louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00559169: Verapamil and Catamenial Epilepsy
Official title: Study of Verapamil in Refractory Catamenial Epilepsy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Catamenial Epilepsy
Keywords: epilepsy
seizures
menstrual cycle
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2007-11-16
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: One in 3 epilepsy patients have refractory seizures. This drug resistance is likely related to the over expression of multidrug resistance proteins (MDR). Progesterone is a known inhibitor of MDRs and the low level of this hormone during the menstrual cycle may exacerbate seizures, perhaps explaining catamenial epilepsy; i.e. seizures occurring during the menstrual cycle. Verapamil suppresses seizures in animal models of epilepsy perhaps by inhibiting MDRs and thus may help patients with refractory seizures. If the study shows improved seizure control, the results will help establish the role of MDRs in refractory epilepsy.


Eligibility criteria: Inclusion Criteria:

* females
* at least 2 seizures per month
* more than 50% of the seizures occur 7 days before or 7 days after the onset of menses
* patient of the Toronto Western Hospital Epilepsy Clinic

Exclusion Criteria:

* cardiovascular history

Primary outcomes:
measure: the percent reduction in seizure frequency
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: College of Physicians and Surgeons of Ontario
name: Danielle Andrade, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01876069: Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Suspected Unresectable Pancreatic Cancer
Official title: Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Endoscopic Ultrasonography-guided Sampling of Suspected Unresectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Olympus
First posted: 2013-06-12
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Background:

Pancreatic cancer is associated with a poor prognosis. Therefore, rapid and accurate diagnosis of a pancreatic mass is important to direct patient management. Endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) is the current standard for sampling pancreatic mass lesions, with diagnostic accuracy of 78% to 95%. But, the EUS-FNA has some limitations include stromal cell tumors and lymphomas may be difficult to diagnose. To overcome these limitations, a new needle device with ProCore reverse-bevel technology was developed recently.

Aims:

The objective of this prospective study is to compare the rate of diagnostic sufficiency in the EUS sampling by using newly developed ProCore needle with conventional FNA needle in suspected unresectable pancreatic cancer. We will also compare the safety, the yield of histologic core tissue and the cost-effectiveness between these modalities.

Detailed description: Patient:

Newly diagnosed pancreatic cancer patient whose cancer lesion is suspected unresectable in diagnostic imaging such as CT or MRI

Procedure:

Each EUS-guided FNA and ProCore aspiration will performed twice in same patient. The priority of order will be given by randomization assignment.

The number of patients required:

Total sixty five patients will be required.

Eligibility criteria: Inclusion Criteria:

* Patients who agree to participate in research
* 18 years of age and older patients less than 80 years old
* Patients who have suspected unresectable pancreatic cancer in imaging studies

Exclusion Criteria:

* Contraindication to endoscopy
* Patients younger than 18 years old or older than 80 years old
* Bleeding tendency
* Cardiopulmonary dysfunction
* Pregnancy

Primary outcomes:
measure: The rates of diagnostic sufficiency
timeFrame: Up to 1 year
Secondary outcomes:
measure: The presence of histologic core
timeFrame: Up to 1 year
Other outcomes:
measure: Procedure related complications
timeFrame: Up to 1 year
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Kwang Hyuck Lee, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01931969: Central Landmark vs USG for IJV Catheterization
Official title: Comparison of Internal Jugular Vein Catheterization Entry Points Determined by Ultrasonography Versus the Central Landmark Guided Method
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Value of Central Landmark Method for Juguler Vein Catheterization
Keywords: Vein catheterization; Ultrasound; Landmark; Complication
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing cardiovascular surgery who needed to have internal jugular vein catheterization

Brief summary: This study is planned to compare right internal jugular vein catheterization entry points determined by ultrasound and the central landmark guided method, and the relationship of each with sternocleidomastoid muscle length and body mass index.


Eligibility criteria: Inclusion Criteria:

-patients undergoing cardiovascular surgery who needed to have internal jugular vein catheterization aged 18y or older-

Exclusion Criteria:

-previous neck surgery, burns, limited neck movement, diffuse goiter or bleeding problems

Primary outcomes:
measure: Success rate with the Central Landmark Method
timeFrame: 1 mounth
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University School Of Medicine
Study officials:
References:
Clinical trial NCT02696369: Trial to Evaluate the Efficacy on Local Anesthesia and Safety of 2% Lidocaine HCl With Different Epinephrine Concentration in Patients Undergoing Surgical Extraction of Impacted Lower Third Molars
Official title: A Multi-center, Randomized, Double-blind, Crossover, phase4 Trial to Evaluate the Efficacy on Local Anesthesia and Safety of 2% Lidocaine HCl With Different Epinephrine Concentration in Patients Undergoing Surgical Extraction of Impacted Lower Third Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Third Molar
Lead sponsor: Huons Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-03-02
Enrollment: 65
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is Phase 4 trial which evaluates the safety and efficacy of 2% Lidocaine HCl with different epinephrine concentration in patients undergoing surgical extraction of impacted lower third molars


Eligibility criteria: Inclusion Criteria:

* Age over 19
* Physical grade 1 or 2 by American Society of Anesthesiologists (ASA)
* Mesioangular or horizontal angulation categorized by winter classification

Exclusion Criteria:

* Allergy or hypersensitivity about the investigated products
* Any infection or edema during the extraction
* The following patients: clotting disorder, hyperthyroidism, arteriosclerosis, cardiac insufficiency, other cardiovascular disorders
* Pregnancy or breast-feeding
* Any conditions that the investigator considers not to appropriate for this study

Primary outcomes:
measure: Pain visual analogue scale (VAS)
timeFrame: Immediately after the extraction
Secondary outcomes:
measure: Onset time of anesthesia
timeFrame: Immediately after administration of IP
measure: Local anesthetic duration
timeFrame: Immediately after onset of anesthesia
measure: Pain VAS
timeFrame: 2, 4, 6 hours after administration of the investigational product (IP)
measure: Onset time of pain after administration of IP
timeFrame: Immediately after injection
measure: Bleeding after extraction measured by the operator
timeFrame: Immediately after extraction
measure: Questionnaire of satisfaction level of the operator
timeFrame: Immediately after extraction
measure: Questionnaire of satisfaction level of the subjects
timeFrame: Immediately after extraction
measure: Dosage of administrated IP
timeFrame: immediately after injection
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Huons
state: Kyeonggi-do
Study officials:
References:
Clinical trial NCT04638569: Comparison of Obturator Nerve Block With Ultrasound Guidance and Anatomical Signs
Official title: Comparison of Obturator Nerve Block With Ultrasound Guidance and Anatomical Signs in Patients Undergoing Transurethral Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Succesful Obturator Nerve Block
Bladder Tumor
Bleeding
Keywords: obturator nerve block
bladder tumor
ultrasonografi
anatomical signs
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group 1; Ultrasound-guided obturator nerve block group 2; obturator nerve block with anatomical signs
Primary purpose: OTHER

Brief summary: Comparison of the obturator nerve block in patients undergoing transurethral resection due to bladder tumor, technically using ultrasound guided or blinded with anatomical signs.

Detailed description: The primary aim of this study is to compare the success rates of ONB techniques performed with ultrasound guided or blind technique. Its secondary purpose is to compare the effect of peroperative bleeding and control cystoscopy performed in the postoperative 3rd month on the presence of recurrent tumor.

Eligibility criteria: Inclusion Criteria:

* ASA I-II patients

Exclusion Criteria:

* Tumors that disrupt the integrity of the bladder,
* bladder floor tumors,
* coagulation disorders,
* motor in the lower limbs
* with sensory disturbances,
* uncooperative patients,
* Known allergy to local anesthetics
* patients with localized infection at the procedure site

Primary outcomes:
measure: Preoperative succesful obturator nerve block
timeFrame: operation time
Secondary outcomes:
measure: peroperative bleeding, Presence of recurrent tumor at postoperative 3rd month
timeFrame: 3 months
Other outcomes:
Locations:
city: Mugla
country: Turkey
facility: Mugla Sitki Kocman University
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: Eylem Yaşar
role: PRINCIPAL_INVESTIGATOR
affiliation: Mugla Sitki Kocman University Department of Anesthesia
name: Ali İhsan Uysal
role: STUDY_CHAIR
affiliation: Mugla Sitki Kocman University Department of Urology
name: İlker Akarken
role: STUDY_CHAIR
affiliation: Mugla Sitki Kocman University Department of Anesthesia
name: basak altiparmak
role: STUDY_CHAIR
affiliation: Mugla Sitki Kocman University Department of Anesthesia
name: semra demirbilek
role: STUDY_CHAIR
References:
Clinical trial NCT03738969: Longitudinal Study of Different Surgical Approaches in Chinese Patients of Uterine Cervical Cancer
Official title: Longitudinal Study of Different Surgical Approaches in Chinese Patients of Cervical Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uterine Cervical Neoplasms
Laparotomy
Laparoscopy
Survival
Mortality
Recurrence
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 3000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients pathological confirmed as uterine cervival cancer and receiving radical hysterectomy or trachelectomy would been included.

Brief summary: This multi-center longitudinal study aims to compare the survival outcomes (including overall survival, progression-free survival and disease-free survival between uterine cervical patients receiving different surgical routes (vaginal, laparotomy and laparoscopy), which is the primary study objective. All clinical and pathological data would be retracted from case reviews, and all survival data would be reached by clinic, telephone and mail follow-up. This study also would analyze the impact on survival outcomes of other factors, including nerve-sparing techniques, neoadjuvant chemotherapy, neoadjuvant radiotherapy and infection of human papillomavirus. The predictive effects of different following protocol and imaging plans will be also compared. Last, the influences of surgical routes on the fertility outcomes (pregnancy and its complications) and the ovarian reserve are important secondary study objectives.


Eligibility criteria: Inclusion Criteria:

* Pathological confirmed as uterine cervical cancer
* Having definite clinical information
* Having received radical hysterectomy or trachelectomy

Exclusion Criteria:

* Not satisfying any of the inclusion criteria

Primary outcomes:
measure: Progression-free survival
timeFrame: Five years
Secondary outcomes:
measure: Overall survival
timeFrame: Five years
measure: Disease-free survival
timeFrame: Five years
Other outcomes:
measure: Pregnancy rate
timeFrame: Five years
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
References:
citation: Chao X, Wu M, Ma S, Tan X, Zhong S, Song X, Li L. Efficacy of different surgical approaches on survival outcomes in patients with early-stage cervical cancer: protocol for a multicentre longitudinal study in China. BMJ Open. 2020 Aug 20;10(8):e038020. doi: 10.1136/bmjopen-2020-038020.
Clinical trial NCT03166969: Predictors of Occult Atrial Fibrillation in 171 Patients With Cryptogenic TIA and Minor Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cryptogenic Transient Ischemic Attack and Minor Stroke
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Retrospective study, single-center, on 171 patients, presented a cryptogenic TIA and Minor stroke.

This study objective is to determine profitability of Holter 21 days for screening paroxystic ACFA / flutter in cryptogenic TIA/Minor stroke, and identify the predictive factors of discovery a paroxystic ACFA on Holter 21 days. Clinical and échocardiographics factors, and brain imaging (scanner and MRI) will be analyzed.


Eligibility criteria: Inclusion Criteria:

* Cryptogenic TIA/Minor stroke
* Age \> 18 years
* Medical care in Neuro Vascular Unit of CH Versailles
* Holter 21 days performed

Exclusion Criteria:

1. ACFA history
2. ECG or telemetry who showed ACFA before the Holter initializing
3. Carotid Stenosis / symptomatic vertebral
4. Arterial dissection
5. Prothrombotic state demonstrated by laboratory tests
6. Infective endocarditis

Primary outcomes:
measure: Number of atrial fibrillation detected on long duration ( 21 days) cardiac rythm holter monitoring
timeFrame: Day 21
Secondary outcomes:
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles
Study officials:
References:
citation: Sudacevschi V, Bertrand C, Chadenat ML, Tarnaud C, Pico F. Predictors of Occult Atrial Fibrillation in One Hundred Seventy-One Patients with Cryptogenic Transient Ischemic Attack and Minor Stroke. J Stroke Cerebrovasc Dis. 2016 Nov;25(11):2673-2677. doi: 10.1016/j.jstrokecerebrovasdis.2016.07.014. Epub 2016 Aug 2.
Clinical trial NCT05911269: Feasibility of Virtual, Tailored, Music-Based Relaxation for Anxiety in Adolescent and Young Adult Cancer Survivors
Official title: Determining the Feasibility of Virtual, Tailored, Music-Based Relaxation for Anxiety in Adolescent and Young Adult Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2023-06-20
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Explanatory-Sequential Mixed Methods Study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Demonstrate the feasibility of conducting an eight-week, (45 min/week), theory driven, virtually-delivered, tailored music-based relaxation (TiMBRe) intervention to decrease anxiety in adolescent and young adult (AYA) cancer survivors with clinically-relevant anxiety.

Detailed description: Initially Sessions 7 and 8 were both body percussion; however, the 04FEB2025 changed this to Session 7 will be body percussion and session 8 will be selected by the participant. This will allow for more tailoring of the intervention.

Eligibility criteria: Inclusion Criteria:

* 15 - 39 years old
* at least one month post cancer treatment
* report clinically relevant anxiety in the past seven days (PROMIS Anxiety 4a scores ≥ 55)35
* speak/read English.

Exclusion Criteria:

* prognosis less than 3 months
* documentation of significant hearing impairment
* plan to receive surgery, radiation, or chemotherapy for cancer treatment during the study period
* plans in place to begin new psychosocial (i.e., cognitive behavioral therapy14 or mindfulness-based stress reduction15) or pharmacological treatments for anxiety during the study. Although, participants may continue psychosocial or pharmacological treatments for anxiety if the treatments were initiated at least eight weeks prior to study enrollment, the dose has not changed, and they report clinically relevant anxiety in the last week.

Primary outcomes:
measure: Acceptability of TiMBRe
timeFrame: up to 8 weeks post start of intervention
measure: Demand of TiMBRe
timeFrame: up to 3 years from start of study
measure: Adherence to TiMBRe
timeFrame: From enrollment to end of treatment at 8 weeks
measure: Practicality of TiMBRe
timeFrame: From enrollment to end of treatment at 8 weeks
Secondary outcomes:
measure: Identification of facilitators and barriers to virtual TiMBRe participation
timeFrame: up to 8 weeks post start of intervention
measure: Change in Anxiety management
timeFrame: at baseline and eight weeks post initiation of treatment
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Robert Knoerl
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00271869: Treatment of Chronic GVHD of Liver or Lungs by ECP
Official title: Phase II Study for Treatment of Chronic Graft-Versus-Host Disease of the Liver or Lungs With Adjunct Extracorporeal Photoimmunotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Graft-Versus Host Disease
Keywords: hematopoietic stem cell transplantation
graft-versus-host disease
treatment
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2006-01-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chronic graft-versus-host disease (GVHD) is a major complication of allogeneic hematopoietic stem cell transplantation and the leading cause of death more than 2 years after transplantation.During the past 30 years survival of patients with chronic GVHD has not improved and steroids remained the most often used therapy. Extracorporeal photoimmunotherapy (ECP)has shown to be efficacious in patients with GVHD. We propose a phase II study to evaluate the safety and efficacy of ECP as adjunct first-line therapy in patients with newly diagnosed chronic GVHD of liver or lungs and need for systemic immunosuppression defined according to the NIH consensus criteria.


Eligibility criteria: Inclusion Criteria:

* Presence of at least one diagnostic clinical sign of chronic GVHD or an appropriate constellation of distinctive signs confirmed by biopsy or other relevant diagnostic tests
* Presence of liver or lung manifestations of chronic GVHD
* Indication for systemic immunosuppressive therapy defined according to NIH consensus
* No prior immunosuppressive therapy for chronic GVHD of the liver or lungs
* Adequate renal, hepatic, pulmonary and cardiac function
* Karnofsky performance score \>- 50%
* Women of childbearing potential must agree to use a reliable method of birth control for the duration of the study
* Signed written informed consent

Exclusion Criteria:

-

Primary outcomes:
measure: GVHD response of the liver or lungs
Secondary outcomes:
measure: transplant-related mortality
measure: relapse-free survival
measure: overall survival
measure: time to complete resolution of chronic GVHD to first-line immunosuppressive therapy
measure: time to discontinuation of immunosuppressive therapy
measure: duration of response to first-line immunosuppressive therapy
measure: percentage of patients in need of secondary treatment for chronic GVHD
measure: incidence of bacterial, viral and fungal infections
measure: side effects of ECP
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Medicine I, BMT
Study officials:
affiliation: Medical University of Vienna
name: Hildegard T Greinix, Professor of Medicine
role: PRINCIPAL_INVESTIGATOR
References: