louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03005223: Drug-Drug Interaction Study Between DWC20155 / DWC20156 and DWC20163 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2016-12-29
Enrollment: 52
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open label, crossover study to explore drug-drug interactions between DWC20155 / DWC20156 and DWC20163 in Healthy Volunteers


Eligibility criteria: Inclusion Criteria:

* Accepts healthy volunteers

Exclusion Criteria:

* Who has allergy to investigational product

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: 0 ~ 24 hours
measure: Area under the time versus plasma concentration curve (AUC)
timeFrame: 0 ~ 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01810523: Stories to Educate Patients With Ankle, Foot, and Knee Injuries
Official title: Comparative Effectiveness of Descriptive Versus Narrative Emergency Department Discharge Instructions for Patient Education on Unnecessary Testing for Ankle, Foot and Knee Injuries
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Injury
Keywords: Acute
lower
extremity
not requiring
diagnostic
imaging
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Study will test the use of narratives on patient satisfaction and translation of an evidence-based approach to the use of X-rays for leg injuries in the Emergency Department (ED). The investigators will identify patients with foot, ankle, or knee injuries for whom X-rays are determined to not be needed. On discharge, patients will receive the current fact-based sheet or that plus a narrative explaining the work-up and treatment of these injuries. Outcomes will be assessed by a survey measuring patient satisfaction and understanding.


Eligibility criteria: Inclusion Criteria:

* Acute traumatic knee, ankle or foot injury presenting to ED
* No indication for X-ray by Ottawa Rules criteria
* ED provider planning to discharge patient

Exclusion Criteria:

* X-ray obtained
* Need for X-ray by established Ottawa Rules criteria
* Children
* Pregnant women
* Patient to be admitted to the hospital
* Patient non-English speaking or illiterate

Primary outcomes:
measure: Patient Satisfaction
timeFrame: 5 minutes after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04846023: Pediatric Delirium Screening in the PICU Via EEG
Official title: Pediatric Delirium Screening in the PICU Via EEG
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delirium
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 220
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single center prospective interventional study of children admitted to a PICU
Primary purpose: DIAGNOSTIC

Brief summary: Delirium in the pediatric intensive care unit (PICU) is a serious problem that has recently attracted much attention. This study will evaluate the use of electroencephalogram (EEG) for delirium screening in the PICU.

Detailed description: Primary objective: In a prospective cohort of children hospitalized in a PICU, EEG features associated with pediatric delirium (via VEEGix) will be identified and the diagnostic value to accurately detect delirium of these features will be calculated.

Secondary objective: To investigate the accuracy and rapidity of delirium diagnosis with the VEEGix.

Eligibility criteria: Inclusion Criteria:

Eligible for inclusion children 1) \<18 years; and 2) admitted to the PICU at the Centre Hospitalier Universitaire Ste-Justine (CHUSJ). To select patients at high risk for delirium, one of the following inclusion criteria will be needed: 3) mechanically ventilated patients; or 4) non-invasively ventilated patients (BiPap, Cpap or high flow nasal cannula); or 5) patients receiving opioids; or 6) patients receiving benzodiazepines.

Exclusion Criteria:

Children 1) suspected of being brain death at the time of PICU entry (Glasgow Coma Scale (GCS) 3 and loss of all brain stem reflexes); 2) with significant clinical developmental delay (based on clinical assessment and/or parental report of developmental problems that affected the child's behavior or ability to communicate; Pediatric Cerebral Performance Category ≥4); 3) planned discharge from the PICU the same or next day.

Primary outcomes:
measure: In a prospective cohort of children hospitalized in a PICU, the EEG features associated with pediatric delirium (via VEEGix) willl be identified.
timeFrame: 1 year recruitment
Secondary outcomes:
measure: To investigate the accuracy and rapidity of delirium diagnosis with the VEEGix.
timeFrame: 1 year recruitment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01152723: Pharmacokinetics With Two New Oral Nicotine Replacement Products and Nicorette® Gum
Official title: Single-dose Pharmacokinetics With Two New Oral Nicotine Replacement Products and Nicorette® Gum. A Study in Healthy Smokers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Keywords: Smoking Cessation, Nicotine pharmacokinetics
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2010-06-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Single-dose pharmacokinetics with two new oral nicotine replacement products and Nicorette® gum.

Detailed description: The study is a single-dose, randomized, cross-over study. The investigational products will be given as single doses at separate visits. The product administrations comprise 30 minutes of chewing. Periods without NRT, lasting for at least 36 hours, will separate treatment visits. Before and after the start of product administration at each treatment visit, blood will be sampled for pharmacokinetic analyses, pre-dose, and during 8 hours after start of product administration. Used gums will be collected and analyzed to determine the amount of remaining nicotine. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects and study personnel.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.

Primary outcomes:
measure: Pharmacokinetic measurements
timeFrame: Baseline and during 8 hours after product administration
Secondary outcomes:
measure: tmax
timeFrame: During 8 hours after start of product administration
measure: Lamda z
timeFrame: During 8 hours after start of product administration
measure: Released amount of nicotine
timeFrame: After 30 minutes of chewing
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: McNeil AB Clinical Pharmacology R&D
Study officials:
affiliation: McNeil AB
name: Elisabeth Kruse, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04969523: Effect of Es-ketamine on Postoperative Delirium Among Old Patients With Lobectomy
Official title: Effect of Es-ketamine on Postoperative Delirium Among Old Patients With Lobectomy: a Multicentre, Double-blind, Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Delirium
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 500
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is the efficiency of es-ketamine on postoperative delirium among old patients with elective lobectomy

Detailed description: This study aimed to investigate the effect of IV es-ketamine vs saline on the incidence of postoperative delirium. It was hypothesized that IV es-ketamine would reduce the incidence of in-hospital delirium during cardiac surgery lobectomy

Eligibility criteria: Inclusion Criteria:

* 60 years old; There is no limit on the gender, ASA (American Society of Anesthesiologists )Ⅰ-Ⅲ

Exclusion Criteria:

* Emergency surgery, severe hepatic and renal dysfunction, shock or coma, psychiatric disease or central nervous system disorder or a history of long-term use of psychiatric medications, cognitive dysfunction, severe arrhythmia or bradycardia, ketamine allergy,drug abuse history and used other sedatives for nearly a week

Primary outcomes:
measure: Postoperative Delirium
timeFrame: 7 days after operation
measure: Postoperative Cognitive Assessment
timeFrame: 7 days after operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05652023: Noninvasive Ultrasound Assessment of Detrusor Dysfunction
Official title: Noninvasive Ultrasound Assessment of Detrusor Dysfunction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Dysfunction
Overactive Bladder
BPH With Urinary Obstruction
Keywords: Detrusor Pressure
Bladder Compliance
Ultrasound
Ultrasound Vibrometery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 2023
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Aim 1:Cohort: Adults (male and female) with non-neurogenic lower urinary tract symptoms from one of the following conditions/symptoms: overactive bladder, benign prostatic hyperplasia, urinary frequency, incomplete bladder emptying, decreased force of urinary stream. N=200 Aim2:Cohort: Male adults with non-neurogenic lower urinary tract symptoms secondary to benign prostatic

Brief summary: The purpose of this study is to test a new ultrasound method called Quantitative Ultrasound Bladder Vibrometry to detect abnormal bladder function.

Detailed description: The purpose of this study is to evaluate the effectiveness of quantitative ultrasound bladder vibrometry (QUBV) as a noninvasive tool for detrusor overactivity assessment and for benign prostatic hyperplasia (BPH) treatment selection. Participants in this study will have a QUBV ultrasound performed at the same time as a urodynamic study that had been ordered as part of their regular clinical care.

Eligibility criteria: Inclusion Criteria:

* Aim1:

Age \>18 scheduled to undergo UDS for their clinical care for one of the included diagnoses.

-Aim2: Inclusions: Age \>45 scheduled to undergo selective photovaporization of the prostate.

Exclusion Criteria:

* Aim1:Obesity (BMI \>35kg/m2), known neurologic disease impacting bladder function (e.g. spinal cord injury, multiple sclerosis, Parkinson's, prior cerebrovascular accident), previous pelvic radiation therapy, previous radical pelvic surgery (such as for uterine or colorectal cancer), prior bladder surgery (including prostate resection), and pregnant or breast-feeding women.
* Aim2:Obesity (BMI \>35kg/m2), known neurologic disease impacting bladder function (e.g. spinal cord injury, multiple sclerosis, Parkinson's, prior cerebrovascular accident), previous pelvic radiation therapy, previous radical pelvic surgery (such as colorectal cancer).

Primary outcomes:
measure: Accuracy of quantitative ultrasound vibrometry for measuring detrusor pressure
timeFrame: time Frame: Up to study completion, an average of 1 year
Secondary outcomes:
measure: Accuracy of quantitative ultrasound vibrometry for selecting BPH patients for de-obstructive surgery
timeFrame: time Frame: Up to study completion, an average of 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Azra Alizad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03295123: Outcome of Children Born After Pregnancy Denial
Official title: Outcome Children Born After Pregnancy Denial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Development
Denial (Psychology)
Disease
Personality Development
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 41
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every children born at term after denial of pregnancy

Brief summary: The objective of this study is to evaluate the impact of denial pregnancy on children's health ( anthropometric data, psychomotor development , disease) at different age of evaluation ( at birth, 9 months, 24 months and between 2 and 6 years post natal age).

The hypothesis is the denial of pregnancy may have repercussions on children's outcome.


Eligibility criteria: Inclusion Criteria:

* Child born after denial of pregnancy
* Child born at term ( \> 37 weeks of gestation)
* Born between the 1st january 2009 and the 30th june 2015 at Maternité Regionale de Nancy

Exclusion Criteria:

* Mother's opposition
* Child doesn't' living in France

Primary outcomes:
measure: height (cm)
timeFrame: birth
measure: height (cm)
timeFrame: 9 months
measure: height (cm)
timeFrame: 24 months
measure: height (cm)
timeFrame: between 2 and 5 years
measure: weight (kg)
timeFrame: birth
measure: weight (kg)
timeFrame: 9 months
measure: weight (kg)
timeFrame: 24 months
measure: weight (kg)
timeFrame: between 2 and 5 years
Secondary outcomes:
measure: psychomotor development
timeFrame: birth
measure: psychomotor development
timeFrame: 9 months
measure: psychomotor development
timeFrame: 24 months
measure: psychomotor development
timeFrame: between 2 and 5 years
measure: disease
timeFrame: birth
measure: disease
timeFrame: 9 months
measure: disease
timeFrame: 24 months
measure: disease
timeFrame: between 2 and 5 years
Other outcomes:
Locations:
city: Nancy
country: France
facility: Maternity Hospital CHRU
Study officials:
References:
Clinical trial NCT00444938: Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device in the Treatment of Bipolar Depression
Official title: Evaluation of the H-Coil (TMS) Device - Safety and Feasibility in Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bipolar Depression
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
First posted: 2007-03-08
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is evaluating the potential antidepressive effect of a 4 week treatment protocol using the H-coil deep TMS device in bipolar depression.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of bipolar depression

Exclusion Criteria:

* No other axis I disorder
* Risk factors for convulsions

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hod Hasharon
country: Israel
facility: Shalvata MHC
Study officials:
affiliation: Shalvata MHC
name: Eiran V Harel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harel EV, Zangen A, Roth Y, Reti I, Braw Y, Levkovitz Y. H-coil repetitive transcranial magnetic stimulation for the treatment of bipolar depression: an add-on, safety and feasibility study. World J Biol Psychiatry. 2011 Mar;12(2):119-26. doi: 10.3109/15622975.2010.510893. Epub 2010 Sep 21.
Clinical trial NCT04053738: The Anti-snoring Bed
Official title: An Intelligent Bed To Monitor And Reduce Snoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Snoring
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2019-08-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Habitual snoring is a widespread complication. Most snorers snore predominately when sleeping in supine position. Therefore, therapeutic interventions force snorers to avoid supine position. Devices that restrict the sleeping position or raise alarms when the user obtains the supine position cause discomfort or disrupt sleep resulting in low compliance. Therefore, anti-snoring mechanisms, which lift the trunk of the user without disturbing sleep, have been proposed.

We set out to investigate whether individual interventions provided by beds with lifting mechanisms are able to stop snoring within three minutes (success rate) and whether the bed reduces the snoring index (number of total snores divided by total time in bed). In addition, we investigat whether the trunk elevation provided by the bed is interfering with the subjective sleep quality assessed using the Groningen Sleep Quality Score.

Subjects are observed for four nights (adaptation, baseline, and two intervention nights). During intervention nights, the bed lifts the trunk of the user in closed-loop manner. Subjects are divided in three groups (non-snorers, snorer group one, and snorer group two). Non-snorers are lifted by the bed at random time points during the night. In snorer group one, a stepwise increase of the bed inclination is compared with going directly to a randomly selected angle. In snorer group two, the influence of a small inclination angle (10°) and a big inclination angle (20°) is compared..


Eligibility criteria: Inclusion Criteria:

* none

Exclusion Criteria:

* Pregnancy
* Previously diagnosed sleep-related breathing disorders
* Chronic lower back pain
* Heart insufficiency that might impede sleeping in supine position
* Inability to follow the procedures of the study, e.g. due to language problems

Primary outcomes:
measure: Effect on snoring
timeFrame: whole night - 4 nights
Secondary outcomes:
measure: Self-Reported Sleep Quality
timeFrame: upon awakening - 4 nights
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Sensory-Motor Systems Lab, ETH Zurich
Study officials:
affiliation: University of Zurich
name: Robert Riener, Prof. Dr. Dr.-Ing.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02883738: Evaluation the Effect of Muscle Functional Electrical Stimulation in the Upper Limb Tremor Invalidating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Limb Tremor Invalidating
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The main objective of this study is to identify the superficial muscle groups involved in gene-related tremor and assess the reduction in the intensity of the tremor after transient electrical stimulation.


Eligibility criteria: Inclusion Criteria:

* Subject with disabling tremor of upper limb
* Subject with essential tremor action and / or lesion

Exclusion Criteria:

* Subject with drug tremor
* Subject presenting an exaggerated physiological tremor
* Subject with isolated resting tremor

Primary outcomes:
measure: evaluation of the intensity of tremor by measuring the hand moving speed (mm / s)
timeFrame: at day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Gui de Chauliac Hospital
Study officials:
References:
Clinical trial NCT02627638: Cancer Patient Perceptions of the Osteopathy Treatment: a Qualitative Study
Official title: Cancer Patient Perceptions of the Osteopathy Treatment: a Qualitative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Patients
Keywords: osteopathy
complementary therapy
symptoms in cancer patients
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: For more than seven years an osteopath has been working in the palliative care unit (PCU) and in both palliative care mobile team (PCMT) as a member of the multidisciplinary team. The patients referred to the osteopath by the palliative care physicians present pains related to cancer, but also to the treatment, in particular to surgery or radiotherapy. The osteopath can help with other symptoms such as constipation or dyspnoea. As this approach is provided in complement of the medicinal approach, it is not considered as an alternative medicine but as a complementary medicine associated to a conventional care. It seemed relevant to the investigators to ask the cancer patients undergoing osteopathic sessions for pain how they saw this complementary therapy.


Eligibility criteria: Inclusion Criteria:

* Advanced illness patients with cancer pain, PS 0 to 2, willing to take part in the study and having signed the informed consent form

Exclusion Criteria:

* Non-communicating patients and patients whose cancer has been cured.
* Patients with fractural risk.

Primary outcomes:
measure: Thoughs and emotions of patients undergoing the two osteopathic sessions as complementary therapy for pain, evaluated using semi-directed interviews
timeFrame: around day 14 (after the second session)
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite Cedex
country: France
facility: Médecine palliative - Groupement Hospitalier Lyon Sud- Hospices Civils de Lyon
Study officials:
References:
citation: Steel A, Tricou C, Monsarrat T, Ruer M, Deslandes C, Sisoix C, Filbet M. The perceptions and experiences of osteopathic treatment among cancer patients in palliative care: a qualitative study. Support Care Cancer. 2018 Oct;26(10):3627-3633. doi: 10.1007/s00520-018-4233-y. Epub 2018 May 4.