louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05758974: Postoperative Complication After G.A
Official title: Postoperative Complications in Children Following Dental General Anesthesia and it's Correlation With The Type of Dental Treatment Done.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Complication of Anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 110
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children will be selected from general anaesthesia unit of Pediatric Dentistry Department, Faculty of Dentistry, Cairo University aged from 3-6 years according to the eligibility criteria.

Brief summary: What are the possible postoperative complications that may occur for children following dental treatment under general anaesthesia and is there a correlation between those complications and type of dental treatment done?

Detailed description: Nowadays, early childhood caries (ECC) remains a significant challenge of public health in Egyptian children. In most cases, children with ECC could accept dental treatment under non-pharmacological behavior management or sedation. However, some very young children or those suffering severe anxiety, mental or physical disabilities, could only be treated under dental general anesthesia (DGA).

Dental general anesthesia (DGA) is a safe and high-quality restorative and preventive treatment option for children with severe early childhood caries (S-ECC), who require extensive dental treatment and exhibit anxiety and emotional or cognitive immaturity or are medically compromised. However, several postoperative complications have been reported in children under DGA in many studies.

For a day-stay, general anesthesia procedure to be an acceptable option, care during and after surgery must be of the highest quality, and postoperative complications must be minimized.

Eligibility criteria: Inclusion Criteria:

1. Children with age range from 3 to 6 years old .
2. Children affected by dental caries in more than 4 primary teeth.
3. Uncooperative child indicated for treatment under G.A
4. Classified by American Society of Anaesthesiologists Physical Status as Class 1
5. Parents accepted to participate and willing to sign an informed consent.

Exclusion Criteria:

* 1) The children whose guardians or caregivers have a problem in communicating with the medical staff

Primary outcomes:
measure: Postoperative pain
timeFrame: Baseline
Secondary outcomes:
measure: Fever
timeFrame: Baseline
measure: Weariness and drowsiness
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
citation: Deng XY, Zhang YH, Zou J, Zhang Q. [Investigation of postoperative complications in children after dental therapy under general anesthesia]. Hua Xi Kou Qiang Yi Xue Za Zhi. 2020 Jun 1;38(3):284-289. doi: 10.7518/hxkq.2020.03.010. Chinese.
Clinical trial NCT02536482: Free Amino Acid-based Formula to Treat Children Cow's Milk Protein Allergy
Official title: Tolerability to a New Free Amino Acid-based Formula in Children With Cow's Milk Protein Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cow's Milk Allergy
Lead sponsor: Edetec Indústria Alimentícia S.A.
Sponsor class: INDUSTRY
Collaborators: name: Faculdade de Ciências Médicas de Minas Gerais
name: Federal University of Minas Gerais
First posted: 2015-08-31
Enrollment: 15
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is a study to assess the tolerance to a new commercially available infant formula in children affected by Cow's Milk Allergy.

Detailed description: In the present study, the children will be followed-up during the treatment with the new formula for Cow's Milk Allergy. They will have monthly doctor's appointment, when the weight, height and symptoms will be evaluated, by a questionnaire and a physical examination.

Eligibility criteria: Inclusion Criteria:

* Children with cow's milk allergy

Exclusion Criteria:

* Children without cow's milk allergy

Primary outcomes:
measure: Study to assess the allergic symptoms, using a questionnaire.
timeFrame: 5 months
Secondary outcomes:
measure: Weight assessment, using a digital infant scale
timeFrame: 5 months
measure: Height assessment, using an infantometer
timeFrame: 5 months
measure: Head circumference, using an infant tape measure
timeFrame: 5 months
Other outcomes:
Locations:
Study officials:
affiliation: UFMG
name: Wendel O Afonso, Master
role: STUDY_DIRECTOR
References:
citation: Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
Clinical trial NCT01301482: Ear Acupuncture for Acute Sore Throat in Patients Unable to Take Non-steroidal Anti-inflammatory Agents (NSAIDs)
Official title: Ear Acupuncture for Acute Sore Throat in Patients Unable to Take Non-steroidal Anti-inflammatory Agents (NSAIDs)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Sore Throat
Keywords: Acute Sore Throat
Ear Acupuncture
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2011-02-23
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effect of ear acupuncture alone in subjects with a contraindication to anti-inflammatory medications in the reduction of pain and hours lost from work in acute sore throat.


Eligibility criteria: Inclusion:

* Male and female subjects (DoD beneficiaries), 18 years or older, with upper respiratory complaints and their primary symptom being acute sore throat.
* Minimum pain score of 5 points on a 11 point scale (0-10 with 10 being the worst pain)

The above with any one of the following:

* Allergy to Non-Steroidal Anti-inflammatory agents (NSAIDs)
* History of significant gastrointestinal bleed
* Previous documented history of stage 2 kidney disease or worse
* History of gastric bypass surgery
* Chronic oral steroids use

Exclusion:

* Absence of one or more ears
* Known Pregnancy
* Known Peritonsillar abscess (PTA)
* Throat, mouth or esophageal cancer
* Active cellulitis of ear
* Ear anatomy precluding identification of acupuncture landmarks
* Use of Hearing Aids that preclude the use of ear acupuncture
* Non-English speaking

Primary outcomes:
measure: Reduction in Pain on Numeric Pain Rating Scale
timeFrame: initial, 15 minute post, 6 hours post, 24 hours post, 48 hours post
Secondary outcomes:
Other outcomes:
Locations:
city: Nellis Air Force Base
country: United States
facility: Mike O'Callaghan Federal Hosptial
state: Nevada
Study officials:
affiliation: Mike O'Callaghan Federal Hospital/Nellis Air Force Base
name: David Moss, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05621382: A Comparison of Radiographic and Visual Analysis Methods for Determining Pelvic Misalignments.
Official title: A Comparison of Radiographic and Visual Analysis Methods for Determining Pelvic Misalignments.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gonstead, Chiropractic, Pelvic Analysis
Lead sponsor: Sherman College of Straight Chiropractic
Sponsor class: OTHER
First posted: 2022-11-18
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients who presented at a chiropractic college health center who were receiving x-rays as part of their care plan.

Brief summary: This study looks to compare pelvic misalignments visualized during patient inspection to actual pelvic misalignments derived from x-ray mensuration.

Detailed description: This study looks to compare pelvic misalignments of 30 subjects visualized before x-ray set up to the actual misalignments derived from x-ray mensuration. 30 outpatients at the Sherman College of Chiropractic Health Center were randomly chosen to participate, and were having x-rays taken as part of their normal course of care in order prevent unnecessary radiation exposure. Patients were told to march in place as they were positioned to the x-ray bucky. Once the patient was set to the bucky, the bucky was moved out of the way and the patient was visualized by a health center intern. The intern evaluated gluteal widths, gluteal fold heights, and foot flare. The bucky was then replaced without patient movement and x-rays were then taken. Two doctors with experience in Gonstead line analysis for the pelvis who were blinded to the x-ray findings, measured pelvic misalignments and the results were compared to the visual analysis.

Eligibility criteria: Receiving x-rays as part of their normal course of care at the Sherman College of Chiropractic Health Center - There were no exclusion criteria

-

Primary outcomes:
measure: A Comparison of Radiographic and Visual Analysis Methods for Determining Pelvic Misalignments.
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Spartanburg
country: United States
facility: Sherman College of Chiropractic
state: South Carolina
Study officials:
References:
Clinical trial NCT03439982: Fecal Transplant for Hepatic Encephalopathy
Official title: A Prospective Single Center Open Label Trial of RBX2660 (Microbiota Suspension) in the Management of Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hepatic Encephalopathy
Keywords: Hepatic encephalopathy, fecal microbiota transplant
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Rebiotix Inc.
First posted: 2018-02-20
Enrollment: 3
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 the study is to determine if fecal microbiota transplant (FMT) can reverse hepatic encephalopathy (HE) in cirrhotic patients who continue to have breakthrough episodes of HE despite maintenance therapy with lactulose and/or rifaximin or metronidazole.

Detailed description: Subjects receive FMT from a single donor by colonoscopy at week 0 and by enema at weeks 1-4. HE is measured by Inhibitory Control Test (ICT) and Stroop test as well as fasting serum ammonia levels.

Eligibility criteria: Inclusion Criteria:

* Adult cirrhotic patients of various etiology on lactulose and/pr rifaximin or metronidazole for minimum 4 weeks as secondary prophylaxis
* Abnormal ICT (\>5 lures) or abnormal Stroop test (\>200 seconds)
* Baseline Conn score 0 or 1
* Infectious etiology of HE has been ruled out

Exclusion Criteria:

* those with tense ascites
* those who do not provide assent
* life expectancy \<3 months
* TIPS within the past 3 months
* neurologic disease such as dementia, Parkinson's, structural brain lesions
* pregnancy
* intestinal obstruction
* alcoholic hepatitis
* active alcohol or substance abuse
* those without stable social support
* concurrent infection such as spontaneous bacterial peritonitis, pneumonia or urinary tract infection
* creatinine clearance less that 50% compared to baseline
* hospital admission for HE within one month of enrollment
* active hepatocellular carcinoma
* active GI bleed

Primary outcomes:
measure: Portion of participants with normalization of ICT or Stroop Test during the study
timeFrame: 8 weeks
Secondary outcomes:
measure: Proportion of patients with normalization ICT or Stroop test scores at 1 week, 2 weeks, 4 weeks and 8
timeFrame: 8 weeks
measure: Changes in serum ammonia level pre and post FMT
timeFrame: 8 weeks
measure: Changes in Quality of Life measured by Chronic Liver Disease Questionnaire (CDLQ) pre and post FMT
timeFrame: 8 weeks
measure: Change in Intestinal Microbiota pre-and post FMT
timeFrame: 8 weeks
measure: Serious Adverse Events
timeFrame: 8 weeks
measure: Change in stool Bile Acids Composition pre and post FMT
timeFrame: 8 Weeks
measure: Changes in stool short chain free fatty acids pre and post FMT
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: Associate Professor
name: Dina Kao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03948282: Ultrasound Assessment of the Inferior Vena Cava in Children
Official title: Ultrasound Assessment of the Inferior Vena Cava in Children; Comparison of Sub-xiphoid and Right Lateral Coronal Views During Spontaneous Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 51
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children undergoing elective dental surgery.

Brief summary: This is a prospective, non-blinded observational study to compare measurement of inferior vena cava (IVC) dimensions with two placement sites of the ultrasound probe (sub-xiphoid and the side or right lateral position).


Eligibility criteria: Inclusion Criteria:

* ASA 1-2 patients scheduled for elective dental surgery under general anesthesia.

Exclusion Criteria:

* History of significant pulmonary disease, cardiac disease, and laparotomy.

Primary outcomes:
measure: IVC diameter
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT03888482: Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 2
Official title: Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Myopia
Keywords: Visual acuity
VA
Daily disposable contact lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2019-03-25
Enrollment: 154
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 purpose of this study was to evaluate visual acuity at distance when wearing DDT2 contact lenses compared to Clariti contact lenses.

Detailed description: Subjects were expected to attend 3 study visits and wear the DDT2 and Clariti study lenses in a crossover design for approximately 14 - 20 days (7 - 10 days for each product).

Eligibility criteria: Key Inclusion Criteria:

* Able to understand and sign an Informed Consent Form that has been approved by an Institutional Review Board.
* Willing and able to attend all scheduled study visits as required per protocol.
* Current wearer of spherical soft contact lenses.

Key Exclusion Criteria:

* Any ocular condition that contraindicates contact lens wear.
* Previous or current habitual wearer of clariti® or DAILIES TOTAL1® contact lenses.

Primary outcomes:
measure: Least Squares Mean Distance Visual Acuity With Study Lenses
timeFrame: Day 8, each product
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Alcon Investigative Site
state: Florida
city: Maitland
country: United States
facility: Alcon Investigative Site
state: Florida
city: Orlando
country: United States
facility: Alcon Investigative Site
state: Florida
city: Bloomington
country: United States
facility: Alcon Investigative Site
state: Illinois
city: Powell
country: United States
facility: Alcon Investigative Site
state: Ohio
city: Warwick
country: United States
facility: Alcon Investigative Site
state: Rhode Island
city: Brentwood
country: United States
facility: Alcon Investigative Site
state: Tennessee
city: Memphis
country: United States
facility: Alcon Investigative Site
state: Tennessee
Study officials:
affiliation: Alcon Research, LLC
name: CDMA Project Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT04525482: Application of Early Goal-directed Sedation in Patients With Severe Brain Injury
Official title: Application of Early Goal-directed Sedation in Patients With Severe Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries, Traumatic
Keywords: Brain Injuries
Early Goal-directed Sedation
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: EGDS management strategy was implemented in ICU patients with severe brain injury, the depth of sedation and GCS score were monitored, and the protective effects of EGDS strategy and standard sedation strategy on the brain of patients with severe brain injury were discussed.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of severe craniocerebral injury
* The GCS score is 6 to 12 points
* Within 12 hours of intubation
* The mechanical ventilation time is greater than 24 hours
* Obtain written consent

Exclusion Criteria:

* Pregnant women
* Acute liver failure
* Dementia or mental illness

Primary outcomes:
measure: Richmond Agitation-Sedation Scale
timeFrame: through study completion, an average of 2 year
measure: Mechanical ventilation time
timeFrame: through study completion, an average of 2 year
measure: length of stay in ICU
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: complication
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05283382: Cannabidiol Effects on Learning and Anxiety
Official title: Cannabidiol Effects on Learning and Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Anxiety and Fear
Keywords: social anxiety
fear conditioning
cannabidiol
electrodermal response
Lead sponsor: University of Connecticut
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Drug group vs. Placebo group
Primary purpose: BASIC_SCIENCE

Brief summary: To examine the extent to which Cannabidiol (CBD) enhances fear conditioning extinction in college undergraduates who show elevated social anxiety. Undergraduates who display elevated social anxiety on standard assessments will be recruited at the University of Connecticut. All participants will be put in a standard fear conditioning paradigm where they are conditioned to fear a face that occasionally is followed by a shock to their wrist. The other face never is paired with a shock. After everybody learns this, half of the participants will receive 600 mg CBD Isolate Gel Capsules one time, and the other half will receive a placebo dose. Participants will then be presented with the faces with no shocks, and the rate and duration of extinction as measured by electrodermal response as well as subjective fear ratings via a visual analogue scale will be examined. It is hypothesized that participants that receive CBD will display enhanced extinction compared to the placebo group, as evidenced by reduced electrodermal response and reduced visual analogue fear ratings.


Eligibility criteria: Inclusion Criteria:

* 18-50 years of age

Exclusion Criteria:

1. Difficulties seeing a computer screen
2. Anyone currently taking CBD within the last 24 hours.
3. Anyone using any cannabis product within the last 24 hours.
4. Heart problems or heart disease
5. A neurological disorder such as epilepsy, stroke, multiple sclerosis, tumor, vascular malformations, aneurysm
6. Are currently pregnant or breast-feeding

Primary outcomes:
measure: Electrodermal activity
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
References:
Clinical trial NCT06728982: Impact Of Metformin In Rectal Cancer Patients
Official title: Impact of Metformin on Complete Pathological Response in Rectal Cancer Patients Receiving Neoadjuvant Concurrent Chemoradiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Rectal Cancer Patients
Keywords: metformin
complete pathological response
rectal patient
neoadjuvant chemoradiotherapy
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized into two groups:

Group A: Patients will receive standard chemoradiotherapy(CRT).

Group B: Patients will self-administer 1000mg of metformin twice daily by mouth:

1. beginning 1-2 weeks before standard CRT.
2. during standard CRT.
3. until 30 days after the end of standard CRT.
Primary purpose: TREATMENT

Brief summary: Design: Prospective, randomized controlled clinical trial Setting: at Minia University Hospital and Minia Oncology Institute. Condition: Colorectal cancer.

To be eligible for participation, patients must meet the following criteria:

1. Histologically confirmed diagnosis of rectal adenocarcinoma.
2. Age starting from 18 and older.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
4. Adequate organ function (renal, hepatic, and hematological)
5. Signed informed consent.

Patients will be randomized into two groups:

Group A: Patients will receive standard chemoradiotherapy(CRT).

Group B: Patients will self-administer 1000mg of metformin twice daily by mouth:

1. beginning 1-2 weeks before standard CRT.
2. during standard CRT.
3. until 30 days after the end of standard CRT.


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed diagnosis of rectal adenocarcinoma.
2. Age starting from 18 and older.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
4. Adequate organ function (renal, hepatic, and hematological)
5. Signed informed consent.

Exclusion Criteria:

1. Metastatic disease.
2. Contraindications to metformin.
3. Significant comorbidities or medical conditions that may interfere with study participation. (D.M, PCO,..)
4. eGFR less than 30 mL/min.
5. Pregnant or breastfeeding women.

Primary outcomes:
measure: Pathological Complete Response (pCR) rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia Oncology Center
city: Minya
country: Egypt
facility: Minia University Hospital
Study officials:
affiliation: Deraya University
name: Omar M Awad, Bsc
role: PRINCIPAL_INVESTIGATOR
affiliation: Minia University
name: Fatma M Mady, professor
role: STUDY_CHAIR
affiliation: Minia University
name: Mona A Saber, PhD
role: STUDY_DIRECTOR
References: