louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04560959: Atlas of Intracranial Recordings on Cortical Responses After Functional tACS
Official title: An Atlas of Cerebral Responses to the Stimuli of the tACS Recorded by SEEG
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Transcranial Alternating Current Stimulation
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: By analyzing the SEEG recordings, we explore the range of cortical functional responses to strings of 77.5Hz stimulations delivered by tACS,


Eligibility criteria: Inclusion Criteria:

* All epileptic patients that would receive the implantation of SEEG electrodes, regardless of the seizure locations;
* There was no metal implantation before;
* Eligible for MRI examination;
* No other lesional neurological disorders;
* Could be well informed by the study protocols.

Exclusion Criteria:

* Suffered from any other mental illnesses prior to the enrollment;
* Those suffering from the serious or unstable organic diseases;
* Pregnant or lactation women, and those who have a plan of pregnant;
* Patients with central nervous system tumors, acute brain injury or infection;
* Skin injured, or allergic to the exposure of the conductive gel;
* Those with implanted devices;
* Those who received modified electrical convulsive therapy, or TMS within the recent one month;
* The score of item 3 (suicidal item) in HAMD-17 equal or greater than 3;
* Enrolled in any other on going trials;
* Other situations evaluated by the researchers as inappropriate to the enrollment

Primary outcomes:
measure: Changes of intracranial activities
timeFrame: Within 250 ms immediately after the stimulation.
Secondary outcomes:
measure: Frequency of the epileptic discharges
timeFrame: 50 minutes during the stimulation and 50 minutes of the interictal baseline before the intervention during the same hour of the day
measure: Event related potential (ERP)
timeFrame: Baseline: 24 hours before the tACS intervention; Observation: Immediately after the end of the tACS intervention.
Other outcomes:
Locations:
Study officials:
affiliation: Department of Neurosurgery, Capital Medical University
name: G.G. Zhao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01310959: Establishing a Data Base for Aplastic Anemia and Other Marrow Failure Syndrome
Official title: Establishing a Data Base for Aplastic Anemia and Other Marrow Failure Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aplastic Anemia and Other Marrow Failure Syndrome
Keywords: Aplastic Anemia Marrow Failure Syndrome
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2011-03-09
Enrollment: 88
Sex: ALL
Minimum age (years): 14
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Aplastic Anemia and Other Marrow Failure Syndrome Database

Brief summary: Establishing a Data Base for Aplastic Anemia and Other Marrow Failure Syndrome

Detailed description: Establishing a Data Base for Aplastic Anemia and Other Marrow Failure Syndrome

Eligibility criteria: Inclusion Criteria:

* Patients with diagnosed Aplastic Anemia and Other Marrow Failure Syndrome Database.

Exclusion Criteria:

* Patients with diagnosis other than Aplastic Anemia and Other Marrow Failure Syndrome Database.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Kfsh & Rc
Study officials:
affiliation: KFSH & RC
name: H Al-Zahrani, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06076759: Intrathecal Dexmedetomidine Versus Intrathecal Morphine Inpatients Undergoing Cardiac Valve Replacement Surgeries
Official title: Intrathecal Dexmedetomidine Versus Intrathecal Morphine Inpatients Undergoing Cardiac Valve Replacement Surgeries: Effect on Postoperative Pain and Diaphragmatic Function
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Valve Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 40
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: SUPPORTIVE_CARE

Brief summary: Comparison between the effects of intrathecal morphine versus intrathecal dexmedetomidine on analgesia and respiratory function, in open heart surgery.

Detailed description: Postoperative pulmonary dysfunction is a well-recognized complication of open-heart surgeries. About 25% of patients who don't present with any severe impaired cardiac function reported to have significant pulmonary dysfunction for at least one week after operation. Many mechanisms could be accused of this dysfunction as respiratory mechanics failure by diaphragmatic paresis or paralysis, pain and muscle guarding, lung atelectasis, drains discomfort, etc.

although pain is the major concern of patients, but sometimes it may not get the proper attention, pain in open heart surgery origins mainly from the surgical incision which is here a median sternotomy the most commonly used approach and the easiest access to the heart region, however median sternotomy may significantly impedes the pulmonary function by the resultant pain of this procedure and cause morbidity and mortality by itself

Eligibility criteria: Inclusion Criteria:

- Cardiac patient scheduled for elective open heart valve replacement surgery.

Exclusion Criteria:

* • Patient refusal

  * Coagulation disorders
  * History of known allergy to the used drugs.
  * Combined procedures (e.gif combined with coronary artery bypass or aortic root surgeries).
  * If thoracotomy or min-sternotomy is planned for the surgery.
  * Re-do and emergency surgeries.
  * History of chronic chest diseases (COPD or IPF).
  * History of thoracotomy, pneumothorax, pneumomediastinum, phrenic nerve injury (as evident by the presence of paralysis of the ipsilateral hemidiaphragm when examined preoperatively).
  * Neuromuscular diseases.
  * Brain injuries.

Primary outcomes:
measure: Total opioids consumption.
timeFrame: First 24 hour postoperatively
Secondary outcomes:
measure: Diaphragmatic function
timeFrame: First 24 hour postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Hany Moustafa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00493259: Health Related QOL, Depression and Lifestyle Changes in Insulin Resistant Adolescents
Official title: Health-related Quality of Life, Depression and the Impact on Successful Incorporation of Lifestyle Changes in Insulin Resistant Adolescents as Evidenced by Changes in BMI, Waist Circumference and Metabolic Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insulin Resistance
Depression
Keywords: Health-Related Quality of Life
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2007-06-28
Enrollment: 78
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adoslescents treated in Children's Mercy Hospital and Clinic, Endocrine clinic.

Brief summary: The purpose of this study is to assess adolescents with Insulin Resistance Syndrome for quality of life and altered health related issues.

Detailed description: Matched historical control study designed to examine outcomes on insulin resistant adolescents who were treated in the Insulin Resistance Syndrome Clinic at Children's Mercy Hospital in the past year. New patients will be screened at baseline, 4 and 12 months to evaluate if there is improvement in the BMI Z-score, HgA1c, lipid profile or waist circumference when depression and/or altered health related quality of life are identified and treated in this population.

Eligibility criteria: Inclusion Criteria:

* Patients 11-17 years of age who are seen in the Insulin Resistance Clinic for the first time
* Historical control: Patients 11-19 years of age seen in the Insulin Resistance Clinic during the prior four months

Exclusion Criteria:

* Co-morbid syndrome (Downs, Turner's, Prader Willi etc)
* Diagnosis of Type 2 Diabetes
* Taking Metformin before the initial visit
* Taking medication for or diagnosis of a psychiatric condition prior to initial visit
* Developmentally delayed

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Adrienne Platt, MS, CPNP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00123500: Wellness Program for Elementary School Personnel
Official title: ACTION! Wellness Program for Elementary School Personnel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Cardiovascular Diseases
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-07-25
Enrollment: 1202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of the project is to develop, implement, and evaluate, through a randomized controlled trial at a worksite, an intervention to promote increased physical activity behavior and healthier eating behavior to reduce overweight and obesity among elementary school personnel.

Detailed description: BACKGROUND:

The dramatic increase in the prevalence of overweight and obesity among adults in the United States during the past two decades is related to increased cardiovascular disease, hypertension, dyslipidemia, diabetes, and other chronic diseases. With 63.9% of working-age adults employed, worksites are targets for prevention and intervention programs to control overweight and obesity. Worksite interventions have the potential to reach a large number of individuals in a common and shared environment.

DESIGN NARRATIVE:

This is a group-randomized trial involving 20 elementary schools in Jefferson Parish public schools. Schools will be the unit of randomization; 10 schools will be randomly allocated to implement the intervention, and 10 schools will serve as controls. The primary aim of the program is to reduce mean body weight. Secondary aims relate to changes at both the individual level and the environmental level. The intervention will address the two major determinants of overweight and obesity: physical activity and diet. A School Wellness Committee at each site will be instrumental in identifying and implementing components of the intervention.

Eligibility criteria: Inclusion Criteria:

* Healthy adults with no contraindications to participating in an intervention to improve eating and exercise behaviors
* Healthy adults with no contraindications to participating in any of the measurement procedures

Exclusion Criteria:

* Inability to participate in routine physical activity

Primary outcomes:
measure: Body mass index (BMI)
timeFrame: Measured at the end of the second year of intervention
Secondary outcomes:
measure: 24-hour dietary recall
timeFrame: Measured at baseline (Fall 2006) and follow-up (Fall 2008)
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
Study officials:
affiliation: Tulane University
name: Larry Webber, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04266600: Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease
Official title: Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease: A Multicenter Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn Disease
Recurrence
Crohn's Ileocolitis
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
Collaborators: name: Montreal General Hospital
First posted: 2020-02-12
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study is looking at the role of the mesentery in disease recurrence for ileocolic Crohn's disease. It is a prospective study that has been designed to perform extended mesenteric excision on patients undergoing their first ileocolic resection for Crohn's disease. Endoscopic recurrence will be monitored with the hypothesis that patients receiving extended mesenteric ileocolic resection will have reduced endoscopic recurrence at 6 months after resection.

(limited mesenteric resection).

Detailed description: The current standard of care for ileocolic Crohn's disease (CD) is a limited mesenteric resection. There is growing, but still limited, evidence that extended mesenteric excision during ileocolic resection is beneficial in decreasing disease recurrence. We propose a prospective multicenter cohort study to better understand the role of extended mesenteric excision in ileocolic CD and how it affects disease recurrence. The primary outcome of this study will be the rate of endoscopic recurrence at 6 months in patients undergoing first-time resection for ileocolic CD. Secondary outcomes will include endoscopic recurrence at 18 months and rates of recurrence requiring surgery by 2 years. These outcomes will be compared to historical controls (limited mesenteric resection). Our hypothesis is that patients receiving extended mesenteric ileocolic resection will have reduced endoscopic recurrence at 6 months after resection. As seen in previous studies, advanced mesenteric and mucosal disease predicts increased surgical recurrence.

Eligibility criteria: Inclusion Criteria:

adults \>18 years old diagnosis of CD limited to the distal ileum/ileocolic region no previous ileocolic resection all forms of CD presentation will be included - stricturing, fistulizing, perforating etc.

Exclusion Criteria:

previous ileocolic resection other sites of CD intraabdominal sepsis

Primary outcomes:
measure: Endoscopic recurrence at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Endoscopic recurrence at 18 months
timeFrame: 18 months
measure: Rates of recurrence requiring surgery by 2 years
timeFrame: 24 months
measure: Post-operative complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT01978600: Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official title: Prospective, Randomized, Single-Center Study to Evaluate 24-hour Intraocular Pressure Control With Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Keywords: Open-Angle Glaucoma
Ocular Hypertension
Simbrinza™
Intraocular Pressure
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-11-07
Enrollment: 89
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 evaluate intraocular pressure (IOP) over a 24-hour period using Simbrinza™ topical ophthalmic suspension.

Detailed description: This study consisted of two phases, a Screening/Eligibility Phase and a Treatment Phase. Both phases required the patient to complete an overnight stay.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of either open-angle glaucoma or ocular hypertension in both eyes.
* Willing and able to attend all study-related visits and be housed overnight at clinical site for the study assessments.
* Must sign an Informed Consent form.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential if pregnant, breastfeeding, or not using adequate birth control.
* Severe central visual field loss in either eye.
* Chronic, recurrent or severe inflammatory eye disease.
* Ocular trauma or ocular surgery within the past 6 months.
* Ocular infection or ocular inflammation within the past 3 months.
* Clinically significant or progressive retinal disease.
* Other ocular pathology, including severe dry eye, that may in the opinion of the investigator preclude the administration of study medication.
* Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
* Any medical condition that would preclude the safe administration of a topical beta-blocker.
* Cannot safely discontinue all glucocorticoids administered by any route.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Mean Nocturnal IOP at Week 4
timeFrame: Week 4: 10PM, 12AM, 2AM, 4AM, 6AM
Secondary outcomes:
measure: Mean Diurnal IOP at Week 4
timeFrame: Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM
measure: Mean 24-hour IOP at Week 4
timeFrame: Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM, 10PM, 12AM, 2AM, 4AM, 6AM
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Danyel Carr, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT04769700: Post-partum Depression, Breastfeeding Adherence and Fear in COVID-19
Official title: Post-partum Depression, Breastfeeding Adherence, and Fear in Women Giving Birth During the COVID-19 Pandemic.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Feeding, Exclusive
Post Partum Depression
Covid19
Keywords: COVID-19
Post-partum depression
Breast feeding
Pandemic
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2021-02-24
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who delivered singletons at term in the last 6 months during the COVID-19 pandemic.

Brief summary: This study aims to explore whether quarantine measures, social distancing and hospital containment policies among women giving birth during the COVID-19 pandemic enhanced psycho-emotional distress in the immediate postpartum period. The investigators tested for depression using the Edinburgh Postnatal Depression Scale (EPDS) in the first 6 postpartum months, and then used the Fear of COVID-19 Scale, measuring also the adherence and practices of breastfeeding according to WHO.


Eligibility criteria: Inclusion Criteria:

* Women aged ≥18 years
* Women who delivered singletons at term in the last 6 months during the COVID-19 pandemic

Exclusion Criteria:

* Women who delivered two or more products
* Women who delivered singletons at term past the last 6 months during the COVID-19 pandemic
* Women who delivered singletons pre or post-term in the last 6 months during the COVID-19 pandemic

Primary outcomes:
measure: Post-Partum Depression Frequency
timeFrame: Baseline
measure: Breast Feeding Adherence and behavior.
timeFrame: Baseline
measure: Fear of Covid-19 severity
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Instituto Mexicano del Seguro Social
state: Jalisco
Study officials:
References:
Clinical trial NCT01835600: Suspension of Mechanical Ventilation in Ureteroscopic Lithotripsy Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypercapnia
Hypoxia
Lead sponsor: Chinese Medical Association
Sponsor class: NETWORK
First posted: 2013-04-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: For some upper ureteral and renal stones,ureteroscopic lithotripsy needs to be performed under general anesthesia with interrupted suspension of mechanical ventilation, which could result in hypercapnia and hypoxia. In this study, the investigators hypothesize that 10 cmH2O PEEP added to the respiratory circuit with 1 L/min 100% oxygen might extend the time of ventilation suspension but have no effect on carbon dioxide retention in blood.

Detailed description: For some upper ureteral and renal stones,ureteroscopic lithotripsy is often perdurbed by the patient's respiratory movement either under epidural anesthesia or general anesthesia with mechanical ventilation. So intermittent suspension of mechanical ventilation under general anesthesia can ensure the surgery to be performed continuously and successfully. But this could result in hypercapnia and hypoxia. So far, there have been few studies focused on the change of the internal environment in blood as result of suspending breath. In this study, the investigators hypothesize that 10 cmH2O PEEP added to the respiratory circuit with 1 L/min 100% oxygen might extend the time of ventilation suspension but have no effect on carbon dioxide retention in blood.

Eligibility criteria: Inclusion Criteria:

ASA I\~III general anesthesia sign the informed consent

Exclusion Criteria:

ASA IV or V woman who is pregnant or plans to bear

Primary outcomes:
measure: change in blood gas
timeFrame: Baseline before suspension of ventilation, 5 min after suspension, 10 min after suspension, 15 min after suspension, 5 min after re-ventilaiton, 10 min after re-ventilation
Secondary outcomes:
measure: Change in systolic blood pressure
timeFrame: Baseline before suspension of ventilation, 5 min after suspension, 10 min after suspension, 15 min after suspension, 5 min after re-ventilaiton, 10 min after re-ventilation
Other outcomes:
measure: duration of the operation
timeFrame: from the start of the surgery to the end of the surgery
measure: recovery time
timeFrame: from the end of anesthesia to return of consciousness
measure: intraoperative awareness
timeFrame: from the initiation of anesthesia to the end of the surgery
Locations:
city: Shanghai
country: China
facility: Yi Zhou
state: Shanghai
Study officials:
References: