louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01483209: Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A
Official title: Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ischemia
Vasopressor
Keywords: Digital ischemia
Vasopressor
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2011-12-01
Enrollment: 2
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 goal of this project is to determine if performing a "chemical sympathectomy" by injecting botulinum toxin A in critically ill patients on vasopressors can treat digital ischemia. This is a prospective, non-randomized pilot study designed to demonstrate proof of concept. We propose to study patients in the intensive care units of Duke Hospital who, secondary to exposure to vasoactive medications used to maintain acceptable blood pressures, have developed signs and symptoms of digital ischemia. A paired T-test will be used to compare pre- and post-injection Laser Doppler measurements for the experimental hand. We will again use a paired t-test to compare the experimental hand against the contralateral control hand. There were no major adverse events reported by the product information sheet or in other related studies of Botox for digital ischemia.


Eligibility criteria: Inclusion Criteria:

* Be admitted to the ICU
* Have digital ischemia and
* Be on a vasopressor infusion

Exclusion Criteria:

* Patients with a history of systemic sclerosis
* Patients actively receiving aminoglycoside antibiotics - aminoglycosides may potentiate the effect of Botox
* Patients who have previously received botulinum toxin (A or B) injections
* Patients with a history of disorders of neuromuscular transmission (e.g myasthenia gravis, Lambert-Eaton, etc.) - Botox may have a lasting effect in these patients given their disorder
* Patients with clinical evidence of an infection in either forearm or hand
* Patients with a history of sensitivity to albumin - Botox is sold in powder form and there is albumin in the formulation
* Pregnancy - Botox is a class C medication
* Rheumatoid Arthritis
* Upper extremity arterio-venous graft or fistula
* Digital necrosis
* History of hand amputation
* Patients whom the intensive care attending physician deems will expire within 48 hours

Primary outcomes:
measure: Perfusion (as Determined by Laser Doppler Measurements)
timeFrame: 12 months
Secondary outcomes:
measure: Digital Amputations
timeFrame: 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke UMC
name: Cynthia Shortell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke UMC
name: Detlev Erdmann, M.D., Ph. D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01591109: A Reversal in the Vascularity of Metastatic Liver Tumors From Colorectal Cancer After the Cessation of Anti-VEGF Therapy
Official title: A Reversal in the Vascularity of Metastatic Liver Tumors in Patients With Colorectal Cancer After the Cessation of Anti-VEGF Therapy: A Study Using Contrast-enhanced Ultrasonography and Histological Techniques.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: NHO - Matsumoto Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-05-03
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents cared by the institution this study was perfomed.

Brief summary: Objective: To assess the effect of bevacizumab on tumor vessels, and the reversibility of the effect, using contrast-enhanced ultrasonography (CEUS) and histology in patients with metastatic liver tumors derived from colorectal cancer.

Background Data: Direct evidence on the reversibility of any change in tumor vascularity upon bevacizumab cessation in the clinical setting is lacking.

Methods: The study included 10 patients who received chemotherapy including bevacizumab, experienced a reduction in tumor vascularity as demonstrated by CEUS and consequently underwent liver resection. CEUS was performed before and immediately after 4 courses of chemotherapy and one day before surgery. The number of microvessels highlighted by anti-CD34 antibody in the viable tumor tissue was counted to quantify the microvessel density (MVD). As a control, 10 surgical specimens from 10 patients who had not received chemotherapy were examined.


Eligibility criteria: Inclusion Criteria:

* patients who received chemotherapy (FOLFOX) including bevacizumab. The patients had an associated reduction in tumor vascularity as estimated by ultrasonography and consequently underwent surgical resection of the metastatic liver tumors for curative purposes.

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01077609: Flixonase Safety in Patients With Allergic Rhinitis (AR)
Official title: Fluticasone Propionate Nasal Spray (Flixonase) Safety in Patients With Allergic Rhinitis Registered in the UK General Practice Research Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis, Allergic, Perennial
Keywords: Intranasal steroids
beclometasone diproprionate
steroid-related outcomes
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-03-01
Enrollment: 1
Sex: ALL
Minimum age (years): 4
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The General Practice Research Database (GPRD). Patient records dated between January 1990 - January 2002 were used to develop the overall study cohort.

Brief summary: This is an inception cohort study that analyses data from an administrative medical records database. The two inception cohorts are: 1) patients initiated on intranasal FP and 2) patients initiated on another INS (not FP). The candidates for the inception cohorts did not use any intranasal steroid in the year prior to initiation.


Eligibility criteria: Inclusion Criteria:

* Patient records dated between January 1990 - January 2002 were used to develop the overall study cohort. The cohort was composed of the following patients:

  1. All patients with at least one prescription for Flixonase
  2. A random sample of patients having at least one prescription for an INS other than Flixonase

Exclusion Criteria:

Patient-level exclusion

* Patients with less than 180 days of continuous eligibility before index date
* Patients who are under four years of age at index date
* Patients who are older than 85 years of age at index date

Episode-level exclusion

-When patient history was divided into Flixonase or other INS use episodes, patients with less than 120 days of eligibility after the last prescription in the episode Patients with an event of interest 180 days prior to patients' entry into the cohort or anytime prior to an episode index date were automatically excluded from the analysis of that event. This exclusion criterion was applied to rule out prevalent conditions.

Primary outcomes:
measure: Steroid-related outcomes: Cataracts, Glaucoma, Nasal septum perforation, Hypercorticism, Adrenal insufficiency, Fractures (limited to hip, wrist and vertebral as proxies for osteoporosis), Otitis media, Sinusitis, Infectious complications of sinusitis
timeFrame: Exposure episodes are defined as any series of prescriptions filled within 60 days of one another. Observation periods capture incident events beginning with the first prescription in the episode and ending 120 days after the last fill date.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05831709: The Influence of Hormone Replacement Therapy and Supervised Exercise Training on Body Composition, Cardiovascular Risk and Insulin Sensitivity in Postmenopausal Women
Official title: De Invloed Van Hormoonsubstitutietherapie En Gesuperviseerde Training Op Lichaamssamenstelling, Cardiovasculair Risico En Insulinegevoeligheid Bij Postmenopauzale Vrouwen
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postmenopause
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 270
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial investigates whether supervised training in combination with hormonal substitution therapy has an impact on body composition, cardiovascular risk, risk for dementia, osteoporosis and insulin sensitivity in postmenopausal women.

Detailed description: 270 postmenopausal women will be included. Each woman will perform a 12 to 24 weeks sports program with supervised training exercises.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women
* Good general health
* BMI: 20-30 kg/m2
* Only the use of cholesterol-, blood pressure- or/and thyroid-regulating medication is permitted

Exclusion Criteria:

* Women who are not yet in the menopause
* BMI \<20- and \>30 kg/m2
* Use of any other medication than cholesterol-, blood pressure- and thyroid-regulating medication

Primary outcomes:
measure: Evaluation of the cardiovascular risk
timeFrame: +12 weeks
measure: Evaluation of the insulin sensitivity
timeFrame: +12 weeks
Secondary outcomes:
measure: Evaluation of the body composition
timeFrame: +12 weeks
measure: Evaluation of the muscle mass
timeFrame: +12 weeks
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital - Women's Clinic
Study officials:
References:
Clinical trial NCT02404909: Inferior Vena Cava Index in Patients Undergoing Liver Resection
Official title: Does Inferior Vena Cava Collapsibility Correlate With Fluid Regimen and Outcome in Patients Undergoing Liver Resection?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Neoplasms
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2015-04-01
Enrollment: 91
Sex: ALL
Minimum age (years): 34
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients underwent liver resection for primary and secondary liver disease

Brief summary: The aim of this study was to evaluate whether IVC index measured intraoperatively was affected by fluid administration and could add any helpful information about the hemodynamics during hepatic resection. In addition, the investigators evaluated whether IVC index was somehow correlated with the risk of postoperative complication.


Eligibility criteria: Inclusion Criteria:

Patients who underwent hepatectomy for primary and secondary liver tumors

Exclusion Criteria:

Patients with tumoral thrombosis or full tumoral involvement/compression of IVC were excluded. Patients unresectable at laparotomy for any extra-hepatic or intrahepatic reason and patients previously submitted to hepatectomy were not included

Primary outcomes:
measure: to investigate the influence of the liver resection on hemodynamic status in terms of hemodynamic indexes changes
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04607109: Long-term Neurodevelopmental Disorders of Prematurely Born Children and Parental Experience
Official title: Neurodevelopmental Assessment and Parents Feelings at 7-8 Years of Age for Prematurely Born Children Involved in the Réseau Périnatal Lorrain Follow-up Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurodevelopmental Abnormality
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 238
Sex: ALL
Minimum age (years): 7
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children born prematurely (\< 33SA) in 2012 and followed up in the RAFAEL network 7 years of age

Brief summary: Thanks to the evolution in knowledge and technical advances in premature newborn intensive care, the survival of very premature infants is now possible. However, prognosis remain sometimes uncertain.

In 2011, the Epipage 2 study showed a significant improvement as compared with the 1997 Epipage1 study with a decrease in mortality and an increase of the survival rate without severe morbidity of 14% for preterm babies born between 25 and 29 weeks and 6% for babies born between 30 and 31 weeks.

However, surviving babies without initial major deficiencies, may later show problems in terms of growth, sensory - motor and/or neuro-psychologic development. This untoward evolution lead to social and family interaction disorders and school difficulties.

In this context, a perinatal care network was created for each Region in France, making it possible to take care of these vulnerable children early on and all along their development. A retrospective study will evaluate 97 pre-term babies born before 33 weeks in 2012 and who are taken care of at Nancy as part of the Lorraine regional network program "Rafael" until they are 7 years old.

The objective is to evaluate objectively the neurocognitive and school abilities of these children at the age of 7.

At 8 years of age, a secondary measure of outcome will be the impact of the eventual neurocognitive consequences on the quality of their family life, on the behavior of the child and the parents' feelings. This way more options to improve the way they are taken care of will be available.


Eligibility criteria: Inclusion Criteria:

* all children prematurely born between 24 and 33 completed week during 2012
* and involved in the Lorraine Perinatal Follow-up program at 7 years old

Exclusion Criteria:

* Children not able to respond to the EDA evaluation

Primary outcomes:
measure: EDA score (Evaluation Des fonctions cognitives et des Apprentissages)
timeFrame: 7 years old
Secondary outcomes:
measure: RAFAEL follow-up questionnaire reply of parents
timeFrame: 8 years old
Other outcomes:
Locations:
city: Nancy
country: France
facility: Maternity Hospital CHRU
Study officials:
References:
Clinical trial NCT00222209: Clinical Study on Implicit Learning, Comorbidity and Stress Vulnerability in Chronic Functional Pain
Official title: Implicit Learning, Comorbidity and Stress Vulnerability in Chronic Functional Pain Syndromes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Irritable Bowel Syndrome
Keywords: Experimental study
chronic pain
operant learning
comorbidity
stress
Fibromyalgia w visceral hypersensitivity
Fibromyalgia w/o visceral hypersensitivity
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2005-09-22
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The project investigates on the role of pain avoidance, comorbidity and stress response for the development of chronic somatic and visceral pain. We, the researchers at University Hospital Mannheim, assume that implicit operant learning of pain sensitization is a central mechanism of the process of pain becoming chronic, which is augmented by fear and by avoidance behaviour. Somatic and psychological comorbidity as well as stress factors are further promoting factors in chronic pain development.

Detailed description: Study 1: Implicit operant learning of sensitization and habituation in an experimental heat pain model will be investigated and compared in healthy controls, chronic pain patients with fibromyalgia, with and w/o visceral pain.

Study 2: Functional imaging of implicit operant learning of sensitization and habituation in an experimental heat pain model (same subgroups as in study 1).

Eligibility criteria: Inclusion Criteria:

* Fibromyalgia according to American College of Rheumatology (ACR) criteria
* Visceral hypersensitivity according to ROME criteria
* Chronic pain according to International Association for the Study of Pain (IASP) criteria

Exclusion Criteria:

* Abnormal quantitative sensory testing
* Psychiatric or neurological anamnesis, except fear and depression
* Acute major depression
* Substance abuse

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: University of Mannheim - Otto-Selz-Institute
Study officials:
affiliation: University of Mannheim
name: Rupert Hoelzl, Prof. Dr. phil.
role: STUDY_DIRECTOR
affiliation: Universitätsmedizin Mannheim
name: Hans-Joachim Bender, Prof. Dr. med. rer. nat.
role: STUDY_DIRECTOR
affiliation: German Cancer Research Centre Heidelberg
name: Lothar-Rudi Schad, Prof. Dr. rer. nat.
role: STUDY_DIRECTOR
References:
citation: Holzl R, Kleinbohl D, Huse E. Implicit operant learning of pain sensitization. Pain. 2005 May;115(1-2):12-20. doi: 10.1016/j.pain.2005.01.026.
citation: Kleinbohl D, Holzl R, Moltner A, Rommel C, Weber C, Osswald PM. Psychophysical measures of sensitization to tonic heat discriminate chronic pain patients. Pain. 1999 May;81(1-2):35-43. doi: 10.1016/s0304-3959(98)00266-8.
Clinical trial NCT05665309: Interest of Pre-operative Use of 3D Printing for Endovascular Treatment of Unruptured Intracranial Aneurysms With Intrasaccular Flow Disruptor
Official title: Interest of Pre-operative Use of 3D Printing for Endovascular Treatment of Unruptured Intracranial Aneurysms With Intrasaccular Flow Disruptor
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intracranial Aneurysm
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a preliminary randomised controlled trial comparing the use of pre-operative 3D models to select an intrasaccular flow disruptor for endovascular aneurysm cure.

Detailed description: Patients will be randomised 3:1 either in the intervention or control group. Intervention consists of using the pre-operative Digital Subtraction Angiography (DSA) to create a 3D plastic model. This model is used to test different sizes of device. At the end of this pre-operative test a single device is recommended for the real procedure. The control group will use the current method for size selection (measurement of mean width and minimum height) on DSA.

Eligibility criteria: Inclusion Criteria:

* Intracranial aneurysm, suitable for a treatment by Woven Endobridge (WEB) device after multidisciplinary team decision
* Consent form signed
* The patient benefits from health insurance

Exclusion Criteria:

* Legal incapacity
* Women at risk of pregnancy

Primary outcomes:
measure: Proportion of patients with successful procedure
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU de Besançon
name: Guillaume CHARBONNIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02165709: Cohort Study of Risk Reducing Salpingectomy
Official title: Cohort Study of Risk Reducing Salpingectomy (RRS) Versus Standard Tubal Sterilization Among Women Who Desire Sterilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sterilization, Tubal
Salpingectomy
Ovary
Prevention & Control
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2014-06-17
Enrollment: 18
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Women undergoing surgical sterilization will be interested in risk reducing salpingectomy, and surgeons performing the procedure will be able to successfully complete the salpingectomy.


Eligibility criteria: Inclusion Criteria:

* Women \> 35 years requesting sterilization as interval procedure OR at time of cesarean delivery
* At least one living child
* English or Spanish speaking
* Sterilization planned as interval (laparoscopic) procedure via Family Planning Clinic services or at time of delivery
* Delivery by cesarean section (planned or following labor)

Exclusion Criteria:

* Age \< 30
* Medical complications that increase risk for surgical bleeding (e.g. Idiopathic thrombocytopenic purpura (ITP); von Willebrand disease (vWD); need for prophylactic or therapeutic anticoagulation)

Primary outcomes:
measure: Percent of women accepting RRS
timeFrame: 12 months
Secondary outcomes:
measure: Percent of women with successful RRS completion
timeFrame: 12 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Hosptials
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Matthew L Zerden, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: