louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00402623: The Effect of Quercetin in Sarcoidosis
Official title: The Effect of Quercetin on the Increased Inflammatory and Decreased Antioxidant Status in Sarcoidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoidosis
Keywords: sarcoidosis
quercetin
supplementation
oxidative stress
inflammation
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2006-11-22
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The exact cause of the chronic lung disease sarcoidosis is still unknown. Consequently, a complete efficacious treatment is still not available. Earlier studies indicate an important key role for oxidative stress, i.e. an imbalance between the production of and the protection against ROS, in the etiology of sarcoidosis. Antioxidants, needed for protection against ROS, are indeed lower in sarcoidosis. Therefore, antioxidant therapy to strengthen the reduced antioxidant defense might be efficacious in sarcoidosis treatment. Since ROS are also capable of initiating and mediating inflammation, antioxidant therapy might also mitigate the elevated inflammation that occurs in sarcoidosis. The flavonoid quercetin possesses both anti-oxidative and anti-inflammatory capacities and might therefore serve as a good candidate for antioxidant therapy in sarcoidosis.

Therefore, the aim of the present study is to determine the effect of quercetin supplementation in sarcoidosis patients on markers of both oxidative stress and inflammation.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of sarcoidosis with emphasize on pulmonary sarcoidosis
* no smoking
* no treatment

Exclusion Criteria:

* clinical diagnosis (and treatment) of other diseases
* symptoms of sarcoidosis in other organs besides the lung
* use of food supplements or vitamins

Primary outcomes:
measure: antioxidant status after 24 hours
timeFrame: 24 hours
measure: inflammatory status after 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: plasma quercetin concentration after 24 hours
timeFrame: 24 hours
measure: plasma malondialdehyde (MDA) levels after 24 hours
timeFrame: 24 hours
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Maastricht University
name: Aalt Bast, PhD
role: STUDY_CHAIR
affiliation: Maastricht University
name: Agnes W Boots, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University
name: Guido R Haenen, PhD
role: STUDY_DIRECTOR
References:
citation: Boots AW, Drent M, de Boer VC, Bast A, Haenen GR. Quercetin reduces markers of oxidative stress and inflammation in sarcoidosis. Clin Nutr. 2011 Aug;30(4):506-12. doi: 10.1016/j.clnu.2011.01.010. Epub 2011 Feb 15.
Clinical trial NCT02909023: Performance of the HBV ELISPOT in the Detection of the T Cellular Immune Response in Patients Infected by HBV or Cured
Official title: Performance of the Hepatitis B Virus (HBV) ELISPOT in the Detection of the T Cellular Immune Response in Patients Infected by HBV or Cured
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Keywords: Hepatitis B Virus
Elispot test
T cellular immune response
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 34
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: Hepatitis B infected patients or cured

Brief summary: Activation of the immune system against a pathogen can be considered one of the most effective interventions in the field of infectious diseases.

Transgene is developing a therapeutic vaccine "TG1050" for the treatment of patients with chronic and treated Hepatitis B. This biotherapy compound is for the development of T cellular immune response in these patients in order to achieve the total elimination of infected cells.

Therefore it is necessary to have measures of ways to assess accurately and reliably the presence of such a response in the study subjects.


Eligibility criteria: Inclusion Criteria:

Man or woman aged ≥18 years old.

Patients with chronic hepatitis B regardless of the genotype.

* treated with nucleotide analogs approved for the treatment of hepatitis B.
* or untreated.
* with a positive or negative antigen HBe
* regardless of the level of transaminases.

Patients with a history of HBV infection (recovered) with seroconversion of antigen HBs spontaneously or under treatment.

Patient with a general state ranging 0 or 1 on the ECOG scale (Eastern Cooperative Oncology Group)

Patient who signed the informed consent

Patient with a social security affiliation

Exclusion Criteria:

patients co-infected with human immunodeficiency virus (HIV) or Hepatitis C virus (HCV).

Patients treated with interferon, immunosuppressive, or experimental treatment consisting of an unapproved molecule for the treatment of hepatitis B.

Patient unable to meet the constraints of the study

Patient transplanted

Patient with a history of cancer or autoimmune disease within 5 years

Pregnant or lactating women

Primary outcomes:
measure: Measurement of T cell response by hepatitis B antigen detected in at least one subject.
timeFrame: at day 1
Secondary outcomes:
measure: The probability of detection of a positive T cell response in a single measurement
timeFrame: at day 1
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
Study officials:
affiliation: Hôpital de la Croix-Rousse
name: Fabien Zoulim, PU PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02698423: Feasibility and Acceptability of Offering Self-sampling to Non-attendees in Primary Care
Official title: Human Papillomavirus Testing Versus Liquid-based Cytology for Non-attendees of Cervical Cancer Screening: Results of a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of the Uterine Cervix
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2016-03-03
Enrollment: 667
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to determine whether human-papillomavirus (HPV) self-sampling can be used as a primary screening test for unscreened women.

Detailed description: Women residing in the canton of Geneva, aged between 25 and 69 years, who haven't had a Pap test in the last three years, will be invited to participate. Participation to the study will be encouraged through public displays, social networks, and medical consultations. Women meeting the eligibility criteria will be enrolled in the study. They will be randomized into two groups and will receive a home-sent letter, inviting them to either come in for a Pap test or to perform and send back the HPV self-sample that they'll receive at their domicile. Both groups will also receive a questionnaire, in order to better understand the reasons for their previous non-attendance to cervical cancer screening.

Eligibility criteria: Inclusion Criteria:

* No previous cervical cancer screening test in the last three years

Exclusion Criteria:

* pregnancy
* previous hysterectomy

Primary outcomes:
measure: Number of Participants Who Performed HPV Self-testing Compared to the Number of Participants Who Responded to the Invitation to Come to the Hospital for Pap Testing
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of Women With a Positive HPV Self-test Who Underwent All the Recommended Follow-up Clinical Investigations.
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02151123: Metabiomics Colon Cancer Clinical Research Study
Official title: Metabiomics Colon Cancer Clinical Research Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colonic Neoplasms
Keywords: Colonic Neoplasms
Colon Cancer
Microbiome
Lead sponsor: Metabiomics Corp
Sponsor class: INDUSTRY
First posted: 2014-05-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with colonic adenocarcinoma undergoing colectomy at University of Colorado

Brief summary: The specific aim of the study is to determine the false negative rate of the Metabiomics Colon Polyp and Colorectal Cancer Assay for Cancer.

Detailed description: The purpose of this study is to conduct clinical research to investigate the association of the gut microbiome with colonic neoplasia. In this case several types of gut microbiome samples will be collected from patients undergoing colectomy for colonic adenocarcinoma; those samples will be tested by Metabiomics Colon Polyp and Colorectal Cancer Assay and the percentage of false negative (test returns a negative for cancer) results determined.

Eligibility criteria: Inclusion Criteria:

* Recently diagnosed with colorectal cancer (CRC) and scheduled for colectomy
* Male or female,
* Age: 18-95 years,
* Able to comprehend, sign, and date the written informed consent form (ICF),
* Able to give informed consent in English
* Women and minorities will be included.

Exclusion Criteria:

* History of Inflammatory Bowel Disease
* Antibiotics within 2 weeks of sample collection.
* Colonoscopy, colon prep or bowel contrast agent within 7 days prior to sample collection
* Any radiation therapy

Primary outcomes:
measure: False negative rate of test for colon cancer
timeFrame: immediately post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado School of Medicine Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado School of Medicine Anschutz Medical Campus
name: Jon Vogel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado School of Medicine Anschutz Medical Campus
name: Christopher Lieu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: George Mason University
name: Patrick Gillevet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03007823: High-activity Natural Killer Immunotherapy for Small Metastases of Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Melanoma
Keywords: Metastatic Melanoma
High-activity natural killer
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shenzhen Hank Bioengineering Institute
First posted: 2017-01-02
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of melanoma.

Detailed description: By enrolling patients with small metastases of melanoma adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree of tumors
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Fuda cancer institute of Fuda cancer hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT04259723: Virtual Reality Assisted Conscious Sedation During TAVI
Official title: Virtual Reality Assisted Conscious Sedation During Transcatheter Aortic Valve Implantation - a Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Aortic Valve Stenosis
Anxiety
Pain
Keywords: TAVI
VR
3D glasses
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic valve stenosis. Pain and anxiety are major contributors to procedural complications. Virtual Reality (VR) glasses have already been used successfully in different clinical settings to treat anxiety and delirium. The aim of this prospective, randomized investigation is to prove the feasibility and safety of VR interventions in patients undergoing conscious sedation during TAVI with local anesthesia only.


Eligibility criteria: Inclusion Criteria:

* Interventional transfemoral TAVI
* Informed consent
* Normal or corrected vision (through glasses)

Exclusion Criteria:

* Patients whose communication is limited due to a language barrier
* Patients who could not watch the 3D video due to uncorrectable vision
* all patients with transapical TAVI were also excluded.

Primary outcomes:
measure: Change in anxiety
timeFrame: at Baseline
measure: Change in anxiety
timeFrame: after 24 hours
Secondary outcomes:
measure: Time of VR
timeFrame: at Baseline
measure: Evaluation of clinical frailty scale
timeFrame: at Baseline
measure: Measurement of pain: visual analog scale
timeFrame: after 24 hours
measure: Length of stay at hospital
timeFrame: up to 5 days
measure: Occurence of vomitting
timeFrame: at Baseline, periprocedural and after 24 hours
measure: Occurence of nausea
timeFrame: at Baseline, periprocedural and after 24 hours
measure: Rate of Intra-hospital mortality
timeFrame: up to 5 days
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study officials:
References:
Clinical trial NCT05510323: Efficacy of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 CKD
Official title: Efficacy and Safety of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Glomerulonephritis, IGA
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 208
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: The purpose of this clinical trial is to evaluate the long-term efficacy and safety of low-dose oral corticosteroids combined with cyclophosphamide therapy and low-dose corticosteroids monotherapy, on a background of maximal RAS inhibitor therapy, for IgA nephropathy with stage 3 or 4 chronic kidney disease.


Eligibility criteria: Inclusion Criteria:

* Biopsy-proven IgA nephropathy;
* Proteinuria ≥1.0g/day while receiving maximum tolerated dose of RAS blockade;
* Estimated glomerular filtration rate 15-60 ml/min/1.73/m2.

Exclusion Criteria:

* Indication or contraindication for immunosuppressive therapy with corticosteroids
* Use of corticosteroids and other immunosuppressive drugs within the last 1 year
* Current unstable kidney function for other reasons
* Under 18 years old
* Patients with secondary IgAN
* Patients who are unlikely to comply with the study protocol in the view of the treating physician

Primary outcomes:
measure: Combined event
timeFrame: up to 6 years
Secondary outcomes:
measure: Proteinuria remission at 6, 12 months and total follow-up period
timeFrame: up to 6 years
measure: Hematuria remission at 6, 12 months and total follow-up period
timeFrame: up to 6 years
measure: The composite of 30% decrease in eGFR, ESRD and all cause death
timeFrame: up to 6 years
measure: The composite of 40% decrease in eGFR, ESRD and all cause death
timeFrame: up to 6 years
measure: The composite of 50% decrease in eGFR, ESRD and all cause death
timeFrame: up to 6 years
measure: Annual eGFR decline rate
timeFrame: up to 6 years
measure: 30% decrease in eGFR
timeFrame: up to 6 years
measure: 40% decrease in eGFR
timeFrame: up to 6 years
measure: 50% decrease in eGFR
timeFrame: up to 6 years
measure: ESRD
timeFrame: up to 6 years
measure: All cause death
timeFrame: up to 6 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: AFMMU
Study officials:
References:
Clinical trial NCT03535623: RIPC During Free Flap With Preoperative Radiotherapy
Official title: Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction in Head and Neck Cancer Patients With Preoperative Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Reperfusion Injury
Other Reconstructive Surgery
Radiotherapy
Keywords: remote ischemic preconditioning
free flap reconstruction
preoperative radiotherapy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Remote ischemic preconditioning (RIPC) has shown organ-protective effects in many clinical settings including patients with ischemic heart disease. However its protective role in head and neck cancer patients with preoperative radiotherapy undergoing free flap reconstructive surgery has not yet been evaluated. The purpose of the current study is to evaluate the effect of RIPC on tissue oxygen saturation and skin temperature of the flap.

Detailed description: Patients undergoing free flap reconstructive surgery for head and neck cancer with preoperative radiotherapy will be randomized to either remote ischemic preconditioning (RIPC) group or control group. On the day of surgery, after induction of anesthesia, RIPC, consisting of 4 cycles of 5-min ischemia (using pneumatic cuff pressure of 200 mmHg) followed by 5-min reperfusion at the upper arm, or sham-RIPC (pressure \< 10 mmHg) will be induced in the RIPC or control group, respectively. Before completion of surgery, RIPC or sham-RIPC will be repeated. Tissue oxygen saturation and skin temperature of the flap will be recorded until postoperative day 1.

Eligibility criteria: Inclusion Criteria:

* Adult head and neck cancer patients undergoing free flap reconstructive surgery with preoperative radiotherapy

Exclusion Criteria:

* Radiotherapy within 4 weeks
* Body mass index \< 18 kg/m\^2 or \> 35 kg/m\^2
* Presence of AV fistula at the arm, any reason to protect arms
* Presence of vascular abnormality or discomfort at arms
* Peripheral vascular disease, peripheral neuropathy, or coagulopathy
* Uncontrolled diabetes mellitus
* Preoperative use of beta-blockers
* Refuse to enrol

Primary outcomes:
measure: tissue oxygen saturation
timeFrame: postoperative day 1
Secondary outcomes:
measure: skin temperature
timeFrame: postoperative day 1
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Youn Joung Cho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05052723: Cabozantinib and Pembrolizumab in Metastatic Pancreas
Official title: Phase II Clinical Trial Evaluating Cabozantinib and Pembrolizumab in Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: Adenocarcinoma
Metastatic
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Exelixis
name: Merck Sharp & Dohme LLC
First posted: 2021-09-22
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate cabozantinib and pembrolizumab for the treatment of metastatic pancreatic adenocarcinoma.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of pancreatic ductal adenocarcinoma
* Evidence of progression or intolerance to previous standard of care pancreatic cancer systemic or locoregional therapies
* Patients must have adequate organ function

Exclusion Criteria:

* Chemotherapy or other locoregional anti-tumoral therapies performed within 28 days of study treatment initiation
* Received palliative radiation therapy within 2 weeks or any other radiation therapy within 4 weeks of start of study intervention
* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation
* Has a diagnosis of immunodeficiency (autoimmune disease) or is receiving chronic systemic steroid therapy
* Clinically significant cardiovascular disease
* Uncontrolled hypertension
* Inability to swallow tablets

Primary outcomes:
measure: Progression-free survival
timeFrame: 1 year
Secondary outcomes:
measure: Change in overall response to therapy
timeFrame: 2 months, 4 months, 6 months, 9 months, 12 months
measure: Complete response
timeFrame: 1 year
measure: Partial response
timeFrame: 1 year
measure: Overall participant survival rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Markey Cancer Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Josepoh Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: