louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00450528: Kinetics of D-Dimers After Abdominal Surgery
Official title: The Kinetics of D-Dimers After Abdominal Surgery as a Function of the Invasiveness of Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Natural Kicetics of d-Dimers After Surgery
Keywords: D-dimers
surgery
kinetics
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2007-03-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to investigate the natural kinetics of D-dimers that occur after abdominal surgery.

Detailed description: Venous thromboembolism (VTE) is a potentially fatal disease with an estimated incidence of 0.1%. One third of the VTE occur as pulmonal embolism with a mortality up to 25% (White RH. Circulation 107:2003)

Serum d-dimer levels are used as sensitive marker for the diagnosis of VTE (Kelly J et al. Arch Intern Med, 162: 2002). Because of its sensitivity, the determination of serum D-dimer levels is an accepted method to exclude VTE in the outpatient setting meaning that VTE may be excluded in case of normal D-dimer levels (Kelly J. Lancet 359: 2002). The specificity of the D-dimer testing, however, is low. This is true especially in the postoperative phase. The interpretation of elevated D-dimer levels in surgical patients remains elusive.

The natural kinetics of D-dimers after surgery is not known. The question to what extent D-dimer levels rise after surgery and how long it may take D-dimer levels to return to normal after surgery is not yet determined. This information is needed to be able to use D-dimer testing for VTE diagnosis in surgical patients.

In this study, D-dimer levels are measured in surgical patients immediately before (day 0) and repeatedly after surgery. D-dimer level measurement will be stopped after D-dimer levels returned to normal.

Eligibility criteria: Inclusion Criteria:

* patients undergoing elective surgery

Exclusion Criteria:

* age \< 18 years
* patients not speaking german
* patients involved in another study
* pregnancy
* concommitant inflammatory disease
* patients with oral anticoagulation
* patients having received fresh frozen plasma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Univeryity Hospital, Clinic for Visceral- and Transplantation Surgery
Study officials:
affiliation: University of Zurich
name: Daniel Dindo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03413228: Nosocomial Influenza Surveillance 2018 - 2022
Official title: Surveillance of Nosocomial Influenza at Edouard Herriot University Hospital, Lyon, France.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hospital-Acquired Infection
Influenza
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Each patient or health-care worker who present ILI (influenza-like illness) at admission or during hospitalization. ILI is defined by fever \> 37,8°C or/and cough or sore throat.

Brief summary: Hospital-acquired influenza is associated with significant morbidity and mortality in hospitalized patients notably elderly patients. Furthermore, it is also associated with a large economic impact for the hospitals.

The transmission of influenza has been mostly reported in pediatric and long-stay units. The chains of transmission of influenza in acute-stay units have to be describe in order to prevent and control potential outbreaks. Furthermore, to know clinical symptoms seems to be important in order to identify potential sources of virus as soon as possible and to set up appropriate hygiene prevention measures. Moreover, the definition of the hospital-acquired influenza has to be harmonized for all over the studies, especially concerning the delay between the admission in the hospital and the symptoms onset.

The aim of this study is to describe the hospital-acquired influenza in a french university hospital of around 800 beds


Eligibility criteria: Inclusion Criteria:

* Adult patients and health-care workers in a participating unit in the study,
* more than 18 years old,
* volunteers,
* who present an influenza-like illness defined by fever \> 37,8°C or/and cough or sore throat.

Exclusion Criteria:

-Everyone who does not present the inclusion criteria.

Primary outcomes:
measure: Proportion of patients and health-care workers who present an influenza illness.
timeFrame: 5 days maximum
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Infection Control unit. Edouard Herriot hospital Lyon - France
Study officials:
References:
Clinical trial NCT05112328: The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding
Official title: The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding: Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critically Ill
Enteral Feeding
Exocrine Pancreatic Insufficiency
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Determine the effect of high-dose pancreatic enzyme supplementation on nutritional indicators and clinical course in critically ill patients undergoing enteral nutrition.


Eligibility criteria: Inclusion Criteria:

* Adults 19 years and older
* Hospitalized in the surgical/medical intensive care unit of the Seoul National University Hospital
* Enteral nutrition
* Patients who consented to this study
* Patients with risk factors for pancreatic exocrine dysfunction

  * Shock (Norepinephrine)
  * Sepsis (3 rd definition of sepsis)
  * Diabetes
  * Cardiac arrest
  * hyperlactatemia serum lactate \> 2 mmol/L)
  * Mechanical ventilation
  * Continuous renal replacement therapy

Exclusion Criteria:

* chronic pancreatitis
* unresectable pancreatic cancer
* History of pancreatectomy
* Underlying diseases in which the effect of Exocrine pancreatic enzyme administration is difficult to show

  * Inflammatory bowel disease
  * Short bowel syndrome

Primary outcomes:
measure: Change of Phase angle (°)
timeFrame: Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition
Secondary outcomes:
measure: Skeletal Muscle Mass (SMM) (kg)
timeFrame: Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
References:
Clinical trial NCT04019028: Real-time Monitoring of Motor Cortical Activity Induced by Low-frequency Repetitive Transcranial Magnetic Stimulation
Official title: Real-time Monitoring of Motor Cortical Activity Induced by Low-frequency Repetitive Transcranial Magnetic Stimulation: Functional Near Infrared Spectroscopic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: low frequency rTMS
fNIRS
Hemodynamic Response
Non-invasive brain stimulation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: In this study, we investigated the effect of low-frequency repetitive trans cranial magnetic stimulation, one of the noninvasive brain stimuli, on the functional changes of the bilateral motor cortical activity in normal subjects using functional near infrared spectroscopy (fNIRS).

Detailed description: In normal subjects,

1. the effect of low-frequency repetitive transcranial magnetic stimulation on cerebral cortex are measured in real time using fNIRS.
2. Changes in cerebral cortical activity before and after stimulation are measured using the motor function test and the motor-induced potential test

Eligibility criteria: Inclusion Criteria:

* Healthy adult men and women without history of central nervous system disease and abnormalities

Exclusion Criteria:

* Under 18 years old, 70 years old or older
* A person who has inserted a metal object in a skull
* A person with complete occlusion of the carotid artery
* A person with epilepsy
* Pregnant and lactating women
* Who is not eligible for the test

Primary outcomes:
measure: Changes of Cortical activation
timeFrame: Baseline and after intervention[Immediately after 20 minutes of intervention]
Secondary outcomes:
measure: Changes in motor evoked potentia
timeFrame: Baseline and after intervention[Immediately after 20 minutes of intervention]
measure: changes in nine hole peg test
timeFrame: Baseline and after intervention[Immediately after 20 minutes of intervention]
measure: Sequential motor task
timeFrame: Baseline and after intervention[Immediately after 20 minutes of intervention]
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Yun-Hee Kimm, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03181061: Determinants of Success, Characterizing the Facilitators of Integrated Abortion Provision
Official title: Determinants of Success, Characterizing the Facilitators of Integrated Abortion Provision
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pregnancy Termination
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2017-06-08
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Providers of Abortion Care

Brief summary: This national, qualitative study of physicians who provide abortion care aims to better understand the facilitators of abortion provision among generalist clinicians in OB-GYN and Family Medicine.

Detailed description: This is a nationwide qualitative study of 20 to 40 physicians who provide abortion services as part of their scope of practice. Providers will participate in a semi-structured interview using an interview guide that addresses 4 domains of interest including: (1) initiation of abortion services, (2) barriers to abortion provision, (3) facilitators of abortion provision and (4) acquired expertise and coaching for success.

Eligibility criteria: Inclusion Criteria:

* Practicing obstetrician-gynecologists and family medicine physicians who currently provide or in the past have provided abortion services (medication abortions, surgical abortions and/or induction abortions) as part of their clinical practice will be eligible for study participation.
* All providers who meet these criteria will be eligible regardless of providers' gestational age cutoff, abortion indication limitations and/or restrictions, or number of abortions provided.

Exclusion Criteria:

* Physicians who work solely at a designated abortion facility, e.g., Planned Parenthood, without an alternate practice site, or who provide only abortions, are not eligible for study participation.

Primary outcomes:
measure: Integration of Abortion Care
timeFrame: April 2017-February 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Lisa Hofler, MD, MBA, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03190161: Music to Reduce Use of Smoking in Patients With Schizophrenia
Official title: Music to Reduce Use of Smoking in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Nicotine Dependence
Smoking, Tobacco
Keywords: Schizophrenia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to explore the impact of self-selected music listening which targets disrupting the reward process maintaining smoking and additionally attenuating the reward processing deficits associated with schizophrenia. Five participants with schizophrenia/schizoaffective disorder who smoke/nicotine will participate in an individual session of self-selected music listening for a half an hour.


Eligibility criteria: Inclusion Criteria:

* clinician verification diagnosis of Schizophrenia or Schizoaffective Disorder
* smoked at least 10 cigarettes per day for the past month
* score of 4 or more on the Fagerstrom Test for Nicotine Dependence73
* psychiatric stability (e.g., no psychiatric hospitalizations within the last year, no expectation for medication change during study participation, no active suicidal ideation, no symptoms that interfere with ability to participate in study activities)
* the capacity to participate in the informed consent process

Exclusion Criteria:

* being medically unstable (e.g., medical condition that requires frequent medical appointments or hospitalizations and interferes with ability to participate in study activities)
* report active substance abuse or testing positive drug or alcohol use
* taking bupropion, varenicline, nicotine replacement products and/or involved in any other smoking cessation treatment
* participating in any treatment or activity that includes music as a focus
* having a seizure disorder, other neurological illnesses, or a family history of seizures

Primary outcomes:
measure: Snaith-Hamilton Pleasure Scale (SHAPS)
timeFrame: 1 Day
measure: Snaith-Hamilton Pleasure Scale (SHAPS) Post Music Session
timeFrame: 1 Day
measure: Pleasure Rating Scale (PRS)
timeFrame: 1 Day
measure: Pleasure Rating Scale (PRS) Post Music Session
timeFrame: 1 Day
measure: Questionnaire of Smoking Urges-Brief (QSU-B)
timeFrame: 1 Day
measure: Questionnaire of Smoking Urges-Brief (QSU-B) Post Music Session
timeFrame: 1 Day
measure: Minnesota Nicotine Withdrawal Scale (MNWS)
timeFrame: 1 Day
measure: Minnesota Nicotine Withdrawal Scale (MNWS) Post Music Session
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Kathleen Tracy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03587961: Personalized Theratyping Trial
Official title: Personalized Theratyping Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Cystic Fibrosis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the use of off-label CFTR modulators that may affect CFTR function in patients with CFTR mutations that are not currently approved for these drugs.

Detailed description: The purpose of this study is to explore the use of off-label CFTR modulators that may affect CFTR function in patients with CFTR mutations that are not currently approved for these drugs. Symdeko (Tezacaftor/Ivacaftor), Orkambi (Ivacaftor and Lumacaftor), correctors of CFTR misfolding and Kalydeco (Ivacaftor), a potentiator of abnormal CFTR gating, will be explored as a treatment for patients with other CF mutations than those currently approved. Patients who have a mutation that responds to a CFTR corrector from in vitro study will be given Symdeko, or Orkambi, depending on the in vitro response pattern. Patients who have mutation response to a potentiator of CFTR function will be given Ivacaftor monotherapy. Patients with a mutation equivalent to wild type will be given Ivacaftor. If the patient is 6-12 years old, we will only study Orkambi or ivacaftor as symdeko is not yet FDA approved in this patient population.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of CF
* Age ≥6 y.o.
* CFTR mutation that may respond to approved correctors/potentiators in the opinion of the study investigators
* Informed Consent/Assent
* Stable CF pulmonary regimen

Exclusion Criteria:

* Exacerbation requiring antibiotic or steroids for \>28 days before trial entry
* Ongoing participation in a CFTR modulator study
* Active smoking in the past 6 months
* History of solid organ transplant
* Any condition which precludes the use of CFTR modulators: e.g. advanced cirrhosis, End-stage Renal Disease (ESRD)
* Any condition that precludes the patient from participation in the opinion of the investigator
* Any meds that have significant drug-drug interactions or any other off label use of CFTR modulators

Primary outcomes:
measure: spirometry
timeFrame: 32 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References:
Clinical trial NCT03576261: Heart Failure and Hemodynamic Stability During Anesthesia Induction
Official title: Does Heart Failure Has Impact on Hemodynamic Stability During Anesthesia Induction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamic Instability
Anesthesia; Adverse Effect
Heart Failure
Diastolic Dysfunction
Venous; Return (Anomaly)
Keywords: hemodynamics
venous return
heart failure
anesthesia
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2018-07-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A consecutive cohort. Signed informed consent is gathered. Non-blinded randomization is conducted to fluid therapy before anesthesia induction. Preoperative diagnostics by echocardiography is conducted to all participants.Two arms, with or without preoperative fluids, are studied regarding hemodynamic stability during anesthesia induction.
Primary purpose: OTHER

Brief summary: The study aim is to investigate whether preoperative heart failure has impact on hemodynamic stability during anesthesia induction by target controlled infusion of anesthesia (TCI) in non-cardiac, non-morbidly obese surgery.

Detailed description: 40 individuals are enrolled to the study after signed informed consent at the day of surgery. The study participants are randomized (non-blinded) to preoperative fluid therapy (preoperative colloid fluid bolus at 6 ml/kg LBW, Gelofusine™, Fresenius Kabi AB, Sweden) or control (no preoperative fluids) before standardized TCI- induction of anesthesia. No other intravenous fluids before anesthesia induction.

Preoperative screening of biventricular systolic and diastolic function of the heart and level of venous return is implemented by transthoracic echocardiography approximately one hour before preoperative fluid therapy and anesthesia induction.

Eligibility criteria: Inclusion Criteria:

* age over 18 years
* body mass index ≤ 35 kg/m2
* electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery

Exclusion Criteria:

* instable angina pectoris
* severe bronchial asthma
* severe COPD
* dementia
* severe heart valve disease
* severe renal failure
* body mass index \> 35 kg/m2

Primary outcomes:
measure: Incidence of blood pressure drops
timeFrame: 20 minutes post anesthesia induction
measure: Incidence of severe blood pressure drops
timeFrame: 20 minutes post anesthesia induction
Secondary outcomes:
measure: Venous return and hemodynamic stability
timeFrame: 20 minutes post anesthesia induction
measure: Systolic heart failure and hemodynamic stability
timeFrame: 20 minutes post anesthesia induction
measure: Diastolic dysfunction and hemodynamic stability
timeFrame: 20 minutes post anesthesia induction
Other outcomes:
Locations:
city: Luleå
country: Sweden
facility: Sunderby teaching hospital
Study officials:
affiliation: Umea Universitet
name: Tomi Myrberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03779061: Study of Remimazolam Tosilate in Patients Undergoing Colonoscopy
Official title: A Phase Ⅲ, Multicentre, Randomized, Single-blinded Study to Evaluate the Safety and Efficacy of the Sedation for Remimazolam or Propofol in Patients Undergoing Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sedation
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-12-19
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the safety and efficacy of the sedation for Remimazolam or Propofol in patients undergoing colonoscopy.

Detailed description: This is a multi-center, parallel-group, single blind study using Remimazolam or propofol for sedation in patients undergoing colonoscopy.Subjects are randomized to different treatment groups (including 1 for Remimazolam Tosilate and 1 for propofol). Fentanyl are permitted before colonoscopy. Efficacy and safety profiles of Remimazolam Tosilate are to be evaluated.

Eligibility criteria: Inclusion Criteria:

* subjects aged 18-65 years；
* intending to undergo colonoscopy;
* ASA( American Society of Anesthesiologists) I or II；
* 18 kg/m²\<BMI(Body Mass Index)\<30 kg/m²;
* the operation time of gastroscopy is not more than 30 min；
* Signed informed consent.

Exclusion Criteria:

Patients need to be Complicated colonoscopy;

* Patients need to be Tracheal intubation;
* Patients with respiratory management difficulties (Modified Mallampati grade IV）;
* one or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
* A history of drug abuse and / or alcohol abuse 2 years prior to the screening period；
* allergic to drugs used in the study;
* pregnant women or those in lactation period
* The subject has participated in other clinical trial within the 3 months prior to randomization.

Primary outcomes:
measure: rate of successful sedation
timeFrame: approximately 3 hours
Secondary outcomes:
measure: Sedation induction time
timeFrame: approximately 3 hours
measure: Sedation recovery time
timeFrame: approximately 3 hours
measure: rate of hypotension
timeFrame: approximately 3 hours
measure: rate of respiratory depression
timeFrame: approximately 3 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Clinical trial Ethnics Committee of Peking Union Medical College Hospital
state: Beijing
Study officials:
References: