louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02372708: Clinical Research on the Treatments on Advanced Malignant Melanoma by Combining in Situ Immunotherapy and Laser Therapy
Official title: Clinical Research on the Treatments on Advanced Malignant Melanoma by Combining in Situ Immunotherapy and Laser Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with stage III (b or c) or stage IV skin (which could not be excised by operations) malignant melanoma

Brief summary: To evaluate the therapeutic efficacy and the safety for the treatments on malignant melanoma by combining semiantigen dinitrophenyl (DNP) in situ immunotherapy and laser therapy, and carry out monitoring on related immunological parameters of the patients.

72 patients with stage III (b or c) or stage IV skin (which could not be excised by operations) malignant melanoma were treated by combining simple semiantigen DNP in situ immunotherapy and laser therapy respectively. The changes in peripheral blood CD4+CD25+Treg regulatory T cells (Treg), CD8+T, CD4+ T effector cells, IL-10, TGF-β and other inhibitory cytokines of the patients were detected, the changes in anti-DNP IgG antibody titer was monitored, the relationship between delayed-type hypersensitivity (DTH) and survival was observed, and results of clinical follow-ups were also examined.


Eligibility criteria: Inclusion Criteria:

* pathologically diagnosed as malignant melanoma, HMB45 (+～++++), S100 (+～++++);
* Basically normal hepatic and renal functions as well as results for blood routine examinations;
* Karnofsky score ≥ 60;
* Anticipated life span for more than three months;
* They were all malignant melanoma patients suffering from skin malignant melanoma of local or distal metastasis unsuitable for operations in their skin;
* The therapeutic efficacy was objectively evaluated with reference to the criteria from WHO;
* All of the subjects had signed the informed consent and had been submitted and approved by the ethic committee of the hospital, the compliance was good and follow-ups can be easily carried out.

Primary outcomes:
measure: ORR
timeFrame: 6 weeks after administration whose achieve CR and PR
Secondary outcomes:
measure: PFS
timeFrame: From enrollment to progression or death, which up to 2 years
measure: OS
timeFrame: From enrollment to death, which up to 2 years
measure: biomarker (peripheral blood CD4+CD25+Treg regulatory T cells (Treg), CD8+T, CD4+ T effector cells, IL-10, TGF-β)
timeFrame: day 0 and day 2,5,10,20
Other outcomes:
Locations:
city: Beijing
country: China
facility: First Affiliated Hospital, Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: First Affiliated Hospital, Chinese PLA General Hospital
name: Nan Du, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01647308: Mechanistic Study of ISIS ISIS-APOCIIIRX in Type 2 Diabetes
Official title: A Randomized, Double Blind, Placebo-Controlled, Phase 2 Study to Investigate the Effects of ISIS 304801 Lowering of ISIS-APOCIIIRX on Triglyceride Levels and Insulin Sensitivity in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Ionis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of ISIS ISIS-APOCIIIRX on Triglyceride Levels and Insulin Sensitivity in Subjects with Type 2 Diabetes on stable treatment with metformin.


Eligibility criteria: Inclusion Criteria:

* BMI \>/= 25 to \</= 40 kg/m2
* Type 2 Diabetes Mellitus and on a stable dose of metformin
* Hypertriglyceridemia

Exclusion Criteria:

* Significant abnormalities in medical history, clinical examination or clinical testing
* Use of oral anti-diabetic medication other than metformin within 3 months prior to dosing
* History of outpatient insulin use for more than 2 weeks in the last year

Primary outcomes:
measure: Total apoC-III
timeFrame: 91 Days
Secondary outcomes:
measure: Insulin Sensitivity
timeFrame: Day 92
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Profil Institute for Clinical Research
state: California
Study officials:
References:
citation: Digenio A, Dunbar RL, Alexander VJ, Hompesch M, Morrow L, Lee RG, Graham MJ, Hughes SG, Yu R, Singleton W, Baker BF, Bhanot S, Crooke RM. Antisense-Mediated Lowering of Plasma Apolipoprotein C-III by Volanesorsen Improves Dyslipidemia and Insulin Sensitivity in Type 2 Diabetes. Diabetes Care. 2016 Aug;39(8):1408-15. doi: 10.2337/dc16-0126. Epub 2016 Jun 6.
Clinical trial NCT03752008: Preschoolers Active at Child Care (PACT)
Official title: Preschoolers Active at Child Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2018-11-23
Enrollment: 131
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 10 childcare centers were cluster-randomized to receive either a physical activity or outdoor free play curriculum.
Primary purpose: OTHER

Brief summary: The aim of this study was to develop, test, and compare two approaches to increasing physical activity (PA) and decreasing sedentary time among young children at child care centers, one which focused on a teacher-led PA curriculum (AP=Active Play!) and the other on increasing outdoor free play time (OP=Outdoor Play!).

Detailed description: This was a matched pair cluster-randomized study in 10 child care centers. One classroom in each pair received either AP or OP, and their providers received a condition-specific 3-hour workshop. Pre- and post-intervention data were collected from classroom observation and accelerometers. Additional information about teachers' attitudes and practices was collected via pre-intervention survey.

Eligibility criteria: Inclusion Criteria:

* Teachers/Staff
* be a teacher/staff member in a participating childcare center
* Students
* be 3 - 5 years old
* be a full day student in the classroom where data collection was occurring

Exclusion Criteria:

-

Primary outcomes:
measure: Pre to post change in preschoolers Physical Activity
timeFrame: baseline and 12 weeks after intervention
measure: Pre to post change in Physical Activity Opportunities
timeFrame: baseline and 12 weeks after intervention
Secondary outcomes:
measure: pre to post Teacher Physical Activity
timeFrame: baseline and 12 weeks after intervention
Other outcomes:
Locations:
Study officials:
affiliation: Seattle Chidlren's
name: Pooja Tandon, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04711408: Virtual Reality During Ultrasound Examination of Women With Endometriosis
Official title: Virtual Reality During Ultrasound Examination of Women With Endometriosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Pelvic Pain
Endometriosis
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2021-01-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the effectiveness of VR as a distraction technique in the management of acute pain and anxiety during ultrasound exam in patients with endometriosis in the outpatient setting.

Detailed description: A prospective, open-label, randomized control trial in a tertiary university-affiliated medical center between April to August 2020. Overall, 100 women will be randomly allocated to undergo ultrasound exam either with the use of VR (study group) or with standard treatment (control group). The primary outcome measures includ self-reported pain, anxiety scores, and vital parameters as pulse rate (PR) and respiratory rate (RR). Pain and anxiety outcomes were measured as numeric rating scores.

Eligibility criteria: Inclusion Criteria:

* patient needed ultrasound with the diagnosis of endometriosis. the diagnosis of endometriosis is based on ultrasound finding or previous surgery.

Exclusion Criteria:

* women who reported the use of analgesia 6 hours prior to the procedure

Primary outcomes:
measure: Assessments of pain through pain score parameter
timeFrame: 20 minutes
measure: Assessments of pain through physiological parameters
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Lis Maternity Hospital, Tel Aviv Sourasky Medical Center
Study officials:
References:
Clinical trial NCT05592808: Comparison of Taping Techniques in Plantar Fasciitis
Official title: Comparison of the Effects of Low-Dye and Kinesio Taping Methods in Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fasciitis
Pain
Foot Diseases
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of Low-Dye and Kinesio Taping on pain and function in individuals with plantar fasciitis.

Detailed description: Subject: In this study, the effects of Low-Dye Taping and Kinesio Taping (KT) on pain and function will be investigated in individuals with plantar fasciitis. There are studies on both Low-Dye banding and KT in the literature and they are popular applications recently. However, to the best of our knowledge, when we look at the Turkish and English literature, no study has been found comparing these two therapeutic massages in terms of pain, functionality and performance.

Purpose: Plantar fasciitis (PF) is a clinical picture characterized by degeneration of the plantar fascia resulting from repetitive microtrauma to the plantar fascia causing an inflammatory reaction. It is one of the most common causes of heel pain in adults. The plantar fascia has a fundamental role in the biomechanics of the foot, supporting the medial longitudinal arch (MLA), distributing forces and stresses of the foot during gait or other loading conditions. Disorders in the musculoskeletal and somatosensory system in patients with plantar fasciitis may cause pain and decrease in functional capacity. Therefore, its purpose is; This study was planned to show the effectiveness of taping methods applied in addition to ESWT in individuals presenting with heel pain. Thanks to the findings to be obtained from our study, it is aimed to contribute to the literature with objective, evidence-based results in this field.

Eligibility criteria: Inclusion Criteria:

* Individuals diagnosed with plantar fasciitis by a physician
* Age between 18 and 30 years
* Agree to participate in the study

Exclusion Criteria:

* Not having surgery
* Disagree to participate in the study
* Infection
* Pregnancy
* Tumor

Primary outcomes:
measure: Change from baseline in Pain at 3 Session
timeFrame: Changes in the VAS scores of the three groups before the treatment
measure: Change from baseline in Pain at 3 Session
timeFrame: Changes in the AOFAS scores of the three groups before the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay University
city: Konya
country: Turkey
facility: Bayram Sönmez ÜNÜVAR
city: Konya
country: Turkey
facility: KTO Karatay University
Study officials:
affiliation: KTO Karatay University
name: Bayram Sönmez ÜNÜVAR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06025708: Quantra QStat Sample Type Comparison
Official title: Impact of Sample Type on the Performance of the Quantra QStat System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulation Defect; Bleeding
Keywords: Quantra
Liver transplantation
Coagulation
Lead sponsor: HemoSonics LLC
Sponsor class: INDUSTRY
First posted: 2023-09-06
Enrollment: 25
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: Adult patients undergoing liver transplant surgery.

Brief summary: This is a single center prospective observational study to compare QStat parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing liver transplantation.

Detailed description: In this single center prospective observational study, 25 cardiac surgery subjects will enrolled, each with parallel artrial and venous samples collected at 3 time points to yield 75 matched samples for analysis on the Quantra System with the QStat Cartridge.

Eligibility criteria: Inclusion Criteria:

* Subject is \>=18 years
* Subject is scheduled for liver transplant surgery
* Subject or subject's legally authorized representative (LAR) is willing to provide informed consent

Exclusion Criteria:

* Subject is younger than 18 years of age
* Subject is pregnant
* Subject is incarcerated at the time of the study
* Subject is affected by a condition that, in the opinion of the treatment team, may pose additional risks
* Subject, or subject's LAR, is unable or unwilling to provide informed consent

Primary outcomes:
measure: Comparison of QStat Clot time (CT) in arterial and venous samples
timeFrame: During liver transplantation surgery
measure: Comparison of QStat Clot stiffness (CS) in arterial and venous samples
timeFrame: During liver transplantation surgery
measure: Comparison of QStat Platelet Contribution to Clot stiffness (PCS) in arterial and venous samples
timeFrame: During liver transplantation surgery
measure: Comparison of QStat Fibrinogen Contribution to Clot stiffness (FCS) in arterial and venous samples
timeFrame: During liver transplantation surgery
measure: Comparison of QStat Clot Stabilty to Lysis (CSL) in arterial and venous samples
timeFrame: During liver transplantation surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT02062008: Validation of Combined PET-MR Quantitative Parameters for Cardiac Applications
Official title: Validation of Combined PET-MR Quantitative Parameters for Cardiac Applications
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiac Disease
Keywords: Positron Emission Tomography-Magnetic Resonance Imaging
Cardiac Disease
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2014-02-13
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to understand how simultaneous PET/MR acquisition can provide novel qualitative and quantitative biomarkers to guide clinical intervention and predict prognosis of patients with cardiovascular disease.

Detailed description: * To compare regional myocardial uptake of FDG on images obtained on a standard PET camera with the new PET/MR camera, in patients with coronary artery disease.
* To compare viability maps obtained with cardiac MR images and FDG-PET for delineation of myocardial infarct core and border zone, in patients with coronary artery disease.
* To correlate MRI myocardial strain with relative myocardial FDG uptake in patients with a previous myocardial infarction.
* To interrogate if simultaneous acquisition of cardiac PET and viability cardiac MR differ from acquisitions obtained independently, with special focus on attenuation correction methods
* To combined MRI scar map with FDG-PET uptake in patients with cardiac sarcoidosis and myocarditis.
* To correlate morphologic characteristics of atherosclerotic disease in the thoracic and abdominal aorta with FDG uptake and ferumoxytol enhancement, as a marker of inflammation.
* To evaluate cardiac strain and myocardial scar burden in obese patients with and without diabetes.

Eligibility criteria: Inclusion Criteria:

* Subjects with ischemic and non-ischemic cardiac disease referred for cardiac PET for viability imaging.

Exclusion Criteria:

* Contraindications for MRI, including cardiac pacemaker, claustrophobia, retained metallic foreign body, cochlear implant, Aneurysm clip in the brain, pregnancy and eGFR less than 45%.

Primary outcomes:
measure: Number of Quality PET and PET/MR Images With Regional Myocardial Uptake of 18F-Fluorodeoxyglucose (FDG) in Participants Without Overt Diagnosis of Ischemic Coronary Artery Disease.
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF University of California in San Francisco
state: California
Study officials:
affiliation: Assistent Professor
name: Karen G Ordovas, MD,MAS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00825708: Evaluation of the Effect of rTMS on Attention in Adults Diagnosed With Attention-Deficit Hyperactivity Disorder (ADHD)
Official title: Evaluation of the Effect of rTMS on Attention in Adults Diagnosed With ADHD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
First posted: 2009-01-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The aim of the study is to evaluate the immediate effect of rTMS on attention in adults diagnosed with ADHD. the design is a double blind sham controlled crossover study.

Detailed description: The subjects were randomly assigned to two groups. group 1 starts with the real rTMS session followed within one week with a sham session. group 2 starts with a sham session and within one week recieve a real session. the subjects go through a neurocognitive evaluation before and after rTMS sessions and a clinical evaluation questionnaire modified for attention.

Eligibility criteria: Inclusion Criteria:

* age 18-65
* diagnosis of ADHD according to DSM IV criteria

Exclusion Criteria:

* other axis I diagnosis
* risk factors for seizure

Primary outcomes:
measure: PANNAS questionnaire modified for attention
timeFrame: within one hour of the rTMS session
Secondary outcomes:
measure: the CANTAB neurocognitive battery
timeFrame: within 2 hours of the stimulation
Other outcomes:
Locations:
city: Hod Hasharon
country: Israel
facility: Shalvata MHC, cognitive and emotion lab
Study officials:
References:
citation: Bloch Y, Harel EV, Aviram S, Govezensky J, Ratzoni G, Levkovitz Y. Positive effects of repetitive transcranial magnetic stimulation on attention in ADHD Subjects: a randomized controlled pilot study. World J Biol Psychiatry. 2010 Aug;11(5):755-8. doi: 10.3109/15622975.2010.484466.
Clinical trial NCT01926808: Vitamin D Serum Concentrations & Supplementation in Children With Cerebral Palsy
Official title: Vitamin D Serum Concentrations and Vitamin D Supplementation in Children and Young Adults With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Lead sponsor: Akron Children's Hospital
Sponsor class: OTHER
First posted: 2013-08-21
Enrollment: 115
Sex: ALL
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severely cognitively impaired, non-mobile children and young adults who are residents at long-term care facility

Brief summary: The purpose of this study is to try to correlate vitamin D dosing and dosing adjustment with Vitamin D levels, measure affects of seizure medications on levels as well as pathologic fractures and bone density in severely cognitively impaired, non-mobile children and adolescents with CP.


Eligibility criteria: Inclusion Criteria:

* Recorded vitamin D supplementation dose (i.e. prescribed diet and any additional sources of vitamin D) with at least two serum vitamin D concentrations recorded in the medical chart from January 1, 2008 to June 30, 2013.
* Resident of HLCCD since 2008

Exclusion Criteria:

* No vitamin D levels recorded.
* History of hyperthyroidism or parathyroid pathology.
* Short gut syndrome that requires TPN.
* Poor medical documentation.
* Heritable disorders that affect vitamin D levels such as Pseudovitamin D deficiency rickets, Vitamin D resistant rickets, autosomal dominant hypophosphatemic rickets and X-linked hypophosphatemic rickets

Primary outcomes:
measure: Change in serum vitamin D concentrations
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: