louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01880138: Effect of Animated Cartoon for Prevention of Emergence Agitation in Children Aged 1.5 - 5 yr After General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sevoflurane Anaesthesia
Keywords: Animated cartoon, Emergence agitation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 17
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Emergence agitation (EA) in children early after sevoflurane anaesthesia is a common postoperative problem, with incidence ranging up to 80%. Younger patients, particularly in the age range from 1.5 to 5 yr of age, are at increased risk of EA. Preoperative anxiety, as measured by the modified Yale Preoperative Anxiety Scale, has been shown to increase the risk of EA for each increment of 10 points in the child's state anxiety score. So, Alleviates preoperative anxiety in Children maybe decrease the incidence and severity of EA. Preschool children enjoy watching animated cartoons, and they can be immersed to animated cartoon so they become oblivious of their surroundings. Therefore, viewing an animated cartoon maybe reduce preoperative anxiety in children. This study was performed to determine effect of animated cartoon for prevention of emergence agitation in children aged 1.5 - 5 yr after general anesthesia


Eligibility criteria: Inclusion Criteria:

1. pediatric patient (1.5-5yrs) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia

Exclusion Criteria:

1. Patients with an abnormal airway, reactive airway disease, gastroesophageal reflux disease, chronic respiratory disease, or a history of an upper respiratory tract infection in the preceding 6-week period

Primary outcomes:
measure: Pediatric Anesthesia Emergence Delirium (PAED) Scale
timeFrame: (PAED) Scale changes from the moment subjects open their eyes, and every 5 minute for 24hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT00992238: A Relative Bioavailability Study of 100 mg Flavoxate Hydrochloride Tablets Under Fasting Conditions
Official title: A Relative Bioavailability Study of 100 mg Flavoxate Hydrochloride Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Padagis LLC
Sponsor class: INDUSTRY
First posted: 2009-10-09
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the relative bioavailability of Flavoxate Hydrochloride tablets 100mg manufactured by Paddock Laboratories, Inc., with that of Urispas® tablets 100mg by SmithKline Beecham Pharmaceuticals under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening

Exclusion Criteria:

* Positive test results for HIV or Hepatitis B or C
* History of allergy or sensitivity to Flavoxate hydrochloride or related drugs

Primary outcomes:
measure: Bioequivalence according to US FDA guidelines
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: PRACS Institute, Ltd
state: North Dakota
Study officials:
affiliation: PRACS Institute, Ltd.
name: Carlson, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06294938: Glycemic Index of Cacao Fruit Pulp in Healthy, Human Subjects
Official title: Determination of Glycemic Index of Cacao Fruit Pulp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Sugar; High
Blood Sugar; Low
Lead sponsor: Mars Wrigley
Sponsor class: INDUSTRY
Collaborators: name: INQUIS Clinical Research
First posted: 2024-03-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: acute, open-labeled, randomized design
Primary purpose: BASIC_SCIENCE

Brief summary: Cacao fruit pulp is a sweet and fruity carbohydrate-rich edible mucilage that is often discarded. The objective of this study is to assess the glycemic response and determine the glycemic index of cacao fruit pulp.

Detailed description: In an acute, open-labeled, randomized design, individuals without diabetes were studied over 120 minutes after consuming 25 grams of available carbohydrate portions of cacao pulp or dextrose.

Eligibility criteria: Inclusion Criteria: Subjects were males or non-pregnant females and in good health.

Exclusion Criteria: Subjects with a known history of AIDS, hepatitis, diabetes or a heart condition. Subjects taking medication or with any condition that might make participation dangerous to the subject, to others, or affect the results.

Primary outcomes:
measure: Plasma Glucose
timeFrame: 1-120 minutes
measure: Incremental area under the curve
timeFrame: 1-120 minutes
measure: Peak plasma glucose
timeFrame: 1-120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: INQUIS Clinical Research
state: Onterio
Study officials:
affiliation: INQUIS Clinical Research
name: Thomas Wolever, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03581838: Eating With Eosinophilic Esophagitis (EoE)
Official title: Eating Behavior in Patients With Eosinophilic Esophagitis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eosinophilic Esophagitis (EoE)
Keywords: EoE
Dysphagia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with EoE that are being seen at Mayo Clinic Esophageal Clinic will be approached. Controls will be individuals who do not have an EoE diagnosis.

Brief summary: Is there a difference in the eating process for patients with active Eosinophilic Esophagitis (EoE) and those with inactive disease?

Detailed description: Eosinophilic esophagitis (EoE) patients develop adapted eating behaviors to prevent symptoms. These patients tend to cut their food small, chew extensively, take copious liquids with meals, and avoid foods that cause symptoms. No studies to date have directly evaluated these eating behaviors in patients with EoE with observation. Furthermore, none of the investigators' current metrics for patient symptom assessment visually evaluate the eating process nor are they compared before and after treatment. As a result, it is unclear if a patient's subjective perception of their eating difficulties and improvement matches with objective measures.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Patients suspected to have Eosinophilic Esophagitis
* Patients being treated for EoE with PPI or a steriod
* EoE patients that are in remission by having less than 22 on the EEsAI questionnaire
* Controls, patients that do not have EoE or other swallowing issues

Exclusion Criteria:

* Clinical evidence of infectious process potentially contributing to dysphagia (candidiasis, CMV,herpes)
* Other cause of dysphagia identified at endoscopy (reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm)
* EoE patients that do not eat sandwiches or feel they could not eat a sandwich.

Primary outcomes:
measure: Observed eating session
timeFrame: 15-90 minutes
Secondary outcomes:
measure: Food slowness during eating session
timeFrame: 15-90 minutes
measure: Water during eating session
timeFrame: 15-90 minutes
measure: Eosinophilic Esophagitis activity Index (EEsAI) questionnaire
timeFrame: 10-15 minutes
measure: Eosinophilic Esophagitis Quality of Life questionnaire
timeFrame: 10-15 minutes
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jeffrey A Alexander
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01365338: A Study To Assess Effects Of PF-04958242 On Bold Functional Magnetic Resonance Imaging During Working Memory Activation And Arterial Spin Labeling At Rest In Healthy Subjects
Official title: Subject And Investigator-Blinded, Sponsor-Open, Randomized, Single-Dose, Placebo-Controlled, Parallel Group Study to Assess Effects of PF-04958242 on Bold Functional MRI During Working Memory Activation and Arterial Spin Labeling at Rest in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Yale University
First posted: 2011-06-03
Enrollment: 112
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study aims to determine whether the drug affects brain activity in healthy volunteers, either when the participants are performing a memory task, or when lying at rest. Subjects will undergo a brain scan under both of these conditions after a dose of either the study drug or a placebo is administered.The secondary objective is to evaluate the safety and tolerability of the four doses of PF-04958242 administered orally to healthy adult participants.

Detailed description: This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Eligibility criteria: Key Inclusion Criteria:

* Body Mass Index (BMI) of 17.5 to 30.5 kilograms per meter squared (kg/m2);
* Total body weight \>50 kilograms (kg) (110 pounds \[lbs\]);

Key Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing);
* Positive urine drug screen;
* Pregnant or nursing females, and females of child bearing potential;
* Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Functional Magnetic Resonance Imaging Data During Working Memory Task
timeFrame: 59 Minutes Post-dose
measure: Arterial Spin Labeling Data
timeFrame: 39 Minutes Post-dose
Secondary outcomes:
measure: Number of Participants Experiencing Adverse Events and Serious Adverse Events
timeFrame: Up to Day 11
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Research Site
state: Connecticut
city: New Haven
country: United States
facility: Research Site
state: Connecticut
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05784038: Observational, Prospective, Cohort Study of Mpox Infection in Brazil (NETPOX)
Official title: Observational, Prospective, Cohort Study of Mpox Infection in Brazil - NETPOX Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Monkeypox
MPOX
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2023-03-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have risk factors for mpox infection in Brazil.

Brief summary: The study is a prospective cohort that evaluates the clinical and immune-metabolic variables that may be linked to the risk and severity of the infection or even hospitalization or death in patients infected with the Mpox virus in Brazil. The expectation is to include at least 80 patients over six months, with a follow-up of 90 days from inclusion, through contact via decentralized visits.


Eligibility criteria: Inclusion Criteria:

* Men and women aged ≥ 18 years with confirmed MPOX infection.

(laboratory-confirmed monkeypox infection is defined as determined by PCR, culture, or antigen test obtained from a sample collected from blood, oropharynx, anal or skin lesion within 4 days of randomization)

Exclusion Criteria:

* Inability to provide informed consent;
* Patient who, judging by the study team, does not have a condition for decentralized follow-up

Primary outcomes:
measure: Composed of incidence of rash, fever, adenopathy, general pain, chills, weakness, occurrence of hospitalization, and neurological repercussions
timeFrame: Up to 90 days after the inclusion
Secondary outcomes:
measure: Death
timeFrame: Up to 90 days after the inclusion
measure: Hospitalizations
timeFrame: Days 15, 30, 60, and 90
measure: Untargeted metabolomics of total plasmas and skin lesion
timeFrame: Days 15, 30, 60, and 90
measure: Viral genomic
timeFrame: Day 0
Other outcomes:
Locations:
city: Belem
country: Brazil
facility: Hospital Universitário João de Barros Barreto
state: Para
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
state: Sao Paulo
city: Rio De Janeiro
country: Brazil
facility: Hospital Naval Marcílio Dias
Study officials:
affiliation: Hospital Albert Einstein
name: Henrique Fonseca
role: STUDY_CHAIR
References:
Clinical trial NCT04962438: Effects of Anti-VEGF Targeted Drugs on Patients' Blood Pressure and Endothelial Function
Official title: Effects of Anti-VEGF Targeted Drugs on Patients' Blood Pressure and Endothelial Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Toxicity
VEGF
Endothelial Dysfunction
Keywords: Cardiac safety
anti-VEGF drugs
Endothelial dysfunction
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thirty tumor patients selected for anti-VEGF drugs, demographic and clinical information of all patients were collected before chemotherapy, ambulatory blood pressure monitoring, endothelial function determination (PWV, EndoPAT)

Brief summary: Explore the effects of anti-VEGF targeted drugs on blood pressure and endothelial function in cancer patients.

Detailed description: Thirty tumor patients with anti-VEGF drugs were selected. Demographic information and clinical information of all patients were collected before chemotherapy. Ambulatory blood pressure monitoring and endothelial function measurement (PWV, EndoPAT) were performed. Ambulatory blood pressure and PWV were reviewed at 2 weeks and 1 month. And EndoPAT, to evaluate the effects of anti-VEGF drugs on blood pressure and endothelial function in cancer patients.

Eligibility criteria: Inclusion Criteria:

* Tumor patients using anti-VEGF drugs

Exclusion Criteria:

* Hypertension, coronary heart disease, valvular heart disease, cardiomyopathy and other organic heart diseases, exclude liver and kidney failure, severe cerebrovascular disease, chronic obstructive pulmonary disease, rheumatic immune system disease

Primary outcomes:
measure: Time ending
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02479438: Gastroesophageal Reflux Disease Prospective Registry
Official title: Gastroesophageal Reflux Disease Prospective Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: GERD
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 744
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of GERD or a similar disease of the stomach, esophagus or digestive tract.

Brief summary: The purpose of this registry is to evaluate information to determine which operations and treatments for gastroesophageal reflux disease or similar diseases of the stomach, esophagus or digestive tract are providing the most benefit including the long-term effects of treatment (or no treatment) and the progression of the disease over time.

Detailed description: All patients in this registry will have a diagnosis of gastroesophageal reflux disease or a similar disease of the stomach, esophagus or digestive tract. Each patient undergoing anti-reflux surgery will be asked to participate in the registry to gather preoperative, intraoperative and postoperative outcomes. The data collected from the registry will be used to assess the outcome of various treatments, both standard and new: some specific areas of interest include the long-term effects of treatment (or no treatment), the progression of the disease over time, and the overall length of survival of the patient.

Eligibility criteria: Inclusion Criteria:

- Any patient undergoing anti-reflux surgery

Exclusion Criteria:

- None

Primary outcomes:
measure: Postoperative patient reported sign and symptoms
timeFrame: Up to 10 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Research University Medical Center
state: Texas
Study officials:
affiliation: Baylor Health Care System
name: Steven Leeds, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02372838: Reconstruction of Extensive Upper Extremity Long Bone Defects With a Microvascular Fibula Flap
Official title: Reconstruction of Extensive Upper Extremity Long Bone Defects With a Microvascular Fibula Flap: a Cross-sectional Study of Long-term Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Limb Salvage
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 13
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty patients with upper extremity long bone bone defect treated with a microvascular fibula transfer. Population aged below 90 years.

Brief summary: This study assesses the long-term functional outcomes of upper extremity long bone defects treated with the free fibula bone transfer.

Detailed description: The study design entails a retrospective review of hospital records and a cross-sectional assessment using patient-reported outcome measures. The purpose of this study is to evaluate the reliability, complications and flap survival rate as well as the long-term functional and health-related quality of life results in patients with upper extremity long bone defect reconstructed using a microvascular fibula bone transfer.

Eligibility criteria: Inclusion Criteria:

* All patients of upper extremity long bone bone defect treated with a microvascular fibula transfer in Helsinki University Central Hospital.

Exclusion Criteria:

* No upper extremity free fibular transfer

Primary outcomes:
measure: The long-term results are good
timeFrame: 10-20 years
Secondary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand questionnaire
timeFrame: 10-20 years
measure: the 15-Dimensions health-related quality of life instrument
timeFrame: 10-20 years
measure: Lower Extremity Functional Scale
timeFrame: 10-20 years
Other outcomes:
Locations:
Study officials:
affiliation: Helsinki University Central Hospital
name: Erkki J. Tukiainen, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01824238: A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-050)
Official title: A 12-Week, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Assess the Efficacy and Safety of MK-0859 When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Therapies in Japanese Patients With Heterozygous Familial Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heterozygous Familial Hypercholesterolemia (HeFH)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2013-04-04
Enrollment: 68
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: This study will evaluate the effects of anacetrapib (MK-0859) on low-density lipoprotein-cholesterol (LDL-C) when compared to placebo in Japanese participants with heterozygous familial hypercholesterolemia when added to an existing statin lipid-modifying therapy.


Eligibility criteria: Inclusion Criteria:

* If female, cannot be of reproductive potential
* Diagnosed with heterozygous familial hypercholesterolemia
* Have been treated with an appropriate and

stable dose of statin± other lipid-lowering medication(s) for at least 6 weeks

Exclusion Criteria:

* Previously participated in a study with a cholesteryl ester transfer protein (CETP) inhibitor
* Homozygous familial hypercholesterolemia
* Severe chronic heart failure
* Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery by-pass graft (CABG), unstable angina, or stroke within 3 months

Primary outcomes:
measure: Percent Change from Baseline in LDL-C (beta-quantification [BQ] method)
timeFrame: Baseline and Week 12
measure: Percentage of Participants who Experience at Least One Adverse Event (AE)
timeFrame: 12 weeks
Secondary outcomes:
measure: Percent Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C)
timeFrame: Baseline and Week 12
measure: Percent Change from Baseline in Non-HDL-C
timeFrame: Baseline and Week 12
measure: Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I)
timeFrame: Baseline and Week 12
measure: Percent Change from Baseline in Apolipoprotein B (Apo-B)
timeFrame: Baseline and Week 12
measure: Percent Change from Baseline in Lipoprotein(a) (Lp[a])
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
Study officials:
References:
citation: Arai H, Teramoto T, Daida H, Ikewaki K, Maeda Y, Nakagomi M, Shirakawa M, Kakikawa T, Numaguchi H, Johnson-Levonas AO, Vaidya S, Blaustein RO. Efficacy and safety of the cholesteryl ester transfer protein inhibitor anacetrapib in Japanese patients with heterozygous familial hypercholesterolemia. Atherosclerosis. 2016 Jun;249:215-23. doi: 10.1016/j.atherosclerosis.2016.03.017. Epub 2016 Mar 25.