louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04350528: Comparison of Chlorpromazine or Pentobarbital Premedications for Pediatric Imaging Procedures
Official title: Comparison of Sedation Using Pentobarbital or Chlorpromazine in Pediatric Non-invasive Imaging Procedure: A Before and After Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Children Sedation
Keywords: Sedation
Medical imaging
Children
Pentobarbital
Chlorpromazine
Efficacy
Safety
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 254
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children undergoing sedation for the purpose of imaging in the pediatric department of Brest hospital

Brief summary: Sedation is often required for pediatric medical imaging procedures to ensure compliance and quality images. Recommendations exist regarding pediatric sedation, but there are currently no guidelines regarding the choice of the sedative drug. We aim to compare the efficacy and adverse events of per os pentobarbital with intravenous chlorpromazine in children undergoing diagnostic imaging procedures.


Eligibility criteria: Inclusion Criteria:

* Children
* Sedation for the purpose of imaging
* Sedation using chlorpromazine or pentobarbital

Exclusion Criteria:

* Refusal to participate

Primary outcomes:
measure: Sedation success
timeFrame: During the procedure
Secondary outcomes:
measure: Induction time
timeFrame: During the procedure
measure: Hospitalization duration
timeFrame: Through procedure completion
measure: Duration of the imaging procedure
timeFrame: During the procedure
measure: Secondary effects
timeFrame: From Procedure until 2 days after
measure: Failure of pentobarbital sedation in children older than 5 years
timeFrame: During the procedure
measure: Failure of pentobarbital sedation in children with a behavioral disorder
timeFrame: During the procedure
measure: Failure of pentobarbital sedation in children under chronic antiepileptic treatment
timeFrame: During the procedure
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: Brest University Hospital in France
name: Juliette Ropars, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01877928: Post-extubation Boussignac CPAP System in Adults With Moderate to Severe Obstructive Sleep Apnea
Official title: Use of the Boussignac CPAP System Immediately Following Extubation to Improve Lung Function in Adults With Moderate to Severe Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea (OSA)
Keywords: Obstructive sleep apnea, CPAP, Boussignac
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2013-06-14
Enrollment: 48
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 assess the efficacy of the Boussignac positive airway pressure system (a mask) applied immediately following post-operative extubation in improving lung function in patients with obstructive sleep apnea (OSA). Assessments will be done before surgery and then at 1, 2 and 24 hours following extubation and will be compared to standard care for perioperative airway support. The study aims to give a broader and more inclusive picture (than the current literature) in terms of whether the Boussignac CPAP system should be considered for utilization by anesthesiologists caring for surgical patients with OSA.


Eligibility criteria: Inclusion Criteria:

-\> 18 years of age

* ASA II-IV
* Previous diagnosis of moderate to severe obstructive sleep apnea
* diagnosed via polysomnography
* BMI \< 40
* scheduled for an abdominal or peripheral surgical procedure requiring endotracheal intubation and admission to hospital

Exclusion Criteria:

* BMI \> 40
* Age \<18 years
* inability to provide signed informed consent
* intra-thoracic
* head or neck surgery
* contraindication for immediate post-extubation application of CPAP
* not expected to be eligible for timely extubation following the surgical procedure

Primary outcomes:
measure: percent forced vital capacity %(FVC)
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: % forced expiratory volume in 1 second (FEV1)
timeFrame: 1,2 and 24 hours post-operatively
Other outcomes:
measure: Peak expiratory flow rate (PEFV)
timeFrame: 1,2 and 24 hours postoperatively
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
Study officials:
affiliation: Queen's University & Kingston General Hospital
name: Kim E Turner, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04670328: Role of Hematological Parameters in the Stratification of COVID-19 Disease Severity
Official title: Role of Hematological Parameters in the Stratification of COVID-19 Disease Severity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Covid-19 disease
Neutrophil to Lymphocyte ratio
hematological manifestations
Lead sponsor: FMH College of Medicine and Dentistry
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 101
Sex: ALL
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diagnosed cases of covid-19

Brief summary: The hemostatic abnormalities in COVID-19 are related with disease progression, severity and mortality. The Objective of our study is to evaluate the role of hematological parameters in determination of COVID-19 disease severity.

Detailed description: Objective:

COVID-19 virus involves respiratory as well as other body systems including cardiovascular, gastrointestinal, neurological, immunological and hematopoietic system. Patient of covid-19 pneumonia presents with wide range of hemostatic abnormalities. These hemostatic abnormalities in COVID-19 are related with disease progression, severity and mortality. The Objective of our study is to evaluate the role of hematological parameters in determination of COVID-19 disease severity.

Material and Method:

This was a retrospective study, conducted in Department of Pathology and Department of medicine, FMH college of Medicine and Dentistry from May 2020 to July 2020. Total of 101, confirmed cases of covid-19 disease, both genders between 17 to 75-year age were included. Hematological parameters were compared in mild, moderate, severe and critical disease group. Continuous variables were analyzed by using non parametric, Kruskal Wallis test while categorical variables were analyzed by chi-square test.

Eligibility criteria: Inclusion Criteria:

* diagnosed cases of covid-19 disease
* Both genders
* 17 to 75 year age

Exclusion Criteria:

* known case of chronic liver disease
* known hematological diseases were excluded

Primary outcomes:
measure: complete blood count- Hemoglobin. White blood count, platelet count, Neutrophil to lymphocyte ratio
timeFrame: 3 months
Secondary outcomes:
measure: PT, APTT and D-dimer
timeFrame: 3 months
Other outcomes:
measure: LDH, serum ferritin level
timeFrame: 3 months
Locations:
city: Lahore
country: Pakistan
facility: FMH college of medicine and dentistry
state: Punjab
Study officials:
affiliation: FMH College of Medicine and Dentistry
name: Ayaz Lone, MBBS,FCPS
role: STUDY_CHAIR
References:
Clinical trial NCT05680428: Early Feeding Versus Conventional Feeding
Official title: Effectiveness of Early Feeding Versus Conventional Feeding After Stoma Reversal in Adult Surgical Surgical Practices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: DHQ mardan
Sponsor class: OTHER
Collaborators: name: DHQ HOSPITAL MARDAN
First posted: 2023-01-11
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare early feeding vs conventional feeding after stoma reversal. The main question it aims to answer are:

• whether it is beneficial to start oral feeding within 12hrs after stoma reversal

Participants will be randomly assigned two groups either early feeding or conventional group


Eligibility criteria: Inclusion Criteria:

* having ileostomy
* no peritonitis
* intestinal obstruction

Exclusion Criteria:

* uncontrolled diabetes
* uncontrolled hypertension
* sepsis

Primary outcomes:
measure: To evaluate the outcome of early versus conventional oral feeding in stoma reversal in terms of postoperative ileus
timeFrame: 5days
Secondary outcomes:
Other outcomes:
Locations:
city: Mardan
country: Pakistan
facility: DHQ
state: Kpk
Study officials:
affiliation: DHQ mardan
name: sajid khan, fcps
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04775628: Forces and Translation Distance During an Inferior Glide of the Shoulder
Official title: Forces and Translation Distance During an Inferior Glide of the Shoulder in Healthy Subjects Measured With the Novel Pliance Glove and Ultrasound Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asymptomatic Condition
Keywords: Manipulation force
Glenohumeral joint
Musculoskeletal Ultrasound Imaging
Lead sponsor: Florida Gulf Coast University
Sponsor class: OTHER
Collaborators: name: Mitchell Todd
name: J.P Speare
name: Eric Shamus
name: Arie van Duijn
First posted: 2021-03-01
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Within subject design
Primary purpose: DIAGNOSTIC

Brief summary: This study evaluates the force and translation distance in the GH joint during a manual inferior glide of the humerus.

Detailed description: There has been limited research on how the variance of force affects MT outcomes and what the best practices of MT should be. No specific force threshold necessary to achieve a predetermined translational distance within the joint has been quantified within the literature. The purpose of this study was to quantify the amount of force necessary to perform an inferior glide to the glenohumeral joint and reach to end-range. A secondary aim was to determine the impact of co-variables, such as gender, height, weight, and age, on the amount of force required to translate the humeral head within the glenohumeral joint. Musculoskeletal Ultrasound imaging using the GE LogiQe was used to measure the translation of the humeral head. The manipulation force was measured using the Novel Pliance Glove device and software.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Able to read the English language fluently

Exclusion Criteria:

* a history of injury of the right shoulder
* right shoulder surgery
* presence of shoulder pain
* comorbidities affecting natural ROM within the dominant shoulder

Primary outcomes:
measure: Translation
timeFrame: 5 minutes
measure: Force measure
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Florida Gulf Coast University
state: Florida
Study officials:
References:
Clinical trial NCT00913328: Effect of Add-on Montelukast to Inhaled Corticosteroids on Airway Responsiveness
Official title: Effect of Add-on Montelukast to Inhaled Corticosteroids in Excessive Airway Narrowing in Adults With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
Airway responsiveness
Dose-response plateau
Montelukast
Add-on to inhaled corticosteroids
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2009-06-04
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Leukotriene receptor antagonists appear to posses additive anti-inflammatory effects to the effect of inhaled corticosteroids.

Hypothesis: Treatment with oral montelukast will lower the dose-response plateau to inhaled methacholine in patients with mild to moderate persistent asthma treated with a stable dose of inhaled corticosteroids.


Eligibility criteria: Inclusion Criteria:

* Non-smoking adults with mild to moderate persistent asthma:

  * FEV1 \> 70 % pred
  * PD20 methacholine \< 3.9 mmol
  * treated for at least 3 months with a stable dose of inhaled corticosteroids
* Documented dose-response plateau to inhaled methacholine on two occasions
* Males and non-pregnant females

Exclusion Criteria:

* Asthma medication other than inhaled corticosteroids and inhaled b2-agonists
* Viral respiratory tract infections within the 3 weeks prior to enrollment

Primary outcomes:
measure: Changes from baseline in maximal FEV1 decline at the dose-response plateau
timeFrame: After 12 weeks of treatment
Secondary outcomes:
measure: Changes from baseline in PD20 methacholine
timeFrame: After 12 weeks of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Erasmus Medical Center
name: Zuzana Diamant, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Heart and Lung Diseases, Hvidovre Hospital, Denmark
name: Charlotte S Ulrik, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05855928: Effectiveness of ES and MT VS ES and PNF Technique Among Bells Palsy Patients
Official title: Effectiveness of Electrical Stimulation and Mime Therapy Versus Electrical Stimulation and PNF Technique Among Bells Palsy Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bell Palsy
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To determine the effectiveness of electrical stimulation with MIME therapy versus electrical stimulation with PNF technique for improving strength \& restoring lost motor function in the patients of Bell's palsy


Eligibility criteria: Inclusion Criteria:

* • Acute, unilateral, lower motor neuron bells palsy patient with house-backmann scale 4

  * Acute onset 1-3 weeks
  * Age group 20-40 years
  * Who were are willing to be a part of the study
  * Patients with the Bell's palsy (Facial paralysis , idiopathic facial paralysis and the herpetic facial paralysis)

Exclusion Criteria:

* • Patient who had the autoimmune disorder, tumors, recent head injury

  * The subject long with the surgery for ear and the fascial nerve palsy
  * Metal dental implants, and pregnant women
  * The patient with any peripheral vascular diseases
  * Central fascial palsy

Primary outcomes:
measure: Facial disability index(FDI) Scale
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Superior University CRC
state: Punjab
Study officials:
References:
Clinical trial NCT05862428: Rectal Misoprostol in Women Undergoing Total Abdominal Hysterectomy for Intraoperative Blood Loss Reduction
Official title: Rectal Misoprostol in Women Undergoing Total Abdominal Hysterectomy for Intraoperative Blood Loss Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraoperative Blood Loss
Lead sponsor: Queen Savang Vadhana Memorial Hospital, Thailand
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 56
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants were devided in two groups. The experimental group received rectal misoprostol before surgery and the control group not received the drug
Primary purpose: PREVENTION

Brief summary: Comparing of the intraoperative blood loss between group rectal misoprostol group and control group

Detailed description: This open-labeled randomized controlled trial was conducted at the Department of Obstetrics and Gynecology, Queen Savang Vadhana Memorial Hospital, Chonburi, Thailand, from February 2022 to September 2022, after approval of the Institution of Review Board of Queen Savang Vadhana Memorial Hospital (IRB No. 001/2565).

Fifty six (56) women with diagnosis of benign uterine disease who were scheduled to perform total abdominal hysterectomy with or without bilateral salpingo-oophorectomy between February 2022 to September 2022 at Queen Savang Vadhana Memorial Hospital were enrolled in this study.

The participants were randomly allocated into two groups, study and control group. The randomization list was kept in a sealed opaque envelope. Study group received two tablets of 200 mcg misoprostol; The drug was inserted rectally 1 hour before operation. Few drops of normal saline were used to dissolve tablets before insertion. Control group that did not receive the drug. The drug was administered by a nurse at Gynecologic ward. The primary outcome was intraoperative blood loss that recorded by measuring amount of blood on the surgical gauzes and swabs by standardized scales and another was recorded from blood in suction container. The secondary outcome was hemoglobin differentiation, rate of blood transfusion and adverse events of misoprostol usage.

Eligibility criteria: Inclusion Criteria:

Female undergoing total abdominal hysterectomy (elective case) with

* No history of bleeding tendency
* No history of anticoagulant drug used within 7 days before surgery
* No contraindications of Misoprostol drug used
* No history of allergic to misoprostol

Exclusion Criteria:

* Can not communicate with Thai language
* Malignancy case
* Emergency case

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: 7 months
Secondary outcomes:
measure: hemoglobin difference
timeFrame: 7 months
measure: Blood transfusion
timeFrame: 7 months
measure: Number of participants that have side effects of misoprostol
timeFrame: 7 months
Other outcomes:
Locations:
city: Chon Buri
country: Thailand
facility: Yingdhanai Pannaraj
state: Chonburi
Study officials:
References:
Clinical trial NCT00436228: To Study And Compare Bioavailability And Safety Of Four Different Formulations Of The Study Drug
Official title: An Open-Label, Randomized, Crossover Study to Estimate the Formulation Effect on the Relative Bioavailability of Single Dose Oral SB-742510 in Healthy Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Subjects
Keywords: healthy volunteer,
Bioavailability,
safety
Phase I,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-02-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: SB-742510 is a semi-synthetic pleuromutilin antibiotic that is being developed for treatment of respiratory infections.

The purpose of this study is to estimate the bioavailability of four different formulations and to evaluate the safety of each of the four formulations


Eligibility criteria: Inclusion Criteria:

* Healthy as determined by a responsible physician, based on medical evaluations performed at screening.
* Healthy adults between 18 and 60 years of age, inclusive.
* Body weight proportional to height.
* Capable of giving written informed consent.
* Female subjects must be of non-childbearing potential.
* QTc less than 450 msec at screening

Exclusion Criteria:

* Any clinically relevant abnormality identified on the screening history and physical or on the 12-lead surface electrocardiogram at screening or pre-dose.
* The subject has a positive pre-study alcohol/urine drug screen.
* History of regular use of tobacco, or nicotine-containing products.
* A positive pre-study HIV antibody, Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody result within 3 months of screening.
* Use of certain prescription or non-prescription drugs, including vitamins, herbal and dietary supplements.
* An unwillingness to comply with lifestyle and/or dietary restrictions.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: GSK Investigational Site
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03605628: Influence of Analgesia and Neuromuscular Block on Abdominal Distension and Operating Conditions Laparoscopic Operations
Official title: Influence of Analgesia and Neuromuscular Block on Abdominal Distension and Operating Conditions During Gynecologic Laparoscopic Operations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Blockade
Lead sponsor: Kreiskrankenhaus Dormagen
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Neuromuscular block improves operation conditions during laparoscopic surgery. In this study, a new measurement tool is assessed: the degree of abdominal distension during the time course of the neuromuscular block is measured and compared with a standardized score (surgical rating score).


Eligibility criteria: Inclusion Criteria:

* laparoscopic gynecologic surgery
* American Society of Anesthesiologists Physical Status ASA 1-2

Exclusion Criteria:

* anticipated difficult airway
* increased risk for pulmonary aspiration
* acute infection
* pregnancy
* impaired liver- oder kidney function
* neuromuscular disease
* chronic intake of drugs known to influence neuromuscular blockade

Primary outcomes:
measure: change in abdominal wall length (cm) during time course of the block
timeFrame: during operation
Secondary outcomes:
measure: Change of surgical Rating scale (SRS) scores during neuromuscular block
timeFrame: during operation
measure: changes of abdominal distension or surgical Rating score (SRS) induced by additional analgesics, sedatives or neuromuscular blocking agents
timeFrame: during operation
Other outcomes:
Locations:
city: Dormagen
country: Germany
facility: Kreiskrankenhaus Dormagen
Study officials:
affiliation: Kreiskrankenhaus Dormagen
name: Stefan Soltesz, MD
role: PRINCIPAL_INVESTIGATOR
References: