louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02830750: Low Fluoroscopy Afib Ablation Registry
Official title: A Multi Center Registry of Low- Fluoroscopy Atrial Fibrillation Ablation Using Electroanatomic Mapping Carto
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Beacon Medical Group
name: Brigham and Women's Hospital
name: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
First posted: 2016-07-13
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have persistant or paroxysmal atrial fibrillation

Brief summary: Prospective data collection of patients undergoing Atrial Fibrillation Ablation.

Detailed description: Clinicians who have experience using low dose fluoroscopy including use of Carto Mapping system will consent patients to allow data collection and a 12 month f/up visit to track adverse events. Clinicians will follow a protocol which will be similar to their standard of care for ablations.

Eligibility criteria: Inclusion Criteria:

* Patient meets accepted AHA/ACC/HRS guideline indications for catheter ablation of paroxysmal or persistent AF
* First or subsequent ablation procedures may be included
* Age 18-75

Exclusion Criteria:

* Known venous malformations or implanted instrumentation (IVC filter)
* Known PV stenosis
* Unable to provide consent
* H/O mechanical mitral valve replacement (unable to rely on EA mapping only)
* Documented left atrial thrombus
* Prior ASD repair Pregnancy
* NYHA \>=3
* EF less than 35%
* CHF within 90 daysRecent MI or coronary revascularization within 90 days
* NOTE: H/O implanted pacemaker or ICD with transvenous leads will NOT be an exclusion criteria, but we will track patients treated with pre-existing transvenous leads with the hypothesis that although fluoroscopy use will be higher in these patients compared to those without leads, but still lower than conventionally treated patients.
* Patients who are undergoing non- standard of care ablations ie, Cyro or FIRM ablations

Primary outcomes:
measure: Atrial Fibrillation
timeFrame: 12 months
Secondary outcomes:
measure: Fluoroscopic Usage
timeFrame: post operative
Other outcomes:
Locations:
city: South Bend
country: United States
facility: Beacon Medical Group
state: Indiana
city: Boston
country: United States
facility: Brigham's Women's Hospital
state: Massachusetts
Study officials:
affiliation: Stanford University
name: Chad Brodt, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01261650: Influence of Transcranial Direct Current Stimulation of the Primary Motor Cortex on Pain Sensation in Patients Suffering From Fibromyalgia Syndrome
Official title: Influence of Transcranial Direct Current Stimulation of the Primary Motor Cortex on Pain Sensation in Patients Suffering From Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Fibromyalgia
Keywords: widespread chronic pain, transcranial direct current stimulation, fibromyalgia
Lead sponsor: Karl Landsteiner Institute of Remobilization and Functional Health
Sponsor class: OTHER
First posted: 2010-12-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fibromyalgia is a common chronic pain syndrome characterized by bad treatable chronic widespread pain present at a similar level for at least 3 months. The aim of this study is to examine if 3 weeks of transcranial direct current stimulation is a suitable therapy to reduce chronic pain.


Eligibility criteria: Inclusion Criteria:

* Patients who have an established diagnosis of fibromyalgia according to the 1990 criteria of the "American College of Rheumatology"
* Symptoms have been present at a similar level for at least 3 months
* Stable medication for at least 2 months
* visual analog scale ≥ 3 (0=no pain; 10=worst possible pain)
* The patient does not have a disorder that would otherwise explain the pain

Exclusion Criteria:

* Alcohol/substance abuse
* Pregnancy
* Neuropsychiatric disorders
* Metal implants near stimulation area
* Cardiac pace maker
* Local injuries
* Inflammatory rheumatic disease
* Acute tumor
* Acute fracture
* Well-defined neuropathic induced pain

Primary outcomes:
measure: Visual Analoge Scale
timeFrame: Difference Baseline - after treatment
Secondary outcomes:
measure: Quality of Life - SF-36
timeFrame: baseline / after treatment / 1 , 2, 3 months after treatment
measure: Fibromyalgia Impact Questionaire
timeFrame: baseline / after treatment / 1,2,3, months after treatment
measure: IL-10 ELISA
timeFrame: baseline / after treatment / 1,2,3, months after treatment
measure: Visual analog scale
timeFrame: 1,2,3 months after treatment
measure: IL-6 ELISA
timeFrame: baseline / after treatment / 1,2,3, months after treatment
measure: IL-4 ELISA
timeFrame: baseline / after treatment / 1,2,3, months after treatment
measure: TNF-alpha ELISA
timeFrame: baseline / after treatment / 1,2,3, months after treatment
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Karl Landsteiner Institute of Remobilisation and Functional Health
Study officials:
affiliation: Karl Landsteiner Institute of Remobilisation and functional Health
name: Michael Quittan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01156350: Haplo-identical Hematopoietic Stem Cell Transplantation Following Reduced-intensity Conditioning in Children With Neuroblastoma
Official title: Haplo-identical Hematopoietic Stem Cell Transplantation Following Reduced-intensity Conditioning in Children With Neuroblastoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neuroblastoma
Keywords: Neuroblastoma - Haplo HSCT - Reduced Intensity Conditioning - immunotherapy NK
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2010-07-02
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To date, no curative option exists for patients with relapsed or refractory stage IV neuroblastoma after previous autologous stem cell transplantation. Our preliminary results of RIC allo-HSCT (protocol RICE) indicate the feasability and low toxicity of allograft in heavily pre-treated children. Furthermore RIC SCT and immunomagnetic CD3/CD19 graft depletion may allow HHCT with lower toxicity and faster engraftment. CD3/CD19 depleted grafts not only contain CD34+ stem cells but also graft-facilitating cells, CD34- progenitors, dendritic and natural killer cells which may allow stable engraftment and participate to GvT effect.

After haploidentical stem cell transplantation anti tumour activity exerted by donor derived NK cells could be stimulated by NK cells injections. Those effects may help to reduce the relapse rate and to impove the outcome of those patients. The investigators prospectively evaluated engraftment and immune reconstitution.

Detailed description: This RICE NK protocol is a multicenter study of Haplo- HSCT using RIC with fludarabine (180 mg/m2), Busulfan IV (3,2 to 4,8 mg/kg/d), TBI 2 grays and CD3/CD19 graft depletion. A minimum of 8 106 CD34+ cells/kg were infused on day 0. No post grafting immunosuppression was applied if the graft contained \< 2.5 x 104 CD3+ cells/kg. At Day 30 and 60 post-graft we perform an donor CD56+ cells injection. The investigators develop this strategy in an European collaboration working on haploidentical stem cell transplantation for childhood refractory and metastatic solid tumors.

Eligibility criteria: Inclusion Criteria:

* High Risk Neuroblastoma
* HLA haplo-identical family donor

Exclusion Criteria:

* patient with fast progressive neuroblastoma
* Lansky \< 60%

Primary outcomes:
measure: Evaluation of the feasibility of the CD3 / CD19 selected haplo identical hematopoietic stem cell transplant after conditioning with reduced intensity in children with neuroblastoma in failure of reference treatments
timeFrame: at one year
Secondary outcomes:
measure: Study of the overall survival Study of graft versus tumor effect at day + 100
timeFrame: at day + 100
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Catherine PAILLARD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05074550: Safety Evaluation Study for Patients With Polycythemia Vera
Official title: Phase I, Open-Label, Multicentre, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of A Single Intravenous PPMX-T003 in Polycythemia Vera
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Polycythemia Vera
Keywords: Myeloproliferative neoplasms
Lead sponsor: Perseus Proteomics Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-12
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is PhaseI Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of PPMX-T003 in Polycythemia Vera


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of PV according to either the 2008 or 2016 WHO classification criteria
* PV patients being only treated with phlebotomy and the interval is 4-9 weeks

Exclusion Criteria:

* Patients administrated drugs for PV treatment such as hydroxyurea or ruxolitinib (aspirin is excluded)

Primary outcomes:
measure: Number of Patients Experiencing Treatment-emergent Adverse Events (TEAEs) in the Study
timeFrame: 45 weeks
Secondary outcomes:
measure: Evaluation of pharmacokinetics of PPMX-T003 after single dose
timeFrame: Day1,Day2,Day7
measure: Evaluation of pharmacokinetics of PPMX-T003 after single dose
timeFrame: Day1,Day2,Day7
measure: Evaluation of pharmacokinetics of PPMX-T003 after single dose
timeFrame: Day1,Day2,Day7
measure: Evaluation of pharmacokinetics of PPMX-T003 after single dose
timeFrame: Day1,Day2,Day7
measure: Evaluation of pharmacokinetics of PPMX-T003 after single dose
timeFrame: Day1,Day2,Day7
measure: Evaluation of pharmacokinetics of PPMX-T003 after single dose
timeFrame: Day1,Day2,Day7
measure: Evaluation of pharmacokinetics of PPMX-T003 after single dose
timeFrame: Day1,Day2,Day7
measure: Examining the expression rate of anti-drug antibodies (ADA)
timeFrame: Day1,Day21,up to 45weeks
Other outcomes:
Locations:
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Izumo
country: Japan
facility: Shimane University Hospital
state: Shimane
city: Osaka
country: Japan
facility: Osaka City University Hospital
Study officials:
References:
Clinical trial NCT01069250: Dynamic and Static Autoregulation After Brain Injury
Official title: Serial Measurement of Static and Dynamic Cerebrovascular Autoregulation After Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Brain Injuries
TBI (Traumatic Brain Injury)
Intracranial Hemorrhages
Keywords: dynamic cerebrovascular autoregulation
static cerebrovascular autoregulation
acute brain injury
transcranial Doppler ultrasound
critical care
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2010-02-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after traumatic brain injury or intracranial bleeding wich had a Glasgow-Coma-Scale (GCS) of less than 8 and were initially sedated, intubated and mechanically ventilated.

Brief summary: The aim of the study assesses static and dynamic cerebrovascular autoregulation daily over one week in patients with traumatic brain injury or intracranial hemorrhage to quantify the temporal profile of the autoregulatory status.


Eligibility criteria: Inclusion Criteria:

* Traumatic brain injury
* Intracranial hemorrhage

Exclusion Criteria:

* Measurement of TCD were impossible
* Injury of the legs (if the both tigh cuffs for dynamic autoregulation could not be fixed)

Primary outcomes:
measure: Disturbed cerebrovascular autoregulation after brain injury
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Medical Center of the Johannes Gutenberg-University Mainz
Study officials:
References:
citation: Schramm P, Klein KU, Pape M, Berres M, Werner C, Kochs E, Engelhard K. Serial measurement of static and dynamic cerebrovascular autoregulation after brain injury. J Neurosurg Anesthesiol. 2011 Jan;23(1):41-4. doi: 10.1097/ANA.0b013e3181f35854.
Clinical trial NCT04906850: Evaluation of the New Variant 501Y.V2 of COVID-19
Official title: Comparison of Mortality in Severe SARS-Cov-2 Infection Caused by the 501Y.V2 Variant and B.1.1.7 Variant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Mortality
SARS-CoV-2 variants
Intensive Care Unit
20I/501Y.V1
20H/501Y.V2
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
Collaborators: name: Central Hospital, Nancy, France
First posted: 2021-05-28
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with 20I/501Y.V1 ("English") or 20H/501Y.V2 ("South African") SARS-CoV-2 variants

Brief summary: In January 2021, the incidence of COVID-19-and its mortality started rising for the third time in France. This rise may associate with three emerging variants, namely, V1, V2, and V3, which are the 20I/501Y.V1 ("English"), 20H/501Y.V2 ("South African"), and 20J/501Y.V3 ("Brazilian") variants, respectively. V1 was recently suggested to increase mortality in people in the United Kingdom who tested positive for COVID-19 on community screening. Very little is known about V2 infection, including its outcomes relative to other strains. In early 2021, V2 spread to the Grand-Est region (northeastern France). Here, the investigators aimed to report mortality data of patients admitted in ICU between February and April 2021 in 3 hospitals in Grand-Est: Metz, Thionville and Nancy.


Eligibility criteria: Inclusion Criteria:

* Admission in ICU in February, March or April 2021
* Patient with a SARS-CoV-2 positive polymerase-chain reaction test
* Patient with 20I/501Y.V1 ("English") or 20H/501Y.V2 ("South African") SARS-CoV-2 variants

Exclusion Criteria:

* Opposed to use data

Primary outcomes:
measure: Mortality 28 days after admission
timeFrame: Day 28
Secondary outcomes:
measure: ICU mortality
timeFrame: Day 1
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
state: Meurthe-et-moselle
city: Metz
country: France
facility: CHR Metz Thionville
state: Moselle
Study officials:
References:
citation: Louis G, Belveyre T, Goetz C, Gibot S, Dunand P, Conrad M, Gaci R, Gette S, Ouamara N, Perez P, Cadoz C, Picard Y, Mellati N. Comparison of SARS-CoV-2 Variants of Concern Alpha (B.1.1.7) vs. Beta (B.1.351) in Critically Ill Patients: A Multicenter Cohort Study. Front Med (Lausanne). 2022 Mar 10;9:828402. doi: 10.3389/fmed.2022.828402. eCollection 2022.
Clinical trial NCT00629850: Respiratory Resistance Training on Sleep Quality in Persons With Spinal Cord Injury
Official title: Concurrent Respiratory Resistance Training and Changes in Respiratory Muscle Strength and Sleep Quality in Persons With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
respiratory muscle training
sleep quality
Lead sponsor: Texas State University, San Marcos
Sponsor class: OTHER
First posted: 2008-03-06
Enrollment: 1
Sex: ALL
Minimum age (years): 18
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 determine if the use of a respiratory resistance trainer will increase respiratory muscle strength, improve sleep quality and improve quality of life in individuals with spinal cord injury.

Hypothesis: Use of the respiratory resistance trainer will improve respiratory muscle strength, improve sleep quality, and improve quality of life among individuals with spinal cord injury.

Detailed description: Individuals with spinal cord injury experience varying degrees of reduced muscle function. Those individuals with high level spinal cord injury, cervical region, may experience reduced diaphragm function. This reduction in function may affect daytime activities as well as sleep quality. Sleep quality in people with spinal cord injury is considered to be worse than sleep quality in the general population. The use of respiratory resistance training devices has been shown to increase muscle strength in people with spinal cord injury. There have been not studies to document potential improvements in sleep quality among individuals with spinal cord injury following respiratory resistance training.

Eligibility criteria: Inclusion Criteria:

* tetraplegia
* quadriplegia

Exclusion Criteria:

* NA

Primary outcomes:
measure: Number of Participants With Improvement in Sleep Quality.
timeFrame: 10 weeks
measure: Change in Maximum Voluntary Ventilation Using Pulmonary Function Device
timeFrame: 10 weeks
measure: Change in Negative Inspiratory Force Using a Pressure Manometer
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Marcos
country: United States
facility: Texas State University-San Marcos
state: Texas
Study officials:
affiliation: Texas State University, San Marcos
name: Lisa Lloyd, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05426850: ctDNA-based MRD Assessment in Local Advanced Esophageal Carcinoma
Official title: Circulating Tumor DNA-based Minimal Residual Disease (MRD) Assessment in Local Advanced Esophageal Squamous Cell Carcinoma Treated by Definitive Concurrent Chemoradiotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Local advanced esophageal squamous cell carcinoma treated by definitive concurrent chemoradiotherapy

Brief summary: To analyze the relationship between the dynamic changes of circulating tumor DNA (ctDNA) and tumor relapse of esophageal squamous cell carcinoma treated by concurrent chemoradiotherapy.


Eligibility criteria: Inclusion Criteria:

1. 18-75 years old.
2. ECOG 0-1.
3. Esophageal squamous cell carcinoma confirmed by pathology.
4. No radiotherapy, chemotherapy, or other treatments prior to enrollment.
5. Locally advanced esophageal squamous cell carcinoma (II-IVa, IVB with supraclavicular lymph node metastasis).
6. No severe abnormal hematopoietic, cardiac, pulmonary, renal, hepatic function, or immunodeficiency.
7. Informed consent signed.

Exclusion Criteria:

1. Less than 50.4Gy/28fx of radiotherapy dose.
2. Without Concurrent chemotherapy.
3. Pregnant or breastfeeding women or fertile patients who refused to use contraceptives.

Primary outcomes:
measure: Relationship between ctDNA status after chemoradiotherapy and relapse.
timeFrame: ctDNA will be tested within 1 year after chemoradiotherapy
Secondary outcomes:
measure: Changes of ctDNA status.
timeFrame: before and at the end of radiotherapy (+1 week); at the end of consolidation chemotherapy (+1 week); at 2 weeks, 1 month, 3 months, 6 months, 9 months, 1 year after dCCRT.
measure: Overall survival (OS).
timeFrame: through study completion, an average of 2 years.
measure: Relapse-free survival (RFS) and progression-free survival (PFS).
timeFrame: through study completion, an average of 2 years.
measure: Relationships between radiomics features, ctDNA status and relapse.
timeFrame: through study completion, an average of 2 years.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai cancer center
state: Shanghai
Study officials:
References:
Clinical trial NCT02224950: Study to Examine the Benefits of Fabric Made With Lyocell/Chitosan/Ceramide in the Treatment of Children With Mild to Moderate Eczema
Official title: Study to Examine the Benefits of Fabric Made With Lyocell/Chitosan/Ceramide in the Treatment of Children With Mild to Moderate Eczema
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
eczema
alternative therapy
complementary therapy
moisturizer
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2014-08-25
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will primarily focus on evaluating the benefits of using a lyocell/chitosan/ceramide fabric as a treatment for young children with mild or moderate eczema. More specifically, the study will focus on the upper limb area in these patients and will examine whether wearing a sleeve made from a lyocell/chitosan/ceramide fabric can improve eczema symptoms compared with wearing a cotton sleeve, no sleeve, or the lyocell / chitosan combination. Patients will be evaluated at 3 intervals over a 3-week period using the following four variables: an eczema severity index, amount of itching, bacteria levels in the affected areas of skin, and amount of water loss in the affected areas.

Detailed description: The study will be evaluated using the following four variables: an eczema severity index, amount/severity of itching, bacteria levels in the affected areas of skin, and amount of water loss in the affected areas. The eczema severity will be scored using the EASI (upper limb subscale); itch will be assessed with a Visual Analog Scale for itch; the skin will be swabbed for bacterial cultures and results are quantified based on microbiology lab standards to be mild, moderate or heavy growth of the bacteria identified; and transepidermal water loss (TEWL) will be measured using a tewameter/capacitive moisture sensor.

Eligibility criteria: Inclusion Criteria:

* Age 3 months to 5 years
* Mild or moderate atopic dermatitis, as determined by Investigator Global Assessment Criteria

Exclusion Criteria:

* Non-English speaking subjects/families
* Families unable to complete study requirements

Primary outcomes:
measure: Benefit of ceramide embedded fabric
timeFrame: 3 weeks
Secondary outcomes:
measure: Bacterial growth
timeFrame: 3 weeks
Other outcomes:
measure: Trans-epidermal water loss
timeFrame: 3 weeks
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Kristen Hook, MD
role: PRINCIPAL_INVESTIGATOR
References: