louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02646956: Taste Preferences for Nutritive and Non Nutritive Sweeteners Among Children and Adults
Official title: Taste Preferences for Nutritive and Non Nutritive Sweeteners Among Children and Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Development
Keywords: Sweet Taste
Psychophysics
Genetics
Diet
Age
Nonnutritive Sweetener
Lead sponsor: Monell Chemical Senses Center
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 82
Sex: ALL
Minimum age (years): 7
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy children and adults living in the Philadelphia area

Brief summary: The goal of the study is to determine whether there are age-, diet- and genetically-related differences in the perception of sweeteners, both nutritive and non-nutritive.

Detailed description: This is an observational 3-day study of children between the ages of 7 and 14 and their mothers. A variety of psychophysical methods determined liking for each of the sweeteners and saliva samples were obtained for genotyping of taste receptor genes. Anthropometric and dietary intake measures were also collected.

Eligibility criteria: Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Allergies and taking medication that affected taste

Primary outcomes:
measure: Liking for the taste of sweeteners measured via the 3-point facial hedonic scale.
timeFrame: Through study completion, an average of 6 months.
measure: Liking for the taste of sweeteners measured via the 5-point facial hedonic scale
timeFrame: Through study completion, an average of 6 months.
measure: Liking for the taste of sweeteners measured via the Monell forced-choice, paired-comparison tracking procedure.
timeFrame: Through study completion, an average of 6 months.
Secondary outcomes:
measure: Genotyping of taste receptor genes via saliva donation
timeFrame: Through study completion, an average of 6 months
measure: BMI calculated from body weight and height measures
timeFrame: Through study completion, an average of 6 months
measure: One day dietary intake collected via the Automated Self-Administered 24-hour dietary recall (ASA24).
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Monell Chemical Senses Center
name: Julie A Mennella, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02631356: The Effect of Succinylated Gelatin on the Blood Viscosity and Oxygen Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Blood Viscosity
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study is to investigate the effect of succinylated gelatin on the blood viscosity and oxygen delivery in patients during surgeries, so as to have a better understanding of the safety in the use of succinylated gelatin for surgical patients.


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18 years and 60 years
* ASA physical status I and II
* surgical procedures requiring general anesthesia with continuous CVP and arterial pressure monitoring

Exclusion Criteria:

* Patients younger than 16 y or older than 60 y
* Body Mass Index (BMI) \<18 or \>30
* Allergy to any of the drugs used
* Severe cardiovascular dysfunction
* Patient refusal

Primary outcomes:
measure: The patient's arterial blood viscosity (mpa.s) as tested by viscometer
timeFrame: up to 5 months (after the infusion of succinylated gelatin )
Secondary outcomes:
measure: The patient's oxygen delivery index (DO2I) as calculated by Vigileo
timeFrame: up to 5 months (after the infusion of succinylated gelatin )
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT01257256: Investigating the Relationships Among Illness Cognition, Social Support, Stress, and Emotional Reactions of Infertile Patients
Official title: Health Service Administration China Medical University
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertile Patients
Keywords: infertile patients
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2010-12-09
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: simple random sampling

Brief summary: The current study attempted to explore the relationships among stressors (cognitions of illness, socioeconomic status, social support, marital stressor, social stressor, etc), perceived stress level, and emotional reactions (anxiety and depression) of infertile patients and to propose the measurement and structural models of infertile aniexty and depression.

Detailed description: The current study attempted to explore the relationships among stressors (cognitions of illness, socioeconomic status, social support, marital stressor, social stressor, etc), perceived stress level, and emotional reactions (anxiety and depression) of infertile patients and to propose the measurement and structural models of infertile aniexty and depression.

Structural Equation Modeling (SEM) will be utilized through AMOS 17 to analyze the data, construct the initial model, and afterward present the modified structural model of the psychological responses for infertile patients.

Eligibility criteria: Inclusion Criteria:male infertile patients(ICD-9:606) and female infertile patients(ICD-9:628).

Exclusion Criteria:non-infertile patients.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References:
Clinical trial NCT02613156: Efficacy Analysis of Complete Laparoscopic Resection of Recurrent Hepatocellular Carcinoma
Official title: Efficacy Analysis of Complete Laparoscopic Resection of Recurrent Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Hepatocellular Carcinoma
Keywords: laparoscopic
hepatocellular carcinoma
recurrence
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-11-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who were diagnosed with recurrent HCC and underwent surgical resection at the Sun Yat-sen University Cancer Center from June 2014 to November 2014

Brief summary: This study is aiming to evaluate the clinical efficacy of complete laparoscopic resection of recurrent hepatocellular carcinoma (HCC).

Detailed description: The investigators conducted a prospective study of 64 patients who were diagnosed with recurrent HCC and underwent surgical resection at the Sun Yat-sen University Cancer Center from June 2014 to November 2014; 31 patients were enrolled in the laparoscopic group and underwent complete laparoscopic resection of HCC, and 33 patients were enrolled in the control group and underwent open surgical resection. The operation time, intraoperative blood loss, shortest distance between the tumor edge and normal liver tissue, postoperative pain scores, postoperative time until the patient could walk, postoperative time until the patient could pass gas, hospital stay, and inpatient costs were compared between the two groups. The patients were followed up for one year after surgery, and the relapse-free survival was compared between the two groups.

Eligibility criteria: Inclusion Criteria:

1. recurrent HCC after open surgery
2. recurrent HCC located in any part of the left lateral lobe or the diaphragm side of the right lobe and near the surface of the liver, which resulted in an easier operation
3. no significant surgical contraindications
4. no major vessel or bile duct tumor invasion and metastasis
5. grade A or B liver function or grade C liver function that recovered to grade A after liver-protective treatment;
6. the patient and his/her family was willing to undergo laparoscopic resection.

Exclusion Criteria:

1. major vessel or bile duct tumor invasion
2. recurrent HCC located in the right liver parenchyma and near secondary vessels and bile ducts, resulting in a difficult operation
3. grade C liver function
4. significant surgical contraindications
5. the patient and his/her family declined laparoscopic hepatectomy.

Primary outcomes:
measure: Perioperative complications
timeFrame: within the first 30 days
Secondary outcomes:
measure: relapse-free survival
timeFrame: 1 year after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Sun Yat-sen University
name: Li Xu
role: STUDY_DIRECTOR
References:
Clinical trial NCT00462956: GW572016 In Patients With Advanced Or Metastatic Breast Cancer
Official title: Phase II Clinical Study of GW572016 in Patients With Advanced or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms, Breast
Keywords: lapatinib
metastatic breast cancer
trastuzumab (Herceptin)
Stage IV breast cancer
ErbB2
ErbB1
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-04-19
Enrollment: 59
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the efficacy and safety of GW572016 in patients with refractory breast cancer and consists of two cohorts of patients. Patients in Cohort A must have ErbB2 overexpressing tumors while patients in Cohort B must have non-ErbB2 overexpressing tumors. Patients eligible for this study must have advanced metastatic breast cancer who have previously received treatment with anthracycline and taxane.


Eligibility criteria: Inclusion Criteria:

* Confirmed advanced (IIIb or Stage IV) breast cancer who have progressed on prior anthracycline and taxanes containing regimens + trastuzumab for cohort A patients.
* Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity.
* Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.

Exclusion Criteria:

* Patients with certain heart problems.

Primary outcomes:
measure: To evaluate tumor response rate in both cohort A (ErbB2 overexpressors) and in cohort B (ErbB2 non-overexpressor) population when treated with GW572016
Secondary outcomes:
measure: Clinical benefitTime to tumor responseLength of responseTime to progression of cancer4 and 6 month progression free survivalOverall survival as well as specific biomarkers in tumor tissue
Other outcomes:
Locations:
city: Ehime
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Saitama
country: Japan
facility: GSK Investigational Site
city: Tochigi
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03068156: Efficacy of 308-nm Excimer Laser for Primary Localized Cutaneous Amyloidosis Treatment in Asians
Official title: Efficacy of 308-nm Excimer Laser for Primary Localized Cutaneous Amyloidosis Treatment in Asians: Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lichen Amyloidosis
Keywords: 308-nm excimer laser
primary localized cutaneous amyloidosis
lichen amyloidosis
Asians
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Ratchadapiseksompotch Fund
First posted: 2017-03-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy of 308-nm excimer laser for primary localized cutaneous amyloidosis treatment in Asians, pilot study.


Eligibility criteria: Inclusion Criteria:

* Patients, aged \>18 years old with lichen amyloidosis diagnosed by using clinical presentation and pathologic features

Exclusion Criteria:

* Those with cutaneous amyloidosis associated systemic diseases
* Pregnancy or lactating woman
* Those who are allergic to urea, olive oil
* Those who are photosensitive to ultraviolet radiation
* Those who had been previously treated with medications/ radiation/ laser within 3 months for systemic and 1 month for topical therapy

Primary outcomes:
measure: Roughness evaluation by using Visioscan® VC98
timeFrame: Change from baseline roughness at every 2 weeks up to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
Study officials:
affiliation: Chulalongkorn University
name: Einapak Amnarttrakul, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00826956: The Change of Pulmonary Blood Flow During One Lung Ventilation
Official title: The Changes of Pulmonary Blood Flow in Nondependent Lung During One Lung Ventilation
Study type: EXPANDED_ACCESS
Overall status: TEMPORARILY_NOT_AVAILABLE
Conditions: One Lung Ventilation
Lead sponsor: Sichuan University
Sponsor class: OTHER
Collaborators: name: West China Hospital
First posted: 2009-01-22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT

Brief summary: To investigate the changes of regional pulmonary blood flow in nondependent lung by transesophageal echocardiography during one lung ventilation


Eligibility criteria: Inclusion Criteria:

* adult patients (ASA physical status I-III) requiring OLV for selective thoracic surgery.

Exclusion Criteria:

* chronic obstructive pulmonary disease
* hypertension
* cardiovascular
* esophageal disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Wang M, Gong Q, Wei W. Estimation of shunt fraction by transesophageal echocardiography during one-lung ventilation. J Clin Monit Comput. 2015 Apr;29(2):307-11. doi: 10.1007/s10877-014-9606-2.
Clinical trial NCT00527956: Facilitation and Barriers to Breastfeeding in the NICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breastfeeding
Prematurity
Keywords: Breastfeeding premature infants
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2007-09-11
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: To date, there is a paucity of research focusing on maternal breastfeeding goals, how these goals may change after an unexpected event such as a preterm birth, and how mothers of ill and preterm infants define breastfeeding success. No studies were identified that focused exclusively on the breastfeeding goals of mothers of hospitalized preterm infants

The purpose of this study is to answer the following research questions: 1) What are the breastfeeding goals of mothers with preterm infants in the NICU? and 2) What are mothers' perceptions of facilitators and barriers to meeting their breastfeeding goals in the NICU?

Detailed description: As the objective of this study is to describe the breastfeeding goals of mothers and their perceptions of breastfeeding support in the NICU, this study will follow a descriptive, qualitative design. Mothers of preterm newborns in the Royal Victoria Hospital will participate in a semi-structured interview about their breastfeeding goals and what they perceived to be facilitators and barriers to achieving their intended goals. During the interviews, the mothers will be asked a set of socio-demographic questions, open-ended questions about their breastfeeding goals, and open-ended questions about their perceptions of barriers and facilitators to meeting these goals in the NICU Participants may also receive one follow-up phone call to clarify their responses to the questions or to validate the information obtained from the interview.

Eligibility criteria: Inclusion Criteria:

1. have one (or more) infant(s) currently admitted in the NICU at the RVH;
2. intended to provide breast milk to their infant(s);
3. are able to speak English; and
4. are willing to be audiotaped during the interview.

Exclusion Criteria:

Include mothers who:

1. never intended to breastfeed;
2. have high risk social situations (for example, known maternal mental illness; involvement of youth protection; known alcohol and drug abuse; adoption; identified congenital anomalies);
3. gave birth at term; and
4. have infants with significant birth defects or serious medical conditions in addition to prematurity.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: McGill Univsersity Health Centre
name: Luisa Ciofani, RN, M.Sc.(A)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06402656: Comparison of Customized and Standard Facemasks for Early Treatment of Class III Malocclusion
Official title: Comparison of Customized and Standard Facemasks for Early Treatment of Class III Malocclusion: Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malocclusion, Angle Class III
Extraoral Traction Appliances
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 24
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare a customized facemask for the treatment of Class III malocclusion in the prepubertal growing patient (patients between the ages of 5 and 12 years) versus a standard commercial facemask. Specifically, preference, pain, difficulty in sleeping, time of use, and possible complications for the two types of facemasks will be analyzed.

This is a single-center, national, controlled, superiority, randomized, crossover, open-label study.

Each patient will be treated with both the customized facemask and the standard commercial facemask. Each patient will wear one type of facemask for 2 months and the other type of facemask for the next 2 months. After 2 weeks and at the end of therapy with each of the facemask types, the patient, with the possible help of the parents, will have to answer a questionnaire about pain and difficulty sleeping and report any complications. In addition, after completing both phases (fourth month), the patient should indicate a preference for one of the two types of mask with which to complete therapy for an additional 6 months.


Eligibility criteria: Inclusion Criteria:

* Age between 5 and 12 years;
* Class III malocclusion, for which early orthopedic treatment with rapid maxillary expander and facemask is indicated.
* signing of informed consent

Exclusion Criteria:

* Cleft lip and/or palate.
* Craniofacial syndromes.

Primary outcomes:
measure: Questionnaire on the preference of the patient for one of the two types of face masks
timeFrame: 4 months
Secondary outcomes:
measure: Pain reported by patients
timeFrame: At 2 weeks and at 2 months after delivery of each of the 2 face masks
measure: Difficulty in sleeping reported by patients
timeFrame: At 2 weeks and at 2 months after delivery of each of the 2 face masks
measure: Number of complications
timeFrame: At 2 weeks and at 2 months after delivery of each of the 2 face masks
measure: Total time wear
timeFrame: At 2 months after delivery of each of the 2 face masks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04461756: Safety and Pharmacokinetics of Vaped Cannabis in Healthy Volunteers
Official title: A Phase I Exploratory Study to Assess the Pharmacokinetics of Single Inhaled Dose of Cannabis (Delta-9-Tetrahydrocannabinol / Cannabidiol) Administered by Vaporization Using a 4-Day Dose Titration In Healthy Male And Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volonteers
Lead sponsor: Tetra Bio-Pharma
Sponsor class: INDUSTRY
Collaborators: name: Algorithme Pharma Inc
First posted: 2020-07-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was to evaluate the pharmacokinetics (PK) of THC, 11-OH-THC and CBD following a single inhaled dose of PPP001 administered by vaporization.

The secondary objective of this study was to determine the safety and tolerability of THC and CBD after a single inhaled dose of PPP001 administered by vaporization in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Body mass index within 21.0 to 32.0 kg/m2, inclusively
* A light-, non- or ex-smoker of nicotine
* A history of recreational cannabis use (at least 10 times in the last 5 years)
* Consumed cannabis in the last 3 months before Day 1 of the study, but not within 1 month before Day 1 of the study
* Presence of intact oral mucosa
* Able to follow instructions at the training vaporizing session
* Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must have been without clinical significance, as determined by an investigator
* No clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs), or ECG, as determined by an investigator

Primary outcomes:
measure: Assessment of adverse events [Safety and Tolerability]
timeFrame: over 5 days
measure: Biochemistry test results [Safety and Tolerability]
timeFrame: over 5 days
measure: Temperature [Safety and Tolerability]
timeFrame: over 5 days
measure: Pulse rate [Safety and Tolerability]
timeFrame: over 5 days
measure: Blood pressure [Safety and Tolerability]
timeFrame: over 5 days
measure: Clinically significant ECG abnormalities [Safety and Tolerability]
timeFrame: over 5 days
measure: Plasma concentrations of delta-9-tetrahydrocannabinol produced by PPP001 were determined. (pharmacokinetics)
timeFrame: over 5 days
measure: Plasma concentrations of 11-OH-delta-9-tetrahydrocannabinol produced by PPP001 were determined. (pharmacokinetics)
timeFrame: over 5 days
measure: Plasma concentrations of cannabidiol produced by PPP001 were determined. (pharmacokinetics)
timeFrame: over 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Alta sciences
state: Quebec
Study officials:
References: