louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00835913: Autonomic Nervous System Alteration Induce by Sepsis: Assessment and Prognosis Impact
Official title: Autonomic Nervous System Alteration Induce by Sepsis:Assessment and Prognosis Impact
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Shock
Severe Sepsis
Keywords: Autonomic nervous system
Sepsis shock
severe sepsis
sinusal change
Myocardiac fixing
NTproBNP
Patient in intensive care unit with sepsis shock or severe
Sepsis
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2009-02-04
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patient transfer in intensive care unit with sepsis chock or severe sepsis define as Bone criteria.

Brief summary: Severe sepsis and septic shock are causes of admission in intensive care units.Modification of natriuretic peptid including NT-proBNP and cardiac autonomic nervous system alteration are reported in sepsis shock and severe sepsis and seems to link to patient prognosis admitted to intensive care units.

Detailed description: Our principal aim is to characterize modulation of cardiac sympathic nervous system in sepsis through the study of sinusal change and myocardiac fixing of MIBG.

The second aim is 1)to assess links between alteration of cardiac sympathic nervous system and NT-PRoBNP variations in sepsis and 2)To know prognostic impact in sympathic nervous system compare to NTproBNP.

Eligibility criteria: Inclusion Criteria:

* Patient over 18 years admitted in intensive care unit and having severe sepsis criteria or septic shock documented or suspected define as Bone Criteria
* hemodynamically stable situation
* sinusal rhythm
* Patient for social security

Exclusion Criteria:

* Minors
* Patient under guardianship or trusteeship
* pregnant or lactating women
* diabetic
* cardiomyopathy known and/or treated or detect in admission
* electro-systolic process permanent or transitory
* neurological history or degenerative pathology
* chronic respiratory insufficiency
* Chronic renal insufficiency

Primary outcomes:
measure: Sinusal variability analysis and myocardic fixation of MIBG performed in 48 hours post admission
timeFrame: 48 hours post admission
Secondary outcomes:
measure: plasmatic measure of NT-ProBNP and catecholamine at admission, day 2 and last day of hospitalisation
timeFrame: 30 days
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: Unit intensive care
name: SCHWEBEL Carole, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06214013: Adaptation of Linehan's Biosocial Model to Emotional Dysregulation in Autism Spectrum Disorder
Official title: Proposal for an Adaptation of Linehan's Biosocial Model to Emotional Dysregulation in Autism Spectrum Disorder: Narrative Review of the Literature and Clinical Case
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Keywords: Autism Disorder
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects (≥18 years old) Having been diagnosed with ASD without intellectual disability

Brief summary: Linehan's biosocial model conceptualizes the factors at play in the development of emotional dysregulation (ED), that is, difficulty regulating one's emotions, in borderline personality disorder (BPD). The model explains ED as the result of the interaction between the person's biological emotional vulnerability and their exposure to early invalidating experiences from those around them. Recently, ED has been shown to be prevalent in autism spectrum disorder (ASD). The objective of the study is to propose an adaptation of Linehan's model to the specificities of ASD to conceptualize the factors contributing to ED in the context of this disorder. To do this, the investigators will carry out a narrative literature review, as well as an illustrative case conceptualization based on the proposed model.


Eligibility criteria: Inclusion Criteria:

* Adult subjects (≥18 years old)
* Having been diagnosed with ASD without intellectual disability
* Presenting severe ED with self-harming behaviors and/or suicidal behaviors

Exclusion Criteria:

- Subjects not meeting the study eligibility criteria

Primary outcomes:
measure: Adaptation of Linehan's biosocial model to emotional dysregulation in autism spectrum disorder
timeFrame: The bibliography research will cover the period from 2015 to 2021.
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Psychiatrie - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT00418613: A Research Study of MK0633 in Patients With Chronic Obstructive Pulmonary Disease (COPD)(0633-009)(COMPLETED)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions of MK0633 in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-01-05
Enrollment: 266
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A clinical study to evaluate the efficacy and safety of MK0633 in patients with Chronic Obstructive Pulmonary Disease (COPD).


Eligibility criteria: Inclusion Criteria:

* Documented COPD defined by clinical history and spirometry, with symptoms including dyspnea, wheezing, chest tightness, cough, sputum production, or nocturnal awakening
* Male or postmenopausal females 40 -75 years of age

Exclusion Criteria:

* Impaired renal function
* History of chronic liver disease or persistent liver function test (LFT) abnormalities
* History of recent cardiovascular clinical event
* Evidence of another clinically significant, active pulmonary disorder such as bronchiectasis or asthma

Primary outcomes:
measure: Pulmonary function test data
timeFrame: Measured over 12 weeks
Secondary outcomes:
measure: Overall daytime symptoms score, total daily beta agonist use, and Chronic Respiratory Disease Questionnaire (CRQ) score
timeFrame: Measured over 12 weeks of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Bernstein JA, Liu N, Knorr BA, Smugar SS, Hanley WD, Reiss TF, Greenberg S. MK-0633, a potent 5-lipoxygenase inhibitor, in chronic obstructive pulmonary disease. Respir Med. 2011 Mar;105(3):392-401. doi: 10.1016/j.rmed.2010.09.021. Epub 2010 Nov 13.
Clinical trial NCT01864213: Efficacy of Ametop Cream in Reducing Pain of Local Anesthetic Infiltration
Official title: The Efficacy of Topical Amethocaine Gel in Reducing the Pain of Local Anesthetic Infiltration Prior to Neuraxial Anesthesia in Non-labouring Pregnant Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-05-29
Enrollment: 78
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Ametop is a numbing cream used to ease the pain of having blood drawn or an IV inserted. It is safe and virtually none enters the blood stream. It's effectiveness at reducing the pain of the freezing injection prior to epidural/ spinal anesthesia in pregnant women has not been studied.

Detailed description: We propose to randomize 70 women to have either the numbing cream or a similar looking moisturizing cream placed on their lower back before their anesthetic. They will rate the discomfort of the freezing injection allowing us to compare the two groups and determine if the numbing cream is effective.

Eligibility criteria: Inclusion Criteria:

* Any pregnant subject undergoing an elective procedure under neuraxial anesthesia.

Exclusion Criteria:

* Any contraindication to neuraxial anesthesia
* Subjects in labour

Primary outcomes:
measure: Pain score
timeFrame: Within 5 minutes of spinal
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Vit Gunka, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00546013: Abdominal Aortic Aneurysms and Pseudoexfoliation Syndrome
Official title: Abdominal Aortic Aneurysms Are Associated With Pseudoexfoliation Syndrome
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Abdominal Aortic Aneurysms
Pseudoexfoliation Syndrome
Hypertension
Keywords: abdominal aortic aneurysms
pseudoexfoliation syndrome
glaucoma
Lead sponsor: European Georges Pompidou Hospital
Sponsor class: OTHER
First posted: 2007-10-18
Enrollment: 208
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: in patients suffering from abdominal aortic aneurism as part of a routine clinical yearly follow-up and hypertensive patients without abdominal aortic aneurism and that were more than 60 years old to have similar mean ages in both groups, as pseudoexfoliation and abdominal aortic aneurism are age-related disorders

Brief summary: Conflicting results have been reported concerning the association of pseudoexfoliation syndrome (PXF) and abdominal aortic aneurysms (AAA). Schumacher et al. reported an association between AAA and PXF, with no consideration of grade. However, a later study did not confirm the association between AAA and PXF. The present study aimed at comparing the relative prevalence of PXF in patients suffering from AAA and in age-matched hypertensive patients.


Eligibility criteria: Inclusion Criteria:

* Presence of abdominal aortic aneurism
* Systemic hypertension without abdominal aortic aneurism over 60 years old

Exclusion Criteria:

* Unknown status for abdominal aortic aneurism

Primary outcomes:
measure: standard ophthalmologic examination to group patients according to their pseudoexfoliation status
timeFrame: Day of standard ophthalmologic examination
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
Study officials:
name: Patrick Rossignol, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03419013: Evaluation of the Performance of an Adhesive Strip
Official title: A Pilot Evaluation of Newly Developed Adhesives and How They Are Impacted by Output
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2018-02-01
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigated the performance of a new adhesive strip when impacted by output


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had an ileostomy for more than one year
4. Have intact skin on the area used in the evaluation
5. Has an ileostomy with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of test product (assessed by investigator)

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigator)
5. Participating in other interventional clinical investigations or have previously participated in this investigation

Primary outcomes:
measure: Trans epidermal water loss
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Head of the pre-clinical department
name: Lene F Nielsen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01079013: Treosulfan-based Conditioning for Allogeneic Stem-cell Transplantation (SCT) in Lymphoid Malignancies
Official title: Phase II Trial of Fludarabine Combined With Intravenous Treosulfan and Allogeneic Hematopoietic Stem-cell Transplantation in Patients With Lymphatic Malignancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non Hodgkin Lymphoma
Hodgkin Lymphoma
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-03-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study hypotheses is that the introduction of dose escalated treosulfan, in substitution to busulfan or melphalan, will reduce toxicity after allogeneic transplantation while improving disease eradication in patients with lymphoid malignancies not eligible for standard transplantation.


Eligibility criteria: Inclusion Criteria:

1. Age less than physiologic 68 years.
2. Patients with NHL and HL with an indication for allogeneic transplantation as follows:

   * Aggressive lymphoma and Hodgkin lymphoma; relapse after autologous transplants
   * Follicular lymphoma; failure of at least one prior regimen
3. Disease must be at chemo-sensitive or stable status to prior therapy before transplant.
4. Patients must have an HLA matched related or unrelated donor willing to donate either peripheral blood stem cells or bone marrow. Matching is based on high-resolution class I (HLA-A, -B, -C) and class II (HLA-DRB1, -DQB1) typing. The goal is to transplant \> 3 x 106 CD34+ cells per kg body weight of the recipient
5. Patients must sign written informed consent
6. Adequate birth control in fertile patients

Exclusion Criteria:

1. Overt progressive disease prior to transplantation.
2. Bilirubin \> 3.0 mg/dl, transaminases \> 3 times upper normal limit
3. Creatinine \> 2.0 mg/dl
4. ECOG-Performance status \> 2
5. Uncontrolled infection
6. Pregnancy or lactation
7. Abnormal lung diffusion capacity (DLCO \< 40% predicted)
8. Severe cardiovascular disease
9. CNS disease involvement
10. Pleural effusion or ascites \> 1 liter
11. Known hypersensitivity to fludarabine or treosulfan
12. Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate

Primary outcomes:
measure: disease-free survival
timeFrame: 2 years after transplantation
Secondary outcomes:
measure: treatment-related mortality
timeFrame: 2 year after transplantation
measure: GVHD
timeFrame: 2 year after transplantation
measure: relapse
timeFrame: 2 year after transplantation
measure: overall survival
timeFrame: 2 year after transplantation
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Chaim Sheba Medical Center
name: Arnon Nagler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02651519: Sleep Quality After Stellate-ganglion Block of Patients Undergoing Breast Cancer Operation
Official title: Sleep Quality After Stellate-ganglion Block of Patients Undergoing Breast Cancer Operation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Deprivation
Keywords: bispectral index
regional cerebral oxygen saturation
Stellate-ganglion block
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2016-01-11
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stellate-ganglion block have been done safely for more than 60 years. It has proved to provide survivors of breast cancer with relief from hot flushes and sleep dysfunction with few or no side-effects. The aim of the present study is to evaluate postoperative sleep quality of patients undergoing breast cancer surgery with Stellate-ganglion block performed in the operation.

Detailed description: This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All patients undergoing breast cancer operation will be randomized 1:1 to the treatment intervention with general anesthesia as an adjunct to Stellate-ganglion block with 0.25% ropivacaine hydrochloride or saline. The objective of the trial is to evaluate the postoperative sleep quality of patients undergoing breast cancer operation with Stellate-ganglion block 0.25% ropivacaine hydrochloride or saline.

Eligibility criteria: Inclusion Criteria:

* At least18 years and pre-menopausal;
* scheduled to undergo elective breast cancer operation;
* American Society of Anaesthesiologists (ASA) risk classification I-II.

Exclusion Criteria:

* (1) patient refusal; (2) known hypersensitivity to the study medication (ropivacaine); (3) long-term use of opioids; (4) a history of psychiatric or neurological disease; (5) a preoperative Pittsburgh Sleep Quality Index (PSQI) global score higher than 6.

Primary outcomes:
measure: sleep quality
timeFrame: first postoperative night
Secondary outcomes:
measure: regional cerebral oxygen saturation
timeFrame: In the operation
Other outcomes:
Locations:
city: Shenyang
country: China
facility: the First Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: First Hospital of China Medical University
name: Wen-fei Tan, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jin F, Li XQ, Tan WF, Ma H, Fang B, Tian AY, Lu HW. Effects of ultrasound-guided stellate-ganglion block on sleep and regional cerebral oxygen saturation in patients undergoing breast cancer surgery: a randomized, controlled, double-blinded trial. J Clin Monit Comput. 2018 Oct;32(5):855-862. doi: 10.1007/s10877-017-0074-3. Epub 2017 Oct 17.
Clinical trial NCT04908319: Hepatic Histopathology in Urea Cycle Disorders
Official title: Hepatic Histopathology in Urea Cycle Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urea Cycle Disorder
Ornithine Transcarbamylase Deficiency
Citrullinemia 1
ARGI Deficiency
ASL Deficiency
Argininosuccinic Aciduria
ASS Deficiency
Hyperargininemia
Carbamyl Phosphate Synthetase Deficiency
NAGS Deficiency
Keywords: Liver transplant
Liver disease
Liver biopsy
Histopathology
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Children's National Research Institute
First posted: 2021-06-01
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with urea cycle disorders

Brief summary: This is a multi-site, retrospective chart review as well as a prospective study to evaluate histopathologic findings in liver samples from individuals with any UCD diagnosis. This study will be conducted at all Urea Cycle Disorders Consortium (UCDC) sites: Baylor College of Medicine in Houston, TX and Children's National Medical Center in Washington D.C.

Detailed description: Urea cycle disorders (UCDs) are among the most common inborn errors of liver metabolism. With early diagnosis and improved treatments, the survival of individuals with UCDs has improved, and this improved survival has led to unmasking of some long-term complications such as hepatic dysfunction and progressive fibrosis in a subset of patients. Hepatic complications in UCDs are quite variable and dependent upon the specific metabolic defect.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary urea cycle disorder based on clinical suspicion confirmed by enzyme activity, DNA testing or metabolite analysis.
* History of liver transplantation and/or liver biopsy OR
* Planned liver transplantation and/or liver biopsy

Exclusion Criteria:

* Unavailability of histopathology report from the liver biopsy or explant, or unavailability of liver tissue or slides from the biopsy or explant OR
* Anticipated inability to obtain pathology report, liver disease, tissue blocks, or pathology slides after liver biopsy or transplantation
* Known history of a secondary cause for liver disease such as chronic viral hepatitis, autoimmune liver disease, short gut, small bowel syndrome, alcohol liver disease, or TPN-related cholestatic disease

Primary outcomes:
measure: Hepatic fibrosis
timeFrame: Day 1
measure: Steatosis
timeFrame: Day 1
measure: Hepatic glycogenosis
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Lindsay Burrage, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: