louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05000138: FDG Digital PET/CT as First Line Investigation for Giant Cell Arteritis
Official title: FDG Digital PET/CT as First Line Investigation for Giant Cell Arteritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Giant Cell Arteritis
Vasculitis
Keywords: FDG PET/CT
digital PET
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 134
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with suspected GCA

Brief summary: Giant cell arteritis (GCA) causes inflammation of the arteries and can lead to serious complications such as blindness, necessitating rapid diagnosis and treatment. Although older technology non-digital PET/CT scans are routinely used for the diagnosis of GCA in large arteries, they have not been able to reliably detect inflammation of the small arteries responsible for blindness. Recent technological advances have enabled PET/CT imaging of millimetric disease in the body, which are now able to resolve small arteries. In the proposed research study, patients who are suspected by their doctors to have GCA will undergo an ultrasound of the temporal arteries, and digital PET/CT scan after injection of radioactive glucose. Digital PET/CT scans will be interpreted for the presence of abnormal uptake in the large and small arteries, as well as for the presence of other causes of the patient's symptoms. The diagnostic accuracy of PET/CT and ultrasound will be evaluated with respect to an expert panel diagnosis of giant cell arteritis and compared. Results will be adjusted for lack of a perfect reference test using advanced statistics. The goal will be to see if digital PET/CT can become a single, integrated test to diagnose this disease.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 50 years, capable and willing to provide informed consent and can tolerate PET/CT.
* ESR ≥ 50 mm/h and/or CRP ≥ 10mg/L within 1 week of PET/CT referral.
* New suspected giant cell arteritis according to at least one of the following criteria:

Cranial GCA symptoms (new-onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, masseter pain on prolonged mastication) PMR symptoms: shoulder and/or hip girdle pain associated with inflammatory stiffness.

Suspected large-vessel vasculitis based on angiography, MRA, or CTA.

Exclusion Criteria:

* Initiation of corticosteroid or immunosuppressive therapy \>4 days before PET/CT.
* Prior TAB or treated GCA with suspected relapse.
* Non-fasting or hyperglycemia (\>11.1 mmol/L) resulting in altered FDG biodistribution.

Primary outcomes:
measure: Diagnostic Performance
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT03015038: Study of the Immune Response in Colon Adenocarcinoma
Official title: Etude De La Réponse Immunitaire Dans L'adénocarcinome Colique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Adenocarcinoma
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: Innate Pharma
First posted: 2017-01-09
Enrollment: 100
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: Patient with colon adenocarcinoma treated by surgery

Brief summary: Duration of each part of the study per patient:

* Screening: From 1 to 4 weeks
* Sampling period (blood and tissue): 1 day
* Follow-up by patient: 60 months
* Total study duration by patient: 84 months
* Total inclusion duration: 24 months
* Total Follow-up duration: 60 months
* Total study duration: 84 months


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 or more.
2. Affiliation to a social security scheme
3. Diagnosis of a colon adenocarcinoma.
4. Patient have signed and dated consent of the study before undertaking procedures related to the study.

Exclusion Criteria:

1. Patients under guardianship / curatorship
2. Following Situations

   * Persons unable to understand, read and / or sign an informed consent
   * Patient with the following functions: investigator or co-investigator, research assistant, pharmacist, study coordinator or having any involvement in the study
   * Uncooperative person or potentially non-compliant for the study and its procedures with predictable difficulties regular monitoring of over 1 year.
   * No affiliation to a social security scheme, a universal medical coverage or any similar plan.
3. Pregnant or lactating women.
4. Patients with HIV seropositivity.
5. Rectal tumor location.

Primary outcomes:
measure: Immune cells trafficking
timeFrame: Day 0
Secondary outcomes:
measure: Infiltration of leucocytes in tumor tissue
timeFrame: Day 0
measure: Safety (Number of adverse events, ECOG status)
timeFrame: After Day 0 until the end of the study (Month 3, Month 6, Month 9, Month 12, Month 15, Month 18,Month 21, Month 24, Month 30, Month 36, Month 42, Month 48, Month 54 and Month 60)
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint Louis
Study officials:
affiliation: Hopital Saint Louis
name: Matthieu Allez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03763838: Acupressure for Fatigue in Ovarian Cancer Survivors
Official title: Acupressure for Fatigue in Ovarian Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Ovarian Cancer
Keywords: Acupressure
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2018-12-04
Enrollment: 170
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to see if accupressure can help reduce the severity of fatigue experienced by ovarian cancer patients. Acupressure involves applying mild to moderate physical pressure by fingers, hand or a device to specific points on the skin to try to bring about a change in the body's functioning, in this case relief from chronic fatigue.


Eligibility criteria: Inclusion Criteria:

* Women aged 21 and older
* Diagnosis of ovarian cancer, stages I to IV
* Have average persistent fatigue defined a \>=4 on the Brief Fatigue Inventory.
* Fatigue must have started at or after the diagnosis of ovarian cancer
* Completed all primary cancer treatments (surgery, chemotherapy at least 6 months prior), except maintenance therapies
* No other planned interventions for fatigue other than current stable medication

Exclusion Criteria:

* Medically unstable
* Acupuncture or acupressure receipt in past year
* Have a diagnosis of untreated mood disorder, e.g., bipolar or major depressive disorder
* Have a current diagnosis of anemia
* Have a current untreated diagnosis of hypothyroidism
* Have an initiation, a cessation or change of treatment of any chronic medications, dietary supplements, behavioral therapy, physical therapy, etc., or any planned change of medications, supplements or therapies during the study
* Have the possibility of becoming pregnant

Primary outcomes:
measure: Change in level of fatigue at week 6
timeFrame: Baseline to week 6
measure: Change in level of fatigue up to week 24
timeFrame: Baseline up to week 24
Secondary outcomes:
measure: Change in quality of life at week 6
timeFrame: Baseline to week 6
measure: Change in quality of life up to week 24
timeFrame: Baseline up to week 24
measure: Change in sleep quality at week 6
timeFrame: Baseline to week 6
measure: Change in sleep quality up to week 24
timeFrame: Baseline up to week 24
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Suzanna M Zick, ND, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zick SM, Kruger G, Harte S, Sen A, Harris RE, Pearce CL. Acupressure for Cancer-fatigue in Ovarian Cancer Survivor (AcuOva) Study: A community-based clinical trial study protocol examining the impact of self-acupressure on persistent cancer-related fatigue in ovarian cancer survivors. Contemp Clin Trials. 2021 Aug;107:106477. doi: 10.1016/j.cct.2021.106477. Epub 2021 Jun 10.
Clinical trial NCT06746038: Evaluation of Extended Wear Hearing Aid for Mild Hearing Loss
Official title: Evaluation of Extended Wear Hearing Aid for Mild Hearing Loss
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sensorineural Hearing Loss
Keywords: extended wear hearing aid
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
Collaborators: name: The Woodlands Hearing Center
First posted: 2024-12-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single group of participants will be fit with the extended wear hearing devices and will be tested in both the aided and unaided conditions in various tasks. Conditions will be counterbalanced and all participants will experience the same conditions. Conditions will include unaided, aided with pre-calculation A, and aided with pre-calculation B.
Primary purpose: TREATMENT

Brief summary: This study will assess the benefit of extended wear hearing aids for subjective listening effort, compared to the unaided condition, in adults with mild sensorineural hearing loss.

Detailed description: This study will assess the benefit of extended wear hearing aids for subjective listening effort, compared to the unaided condition, in adults with mild sensorineural hearing loss. Participants will be experienced hearing aid users who have previously worn or currently wear extended wear hearing devices. The primary objective will be to assess subjective listening effort, compared to unaided.

Eligibility criteria: Inclusion Criteria:

* Meets requirements outlined on Lyric Candidacy Form
* Current Lyric hearing instrument user
* 18 years of age or older at time of enrollment in the study
* Mild sensorineural hearing loss as defined by WHO, 4 frequency PTA of 20-34 dB HL, in the better hearing ear
* Good understanding (read/write/speak) of the English language
* Willingness to comply with all study requirements

Exclusion Criteria:

* Does not meet requirements outlined on Lyric Candidacy Form (see Chapter 9 of the TMF/ISF for SRF-469)
* Difficulty understanding/reading instructions when corrected for vision loss
* Impairments that would restrict participation in any of the evaluations
* Ear health conditions present at baseline that prevent immediate device replacement
* Conditions that would indicate the need for medical referral prior to hearing aid fitting, according to clinic's standard protocol

Primary outcomes:
measure: NASA Task Load Index (NASA-TLX)
timeFrame: Day 1 of 1 day study
Secondary outcomes:
measure: AZBio Speech in noise testing
timeFrame: Day 1 of 1 day study
Other outcomes:
Locations:
city: Shenandoah
country: United States
facility: The Woodlands Hearing Center
state: Texas
Study officials:
References:
Clinical trial NCT00863538: Phase II Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Official title: An Open-label, Phase II Study of KPS-0373 in Patients With SCD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spinocerebellar Degeneration
Keywords: Spinocerebellar degeneration
Thyrotropin-Releasing Hormone (TRH)
SCD
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-03-18
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy, safety and pharmacokinetics profile of KPS-0373 in patients with SCD


Eligibility criteria: Inclusion Criteria:

* SCD with mild to moderate ataxia

Exclusion Criteria:

* Patients with secondary ataxia
* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Primary outcomes:
measure: Scale for the assessment and rating of ataxia (SARA), ADL(Flow-FIM), Patient Improvement Impression
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hokkaido Region
country: Japan
facility: Japan
city: Kansai Region
country: Japan
facility: Japan
city: Kanto Region
country: Japan
facility: Japan
Study officials:
affiliation: Kissei Pharmaceutical Co., Ltd.
name: Yasuhiro Omori
role: STUDY_DIRECTOR
References:
Clinical trial NCT03793738: Anterior Component Separation Versus Posterior Component Separation for Repair of Large Ventral Hernias
Official title: Anterior Component Separation Versus Posterior Component Separation for Repair of Large Ventral Hernias: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Large Midline Ventral Hernia
Keywords: anterior component separation, TAR
Lead sponsor: Tbilisi State Medical University
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates effect of anterior component separation and posterior component separation and transversus abdominis muscle release methods for treatment of midline ventral hernias.

Detailed description: The anterior component separation technique requires an extensive subcutaneous flap elevation, incision of the external oblique aponeurosis, and incision of the posterior rectus sheath.

The posterior component separation technique utilized the retromuscular space, accessed by incising the posterior rectus sheath and dissecting the posterior sheath between the internal oblique and transversus abdominis muscles. Transversus abdominis muscle release dissected the posterior sheath back to the transversus abdominal muscle and accessed the space between muscle and trasversalis fascia.

Eligibility criteria: Inclusion Criteria:

* subject has midline ventral hernia
* patient's approval to participate in the study

Exclusion Criteria:

* strangulated hernia
* patient's preference for either operative technique
* patient's refusal to participate in the study

Primary outcomes:
measure: Hernia recurrence
timeFrame: during 3 year after surgery
Secondary outcomes:
measure: Wound complications
timeFrame: 30 day after surgery
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Tbilisi State Medical University
Study officials:
affiliation: Tbilisi State Medical University
name: Zaza Demetrashvili, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05995938: Mindfullnes-Based Cognitive Therapy Effect
Official title: Mindfullnes-Based in Surgery Patients for Cognitive Therapy Effect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfullnes-Based Cognitive Therapy and Adherence to Immunosuppressive Therapy
Keywords: Liver Recipients
Transplantation
Mindfulness
Lead sponsor: Istanbul Aydın University
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Experimental
Primary purpose: BASIC_SCIENCE

Brief summary: Objective: In this study, the effect of mindfulness-based cognitive therapy on compliance with immunosuppressive therapy in liver transplant patients was evaluated. Method: It was conducted the study in a randomized controlled type with n=120 participation of liver transplant recipients of a transplant hospital. It was applied mindfulness-based cognitive therapy to liver recipients in the experimental group.

Detailed description: It was used simple random sampling method in assigning liver recipients to the experimental and control groups. Discharged liver transplant patients are informed about the use of immunosuppressive drugs and the drug is prescribed. Liver transplant patients drugs.

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria involved (i) being a liver transplant recipient, (ii) currently having immunosuppressive treatment, (iii) being 18 years or older (iv) having no language or communication barrier and (v) agreeing to participate in the study.

Liver transplant recipients

Exclusion Criteria:

* The exact opposite of the inclusion criteria the exclusion criteria.

Primary outcomes:
measure: The Effect of Mindfulness-Based Cognitive after Liver Transplantation
timeFrame: Both groups experiment and control. It was used Mindfullnes scale and immunosuppressive terapy adherence scale. It was done measure before and after Mindfullnes-Based Cognitive Therapy.
Secondary outcomes:
measure: Mindfullnes-Based Cognitive Therapy
timeFrame: total of six month.from 1 october 2022 to 30 Jan 2023
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: the Liver Transplant Hospital affiliated with Turgut Özal Medical Center of İnönü University of Malatya/Turkey.
Study officials:
References:
Clinical trial NCT03297138: Fistula Laser Closure
Official title: Fistula Laser Closure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fistula;Rectal
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 60
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: Patient having a surgical indication using FiLAC laser technique

Brief summary: The anal complex fistula constitutes a challenge in proctologic surgery because of the of its therapeutic care complexity due to the frequency of recurrences and the necessity to protect the sphincter function.

For several years,differents techniques were developed "said sphincter sparing techniques" to handle fistulas at risk on the anal continence.

Recently there is one of them , named FiLAC using a clip system not yet evaluated.

The purpose is to assess the success rate of his new surgery technique.


Eligibility criteria: Inclusion Criteria:

* Patient with anal fistula drained at least 3 months before inclusion.

Exclusion Criteria:

* Fistula not well drained

Primary outcomes:
measure: surgery success rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
References:
Clinical trial NCT05197738: Research Framework Exploring Sleep Health
Official title: Research Framework Exploring Sleep Health
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep
Sleep Apnea
Obesity
Mood
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General adult population.

Brief summary: This is a digital health study in which participants are recruited to collect sleep and activity data from digital activity trackers. We are also collecting survey/questionnaire data on baseline health and sleep characteristics as well as bi-weekly assessments of sleep quality and mood. Overall, we aim to examine how sleep relates to physical and mental health in a large population of activity tracker users.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Residing within the United States
* Ability to use the REFRESH app on the participant's own smartphone device

Exclusion Criteria:

* In-ability to consent

Primary outcomes:
measure: Patient Health Questionnaire 9
timeFrame: Administered one time at enrollment
measure: Bi-weekly mood scores
timeFrame: Averaged bi-weekly over a two month period
measure: Subjective sleep quality
timeFrame: Averaged bi-weekly over a two month period
measure: Change in BMI
timeFrame: Measured as the difference between BMI reported at the beginning of the study and at the two-month mark.
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Research Institute
state: California
Study officials:
affiliation: Scripps Research Institute
name: Stuti Jaiswal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01080638: Intracoronary Bolus Only Compared With Intravenous Bolus and 12-hours Infusion of Abciximab in Non-ST Elevation Myocardial Infarction.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Myocardial Infarction
Angioplasty
Keywords: abciximab
Myocardial Infarction
angioplasty
Platelet
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2010-03-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intracoronary bolus Abciximab single is non-inferior to intravenous and continuous 12- hours infusion in the size reduction of infarction on cardiac magnetic resonance in Non-ST elevation Myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* non-ST segment elevation acute myocardial infarction
* within 48 hours presence of chest pain
* Troponin-T or I positive before CAG
* First myocardial infarction
* will be performed coronary angioplasty

Exclusion Criteria:

* under 18 years of age,80 years or older
* Bleeding tendency
* History of major surgery within 4 weeks
* Major stroke within 2 years
* Thrombocytopenia (\<120,000 / uL)
* Cardiogenic shock
* Known allergy to aspirin, heparin, or abciximab
* Contraindication of MRI at study entry (implanted pacemakers, defibrillators, intracranial metallic implants etc)
* Chronic atrial fibrillation
* Pregnancy

Primary outcomes:
measure: In cardiac MRI- infarct size (total late enhancement volume at day 3-7)
timeFrame: day 3~7 after percutaneous coronary intervention
Secondary outcomes:
measure: in-hospital and after 1-months:the major adverse cardiovascular events : death, myocardial infarction, hospitalization for heart failure, myocardial ischemia, etc.
timeFrame: 1 month
measure: b. major bleeding : Hemoglobin 4 or more reduction, 2-unit If you need more than two RBC transfusions, intracranial or retroperitoneal bleeding, urgent operation for bleeding complication.
timeFrame: 1 month
measure: TIMI III flow count /myocardial blush score after PCI
timeFrame: 1 day
measure: At cardiac MRI : LV ejection fraction,LV end-systolic volume,LV end diastolic volume,regional wall motion score index
timeFrame: 1 week
measure: Discharge, 1- month after comparing NT-proBNP
timeFrame: 1 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital
Study officials:
affiliation: Assistant professor, Cardiology, Department of internal medicine,Seoul National University Hospital
name: Hyun-Jae Kang, Prof
role: STUDY_DIRECTOR
References: