louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06396130: The Effect of Photobiomodulation Using Low-Level Diode Laser Therapy on Postoperative Pain in Symptomatic Lower Molar Teeth With Irreversible Pulpitis and Apical Periodontitis; a Randomized Controlled Clinical Trial
Official title: The Effect of Photobiomodulation Using Low-Level Diode Laser Therapy on Postoperative Pain in Symptomatic Lower Molar Teeth With Irreversible Pulpitis and Apical Periodontitis; a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Effect of Photobiomodulation Using Diode Laser
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study aims to assess the effect of photobiomodulation using low-level diode laser therapy on postoperative pain after single-visit root canal treatment of mandibular molars with symptomatic irreversible pulpitis and apical periodontitis.


Eligibility criteria: Inclusion Criteria:

* . Mature multirooted mandibular molar teeth with: i. Pre-operative sharp pain marked on the VAS scale by reading not less than 6. ii. Clinical diagnosis of symptomatic irreversible pulpitis with periapical periodontitis.

iii. Normal periapical radiographic appearance or slight widening in lamina dura. iv. Positive response and pain provoked by percussion.

- Patients who agree to provide written consent and attend for recall appointments.

Exclusion Criteria:

* Patients who used NSAIDs in the 24 hours before treatment.
* Medically compromised patients having significant systemic disorders. (ASA III or IV).
* Patients with two or more adjacent teeth requiring endodontic treatment.
* Pregnant or nursing females. 5. Teeth that have:

  i. Periodontal affection (with pocket depth greater than 5mm, associated with swelling orfistulous tract, or greater than grade I mobility).

ii. No possible restorability. iii. Signs of pulpal necrosis; associated sinus tract or swelling.

Primary outcomes:
measure: Intensity of postoperative pain
timeFrame: 24, 48 and 72 hours
Secondary outcomes:
measure: Total number of analgesic tablets taken in case of intolerable pain
timeFrame: Post instrumentation at 24, 48 and 72 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03212430: The Effect of Intravenous L-kynurenine (LKYN) on Cerebral Hemodynamics in Healthy Volunteers
Official title: The Effect of Intravenous L-kynurenine (LKYN) on Cerebral Hemodynamics in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Headache
Keywords: L-kynurenine
Cerebral hemodynamic
Headache
Mohammad Al-Mahdi Al-Karagholi
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Pilot, Open label
Primary purpose: OTHER

Brief summary: To measure the cerebral hemodynamic effect of L-kynurenine.

Detailed description: Aim: To investigate the physiological effect of L-Kynurenine after intravenous administration to healthy volunteers.

Hypothesis: L-kynurenine induces vasodilation in the cerebral vessels and trigger headache in healthy individuals.

Methods: 6 healthy volunteers will receive intravenous infusion of L-kynurenine using the following doses 50 microgram/kg, 100 microgram/kg, 150 microgram/kg, 300 microgram/kg, 500 microgram/kg, 1 mg/kg and 5 mg/kg over 20 min on 7 different days with at least 1 day in between. Before and after infusion (at 20, 40, 60, 80 and 100 min) we will record vital signs, circumferences of middle cerebral artery, superficial temporalis artery and headache intensity and characteristics.

The subjects will then have a questionnaire about headache for the following 24 hours.

Eligibility criteria: Inclusion Criteria:

1. Healthy volunteers of both sexes.
2. 18-60 years.
3. 50-90 kg.
4. Women of childbearing potential must use adequate contraception.

Exclusion Criteria:

1. All primary headaches
2. First-degree relative with migraine
3. Headache less than 48 hours before the tests start
4. Daily consumption of drugs of any kind other than oral contraceptives.
5. Pregnant or nursing women. Cardiovascular disease of any kind, including cerebrovascular diseases.

Primary outcomes:
measure: Velocity of MCA (VMCA)
timeFrame: Change from baseline VMCA at two hours after administration of L-kynurenine
measure: The diameter of the STA (superficial temporal artery)
timeFrame: Change from baseline VMCA at two hours after administration of L-kynurenine
measure: Headache
timeFrame: occurrence of headache undtil 24 hours after infusion.
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Rigshospitalet-Glostrup
state: Nordre Ringvej 57
Study officials:
affiliation: Professor of neurology
name: Messoud Ashina, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03008330: High-activity Natural Killer Immunotherapy for Small Metastases of Tongue Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Tongue Cancer
Keywords: Metastatic tongue cancer
High-activity natural killer
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shenzhen Hank Bioengineering Institute
First posted: 2017-01-02
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of tongue cancer.

Detailed description: By enrolling patients with small metastases of tongue cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree of tumors
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Fuda cancer institute of Fuda cancer hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT06288230: An Open Label Study of Gene Therapy Product (Vesemnogene Lantuparvovec) in Spinal Muscular Atrophy
Official title: Study of AAV-hSMN1 (Vesemnogene Lantuparvovec) Gene Therapy in Subjects with Progressive Spinal Muscular Atrophy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Spinal Muscular Atrophy
Lead sponsor: Lantu Biopharma
Sponsor class: INDUSTRY
First posted: 2024-03-01
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is an interventional study to evaluate safety and efficacy of AAV-hSMN1 in spinal muscular atrophy patients.

Detailed description: Study duration per participant is approximately 25 months including an approximately 30-day screening/baseline period, an approximately 24-month study observation period including 1 treatment day, and an approximately 24-month follow-up period.

Patients will be tested at baseline and return for follow-up visits twice a week through the first month post dose, and followed by visits at months 2, 3, 6 12, 18 and 24 post infusion. Unscheduled visits may occur if the investigator determines that they are necessary.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of SMA based on gene mutation analysis with bi-allelic survival motor neuron (SMN1) mutations (deletion or point mutations).
* Patients or Parent(s)/legal guardian(s) willing and able to complete the informed consent process and comply with study procedures and visit schedule.

Exclusion Criteria:

* Active viral infection (includes HIV or serology positive for hepatitis B or C).
* Use of invasive ventilatory support (tracheotomy with positive pressure) or pulse oximetry \<95% saturation.
* Concomitant illness and any drug that in the opinion of the investigator creates unnecessary risks for gene transfer.
* Clinically significant abnormal laboratory values.
* Participation in a recent SMA treatment clinical trial that in the opinion of the PI creates unnecessary risks for gene transfer.
* Patient with signs of aspiration based on a swallowing test and unwilling to use an alternative method to oral feeding.

Primary outcomes:
measure: Numbers of participants with adverse events (AEs), serious adverse events (SAEs)
timeFrame: Baseline up to 24 months
Secondary outcomes:
measure: Change from baseline in hours of daily ventilation support and motor function
timeFrame: Baseline up to 24 months
measure: Change from baseline in ambulatory function
timeFrame: Baseline up to 24 months
measure: Change from baseline in Hammersmith Functional Motor Scale - Expanded (HFMSE)
timeFrame: Baseline up to 24 months
Other outcomes:
Locations:
city: Kunming
country: China
facility: Kunming Hope of Health Hospital
state: Yunnan
Study officials:
References:
Clinical trial NCT03508830: Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial
Official title: Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial - Liposomal Bupivacaine Versus Standard Bupivacaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thoracic Diseases
Postoperative Pain
Opioid Use
Keywords: Liposomal Bupivacaine
Intercostal Nerve Block
Minimally Invasive Thoracic Surgery
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial is a single center, double-blind, randomized, active-comparator controlled clinical trial to assess the analgesic efficacy of intercostal nerve block by Liposomal Bupivacaine versus Standard Bupivacaine in subjects undergoing lung resection by robotic or video-assisted thoracoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* Robotic or Video-Assisted Lung Resection for All Indications

Exclusion Criteria:

* Additional Thoracic Procedures (beyond lung resection and mediastinal lymphadenectomy)
* Extra-Thoracic Procedures
* Hypersensitivity to Amide Local Analgesia
* Cardiac Conduction Abnormalities
* Hepatic Dysfunction
* Preoperative Neuropathic Pain and/or Preoperative Daily Opioid Usage

Primary outcomes:
measure: Average Daily In-Hospital Use of Opioids
timeFrame: Average over Entire Length of Hospitalization (Up to 1 Week)
Secondary outcomes:
measure: Average Daily In-Hospital Pain Score
timeFrame: Average over Length of Hospitalization - Up to 1 Week
measure: Number of Participants With Postoperative Pneumonia
timeFrame: Index Hospitalization following Surgery until Discharge - Up to 1 Week
measure: Length of Stay
timeFrame: Index Hospitalization following Surgery until Discharge - Up to 1 Week
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
References:
Clinical trial NCT02827825: Patients Undergoing Strokes Admitted in Intensive Care Requiring Neurosurgical ICU Crossing: Patient Profile and Prognosis
Official title: Patients Undergoing Strokes Admitted in Intensive Care Requiring Neurosurgical ICU Crossing: Patient Profile and Prognosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Stroke
Keywords: Neurosurgical
Intensive Care
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 50
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: Patients admitted in Intensive Care Requiring Neurosurgical for ischemic or hemorrhagic stroke. then, admitted secondarily in ICU

Brief summary: The aim of this study is to describe the population of patients admitted to the ICU in neurosurgery for stroke requiring secondary care in intensive care and their future.

Detailed description: Methodology :

DESIGN:

Retrospective observational study single center, non-interventional Term study over 2 years, retrospectively

Acquisition of data:

* Study of computer file: report available on DxCare hospital and Cora
* Collection of data as excel spreadsheet
* Statistical analysis: local management
* Anonymity of data:

  * For each subject will be awarded an identifier (original name and surname - year of birth) and the data will be entered on a computer file which will be sent to the statistician in charge of analyzing the GHPSJ site. There will be no exchange of personal data for this study is single center on the site GHPSJ.

Development of the study:

* Procedure:

  * Series includable patients from the PMSI data
  * Select folders according the inclusion criteria
  * Collecting information from files on Excel spreadsheet by the internal charge of data collection (Sylvain CHAWKI)
  * Statistical Analysis
  * Writing Article
* Expected duration of patient recruitment: Retrospective of 2 and a half years from January 1, 2013 to April 31, 2015

Eligibility criteria: Inclusion Criteria:

* Admitted USINV for ischemic or hemorrhagic stroke
* Admitted secondarily in ICU

Exclusion Criteria:

* Admission in ICU in first
* Administrative Admission in Intensive Care Requiring Neurosurgical within the thrombolysis alert regulated by the neurovascular guard but going directly to ICU imaging waning
* Subarachnoid hemorrhage

Primary outcomes:
measure: Death event
timeFrame: Day 1 after hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: ZUBER Mathieru, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06665425: PK,PD and DDI of Epaminurad and C2406 in Healthy Volunteers
Official title: An Open-label, Crossover, Phase 1 Clinical Trial to Evaluate the Pharmacokinetic/pharmacodynamic Drug-drug Interactions and Safety/tolerability of Epaminurad and C2406 When Co-administered in Healthy Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2024-10-30
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Phase 1 Study to evaluate the safety, PK/PD, drug-drug interaction(DDI) of Epaminurad and C2406 in Healthy Volunteers


Eligibility criteria: Inclusion Criteria:

1. Age: 19\~50
2. Weight: between 50.0 kg\~90.0 kg, Body Mass Index(BMI): 18.0 kg/m\^2 or heavier and below 30.0 kg/m\^2

Exclusion Criteria:

1. Medical history- chronic liver disease, acute gout attack, uric acid stone, diabetes, hypertension, hyperlipidemia or lipid abnormality
2. Clinical examination

   * eGFR (CKD-EPI) \< 90mL/min/1.73m\^2
   * Serum uric acid \< 3 mg/dL or \> 7 mg/dL
   * AST (SGOT), ALT (SGPT) \> upper limit of normal ranges X 1.5
   * Total bilirubin, γ-GTP \> upper limit of normal ranges X 1.5
   * CK \> upper limit of normal ranges X 2
   * Positive serologic results

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 7 days
measure: Peak plasma concentrations (Cmax)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-sang Yu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03779425: VR-Based Physical Therapy Pilot Study
Official title: VR-Based Physical Therapy Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extremity Fracture Lower
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: KairosXR
name: AO North America
First posted: 2018-12-19
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the feasibility and acceptability of using the virtual reality-based physical therapy platform in patients with extremity fracture.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* Diagnosed with an operative fracture of the femur and/or tibia
* referred to physical therapy as standard of care

Exclusion Criteria:

* Injury Severity Score(ISS) \> 18
* bilateral lower extremity injuries that preclude crutch ambulation
* associated spine fractures
* Glasgow Coma scale (GCS) \< 15 at time of discharge
* major peripheral nerve injury

Primary outcomes:
measure: Patient satisfaction
timeFrame: Assessed directly after virtual reality physical therapy session
measure: Patient Preference
timeFrame: Assessed directly after virtual reality physical therapy session
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: Ida L Gitajn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00841425: Airway Responsiveness and Inflammation in Adolescent Elite Swimmers: a 3-Year Prospective Follow-up Study
Official title: Airway Responsiveness and Inflammation in Adolescent Elite Swimmers: a 3-Year Prospective Follow-up Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2009-02-11
Enrollment: 33
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were all elite swimmers and part of the Danish National Swimming Association's talent program for young swimmers at the baseline study.

Brief summary: Previously the investigators have found that adolescent elite swimmers, who have been involved in competitive swimming for only a few years, have not developed respiratory symptoms, signs of airway inflammation or airway hyperresponsiveness exept for a slight increase in airway responsiveness to eucapnic voluntary hyperpnea. In the current study, the investigators will be doing a 3-year follow-up study on the swimmers studied previously.

Detailed description: Even though studies suggest that elite sport can cause AHR and airway inflammation, more studies are needed to elucidate how and when AHR and airway inflammation develop; and there is a lack of follow-up studies. The present study will give us a chance to do a follow-up study to register changes in AHR and airway inflammation in athletes without any significant airway changes at baseline.

Eligibility criteria: Inclusion Criteria:

* Age 15-19 years
* Part of the Danish National Swimming Association's talent program for young swimmers at the baseline study
* Informed consent

Exclusion Criteria:

* Upper respiratory tract infection in the previous 4 weeks (visits will be postponed)

Primary outcomes:
measure: Airway responsiveness to eucapnic voluntary hyperpnea and methacholine
timeFrame: Three years
Secondary outcomes:
measure: Airway inflammation
timeFrame: Three years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Respiratory and Allergy Research Unit, Department of Respiratory Medicine L, Bispebjerg Hospital
Study officials:
affiliation: Respiratory and Allergy Research Unit, Bispebjerg Hospital
name: Lars Pedersen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pedersen L, Lund TK, Barnes PJ, Kharitonov SA, Backer V. Airway responsiveness and inflammation in adolescent elite swimmers. J Allergy Clin Immunol. 2008 Aug;122(2):322-7, 327.e1. doi: 10.1016/j.jaci.2008.04.041. Epub 2008 Jun 12.