louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01770197: Outcome of Intravenous Thrombolysis for Stroke Patients in the 3-4.5 Hour Time Window
Official title: The Feasibility and Outcome of Intravenous Thrombolysis for Stroke Patients in the 3-4.5 Hour Time Window in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: China
Stroke
Thrombolytic therapy
Lead sponsor: Wuhan General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2013-01-17
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: stroke patients in the 3-4.5 hour time window

Brief summary: The time window for intravenous recombinant tissue plasminogen activator treatment in ischemic stroke patients has been extended to 4.5h. Little is known about intravenous recombinant tissue plasminogen activator use in the 3-4.5 hour time window among Chinese stroke patients. This exploratory study was to describe the feasibility and outcome of treatment with intravenous recombinant tissue plasminogen activator in the expanded time window, and to offer suggestions for future clinical work in China.

Detailed description: Favorable clinical outcome of intravenous recombinant tissue plasminogen activator was assessed by absolute changes in the National Institute of Health Stroke Scale score at 24 hours and by the improvement of modified Rankin Scale score at discharge or 6-month follow-up. The safety of intravenous recombinant tissue plasminogen activator was assessed by the rate of mortality, intracerebral hemorrhage and other common complications. Multivariate logistic regression models were used to evaluate factors associated with favorable clinical outcome.

Eligibility criteria: Inclusion Criteria:stroke patients in the 3-4.5 hour time window -

Exclusion Criteria:stroke patients in more than 4.5 hour time window

-

Primary outcomes:
measure: National Institute of Health Stroke Scale score and modified Rankin Scale
timeFrame: Outcome measure will be assessed at 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wuhan General Hospital of Guangzhou Command
name: Wuhan G H, High
role: STUDY_CHAIR
References:
Clinical trial NCT04639297: NeuroVision vs Standard Neuromonitoring
Official title: NeruoVision Versus Standard Hospital Neuromonitoring, Influence on the Rate of Neurologic Injury Following Spine Surgery? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurologic Deficits
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 148
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to perform a prospective, randomized, controlled clinical trial to assess the utility of IONM in patients undergoing primary, single or multilevel lateral spinal procedures. Subjects will be randomized to undergo a lateral spine surgery with the use of NeuroVision® IONM or conventional hospital based IONM to assess incidence of new-onset neurological injury.

Detailed description: Elective spinal surgery for the correction of degenerative spinal pathology may involve significant intraoperative risks that can influence postoperative neurologic outcomes. Spinal cord monitoring had made it possible to track the spine and nerve root sensory and motor tracts. This has improved the ability to conduct minimally invasive surgery by allowing surgeons to operate without direct visualization of the neurologic elements.

Intraoperative neuromonitoring (IONM) of the spinal cord is primarily accomplished by both somatosensory evoked potentials (SSEP) and transcranial motor evoked potentials (tcMEPs). Due to a shortage in personnel trained to evaluate neuro-monitoring results, surgeon-driven systems have been established. An example of a surgeon driven monitoring system is NeuroVision®, which interacts with the surgeon during the operation by providing real-time visible and auditory tcMEP and compound muscle action potential (CMAP) waveforms. This stands in comparison to hospital based methods of IONM.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing a primary single or multilevel lateral spinal surgery procedures for degenerative pathology Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, central stenosis, foraminal stenosis herniated nucleus pulposus, degenerative disc disease, spondylosis, and osteophytic complexes
* Patients able to provide informed consent

Exclusion Criteria:

* Active infection
* Active or history of malignancy
* Spinal traumatic injury within the past 2 years

Primary outcomes:
measure: Incidence of new-onset neurological injury
timeFrame: Enrollment up to 2 years postoperatively
Secondary outcomes:
measure: Cost analysis of IONM use
timeFrame: Enrollment up to 1 month post-operative
measure: False positive and false negative events in each modality
timeFrame: Intraoperatively up to 1 day post-operative
measure: Adverse Events
timeFrame: Postoperative to documented progress assessed up to 2 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
Clinical trial NCT00487877: Measurements of Skin Physiological Parameters as Mean of Metabolic Assessment
Official title: Measurements of Skin Physiological Parameters as Mean of Metabolic Assessment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hungry-Satiation Situation
Keywords: metabolism, temperature changing, skin, heart rate
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-06-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: To investigate the relationship between hungry-satiation situation including meal time and metabolism, skin temerature changing, simpathetic \& para-simpathetic response To investigate the relashionship between hungry-satiation situation including meal time and heart rate


Eligibility criteria: Inclusion Criteria:

1. Over 18 years old
2. BMI: 22-30 Kg / m2

Exclusion Criteria:

1. Any unbalanced chronic disease
2. Any infection disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: The Unit of clinical Nutrition
Study officials:
affiliation: unaffiliation
name: Nachum Vaisman, Prof.
role: PRINCIPAL_INVESTIGATOR
name: Nachum Vaisman, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00460577: Efficacy of Formoterol vs Ipatropioum Bromide Plus Fenoterol in Children (5-<12 Years) With Acute Bronchial Obstruction
Official title: Randomized, Double Blind, Double Dummy, Placebo Controlled Trial to Compare the Effectiveness of Formoterol vs Ipatropioum Bromide Plus Fenoterol in Asthmatic Children (5-<12 Years) With Acute Bronchial Obstruction Attending Emergency Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Bronchial Obstruction, Asthma
Keywords: Asthma, Formoterol, Bronchial Obstruction, Children
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-04-16
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine efficacy and tolerability of inhaled Formoterol vs nebulized Ipatropioum Bromide plus Fenoterol in cumulative sequential doses in asthmatic children (5-\<12 years) with acute bronchial obstruction attending emergency services


Eligibility criteria: Inclusion Criteria:

* Asthmatic children 5-\<12 years old, requiring emergency services for acute bronchial obstruction mild to moderate determined by functional and clinical evidence

Exclusion Criteria:

* Patients with severe acute bronchial obstruction determined by functional and clinical evidence
* Patients unable to use the inhaling device at time of treatment
* Patients who received a bronchodilator drug within the last 12 hours
* Patients who received inhaled steroids within the last 72 hours
* Patients who received systemic steroids within the last 7 days
* Patients with near fatal asthma history
* Patients with fever (\>38.5°C axillar temp)
* Patients with any clinical significance condition

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation
timeFrame: Baseline,4 hours
measure: Mean Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Final Evaluation
timeFrame: Baseline,4 hours
measure: Mean Change in Pulse Oxymetry From Baseline to Final Evaluation
timeFrame: Baseline, 4 hours
measure: Mean Change in the Conway Clinical Scale Score From Baseline to Final Evaluation
timeFrame: Baseline,4 hours
Secondary outcomes:
measure: Safety Assessed by: Pulse Oxymetry, Clinical Assessments, Adverse Events
timeFrame: 4 hours
measure: Pharmacoeconomic Analysis
timeFrame: 4 hours
Other outcomes:
Locations:
city: Caracas
country: Venezuela
facility: Novartis Investigator site - five sites in Caracas
city: Maracaibo
country: Venezuela
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis de Venezuela
name: Novartis de Venezuela
role: STUDY_CHAIR
References:
Clinical trial NCT02388477: Trial of the Use of Doxycycline After Rotator Cuff Repair
Official title: Randomized Controlled Trial of the Use of Doxycycline After Rotator Cuff Repair
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Rotator Cuff Injury
Keywords: rotator cuff repair
Doxycycline
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 0
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 purpose of this study is to examine healing after rotator cuff repair in subjects either treated with Doxycycline or placebo post-operatively.

Detailed description: Basic Science small animal model data indicates that matrix metalloproteinase (MMP) inhibition via doxycycline results in improved early rotator cuff repair biomechanics and histology. Rotator cuff repair failure and retear is a significant clinical problem. The effects of MMP inhibition on human rotator cuff tear repair healing and outcomes is unknown, but may potentially improve healing rates and outcomes. Our purpose is to evaluate the effects of early oral doxycycline on healing and outcomes following arthroscopic rotator cuff repair.

Eligibility criteria: Inclusion Criteria:

* repair of rotator cuff
* age 18 and above
* able to swallow capsules

Exclusion Criteria:

* less than 18
* unable to read or understand consent form
* unable to swallow capsules
* allergy to doxycycline

Primary outcomes:
measure: rotator cuff ultrasound of post-operative shoulder
timeFrame: one year
Secondary outcomes:
measure: American Shoulder and Elbow Surgeons score
timeFrame: 6 weeks, 3mos, 6mos, 1yr and 2 yr.
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Aman Dhawan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06588777: Ultrasound Guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) Versus Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy
Official title: Ultrasound Guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) Versus Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Modified Thoracoabdominal Nerve Block
Quadratus Lumborum Block
Keywords: Laparoscopic cholecystectomy
modified thoracoabdominal nerve block
quadratus lumborum block
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to compare the efficacy of using Ultrasound guided modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) versus quadratus lumborum block for postoperative analgesia in laparoscopic cholecystectomy under general anesthesia.


Eligibility criteria: Inclusion Criteria:

* Adult patients aging ≥ 21 years to ≤ 70 of both sexes.
* Patients undergoing Laparoscopic cholecystectomy surgeries.
* ASA physical status classes I - II.

Exclusion Criteria:

* Patient's refusal of procedure or participation in the study.
* ASA classes III or above.
* Coagulopathy and bleeding disorders.
* Evidence of Local skin infections at site of injection.
* Body mass index \>40kg/m2
* A history of relevant local anesthetic allergy.

Primary outcomes:
measure: Time to first Rescue Analgesia
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: The total requirements of rescue analgesia Meperidine (pethidine) over the first 24 hours postoperative
timeFrame: 24 hours postoperative
measure: Heart rate
timeFrame: at intervals of 0 (PACU), 1, 2, 4, 6, 12, 18 and 24 hours postoperatively
measure: Blood pressure
timeFrame: at intervals of 0 (PACU), 1, 2, 4, 6, 12, 18 and 24 hours postoperatively
measure: Spo2 measuring
timeFrame: at intervals of 0 (PACU), 1, 2, 4, 6, 12, 18 and 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams university hospitals
Study officials:
References:
Clinical trial NCT05862077: Long-term Exercise Effect of EX1 Exercise Program
Official title: Long-term Exercise Effect of EX1 Exercise Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Exercise program
Wearable hip assist robot
Gait
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Samsung Electronics
First posted: 2023-05-17
Enrollment: 45
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study was to investigate the effect of a long-term exercise program using a wearable exoskeleton robot (EX1) on muscular strength in healthy adults aged 19 to under 65 years, compared to an exercise program without EX1.


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 19 to less than 65 years without a history of central nervous system disease

Exclusion Criteria:

* Those who have difficulty walking independently due to problems such as visual field defects or fractures
* Those who have difficulty participating in exercise programs due to adult diseases such as uncontrolled hypertension and diabetes
* Those who are at risk of falling while walking due to severe dizziness
* Those who are less than 140 cm or more than 185 cm in height that is not suitable size for the wearing of the walking assistance robot
* Those who are overweight based on body mass index (BMI) 35 or higher

Primary outcomes:
measure: Change on gait function (muscle activation)
timeFrame: Session 0 (initial visit); after session 18 (at approximately 6 weeks)
Secondary outcomes:
measure: Change in heart rate
timeFrame: Every session (total 18 sessions/ 30 minutes)
measure: Reduction in stress level
timeFrame: Session 0 (initial visit); after session 18 (at approximately 6 weeks)
measure: Reduction in body fat percentage
timeFrame: Session 0 (initial visit); after session 18 (at approximately 6 weeks)
measure: User Satisfaction Questionnaire
timeFrame: After session 18 (at approximately 6 weeks)
measure: Change on gait function (kinematic)
timeFrame: Session 0 (initial visit); after session 18 (at approximately 6 weeks)
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Sungkyunkwan University
Study officials:
References:
Clinical trial NCT05898477: Describing Treatment Outcomes and Responses in Lymphoma-associated Hemophagocytic Lymphohistiocytosis
Official title: Describing Treatment Outcomes and Responses in Lymphoma-associated Hemophagocytic Lymphohistiocytosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma
Hemophagocytic Lymphohistiocytoses
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of Hemophagocytic lymphohistiocytosis (HLH)

Brief summary: The purpose of the study is to describe Hemophagocytic lymphohistiocytosis (HLH) in patients with lymphoma to identify possible therapeutic strategies to improve overall survival of the patients with lymphoma associated hemophagocytic lymphohistiocytosis.

Detailed description: Retrospective, multi-institutional study focused on describing the clinical features, laboratory parameters, treatments, and outcomes among individuals presenting with HLH in the setting of a lymphoma

Eligibility criteria: Inclusion Criteria:

* Patients with lymphoma that are fulfilling at least one of the following:

A. Meeting 5 of 8 HLH-2004 diagnostic criteria OR B. Are OHI index positive (sCD25\>3,900 U/mL and ferritin\>1,000 ng/mL)

Exclusion Criteria:

* Patients developing HLH\> 1 month after lymphoma diagnosis (for aggressive lymphomas)
* Patients with incomplete treatment and response documentation

Primary outcomes:
measure: To determine the factors predicting 180 days overall survival of patients with cancer that are HLH-2004/OHI+
timeFrame: The participant's survival would be assessed at 180 days from the malignancy diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Gaurav Goyal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01248377: Skin Testing and ELISPOT Assay in Patients With a History of Non-Immediate Reactions to Cephalosporins
Official title: The Results of Skin Testing and The Detection of Cytokine Secretion From Drug Specific Peripheral Blood Mononuclear Cells Using ELISPOT Assay in the Diagnosis of Nonimmediate Reactions to Cephalosporins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cephalosporin Allergy
Non-immediate Drug Reactions
Keywords: Cephalosporins
Drug hypersensitivity
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2010-11-25
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a history of non-immediate hypersensitivity reactions to cephalosporins

Brief summary: This study aims to compare the results of skin testing and ELISPOT assay in patients with a history of non-immediate reactions to cephalosporins

Detailed description: Patients with a history of non-immediate reactions to cephalosporins will be tested by patch test and/or intradermal test. Peripheral blood mononuclear cells will be collected to analyzed cytokine secretions by ELISPOT assay

Eligibility criteria: Inclusion Criteria:

1. Patients with a history of non-immediate hypersensitivity reactions to cephalosporins
2. At least 18 years of age

Exclusion Criteria:

1. Suffering from severe systemic disease/ in bad health
2. Being pregnant
3. Patients with a history of immediate reactions to cephalosporin

Primary outcomes:
measure: The skin testing results of Cephalosporin skin test compared to ELISPOT assay
timeFrame: 1 year
Secondary outcomes:
measure: The result of cross reactivity between Cephalosporins and other Betalactams determined by skin testing and ELISPOT assay
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Jettanong Klaewsongkram, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tanvarasethee B, Buranapraditkun S, Klaewsongkram J. The potential of using enzyme-linked immunospot to diagnose cephalosporin-induced maculopapular exanthems. Acta Derm Venereol. 2013 Jan;93(1):66-9. doi: 10.2340/00015555-1386.
Clinical trial NCT02769377: Glucometer and Mobile-phone Based Data Transfer System in Diabetes
Official title: Efficacy of Combination of Glucometer and Mobile-phone Based Data Transfer System on Glycemic Control in Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes
Keywords: diabetes, glucometer, mobile-phone
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 300
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 determine if glucometer combined with mobile-phone based data transfer system would be useful for patient diabetes to manage their glycemic control.

Detailed description: Patients with diabetes who are advised by their providers to self-monitoring of blood glucose are eligible. Patients who decline or are not able to do self-monitoring of blood glucose will serve as controls.

Eligibility criteria: Inclusion Criteria:

1. Patient with diabetes
2. Patients' providers advised self-monitor of blood glucose
3. Provided written informed consent.

Exclusion Criteria:

1. Patients had other medical condition that were considered not eligible by the medical team members

Primary outcomes:
measure: HbA1c
timeFrame: HbA1c change from baseline at month 3 and 6
Secondary outcomes:
measure: Hypoglycemia
timeFrame: event of hypoglycemia at month 3 and 6
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: Wayne Sheu, MD. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: