louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03784833: A Registry Study of Biomarkers in Heart Failure
Official title: A Registry Study of Biomarkers in Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Keywords: heart failure
Lead sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University Second Hospital
name: Second Affiliated Hospital of Wenzhou Medical University
name: Beijing Luhe Hospital
name: China-Japan Friendship Hospital
First posted: 2018-12-24
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with heart failure accorrding to Inclusion and exclusion criteria.

Brief summary: The registry study aims to discover the prognostic value of bio-markers in heart failure

Detailed description: The purpose of this study is to investigate the prognostic value of biomarkers in Heart Failure.Patients with confirmed diagnosis of heart failure are enrolled.The primary outcome is all-cause mortality based on the death certificates. The secondary outcome is readmission for heart failure and all-cause mortality/readmission for heart failure according to the patients' medical records.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years at the time of admission to the hospital
* With symptoms of new-onset or worsening heart failure
* Received or is eligible to receive a principal hospital discharge diagnosis of HF
* With signs and syndromes as follows: dyspnea at rest or with minimal exertion (dyspnea, orthopnea, or edema)；Rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography.
* Patients who received packed red blood cells, whole blood, or platelets less than 10 days before the blood sample was taken;

Exclusion Criteria:

* Have objective evidence of cardiac dysfunction documented either by plasma concentrations of BNP and/or N-terminal pro-brain natriuretic peptide (NT-proBNP) \<35 pg/mL or \<125 pg/ml, respectively
* Current known inability to follow instructions or comply with follow-up procedures.
* Eligible patients without informed consent form

Primary outcomes:
measure: Number of death (all cause)
timeFrame: 2 years of follow-up
Secondary outcomes:
measure: Number of rehospitalizations for acute heart failure (HF)
timeFrame: 2 years of follow-up
measure: Number of death ( all cause) or readmission for heart failure
timeFrame: 2 years of follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: The Key Laboratory of Remodeling-Related Cardiovascular Disease, Ministry of Education, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart,Lung and Blood Vessel Diseases
name: Jie Du, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT04143087: Withdrawal or Reduction TKIs in CML-CP
Official title: A Multicenter, Open-access Study of CML-CP Patients Treated With Effective TKIs at Least 5 Years and MR4.5(BCR/ABLIS<0.0032%) Maintenance More Than 18 Months Who Treatment With Half TKIs or Discontinue
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: MMR on 12 Month
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosed CML chronic phase,Age 18-70 years old,gender is not limited

Brief summary: Compare MMR on 12 month treated with half TKIs(including imatinib, dasatinib, and nilotinib) or TKIs withdrawal.

Detailed description: 1. Chronic myeloid leukemia-Chronic phase(CML-CP) patients treated with receive effective Tyrosine kinase inhibitor -TKI(including imatinib, dasatinib and nilotinib) for more than 5 years, and patients with BCR/ABLIS continuous negative in the last 18 months were randomly admitted to maintain the original effective TKI by half or stop taking .
2. Q-pcr detected BCR/ABLIS in peripheral blood once every month, once every two months after half a year, and continuously monitored for 12 months.
3. If the patients detected molecular recurrence (loss of MMR, BCR/ABLIS \> 0.1%), the original dose of TKI should be administered again.

Eligibility criteria: Inclusion Criteria:

1. Age 18-70 years old, gender is not limited;
2. Diagnosed CML chronic phase and effective TKI(including imatinib, dasatinib, and nilotinib) was continued for more than 5 years
3. Q-PCR monitored BCR/ABLIS duration \< 0.0032% in the last 18 months
4. Informed consent of the patient or his legal representative

Exclusion Criteria:

1. Patients had history of CML-AP or CML-BC
2. CML patients with previous or current ABL kinase mutations
3. CML Patients who have received allogeneic hematopoietic stem cell transplantation
4. CML Patients who have received immunotherapy (except interferon, including car-t and other cellular immunotherapy)
5. Woman who is pregnant or nursing

Primary outcomes:
measure: MMR(BCR/ABL IS<0.01) on 12 moth
timeFrame: 12 moth
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: NanfangH
state: Guangdong
Study officials:
References:
Clinical trial NCT04054687: Intranasal TXA for Anterior Epistaxis in the Emergency Department
Official title: Intranasal TXA for Anterior Epistaxis in the Emergency Department
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Epistaxis
Lead sponsor: Mercy Health Ohio
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy of and patient satisfaction with the use of intranasal tranexamic acid (TXA) for anterior nosebleeds in the emergency department (ED).

Detailed description: Pledget soaked in either saline or TXA will be applied to the bleeding nare of the patient presenting with anterior epistaxis. After fifteen minutes, the pledget will be removed and patient reassessed.

Informed consent will be obtained prior to patient enrollment.

Enrolled patients will be placed in one of two groups: either the group receiving a cotton pledget soaked in (0.9%) saline or (100mg/1mL) TXA. Patients will initially be asked to gently blow their nose to remove any clots. Group 1 will receive the saline soaked pledget. After fifteen minutes the pledget will be removed. If patient continues to bleed within a reevaluation period of fifteen minutes, this will be deemed a 'failure' and the examiner will pack the nose with the method of his or her choice. Group 2 will receive the TXA soaked pledget and the procedure will continue like Group 1.

Patient satisfaction will be assessed in both groups during ED stay and one week after ED stay.

Eligibility criteria: Inclusion criteria:

• Patients 18 years and older with anterior epistaxis

Exclusion criteria:

* Patients with inability to give consent
* Patients without a working telephone number
* Patients lacking the mental capacity to make their own decisions
* Patients with posterior epistaxis
* Epistaxis following major trauma
* Patients with known bleeding disorder like hemophilia and thrombocytopenia
* Prisoners
* Patients hemodynamically unstable
* Pregnant patients
* Patients with a known allergy to TXA
* Patients with a visibly bleeding vessel
* Those recently post-op nasal/sinus surgery (within ten days) will also be excluded

Primary outcomes:
measure: Bleeding cessation
timeFrame: 15 minutes
Secondary outcomes:
measure: Patient satisfaction: 10 point scale
timeFrame: Before ED discharge (up to 24 hours) and 1 week after ED discharge
measure: Bleeding cessation
timeFrame: 1 week
Other outcomes:
Locations:
city: Boardman
country: United States
facility: St Elizabeth Boardman Hospital
state: Ohio
city: Youngstown
country: United States
facility: St Elizabeth Youngstown
state: Ohio
Study officials:
affiliation: Mercy Health
name: Timothy Barreiro
role: STUDY_CHAIR
References:
Clinical trial NCT02386787: Ultrasound Assessment of Gastric Content for Semi Emergency Surgery
Official title: Ultrasound Assessment of Gastric Content for Semi Emergency Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Surgical Procedure, Unspecified
Keywords: Ultrasonography
Non-elective surgery
Anesthesia
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-03-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Aspiration of gastric content is a rare but serious complication of anesthesia. In this context, preoperative fasting for elective surgery is well defined. In an emergency situation, international guidelines recommend rapid sequence of anesthesia to reduce the risk of aspiration. In semi emergency situation, there is no consensus about the anesthetic procedure even if a preoperative fasting has been observed due to uncertainty of gastric emptying related to stress or painful condition. The choice of anesthesia induction technique depends mainly on the anesthetist. Ultrasonography is a non invasive bedside tool that can provide reliable quantitative information about the volume of gastric content.


Eligibility criteria: Inclusion Criteria:

* undergoing a non-elective surgery
* having a preoperative fasting period of six hours

Exclusion Criteria:

* patients with digestive diseases (gastroesophageal reflux disease, hiatal hernia, active peptic ulcer, upper gastrointestinal bleeding, vagal denervation, pyloric stenosis, extrinsic digestive compression, occlusive syndrome), neurologic diseases (spinal cord injury over T10, amylose, Shy-Drager syndrome)
* patients with full stomach (preoperative fasting under 6 hours),
* pregnant women (over 15 weeks of amenorrhea)
* patients who received premedication.

Primary outcomes:
measure: patients with full stomach
timeFrame: baseline
Secondary outcomes:
measure: duration of preoperative fasting
timeFrame: baseline
measure: type of surgery disease
timeFrame: baseline
measure: preoperative pain
timeFrame: baseline
measure: feeling of hunger
timeFrame: baseline
measure: nausea and vomiting
timeFrame: baseline
measure: type of anesthetic procedure performed
timeFrame: baseline
measure: inhalation of gastric contents
timeFrame: baseline
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: Chu de Saint Etienne
Study officials:
affiliation: CHU de Saint Etienne
name: Julie GAVORY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04668287: Improving Students' Self-esteem With an Online Intervention
Official title: Improving Students' Self-esteem With an Online Intervention Based on the Fennel Model: An Open-label, Uncontrolled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self Esteem
Lead sponsor: West University of Timisoara
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-Label Pilot Study
Primary purpose: OTHER

Brief summary: The aim of this study is to measure the impact of an online intervention on students' self-esteem, using the model outlined by Melanie Fennell.

Detailed description: The purpose of this study is to test the level of students' self-esteem (explicit and implicit) before and after an online intervention. All selected participants will enjoy one of the online working groups led by a psychologist for five weeks. In these group sessions, students will be trained to identify how their low self-esteem was developed, what are those factors that maintain their low self-esteem and what can they do for improving their low self-esteem, using Fennell model.

Eligibility criteria: Inclusion Criteria:

* Low Self-Esteem (Cut-off=35 at Rosenberg self-esteem scale)
* Being first year student in West University of Timisoara

Exclusion Criteria:

* Severe clinical depression symptoms (Cut-off=15 at PHQ9)
* Severe clinical anxiety symptoms (Cut-off=15 at GAD7)

Primary outcomes:
measure: Changes in Rosenberg's Self Esteem Scale
timeFrame: Change from Pre- to Post-Intervention (5 weeks)
Secondary outcomes:
measure: Name Letter Test
timeFrame: Change from Pre- to Post-Intervention (5 weeks)
measure: Academic Burnout Scale
timeFrame: Change from Pre- to Post-Intervention (5 weeks)
measure: Generalised Anxiety Disorder Assessment (GAD7)
timeFrame: Change from Pre- to Post-Intervention (5 weeks)
measure: Patient Health Questionnaire-9 (PHQ9)
timeFrame: Change from Pre- to Post-Intervention (5 weeks)
measure: Treatment Satisfaction Questionnaire
timeFrame: Post-Intervention (5 weeks)
measure: Therapeutic factors
timeFrame: Post-Intervention (5 weeks)
measure: System usability
timeFrame: Post-Intervention (5 weeks)
Other outcomes:
Locations:
city: Timişoara
country: Romania
facility: West University of Timișoara
Study officials:
References:
Clinical trial NCT02889887: Relationship Between Sensory Processing and Motor Development
Official title: The Investigation of Relationship Between Sensory Processing and Motor Development in Preterm Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sensation Disorders
Keywords: Preterm
Sensory Processing
Motor Development
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 60 infants who were born preterm (n=30) and term (n=30), the corrected and chronological ages between 10-12 months, were included in this study.

Brief summary: The aim of this study is to analyse correlation between the sensory processing and motor development in preterm infants.

Detailed description: The aim of this study is to analyse correlation between the sensory processing and motor development in preterm infants. A total of 60 infants who were born preterm (n=30) and term (n=30), the corrected and chronological ages between 10-12 months, were included in this study. Test of Sensory Function in Infants was used to evaluate sensory processing, and Alberta Infant Motor Scale was used to evaluate motor development.Spearman correlation test indicated strong positive relation between sensory processing and motor development in preterm infants. Given the relationship between sensory processing and motor development in preterm group, for effective implementation of physiotherapy assessments and interventions, it was thought that it is necessary to evaluate the sensory processing as well as the motor development in preterm infants.

Eligibility criteria: Inclusion Criteria:

* gestational age lower than 37 month
* corrected age within 10-12 months
* without congenital anomaly or systemic disease
* stay in Neonatal Intensive Care Unit (NICU) at least 2 weeks

Exclusion Criteria:

* taken physiotherapy or sensory integration therapy in any rehabilitation center
* having newborn retinopathy

Primary outcomes:
measure: The investigation of sensory processing in preterm infants
timeFrame: Day 1
Secondary outcomes:
measure: The investigation of motor development in preterm infants
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Gazi University
name: HALİL İ ÇELİK
role: PRINCIPAL_INVESTIGATOR
References:
citation: Celik HI, Elbasan B, Gucuyener K, Kayihan H, Huri M. Investigation of the Relationship Between Sensory Processing and Motor Development in Preterm Infants. Am J Occup Ther. 2018 Jan/Feb;72(1):7201195020p1-7201195020p7. doi: 10.5014/ajot.2018.026260.
Clinical trial NCT00522587: Sevoflurane-Remifentanil Interaction: Multiple Response Surfaces, Validation of Calibration Stimuli, Validation of the Intraoperative Isobole Concept and Investigating Remifentanil Induced Opioid Tolerance
Official title: Sevoflurane-Remifentanil Interaction: Multiple Response Surfaces, Validation of Calibration Stimuli, Validation of the Intraoperative Isobole Concept and Investigating Remifentanil Induced Opioid Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anesthesia
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2007-08-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During this study, the pharmacodynamic interactions between sevoflurane and remifentanil will be studied.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesia class I and II patients
* Aged 18-60 years
* Scheduled for surgery under general anesthesia

Exclusion Criteria:

* Weight less than 70% or more than 130% of ideal body weight
* Neurological disorder
* Diseases involving the cardiovascular system (hypertension, coronary artery disease, prior acute myocardial infarction (AMI), any valvular and/or muscular disease involving decrease of the ejection fraction, arrhythmias, which are either symptomatic or require continuous medication/pacemaker/automatic implantable cardioverter defibrillator \[AICD\])
* Pulmonary disease including asthma, severe chronic obstructive pulmonary disease (COPD), etc.
* Gastric diseases including reflux, endocrinological diseases
* Recent use of psycho-active medication, including alcohol.

Primary outcomes:
measure: EEG depression and arousal reactions in response to different clinically relevant stimuli
timeFrame: 60 to 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Michel Struys, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03318887: Impact of Sofosbuvir and Daclatasvir Concentration on HCV RNA
Official title: Sofosbuvir Plus Daclatasvir With or Without Ribavirin for Chronic Hepatitis C Infection: Impact of Drug Concentration on Viral Load Decay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: Cirrhosis
Direct acting antiviral agents
Hepatitis C
Pharmacological monitoring
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All HCV infected patients from the Department of Hepatology, Croix-Rousse Hospital, Lyon, France receiving sofosbuvir/daclatasvir with or without ribavirin between February and September 2014 were considered

Brief summary: Sofosbuvir plus daclatasvir with or without ribavirin is one of the currently recommended treatment option for chronic hepatitis C. The objectives were to identify factors associated with sofosbuvir/daclatasvir plasma concentrations variations and to evaluate their impact on viral kinetics.


Eligibility criteria: Inclusion Criteria:

* Patients with hepatitis C virus infection treated with sofosbuvir/daclatasvir
* Patients with at least one measurement of sofosbuvir or daclatasvir plasma concentration
* Follow-up of at least 3 months after the end of treatment

Exclusion Criteria:

* Patients with severe renal failure (estimated glomerular filtration rate (eGFR)\<30ml/min/1.73m2)
* Patients with liver transplantation during therapy

Primary outcomes:
measure: Sofosbuvir/daclatasvir plasma concentration
timeFrame: Sofosbuvir/daclatasvir plasma concentrations were measured at week 4, 8, 12 and 24 during therapy
Secondary outcomes:
measure: HCV viral load
timeFrame: At treatment initiation, at week 4, 8, 12 and 24 of therapy and 12 weeks after the end of treatment
Other outcomes:
Locations:
city: Lyon
country: France
facility: Croix-Rousse Hospital, Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Fabien Zoulim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03786887: The 90% Effective Dose of Nalbuphine in Mechanical Ventilated Patients in the ICU
Official title: The 90% Effective Dose of Nalbuphine in Mechanical Ventilated Patients in the ICU
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain
Keywords: mechanical ventilation
nalbuphine
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the effective nalbuphine dose in 90% of intubated patients in the ICU, including the continuous infusion dose and a bolus dose during moving to the lateral decubitus position. Pain will assessed using a Behavioural Pain Scale (BPS) requiring a score of 3-4.

Detailed description: The continuous nalbuphine infusion dose starts at 100ug/kg/h, if the BPS scores reaches 3-4, the continuous infusion dose would be decreased by 20 ug/kg/h for next patients. If not, increased by 20 ug/kg/h.

The nalbuphine bolus is injected 5 min before turning the patients and the dose (starting at 0) is increased by 0.05 mg/kg, prior to each subsequent turn to lateral decubitus until a BPS score of 3-4 is obtained.

Eligibility criteria: Inclusion Criteria:

* Mechanical invasive ventilation
* Sedated only with nalbuphine

Exclusion Criteria:

* Pregnant or breast-feeding woman
* Age below 18 or over 80 years
* An indication for deep sedation (e.g.the initial stage of septic shock, acute brain injury or acute respiratory distress syndrome)
* Renal dialysis
* The inability to assess pain by the BPS scale (e.g. paralysis)
* BMI less than 18 or more than 35
* Preadmission use of opioid analgesic for chronic pain
* Severe hepatic failure
* State of consciousness with impossibility to use self-assessment scale; monoamine oxidase inhibitors

Primary outcomes:
measure: Continuous pumping dose of nalbuphine
timeFrame: 2 days
measure: Nalbuphine bolus dose
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Critical Care Medicine, Union Hospital, Wuhan
Study officials:
References:
citation: Chaveron D, Silva S, Sanchez-Verlaan P, Conil JM, Sommet A, Geeraerts T, Genestal M, Minville V, Fourcade O. The 90% effective dose of a sufentanil bolus for the management of painful positioning in intubated patients in the ICU. Eur J Anaesthesiol. 2012 Jun;29(6):280-5. doi: 10.1097/EJA.0b013e328352234d.