louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06546345: Post Market Clinical Follow-Up KeriFlex®
Official title: Effectiveness and Safety of the Silicone Joint Implant KeriFlex® and of Its Associated Instruments in the Treatment of MCP and PIP Arthritis: Post Market Clinical Follow up
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatoid Arthritis
Degenerative Arthritis
Traumatic Arthritis
Lead sponsor: Keri Medical SA
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any type of population requiring a surgical procedure covered by the device and presenting bone quality deemed satisfactory by the surgeon.

Brief summary: The general objective of this study is to assess the performance and safety of the KeriFlex® silicone joint implant and its associated instruments, used in accordance with the labeling and instructions in force.

The performance and safety of the KeriFlex® joint implant will be established in the short and long term with regard to the life cycle of the implant.


Eligibility criteria: Inclusion Criteria:

* Adult patients (age ≥ 18 years)
* Patients who are going to undergo arthroplasty of the metacarpophalangeal or proximal interphalangeal joint using a KeriFlex® implant in accordance with the instructions for use and the labelling in force.
* Patients with rheumatoid arthritis, osteoarthritis or post-traumatic osteoarthritis

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patients with an intellectual disability who cannot follow their surgeon's instructions
* Patients with general surgery contraindications and particularly to the implantation of a KeriFlex® implant
* Patients with acute or chronic, local or systemic infections
* Metacarpal or phalanx destruction or poor bone quality preventing adequate fixation
* Muscle loss, alteration or vascular deficiency in the affected finger
* Patients with significant physical activity involving treated joint
* Children, young growing patients with open epiphyses

Primary outcomes:
measure: Assessment of the effectiveness of the KeriFlex® implant in improving the functional results of the hand
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon Cedex
country: France
facility: CHU Jean Minjoz
city: Lesquin Cedex
country: France
facility: Clinic Lille Sud
city: Pessac
country: France
facility: Institut aquitain de la main et du membre supérieur
Study officials:
References:
Clinical trial NCT05859945: Navigating the Clinical Trial Process for Hepatocellular Carcinoma
Official title: A Critical Analysis of Hepatocellular Carcinoma Trials: Perspectives From Patient Experiences
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with hepatocellular carcinoma who are actively considering participating in an observational clinical study, but have not yet completed enrollment and randomization.

Brief summary: Clinical trials can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical study, both positive and negative.

The goal is to identify the obstacles and challenges that prevent participation in hepatocellular carcinoma clinical research, as well as the reasons for withdrawal or discontinuation.

Insights gained from this study will ultimately benefit those with hepatocellular carcinoma who may be invited to participate in clinical research in the years to come.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with hepatocellular carcinoma
* Willing to comply with all study related procedures and assessments
* Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and in the protocol

Exclusion Criteria:

* No documented diagnosis of hepatocellular carcinoma
* Any serious and/or unstable pre-existing medical disorders
* Pregnant or lactating woman

Primary outcomes:
measure: Rate of patients who decide to enroll in a hepatocellular carcinoma clinical study.
timeFrame: 3 months
measure: Number of hepatocellular carcinoma study participants who remain in clinical trial until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Frenette C, Gish R. Targeted systemic therapies for hepatocellular carcinoma: clinical perspectives, challenges and implications. World J Gastroenterol. 2012 Feb 14;18(6):498-506. doi: 10.3748/wjg.v18.i6.498.
citation: Haber PK, Puigvehi M, Castet F, Lourdusamy V, Montal R, Tabrizian P, Buckstein M, Kim E, Villanueva A, Schwartz M, Llovet JM. Evidence-Based Management of Hepatocellular Carcinoma: Systematic Review and Meta-analysis of Randomized Controlled Trials (2002-2020). Gastroenterology. 2021 Sep;161(3):879-898. doi: 10.1053/j.gastro.2021.06.008. Epub 2021 Jun 12.
citation: Luo XY, Wu KM, He XX. Advances in drug development for hepatocellular carcinoma: clinical trials and potential therapeutic targets. J Exp Clin Cancer Res. 2021 May 18;40(1):172. doi: 10.1186/s13046-021-01968-w.
Clinical trial NCT05079945: Tractography and Diffusion Tensor Imaging of the Human Spinal Cord in Healthy Subjects : Anatomical Atlas
Official title: Tractography and Diffusion Tensor Imaging of the Human Spinal Cord in Healthy Subjects : Anatomical Atlas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteer
Keywords: Tractography, DTI, MRI, spinal cord
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Today, Spinal cord pathologies, whether are tumoral, vascular, traumatic, malformative, inflammatory, or degenerative still constitute a major medico-surgical challenge due to the particular anatomy of the spinal cord. Indeed, the spinal fibers (whether they have a sensory or motor function) are all condensed in an extremely small volume. To date, there is no reliable technique to know the precise position of the spinal tracts specifically involved in the sensory and motor functions of the upper and lower limbs.

The purpose of this study is to evaluate the feasibility for differentiating spinal tracts by tractography from a cerebral Diffusion tensor imaging (DTI) Magnetic Resonance Imaging (MRI) sequence (associated with an anatomical sequence) by performing a stitching process with spinal cord DTI MRI sequence, in healthy subjects. The criterion of differentiation of the tracts will be assessed by highlighting already known cerebral tracts (cortico-spinal fibers, spinothalamic, posterior cord) and which will be monitored at the spinal level.


Eligibility criteria: Inclusion Criteria:

* patient\> 18 years old
* Healthy volunteer
* Social insured in France
* Patient who signed the informed consent of the study

Exclusion Criteria:

* Medical or surgical history of disease that may affect the central nervous system, or the spine
* History of spine or spinal cord trauma.
* Spinal osteoarthritis which can lead to a medullary hyper signal.
* Contraindication to MRI: claustrophobia, pace-maker, defibrillator, metallic foreign bodies, etc.
* Subjects benefiting from legal protection (curatorship, guardianship or safeguard of justice).
* Pregnant and / or breastfeeding woman.

Primary outcomes:
measure: Spinal tracts differentiation and identification
timeFrame: date of Tractography procedure (DTI MRI)
Secondary outcomes:
measure: Spinal cord Tracts Atlas
timeFrame: 12 months (end of recruitment and exams)
Other outcomes:
Locations:
city: Bron
country: France
facility: Dauleac Corentin
Study officials:
affiliation: Hospices Civils de Lyon
name: DAULEAC Corentin, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04740645: NOCDURNA PASS Study Using Registries in Denmark, Germany and Sweden
Official title: Post-authorisation Safety Study of NOCDURNA for the Symptomatic Treatment of Nocturia Due to Idiopathic Nocturnal Polyuria: A Multi-country Cohort Study Using Secondary Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Drug Event
Keywords: Nocturia
NOCDURNA
Post-authorisation Safety Study
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-02-05
Enrollment: 1099545
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with nocturia due to idiopathic nocturnal polyuria or treatment for LUTS.

Brief summary: A study using medical records to evaluate safety issues for the NOCDURNA drug using national register data from Denmark and Sweden, and a health care register covering parts of Germany.


Eligibility criteria: Inclusion Criteria:

* Usage of NOCDURNA recorded as dispensations from drugstores in adults or or usage of drugs for LUTS.

Exclusion Criteria:

* Multiple dispensation of NOCDURNA on the same day or treatment with vasopressin 6 months before study start.

Primary outcomes:
measure: Incidence rate of symptomatic hyponatraemia
timeFrame: Through study completion, typically 2 months
Secondary outcomes:
measure: Incidence rate of hyponatraemia requiring hospital intensive care
timeFrame: Through study completion, typically 2 months
measure: Incidence and severity of clinically significant hyponatraemia
timeFrame: Through study completion, typically 2 months
measure: Rate of all-cause mortality
timeFrame: Through study completion, typically 2 months
measure: Incidence rate of major adverse cardiovascular events (MACE)
timeFrame: Through study completion, typically 2 months
measure: Incidence rate of major venous thromboembolic events (VTEs)
timeFrame: Through study completion, typically 2 months
measure: Incidence rate acute exacerbation of congestive heart failure
timeFrame: Through study completion, typically 2 months
measure: Incidence of serious adverse events of MACE and VTE in Sweden
timeFrame: Through study completion, typically 2 months
Other outcomes:
Locations:
city: Bremen
country: Germany
facility: German health care register, BIPS (there may be other sites)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References:
Clinical trial NCT02782845: An Expanded Access Program of Pegfilgrastim (Neulastim) in Participants With Non-Hodgkin's Lymphoma (NHL)
Official title: Expanded Access Program of Pegfilgrastim in Patients With Non-Hodgkin Lymphoma (NHL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-05-25
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the prophylactic effect of pegfilgrastim (Neulastim) on febrile and/or Grade IV neutropenia in participants receiving chemotherapy (CT) or immunochemotherapy (ICT) as first or second line treatment for NHL. Pegfilgrastim will be administered at a fixed dose of 6 milligrams (mg) subcutaneously 24 hours after the last dose of CT or ICT in each treatment cycle.


Eligibility criteria: Inclusion Criteria:

* NHL supported by an Immunohistochemical report
* Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to (\>/=) 2
* Total serum bilirubin less than (\<) 2 times upper limit of normal (ULN)
* Absolute neutrophil count (ANC) greater than (\>) 2 x10\^9 per liter (/L)

Exclusion Criteria:

* Bone marrow compromised \> 10 percent (%)
* Any malignant myeloid condition
* Active infections requiring systemic anti-infectious therapies (antibiotics, antifungal drugs, antiviral drugs) within 72 hours prior to CT or ICT initiation
* Known hypersensitivity reactions to Escherichia coli derived products
* Pregnant or nursing participants. Women with childbearing potential should use a safe contraceptive method

Primary outcomes:
measure: Percentage of Participants with Febrile Neutropenia (Absolute Neutrophil Count [ANC] <0.5x10^9/L and Temperature ≥38 degrees Celsius) And/Or Grade IV Neutropenia (ANC<0.5x10^9/L) in Cycle 1
timeFrame: Cycle 1 (Up to 21 days)
Secondary outcomes:
measure: Percentage of Participants with Febrile Neutropenia (ANC <0.5x10^9/L and temperature ≥38 degrees Celsius) And/Or Grade IV Neutropenia (ANC<0.5x10^9/L) in Cycles 2 to 6
timeFrame: Cycles 2 to 6 (Up to 105 days)
measure: Percentage of Participants with Adverse Events
timeFrame: up to approximately 1.5 years
Other outcomes:
Locations:
city: Bogota
country: Colombia
city: Chihuahua
country: Mexico
city: Chihuahua
country: Mexico
city: Estado de Mexico
country: Mexico
city: Guadalajara
country: Mexico
city: Leon
country: Mexico
city: Leon
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Obregon
country: Mexico
city: Puebla
country: Mexico
city: Queretaro
country: Mexico
city: Tepic
country: Mexico
city: Toluca
country: Mexico
city: Veracruz
country: Mexico
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT00238745: Study Evaluating Bazedoxifene Dose-Response in Japanese Patients With Postmenopausal Osteoporosis.
Official title: Bone Mineral Density Increase and Safety of TSE-424 Compared to Placebo in Osteoporotic Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postmenopausal Osteoporosis
Keywords: Postmenopausal Osteoporosis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-13
Enrollment: 375
Sex: FEMALE
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Dose-response in Japanese patients with postmenopausal osteoporosis.


Eligibility criteria: Inclusion Criteria:

* Must be postmenopausal and diagnosed as osteoporosis based on bone mineral density and/or vertebral fracture.

Exclusion Criteria:

* Diseases which possibly induce secondary osteoporosis or osteopenia and affect on bone metabolism.

Primary outcomes:
measure: Bone mineral density of lumbar spine (L1-L4) at 2 years.
Secondary outcomes:
measure: Bone metabolic makers, bone fracture, bone mineral density of lumbar spine (L2-L4) and lip, lipid parameters, height and adverse events.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Itabashi A, Yoh K, Chines AA, Miki T, Takada M, Sato H, Gorai I, Sugimoto T, Mizunuma H, Ochi H, Constantine GD, Ohta H. Effects of bazedoxifene on bone mineral density, bone turnover, and safety in postmenopausal Japanese women with osteoporosis. J Bone Miner Res. 2011 Mar;26(3):519-29. doi: 10.1002/jbmr.252.
Clinical trial NCT02420145: Yoga for Abdominal Obesity
Official title: Randomized-controlled Trial of Yoga for Women With Abdominal Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Abdominal
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized trial is to investigate the effects of a 12-week yoga intervention compared to no specific intervention on weight-related outcomes, well-being, and health behaviour in 60 females with abdominal obesity.


Eligibility criteria: Inclusion Criteria:

* Waist circumference at least 88cm
* Body mass index at least 25
* Sedentary
* Physical and mental ability to participate in the yoga intervention
* Willingness to participate in at least 18 of 24 yoga sessions and the whole-day workshop

Exclusion Criteria:

* Dementia
* Psychosis
* Severe hypertension (diastolic blood pressure more than 120mmHg)
* Type 1 diabetes or insulin-dependent 2 diabetes
* Coronary artery disease
* Myocardial infarction
* Lung embolism
* Stroke
* Regular physical activity or yoga practice
* Pregnancy

Primary outcomes:
measure: Waist circumference
timeFrame: Week 12
Secondary outcomes:
measure: BMI
timeFrame: Week 12
measure: Body weight
timeFrame: Week 12
measure: Quality of life
timeFrame: Week 12
measure: Self esteem
timeFrame: Week 12
measure: Body awareness
timeFrame: Week 12
measure: Body responsiveness
timeFrame: Week 12
measure: Perceived stress
timeFrame: Week 12
measure: Health-specific self-efficacy
timeFrame: Week 12
measure: Fruits and vegetables consumption
timeFrame: Week 12
measure: Physical activity
timeFrame: Week 12
measure: Adherence
timeFrame: Week 12
measure: Adverse events
timeFrame: Week 12
measure: Qualitative interview
timeFrame: Week 12
measure: Waist-hip ratio
timeFrame: Week 12
measure: Bioelectrical impedance analysis
timeFrame: Week 12
measure: Systolic blood pressure
timeFrame: Week 12
measure: Diastolic blood pressure
timeFrame: Week 12
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
Study officials:
References:
Clinical trial NCT03622645: An Objective Measurement Method With The Leap Motion Sensor For Hand And Wrist's Range Of Motion
Official title: Developing An Objective Measurement Method With The Leap Motion Sensor For Hand And Wrist's Range Of Motion: Validity And Reliability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Range of Motion
Keywords: Range of motion
Wrist
Hand
Finger
Measurement
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study was to develop a low cost, clinically easy to use measurement method with the Leap motion sensor for objectively evaluating range of motion (ROM), and to investigate the validity and reliability of this application.

Detailed description: . Wrist flexion / extension, radial / ulnar deviation, supination / pronation, 1.-5. of the fingers DIP, PIP and MCP flexion / extension ROM measurements will be made with universal goniometer and developed Leap motion sensor (LMC) based measurement method.

The study consists of two basic steps:

1. Development of measurement method with LMC Identification of normROM measurement procedure Identification of ROM measurement reporting Establishing the precursor version of the software of the measurement method Checking ROM measurement performance criteria and providing feedback Measuring the movement defined on 5 persons and providing feedback Creation of the last available version of the measurement method
2. Validity and reliability study Measurements of hand and wrist ROM with developed measurement method with LMC and universal goniometer for three times and calculation mean of three measurement for two methods

Eligibility criteria: Inclusion Criteria:

* Healthy individuals

Exclusion Criteria:

* Have any hand/wrist problems between the ages of 18-40 years.

Primary outcomes:
measure: Range of Motion
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Arman N, Oktay AB, Tarakci D, Tarakci E, Akgul YS. The validity of an objective measurement method using the Leap Motion Controller for fingers wrist, and forearm ranges of motion. Hand Surg Rehabil. 2021 Sep;40(4):394-399. doi: 10.1016/j.hansur.2021.03.007. Epub 2021 Mar 26.
Clinical trial NCT06776445: Gabapentin Alone and in Combination With Carvedilol for the Treatment of Rosacea-Associated Flushing and Erythema:a Randomized Controlled Clinical Trial
Official title: Gabapentin Alone and in Combination With Carvedilol for the Treatment of Rosacea-Associated Flushing and Erythema:a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rosacea
Rosacea Subtype 1 (Erythematotelangiectatic)
Keywords: rosacea
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if Gabapentin works to treat flushing/erythema associated with rosacea. It will also learn about the safety of drug Gabapentin. The main questions it aims to answer are:

* Does drug Gabapentin reduce flushing and erythema associated with rosacea?
* What medical problems do participants have when taking drug Gabapentin? Researchers will compare Gabapentin to a positive control (minocycline plus hydroxychloroquine, a first-line treatment for rosacea) to see if drug Gabapentin works to reduce flushing and erythema associated with rosacea


Eligibility criteria: Inclusion Criteria:

* Initial treatment in our hospital; ② Diagnosed by two experienced dermatologists and in accordance with the updated diagnostic criteria of the National Rosacea Society (NRS) Expert Committee \[38\], unconscious disorder and no communication disorder; ③ did not receive any other form of treatment within 4 weeks; ④ Patients who were followed up for 8 weeks or more and had complete clinical data; ⑤ Informed consent was signed before treatment, and the clinical data were agreed to be used for scientific research

Exclusion Criteria:

① received other treatment within 4 weeks of this treatment; ② facial flushing caused by other diseases and local irritation; ③ Patients with contraindication to minocycline, hydroxychloroquine, gabapentin and carvedilol; ④ Unable to complete follow-up and serum specimen collection; ○5 patients were intolerant to minocycline, hydroxychloroquine and carvedilol; ○6 Lactation, pregnancy, liver and kidney dysfunction, psychiatric diseases, cardiovascular and cerebrovascular diseases, systemic lupus erythematosus and other systemic diseases.

Primary outcomes:
measure: the score of CEA ( Clinician Erythema Assessment )
timeFrame: 4 weeks, 8 weeks, 12 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: First Affiliated Hospital of Chongqing Medical University
Study officials:
References: