louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00485589: A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM)
Official title: A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab in Combination With Methotrexate (MTX) Compared to MTX Alone in Methotrexate- Naive Patients With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: FILM
RA
anti-CD20
CD20
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Roche Pharma AG
First posted: 2007-06-13
Enrollment: 613
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 will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who are naive to methotrexate. Patients will be randomized to receive placebo, ocrelizumab 200mg i.v. or ocrelizumab 500mg i.v. on Days 1 and 15. Repeat courses of i.v. treatment will be administered at weeks 24, 52 and 76. All patients will receive concomitant methotrexate (7.5 mg escalating to 20mg p.o. weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.


Eligibility criteria: Inclusion criteria:

* Age ≥ 18
* Rheumatoid arthritis for 3 months-5 years
* Naive to methotrexate
* If receiving steroids or NSAIDs, must be on a stable dose for 4 weeks prior to baseline

Exclusion criteria:

* Rheumatic autoimmune disease or inflammatory joint disease other than RA
* Prior receipt of any biologic therapy for RA
* Concurrent treatment with any DMARD

Primary outcomes:
measure: Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 52
timeFrame: Baseline to Week 52
Secondary outcomes:
measure: Percentage of Participants Without Radiographic Progression (RP) at Week 52
timeFrame: Week 52
measure: Percentage of Participants With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Week 52
timeFrame: Baseline to Week 52
measure: Percentage of Participants in Disease Activity Score 28 (DAS28) Remission at Weeks 24 and 52
timeFrame: Week 24 and Week 52
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Wolfgang Dummer, M.D.
role: STUDY_DIRECTOR
References:
citation: Emery P, Rigby W, Tak PP, Dorner T, Olech E, Martin C, Millar L, Travers H, Fisheleva E. Safety with ocrelizumab in rheumatoid arthritis: results from the ocrelizumab phase III program. PLoS One. 2014 Feb 3;9(2):e87379. doi: 10.1371/journal.pone.0087379. eCollection 2014.
Clinical trial NCT01985789: Anti-histamines and Methacholine Challenges.
Official title: The Effect of Antihistamines on Methacholine Challenge Testing in Asthma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: airway hyperresponsiveness
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2013-11-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The asthmatic airway is identified and studied using inhaled agents such as histamine and methacholine. The use of antihistamines prior to the test will inhibit the test result if histamine is used to cause airway constriction. If using methacholine, this may also be true depending on whether old (e.g. benadryl) or new (e.g. desloratadine) antihistamines are used. This study will look at the effect of old and new antihistamines on inhaled methacholine challenge response in individuals with mild asthma.


Eligibility criteria: Inclusion Criteria:

* Baseline forced expiratory volume in 1s (FEV1) of 70% or more of predicted
* Methacholine provocative concentration causing a 20% fall in FEV1 16mg/ml or less
* No respiratory infection or change in allergen exposure for 4 weeks prior to screening and throughout the study
* No significant medical co-morbidities
* allergy

Exclusion Criteria:

* pregnant or breastfeeding females
* unable to withhold antihistamines, anticholinergics, long acting bronchodilators and combination therapies

Primary outcomes:
measure: change in methacholine pc20
timeFrame: change from baseline (pre dose) at 2 hours (post dose)
Secondary outcomes:
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan, Department of Medicine, Division of Respirology, Critical Care and Sleep Medicine
name: Donald W Cockcroft, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05458089: 18F-FDG PET/CT in the Diagnosis of Tuberculous Pericarditis
Official title: 18F-FDG PET/CT in the Diagnosis of Tuberculous Pericarditis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diagnostic Self Evaluation
Lead sponsor: Wuxi No. 4 People's Hospital
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 11
Sex: ALL
Minimum age (years): 48
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 11 patients confirmed with tuberculous pericarditis were enrolled in this study.

Brief summary: A total of 11 patients confirmed with tuberculous pericarditis were enrolled in this study to analyze the diagnostic value of 18F-FDG PET/CT for tuberculous pericarditis.

Detailed description: A total of 11 patients with tuberculous pericarditis, who underwent 18F-FDG PET/CT from January 2015 to February 2022 in the affiliated hospital of Jiangnan university were retrospectively reviewed in this study to analyze the diagnostic value of 18F-FDG PET/CT in tuberculous pericarditis.

Eligibility criteria: Inclusion Criteria:

patients confirmed as tuberculous pericarditis through follow-up.

Exclusion Criteria:

patients confirmed as other pericarditis through follow-up.

Primary outcomes:
measure: the diagnostic sensitivity of 18F-FDG PET/CT for tuberculous pericarditis
timeFrame: 01,2015-02,2022
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04509089: Establishing Correlation Between Non-invasive Pulmonary Blood Pressure Readings and Swan-Ganz Results
Official title: Establishing Correlation Between Non-invasive Pulmonary Blood Pressure Readings and Swan-Ganz Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Lead sponsor: Suremedix Ltd
Sponsor class: INDUSTRY
First posted: 2020-08-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Pulmonary hypertension (PH) is prognostic indicator in heart failure patients for poor outcome, however, it is challenging for monitoring. The current study is designed to explore whether data generated using Suremedix Device including a pump and non-invasive sensors including, chest motion sensor, photoplethysmography (PPG), and Electrocardiography (ECG), can be used to identify detectable oscillations that are correlated with the mean, the diastolic and the systolic pressure values of the pulmonary artery, as measured using the gold-standard Swan-Ganz method.


Eligibility criteria: Inclusion Criteria:

* Heart Failure patient scheduled for right heart catheterization (Swan-Ganz)
* Age range: 18 - 80 years
* Pulmonary artery systolic pressure values ≤50 mmHg according to Swan - Ganz measurement
* Able and willing to sign informed consent

Exclusion Criteria:

* History or current diagnosis of asthma or any other significant pulmonary disease
* Jugular access site
* Atrial fibrillation
* Prior lung volume reduction surgery, lobectomy or pneumonectomy, or lung transplantation
* Requirement for any ventilator support (including CPAP or BPAP)
* Use of long-term oxygen therapy
* Known upper airway obstruction
* Known susceptibility to pneumothorax or pneumothorax in the medical history
* Chest surgery or pacemaker implantation in the prior 6 months
* Significant primary valvular disease
* Major cardiovascular event within the prior 3 months
* Current heavy smoker (more than one pack per day)
* Any diagnosed respiratory tract infection (including upper respiratory tract), airway or lung disease or COPD exacerbation in the prior 3 months
* Female patient pregnant or breast-feeding or planning to be pregnant in the next year
* Diagnosis of Obstructive Sleep Apnea
* Unexplained muscle weakness. Unable to comfortably lie down for 30 minutes
* Current hospitalization due to CHF deterioration
* Patients with a Body Mass Index (BMI) ≥ 40kg/m2
* Any condition that the PI believes could interfere with the intent of the study or would make participation not in the best interest of the patient

Primary outcomes:
measure: Pressure waveform
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Ben Ben Avraham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04139889: Diagnosis of Laryngeal Lesions Using the Probe-based Confocal Laser Endomicroscopy
Official title: The Diagnosis of Laryngeal Lesions Using the Probe-based Confocal Laser Endomicroscopy in Vivo
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Laryngeal Leiomyoma
Probe-based Confocal Laser Endomicroscopy
Keywords: Probe-based confocal laser endomicroscopy
Optical biopsy
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with suspicious unidentified lesions were collected in this study in Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, who need to be underwent microscopic laryngoscopy.

Brief summary: To evaluate the diagnosis of laryngeal lesions using the Probe-based Confocal Laser Endomicroscopy in vivo.

Detailed description: In this study, we will conduct in-vivo confocal laser endoscopic imaging studies of laryngeal and precancerous lesions to explore the value of pCLE in the diagnosis of laryngeal cancers.

Eligibility criteria: Inclusion Criteria:

1. 18≤Male or female age ≤85 years old;
2. patients with vocal cord lesions founded by white light laryngoscope and needed to perform laryngeal microsurgery;
3. Willing and able to comply with study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

1. Male or female \<18 years old, or Male or female \>85 years;
2. The patient has abnormal blood or coagulation function, and there is a risk of bleeding during the examination;
3. The patient has severe cardiopulmonary function or liver and kidney dysfunction and cannot tolerate surgery.
4. The patient has a history of allergies to drugs or food.
5. The patient has a positive serotonin sodium allergy test and is allergic to sodium fluorescein;
6. Lactation or pregnant women.
7. Refusal to sign the informed consent form.
8. Others who do not take this test.

Primary outcomes:
measure: pCLE diagnostic classification
timeFrame: 6 months
Secondary outcomes:
measure: the image analysis by machine learning
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Otorhinolaryngology Department of Eye & ENT Hospital, Fudan University
name: Huawei Li, PhD &MD
role: STUDY_CHAIR
References:
Clinical trial NCT03123289: Novel Gallium 68 Citrate in Orthopedic Infections
Official title: Novel Gallium 68 Citrate in Orthopedic Infections
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Joint Prosthesis
Keywords: PET/CT
68Gallium Citrate
Orthopedic Hardware infection
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Same patients are scanned with two radiotracers within 24-48 hours. Results of the two scans are compared against each other.
Primary purpose: DIAGNOSTIC

Brief summary: In the proposed study, our aim is to evaluate the uptake of 68Gallium-citrate in patients with failed joint prosthesis and compare it with that of conventional 18fluorine-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) scan. We will perform PET/CT scan with 68Gallium citrate and 18F-FDG in subjects with failed hip or knee prosthesis. Both 68Gallium-citrate and 18F-FDG scans, done within 24-48 hours from each other, will be performed within 4 weeks before surgical evaluation/revision of the hardware.


Eligibility criteria: Inclusion Criteria:

* At least 6 months after hip replacement with complaint of joint pain.
* Radiographic studies compatible with prosthesis loosening (i.e. periprosthetic infection or aseptic loosening).
* Pending surgical evaluation and tissue sampling within the next few weeks to differentiate between infection and aseptic loosening.

Exclusion Criteria:

* Inability to consent
* Pregnancy or known or suspected hypersensitivity to metals or gallium
* Joint replacement for any reason other than primary or secondary osteoarthritis
* Prior surgical therapy for prosthesis failure after initial hospital discharge
* Active inflammatory/infectious process at any location other than prosthetic joint (Sarcoidosis, Rheumatoid arthritis, HIV infection, SLE)

Primary outcomes:
measure: 68Gallium-citrate and 18F-FDG uptake (SUV) surrounding the femoral and acetabular components of the prosthesis
timeFrame: 1 year
Secondary outcomes:
measure: Sensitivity, specificity, and accuracy of 68Gallium-citrate and 18F-FDG scans, by using surgical pathology results as the gold standard.
timeFrame: 1 year
Other outcomes:
Locations:
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Nasrin Ghesani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00690989: Retrospective Evaluation of Patient Failure to Follow-up at a Community Based Headache Clinic
Official title: If You Build it, They Will Come; But Will They Return for Follow-up? A Retrospective Assessment of Potential Risk Factors for Patient Failure to Follow-up at a Community Based Headache Clinic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Headache
Keywords: Headache
Adherence
Followup
Lead sponsor: Kilgo Headache Clinic
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-06-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community based headache clinic population

Brief summary: This is a retrospective review of the records of patients seen at the Kilgo Headache Clinic in Alabama between 7/1/05 and 6/30/07. The goal of the study is to identify factors at the time of the initial office visit that can be used to predict failure to follow-up.


Eligibility criteria: Inclusion Criteria:

* Headache
* Initial office visit between 7/1/05 and 6/30/07

Exclusion Criteria:

* None

Primary outcomes:
measure: Adherence to followup recommendations
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kilgo Headache Clinic
name: Gary R. Kilgo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06885489: The Effect of Acceptance and Commitment Therapy-Based Intervention
Official title: The Effect of Acceptance and Commitment Therapy-Based Intervention on Depression, Anxiety, Stress and Psychological Well-Being Levels in University Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorder
Depression Disorders
Stress
Anxiety
Acceptance and Commitment Therapy
Psychological Well-being
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Mental health is essential for students' emotional, cognitive, and social well-being. University life presents significant academic, social, and financial challenges, leading to increased stress, anxiety, and depression. These psychological difficulties negatively impact students' academic performance, relationships, and overall quality of life. Despite these challenges, many students avoid seeking professional help.

Acceptance and Commitment Therapy (ACT) is an effective approach that enhances psychological resilience and helps individuals cope with stress, anxiety, and depression. Instead of changing negative thoughts, ACT fosters psychological flexibility, encouraging individuals to develop a healthier relationship with them. Research supports ACT's effectiveness in reducing psychological distress, improving emotional regulation, and enhancing life satisfaction


Eligibility criteria: Inclusion Criteria:

* ust be currently enrolled as a full-time student at a university.

Exclusion Criteria:

* Individuals with significant cognitive impairments or those unable to understand the study procedures.

Primary outcomes:
measure: Depression, Anxiety and Stress Scale (DASS-21)
timeFrame: 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk Üniversitesi
state: Ağrı
Study officials:
References:
Clinical trial NCT01056289: Study Comparing Discontinuation Symptoms Of DVS SR In Subjects With Major Depressive Disorder (MDD)
Official title: A Randomized, Double-Blind, Parallel Group Study To Compare Discontinuation Symptoms In Abrupt Discontinuation Versus A 1-Week Tapering Regimen In Subjects With MDD Treated For 24 Weeks With Open-Label 50 mg DVS SR Formulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-01-26
Enrollment: 480
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: Study Comparing Discontinuation Symptoms in subjects with Major Depressive Disorder treated for 24 Weeks with Open-label 50 mg Desvenlafaxine Succinate Sustained-Release Formulation (DVS SR)


Eligibility criteria: Inclusion Criteria:

* Primary Diagnosis of Major Depressive Disorder
* Hamilton Psychiatric Rating Scale for Depression-17-Item score of greater than or equal to 14 at baseline

Exclusion Criteria:

* Current psychoactive substance abuse or dependence, manic episode, or a lifetime diagnosis of bipolar or psychotic disorder
* Potentially violent to others or is at significant risk for suicide
* History or current evidence of gastrointestinal disease or history of surgery known to interfere with absorption or excretion
* Known presence of raised intraocular pressure or history of narrow angle glaucoma

Primary outcomes:
measure: Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase
timeFrame: Double-blind phase: Week 1 (Study Day 175), Week 2 (Study Day 182)
Secondary outcomes:
measure: Percentage of Participants With Taper Adverse Events (AEs) in the Double-blind Phase
timeFrame: Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196)
measure: Percentage of Participants Who Were Unable to Successfully Complete Tapering of the Study Drug Because of the Number and/or Severity of Their Discontinuation Symptoms
timeFrame: Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196)
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Ninan PT, Musgnung J, Messig M, Buckley G, Guico-Pabia CJ, Ramey TS. Incidence and Timing of Taper/Posttherapy-Emergent Adverse Events Following Discontinuation of Desvenlafaxine 50 mg/d in Patients With Major Depressive Disorder. Prim Care Companion CNS Disord. 2015 Feb 5;17(1):10.4088/PCC.14m01715. doi: 10.4088/PCC.14m01715. eCollection 2015.
Clinical trial NCT05503589: The Psychological Effect of the Covid-19 Pandemic
Official title: The Psychological Effect of the Covid-19 Pandemic on Turkish Intern Students
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychological Distress
Keywords: psychological distress
Covid-19
saliva cortisol
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: intern students at the Faculty of Health Sciences of Kutahya Health Sciences University

Brief summary: At the end of 2019, the novel coronavirus disease (Covid-19), which emerged in China, has become a public health emergency of international concern. Disease outbreaks both affect the physical and psychological health of individuals. The aim of this study was to investigate the levels of stress, anxiety, depression, and Covid-19 fear in health sciences intern students during the Covid-19 pandemic.


Eligibility criteria: Inclusion Criteria for students:

* be over 18 years old
* have taken the professional practice/internship lecture
* be practicing in the hospital
* not have any disease

Inclusion Criteria for control:

* over the age of 18
* without any disease
* who routinely work during the pandemic

Exclusion Criteria:

* body mass index (BMI) \<17 kg/m2
* any chronic illness, psychological disorder, and perception problem
* be dental operation or significant damage to the teeth or oral mucosa

Primary outcomes:
measure: The Fear of Covid-19 Scale
timeFrame: 5 minutes
measure: Depression Anxiety and Stress Scale
timeFrame: 10 minutes
measure: Saliva cortisol level
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kutahya Health Sciences University- Health Sciences Faculty
Study officials:
affiliation: Kutahya Health Science University
name: Gamze KURT, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: