louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00585338: Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser
Official title: Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Vascular Lesion
Keywords: facial telangiectasia,
leg vein telangiectasia
Port Wine Stain birthmarks
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2008-01-03
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Dermatologists have for many years treated vascular lesions by a variety of modalities including cryosurgery, electrotherapy, dermabrasion and radiation.

It has been hypothesized that simultaneous delivery of these two wavelengths may provide safer, and in some cases more effective, vascular lesion removal.

The Tandem laser is capable of emitting multiple cryogen spurts intermittently with multiple 532/1064 nm laser pulses.This mode may reduce malformed blood vessels with a low incidence of long-term side effects.

Detailed description: The researcher can determine the blanching of vascular lesions after Tandem laser with multiple 532/1064 nm laser pulses treatment.

The researcher will select one to four test sites spots for laser treatment. will be Different laser parameters can be used for each test site. The research will evaluate of the test sites at 6-12 weeks for bruising and blanching. Parameters of the test area with the greatest degree of blanching without adverse effects will be utilized for further treatment. If no test area is determined to have blanching without adverse effects, further test sites may be performed.

Eligibility criteria: Inclusion Criteria:

* Adult age 18 years and older
* Diagnosis of vascular lesion

Exclusion Criteria:

* Age \<18
* Pregnancy
* History of cutaneous photosensitivity
* Any therapy to the proposed treatment sites within the previous two months
* Current participation in any other investigational drug or device evaluation

Primary outcomes:
measure: Laser treatment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute Medical and Surgical Clinic
state: California
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: John S Nelson, M.D, PhD
role: STUDY_DIRECTOR
affiliation: Beckman Laser Institute University of California Irvine
name: Wangcun Jia, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beckman Laser Institute University of California Irvine
name: Kristen Kelly, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02206438: The Clinical Efficacy of Supraglottic Airway Device, Self-pressurized Air-Q Intubating Laryngeal Airway (ILA -SP) in Adult Patients: Comparison With Classic-laryngeal Airway (c-LMA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: supraglottic airway devices
the classic laryngeal mask airway
the self-pressurised air-Q intubating laryngeal airway in adult patients
elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway in adult patients
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-08-01
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these devices ,classic laryngeal airway has been typically widely used. The self-pressurised air-Q (air-Q) is newly developed supraglottic airway devices. It is a new single-use device that may optimise the airway sealing while reducing the potential for postoperative complications such as sore throat. The overall structure of the air-Q SP is identical to the original air-Q, except with regard to the inflatable cuff. The aim of this randomized trial was to compare the clinical performance of the classic LMA and the air-Q SP.


Eligibility criteria: Inclusion Criteria:

* Adult patients (20-75 of age) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway

Exclusion Criteria:

* Patients with a potentially difficult airway, risk of aspiration such as gastroesophageal reflux disease, or active upper respiratory tract infection

Primary outcomes:
measure: airway leak pressure measured after device insertion
timeFrame: within 5min to 10 min insertion of each device
Secondary outcomes:
measure: Insertion time
timeFrame: During and 1 min after insertion of each device
Other outcomes:
measure: Ease of insertion
timeFrame: During and 1 min after insertion of each device
Locations:
city: Seoul
country: Korea, Republic of
facility: Human research Protection Center, Gangnam Severance Hospital,
Study officials:
References:
citation: Ha SH, Kim MS, Suh J, Lee JS. Self-pressurized air-Q(R) intubating laryngeal airway versus the LMA(R) Classic: a randomized clinical trial. Can J Anaesth. 2018 May;65(5):543-550. doi: 10.1007/s12630-018-1082-6. Epub 2018 Feb 6.
Clinical trial NCT06831838: A Randomized Controlled Trial (RCT) to Determine the Efficacy of a Multidisciplinary CBT Based Pain Management Program for the Treatment of Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS) in Breast Cancer Survivors
Official title: A Randomized Controlled Trial (RCT) to Determine the Efficacy of a Multidisciplinary CBT Based Pain Management Program for the Treatment of Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS) in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-02-18
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 purpose of this research is to evaluate the effectiveness of a multidisciplinary pain management program for AIMSS in reducing pain, subjective cognitive complaints, psychological distress, and impaired functional status resulting in improved adherence to Aromatase Inhibitor medications compared to usual care. We want to identify predictors of improvement in pain, functional status, subjective cognition and mood following participation in the program.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* ECOG ≤ 2
* Stage 0-III HR+ breast cancer in need of strategies to reduce symptoms and improve quality of life

Exclusion Criteria:

• Less than 18 years of age.

- Stage 4 HR+ breast cancer

Primary outcomes:
measure: Adherence to Aromatase Inhibitors (AIs)
timeFrame: Baseline, 3 months, 6 months
measure: AIMSS Follow-up Questionnaire
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Brief Pain Inventory
timeFrame: Baseline, 3 months, 6 months
measure: Center for Epidemiologic Studies of Depression - Revised Questionnaire
timeFrame: Baseline, 3 months, 6 months
measure: Pain Catastrophizing Scale
timeFrame: Baseline, 3 months, 6 months
measure: Brief Resilience Scale
timeFrame: Baseline, 3 months, 6 months
measure: Social Support Survey
timeFrame: Baseline, 3 months, 6 months
measure: World Health Organization (WHO) Disability Assessment Schedule
timeFrame: Baseline, 3 months, 6 months
measure: State-Trait Inventory
timeFrame: Baseline, 3 months, 6 months
measure: Cognitive Functioning Index (CFI)
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Barbara Bruce, Ph.D., LP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01278238: Optimization of Hemodynamic Conditions During Caesarean Section Under Spinal Anaesthesia
Official title: Hemodynamic Effect of Prophylactic Phenylephrine Versus Lower Limb Compression in Women During Caesarean Section Under Spinal Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caesarean Section
Keywords: Hypotension
Caesarean section
Spinal anaesthesia
Lower limb compression / wrapping
Phenylephrine
Lead sponsor: Anestesiavdelingen Baerum Sykehus
Sponsor class: OTHER
First posted: 2011-01-17
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine wether intravenous Phenylephrine, administered as start bolus and following continuous infusion (specific dosage per weight), or optimal lower limb bandaging is more effective in preventing hypotension during caesarean section under spinal anaesthesia in healthy women.

The hypothesis is that the Phenylephrine model is superior to lower limb compression in preventing hypotension.


Eligibility criteria: Inclusion Criteria:

Healthy women Elective caesarean section under spinal anaesthesia Informed consent Age 18-40 ASA 1-2 BMI 18-32 prior to pregnancy Height 160-180 cm

Exclusion Criteria:

Any form of disease or anomalities:

Heart or vascular disease Cerebrovascular disease Other somatic or psychiatric disease Hypertension or preeclampsia Contraindication against spinal anaesthesia Anomalities concerning pregnancy and foster

Primary outcomes:
measure: Invasive arterial bloodpressure
timeFrame: Until end of operation, up to roughly 1 hour
Secondary outcomes:
measure: pH value from umbilical vessels of the newborn
timeFrame: straight after delivery
measure: APGAR score of the newborn
timeFrame: 1 + 5 + 10 minutes after delivery
measure: Need for rescue pressor (ephedrine, phenylephrine)
timeFrame: Until end of operation, roughly 1 hour
measure: Cardiac Output
timeFrame: Until end of operation, roughly 1 hour
Other outcomes:
Locations:
city: Rud
country: Norway
facility: Bærum Sykehus
state: Akershus
Study officials:
affiliation: Bærum sykehus
name: Jana Christine Kuhn, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03008538: Socket Preservation Using Autogenous Bone Graft Versus MPM
Official title: Dental Implant Placement in Extraction Socket of Mandibular Anterior and Premolar Areas Treated With Mineralized Plasmatic Matrix Versus Autogenous Bone Graft
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Bone Graft; Complications
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Studying the comparative effectiveness of socket preservation using autogenous bone graft versus MPM for implant insertion.

Detailed description: To assess bone quality, stability of implants placed in fresh extraction sockets of mandibular anterior and premorals augmented by MPM (Mineralized Plasmatic Matrix) versus autogenous bone graft (gold standard), at different follow-up periods (0, 3, 6, 9 months).

Eligibility criteria: Inclusion Criteria:

1. Medically free patients.
2. Patients with mandibular anterior and premolar hopeless teeth indicated for extraction.
3. Evaluated bone height on X.Ray to be (0-4 mm buccal bone dehiscence).
4. Age between 18 and 40 years.
5. Both sexes.
6. Patients physically able to tolerate surgical and restorative procedures. Good oral hygiene.
7. Highly motivated patients.

Exclusion criteria:

1. Smokers.
2. Pregnant or lactating females.
3. Presence of any pathosis in the pre-implant site.
4. Presence of Para functional habits.
5. History of oral radiotherapy.
6. History of prolonged steroids use
7. Psychological disorders.

Primary outcomes:
measure: Patient Satisfaction regarding function, to be measured using patient questionnaire.
timeFrame: 3 Months.
Secondary outcomes:
measure: Comparative histomorphometric analysis, to be measured using a digital software called (leica QWin 500) and unit of measurements are to be (Pixels).
timeFrame: 3 Months.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02851238: Driving Pressure and Postoperative Pulmonary Complications
Official title: Driving Pressure Limited Ventilation Decreases Postoperative Pulmonary Complications in One-Lung Ventilation: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: One-Lung Ventilation
Postoperative Respiratory Complications
Driving Pressure
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 312
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to prove that driving pressure limited ventilation is superior in preventing postoperative pulmonary complications to existing protective ventilation.


Eligibility criteria: Inclusion Criteria:

* Adults greater than or equal to 19 years
* Patient who undergoes one-lung ventilation for thoracic surgery

Exclusion Criteria:

* The American Society of Anesthesiologists (ASA) Physical Status classification greater than or equal to 4
* Patient who is contraindicated with application of positive end expiratory pressure
* Patient who rejects being enrolled in the study

Primary outcomes:
measure: The incidence of postoperative pulmonary complications
timeFrame: within the first 3 days after surgery
Secondary outcomes:
measure: Partial pressure of oxygen in arterial blood
timeFrame: during surgery
measure: The ratio of partial pressure arterial oxygen and fraction of inspired oxygen
timeFrame: on the first postoperative day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Samsung Medical Center
name: Hyun Joo Ahn, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04967638: Survival Analysis of Oral Cancer Patients
Official title: Survival Analysis of Segmental Mandibulectomy With Immediate Vascularized Fibula Flap Reconstruction in Stage IV Oral Squamous Cell Carcinoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: Squamous cell carcinoma
Free fibula flap
Prognosis
Survival
Mandibular reconstruction
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The files of patients diagnosed and treated between January 1996 to June 2019 for OSCC were retrospectively reviewed. The patients who underwent primary ablative tumor resection with segmental mandibulectomy and immediate VFF reconstruction were retrieved from the database

Brief summary: This study aims to assess the survival rate of oral squamous cell carcinoma (OSCC) patients following immediate mandibular reconstruction with vascularized fibula flap (VFF) and to identify risk factors influencing the overall survival rate and postoperative outcomes.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of stage IV OSCC
* Follow-up period more than one year.

Exclusion Criteria:

* Non-neoplastic diseases
* Two-staged reconstruction
* Presurgical distant metastasis

Primary outcomes:
measure: The overall cumulative survival
timeFrame: 5th year
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT03206138: Safety and Efficacy of GX-188E Administered Via EP Plus GX-I7 or Imiquimod.
Official title: A Randomized, Open-label Study to Evaluate the Safety and Efficacy of GX-188E, a DNA Therapeutic Vaccine Administered Intramuscularly by Electroporation, With GX-I7 Intravaginal Application or Imiquimod Topical Application in HPV16 and/or 18 Positive Patients With CIN3.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Intraepithelial Neoplasia 3
Keywords: Investigator trial
Cervical Intraepithelial Neoplasia
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Genexine, Inc.
First posted: 2017-07-02
Enrollment: 50
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to investigate the safety and efficacy of GX-188E administered IM plus local administration of GX-I7 or Imiquimod at cervix in subjects with cervical intraepithelial neoplasia (CIN) 3.


Eligibility criteria: Inclusion Criteria:

* Able and willing to comply with all study procedures and voluntarily signs informed consent form.
* Female subjects age 19-50 years.
* HPV 16 and/or 18 positive.
* Colposcopy is satisfactory based on visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area
* Histopathologically diagnosed with Cervical Intraepithelial Neoplasia 3, CIN 3.

Exclusion Criteria:

* Pregnancy or breastfeeding
* History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines are not excluded).
* Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV).
* Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study.

Primary outcomes:
measure: Ratio of subjects who have histopathological regression of cervical lesions to CIN 1 or less in HPV 16 or 18-associated CIN3 subjects.
timeFrame: at week 20
Secondary outcomes:
measure: Ratio of subjects with clearance of HPV 16 or 18 and histopathological regression of cervical lesions to CIN 1 or less.
timeFrame: at week 20, and week 36
measure: The change of cytology of uterine cervix compared to baseline.
timeFrame: at screening, week 12, week 20, and week 36
measure: Flt-3L concentrations in blood samples.
timeFrame: at week 14, week 20, and week 36.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's hospital
Study officials:
References:
Clinical trial NCT05501938: Physical Exam Indicated Cerclage in Singleton Gestation 24 Weeks to 25 Weeks and 6 Days Gestation
Official title: Randomized Controlled Trial: Physical Exam Indicated Cerclage in Singleton Gestation 24 Weeks to 25 Weeks and 6 Days Gestation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Birth
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention (cerclage) and control (no-cerclage) to reduce/prevent preterm delivery in those with a dilated cervix between 24w0d and 25w6d
Primary purpose: PREVENTION

Brief summary: RCT assessing preterm delivery rate in singleton pregnancies having a physical-exam indicated cerclage placed between 24 weeks and 25 weeks and 6 days. Patients randomized to either cerclage intervention or routine standard of care (no cerclage).


Eligibility criteria: Inclusion Criteria:

1. Pregnant women 18 years of age or older
2. Nulliparous patient, has not had a preterm to term delivery
3. Singleton pregnancy
4. English or Spanish speaking
5. Asymptomatic cervical dilation between 1- 2 cm, without visible membranes beyond the external cervical os and without any evidence of infection, active labor or active bleeding between 24 0/7 and 25 6/7 weeks gestation

Exclusion Criteria:

1. Twin or higher order multi-fetal gestation
2. Multiparous patient, has had one or more preterm to term deliveries
3. Cervical dilation more than 2 cm either at the beginning of the study or any time during the study
4. Amniotic membranes prolapsed beyond the external os
5. Fetal reduction procedure performed during current pregnancy
6. Ruptured membranes prior to randomization
7. Major fetal structural anomaly
8. Fetal chromosomal abnormality, suspected or confirmed with additional genetic testing
9. Cerclage already in place for other indication
10. Active vaginal bleeding
11. Suspicion of chorioamnionitis
12. Placenta previa
13. Painful regular uterine contractions
14. History of preterm birth before 37 weeks gestation
15. Non-English or non-Spanish speaking

    a. Given that the study is explained in person and consent forms are written in English, there is no guarantee that the study will be explained correctly when using a phone translator. The same is true if the current English consent form were to be translated into a language other than English. There is no way to confirm that the integrity of the study is being upheld by using translating services. If the integrity of the study is not upheld, then this poses harm to the patient.
16. Women under 18 years of age

Primary outcomes:
measure: Preterm Delivery Rate
timeFrame: 1 Year
Secondary outcomes:
measure: Neonatal Outcomes
timeFrame: 1 Year
Other outcomes:
measure: Cerclage Surgical Complications
timeFrame: 1 year
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
References: