louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01259570: Bioavailability of Vitamin D Encapsulated in Casein Micelles, Compared to Its Bioavailability in the Milk-fat, or in a Synthetic Emulsifier Currently Used for Supplementation and Enrichment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Individuals
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Technion, Israel Institute of Technology
First posted: 2010-12-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The encapsulation within CM may improve bioavailability (BA) of vitamin D (VD), even in absence of fat.

As a model the investigators have chosen nonfat yoghurt. The investigators will prepare yoghurts from 4 milks: (1) Skimmilk enriched with 50,000 IU/150gr VD encapsulated in CM2 ; (2) 3% fat milk wherein same dose of VD - dissolved in milk fat and homogenized into skimmilk; (3) 3% fat milk wherein VD, at same dose, will be in CM; (4) Placebo: unenriched skimmilk. 120 healthy adults aged 18-65 will randomized to 5 groups and receive 150 gr yoghurt. Blood will be drawn before ingestion and on days 1,7,14. 25(OH)D will be det. by CMIA. In vitro simulated digestion will be studied.

Expected results: The BA of VD in CM would not be lower than in fat


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Metabolic disorder

Primary outcomes:
measure: Bioavailability of vitamin D encapsulated in casein micelles, compared to its bioavailability in the milk-fat.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03972670: Correlation Between Postoperative Central Corneal Thickness and Endothelial Damage After Cataract Surgery
Official title: Correlation Between Postoperative Central Corneal Thickness and Endothelial Damage After Cataract Surgery by Phacoemulsification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Phacoemulsification
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 85
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: All patients undergoing surgery were older than 18 years. Subjects had cataract up to C5, N4 and P5 on the LOCS III classification

Brief summary: To study correlation between postoperative corneal edema and endothelial cell loss after cataract surgery by microcoaxial phacoemulsification.

Detailed description: Cataract surgery facilitates improved visual acuity through extraction of an opacified lens, followed by intraocular lens implantation. An average adult cornea has 2000 to 2500 cells/mm2, a count that diminishes with age with a rate of attrition of approximately 0.3% to 0.5% per year. Long-term postoperative corneal transparency depends on the morphological stability and functional integrity of the corneal endothelium. It is well established that all surgical interventions that require entry into the anterior chamber result in some damage to the corneal endothelium.

Endothelial cell loss results in cell hypertrophy to maintain continuity, resulting in a change in endothelium cell density and morphology. Many studies have assessed the impact of various surgical techniques on endothelial damage and numerous studies have investigated the factors influencing endothelial cell loss after phacoemulsification. The goal of this study is to investigate the correlation of postoperative corneal edema with the reduction of endothelial corneal cell density after phacoemulsification.

Eligibility criteria: Inclusion Criteria:

* The presence of senile cataract with equivalent grades and a history of visual acuity regression

Exclusion Criteria:

* Patient with total white cataract
* With history of ocular surgery
* With other eye diseases (corneal pathology, Fuchs dystrophy, uveitis and glaucoma) or systemic diseases (diabetic disorder and dementia)

Primary outcomes:
measure: Pachymetry
timeFrame: Day 1
Secondary outcomes:
measure: Endothelial cell density
timeFrame: Day 1
measure: Pachymetry after 1 month
timeFrame: Day 30
measure: Endothelial cell density after 1 month
timeFrame: Day 30
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01576770: In Children, Does Using a Synera Patch Decrease Pain When Injecting Propofol at Anesthesia Induction?
Official title: In Children, Does the Use of Synera Patch for Local Analgesia Before Vascular Access Reduce Pain Associated With Propofol Injection for Anesthesia Induction?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain on Propofol IV Injection
Keywords: propofol
Pain
Synera Patch
Gebauer's Ethyl Chloride topical anesthetic
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: ZARS Pharma Inc.
First posted: 2012-04-12
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate if the Synera Patch (lidocaine/tetracaine patch), used to numb the skin before IV placement, is effective in reducing pain associated with propofol IV administration when inducing general anesthesia, compared to Gebauer's Ethyl Chloride topical anesthetic skin refrigerant.

Detailed description: Commonly, anesthesiologists inject Propofol, a sleeping medication, intravenously to induce general anesthesia. Propofol injection is associated with pain that can be severe.

The investigators also place a lidocaine/tetracaine skin patch (Synera) to decrease pain associated with IV placement. Because the local anesthetics of the Synera patch diffuse deep underneath the skin, in this study the investigators would like to evaluate whether the application of Synera Patch can decrease the pain associated with propofol injection.

Children will be randomized to receive either the patch or the Ethyl Chloride before the IV placement. A total of 33 patients will be enrolled in each group.

Eligibility criteria: Inclusion Criteria:

* Healthy, outpatient children, 6-17 years old
* American Society of Anesthesiologist Physical Classification rating of 1 or 2
* Elective procedure requiring general anesthesia at Memorial Herman Hospital, The Medical Center, Houston, Texas

Exclusion Criteria:

* Skin disease or infection (on dorsum of hands)
* Allergy to lidocaine or tetracaine

Primary outcomes:
measure: Number of children in each group who do not feel pain or have mild pain on propofol injection.
timeFrame: Within one hour, plus or minus one half hour
Secondary outcomes:
measure: Pain intensity
timeFrame: Within one hour, plus or minus one half hour
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Herman Hospital
state: Texas
Study officials:
affiliation: University of Texas Health Sciences Center at Houston
name: Samia N Khalil, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02199470: β-cell Function in Type 1 Diabetes May Not Be As Low As Presumed
Official title: β-cell Function in Type Diabetes May Not Be As Low As Presumed
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: TYPE 1 DIABETES
Keywords: β-CELLS,
MIXED MEAL TEST,
C-PEPTİDE
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with type 1 diabetes

Brief summary: Enhancing endogenous insulin production in type 1 diabetic patients (T1DP) can improve glycemic control and decrease complications and rates of mortality. However, it can be succesfull even if sufficient β-cell function is present. We aimed to evaluate the extent of β-cell function by determining fasting levels of C-peptide and those after meal stimulus.

Detailed description: Background and aims: Enhancing endogenous insulin production in type 1 diabetic patients (T1DP) can improve glycemic control and decrease complications and rates of mortality. However, it can be succesfull even if sufficient β-cell function is present. We aimed to evaluate the extent of β-cell function by determining fasting levels of C-peptide and those after meal stimulus.

Materials and Methods: One hundred and thiryfive T1DP were planned to enrolı to the study. Ethics comittee of our hospital approved the study protocol, which was in accordance with the Helsinki Declaration. Fasting C-peptide levels of all participants and stimulated (at 90 th minute post mixed meal) C-peptide levels of 54 will be measured by using an electrochemiluminescence assay. Two categorizations will be done using fasting (the first categorization ) and at 90th minute post mixed meal test (the second categorization) of C-peptide levels. For the first categorization; the groups will be classified as follows: patients with undetectable ≤0.1 ng/mL (group 1); with minimal 0.1-0.8 ng/ml (group 2); and with sustained ≥0.8 ng/mL(group 3) C-peptide levels. For the second categorization, groups will be as follows: patients with undetectable ≤0.1 ng/mL (group 1); with minimal 0.1-0.8 ng/ml (group 2); and with sustained ≥0.8 ng/mL (group 3) C-peptide levels which increased at the 90th minute after the meal ≥150% of fasting C-peptide level.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetic patients who have accepted to have mixed meal tolarance test

Exclusion Criteria:

* Patients with type 2 diabetes,
* patients with MODY

Primary outcomes:
measure: We aimed to evaluate the extent of β-cell function by determining fasting levels of C-peptide and those after meal stimulus.
timeFrame: 1 day (the duration of mixed test is 90 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medeniyet University Goztepe Training and Research Hospital
Study officials:
affiliation: Istanbul Medeniyet University
name: Gonca Incemehmet Tamer, I
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04726436: Dextrose Effect on Postoperative Nausea and Vomiting (PONV)
Official title: The Impact of Timing and Dosing of Dextrose Solution on Postoperative Nausea and Vomiting.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study to assess which time and dose of dextrose solution more effective in decreasing postoperative nausea and vomiting.

Detailed description: All patients signed informed consent after excluding patients not candidate for the study.patients were divided to three groups, taking either 0.9% saline as control group(group C), dextrose 5%(group D5) or dextrose 10%(group D10).

Eligibility criteria: Inclusion Criteria:

* Female non-smokers adults (age 18-65 years)
* ASA I-II who were listed for elective surgery under general anesthesia (surgery which is risk for PONV).

Exclusion Criteria:

* Severe hypertension
* Coagulopathy
* Significant hepatic or renal disease
* Diabetes mellitus or abnormal blood glucose on the morning of surgery
* Withdrawal of consent
* Severe intraoperative hypotension requiring large volume intravascular fluid treatment
* Protocol violations including nitrous oxide administration.

Primary outcomes:
measure: Postoperative nausea and vomiting within 24 hour
timeFrame: 24hour after surgery
Secondary outcomes:
measure: Number of doses of antiemetics required to control PONV.
timeFrame: 24hour postoperative
measure: Number of classes of antiemetics
timeFrame: 24 hour postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
state: Assuit
Study officials:
References:
citation: Zorrilla-Vaca A, Marmolejo-Posso D, Stone A, Li J, Grant MC. Perioperative Dextrose Infusion and Postoperative Nausea and Vomiting: A Meta-analysis of Randomized Trials. Anesth Analg. 2019 Oct;129(4):943-950. doi: 10.1213/ANE.0000000000004019.
Clinical trial NCT01165736: To Calculate the Pharmacokinetics (Concentration of Compound in and Rate of Excretion From the Blood) Following a Very Low Dose of Compound Which Will Not Have Any Pharmacological Activity
Official title: An Exploratory, Open Label, Randomized, Parallel Group Study To Investigate The Pharmacokinetics Of Single Intravenous And Oral Micro Doses Of PF-05186462, PF-05089771, PF-05241328 And PF-05150122 In Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacokinetics
safety
tolerability
Chronic Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-07-20
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to calculate the pharmacokinetics (concentration of compound in and rate of excretion from the blood) following a very low dose of compound which will not have any pharmacological activity and to monitor for the safety and tolerability of each of the compounds in the study.


Eligibility criteria: Inclusion Criteria:

* healthy male subjects between the ages of 18 and 50 years inclusive. (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests)
* Body Mass Index (BMI) of 17.5 to 30.5kg/m2l and a total body weight of between 50 and 100kg inclusive.
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.

Exclusion Criteria:

* Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing)
* History of febrile illness within 5 days prior to the first dose a positive urine drug screen

Primary outcomes:
measure: Safety and tolerability (heart rate, blood pressure, QTcF, clinical chemistry)
timeFrame: up to 3 days post dose
measure: pharmacokinetics of each of the four compounds measuring Clearance, volume of distribution, elimination half life and area under the effect curve
timeFrame: up to 3 days post dose
Secondary outcomes:
measure: safety and tolerability of each of the four compounds (heart rate, blood pressure, QTcF, clinical chemistry)
timeFrame: up to 3 days post dose
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02760836: Predictive Model of Clinical Outcomes Using Web-based Self-reporting Symptom Diary for Crohn's Disease
Official title: Development and Validation of Predictive Model of Clinical Outcomes Using Pattern Analysis of Web-based Self-reporting Symptom Diary for Crohn's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn's Disease
Keywords: Crohn's disease
disease outcomes
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Crohn's disease from 4 tertiary referral centers.

Brief summary: The purpose of this study is to develop and validate a predictive model of clinical outcomes based on the results of web-based self-reporting symptom diary for Crohn's disease.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed of Crohn's disease within 6 months
* Must record their symptom in a web-based symptom diary at least 4 consecutive times for 2 months.

Exclusion Criteria:

* Not able to use smart phone.

Primary outcomes:
measure: Hospitalization
timeFrame: 2 years
measure: Unscheduled visit
timeFrame: 2 years
Secondary outcomes:
measure: Bowel resection surgery
timeFrame: 2 years
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
affiliation: Kyungpook National University Hospital
name: Eun Soo Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01837836: Effect of Health Education on Water Handling Practices in Rural Pondicherry
Official title: Effect of Health Education on Water Handling Practices in Rural Pondicherry
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Drinking Water Handling Practice
Knowledge of Water Borne Diseases
Bacteriological Quality of Water
Keywords: Health education
water handling practices
Bacteriological quality of water
Lead sponsor: Sri Manakula Vinayagar Medical College and Hospital
Sponsor class: OTHER
First posted: 2013-04-23
Enrollment: 980
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the drinking water handling practices at household level and to determine the effect of health education on the drinking water handling. Participants from study villages, mainly homemakers, school children and water tank operators who are willing to participate, will be targeted.

Baseline assessment of household practices related to water will be done. Followed by a health education regarding the healthy practices will be given to them. Practice of household water chlorination will be promoted. The healthy behavior will be reinforced through reminders and community activities of self help groups for one year.

The study participants will be benefited from survey in terms of

1. Improved knowledge and practices of drinking water handling
2. Risk reduction of water borne illness to family members


Eligibility criteria: Inclusion Criteria:

* Subjects of five study villages

Exclusion Criteria:

* Those who anticipate to move out of study area in next one year

Primary outcomes:
measure: Number of subjects following hygienic drinking water handling practices
timeFrame: Outcome measure will be assessed at baseline and after one year of health education intervention.
Secondary outcomes:
measure: Number of subjects with improved knowledge and practices related to water borne illnesses
timeFrame: Outcome measure will be assessed at baseline and after one year of health education intervention.
Other outcomes:
measure: Number of household drinking water samples with improved bacteriological quality
timeFrame: Outcome measure will be assessed at baseline and after one year of health education intervention.
Locations:
city: Pondicherry
country: India
facility: Sri Manakula Vinayagar Medical College and Hospital
Study officials:
affiliation: Sri Manakula Vinayagar Medical College and Hospital, Pondicherry
name: Arun G Ghorpade, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02015936: Physical Activity for Advanced Stage Cancer Patients
Official title: Physical Activity for Advanced Stage Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: stage III cancer
stage IV cancer
cancer
advanced stage cancer
Nintendo Wii training
exercise
physical training
physical function
physical fitness test
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: University of South Florida
First posted: 2013-12-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to understand if a home-based physical activity program can improve symptoms and physical function among patients with advanced stage cancer.

Detailed description: This program includes use of the Nintendo Wii Fit™Plus (Wii Fit) and home visits by a nurse. The same nurse will attend all of the visits.

Eligibility criteria: Inclusion Criteria:

* have stage III or IV cancer diagnosis
* able to understand English
* have a Karnofsky Performance Status (KPS) score of 60% (able to care for most of the personal needs)
* have fatigue and/or two other target symptoms
* have been cleared by their provider to engage low to moderate intensity physical activities

Exclusion Criteria:

* are hospitalized
* have lesion or metastasis of bone
* have a cardiac pacemaker
* have a history of seizure or loss of consciousness
* have been using a Wii Fit
* diagnosed cognitive impairment

Primary outcomes:
measure: Rate of Participation Among Eligible Patients
timeFrame: 6 weeks per participant
Secondary outcomes:
measure: Rate of Positive Response to Participation
timeFrame: 6 weeks per participant
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: University of South Florida
name: Hsiao-Lan Wang, Ph.D., RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00370136: Sentinel Node With Ultrasound Contrast in Melanoma
Official title: Sentinel Node Diagnostics With Ultrasound Contrast in Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Melanoma
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2006-08-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose is to evaluate,in 20 patients, if the sentinel node(s) in melanoma can be detected by lymph contrast ultrasound. In comparing the patients will also get lymph-scintigraphy and sentinel node detection wiht blue dye.

The goal is to improve the method for detecting sentinel node(s) in melanoma.


Eligibility criteria: Inclusion Criteria:

* Malignant melanoma on a extremity,
* No spread of the cancer,
* Patients over 18 years old,

Exclusion Criteria:

* Pregnancy,
* Lactating,
* Severe hart disease,

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen univercity hospital, Department of Radiology, section of ultrasound
Study officials:
affiliation: Department of Radiology, section ultrasound
name: Michael B Nielsen, MDSc
role: PRINCIPAL_INVESTIGATOR
References: