louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04036669: Adipokines as Predictors of Foot Function, Pain, and Disability in Patients With Rheumatoid Arthritis
Official title: Foot Bone Mineral Density and Inflammation in Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Healthy Control
Keywords: rheumatoid arthritis, adipokines, foot function index, f-BMD
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 160
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eighty patients diagnosed with Rheumatoid arthritis according to American Rheumatology Association criteria and radiographic analysis for at least 10 years previously were randomly involved in this study, and eighty age and sex matched healthy controls were included in the study following assignment of informed consent.

Brief summary: Significant increase in the levels of serum adiponectin, ADA, and hsCRP was reported in all RA patients compared to controls.

Compared to patients with early RA, the increase in these markers significantly correlated with disease activity (DAS-ESR), lower f-BMD, radiographic scoring, pain, FFI, and functional limitations in patients with established RA.

Adiponectin showed a negative correlation with serum levels of both ADA and hsCRP. By using ROC curve analysis, optimal cut-off values of adiponectin (28.8 µg/ml), ADA (27.3 IU/L), and hsCRP (1.6 mg/L) could be used to estimate early RA in 45 % of the patients. Similarly, using cut-off values of adiponectin (32.8 µg/ml), ADA (26.1 IU/L ml), and hsCRP (2.5 mg/L), established RA could be predicted in 55 % of patients with 98-99% accuracy.

Detailed description: The present study attempts to evaluate the efficacy of adiponectin, ADA, and foot bone mineral density (fBMD) as predictors of the disease progression in patients with rheumatoid arthritis. A total of 80 RA patients and eighty age and sex-matched healthy controls were included in this study.

Eligibility criteria: Inclusion Criteria:

* patients who diagnosed with Rheumatoid arthritis according to American Rheumatology Association criteria and radiographic analysis for at least 10 years previously were randomly involved in this study
* Not receiving any drugs affecting the data obtained
* had Normal daily diets

Exclusion Criteria:

* Subjects with obvious ischemic heart disease (angina, myocardial infarction, and lead electrocardiogram abnormalities),
* HCV, HBV, chronic liver and kidney diseases, hypothyroidism.
* Drugs (diuretics; oral contraceptives).

Primary outcomes:
measure: Estimation of Foot bone mineral density (f-BMD)
timeFrame: 3 months
measure: Foot Function Index
timeFrame: 3 months
Secondary outcomes:
measure: Assessment of serum Adiponectin concentration
timeFrame: 3 months
measure: Assessment of serum Adenosine deaminase (ADA) activity
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02968069: A Predictive Model Based on Narrow Band Imaging for Early Gastric Cancerous Lesions
Official title: Development and Validation of a Predictive Model for Early Gastric Cancerous Lesions Under Endoscopic Observation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Early Gastric Cancer
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Putuo District Center Hospital
name: Shanghai MCC worker hospital
First posted: 2016-11-18
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Without high diagnostic efficacy of endoscopic forceps biopsy (EFB) and with low diagnostic efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community hospitals in China, it is urgent to improve diagnostic efficacy for gastric cancerous lesions.The investigators will conduct a study to develop and validate a diagnostic model based on NBI for early gastric cancerous lesions under endoscopic observation.

Detailed description: Endoscopic forceps biopsy (EFB) is considered the gold standard and most commonly used for histological diagnosis of gastric epithelial neoplasia before proper management.Many studies have shown that there exist considerable discrepancies between EFB and subsequently resected specimens with discrepancy rate of 27.1-44.5%. On the other hand, with low diagnostic efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community hospitals in China, not higher diagnostic accuracy of gastric cancerous lesions could be observed. Here, the investigators will conduct a study to develop and validate a diagnostic model based on narrow band imaging for early gastric cancerous lesions under endoscopic observation, trying to improve overall diagnostic efficacy for gastric cancerous lesions.

Eligibility criteria: Inclusion Criteria:

* Suspected of having a cancerous lesions
* The age of patients is from 40-80 years
* Patients must undergo esophagogastroduodenoscopy

Exclusion Criteria:

* Clinical diagnosis of advanced gastric cancer
* Acute upper gastrointestinal bleeding
* Severe systemic diseases
* Refuse to attend the study

Primary outcomes:
measure: Accuracy of the diagnostic model in histological prediction of gastric cancerous lesions
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai,China,Shanghai Institute of Digestive Disease, Shanghai
name: Xiaobo Li, MD.Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02121769: Omegaven Expanded Access Protocol
Official title: Protocol for Patients With Parenteral Nutrition Associated Liver Disease (PNALD) to Access Parenteral Fish Oil (Omegaven®) - Omegaven IND 122375
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Parenteral Nutrition Associated Liver Disease
Keywords: cholestasis
short bowel syndrome
Lead sponsor: St. Luke's Health System, Boise, Idaho
Sponsor class: OTHER
First posted: 2014-04-24
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD

Brief summary: Omegaven is an intravenous fat emulsion (IFE) comprised of omega-3 fatty acids derived from fish oil. It will be used in an open label compassionate use treatment protocol, as an alternative to soybean oil (omega-6), as the sole IFE source of parenteral nutrition in an effort to reduce and/or reverse parenteral nutrition associated liver disease. The study will evaluate the safety and efficacy of Omegaven use in pediatric patients with PN dependence and PNALD.


Eligibility criteria: Inclusion Criteria:

* Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days
* Parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of ≥ 2 mg/dL on the last two consecutive bilirubins while on PN. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.
* Failed standard/conventional therapies to prevent progression of PNALD.
* Age newborn to 17 years of age
* Signed informed consent.

Exclusion Criteria:

* Allergy to eggs and/or shellfish
* Female who is pregnant or lactating
* Severe hemorrhagic disorder
* Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency,)
* 18 years of age or older
* Parent/legally authorized representative is unwilling to consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boise
country: United States
facility: St. Luke's Pediatric Gastroenterology
state: Idaho
Study officials:
affiliation: Pediatric Gastroenterology
name: Tyler Burpee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06571669: BOOM-IBD2 Pivotal Clinical Trial
Official title: BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of Sacral Neuromodulation for the Treatment of IBD.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ulcerative Colitis
Inflammatory Bowel Diseases
Lead sponsor: Boomerang Medical
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The BOOM-IBD2 clinical trial is designed to evaluate the effectiveness of sacral neuromodulation for the treatment of IBD.


Eligibility criteria: Inclusion Criteria:

* Male or female
* 18 to 85 years of age
* Diagnosed with ulcerative colitis
* Ability and willingness to consent to participate by signing the informed consent form
* Ability to comply with the protocol and willingness to comply with all follow up requirements

Exclusion Criteria:

* Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study
* Any psychiatric or personality disorder at the discretion of the study investigator
* Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess)
* Active clostridium difficile infection of the colon
* Active cytomegalovirus (CMV) infection of the colon
* Evidence of colonic perforation
* Fulminant colitis requiring emergency surgery
* Microscopic, ischemic or infectious colitis
* Unresected neoplasia of the colon
* Colonic stricture unable to pass a colonoscope
* Current evidence of cancer in the gastrointestinal tract
* Current participation in another clinical trial
* Previous history of surgery for ulcerative colitis, or probably to require such intervention
* Previously implanted with a neurostimulation device or participated in a neurostimulation trial
* Inability to operate the patient programmer

Primary outcomes:
measure: Bowel Urgency
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Las Vegas Medical Research LLC, DBA Vector Clinical Trials
state: Nevada
city: New York
country: United States
facility: Columbia University Irving Medical Center/New York Presbyterian Hospital
state: New York
Study officials:
References:
Clinical trial NCT05371769: Evaluation of the Efficiency of the Chronic Pain Management Training Program
Official title: Evaluation of the Efficiency of the Chronic Pain Management Education Program Developed for Nursing Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Caries
Chronic Pain
Keywords: Chronic pain
Nursing student education
Web-Technology based education
Lead sponsor: Çankırı Karatekin University
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization: After applying the exclusion criteria to a total of 94 students, the students who accepted to participate in the study was randomly selected into two groups (A and B) of 35 students by simple random sampling by creating a computer-assisted simple random numbers table (www.randomizer.org). Selected students was randomly assigned so that the general academic achievement grades of both groups were homogeneous. The groups was randomly assigned to the intervention or control group by the code "A" and "B" by the software specialist.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The research will be conducted to evaluate the effectiveness of the web-based chronic pain management training program developed for nursing students. It is planned in a randomized controlled triple-blind design with the final year nursing students of the Nursing Department of Çankırı Karatekin University in a pre-test-post-test order.


Eligibility criteria: Inclusion Criteria:

* Nursing Grade 4
* with internet access
* Students who volunteered to participate in the research

Exclusion Criteria:

* Having a diagnosed psychiatric disorder
* Difficulty in understanding and speaking Turkish
* Graduated from Health Vocational High School
* Attending any training on pain and/or having a pain education certificate

Primary outcomes:
measure: Introductory features form
timeFrame: pre-intervention
measure: Scale of attitudes of students studying in the field of health towards patients with chronic pain
timeFrame: pre-intervention
measure: Scale of attitudes of students studying in the field of health towards patients with chronic pain
timeFrame: immediately after the intervention
measure: Chronic pain management knowledge test
timeFrame: pre-intervention
measure: Chronic pain management knowledge test
timeFrame: immediately after the intervention
measure: Chronic pain management training program evaluation form
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Çankırı
country: Turkey
facility: Nefise Cevriye SUCU ÇAKMAK
Study officials:
References:
Clinical trial NCT00078169: Motivational Enhancement for Spanish Speaking Individuals - 1
Official title: Motivational Enhancement for Spanish Speaking Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Substance-Related Disorders
Keywords: behavioral intervention
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Miami
First posted: 2004-02-23
Enrollment: 463
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare a three-session Spanish version of Motivational Enhancement Therapy (MET) to standard treatment to see how well MET engages and retains Spanish-speaking clients in outpatient substance abuse treatment.


Eligibility criteria: Inclusion Criteria:

All subjects included unless medical/psychiatrically unstable

Primary outcomes:
measure: Treatment retention, drug and alcohol abstinence
Secondary outcomes:
Other outcomes:
Locations:
city: Greeley
country: United States
facility: Island Grove RTC
state: Colorado
city: Miami
country: United States
facility: Miami Behavioral Health
state: Florida
city: Albuquerque
country: United States
facility: Counseling & Psychotherapy Institute
state: New Mexico
city: Santa Fe
country: United States
facility: The Life Link
state: New Mexico
city: Long Island City
country: United States
facility: Narco Freedom (Bridge Plaza)
state: New York
city: Portland
country: United States
facility: Changepoint - Cedar Hills Blvd
state: Oregon
city: Portland
country: United States
facility: Changepoint, Inc.
state: Oregon
Study officials:
affiliation: Yale University
name: Kathleen Carroll, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03491969: Clinical Study of Lipoic Acid on Ischemic Heart Failure
Official title: Clinical Study of Lipoic Acid on Ischemic Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ischemic Heart Failure
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2018-04-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The study will evaluate the efficacy of alpha-lipoic acid(α-LA) on mortality in patients with ischemic heart failure (NYHA Class II - IV and EF =\< 45%).


Eligibility criteria: Inclusion Criteria:

* patients ≥ 18 years of age, male or female.

  * Patients with a diagnosis of AMI (\>30 days) according to the global definition. ③Patients with a diagnosis of CHF (NYHA class II-IV) and reduced ejection fraction (EF =\< 45%) and elevated BNP（NT-proBNP≥600pg/ml or BNP≥150pg/ml; NT-proBNP ≥400 pg/mL or BNP ≥100 pg/mL if patients was hospitalized for heart failure within 12months).

    * Patients must be treated with standardized heart failure medications treatment at a stable dose for at least 4 weeks.

      * Patients must give written informed consent before any assessment is performed.

Exclusion Criteria:

* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.

  * allergy to any of the study drugs, drugs of similar chemical classes（Vitamin B） as well as known or suspected contraindications to the study drugs.

    * Previous history of intolerance to recommended target doses of α-LA.

      * Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy).

        ⑤ Symptomatic hypotension and/or a SBP \< 100 mmHg.

        ⑥ Severe liver function abnormalities (ALT or AST more than 3 times of the normal upper limit).

        ⑦ Estimated GFR \< 30 mL/min/1.73m2 as measured by the simplified MDRD formula.

        ⑧ Serum potassium \> 5.2 mmol/L.

        ⑨ Pregnant women or women preparing for birth.

Primary outcomes:
measure: Number of participants that had first occurrence of the composite endpoint
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03337269: Effectiveness of Targeted Educational Interventions at Increasing HPV Vaccine Acceptability and Uptake
Official title: Effectiveness of Targeted Educational Interventions at Increasing HPV Vaccine Acceptability and Uptake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HPV-Related Cervical Carcinoma
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2017-11-08
Enrollment: 256
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study aims to assess the effectiveness of targeted educational interventions in increasing the acceptability and knowledge of the HPV vaccine among females ages 12 through 26. Subjects will be randomized to one of three study arms (no intervention, viewing an educational video or reading an educational handout) and then a questionnaire will be administered to assess knowledge and acceptability of the HPV vaccine. Subject charts will be reviewed to assess for initiation of the HPV vaccine.


Eligibility criteria: Inclusion Criteria:

1. Females ages greater than or equal to 12 years and less than or equal to 26 years
2. Presenting to a gynecology clinic for a routine or problem visit
3. Ability to read and write

Exclusion Criteria:

1. Women ages less than or greater than 12 years or greater than 26 years
2. Women with known cervical cancer
3. Known pregnancy
4. Prior initiation or completion of the HPV vaccine series

Primary outcomes:
measure: HPV vaccine acceptability
timeFrame: Up to 6 months
Secondary outcomes:
measure: HPV vaccine knowledge
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
citation: Cory L, Cha B, Ellenberg S, Bogner HR, Hwang WT, Smith JS, Haggerty A, Morgan M, Burger R, Chu C, Ko EM. Effects of Educational Interventions on Human Papillomavirus Vaccine Acceptability: A Randomized Controlled Trial. Obstet Gynecol. 2019 Aug;134(2):376-384. doi: 10.1097/AOG.0000000000003379.
Clinical trial NCT00001169: Clinical Investigation of Infections Due to Leishmanial Parasites
Official title: Clinical Investigation of Infections Due to Leishmanial Parasites
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leishmaniasis
Leishmaniasis, Visceral
Keywords: Chemotherapy
Cytokines
Immunology
Kala-Azar
Leishmaniasis
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: Mechanisms of host immune response to intracellular protozoa will be investigated in patients with naturally acquired infection employing a variety of in-vitro techniques. Both non-specific and antigen-specific humoral and cellular immune responses will be assessed. Parasites will be isolated from patients, cultivated in-vitro, and characterized. Responses to chemotherapy will be assessed parasitologically, immunologically and clinically.

Detailed description: The main purpose of this protocol is to permit us to see patients who are referred to us for diagnosis and treatment of known or suspected leishmaniasis (from the Peace Corps, Smithsonian Institution, tourists, etc.). In the process of working up these patients, we sometimes encounter parasite isolates that are useful for research. We also can perform tests of cell-mediated immune function to evaluate how patients are responding to therapy. In addition, the protocol permits us to observe therapeutic responses to other drugs besides pentavalent antimony, if necessary.

Eligibility criteria: Must be between the ages of 1 and 65 years.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Allergy and Infectious Diseases (NIAID)
state: Maryland
Study officials:
References:
citation: Ponce C, Ponce E, Morrison A, Cruz A, Kreutzer R, McMahon-Pratt D, Neva F. Leishmania donovani chagasi: new clinical variant of cutaneous leishmaniasis in Honduras. Lancet. 1991 Jan 12;337(8733):67-70. doi: 10.1016/0140-6736(91)90734-7.
citation: Velasco O, Savarino SJ, Walton BC, Gam AA, Neva FA. Diffuse cutaneous leishmaniasis in Mexico. Am J Trop Med Hyg. 1989 Sep;41(3):280-8.
citation: Badaro R, Falcoff E, Badaro FS, Carvalho EM, Pedral-Sampaio D, Barral A, Carvalho JS, Barral-Netto M, Brandely M, Silva L, et al. Treatment of visceral leishmaniasis with pentavalent antimony and interferon gamma. N Engl J Med. 1990 Jan 4;322(1):16-21. doi: 10.1056/NEJM199001043220104.