louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01961505: Topical Compound Tripterygium Wilfordii Hook F for Patients With Active Rheumatoid Arthritis
Official title: A Randomized Controlled Study to Determine the Effects and Safety of Topical Compound Tripterygium Wilfordii Hook F in Patients With Active Rheumatoid Arthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Active Rheumatoid Arthritis
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2013-10-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rheumatoid Arthritis (RA) is an autoimmune disease that results in a chronic inflammatory disorder that may affect many synovial joints, and may cause serious disability. It has been confirmed that Tripterygium wilfordii Hook F has effects of anti-inflammatory, immunosuppressive and cartilage protection. This is a prospective randomized controlled study to evaluated the efficacy and safety of external application with compound Tripterygium wilfordii Hook F in treating of patients with rheumatoid arthritis (RA).


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of rheumatoid arthritis, as defined by the American Rheumatism Association 1987 Revised Criteria or European League Against Rheumatism criteria (2009).
* Patients must have moderately to severely active RA,and the DAS-28 score should be from 3.2 to 5.1.
* If taking disease modifying antirheumatic drug (DMARDs)(e.g.Methotrexate), subject must have been on a stable dose for ≥ 3 months prior to randomization.
* If taking non-steroidal anti-inflammatory drugs (NSAIDs), subject must have been on a stable dose for ≥ 4 weeks prior to randomization.
* 16 to 65 years old, having signed the informed consent.

Exclusion Criteria:

* Patients who have skin burst or allergies.
* Patients with sever diseases in Cardiovascular, brain, lung, liver, kidney and hematopoietic system.
* Patients who have been treated by tripterygium, hormones or biological agents.
* Patients who have not been treated by DMARDs before.
* Patients who are unwilling to comply with all study procedures.

Primary outcomes:
measure: ACR20 criteria
timeFrame: Week 4
Secondary outcomes:
measure: ACR50 criteria
timeFrame: Week 4
measure: 28-joint count Disease Activity Score (DAS28)
timeFrame: Baselin and week 4
Other outcomes:
Locations:
Study officials:
affiliation: Guang'anmen Hospital
name: Quan Jiang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01938105: Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer
Official title: Preoperative Concurrent Chemoradiotherapy Combined With Nimotuzumab Injection for Locally Advanced Cervical Cancer: a Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Locally Advanced Cervical Cancer
Keywords: Cervical cancer
Nimotuzumab
Intensity-modulated radiation therapy
Concurrent chemoradiotherapy
Lead sponsor: People's Hospital of Guangxi Zhuang Autonomous Region
Sponsor class: OTHER
Collaborators: name: Wu Jieping Medical Foundation
First posted: 2013-09-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the feasibility and efficacy of preoperative nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable, locally advanced cervical cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically proven squamous cell cervical cancer
* Stages IB2-IIIB according to FIGO Staging System
* Age:18-75
* ECOG\<2
* Normal bone marrow function
* Initial assessed and considered not candidates for operation
* Signed study-specific consent form

Exclusion Criteria:

* Pregnant or lactating women
* Patients with other malignancies
* Patients who received radiotherapy or chemotherapy previously
* Presence of uncontrolled life-threatening illness
* Allergy to platinum or monoclonal antibody

Primary outcomes:
measure: Treatment related toxicities
timeFrame: at 1 year
measure: Tumor response after preoperative treatment
timeFrame: assessed at 4-5 weeks after the completion of preoperative treatment
Secondary outcomes:
measure: Progression-free survival
timeFrame: at 1 year
measure: Overall survival
timeFrame: at 1 year
Other outcomes:
Locations:
city: Nanning
country: China
facility: People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
Study officials:
affiliation: People's Hospital of Guangxi Zhuang Autonomous Region
name: Heming Lu, MS
role: STUDY_CHAIR
affiliation: People's Hospital of Guangxi Zhuang Autonomous Region
name: Heming Lu, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: People's Hospital of Guangxi Zhuang Autonomous Region
name: Yun Mo, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03784105: Codeine on Pharyngeal and Esophageal Motility
Official title: Effect of Codeine on Pharyngeal and Esophageal Motility in Healthy Subjects: a Double-blind, Placebo-controlled, Randomized, Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Esophageal Motility Disorders
Keywords: codeine
Esophageal motility
Pharyngeal motility
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-12-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blind, placebo-controlled, randomized, cross-over study in healthy volunteers
Primary purpose: OTHER

Brief summary: Opioids act on opioid receptors located in the brain as well as in the gastrointestinal (GI) tract to induce changes in motility. A variety of studies have linked chronic opioid use with changes in intestinal and to a lesser extent esophageal motility. Less is known about acute administration effects on distal esophageal motility and LES and even less with respect to proximal esophagus, UES and pharynx. Codeine, an opioid receptor agonist, by acting both centrally as well as in the periphery may induce changes in parts of the GI tract implicated in deglutition. Therefore, to evaluate the hypothesis the researchers will study motility patterns in the pharynx, UES, proximal and distal esophagus and LES in 22 healthy volunteers receiving placebo or codeine (60 mg) in a double-blind randomized cross-over controlled fashion. Motility patterns will be studied using state-of-the-art criteria and analytic tools (Chicago 3.0, AIMPlot analysis).


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers aged between 18-60 years old
* Written informed consent

Exclusion Criteria:

* No chronic disease/medication
* No GI symptoms
* Not pregnant or breast-feeding
* No history of head/neck surgery
* Not allergic to codeine

Primary outcomes:
measure: Difference in distal contractile integral
timeFrame: 1 week
measure: Difference in integrated relaxation pressure
timeFrame: 1 week
measure: Difference in distal latency
timeFrame: 1 week
measure: Difference in pressure flow
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Jan Tack
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
citation: Geeraerts A, Geysen H, Ballet L, Hofmans C, Clevers E, Omari T, Manolakis AC, Mols R, Augustijns P, Vanuytsel T, Rommel N, Tack J, Pauwels A. Codeine induces increased resistance at the esophagogastric junction but has no effect on motility and bolus flow in the pharynx and upper esophageal sphincter in healthy volunteers: A randomized, double-blind, placebo-controlled, cross-over trial. Neurogastroenterol Motil. 2021 May;33(5):e14041. doi: 10.1111/nmo.14041. Epub 2020 Nov 24.
Clinical trial NCT03058705: Near Infrared Fluorescence Imaging for Bladder Cancer Detection
Official title: Pilot Study: Assessing Near Infrared Fluorescence Imaging Medical Technology for the Detection of Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Imagin Medical
First posted: 2017-02-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The primary outcome of this study is to determine the minimal dwell time needed for adequate detection of hexaminolevinulate HCL avid tumors using protoporphyrin IX (PpIX) near infrared fluorescence (NIRF).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of bladder mass on office cystoscopy suspicious for malignancy, either newly diagnosed or a recurrent tumor.
* Planned transurethral resection of bladder tumor in the operating room.
* Ability to give informed consent.
* Willing to spend time for the study
* Men or women (age 18 or older)
* Any racial or ethnic origin

Exclusion Criteria:

* Pregnancy
* Nursing mother
* Diagnosis of porphyria
* Gross hematuria
* BCG immunotherapy or intravesical chemotherapy within the past 90 days
* Known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid

Primary outcomes:
measure: Minimal Dwell Time
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Edward M Messing, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03378505: Impact of Mobile App on Purpose and Well-Being Among College Students
Official title: Living Purposefully: The Role of Mobile App JOOL in Promoting Well-being and Academic Success
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to two conditions. Half of the participants will be required to use a daily check-in mobile app that promotes alignment of daily behaviors with their individualized life purpose. The other half of participants will complete brief bi-weekly reflections. Alternative assignment provided for non-participating students.
Primary purpose: BASIC_SCIENCE

Brief summary: This study will examine the impact of a mobile app (JOOL) focused on promoting purposeful living on student health behaviors, academic performance, self-regulation, well-being, resiliency, and self-efficacy.

Detailed description: Participants will be recruited from a large undergraduate classroom. Participants will be randomly assigned to one of two conditions and asked to complete either online reflections or engage with a mobile app over the course of the semester. Students who elect to not participate will be provided an alternate assignment to complete, to be coordinated by their teaching assistant. Participants will additionally be asked to complete (1) a pre-survey, (2) post-survey, and follow-up survey 14 days after the class concludes. The study will examine changes in health-related behaviors, resiliency, well-being, and self-efficacy reported between the start and conclusion of semester/study.

Eligibility criteria: Inclusion Criteria:

* Minimum age of 18 years
* Enrolled in Consuming Happiness course during the Spring 2017-18 semester.
* Must have access to WiFi, cellular service or computer with internet connection and web browser.

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in Health Behaviors
timeFrame: 14 weeks post start (1 semester)
measure: Change in Resiliency
timeFrame: 14 weeks post start (1 semester)
measure: Change in Self-Regulation
timeFrame: 14 weeks post start (1 semester)
measure: Change in belief of ability to perform difficult tasks or cope with diversity
timeFrame: 14 weeks post start (1 semester)
measure: Change in Well-Being
timeFrame: 14 weeks post start (1 semester)
Secondary outcomes:
measure: Change in Health Behaviors
timeFrame: 14 days (2 weeks) after end of study (16 weeks post start)
measure: App Perceptions
timeFrame: 14 days (2 weeks) after end of study (16 weeks post start)
Other outcomes:
Locations:
city: Madison
country: United States
facility: School of Human Ecology
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Charles Raison, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04842305: Mucosal Immunity in Terms of SARS-CoV-2 Antibodies in Saliva After COVID-19 Infection and Vaccination
Official title: Induction of SARS-CoV-2 Spike Glycoprotein Antibodies in Saliva and Plasma in Response to a COVID-19 Infection, Systemic COVID-19 Vaccination, and the Combination of COVID-19 and Vaccination
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: sars-cov-2 antibodies
saliva
mucosal immunity
vaccination
covid19
spike glycoprotein
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who belong to one of the following four groups will be included G1=SARS-COV-2 Naïve (=Not SARS-CoV-2 vaccinated and COVID-19 negative), G2=COVID-19 convalescents, G3=Vaccinated with Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1-S vaccine, G4=COVID-19 positive and vaccinated with Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1-S vaccine

Brief summary: The Primary Objective of This Single-center Study is to Investigate the SARS-CoV-2 Spike Glycoprotein RBD Antibody Concentration in Saliva and Serum in Healthy Non Vaccinated and Non-SARS-CoV-2 Infected, COVID-19 Convalescents, Persons Vaccinated With Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1 nCov-19 AZD1222 Vaccines, and Convalescent COVID-19 Patients That Have Subsequently Been Vaccinated. A Potential Difference in the Immunoglobulin Concentrations of the Pfizer-BioNTech BNT162b2 Vaccine, Moderna mRNA-1273 vaccine and the AstraZeneca ChAdOx1-S Vaccine Will be Uncovered. This Knowledge About the Mucosal Immunity Will be Important for Further Designing of Vaccine Strategies.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Both Hospital staff as well as non-health care workers will be invited to participate

Exclusion Criteria:

* Individuals not fulfilling the inclusion criteria or declining blood or saliva collection.
* Exclusion criteria are neck breathers (tracheostomy/laryngectomy patients) or other nasopharyngeal or oropharyngeal anomalies that do not allow for sampling using Salivette.

Primary outcomes:
measure: Titer of SARS-CoV-2 spike glycoprotein RBD antibodies in saliva and plasma
timeFrame: Between 21 and 200 days after infection/vaccination
Secondary outcomes:
measure: Titer of SARS-CoV-2 spike glycoprotein RBD antibodies in saliva and plasma
timeFrame: Between 21 and 200 days after vaccination
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01795105: ABF Tourette's Disorder Post Marketing Surveillance Study
Official title: Post-Marketing Surveillance of Safety and Efficacy of Abilify® Tablets in Korean Patients With Tourette's Disorder Under the "New Drug Re-Examination"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tourette's Disorder
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-02-20
Enrollment: 692
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients 6 to 18 years of age with Tourette's Disorder according to the approved product market authorization

Brief summary: This is a Post-Marketing Surveillance study of Abilify® tablets in accordance with Korean regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: KFDA Notification No. 2010-94 dated 27 December 2010).

Detailed description: This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the patient's follow-up is not prescriptive in nature and must be left up to the judgment of the physician (investigator), within the period of observation set forth in the protocol.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients 6 to 18 years of age with Tourette's Disorder
* Patients who are prescribed Abilify® treatment as per investigator's medical judgment.
* Patients who gave written authorization to use their personal and health data
* Patients starting Abilify® treatment after agreement is in place

Exclusion Criteria:

* Patients with known hypersensitivity to Aripiprazole or any excipients of Abilify®
* Patients who have been treated with Abilify®
* Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency, or glucose-galactose malabsorption
* Patients with score 0(Not assessed) or 1(Normal, not at all ill) in the TS-CGI-S
* Patients participating in other clinical trial

Primary outcomes:
measure: Frequency (n) of Subjects With Adverse Event
timeFrame: Follow-up at least once from baseline to 6 weeks and at least 12weeks
Secondary outcomes:
measure: Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement)
timeFrame: at least 6, 12 weeks interval from baseline
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Medical Center
Study officials:
References:
Clinical trial NCT04701905: The Offer of Neurosurgery Care in the Grand Est of France During the Health Crisis Linked to Covid-19
Official title: The Offer of Neurosurgery Care in the Grand Est of France During the Health Crisis Linked to Covid-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Pandemic
Keywords: COVID-19 Pandemic
Coronavirus
Sars-cov-2
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 450
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: Patient entering the neurosurgery care sector requiring treatment between 03/16/2020 and 06/15/2020

Brief summary: During this exceptional health crisis, this study of the current care of a neurosurgical activity, which is essential in a University Hospital Centre, will enable us to better understand how we function, the response given to a population with the means at our disposal, the implementation of new therapeutic strategies and their limits, ethical reflection, and, how to pursue a distributive and quality medicine.

The restriction of conventional medical resources to our care activity (resuscitation, personnel, operating theatre, constraints linked to the risk of contamination...) is leading to a new medical organisation imposing new Covid-19 standards, the description of which seems essential to us.

A knowledge of the strategies to be adopted during a disaster health situation in order to continue providing care to the civilian population. How can we prevent the setting up of health care systems outside the cause of the health crisis? n triage medicine, Avoiding the "burn-out" of doctors struck by the health crisis.


Eligibility criteria: Inclusion Criteria:

* Patient aged over 18;
* Entering the neurosurgery care sector requiring support between 03/16/2020 and 06/15/2020;
* Having not expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion Criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship or guardianship
* Subject under safeguard of justice

Primary outcomes:
measure: Retrospective analysis of the management of neurosurgical pathologies in a health crisis situation of the Covid-19 pandemic
timeFrame: The files analysed retrospectily from March 16, 2020 to June 15, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Department of Neurosurgery - Strasbourg University Hospitals
Study officials:
affiliation: Department of Neurosurgery - Strasbourg University Hospitals
name: François PROUST, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: