Inclusion Criteria:

\>=65 years presenting actinic keratosis on scalp and/or face

Exclusion Criteria:

Patients who, due to health problems or lifestyle habits, do not expose themselves regularly to UV radiation (outdoor) for at least one hour a day.

Primary outcomes:
measure: QOL UV sensor
timeFrame: Up to week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Dermatology Unit (Hospital Clinic)
Study officials:
References:
Clinical trial NCT04598373: Effects of Interdisciplinary Treatment on Sickness Absence in Patients With Chronic Pain
Official title: Effects of Interdisciplinary Treatment on Sickness Absence in Patients With Chronic Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: Dalarna University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: Forte
First posted: 2020-10-22
Enrollment: 25000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that visited a Swedish SQRP-affiliated IDT specialist clinic.

Brief summary: Chronic pain is a globally prevalent condition that causes enormous social costs; largely due to sickness absence. A common intervention for patients with chronic pain problems is interdisciplinary treatment (IDT), which consists of a combination of physical exercise, cognitive behavioural therapy and work training coordinated in an interdisciplinary team. Based on data from Swedish National Registers, this study evaluates the effects of IDT on sickness absence.

Detailed description: This is a completely register-based observational cohort study. The study population is defined from the Swedish Quality Registry for Pain Rehabilitation (SQRP), which routinely aggregates data from specialist IDT pain management clinics across Sweden. SQRP contains information on the exposure/intervention: whether a patient that visited a SQRP-affiliated clinic was allocated to an IDT program (test) or not (control); t0 defined as the day of the IDT assessment. Microdata from SQRP is linked to other Swedish registers via the unique personal identification number held by all Swedish residents. Outcome data is obtained from the Swedish Social Insurance Agency. Registers managed by the National Board of Health and Welfare include data on dispensed prescription pharmaceuticals and specialist health care.

Markov multistate survival-based methods will be used to compare the sickness absence between groups. Specifically, length of stay per sickness absence state (no sickness absence, sick leave, and disability pension) will be compared over five years from t0. Both crude and adjusted estimates will be presented. Adjustment will be made based on our hypothesis about causal relationships and include: history of sickness absence, sociodemographics (age, sex, sociodemographic status), patient disability (emotional distress, everyday interference, and confidence in future improvement), and governmental policy (IDT assessment year and geographical region of IDT clinic).

Eligibility criteria: Inclusion Criteria:

* IDT startyear: 2009-2016
* Age 18-60 yeras
* Pain duration of minimum 90 days

Exclusion Criteria:

* Cancer in the previous 5 years
* An IDT assessment in the previous 2 years
* Full or partial disability pension in the year preceding the IDT assessment

Primary outcomes:
measure: Sickness absence
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01987973: Allograft Reconstruction of Massive Rotator Cuff Tears vs Partial Repair Alone
Official title: Arthroscopic Repair of Chronic Two-tendon Rotator Cuff Tears by Human Dermal Allograft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Syndrome
Rotator Cuff Injury
Disorder of Rotator Cuff
Full Thickness Rotator Cuff Tear
Skin Graft (Allograft) (Autograft) Failure
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 29
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 investigators hypothesize that the use of an allograft adjuvant to partial repair will lead to improved shoulder outcome measure scores compared to partial repair alone in massive rotator cuff tears.

Detailed description: A total of 30 patients will be enrolled in the study. Subjects will be randomized into two arms, either (1) Partial Repair/Debridement or (2) Allograft Reconstruction.

The patients will complete a structured clinical examination conducted by a sports medicine fellowship trained orthopaedic consultant, Pre-operatively and Post-operatively at 6 weeks, 3, 6, 12, 24 months. The examination will consist of range of motion testing by goniometer as well as strength testing by hand dynamometer. The patient will also complete the Western Ontario Rotator Cuff Index (WORC) questionnaire.

The main benefit of this procedure is that patients who have currently irreparable massive, chronic rotator cuff tears may acquire a means for their cuff to be repaired. This may aid in improving function of the shoulder, restoring ability to complete activities of daily living, while decreasing pain and sleep disturbances. This would allow the participant to become more functional after rehabilitation. It is our belief that this study could provide new information in helping to understand this relationship, which would in turn lead to future study in this area of orthopaedic surgery.

Eligibility criteria: Inclusion Criteria:

* Large/Massive rotator cuff tear \>3cm proven on MRI

Exclusion Criteria:

* Non surgical candidate, unable to consent

Primary outcomes:
measure: Western Ontario Rotator Cuff (WORC) Index
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Ivan H Wong, MD FRCS(C)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong I, Sparavalo S, King JP, Coady CM. Bridging Allograft Reconstruction Is Superior to Maximal Repair for the Treatment of Chronic, Massive Rotator Cuff Tears: Results of a Prospective, Randomized Controlled Trial. Am J Sports Med. 2021 Oct;49(12):3173-3183. doi: 10.1177/03635465211039846. Epub 2021 Sep 8.
Clinical trial NCT07024173: A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer
Official title: A Multicenter, Open-label, Randomized Controlled Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer With Disease Progression After Previous Endocrine Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Locally Advanced Breast Cancer
Metastatic Breast Cancer
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-17
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multicenter, open-label, randomized controlled, Phase 3 clinical trial.


Eligibility criteria: Inclusion Criteria:

1. Women aged 18 to 75 years old (including both values).
2. ECOG Physical Strength Status (PS) : 0 to 1 point.
3. Patients with locally advanced or metastatic breast cancer confirmed by histology.
4. Patients previously received 1-2 lines of endocrine therapy.
5. Expected survival \> 6 months.
6. The functional level of the organs must meet the requirements.
7. Subjects that voluntarily participate in this clinical trial, be willing and able to abide by the procedures related to clinical visits and research, understand the research procedures and have signed the informed consent.

Exclusion Criteria:

1. Patients with rapid disease progress and investigators determine that endocrine therapy is not suitable or tolerant.
2. A history of severe clinical cardiovascular diseases.
3. Patients with uncontrollable tumor-related pain as judged by investigators.
4. Severe infection exists within 4 weeks before the first study administration.
5. Patients with clinically significant endometrial abnormalities.
6. Untreated active hepatitis.
7. Patients known to be allergic to HRS-8080 components.
8. Pregnant and lactating women, or those planning to become pregnant during the study period.

Primary outcomes:
measure: Progression free survival (PFS) evaluated by investigators.
timeFrame: Approximately 2 years.
Secondary outcomes:
measure: Progression free survival (PFS) evaluated by the blinded independent central review (BICR).
timeFrame: Approximately 2 years.
measure: Overall response rate (ORR).
timeFrame: Approximately 2 years.
measure: Clinical benefit rate (CBR).
timeFrame: Approximately 2 years.
measure: Duration of response (DOR).
timeFrame: Approximately 2 years.
measure: Overall survival (OS).
timeFrame: Approximately 3 years.
measure: Adverse events (AEs).
timeFrame: Approximately 2 years.
measure: Serious adverse events (SAEs).
timeFrame: Approximately 2 years.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
References:
Clinical trial NCT01867073: A Clinical Pharmacodynamic and Pharmacogenetic Study of OPB-51602 in Patients With Advanced Solid Tumours
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Solid Tumors
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2013-06-03
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll patients from the extension cohort an ongoing phase I study of OPB51602, to study the tumour response in selected tumour types, as a proof of concept.

Brief summary: OPB-51602 is a novel oral small molecule STAT3 inhibitor developed by Otsuka Pharmaceutical Company, Ltd, and is currently undergoing clinical investigation at the National University Health System (NUHS), Singapore. The proposed correlative pharmacodynamic and pharmacogenetic biomarker study is initiated and funded by the investigators, and will be conducted in conjunction with the extension phase I protocol of OPB-51602 in patients with advanced solid tumours (Study code 266-09-801-01/ DSRB protocol B/09/514). All biomarker and pharmacogenetic samples will be collected, stored and analysed at the local laboratory of the study site (Cancer Science Institute, National University Health System, Singapore, Dr Boon-Cher Goh).


Eligibility criteria: Inclusion Criteria:

Advanced Solid Tumor

Exclusion Criteria:

Non advanced solid tumor

Primary outcomes:
measure: Inhibition of STAT3 phosphorylation in peripheral mononuclear blood cells (PBMCs)pharmacodynamic effect of OPB-51602 in surrogate tissue.
timeFrame: 1 year
Secondary outcomes:
measure: To identify single nucleotide polymorphisms (SNPs) that correlate with OPB-51602 pharmacokinetics and pharmacodynamics
timeFrame: 1 Year
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References:
citation: Yu H, Jove R. The STATs of cancer--new molecular targets come of age. Nat Rev Cancer. 2004 Feb;4(2):97-105. doi: 10.1038/nrc1275. No abstract available.
citation: Buettner R, Mora LB, Jove R. Activated STAT signaling in human tumors provides novel molecular targets for therapeutic intervention. Clin Cancer Res. 2002 Apr;8(4):945-54.