louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00515359: RCT for Intermittent Versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies
Official title: RCT for Intermittent Versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Encephalopathy
Developmental Delay and Behavioral Changes
Cord Tumor Compression or Instability
Cord Tethering or Malformation
Keywords: Sedation
MRI
pediatric
propofol
brain
spine
quality of MRI
Continuous propofol dosing
continuous propofol administration
Intermittent propofol dosing
intermittent propofol administration
Sedative agent
propofol continuous infusions
Recovery time
Complications of sedation
bolus dosing
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
Collaborators: name: Helen DeVos Children's Hospital
First posted: 2007-08-13
Enrollment: 276
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RCT for Intermittent versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies

Detailed description: A study comparing the dose of propofol used as a continuous infusion versus intermittent bolus dosing looking at recovery time complications, and quality of the MRI studies in Pediatric Sedation Services for patients age 1 month to 18 years receiving an brain or spine MRI.

Eligibility criteria: Inclusion Criteria:

* Age 1 month to 18 years
* Receiving a brain or spine MRI with propofol sedation
* Deemed safe to undergo sedation with propofol based on a pre-sedation examination
* Patient judged not to require any pre-medication with any other medication except nasal decongestants or anticholinergic medications

Exclusion Criteria:

* Patient below or above set age limits.
* Patient requires MRI studies on other body areas.
* Patient requires pre-medication with a sedative or tranquilizer
* Patient requires additional medications during sedation to complete the procedure.
* Propofol is being used as a rescue sedative to complete the procedure.
* Propofol is being used as a rescue sedative to complete a procedure that was initiated by another sedative.
* Patients who develop complications that require termination of the imaging procedure will not be included in the dose or recovery time calculations, but the complication will be counted as such in their respective group and study will be reported as non-diagnostic.
* Insulin dependent diabetes
* Thyroid disease

Primary outcomes:
measure: to compare recovery time, complications and quality of the MRI studies when continuous infusion of propofol was used versus intermittent bolus dosing
timeFrame: study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
Study officials:
affiliation: Helen DeVos Children's Hospital
name: Nabil Hassan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04674059: A Descriptive Study on Patients With Bipolar Disorder in Rwanda
Official title: A Descriptive Study on Patients With Bipolar Disorder in Rwanda
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mental Disorder
Bipolar Disorder
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Rwanda
name: Mental Health Services in the Capital Region, Denmark
First posted: 2020-12-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatients with bipolar disorder in Rwanda

Brief summary: The aim is to provide a comprehensive assessment regarding the service provision and the accessibility to intensive mental health care in Rwanda

Detailed description: The aim is to provide a comprehensive assessment regarding the service provision and the accessibility to intensive mental health care in Rwanda for patients with bipolar disorder.

Knowing about the barriers to treatment, risk and protective factors as well as the current treatment offered for patients with bipolar disorder is essential for the development of therapeutic approaches and improvement in access to care. Up to now, no data on characteristics of patients with bipolar disorder in Rwanda and related risk and protective factors is available. For this purpose, all outpatients with bipolar disorder in Rwanda age \> 18 years, will over a 1-year period be invited to participate in a survey on their experience living with bipolar disorder in Rwanda. Moreover, patients and relatives will be invited for in-depth interviews to explore their perceptions and experiences with the mental health system. Health care providers will meet for focus discussions on to assess the experience, knowledge and practice of caregiving for individuals with bipolar disorder.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of Bipolar Disorder type I or II that meets DSM-V diagnostic criteria
* Age ≥ 18 years

Exclusion Criteria:

* None

Primary outcomes:
measure: Diagnoses
timeFrame: 1 year
measure: Diagnostic delay
timeFrame: 1 year
measure: Number of previous psychiatric hospitalisations
timeFrame: 1 year
measure: Number of previous crises
timeFrame: 1 year
measure: Types of medical treatment provided
timeFrame: 1 year
measure: Medical Adherence
timeFrame: 1 year
measure: The referral pathways
timeFrame: 1 year
measure: Degree of internal stigma
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Aarhus
name: Per Kallestrup, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT03331159: Evaluation of Fusion After ALIF With an Osteoinductive Material or With Homologus Bone
Official title: Evaluation of Fusion After Anterior Lumbar Interbody Fusion With a New Osteoinductive Bone Substitute Material: a First Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fusion of Spine, Lumbar Region
Keywords: Lumbar Fusion
Hydroxyapatite
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

Brief summary: The aim of this study was to determine whether instrumented anterior lumbar interbody Fusion with a new nanocrystalline hydroxyapatite embedded in a silica gel matrix (NH-SiO2) was associated with superior radiological and clinical outcomes at 12 months follow-up compared with instrumented ALIF with homologous bone

Detailed description: This randomized clinical trial included two groups of 20 mature patients with mono- or multisegmental degenerative disease of the lumbar spine who were suitable to undergo mono- or bisegmental ALIF fusion at the level L4/L5 and L5/S1 with a carbon fiber reinforced polymer ALIF cage filled with either NH-SiO2 or homologous bone (HB). Patients were followed 12 months postoperatively. The primary aim was to compare postoperative disability as measured by the Oswestry Disability Index (ODI). Secondary aims were to compare postoperative radiographic outcomes and differences in pain and quality of life between these groups.

Eligibility criteria: Inclusion Criteria:

* chronic low back pain
* sensorimotor deficits
* radiculopathy and spinal claudication symptoms, all caused by degenerative changes in the lumbar spine, which were resistant to conservative pain therapy and / or physiotherapy

Exclusion Criteria:

* previous surgeries in the abdominal Region
* previous fusion surgery in the lumbar spine.

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Fusion rate
timeFrame: 12 months after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06304259: Effect of Different Modalities of Cryotherapy on Post-Operative Pain in Patients With Symptomatic Irreversible Pulpitis
Official title: The Effect of Different Modalities of Cryotherapy on Post-Operative Pain Level in Patients With Symptomatic Irreversible Pulpitis (Randomized Control Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endodontic Disease
Endodontically Treated Teeth
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Problem statement: The post-operative pain after endodontic treatment. aim of study: The study is aiming to compare postoperative pain after submucosal cold saline injection (submucosal cryotherapy) (SMC) versus intra-canal cryotherapy (ICC) in mandibular single rooted premolars with symptomatic irreversible pulpitis with symptomatic apical periodontitis (SAP). The material and methods: Subjects and methods: sixty patients will be randomly divided into three groups: the SMC group, the ICC group, and the control group. The patients' postoperative pain will be recorded at 12, 24, and 48 hours postoperatively by questioning them. Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab.


Eligibility criteria: Inclusion Criteria:

* Older than age of 18 years
* Participants willing to commit for the entire period of the trial and Both genders
* agreed to sign the written consent after full explanation of the study
* Having a mandibular single rooted premolar tooth with vital pulp
* These patients were also suffering from symptoms of symptomatic irreversible pulpitis and apical periodontitis, intermittent or continuous sharp pain that lasts longer after removal of the stimulus. on the basis of the clinical symptoms of severe preoperative pain (visual analogue scale)

Exclusion Criteria:

* Vulnerable group; prisoners, pregnant females, mentally ill, etc...
* Teeth with open apices
* A previous root canal treatment
* Sinus tracts
* Presence of periodontal pockets \>3 mm in the affected tooth

Primary outcomes:
measure: postoperative pain
timeFrame: After 12 hours
measure: postoperative pain
timeFrame: After 24 hours
measure: postoperative pain
timeFrame: After 48 hours
Secondary outcomes:
measure: Substance P level
timeFrame: After 15 minutes from access cavity preparation
measure: Substance P level
timeFrame: After 30 minutes from access cavity preparation
measure: Substance P level
timeFrame: after 24 hour
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Ain shams University
Study officials:
References:
Clinical trial NCT02322359: Compression Is Life In Cardiac Arrest - Fatigue Study
Official title: Impact of a Feedback Device, CPRmeter®, on Chest Compression Quality During Extend Cardio-pulmonary Resuscitation. A Manikin Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Volunteers from University hospital of Caen pre-hospital unit

Brief summary: Context: Chest compressions represent an important physical effort leading to fatigue and cardiopulmonary resuscitation quality degradation. Despite a known harmful effect of chest compressions interruptions, current guidelines still recommend provider switch every 2 minutes. Feedback impact on chest compressions quality during an extended cardiopulmonary resuscitation remains to be assessed.

Study design: simulated prospective monocentric randomized crossover trial. Participants and methods: Sixty professionals rescuers of the pre-hospital care unit of University Hospital of Caen (doctors, nurses and ambulance drivers) are enrolled to performed 10 minutes of continuous chest compression on manikin (ResusciAnne®, Laerdal), twice, with and without a feedback device (CPRmeter®). Correct compression score (the main criterion) is defined by reached target of rate, depth and leaning at the same time (recorded continuously).

Hypothesis: Feedback device delay fatigue effect arises during cardiopulmonary resuscitation.


Eligibility criteria: Inclusion Criteria:

* Operational staff of University hospital of Caen pre-hospital unit

Exclusion Criteria:

* medical contraindication
* refusal

Primary outcomes:
measure: Correct compression score
timeFrame: 24h
Secondary outcomes:
measure: Decrease time of 30% of correct compression score
timeFrame: 24h
measure: chest compression deep
timeFrame: 24h
measure: chest compression rate
timeFrame: 24h
measure: percentage of chest compression without leaning
timeFrame: 24h
measure: percentage of chest compression with correct deep
timeFrame: 24h
measure: percentage of correct chest compression rate
timeFrame: 24h
measure: participants' fatigue (Borg's scale)
timeFrame: 24h
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital of Caen
Study officials:
affiliation: University Hospital of Caen
name: Clement BULEON, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00744159: Prospective Comparison of Immunological Benefit of Laparoscopic Colectomy
Official title: Prospective Comparative Study of Immunological Benefit Between Laparoscopic Colectomy and Open Colectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immunity
Keywords: colon cancer
laparoscopic colorectal surgery
cellular immunity
HLA-DR expression on monocyte
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2008-08-29
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospital based cohort

Brief summary: This study aimed to clarify existence of immunological benefit of laparoscopic colon cancer surgery compared to open colon surgery.

Detailed description: Patients with clinical stage Ⅲ left colon and upper rectal cancer were prospectively assigned to undergo LC (n=35) or OC (n=39). Factors related to cellular immunity of host (total lymphocyte count, CD4 lymphocyte, CD8 lymphocyte, CD4/CD8 ratio, HLA-DR expression on monocyte (mHLA-DR)) were examined preoperatively, on the 1st day of operation (POD1) and the 5th day of operation (POD5).

Eligibility criteria: Inclusion Criteria:

* Biopsy proven of colon cancer
* Preoperatively suspected as clinical stage III colon cancer
* Lesion located Descending colon, sigmoid colon and upper rectal cancer

Exclusion Criteria:

* Could not perform curative resection
* Intestinal obstruction, perforation, intra-abdominal abscess
* Severe medical illness
* Immunopathy

Primary outcomes:
measure: Immune factors
timeFrame: post OP 5th day
Secondary outcomes:
measure: Post-operative complications
timeFrame: POD 7th days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Department of surgery
Study officials:
affiliation: Samsung Medical Center
name: Woo Yong Lee, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05127759: The Efficacy and Safety of HLX208 in Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation
Official title: An Open Label, Multicenter Phase II Clinical Study to Evaluate Efficacy , Safety and PK of HLX208 in Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
mCRC
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2021-11-19
Enrollment: 25
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: The purpose of this study was to assess efficacy, safety and PK in metastatic colorectal cancer (mCRC) given HLX208 (BRAF V600E inhibitor).


Eligibility criteria: Inclusion Criteria:

1. Age\>=18Y;
2. Good Organ Function;
3. Expected survival time ≥ 3 months;
4. Metastatic/recurrent advanced BRAF V600E mCRC that have been diagnosed histologically and have failed first line treatment;
5. At least one measurable lesion as per RECIST v1.1;
6. ECOG score 0-1.

Exclusion Criteria:

1. Previous treatment with BRAF inhibitors or MEK inhibitors
2. Symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 6 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
3. Active clinical severe infection;
4. A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.

Primary outcomes:
measure: ORR
timeFrame: up to 2 years
Secondary outcomes:
measure: PFS
timeFrame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
measure: OS
timeFrame: from the date of first dose until the date of death from any cause，assessed up to 2 years
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
Study officials:
References:
Clinical trial NCT03296059: Transfusion of Red Blood Cells for Acute Respiratory Distress Syndrome(ARDS) in Neonates
Official title: Transfusion of Red Blood Cells for Acute Respiratory Distress Syndrome(ARDS) in Neonates: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Red Blood Cells(RBC)
Acute Respiratory Distress Syndrome (ARDS)
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2017-09-28
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute respiratory distress syndrome (ARDS) in neonates has been defined in 2017.

The death rate is over 50%.There are no special treatments for acute respiratory distress syndrome.

Detailed description: Acute respiratory distress syndrome (ARDS) is one of the serious complications in critically ill neonates. It can result in severe hypoxemia refractory to mechanical ventilation. There are few options for mechanical ventilation for such situations such as high frequency oscillation ventilation and extracorporeal membrane oxygenation. The aim of the present study is to determine whether transfusion of red blood cells can decrease the mortality in neonate with ARDS.

Eligibility criteria: Inclusion Criteria:

* diagnosed with neonatal ARDS.
* informed parental consent has been obtained

Exclusion Criteria:

* major congenital malformations or complex congenital heart disease
* transferred out of the neonatal intensive care unit without treatment

Primary outcomes:
measure: death rate
timeFrame: within 100 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
state: Chongqing
Study officials:
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: Shi Yuan, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01499459: Autologous Mesenchymal Stem Cell Transplantation in Liver Cirrhosis
Official title: Efficacy of Exvivo Expanded Autologous Mesenchymal Stem Cell Transplantation Via Peripheral Vein in Patients With Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhosis
Keywords: liver cirrhosis
autologous mesenchymal stem cell transplantation
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2011-12-26
Enrollment: 25
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
Primary purpose: TREATMENT

Brief summary: This study is aiming to investigate the efficacy of autologous mesenchymal stem cell (MSC) transplantation in 25 randomized patients with liver cirrhosis autologous mesenchymal stem cell will be derived from patients' bone marrows and will be infused via peripheral vein. Liver biopsies will be performed in every patient in the beginning and at 6th month.


Eligibility criteria: Inclusion Criteria:

* radiological, clinical and histopathological diagnosis of liver cirrhosis
* absence of hepatocellular carcinoma or any malignancies
* no psychiatric disorder
* no serous cardiovascular and pulmonary comorbidities
* serum total bilirubin levels less than 5 mg/dL
* platelet counts more than 30.000 mm3
* more than one year follow up period after initiation of antiviral drugs

Exclusion Criteria:

* alcohol intake in last one year
* initiation of antiviral medication in last one year
* systemic diseases

Primary outcomes:
measure: clinical improvement
timeFrame: clinical improvement parameters will be assessed six month after mesenchymal stem cell transplantation
Secondary outcomes:
measure: liver regeneration
timeFrame: 6.th month after MSC transplantation
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Military Medical Academy Department of Gastroenterology
Study officials:
affiliation: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
name: murat kantarcioglu, MD
role: PRINCIPAL_INVESTIGATOR
References: