louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03926429: Features and Outcomes of Patients With Reactive Arthritis
Official title: A Bicentre Retrospective Study of Features and Outcomes of Patients With Reactive Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with active reactive arthritis

Brief summary: The aim of this study is to assess the incidence and the clinical and therapeutic characteristics of reactive arthritis and to compare them with those of a historical cohort. We hypothesised that improved hygiene together with prevention and treatment of sexually transmitted infections may have decreased the incidence of reactive arthritis.


Eligibility criteria: Inclusion Criteria:

* reactive arthritis diagnosed in one of the two rheumatology departments from Centre Hospitalier Lyon Sud or Besançon

Exclusion Criteria:

* presence of other known causes of arthritis, such as other defined spondyloarthritides, septic arthritis, Lyme disease, microcrystalline arthritis or rheumatoid arthritis

Primary outcomes:
measure: To determine the incidence of reactive arthritis in patients hospitalised in the rheumatology department
timeFrame: December 2014
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon
name: Fabienne COURY-LUCAS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02468180: Primary Prophylaxis of Gastric Variceal Bleed
Official title: Primary Prophylaxis of Gastric Variceal Bleed: Endoscopic Cyanoacrylate Injection Versus Balloon-occluded Retrograde Transvenous Obliteration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Varices
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric variceal bleeding.


Eligibility criteria: Inclusion Criteria:

1. Cirrhosis
2. Patients with high risk gastric varices (GOV2 or IGV1)
3. Presence of gastrorenal shunt

Exclusion Criteria:

1. Acute bleed or past history of bleed from gastric varices
2. Previous treatment of gastric varices.
3. Non-cirrhotic portal hypertension
4. Contraindications to cyanoacrylate injection or BRTO
5. Portal cavernoma
6. Hepatorenal syndrome
7. Proven malignancy including hepatocellular carcinoma
8. End-stage renal disease under renal replacement therapy;
9. Cardiorespiratory failure
10. Pregnancy or patients not giving informed consent for endoscopic procedures

Primary outcomes:
measure: Bleeding rate from gastric varices
timeFrame: 3 years
Secondary outcomes:
measure: Eradication rate of gastric varices
timeFrame: 3 years
measure: Number of participants with increase or decrease in the size of gastric varices
timeFrame: 3 years
measure: Number of participants with appearance or worsening of new oesophageal varices
timeFrame: 3 years
measure: Number of participants with appearance or worsening of portal hypertensive gastropathy
timeFrame: 3 years
measure: Number of participants with appearance or worsening of ascites
timeFrame: 3 years
measure: Number of participants with complication
timeFrame: 3 years
measure: Average in-hospital stay
timeFrame: 3 years
measure: Cost of treatment
timeFrame: 3 years
measure: Mortality rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT03531580: Comparing Brain Images Before and After MRI-upgrade - TimFit Upgrade Study
Official title: Brain Images Before and After Upgrade of the MRI-scanner (Siemens Tim TRIO vs Siemens PRISMA FIT) - The TimFit Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuroimaging
Quality Control
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In the Ghent University, an upgrade of the MRI-scanner used for research from Siemens Trio Tim to Siemens Prisma Fit is planned in the near future. As a change of MRI hard- and software might influence brain images, it is necessary to evaluate the images before and after the upgrade.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteer

Exclusion Criteria:

* Protheses or artificial implants, no magnetic or metal parts in the body
* Being pregnant or breastfeeding
* Having claustrophobia

Primary outcomes:
measure: Change in grey matter volume before versus after MRI-upgrade
timeFrame: 7 months, 4 scan sessions of max 1 hour
measure: Change in cerebral perfusion (ml/100g/min) using Arterial Spin Labeling before versus after MRI-upgrade
timeFrame: 7 months, 4 scan sessions of max 1 hour
measure: Change in arterial transit times before versus after MRI-upgrade
timeFrame: 7 months, 4 scan sessions of max 1 hour
measure: Change in functional connectivity (fc) using Resting State functional MRI before versus after MRI-upgrade
timeFrame: 7 months, 4 scan sessions of max 1 hour
measure: Change in effective connectivity using resting state functional MRI before versus after MRI-upgrade
timeFrame: 7 months, 4 scan sessions of max 1 hour
measure: Change in white matter diffusion before versus after MRI-upgrade
timeFrame: 7 months, 4 scan sessions of max 1 hour
measure: Difference in image quality of FLAIR image before versus after MRI-upgrade
timeFrame: 7 months, 4 scan sessions of max 1 hour
measure: Difference in image quality of SWI image before versus after MRI-upgrade
timeFrame: 7 months, 4 scan sessions of max 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
Study officials:
affiliation: University Hospital, Ghent
name: Eric Achten, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01807780: Safety, Immunogenicity And Efficacy Of Vaccination In Military Personnel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaccination Adverse Events
Vaccination Failure
Specific Antibody Response
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2013-03-08
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if multiple vaccination in military personnel may be correlated with the appearance of poorly defined diseases as symptomatic multisyndrome, autoimmune or lymphoproliferative disorders. At the same time, considering possible interference between different vaccines, proteins and polysaccharides, living and inactivated, the study aims to assess the immunogenicity and efficacy also in relation to the specific Human Leucocyte Antigens (HLA) genetic structure.


Eligibility criteria: Inclusion Criteria:

* Military volunteers
* No recently immunized

Exclusion Criteria:

* Pregnancy
* Documented immunodepression
* Documented allergy or hypersensitivity to vaccines

Primary outcomes:
measure: immunomediated disorders related to multiple vaccination
timeFrame: three years
Secondary outcomes:
measure: efficacy of multiple vaccination
timeFrame: Three years
measure: immunogenicity of multiple vaccination
timeFrame: Three years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: University of Roma La Sapienza
state: Italia
Study officials:
affiliation: sapienza università di roma
name: Raffaele D'Amelio, MD
role: STUDY_CHAIR
References:
citation: Ferlito C, Biselli R, Mariotti S, von Hunolstein C, Teloni R, Ralli L, Pinto A, Pisani G, Tirelli V, Biondo MI, Salerno G, Andreasi Bassi L, Lulli P, Autore A, Scagliusi A, Tomao E, Germano V, Picchianti Diamanti A, Caporuscio S, Milanetti F, Salemi S, Nisini R, D'Amelio R. Tetanus-diphtheria vaccination in adults: the long-term persistence of antibodies is not dependent on polyclonal B-cell activation and the defective response to diphtheria toxoid re-vaccination is associated to HLADRB1 *01. Vaccine. 2018 Oct 29;36(45):6718-6725. doi: 10.1016/j.vaccine.2018.09.041. Epub 2018 Sep 27.
Clinical trial NCT03996980: Effect Mechanism of Custom-made Foot Orthoses in Patients With Chronic Low Back Pain
Official title: Effect Mechanism of Custom-made Foot Orthoses on Foot Pronation Subjects and Chronic Low Back Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low Back Pain
Foot Pronation
Keywords: Low back pain
custom-made foot orthoses
Foot
pronation
posture
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Excessive foot pronation has been recognized as being linked to chronic low back pain (CLBP). The use of compensating custom-made foot orthoses has not been entirely explored as an effective therapy for CLBP Objective: to investigate the effects of wearing custom made foot orthoses compared to placebo orthoses in patients with pronated feet and chronic low back pain (CLBP).

Detailed description: Excessive foot pronation has been recognized as being linked to CLBP. Foot hyperpronation may cause malalignment of the lower extremity.There is a wide variety of treatments for CLBP, and it is suggested that excessive pronation of the foot has been linked to CLBP.The use of compensating custom-made foot orthoses has not been entirely explored as an effective therapy for CLBP.

Customized foot orthoses alter the position of the foot during weight-bearing. The goal is to eliminate compensation of the foot due to structural deformity or misalignment and redistribute abnormal plantar pressures.Custom-made foot orthoses may contribute to improving chronic low back pain. This question represents an important benefit for patients and for the public health system by reducing expensive treatments, such as surgery or long periods of rehabilitation

Eligibility criteria: Inclusion Criteria:

* Males and females between 18 and 65 years old
* Presence of CLBP
* Foot Posture Index pronated in one or both feet (henceforth, FPI) ≥ +6

Exclusion Criteria:

* Serious illness
* Current participation in another research study
* Pregnancy
* Previous back or foot surgery
* Current treatment of foot pathology or back, and leg length discrepancy \> 5 mm

Primary outcomes:
measure: Assess chronic low back pain
timeFrame: At the moment of inclusion in the study
measure: Assess chronic low back pain
timeFrame: At the moment of inclusion in the study
measure: Assess the position of the foot
timeFrame: At the moment of inclusion in the study
measure: Assess chronic low back pain
timeFrame: After four weeks of use of the orthose treatment.
measure: Assess chronic low back pain
timeFrame: After four weeks of use of the orthose treatment.
measure: Assess the position of the foot
timeFrame: After four weeks of use of the orthose treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Manuel Pabón Carrasco
Study officials:
References:
Clinical trial NCT01196780: An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNF Therapy (REPEAT)
Official title: MabThera Post Marketing Observational Study in TNF-IR Patients to Assess Efficacy and Safety of REPeated Courses in routinE ClinicAl pracTice
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-09-08
Enrollment: 1240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with an inadequate response to prior anti-TNF therapy

Brief summary: This observational study will assess the efficacy and safety of MabThera/Rituxan (Rituximab) in patients with active rheumatoid arthritis who have had an inadequate response or are intolerant to anti-TNF therapy. Data will be collected from patients initiated on MabThera/Rituxan therapy according to standard of care in routine clinical practice. For each patient data will be collected for 92 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Active Rheumatoid Arthritis
* Inadequate response to anti-TNF
* Eligible for MabThera/Rituxan therapy according to physician's decision

Exclusion Criteria:

* According to Summary of Product Characteristics

Primary outcomes:
measure: Efficacy: Change in Disease Activity Score - erythrocyte sedimentation rate (DAS28 - ESR)
timeFrame: from baseline to Week 92
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: 4 years
Other outcomes:
Locations:
city: Bucuresti
country: Romania
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00753480: A Study of D4064A Administered to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Official title: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of D4064A Administered Intravenously to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer After a Platinum-Containing Regimen
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cancer
Keywords: EOC
PPC
FTC
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-16
Enrollment: 56
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: This is a Phase I, multicenter, open-label, dose-escalation study of single-agent D4064A administered by IV infusion to patients with recurrent or persistent epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC), and fallopian tube cancer (FTC) who have previously received a platinum-containing regimen. The study will enroll up to 56 patients at up to six investigative sites in the United States.


Eligibility criteria: Inclusion Criteria:

* ECOG performance status of 0 or 1
* Advanced, histologically documented epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed during or within 12 months of treatment with a platinum-containing chemotherapy regimen, and for which no standard therapy exists
* History of receiving five or fewer prior chemotherapy-containing regimens for EOC, PPC, or FTC (including primary therapy)

Exclusion Criteria:

* Prior treatment with chemotherapy or experimental anti-cancer agents within 4 weeks prior to Day 1
* Prior treatment with oregovomab (OvaRex(R)) or abagovomab
* History or clinical evidence of central nervous system or brain metastases
* Grade ≥ 2 peripheral neuropathy
* History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
* History of clinically symptomatic liver disease, including viral or other hepatitis, history of or current alcoholism, or cirrhosis
* Untreated or persistent/recurrent malignancy (other than EOC, PPC, or FTC)

Primary outcomes:
measure: Incidence and nature of dose-limiting toxicities (DLTs)
timeFrame: Length of study
Secondary outcomes:
measure: Incidence, nature, and severity of adverse events
timeFrame: Length of study
measure: Incidence of anti-D4064A antibodies
timeFrame: Length of study
measure: Changes in vital signs and clinical laboratory results
timeFrame: Length of study
Other outcomes:
Locations:
city: New York
country: United States
facility: Investigational Site
state: New York
city: Nashville
country: United States
facility: Investigational Site
state: Tennessee
Study officials:
affiliation: Genentech, Inc.
name: Scott Holden, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00473980: Preoperative Non-steroidal Anti-inflammatory Drugs(NSAID) to Colorectal Cancer Patients
Official title: Preoperative Treatment With NSAID in Colorectal Cancer Patients in Relationship to Tumor Host Reactions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Cancer
Keywords: MHC
CTLs
Colon carcinoma
NSAID
Survival
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2007-05-16
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to evaluate effects of NSAIDs on immune activity inside and close to tumor tissue in patients with colorectal cancer.

Detailed description: Study and control patients are randomized to receive preoperative treatment with indomethacin or celecoxib compared to sham treatment.Tumor biopsies are taken at operation and used for analyses of tumor immunity and gene expression.

Eligibility criteria: Inclusion Criteria:

* Colon carcinoma scheduled for curative operation

Exclusion Criteria:

* Diabetes, steroid medication, liver and kidney impairment

Primary outcomes:
measure: Immune reactivity
timeFrame: Acute evaluations
Secondary outcomes:
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Department of Surgery
Study officials:
affiliation: Göteborg University
name: Kent Lundholm, MD, prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00588380: GLP1R Polymorphisms and Response to GLP1
Official title: A Pilot Study Examining How Common Genetic Variation in GLP1R Alters Response to GLP1 Infusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: GLP-1
Insulin Secretion
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-01-08
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Glucagon-like Peptide-1 (GLP-1) is an important incretin hormone which acts as a powerful insulin secretagogue. Defects in GLP-1 synthesis and secretion are thought to be part of the pathogenesis of type 2 diabetes. Furthermore GLP-1 based therapy is an important part of the therapeutic armamentarium for the treatment of type 2 diabetes. The GLP-1 receptor (GLP1R) is the principal site of action of GLP-1 and GLP-1 receptor agonists like exenatide and liraglutide. The gene coding for this receptor, GLP1R, is highly polymorphic and contains numerous non-synonymous Single Nucleotide Polymorphisms (nsSNPs) which could potentially alter response to endogenous or exogenous GLP-1 or GLP-1R agonists. Indeed there is some in vitro data to support this concept. We propose to utilize a hyperglycemic clamp to test the insulin secretory response to infused GLP-1 in healthy volunteers to determine the effect of genetic variation in GLP1R on response to GLP-1.


Eligibility criteria: Inclusion Criteria:

* Aged 18-40
* fasting glucose concentration of less than 95 mg/dl.

Exclusion Criteria:

* Individuals with a BMI \< 19 or \> 40 kg/m\^2
* active systemic illness
* medication that can alter gastric emptying, insulin secretion \& action
* history of abdominal surgery (other than appendectomy or tubal ligation).

Primary outcomes:
measure: Insulin Secretion at 150-180 Minutes.
timeFrame: 150 - 180 minutes after GLP-1 infusion
Secondary outcomes:
measure: Insulin Secretion at 210-240 Minutes
timeFrame: 210 - 240 minutes after GLP-1 infusion
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Adrian Vella, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sathananthan A, Man CD, Micheletto F, Zinsmeister AR, Camilleri M, Giesler PD, Laugen JM, Toffolo G, Rizza RA, Cobelli C, Vella A. Common genetic variation in GLP1R and insulin secretion in response to exogenous GLP-1 in nondiabetic subjects: a pilot study. Diabetes Care. 2010 Sep;33(9):2074-6. doi: 10.2337/dc10-0200.