louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03107299: Evaluation of the Impact of 3 Methods of Communication on the Adherence of Methotrexate in Patients With Rheumatoid Arthritis
Official title: Evaluation of the Impact of 3 Methods of Communication on the Adherence of Methotrexate in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Methotrexate
Polyarthritis; Rheumatoid
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Methotrexate (MTX) is the first-line treatment for rheumatoid arthritis (RA). Poor adherence of this treatment decreases the control of the disease and the effectiveness of the associated treatments.

The aim would be to study the observance of patients with RA and to be able to propose adequate solutions favoring patient compliance and thus the stability of the pathology.

For this purpose, 3 methods of communication have been put in place to encourage adherence: usual care by the rheumatologist, sms sending or pharmaceutical maintenance.


Eligibility criteria: Inclusion Criteria:

* Adult patients attending Day Hospital or consultation of rheumatology with rheumatoid polyarteritis and under treatment with MTX alone or in combination with another therapeutic, fixed dosage for at least 3 months.
* Consenting Patient
* Literate French-speaking patient,
* Patient with a mobile phone
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Patient not managing his own treatment

Primary outcomes:
measure: CQR19 (Compliance Questionnaire Rheumatology) Compliance Measurement Surveywith rheumatoid arthritis.
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
citation: Mary A, Boursier A, Desailly Henry I, Grados F, Sejourne A, Salomon S, Fardellone P, Brazier M, Goeb V. Mobile Phone Text Messages and Effect on Treatment Adherence in Patients Taking Methotrexate for Rheumatoid Arthritis: A Randomized Pilot Study. Arthritis Care Res (Hoboken). 2019 Oct;71(10):1344-1352. doi: 10.1002/acr.23750.
Clinical trial NCT04944199: Asthma Control: Increased Physical Activity in Young Adults
Official title: Impact of Increased Physical Activity in Young Adult Asthmatic Patients on Patient Perception of Pulmonary Health and Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Young Adults
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Investigators want to study to see if patients who participate in a physical activity intervention involving increasing daily step counts will have better mini asthma quality of life questionnaire (Mini AQLQ) scores at the end of the study period compared to patients that are in the control group and do not increase daily step counts. Participants will be randomized into the two groups.

Detailed description: The Control group (usual care group) of 75 patients will not participate in the intervention but will take an asthma control survey at baseline (point of enrollment into the study) and about 4-6 weeks after.

The Intervention group of 75 patients who will participate in the intervention of step counts and take an asthma control survey at baseline (point of enrollment into the study) and about 4-6 weeks after.

Eligibility criteria: Inclusion Criteria:

* Patients within the Geisinger South Wilkes-Barre Primary Care clinic with a diagnosis of mild to moderate asthma

Exclusion Criteria:

* Patients with any medical history which would prohibit their ability to participate in increased exercise, and/or patients that are diagnosed or associated with severe asthma

Primary outcomes:
measure: Change in the Mini Asthma Quality of Life Questionnaire Score as a result of increased physical activity.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Wilkes-Barre
country: United States
facility: Geisinger South Wilkes-Barre Primary Care Clinic
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Jason Woloski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06885099: Ease of Use Study of the FemPulse System
Official title: Ease of Use Study of the FemPulse System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overactive Bladder (OAB)
Keywords: neuromodulation
Lead sponsor: FemPulse Corporation
Sponsor class: INDUSTRY
First posted: 2025-03-20
Enrollment: 20
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to demonstrate that the FemPulse System can be used as indicated

Detailed description: The objective of the study is to demonstrate that the FemPulse System can be used as indicated in the Patient and Clinician Instructions for Use (IFU), as applicable.

Eligibility criteria: Key Inclusion Criteria:

1. Females, defined as a person with a cervix, ≥21 years old, with OAB symptoms, as confirmed by a physician. OAB is defined by urinary urgency, usually with urinary frequency and nocturia, with or without urgency urinary incontinence with symptoms .
2. Able to read, comprehend, and reliably provide informed consent and study-related information.
3. Willing and able to comply with study required procedures and visits

Exclusion Criteria:

1. Any significant pain, neurologic, psychological condition or other factors, that in the investigator's judgment, might confound the protocol study assessments, and adherence to the protocol.
2. Has a metal pelvic implant or an active implantable medical device, including but not limited to a cardiac pacemaker, cardioverter-defibrillator or neurostimulator 3 History of a cardiac condition including, but not limited to, clinically significant abnormal ECG or arrhythmia that may interfere with study participation as determined by investigator.

4. Systemic condition or disease that may interfere with study participation or not an appropriate study candidate, as determined by study investigator.

Primary outcomes:
measure: Patient Usability of System
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Holy Cross Women's Hospital
state: Florida
Study officials:
affiliation: FemPulse Corporation
name: Roshini Jain
role: STUDY_DIRECTOR
References:
Clinical trial NCT05443399: What Makes a Cup, a Cup? Generalizing Novel Words
Official title: Technological Timescales: Identifying the Impact of Digital Media on the Mechanisms of Word Learning. Aim 2: What Makes a Cup, a Cup? Generalizing Novel Words
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-07-05
Enrollment: 212
Sex: ALL
Minimum age (years): 17
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this work is to address increasing concerns about young children's digital media exposure and language outcomes by testing how the times course of word learning unfolds in digital environments and the cascading impact of digital media on vocabulary outcomes. The findings will have important implications for understanding when and where optimal word learning from media can occur.

Detailed description: The goal of the current proposal is to identify how digital media alters the mechanisms of word learning and subsequently impacts the lexical foundation on which a child's vocabulary is built. Specifically, the proposal aims to identify the impact of digital media on 1) the processes underlying real-time word learning, and 2) the processes of language generalization and vocabulary growth. Specific Aim 1 will use a novel word learning task to test children's ability to map and retain new words within and between digital media (2D images on a tablet) and real world objects (3D objects). Specific Aim 2 will probe children's novel label generalization abilities within and between 2D and 3D modalities using a novel noun generalization task. Further, individual differences in a child's prior technology experience will be measured and used to predict overall vocabulary as well as performance within and between each task. This Clinical Trial record focuses on Specific Aim 2.

Eligibility criteria: Inclusion Criteria:

* between 18-30 months old

Exclusion Criteria:

* diagnosed developmental delay or disorder
* exposure to more than 25% of another language

Primary outcomes:
measure: Generalization performance
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Stillwater
country: United States
facility: Oklahoma State University
state: Oklahoma
Study officials:
References:
Clinical trial NCT04857099: Impact of the Navilas ® Micropulse Laser Treatment for Macular Edema Within the CHU Brugmann Hospital Macular Edema
Official title: Retrospective Study Within the Brugmann University Hospital of the Navilas ® Micropulse Laser Treatment for Macular Edema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Edema
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective study including 23 files of patients treated with the Navilas ® micropulse laser, in the period from 04/25/2018 to 11/10/2020

Brief summary: The Navilas® micropulse laser can be used to treat patients with macular edema and good visual acuity, which therefore do not fall within the indications for conventional treatments by intravitreal injections.

The CHU Brugmann Hospital is the only center to own this laser in Belgium.This study aims to evaluate the efficacy of this laser.


Eligibility criteria: Inclusion Criteria:

* Diffuse macular edema without focal edema source accessible by focal laser (e.g. capillary telangiectasia)
* Central retinal thickness ≤ 400microns.
* Patient does not meet the reimbursement criteria for intra-vitreous injections(IVI) of anti-VEGF (eg AV\> 5/10).
* IVI are contraindicated.
* Physician considers that it is preferable to space out the injections because of the side effects (eg. ocular disturbance during IVI, eye pain, sensation of a foreign body, spots in the visual field generating a visual gene etc.)
* Patient wishing to space the anti-VEGF IVI.

Exclusion Criteria:

* Macular edema of a different etiology than diabetic macular edema or venous thrombosis (e.g. cataract extraction, vitreomacular traction, epiretinal membrane etc.)
* Central retinal thickness \> 400 microns.
* The eye presents a focal edematous maculopathy accessible to conventional laser.

Primary outcomes:
measure: Visual acuity
timeFrame: Baseline versus three months after treatment
measure: Retinal thickness change
timeFrame: Baseline versus three months after treatment
measure: Periodicity of anti-VEGF injections
timeFrame: Baseline versus three months after treatment
measure: Scar - assessed by optical coherence tomography
timeFrame: Three months after treatment
measure: Scar - assessed by fluorescein angiography
timeFrame: Three months after treatment
measure: Scar - assessed by auto-fluorescence fundus images
timeFrame: Three months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Roman Kemani
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05169099: Post-operative Results of the Trapezometacarpal (TMC) Prosthesis for Advanced Pre-operative Deformities
Official title: Comparative Study of the Results of Trapeziometacarpal Prostheses According to the Preoperative Deformation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhizarthrosis
Arthritis
Keywords: Trapezometacarpal joint arthritis
Adduction angle <25 degrees
Decrease of the grasping and pinching forces
Z deformity of the thumb
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-12-23
Enrollment: 400
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 operated with trapezometacarpal joint arthroplasty for trapezometacarpal joint arthritis

Brief summary: Trapezometacarpal protheses are implanted for patients with trapezometacarpal arthritis. Having a pre-operative thumb adduction angle of less than 25 degrees with hyperextension, meaning a " Z-deformity " are somehow a reason to go for another surgical treatment: trapezectomy with ligament reconstruction. This study will aim at analyzing the results of another surgical treatment which is the trapezometacarpal arthroplasty in this type of deformities.


Eligibility criteria: Inclusion criteria:

* Patient with TMC joint arthritis
* Patient with adduction \<25 degrees
* Patients with Z deformity
* Patient operated for TMC joint arthroplasty

Exclusion criteria:

- TMC arthroplasty implanted for fractures

Primary outcomes:
measure: Number of Participants with Mobility of the trapezometacarpal joint
timeFrame: 1 day
Secondary outcomes:
measure: Number of Participants with Grasping force measured
timeFrame: 1 day
measure: Number of Participants with Pinching force
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Michel CHAMMAS, PUPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT04717999: Pilot Study of NKG2D CAR-T in Treating Patients With Recurrent Glioblastoma
Official title: Pilot Study of UWNKG2D CAR-T in Treating Patients With Recurrent Glioblastoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Recurrent Glioblastoma
Lead sponsor: UWELL Biopharma
Sponsor class: INDUSTRY
First posted: 2021-01-22
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot phase I study to evaluate the safety and efficacy of NKG2D CAR-T cell therapy in patients with relapsed and/or refractory glioblastoma


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed glioblastoma multiforme (GBM) and are at first or second relapse.
* Hemoglobin ≥ 9.0 g/dl, absolute neutrophil count (ANC) ≥ 1,000 cells/µl, platelets ≥ 125,000 cells/µl
* No active infection of HIV, HTLV and Syphilis
* Adequate renal function
* Adequate hepatic function
* Adequate cardiac function
* Adequate venous access for apheresis, and no other contraindications for leukapheresis
* Voluntary informed consent is given.

Exclusion Criteria:

* Pregnant or lactating women.
* Uncontrolled active infection.
* History of hepatitis B or hepatitis C infection.
* Previously treatment with any gene therapy products or cell therapy product in past 28 days.
* Cannot undergo MRI with contrast or SPECT/CT
* HIV infection.
* Have autoimmune disorders
* Have active infection or inflammatory disorders
* Prescreening test results in expansion rate less than 5 folds
* An allergy to gentamycin and/or streptomycin

Primary outcomes:
measure: Number of Participants who experience a Dose-Limiting Toxicity (DLT)
timeFrame: 2 years
Secondary outcomes:
measure: Overall Response Rate
timeFrame: 1 year
measure: Progression-free survival
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01428999: Effects of Probiotics on Improving the Gastrointestinal Function and Intestinal Bacterial Flora
Official title: Effects of Probiotics on Improving the Gastrointestinal Function and Intestinal Bacterial Flora
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Function
Intestinal Bacteria Flora
Keywords: probiotics
gastrointestinal function
intestinal bacteria flora
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2011-09-05
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of "combined probiotics" to improve the gastrointestinal function and intestinal bacteria flora

Detailed description: Probiotics were known to improve gastrointestinal function before. This is a single-blind placebo control clinical study. We will perform gastrointestinal function questionnaire and collect stool as baseline data before the study (0-week). Then healthy subjects will be randomized to two groups.

Experimental: probiotics 1 pack bid for 3 weeks. Probiotics : (AB-kefir)：Lactobacillus acidophilus,Bifidobacterium longum,Lactobacillus paracasei,Lactobacillus rhamnosus,Lactobacillus fermentum,Streptococcus thermophilus,Lactobacillus helveticus,Kluyveromyces fragilis. Other components include starch,oligosaccharide,yeast powder, superior standard spice， calcium pantothenate， VitB1， VitB12， biotin and folic acid.

Placebo group: placebo 1 pack bid for 3 weeks. Placebo: Except the probiotics (AB-kefir),the other components are the same with study group.

Then gastrointestinal function questionnaire and stool collection will be performed at the end of 1st, 2nd, 3rd, and 4th weeks after starting the study.

Eligibility criteria: Inclusion Criteria:

* Healthy people who are aged between 20 and 40 years

Exclusion Criteria:

* 1. People who use probiotics medication and food that can inhibit bacteria growth within one month before the study 2. People who have active infection 3. People who have active or chronic gastro-intestinal disease 4. People who have diarrhea within two weeks before the study 5. People who are drug or alcohol abuser 6. People who are poor compliance

Primary outcomes:
measure: Changes of gastrointestinal function after probiotics use
timeFrame: 28 days
Secondary outcomes:
measure: Changes of intestinal bacteria flora after probiotics use
timeFrame: 28 days
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng-Kung University Hospital
name: Ming-Cheng Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03723499: Endoscopic Treatment of Bronchial Carcinoid Tumors
Official title: Feasibility and Therapeutic Method of Endoscopic Treatment of Bronchial Carcinoid Tumors: 22 Years Experience of Saint-Etienne
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoid Tumor
Keywords: Carcinoid tumors
Endoscopic treatment
Recurrence
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated by endoscopic approach for a carcinoid tumor will be included.

Brief summary: Carcinoid tumors of the lung are considered to be a low-grade malignancy. Surgical resection is considered the standard approach. Recent data has shown that a complete endoscopic treatment could be considered. An endoscopic treatment is can be a alternative to invasive surgery.

Detailed description: The objective of this study is to evaluate the feasibility and therapeutic method of endoscopic treatment of bronchial carcinoid tumors.

Eligibility criteria: Inclusion Criteria:

* Patients treated by endoscopic approach for a carcinoid tumor at the University Hospital Centre of Saint-Etienne between November 1995 to December 2017.

Exclusion Criteria:

* Patients treated for a recurrence of carcinoid tumor.
* Patients with metastatic disease.

Primary outcomes:
measure: Complete endoscopic treatment
timeFrame: Month 1
Secondary outcomes:
measure: Type of endoscopic method used
timeFrame: Month 1
measure: Tumor localization
timeFrame: Month 1
measure: Deadline before recurrence
timeFrame: 10 years
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Jean-Michel VERGNON, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00242099: Clinical Utility of Monitoring for Human Herpesvirus-6 (HHV-6) and Human Herpesvirus-7 (HHV-7) After Liver Transplant
Official title: The Clinical Utility of Monitoring for Human Herpesvirus-6 (HHV-6) and Human Herpesvirus-7 (HHV-7) After Liver Transplant: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Transplant
Keywords: liver transplant
HHV-6
HHV-7
Human Herpesvirus-6
Human Herpesvirus-7
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2005-10-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Human herpesvirus-6 (HHV-6) and -7 (HHV-7) infections are common after transplantation. Such infections may predispose transplant patients to other infections, contribute to a recurrence of hepatitis C virus, and affect rejection and function of the transplanted liver. Given the significant clinical impact of these viruses, routine laboratory monitoring may be beneficial by identifying patients who have persistent or high levels of infection. In these patients, immunosuppressive medications could be adjusted, or antiviral medications administered. There are currently no randomized trials that address this important question. This prospective, randomized trial will analyze whether routine laboratory monitoring for HHV-6 and -7 is clinically useful, and whether it would improve overall outcomes in transplant recipients.


Eligibility criteria: Inclusion Criteria:

* Male or female patients who fulfill the following criteria are eligible for inclusion:

  * Recipients of a liver transplant
  * Able to give written informed consent
  * Are willing and able to comply with the protocol
  * Age \>= 18 years

Exclusion Criteria:

The following patients are not eligible for inclusion in the study:

* Patients unwilling or unable to give informed consent

Primary outcomes:
measure: Adverse clinic events due to direct or indirect effects.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Atul Humar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Deepali Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fernandez-Ruiz M, Kumar D, Husain S, Lilly L, Renner E, Mazzulli T, Moussa G, Humar A. Utility of a monitoring strategy for human herpesviruses 6 and 7 viremia after liver transplantation: a randomized clinical trial. Transplantation. 2015 Jan;99(1):106-13. doi: 10.1097/TP.0000000000000306.