louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05202171: The Effects of Cervical Stabilization Exercise Training With Telerehabilitation in Individuals With Migraine
Official title: The Effects of Cervical Stabilization Exercise Training With Telerehabilitation in Individuals With Migraine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is to investigate the effects of cervical stabilization exercise training applied with telerehabilitation in individuals with migraine.

Detailed description: Cervical muscles are adversely affected in individuals with migraine. It is important to investigate the effects of cervical muscle training in these individuals. Telerehabilitation applications have been used frequently in many patients in recent years. It is necessary to examine the effects of cervical stabilization exercises applied with telerehabilitation in individuals with migraine.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-55,
* To be diagnosed with migraine by a neurologist according to International Headache Society criteria,
* Having at least 3 migraine attacks per month,
* Volunteering to participate in the study,
* Having the opportunity to access devices such as computers, phones and tablets with internet connection,
* Not having any problems that prevent cooperation and understanding

Exclusion Criteria:

* Having other accompanying headache types,
* Being pregnant,
* Being in the breastfeeding period,
* Having a history of trauma, fracture or surgery in the craniocervical region,
* Presence of concomitant neurological and/or inflammatory rheumatic disease
* Presence of serious psychiatric problems,
* History of malignancy,
* Changes in medical treatment during the study period,
* Receiving physiotherapy for the cervical region in the last 6 months

Primary outcomes:
measure: The characteristic of the migraine
timeFrame: change from baseline at 8 weeks
Secondary outcomes:
measure: Cervical range of motion
timeFrame: change from baseline at 8 weeks
measure: Upper cervical region movements
timeFrame: change from baseline at 8 weeks
measure: Performance of the deep neck flexor muscles
timeFrame: change from baseline at 8 weeks
measure: Cranio-vertebral angle
timeFrame: change from baseline at 8 weeks
measure: Disability Status
timeFrame: change from baseline at 8 weeks
measure: Sleep quality
timeFrame: change from baseline at 8 weeks
measure: Life quality
timeFrame: change from baseline at 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Seyda Toprak Celenay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02317471: Immunotherapy of Gastric Cancer With Autologous Tumor Derived Heat Shock Protein gp96
Official title: Immunotherapy of Gastric Cancer With Autologous Tumor Derived Heat Shock Protein gp96
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Gastric Carcinoma
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Cure&Sure Biotech Co., LTD
First posted: 2014-12-16
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of autologous gp96 treatment of gastric cancer.


Eligibility criteria: Inclusion Criteria:

1. Disease characteristics: Histologically confirmed gastric carcinoma: clinical stage III (according to the Japanese gastric cancer classification), must have undergone radical resection
2. Able to read and understand the informed consent document, must sign the informed consent
3. Age: 18 to 75 years old
4. Availability of at least 0.5 g tumor sample
5. ECOG ≤1；life expectancy \>=12 weeks, able to comply with study-related procedures
6. Adequate bone marrow function including the absence of lymphopenia (ANC \> 1,500/ mm3; Hemoglobin \> 10g/dL ; platelet count \>100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase \[AST\], alanine amino transferase \[ALT\] \<2.5 times institutional upper limit of normals \[IULNs\] and bilirubin (total) \<1.5 times IULN), and adequate renal function (BUN and creatinine \<1.5 times IULNs)
7. Normal heart function
8. NOT participate in ANY other clinical trials within 4 weeks prior to vaccination.

Exclusion Criteria:

1. Unable to get the informed consent
2. Female patients who are pregnant or breastfeeding
3. Progression prior to treatment as determined by the principal investigator
4. Transplant recipient
5. Patients currently diagnosed with Human Immunodeficiency Virus or other active uncontrolled infection
6. Unstable or severe intercurrent medical conditions
7. Patient with allergic constitution
8. Patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids.

Primary outcomes:
measure: Disease free survival
timeFrame: 2 years
measure: Number of participants with adverse events related to gp96 immunotherapy
timeFrame: participants will be followed from the day of the first vaccination to the 30th day after the last vaccination.
Secondary outcomes:
measure: Changes in antigen specific T cells
timeFrame: within 3 days before the first vaccination and within 3 days after the 10th vaccination
measure: Overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Lin Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01980771: Barbershop Talk: HIV Prevention for African American Heterosexual Men
Official title: Barbershop Talk: HIV Prevention for African American Heterosexual Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
prevention
men
African American
Lead sponsor: State University of New York - Downstate Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2013-11-11
Enrollment: 860
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This program utilizes a community-engaged research approach to implementing and evaluating a program that seeks to reduce sexual risk behavior among Black adult heterosexual men. The investigators aims are to assess the impact of this linguistically and culturally tailored HIV prevention program on the sexual risk of heterosexual, African American men aged 18 and older, to assess the intervention's impact on the more proximal social and psychosocial variables that the program is designed to change, and to identify key contextual level factors that may impact the intervention's impact across segments of this priority population.


Eligibility criteria: Inclusion Criteria:

* Unprotected sex in the past three months
* Identify as Black or African American

Exclusion Criteria:

* Having been in an HIV prevention research study in the last six months
* Reporting a history in the past five years of injection drug use
* Reporting a history in the past five years of having sex with other men
* Reporting an HIV-positive serostatus
* Inability to understand spoken English.

Primary outcomes:
measure: Sexual Behavior
timeFrame: Six month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Arthur Ashe Institute for Urban Health, Inc.
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
Study officials:
affiliation: State University of New York - Downstate Medical Center
name: Tracey E Wilson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilson TE, Gousse Y, Joseph MA, Browne RC, Camilien B, McFarlane D, Mitchell S, Brown H, Urraca N, Romeo D, Johnson S, Salifu M, Stewart M, Vavagiakis P, Fraser M. HIV Prevention for Black Heterosexual Men: The Barbershop Talk with Brothers Cluster Randomized Trial. Am J Public Health. 2019 Aug;109(8):1131-1137. doi: 10.2105/AJPH.2019.305121. Epub 2019 Jun 20.
Clinical trial NCT04085471: CTHRC1 Abiomarker in Rheumatoid Arthritis Diagnosis
Official title: CTHRC1 Apromising Biomarker in Rheumatoid Arthritis Diagnosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: measurement of CTHRC1in RA patints

Brief summary: The purpose of the study is to determine whether plasma levels of the collagen triple helix repeat containing (CTHRC1) protein can serve as a blood-based biomarker for diagnosis of rheumatoid arthritis (RA) ,and furthermore its correlation with disease activity.

Detailed description: Rheumatoid arthritis (RA) is a chronic, progressive, autoimmune disease of synovial joints. Characterized by periods of flares with high disease activity involving both a systemic immune response and tissue-specific inflammatory events that can lead to erosive joint and bone destruction and subsequent disability . Currently, diagnosis of RA is based mainly on the extent of tenderness and swelling of the joints , levels of acute-phase reactants such as C-reactive protein (CRP) ,erythrocyte sedimentation rate(ESR) , high titers of rheumatoid factor (RF) and high titers of antibodies against cyclic citrullinated peptide (anti-CCP) in the plasma .Of interest, CTHRC1 is a secreted modulator of Wnt signaling, which is a key regulator of joint remodeling, and promotes cell proliferation and migration. Therefore, CTHRC1 may contribute to multiple aspects of the pathogenic FLS behavior in RA and modulate processes that promote synovial hyperplasia and invasion.The expression pattern of CTHRC1 in pannus, its role in the function of FLS relevant to cartilage damage in RA, and CTHRC1's association with disease severity in murine arthritis raised the question of whether CTHRC1 could be used as a marker for RA diagnosis and monitoring of disease activity in patients

Eligibility criteria: Inclusion Criteria:

* -Patients diagnosed as RA.
* Patients ( \>18)who are age and sex matched with the controls

Exclusion Criteria:

. Other Rheumatologic diseases. .Patients with malignancy . .Patients with hepatic disease .

Primary outcomes:
measure: CTHRC1 Apromising biomarker in rheumatoid arthritis diagnosis
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Myatt GL, Ecobichon DJ, Greenhalgh R. Fenitrooxon and S-methyl fenitrothion: acute toxicity and hydrolysis in mammals. Environ Res. 1975 Dec;10(3):407-14. doi: 10.1016/0013-9351(75)90036-5. No abstract available.
Clinical trial NCT00172471: The Relationship Between Sleep Disorders and Cytokine Levels Among Hemodialysis and Peritoneal Dialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Failure
Sleep Disorder
Hemodialysis
Peritoneal Dialysis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Sleep disorders are common in patients with end-stage renal disease on both hemodialysis and peritoneal dialysis and are associated with significant medical, psychological and social disturbances. Numerous factors have been suggested as contributing to or associated with the high prevalence of sleep disturbance in this population.

Increasing evidence suggests that cytokines are involved in the regulation of sleep and wakefulness and that the communication between the sleep and the immune system is bi-directional. Blood-dialyzer or peritoneum-dialysate interaction during dialysis therapy has the potential to activate mononuclear cells leading to production of inflammatory cytokines. These cytokines are believed to play a significant role in dialysis-associated morbidity and mortality. Nevertheless, a cytokine overproduction may alter sleep pattern in chronic dialyzed patients, thus explaining the presence of sleep disorders in these patients. In the other way, sleep loss may have effects on immune process and secretion of cytokines in chronic dialyzed patients. The purpose of this study was to examine the relationship between quality of sleep and serum cytokine levels in hemodialysis and peritoneal dialysis patients.


Eligibility criteria: Inclusion Criteria:

* ESRD Patients with hemodialysis or peritoneal dialysis

Exclusion Criteria:

* Malignancy, hospitalization, infection, inflammation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Division of Nephrology, Department of Internal Medicine, National Taiwan University Hospital
Study officials:
affiliation: Department of Internal Medicine, National Taiwan University Hospital
name: Jenq-Wen Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02036671: Novel Endovascular Access Trial (NEAT)
Official title: Novel Endovascular Access Trial (NEAT): A Study of the FLEX System for Percutaneous AV Fistula Creation in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Arteriovenous fistula
Fistula
Chronic kidney disease
Percutaneous
Kidney Disease
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
CKD
hemodialysis
Lead sponsor: TVA Medical Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and efficacy of the FLEX System when used to create an arteriovenous fistula (AVF or AV fistula) percutaneously in patients with Chronic Kidney Disease (CKD) who require hemodialysis vascular access.

Detailed description: This is a 12 month multi-center non-randomized investigational study to evaluate the safety and efficacy of the FLEX system to create an endovascular AVF in patients with CKD who require hemodialysis vascular access.

Eligibility criteria: Inclusion Criteria:

* Eligible for a native surgical arteriovenous fistula, as determined by the treating physician.
* Adult (age \>18 years old).
* Established, non-reversible kidney failure requiring hemodialysis.
* Written informed consent obtained.

Exclusion Criteria:

* Functioning surgical access in the planned treatment arm.
* Pregnant women.
* New York Heart Association (NYHA) class III or IV heart failure.
* Allergy to contrast dye.

Primary outcomes:
measure: Primary Efficacy Endpoint:
timeFrame: within 3 months
Secondary outcomes:
measure: Safety Endpoint
timeFrame: within 3 months
measure: EndoAVF-related Re-intervention Rate
timeFrame: 3, 6 and 12 months
measure: Primary Patency
timeFrame: 3, 6 and 12 months
measure: Cumulative Patency
timeFrame: 3, 6 and 12 months
measure: Functional Usability
timeFrame: 4 weeks post procedure, up to 12 months
Other outcomes:
Locations:
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Halifax
country: Canada
facility: QE II Health Sciences Center
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health Oshawa
state: Ontario
city: Toronto
country: Canada
facility: The Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: CHUM, Notre-Dame Hospital
state: Quebec
city: Grafton
country: New Zealand
facility: Auckland City Hospital
Study officials:
affiliation: The Toronto General Hospital
name: Charmaine Lok, MD, MSC, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: The Toronto General Hospital
name: Dheeraj Rajan, MD, BSc, FRCPC, FSIR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05755971: Therapeutic Effects of Combination Tape in Knee Osteoarthritis
Official title: Combination Taping in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: combination taping
osteoarthritis
Lead sponsor: Batterjee Medical College
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 51
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Blinded randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Taping is a non-invasive technique that has been used for various musculoskeletal conditions, including knee OA. However, there is limited research on the effects of combination taping techniques on disability, functional capacity, and knee isokinetic torque in patients with knee OA.

Detailed description: Osteoarthritis (OA) is a common chronic condition, characterized by progressive loss of joint cartilage, leading to joint pain, stiffness, and functional disability. Knee OA is one of the most prevalent forms of OA, affecting millions of people worldwide. Various non-surgical treatment options have been reported, one of them is taping techniques. Combination taping is a unique treatment option, where two different types of taping is applied. However, there is limited research on the effects of combination taping techniques on disability, functional capacity, and knee isokinetic torque in patients with knee OA. So this study will be conducted to explore therapeutic effects in individuals who are suffering from knee OA

Eligibility criteria: Inclusion Criteria:

* second degree knee osteoarthritis

Exclusion Criteria:

* Sever obesity, sever osteoarthritis, history of knee surgery, allergy to the tape

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Nine weeks
Secondary outcomes:
measure: 6 minute walk test
timeFrame: Nine weeks
measure: Time up and go test
timeFrame: Nine weeks
measure: Knee isokinetic torque
timeFrame: Nine weeks
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: Batterjee Medical College
state: Makkah
Study officials:
affiliation: BMC
name: Osama R Ibrahim, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: BMC
name: Olfat M Ali, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03804671: A Study in Healthy Men to Measure the Amount of BI 730357 in the Blood When Taken as a Tablet
Official title: Investigation of Pharmacokinetics and Absolute Oral Bioavailability of BI 730357 Administered as an Oral Dose With an Intravenous Microtracer Dose of BI 730357 BS (C-14) in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-01-15
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the absolute oral bioavailability of BI 730357 administered as tablet compared with \[C-14\]BI 730357 BS administered as intravenous microtracer


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 65 years (inclusive)
* Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
* Further inclusion criteria apply

Exclusion Criteria:

* Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 139 mmHg, diastolic blood pressure outside the range of 45 to 89 mmHg, or pulse rate outside the range of 40 to 100 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Clinically significant gastrointestinal (including known or suspected inflammatory bowel disease), hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Further exclusion criteria apply

Primary outcomes:
measure: Area Under the Concentration-time Curve of BI 730357 Over the Time Interval From 0 to Infinity (Dose Normalized).
timeFrame: Test treatment T: within 3h before and 1,1.5,2,2.5,3.5,5,7,12,24,72,120,168h after oral administration. Reference treatment R: within 3h before and 5,10,15,30,45 minutes and 1.25,2.25,3.75,5.75,10.75,22.75,70.75,118.75,166.75h after start of iv infusion.
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: ICON
Study officials:
References: