louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03692130: Treatment of Depression With Mindfulness, Acceptance and Commitment
Official title: Mindfulness, Acceptance and Commitment Combined in Cognitive Behavioral Group Therapy (MAC-CBT®) for Patients With Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychotherapy
Depression
Keywords: Acceptance
Mindfulness
Commitment
Group-Psychotherapy
Lead sponsor: Neuropsychiatrischen Zentrums Hamburg-Altona
Sponsor class: OTHER
Collaborators: name: Universitätsklinikum Hamburg-Eppendorf
First posted: 2018-10-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group with new treatment, one group with known and defined treatment
Primary purpose: TREATMENT

Brief summary: Randomized trial to proof the effects and efficacy of a new mindfulness and acceptance based group-treatment for depressive patients

Detailed description: In this study, a randomized trial is conducted in which the participants are allocated to two different care services (MAC-CBT® vs. progressive muscle relaxation). Participants are patients with depression who have been made aware of the group therapy by their treating physicians or psychotherapists or who have read the advertising in waiting areas or on the investigators homepage. An extensive psychometric survey will be conducted at the start of the study in an interview session with a psychotherapist, who also judges if the participants are able to participate in a therapy group. The MAC-CBT® group receives an eight-session group therapy, in which the aspects of mindfulness, acceptance and commitment are taught in detail. The control group will receive an eight-session treatment with progressive muscle relaxation. Input and output results are determined using validated survey instruments. In addition, the investigators will check the data for moderating variables (e.g. age, gender, previous treatments...).

Eligibility criteria: Inclusion Criteria:

* Depressive Disorder

Exclusion Criteria:

* Somatic disorder
* psychotic disorder
* personality disorder

Primary outcomes:
measure: Depression - Patient Health Questionnaire-9
timeFrame: Measurement of PHQ-Data 3 months after inclusion of participant
Secondary outcomes:
measure: Quality of Life - European Quality 5 Dimensions on 3 Levels
timeFrame: Measurement of QoL 3 months after inclusion of participant
measure: Anxiety - Generalized Anxiety Disorder
timeFrame: Measurement of Generalized Anxiety 3 months after inclusion of participant
measure: Acceptance and Commitment - Questionnaire of Mindfulness, Acceptance and Commitment (MAC-Q)
timeFrame: Measurement of Mindfulness, Acceptance and Commitment 3 months after inclusion of participant
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Neuropsychiatric Center of Hamburg
Study officials:
affiliation: Managing Director
name: Peter Tonn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01657630: Accu-Chek Combo in Young Patients
Official title: Evaluation of the Use of the Accu-Chek Combo System in Young Patients With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: Insulin Pump Therapy
Type 1 Diabetes
Treatment Satisfaction
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2012-08-06
Enrollment: 13
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young patients with type 1 Diabetes treated at the institute of Endocrinology and Diabetes, Schneider Children's Medical Center, which is a tertiary hospital

Brief summary: This is an open, prospective, descriptive study aiming to evaluate the change in treatment satisfaction of primary care givers of young children who use the Accu-Chek Combo System. Patients will routinely be scheduled and start their therapy with the Accu-Chek Combo System on visit 1. Twelve weeks later the final acquisition of data will occur. Diabetes Treatment Satisfaction Questionnaires (DTSQ) will be completed at baseline and after 12 weeks, a distinct acceptance questionnaires will be completed at final visit. In addition, Diabetes related therapeutic information will be collected and data about the use of the device components will be downloaded from the Accu-Chek Combo System


Eligibility criteria: Inclusion Criteria:

* Diabetes Mellitus type 1
* Continuous Subcutaneous Insulin Infusion(CSII)therapy(for at least 6 months)
* Age below 6 years
* Planned and scheduled change to a Accu-Chek Combo System within the next 3 weeks at least
* Signing on an Inform Consent Form

Exclusion Criteria:

* Patient has been diagnosed with progressive/serious diseases that in judgment of the physician preclude successful completion of the observational period
* primary care giver not skilled enough to comment in a qualitative way

Primary outcomes:
measure: Diabetes Treatment Satisfaction
timeFrame: after 12 weeks
measure: Study device acceptance
timeFrame: after 12 weeks
Secondary outcomes:
measure: Mean Blood Glucose level
timeFrame: after 12 weeks
measure: Number of Hypoglycemia Events
timeFrame: after 12 weeks
measure: Number of Hyperglycemia Events
timeFrame: after 12 weeks
measure: HbA1c
timeFrame: after 12 weeks
measure: postprandial SMBG (self monitoring blood glucose)
timeFrame: after 12 weeks
measure: Overall number of BG (Blood glucose) measurements
timeFrame: after 12 weeks
measure: Number of ketosis events
timeFrame: after 12 weeks
measure: Number of Diabetic Ketoacidosis (DKA) events
timeFrame: after 12 weeks
measure: preprandial SMBG (self monitoring blood glucose)
timeFrame: after 12 weeks
Other outcomes:
Locations:
city: Petah-Tikva
country: Israel
facility: Schneider Children's Medical Center
Study officials:
affiliation: Schneider Children's Medical Center
name: Moshe Phillip, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05402930: Angiomammography and Neoadjuvant Chemotherapy
Official title: Usefulness of Angiomammography for Predicting the Response to Neoadjuvant Chemotherapy in Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasms
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 100
Sex: FEMALE
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 best prognostic factor following neoadjuvant chemotherapy is the pathological complete response (pCR). pCR is defined as the absence of invading cells in the breast and lymph nodes following neoadjuvant chemotherapy treatment. Since patients with pCR have a better prognosis than those without pCR, some studies have evaluated different methods to predict pCR early in treatment. Thus, patients who do not respond optimally to treatment could be identified early and changed treatment in order to maximize the chances of pCR and avoid the morbidity of poorly effective treatments. To do this, several modalities have been proposed, including MRI, mammography, ultrasound, positron emission tomography, elastography, and serial biopsies, but these techniques have shown predictive and sometimes expensive. Nevertheless, assessment of tumor response after cycle 2 has been suggested to be appropriate for the prediction of pCR.

The main objective of this study is to compare the performance of two diagnostic modalities, namely CESM and MRI, in the evaluation of the response of a malignant breast tumor to neoadjuvant chemotherapy and the prediction of pCR. The radiological response will also be compared to the clinical response.


Eligibility criteria: Inclusion Criteria:

* Female aged 18 and over
* Histologically proven breast cancer by large gauge needle
* No evidence of distant metastasis
* Neoadjuvant chemotherapy with or without concomitant targeted therapy
* Breast tumor initially measurable by clinical examination

Exclusion Criteria:

* Refusal to perform the biopsy or surgery
* Pregnant or possibly pregnant woman
* Usual contraindication to contrast product

  * Significant kidney failure
  * Allergy to contrast medium
* frank hyperthyroidism
* Usual contraindications to MRI

Primary outcomes:
measure: Number of patients with a pCR accoreding to angiomammography, based on a 50% reduction in lesion size at angiomammography
timeFrame: Cycle 2 (each cycle being 21 days), i.e., after the chemotherapy on day 1 of cycle 2 and before cycle 3.
Secondary outcomes:
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: St-Sacrement Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT04149730: Adrenaline During Resuscitation From Pulseless Electrical Activity
Official title: Adrenaline During Resuscitation From Pulseless Electrical Activity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Arrest
Keywords: Epinephrine
Pulseless electrical activity
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: University of Pennsylvania
First posted: 2019-11-04
Enrollment: 280
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: The population will consist of patients suffering cardiac arrest while being hospitalized at St. Olavs hospital.

Brief summary: This is a prospective observational study at St. Olavs hospital in Norway. Data are gathered from defibrillators that have been in use during resuscitation from cardiac arrest. Aim is to investigate the changes in electrocardiograms (ECG) during resuscitation from pulseless electrical activity (PEA), which is a type of cardiac arrest. ECG changes may be useful as a prognostic marker during resuscitation from PEA. In addition the researchers will describe the effect of adrenaline and chest compressions on clinical state transitions during resuscitation from pulseless electrical activity. Clinical state transitions are changes between different types of cardiac arrest. This study is expected to increase our understanding of the dynamics during treatment of cardiac arrest.


Eligibility criteria: Inclusion Criteria: Cardiac arrest among hospitalized patients presenting with PEA as the primary rhythm.

Primary outcomes:
measure: QRS frequency
timeFrame: Every 3 minutes from start till end of cardiopulmonary resuscitation
measure: QRS width
timeFrame: Every 3 minutes from start till end of cardiopulmonary resuscitation
measure: Changes of clinical states
timeFrame: Every 3 minutes from start till end of cardiopulmonary resuscitation
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Eirik Skogvoll, md prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT02133430: Optimized Anesthesia to Reduce Incidence of Postoperative Delirium
Official title: Optimized Anesthesia to Reduce Incidence of Postoperative Delirium in Elderly Undergoing Elective, Non-cardiac Surgery: a Randomized Controlled Trial (POD-II)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Postoperative Delirium
Keywords: Postoperative delirium
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
Collaborators: name: National Research Council of Thailand
First posted: 2014-05-08
Enrollment: 140
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the difference of incidence of postoperative delirium between patients received general anesthesia guided by Bispectral index (BIS) and patients received general anesthesia using standard technique.

Detailed description: General anesthesia is one of precipitating factor of postoperative delirium which Its mechanism is still unknown. General anesthesia can affect on pattern of electroencephalograph. Previous studies showed that patients received BIS guided anesthesia could wake up faster, earlier extubation and stay in recovery room shorter compared to standard general anesthesia. Optimized level of anesthesia by BIS could reduce cognitive dysfunction in elderly patients and reduce biological marker of brain injury. Therefore, the investigators hypothesized that adjustment of general anesthesia by BIS guided could protect central nervous system and reduce incidence of postoperative delirium.

Eligibility criteria: Inclusion Criteria:

* Patients age equal or more than 65 years.
* Patients undergoing general anesthesia.
* Patients undergoing scheduled, non-cardiac surgery

Exclusion Criteria:

* Patients undergoing neurosurgery.
* Patients cannot understand Thai language.
* Patients who have severe visual or hearing impairment.

Primary outcomes:
measure: Number of patients have postoperative delirium
timeFrame: Participants will be followed during the duration of hospital stay, an expected avarage of two weeks.
Secondary outcomes:
measure: Number of patients with impaired cognitive function
timeFrame: Up to 6 months
measure: Time to recovery
timeFrame: The end of surgery
Other outcomes:
Locations:
city: Maung
country: Thailand
facility: Department of Anesthesiology, Faculty of Medicine, Chiang Mai University
state: Chiang Mai
Study officials:
affiliation: Department of Anesthesiology, Faculty ofMedicine, Chiang Mai, University, Chiang Mai, Thailand
name: Dr. Yodying Punjasawadwong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand,50200
name: Dr. Tanyong Pipanmekaporn, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03662230: Incidence and Severity of Acute Respiratory Distress Syndrome (ARDS) in the French Wounded Soldiers
Official title: Incidence and Severity of Acute Respiratory Distress Syndrome (ARDS) in the French Wounded Soldiers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Keywords: war wounds
intensive care unit
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient evacuated from the theatre of outside operation and hospitalized in intensive care unit in France between 2001 et 2017

Brief summary: The purpose of this study is to evaluate the incidence of the ARDS in the French wounded soldiers.

Detailed description: The Acute Respiratory Distress Syndrome (ARDS) complicates war wounds. Among the repatriated wounded persons, it can appear in the first 7 days.

It has been well described among American soldiers and it is known that it's serious, frequent and multifactorial.

However, not a single study has described the frequency and the severity of the ARDS in French wounded soldiers.

Thus the purpose of this study is to estimate the incidence and severity of the ARDS among the French wounded soldiers, admitted in continuing care and intensive care unit between 2001 and 2017.

The analysis of this data collection will let us improve the medical care of the ARDS in Outside Operation.

Eligibility criteria: Inclusion Criteria:

* Patient evacuated from the theatre of outside operation and hospitalized in intensive care unit in France between 2001 et 2017

Exclusion Criteria:

* Opposition to the use of personal data

Primary outcomes:
measure: Incidence of ARDS
timeFrame: Day 7
Secondary outcomes:
measure: Assess the severity of ARDS
timeFrame: 7 days
measure: Description of the severity of ARDS
timeFrame: 7 days
measure: Mortality
timeFrame: Day 90
measure: Assessment of the severity of ARDS
timeFrame: 7 days
Other outcomes:
Locations:
city: Toulon
country: France
facility: Hôpital d'Instruction des Armées Sainte Anne
state: Var
Study officials:
affiliation: Hopital d'Instruction des Armées Sainte Anne
name: Julien Bordes, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01530230: ST- Depression on Electrocardiogram During Caesarean Section in Regional Anaesthesia in Women With Preeclampsia
Official title: Randomised Study on Cardiac Effects of Oxytocin During Caesarean Section in Preeclamptic Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preeclampsia
Keywords: cesarean section
electrocardiography
heart
hypotension
ischemia
oxytocin
preeclampsia
regional anesthesia
ECG changes suggestive of myocardial ischemia
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2012-02-09
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The investigators examined whether there was a difference in the occurrence of ST depressions after injection of five or ten units of oxytocin, in preeclamptic patients delivered by caesarean section (CS) under regional anesthesia.

Detailed description: ST depression on electrocardiograms has been reported in healthy women undergoing cesarean section in regional anesthesia. The investigators examined whether there was a difference in the occurrence of electrocardiogram changes suggestive of myocardial ischemia (ST depressions) in preeclamptic patients randomized to five or ten units of oxytocin during cesarean section with regional anesthesia.

In a double-blind randomized controlled study preeclamptic patients undergoing cesarean section under spinal anesthesia were randomized to 5 or 10 units of oxytocin, given as an intravenous bolus. A Holter monitor was used to record electrocardiograms. Non-invasive blood pressure and heart rate were monitored.

Eligibility criteria: Inclusion Criteria:

* women with preeclampsia undergoing CS under spinal anesthesia. Preeclampsia was diagnosed if blood pressure was ≥ 140/90 mm Hg and if proteinuria of more than 1000 mg/day persisted.

Exclusion Criteria:

* multiple birth,
* obesity (body mass index \> 35),
* age \< 18 years,
* complications of the pregnancy other than preeclampsia or non-proficiency in the Swedish language

Primary outcomes:
measure: Depression of the ST segment on electrocardiograms
timeFrame: From start of caesarean section until 20 minutes after delivery
Secondary outcomes:
measure: Mean arterial pressure and heart rate.
timeFrame: From start of caesarean section until 20 minutes after delivery
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Department of Obsterics and Gynecology
Study officials:
References:
Clinical trial NCT01701830: Serum Omentin-1 and Carotid Atherosclerosis In Non-Diabetic Chronic Kidney Disease
Official title: The Relationship Between Serum Omentin-1 and IL-6 and Carotid Atherosclerosis In Non-Diabetic Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-diabetic Chronic Kidney Disease
Atherosclerosis
Keywords: omentin-1
carotid atherosclerosis
kidney disease
Lead sponsor: Kocaeli Derince Education and Research Hospital
Sponsor class: OTHER
First posted: 2012-10-05
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Department of Nephrology, Check-up clinic

Brief summary: The aim of the study is to evaluate whether a low level of serum omentin-1 is associated with carotid atherosclerosis and mediated by inflammation.

Detailed description: Atherosclerotic cardiovascular disease is markedly increased in chronic kidney disease. There are a lot of risk factor, along with conventional risk factors. Serum onemtin-1 is a adipokine and suggested as a new marker for vascular disease.It has some anti-atherogenic properties. Studies investigating serum omentin-1 level have usually conducted in patients with diabetes mellitus.

Eligibility criteria: Inclusion Criteria:

* between ages of 18 - 65 years old chronic kidney disease of stage 3-4

Exclusion Criteria:

* Chronic kidney disease of stage 5
* The history of ischemic cardiovascular disease (myocardial infarction, unstable angina, stroke, peripheral artery disease, or cardiovascular revascularization)
* Severe heart failure
* Stage 2 hypertension
* Diabetes mellitus
* Corticosteroid therapy
* Severe hepatic disease
* Smoking
* Inflammatory disease
* Acute infectious disease
* Malignancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Izmit
country: Turkey
facility: Department of Nephrology, Check-up Clinic,Kocaeli Derince Education and Traning Hospital
state: Kocaeli
Study officials:
affiliation: Kocaeli Derince Education and Training Hospital
name: Erkan SENGUL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03725930: Premedication by Clonidine Intranasal in Pediatric Surgery
Official title: Premedication by Clonidine Intranasal in Pediatric Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Child Preschool
Keywords: paediatric
premedication
clonidine
intranasal
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are few studies using intra nasal way to dispense premedication in pediatrics.

This study will evaluate anxiolysis effect of Intranasal premedication with Clonidine vs Placebo.

Two groups, randomized,

Total of 150 patients (75 in each group) :

Involvement in study for one patient : 7 days Duration of study including inclusion and data analysis : 18 months (inclusion 12 months; data analysis 6 months)


Eligibility criteria: Inclusion Criteria:

1. Child from 1 to 5 years
2. Weight between 10 to 25 kgs
3. Scheduled minor surgery
4. Oral and written information and consent given by main investigator to both of the parents or legal(s) representative(s).
5. ASA score 1 or 2
6. Patient with social care insurance

Exclusion Criteria:

1. Refusal of one of the parental authority or legal representing
2. Concomitant participation to a clinical trial with use of a drug
3. Known hypersensitivity or contraindication to Clonidine or one of its excipients
4. Airway infection within 3 weeks before inclusion
5. Intravenous induction of anesthesia
6. Antecedent of arrhythmia or congenital heart disease
7. Mental disorder or current psychoactive medication

Primary outcomes:
measure: Anxiolysis score
timeFrame: at 30 minutes after premedication
Secondary outcomes:
measure: Acceptation of mask at the induction of anesthesia
timeFrame: 1 hour after premedication
measure: Agitation score after the extubation
timeFrame: 15 min after extubation
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU Lille
state: Nord
Study officials:
affiliation: University Hospital, Lille
name: Dina BERT, MD
role: PRINCIPAL_INVESTIGATOR
References: