louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05648266: Serratus Plane Block After Minimally Invasive Mitral Valve Repair
Official title: Serratus Plane Block After Minimally Invasive Mitral Valve Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Minimal Invasive Cardiac Surgery
Minimal Invasive Cardiac Surgery Mitral Valve Surgery
Serratus Anterior Plane Block
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients undergoing minimally invasive mitral valve reconstruction via small thoracotomy are randomized into two groups.

The intervention group receives serratus anterior plane block after minimally invasive mitral-valve reconstruction, following 48h infusion with ropivacaine 2% continually.

The control group receives a placebo pump without infusion. Primary endpoints are perceived pain using a numeric pain rating scale and opioid consumption during the hospital stay.


Eligibility criteria: Inclusion Criteria:

-Planned minimal invasive mitral valve repair via right anterior thoracotomy

Exclusion Criteria:

* Pregenancy
* Opioid abuse
* Historyof chronic pain
* Allergy to local anaesthetics (in this case ropivacain)
* Patients who simultaneously participate in another interventional clinical trial, unless the Principal Investigators of the clinical trials give consent by mutual agreement Soft tissue infection in the area of the procedure

Primary outcomes:
measure: Analgesic effect of SAPB in MIC-MVR
timeFrame: within 48 hours after surgery
Secondary outcomes:
measure: Analgesic effect of SAPB in MIC-MVR
timeFrame: within 48 hours after surgery
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Hospital Hamburg Eppendorf
Study officials:
References:
Clinical trial NCT00006166: North American Study for the Treatment of Refractory Ascites (NASTRA)
Official title: The North American Study for the Treatment of Refractory Ascites (NASTRA) Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ascites
Liver Cirrhosis
Keywords: refractory ascites
paracenteses
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2000-08-09
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The NASTRA Clinical Trial is a multi-center, randomized, controlled clinical trial designed to determine if treatment with transjugular intrahepatic portasystemic shunts (TIPS) is superior to high volume paracentesis (total paracentesis, TP) for the treatment of refractory ascites due to cirrhosis. Only patients with clinically tense symptomatic ascites (shortness of breath, umbilical hernia, abdominal pain and/or distension, and/or limitation of activity) who have either diuretic-resistant ascites or diuretic-intractable ascites are being studied.


Eligibility criteria: Inclusion Criteria:

* Cirrhosis as documented by biopsy or clinical/laboratory parameters WITH
* Tense symptomatic ascites and need for paracentesis (10 L) within last 2 months AND
* Failure of medical therapy as defined by the inability to lose at least 3.3 lbs/week while on maximum doses of diuretics or diuretic related complications (severe hyponatremia, hypercalcemia, azotemia or encephalopathy)

Exclusion Criteria:

* Causes of ascites other than cirrhosis and portal hypertension
* Terminal liver failure
* Portal vein thrombosis
* Congestive heart failure
* Acute renal failure
* Active encephalopathy
* Alcoholic hepatitis
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Richmond
country: United States
facility: Medical College of Virginia Hospitals
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Toronto
country: Canada
facility: The Toronto Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT01619566: Cymbalta for Fibromyalgia Pain - Predictive Value of Small Fiber Changed
Official title: Duloxetine (Cymbalta): for Fibromyalgia: An Open Label Study to Assess Potential Mechanisms for Fibromyalgia in Peripheral Tissue Innervation That Could Predict Therpeutic Responsiveness to Duloxetine.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Duloxetine
Cymbalta
Pain
Peripheral Nerve
Biopsy
Predictive
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2012-06-14
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subjects with Fibromyalgia who respond to Duloxetine have specific nerve fiber characteristics. This can be used to predict which future patients will respond to Duloxetine.

Detailed description: Subjects will have skin biopsies taken and evaluated for specific pathologies. All subjects will undergo a treatment period with Duloxetine. The analysis will correlate treatment effectiveness with pathological skin biopsy findings to predict future treatment success.

Eligibility criteria: Inclusion Criteria: Treatment Arm

* Fibromyalgia Diagnosis
* Female
* Over the age of 18, under the age of 70
* Understands English
* Not Pregnant/planning to become pregnant

Exclusion Criteria:

* No major psychiatric disorders
* No major unconrolled systemic diseases which may require hospitalization in the next 6 months
* Pregnant

Inclusion Criteria: Control Arm

* Female
* Over the age of 18, under the age of 70
* Understands English
* Not Pregnant/planning to become pregnant

Exclusion Criteria: Control Arm

* No major psychiatric disorders
* No major unconrolled systemic diseases which may require hospitalization in the next 6 months
* Pregnant

Primary outcomes:
measure: Pain Reduction
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego Medical Centers
state: California
Study officials:
affiliation: employee
name: tobias moeller-bertram, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03977766: Feasibility of a Process of Digital Validation of Chemotherapies in a Day Treatment Unit
Official title: Feasibility of a Process of Digital Validation of Outpatients Chemotherapies in a Day Treatment Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Solid Tumor, Adult
Keywords: digital application
outpatients chemotherapy
chemotherapy validation
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of CPV 2.0 study is to evaluate a process of digital prevalidation of outpatients chemotherapy thanks to a numeric application. This digital tool is based on the combination of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to a decisional algorithm.

After cycle 1, chemotherapy digital prevalidation will be done with the help of a nurse for two consecutive cycles (cycles 2 and 3). Patients will then have to use to application by themselves for the two following cycles (cycles 4 and 5)


Eligibility criteria: Inclusion Criteria:

* Age \<80 (if age\>70 years, a G8 score\>14 is required)
* ECOG\<3
* Pathology (solid tumor, in neoadjuvant, adjuvant or metastatic setting)
* Patient receiving an IV cytotoxic chemotherapy in a day treatlent unit for at least 5 cycles, with at least an injection at day 1, day 8 and day 15
* Familiar with digital tools

Exclusion Criteria:

* Emergency
* patient feeling unease with the use of a smartphone

Primary outcomes:
measure: Sensitivity of the digital application
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institut Paoli-Calmettes
name: Loui Tassy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00610766: International PRospective Multicenter Study On RadiaTion Dose Estimates Of Coronary CT AngIOgraphy IN Daily Practice
Official title: International PRospective Multicenter Study On RadiaTion Dose Estimates Of Coronary CT AngIOgraphy IN Daily Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Keywords: coronary CT angiography
radiation dose estimates
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2008-02-08
Enrollment: 1965
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 with indication for cardiac imaging by MSCT

Brief summary: Estimation of radiation dose of coronary multislice computed tomography (MSCT) angiography in daily practice in an international, multicenter and vendor-independent trial.

Detailed description: Prospective analysis of cardiac CT angiographies enrolled over 1 month

Collection of 1 axial data set and the "patient dose protocol" (including kV, mAs, CTDI, DLP, etc.) on a CD

Dose estimation in dose/cm with the use of a method proposed by the European Working Group for Guidelines on Quality Criteria in CT.

Assessment of diagnostic, qualitative image quality on a per-vessel basis by the participating study sites and in randomly selected cases by the primary study investigators (approximately 5-10% of patients to "spot check" interobserver variability of image quality assessments)

Assessment of image quality with the use of quantitative parameters including image noise, signal-to-noise and contrast-to-noise ratios

Eligibility criteria: Inclusion Criteria:

* assessment of coronary arteries
* acute chest pain or "triple rule out"
* evaluation after PCI (stents)
* evaluation of bypass grafts
* before or after EP study
* cardiac anomalies

Exclusion Criteria:

* pregnancy
* contraindications against contrast media

Primary outcomes:
measure: Radiation dose estimates of coronary MSCT angiography in daily practice
timeFrame: 1 month
Secondary outcomes:
measure: Comparison of dose estimates between 16-slice, 64-slice, DSCT and other CT systems
timeFrame: 1 month
measure: Frequency of dose-saving algorithm's use (e.g.: ECG-dose pulsing / Care Dose 4D / 100kv
timeFrame: 1 month
measure: Assessment of potentials for additional dose savings (e.g. entire scan length; the distance between scan start to begin of coronary arteries and distance end of coronary arteries to end of scan)
timeFrame: 1 month
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Joerg Hausleiter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06010966: Effect of iTBS on Children With ADHD
Official title: Effect of Intermittent TBS on Children With ADHD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ADHD
rTMS
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 54
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Attention Deficit/Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder characterized by persistent symptoms of attention deficit and/or hyperactivity/impulsivity . Currently, the first line drugs for treating ADHD are central stimulants such as Tomoxetine and Guanfaxine. However, there is a risk of drug abuse and misuse, which often affects sleep and appetite, only 50% of patients can fully tolerate. This project uses the iTBS stimulation on weekends, children with ADHD finish scale evaluation, magnetic resonance imaging analysis, and cognitive function before and after stimulation, This study explores its therapeutic effect on attention deficit in children and adolescents with ADHD.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ADHD in accordance with DSM-V;
* Age 6-12 years old, regardless of gender
* Right-handed
* Han nationality or born in the Han nationality Ghetto
* The course of the disease is greater than 6 months
* Webster children's intelligence ≥ 70
* The patient's guardian agrees and signs an informed consent form.

Exclusion Criteria:

* Concomitant mental disorders such as anxiety and depression;
* Widespread developmental disorders and other neurological developmental related disorders;
* Complication with other important organ diseases such as heart and lungs;
* Suffering from diseases such as epilepsy and tic disorder;
* Individuals who cannot tolerate rTMS treatment or cannot cooperate with treatment.
* Patients taking psychoactive drugs, antipsychotics, antidepressants, or mood stabilizers 3 months prior to enrollment or during rTMS treatment; In addition to the minimum effective therapeutic dose of Tomoxetine (1.2-1.4 mg • kg/day), there has been systematic use of first-line ADHD drugs in clinical practice Webster's intelligence\<70
* Implantation of metal and electronic components in the body (excluding the oral cavity), such as pacemakers;

Primary outcomes:
measure: ADHD-RS
timeFrame: 4 weeks
Secondary outcomes:
measure: fMRI
timeFrame: 4 weeks
measure: Stroop color-wordtask (SCWT)
timeFrame: 4 weeks
measure: TMT task
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Psychiatry, First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Shaohua Hu, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT05529966: Comparing NGENUITY vs Conventional Microscope in a New Hydrus User
Official title: Comparing NGENUITY vs Conventional Microscope in a New Hydrus User
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Alcon Vision
First posted: 2022-09-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To compare the potential efficiency and educational value of using NGENUITY (3D camera system, FDA approved for this indication) vs the conventional microscope for Hydrus microstent placement by new users.


Eligibility criteria: Inclusion Criteria:

* Patients with mild to moderate primary open angle glaucoma as defined by AGS with visually significant age-related cataract undergoing uncomplicated cataract surgery and Hydrus microstent
* Either eye or both eyes may participate

Exclusion Criteria:

* Lack of patient cooperation severely affecting ability to place stent with any visualization technique
* Angle abnormalities including PAS in nasal quadrant
* Unable to properly visualize the angle due to complicated cataract surgery

Primary outcomes:
measure: Time of First Cannula in Until Satisfactory Stent Placement and Cannula Out
timeFrame: up to 1 hour
Secondary outcomes:
measure: Number of Trabecular Meshwork Piercing Attempts Needed to Place Stent
timeFrame: up to 1 hour
measure: Number of Anterior Chamber Entry and Reentry Attempts During Stent Placement
timeFrame: up to 1 hour
measure: Number of Microscope Focus or Position Readjustments Needed During Stent Placement
timeFrame: up to 1 hour
measure: Change in Attending Questionnaire Score
timeFrame: Up to 5 minutes
measure: Change in Fellow Questionnaire Score
timeFrame: Up to 5 minutes
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Byers Eye Institute
state: California
Study officials:
affiliation: Stanford University
name: Robert T Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05214066: Efficacy and Safety Study of 4-Day ATG Regimen for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT
Official title: Prospective Study of Combined 4-Day ATG Regimen for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: aGVHD
cGVHD
Keywords: ATG
Matched sibling donor
peripheral blood stem cell transplantation
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the efficacy and safety of combined ATG #antithymocyte globulin # regimen (5mg/kg divided from day -5 to day -2) for aGVHD(acute graft-versus-host disease ) prophylaxis in matched sibling donor peripheral blood stem cell transplantation (MSD-PBSCT).

Detailed description: Transplantation with G-CSF #Granulocyte colony stimulating factor #mobilized peripheral blood stem cell (PBSCT) has been a stable transplant setting with matched sibling donor transplantation. Unmanipulated haploidentical donor PBSCT (haplo-PBSCT) has been applied in patients with hematologic malignancies. In our previous cohort study, haplo-PBSCT was associated with lower incidence of severe acute GVHD and extensive chronic GVHD compared with matched sibling donor PBSCT (MSD-PBSCT). Haplo-PBSCT has the same GVHD prophylaxis regimen with MSD-PBSCT, except ATG. It suggested the potential advantage of ATG in prophylaxis of GVHD and improvement of long term quality of life of the transplant recipients, which motivate us to observe the efficacy of combined ATG regimen for GVHD prophylaxis in MSD-PBSCT.

Eligibility criteria: Inclusion Criteria:

* Patients were aged from 14 to 65 years;
* Patients were diagnosed of acute leukemia or MDS;
* There were indications of MSD-PBSCT for these patients;
* Patients without any uncontrolled infections or without severe pulmonary, renal, hepatic or cardiac diseases.

Exclusion Criteria:

* Patients with any uncontrolled infections or with severe pulmonary,renal, hepatic or cardiac diseases;
* AML patients with t (15;17).

Primary outcomes:
measure: Number of participants with severe cGVHD
timeFrame: 1 year
Secondary outcomes:
measure: Number of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria)
timeFrame: 100 days
measure: OS
timeFrame: 1 year
measure: Number of participants relapse as assessed by NCCN (National Comprehensive Cancer Network )criteria
timeFrame: 1 year
measure: DFS
timeFrame: 1 year
measure: NRM
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Daihong Liu, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03134066: Neurocognitive Features of Patients With Treatment-Resistant Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Treatment Resistant Depression
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligibility for participants includes those ages 18-80 years old who meet criteria for a moderate/severe (as indicated by a score of \> 14 on the QIDS-SR) depressive episode (unipolar or bipolar mood disorder), have a history of at least three failed antidepressant trails, and are seeking non-research ketamine treatment through the ketamine clinic at Massachusetts General Hospital (and are deemed appropriate for treatment at the clinic. Participants must also be able to read, understand, and provide written informed consent in English.

Brief summary: There is an urgent need for novel and effective interventions for treatment-resistant depression (TRD). In previous studies, ketamine has been shown to rapidly reduce depressive symptoms; however, the exact mechanisms of action of ketamine remain unknown. There are some preliminary findings to suggest that ketamine may exert its antidepressant effects through promotion of neurogenesis in the dentate gyrus. The aim of this study is to help delineate the neurocognitive effects of ketamine exposure using a behavioral task (specifically, a pattern separation task) and a battery of other well-established cognitive measures.

This is an assessment-only study, as we will be recruiting subjects to complete an assessment battery at two time points, before and after receiving ongoing ketamine administrations for at least four weeks.


Eligibility criteria: Inclusion Criteria:

1. be 18-80 years old
2. be able to read, understand, and provide written informed consent in English,
3. meet criteria for a current moderate/severe (\> 14 on QIDS-SR) depressive episode (unipolar or bipolar mood disorder),
4. have a history of \> 3 failed antidepressant trials, and be
5. be seeking ketamine ongoing treatment through the ketamine clinic at Massachusetts General Hospital and be deemed appropriate for the clinic.

Exclusion Criteria:

1. Subjects who will not provide consent to neuropsychological testing
2. Subjects who are not deemed appropriate for the ketamine clinic will not be enrolled

Primary outcomes:
measure: Change in pattern separation task results
timeFrame: Baseline - post at least 2 weeks on a stable dose of intranasal ketamine
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: