louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00274209: Chromoendoscopy for Ulcerative Colitis Surveillance
Official title: Impact of Chromoendoscopy on the Detection of Neoplasia in Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Crohn's Disease
Keywords: Ulcerative colitis
Crohn's disease
Chromoendoscopy
Dysplasia
Neoplasia
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2006-01-10
Enrollment: 100
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: Patients with ulcerative colitis satisfying criteria for surveillance colonoscopy

Brief summary: Long-standing ulcerative colitis is associated with an increased cancer risk. Chromoendoscopy with dye spraying can detect subtle abnormalities that are not visible with standard endoscopy. The purpose of this study is to determine if chromoendoscopy with fewer "targeted biopsies" can replace standard colonoscopy with multiple "random" biopsies.

Detailed description: Patients with ulcerative colitis (UC) are at increased risk for colon cancer. Current guidelines recommend periodic surveillance colonoscopy in individuals who fulfill certain high-risk criteria. Endoscopists must perform a high number of biopsies (over 33 per patient) in order to increase the yield of such procedures. Chromoendoscopy (CE) has the ability to identify subtle lesions that are otherwise missed by standard endoscopy. Whether CE can replace standard colonoscopy in the surveillance of patients with UC is unknown.

Comparison: both standard biopsies and targeted biopsies will be obtained during colonoscopy from patients with UC who are candidates for surveillance colonoscopy. The yield of the two methods will be compared based on the number of biopsies required to identify one dysplastic (precancerous) lesion.

Eligibility criteria: Inclusion Criteria:

* Ulcerative colitis, pancolitis \> 8 years; left-sided \> 15 years or
* history of PSC or
* history of previous dysplasia on colon biopsies or
* family history of colon cancer in first degree relative

Exclusion Criteria:

* any condition that precludes colonoscopy
* expected survival less than 1 year

Primary outcomes:
measure: Prevalence of dysplastic lesions by white light vs. chromoendoscopy
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Michael V Chiorean, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05427409: Ingestion of Beta-alanine Effects in Well-trained Tennis Players
Official title: Ingestion of Beta-alanine Improves Neuromuscular Performance in Well-trained Tennis. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Beta-alanine
Placebo
Lead sponsor: Universidad Francisco de Vitoria
Sponsor class: OTHER
Collaborators: name: University of Seville
name: University of Greenwich
First posted: 2022-06-22
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Beta-alanine is considered as ergogenic aids with good to strong evidence for improving sports performance in specific sports context scenarios. However, most of the studies has been realized in endurance, with limited evidence in intermittent sports, especially in racket sports. Thus, the aim of this study was to explore the effects of 4-weeks ingestion of beta-alanine on neuromuscular performance in well-trained tennis players.

Detailed description: Fourteen tennis players (23.3 ±3.7 years) between 50-250 national tennis ranking participated in this study. Participants were randomly divided into two groups that realized a neuromuscular battery after beta-alanine (4.8 gr/daily during 4-weeks) or placebo (i.e., fructose) (4.8 grams/daily during 4-weeks). Before and after the supplementation period tennis performed a neuromuscular test battery in a tennis court consisted in different test such as; serve velocity, countermovement jump, isometric handgrip strength, 10-m sprint, modified 5-0-5 agility test and repeated sprint ability. After 48 h of the realization of neuromuscular test battery, tennis players performed VO2max consumption test (i.e., treadmill).

Eligibility criteria: Inclusion Criteria:

* Well-trained tennis players, between 18-35 years old (50-200 between tennis ranking)

Exclusion Criteria:

* Suffering from any chronic pathology or an injury in the month prior to the investigation.
* Intolerance to beta-alanine ingestion
* Amateur tennis players.

Primary outcomes:
measure: Repeated sprint ability test.
timeFrame: 4-weeks
measure: VO2 max treadmill test
timeFrame: 4-weeks
Secondary outcomes:
measure: Serve velocity
timeFrame: 4-weeks
measure: Contermovement Jump
timeFrame: 4-weeks
measure: 10m sprint
timeFrame: 4-weeks
measure: Isometric handgrip strength
timeFrame: 4-weeks
measure: Modified agility test 5-0-5
timeFrame: 4-weeks
Other outcomes:
Locations:
city: Pozuelo De Alarcón
country: Spain
facility: Universidad Francisco de Vitoria
state: Madrid
Study officials:
affiliation: Universidad Francisco de Vitoria
name: Iñaki Quintana García-Milla, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03838809: Electromyography-biofeedback on the Motor Activation of the Extension of the Hand
Official title: Effect of a Neurological Physiotherapy Program With Electromyography-biofeedback on the Motor Activation of the Extension of the Hand and Dorsiflexion of the Foot in Cerebrovascular Damage: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Complication
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 28
Sex: ALL
Minimum age (years): 74
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: Biofeedback-Surface electromyography (BIO-SEMG) is a relatively recent physiotherapy technique. Although its use is widespread in sports science and sports performance, its use for the rehabilitation of patients with neurological pathologies is less studied.

Objective: The purpose of this research was to determine the changes that occur in the application of BIO-SEMG in the muscles responsible for the extension and the dorsiflexion of the hand and the foot in subjects with cerebrovascular damage.

Design: A randomized, double-blind, two-arm parallel group study was performed.

Patients: A sample of 28 subjects with limited extension of the hand and dorsiflexion of the foot as a consequence of a stroke was randomized divided in intervention or control groups.

Methods: The subjects of the intervention group underwent 12 sessions of BIO-SEMG, of 15-minute duration each of them, in the upper and lower members. On the other hand, the control group underwent another 12 sessions of 15-minute duration, in which manual physiotherapy techniques were performed.


Eligibility criteria: Inclusion Criteria:

* Patients with a stroke
* Limitation of the hand and foot extension

Exclusion Criteria:

* Patients with some contraindication against the surface electromyography biofeedback technique, for instance, people with pacemaker, with cardiovascular antecedents, etc.
* Patients receiving other physiotherapy treatment 2 months before the beginning of the study
* Patients that decline to sign the informed consent.

Primary outcomes:
measure: Extension Degree
timeFrame: 3 months
Secondary outcomes:
measure: Fugl Meyer Test
timeFrame: 6 months
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
affiliation: Catholic University of Murcia
name: Juan José Hernández Morante, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gamez AB, Hernandez Morante JJ, Martinez Gil JL, Esparza F, Martinez CM. The effect of surface electromyography biofeedback on the activity of extensor and dorsiflexor muscles in elderly adults: a randomized trial. Sci Rep. 2019 Sep 11;9(1):13153. doi: 10.1038/s41598-019-49720-x.
Clinical trial NCT06171009: Brief Mindfulness Intervention for Orthopedic Patients: Mechanistic Investigation
Official title: Brief Mindfulness Intervention for Orthopedic Patients in the Clinic Waiting Room: Mechanistic Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The analgesic effects of a 4-minute audio-recorded mindfulness intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation. Analgesic mechanisms of mindfulness will also be investigated.


Eligibility criteria: Inclusion Criteria:

* Age ≥18
* Seeking treatment at the Tallahassee Orthopedic Center

Exclusion Criteria:

* Cognitive impairment preventing completion of study procedures.
* Other unstable illness judged by medical staff to interfere with study involvement.

Primary outcomes:
measure: Change in Pain Unpleasantness Numeric Rating Scale
timeFrame: Immediately before to after 4-minute audio recording
Secondary outcomes:
measure: Change in Pain Intensity Numeric Rating Scale
timeFrame: Immediately before to after 4-minute audio recording
measure: Change in Decentering
timeFrame: Immediately before to after 4-minute audio recording
measure: Change in Self-Transcendent State
timeFrame: Immediately before to after 4-minute audio recording
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Tallahassee Orthopedic Clinic (TOC)
state: Florida
Study officials:
References:
Clinical trial NCT04717609: Saphenous Nerve Block for Partial Meniscectomy
Official title: Surgeon Performed Saphenous Nerve Block at the Medial Femoral Condyle for Arthroscopic Partial Meniscectomy and Meniscus Repair: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pain, Joint
Pain, Procedural
Meniscectomy
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Partial meniscectomy and meniscus repair are two of the most common orthopedic surgery procedures. As these procedures are being increasingly performed in ambulatory surgical centers, there has been a shift towards providing improved analgesia to ensure timely discharge, as well as preventing unwanted pain and side effects. As such, it has become common practice to use an intra-articular injection of local anesthetic to achieve post-operative pain control. However, these effects are short lived, requiring a multimodal approach to analgesia. To date, no optimal pain control strategy has been described for arthroscopic partial meniscectomy or meniscus repair. The purpose of this study is to examine the outcomes of subcutaneous saphenous nerve block with 0.5% ropivacaine at the medial femoral epicondyle/adductor hiatus plus portal 0.5% ropivacaine injection vs portal 0.5% ropivacaine injection alone for patients undergoing arthroscopic partial meniscectomy or meniscus repair.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Scheduled for arthroscopic meniscectomy or meniscus repair

Exclusion Criteria:

* Multiple-ligament injury
* Primary ACL reconstruction or ACL revision reconstruction
* Articular cartilage restoration surgery
* Evidence of microfracture
* History of allergy to local anesthetics
* Pre-existing saphenous neuropathy
* Unable to be prescribed opioids due to allergy or other reason

Primary outcomes:
measure: Reduced Pain Levels
timeFrame: 10 days
measure: Quality of Recovery
timeFrame: 20 minutes
measure: Reduced Pain Levels
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00006309: Pooling of Cohort Studies on Diet & Coronary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-09-29
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To quantify the role of dietary factors in the etiology of coronary heart disease by pooling data from 10 major prospective studies on diet and coronary heart disease.

Detailed description: DESIGN NARRATIVE:

Specific hypotheses tested included an adverse effect of saturated fat and carotenoids (alpha-carotene, lutein, and lycopene), flavonoids, folic acid, and vitamin B6. Plausible biological interactions between nutrients, such as fatty acids of the n-6 and n-3 series were also explored. Each participating center sent data on tape to the coordinating unit at the Department of Nutrition, Harvard School of Public Health. The relations of dietary factors and coronary heart disease were first estimated within each study and compared for consistency. Data were then combined to obtain the best overall estimates, taking into account the validity of dietary data collected at each center. Members from study centers met annually to discuss the interpretation of findings. Over 6,000 cases of myocardial infarction or coronary death were anticipated, which should have provided excellent precision in measuring associations, and allowed the comparison of extreme intakes that were poorly represented in individual studies.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Alberto Ascherio
References:
citation: Pereira MA, O'Reilly E, Augustsson K, Fraser GE, Goldbourt U, Heitmann BL, Hallmans G, Knekt P, Liu S, Pietinen P, Spiegelman D, Stevens J, Virtamo J, Willett WC, Ascherio A. Dietary fiber and risk of coronary heart disease: a pooled analysis of cohort studies. Arch Intern Med. 2004 Feb 23;164(4):370-6. doi: 10.1001/archinte.164.4.370.
citation: Knekt P, Ritz J, Pereira MA, O'Reilly EJ, Augustsson K, Fraser GE, Goldbourt U, Heitmann BL, Hallmans G, Liu S, Pietinen P, Spiegelman D, Stevens J, Virtamo J, Willett WC, Rimm EB, Ascherio A. Antioxidant vitamins and coronary heart disease risk: a pooled analysis of 9 cohorts. Am J Clin Nutr. 2004 Dec;80(6):1508-20. doi: 10.1093/ajcn/80.6.1508.
Clinical trial NCT06203587: Clinical Study of GPA33-specific PET/CT for the Diagnosis of Colorectal Cancer
Official title: Clinical Study of GPA33-specific PET/CT for the Diagnosis of Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Positron-Emission Tomography
Colorectal Neoplasms
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this study, we will first investigate the imaging safety and feasibility of \[68Ga\]Ga-NOTA-WWH347 and \[18F\]F-H3RESCA-WWH347 PET/CT in patients with primary and/or metastatic colorectal cancers. The second goal of the study is to preliminarily investigate the diagnostic efficacy (e.g., sensitivity and specificity) of \[68Ga\]Ga-NOTA-WWH347 and \[18F\]F-H3RESCA-WWH347 PET/CT in patients with primary and/or metastatic colorectal cancers. This study will provide a new method for the noninvasive target-specific diagnosis of colorectal cancer, and provide an intuitive and clear imaging basis for clinical diagnosis, differential diagnosis and treatment.


Eligibility criteria: Inclusion Criteria:

1. Be between 18 and 65 years of age and of either sex.
2. Patients with colorectal cancer confirmed by puncture or surgical pathology.
3. Written informed consent signed by the subject or legal guardian or caregiver.
4. Willingness and ability to cooperate with all programs of this study.

Exclusion Criteria:

1. Severe hepatic or renal insufficiency;
2. Targeted therapy before radiotherapy or PET/CT scan. Renal function: serum creatinine less than or equal to the upper limit of the normal range;
3. Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.
4. History of serious surgery in the last month.
5. Those who have participated in other clinical trials during the same period.

Primary outcomes:
measure: Establishment and optimization of imaging method for [68Ga]Ga-NOTA-WWH347 or [18F]F-H3RESCA-WWH347 PET/CT.
timeFrame: 90mins from time of injection
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
Study officials:
affiliation: Huashan Hospital
name: Fang Xie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01861587: Evaluation of the Effectiveness of tDCS in the Management of Perioperative Pain
Official title: Evaluation of the Effectiveness of tDCS in the Management of Perioperative Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Operative Pain
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 27
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: OTHER

Brief summary: The purpose of this study is to determine whether a new medical technology can help reduce post-operative pain. The new technology is called Transcranial Direct Current Stimulation.

Detailed description: This study aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) in the management of postoperative pain. Specifically, this study will determine whether patients undergoing any type of inpatient surgical procedure that routinely requires at least a 1-day inpatient stay post-operatively will report less pain and use less opioid analgesics following a series of 20-minute sessions of tDCS (compared to sham tDCS) delivered up to twice per day post-operatively. In addition to comparing the effects of real tDCS to sham tDCS, the present study will evaluate the interaction of dose (number and frequency of tDCS sessions) and surgery type.

Eligibility criteria: Inclusion Criteria:

* 18 years-75 years of age
* surgery at Medical University of South Carolina
* at least 2 days of post-operative stay

Exclusion Criteria:

* history of seizures or epilepsy
* family history of seizures
* taking any medications shown to lower seizure threshold
* metal implants above the waist
* pregnant
* brain tumors or lesions
* pacemaker

Primary outcomes:
measure: Patient Controlled Analgesia (PCA) Hydromorphone Usage
timeFrame: Participants were followed for the duration of hospital stay, an average of 48 hours.
measure: Average Pain at Least
timeFrame: Baseline and Discharge
measure: Average Pain at Worst
timeFrame: Baseline Only
measure: Average Pain
timeFrame: Baseline Only
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Brain Stimulation Laboratory, Institute of Psychiatry
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Jeffrey Borckardt, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05794087: The Role of Macrophage Activation in Lung Injury Following Ozone Exposure
Official title: Activated Macrophages and Ozone Toxicity II
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Air Pollution
Keywords: Macrophage
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2023-03-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects will be randomly assigned to either clean air or ozone for the first exposure then crossed over to the alternate arm for the second exposure.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to better understand the mechanisms of lung injury from ozone exposure. Subjects will participate in two exposure sessions: filtered air and 0.2 ppm ozone. The exposure visits will be at least 2 weeks apart. Subjects will be asked to produce sputum through coughing after each exposure. The samples will be analyzed for macrophage activity.

Detailed description: Subjects will be asked to come to the Rutgers EOHSI clinical center (Piscataway, NJ) for 5 study visits. A physical exam to determine eligibility will be done at the first study visit. If the subject is healthy and able to produce a sputum sample, he/she will then be scheduled for 2 3-hour exposure visits, at least 2 weeks apart. One exposure will be to clean air and the other exposure will be to 0.2 ppm ozone. During the exposures, subjects will be requested to ride an exercise bicycle intermittently (approximately every 15 minutes). A follow-up visit for sputum collection will be scheduled either 24, 48, or 72 hours after each exposure visit. Blood and exhaled breath samples will also be collected at each visit.

Eligibility criteria: Inclusion Criteria:

* Vaccinated against COVID-19

Exclusion Criteria:

* Cardiovascular disease
* Respiratory disease
* Recent (within 4 weeks) respiratory or COVID-19 symptoms
* Diabetes
* Pregnancy
* HIV Infection
* History of smoking within the past 5 years.
* Orthopedic or rheumatologic conditions which would interfere with cycle use
* Inability to produce a sputum plug at screening
* Daily use of antioxidant supplements, excluding those in a multivitamin. These supplements include Vitamin C or E, selenium, beta-carotene, lycopene, lutein, zeaxanthin and ginkgo biloba. Supplements taken less frequently but at least once a week will be reviewed by the principal investigator for eligibility determination.

Primary outcomes:
measure: Metabolic activity of inflammatory cells in induced sputum
timeFrame: Within 3 days of exposure
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers - EOHSI
state: New Jersey
Study officials:
affiliation: Rutgers School of Public Health
name: Howard M Kipen, MD
role: PRINCIPAL_INVESTIGATOR
References: