louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04740294: Efficacy of Magnesium Sulfate Bolus in Pediatric Patients With Bronchiolitis
Official title: Efficacy of Magnesium Sulfate Bolus in Pediatric Patients With Bronchiolitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Bronchiolitis, Viral
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized placebo-controlled pilot study with 1:1 randomization
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to more rigorously evaluate the response to a single bolus of magnesium sulfate in a population of patients with moderate to severe bronchiolitis. The primary outcome will be to evaluate the effect of this therapy on clinical respiratory status. Secondary outcomes of interest will include the incidence of adverse effects and safety profile of magnesium bolus use in this population.

Detailed description: This randomized placebo-controlled pilot study is designed to evaluate the above referenced outcomes. Study drug initiation will occur in the local pediatric intensive care unit in patients with a clinical diagnosis of bronchiolitis and whose parent/LAR consents for their participation. Our goal is to enroll and evaluate a total of 40 patients.

Upon obtaining informed consent, the participant will receive an enrollment history and physical to include: baseline Modified Pulmonary Index Score (MPIS), blood pressure, vital signs, and epidemiologic data. The participant will then receive either a bolus of 50mg/kg Magnesium Sulfate (MgSO4) or normal saline as placebo medication over twenty minutes. Vital signs and MPIS will be monitored according to the study schedule, for a total of six hours. During the period of monitoring subjects will not receive additional bronchodilators unless otherwise deemed clinically necessary by the subject's attending physician. If administered, these will be recorded by investigative team.

Eligibility criteria: Inclusion Criteria:

* Infants under 12 months of age
* Admitted to the pediatric intensive care unit
* Moderate/severe bronchiolitis using MPIS
* Less than 24 hours of admission to the PICU
* Parent/LAR consents for infant to participate

Exclusion Criteria:

* Patients with the following conditions are ineligible: chronic lung disease, unrepaired congenital heart disease, and cyanotic heart disease.

Primary outcomes:
measure: To evaluate the effect of this therapy on clinical respiratory status
timeFrame: 6 hours post bolus of medication versus placebo
Secondary outcomes:
measure: Identify the incidence of adverse effects and safety profile of magnesium sulfate
timeFrame: 6 hours post bolus of medication versus placebo
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Norton Children's Hospital
state: Kentucky
Study officials:
affiliation: University of Louisville
name: John W Berkenbosch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02284594: Adult Influenza Vaccination Text Message Reminders With Electronic Health Record Alerts
Official title: Adult Influenza Vaccination Text Message Reminders With Electronic Health Record Alerts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2014-11-06
Enrollment: 4026
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Influenza infection leads to on average 3000-49,0000 deaths and 150,000 hospitalizations annually. While vaccination is the cornerstone of preventing influenza infection, vaccination coverage in adults is low. Latino adults have the lowest coverage rates. Text message reminders have been used successfully for improving influenza vaccination for children. This study will assess the use of text messaging to improve influenza vaccination coverage rates in a largely minority, publicly insured adult population. We will also assess if the patient having received a text message makes the patient more likely to accept vaccination when their provider has received in electronic alert regarding need for influenza vaccination in the electronic health record.


Eligibility criteria: Inclusion Criteria:

* \> or = 18 years of age
* at least one visit to the AIM clinic during previous 6 months
* a cell phone number in the registration system
* fluent in English or Spanish

Exclusion Criteria:

- Receipt of influenza vaccination during the 2014-2015 influenza season prior to randomization

Primary outcomes:
measure: influenza vaccination
timeFrame: up to 5 months
Secondary outcomes:
measure: influenza vaccination
timeFrame: up to 2 months
measure: captured opportunity
timeFrame: up to 5 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center/ NewYork Presbyterian Hospital Ambulatory Care Network
state: New York
Study officials:
affiliation: Columbia University
name: Melissa Stockwell, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01394094: Effects of Gum Chewing on Recovery of Bowel Function Following Benign Gynecologic Surgery
Official title: Effects of Gum Chewing on Recovery of Bowel Function Following Benign Gynecologic Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Recovery of Bowel Function, Due to Gum Chewing
Keywords: Gum chewing
Bowel function
benign gynecologic surgery
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2011-07-14
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Gum chewing can promotes the return bowel function after gynecologic surgery.

Detailed description: Following abdominal surgery for treatment of benign gynecologic surgery, paralytic ileus may be develops. Gum chewing can promotes the return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes secretion. This study will be evaluate effects of adding gum chewing to the conventional postoperative feeding protocol on the return of bowel function, its related complication, and patients's satisfaction.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing abdominal surgery for benign gynecologic conditions at Maharaj Nakorn Chiang Mai hospital

Exclusion Criteria:

* Perioperative hyperalimentation
* Recent chemotherapy (within 3 weeks before surgery)
* Previous bowel surgery
* Inflammatory bowel disease
* Previous abdominal or pelvic radiation
* Need for immediate postoperative endotracheal intubation
* Need for postoperative admission to intensive care unit
* Undergoing emergency surgery with oral intake of fluid or food with in 4 hours before surgery

Primary outcomes:
measure: Time to first flatus
timeFrame: Up to 7 days after surgery
Secondary outcomes:
measure: Incidence and severity of postoperative nausea, vomiting and abdominal discomfort
timeFrame: Up to 7 days after surgery
measure: Incidence of postoperative complications
timeFrame: Up to 7 days after surgery
measure: Time to first regular diet
timeFrame: Up to 7 days after surgery
measure: Time to first defecation
timeFrame: Up to 7 days after surgery
measure: Hospital stay
timeFrame: Up to 7 days after surgery
measure: Patients's satisfaction
timeFrame: Up to 7 days after surgery
Other outcomes:
Locations:
city: Amphoe Muang
country: Thailand
facility: Faculty of Medicine, Chiang Mai University
state: Chiang Mai
Study officials:
affiliation: Chiang Mai University, Thailand
name: Manatsawee - Manopunya, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06597994: Augmenting Urinary Reflex Activity: Study 3
Official title: Therapy Optimisation Study of Adaptive Pudendal Neuromodulation in Women With Urinary Incontinence Implanted With the Amber UI System.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Amber Therapeutics Ltd
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

Brief summary: AURA-3 study (Augmenting Urinary Reflex Activity Study 3) is a single arm, short-duration (8 month) cohort follow up study of preceding interventional medical device study, AURA-2.


Eligibility criteria: Inclusion Criteria:

* Participant has exited the AURA-2 clinical investigation.
* Participant has an implanted Amber UI system.
* Consents to participation.

Exclusion Criteria:

* Participant has withdrawn from AURA-2 clinical investigation.
* Participant is pregnant.
* A past or current condition that in the opinion of the PI contraindicates enrolment (PI discretion).

Primary outcomes:
measure: Change in absolute recharge performance
timeFrame: 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months
measure: Change in relative recharge performance
timeFrame: 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months
Secondary outcomes:
measure: Change in recharge usability
timeFrame: 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months
measure: Fully adaptive mode usability
timeFrame: 48 hours; 2 months; 8 months
measure: Fully adaptive mode specificity
timeFrame: 48 hours; 2 months; 8 months
measure: Adverse Device Events
timeFrame: 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University Hospital Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Stefan De Wachter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06185894: Single-step Placenta Accreta Resective Technique Tourniqueted vs Absence, Conservative Uterine Surgery
Official title: Single-step Placenta Accreta Resective Technique Tourniqueted vs Absence, Conservative Uterine Surgery (SPARTACUS) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Placenta Accreta
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: An optimal international standard for PAS surgery is not yet available, and the establishment of a suitable surgical method is an important focus of in PAS management.

Objective: To assess the efficacy and safety of tourniquet uses for conservative approach in the management of placenta accerta spectrum.

Patients and Methods: 40 pregnant women who underwent conservative management of placenta accrete at Kasr El-Aini hospital (Obstetrics and gynecology department - Faculty of medicine - Cairo university) were included and were divided according to the use of tourniquet into 2 equal groups: Study group (tourniquet group): consists of 20 women for whom tourniquet was used in the lower part of the uterus during surgical treatment of placenta accreta spectrum.Control group (no tourniquet group): consists of 20 women for whom no tourniquet was used.


Eligibility criteria: Inclusion Criteria:

* Pregnant females with previous CS deliveries (at least 1).
* Patients with ultrasound criteria of placenta accerta spectrum.
* Patients desiring fertility (uterine conservation).
* Patients with gestational age that completed 34 weeks (or more) confirmed by the 1st day of the LMP or 1st trimester ultrasound scan.

Exclusion Criteria:

* Maternal age above 40 years.
* Chronic medical disorders (e.g., cardiac, renal, DM and hepatic diseases).
* Patients presented with severe antepartum hemorrhage (unstable vital signs).
* Patients requested radical management (caesarean hysterectomy).

Primary outcomes:
measure: Intraoperative quantified blood loss
timeFrame: during operation
Secondary outcomes:
measure: amount of blood and blood product transfusion
timeFrame: during operation and 48 hours post operative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT06230094: Effect of 8 Weeks Moderate & High Intensity Training on Cognitive Functions and Sleep of Female Students
Official title: Effect of 8 Weeks Moderate & High Intensity Training on Cognitive Functions and Sleep of Female Students
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep
Cognition
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: this study aims to assess ther effectiveness of moderate \& high intensity training on cognitive functions and sleep of female students

Detailed description: In group A for moderate intensity training brisk walk will be performed(HR will be between 50%- 60% of maxHR).

warmup exercise will be performed to achieve 50%HR and then brisk walk will be performed till she reaches 60%HR.

This protocol will be followed for 5days per week. In group B for high intensity training skipping rope will performed (HR will be between 70%-85% of maxHR).

warmup exercise will be performed to achieve 70%HR and then skipping rope will be performed till she reaches 85%HR.

This protocol will be followed for alternative 3days per week.

Eligibility criteria: Inclusion Criteria:

* female students
* age between 18- 25

Exclusion Criteria:

* History of trauma/ injury
* mental illness
* physical deformity
* infection,fever

Primary outcomes:
measure: Stroop test for Cognitive Function
timeFrame: 8 weeks
measure: Pittsburg sleep quality index ,
timeFrame: 8 weeks
measure: Digit span test
timeFrame: 8 weeks
measure: Sleep quality scale
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sargodha
country: Pakistan
facility: Sargodha institute of health sciences
state: Punjab
Study officials:
affiliation: Riphah International University Islamabad
name: Tabinda Kanwal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00998894: Randomized Trial of Alerts in Patients Demonstrating a "Triple Low"
Official title: A Randomized Effectiveness Trial of Early Hemodynamic Support in Patients Demonstrating a "Triple Low" of Mean-arterial Pressure, End-tidal Anesthetic Concentration, and Bispectral Index
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Bispectral Index
Low Mean Arterial Blood Pressure
Low End-tidal Anesthetic Concentration
Keywords: BIS
MAC
MAP
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2009-10-21
Enrollment: 9846
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adults presenting for non-cardiac surgery under volatile general anesthesia

Brief summary: The investigators propose to test the theory that smart alarms for the Triple Low State incorporated into a decision support system built into an electronic anesthesia record will prompt clinicians to intervene earlier in situations that would otherwise provoke little concern, and that the alert system will reduce 90-day mortality. Specifically, the investigators will test the hypothesis that providing Triple Low alerts reduces 90-day mortality.


Eligibility criteria: Inclusion Criteria:

* Adults presenting for non-cardiac surgery under volatile general anesthesia

Primary outcomes:
measure: 90-day mortality
timeFrame: 90-days
Secondary outcomes:
measure: 30-day mortality
timeFrame: 30-days
measure: Response to alerts
timeFrame: Intraoperative
measure: Hospital-free days within the initial postoperative month
timeFrame: 30-days
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Daniel I Sessler, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03587194: Evaluation of Add on Enstilar in Patients Using Otezla for Psoriasis
Official title: A Single Center Study to Evaluate the Effectiveness and Safety of Add on Enstilar® in Patients Using OTEZLA® for Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: Psoriasis Treatment Center of Central New Jersey
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2018-07-16
Enrollment: 50
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: Add-on Enstilar to Otezla therapy.

Detailed description: 50 adult patients with moderate to severe plaque psoriasis will be given OTEZLA® for 16 weeks with add-on Enstilar.

Eligibility criteria: Inclusion Criteria:

1. Male or female adult ≥ 18 years of age;
2. Diagnosis of chronic plaque-type psoriasis
3. Moderate to severe plaque type psoriasis as defined at baseline by:

   * PGA score of 3 or greater
   * BSA affected by plaque-type psoriasis of 10% or greater
   * PASI ≥ 12
4. Able and willing to give written informed consent prior to performance of any study-related procedures
5. Must be in general good health (except for disease under study) as judged by the Investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).

Exclusion Criteria:

1. Other than psoriasis, any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is uncontrolled.
2. Forms of psoriasis other than chronic plaque-type (e.g., Pustular erythrodermic and/or guttate psoriasis) or drug induced psoriasis
3. Subjects who previously used any biologic agent for psoriasis.
4. Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin and cyclosporine).
5. Patient used topical therapies to treat psoriasis on the hands and/or feet within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).
6. Patient received UVB phototherapy within 2 weeks of Baseline.

Primary outcomes:
measure: Psoriasis Area Severity Index 75 at Week 12
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
Study officials:
affiliation: dreamacres1@aol.com
name: Jerry Bagel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04514094: Silver Diamine Fluoride Effectiveness Versus Atraumatic Restorative Treatment in Arresting ECC
Official title: Effectiveness of Silver Diamine Fluoride in Arresting Early Childhood Caries: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Childhood Caries
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was conducted to evaluate the effectiveness of the biannual application of 38% silver diamine fluoride in arresting early childhood caries when compared to atraumatic restorative treatment.

Detailed description: Owing to the virulent nature of early childhood caries (ECC) and its consequences if left untreated, immediate intervention is indicated to control the condition.

Barriers to intervention as young age, uncooperative patient behavior and lack of access to dental care are however, very common. The use of silver diamine fluoride as an anticaries agent is of growing popularity worldwide due to its promising results, safety of use, ease of application and relatively low cost. Further research is still required in order to provide evidence-based recommendations regarding the use of SDF in arresting early childhood caries. Purpose: To evaluate the effectiveness of biannual application of 38% silver diamine fluoride in arresting early childhood caries when compared to atraumatic restorative treatment.

Eligibility criteria: Inclusion Criteria:

* For children:

  1. Healthy children.
  2. Age range 2-5 years.
  3. Informed consent (Appendix I)

For teeth:

* Teeth with active dentin lesions corresponding to ICDAS II score 5 and 6.
* Teeth having lesions that are considered active according to ICDAS II activity criteria for coronal primary caries.

Exclusion Criteria:

* For children:

  1. Children with systemic diseases.
  2. Children with reported allergy to silver or to any other component in the materials used.
  3. Children unable to return for recall visits.

For teeth:

* Clinical or radiographic signs of pulpal involvement.(pain, abscess, sinus, obvious discoloration, premature hypermobility, internal or external root resorption).
* Teeth with inactive lesions.

Primary outcomes:
measure: change in clinical success/failure rate
timeFrame: at 6 and 12 months
Secondary outcomes:
measure: Duration of the intervention visit
timeFrame: During the procedure
measure: Patient Satisfaction
timeFrame: after the 4th week
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References: