louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01330745: Microcirculation in Cardiac Surgery
Official title: Mesenteric Microcirculatory Function Study Through Sublingual Evaluation During Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Disorder
Keywords: cardiopulmonary bypass
mesenteric
microcirculatory function
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2011-04-07
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether cardiopulmonary bypass affects mesenteric microcirculatory function, using sublingual evaluation, in cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* age\> 18 years old
* aortic valvular disease needing aortic valve replacement

Exclusion Criteria:

* Age\<18 years old
* emergent cardiac surgery
* other cardiac surgery

Primary outcomes:
measure: Microcirculatory impairment
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Fabien Doguet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06396845: Assessing the Benefits of Robotic and Laparoscopic Surgery for Mid and Low Rectal Cancer in Patients: The Charlson Comorbidity Index (CCI)
Official title: Assessing the Benefits of Robotic and Laparoscopic Surgery for Mid and Low Rectal Cancer in Patients: The Charlson Comorbidity Index (CCI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Robotic
Laparoscopic
Anterior Resection for Rectal Cancer
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 505
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who underwent robotic or laparoscopic anterior resection for rectal cancer.

Brief summary: This retrospective study collected participants who underwent robotic or laparoscopic anterior resection for rectal cancer at the North People's Hospital in Jiangsu from January 2019 to January 2023.


Eligibility criteria: Inclusion Criteria:

The criteria include: (1) pathology of low rectal cancer (within 10 cm from the anal margin); (2) access to comprehensive pathological and computed tomography (CT) data; (3) completeness of clinical data.

Exclusion Criteria:

patients with other malignant tumors besides rectal cancer, benign disease surgery, and emergency surgery.

Primary outcomes:
measure: postoperative recurrence rate
timeFrame: 2018-2024
Secondary outcomes:
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT00005745: Consequences and Correlates of Weight Fluctuations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Diabetes Mellitus
Heart Diseases
Hypertension
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: FEMALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To quantify the association between multiple intentional weight losses (i.e., weight fluctuations) and the development of hypertension and diabetes mellitus among 50,790 female nurses participating in the ongoing Nurses' Health Study II. In addition to assessing the consequences of weight fluctuations, their correlates and course were identified.

Detailed description: BACKGROUND:

In the United States, approximately one third of adult women are trying to lose weight. Most weight losses are not sustained and in fact may be followed by gains of at least as much weight as was intentionally lost. It is unclear whether there are adverse outcomes associated with multiple intentional weight losses.

DESIGN NARRATIVE:

The prospective study addressed the impact of weight fluctuation on development of hypertension (HPT) and diabetes (DM) by following women who significantly fluctuated in weight compared to those who generally maintained a stable weight. The subject source was all participants between 1989 and 1993 in the Nurses Health Study II (NHS) who did not experience a full term pregnancy between 1989 and 1993 and who were free of HPT, DM and cancer in 1993. A random sample of each of two weight fluctuation classifications, \>20 lbs. (3 or more times) and 10-19 lbs. (3 or more times) was identified. A control group of non-fluctuators was matched by age and body mass index strata. Baseline data consisted of information obtained from the 1993 NHS II follow-up along with supplemental questionnaires sent to study participants to elicit specific information on past and present weight gain/loss and intentionality of weight fluctuation. Prospective data came from follow-up questionnaires in 1995, 1997, and 1999. Hypertension and DM ascertainment were obtained from self-report in the questionnaire. This ascertainment method appeared quite adequate based on validity studies carried out on subsamples of this cohort.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Alison Field
References:
citation: Field AE, Wing RR, Manson JE, Spiegelman DL, Willett WC. Relationship of a large weight loss to long-term weight change among young and middle-aged US women. Int J Obes Relat Metab Disord. 2001 Aug;25(8):1113-21. doi: 10.1038/sj.ijo.0801643.
Clinical trial NCT00470145: Comparison Of Two Tablet Formulations Of SB-568859
Official title: A Randomised, Single Blind, 2 Period, Crossover Study to Compare the Single Dose Pharmacokinetics and Tolerability of Formulations Containing Unmilled and Micronised SB-568859 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atherosclerosis
Keywords: unmilled formulation,
micronised formulation
relative bioavailability,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-05-07
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: SB-568859 is a medication that is being developed for the treatment of atherosclerosis (hardening of the arteries). The purpose of this study is to see if there is a difference in how the human body takes up the study drug depending on how the study drug is made. This study will compare SB-568859 tablets that are made in 2 different ways. This is not a treatment study.


Eligibility criteria: Inclusion Criteria:

* Healthy men and sterile women between 18 and 50 years old
* Body weight greater than 50 pounds and a body mass index between 19 and 31
* Normal electrocardiogram

Exclusion criteria:

* No history of asthma or severe allergic reactions
* No history of or current drug use
* No Hepatitis or HIV/AIDS
* No excessive alcohol use
* No smoking or tobacco use
* No use of prescription drugs, over-the-counter drugs or vitamins within 7 days
* No use of herbal supplements within 14 days
* No treatment with an investigational drug within 30 days.
* No treatment with 4 or more investigational drugs in the last 12 months
* No grapefruit or grapefruit juice in the last 7 days
* No donation of blood in the last 8 weeks
* No history of allergy to heparin
* No history of liver or gall bladder disease
* Unwillingness to use contraception

Primary outcomes:
measure: Comparison of the amount of SB-568859 found in the blood over a period of 6 days after a single dose of each of the two types of tablets
timeFrame: 6 days
Secondary outcomes:
measure: Assessment of the safety and tolerability of SB-568859 after a single dose of each of the two types of tablets based on blood and urine tests, vital signs, electrocardiograms and reporting of side effects over a period of 6 days after each dose.
timeFrame: 6 days
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: GSK Investigational Site
state: New York
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02383745: EEG in In-hospital Patients With Seizure or Altered Mental State
Official title: Integrating EEG Into Acute Medicine: EEG in In-hospital Patients With Seizure or Altered Mental State Who Have Been Consulted by Medical Emergency Team
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Status Epilepticus
Seizure
Altered Mental Status
Keywords: Acute EEG
status epilepticus
seizure
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2015-03-09
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In-hospital patients, who have seizure or altered mental state and have been consulted by MET-team

Brief summary: In Kuopio University Department of Clinical Neurophysiology there have been designed a fast EEG electrode, that is suitable for acute emergency use. It is easy to set up, records high quality EEG and can detect the most important EEG abnormalities comparable to conventional EEG. This study will address the clinical use of acute EEG with fast electrode set in in-hospital patients who have been consulted by Medical Emergency Team because of seizure or altered mental state of uncertain etiology. Patients are going to be treated in ICU and EEG monitoring will continue for 24 hours.


Eligibility criteria: Inclusion Criteria:

* In-hospital patients who have a seizure or altered mental state and are going to be treated in ICU

Exclusion Criteria:

* Patiets that are not going to be treated in ICU
* Patients with a Do Not Attempt to Resuscitate - decision

Primary outcomes:
measure: Quantity of EEG abnormalities detected
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: Northern Savo
Study officials:
affiliation: Professor in Clinical Neurophysiology
name: Esa Mervaala, MD, PhD,professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01464047: Korean Post-marketing Surveillance for Sprycel®
Official title: Korean Post-marketing Surveillance for Sprycel®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia, Myelomonocytic, Chronic
Leukemia-Lymphoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-11-03
Enrollment: 670
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who were never treated with Sprycel®

Brief summary: The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Sprycel® so that the regulatory authority can manage the marketing approval properly.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
* Adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including Imatinib
* Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) with resistance or intolerance to prior therapy

Exclusion Criteria:

* According to Warning/Caution in local label

Primary outcomes:
measure: Adverse events occurrence
timeFrame: 30 days after last dose of study drug
Secondary outcomes:
measure: Improvement in hematologic response
timeFrame: 4 weeks after registration
measure: Improvement in cytogenetic response
timeFrame: 12 weeks after registration
measure: Overall efficacy assessment by investigator's discretion
timeFrame: 4 weeks after registration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05027347: Detection of Plasma Circulating Tumor DNA in Gastric Cancer
Official title: Detection of Plasma Circulating Tumor DNA in Gastric Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Circulating Tumor DNA (ctDNA)
Gastric Cancer
Lead sponsor: University Medical Center Ho Chi Minh City (UMC)
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with early and locally advanced stage (I, II and IIIA) gastric cancer

Brief summary: The aim of this study is to develop a protocol for detection of circulating tumor DNA (ctDNA) in plasma of patients with early stages of gastric cancer.

Detailed description: Gastric cancer (GC) is the fifth most common cancer worldwide and the third leading cause of cancer deaths. Earlier detection of GC can dramatically increases the five-year survival rate up to \> 90%. The current endoscopy and tissue biopsy remain excessively expensive for middle-income nations, in addition to being fairly invasive, with possible complications. Additionally, most of serum-based biomarkers such as carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), carbohydrate antigen 72-4 (CA72-4), and carbohydrate antigen 125 (CA125) are not recommended for detection of GC due to the limit of specificity and sensitivity in the early stages of GC. Thus, it is essential to identify new biomarkers for diagnosis of early stages of GC. In this study, the investigators develop an ultradeep massive parallel sequencing (MPS) assay to detect tumor derived mutations (TDM) in plasma of early stages of GC. This study provides proof-of-principle for eventual clinical employment of circulating DNA, via liquid biopsy, for detection of early stages of GC.

Eligibility criteria: Inclusion Criteria:

1. Male or Female patients aged 18 years and older
2. Histologically proven stage (I, II and IIIA) gastric adenocarcinoma
3. Naivety to treatment.
4. No known other concomitant cancer diagnosis
5. Signed informed consent

Exclusion Criteria:

1. Pathologically late stage (stage IIIB and IV) or metastatic gastric adenocarcinoma
2. Underwent any type of treatment
3. Unable to undergo biopsy

Primary outcomes:
measure: The sensitivity and and specificity of our mutation-based assay for detecting early-stage gastric cancer patients
timeFrame: 1 months after collecting blood and specimen
Secondary outcomes:
measure: Limit of detection (LOD): the lowest variant allelic frequency that can be reliably detected
timeFrame: 1 months after collecting blood and specimen
measure: The concordance rate of mutation results between plasma and tissue biopsy assay
timeFrame: 1 months after collecting blood and specimen
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University Medical Center Ho Chi Minh City
Study officials:
References:
Clinical trial NCT03381547: A 3-Way Crossover Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518)
Official title: An Open Label, Randomized, Single Dose, 3-Way Crossover Study to Evaluate the Pharmacokinetics of Different Dose Levels and Dose Formulations of AM0010 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Subjects
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: ARMO BioSciences
First posted: 2017-12-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To evaluate the pharmacokinetics of different dose levels and dose formulations of pegilodecakin in healthy adult participants.

Detailed description: An open label, randomized, single dose, 3-way crossover study to evaluate the pharmacokinetics of different dose levels and dose formulations of pegilodecakin in healthy adult participants.

Eligibility criteria: Inclusion Criteria:

1. Male or female between 18 and 55 years of age, inclusive
2. Must have a body mass index (BMI) between 19 and 32 (kg/m2) at study Screening
3. Must be HIV negative by HIV 1/0/2 testing
4. Must be Hepatitis B (HBV) surface antigen negative
5. Must be Hepatitis C (HCV) antibody negative
6. Females must have a negative serum pregnancy test
7. Females of childbearing potential must agree to utilize protocol recommended highly effective contraception methods from Screening throughout the duration of study dosing and for 30 days following the last dose of study drug.
8. Must refrain from blood donation from 30 days prior to Day 0 through completion of the study and continuing for at least 30 days from date of last dose of study drug

Exclusion Criteria:

1. Pregnant or lactating subjects
2. Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing
3. Have poor venous access and are unable to donate blood
4. Have been vaccinated within 90 days of study dosing
5. Current alcohol or substance abuse judged by the Investigator to interfere with subject compliance
6. Have history of significant drug sensitivity or drug allergy.

Primary outcomes:
measure: Pharmacokinetic parameters, Cmax
timeFrame: 43 days
measure: Pharmacokinetic parameters, Tmax
timeFrame: 43 days
measure: Pharmacokinetic parameters, AUC
timeFrame: 43 days
measure: Pharmacokinetic parameters, CL/F
timeFrame: 43 days
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
timeFrame: 43 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Development
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01560247: Percutaneous Recanalization in Ischemic Stroke Management in Europe Observational Registry
Official title: Percutaneous Recanalization in Ischemic Stroke Management in Europe Observational Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Keywords: Stroke
Ischemic Stroke
Revascularization
Mechanical thrombectomy
Neurothrombectomy
Lead sponsor: MindFrame, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-22
Enrollment: 1000
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: The purpose of this registry is to compile data in a "real world setting". All subjects in whom there is an attempt to use the device will be included in the registry. All subjects must be recruited according to the Mindframe System "Instructions For Use".

Brief summary: To determine the revascularization rate, clinical efficacy and safety of the CE-marked MindFrame System in ischemic stroke patients

Detailed description: To determine the revascularization rate, clinical efficacy and safety in a "real-world setting" of the CE-marked MindFrame System in ischemic stroke patients with thrombotic neurovascular occlusions caused by an embolus deemed appropriate for endovascular treatment. Target vessels include the basilar, internal carotid and middle cerebral (M1 and M2 segments) arteries.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ischemic stroke for whom the physician has prescribed mechanical thrombectomy as appropriate therapy

Exclusion Criteria:

* Intracranial hemorrhage

Primary outcomes:
measure: Procedural Efficacy
timeFrame: Immediate postprocedure
measure: Safety
timeFrame: 90 days postprocedure
measure: Clinical Efficacy
timeFrame: 90 days postprocedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Michael Soderman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03889847: Comparison of Fiberoptic Bronchoscopic Intubation Between Silicone and Polyvinylchloride Double Lumen Tube.
Official title: Comparison of Fiberoptic Bronchoscopic Intubation Between Silicone and Polyvinylchloride Double Lumen Tube.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation;Difficult
Keywords: Fiberoptic intubation
double lumen tube
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 46
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: One lung ventilation (OLV) is required during thoracic procedure such as lung and esophagus surgery, and carried out by double lumen tube(DLT). Direct insertion of DLT over a fibreoptic bronchoscope (FOB) is considered more difficult and traumatic than that of a single-lumen tube. Recently, One recent simulation study demonstrated that a soft silicone DLT with a flexible, wire-reinforced bronchial tip (Fuji-Phycon tube) may shorten the time to intubation via tube exchange when compared with less compliant, polyvinyochloride(PVC) DLTs such as the Shilly or Rusch DLT. HumanBroncho® (Insung Medical, Seoul, Korea) is a new silicone DLT with a soft, flexible, non-bevelled, wire-reinforced tip. The oval shape, obtuse angle, and short lateral internal diameter of the bronchial lumen and its flexibility may allow for advancement to the trachea over the FOB easier than the Shilly tube.

In the present study, The investigators aimed to test the hypothesis that the silicone DLT would be easier than PVC DLT with regard to railroading grade over an FOB. Investigators further aimed to compare the intubation time over the FOB between the silicone DLT and PVC DLT.


Eligibility criteria: Inclusion Criteria:

* patients undergoing thoracic surgery and one lung ventilation American Society of Anesthesiologist physical status 1,2

Exclusion Criteria:

* abnormal upper airway, gastrointestinal disease, risk of aspiration, BMI \> 35

Primary outcomes:
measure: railroading grade
timeFrame: an average of 2 minutes
Secondary outcomes:
measure: insertion time
timeFrame: an average of 2 minutes
measure: number of patients with trauma around glottis, observed by FOB
timeFrame: an average of 2minutes
measure: number of patients with tube repositioning during the surgery
timeFrame: an average of 3.5 hours
measure: number of patients with complication of hoarseness, sore throat, and swallowing difficulty
timeFrame: an average of 30 minutes
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou universiry hospital
state: Gyeonggi-do
Study officials:
affiliation: Ajou University School of Medicine
name: Dae Hee Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References: