louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00370929: A Study of Meditation as a Treatment for Epilepsy
Official title: Treatment of Epilepsy by Meditation and Cultivation of Emotional Balance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2006-09-01
Enrollment: 8
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: Epileptic seizures may occur at times of stress and commonly increase life stress. This study will evaluate whether meditation improves seizure control and quality of life for individuals with uncontrolled epilepsy.

Detailed description: Individuals who have uncontrolled epilepsy commonly experience disability, depression, anxiety and injuries from seizures. For such individuals, ideal treatments should improve quality of life through control of seizures and improved emotional state. Meditation with cultivation of emotional balance is known to improve emotional state and may also benefit seizure control in some individuals. In this study, individuals with uncontrolled epilepsy will receive detailed training in meditation to determine whether the training leads to improvements in seizure control and various measures of emotion and quality of life.

Eligibility criteria: Inclusion Criteria:

* 6 or more seizures per month
* ability to participate in meditation

Primary outcomes:
measure: Seizure frequency
timeFrame: 20 weeks
measure: Quality of Life
timeFrame: 20 weeks
Secondary outcomes:
measure: Mood
timeFrame: 20 weeks
measure: Affect
timeFrame: 20 weeks
measure: Anxiety
timeFrame: 20 weeks
measure: Sleep quality
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Geffen School of Medicine at UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: John Stern, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01262729: Xenon and Therapeutical Hypothermia After Successful Cardiopulmonary Resuscitation
Official title: Xenon and Therapeutical Hypothermia After Successful Cardiopulmonary Resuscitation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Efficacy and Safety of Xenon Inhalation
Successful Cardiopulmonary Resuscitation
Addition to Therapeutical Hypothermia
Keywords: xenon inhalation
therapeutical hypothermia
patients after cardiopulmonary resuscitation
efficacy
safety
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2010-12-17
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this clinical trial will be checked, whether 2 hour ventilation with xenon has neuroprotective effects in patients with out of hospital cardiac arrest and successful cardiopulmonary resuscitation

Detailed description: Patients with out of hospital cardiac arrest and successful cardiopulmonary resuscitation will be randomized in two groups. First group (Treatment group) will be inhalated with xenon within 2 hours in addition to therapeutical hypothermia. The second group (Control group) will be treated with therapeutical hypothermia in accordance to international guidelines.

Eligibility criteria: Inclusion Criteria:

* Patients with out of hospital cardiac arrest and successful cardiopulmonary resuscitation, which will be treated at Department of Internal Medicine I, University Hospital Aachen

Exclusion Criteria:

* Patients younger than 18 years
* Xenon allergy
* Pregnancy
* High expired oxygen requirement (\>70%) in order to maintain adequate arterial oxygen saturation (SpO2\>94%) at the beginning of treatment

Primary outcomes:
measure: Significant difference between treatment group and control group
timeFrame: within 28 days after cardiac arrest
Secondary outcomes:
measure: Safety and efficacy of xenon ventilation within 2 hours after successful cardiopulmonary resuscitation
timeFrame: within 28 days after cardiac arrest
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Surgical Intensive Care - Adults, University Hospital Aachen
state: NRW
Study officials:
affiliation: Surgical Intensive Care - Adults, University Hospital Aachen
name: Michael Fries, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fries M, Brucken A, Cizen A, Westerkamp M, Lower C, Deike-Glindemann J, Schnorrenberger NK, Rex S, Coburn M, Nolte KW, Weis J, Rossaint R, Derwall M. Combining xenon and mild therapeutic hypothermia preserves neurological function after prolonged cardiac arrest in pigs. Crit Care Med. 2012 Apr;40(4):1297-303. doi: 10.1097/CCM.0b013e31823c8ce7.
Clinical trial NCT00880529: Pain Relief for Ventilated Patients With Multiple Rib Fractures Using the ON-Q Pain Relief System
Official title: Does Continuous Subcutaneous Paravertebral Infusion of Bupivicaine With the ON-Q Pain Relief System vs. Standard IV Pain Management Decrease Ventilator Dependence in Trauma Patients With Multiple Rib Fractures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Rib Fractures
Keywords: rib fractures
ventilator
ON-Q
analgesia
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
First posted: 2009-04-13
Enrollment: 2
Sex: ALL
Minimum age (years): 18
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 find out if patients having the ON-Q post-op Pain Relief System for pain management of multiple rib fractures will require fewer ventilator days, and will need less IV pain medicine to control their pain, and as a result have improved respiratory function during their recovery.

The standard of care for providing pain relief for rib fractures is to use an opioid drug that is injected into the vein but also has side effects. Increased doses can lead to over sedation and consequently lead to difficulty with breathing. The ON-Q pain relief systems uses a local anesthetic under the skin. The anesthetic is called bupivicaine, and it is delivered from a thin tube approximately 10 inches long is tunneled under the skin along the back and parallel to the spine. The medication is stored in an elastic pump which delivers a slow continuous drip of medication from multiple holes in the tubing. Subjects will be randomized to either standard intravenous opioid pain management or the ON-Q pain relief device with supplemental opioid medication if needed. The device will remain in use until the subjects are able to breathe without the ventilator.


Eligibility criteria: Inclusion Criteria:

* \> 18 years of age
* 3 or more rib fractures
* Intubated ready for weaning from ventilator support
* FI02 \< 50%
* Peep \< 10cm H2O

Exclusion Criteria:

* \< 18 years of age
* Pregnant
* Unable to communicate pain status
* Allergy to local anesthetics
* Coagulopathy
* Skin lesions or abnormalities from previous injury or surgery
* \< 3 rib fractures

Primary outcomes:
measure: Time from weaning process initiation to discontinuation of ventilatory support
timeFrame: Time will be measured in hours from initation of ventilator weaning to no ventilatory support needed
Secondary outcomes:
measure: total dose of narcotics given will be identified and reported as mcg or mg each 24 hour period that ON-Q pain pump is being used.
timeFrame: each 24 hours
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
Study officials:
affiliation: The Cooper Health System
name: Cynthia R Fusco, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01408329: Effects of Cyclic Variations in Altitude Conditioning (CVAC) on Wellness and Activity Measures
Official title: Effects of Cyclic Variations in Altitude Conditioning (CVAC) on Wellness and Activity Measures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
First posted: 2011-08-03
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Cyclic Variation in Altitude Conditioning (CVAC) is a new technique that uses a pod-like device to expose users to controlled fluctuations in air pressure. It is designed to promote quicker altitude acclimatization, thus promoting improvements in exercise capacity at altitude and, possibly, at sea level. However, over the past few years, anecdotal stories from users of the device suggest that the CVAC treatments might be causing changes beyond the expected endurance exercise performance benefits. Therefore, the purpose of the study is to obtain data on some of the previous anecdotal claims regarding the device (e.g. increases in strength, improved glucose tolerance, reduction of neuropathic pain and decreased joint swelling) as well as to obtain broad questionnaire data in order to identify more specific variables to investigate in future studies.


Eligibility criteria: Inclusion Criteria:

* Healthy middle aged men at risk for metabolic syndrome

Exclusion Criteria:

* Uncontrolled hypertension,
* sensitive ears,
* anything that would preclude person from sustaining rapid pressure changes

Primary outcomes:
measure: Plasma Glucose Concentration
timeFrame: Glucose measurements were made at baseline, 3, 6, & 10 weeks. Blood was collected consistently after a 10-12 h fast the morning after a CVAC session (except for baseline).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Veterans Affairs Palo Alto Health Care System
name: Anne Friedlander, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01078129: Cognitive Remediation Therapy and Schizophrenia
Official title: Efficacy of Hierarchized Computer-assisted Cognitive Remediation Therapy in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: cognitive deficits
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
Collaborators: name: University Hospital, Grenoble
name: University Hospital, Clermont-Ferrand
First posted: 2010-03-02
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objectives:

The purpose of this study is to determine the impact of a new Cognitive Remediation Therapy (CRT) on cognition, social autonomy, symptoms and brain functioning in patients with schizophrenia.

Detailed description: Methods:

In a 2 arms blind study versus sham,80 patients with schizophrenia were enrolled in a program consisting of 14 training sessions of 4 cognitive functions (attention/concentration, topological memory, logical reasoning, executive functions)by means REHACOM® software. Measures of cognitive functioning using the Cogtest® battery as well as social autonomy (Social Autonomy Scale, EAS) and schizophrenia symptoms (Positive And Negative Syndrome Scale, PANSS) were undertaken at the beginning and the end of the meetings of remediation.

Among those 80 participants, 30 patients to (15 active / 15 sham) were randomized to participate in an fMRI study in order to investigate the impact of such CRT program on brain functioning (n-back task before CRT and 3 months later).

Eligibility criteria: Inclusion Criteria:

* schizophrenia (DSM IV criteria)
* remitted symptoms
* french language
* informed consent

Exclusion Criteria:

* addiction, neurological disease
* only for second randomized patient participating in MRI study (n=30) : MRI counterindications

Primary outcomes:
measure: cognitive deficits (attention/concentration, topological memory, logical reasoning, executive functions)
timeFrame: before and after CRT (3 months later)
Secondary outcomes:
measure: brain functioning (fMRI)
timeFrame: before and after CRT (3 months later)
measure: schizophrenia symptoms
timeFrame: before CRT and 3 months later
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital le vinatier
Study officials:
affiliation: Hopital le Vinatier
name: Thierry d'amato, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bor J, Brunelin J, d'Amato T, Costes N, Suaud-Chagny MF, Saoud M, Poulet E. How can cognitive remediation therapy modulate brain activations in schizophrenia? An fMRI study. Psychiatry Res. 2011 Jun 30;192(3):160-6. doi: 10.1016/j.pscychresns.2010.12.004. Epub 2011 May 2.
Clinical trial NCT01156129: Interventions to Decrease the Impact of Post-OPerative Ileus After Liver Transplant or Resection Surgery
Official title: Interventions to Decrease the Impact of Post-Operative Ileus After Liver Transplant or Resection Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ileus
Keywords: liver transplant
liver resection
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2010-07-02
Enrollment: 111
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial to assess ways to address post-operative ileus (POI) in adult patients on the liver transplant service undergoing either liver transplant or resection surgery. Patient who speak and understand English will be randomized into one of three groups including a.)control group receiving standard therapy for post-operative ileus, b.)group receiving standard therapy and acupressure bracelets, and c.)group receiving standard therapy and sugar free gum four times daily.

Detailed description: Any patient undergoing liver transplant or resection surgery will be asked to participate in the study and assigned to a control or investigational group. Pertinent information will be collected from the medical record including gender, age in years, diagnosis, type of surgery, length of stay, medications used for pain or nausea, and first bowel movement. The subjects will also be asked to keep a journal of their bowel habits, signs and symptoms of gastrointestinal distress/post-operative ileus, use of medications, first bowel movement, satisfaction with bowel management and any additional comments.

Aims of the study are to determine the effectiveness of the three arms of this trial for the resolution of POI as noted by first post-operative bowel movement; to determine if there is a difference in the length of stay based on the interventions; and to determine if there is a difference in patient satisfaction based on the intervention.

Eligibility criteria: Inclusion Criteria:

* Patients 19 years or older who speak and read English and have had a liver transplant or liver resection surgery

Exclusion Criteria:

* Patients less than 19 years of age having liver transplant or liver resection surgery
* Non-English speaking
* Pregnancy

Primary outcomes:
measure: Timing of first post operative bowel movement
timeFrame: Days post operative
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Time from admission to discharge post surgery
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Unversity of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Laurel W Williams, MSN,RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04563429: Vitamin A for BPD Prevention
Official title: Vitamin A Oral Supplementation as a Preventive Treatment for Chronic Lung Disease Among Infants Born Before 29 Weeks of Gestation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: The Relationship Between Oral Vitamin A Administration and the Incidence of BPD in Preterm Infants Born Before Week 29 of Pregnancy
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-09-24
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Chronic bronchopulmonary dysplasia (BPD) is a very common complication in preterm infants born at a young gestational age, and is a serious disease that impairs respiratory long-term outcome and is associated with higher-frequency neurodevelopmental injury. Lowering the incidence of BPD may improve the health of the preterm babies and neurodevelopmental delay of preterm infants.Vitamin A deficiency may be one of the factors associated with the development of BPD in preterm infants. According to the literature, oral vitamin A administration can lower the incidence of BPD. In our study we plan to give 5000 units of retinol / dose / day, every day for 28 days.


Eligibility criteria: Inclusion Criteria:

* Premature babies under 29 weeks, at any birth weight
* A preterm baby is less than 4 days to life

Exclusion Criteria:

* Major congenital malformations
* Known chromosomal disorders

Primary outcomes:
measure: Incidence of BPD at 28 days
timeFrame: 28 days of life
measure: Incidence of mortality at 28 days
timeFrame: 28 days of life
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chaim Sheba Medical Center, Tel Hashomer, Israel
name: Leah Leibovich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01609829: iCOMtrain, Development and Evaluation of a Combined Training of Technical and Non-Technical Skills During the Management of Simulated Incidents in Intensive Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Technical and Non-technical Training of Airway Management on ICU
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2012-06-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Doctors and nurses working on the surcical ICU.

Brief summary: The normal, the anticipated difficult and the unanticipated difficult airway are trained in the patient safety simulation center (University Hospital Zürich) and the training is being observed by video installation.

Step 1: normal airway (Phantom), technical training

Step 2: difficult airway (SimMan 3G), technical training

Step 3: Simulation of normal and difficult airway management on ICU (SimMan 3G), technical and non-technical (CRM - crew resource management) training.


Eligibility criteria: Inclusion criteria:

* doctors and nurses with a minimum of 12 moths of work experience.

Exclusion criteria:

* staff members that deny participation or don't meet the inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Children's Hospital, Anesthesiology
state: ZH
Study officials:
affiliation: University Childrens Hospital Zurich, Anesthesiology
name: Bastian Grande, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06883929: The Effect of Virtual Reality Application on Anxiety and Fear Levels of Children Planned for Daily Surgery
Official title: The Effect of Vırtual Realıty Applıcatıon on the Anxıety and Fear Levels of Chıldren Who Are Planned for Daıly Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child
Fear
Anxiety
Keywords: Child
Anxiety
Fear
Distraction
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 80
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objective: This study was conducted to determine the effect of the animation video to be watched by child patients aged 5-10 before day surgery on their anxiety and fear levels in the preoperative period. Method: This research, which was conducted as a randomized controlled experimental study, was conducted with 80 children. Participants sociodemographic data, blood pressure, heart rate, Child Fear Scale and Yale Modified Preoperative Anxiety Scale Child Form were used to collect data. Comparisons in independent pair groups with Kolmogorov Smirnow Test whether the data received comply with normal distribution; Since the assumption of normality is met, comparisons in dependent pair groups are made with the significance test (t test) of the difference between two means; Since the assumption of normality was met, the significance test of the difference between two spouses was performed (two paired samples t test).

Detailed description: Objective: This study was conducted to determine the effect of the animation video to be watched by child patients aged 5-10 before day surgery on their anxiety and fear levels in the preoperative period. Method: This research, which was conducted as a randomized controlled experimental study, was conducted with 80 children. Participants sociodemographic data, blood pressure, heart rate, Child Fear Scale and Yale Modified Preoperative Anxiety Scale Child Form were used to collect data. Comparisons in independent pair groups with Kolmogorov Smirnow Test whether the data received comply with normal distribution; Since the assumption of normality is met, comparisons in dependent pair groups are made with the significance test (t test) of the difference between two means; Since the assumption of normality was met, the significance test of the difference between two spouses was performed (two paired samples t test).

Eligibility criteria: Inclusion Criteria:

Not having an audiovisual disease

Exclusion Criteria:

Having an audiovisual disease

Primary outcomes:
measure: Child fear scale
timeFrame: 6 months
Secondary outcomes:
measure: Yale modified preoperative anxiety scale pediatric form
timeFrame: 6 months
Other outcomes:
Locations:
city: Bitlis
country: Turkey
facility: Bitlis Il Sağlık Müdürlüğü
Study officials:
References: