louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00666601: Microdialysis and Pharmacokinetic Study of TR-701
Official title: An Open Label, Single Dose, Microdialysis and Pharmacokinetic Study of TR-701 in Normal Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Microdialysis
Antibiotic
Healthy subjects
Lead sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2008-04-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to measure the penetration of TR-700 into subcutaneous adipose tissue and skeletal muscle after a single oral dose of 600 mg TR-701

Detailed description: This study will be conducted in two parts: a Pilot Study and a Main Study. The Pilot Study will be conducted to assess recovery of exogenously administered TR-700 (microbiologically active moiety) via microdialysis. In the Main Study, pharmacokinetics of TR-700 will be determined in both soft tissues (via microdialysis) and plasma after a single oral dose of 600 mg TR-701 (prodrug).

Eligibility criteria: Inclusion Criteria:

* Body mass index of 20 to 29 kg/m2
* Agree not to consume any products containing tobacco, alcohol, quinine, grapefruit, caffeine, or high levels of tyramine
* Agree not to use any other medication
* Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control

Exclusion Criteria:

* History of gastric or duodenal ulcer within 1 year before enrollment
* Has known or suspected hypersensitivity or intolerance to heparin, if an indwelling cannula (e.g., heparin lock) is used
* Recent febrile illness (less than 72 hours before the first intake of study medication).
* Significant blood loss (300 mL) or donation of blood within the 60 days before the Screening visit
* Women who are pregnant or breast-feeding

Primary outcomes:
measure: Subcutaneous tissue concentrations of TR-700
timeFrame: Single day
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: General Clinical Research Center
state: Florida
Study officials:
affiliation: University of Florida
name: Harmut Derendorf, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sahre M, Sabarinath S, Grant M, Seubert C, Deanda C, Prokocimer P, Derendorf H. Skin and soft tissue concentrations of tedizolid (formerly torezolid), a novel oxazolidinone, following a single oral dose in healthy volunteers. Int J Antimicrob Agents. 2012 Jul;40(1):51-4. doi: 10.1016/j.ijantimicag.2012.03.006. Epub 2012 May 13.
Clinical trial NCT06231901: Comparison of CO-OP and GDT on Occupational Performance and Functional Status in the CP
Official title: Comparison of Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach and Goal-Directed Training on Occupational Performance and Functional Status in Children With Cerebral Palsy: A Three-Armed Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Occupational Problems
Cognitive Orientation
Goals
Keywords: cerebral palsy
occupational performance
functional status
CO-OP
goal directed training
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed as a three-armed, single-blinded, randomized, controlled trial to examine the effectiveness of CO-OP and GDT interventions on occupational performance and functional status in children with CP compared with their usual care.

Detailed description: Cerebral palsy (CP) is a group of neurological disorders that affect movement, muscle tone, and posture, causing activity limitations that originated in the developing fetal or infant brain that are attributed to non-progressive disorders. Symptoms such as spasticity and contracture in CP cause a decrease in functional skill level with limitations in daily living activities such as learning a new skill or self-dressing and handwriting. In this disease, the simultaneous presence of sensory, cognitive, perceptual, and behavioral impairments significantly undermines the acquisition and execution of functional skills, autonomy in daily living, and active engagement in leisure activities. This study was planned to investigate and compare the impact of CO-OP and GDT on the occupational performance and functional status of children with CP.

Eligibility criteria: Inclusion Criteria:

* being between 5-10 years of age
* being diagnosed with CP
* having adequate language abilities to make contact with a therapist and be informed during intervention.

Exclusion Criteria:

* they were receiving any other treatment
* they had been diagnosed with mental retardation
* they had serious vision or hearing problems.

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: "up to 12 weeks"
measure: Pediatric Evaluation of Disability Inventory (PEDI):
timeFrame: "up to 12 weeks"
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Sıhhiye
Study officials:
affiliation: Hacettepe University
name: zeynep kolit, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: HATAY MUSTAFA KEMAL ÜNİVERSİTESİ
name: Rüya gül temel, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Gamze ekici, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06125301: Multiple Sclerosis Self Monitoring Study
Official title: The Multiple Sclerosis Self Monitoring Study: An Intervention Study on the Effect of Digital Self-monitoring-based Management of Relapsing and Remitting Multiple Sclerosis on Self-efficacy, Clinical Outcomes and Cost-effectiveness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is a multicenter, prospective, randomized controlled trial (RCT) to compare the effectiveness of a smartphone-based self-monitoring and self-management tool on control self-efficacy with respect to standard clinical practice for patients with relapsing-remitting multiple sclerosis (RRMS). RRMS patients will be recruited and screened for study eligibility at four Dutch MS centers. Following inclusion, participants will be randomly allocated to the intervention group (use of MS sherpa® in addition to standard care) or control group (standard care only). The duration of follow-up is 12 months with study visits at baseline and 12 months, and additional study assessments coupled with every clinical visit as part of standard care during the follow-up period.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent form.
2. Able to comply with the study protocol, as judged by the investigator.
3. A minimum age of 18 years.
4. Have a definite diagnosis of RRMS according to the revised McDonald 2017 criteria.
5. Have a length of disease duration of ≥12 months, from date of MS diagnosis.
6. Have clinical disease activity (one or more reported relapses) and/or radiological disease activity (new/enlarged T2 lesions or T1 contrast-enhancing lesions) within the past 12 months.
7. Willing and able to install and use MS sherpa® on own smartphone with Android (version 4.4 or higher) or iOS (version 9 or higher) operating system.
8. Willing to stay for treatment with the same hospital during the year of study.
9. Willing to follow the rules of conduct as described in Appendix A during the year of study.

Exclusion Criteria:

1. EDSS of \> 6.5 at baseline screening.
2. Presence of a cognitive, visual or upper extremity deficit that disables the use or measurements of MS sherpa® on the smartphone, as judged by the investigator.
3. Concomitant use of health monitoring apps or devices for MS during the study.
4. Concomitant participation in another intervention trial in MS.

Primary outcomes:
measure: the Multiple Sclerosis Self-Efficacy Control scale (MSSE-C)
timeFrame: One year
Secondary outcomes:
measure: Decision making process - caregiver
timeFrame: One year
measure: Decision making process - patient
timeFrame: One year
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie VUmc
Study officials:
References:
Clinical trial NCT03408301: The Status of Autonomic Tone Before Tourniquet Deflation During Total Knee Replacement
Official title: The Effects of Sympathovagal Balance Before Tourniquet Deflation on a Decrease in Arterial Blood Pressure Following the Deflation During Total Knee Replacement Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotension
Blood Pressure, Low
Lead sponsor: Daegu Catholic University Medical Center
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing total knee replacement arthroplasty in a tertiary university hospital

Brief summary: This study evaluates the influences of the status of sympathovagal balance before tourniquet deflation on a decrease in arterial blood pressure following the deflation during total knee replacement arthroplasty

Detailed description: Patients present with different hemodynamic profiles after intraoperative tourniquet deflation during total knee replacement arthroplasty.

Sympathovagal balance can be measured before tourniquet deflation and might determine the hemodynamic response to tourniquet deflation.

Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists physical status I - II
2. Body mass index \< 35 kg/m2

Exclusion Criteria:

1. Coagulation deficiencies
2. Known allergies to local anesthetics
3. Neurologic deficit on the side being operated on
4. Inflammation at the lumbar puncture site
5. Cardiac conduction disorders or arrhythmias
6. Congestive heart failure
7. Serum electrolyte abnormalities
8. Psychiatric disorders
9. Patient's refusal
10. Difficulty communicating with medical personnel
11. Severe hypovolemia
12. Increased intracranial pressure
13. Severe aortic stenosis
14. Severe mitral stenosis

Primary outcomes:
measure: Sympathovagal balance
timeFrame: During 5 minutes before tourniquet deflation
Secondary outcomes:
measure: Noninvasive hemodynamic parameters
timeFrame: During 5 minutes before tourniquet deflation
measure: Maximum percent change in mean arterial blood pressure
timeFrame: During 10 minutes after tourniquet deflation
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
Study officials:
affiliation: Daegu Catholic University Medical Center
name: JongHae Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06126601: Incidence and Clinical Impact of Serum Hyperamylasemia (POH) After Pancreatectomy on Postoperative Outcome and Patient Safety
Official title: Incidence and Clinical Impact of Serum Hyperamylasemia (POH) After Pancreatectomy on Postoperative Outcome and Patient Safety
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatectomy
Hyperamylasemia
Pancreatitis, Acute
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients undergoing a pancreatic resection

Brief summary: Recent evidence suggests that postoperative hyperamylasemia (POH) is a predictor of morbidity after pancreatectomy. This is based on the assumption that pancreatitis after pancreatectomy (PPAP) is a major trigger for the development of complications and is indicated by hyperamylasemia. Standardized prospective analysis and correlation with other laboratory parameters, hasn't been performed to date.

Therefore the overall study aims are:

* To prospectively evaluate the incidence and assess the clinical value of biochemical changes for the postoperative course.
* To confirm and improve the definition and classification of postpancreatectomy acute pancreatitis (PPAP) of the International Study Group of Pancreatic Surgery (ISGPS) and to provide knowledge for effective early management of complications.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing pancreatic resection for malignant and benign disease with or without pancreatic anastomosis
* Patients aged 18-85 years
* Willingness to participate as demonstrated by giving a written informed consent.

Exclusion Criteria:

* Necrosectomy (endoscopic or open) for primary acute pancreatitis or within laparotomy
* Age less than 18 years
* Surgical drainage procedures without pancreatic resection (cystojejunostomy for pancreatic pseudocysts)
* One-stage total pancreatectomy
* Missing written consent

Primary outcomes:
measure: Incidence of PPAP (Postpancreatectomy Acute Pancreatitis)
timeFrame: 90 days after surgery
measure: Significance of biochemical changes (postoperative hyperamylasemia and hyperlipasemia)
timeFrame: 90 days after surgery
Secondary outcomes:
measure: Correlation between hyperamylasemia and rescue pancreatectomy after pancreatoduodenectomy
timeFrame: 90 days after surgery
measure: Correlation between hyperamylasemia and radiological findings for pancreatitis
timeFrame: 90 days after surgery
measure: Incidence of postoperative mortality
timeFrame: 90 days after surgery
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Hospital Dresden, Dept. Visceral, Thoracic and Vascular Surgery
Study officials:
affiliation: University Hospital Dresden
name: Marius Distler, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02533401: A Study of Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)
Official title: A Multicenter, Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of Rituximab Plus Fludarabine and Cyclophosphamide (FCR) as First-Line Treatment in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphocytic Leukemia, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-08-26
Enrollment: 34
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 study will evaluate the efficacy and safety of rituximab in combination with chemotherapy (fludarabine and cyclophosphamide) in participants with B-cell CLL.


Eligibility criteria: Inclusion Criteria:

* Adult participants greater than or equal to (≥) 18 years of age
* B-cell CLL
* No previous treatment for leukemia

Exclusion Criteria:

* History of other malignancies within 2 years before study entry, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, prostate cancer, or breast cancer
* Comorbid condition requiring long-term (greater than \[\>\] 1 month) systemic corticosteroids during study treatment
* Known infection with hepatitis B or C virus or with human immunodeficiency virus (HIV)

Primary outcomes:
measure: Percentage of Participants With Death or Disease Progression
timeFrame: Up to 5 years (from Baseline until disease progression or death, whichever occurred first)
measure: Progression-Free Survival (PFS)
timeFrame: Up to 5 years (from Baseline until disease progression or death, whichever occurred first)
measure: Percentage of Participants Who Died
timeFrame: Up to 5 years (from Baseline until death)
measure: Overall Survival (OS)
timeFrame: Up to 5 years (from Baseline until death)
measure: Percentage of Participants With Complete Response (CR), Nodular Partial Response (nPR), or Partial Response (PR)
timeFrame: Up to 4 years (assessed every 3 months during 6-month treatment period, every 2 months during 6-month safety follow-up, then every 3 months during 3-year safety follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Córdoba
country: Argentina
city: La Plata
country: Argentina
city: Pilar
country: Argentina
city: Rosario
country: Argentina
city: Caracas
country: Venezuela
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT02751372: 18794 - Human Photo Toxicity 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: 2016-04-26
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 Authorization Form in conformance with 45CFR 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 dermatoses;
* 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 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 NCT00694304: Open-label Safety Extension Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults
Official title: A Long-term, Open-label, Flexible-dose, Extension Study Evaluating the Safety and Tolerability of [Vortioxetine] Lu AA21004 in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Long-term
Safety
Open-label
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2008-06-10
Enrollment: 535
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed 8-week acute treatment.


Eligibility criteria: Inclusion Criteria:

- Patients who completed 8-week short-term treatment study for Major Depressive Episode, NCT00635219 / 11984A

Exclusion Criteria:

* Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Ed., Text revision (DSM-IV TR)
* Female patients of childbearing potential who are not using effective contraception
* Use of any psychoactive medication

Other protocol-defined inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Number of Patients With Adverse Events (AEs)
timeFrame: Baseline to end of the 4-week safety follow-up period
measure: Percentage of Patients Who Withdrew Due to Intolerance to Treatment
timeFrame: Baseline to Week 52
Secondary outcomes:
measure: Change From Baseline in MADRS Total Score After 52 Weeks of Treatment
timeFrame: Baseline and Week 52
measure: Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment
timeFrame: Baseline and Week 52
measure: Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment
timeFrame: Baseline and Week 52
measure: Change From Baseline in CGI-S Score After 52 Weeks of Treatment
timeFrame: Baseline and Week 52
measure: Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)
timeFrame: Week 52
measure: Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)
timeFrame: Week 52
measure: Proportion of Patients With a MADRS Total Score >=22 After 52 Weeks of Treatment
timeFrame: Baseline and Week 52
measure: Change From Baseline in SDS Total Score After 52 Weeks of Treatment
timeFrame: Baseline and Week 52
Other outcomes:
Locations:
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: Baldwin DS, Hansen T, Florea I. Vortioxetine (Lu AA21004) in the long-term open-label treatment of major depressive disorder. Curr Med Res Opin. 2012 Oct;28(10):1717-24. doi: 10.1185/03007995.2012.725035. Epub 2012 Sep 17.
Clinical trial NCT06254404: Impact of Protamine Dose Reduction on Platelet Aggregation After Extracorporeal Circulation for Minimally Invasive Aortic Valve Replacement Surgery
Official title: Impact of Protamine Dose Reduction on Platelet Aggregation After Extracorporeal Circulation for Minimally Invasive Aortic Valve Replacement Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Protamine Dose
Protamine Adverse Reaction
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 50
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: Determining the minimum effective dose of protamine after extracorporeal circulation for mini-sternotomy aortic valve replacement surgery.


Eligibility criteria: Inclusion Criteria:

* Mini-sternotomy aortic valve replacement surgery
* Major patients

Exclusion Criteria:

* Hypersensitivity to protamine
* Coagulation Abnormalities
* Heparin allergy
* Pregnant women
* Jehovah's Witnesses

Primary outcomes:
measure: Minimum effective dose of protamine after extracorporeal circulation. A bottom-up and top-down method will define CP 50.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: