louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04752748: Power Doppler in Hand Joints of Early RA Patients
Official title: Power Doppler in Hand Joints is a Predictor of Therapeutic Failure in Women With Early Rheumatoid Arthritis Naive for Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Rheumatoid Arthritis
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Woman diagnosed eith early rheumatoid arthritis naive for treatment

Brief summary: It is a prospective case-control study with women diagnosed early rheumatoid arthritis. Three therapeutic failures were considered: failure 1 - to the first Disease-modifying antirheumatic drugs (DMARDs) (methotrexate); failure 2 - to the second DMARDs (leflunomide) and failure 3 - to the first immunobiological drugs (adalimumab). Ultrasound was performed bilaterally on the 2nd and 3rd metacarpophalangeal joints (MCFs), proximal interphalangeal joints (IFPs), and wrists (US10). Ultrasound measurements (qualitative and semi-quantitative) evaluated: 1 - inflammatory: synovial and tenosynovial proliferation in gray scale and power Doppler (0-3); 2 - joint damage: bone erosion (qualitative and semi-quantitative) and cartilage damage (qualitative and semi-quantitative). Clinical and laboratory variables were also assessed blindly at baseline and after 12, 24 e 48 weeks.


Eligibility criteria: Inclusion Criteria:

* early rheumatoid arthritis fulfilment of the 2010 ACR/EULAR RA classification criteria;
* age between 18-65 years;
* female gender,
* naive for treatment.

Exclusion Criteria:

* use of oral \> 10 mg/d glucocorticoid in the previous three weeks;
* serum aspartate aminotransferase or alanine aminotransferase level \> 3 times the upper limit of normal;
* bone marrow, auto-imune, lymphoproliferative or infectious diseases;
* pregnancy.

Primary outcomes:
measure: Changes in Synovial blood flow (power doppler)
timeFrame: Baseline, after 4, 12, 24 and 48 weeks
Secondary outcomes:
measure: Change in Synovial Proliferation
timeFrame: Baseline, after 4, 12, 24 and 48 weeks
measure: Changes in Tenosynovitis
timeFrame: Baseline, after 4, 12, 24 and 48 weeks
measure: Changes in Joint Damage
timeFrame: Baseline, after 4, 12, 24 and 48 weeks
measure: Changes in C-reactive protein level (mg/liter)
timeFrame: Baseline, after 4, 12, 24 and 48 weeks
measure: Changes in erythrocyte sedimentation rate level (mm/hour)
timeFrame: Baseline, after 4, 12, 24 and 48 weeks
measure: Changes in function
timeFrame: Baseline, after 4, 12, 24 and 48 weeks
measure: Changes in upper limb function
timeFrame: Baseline, after 4, 12, 24 and 48 weeks
measure: Changes in disease activity score
timeFrame: Baseline, after 4, 12, 24 and 48 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01762748: Effect of Saccharomyces Boulardii in Patients in the Waiting List for Liver Transplant
Official title: Effect of Saccharomyces Boulardii in Patients in the Waiting List for Liver Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Cirrhosis
Keywords: Probiotic
liver
transplant
permeability
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2013-01-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effect of Saccharomyces boulardii in patients in the waiting list for liver transplant.

Detailed description: Increased intestinal permeability are related to the major complications of liver cirrhosis. The administration of probiotics has been suggested to improve the barrier function of the mucosa and consequently avoid the complications of the disease. The objective of this study was to evaluate the effect of Saccharomyces boulardii in patients in the waiting list for liver transplant.

Eighteen patients were treated with Saccharomyces boulardii. Intestinal permeability (lactulose/mannitol ratio) and laboratory parameters were evaluated immediately before the beginning of treatment, after a thirty-day period of treatment with probiotic and at the end of the second study month (after a thirty-day period without treatment with probiotic). Twenty healthy volunteers were also submitted for the intestinal permeability test.

Eligibility criteria: Inclusion Criteria:

* patients in the waiting list for liver transplant with viral, alcoholic or cryptogenic cirrhosis

Exclusion Criteria:

* patients younger than 18 years or older than 65 years.
* patients with renal failure, congestive heart failure, nephrotic syndrome, diabetes and thyroid diseases that interfered with absorption, flux of water and solutes and intestinal motility, in order to avoid interference with the intestinal permeability tests

Primary outcomes:
measure: Intestinal permeability
timeFrame: Change from intestinal permeability at two months
Secondary outcomes:
measure: Effect of Saccharomyces boulardii on laboratory parameters
timeFrame: Change from laboratory parameters in two months
measure: Number of participants with adverse effect
timeFrame: Adverse effect in two months
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Alfa Institute of Gastroenterology - Transplant Outpatient Clinic at Federal University of Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Maria Isabel Correia, PhD
role: STUDY_CHAIR
affiliation: Federal University of Minas Gerais
name: Juliana Liboredo, PhD degree
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03395548: Stability of the Microbiome in IBD and IBS
Official title: Stability of the Intestinal Microbiome in Patients Suffering From Inflammatory Bowel Disease (IBD) and Irritable Bowel Syndrome (IBS) Under the Influence of an Osmotic Laxans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microbiota
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In this study the investigators aim to investigate the changes of the intestinal microbiome in three different cohorts (IBD, IBS, healthy) after applying the uniform disruptive factor of osmotic diarrhea induced by macrogol. The investigators hypothesis is that ill people will show more severe changes of the microbiome than healthy people and that these changes persist longer.

Detailed description: I

Eligibility criteria: Inclusion Criteria:

* patients with inflammatory bowel disease and irritable bowel syndrome and stable therapy since three months
* patients with the indication for colonoscopy

Exclusion Criteria:

* age under 18
* pregnancy
* new therapy planned
* change of therapy within the last three months
* acute exacerbation of the inflammatory bowel disease
* colon pathologies of other origin: colocarcinoma, Illnesses with diarrhea (f.e.microscopic colitis), short bowel syndrome, malabsorption, colectomy
* intake of antibiotics in the last three months
* intake of probiotics in the last month
* intake of antibiotics or probiotics during the study
* new proton pump inhibitor therapy
* significant change of nutrition in the last three months
* holidays outside europe in the last month
* gastroenteritis in the last three months
* intake of laxatives
* nonsteroidal antiinflammatory drugs should be avoided and documented

Primary outcomes:
measure: Changes of the microbiome
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universitätsklinikum Graz
state: Styria
Study officials:
affiliation: Medical University of Graz
name: Andreas Blesl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03533348: Preparative Fasting Before Contrast-enhanced Computed Tomography
Official title: Preparative Fasting for Contrast-enhanced Computed tomography-a Prospective Randomized Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: X-ray Contrast Media Adverse Reaction
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 2148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants are inpatients who are undergoing contrast enhanced computed tomography that will be divided into two cohorts. The first will need at least 4 hours of fasting prior to contrast enhanced computed tomography scans and the second will be allowed to eat and drink freely prior to contrast enhanced computed tomography scans

Brief summary: The study aims to determine whether there is a need for preparative fasting prior to contrast-enhanced computed tomography (CT).

Detailed description: The use of fasting orders for imaging and other procedures is common, this seemingly benign practice can lead to real harms to patients and poor satisfaction with their care. The nothing per os (NPO) order is sometimes used in CT scans because gastrointestinal tract contents can interrupt visualization of the intestinal lumen, but more commonly NPO orders are are thought to protect all supine patients from aspiration during delivery of intravenous contrast. There is limited evidence to support such practice of NPO orders prior to contrast-enhanced CT scans. The authors' main objective is to determine if there is a need for preparative fasting prior to contrast-enhanced CT scans.

Eligibility criteria: Inclusion Criteria:

- Patients undergoing contrast-enhanced CT scans

Exclusion Criteria:

1. Pateints undergoing CT scans while sedated.
2. Patients under the age of 18 years
3. Patients who suffer from a mental disorder that prevents them:

   1. from understanding what s/he consents to and/ or
   2. from choosing decisively and/ or
   3. from communicating his/her consent
4. Patients who were instructed not to eat due to requirements of a specific study (for example.. computed tomography enterography-CTE)

Primary outcomes:
measure: Aspiration pneumonitis
timeFrame: Day 1
Secondary outcomes:
measure: Gastrointestinal symptoms
timeFrame: Hour 1
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Emek Medical Center
Study officials:
affiliation: Emek Medical Center
name: Naiel Bisharat, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neeman Z, Abu Ata M, Touma E, Saliba W, Barnett-Griness O, Gralnek IM, Rock W, Bisharat N. Is fasting still necessary prior to contrast-enhanced computed tomography? A randomized clinical study. Eur Radiol. 2021 Mar;31(3):1451-1459. doi: 10.1007/s00330-020-07255-0. Epub 2020 Sep 8.
Clinical trial NCT03162848: SystemCHANGE™ Intervention on Medication Adherence in Older Adults With Heart Failure
Official title: Impact of SystemCHANGE™ Intervention on Medication Adherence in Older Adults With Heart Failure: A Pilot RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Heart Failure
Aging
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 2
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this pilot RCT study is to evaluate the acceptability and feasibility of a SystemCHANGE™ intervention to improve medication adherence in older adults with heart failure. The intervention focuses on changing the individual's environment by incorporating medication taking into existing routines using small experiments with feedback, and receiving support from people who impact routines.


Eligibility criteria: Inclusion Criteria:

* age 50 years or older
* HF diagnosis confirmed by their physician utilizing their most recent ejection fraction
* prescribed diuretics
* self-administering medications
* able to open an electronic cap
* able to speak, hear and understand English
* not hospitalized,
* no cognitive impairment as determined by a score of 4 or greater on the 6-item mini-mental status exam.

Primary outcomes:
measure: Acceptability and feasibility using open ended questionnaire
timeFrame: one point in time at the end of the maintenance phase which is 3 months after randomization into groups
Secondary outcomes:
measure: Systems thinking using questionnaire
timeFrame: baseline and after 2 month intervention phase
measure: Kansas City Cardiomyopathy Questionnaire
timeFrame: baseline and after 2 month intervention phase
measure: Medication adherence using medication event monitoring systems
timeFrame: after randomization through end of maintenance phase for a total of 3 months
Other outcomes:
Locations:
city: Belleville
country: United States
facility: Belleville Memorial
state: Illinois
Study officials:
affiliation: University of Missouri, Kansas City
name: Angela Andrews, PhD(c)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00055848: Genetic Study of Familial Factors in Patients With Colon Cancer
Official title: Familial Factors in the Development of Colon Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: adenocarcinoma of the colon
stage I colon cancer
stage II colon cancer
stage III colon cancer
stage IV colon cancer
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-03-07
Enrollment: 600
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with colon cancer or polyps age 70 or under. Specifically, patients previously enrolled on CLB-9581, CLB-89803 and CLB-80001.

Brief summary: RATIONALE: Genetic studies may help in understanding the genetic processes involved in the development of some types of cancer.

PURPOSE: Clinical trial to study the cancer-related genes in patients who have colon cancer or adenomatous polyps.

Detailed description: OBJECTIVES:

* Identify human colon neoplasia susceptibility genes in patients with colon cancer or adenomatous polyps.
* Correlate the inheritance of novel susceptibility alleles for adenomatous polyposis of the colon with colon neoplasia in these patients.
* Correlate colon neoplasia susceptibility with the presence of COX-2, sPLA2, and DNMT genes in these patients.
* Identify a novel gene that governs increased susceptibility to colon adenoma and cancer in the genome of these patients.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of colon cancer or polyps at age 70 or under
* Has a living full sibling with diagnosis of colon cancer or polyps at age 70 or under
* No history of familial adenomatous polyposis syndrome
* No hereditary nonpolyposis colon cancer, according to Amsterdam criteria
* No known I1370K adenomatous polyposis of the colon susceptibility variant
* Enrolled on 1 of the following clinical trials:

  * CLB-9581
  * CLB-89803
  * CLB-80001 NOTE: Patients do not need to be receiving protocol therapy. Patients who are outside the treatment protocol's follow-up range are eligible. Patients who discontinued therapy for any reason, including toxic effects, are eligible.

PATIENT CHARACTERISTICS:

Age

* 70 and under at diagnosis

Other

* No significant psychiatric illness that would preclude giving informed consent
* No inflammatory bowel disease (in patient or sibling)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Goldsboro
country: United States
facility: Wayne Memorial Hospital, Incorporated
state: North Carolina
Study officials:
affiliation: Dana-Farber/Brigham and Women's Cancer Center
name: Monica M. Bertagnolli, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00636948: Rectal Cancer Trial On Defunctioning Stoma
Official title: Rectal Cancer Trial On Defunctioning Stoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Keywords: Rectal cancer surgery
Symptomatic anastomotic leakage
Defunctioning stoma
TME surgery
Lead sponsor: Rectal Cancer Trial on Defunctioning Stoma Study Group
Sponsor class: OTHER
First posted: 2008-03-17
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients operated for rectal cancer in whom low anteriror resection with or without preoperative adjuvant treatment was the planned treatment, who did not have any intraoperative adverse events and who had accepted participation.

Brief summary: The hypothesis of the present trial was that the use of a defunctioning loop stoma reduces the rate of symptomatic anastomotic leakage from 15% to 7.5% after low anterior resection of the rectum for cancer.

Detailed description: The assumption that a defunctioning loop stoma reduces symptomatic anastomotic leakage from 15% to 7.5%, with a level of statistical significance of 5% and a statistical power of 80%, requires randomization of 220 patients.

Eligibility criteria: Inclusion Criteria:

* Absence of intraoperative adverse events according to the study protocol and the operating surgeon.

Exclusion Criteria:

* Presence of intraoperative adverse events according to the study protocol and the operating surgeon.

Primary outcomes:
measure: Symptomatic anastomotic leakage following low anterior resection of the rectum for cancer with and without a defunctioning stoma. Anorectal function after one and five years without defunctioning stoma.
timeFrame: 30 days, one year and five years.
Secondary outcomes:
measure: Reoperation within 30 days of initial surgery.
timeFrame: 30 days
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Department of Surgery, Linköping University Hospital
Study officials:
affiliation: Department of Surgery, Linköping University Hospital
name: Rune Sjödahl, MD, PhD
role: STUDY_CHAIR
References:
citation: Matthiessen P, Hallbook O, Rutegard J, Simert G, Sjodahl R. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Ann Surg. 2007 Aug;246(2):207-14. doi: 10.1097/SLA.0b013e3180603024.
citation: Floodeen H, Hallbook O, Rutegard J, Sjodahl R, Matthiessen P. Early and late symptomatic anastomotic leakage following low anterior resection of the rectum for cancer: are they different entities? Colorectal Dis. 2013 Mar;15(3):334-40. doi: 10.1111/j.1463-1318.2012.03195.x.
citation: Matthiessen P, Lindgren R, Hallbook O, Rutegard J, Sjodahl R; Rectal Cancer Trial on Defunctioning Stoma Study Group. Symptomatic anastomotic leakage diagnosed after hospital discharge following low anterior resection for rectal cancer. Colorectal Dis. 2010 Jul;12(7 Online):e82-7. doi: 10.1111/j.1463-1318.2009.01938.x. Epub 2009 Jul 7.
Clinical trial NCT04332848: Susceptibility Testing Guided Versus Empirical Therapy for Refractory H. Pylori Infection
Official title: Comparison of Susceptibility Testing Guided Versus Empirical Therapy for the Third-line Eradication of H. Pylori- a Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori,Susceptibility testing,empirical,third-line treatment
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 360
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: Therefore, we aimed to

1. compare the efficacy of susceptibility testing guided therapy vs. empirical therapy in the third-line eradication for refractory H. pylori infection
2. assess the long-term impact of eradication therapy on the antibiotic resistance and microbiota of the gut flora and the metabolic factors.

Methods: This will be a multi-center, open labeled trial

Patients: 360 patients with failure to H. pylori eradication for at least two times will be enrolled Determination of antibiotic resistance of H. pylori:

Agar dilution test will be used to determine the minimum inhibitory concentrations of levofloxacin, tetracycline, rifabutin, and clarithromycin to guide the selection of antibiotics.

Treatment regimens and assignment: Eligible patients will be randomized to receive either one of the treatments (A) Susceptibility testing guided therapy or (B) Empirical therapy

Outcome Measurement:

Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) analyses.

Secondary End Point: 1. Eradication rate according to per protocol analysis (PP analysis); 2. Frequency of adverse effects.


Eligibility criteria: Inclusion criteria

* Adult (equal or greater than 20 years old) patients who failed from at least two eradication therapies for H. pylori infection will be enrolled.

Primary outcomes:
measure: The primary outcome is the eradication rate in the third treatment according to intention-to treat (ITT) analysis.
timeFrame: 6 weeks
Secondary outcomes:
measure: Adverse effects
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Mei-Jyh Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: