louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03152981: Analysis of Change of Optic Nerve Sheath Diameter in Robot Assisted Laparoscopic Radical Prostatectomy
Official title: Analysis of Change of Optic Nerve Sheath Diameter Using Ultrasonography in Robot Assisted Laparoscopic Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Optic Nerve Sheath Diameter
Robot Assisted Laparoscopic Radical Prostatectomy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the present study, The investigators evaluated whether anesthetic agents effects on Optic Nerve Sheath Diameter in patients undergoing Robot Assisted Laparoscopic Radical Prostatectomy


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing robotic laparoscopic radical prostatectomy
2. Adults 20 to 80 years of age
3. American Society of Anesthesiologists Physical grade 1-2

Exclusion Criteria:

1. Patients who did not agree to participate in the study
2. Patients with ophthalmic diseases
3. Patients with previous history of ophthalmic surgery
4. Patients with neurological disorders
5. Patients with history of head surgery due to neurological disorders

Primary outcomes:
measure: Optic Nerve Sheath Diameter
timeFrame: 1 hour after Trendelenburg position
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National Univ. Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National Univ. Bundang Hospita
name: Eunsu Choi, Pf
role: STUDY_CHAIR
References:
Clinical trial NCT05847881: Toward Thriving: A Set of Reflective Tools to Empower Chronic Pain Patients and Help Them Envision a Personal Path to Thriving.
Official title: Toward Thriving: A Set of Reflective Tools to Empower Chronic Pain Patients and Help Them Envision a Personal Path to Thriving.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Positive psychology intervention
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2023-05-08
Enrollment: 23
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: The purpose of this study is to introduce and test the usefulness of a reflective process meant to empower people with chronic pain and help support participant's resiliency and thriving.

The study team hypothesizes that:

-Greater or equal to 80 percent of participants will report that the intervention was relatively easy to understand after orientation, low burden, potentially effective, and will have completed at least 2 of the 3 reflective tools.


Eligibility criteria: Inclusion Criteria:

* Persistent or recurrent pain lasting longer than 3 months
* Able to read and write English

Exclusion Criteria:

* Cancer (History of any bone-related cancer or cancer that metastasized to the bone; Currently in treatment for any cancer or plan to start cancer treatment in the next 12 months; History of any cancer treatment in the last 24 months)
* Active substance abuse
* Uncontrolled depression or psychosis
* Visual or hearing difficulties that would preclude participation
* Individuals started receiving disability or compensation within the past year, or currently involved in litigation
* Current/planned (in the next 2 years) enrollment in another study of a device or investigational drug that would interfere with this study, this may include participation in a blinded trial.
* Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators. This would include but not be limited to severe psychiatric disorders, active suicidal ideations or history of suicide attempts, and an uncontrolled drug and/or alcohol addiction)

Primary outcomes:
measure: Participants Engaged in the Interventions
timeFrame: Baseline (T1) to Exit Interview (T4), up to 68 days
Secondary outcomes:
measure: Patient Global Impression of Change (PGIC) at T4 Exit Interview
timeFrame: at T4 Exit Interview, up to 68 days
measure: Change in Pain Interference Based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Version 2.0 Between Baseline (t1) and Approximately 68 Days (t4 Exit Interview)
timeFrame: Up to 68 days
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Hannah Smotrich
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05907681: Prospective Observational Study on Outcome of High-precision Hypo-fractionated Radiotherapy in Metastatic Breast Cancer (PRECISE-M)
Official title: Prospective Observational Study on Outcome of High-precision Hypo-fractionated Radiotherapy in Metastatic Breast Cancer (PRECISE-M)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Metastatic Breast Cancer
Radiation Therapy Complication
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 400
Sex: FEMALE
Minimum age (years): 19
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: Women treated with hypofractionated RT using IMRT, SBRT, or proton therapy for metastatic breast cancer

Brief summary: This study is a prospective observational study on outcomes of high precision hypo-fractionated radiotherapy in breast cancer with distant metastasis.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed breast cancer
* presence of distant metastasis
* radiation therapy using IMRT, SBRT, or proton therapy is done or planned
* Able and willing to comply with the study protocol

Exclusion Criteria:

* unable to adhere to the study protocol

Primary outcomes:
measure: Local control rate
timeFrame: 1-year
Secondary outcomes:
measure: Overall survival rate
timeFrame: 1-year
measure: Disease-free survival
timeFrame: 1-year
measure: Treatment-related toxicities
timeFrame: 1-year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Haeyoung Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04932681: Use of Medicinal Plants and Other Alternative and Complementary Medicines by Patients With Cancer in Reunion Island
Official title: Evaluation of the Use of Medicinal Plants and Other Alternative and Complementary Medicines by Patients With Cancer in Reunion Island
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
Collaborators: name: APLAMEDOM
First posted: 2021-06-21
Enrollment: 520
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: Patients with cancer linving in the Reunion Island

Brief summary: Exploratory, observational and cross-sectional study with the aim of describing the use of plants for medicinal purposes (and other Complementary and Alternative Medicine) and identifying the determinants of this use. The methodology envisaged is mixed with an exploratory design combining qualitative (interviews) and quantitative techniques (questionnaires).

To knowledge of investigators, no study has been carried out in Reunion Island on the use of plants and other alternative and complementary medicines among cancer patients.


Eligibility criteria: Inclusion Criteria:

* Living in Reunion Island
* Suffering from cancer (solid tumors, hematological malignancies)
* Able to answer a questionnaire
* Patient who does not oppose to the research

Exclusion Criteria:

* Person of legal age under guardianship or under legal protection
* Persons who do not understand French or Reunionese Creole

Primary outcomes:
measure: Use of herbal medicine
timeFrame: Day 1
Secondary outcomes:
measure: Barriers of dialogue between patient and practionner
timeFrame: Day 1
measure: Need for Information on Complementary and Alternative Medicine
timeFrame: Day 1
measure: Improving questionnaire after the practionners' focus group
timeFrame: Day 1
Other outcomes:
Locations:
city: Saint-Denis
country: Réunion
facility: CHU La Réunion
city: Sainte-Clotilde
country: Réunion
facility: Clinique Saint Clotilde
Study officials:
References:
Clinical trial NCT00684892: Safety and Feasibility Study of the Chartis System With Heterogeneous Emphysema Prior to Endobronchial Lung Volume Reduction (ELVR)
Official title: A Safety and Feasibility Study of the Chartis System in Subjects With Heterogeneous Emphysema Prior to Endobronchial Lung Volume Reduction (ELVR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Heterogeneous Emphysema
Keywords: Emphysema
Endobronchial Lung Volume Reduction
Lead sponsor: Pulmonx Corporation
Sponsor class: INDUSTRY
First posted: 2008-05-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the safety and feasibility of the Chartis System in measuring air flow and pressures in isolated lung compartments in emphysema patients prior to endobronchial lung volume reduction (ELVR).


Eligibility criteria: Inclusion Criteria:

* Heterogeneous emphysema as determined by high-resolution CT scan
* Scheduled for clinically indicated ELVR procedure

Exclusion Criteria:

* Hyperexcretive chronic bronchitis or excessive sputum secretion
* Active pulmonary infection
* Active asthma or lung hyper-responsiveness

Primary outcomes:
measure: Adverse events
timeFrame: Until end of study procedure
Secondary outcomes:
measure: Technical success
timeFrame: During procedure and up 1 week post procedure
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik am Universitatsklinikum Heidelberg
Study officials:
affiliation: Thoraxklinik am Universitatsklinikum Heidelberg
name: Felix Herth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00797992: Bevacizumab Intravitreal for Myopic Choroidal Neovascularization
Official title: Bevacizumab Intravitreal for Myopic Choroidal Neovascularization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myopic Choroidal Neovascularization
Keywords: Bevacizumab
Myopia
Complications
Neovascularization
OCT
Lead sponsor: Instituto de Olhos de Goiania
Sponsor class: OTHER
First posted: 2008-11-25
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary to pathologic myopia (PM-CNV).

Detailed description: Nineteen consecutive patients (19 eyes) with subfoveal PM-CNV, 18 of whom had been unsuccessfully treated with Visudyne PDT, were treated with IVT of 1.25 mg bevacizumab or 0.5mg ranibizumab. ETDRS best corrected visual acuity, macular thickness on OCT scans, and angiographic features were recorded and evaluated. The aspect of OCT scans passing across the PM-CNV was also analyzed. IVTs were repeated only in case of persistent angiographic leakage and if OCT scans showed retinal thickening or edema and serous retinal detachment. The follow-up period was at least 6 months.

Eligibility criteria: Inclusion Criteria:

* Myopic CNVM,

Exclusion Criteria:

* Patients with poor compliance
* Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications like recent history of Stroke or myocardial infraction (\< one year). (Physician clearance was obtained for all patients).
* Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentis which is FDA approved.
* Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery.
* Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant macular oedema (CSME) etc. that affects vision and does not respond adequately to usual treatment methods.
* Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR.
* Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: Instituto de Olhos de Goiania
state: GO
Study officials:
affiliation: Instituto de Olhos de Goiania
name: Joao J Nassaralla, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05728892: Melatonin and Its Effect on the Perioperative Opioid Needs in Pediatric Patients Undergoing Laparoscopic Surgery.
Official title: Melatonin and Its Effect on the Perioperative Opioid Needs in Pediatric Patients Undergoing Laparoscopic Surgery.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 72
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the role of Preoperative Melatonin adminsteration in pediatric patients undergoing laparoscopic surgeries regarding its analgesic and sedative effects


Eligibility criteria: Inclusion Criteria:

* Age from 2 to 10 years.
* Sex: Both sexes.
* Patients with ASA classificaion I and II.

Exclusion Criteria:

* Declining to give written informed consent.
* History of allergy to the medications used in the study.
* psychiatric disorder.
* ASA classification III-V.
* Fever ,cough , asthma or upper respiratory tract infection, neuromuscular disorders, spine abnormalities.
* Anticipated difficult airway .
* History of malignant hyperthermia

Primary outcomes:
measure: Postoperative pain
timeFrame: Discharge from postanesthesia care unit (1 hour)
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university hospital
state: Abbasia
Study officials:
References:
Clinical trial NCT00927992: Study Evaluating Liver Transplantation in Haemophilia Patients in Spain
Official title: Liver Transplantation in Haemophilia Patients in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia
Hemophilia B
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-25
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with haemophilia who underwent liver transplantation and who have been followed-up at any site in Spain.

Brief summary: This study will analyze survival and outcome of patients with severe haemophilia who undergo liver transplantation in Spain

Detailed description: Probability Sample

Eligibility criteria: Inclusion Criteria:

* Patients with haemophilia who underwent liver transplantation and who have been followed-up at any site in Spain.

Exclusion Criteria:

* Patients without informed consent form.

Primary outcomes:
measure: Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation
timeFrame: Post liver transplantation up to Month 3
measure: Number of Participants With Acute Rejection of Liver Transplant
timeFrame: Post liver transplantation up to Month 3
measure: Number of Participants With Hepatitis C Viral Infection Recurrence After Liver Transplantation
timeFrame: Post liver transplantation up to Month 3
measure: Number of Participants Who Survived After Liver Transplantation
timeFrame: Post liver transplantation up to Month 3
Secondary outcomes:
measure: Number of Participants Requiring Exogenous Clotting Factor Infusion During Liver Transplantation
timeFrame: Up to Day 5 post liver transplantation
measure: Dose of Exogenous Clotting Factors Used During Liver Transplantation
timeFrame: Up to Day 5 post liver transplantation
measure: Number of Participants With and Without Hemophilia Requiring Immunosuppressive Therapy, Had Acute Rejection, Hepatitis C Viral Infection Recurrence and Who Survived After Liver Transplantation
timeFrame: Post liver transplantation up to Month 3
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05583292: Mortality Predictions With Scorring Indices in Gastrointestinal Tumours
Official title: The Effectiveness of ASA, SORT and Sarcopenia Indices in Estimating Mortality and Morbidity in Gastrointestinal Tumour Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Tumours
Keywords: ASA-PS
SORT
Sarcopenia
Mortality
Morbidity
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 111
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: patients undergoing gastrointestinal tumor surgery in a tertiary madical center

Brief summary: The ASA-PS, SORT and Sarcopenia scores of the patients who will undergo surgery for a gastrointestinal tumor will be recorded. Thus, the correlation between preoperative indices and mortality/morbidity will be evaluated.

Detailed description: ASA-PS values of patients who are planned to be operated due to gastrointestinal tumor will be recorded, then SORT (The Surgical Outcome Risk Tool) values will be calculated from sortsurgery.com. Sarcopenia measurements will be made by the radiologist from the abdomen CT at the L-3 level.

The pathology results of the patients will be recorded. Morbidity and mortality rates will be recorded in the short and long term.

Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* operation for gastrointestinal tumors

Exclusion Criteria:

* patient rejection

Primary outcomes:
measure: rate of mortality
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Prof. Dr. Cemil Taşcıoğlu City Hospital
Study officials:
affiliation: Prof. Dr. Cemil Tascıoglu City Hospital
name: fethi gültop, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01399892: Effect of Fiber Supplementation in Children With Type 1 Diabetes
Official title: Effects of Fiber Supplementation on Glycemic Excursions and Incidence of Hypoglycemia in Children With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 10
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: High fiber foods are recommended as a preferential source of carbohydrate by the Nutrition Study Group of the European Association for the Study of Diabetes. Dietary fibers may delay glucose absorption and reduce postprandial glycemic excursion. They also appear to have a beneficial effect on cholesterol levels. It has been shown, in few short term adult studies, that high fiber foods reduce postprandial blood glucose levels. The American Diabetes Association feels that there is little evidence confirming the positive effect of high fiber foods on blood glucose control. It is not clear whether a high fiber diet can improve glycemic control and/or reduce the risk of hypoglycemic events. Our hypothesis is that children with type 1 diabetes will benefit from having added fibers in their diet. The investigators plan to study blood glucose values using a continuous blood glucose monitor before and after dietary fibers are introduced. This will help us determine whether a diet rich in fiber should be recommended in all children with type 1 diabetes mellitus


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria are: Diagnosis of type I diabetes for at least two years prior to enrollment, the ability tolerate wearing the continuous blood glucose monitoring device for a total of 6 days, and the ability to follow a prescribed meal plan.

Exclusion Criteria:

* The exclusion criteria are: Medical conditions that could potentially affect the absorption of nutrients such as celiac disease of inflammatory bowel disease and the use of any fiber supplements at home.

Primary outcomes:
measure: incidence of hypoglycemia after fiber supplementation
timeFrame: continuous glucose monitoring over 72 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Aida N Lteif, MD
role: PRINCIPAL_INVESTIGATOR
References: