louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00406432: A Repeat Dose Pharmacokinetic Study Of Paroxetine CR Tablet In Healthy Chinese Subjects
Official title: A Steady-state Study to Assess the Pharmacokinetic Profile of Paroxetine After 14 Day Repeated Daily Dosing of the Controlled Release Paroxetine Tablet (25 mg) in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depressive Disorder
Keywords: BRL029060/Paroxetine CR
pharmacokinetics
repeat dose
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-12-04
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study was designed to assess the steady-state pharmacokinetic profile of paroxetine after 14 day repeated daily dosing of the controlled release tablet formulation (25 mg) in healthy Chinese subjects.


Eligibility criteria: Inclusion criteria:

* 19-45 years healthy Chinese subjects
* Body weight \> 50 kg
* BMI between 19-25
* serological negative for HIV, syphilis and hepatitis B and C
* no abnormalities in ECG
* Female with negative pregnancy and male has no plan to have a child during and 3 months after the study.

Exclusion criteria:

* History of chronic physical/mental disease, current disease and concomitant medication

Primary outcomes:
measure: pharmacokinetic parameters
timeFrame: Up to 21 days
Secondary outcomes:
measure: safety parameters(adverse events, lab test results,vital signs,electrocardiograph)
timeFrame: Up to 21 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00223132: Suture Granuloma in Body Contouring Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Laxity of Abdomen, Thighs, Chest, Back, and Neck
Keywords: bariatric surgery
body contouring
skin laxity
plastic surgery
suture granuloma
absorbable sutures
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2005-09-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate the effect of different suture material on the incidence of suture granuloma.

Detailed description: Bariatric surgery has evolved as an effective treatment for morbid obesity, inducing rapid and predictable weight loss within a period of 12 to 18 months following surgery. Consequently, body contouring after weight loss is emerging as the fastest growing field of plastic surgery. Patients seek consultation with a plastic surgeon to correct skin laxity of the abdomen, thighs, chest, back, and neck.

A major problem in body contourinig is the extrusion of absorbable suture material used for dermal closure. Long incisions and high tension inherent to body contouring surgery mandate a secure dermal closure. While absorbable sutures are preferred, they can result in suture granuloma and extrusion.

Eligibility criteria: Inclusion Criteria:

Men and women 18 years and older

Exclusion Criteria:

Subjects with active infectious collagen disease,significant anatomic asymmetry that creates markedly different wound tension and/or geometry between left and right side Subjects who cancel their surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Medtronic - MITG
name: Donna Doran
role: STUDY_DIRECTOR
References:
Clinical trial NCT01328132: Effect of Hyperoncotic Albumin on Vascular Hemodynamics and Oxygen Delivery Following Orthotopic Liver Transplant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Other Complications of Liver Transplant
Keywords: Liver
transplant
albumin
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2011-04-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to assess the effect of hyperoncotic albumin on vascular hemodynamics and oxygen delivery after orthotopic liver transplant. The secondary aim is to try to identify the dominant physiological mechanism so that we will be able to better identify patients that may benefit from the use of albumin (25%) boluses in addition to standard care in patients following liver transplantation.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Patients from the Critical care Unit
* Patients with a pulmonary artery occlusion catheter Inclusion:patients immediately following liver transplantation

Exclusion Criteria:

* Patients not giving informed consent
* Patients who have received \> 300 ml of albumin within 24 hours prior to inclusion
* Patients known to have previous adverse reaction to human albumin solution
* Patients who have religious restriction to receive human blood products
* Patient who have initial graft failure
* Patients with fluctuating hemodynamics
* Concerns of the treating surgeon

Primary outcomes:
measure: Cardiac index (CI)
timeFrame: 60 minutes after the infusion of the fluid
Secondary outcomes:
measure: Cardiac function response
timeFrame: 30 and 60 minutes after the infusion of the fluid
measure: A decrease in leak and plasma expansion
timeFrame: 30 and 60 minutes after the infusion of the fluid
measure: Cardiac output response
timeFrame: 30 and 60 minutes after the infusion of the fluid
measure: Detoxification effect of albumin
timeFrame: 30 and 60 minutes after infusion
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Sheldon Magder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01958632: Muscle-in-vein Conduits for Digital Nerve Reconstruction
Official title: Evaluation of Sensory Recovery After Reconstruction of Digital Nerves of the Hand Using Muscle-in-vein Conduits in Comparison to Nerve Suture or Nerve Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sensory Recovery
Lead sponsor: BG Trauma Center Tuebingen
Sponsor class: OTHER
First posted: 2013-10-09
Enrollment: 77
Sex: ALL
Minimum age (years): 10
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The actual study should provide a first direct comparison between results after reconstruction of sensory nerves of the hand using muscle-in-vein conduits to the standard methods of nerve transplantation and direct nerve suture.


Eligibility criteria: Inclusion Criteria:

complete digital nerve injuries, nerve reconstruction in the first 6 months post trauma

Exclusion Criteria:

total or subtotal amputations

Primary outcomes:
measure: Semmes-Weinstein-Monofilament test
timeFrame: The earliest 6 months post-OP
Secondary outcomes:
measure: Two-point-discrimination
timeFrame: The earliest 6 months post-OP
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: BG Trauma Center
Study officials:
References:
Clinical trial NCT03688932: Effects of WBV Associated With IMT on Functionality
Official title: Effects of Whole Body Vibration Associated With the Inspiratory Muscle Training Program on Functional Capacity, Balance and Muscle Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly Syndrome
Keywords: aging
functional capacity
muscle metabolism
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 42
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The pre-frail elderly are a population more vulnerable to diminished functionality and future disabilities. Thus, interventions focused on the prevention of sarcopenia are indicated to prevent dysfunction in this population. This study aims to evaluate the effects of whole body vibration training associated with inspiratory muscle training on functional outcomes, balance and muscle metabolism in pre-frail elderly women.


Eligibility criteria: Inclusion Criteria:

* To able to walk without assistance
* Good understanding to carry out the proposed tests, evaluated through the Mini Mental State Examination (MMSE).

Exclusion Criteria:

* Contraindication or difficulty to perform evaluation procedures
* Users of medications that interfere with the cardiovascular and / or muscular system
* Smokers
* Neuromuscular or degenerative diseases
* Pulmonary comorbidities
* Heart diseases and labyrinthitis

Primary outcomes:
measure: Walking Distance
timeFrame: Change from Baseline walking distance at 3 months
Secondary outcomes:
measure: Balance
timeFrame: Change from Baseline balance at 3 months
measure: Functionality
timeFrame: Change from Baseline functionality at 3 months
measure: Hand grip strength
timeFrame: Change from Baseline hand grip strength at 3 months
measure: Muscle Metabolism
timeFrame: Change from Baseline muscle metabolism at 3 months
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Federal University of Pernambuco
state: Pernambuco
Study officials:
References:
Clinical trial NCT03298932: 2D Strain of Right Ventricle in Peroperative of Cardiac Surgery
Official title: 2D Strain of Right Ventricle in Peroperative Cardiac Surgery : Evaluation of Early Signs of RV Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Disorder
Keywords: Transesophageal echography
Perioperative cardiac surgery
Aortic valve replacement
2D strain of right ventricle
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient eligible for aortic valve surgery

Brief summary: Evaluation of the right ventricle (RV) deformation (strain) with 2D speckle tracking technics obtained by echocardiographies (TEE) in peroperative period of cardiac surgery .

TEE is performed for each patient of cardiac surgery during the operation time .

This new evaluation parameter of RV could be a good tool to assess the early RV dysfunction after cardiac surgery.

Detailed description: Monitoring of 2D strain of right ventricle free wall by TEE in perioperative of cardiac surgery :

In preoperative time After sternotomy After surgery Inclusions of patients elected for aortic valve surgery without coronary diseases or previous RV dysfunction.

Comparison with others echocardiographic parameters of RV evaluation Association with right ventricle insufficiency after cardiac surgery.

Eligibility criteria: Inclusion Criteria:

* patient eligible for aortic valve surgery

Exclusion criteria:

* previous right ventricle dysfunction
* severe coronary disease

Primary outcomes:
measure: 2D strain modification of right ventricle after cardiac surgery
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve réanimation
Study officials:
affiliation: University Hospital, Montpellier
name: Géraldine CULAS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01842932: Usefulness Of Flospan As A Premedication For Colonoscopy
Official title: Usefulness Of Flospan As A Premedication For Colonoscopy : A Randomized Double Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colonoscopy
Keywords: Colonoscopy
Anticholinergics
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2013-04-30
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Usefulness of Flospan as a premedication for colonoscopy: A randomized double-blind controlled trial

Detailed description: Cimetropium bromide is premedication of colonoscopy. However, it is contraindication for some diseases; benign prostatic hyperplasia(BPH) or other obstructive uropathy, intestinal obstruction, pyloric stenosis, glaucoma, myasthenia gravis, megacolon, paralytic ileus. In this cases, Flospan (phloroglucin) is effective alternative drug. So our research was to compare the effects of these two drugs.

Eligibility criteria: Inclusion Criteria:

* Recipient endoscopic diagnostic purposes.

Exclusion Criteria:

* If you currently pregnant, or of childbearing potential
* Previous abdominal surgery or bowel resection.
* If under 18 years of age
* If the last two days, the administration of anticholinergic

Primary outcomes:
measure: Non inferiority of phloroglucin to cimetropium bromide
timeFrame: Up to ten months
Secondary outcomes:
measure: Total diagnostic colonoscopy exam time
timeFrame: 1 year
measure: Evaluation of practitioners
timeFrame: 1 year
measure: Evaluation of subjects
timeFrame: 1 year
measure: Peristalsis time of transverse colon
timeFrame: 1 year
measure: Total dose and times of sedatives for pain control
timeFrame: 1 year
measure: Time of cecal intubation
timeFrame: 1 year
Other outcomes:
measure: Bowel cleansing status
timeFrame: 1 year
measure: Heart rate, respiratory rate, oxygen saturation, blood pressure
timeFrame: 1 year
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Ajou University School of Medicine
name: Kee Myung Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06441032: Retrospective Database Study: Survival of Cast Restorations - Restorations Made of Precious Metal vs. Non-precious Metal
Official title: Survival of Cast Restorations - Restorations Made of Precious Metal vs. Non-precious Metal
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Dental Restoration Failure
Lead sponsor: University of Göttingen
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients insured in the statutory health insurance who received single-tooth cast restorations made of precious metal or non-precious metal (e.g. partial crowns, crowns) within the Department of Preventive Dentistry, Periodontology and Cariology between 1997 and 2022.

Brief summary: The aim of this study is to determine and compare the longevity of single-tooth cast restorations made of precious metal vs. non-precious metal (e.g. partial crowns, crowns) and to determine the influence of patient-, tooth-, treatment-, and restoration-specific parameters on longevity.

Patients who received single-tooth cast restorations made of precious metal or non-precious metal (e.g. partial crowns, crowns) between 1997 and 2022 will be retrospectively analyzed. Patient-, tooth-, treatment-, and restoration-specific parameters will be obtained from digital and paper-based dental records.

Survival and success of the restorations will be assessed using Kaplan-Meier statistics. Mean annual failure rates (mAFR) and median survival time will be calculated (Kaplan-Meier statistics). Potential predictive factors will be tested using log-rank tests and multi-variate Cox-regression analysis.

Detailed description: No patient treatment is associated with the study.

Eligibility criteria: Inclusion Criteria:

* Patients insured in the statutory health insurance.
* Patients who received single-tooth cast restorations made of precious metal or non-precious metal (e.g. partial crowns, crowns) within the Department of Preventive Dentistry, Periodontology and Cariology between 1997 and 2022.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Success of restoration
timeFrame: 1997-2023
Secondary outcomes:
measure: Survival of restoration
timeFrame: 1997-2023
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology
state: Lower Saxony
Study officials:
References:
Clinical trial NCT01471132: Sequential HIPEC of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis
Official title: Phase 2 Study of Sequential Hyperthermic Intraperitoneal Chemotherapy of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis or Positive Free Cancer Cells in Abdomen
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Metastases to Perineum
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2011-11-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The recurrence and metastasis of peritoneum is always the lethal consequence for gastric cancer patients, and there is no effective therapy until now. It has been reported by Dr.Fujimoto that intraperitoneal chemotherapy plus hyperthermic therapy, which called hyperthermic intraperitoneal chemotherapy (HIPEC), can eliminate and suppress the free cancer cells and tiny metastasis in abdomen. Refer to the experience of systematic chemotherapy, HIPEC with combination regimen would have a brighter prospect. In this study, the investigators would use Oxaliplatin and paclitaxel sequent as HIPEC regimen. The safety and overall survival would be observed and evaluated.


Eligibility criteria: Inclusion Criteria:

* Histologically proved gastric adenocarcinoma.
* Peritoneum metastasis is observed or suspected by laparoscopy or radiologic examination,or free cancer cells are detected in peritoneal lavage liquid.
* Potentially resectable gastric cancer.
* ALT, AST \< 80U/L; Total Bilirubin \< 30μmol/L; WBC \> 4x10\^9/L; PLT \> 100x10\^9/L; Cr \< 1.5 fold normal value.
* ECOG 0-2 points.
* Expected survival time longer than 3 months.
* Informed consent.

Exclusion Criteria:

* Recurrent gastric cancer.
* Pregnant or lactating women.
* Allergic to oxaliplatin or paclitaxel.
* Abnormal liver/kidney function.
* Serious heart/metabolic disease.

Primary outcomes:
measure: Overall Survival
timeFrame: every 3 month postoperation up to 24 months
Secondary outcomes:
measure: Safety
timeFrame: every 3 month postoperation up to 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jiafu Ji
role: STUDY_CHAIR
References:
Clinical trial NCT06963632: A Real-world Study on Golidocitinib-based Therapeutic Regimens for the Treatment of Patients With Peripheral T-cell Lymphoma
Official title: A Real-world Study on Golidocitinib-based Therapeutic Regimens for the Treatment of Patients With Peripheral T-cell Lymphoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Peripheral T-cell Lymphoma (PTCL)
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 1000
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: Patients with peripheral T-cell lymphoma who would benefit from golicitinib

Brief summary: This real-world study aims to evaluate the safety and efficacy of golidocitinib-based treatment regimens in patients with peripheral T-cell lymphoma (PTCL), without intervention in the selection of therapeutic strategies. A total of 1,000 PTCL patients are planned to be enrolled. After screening, eligible participants meeting the inclusion and exclusion criteria will be assigned to one of three predefined cohorts:

Cohort 1: Treatment-naïve patients with PTCL or NK/T-cell lymphoma.

Cohort 2: Patients receiving maintenance therapy following remission after first-line induction treatment for PTCL.

Cohort 3: Patients with relapsed or refractory PTCL or relapsed/refractory NK/T-cell lymphoma.

There is no cap on the number of participants in each cohort.


Eligibility criteria: Inclusion Criteria:

1. Voluntarily sign and acknowledge understanding of the Informed Consent Form
2. Clinically confirmed diagnosis of peripheral T-cell lymphoma
3. Inclusion of PTCL patients who initiated a Golidocitinib-based treatment regimen within the past 3 months
4. Compliance with clinical management and provision of disease-related historical medical information required for the study, including but not limited to medical records, treatment history, and prior/prescribed therapeutic regimens

Exclusion Criteria:

1. Poor patient adherence
2. Investigator-deemed ineligibility for enrollment

Primary outcomes:
measure: Objective Response Rate
timeFrame: up to 24 weeks after enrollment
measure: Safety such as adverse events
timeFrame: up to 4 weeks after the last dose
Secondary outcomes:
measure: Duration of Response
timeFrame: Baseline up to data cut-off(up to approximately 3 years)
measure: Progression-free survival
timeFrame: Baseline up to data cut-off(up to approximately 3 years)
measure: Overall survival
timeFrame: Baseline up to data cut-off(up to approximately 3 years)
Other outcomes:
Locations:
Study officials:
References: