louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00763789: Local Anaesthesia and Remifentanil Sedation Versus Total Intravenous Anaesthesia for Hysteroscopic Surgery in an Ambulatory Surgery Department.
Official title: Local Anaesthesia and Remifentanil Sedation Versus Total Intravenous Anaesthesia for Hysteroscopic Surgery in an Ambulatory Surgery Department. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Conscious Sedation
Remifentanil
Hysteroscopic Surgery
Anesthesia Recovery Period
Ambulatory Surgery
Keywords: conscious sedation
remifentanil
hysteroscopic surgery
anesthesia recovery period
ambulatory surgery
patient satisfaction
length of stay
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2008-10-01
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare a new method: the combination of conscious sedation with remifentanil (a shortlasting opioid drug) and local anaesthesia, with the traditional general anaesthesia for hysteroscopic surgery. The primary outcomes are: the time spent in the operation room, the time to full mobilisation postoperatively and the time to complete recovery postoperatively and the time to discharge. Secondary outcome: patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years,
* ASA classification I-II
* Speaks and writes danish
* Signed informed consent

Exclusion Criteria:

* ASA classification III-VI
* Emotional disorder - medically treated within a week before surgery
* Patients in risk of perioperative aspiration - who must be intubated
* BMI \> 35
* Patients who have been using pain medicine within a week before surgery (except PCM and NSAID)
* Patients who have been using sleeping medicine or sedatives within a week before surgery

Primary outcomes:
measure: the total time spent in the operating room
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital Herlev
Study officials:
References:
Clinical trial NCT02141789: Outpatient Psychotherapeutic Treatment for Alcohol Dependent Individuals With Comorbid Psychiatric Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Dependence
Lead sponsor: University of Konstanz
Sponsor class: OTHER
First posted: 2014-05-19
Enrollment: 30
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: Research has shown that alcohol dependence often co-occurs with comorbid anxiety disorders and/or depression. Anxiety and depression influence the course and treatment of alcohol dependence and are a major risk factor for alcohol relapse within the first three months after detoxification. Therefore, there is need for combined treatment (integrated therapy) of alcohol dependence and comorbid psychiatric disorders, e.g. anxiety and/or depression. Until today, there are no systematic outpatient treatment offers for this special group of patients in Germany. In this study we want to investigate if integrated outpatient cognitive behavioral therapy can prevent and decrease alcohol relapse within the first three months after detoxification. Therefore we hypothesize that immediate start of integrated outpatient psychotherapy will reduce relapse variables compared to treatment as usual which is characterized by non-immediate start of therapy due to the required application for insurance coverage.


Eligibility criteria: Inclusion Criteria:

* alcohol dependence
* comorbid anxiety or mood disorder

Exclusion Criteria:

* severe mental illness: psychosis, mania, personality disorders
* current suicidality
* non-compliance with appointments during first 5 sessions

Primary outcomes:
measure: Relapse
timeFrame: 3 months
measure: Days with heavy alcohol drinking
timeFrame: 3 months
Secondary outcomes:
measure: Comorbid psychiatric symptoms
timeFrame: 3 months
Other outcomes:
Locations:
city: Konstanz
country: Germany
facility: University of Konstanz, Outpatient Clinic for Psychotherapy
Study officials:
affiliation: University of Konstanz
name: Michael Odenwald, Dr. rer. nat.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schawohl A, Adam M, Odenwald M. What's Next After Withdrawal Treatment? A Randomized Controlled Pilot Study on Integrated Outpatient Psychotherapy in Alcohol-Dependent Patients With Dual Diagnoses. Zeitschrift für Klinische Psychologie und Psychotherapie. 2018; 47(3): 153-162. doi: 10.1026/1616-3443/a000487
Clinical trial NCT03309189: Swiss Childhood Health and Nutrition Survey
Official title: National Studie Gesundheit Und Ernährung Von Primarschülern
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight and Obesity in Schoolchildren
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2017-10-13
Enrollment: 2292
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All children at the selected schools and in the defined age range are eligible.

Brief summary: The aim of the present study is to assess the prevalence of overweight and obesity in 6 to 12 year old children in Switzerland. This data will be used to investigate trends in the development of overweight and obesity in Switzerland. In addition, a questionnaire will be used to assess data on physical activity, nutrition, health and socioeconomic background and waist circumference as well as skin fold thicknesses will be measured.


Eligibility criteria: Inclusion Criteria:

* age between 6 and 12 years

Exclusion Criteria:

* none

Primary outcomes:
measure: Prevalence of overweight and obesity
timeFrame: 1 day of first visit
Secondary outcomes:
measure: Waist circumference
timeFrame: 1 day of first visit
measure: body fat %
timeFrame: 1 day of first visit
measure: Physical activity
timeFrame: 1 day of first visit
measure: Nutrition
timeFrame: 1 day of first visit
measure: General health
timeFrame: 1 day of first visit
measure: Socioeconomic background
timeFrame: 1 day of first visit
Other outcomes:
measure: Age
timeFrame: 1 day of first visit
measure: Gender
timeFrame: 1 day of first visit
Locations:
city: Zürich
country: Switzerland
facility: ETH Zurich
Study officials:
affiliation: ETH Zurich
name: Isabelle Herter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00804089: Traditional Acupuncture and Myofascial Trigger Point Dry Needling and Acupressure for Chronic Low Back Pain
Official title: Randomised Comparative Pragmatic Clinical Trial of Traditional Acupuncture and Superficial Dry Needling and Acupressure of Myofascial Trigger Points for the Treatment of Patients With Chronic Mechanical Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain, Chronic
Acupuncture
Dry Needling
Acupressure
Acupuncture Points
Trigger Points, Myofascial
Lead sponsor: Hermano Miguel Foundation
Sponsor class: OTHER
Collaborators: name: Ecuadorian Federation of Physiotherapy, Tungurahua Branch
name: Technical University of Ambato
First posted: 2008-12-08
Enrollment: 90
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 purpose of this study is to compare the therapeutic effects of acupuncture using traditional acupoints and Ashi points with myofascial trigger points superficial dry needling and acupressure, followed by postisometric stretching of the appropriate muscles, in the treatment of patients with chronic mechanical low back pain.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of mechanical lower back pain for at least three months.
* The chronic mechanical lower back pain is the chief complaint, with or without leg pain.
* The lower back pain is disabling to the degree that affects the patient's routine job and/or his or her lifestyle.

Exclusion Criteria:

* Patients with tumor, infection, major trauma to the spine causing fracture or disruption of the major ligaments, or cauda equina syndrome.
* Patients with neurological signs of spinal nerve compression.
* Patients having undergone spinal surgery, facet joint block and/or corticoid injection.
* Patients with general contraindications for acupuncture or acupressure treatment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ibarra
country: Ecuador
facility: Social Security Hospital
state: Imbabura
city: Ambato
country: Ecuador
facility: Social Security Hospital
state: Tungurahua
Study officials:
affiliation: Hermano Miguel Foundation
name: Sergiy Voznesenskyy, Ph.D. B.P.T.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01499589: Can the Usage of Regional Block Room Save the Time of Anesthesia Team
Official title: Can the Usage of Regional Block Room Save the Time of Anesthesia Team in the Main Orthopedic Operating Room?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Time
Keywords: anesthesia-controlled time
turnover time
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-12-26
Enrollment: 800
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: elective orthopedic surgical patients that require for anesthesia

Brief summary: Study of time usage of anesthesia team inside the main operating room compares between 2 groups of

* Performing regional anesthesia inside the operating room
* Performing regional anesthesia in the block room

Study purpose: How much will the investigators save time in the main operating room if we perform the regional anesthesia in the block room?

Detailed description: Anesthesia-controlled time means anesthesia pre-procedure time plus anesthesia post-procedure time.

We also compares the anesthesia-controlled time in 3 groups of

* general anesthesia
* regional anesthesia
* general anesthesia combined with regional anesthesia

Eligibility criteria: Inclusion Criteria:

* elective orthopedic surgical patients that require for anesthesia ( start 9AM-4PM)

Exclusion Criteria:

* surgery under local infiltration

Primary outcomes:
measure: anesthesia-controlled time
timeFrame: 3 months
Secondary outcomes:
measure: turnover time
timeFrame: 3 months
measure: number of elective cases after 4PM
timeFrame: 3 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Suwimon Tangwiwat, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01573689: Bereaving, But Not Alone : the Development and Actualization of a Mutual Aid Group for Children Who Have Lost a Parent.
Official title: Bereaving, But Not Alone : the Development and Actualization of a Mutual Aid Group for Children Who Have Lost a Parent.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mourning,
Grief,
Bereavement.
Keywords: bereaved children, mutual aid group, death, group intervention.
Lead sponsor: Université de Montréal
Sponsor class: OTHER
First posted: 2012-04-09
Enrollment: 4
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The methodology of this clinical trial is based on the realisation of a group intervention with children who lost a parent. Interviews preintervention and postintervention with participants will be done as well. The purpose of this study is to answer the following question: "What are the benefits for children who are in the process of bereaving a parent to participate in a group work intervention based on the mutual aid model ?". The aim of the research is to explore the benefits for grieving children to participate in an group work intervention based on the mutual aid model. To do so, the research has three distinct objectives : 1) to develop and apply a program of group work interventions for grieving children based on the mutual aid model ; 2) to explore the extent to which participation in the group facilitates changes in the children's discourse about death and the loss of their parents, and 3) to examine, from the children's own perceptive, the possible impact that their participation in the group have on their experience of bereavement.


Eligibility criteria: Inclusion Criteria:

* Children between 8 and 12 years old.
* Children who had lost a parent within 3 months and two years before the beginning of the group intervention.

Exclusion Criteria:

* Children who experimented death of his parent by suicide.

Primary outcomes:
measure: Mutual aid group intervention
timeFrame: 8 weeks
Secondary outcomes:
measure: Interview before the group intervention
timeFrame: one of 60 minutes
measure: Interview after the group intervention
timeFrame: One of 60 minutes
Other outcomes:
Locations:
city: Laval
country: Canada
facility: Lumi-Vie
state: Quebec
Study officials:
References:
Clinical trial NCT02119689: Vascular Reparative Mechanism in Diabetes
Official title: Vascular Reparative Mechanism by ACE2/Ang-(1-7) in Diabetes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetic Retinopathy
Keywords: Diabetes
Retinopathy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2014-04-22
Enrollment: 78
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: Ophthalmology and Primary Care Clinics

Brief summary: The purpose of this research study is to study blood stem cells in diabetic patients and normal patients. We would like to better understand if these cells, called endothelial precursor cells (EPCs), are not working as expected in people with diabetes. We would like to see if the function of these cells can predict the development of diabetic retinopathy.

Diabetic retinopathy is an eye disease associated with diabetes in which the cells of the retina are damaged. It can cause blurred vision, vision loss, blindness or possible bleeding in the retina. Even with current treatments, the quality of life for people with diabetic retinopathy is much reduced.


Eligibility criteria: Inclusion Criteria:

* Men or women 18 years or older
* 39 type 1 or type 2 diabetic patients
* 13 with mild retinopathy
* 13 with moderate retinopathy
* 13 with severe, nonproliferative retinopathy
* 39 age and sex matched healthy controls

Exclusion Criteria:

* Current pregnancy as evidence by a urine pregnancy test as the blood from a pregnant female will influence the results of the laboratory tests

Primary outcomes:
measure: The ACE/ACE2 ratio within EPC's
timeFrame: up to 216 weeks
Secondary outcomes:
measure: The balance of the RAS (renin-angiotensin system) within EPCs
timeFrame: up to 216 weeks
Other outcomes:
measure: Photography findings
timeFrame: up to 216 weeks
measure: Fluorescein angiogram findings
timeFrame: up to 216 weeks
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Maria B Grant, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03531489: Study of Ambulatory Respiratory Assist Device in Chronic Obstructive Pulmonary Disease Patients
Official title: Pilot, Single Center Study of Ambulatory Respiratory Assist Device in Chronic Obstructive Pulmonary Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Chronic Obstructive Pulmonary Disease
Lead sponsor: Right-Air
Sponsor class: INDUSTRY
Collaborators: name: University of Pennsylvania
First posted: 2018-05-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is a two-part small scale, open-label, pilot study to evaluate feasibility and proof-of-concept for a respiratory assist medical device. The study population will consist of severe Chronic Obstructive Pulmonary Disease (COPD) subjects.


Eligibility criteria: Inclusion Criteria:

1. Moderate to severe COPD (by ATS criteria)

1. FEV1/FVC \<0.70
2. FEV1 \< 60% Predicted

Exclusion Criteria:

1. Physical limitation that prevents walking for 6 minutes (e.g. lower extremity amputation, arthritis limiting function, significant angina, etc...)
2. Lung pathology not explained by COPD, which may limit functional capacity (e.g. pulmonary fibrosis, malignancy, history of lung reduction surgery, etc...)
3. Pregnancy
4. Age \<18

Primary outcomes:
measure: Assess distance travelled during 6-minute walk tests performed with and without device.
timeFrame: 6 months
Secondary outcomes:
measure: Assess for patient improvement in shortness of breath scores
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: John Hansen-Flaschen
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: John Hansen-Flaschen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01571440: Soluble Corn Fiber and Calcium Utilization in Adolescents
Official title: The Effect of Soluble Corn Fiber on Calcium Utilization and Retention and Gut Microflora in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: Bone
adolescents
fiber
healthy
boys
girls
camp
calcium
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Tate and Lyle Ingredients Americas LLC
First posted: 2012-04-05
Enrollment: 24
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to determine the effect of soluble corn fiber on calcium absorption and retention and gut microflora in adolescent boys and girls.

Detailed description: In a previous study, soluble corn fiber (SCF) was found to greatly enhance calcium utilization and bone properties in a growing rat model. Because factors that enhance bone density and mineral content can potentially result in a skeleton that will resist fracture later in life, it is important to investigate this potential in adolescents. Therefore, the objective of this study was to determine the effect of SCF on calcium absorption and retention in adolescent boys and girls. A second objective of this study was to assess whether additional dietary fiber leads to changes in gut microflora which may influence calcium absorption. During this two-phase metabolic camp participants consumed packages of fruit snacks supplemented with either 0 or 6 grams of soluble corn fiber twice a day during the first phase of the study, and switch to the opposite treatment during the second phase, with a 2-week washout period in between. Subjects collected all excreta during both phases and calcium absorption, gut microbiota, height, weight, and bone density were evaluated throughout the 6-week period of the study.

Eligibility criteria: Inclusion Criteria:

* Normal, healthy, white adolescents (Hispanic or non-Hispanic)
* Boys age 13-15
* Girls age 12-14

Exclusion Criteria:

* Abnormal kidney or liver function
* Malabsorptive disorders
* Anemia
* Smoking
* History of medications that affect calcium metabolism
* Body weight outside 5-95 percentile body mass index (BMI) for age
* Regular consumption of illegal drugs
* Contraceptive use
* Pregnancy

Primary outcomes:
measure: Calcium absorption and retention
timeFrame: up to three weeks
measure: Gut microbial profile
timeFrame: up to three weeks
Secondary outcomes:
measure: Bone mineral content and density
timeFrame: up to three weeks
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Berdine Martin, PhD
role: STUDY_DIRECTOR
affiliation: Purdue University
name: Connie Weaver, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00383344: Use of FDG PET/CT to Evaluate Crohn Disease
Official title: Phase II Study on the Role of the Positron Emission Tomography Combined With CT Scan for the Evaluation on Crohn Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn Disease
Keywords: Crohn Disease
Positron Emission Tomography
Colonoscopy
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2006-10-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study will permit to determine the role of FDG PET/CT to diagnose Crohn Disease and recurrence of Crohn disease after having compared results of PET/CT's with results of exams routinely performed(colonoscopy and bowel follow through).

Detailed description: Crohn disease is an inflammatory disease of the digestive system that may affect the small and large intestines. Remission and recurrence clinically characterized its development. When recurrence occurs, a careful examination is necessary in order to determine the extent and the severity of the disease. Actual exams performed are invasive and uncomfortable(colonoscopy and bowel follow through). Compare to these exams, PET/CT is less fierce to undergo and has less risks. Two groups are proposed in this project: 15 patients will be enroll in the active disease group and 15 patients will be enroll in the remission group. In regards of the area and the extent of the disease,PET/CT exams shall provide similar information than what usual tests provide. PET/CT exams shall also provide more information in order to better differentiate inflammatory stenosis from scars stenosis especially located in the small intestine.

Eligibility criteria: Inclusion Criteria:

* Men or women known having a Crohn's disease de novo diagnosis or a Crohn's disease recurrence based on a seven days questionnaire and a physical exam.
* Men or women with a past history of Crohn's disease but considered clinically in remission based on a seven days questionnaire, a physical exam and a Crohn's disease activity index (CDAI) score \< to 150.

Exclusion Criteria:

* Men or women less than 18 years of age
* Pregnancy
* Breastfeeding
* Renal failure
* Suspicion of a Crohn's disease infectious complication (abscess,fistula)
* Infectious colitis determined at the initial checkup
* Diabetes
* Severe allergy to iode contrast

Primary outcomes:
measure: Diagnosis of Crohn Disease de novo and Crohn Disease recurrences with FDG PET/CT.
Secondary outcomes:
measure: Detection of inflammatory areas not suspected with usual tests
measure: Detection of an inflammatory activity for remission patients
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: CHUS/CRC
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: François Bénard, MD
role: PRINCIPAL_INVESTIGATOR
References: