louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02808065: Validation of Population Pharmacokinetic Model Derived From Healthy Volunteer in Kidney Transplant Recipients
Official title: Validation of Population Pharmacokinetic Model Derived From Healthy Volunteer in Kidney Transplant Recipients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Transplantation
Keywords: Kidney transplant
Kidney transplantation
Renal transplant
Renal transplantation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Food and Drug Safety, Korea
First posted: 2016-06-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40 kidney transplant recipients

Brief summary: Pharmacokinetic model to predict interaction between tacrolimus and mycophenolate was developed through clinical trial with healthy volunteer. The purpose of this study is to confirm predictability of developed pharmacokinetic model in kidney transplant recipients.

Detailed description: Study participants take their immunosuppressant as usual. One day, blood is drawn at predose and 1, 2, 3, 4-hour postdose to compare observed concentration with model-predicted concentration of tacrolimus and mycophenolate.

Eligibility criteria: Inclusion Criteria:

* Age of 18 years or older
* At least 6 months after kidney transplantation
* Were on tacrolimus alone or tacrolimus plus mycophenolate based immunosuppressive regimen
* Maintained stable dose of immunosuppressants for at least two weeks

Exclusion Criteria:

* AST or ALT \>3 upper limit of normal range
* Had gastrointestinal disorder that may affect an absorption of drug
* Coadministration of drugs that may affect the pharmacokinetics of immunosuppressive drug
* Multi-organ transplant recipient
* Severe psychiatric disorder
* Drug or alcohol abuser
* Pregnant
* Low compliance

Primary outcomes:
measure: Tacrolimus concentration
timeFrame: 0, 1, 2, 3, 4 hours post-dose
Secondary outcomes:
measure: Mycophenolate concentration
timeFrame: 0, 1, 2, 3, 4 hours post-dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yon Su Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06912165: A Study of WD-890 in Participants With Moderate-to-Severe Plaque Psoriasis
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of WD-890 Tablets for the Treatment of Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Brief Description of Focus of Study
Lead sponsor: Zhejiang Wenda Medical Technology Co., Ltd.
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Th purpose of the study is to evaluate the dose response of WD-890 in efficacy at Week 16 in participants with moderate-to-severe plaque psoriasis.

Detailed description: The total duration of this study is up to 24 weeks which includes a screening period of less than or equal to (\<=) 4 weeks, a 16-week treatment period, and a 4-week safety follow-up period. Aged 18 to 70 years (inclusive) were enrolled in this study. Participants were randomized to receive WD-890 or placebo.

Eligibility criteria: Inclusion Criteria:

* Male or female participant aged 18 to 70 years(inclusive)at the time of informed consent.
* Diagnosis of plaque psoriasis for at least 6 months prior to the screening visit.

  ≥10% of BSA involvement at screening visit and randomization;
* Psoriasis Area and Severity Index (PASI) score ≥12 and static Physician's Global Assessment (sPGA) ≥3 at screening visit and randomization

Exclusion Criteria:

* Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, inverse, pustular,or drug induced psoriasis.)
* Has uncontrolled arterial hypertension characterized by a systolic blood pressure (BP) ≥160 mm Hg or diastolic BP ≥100 mm Hg Note: Determined by 2 consecutive elevated readings. If an initial BP reading exceeds this limit, the BP may be repeated once after the subject has rested sitting for ≥10 minutes. If the repeat value is less than the criterion limits, the second value may be accepted
* Class III or IV congestive heart failure by New York Heart Association Criteria
* Participant with a history of chronic bacterial infections (e.g., chronic pyelonephritis, chronic bronchiectasis, or chronic osteomyelitis).

Primary outcomes:
measure: Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16
timeFrame: Screening up to Week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College
state: Jiangsu
Study officials:
References:
Clinical trial NCT01128465: Pharmacokinetic and -Dynamic of Propofol During Awake Craniotomy
Official title: Investigation on the Pharmacokinetic and -Dynamic of Propofol During Awake Craniotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Tumor
Keywords: propofol
awake craniotomy
patients requiring an awake craniotomy for brain tumor/lesion resection
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2010-05-24
Enrollment: 10
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: Patients of a University Hospital requiring an awake craniotomy for resection of a brain tumor or lesion

Brief summary: Certain kind of neurosurgical procedures require intraoperative alertness of the patient, for example to perform speech tests during brain tumor resection. With respect to anaesthesia, it is therefore required that the patient is asleep during the beginning and the end of the procedure, however fully awake in between. To do so, the anaesthetic propofol is used and an accurate knowledge of its pharmacokinetic and -dynamic (pk/pd) parameters is required to optimally control anaesthesia. However, diverse pk/pd-parameter sets have been described in the literature.

The aim of the study is to investigate whether the pk/pd model proposed by Marsh et al. or by Schnider et al. more accurately describe the pk/pd of propofol during awake craniotomy.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for awake craniotomy

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: prediction error for propofol plasma concentrations
timeFrame: day of surgery (day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Dept. of Anaesthesiology and Intensive Care Medicine, Univ. of Bonn
Study officials:
affiliation: Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn, Germany
name: Martin Soehle, MD, DESA, D habil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schnider TW, Minto CF, Gambus PL, Andresen C, Goodale DB, Shafer SL, Youngs EJ. The influence of method of administration and covariates on the pharmacokinetics of propofol in adult volunteers. Anesthesiology. 1998 May;88(5):1170-82. doi: 10.1097/00000542-199805000-00006.
citation: Marsh B, White M, Morton N, Kenny GN. Pharmacokinetic model driven infusion of propofol in children. Br J Anaesth. 1991 Jul;67(1):41-8. doi: 10.1093/bja/67.1.41.
citation: Soehle M, Wolf CF, Priston MJ, Neuloh G, Bien CG, Hoeft A, Ellerkmann RK. Comparison of propofol pharmacokinetic and pharmacodynamic models for awake craniotomy: A prospective observational study. Eur J Anaesthesiol. 2015 Aug;32(8):527-34. doi: 10.1097/EJA.0000000000000255.
Clinical trial NCT05705765: Effects on Balance of Suspension Exercise vs. Exercise on Unstable Surfaces
Official title: Effects on Balance in the Young Adult of Suspension Exercise vs. Exercise on Unstable Surfaces: a Quasi-randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance Training
Instability
Keywords: Suspension training
Instability training
Balance
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Most human movements are executed while in a state of postural instability. For this reason, instability training is a highly-specific method that is intended to improve balance and postural control. This research aimed to determine the effect of instability training on the balance of individuals with similar baseline abilities, who initiated training within different stability conditions. Research question: Does different type of instability training determine improvements in balance?


Eligibility criteria: Inclusion Criteria:

* University students aged 18-35 years.

Exclusion Criteria:

* Muscle skeletal injury in the preceding 6 months.
* Athletes from any field.
* Those with known blance disorders (e.g. vertigo and central or vestibular disorder).

Primary outcomes:
measure: Y Balance Test
timeFrame: 0 week
measure: Y Balance Test
timeFrame: 5 week
Secondary outcomes:
measure: Emery Test
timeFrame: 0 week, 5 week.
measure: Romberg Test
timeFrame: 0 week, 5 week.
measure: Sidewide Test
timeFrame: 0 week, 5 week
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Faculty of Physiotherapy of the University of Valencia
Study officials:
affiliation: University of Valencia
name: David Hernández-Guillén, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03634865: Screw Lengths in Radius Volar Plates
Official title: Volar Plates for Distal Radius : Can Epiphyseal Screw Length be Predicted
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radius; Fracture, Lower or Distal End
Tendon Injury - Upper Limb
Fracture Fixation, Internal
Keywords: Bone trauma-fracture
Radius
CT-scan
Internal fixation
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 41
Sex: ALL
Minimum age (years): 17
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that underwent for a CT-Scan of the distal radius from October 2016 to February 2018

Brief summary: Background Fractures of the distal radius are among the most common. Major complications, including irritation and rupture of the extensor tendons, may occur if epiphyseal screws of inappropriate length are used.

Questions/Purposes The main objective of the present study was to determine whether the optimal epiphyseal screw length can be determined by reference to the diaphyseal screw length.

Methods Forty CT scans were semi-automatically segmented. A 3D model of the volar plate was affixed to each distal radius with simulation. The maximum lengths of the diaphyseal screws, as well as the four distal epiphyseal screws, were measured. Linear regression analysis was performed.


Eligibility criteria: Inclusion Criteria:

* All CT-scans available in our database

Exclusion Criteria:

* Any pathology that could affect the radius morphology
* Refuse to participate

Primary outcomes:
measure: Main objective
timeFrame: The measures were performed after the CT-Scans were realized. The CT-Scans were performed from October 2016 to February 2018. The measures on the CT-Scans were realized in june 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHUR de Brest
Study officials:
References:
Clinical trial NCT06393465: Real-World Effectiveness of High-Dose Tafamidis on Neurologic Disease Progression in Mixed-Phenotype Transthyretin Amyloid Cardiomyopathy
Official title: Real-World Effectiveness of High-Dose Tafamidis on Neurologic Disease Progression in Mixed-Phenotype Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-05-01
Enrollment: 50
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: The study will include patients with mixed-phenotype ATTR-CM who are treated in the Amyloidosis Program at MedStar in the U.S and three other study sites (Canada, Portugal and Italy).

Brief summary: This study will examine the clinical effectiveness of Tafamidis in patients with Mixed Phenotype Transthyretin Amyloidosis using data that already exist in patients' medical records


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years at diagnosis.
* Diagnosed with ATTRv-CM or ATTRwt-CM, mixed phenotype.
* Treated with tafamidis, as VYNDAMAX 61 mg (one 61-mg tafamidis capsule) orally once daily for ≥12 months or started on tafamidis 20 mg then switched to VYNDAMAX 61 mg for ≥12 months
* Have had ≥1 pre- and ≥1 post-treatment neurologic assessments.

Exclusion Criteria:

* History of any organ transplant.
* Individuals who are non-ambulatory.
* Prior or current treatment with any disease-modifying therapy (investigational or approved) alone or in combination, except tafamidis, as VYNDAQEL 80 mg \[four 20-mg tafamidis meglumine capsules\] orally once daily or VYNDAMAX 61 mg \[one 61-mg tafamidis capsule\] orally once daily.
* Peripheral neuropathy attributed to causes other than ATTR amyloidosis (eg, diabetes mellitus, B12 deficiency, hypothyroidism, shingles,Lyme disease, HIV infection, secondary to injury, chronic kidney disease).
* Patient's data fails to pass data quality checks.

Primary outcomes:
measure: Rate of neurologic disease progression
timeFrame: Baseline through at least 12 months of treatment
Secondary outcomes:
measure: Change from Baseline in modified Body Mass Index (BMI)
timeFrame: Baseline (BL) through at least 12 months of treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03402165: Serum Alpha-fetoprotein Levels and Response to Direct Antiviral Therapy in Patients With Chronic Hepatitis C
Official title: Impact of Serum Alpha-fetoprotein Levels on the Response to Direct Antiviral Therapy in Egyptian Patients With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis C
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 1200
Sex: ALL
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: Alpha-fetoprotein Levels on the Response to direct Antiviral Therapy in Patients with Chronic Hepatitis C

Detailed description: Impact of Serum Alpha-fetoprotein Levels on the Response to direct Antiviral Therapy in Egyptian Patients with Chronic Hepatitis C

Eligibility criteria: Inclusion Criteria:

* HCV patients who will undergo treatment by direct acting antiviral agents.

Exclusion Criteria:

* Patients with decompensated liver disease

Primary outcomes:
measure: Number of patients with sustained virologic response
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Tanta University
name: Rehab Badawi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Al-Azhar University
name: Mohamed Alboraie, MD
role: STUDY_DIRECTOR
affiliation: Tanta University
name: Sherief Abd-Elsalam, MD
role: STUDY_DIRECTOR
affiliation: Helwan University
name: Mohamed el kassas, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06392165: Evaluation of Adhesion Properties in Wound Care Devices
Official title: Evaluation of Adhesion Properties in Wound Care Devices
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adhesion Properties of Wound Care Devices
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2024-04-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: intra-individual test with up 12 test samples per study run; this treatment is announced here as single group study.
Primary purpose: OTHER

Brief summary: Molnlycke manufactures and markets self-adhesive wound care devices intended to protect various types of wounds during treatment. This study aims to measure and evaluate the adhesion properties of self-adhesive wound care devices. To measure the adhesion properties test strips will be applied to the participant's skin for a predetermined time and will be removed while measuring the adhesion properties afterwards. This method has been chosen since there is no in vitro method available that can simulate adhesion to human skin


Eligibility criteria: Inclusion Criteria:

* Confirmed eligibility and signed consent form.

Exclusion Criteria:

* Known plaster allergy or other known contact hypersensitivity
* Pregnant or breastfeeding individual.

Primary outcomes:
measure: Peel Off Force
timeFrame: up to 48 hours
Secondary outcomes:
measure: Humidity
timeFrame: up to 48 hours
measure: Redness
timeFrame: up to 48 hours
measure: Pain assessment
timeFrame: up to 48 hours
Other outcomes:
measure: Adhesive residuals
timeFrame: up to 48 hours
measure: Loosening
timeFrame: up to 48 hours
measure: Comments
timeFrame: up to 48 hours
Locations:
city: Gothenburg
country: Sweden
facility: Mölnlycke Health Care AB
Study officials:
References:
Clinical trial NCT01981265: Genome-wide Study for Disease Susceptibility Gene(s) in Patients With Hand Osteoarthritis
Official title: Genome-wide Study for Disease Susceptibility Gene(s) in Patients With Hand Osteoarthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hand Osteoarthritis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-11-11
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Participating patients must be at least 45 years of age.
2. All Patients must have radiographic hand OA.
3. All Patients must be of Han Chinese ethnic background.
4. Enrolled participants must give voluntary written consents to participate in this study.

Brief summary: This is a case-control study involving one medical center and one research institute to develop a data-set containing a minimum of 100 osteoarthritis cases, minimum of 100 independent controls of similar gender ratio and a minimum of 100 disease controls (cases with hip and/or knee OA) to associate DNA sequence (allelic) variations in candidate genes with osteoarthritis phenotypes.

This study is intended to begin at the Institute of Biomedical Sciences at Academia Sinica (which includes National Genotyping Center (NGC) and National Clinical Core (NCC)), National Taiwan University Hospital.


Eligibility criteria: Exclusion Criteria:

1. Patients with the following diseases will be excluded：Rheumatoid arthritis, Gout arthritis, Psoriatic arthropathy, Hypertrophic osteoarthropathy, Hypermotility syndrome, Hemochromatosis, Post-traumatic OA, Other secondary-form OA and Lupus.
2. The individual is excluded if the hand X-rays show MCP changes compatible with hemochromatosis. The site then is obligated to measure fasting transferrin saturation (FE/TIBC ratio) and if \>55%, the individual is excluded.
3. Have more than 3 swollen MCP joints equal to, or greater than KL grade 2.
4. Be unable to give informed consent.
5. One cannot participate in this study if other members of his or her immediate family have already been recruited (Only one person from each family can participate in the study).

Primary outcomes:
measure: Hand Osteoarthritis related gene expression assay
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Orthopedics, National Taiwan University Hospital and National Taiwan University College of Medicine
name: Chih-Hao Chang
role: STUDY_DIRECTOR
References:
Clinical trial NCT00170365: Restorative Yoga for Stress Management
Official title: Restorative Yoga for Stress Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Anxiety
Keywords: Stress
Yoga
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: Hennepin Faculty Associates
First posted: 2005-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study examined Restorative Yoga as a method of stress reduction for the HFA Addiction Medicine Clinic staff volunteers.

Detailed description: The purpose of this study is to determine if there is a perceived benefit from adding a restorative yoga class as a method of stress reduction for the HFA Addiction Medicine Clinic staff. Working in a busy clinic can be very stressful. While it is not always possible to completely eliminate stress from our lives, it is known that stress reduction techniques help to diminish the negative consequences of stress. This study was designed to answer the following question "How much change in perceived stress is obtained through weekly Restorative Yoga sessions?" Study population were members of the HFA Addiction Medicine Clinic. All staff completed the Spielberger Job Stress Survey and the State-Trait Anxiety Inventory at baseline and at six months following intervention onset. Volunteers from the Addiction Medicine Clinic attended weekly restorative yoga sessions 45 minutes in length held over the noon hour. Serial State-Trait Anxiety Inventory and weekly questionnaire regarding the perceived effects of the restorative yoga on aspects fo patient care were completed by study volunteers.

Eligibility criteria: Inclusion Criteria:

* member of HFA Addiction Medicine Clinic staff
* willing to participate in the restorative yoga sessions and to complete study instruments

Exclusion Criteria:

* unwilling to participate in the restorative ygoa sessions (assigned then to the control group)

Primary outcomes:
measure: The primary outcome measurement were the Spielberger State-Trait Anxiety Inventory scores.
Secondary outcomes:
measure: Secondary measurements were :
measure: -number of sessions attended
measure: -results of restorative yoga questionnaire on patient care and stress levels
measure: -results of Job Stress Survey
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin Faculty Associates/ Hennepin County Medica Center
state: Minnesota
Study officials:
affiliation: Hennepin Faculty Associates/ Hennepin County Meical Center
name: Kathleen M Wesa, M.D.
role: PRINCIPAL_INVESTIGATOR
References: