louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04524780: Use of Intracardiac Echocardiography or Left Atrial Appendage Radiography to Guide Implantation of a Left Atrial Appendage Occlusion Device.
Official title: Use of Intracardiac Echocardiography or Left Atrial Appendage Radiography to Guide Implantation of a Left Atrial Appendage Occlusion Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Left Atrial Appendage Occlusion
Lead sponsor: The Second Hospital of Hebei Medical University
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 60 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion, which were divided into two groups. The operation was performed under the guidance of intracardiac echocardiography and left atrial appendage radiography, respectively (allocation ratio 1:1).
Primary purpose: TREATMENT

Brief summary: A total of 60 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion, which were divided into two groups. The operation was performed under the guidance of intracardiac echocardiography and left atrial appendage radiography, respectively (allocation ratio 1:1). During the operation, the total amount of contrast medium injected, the fluoroscopy time and the time from femoral vein puncture to transseptal puncture to closure were recorded in all patients. The diameter and depth of the left atrial appendage opening were measured by angiography in group A(ICE group), and measured by ICE in group B(radiography group). The size of the occluder device was selected according to the measurement size of the two groups, the occluder device success rate of the two groups was compared, and the relationship between measurement size and the size of the occluder device was obtained.


Eligibility criteria: Inclusion Criteria:

patients taking class I and class III antiarrhythmic drugs could not prevent atrial fibrillation, patients younger than 80 years old Cha2ds2-vasc score ≥2 and Has-bled score ≥3, not suitable for long-term oral anticoagulant drugs.

Exclusion Criteria:

Patients with a history of atrial thrombosis or valvular heart disease (moderate or severe valve stenosis or severe valve regurgitation), patients undergoing prosthetic heart valve replacement, pregnant women, patients with previous liver and kidney diseases, malignant tumors or blood system diseases.

Primary outcomes:
measure: record contrast media as well as fluoroscopy time were recorded
timeFrame: in the procedure
measure: measure left atrial appendage opening and depth in different angles by intracardiac echocardiography
timeFrame: in the procedure
measure: measure left atrial appendage opening and depth in different angles by radiography
timeFrame: in the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Second Hospital of Hebei Medical University
state: Hebei
Study officials:
References:
Clinical trial NCT04964180: Rectal Indomethacin Versus Intraperitoneal Lidocaine for Analgesia After Laparoscopic Cholecystectomy
Official title: Rectal Indomethacin Versus Intraperitoneal Lidocaine for Analgesia After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Operative Pain
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hospitals, Qena, Egypt in period between May 2020 to May 2021.eighty patients was scheduled to elective laparoscopic cholecystectomy , divided Into two groups randomly using closed envelop method. Group IP lidocaine(40 patients ) received 200 ml saline containing 200 mg 2%lidocaine immediately after abdominal cO2 insufflation( pneumoperitoneum) the surgeon sprayed the total solution on the upper surface of the liver under the right subdiaphragmatic space, left subdiaphragmatic space and around the cholecystectomy site , all patients were maintained in trendelenberg position.

At the end of the laparoscopic procedure, group indomethacin (40 patients) recived two 100 mg indomethacin rectal suppositories 2 hours prior to surgery


Eligibility criteria: Inclusion Criteria:

* .ASA physical status 1-2 patients.
* 18-60 years old .

Exclusion Criteria:

* using or allergic to nonsteroidal anti inflammatory drugs (NSAIDs) or aspirin .
* history of serious hepatic disease.
* renal or gastrointestinal disease.
* bleeding disorder.
* body mass index BMI \<18 or ˃30 m2/kg.
* history of abdominal surgery or chronic pain disorder other than gallbladder.
* disease or allergy to lidocaine.

Primary outcomes:
measure: VAS scores postoperative
timeFrame: 24 hours posoperative
measure: postoperative opoiods analgesics requirements
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Pain starting time after surgery and Pethidine required first time.
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: Gad sayed Gad
state: Qena
Study officials:
References:
Clinical trial NCT00763880: Hematoma Block as an Adjunct to Procedural Sedation for Forearm Fracture Reduction
Official title: Hematoma Blocks in Forearm Fractures: An Effective Adjunct to Procedural Sedation?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Forearm Fracture
Keywords: Hematoma block
Lidocaine
Forearm fracture
Radius fracture
Ulna fracture
Ketamine
Midazolam
Procedural sedation
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2008-10-01
Enrollment: 89
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of our study is to determine if the use of a hematoma block together with intravenous sedation and analgesia is an effective means of managing forearm fractures in the Emergency Department. To determine this, we have designed a randomized, double-blind, placebo controlled trial of hematoma block versus saline for the manipulation of forearm fractures under conscious sedation with ketamine and midazolam. Our hypotheses are two-fold: First, the use of a hematoma block together with conscious sedation will allow for improved pain control. Second, the use of a hematoma block together with conscious sedation will allow us to use less sedation, therefore promoting faster recovery from sedation and more efficient patient turnover in the Emergency Department.


Eligibility criteria: Inclusion Criteria:

* English or Spanish speaking
* Ages 3-17
* Closed distal forearm fracture requiring reduction under sedation in the Emergency Department
* Fracture involves the distal third of the forearm

Exclusion Criteria:

* Multiple trauma victims
* Associated nerve or vascular damage
* Associated elbow or humerus injury
* Sensitivity or allergy to lidocaine
* Contraindications to procedural sedation
* Previous attempts at reduction for the same injury

Primary outcomes:
measure: Total sedation time
timeFrame: Evaluated upon completion of procedure
Secondary outcomes:
measure: Non-union
timeFrame: 1 month
measure: Need for re-manipulation
timeFrame: 1 week
measure: Adverse effects of sedation
timeFrame: For the duration of the procedure
measure: Adverse effects of hematoma block
timeFrame: 1 month
measure: Pain control
timeFrame: For entire duration of procedure
Other outcomes:
Locations:
city: Providence
country: United States
facility: Hasbro Children's Hospital/Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Erika Constantine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01712880: Treatment of Acute Periprosthetic Total Hip Arthroplasty Infections
Official title: The Treatment of the Acute Periprosthetic Hip Infection After Uncemented Total Hip Arthroplasty: A Randomized Study Comparing Open Debridement Component Retention (ODCR) With Modular Exchange Versus One Stage Exchange Arthroplasty
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Periprosthetic Infection Total Hip Arthoplasty
Lead sponsor: OrthoCarolina Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: Midwest Orthopaedics at Rush
name: University of California, San Francisco
name: Emory University
First posted: 2012-10-24
Enrollment: 0
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 determine the success rate of two treatments for infection after total hip replacement: single stage arthroplasty exchange (your surgeon will take out your original implants and replace them with a complete new set) compared to irrigation and debridement with modular exchange (your surgeon will clean your implants with a surgical solution and take out the plastic liner and replace it with a new one - the rest of your hip implants will stay in place). The goal is to see if one is better than the other for the treatment of hip infection after a total hip replacement. A successful treatment means that you did not have to have another surgery on your hip for an infection-related reason.


Eligibility criteria: Inclusion Criteria:

1. Return to the OR for a drainage procedure within six weeks of index primary uncemented arthroplasty 1a) Exam findings within six weeks of index operation:

   * Drainage for more than 7 days
   * Wound appearance consistent with deep infection or hematoma
   * Persistent fever or evidence of bacteremia
   * All patients currently deemed appropriate for irrigation and debridement
2. Labs

   - Rising inflammatory seromarkers
3. Aspiration with a positive culture

Exclusion Criteria:

1. Previous history of periprosthetic infection
2. Prisoners
3. Patients not willing to consent for the proposed treatment
4. Patients with altered mental status
5. Concurrent metastatic infection
6. Superficial Infection

Primary outcomes:
measure: Success
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina Research Institue
state: North Carolina
Study officials:
References:
Clinical trial NCT02002780: Recognizing and Treating Psychosocial Stress Among Children With Complex Heart Problems
Official title: Recognizing and Treating Psychosocial Stress Among Children With Complex Heart Problems
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Psychosocial Stress
Keywords: pediatrics
stress
cardiac surgery
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2013-12-06
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research project has two goals. The first goal is to find one or more questionnaires that can accurately identify children who are experiencing high levels of stress or emotional health issues during a regular clinic visit. The second goal is to find out whether children who are experiencing stress or emotional health problems are able to attend a day camp programme and complete activities at home that are designed to help them cope better with stress. We also want to find out if the day camp and home activities are helpful.

Detailed description: This research will investigate the psychological stress experienced by children who have had surgery for a complex heart problem. Measures of quality of life among children with heart problems indicate that those 8 to 12 years of age have lower quality of life scores than younger or older children.

Children who survive a critical illness requiring a multi-day stay in a pediatric intensive care unit are at risk for a variety of psychiatric morbidities. Depression, anxiety and post-traumatic stress disorder occur in 7% to 28% of patients.

A systematic review of psychological adjustment among children with heart problems indicates that parent reports (but not child self-reports) are useful in detecting problems with psychological adjustment. While parent reports tend to identify increased social and behaviour problems, child self-reports indicate more frequent symptoms of depression compared to healthy peers.

Eligibility criteria: Inclusion Criteria:

* children who have had surgery for a complex heart problem
* children with heart problems requiring on-going medical care
* age 6 to 12 years

Exclusion Criteria:

* the child has had an intervention (catheterization or surgery) within the previous 6 months,
* the child has an identified cognitive or emotional health disability,
* the child or parents do not speak English sufficiently well to respond to the screening instruments, or
* the child's clinic visit is for an acute illness or change in health status.

Primary outcomes:
measure: Change in psychosocial stress scores resulting from the intervention
timeFrame: Baseline and end of study (at about month 10 -11)
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Brian McCrindle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01186380: Safety of the PET-512MC Transesophageal Transducer
Official title: Safety of the PET-512MC Transesophageal Transducer (TEE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transesophageal Transducer
Keywords: TEE
Transesophageal
Transducer
Esophagus
Ease of passage and during transitioning into and down the esophagus to complete a normal TEE study
Lead sponsor: Toshiba America Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients ages 18 and above

Brief summary: The objective of this Study is to demonstrate the safety of the PET-512MC TEE transducer as it is inserted and transitioned into the esophagus through the mouth.

Detailed description: The PET-512MC is a multiplane transesophageal transducer designed for use with Toshiba Diagnostic Ultrasound Systems for the visualization of the heart (and other organs) as a real-time ultrasound image. It is inserted into the esophagus through the mouth to visualize a plane of the heart through the esophageal wall.

The purpose of this Study is to demonstrate the safety of the PET-512MC TEE transducer and gather feedback from the investigators related to the insertion of the transducer. The data will be used to determine the usability of the transducer in the clinical environment.

Eligibility criteria: Inclusion Criteria:

* Adult male and female patients ages 18 and above who have been scheduled for a TEE procedure by their physician
* Informed consent understood and signed
* Compliance with post-treatment and follow-up protocol requirements

Exclusion Criteria

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
Study officials:
affiliation: Christ Hospital
name: Gregory B Clarke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01718080: The Effects of Puberty and Weight on Sugar Metabolism in Children
Official title: The Role of Puberty and Insulin Resistance in the Development of Hyperglucagonemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight
Leanness
Adolescent
Keywords: Obese, Lean, Pubertal, Prepubertal, Glucose, Adolescents, Type 2 Diabetes
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2012-10-31
Enrollment: 83
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prepubertal and pubertal subjects.

Brief summary: Our goal is to investigate how hormones that control blood sugar, hunger, and stomach emptying change with puberty and being overweight. These substances change with a meal.

* For this, we need to compare lean and overweight children.
* We need to study them before and during puberty.
* All children in the study will be tested before and after a liquid meal.


Eligibility criteria: Inclusion Criteria:

All groups:

Healthy lean and otherwise healthy overweight children and adolescents between the ages of 8 and 17.

Exclusion Criteria:

Same for all groups

The subjects will be excluded if they have:

* a history of chronic disease
* allergy to acetaminophen
* evidence or history of chemical abuse
* abnormal lab values
* pregnancy

Primary outcomes:
measure: Overweight and Lean Children Sugar Metabolism Before and During Puberty
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Luisa M. Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05755880: Low Dose Dexamethasone to Local Anesthetic in Caudal Analgesia on Healing Process After Orthopaedic Surgery
Official title: Effect of Addition of Single Low Dose Dexamethasone to Local Anesthetic in Caudal Analgesia on Healing Process After Pediatric and Adolescent Orthopaedic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 60
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: Addition of dexamethasone to local anesthetics infiltration has been proven to augment postoperative analgesia, prolongs anesthesia time and sometimes reduces the needed dose of local anesthetics and consequently, decreases their side effects and enhances early ambulation and hospital discharge (mainly due to decreased need for opioid use

Detailed description: Long-term corticosteroids prescribing was associated with many adverse effects, as increased skin pigmentation, lowering immunity (catching opportunistic infections like herpes zoster, candida and cutaneous abscesses or even flaring localized infections), resistant hyperglycemia, renal impairment, hypertension, impaired healing, thinning skin that bruises easily, adrenal gland suppression, facial erythema, stria, acne, mild hirsutism, blurring vision, muscle weakness, glaucoma, cataract, thinning of hair, osteoporosis, and psychiatric disturbances (including mood fluctuations, depression or manic disorders).

Localized infection at site of injection is a known logical absolute contraindication for any injection including corticosteroids due to fearing of flaring of infection. Also, there is no single published article discussing an infection due to corticosteroids injection as an adjuvant to local anesthetics as it is always explained by inadequate aseptic technique performance.

In this study we will search if there is a role for corticosteroids in delaying healing process after orthopedic surgery. And compare the incidence of postoperative infection after surgery.

Eligibility criteria: Inclusion Criteria:

* 1. Age: 1month up to 18 years old 2. Orthopaedic surgeries with average time up to one hour 3. Traumatic and orthopaedic indications for surgery

Exclusion Criteria:

1- Open fractures 2. Infected surgery 3. Hypersensitivity to dexamethasone 4. Bad nutritional conditions as Marasmus, Cerebral palsy and Kwashiorkor

Primary outcomes:
measure: Visual analogue scale
timeFrame: 30 minutes after recovery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Choi S, Rodseth R, McCartney CJ. Effects of dexamethasone as a local anaesthetic adjuvant for brachial plexus block: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2014 Mar;112(3):427-39. doi: 10.1093/bja/aet417. Epub 2014 Jan 10.
Clinical trial NCT05774080: An Observational Study of Patients with Chronic Gastrointestinal Disease
Official title: An Observational Study of Patients with Chronic Gastrointestinal Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gastrointestinal Diseases
Lead sponsor: Target PharmaSolutions, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-17
Enrollment: 500000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include adults who are being managed for the chronic GI diseases EGIDs, UC or CD.

Brief summary: TARGET-GASTRO is an observational research study to conduct a comprehensive review of outcomes for patients with the chronic gastrointestinal (GI) diseases: eosinophilic gastrointestinal disease (EGID), ulcerative colitis (UC) or Crohn's disease (CD).


Eligibility criteria: Disease Cohort

Inclusion Criteria:

* Adult\* patients at the time of enrollment with a diagnosis or major symptom of EGIDs, UC, or CD by ICD-10 code in the EHR interface

Exclusion Criteria:

* Death
* Manual removal (sponsor or site request)
* No EHR interface encounter \> 3 years.

Engaged Cohort

Inclusion Criteria:

* Adult\* patients diagnosed and managed for these conditions invited to participate
* Ability to provide written informed consent

Exclusion Criteria:

* Patient expressed desire to withdraw consent to complete PROs
* Failure to complete PROs within 24 weeks of initial invitation
* Greater than 24 months lapse of survey completion after baseline surveys completed
* Additionally, the criteria detailed for Disease Cohort apply to the Engaged Cohort.

Primary outcomes:
measure: To characterize the natural history of disease in patients with GI disease from various etiologies
timeFrame: 20 Years
measure: To assess safety and effectiveness of treatments
timeFrame: 20 Years
Secondary outcomes:
measure: To evaluate provider management practices in the treatment of patients with EGIDs, UC and CD
timeFrame: 20 Years
measure: To evaluate longitudinal and patient reported outcomes in patients with EGIDs, UC and CD
timeFrame: 20 Years
measure: To select and evaluate quality of care measures for patients with GI Diseases
timeFrame: 20 Years
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health/Wake Forest University School of Medicine
state: North Carolina
Study officials:
References: