louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04455737: Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision
Official title: Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Neoplasms
Keywords: indigo carmine
lymph node
pathology
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing elective, oncologic rectum resection in TaTME technique

Brief summary: Background: An exact lymph node staging is essential in the treatment of rectal cancer.

Objective: The aim of this study was to assess the effect of indigo carmine injection on the number of retrieved and positive lymph nodes after transanal total mesorectal excision (taTME).

Design: This is a retrospective, non-randomised study. Settings: This study was conducted at a tertiary hospital by a multidisciplinary team.

Patients: Between 2013 and 2019, patients undergoing transanal total mesorectal excision were analysed. Patients with indigo carmine injection (intervention group) were compared to those without (control group).

Interventions: Transanal total mesorectal excision was performed with or without ex vivo intra-arterial indigo carmine injection.

Main Outcome Measures: The number of retrieved and positive lymph nodes was the primary outcome measure.


Eligibility criteria: Inclusion Criteria:

* elective, oncologic rectum resection in TaTME technique for proven or highly suspected rectal cancer.

Exclusion Criteria:

* abdominoperineal resection
* extended colon resection
* previous surgery of the rectum, the left colon or the mesocolon/-rectum
* patients rejecting retrospective data analysis

Primary outcomes:
measure: retrieved lymph nodes
timeFrame: 1 - 7 days after surgery
Secondary outcomes:
measure: positive lymph nodes
timeFrame: 1 - 7 days after surgery
measure: N stage
timeFrame: 1 - 7 days after surgery
measure: survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Rorschach
country: Switzerland
facility: Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen
Study officials:
affiliation: Kantonsspital St. Gallen, Rorschach branch, Department of Surgery
name: Walter Brunner, MD MSc MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03586037: Evaluating the Pharmacokinetic Interaction Between AD-2011 and AD-2012
Official title: An Open-label, Sequence-randomized, Three-period, Six-sequence, Multiple Dosing Crossover Clinical Trial to Evaluate the Pharmacokinetic Interaction Between AD-2011 and AD-2012 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperlipidemias
Hypertension
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-13
Enrollment: 36
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2011 and AD-2012 in healthy male volunteers.

Detailed description: To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the single administration of AD-2011 and AD-2012.

Eligibility criteria: Inclusion Criteria:

* Healthy male between 19 and 50 years of age at the time of screening
* Weight between 50 kg and 90 kg and body mass index (BMI) between 18.0 kg/m2 and 27.0 kg/m2

Exclusion Criteria:

* Clinically significant disease or history of clinically significant disease such as liver, kidney, nervous system, respiratory, endocrine\*hematologic, cardiovascular, urinary, psychiatric
* Gastrointestinal problem or history of gastrointestinal problem and history of gastrointestinal surgery
* AST, ALT values over than 1.5 times of ULN at screening
* HDL values less than 35 mg/dL
* A person who has a history of drug abuse or who has positive result for an abuse drug in a urine screening test

Primary outcomes:
measure: Peak Plasma Concentration
timeFrame: pre-dose to 24 hours
measure: Area under the plasma concentration versus time curve
timeFrame: pre-dose to 24 hours
Secondary outcomes:
measure: Time to reach Cmax
timeFrame: pre-dose to 24 hours
measure: Concentration
timeFrame: pre-dose to 24 hours
measure: Elimination half-life
timeFrame: pre-dose to 24 hours
measure: Clearance
timeFrame: pre-dose to 24 hours
measure: Volume of distribution
timeFrame: pre-dose to 24 hours
measure: Number of participants with adverse events
timeFrame: From Day 1 up to Day 45
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: In-Jin Jang, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huh KY, Lee SW, Lee SB, Kim KT, Jang IJ, Lee S. Pharmacokinetic Interaction Among Ezetimibe, Rosuvastatin, and Telmisartan. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1290-1296. doi: 10.1002/cpdd.926. Epub 2021 Mar 1.
Clinical trial NCT00261937: Inhaled Furosemide Versus Placebo for Acute Viral Bronchiolitis in Hospitalized Infants
Official title: Inhaled Furosemide Versus Placebo for Acute Viral Bronchiolitis in Hospitalized Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bronchiolitis
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-12-06
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We hypothesize that inhaled Furosemide will be an effective treatment in infants with acute bronchiolitis.


Eligibility criteria: Inclusion Criteria:

* Age: 0-12 months.
* Infants who are otherwise healthy
* Infants with chronic lung disease of prematurity (BPD) will be included, but will be analyzed separately.
* Parents signed a written informed consent.

Exclusion Criteria:

* • Other previous or co-morbidity, specifically: respiratory (other than BPD, like Asthma or Cystic Fibrosis), cardiac or renal disease or anomaly.

Primary outcomes:
measure: Clinical respiratory effects
Secondary outcomes:
measure: 1. The duration of hospitalization
measure: 2. Time weaned off oxygen
measure: 3. Time to full enteral feeding
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center and Naharia Galilli Medical Center
Study officials:
affiliation: Bnai Zion Medical Center
name: Amir Kugelman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bar A, Srugo I, Amirav I, Tzverling C, Naftali G, Kugelman A. Inhaled furosemide in hospitalized infants with viral bronchiolitis: a randomized, double-blind, placebo-controlled pilot study. Pediatr Pulmonol. 2008 Mar;43(3):261-7. doi: 10.1002/ppul.20765.
Clinical trial NCT03817437: Correlation Study Between Socio-economical Deprivation and Oral Health in Children of 9 Years of Age
Official title: Correlation Study Between Socio-economical Deprivation and Oral Health in in French Children of 9 Years of Age in 2017. A Nationwide Database Retrospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tooth Decay
Missing Tooth/Teeth
Keywords: Oral health
Odontology
Epidemiology
Public health
Deprivation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 600000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients born in 2008

Brief summary: Retrospective, observational cohort study.

Objectives :

To search for correlations between socio-economical deprivation and oral health in french children of 9 years of age.

To study the annual use of oral and dental care of children from 6 to 9 years of age depending on their geographical and socio-economical environment, and the medical demography ; To identify and study the share of the cohort not using oral and dental care, and the socio-economical and geographical factors implicated in this non-use of care.

The study will use data from the french nationwide healthcare systems database (SNDS) and data from the french national institute of statistics and economic studies (INSEE).


Eligibility criteria: Inclusion criteria:

* Being born in 2008
* Being covered by the mandatory french national health insurance plan without discontinuity between 2014 and 2017
* Living in France without discontinuity between 2014 and 2017

Exclusion criteria:

- None

Primary outcomes:
measure: Correlations (odds-ratios) between several socio-economical indicators and oral care use
timeFrame: 36 months
Secondary outcomes:
measure: Mean numbers of several types of oral cares depending on the patients geographical and socio-economical environment
timeFrame: 36 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Guillaume BOUREL, MsC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03232437: Reproducibility of HbA1c Measurement on the Aina HbA1c Monitoring System
Official title: A Multicenter Study to Evaluate the External Precision of the Aina HbA1c Monitoring System in Quantitative Measurement of Glycosylated Hemoglobin (HbA1c)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: HbA1c
Lead sponsor: Jana Care
Sponsor class: INDUSTRY
Collaborators: name: The Forsyth Institute
name: Orange County Research Center
name: ActivMed Practices & Research
First posted: 2017-07-28
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy and Diabetic patients

Brief summary: A three site study to evaluate the reproducibility of the Aina HbA1c Monitoring System in quantitative determination of glycosylated hemoglobin (HbA1c) took place at the following sites:

1. Forsyth Institute in Cambridge, MA
2. Orange County Research Center in Tustin, CA
3. ActivMed Practices \& Research in Methuen, MA

Detailed description: Each site tested three identical samples of HbA1c, at three different levels of HbA1c measurement. Samples were drawn at the Forsyth Institute, received and blinded by the Sponsor, and returned to Forsyth Institute for testing. Samples were tested in triplicate, twice per day, over the course of five days, by three trained operators.

Eligibility criteria: Inclusion Criteria:

* Agree to the terms of this consent form
* Sign this consent form
* Be 18 years or older
* Have an HbA1c measured by a reference method within the last three months or based on medical history that is expected to fall in the range of 4 to 15%
* Provide blood samples from your arm and finger
* Come in in the morning of the study visit

Exclusion Criteria:

* Not have a recent history of anemia or hemoglobin concentration above 20%
* Not be pregnant
* Not have previously given a blood sample to the Study Sponsor for a study

Primary outcomes:
measure: Precision (as measured by %CV) of HbA1c measurements
timeFrame: Each sample was measured in triplicate, twice per day, over the course of five days
Secondary outcomes:
Other outcomes:
Locations:
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Cambridge
country: United States
facility: The Forsyth Institute
state: Massachusetts
city: Methuen
country: United States
facility: ActivMed Practices & Research
state: Massachusetts
Study officials:
affiliation: Forsyth Institute
name: Hatice Hasturk, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orange County Research Center
name: Joel Neutel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ActivMed Practices & Research
name: Michael McCartney, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04923737: Immunomodulatory Effects of Dexmedetomidine Infusion
Official title: Immunomodulatory Effects of Dexmedetomidine Infusion After Laparoscopic Major Abdominal Surgeries: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Abdominal Surgery
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anesthetic management may affect both immunostimulatory and immunosuppressive mechanisms directly by modulating immune cell function or indirectly by attenuating the stress response, Thus, the choice of anesthetic technique may affect clinical outcomes by perturbing the balance between pro- and anti-inflammatory responses,anesthetics favoring this delicate balance are thus desirable as their use may reduce postoperative complications and mortality


Eligibility criteria: Inclusion Criteria:

* scheduled for elective laparoscopic major abdominal surgeries;
* ASA class II-III

Exclusion Criteria:

- 1- Patients with severe infection or diseases in respiratory system 2- Patients with severe arrhythmia or bradycardia 3- Patients with severe diseases in liver, kidney, endocrine or immune system. 4- Patients with history of uncontrolled hypertension, A-V conduction block. 5- Patients who had administrated the α-adrenergic agonists or β-receptor antagonist.

6- Patients who received the chemotherapy, radiotherapy, or immunotherapy within one month before operation 7- Patients who had feverbefore operation

Primary outcomes:
measure: immune-modulatory effects
timeFrame: three days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Rehab Abd Elraof Abd Elaziz
Study officials:
affiliation: Alexandria University
name: rehab A. Abd Elaziz, Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00780637: Brachial Artery t-PA Release in Heart Transplant Recipients
Official title: Characterization of Brachial Arterial t-PA Release, Vasodilator Function, and Vascular Compliance and Correlation With Fibrinolytic Balance, Oxidative Stress, and Inflammation Measures in Heart Transplant Recipients (SCCOR Project 1, Aim 3C)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Transplantation
Keywords: Heart Transplant
Endothelial Function
Fibrinolysis
Transplant recipients at baseline
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2008-10-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Bradykinin stimulates t-PA release from intact vessels, but not from endothelial cells in culture. It has been proposed that the nerves of blood vessels are the source of bradykinin stimulated t-PA release. In order tho test this hypothesis, we intend to infuse bradykinin into the brachial (arm) artery and the coronary arteries of heart transplant recipients and control subjects. This is because heart transplant recipients do not have nerves to their coronary arteries.

This protocol studies the effects of bradykinin on t-PA release in the forearm of transplant recipients. The brachial artery has intact nerves.

Separate protocols address coronary artery infusions in healthy subjects and transplant recipients and forearm infusions in healthy subjects.


Eligibility criteria: Inclusion criteria:

1. Adults 18 years and greater who have undergone heart transplantation
2. Healthy

Exclusion criteria:

1. PVC \< 30
2. Hypertensive subjects on ACE inhibitors
3. Pregnant or nursing mothers
4. Diabetic with HbA1C \> 7.5 or stigmata of end organ damage (neuropathy, retinopathy, nephropathy, cardiomyopathy)
5. Cholesterol \> 30 mg/dL above NCEP accepted level based on cardiac risk.
6. Triglycerides \> 200
7. Previously diagnosed obstructive coronary artery disease
8. Renal insufficiency (Creatinine ≥ 1.5 mg/dl)
9. History of cerebrovascular disease
10. Any chronic inflammatory disease (rheumatologic, inflammatory bowel disease, etc)
11. Uncontrolled Stage 2 Hypertension (160/100 mmHg), or end organ damage due to hypertension (left ventricular hypertrophy, atrial fibrillation, hematuria, renal insufficiency, prior cerebrovascular disease).
12. Angiotensin converting enzyme inhibitor use
13. Coagulopathy (INR ≥ 1.5, PTT ≥ 150% of control)
14. Peripheral Vascular Disease
15. Other chronic medical illnesses at the discretion of the investigators

Primary outcomes:
measure: Peak t-PA release
timeFrame: Single Study Visit
Secondary outcomes:
measure: t-PA release at various doses
timeFrame: Single Study Visit
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: James AS Muldowney, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00235937: Study on Pre-menopausal Patients With Advanced ER and PR + BC Treated With Arimidex Plus Zoladex
Official title: An Open, Phase II Trial Assessing the Objective Response Rate After Combination of Arimidex® 1mg Per os/Day and Zoladex® 3.6 mg Sub Cut/Monthly as 1st Treatment for Premenopausal Receptor Positive Advanced or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Premenopausal
Advanced Breast Cancer
Metastatic Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 45
Sex: FEMALE
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 efficacy and tolerance of the association of two drugs already marketed and used to treat your disease: Arimidex® 1 Mg per day per os and Zoladex® 3,6 Mg in injections under cutaneous once per month in subjects with breast cancer.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent, premenopausal women 18 years or older, histologically or cytologically confirmed locally advanced or metastatic breast cancer, suitable for endocrine treatment, no curative treatment available,, one or more measurable lesions, life expectancy more than 6 months, normal biological parameters.

Exclusion Criteria:

* Presence of life-threatening metastases, previous endocrine therapy or chemotherapy for advanced or metastatic disease, any previous treatment with hormone (LH-RH) severe or uncontrolled systemic disease, pituitary adenoma, High risk of medullar compression.

Primary outcomes:
measure: Determine the feasibility and efficacy of the combination of these 2 drugs in these patients
Secondary outcomes:
measure: To assess clinical benefit rate, time to progression, duartion of response and safety in patients treated with the combination of these 2 drugs
Other outcomes:
Locations:
city: Angers
country: France
city: Caen
country: France
city: Poitiers
country: France
city: Rennes
country: France
city: Rouen
country: France
city: Saint-Herblain
country: France
city: Toulouse
country: France
Study officials:
affiliation: AstraZeneca
name: AstraZeneca France Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02089737: Panitumumab for Intravenous Infusion 100 mg and 400 mg Special Drug Use Surveillance "Survey on Unresectable, Advanced or Recurrent Colorectal Cancer With Wild-type KRAS Gene" (All-patient Surveillance)
Official title: Vectibix for Intravenous Infusion 100 mg and 400 mg Special Drug Use Surveillance "Survey on Unresectable, Advanced or Recurrent Colorectal Cancer With Wild-type KRAS Gene" (All-patient Surveillance)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced or Recurrent Colorectal Cancer
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-03-18
Enrollment: 3091
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: Unresectable, advanced or recurrent colorectal cancer with wild-type KRAS gene

Brief summary: The efficacy and safety of panitumumab (Vectibix) in the routine clinical setting will be studied.

Specifically, information will be collected on the following as events of interest: skin disorders, interstitial lung disease, infusion reactions, electrolyte abnormalities, and cardiac disorders.

Detailed description: The efficacy and safety of panitumumab (Vectibix) in the routine clinical setting will be studied.

Participants of this surveillance will be patients with unresectable, advanced or recurrent colorectal cancer with the wild-type KRAS gene. The planned sample size is 2,000 patients.

The usual adult dosage is 6 mg/kg of panitumumab given by intravenous drip infusion over a 60-minute period once every 2 weeks. The dosage may also be reduced as needed, depending on the patient's condition.

Eligibility criteria: Inclusion Criteria:

* Unresectable, advanced or recurrent colorectal cancer with wild-type KRAS gene

Exclusion Criteria:

* Patients with a medical history of severe hypersensitivity to any of the ingredients of Vectibix

Primary outcomes:
measure: Number of Participants With Adverse Drug Reactions
timeFrame: Baseline through Week 42
Secondary outcomes:
measure: Progression-free Survival
timeFrame: Up to Week 42 or death (whichever occurred first)
measure: Overall Survival
timeFrame: Up to Week 42 or death (whichever occurred first)
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Postmarketing Group Manager
role: STUDY_CHAIR
References: