louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01165086: Reducing Dietary Energy Density by Incorporating Vegetables in Order to Decrease Energy Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-07-19
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study will test the hypothesis that incorporating vegetables into meals as a method of reducing the energy density will result in increased vegetable intake and decreased energy intake.


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 20-45 years

Primary outcomes:
measure: Energy intake
timeFrame: 3 weeks
Secondary outcomes:
measure: Vegetable intake
timeFrame: 3 weeks
Other outcomes:
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
Study officials:
References:
citation: Blatt AD, Roe LS, Rolls BJ. Hidden vegetables: an effective strategy to reduce energy intake and increase vegetable intake in adults. Am J Clin Nutr. 2011 Apr;93(4):756-63. doi: 10.3945/ajcn.110.009332. Epub 2011 Feb 2.
Clinical trial NCT05549986: Discriminant Ability of the Shock Index, Modified Shock Index, and Reverse Shock Index Multiplied by the Glasgow Coma Scale on Mortality in Adult Trauma Patients: A PATOS Study
Official title: Discriminant Ability of the Shock Index, Modified Shock Index, and Reverse Shock Index Multiplied by the Glasgow Coma Scale on Mortality in Adult Trauma Patients: A PATOS Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Shock, Traumatic
Morality
Keywords: Shock index(SI)
Modified Shock Index (MSI)
Reverse Shock Index Multiplied by the Glasgow Coma Scale (rSIG)
Mortality
Pan-Asian Trauma Outcomes Study (PATOS)
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 105641
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study included adult patients (≥18 years) EMS-transported from January 2016 to December 2020. Patients with missing entries of age, sex, triage, SBP, DBP, HR, or GCS were excluded. Entries with missing records of in-hospital mortality or 30-day mortality were excluded from the short-term mortality cohort analyses. Patients without a Modified Rankin Scale (MRS) record at discharge were excluded from the functional outcome cohort analyses.

Brief summary: We evaluated a cohort of adult trauma patients transported to emergency departments. The first vital signs were used to calculate the SI, MSI, and rSIG. The areas under the receiver operating characteristic curves (AUROCs) and test results were used to compare the discriminant performance of the indices on short-term mortality and poor functional outcome. A subgroup analysis of geriatric patients, traumatic brain injury, penetrating injury, and non-penetrating injury was performed.


Eligibility criteria: Inclusion Criteria:

* Adult patients (≥18 years) EMS-transported from January 2016 to December 2020

Exclusion Criteria:

* Patients with missing entries of age, sex, triage, SBP, DBP, HR, or GCS were excluded.
* Entries with missing records of in-hospital mortality or 30-day mortality were excluded from the short-term mortality cohort analyses.
* Patients without a Modified Rankin Scale (MRS) record at discharge were excluded from the functional outcome cohort analyses.

Primary outcomes:
measure: Discriminant power of SI, MSI, and rSIG on short-term mortality for adult traumatic patients
timeFrame: 30 days
Secondary outcomes:
measure: Discriminant power of SI, MSI, and rSIG on functional outcome for adult traumatic patients
timeFrame: We defined no symptoms, no significant disability, slight disability, and moderate disability (MRS 0-3) as favorable functional outcomes and moderately severe disability, severe disability, and death (MRS 4-6) as poor functional outcomes
Other outcomes:
Locations:
Study officials:
affiliation: Mackay Memorial Hospital
name: Tse-Hao Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00030186: Open Study of CEP-701 in Patients With Refractory Acute Myeloid Leukemia With FLT-3 Mutation
Official title: An Open-Label Study of CEP-701 in Patients With Refractory, Relapsed, or Poor Risk Acute Myeloid Leukemia Expressing FLT-3 Activating Mutations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia, Myeloid
Keywords: AML
FLT-3 mutation
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2002-02-08
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the response rate of patients with refractory, relapsed or poor risk AML expressing FLT-3 activating mutations, when administered CEP-701 at a dosage of 60 mg 2 times a day.

Detailed description: This is an open-label study of CEP-701 in patients with refractory, relapsed, or poor risk AML expressing FLT-3 activating mutations. Patients who meet eligibility criteria will be enrolled at a dosage of 60 mg orally 2 times a day for 28 days (1 cycle). Upon completion of cycle 1, the dosage may be increased to 80mg 2 times a day or decreased to 40 mg 2 times a day, dependent upon response to 60 mg dosage.

Eligibility criteria: INCLUSION CRITERIA:

* patient must have confirmed diagnosis of refractory or relapsed AML that expresses a FLT-3 mutation
* patient must have life expectancy of more than 2 months
* patient must be fully recovered from reversible side effects of previous therapy for cancer

EXCLUSION CRITERIA:

* total bilirubin, ALT or AST greater than 2 times upper limit of normal
* patient \<65 years of age with estimated creatinine clearance less than 60 mL/min; patient \>65 years of age with serum creatinine \> 1.5 times the upper limit of normal (ULN)
* received any investigational drug within past 4 weeks
* GI disturbance/malabsorption that may affect absorption of CEP-701
* HIV positive
* received NSAID within prior 14 days
* has active infection

Primary outcomes:
measure: Blood Samples and/or bone marrow assessments for complete remission (CR), complete tumor clearance (CTC), or hematologic response (HR) from bone marrow
timeFrame: 56 days
Secondary outcomes:
measure: Number of days to response
timeFrame: 56 Days
measure: Number of days to disease progression
timeFrame: 56 Days
measure: Levels of FLT-3 phosphorylation inhibition in vivo
timeFrame: 56 Days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04595786: The Safety of Intravenous Tranexamic Acid in Patients Undergoing Supratentorial Meningiomas Resection
Official title: A Randomized, Parallel-group, Placebo Control, Non-inferiority Trial to Investigate the Safety of Intravenous Tranexamic Acid in Patients Undergoing Supratentorial Meningiomas Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seizures
Meningioma
Keywords: meningioma
blood management
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Growing evidence of Tranexamic Acid (TXA) being used to reduce blood loss and blood transfusions in various guidelines. However, the adverse effects of TXA especially seizure has always been a problem of concern, especially in neurosurgery. Therefore, this study aims to provide a scientific evidence for the safety of TXA in supratentorial meningiomas resection patients.


Eligibility criteria: Inclusion Criteria:

* 1) age 18-80 years
* 2) American Society of Anesthesiologist (ASA) classification score I\~III

Exclusion Criteria:

* 1) allergic to tranexamic acid
* 2) preoperative seizures
* 3) history of thrombotic disease
* 4) chronic kidney disease
* 5) breastfeeding or pregnancy
* 6) refuse to participate in the study

Primary outcomes:
measure: Early postoperative seizures within 7 days
timeFrame: Within 7 days after surgery
Secondary outcomes:
measure: The incidence of non-epileptic complications
timeFrame: Within 7 days after the intervention
measure: Estimated intraoperative blood loss
timeFrame: During surgery
measure: The changes in haemoglobin concentrations
timeFrame: During surgery
measure: The intraoperative blood transfusion volume and rate
timeFrame: During surgery
measure: The intraoperative cell saver volume and rate
timeFrame: During surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Yuming Peng, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li S, Yan X, Li R, Zhang X, Ma T, Zeng M, Dong J, Wang J, Liu X, Peng Y. Safety of intravenous tranexamic acid in patients undergoing supratentorial meningiomas resection: protocol for a randomised, parallel-group, placebo control, non-inferiority trial. BMJ Open. 2022 Feb 2;12(2):e052095. doi: 10.1136/bmjopen-2021-052095.
Clinical trial NCT01629186: Nose-close and Abdomen-compression in Pediatric Flexible Bronchoscopy
Official title: Nasopharyngeal Oxygen With Nose-close and Abdomen-compression in Pediatric Flexible Bronchoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Hypoxemia
Keywords: CPR
flexible bronchoscope
resuscitation
ventilation
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2012-06-27
Enrollment: 156
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The nasopharyngeal oxygen (NPO) with Nose-close (NC) and Abdomen-compression (AC) technique may use for support or rescue asphyxiated infants during Flexible bronchoscopy.

Detailed description: OBJECTIVES: To evaluate the efficacy of a novel cardiopulmonary resuscitation (CPR) technique-nasopharyngeal oxygenation with nose-close and abdomen-compression (NPO-NC-AC)-in small infants during flexible bronchoscopy (FB).

METHODS: Infants with body weight (BW) \<5.0 kg and receiving nasal diagnostic or interventional FB (dFB, iFB) were enrolled. Under NPO (0.5 L/kg/min), when infant's heart rate (HR) \<80 beats/min or oxygen saturation (SpO2) \<85% for more than 10 seconds, rescue NC-AC was initiated. It was performed by (1) increased NPO flow to 0.5-1.0 L/kg/min; (2) NC 1 second for inspiration; and (3) AC 1 second for expiration with simultaneously released nostrils. Repeat doing steps (2) and (3) at a rate of 30 cycles/min until HR, SpO2, and blood pressure (BP) returned to normal. Cardiopulmonary parameters were monitored and analyzed.

Eligibility criteria: Inclusion Criteria:

* body weight (BW) less than 5.0 kg;
* receiving nasal approach flexible bronchoscopy.

Exclusion Criteria:

* cannot nasal approach flexible bronchoscopy.

Primary outcomes:
measure: Heart rate (beat/min)
timeFrame: Participants will continually monitoring by EKG for 2 days after the procedure.
Secondary outcomes:
measure: Oxygen saturation by pulse oximetry
timeFrame: Participants will continually monitoring by pulse oximeter for 2 days after the procedure.
measure: Mean blood pressure (mmHg)
timeFrame: Participants will continually monitoring by sphygmomanometer for 2 days after the procedure.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei-Veterans General Hospital
Study officials:
affiliation: Department of Pediatrics; Taipei-Veteran General Hospital
name: Wen-Jue Soong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soong WJ, Shiao AS, Jeng MJ, Lee YS, Tsao PC, Yang CF, Soong YH. Comparison between rigid and flexible laser supraglottoplasty in the treatment of severe laryngomalacia in infants. Int J Pediatr Otorhinolaryngol. 2011 Jun;75(6):824-9. doi: 10.1016/j.ijporl.2011.03.016. Epub 2011 Apr 21.
Clinical trial NCT02517086: Vascular Changes Due to Different Treatments of Lymphedema Secondary to Postoperative Breast Cancer
Official title: Vascular Changes Due to Different Treatments of Lymphedema Secondary to Postoperative Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lymphedema
Keywords: blood circulation
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 3
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objective of this study is to evaluate the effect of elastic compression, functional compressive bandaging (ECF) and active exercises in the bloodstream of the upper member ipsilateral to the surgical procedure for the treatment of breast cancer.

Detailed description: With increasing survival of women treated for breast cancer, it becomes necessary to evaluate the effect of therapeutic resources in morbidity due to surgical treatment of breast cancer. The objective of this study is to evaluate the effect of elastic compression, functional compressive bandaging (ECF) and active exercises in the bloodstream of the upper member ipsilateral to the surgical procedure for the treatment of breast cancer. The study will be conducted according to design random cross over and wash out period of 7 days. They will be evaluated 30 volunteers aged between 45 and 70 years, submitted to treatment of breast cancer. The volunteers will be submitted to three different therapeutic procedures applied randomly by lot: active exercises, functional compressive bandaging with active exercises and elastic compression with active exercises. The profile of blood flow, including speed and direction, will be assessed by Doppler ultrasound before and after, at 0, 15, 30 minutes. Normality will be verified by the Shapiro-Wilk test, and the effect of behavior between pre- and post-intervention will be evaluated by ANOVA two-way followed by post-hoc test Friedman followed rank, p \<0.05 . The data obtained in the study are intended to enhance the forms of physical therapy intervention in the face of circulatory morbidities resulting from breast cancer treatments.

Eligibility criteria: Inclusion Criteria:

* women diagnosed with breast cancer undergoing surgical treatment combined with axillary dissection or sentinel node biopsy
* diagnosed with moderate to severe unilateral lymphedema

Exclusion Criteria:

* Women with muscle-tendon injury and / or joint damage in the -affected limb,
* skin disorders,
* diabetes,
* circulatory disease not controlled, -chemotherapy
* radiotherapy,
* diagnostic with metastasis in the upper limb
* women pregnancy.

Primary outcomes:
measure: Doppler Ultrasound- velocity of blood flow
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo- Ribeirao Preto- Brazil
name: Elaine Guirro
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01374386: Impact of Exergaming on Adolescent Youth
Official title: RCMI Clinical Research Infrastructure Initiative: Exergaming
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Childhood Obesity
Keywords: adolescent obesity
Lead sponsor: Charles Drew University of Medicine and Science
Sponsor class: OTHER
First posted: 2011-06-16
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to gather information on how much exercising with video games (ExerGaming) can increase the physical activity among overweight and youth. This study will try to see if participating in physical activity and exercising with video games at the same time can make overweight children move around more to better their own health. The hypothesis is that those in Exergaming arm will physiological changes and increase physical activity.


Eligibility criteria: Inclusion Criteria:

* male and female
* aged 12-14 years
* baseline BMI \> 25
* gender- and age-specific 85th percentile cutoff points from the CDC growth chart
* parental consent and subject assent

Exclusion Criteria:

* subjects not meeting the inclusion criteria or with physician-determined musculoskeletal, cardiopulmonary, metabolic, psychological, neuro-developmental or behavioral conditions that make mild-to-moderate physical activity potentially hazardous.
* Participants under the age of 12 are excluded from the study because Weingart YMCA has an age policy. Children under the age of 12 are not allowed to be at the facility alone. Therefore, the minimum age for the study is 12 years old so supervision is not a problem.

Primary outcomes:
measure: Change in mean daily physical activity
timeFrame: 2 years
Secondary outcomes:
measure: Change in caloric expenditure, body composition, and BMI
timeFrame: 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Charles Drew University of Medicine and Science
state: California
Study officials:
affiliation: Charles Drew University of Medicine and Science
name: David Martins, MD, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02241486: Sublingual Fentanyl and Procedural Burn Pain
Official title: A Randomized, Double-blind, Placebo-controlled, Cross-over Trial of Sublingual Fentanyl Spray (Subsys) and Oral Morphine for Procedural Wound Care in Adult Patients With Burn Injury Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Burn Pain
Keywords: Burn pain
Procedural pain
Sublingual fentanyl
Morphine
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.

Detailed description: The purpose of this study is to examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury. It will be compared with a standard treatment regimen of oral morphine. The hypothesis is that the fentanyl spray will be more effective for the treatment of procedural pain in patients with burn injury.

Eligibility criteria: Inclusion Criteria:

* Subject capable of giving consent
* Age 18-65
* Total burn surface area greater than or equal to 5%
* Opioid tolerant
* BMI less than or equal to 35

Exclusion Criteria:

* Subjects with cognitive or psychiatric impairment that would preclude study participation or compliance with protocol
* Allergy to fentanyl, morphine, naloxone
* Pregnancy, intent to become pregnant or lactating
* Evidence of burn injury to oral mucosa
* Active illicit drug use or illicit drug abuse history

Primary outcomes:
measure: Pain Relief
timeFrame: 60 min
Secondary outcomes:
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center Burn Unit
state: Illinois
Study officials:
affiliation: Department Anesthesiology Loyola University Medical Center
name: Joseph R Holtman Jr, MD Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05249686: Effects of Two Different Physical Therapy Protocols After an Endodontic Intervention
Official title: Effects of Two Different Physical Therapy Protocols After an Endodontic Intervention: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Root Canal Therapy
Endodontically Treated Teeth
Keywords: Dry Needling
Manual Therapy
Temporomandibular Joint
Cervical spine
Root Canal Therapy
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a randomized controlled trial with 3 different groups
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the clinical results produced by a manual therapy treatment combined with dry needling (MT+DN) and a manual therapy treatment (TM) versus a control (C), to normalize the altered cervico-mandibular variables after a session of root canal therapy.


Eligibility criteria: Inclusion Criteria:

* Being over 18 years old and requiring an endodontic intervention.

Exclusion Criteria:

* Have received TMJ or cervical treatment during the last month, presented any red flag, neurological or cognitive impairment (inability to understand the questionnaires or examination).

Primary outcomes:
measure: Mean change from baseline in Maximum Active Mouth Opening at 1 week
timeFrame: Baseline and 1 week
Secondary outcomes:
measure: Mean change from baseline in Pain intensity at 1 week
timeFrame: Baseline and 1 week
measure: Mean change from baseline in Pressure Pain Threshold (PPT) at 1 week
timeFrame: Baseline and 1 week
measure: Mean change from baseline in Myofascial Trigger Points (MTrPs) at 1 week
timeFrame: Baseline and 1 week
measure: Mean change from baseline in Cervical Spine Range of Movement (ROM) at 1 week
timeFrame: Baseline and 1 week
measure: Mean change from baseline in TMD-Pain Screener (TMJ Function) at 1 week
timeFrame: Baseline and 1 week
measure: Mean change from baseline in Helkimo Index (TMJ Function) at 1 week
timeFrame: Baseline and 1 week
measure: Mean change from baseline in Jaw Functional Limitation Scale (JFLS-20) (TMJ Function)
timeFrame: Baseline and 1 week
measure: Mean change from baseline in Neck Disability Index (NDI) (Neck Function) at 1 week
timeFrame: Baseline and 1 week
measure: Mean change from baseline in Headache Impact Test (HIT-6) (Headache Disfunction) at 1 week
timeFrame: Baseline and 1 week
Other outcomes:
Locations:
city: Huesca
country: Spain
facility: Servicio de Prácticas Odontológicas del Grado en Odontología de la Universidad de Zaragoza
state: Aragon
Study officials:
References: