louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00737451: Association of Thyroid Autoimmunity and Chronic Urticaria
Official title: Association of Thyroid Autoimmunity and Chronic Urticaria in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Itching
Chronic Urticaria
Keywords: urticaria
goiter
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2008-08-19
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 and above with complaint of skin itching

Brief summary: Increase prevalence of thyroid autoimmunity is found in patients with chronic urticaria. About 5-34% of chronic urticaria patients is associated with the presence of thyroid autoimmunity who are euthyroid status whereas 5-10% of them with either hyperthyroidism or hypothyroidism.

Detailed description: There is no such report on the association of thyroid autoantibodies and chronic urticaria in Taiwan population yet. This study is designed to investigate the prevalence of thyroid autoimmunity associated with chronic urticaria in Taiwanese population. In addition, we intend to find out the change in the level of thyroid autoimmunity after the treatment in order to further understand their relationship. We also intend to find out the prognostic parameters in patients with the presence of thyroid autoimmunity and chronic urticaria.

Eligibility criteria: Inclusion Criteria:

* 18 years old and above
* skin itching for more than 6 months

Exclusion Criteria:

* pure physical urticaria, infectious diseases, and food or food addictive hypersensitivity, chronic infection

Primary outcomes:
measure: The prevalence of thyroid autoimmunity in chronic urticaria in Taiwan
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Pan-Chiao
country: Taiwan
facility: Far Eastern Memorial Hospital
state: Taipei
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Jiang Ju Ying, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01388751: Mallet Finger Splinting Study
Official title: Night Splinting After 6 to 8 Weeks of Continuous Splinting for Mallet Finger
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mallet Finger
Keywords: Mallet Finger splinting
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-07-07
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Do patients that night splint for 1 month after 6-8 weeks of continuous splinting for a mallet injury have the same extensor lag 4 months after initiating treatment as patients that do not perform night splinting?

Secondary Question: Is night splinting a predictor of DASH score or patient satisfaction (on a 5-Point Likert scale)?


Eligibility criteria: Inclusion Criteria:

* All adult, English-speaking patients in the practice of Dr. Jesse Jupiter, Dr. Chaitanya Mudgal, or Dr. David Ring electing splint treatment for mallet deformity will be invited to enroll on their follow-up visit 6-8 weeks after initiating splint treatment.

Exclusion Criteria:

1. Open lesions
2. Mallet fracture more than 2 weeks old
3. Mallet fracture with subluxation of the distal interphalangeal joint.

Primary outcomes:
measure: Extensor Lag
timeFrame: 4 months
Secondary outcomes:
measure: DASH score
timeFrame: 4 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Mass. General Hospital
name: David Ring, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04031651: Key Specialized Monitoring of Clinical Safety of Pudilan Xiaoyan Oral Liquid in the Real World
Official title: Key Specialized Monitoring of Clinical Safety of Pudilan Xiaoyan Oral Liquid in the Real World
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Infectious Diseases
Keywords: Pudilan Xiaoyan Oral Liquid
Safety monitoring
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Xiyuan Hospital of China Academy of Chinese Medical Sciences
First posted: 2019-07-24
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To obtain the characteristics of adverse reactions/incidents, analyze the influencing factors and calculate the incidence of adverse reactions/incidents monitored by Pudilan Xiaoyan Oral Liquid in key specialties in the real world, so as to provide a basis for clinical safe and rational drug use.

Brief summary: To obtain the characteristics of adverse reactions/incidents, analyze the influencing factors and calculate the incidence of adverse reactions/incidents monitored by Pudilan Xiaoyan Oral Liquid in key specialties in the real world, so as to provide a basis for clinical safe and rational drug use.


Eligibility criteria: Inclusion Criteria:

* (1)Upper respiratory tract infection patients using Pudilan antiphlogistic oral liquid ;
* (2)Aged between 18 and 80.

Exclusion Criteria:

* Lactating women, pregnant women, pregnant planners, psychiatric patients, etc.

Primary outcomes:
measure: Incidence of Adverse Drug Reaction
timeFrame: 7 days
Secondary outcomes:
measure: The Ratio of Body Temperature to Normal
timeFrame: 7 days
measure: Change of liver function
timeFrame: 7 days
measure: Change of renal function
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese
name: Yanming Xie, BA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05283551: Famciclovir in Multiple Sclerosis
Official title: A Phase 2 Open Label Clinical Trial to Determine the Effect of Famciclovir on Epstein-Barr Virus Activity as Measured by EBV Shedding in Saliva of Patients With Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Multiple Sclerosis
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a proof-of-concept study in 30 patients with established Relapsing Remitting Multiple Sclerosis (RRMS). IMP is Famciclovir. It is a phase II type A open label study. Each individuals participation in the study will last 36 weeks and will be divided into three phases: pre-treatment (12 weeks), treatment with famciclovir (12 weeks), and post-treatment (12 weeks). During the first 12 week phase patients will remain on their usual treatment alone; this will be followed by three months of co-treatment with famciclovir and then followed by a final three months post-famciclovir treatment where participants will continue to take their usual treatment for RRMS. The primary aim is to explore the effect of famciclovir (500mg BD) on Epstein-Barr virus (EBV) shedding in the saliva of patients with MS


Eligibility criteria: Inclusion Criteria:

* Diagnosed with MS
* Males and females aged over 18
* Taking Natalizumab (Tysabri) for the treatment of MS,
* Be able to provide informed consent to take part in this study.
* Female patients of childbearing potential (defined in section 13.4) must be willing to follow protocol contraceptive requirements.

Exclusion Criteria:

* Taking MS disease modifying treatment other than natalizumab (Tysabri)
* On no treatment for MS
* Taking additional immunomodulatory agents (either for MS treatment or other reasons)
* Has received a course of high dose oral or intravenous steroids within 3 months of study entry. The use of low dose (total daily dose \<10mg) and/or the use of topical steroids will not act as an exclusion criteria.
* Taking antiviral or antiretroviral medication for any reason
* Known allergy to penciclovir, acyclovir, valaciclovir or famciclovir
* Taking probenecid
* Significant renal (CKD 3 or 4) and/or liver (ALT\>3x ULN) impairment
* Pregnant, or unwilling to take measures to prevent pregnancy
* Breastfeeding

Primary outcomes:
measure: Effect of famciclovir on Epstein-Barr virus (EBV) shedding
timeFrame: Baseline to 36 Weeks
Secondary outcomes:
Other outcomes:
measure: Explore the effect of famciclovir (500mg BD) on serological markers of Epstein-Barr virus (EBV) infection (anti-EBNA-1 and anti-VCA IgG)
timeFrame: Baseline to 36 Weeks
measure: Explore the effect of famciclovir (500mg BD) on Epstein-Barr virus (EBV) viral replication in blood
timeFrame: Baseline to 36 Weeks
Locations:
city: London
country: United Kingdom
facility: Royal London Hospital, Barts Health NHS Trust
Study officials:
References:
Clinical trial NCT02281851: Examining Endogenous Antioxidant Levels in Well Trained Cyclists
Official title: The Effects of Habitual Antioxidant Supplementation on Endogenous Antioxidants and Oxidative Damage in Well Trained Cyclists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxidative Stress
Keywords: Endogenous antioxidants
Antioxidant supplements
Vitamin Supplements
Exercise adaptations
Oxidative stress
Redox regulation
Cycling - exercise
Lead sponsor: University of Birmingham
Sponsor class: OTHER
First posted: 2014-11-04
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cyclist from the local West Midlands (United Kingdom) area will be invited to take part in the study.

Brief summary: This study will investigate whether increased habitual intake of antioxidant supplements effects the concentration of endogenous antioxidants, the response of antioxidants to exercise, and differences in oxidative damage compared to a non-supplemented group.


Eligibility criteria: Inclusion Criteria:

* Male,
* BMI 18.8 29.9 kg/m2
* cycle 3-7 times a week for durations longer than 60 minutes
* cycled for a minimum of 3 years
* accustomed to exhaustive cycling protocols
* healthy (no known cardiovascular or metabolic disease)

Exclusion Criteria:

* answering "NO" to any question on the general health questionnaire would result in exclusion from the study
* current participation in another clinical study
* current or recent smoker (last 30 days)
* prescription or non-prescription of anti-inflammatory use \>30 days prior to the experiment commencing or any other medications that in the opinion of the investigator may interfere with redox signalling

Primary outcomes:
measure: Difference in Resting Levels of Endogenous Antioxidant Proteins in Skeletal Muscle - Superoxide Dismutase 2 (SOD-2)
timeFrame: Protein concentrations will be measured at baseline only
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: School of Sport Exercise and Rehabilitation Sciences, University of Birmingham
state: West Midlands
Study officials:
affiliation: University of Birmingham
name: Sarah Aldred, MSc PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05925751: Deep Learning Signature for Predicting Complete Pathological Response to Neoadjuvant Chemoimmunotherapy in Non-small Cell Lung Cancer
Official title: An Integration of a Computed Tomography/Positron Emission Tomography/Whole Slide Image (CT/PET/WSI) Based Deep Learning Signature for Predicting Complete Pathological Response to Neoadjuvant Chemoimmunotherapy in Non-small Cell Lung Cancer: A Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer
Neoadjuvant Chemoimmunotherapy
Complete Pathological Response
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
Collaborators: name: Ningbo No.2 Hospital
name: Zunyi Medical College
name: The First Affiliated Hospital of Nanchang University
First posted: 2023-06-29
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Resected Stage I-III NSCLC following neoadjuvant chemoimmunotherapy

Brief summary: The purpose of this study is to evaluate the performance of a CT/PET/ WSI-based deep learning signature for predicting complete pathological response to neoadjuvant chemoimmunotherapy in non-small cell lung cancer


Eligibility criteria: Inclusion Criteria:

1. Age ranging from 20-75 years;
2. Patients who underwent curative surgery after neoadjuvant chemoimmunotherapy for NSCLC;
3. Obtained written informed consent.

Exclusion Criteria:

1. Missing image data;
2. Pathological N3 disease.

Primary outcomes:
measure: Area under the receiver operating characteristic curve
timeFrame: 2023.5.1-2023.10.31
Secondary outcomes:
measure: Sensitivity
timeFrame: 2023.5.1-2023.10.31
Other outcomes:
measure: Specificity
timeFrame: 2023.5.1-2023.10.31
measure: Positive predictive value
timeFrame: 2023.5.1-2023.10.31
measure: Negative predictive value
timeFrame: 2023.5.1-2023.10.31
measure: Accuracy
timeFrame: 2023.5.1-2023.10.31
Locations:
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Ningbo
country: China
facility: Ningbo HwaMei Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT00359151: Celebrex Total Knee Arthroplasty Study
Official title: Multicenter, Double Blind, Randomized, Placebo Controlled Trial Of The Efficacy And Safety Of Usual Care Plus Celecoxib Compared To Placebo For Peri-Operative And Rehabilitation Pain Control And Return To Function In Osteoarthritis Patients Undergoing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoarthritis
Pain
Keywords: Perioperative care of total arthroplasty assessing opioid consumption
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-01
Enrollment: 22
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: This study will investigate the benefits of administering celecoxib (Celebrex), a selective cyclooxygenase -2 (COX-2) inhibitor, in treating osteoarthritis (OA) subjects undergoing elective unilateral primary total knee arthroplasty (TKA) from the pre-operative phase to the management of post total knee replacement pain, and through the 6 weeks of physical therapy and rehabilitation.


Eligibility criteria: Inclusion Criteria:

* The subject is a male or female 18 years or older with osteoarthritis of the knee scheduled to undergo elective unilateral primary total knee arthroplasty because of OA, performed under a standardized regimen of anesthesia and procedure.

Exclusion Criteria:

* Subject has a history of inflammatory arthritis (e.g. rheumatoid arthritis, ankylosing spondylitis) other than osteoarthritis.

Primary outcomes:
measure: To assess the effects of celecoxib on the cumulative amount of opioid administered to OA subjects undergoing unilateral total knee arthroplasty.
timeFrame: 19 July 2007
Secondary outcomes:
measure: To assess the effects of celecoxib on pain and function during the peri-operative period and the post-operative rehabilitation phase.
timeFrame: 19 July 2007
measure: To assess the safety and tolerability of celecoxib in this study population.
timeFrame: 19 July 2007
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Englewood
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Bellaire
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06755151: Fenofibrate in Primary Biliary Cholangitis: a Real World Study
Official title: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Combination with Ursodeoxycholic Acid in Subjects with Primary Biliary Cholangitis (PBC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Primary Biliary Cholangitis (PBC)
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Combination with Ursodeoxycholic Acid in Subjects with Primary Biliary Cholangitis (PBC)


Eligibility criteria: Inclusion Criteria:

1. Must have given written informed consent (signed and dated)
2. Completed in a PBC study with fenofibrate(NCT05749822,NCT06174402)
3. ALP\> 1\*ULN
4. Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose

Exclusion Criteria:

1. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar
2. A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results

Primary outcomes:
measure: Treatment emergent adverse events (TEAEs)
timeFrame: Through study completion, up to 120 Months
Secondary outcomes:
measure: Death
timeFrame: 120 months
measure: Liver transplantation
timeFrame: 120 months
measure: Normalization of ALP
timeFrame: 120 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT00578851: A Clinical Investigation of the C2a-Taper™ Acetabular System
Official title: Post Approval Study of the C2a-Taper™ Acetabular System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Avascular Necrosis
Congenital Hip Dysplasia
Traumatic Arthritis
Keywords: Hip Arthroplasty
Hip Arthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2007-12-21
Enrollment: 28
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: Multi-Center study conducted in the United states on patients who meed the inclusion / exclusion criteria identified in the protocol.

Brief summary: The objective of this study is to gather clinical and survivorship information for the C2a-Taper™ Acetabular System, a ceramic-on-ceramic hip articulating system.

Detailed description: Study Design:

Phase 1

Sites will collect the following types of data:

Clinical-Total Harris Hip Score, Radiographic Evaluation- measurements on acetabular and femoral components Survivorship-removal/revision of one or more components (i.e. liner, head, shell and/or stem) Safety- All other adverse events

Follow-up Visit schedule

* 6 week ± 2 weeks
* 6 month ± 1 month
* 1 year ± 3 months
* 2 years ± 3 months
* 3 years ± 3 months
* 4 years ± 3 months
* 5 years ± 3 months

Phase 2:

Patients continue to be followed on an annual basis (Years 6-10) via mail. A self assessment form is sent directly to the subject on an annual basis starting in the 6th post-operative year.

Eligibility criteria: Inclusion Criteria:

* Skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis

Exclusion Criteria:

* Patients with: Osteoporosis, metabolic disorders, osteomalacia, rapid joint destruction, vascular insufficiency, muscular atrophy, and neuromuscular disease

Primary outcomes:
measure: Harris Hip Score, Radiographic Evaluation
timeFrame: 5 years
Secondary outcomes:
measure: Survivorship
timeFrame: 10 years
Other outcomes:
Locations:
city: Cedar Rapids
country: United States
facility: Physician's Clinic of Iowa, PCI
state: Iowa
city: Lexington
country: United States
facility: Lexington Clinic
state: Kentucky
Study officials:
affiliation: Zimmer Biomet
name: Kara Mezger
role: STUDY_DIRECTOR
References:
Clinical trial NCT03650751: Clinical Study on Screening of Nursing Evaluation Indicators of Stroke Patients
Official title: Convenience Sampling，Clinical Study on Screening of Nursing Evaluation Indicators of Stroke Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: stroke；nursing assessment；condition of a patient；deterioration；
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Shenzhen 2nd People's Hospital ，Neurology wards

Brief summary: The purpose of this study was to use Delphi method to screen the nursing observation indexes of patients with stroke, and to screen the sensitive indexes with high correlation with the severity of stroke.It is used to guide nursing staff to observe the nursing of patients with cerebral apoplexy.


Eligibility criteria: Inclusion Criteria:

①according to the diagnostic criteria which was revisied in 1996 at the fourth national cerebrovascular disease conference,Patients were diagnosed with cerebral apoplexy through computerized tomographic scanning or Magnetic Resonance Imaging examination.

②Patients who volunteer to participate in the study and Sign the consent form.

Exclusion Criteria:

①Patients With other serious diseases, such as tumor, grade 2 or above of cardiac function.

②Had a history of mental illnes.

Primary outcomes:
measure: construct a nursing evaluation system for stroke patients
timeFrame: October 1st, 2017 - October 1st, 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen second people's hospital
state: Guangdong
Study officials:
affiliation: Shenzhen 2nd People's Hospital
name: xiaohua XIE, Master
role: STUDY_DIRECTOR
References: