louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01562704: Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI
Official title: Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: mechanism of action of paracetamol in the brain structures
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Dr. Gisèle PICKERING (MCU, PH)
name: Dr. Betty JEAN (PH)
First posted: 2012-03-26
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Paracetamol is one of the most widely used analgesic in the world, indicated for the symptomatic treatment of fever and pain. The objective of this study is to evaluate the mechanism of action of paracetamol (versus placebo) in the brain with new assessment tools (functional MRI and test inducing pain by thermal stimulation.

Detailed description: Visit 1 / Visit 2 Inclusion of the subject, Clinical examination Trainings tests

Study period 1 Clinical examination Measurement of the basal pain thresholds Administration of product (T0) T0+100min : Thermal stimulation according to the established paradigm and fMRI data acquisition T0+180min : Thermal stimulation according to the established paradigm and fMRI data acquisition

Study period 2: same of period 1.

Eligibility criteria: Inclusion Criteria:

* - Healthy volunteers
* Aged at last 18 years and over 60 years
* Male
* Non-smoking subject
* Fasting coffe, tea, coca-cola or other stimulant products since the last evening
* Subject free of any treatment within 7 days prior to inclusion including no use of analgesics or anti-inflammatory treatments

Exclusion Criteria:

* Contraindications to the administration of paracetamol
* Contraindications to the completion of MRI
* Medical history and/or surgical judged by the investigator as being incompatible with the test
* Progressive disease at the inclusion

Primary outcomes:
measure: Difference between the matrice plans obtained in both treatments (paracetamol or placebo) and 100 min after administration of paracetamol or placebo in brain structures
timeFrame: 100 min after administration of paracetamol or placebo
Secondary outcomes:
measure: Difference between the matrice plans obtained in both treatments (paracetamol or placebo) and 180 min after administration of paracetamol or placebo in brain structures
timeFrame: 180 min after administration of paracetamol or placebo
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Gisèle PICKERING
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pickering G, Kastler A, Macian N, Pereira B, Valabregue R, Lehericy S, Boyer L, Dubray C, Jean B. The brain signature of paracetamol in healthy volunteers: a double-blind randomized trial. Drug Des Devel Ther. 2015 Jul 23;9:3853-62. doi: 10.2147/DDDT.S81004. eCollection 2015.
Clinical trial NCT04518904: Establishment of a Prognosis Prediction Model and Scoring Criteria of Pulmonary Contusion Caused by Severe Thoracic Trauma
Official title: Establishment of a Prognosis Prediction Model and Scoring Criteria of Pulmonary Contusion Caused by Severe Thoracic Trauma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Contusion , Chest Trauma , Prediction Model
Keywords: pulmonary contusion
severe chest trauma
prediction model
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 800 cases of patients were hospitalized from 2014 to 2019.All patients were Chinese.

Brief summary: Pulmonary contusion caused by severe thoracic trauma is a complex disease. Some patients may be secondary to severe complications such as pulmonary infection or even acute respiratory distress syndrome. At present, there have been no reports on related studies based on Chinese population. In this study, 800 patients with pulmonary contusion will be retrospectively investigated to determine the risk factors and independent risk factors of their poor prognosis, and to construct a prognosis prediction model and scoring criteria.


Eligibility criteria: Inclusion Criteria:

Chinese patients aged 18 to 80 years,severe chest trauma (flail chest, more than 4 rib fractures without flail chest, multiple anterior rib fractures with sternal fractures, bilateral fractures, severely displaced sternal fractures),pulmonary contusion.

Exclusion Criteria:

Patients were excluded if they had a history of tuberculosis, heart failure,respiratory failure,severe brain injury(GSC score \< 15),loss of consciousness, spinal fracture complicated with paraplegia,abdominal trauma requiring surgical intervention,shock.

Primary outcomes:
measure: To build a prognostic prediction model and standard scoring system for pulmonary contusion caused by severe chest trauma
timeFrame: 2020.1-2020.6,enter data by protocol, statistical analysis,
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04853901: Remdesivir Efficacy In Management Of COVID-19 Patients
Official title: Remdesivir Efficacy In Management Of COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid19
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is open label randomized interventional phase 3 clinical trial. Patients with confirmed Covid-19 cases who was hospitalized in Two university isolation hospitals (Ain Shams University and Assiut University ) assigned hospitals for isolation.

Detailed description: The study is open label randomized interventional phase 3 clinical trial. Patients with confirmed Covid-19 cases who was hospitalized in Two university isolation hospitals (Ain Shams University and Assiut University ) assigned hospitals for isolation.

The included patients receive. Intervention group: Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days + Methylprednisolone 1-2mg/kg for 5-7 days Control group: standard of care without Remdesivir

Eligibility criteria: Inclusion Criteria:

Adult 18 -80 years old Must have laboratory confirmed COVID-19(A patient with laboratory confirmation (Positive RT-PCR) of COVID-19 infection, irrespective of clinical signs and symptoms according to Ain Shams University Hospitals Consensus Statement on Management of Adult COVID-19 Patients.

Must have severe or immediately life-threatening COVID-19,

* Severe disease is defined as:

  * Dyspnea,
  * Respiratory frequency ≥ 30/min,
  * Blood oxygen saturation ≤ 93%,
  * Partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, and/or lung infiltrates \> 50% within 24 to 48 hours
* Life-threatening disease is defined as:

  * respiratory failure,
  * septic shock, and/or
  * multiple organ dysfunction or failure
* Must provide informed consent by patient or his/her legal guardian or Professional Legal Representative

Exclusion Criteria:

* Mild to moderately affected COVID 19 confirmed patients.
* pregnancy, lactation.
* known hepatic failure.
* Patient who is not likely to comply to study procedures.
* Creatine clearance \<30 ml/min.
* Elevated transaminases \> 5 fold ULN.

Primary outcomes:
measure: Evaluation of viral clearance
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
state: Non-US
Study officials:
affiliation: Faculty of Medicine Ain Shams University
name: Hany E Dabbous, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01704001: Clinical Pharmacokinetics Study of ART-123 in Disseminated Intravascular Coagulation (DIC) Subjects With Renal Impairment
Official title: A Post-Marketing Clinical Pharmacokinetics Study of ART-123 in DIC Subjects With Renal Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Disseminated Intravascular Coagulation
Keywords: ART-123
Disseminated Intravascular Coagulation
Pharmacokinetics
Lead sponsor: Asahi Kasei Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2012-10-11
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the impact of impaired renal function on the pharmacokinetics of ART-123 in patients with Disseminated Intravascular Coagulation.

To investigate the safety of ART-123 in patients with Disseminated Intravascular Coagulation.


Eligibility criteria: Inclusion Criteria:

* Japanese Association for Acute Medicine-defined DIC criteria score \>= 4
* Written informed consent from patient or guardian

Exclusion Criteria:

* Patients showing intracranial, pulmonary, gastrointestinal hemorrhage
* Patients with a history of cerebrovascular disorders within the past 52 week
* Patients with a history of hypersensitivity to the ingredients of ART-123 preparations
* Pregnant women, nursing mothers or possibly pregnant women

Primary outcomes:
measure: Composite of Pharmacokinetics
timeFrame: pre-dose, 0,2,4,8,24 hours post-dose
measure: Incidence rate of hemorrhage related adverse events
timeFrame: from the start of infusion to 8days after the cessation of infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Oita
country: Japan
Study officials:
References:
Clinical trial NCT02595801: Surgery in Early Life and Child Development at School-entry: A Population-based Study
Official title: Surgery in Early Life and Child Development at School-entry: A Population-based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery in Early Childhood
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: McMaster University
name: Institute for Clinical Evaluative Sciences
First posted: 2015-11-03
Enrollment: 188628
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children attending public or Catholic school in Ontario who have completed the Early Development Instrument

Brief summary: The central hypothesis is that surgery and anesthesia exposure in children with immature structural and functional brain development has long-term adverse effects on child development at school-entry compared with children not exposed to anesthesia.

The secondary hypothesis is that frequency of surgery and anesthesia exposure in children with immature structural and functional brain development has a dose-dependent association with worsened child development outcomes at school-entry.

The overall objective is to investigate the association between surgery/anesthesia exposure(s) in children in Ontario and major child development outcomes (physical health and well being, social competence, emotional maturity, and language and cognitive development) at school entry as measured by the Early Development Instrument.


Eligibility criteria: Inclusion Criteria:

* Completion of the Early Development Instrument in Ontario

Exclusion Criteria:

* Children with physical or developmental disabilities identified in the Early Development Instrument
* Not born in Canada
* Having undergone fetal interventions, radiation or brachytherapy, local pharmacotherapy, systemic cancer chemotherapeutic procedures, therapeutic interventions of the cardiovascular system
* Patients of a cardiology or cardiovascular service

Primary outcomes:
measure: Early developmental vulnerability
timeFrame: Assessed between five and six years of age
Secondary outcomes:
measure: Performance in specific Early Development Instrument domains
timeFrame: Assessed between five and six years of age
measure: Multiple challenge index
timeFrame: Assessed between five and six years of age
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References:
Clinical trial NCT05724901: At-Home Gait Assessment
Official title: A Wearable Remote Data Capture Solution for Home-Based Gait Assessment in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Gait Analysis
telehealth
sensor-based gait analysis
home-based
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2023-02-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (ages 18-70) diagnosed with MS, any subtypes (Relapsing Remitting, Primary Progressive, or Secondary Progressive MS).

Brief summary: The goal of this study is to validate an MS Gait Remote Capture and Analysis (MS-GRCA) system based on wearable shoe-based motion sensors for home-based and repeatable gait assessments.

Detailed description: This is a single-site observational longitudinal study to validate an MS Gait Remote Capture and Analysis system for home-based and repeatable gait assessments. The investigators will recruit 30 participants who will have an in-person baseline visit (informed consent, standard gait assessment, sensor-based gait assessment, self-reported questionnaires), followed by three remote visits (sensor-based gait assessment, SUS questionnaire \[last remote visit only\]).

Eligibility criteria: Inclusion Criteria:

* Ages 18-70 years old (inclusive)
* Confirmed diagnosis of MS (any MS subtypes, Relapsing Remitting \[RR\], Primary Progressive \[PP\], or Secondary Progressive \[SP\])
* PDSS score from 0 to 5
* Stable and continuous access to internet at home
* Adequate home facilities (enough space, quiet and distraction free area)
* Ability to provide informed consent.

Exclusion Criteria:

* Below average estimated premorbid cognitive functioning (based on WRAT-4 reading recognition standard z-score \< 85).
* Presence of severe cognitive impairment (based on SDMT age normative z-score \< -3.0).
* Presence of primary neurological disorders other than MS or primary psychiatric disorder that would influence ability to complete assessments.

Primary outcomes:
measure: Mean Gait Velocity
timeFrame: Up to Week 4
Secondary outcomes:
measure: Mean Stride Length
timeFrame: Up to Week 4
measure: Mean Double Support Duration
timeFrame: Up to Week 4
measure: Mean Stance Duration
timeFrame: Up to Week 4
measure: Mean Cadence
timeFrame: Up to Week 4
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Leigh Charvet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06113601: Assessment of Admission to the ICU of Onco-hematological Patients.
Official title: Assessment of Admission to the ICU of Onco-hematological Patients. Income Patterns and Results.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hematological Diseases
Critical Illness
Lead sponsor: University Hospital A Coruña
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of solid organ or hematological tumor who are admitted to the hospital and require ICU evaluation.

Brief summary: Multicenter, observational and prospective study.

Detailed description: The data collection period will include 6 consecutive months, starting from the date of acceptance or conformity of the CEIC. Or, until an adequate sample size is reached that guarantees the statistical relevance of said analysis. All patients will subsequently be followed up 3 months after discharge from the ICU.

Eligibility criteria: Inclusion Criteria:

* Adults
* Solid organ tumor or hematological malignancy,

Exclusion Criteria:

-under 18 years old

Primary outcomes:
measure: Hospital mortality.
timeFrame: During the 6 months of the study.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02097901: Microfracture in Rotator Cuff Injury Repair
Official title: Microfracture in Rotator Cuff Injury Repair
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Rupture of the Rotator Cuff
Keywords: Rotator Cuff
Injury
Repair
Microfracture
Healing
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2014-03-27
Enrollment: 100
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: The hypothesis is that microfractures in the footprint of the humerus will aid to improve the tendon healing to the bone. The aim of the study is to investigate whether the use of microfractures at the footprint of the rotator cuff will improve the tendon healing when reinserted. Patients undergoing surgery for a rotator cuff injury will be randomised to repair with or without microfracture.


Eligibility criteria: Inclusion Criteria:

- Patients over the age of 18 with a full thickness rotatorcuff rupture.

Exclusion Criteria:

* Isolated rupture of the subscapularis
* Tendon atrophia
* Goutallier grade 3-4 fatty degeneration
* Fracture surgery in same shoulder
* Inflammatory or neurologic affection of shoulder
* Other disabling disease
* Unwilling to participate in study

Primary outcomes:
measure: Change in Western Ontario Rotator Cuff Index (WORC)
timeFrame: 0, 3 and 12 months
measure: Change in Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH)
timeFrame: 0, 3 and 12 months
Secondary outcomes:
measure: MRI integrity of the rotatorcuff
timeFrame: 12 months
Other outcomes:
measure: Strength of rotatorcuff
timeFrame: 3 and 12 months
measure: Function of rotatorcuff
timeFrame: 3 and 12 months
measure: Complications
timeFrame: 12 months
Locations:
city: Køge
country: Denmark
facility: Køge Sygehus
state: Lykkebækvej 1
Study officials:
affiliation: Køge Sygehus
name: Lars Blønd, M.D
role: STUDY_DIRECTOR
affiliation: Køge Sygehus
name: Gunner S Barfoed, M.D
role: STUDY_DIRECTOR
affiliation: Køge Sygehus
name: Thomas JN Sørensen, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT04675801: SAfety and EFficacy of Bridging Antithrombotic Therapy During Elective Non-cardiac Surgery
Official title: Safety and Efficacy of Bridging Antithrombotic Therapy During Elective Non-cardiac Surgery for Coronary Artery Disease Patients Treated With Oral Antiplatelet Agents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: Bridging antithrombotic therapy
Non-cardiac surgery
coronary artery disease
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 950
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Coronary artery disease patients treated with oral antiplatelet therapy are planned to undergo non-cardiac surgery with high or extremely high surgical bleeding risk

Brief summary: Patients with coronary artery disease, especially after PCI, require long-term oral antiplatelet therapy. However, this patient population may inevitably require non-cardiac surgery for a variety of conditions. In order to avoid the occurrence of bleeding events, oral antiplatelet agents are usually discontinued before non-cardiac surgery in patients with coronary artery disease, which may increase the incidence of ischemic events. Therefore, it is important to provide patients with the optimal perioperative antithrombotic treatment to balance the risk of bleeding and ischemia.


Eligibility criteria: Inclusion Criteria:

1. Aged 18 years or over
2. Established coronary artery disease being treated with oral antiplatelet therapy
3. Non-cardiac surgery is planned and bridging antithrombotic therapy is considered necessary
4. Agree to participate in the study and provide written informed consent

Exclusion Criteria:

1. According to the consensus of Chinese experts on antiplatelet therapy in 2013, the surgical bleeding risk is low or extremely low
2. Requiring emergency non-cardiac surgery within 24 hours after admission
3. Currently being bleeding
4. Moderate or severe ischemic stroke or spontaneous intracranial hemorrhage in the past 6 months or traumatic intracranial hemorrhage in the past 1 year
5. Intracranial diseases or hemorrhagic diathesis
6. Contraindications for LMWH or GP IIb/IIIa receptor antagonists

Primary outcomes:
measure: Major adverse cardiovascular events
timeFrame: Perioperative period
Secondary outcomes:
measure: TIMI major or minor bleeding
timeFrame: Perioperative period
measure: Net adverse clinical events
timeFrame: Perioperative period
measure: Net adverse clinical events
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Xiaoli Liu, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03638401: Epidural vs. Wound Catheter Following Liver Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transplant Surgery
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Good postoperative pain control after any major surgery allows early mobilization, minimises postoperative complications and reduces patient distress. Multiple different methods of delivering analgesia have been described.

This study aims to compare postoperative pain control between patients with epidural analgesia versus the combination of continuous infiltration of local anaesthetic with wound catheters, TAP block and IV PCA with opiate analgesia following open liver resection. The investigators expect that pain control will be similar between the two groups but that the utilization of wound catheters will confer benefit due to the lack of systemic side effects associated with epidural analgesia


Eligibility criteria: Inclusion Criteria:

* All adult patients scheduled to undergo an open liver resection at this hospital will be eligible to participate.

Exclusion Criteria:

* Patients with a contraindication to either epidural or wound catheter
* Inability to give written, informed consent
* Aged less than 18 years old
* Liver resection combined with a secondary surgical procedure
* Body mass index of \<18 or \>40
* Pregnancy or lactation
* A history of chronic pain requiring regular opioid analgesia
* Prisoners

Primary outcomes:
measure: The length of hospital stay following open liver resection
timeFrame: 6 months (or length of the study)
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
Study officials:
References: