louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01949753: Influence of Pregnenolone on Exposure Therapy in Obsessive-compulsive Disorder
Official title: Influence of Pregnenolone on Distress and Autonomic Parameters During Cognitive-behavioral Exposure Therapy in Patients With Obsessive-compulsive Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Obsessive-compulsive Disorder (OCD)
Keywords: Obsessive-compulsive disorder (OCD)
Exposure therapy
Extinction learning
Pregnenolone
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2013-09-24
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: BASIC_SCIENCE

Brief summary: Characterization of the influence of pregnenolone vs. placebo on subjective distress and autonomic functioning during cognitive-behavioral exposure therapy in patients with obsessive-compulsive disorder.

Detailed description: Main out-come parameters:

Inter-session habituation as per SUD (100 mm VAS), Y-BOCS

Secondary out-come parameter:

HF/LF of HRV, Salivary epinephrine

Eligibility criteria: Inclusion Criteria:

-OCD according to DSM-IV criteria.

Exclusion Criteria:

* Acute suicidality
* psychotic disorders,
* bipolar disorder
* substance dependency
* organic brain disorder
* pregnancy
* lactation
* tuberculosis
* gastric/duodenal ulcer
* diabetes mellitus
* acute inflammation
* autoimmune disorders
* arterial hypertension
* therapy with glucocorticoids (up to 4 weeks ago)

Primary outcomes:
measure: Subjective units of distress (SUD)
timeFrame: During exposure therapy
Secondary outcomes:
measure: Low/high frequency index of heart rate variability (L/HFI)
timeFrame: During exposure therapy
Other outcomes:
measure: Salivary cortisol, noradrenaline, pregnenolone; heart rate, blood pressure
timeFrame: During exposure therapy
Locations:
city: Hamburg
country: Germany
facility: University Hospital Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Michael Kellner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00419653: Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy
Official title: Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy With Amisulpride, Olanzapine or Haloperidol. A Study With Functional Magnetic Resonance Imaging (fMRI) and Diffusion Tensor Imaging (DTI)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: schizophrenia fMRI drug therapy amisulpride
Lead sponsor: University of Jena
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2007-01-09
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to investigate the modulation of regional brain activation in schizophrenic patients by psychopharmacological treatment with either haloperidol, amisulpride or olanzapine. The study will be performed with functional magnetic resonance imaging (fMRI) and diffusion tensor imaging (DTI).

Detailed description: The current study aims to investigate the following issues:

* Changes in cognitive activation patterns under therapy with the typical neuroleptic haloperidol as compared to the atypical antipsychotics amisulpride and olanzapine
* Relationship of these changes in activity to psychopathological, neuropsychological and pharmacotherapeutic variables (e.g. drug plasma level) as well as to certain biological markers (HVA, prolactin)
* Relationship between diffusion anisotropy as an indicator for structural connectivity and cognitive activation patterns under antipsychotic treatment

Eligibility criteria: Inclusion Criteria:

* In- and outpatients of either sex
* Able to comply with the protocol
* Having given their written informed consent of their own free will
* Total BPRS (PANSS-derived, 1-7 points) minimum 36 points at baseline
* Schizophrenic or schizophreniform disorder according to DSM-IV criteria (295.10, .30, .40, .90)
* Definite right-handedness (according to the modified Edinburgh Handedness Inventory)
* Age 18 - 50 years

Exclusion Criteria:

* Co-morbid psychiatric axis I disorder (DSM-IV) other than schizophrenia
* Axis II disorder according to DSM-IV
* Present or past history of substance and drug dependence (including alcohol dependence)
* Participation in a clinical trial within the previous three months
* Lack of insight
* Suicidal ideations or aggression against others
* Consumption of caffeine-containing beverages within 6 hours before assessments
* Clinically significant findings in ECG or EEG
* Known intolerance against neuroleptics

Primary outcomes:
measure: Activation/deactivation in fMRI
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: FSU Jena
name: Ralf Schlösser, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03223051: Development of a Space Exploration Assessment for Children With Spinal Muscular Atrophy
Official title: Development of a Space Exploration Assessment for Children With Spinal Muscular Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Muscular Atrophy
Assessment, Self
Keywords: Spinal Muscular Atrophy
Children
Motor assessment
Space exploration
Upper limbs
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this randomized study is to develop a new motor assessment of space exploration in a 2D environment with upper limbs for children with spinal muscular atrophy 1 and 2 from 3 until 16 years old.

Detailed description: Thirty children are included in the prospective randomized study. They are evaluated with the new test, Space Exploration Test (TES), and with the Motor Function Measure (MFM), a gold standard scale. The objective is to compare the results and to demonstrate the complementarity of the two tools.

Eligibility criteria: Inclusion Criteria:

* children, girls and boys, from 3 to 16 years old,
* with Spinal Motor Atrophy 1 and 2
* with social protection

Exclusion Criteria:

* cognitive disorders preventing understanding

Primary outcomes:
measure: Motor Function Measure (MFM)
timeFrame: 1 hour
Secondary outcomes:
measure: Space Exploration Test (SET)
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Garches
country: France
facility: Hopital Raymond Poincare
city: Garches
country: France
facility: Nicolas ROCHE, Md PhD
Study officials:
affiliation: Raymond Poincare HOSPITAL
name: Nicolas ROCHE, MDphD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00841451: Pulmonary Vein Isolation Outcomes With Fish Oils
Official title: Pulmonary Vein Isolation Outcomes With Eicosapentaenoic Acid (EPA)and Docosahexaenoic Acid (DHA)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Persistent
Paroxysmal
Pulmonary Vein isolation
Omega three fatty acids
Fish Oils
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2009-02-11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Fish oil therapy may decrease the incidence of cardiac arrhythmias. This study will test whether pre-treatment with fish oils before catheter ablation of atrial fibrillation decreases the early post operative occurrence of atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* Paroxysmal Atrial fibrillation (PAF).
* Persistent atrial fibrillation. Persistent AF is not self-limited.

Exclusion Criteria:

* Previous pulmonary vein isolation ablation procedure
* Contraindication for anticoagulation
* Permanent AF
* Severe valvular pathology
* Concurrent use of antiarrhythmic medications
* Inability to give consent
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: New York
country: United States
facility: University Medical Practice Associates 425 West 59th St. #9C
state: New York
city: New York
country: United States
facility: St.Luke's Hospital 1111 Amsterdam Ave. 3rd Floor Cardiology
state: New York
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center
name: Suneet Mittal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03197051: Impact of Perioperative Shedding of the Endothelial Glycocalyx on the Incidence of Postoperative Acute Kidney Injury in Patients Undergoing Valvular Heart Surgery.
Official title: Impact of Perioperative Shedding of the Endothelial Glycocalyx on the Incidence of Postoperative Acute Kidney Injury in Patients Undergoing Valvular Heart Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Valvular Heart Disease
Keywords: Endothelial glycocalyx
Acute kidney injury
Valvular heart disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-06-23
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing valvular heart surgery (\>20 years old)

Brief summary: Endothelial glycocalyx, the luminal structure of healthy vasculature, plays critical roles in regulation of inflammatory responses, vascular permeability, blood coagulation. It can be easily damaged by ischemia/reperfusion, hypoxemia, oxidative stress, endotoxin. Accordingly, the relationship between the shedding of endothelial glycocalyx and the prognosis of diseases such as diabetes mellitus, atherosclerosis, malignancy has been researched.

In cases of cardiac surgery, patients cannot help but be exposed to ischemia/reperfusion, oxidative stress which can damage endothelial glycocalyx. In this research, the investigators would like to discover the impact of perioperative shedding of the endothelial glycocalyx on the incidence of postoperative acute kidney injury in patients undergoing valvular heart surgery.

Detailed description: Syndecan-1, Heparan sulfate serve as biomarkers of glycocalyx degradation. Both biomarkers will be measured 2 times, before the anesthetic induction, and immediately after weaning from cardiopulmonary bypass, during the valvular heart surgery.

Postoperative acute kidney injury up to postoperative 48 hours, Composite morbidity and mortality up to postoperative 30 days will be checked.

Eligibility criteria: Inclusion Criteria:

- Patients undergoing valvular heart surgery (\>20 years old)

Exclusion Criteria:

* Emergency operation
* Aorta surgery (Graft replacement of Total arch or Descending thoracic aorta)
* Minimal invasive surgery
* Chronic kidney disease (eGFR\<30mL/min/1.73m2) / Dialysis history
* Infective endocarditis
* Malignancy
* Patients who cannot give Informed consent (e.g. Illiterate, Foreigners)
* Patients who are already enrolled to another study than can affect the results

Primary outcomes:
measure: Acute kidney injury
timeFrame: Up to Postoperative 48 hours
Secondary outcomes:
measure: Composite morbidity and mortality (by STS Major morbidity endpoint)
timeFrame: Up to postoperative 30 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT03936751: Obstructive Sleep Apnea Treatment on Cardiovascular Events in Patients With Acute Cardiogenic Pulmonary Edema: CPAP-CARE STUDY.
Official title: Impact of Obstructive Sleep Apnea Treatment on Cardiovascular Events in Patients With Acute Cardiogenic Pulmonary Edema: a Multicenter Randomized Controlled Study (CPAP-CARE STUDY).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Obstructive Sleep Apnea
Pulmonary Edema Cardiac Cause
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Philips Respironics
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2019-05-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite the advances in the treatment of acute cardiogenic pulmonary edema (ACPE), the readmissions rates and cardiovascular events remain very high. In this context, it is possible that other potential risk factors may influence the poor prognosis of the ACPE. One of these potential candidates is Obstructive Sleep Apnea(OSA). This study was designed to evaluate the impact of OSA treatment with CPAP in consecutive patients with ACPE. The primary outcome will be to evaluate the impact of CPAP on the recurrence of ACPE in the 1-year follow-up.


Eligibility criteria: Inclusion Criteria:

* Hypertensive acute Cardiogenic Pulmonary Edema
* Moderate to Severe OSA

Exclusion Criteria:

* Professional drivers
* Pregnancy
* Non-Cardiogenic Pulmonary edema
* Terminal cancer

Primary outcomes:
measure: Rate of ACPE recurrence
timeFrame: 1-year
Secondary outcomes:
measure: Rate of all-cause mortality
timeFrame: 1-year
measure: Rate of cardiovascular mortality
timeFrame: 1-year
measure: Number of new hospital admissions
timeFrame: 1-year
measure: Blood pressure effects ( (mmHg)
timeFrame: 1-year
measure: Levels of BNP levels (pg/ml)
timeFrame: 1-year
measure: Cardiac function (left ventricular ejection fraction - %)
timeFrame: 1-year
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: PROCAPE - University of Pernambuco
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Samaritano
state: SP
city: Sao Paulo
country: Brazil
facility: Heart Institute (InCor)
city: Sao Paulo
country: Brazil
facility: Hospital Dante Pazzanese
Study officials:
References:
Clinical trial NCT00889551: Pregnancy and Growth of Adolescent Mothers and Their Child
Official title: Pregnancy and Growth of Adolescent Mothers and Their Child
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adolescent
Pregnancy
Development
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2009-04-29
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adolescent mothers and their child that are in the ambulatory of growth and development in the pediatrics center of Braslia University Hospital - HUB

Brief summary: This study intends to observe the epidemiology of pregnancy and growth of adolescent mothers and their child in their first year on the development and growth ambulatory at Brasilia University Hospital (HUB).

The study hypothesis is that adolescent growth is disturbed by a pregnancy in this age. Another hypothesis is that their child's growth and development could be obstructed.


Eligibility criteria: Inclusion Criteria:

* in the HUB ambulatory of growth and development pediatric center

Exclusion Criteria:

* mothers who are more than 19 years old

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Braslia University Hospital
state: Distrito Federal
Study officials:
References:
Clinical trial NCT01018251: Positron Emission Tomography in Monitoring Treatment Response in Women With Newly Diagnosed Breast Cancer
Official title: Monitoring Treatment Response in Women With Breast Cancer Utilizing FLT-PET/CT
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Adult Women With a New Diagnosis of Invasive Breast Cancer (Have Not Undergone Treatment)
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2009-11-23
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will investigate the sensitivity and specificity of FLT-PET/CT in primary breast cancer detection and in the use of FLT-PET in monitoring how well a breast tumor respond to treatment. We will compare this technique with other imaging modalities as well as with tissue collection (during a biopsy). We will recruit women with a newly diagnosed invasive breast cancer, who are able to tolerate undergoing a PET/CT (possibly two scans) scan,

Detailed description: Our overall goal is to use this clinical trial as a platform to validate fibroblast activation protein (FAP) as a biomarker for the tumor microenvironment and to explore the dynamic interaction between proliferating tumor cells and the tumor microenvironment. Our long term goal is to develop new drugs that will target the tumor microenvironment as novel therapeutic and chemoprevention strategies.

Eligibility criteria: Inclusion Criteria:

* Breast biopsy positive for an invasive malignancy (core needle, mammatone, or incisional biopsy)
* Participants must be planning to have surgery at the Hospital of the University of Pennsylvania
* Participants must be able to tolerating lying on the table for about an hour
* Newly diagnosed primary breast cancer, which is classified as being operable (T1-T4)

Exclusion Criteria:

* Pregnant women
* History of severe renal disease
* Prior history of breast cancer of the study breast within the last five years.

Primary outcomes:
measure: Sensitivity and specificity of FLT-PET comparing with standard FDG-PET
measure: Correlate SUV with % Ki67 nuclear stain
Secondary outcomes:
measure: Change in SUV with change in tumor proliferation index (%Ki67 nuclear stain) (when neoadjuvant therapy is used)
measure: Tumor volume pre and post chemotherapy as assessed by clinical exam, breast imaging studies, histopathological examination, and breast cancer outcome parameters (when neoadjuvant therapy is used)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03797651: Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial
Official title: Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease, Acute Coronary Syndrome
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 2850
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We hypothesized that ticagrelor monotherapy might be enough to prevent thromboembolic events without aspirin after PCI in patients with acute coronary syndrome(ACS). Moreover, ticagrelor monotherapy will reduce bleeding risk compared to DAPT with aspirin plus ticagrelor. We will also evaluate 1-year safety and efficacy of Orsiro stent for patient with acute coronary syndrome. After confirmation of enrollment, patients will be randomized to continue standard treatment (aspirin plus ticagrelor) for 1 year or to stop aspirin after discharge or less than 1 month after PCI (ticagrelor monotherapy). Randomization will be stratified according to 1) the presence of diabetes and 2) ST elevation myocardial infarction (MI). Baseline clinical and angiographic characteristics, laboratory findings will be assessed at the time of randomization. All patients will provide informed consent on their own initiative.


Eligibility criteria: Inclusion Criteria:

1. Patients ≥19 years old
2. Patients who received new generation sirolimus-eluting (Orsiro® series) stent implantation for treating ACS, including acute MI and unstable angina
3. Provision of informed consent

Exclusion Criteria:

1. Age\> 80 years
2. Increased risk of bleeding, anemia, thrombocytopenia
3. A need for oral anticoagulation therapy
4. Pregnant women or women with potential childbearing
5. Life expectancy \< 1 year

Primary outcomes:
measure: Net clinical benefit
timeFrame: 1 year after procedure
Secondary outcomes:
measure: Each components of net clinical benefit
timeFrame: 1 year after procedure
measure: Cardiovascular mortality
timeFrame: 1 year after procedure
measure: Major or minor bleeding
timeFrame: 1 year after procedure
measure: Major adverse cardiac event
timeFrame: 1 year after procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine
Study officials:
affiliation: Division of Cardiology, Severance Hospital, Yonsei University College of Medicine
name: Myeong-Ki Hong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03467451: Rétrospective Evaluation of the Performance and the Safety of the Endoscopic Mucosectomy With Anchorage
Official title: Rétrospective Evaluation of the Performance and the Safety of the Endoscopic Mucosectomy With Anchorage of the Tip of the Loop
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polyps of Colon
Lead sponsor: Hôpital Edouard Herriot
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both male and female over 18 years old with other rectal or colic résections from 10 to 30 mm into the past

Brief summary: This safe and simple technique without extra cost would allow us to improve R0 resection ratio and so decrease relapses and the time between two different exams


Eligibility criteria: Inclusion Criteria:

* Age over 18 years old
* Other rectal or colic résections from 10 to 30 mm into the past

Exclusion Criteria:

* Colitis, Crohn Disease or Ulcerative Colitis
* Intense fibrosis under the lesion

Primary outcomes:
measure: Measure the proportion of R0 resections of anchored mucosectomies from 10 to 30 mm colon and rectum lesions
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Edouard Herriot Hospital
name: Mathieu Pioche
role: PRINCIPAL_INVESTIGATOR
References: