louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05757752: Mind Body Program for Vascular Disease
Official title: Mind Body Program for Vascular Disease Proof-of-Concept Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Peripheral Arterial Disease
Peripheral Vascular Diseases
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 0
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: The purpose of the current study is to conduct a proof-of-concept test regarding the delivery of a Mind Body Program for vascular disease, focusing on support for depression, stress, and adherence, as part of patients' chronic disease management for peripheral artery disease (PAD).


Eligibility criteria: Inclusion Criteria:

* Rutherford score 1-4 (mild-severe claudication, or ischemic rest pain)
* Resting ankle-brachial index assessment ≤0.90 or drop in post-exercise ankle pressure ≥20 mmHg or non-compressible ankle-brachial index (≥1.30) or toe brachial index less than 0.70 in the past year
* Positive depression screening result (positive PHQ-9 result ≥10) or high stress screening result (10-item Perceived Stress Scale Score ≥27)

Exclusion Criteria:

* Not speaking either English or Spanish
* Age ≥18 years
* Currently incarcerated
* Current alcohol dependency or other substance use disorder (score ≥ 5 on NM-ASSIST)
* Cognitive impairment (T-MoCA Short \<10)
* Acute suicidal risk (positive screen ASQ Tool)
* History of psychosis or bipolar disorder
* Previously enrolled in the study
* Unable to provide written informed consent

Primary outcomes:
measure: Change in PAD-Specific Health Status on the Peripheral Artery Questionnaire (PAQ)
timeFrame: Baseline and 6months.
measure: Change in Depressive Symptoms assessed by Symptom Checklist-20 (SCL-20)
timeFrame: Baseline, 3months, and 6months.
measure: Change in Depressive Symptoms assessed by Patient Health Questionnaire (PHQ-9)
timeFrame: initial screening, baseline, 3months, and 6months
measure: Change in Stress Symptoms assessed using Perceived Stress Scale (PSS-10)
timeFrame: initial screening, baseline, 3months, and 6months.
Secondary outcomes:
measure: Change in Care Satisfaction using COPES Satisfaction with Depression Question
timeFrame: baseline and 6months
Other outcomes:
measure: Change in Physical activity using step count
timeFrame: baseline, 3months, and 6months
measure: Change in Physical activity using Walking Impairment Questionnaire
timeFrame: baseline, 3months, and 6months
Locations:
city: New Haven
country: United States
facility: Yale New Haven Health Hospital
state: Connecticut
Study officials:
References:
Clinical trial NCT00005652: Phase II Study of Rituximab in Patients With Immune Thrombocytopenic Purpura
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Purpura, Thrombocytopenic, Idiopathic
Keywords: hematologic disorders
immune thrombocytopenic purpura
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
First posted: 2000-05-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine the response rate and response duration to rituximab in patients with immune thrombocytopenic purpura.

II. Evaluate the toxicity associated with this treatment regimen in these patients.

III. Evaluate the alteration in antiplatelet antibody with this treatment regimen in these patients.

Detailed description: PROTOCOL OUTLINE: Patients receive rituximab IV on days 1, 8, 15, and 22. Patients who achieve a clinical response lasting over 4 months may receive a second course of rituximab.

Patients are followed at 5, 6, 8, and 12 weeks, and then at 6 and 9 months.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Clinically confirmed immune thrombocytopenic purpura (ITP) Platelet count less than 75,000/mm3 on two occasions at least 1 week apart within past month

Normal to increased numbers of megakaryocytes on bone marrow examination within past 6 months

Failed prior steroid therapy (i.e., unable to achieve sustained platelet count greater than 75,000/mm3)

No drug associated ITP

No B cell malignancies

No evidence of disseminated intravascular coagulation (DIC)

--Prior/Concurrent Therapy--

Endocrine therapy: Concurrent steroids allowed as long as platelet count is less than 75,000/mm3 and dose is not changed within past 2 weeks or during study

Other:

* No other concurrent medical therapy for immune thrombocytopenia purpura (ITP)
* At least 2 weeks since prior therapy for ITP (except steroids)
* At least 4 weeks since prior cyclosporine

--Patient Characteristics--

Performance status: ECOG 0-2

Life expectancy: At least 6 months

Renal: Creatinine no greater than 2.0 mg/dL

Cardiovascular: No congestive heart failure or symptomatic coronary insufficiency

Other:

* No clinically significant bleeding (i.e., other than mild mucosal bleeding or petechiae)
* No sepsis or fever
* No active infection requiring therapy
* No active chronic viral infection
* HIV negative
* No other concurrent or prior malignancy within past 5 years except squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Comprehensive Cancer Center
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Mansoor Noorali Saleh
role: STUDY_CHAIR
References:
Clinical trial NCT05974852: Effect of Ocrelizumab on Choroid Plexus Changes in Patients With PPMS
Official title: Effect of Ocrelizumab on Choroid Plexus Changes in Patients With Primary-progressive Multiple Sclerosis Participating in the ORATORIO: a Post-hoc Analysis of a Double-blind, Randomized, Phase 3, Placebo-controlled Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Primary Progressive Multiple Sclerosis
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2023-08-03
Enrollment: 732
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary progressive multiple sclerosis

Brief summary: The goal of this non-interventional, observational study is to learn if cortical plexus enhancement in patients with primary progressive multiple sclerosis occurs in response to the autoimmune inflammatory process.

Detailed description: To study the effect of ocrelizumab on choroid plexus changes in patients with primary-progressive multiple sclerosis participating in the ORATORIO: a post-hoc analysis of a double-blind, randomized, phase 3, placebo-controlled study

Eligibility criteria: Inclusion Criteria:

* Patient participating in the ORATORIO study
* MRI scans available at baseline
* Presence of T2-weighted image (WI) (FLAIR, T2/PD), and 3D T1-WI at baseline

Exclusion Criteria:

- None

Primary outcomes:
measure: T2 lesion volume
timeFrame: 5 years
Secondary outcomes:
measure: Changes in choroid plexus
timeFrame: 5 years
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Buffalo Neuroimaging Analysis Center
state: New York
Study officials:
References:
Clinical trial NCT01552252: Evaluation of an Apple Juice Drink With POs-Ca
Official title: Development and Evaluation of a Low Erosive Apple Juice Drink With Phosphoryl Oligosaccharides of Calcium (POs-Ca)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Food Preferences
Keywords: POs-Ca
calcium additives
drink
Lead sponsor: Tokyo Medical and Dental University
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The null hypothesis tested was that there are no differences in the taste palatability of the apple juices before and after adding POs-Ca.


Eligibility criteria: Inclusion Criteria:

* healthy adult subjects
* No eating or drinking within 30 minutes before the start time of the trials
* No tooth brushing within 30 minutes before the start time of the trials

Exclusion Criteria:

* apple hypersensibility

Primary outcomes:
measure: Visual Analogue Scale of taste palatability
timeFrame: At time when the subjects have finished drinking, an expected average of 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tokyo Medical and Dental University
name: Hitomi Mita
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01545752: Comparing Interactive and Non-interactive CD-based Method
Official title: Comparing Interactive and Non-interactive CD-based Method in Teaching Medical Terminology
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Interactive CD-based Education
Keywords: elearning
CD-based education
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Using different methods of electronic learning has been increasingly developed by emerging electronic educational technologies. They could apply on the net, CDs, Mobile, etc in different usage alternatives: interactive and non-interactive both in online and off-line approaches. In this educational trial, the interactive and non-interactive CD-based method for teaching medical terminology to nursing students of MUMS school of nursing and Midwifery during 2009-2012 was compared.


Eligibility criteria: Inclusion Criteria:

* Nursing students studying in MUMS school of nursing and passing Medical Terminology

Exclusion Criteria:

* any other discipline,
* students of other schools

Primary outcomes:
measure: students' mean Scores
timeFrame: up to three years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03741452: Transversalis Fascia Plane Block in Caesarean Section Patients
Official title: Evaluation of Ultrasound-guided Transversalis Fascia Plane Block for Postoperative Analgesia in Cesarean Section: A Prospective, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transversalis fascia plane block is a regional anesthesia technique described ten years ago. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that transversalis fascia plane block could be efficacious for providing postoperative analgesia in the cesarean section, the investigators have implemented the application of this blockade into practice at the clinic. The main purpose of this study is to evaluate the analgesic effect of ultrasound-guided bilateral transversalis fascia plane block in cesarean section.


Eligibility criteria: Inclusion Criteria:

* patients undergoing cesarean section under general anesthesia ASA I-II

Exclusion Criteria:

* patients undergoing cesarean section under neuraxial anesthesia morbidly obesity ASA III - IV infection of the skin at the site of needle puncture area patients with known allergies to any of the study drugs coagulopathy recent use of analgesic drugs

Primary outcomes:
measure: 24 hours tramadol consumption
timeFrame: 24 hour
Secondary outcomes:
measure: Numeric rating scale for postoperative pain intensity
timeFrame: 24 hours
measure: Postoperative nausea and vomiting
timeFrame: 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Maltepe University faculty of medicine
Study officials:
References:
citation: Tulgar S, Serifsoy TE. Transversalis fascia plane block provides effective postoperative analgesia for cesarean section: New indication for known block. J Clin Anesth. 2018 Aug;48:13-14. doi: 10.1016/j.jclinane.2018.04.006. Epub 2018 Apr 22. No abstract available.
citation: Sondekoppam RV, Ip V, Johnston DF, Uppal V, Johnson M, Ganapathy S, Tsui BCH. Ultrasound-guided lateral-medial transmuscular quadratus lumborum block for analgesia following anterior iliac crest bone graft harvesting: a clinical and anatomical study. Can J Anaesth. 2018 Feb;65(2):178-187. doi: 10.1007/s12630-017-1021-y. Epub 2017 Nov 21.
Clinical trial NCT01505452: Study of Surgical Technique With Use of Single-radius Prosthesis in Total Knee Replacement
Official title: Translational Error in Flexion-extension Gap Balancing With Singe Radius Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis of Knee
Lead sponsor: Athens Orthopedic Clinic, P.A.
Sponsor class: OTHER
Collaborators: name: Stryker Orthopaedics
First posted: 2012-01-06
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinic based population (patients undergoing total knee replacement at an orthopedic surgery clinic).

Brief summary: The purpose of this study is to clinically demonstrate a phenomenon of measurement error that can occur during placement of a specific type of total knee replacement prosthesis (single radius femoral component) using a certain type of surgical technique (flexion/extension gap balancing).


Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo primary total knee arthroplasty performed by the principal investigator
* Use of a single radius posterior-stabilized TKA prosthesis is planned
* Spinal anesthetic is planned
* Diagnosis of osteoarthritis
* Has normal knee ligaments with no history of previous injury or surgery to ligaments, or other pathologic condition
* Has at least 100 degrees knee flexion preoperatively (measured by long goniometer)
* Gives valid informed consent
* Age 18 years or older

Exclusion Criteria:

* Patient receives general anesthetic
* Diagnosis other than osteoarthritis (e.g., rheumatoid arthritis, avascular necrosis, post-traumatic arthritis)
* History of any prior knee ligament injury, or any surgery to ligaments
* Any connective tissue disease affecting integrity of the ligaments (must have normal ligaments)
* History of long bone fracture in the affected leg
* Flexion contracture that would interfere with ability to establish extension gap reliably (judgment of investigator)
* Maximum pre-operative knee flexion is less than 100 degrees.
* Patient is non-ambulatory
* Any preclusion or inability to use navigation
* Treatment with single radius posterior stabilized TKA prosthesis is not indicated
* Participation is not in best interest of patient for any reason
* Cannot or does not give valid informed consent
* Female patient who is currently pregnant
* Age less than 18 years
* Body mass index greater than 40 kg/(m\*m)
* Incarcerated

Primary outcomes:
measure: Difference in varus/vagus laxity of the knee joint measured with the knee positioned at a 90 degree angle with posteriorly stabilized vs. cruciate retaining trails in place.
timeFrame: At the time of the surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: United States
facility: Athens Orthopedic Clinic
state: Georgia
city: Athens
country: United States
facility: St Mary's Hospital
state: Georgia
Study officials:
affiliation: Athens Orthopedic Clinic
name: Ormonde M Mahoney, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06428552: To Evaluate the Efficacy of Mobile Applications in Tailoring and Enhancing Rehabilitation Interventions for Pediatric CP
Official title: To Evaluate the Efficacy of Mobile Applications in Tailoring and Enhancing Rehabilitation Interventions for Pediatric Patients With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 96
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The world of technology is changing and becoming more advanced. Children with cerebral palsy can benefit from the technology to enhance their mobility, balance, and coordination through mobile applications. A lot of applications are made to offer games and interactive therapy activities that focus on balance, coordination, and motor skills.

Detailed description: They may find these activities entertaining as well as helpful, which makes their rehabilitation more pleasurable. This work builds on previous studies by making a mobile application that may be accessed from any location, giving therapeutic treatments more distribution flexibility. This is especially helpful for those with cerebral palsy who might have mobility issues that make it challenging to consistently attend in-person therapy sessions. Cerebral palsy children can perform organized exercises at home with the help of mobile application made for therapeutic activities and rehabilitation. Therapeutic activities may be customized to meet the unique demands of each patient, guaranteeing that the treatment plan is in line with their capabilities and objectives. Caregiver's involvement in the treatment process is a common element of app created specifically for people with cerebral palsy. This might involve providing tools to enhance home-based care, educating caregivers through resources, and monitoring progress in order to promote a team-based approach to treatment.

Eligibility criteria: Inclusion Criteria:

* Children with cerebral palsy
* Children aged between 5 to 16 years

Exclusion Criteria:

* Children with unstable epilepsy, chronic heart abnormalities , asthma , anemia and other medical conditions
* undergone botulinum neurotoxin A (BoNT-A)injections or surgery in the previous 2 months or 6 months respectively. "

Primary outcomes:
measure: questionnaire(QUIS)the application software
timeFrame: 12 Months
measure: Pedi Cat Questionnaire
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Hope Rehabilitaion Centre, Mansoor Hospital Lahore , ChildRehab Sangla Hill
Study officials:
References:
Clinical trial NCT00356252: Biological Functions of Carotenoids in Humans
Official title: Functional Bioavailability of Carotenoids in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative DNA Damage
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: BASF
First posted: 2006-07-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will examine the the efficiency fo absorption of major plant pigments, carotenoids, (lutein, beta-carotene and lycopene)and will measure the biological functions of carotenoids in healthy women in response to an 8-week period of carotenoid supplementation.

The antioxidant capacity (in both the aqueous and lipid compartments), DNA oxidation (single cell gel electrophoresis), Insulin-like Growth Factor (IGF-1), Insulin-like Growth Factor Binding Protein-3 (IGFBP-3), (gene expression profile (high-density filter-based cDNA microarrays), lipid peroxidation (MDA analysis and Isoprostane determination), and antioxidant nutrient levels (carotenoids, tocopherols, ascorbic acid and uric acid) in the circulation will be measured every other week throughout the study period.


Eligibility criteria: Inclusion Criteria:

* normal hematologic parameters, normal serum albumin, normal liver function, normal kidney function, absence of fat malabsorption and no drug intake which would interfere with fat absorption, metabolism or blood clotting.

Exclusion Criteria:

* Subjects with a history of kidney stones, active small bowel disease or resection, atrophic gastritis, hyperlipidemia, insulin-requiring diabetes, alcoholism, pancreatic disease, or bleeding disorders. Exogenous hormone users, smokers. Subjects weighing greater than 20% above or below the NHANES median standard.

Primary outcomes:
measure: DNA damage
measure: plasma carotenoid concentrations
Secondary outcomes:
measure: lipid peroxidation
measure: Total antioxidant capacity
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jean Mayer USDA-Human Nutrition Research Center on Aging, Tufts University
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Kyung-Jin Yeum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhao X, Aldini G, Johnson EJ, Rasmussen H, Kraemer K, Woolf H, Musaeus N, Krinsky NI, Russell RM, Yeum KJ. Modification of lymphocyte DNA damage by carotenoid supplementation in postmenopausal women. Am J Clin Nutr. 2006 Jan;83(1):163-9. doi: 10.1093/ajcn/83.1.163.
Clinical trial NCT05470452: Validating the Safety and Effectiveness of ENDOANGEL Upper Gastrointestinal Endoscope Image Auxiliary Diagnostic Software
Official title: Validating the Safety and Effectiveness of ENDOANGEL Upper Gastrointestinal Endoscope Image Auxiliary Diagnostic Software
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The upper Gastrointestinal Endoscope Image Auxiliary Diagnostic Software developed by Wuhan ENDOANGEL Medical Technology Co., Ltd. is used for the identification of gastric cancer in endoscopic magnification mode in definitive images to assist in the diagnosis of upper gastrointestinal gastric cancer lesions. The aim of this study is to evaluate the safety and effectiveness of the software in clinical use.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18, male or female；
2. Cases with complete, clear imaging data, including images under white light and magnified stained images；
3. Complete pathological diagnosis of upper digestive tract lesions;
4. The included cases were excluded from the software development.

Exclusion Criteria:

1. Cases whose image data did not meet the evaluation requirements;
2. The investigator considered the case unsuitable for the clinical trial.

Primary outcomes:
measure: AFROC-AUC
timeFrame: 3 months
Secondary outcomes:
measure: Cancer identification Sensitivity
timeFrame: 3 months
measure: Cancer identification specificity
timeFrame: 3 months
measure: Cancer Identification Diagnosis Compliance Rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References: