louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06853119: Magnetic Resonance Imaging in Patients with Trigeminal Neuralgia
Official title: Study on Brain Function and Structural Changes in Patients with Trigeminal Neuralgia Based on Magnetic Resonance Imaging.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Trigeminal Neuralgia (TN)
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with TN undergoing PBC and healthy controls matched by age and sex.

Brief summary: This study intends to use MRI technology to analyze the dynamic changes and microstructure changes of the brain network in patients with trigeminal neuralgia, evaluate the blood-brain barrier and water exchange rate, and further analyze their correlation with clinical indicators, so as to explore the changes in brain structural plasticity and potential neural mechanisms


Eligibility criteria: Inclusion Criteria:

* The diagnosis was TN according to the ICHD.
* Patients requiring surgical treatment due to ineffective or intolerant treatment with carbamazepine or oxasepine before operation;
* First surgical treatment;
* Right-handed dominant;
* There was no significant loss of sensation

Exclusion Criteria:

* Secondary TN;
* Associated with other types of chronic pain or neuropsychiatric disorders;
* History of head trauma or stroke or cerebrovascular ischemia;
* History of microvascular decompression or other treatments (gamma knife radiosurgery, etc.);
* Unable to cooperate independently;
* Contraindications, such as uncontrolled infection, coagulopathy, etc.;
* MRIcontraindications (e.g., pacemaker, claustrophobia, etc.)

Primary outcomes:
measure: Scanning sequence of magnetic resonance imaging (MRI)
timeFrame: Preoperative routine MRI examination
Secondary outcomes:
measure: Brief Pain Inventory (BPI)
timeFrame: Baseline, until to discharge (an average of 3 days), 3 months after surgery
measure: Simplified McGill pain questionnaire (SF-MPQ)
timeFrame: Baseline, 3 months after surgery
measure: Douleur Neuropathique 4 Questions (DN4)
timeFrame: Baseline, 3 months after surgery
measure: Beck Depression Inventory (BDI)
timeFrame: Baseline, 3 months after surgery
measure: Beck Anxiety Inventory (BPI)
timeFrame: Baseline, 3 months after surgery
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, 3 months after surgery
measure: Blood immune inflammation indicators
timeFrame: Baseline
measure: PBC asscoated adverse reactions
timeFrame: 24 hours after surgery, 3 months after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03560141: Clinical Performance of a Silicone Hydrogel Contact Lens Following One Night of Extended Wear
Official title: Clinical Performance of a Silicone Hydrogel Following One Night of Extended Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Keywords: Contact Lens
Extended Wear
Contralateral Wear
Vision Correction
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2018-06-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: In this contralateral study, subjects will be randomized to wear the investigational lens in 1 eye and the control lens in the other eye.
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens following 1 night of extended wear.

Detailed description: Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 4 scheduled study visits. The lenses will be worn continuously from the time of dispense on Day 1 until lens collection at the Day 2 Follow-up/Exit Visit.

Eligibility criteria: Key Inclusion Criteria:

* Able to understand and sign an approved Informed Consent form.
* Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week in either a daily wear or extended wear modality.
* Best Corrected Visual Acuity (BCVA) of 20/25 or better in each eye.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
* Current Biofinity® lens wearer.
* Pregnant or breast-feeding.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Visual Acuity (VA) With Study Lenses, Collected by Eye
timeFrame: Day 1 Dispense; Day 1 Follow-up Prior to Sleeping; Day 2 Follow-up Upon Eye Opening; Day 2 Follow-up Approximately 1 Hour after Awakening/Exit
Secondary outcomes:
Other outcomes:
Locations:
city: Johns Creek
country: United States
facility: Alcon Investigative Site
state: Georgia
Study officials:
affiliation: Alcon Research, LLC
name: CDMA Project Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT05101941: Immediate Dental Implant Placed in the Presence of Chronic Inflammatory Periapical Lesions
Official title: Evaluating the Osseointegration of Immediate Dental Implant Placed in the Presence of Chronic Inflammatory Periapical Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immediate Dental Implant
Tooth Exratction
Periapical; Infection
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Compromised teeth with periapical pathologies are removed before dental implant placement and sockets are left to heal.

Some clinicians began to immediately place dental implants in fresh extraction sockets associated with chronic inflammatory periapical lesions and these studies revealed high success rates

Detailed description: 12 implants will be immediately placed in sockets associated with chronic periapical granuloma. Clinical (Wound healing, Pain, swelling, implant stability) and radiographic parameters (Peri-implant radiolucency) will be evaluated

Eligibility criteria: Inclusion Criteria:

* Adult patients ranging from 18 to 45 years with no gender predilection agreed to come for minimum follow-up visits for 6 months.
* Adequate bone beyond teeth apices without jeopardizing any anatomical structure.
* Single rooted mandibular teeth with chronic inflammatory periapical lesions represented as periapical radiolucency, pulp necrosis, sinus tract, failed RCT.

Exclusion Criteria:

* Smokers and alcoholics.
* Medically compromised patients having uncontrolled diabetes or coagulation disorders.
* Restorable teeth.
* Periodontitis.

Primary outcomes:
measure: Change in Implant stability
timeFrame: immediately, at 3 months and 6 months
measure: Change in peri implant radiolucency
timeFrame: immediately, and 6 months
Secondary outcomes:
measure: Change in pain score
timeFrame: within a week
measure: Change in swelling status
timeFrame: within a week
measure: Change in Early Wound Healing Index
timeFrame: at 2 weeks, 4 weeks, and 8 weeks
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT01490541: The Predictive Scores for Gastric Cancer in Gastric Intestinal Metaplasia (GIM) Patient: a Recommendation for Thai Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Intestinal Metaplasia
Keywords: Gastric intestinal metaplasia
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
First posted: 2011-12-13
Enrollment: 280
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All GIM patients in KCMH whose diagnosed from 1997 to 2005, at least 280.

Brief summary: The predictive scores for gastric cancer in gastric intestinal metaplasia(GIM) patient: a recommendation for Thai population.

Objective:

To evaluate major risk factors for gastric cancer in gastric intestinal metaplasia(GIM) patient in order to propose the appropriate recommendation for Thai people.

Research Design:

Single center, retrospective-cohort study.

Detailed description: Study population and Sample size at Faculty of Medicine, Chulalongkorn University The patients who were diagnosed gastric intestinal metaplasia from 1997 to 2012 and then follow up for 5 years. Estimate sample size =280

* Investigational product, dosage \& route of administration
* Questionnaire for explore the risk factors
* EGD with biopsy
* Blood sampling for gastro panel
* Duration of participation
* 5 years or until diagnose gastric cancer

Statistical method:

Unconditional-binary-logistic regression

Eligibility criteria: Inclusion Criteria:

1. All patients were diagnosed GIM
2. All patients have to sign the consent form

Exclusion Criteria:

1. Previous gastric surgery including gastrectomy and bypass surgery
2. Bleeding tendency including decompensated cirrhosis, chronic kidney disease and long-tem antiplatelets or anticoagulants
3. HIV infection
4. History of proton pump inhibitor use within 1 week
5. History of antibiotic use within 4 weeks

Primary outcomes:
measure: The prevalence of early gastric cancer in gastric intestinal metaplasia(GIM) patient from 5 year-follow-up in Thai population
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rapat Pittayanon
Study officials:
affiliation: King Chulalongkorn Memorial Hospital
name: Rungsun Rerknimitr, Professor
role: STUDY_DIRECTOR
affiliation: King Chulalongkron Memorial Hospital
name: Rapat Pittayanon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04431141: Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin
Official title: A Randomized, Open-label, Multiple-dose, Cross-over Dosing Study to Evaluate Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-16
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is to evaluate pharmacokinetic drug interaction between teneligliptin and empagliflozin in healthy adults.


Eligibility criteria: Inclusion Criteria:

* Healthy adults between 19 and 45 years of age (both inclusive) at the screening visit
* Body mass index between 19 kg/m2 and 28 kg/m2 (both inclusive) at the screening visit
* Subjects must voluntarily decide to participate in the study and provide written informed consent to comply with study instructions

Exclusion Criteria:

* History of type 1 diabetes mellitus and/or diabetic ketoacidosis
* Severe infection, surgery, or severe trauma within 6 months prior to the screening visit
* Hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
* Treatment with any investigational product or study drug in another clinical trial or bioequivalence study within 180 days prior to the screening visit
* Any laboratory test or 12-lead ECG finding based on which the subject is determined ineligible to participate in the study
* Subject determined by the principal investigator to be ineligible for study conduct for other reasons

Primary outcomes:
measure: Cmax,ss of teneligliptin and empagliflozin
timeFrame: 72 hours
measure: AUCτ,ss of teneligliptin and empagliflozin
timeFrame: 72 hours
Secondary outcomes:
measure: Tmax,ss of teneligliptin and empagliflozin
timeFrame: 72 hours
measure: t1/2β of teneligliptin and empagliflozin
timeFrame: 72 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Pharmacology, Asan Medical Center
Study officials:
References:
Clinical trial NCT05823441: Effect of Oxytocin Nasal Inhalation on Empathy Analgesia
Official title: Effects of Oxytocin Nasal Inhalation and Social Familiarity on Empathy Analgesia: a Factorial Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oxytocin
Pain
Empathy
Social Familiarity
Analgesia
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study recruited healthy volunteers and randomly divided them into four groups. They inhaled oxytocin or saline, and watched a pain test video with photos of acquaintances or strangers, respectively, to test whether their feelings of the same thermal pain stimulus had changed.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* During pregnancy;
* Have participated in any research related to pain;
* Sleep disorders;
* Used alcohol, caffeine, nicotine, or other psychoactive substances within 24 hours before the test;
* Experienced intense pain requiring medical analgesia within three months prior to the trial;
* Taking any medication, including over the counter medication;
* Addiction to alcohol, tobacco, or drugs;
* A history of any respiratory, circulatory, neurological, musculoskeletal, and/or mental illness;
* Current symptoms of depression and/or anxiety. (See quantitative sensor testing for specific standards)

Primary outcomes:
measure: NRS score
timeFrame: Half an hour after inhaling spray
Secondary outcomes:
measure: EEG
timeFrame: about 3 hours
measure: Brief Profile Of Mood States
timeFrame: about 3 hours
measure: Beck Depression Inventory
timeFrame: about 3 hours
measure: WLEIS-C
timeFrame: about 3 hours
measure: STAI
timeFrame: about 3 hours
measure: BES-C
timeFrame: about 3 hours
measure: The Positive and Negative Affect Scale
timeFrame: about 3 hours
measure: NRS score
timeFrame: about 3 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05501041: Measuring Symptom Relief After Radiofrequency Ablation of the Thyroid
Official title: Quantification of Symptom Relief Following Percutaneous Ablation of the Thyroid
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Thyroid
Keywords: Thyroid Radiofrequency Ablation Procedure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing ablation for symptomatic thyroid nodule(s)

Brief summary: The purpose of this study is to measure the impact of thyroid radiofrequency ablation procedure on patients with thyroid-related symptoms using a modified pre-existing scoring system.


Eligibility criteria: Inclusion Criteria:

- Undergoing Radiofrequency Ablation (RFA) for symptomatic thyroid nodule(s).

Exclusion Criteria:

- Decline to participate in research.

Primary outcomes:
measure: Change in symptoms before and after ablation
timeFrame: Baseline and 1-, 3-, 6-, 12-, 18-, and 24-months following treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Thomas Atwell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05647941: Neo-adjuvant Chemotherapy Evluation in Gastric Cancer Patients Based on Circulating Exosomal LncRNA-GC1
Official title: Non-invasive Response Assessment of Neo-adjuvant Chemotherapy in Gastric Cancer Patients Based on Circulating Exosomal LncRNA-GC1
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Chemotherapy Effect
Keywords: Circulating exosomal lncRNA-GC1
Advanced Gastric Carcinoma
treatment response
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 700
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: Community Sample Shanxi - Hospital and community sample Beijing -Hospital

Brief summary: The investigators hope that through the analysis and research to find determine whether lncRNA-GC1 could serve as a non-invasive biomarker for monitoring the neo-adjuvant chemotherapy response for personalized medicine for gastric cancer.

Detailed description: The LncRNA-GC1could noninvasively track dynamics of tumor burden and has been proposed as a real-time biomarker that can provide both predictive and prognostic values. But the value in monitoring the neo-adjuvant chemotherapy response is unclear. The investigators hope that through the analysis and research to find determine whether lncRNA-GC1 could serve as a monitoring biomarker for patients with gastric cancer receiving neo-adjuvant chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Having signed informed consent
* Age≥ 18 years old
* Histologically confirmed gastric adenocarcinoma
* radiographically identified as advanced gastric cancer

Exclusion Criteria:

* Other previous malignancy within 5 year
* Surgery (excluding diagnostic biopsy) within 4 weeks prior to study
* Pregnancy or lactation period
* Legal incapacity

Primary outcomes:
measure: Detection of levels of circulating exosomal lncRNA-GC1
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital Ethics Committee
state: Beijing
Study officials:
References:
Clinical trial NCT02507141: Reflectance Confocal Microscopy of Oral Cancers in Vivo: a Preliminary Trial Comparing Intra-oral Imaging With Pathology
Official title: Reflectance Confocal Microscopy of Oral Cancers in Vivo: a Preliminary Trial Comparing Intra-oral Imaging With Pathology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Squamous Cell Carcinoma (SCC) of the Oral Cavity
Keywords: Reflectance Confocal Microscopy
15-128
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2015-07-23
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential research subjects in the Head and Neck Service will be identified by a member of the patient's treatment team, the protocol investigator, or a member of the research team at Memorial Sloan Kettering Cancer Center (MSK).

Brief summary: The purpose of this study is to get images (pictures) of oral lesions, which occur inside the mouth, before the patient's surgery using a special camera. These pictures will be used in our research to evaluate a new technology that uses a laser and takes pictures of the microscopic structure of tissue. The technology is called "reflectance confocal microscopy." We would like to compare what the camera sees to biopsies (pathology) of the same area. We will evaluate the pictures obtained from the patient to determine whether this technology may be useful in the future. We hope this technology can be used as a tool for early diagnosis of oral cancers and for guiding surgery.


Eligibility criteria: Inclusion Criteria:

* Patients with biopsy-proven oral SCC who are scheduled to undergo surgery in the MSK Head and Neck Service.
* Ability to sign informed consent.
* Age ≥ 18 years.

Exclusion Criteria:

* Cancer located on a site that may not be convenient or accessible for imaging with the current version of the RCM device (gingivobuccal region, back of the oral cavity, back of the tongue, floor of the mouth, deep under the tongue, etc.).
* Inability to give informed consent.

Primary outcomes:
measure: Reflectance Confocal Microscopy (RCM) images
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (consent only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (consent only)
state: New Jersey
city: Harrison
country: United States
facility: Memorial Sloan Kettering West Harrison (consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (consent only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Snehal Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02434341: Sleep in Critically Ill Patients on Mechanical Ventilation in ICU
Official title: Sleep Investigation in 3 Homogeneous Groups of Wake Mechanically Ventilated Patients in ICU: 1st Group - Septical Patients; 2nd Group - COPD Patients; 3rd Group - Surgical Patients, in Order to Define Common Sleep Features Within the Groups
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polysomnographic Sleep Characteristics
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: wake

Brief summary: 15 patients with sepsis, 15 patients with COPD and 15 surgical patients will undergo polysomnographic sleep monitoring up to 24 hours in order to define if there are common sleep features within the groups

Detailed description: It is an observational study in order to define if there are common polysomnographic sleep features within the following three groups of wake critically ill patients on mechanical ventilation in ICU: the group of septical patients, the group of patients with chronic obstructive pulmonary disease in exacerbation and the group of surgical patients without sepsis.

15 patients will be included in each group. They will undergo polysomnographic sleep monitoring during up to 24 hours.

Polysomnograms will be studies then in order to find out if there are common sleep characteristics within the homogeneous patient groups of critically ill.

Eligibility criteria: Inclusion Criteria:

* wake non-sedated patients
* mechanical ventilation

Exclusion Criteria:

* age \< 18 years
* pregnant
* Glasgow Coma Scale \< 11
* sedated patients

Primary outcomes:
measure: polysomnographic sleep features
timeFrame: polysomnographic sleep assessment during up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Intensive Care Unit, Odense University Hospital
Study officials:
affiliation: University of Southern Denmark
name: Yuliya Boyko, MD
role: PRINCIPAL_INVESTIGATOR
References: