louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00901602: Lebanese Interhospital Pneumococcal Surveillance Program
Official title: Lebanese Interhospital Pneumococcal Surveillance Program (LIPSP)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pneumonia
Meningitis
Sepsis
Bacteremia
Keywords: streptococcus pneumoniae
pneumococcus
pneumonia
meningitis
serotypes
bacteremia
sepsis
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
Collaborators: name: PneumoADIP
name: Pfizer
First posted: 2009-05-14
Enrollment: 700
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with invasive pneumococcal disease with positive culture of S. pneumoniae from a normally sterile site (blood, CSF, etc.)

Brief summary: Streptococcus pneumoniae (pneumococcus) is a bacterium that causes severe infections in children and adults such as meningitis, pneumonia, and blood stream infection. There are many types of these bacteria defined by the type of sugar coat that they have. These are classified as serotypes. There are common serotypes that cause severe disease and are preventable by vaccination of children. Other less common types are more difficult to prevent. The investigators aim to determine the serotypes that cause invasive pneumococcal disease in Lebanon and to study their sensitivity to different antibiotics. The investigators will collect bacterial isolates from different hospitals in Lebanon isolated from the blood or spinal fluid of patients with invasive pneumococcal disease. This information will help the investigators determine the usefulness of available pneumococcal vaccines in preventing these infections. The data will be distributed to all primary care physicians treating children in Lebanon and will be shared with the Ministry of Health.


Eligibility criteria: Inclusion Criteria:

* Samples included in the study are those that are:

  * culture proven
  * invasive pneumococcal infections
  * in patients of all ages admitted to different hospitals all over Lebanon
* Acceptable samples include:

  * positive isolates from blood
  * cerebrospinal fluid
  * other normally sterile body sites such as empyema fluid, abscesses, joint fluid, middle ear fluid obtained by tympanocentesis in the operating room, and lung needle aspiration

Exclusion Criteria:

* non S. pneumoniae isolates

Primary outcomes:
measure: Serotype prevalence of S. pneumoniae in invasive pneumococcal disease
timeFrame: yearly
Secondary outcomes:
measure: Determine the antibiotic sensitivity of S. pneumoniae and the association with specific serotypes
timeFrame: yearly
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut
Study officials:
affiliation: American University of Beirut Medical Center
name: Ghassan S Dbaibo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02451202: Deep vs Moderate Neuromuscular Blockade With Rocuronium in Patients Undergoing Endolaryngeal Procedures
Official title: A Comparison of Surgical Conditions Between Deep vs Moderate Neuromuscular Blockade With Rocuronium in Patients Undergoing Endolaryngeal Procedures.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Laryngoscopic Surgical Procedures
Keywords: "surgical conditions"
"deep neuromuscular blockade"
"deep neuromuscular paralysis"
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2015-05-21
Enrollment: 102
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: It is unknown the impact of deep neuromuscular paralysis and using a novel agent, sugammadex as an reversal in endolaryngeal surgery.

We will conduct a clinical study aiming to compare two treatment strategies; Deep neuromuscular Blockade and moderate Neuromuscular Blockade. We hypothesize that deep NMB will offer better stillness. We will also descriptively examine if patients would be safely discharged from a recovery room.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 - 60 years; ASA I-III.
* Subjects have been planned for elective endolaryngeal. Procedures (Direct Laryngoscopy with laser (micro-)surgery in patients with Tis, T1, T2, supraglottis and glottis carcinoma)

Exclusion Criteria:

* Any renal impairment (CrCL \< 80 ml/ min)
* Any hepatic impairment; Child Pugh A, B or C
* BMI \> 30 kg m2
* Known or suspected generalized neuromuscular disorders
* Allergies to Rocuronium, Sugammadex, Sevoflurane, Propofol, fentanyl used during general anesthesia
* Hypersensitivity to the active substance or to any of the excipients
* Female patient who are pregnant and breastfeeding.
* Patient with poor Glasgow Coma Score and mental derangement who is unable to give informed consent.
* Patient with Tracheostomy tube.

Primary outcomes:
measure: Proportion of Patients Who Have a Clinically Acceptable Surgical Conditions
timeFrame: intraoperative
Secondary outcomes:
measure: Time to Modified Aldrete's Score ≥ 9
timeFrame: Minutes from Post Anesthesia Care Unit (PACU) arrival to patients were considered fit for discharge from the PACU.
Other outcomes:
Locations:
Study officials:
affiliation: Anesthesiology Department, Faculty of Medicine, Culalongkorn University.
name: Oraluxna Rodanant, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04267302: Baby Item Learning and Development Study
Official title: Baby Item Learning and Development Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Infant Development
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this study is to experimentally test whether baby items can promote healthy infant development.


Eligibility criteria: Inclusion Criteria:

* Mothers and their infants must be healthy with no known birth complications
* Infants must be born full term (at least 37 weeks gestation)
* Mother must speak English
* Mothers must be at least 28 weeks along in their pregnancy. Mothers with newborns who are less than 2 weeks will be included.

Exclusion Criteria:

* Participants who does not meet all the inclusion criteria.

Primary outcomes:
measure: Cognitive skill as assessed via eye tracking
timeFrame: 8 months
measure: Parental Engagement
timeFrame: 8 months
measure: Infant Reactivity (Crying) assessed by the Face to Face/Still Face Procedure
timeFrame: 8 months
measure: Infant Reactivity (Smiling) assessed by the Face to Face/Still Face Procedure
timeFrame: 8 months
measure: Oxytocin levels
timeFrame: 8 months
measure: Percentage of infant and adult vocalizations time
timeFrame: Up to 8 hours
measure: Percentage of infant and adult turn taking
timeFrame: Up to 8 hours
measure: Percentage of Infant crying time
timeFrame: Up to 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Elizabeth Simpson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06817902: TMS Pilot in Early AD II
Official title: A Preliminary Sham-Controlled Theta Burst Stimulation (TBS) Study in Early-Stage Alzheimer's Disease (AD)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Alzheimer Disease
Keywords: transmagnetic stimulation
functional MRI guided theta burst stimulation
intermittent theta burst stimulation
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 6
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Alzheimer's disease (AD) is a progressive neurodegenerative condition affecting 6.2 million individuals in the United States, resulting in an annual cost of care of $305 billion. AD is functionally characterized by progressive degeneration of large-scale brain networks (LSBNs), including the default mode network (DMN) presumably from the deposition of amyloid plaques and neurofibrillary tangles. Available FDA-approved medications for AD such as donepezil and memantine offer limited benefit and modest impact on quality of life. Transcranial magnetic stimulation (TMS) with intermittent theta burst stimulation (iTBS) offers a non-invasive alternative to pharmacotherapy in persons with AD. We propose a case series study to compare sham with iTBS.


Eligibility criteria: Inclusion Criteria:

* Established diagnosis of Mild cognitive impairment (MCI)/mild AD
* Evidence for central nervous system (CNS) amyloidosis (e.g., Amyloid Positron Emission Tomography (PET) or Cerebrospinal fluid (CSF) biomarkers consistent with AD)
* Prior brain imaging performed
* Mini Mental Status Examination (MMSE) \>24
* Clinical Dementia Rating (CDR) 0.5-1
* Stable dose of cholinesterase inhibitors and memantine for at least one month
* Subjects are between 40-90 years of age

Exclusion Criteria:

* Non-AD dementia including, but not limited to, Lewy body dementia, frontotemporal dementia, vascular dementia, Jakob-Creutzfeldt disease, etc.
* Inability to tolerate resting state-function magnetic resonance imaging (rs-fMRI)
* Contraindication of rs-fMRI due to implants or metal
* Seizure disorder

Primary outcomes:
measure: Effect of TBS on cognition between and within subjects using Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS)
timeFrame: baseline, 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: HealthPartners Neuroscience Center
state: Minnesota
Study officials:
affiliation: HealthPartners Institute
name: Bhavani Kashyap, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02953002: The Correlation Between The New Sepsis Scores - SOFA, Quick SOFA and Calibrated Automated Thrombogram Values
Official title: The Correlation Between The New Sepsis Scores - SOFA, Quick SOFA and Calibrated Automated Thrombogram Values
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Coagulopathy
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 men and womens diagnosed with sepsis.

Brief summary: In total 200 subjects with diagnosis of sepsis, are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant. The investigators will measure the thrombin generation in plasma assessed by the calibrated automated thrombogram (CAT). Sequential Organ Failure Assessment score SOFA will be calculated. The relation between SOFA score and thrombin measurements will be determined.


Eligibility criteria: Inclusion Criteria:

* age above 18
* sepsis diagnosis

Exclusion Criteria:

* oncology patient.
* anticoagulant treatment
* pregnancy

Primary outcomes:
measure: correlation between sofa score and thrombin generation
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Emek medical center
Study officials:
References:
Clinical trial NCT03671902: Noninvasive Monitoring in Lower Body Negative and Positive Pressure Tests
Official title: Noninvasive Monitoring in Lower Body Negative and Positive Pressure Tests
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhage
Keywords: Phonocardiogram
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of these studies is to assess the use of phonocardiograhy to monitor blood volume. We will evaluate phonocardiographic parameters in normal subjects in increasing levels of lower body negative pressure (LBNP) and lower body positive pressure (LBPP).


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Good health
* Free of systemic diseases
* No contraindications to LBNP/LBPP exposure
* Normal resting systolic blood pressure (SBP, 100-140 mm Hg) and diastolic blood pressure (DBP, 60-90 mm Hg)

Exclusion Criteria:

* Pregnancy
* Prior history of cardiovascular disease

Primary outcomes:
measure: Change in the phonocardiographic systolic index (PSI)
timeFrame: Baseline, and at each incremental change of 5-10 mmHg up to 40 mm Hg. Total duration per arm is up to 45 min
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Jay C. Buckey, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00944502: To Evaluate the Efficacy and Tolerability of the Use of Vitatonus Dexa Compared to Dexamethasone in Patients With Neuralgia of Various Origins
Official title: Multicenter Clinical Study, Phase III, Prospective, Randomized, Double-blind, Comparative to Evaluate the Efficacy and Tolerability of the Use of Vitatonus Dexa Compared to Dexamethasone in Patients With Neuralgia of Various Origins
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Neuralgia
Keywords: Neuralgy
Dexamethasone
Complex Vitamins
Injection
Symptoms of neuralgy of various origins
Lead sponsor: Bunker Industria Farmaceutica Ltda.
Sponsor class: INDUSTRY
First posted: 2009-07-23
Enrollment: 104
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: To evaluate the efficacy and tolerability of Vitatonus Dexa compared with dexamethasone in the signs and symptoms of neuralgia of various origins.

Clinical study, randomized prospective and random in nature, with a patients diagnosed with neuralgia of diverse origin.

Patients will be include in sufficient quantity to achieve the minimum of 104 evaluable patients.


Eligibility criteria: Inclusion Criteria:

1. Patients who consent to participate in the study by signing the ICF;
2. Patients of any ethnic group of both sexs aged over 18 years;
3. Patients with clinical diagnosis of neuralgia of various origins.
4. Patients who present scores on the Visual Analogue Scale (VAS) greater than or equal to 4 for PAIN.

Exclusion Criteria:

1. Patients with known hypersensitivity to lidocaine and thiamine or any component of the formula;
2. Pregnant women and nursing mothers;
3. Hypertensive or cardiac patients;
4. Patients with history of ulcers in the stomach or duodenum, diabetes mellitus or severe infections;
5. Patients who use levodopa, salicylates, colchicine, aminoglycosides, chloramphenicol, anticonvusivantes or potassium supplement.
6. Patient with a history of alcohol or use illicit drugs;

Primary outcomes:
measure: Observation of adverse events related to medication. The causality of adverse events concerning the use of medication will be given after applying the Naranjo Algorythm
timeFrame: Ten days
Secondary outcomes:
measure: Efficacy evaluation Likert scale and Visual Analogue
timeFrame: Ten days
Other outcomes:
Locations:
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC
state: São Paulo
Study officials:
affiliation: Faculdade de Medicina do ABC
name: Rosa Hasan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06920602: AI Chatbot for Migraine Management in Hong Kong Women
Official title: Development and Evaluation of an AI-empowered Voice-interactive Chatbot for Migraine Management Among Hong Kong Women: a Pilot Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Migraine
Keywords: migraine
RCT
migraine diary
artificial intelligence
chatbot
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Nethersole Institute of Continuing Holistic Health Education (NICHE)
First posted: 2025-04-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The goal of this randomized crossover trial is to examine whether the AI-empowered chatbot will effectively collect comprehensive migraine feature data and demonstrate higher compliance, accuracy, utilization, acceptability, feasibility, and validity in migraine feature tracking compared to traditional paper-based migraine diaries among Hong Kong women with migraine.

Participants will use different tools (AI-empowered voice-interactive chatbot or paper migraine diary) for migraine tracking. Participants will be randomly allocated to one of two intervention sequences: (1) AI-empowered voice-interactive chatbot followed by paper migraine diary, or (2) paper migraine diary followed by AI-empowered voice-interactive chatbot. The study will consist of two intervention periods, each lasting one month, with a 1:1 allocation ratio.


Eligibility criteria: Inclusion Criteria:

* Women aged 18 years or older
* Meet diagnostic criteria for migraine according to ICHD-3
* Experiencing at least 2 headache days per month
* Living in Hong Kong
* Fluent in Cantonese
* Owning a smartphone with internet access
* Willing to provide informed consent

Exclusion Criteria:

* Individuals with severe cognitive impairments or communication difficulties
* Those unable to use a smartphone or the chatbot due to physical or mental limitations
* Using another alternative electronic migraine diary during recruitment or in the past 12 weeks

Primary outcomes:
measure: Compliance
timeFrame: At the end of each 1-month intervention period
measure: Accuracy
timeFrame: At the end of each 1-month intervention period
Secondary outcomes:
measure: Utilization
timeFrame: At the end of each 1-month intervention period
measure: Acceptability
timeFrame: At the end of each 1-month intervention period
measure: Feasibility
timeFrame: At the end of each 1-month intervention period
measure: Validity
timeFrame: At the end of each 1-month intervention period
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic Univeristy
name: Yao Jie Xie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01162902: Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation
Official title: Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Stable Angina
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-07-15
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatments for stable angina includes drug therapy such as calcium-channel blocker, beta blocker, and ACEI/ARB. To obtain good prognosis in patients with coronary artery disease,preventing or correcting the progression of atherosclerosis and dyslipidemia is more important than relieving angina symptom. Dysfunction of microvessel is one of the most important factor in patients with coronary artery disease. Recently, we developed the new non-invasive method of evaluating the microvessel in fundus. With this methods, we will compare the effect of each drug (beta blocker, CCB, ARB).


Eligibility criteria: Inclusion Criteria:

* Stable angina patients whose coronary lesions is confirmed by angiography or receives PCI
* Unstable Angina/NSTEMI patients who completed PCI for main lesions
* Either systolic \> 130mmHg or diastolic \> 80mmHg, or patients with anti-hypertensive drugs

Exclusion Criteria:

* STEMI patients within one month
* Variant Angina
* Liver function abnormality or renal failure
* History of Hypersensitivity to testing drugs
* Severe heart failure(NYHA class\>3) or uncorrectable hematologic disease
* Woman possible to be pregnant
* Uncontrolled diabetes
* Expected life span \< one year

Primary outcomes:
measure: Wall to lumen ratio of fundus vessel
timeFrame: baseline, 9 months
Secondary outcomes:
measure: lipid parameter
timeFrame: baseline, 9 months
measure: Serum markers of inflammation
timeFrame: baseline, 9 months
measure: Change of nitrate need
timeFrame: baseline, 1 months, and 3 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: