louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01164540: Study on the Effect of Rosuvastatin Treatment on the Prevention of Thrombosis in Patients With Previous Thrombosis
Official title: A Randomised, Double-blind, Placebo-controlled, Event Driven, Phase III Study of Rosuvastatin 20 mg Once Daily in the Long Term Prevention of Recurrent Venous Thromboembolism in Patients With Deep Vein Thrombosis or Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Venous Thrombosis
Pulmonary Embolism
Keywords: Deep venous thrombosis
Pulmonary embolism
rosuvastatin treatment
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-07-16
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates whether treatment with rosuvastatin on top of standard anti-coagulant treatment will decrease the risk of recurrent venous thromboembolism and arterial thromboembolic events in patients with previous deep vein thrombosis or pulmonary embolism.


Eligibility criteria: Inclusion Criteria:

* Signed informed Consent.
* Patients with venous thromboembolism who are treated with anti-coagulant according to the current guidelines

Exclusion Criteria:

* Patients in need of or already treated with lipid lowering drugs
* Active liver or kidney disease or dysfunction or muscle disorders
* Unstable medical or psychological condition that interferes with study participation
* Pregnant woman or woman with childbearing potential who are not willing to use contraception
* History of statin-related muscular pain, or hypersensitivity to statins

Primary outcomes:
measure: Any event of venous thromboembolism (i.e. Deep Vein Thrombosis (DVT) and/or fatal or non-fatal Pulmonary Embolism(PE))
timeFrame: Time to first occurrence in the overall treatment period, with a median treatment period of 9,5 months
Secondary outcomes:
measure: All cause mortality
timeFrame: Time to occurrence in the overall treatment period, with a median treatment period of 9,5 months
measure: Any event of the composite of venous thromboembolism or arterial thromboembolism/major adverse cardiovascular event (MACE)
timeFrame: Time to first occurrence in the overall treatment period and during the "on Vitamin K Antagonist (VKA)" treatment period
Other outcomes:
Locations:
Study officials:
affiliation: Academic Medical Centre
name: H. R. Büller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Michael Cressman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03430440: Comparison of Analgesic Effects According to Patient-controlled Epidural Analgesia Modes in Patients Undergoing Open Gastrectomy
Official title: Comparison of Analgesic Effects According to Patient-controlled Epidural Analgesia Modes in Patients Undergoing Open Gastrectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Open Gastrectomy With Gastric Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Epidural PCA (patient controlled analgesia) for post-operative pain management are effective analgesic method. It is widely used in the postoperative pain management for decades.

PCA pumps typically set a fixed basal infusion rate to infuse the analgesics at a constant rate per every hour (conventional mode). In contrast, the newly developed computer-integrated patient-controlled analgesia (CIPCA) mode increases or decreases the basal infusion rate with the use of the patient's bolus button. The CIPCA mode sets the basal infusion rate, the increase / decrease rate of basal rate, and the increment / decrement interval. If the patient presses the bolus button within the set time interval, the set infusion rate is increased because the analgesic is more required. If the bolus button is not pressed during the set time interval, the infusion rate is decreased. Therefore, it can be said that it is an effective method to control the dose of analgesic agent more sensitively to changes in patient's needs and pain.


Eligibility criteria: Inclusion Criteria:

1. elective open gastrectomy due to stomach cancer
2. ASA classification Ⅰ-Ⅲ

Exclusion Criteria:

1. hematologic clotting defect
2. sepsis
3. distance metastasis
4. PCA drug (fentanyl, Ropivacaine) allergy
5. Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner)
6. pregnant, lactating women

Primary outcomes:
measure: Postoperative pain (numerical rating scale: 0 ~ 10)
timeFrame: at 6 hours postoperatively
Secondary outcomes:
measure: Postoperative pain (numerical rating scale: 0 ~ 10)
timeFrame: at 1, 24, and 48 hours after surgery
measure: PCA total dose/additional analgesic dose
timeFrame: at 1, 6, 24, 48 hours after surgery
measure: Side effects of PCA (area and vomiting / hypotension / muscle weakness
timeFrame: at 1, 6, 24, 48 hours after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT03898440: Fetal Ano-genital Distance in 2D Ultrasound.
Official title: Using Anogenital Distance to Determinate Fetal Gender Beetween 18 et 41 Weeks of Gestation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urogenital Abnormalities
Prenatal Disorder
Sex Development Disorder
Keywords: anogenital distance
prenatal
sex determination
androgen
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 318
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pregnant women follow up at Brest Hospital to 18 weeks of gestation until term, except suspicion of fetal pelvic malformations and patients without an exact echographic datation of pregnancy between 11 and 13+6 weeks of gestation.

Brief summary: The purpose of this study is to determine a threshold value of fetal anogenital distance in 2D ultrasound to differentiate male fetuses from female fetuses, starting 18 weeks of gestation and until the due date.

The study also evaluates the feasibility of the measure and its interobserver variability.

Detailed description: The anogenital distance of female newborns is shorter than that of male newborns.

Urogenital disorders, such as hypospadias and micro-penis, are associated with a shorter anogenital distance.

Anogenital distance is a good marker of fetal exposure to androgenic substances.

Prenatal anogenital distance ultrasound measure can help the diagnosis in case of doubt about fetal sexual phenotype or in case of urogenital disorder suspicion (hypospadias or micropenis).

Is the anogenital distance easy to make measure? Can this procedure be reproduced? What are the threshold values to determine fetal sex at each term of pregnancy?

Eligibility criteria: Inclusion Criteria:

* pregnant woman
* sonographic fetal follow up in Brest Hospital
* term\>18 weeks of gestation

Exclusion Criteria:

* No datation between 11 weeks of gestation and 13 weeks of gestation and 6 days by crown-rump length measurement
* Minor
* no consent
* ultrasound performed by an operator without ultrasonography graduation

Primary outcomes:
measure: fetal anogenital distance
timeFrame: During fetal ultrasound exam
Secondary outcomes:
measure: Interobserver variability
timeFrame: During fetal ultrasound exam
measure: Ano-genital distance in mm
timeFrame: During fetal ultrasound exam
measure: Estimated fetal weight
timeFrame: During fetal ultrasound exam
measure: neonatal sex determination
timeFrame: During fetal ultrasound exam
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest (Morvan)
Study officials:
affiliation: CHRU Brest - Morvan hospital
name: Anne-Hélène SALIOU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00948740: The Effect of Vitamin D on Urinary Calcium Excretion in Kidney Stone Formers With High Urinary Calcium
Official title: Phase III Study of the Effect of Vitamin D Repletion on Urinary Calcium Excretion in Kidney Stone Formers With Vitamin D Deficiency and High Urinary Calcium
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Vitamin D Deficiency
Nephrolithiasis
Keywords: vitamin D
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2009-07-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that a 3 month course of vitamin D supplementation to treat 25(OH)D deficiency in stone formers with high levels of 24-hour urinary calcium will not increase urinary calcium excretion by greater than 10%.

Detailed description: We plan to conduct a clinic-based interventional study of 30 patients followed at Brigham and Women's Hospital with history of nephrolithiasis, urinary calcium excretion between 200 and 400 mg/day, and 25-vitamin D deficiency (defined as serum level ≤ 25ng/ml). The intervention is oral ergocalciferol 50,000 IU per week for 8 weeks \[1\], and each participant will serve as his own control. The outcome is the change in urinary calcium excretion. The planned study duration is 3 months. We will have greater than 95% power to detect a 10% increase in 24-hour urinary calcium

Eligibility criteria: Inclusion Criteria:

* History of nephrolithiasis
* 25(OH)D deficiency (defined as serum level ≤ 25ng/ml) within 3 months of enrollment
* 24-hour urinary calcium excretion \> 199 mg/day and \< 400 mg/day (measured less than 6 months prior to study enrollment)

Exclusion Criteria:

* Non-Caucasian
* Women of child-bearing age (age \< 50)
* Known uric acid, cystine, or struvite stone disease
* Hypercalcemia (serum calcium \> 10.4 mg/dl within the past 12 months)
* Gross hematuria within the past 6 months
* Acute stone event within the past 2 months
* Recent stone intervention within the past 1 month
* Suspected or known secondary causes of hypercalciuria such as primary hyperparathyroidism, sarcoidosis, hyperthyroidism, or malignancy (except non-melanoma skin cancer)
* Addition or dose change of medicines potentially affecting urinary calcium since enrollment 24-hour urine collection (including diuretics, magnesium supplements, potassium supplements, potassium citrate, and vitamin D supplementation)

Primary outcomes:
measure: Urinary calcium level after treatment with ergocalciferol will be compared with the pre-treatment level. The primary outcome is the change in urinary calcium excretion.
timeFrame: 1-2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jie Tang, M.D., M.Sc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06556940: G.I. Pharmacokinetics of LMN-401 in Individuals With Ileostomies
Official title: A Clinical Trial to Assess the Intraluminal Pharmacokinetics of LMN-401 in Individuals With Ileostomies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Travelers Diarrhea
Lead sponsor: Lumen Bioscience, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-16
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this interventional study is to learn about the intraluminal pharmacokinetics (PK) of the investigational drug LMN-401 in adult healthy volunteers with ileostomies. LMN-401 is being developed as a potential new treatment for Traveler's Diarrhea. The study will also learn about the safety of the investigational drug LMN-401.

The main questions it aims to answer are:

* What is the timing and amount of components of investigational drug LMN-401 detected in the collected ileostomy material?
* Is LMN-401 safe and well tolerated in healthy volunteers taking the investigational drug?

Researchers will compare the timing and amount of investigational drug components detected in the ileostomy material in volunteers taking the investigational drug LMN-401 formulated into tablets with different properties. The impact of the study participant's fed or fasted state on the timing and amount of drug components detected in the ileostomy material will also be evaluated.

Each study participant will come into the research clinic for four study visits. Study participants will receive the investigational product formulated into tablets with different properties. Ileostomy material will be collected at baseline (pre-dose) and every two hours after investigational product dose administration for 10 hours.


Eligibility criteria: Inclusion Criteria:

* Aged 19 years and above
* Medically stable
* Mature and stable ileostomy (no revisions in past 6 months)
* Willing and able to participate in all study visits
* Willing and able to provide informed consent

Exclusion Criteria:

* Unable or unwilling to provide adequate informed consent
* Gastroparesis
* Using or planning to use anti-diarrheal medication
* Using or planning to use opioids
* Clinically significant disease
* Women who are pregnant, intending to become pregnant, or breastfeeding
* Non-English speakers

Primary outcomes:
measure: Quantification of LMN-401 components in ileostomy material over time.
timeFrame: Ten hours post administration of study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Maroochydore
country: Australia
facility: Coastal Digestive Health Research Institute Pty Ltd
Study officials:
References:
Clinical trial NCT00979940: Effects of Short Term, High Dose Atorvastatin Therapy on Periprocedural Myonecrosis and Platelet Inhibition After Percutaneous Coronary Intervention (PCI)
Official title: Effects of Short Term, High Dose Atorvastatin Therapy on Periprocedural Myonecrosis and Platelet Inhibition After PCI
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: atorvastatin
clopidogrel
percutaneous intervention
periprocedural myonecrosis
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2009-09-18
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study plans to evaluate the use of atorvastatin in patients with coronary artery disease given immediately before PCI and whether it will decrease the amount of heart damage after PCI.


Eligibility criteria: Inclusion Criteria:

* patients undergoing revascularization for significant coronary artery disease
* age range 21-85 years

Exclusion Criteria:

* non-STEMI, STEMI
* cancer
* renal failure with creatinine\>3.0mg/dl
* liver cirrhosis
* lymphoproliferative disorder
* pregnancy
* thrombocytopenia\<150'000
* coagulopathy (INR\>1.5)
* abnormal liver function tests
* illicit drug use
* history of statin intolerance
* history of rhabdomyolysis
* planned use of Glycoprotein IIb/IIIa inhibitors during PCI
* current therapy with atorvastatin, pravastatin, lovastatin, fluvastatin, or rosuvastatin

Primary outcomes:
measure: Periprocedural Myonecrosis
timeFrame: 16-24 hours post PCI
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Wishard Hospital
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Rolf Kreutz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kreutz RP, Breall JA, Sinha A, von der Lohe E, Kovacs RJ, Flockhart DA. Simultaneous administration of high-dose atorvastatin and clopidogrel does not interfere with platelet inhibition during percutaneous coronary intervention. Clin Pharmacol. 2016 Jun 3;8:45-50. doi: 10.2147/CPAA.S98790. eCollection 2016.
Clinical trial NCT02177240: A Comparison of the Flex-it® to the GlideRite® Stylet for GlideScope® in Simulated Difficult Intubations.
Official title: A Randomized Comparison of the Flex-it® Articulating Stylet to the GlideRite® Rigid Stylet for Orotracheal Intubation Using the GlideScope® in Simulated Difficult Intubations. A Double Blinded Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Difficult Intubation
Keywords: GlideScope®
GlideRite®
Flex-it®
Difficult intubation
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2014-06-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the Flex-it® Articulating Stylet or the GlideRite® Rigid Stylet is more effective and less traumatic in the context of difficult GlideScope® intubations.

Detailed description: Pre-operatively patient are approached and enrolled according to inclusion and exclusion criteria.

Demographic data is then recorded and afterwards the patient is randomized (randomization.com) but is blinded to the group.

The patient is outfitted with a Philadelphia® cervical collar and a BIS® monitor before induction of anesthesia.

The anesthetist is blinded to the randomization group. Once asleep, the patient is intubated using the GlideScope® with the single-use blade and one of the randomized intubation stylets by an operator.

Intubation and tube manipulation times, vital signs and BIS level are recorded via a nurse or video camera.

Verbal cues are given for start of laryngoscopy, tube manipulation and confirmation of CO2 which is recorded by the camera microphone.

Patient is questioned about hoarseness and sore throat when leaving the post anesthesia care unit according to our local protocol and 24hr after the surgical procedure.

The data is then taken from the video and analyzed by a blinded operator.

Eligibility criteria: Inclusion Criteria:

* ASA status 1-2
* BMI \< 35
* Elective surgery
* General Anesthesia

Exclusion Criteria:

* Difficult intubation
* Indication for rapid sequence intubation
* Contraindication for cervical collar

Primary outcomes:
measure: Intubation time
timeFrame: During intubation
Secondary outcomes:
measure: Sore throat/Hoarseness
timeFrame: Day 0 (immediate post-operative)
measure: Sore throat/Hoarseness
timeFrame: Day 1 (24hr post-operative)
measure: Verbal Intubation difficulty scale
timeFrame: 15 minutes after intubation
measure: Tube manipulation time
timeFrame: During Intubation
measure: Resistance during stylet extraction
timeFrame: 15 minutes after intubation
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
Study officials:
affiliation: HMR
name: John Viet Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HMR
name: Issam Tanoubi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03936140: The Effect of Iloprost on Oxygenation During One-lung Ventilation for Lung Surgery
Official title: The Effect of Iloprost on Arterial Oxygenation and Shunt Fraction During One-lung Ventilation for Lung Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: The Catholic University of Korea
First posted: 2019-05-03
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During one-lung ventilation in patients undergoing thoracic surgery, the persistent flow in the non-ventilated lung increases intrapulmonary shunt and decreases systemic arterial oxygenation. This prospective, randomized, double blind study was conducted to evaluate the effects of inhaled iloprost during one-lung ventilation on arterial oxygenation and shunt fraction during thoracic surgery.


Eligibility criteria: Inclusion Criteria:

* elective video-assisted thoracoscopic surgery (VATS) lobectomy
* 20 \< age \< 75
* American Society of Anesthesiologists (ASA) classification I\~III

Exclusion Criteria:

* ASA classification IV
* New York Heart Association (NYHA) class III\~IV
* Severe obstructive lung disease / restrictive lung disease
* Pulmonary hypertension
* End-stage organ disease (i.e. hepatic failure, renal failure)
* Arrhythmia
* Previous history of thoracic surgery

Primary outcomes:
measure: PaO2(partial pressure of arterial oxygen)
timeFrame: 30 min after treatment
measure: Pulmonary shunt fraction
timeFrame: 30 min after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Wonjung Hwang
role: PRINCIPAL_INVESTIGATOR
References: