louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02472405: Multiplex Laser vs. PDL (Pulsed Dye Laser ) in the Treatment of Surgical Scars
Official title: Comparing the 595/1064nm Multiplex Laser to the 595nm PDL in the Treatment of Surgical Scars in a Blinded, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scar
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant scar was randomized to the 3 treatment arms.
Primary purpose: TREATMENT

Brief summary: This study aims to determine if the 595nm Pulsed dye laser, the combined 595/1064nm Multiplex laser or no treatment results in a better outcome in the quality of the surgical scar using the multiplex cynergy laser, starting treatment the day of suture removal.

Detailed description: This study aims to determine if the 595nm Pulsed dye laser, the combined 595/1064nm Multiplex laser or no treatment results in a better outcome in the quality of the surgical scar using the multiplex cynergy laser, starting treatment the day of suture removal.

Patients will be offered the opportunity of enrolling in the trial before their surgery. If they qualify and agree to participate they will sign informed consent and Health Insurance Portability and Accountability Act (HIPAA) form.

The surgical defect should be closed primarily, with the minimal scar length being 3cm. The scar will be randomized into 3 equal thirds, each third will randomly receive either: no treatment, 595nm PDL, or 595/1064nm Multiplex laser. A total of 3 laser treatments will be performed over a period of 3 weeks (one treatment session performed every week), and the patient will come in for a final follow up visit, for a final assessment of the scar using the Patient and Observer Scar Assessment Scale (POSAS) system.

Eligibility criteria: Inclusion Criteria:

* Fitzpatrick skin types 1-3
* Suture line should be at least 3 cm long

Exclusion Criteria:

* The patient should not be receiving any alternate systemic, topical or intralesional treatment of the scars during the study
* Pregnant or lactating females
* Fitzpatrick skin type 4-6
* A history of keloids or hypertrophic scars

Primary outcomes:
measure: POSAS (The Patient and Observer Scar Assessment Scale) Measure
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center
state: Florida
Study officials:
affiliation: University of Miami Sylvester Comprehensive Cancer Center
name: Keyvan Nouri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00549705: Registry of Hospitalized Patients Treated With Fondaparinux
Official title: Registry of Hospitalized Patients Treated With Fondaparinux
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Vein Thrombosis
Pulmonary Embolism
Keywords: Anticoagulation
Thrombosis
Bleeding
Clotting
Pulmonary Embolism
Deep Vein Thrombosis
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2007-10-26
Enrollment: 220
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: BWH hospitalized patients receiving Fondaparinux

Brief summary: Registry of Hospitalized patients at Brigham and Women's Hospital treated with Fondaparinux

Detailed description: The use of antithrombotic agents in the hospital is the mainstay of therapy for the treatment or prophylaxis of venous thromboembolism (VTE) and acute coronary syndrome (ACS). Concern with the administration of heparins and risk for adverse sequelae has led to the development of newer, longer-acting agents. Fondaparinux offers once daily administration with only an extremely small risk of developing heparin induced thrombocytopenia.

Recent data have further demonstrated the efficacy and safety of Fondaparinux in VTE and ACS, expanding its use in clinical practice. We aim to: 1) determine how Fondaparinux is being used in a "real life" clinical setting, a tertiary-care academic medical center (BWH), and 2) assess the associated clinical outcomes at 90 days after initiation of Fondaparinux.

Eligibility criteria: Inclusion Criteria:

* BWH hospitalized patients receiving Fondaparinux

Primary outcomes:
measure: Venous Thromboembolism and Bleeding Events
timeFrame: 90 Days
Secondary outcomes:
measure: Mortality
timeFrame: 30 Days
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Samuel Z Goldhaber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06175598: Analysis of the Causes of Redo Pull-through for Recurrent Constipation and the Risk Factors Affecting the Prognosis of the Hirschsprung's Disease and Allied Disorders
Official title: Analysis of the Causes of Redo Pull-through for Recurrent Constipation and the Risk Factors Affecting the Prognosis of the Hirschsprung's Disease and Allied Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Pediatric ALL
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 79
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study collected comprehensive clinical data and compiled postoperative follow-up data from patients who underwent corrective surgery for HSCR and ADHD and subsequently required redo-PT due to recurrent constipation.

Brief summary: The goal of this observational study is to conducted a comprehensive analysis of the factors contributing to redo- Pull-through surgery for constipation recurrence in Children who are suffering from Hirschsprun' s disease (HSCR) and its allied disorders (ADHD) . The main question\[s\] it aims to answer are:

1. Our study focused on the treatment and prognosis of these conditions, drawing upon 16 years of patient data and clinical experiences"
2. What are the key risk factors affecting the prognosis of recurrent constipation patients undergoing repeat PT?


Eligibility criteria: Inclusion Criteria:

1. Patients admitted to the department of pediatric surgery at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, between January 2005 and December 2021;
2. HSCR and ADHD patients admitted due to "constipation recurrence" and requiring redo-PT.

Exclusion Criteria:

1. Patients undergoing staged surgeries or undergoing internal sphincterotomy;
2. Patients with concomitant severe congenital anomalies such as Down syndrome; (3) Patients with incomplete postoperative follow-up data after redo-PT.

Primary outcomes:
measure: Participants with redo-pull-through surgery for recurrent constipation
timeFrame: 1990-2023
measure: Participants with and without postoperative complications
timeFrame: through study completion, an average of 33 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Pediatric Surgery
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Jiexiong Feng, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02848898: The Effects of Focal Vibration on Spasticity in Multiple Sclerosis Patients
Official title: The Effects of Focal Vibration on Central and Peripheral Spasticity in Multiple Sclerosis Patients. A Randomized, Multicenter, Double Blinded vs Placebo Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Focal Vibrations
Neurorehabilitation
Spasticity
Multiple Sclerosis
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial consists of application of little devices (named Equistasi®) generating focal vibrations to treat spasticity in neurological patients, affected by multiple sclerosis. The expected effects are on gait and postural instability.


Eligibility criteria: Inclusion Criteria:

* Multiple Sclerosis affected
* Spasticity
* EDSS (Expanded Disability Status Scale) 0 - 5,5
* Patients able to sign informed consent

Exclusion Criteria:

* Age less than 18 years old and more than 65 years old
* Pacemaker
* Pregnancy
* Comorbidities as: cancer, hypertension not controlled by drugs
* concurrent therapies with antidepressant or corticosteroids

Primary outcomes:
measure: Gait Velocity
timeFrame: one year
measure: First step length
timeFrame: one year
measure: Swing phase
timeFrame: one year
measure: Stance phase
timeFrame: one year
measure: Double support time
timeFrame: one year
Secondary outcomes:
measure: H/M ratio
timeFrame: one year
measure: Berg Balance Scale
timeFrame: one year
measure: Modified Fatigue Scale
timeFrame: one year
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Prof. Giuseppe Orefice
state: Campania
Study officials:
References:
Clinical trial NCT06383598: PD-L1 Specific 68Ga-THP-PD-L1-3 Probe for PET Imaging in Solid Tumors
Official title: PD-L1 Specific 68Ga-THP-PD-L1-3 Probe for PET Imaging in Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Solid Tumor
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study is to constrcut a noninvasive approach 68Ga-THP-PD-L1-3 PET/CT to detect the PD-L1 expression of tumor lesions in patients with solid tumors and to identify patients benefiting from anti-PD-L1 treatment.

Detailed description: Analysis plan: 1. recruit 10 participants to analyze preliminary pharmacokinetic/first-in-human dose (FIH), major organ distribution and tumor uptake information via whole-body PET/CT imaging; 2. recruit 20-30 participants to analyze in vivo safety and tumor targeting information; and 3. recruit all participants for a final summary.

Eligibility criteria: Inclusion Criteria:

1. Aged \>18 years old; ECOG 0 or 1;
2. Patients with solid tumorsin or suspected tumor lesions;
3. life expectancy \>=12 weeks.

Exclusion Criteria:

1. Significant hepatic or renal dysfunction;
2. Is pregnant or ready to pregnant;
3. Cannot keep their states for half an hour;
4. Refusal to join the clinical study;
5. Suffering from claustrophobia or other mental diseases;
6. Any other situation that researchers think it is not suitable to participate in the experiment

Primary outcomes:
measure: Standardized uptake value（SUV）
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Hua Zhu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03389698: Developing Advanced Blood-Brain Barrier Permeability Imaging for Early AD
Official title: Developing Advanced Blood-Brain Barrier Permeability Imaging for Early Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy cognitively normal control subjects of both age cohorts will be recruited by the study coordinator from (i) a pool of established volunteer subjects at NYU Langone Health who previously participated in research and who have agreed to be contacted about future research, (ii) Health Insurance Portability and Accountability Act of 1996 (HIPAA)-compliant databases such as RedCap and DataCore, and (iii) individuals who have contacted NYU to express interest in participating in research as a healthy volunteer.

Subjects with aMCI will be recruited by Dr. Wisniewski from an ongoing NIH-funded large grant at NYU Barlow Center.

Brief summary: Aging is the primary risk factor in aging-related dementia. An important initiating factor for the development and progression of cognitive impairment is disruption of the blood-brain barrier (BBB). BBB plays an important role in maintaining normal brain homeostasis and protecting neural tissues from toxins. It is hypothesized that such changes known to be common in aging and can be an early process that precedes Alzheimer's Disease (AD). The microvascular changes related to subtle BBB disruption can be measured with permeability-surface area (PS) derived from GRASP DCE-MRI acquired less than 10 minutes, and the patterns of increased PS in normal and abnormal aging are different.


Eligibility criteria: Inclusion Criteria:

* Subjects that have been diagnosed with aMCI ages 65-85

Exclusion Criteria:

* Pregnant, planning to get pregnant, or nursing.
* Claustrophobia
* Cardiac pacemaker
* Intracranial clips, metal implants, unremovable jewelries, metal in eyes.
* History or presence of any other major medical, neurologic or psychiatric conditions, such as Alzheimer's diseases, Parkinson's diseases, and stroke.
* Renal or liver disease as this may cause concerns related to Gad-based contrast agent
* Allergy to the contrast agent Gadolinium

Primary outcomes:
measure: Permeability Surface Area (PS) as Measured by GRASP DCE-MRI Sequence
timeFrame: Up to 21 Minutes
measure: Blood-Brain Barrier (BBB) Permeability as Measured by GRASP DCE-MRI Sequence
timeFrame: Up to 21 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Yulin Ge, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03068598: Suicide Sleep Monitoring (Ssleem)
Official title: Connected Sleep Recording Device for Suicidal Patients, Acceptability Study - Suicide Sleep Monitoring (Ssleem)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide, Attempted
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The subject will receive a watch connected to a smartphone, wear at night and objectively evaluate sleep in ecological conditions
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Promising results have shown that interventions to reduce insomnia diminish suicidal ideation. A better understanding of the bidirectional mechanism between sleep disturbances and suicide behavior will allow the design of tailored interventions to prevent suicide attempts.

Significance of the proposed study for the field The aim of the present is to assess the feasibility and the acceptability of sleep tracking monitoring in a sample of suicide attempters. The investigator hypothesize that sleep monitoring using a connected object is feasable and acceptable by patients.


Eligibility criteria: Inclusion Criteria:

* male or female, aged 18 or older,
* with suicide attempt or suicidal ideas history,
* able to understand the study,
* insured persons,
* having signed a consent form.

Exclusion Criteria:

* minor patient,
* patient whose clinical status is incompatible with informed consent,
* patient tattooed on both wrists
* patient under guardianship or curatorship

Primary outcomes:
measure: Acceptability of the sleep recorder device in patients with previous history of suicide attempts
timeFrame: 5 days after discharge
Secondary outcomes:
measure: Link between the connected record and the data collected using a self-administered questionnaire evaluating qualitatively and quantitatively sleep.
timeFrame: 5 days after discharge
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT02766998: Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery
Official title: Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Defects
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 2
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single center, safety and feasibility trial to evaluate the use of autologous umbilical vein as shunts or conduits in neonatal cardiac surgery. Subjects will be identified here at the Advanced Fetal Care Center (AFCC) following diagnosis of congenital heart disease (CHD) with single ventricle physiology of the fetus via fetal echocardiogram. At time of cesarean section or vaginal delivery, umbilical cord will be harvested in a sterile fashion and the umbilical vein will be dissected free and preserved until first clinically indicated Stage I palliative procedure between day 3 and 7 of life. Subjects will be followed until their Stage II palliative procedure.


Eligibility criteria: Inclusion Criteria:

* All fetal diagnoses of complex congenital heart disease diagnosed by fetal echocardiogram requiring cardiac repair with Blalock-Taussig Shunt or Right Ventricle to Pulmonary Artery conduit will be eligible.
* This includes all pre-natal diagnoses of any single ventricle circulation physiology (SVP).
* Subjects being delivered via cesarean section or vaginally at Brigham and Women's Hospital will be considered.

Exclusion Criteria:

* meconium at delivery
* symptomatic Group B Streptococcus (GBS) positive mothers
* mothers with chorioamnionitis
* Hepatitis B or C positive mothers
* HIV positive mothers.
* If unable to collect viable cord on the day of delivery of already enrolled subjects, the subject will be removed from the study on day of birth.

Primary outcomes:
measure: Absense of primary serious adverse events
timeFrame: from time of insertion to time of Stage II procedure, approximately 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Cardiovascular Surgeon
name: Sitaram Emani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04589598: Femoral Neck System and Multiple Cannulated Screws in Femoral Neck Fracture
Official title: Comparison Between Femoral Neck System and Multiple Cannulated Screws in Non-displaced Femoral Neck Fracture
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Femoral Neck Fractures
Keywords: Femoral Neck Fractures
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: DePuy Synthes
First posted: 2020-10-19
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators will compare the clinical outcomes of femoral neck system with conventional multiple cannulated screw in non-displaced femoral neck fracture.

Detailed description: Clinical outcomes include reoperation, loss of fixation, and change of mobility.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* non-displaced femoral neck fracture
* community ambulator

Exclusion Criteria:

* younger than 18 years
* displaced femoral neck fracture
* intertrochanteric fracture
* subtrochanteric fracture

Primary outcomes:
measure: Reoperation
timeFrame: 3 months
measure: Reoperation
timeFrame: 6 months
measure: Reoperation
timeFrame: 9 months
measure: Reoperation
timeFrame: 12 months
measure: Reoperation
timeFrame: 24 months
Secondary outcomes:
measure: loss of fixation
timeFrame: 3 months
measure: loss of fixation
timeFrame: 6 months
measure: loss of fixation
timeFrame: 9 months
measure: loss of fixation
timeFrame: 12 months
measure: loss of fixation
timeFrame: 24 months
Other outcomes:
measure: mobility change
timeFrame: 3 months
measure: mobility change
timeFrame: 6 months
measure: mobility change
timeFrame: 9 months
measure: mobility change
timeFrame: 12 months
measure: mobility change
timeFrame: 24 months
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Young-Kyun Lee
role: PRINCIPAL_INVESTIGATOR
References: