linjc16/ctgov huggingface dataset:
Feasibility Study of Using Molecular Fluorescence Guided Surgery in Endometriosis

Study Overview
=================
Brief Summary
-----------------
Incomplete resection of endometriosis lesions often results in recurrence of symptoms and the need for repeated surgery, with considerable associated morbidity. The aim of this pilot project is to determine the feasibility of fluorescence imaging to improve the treatment of endometriosis in the future.

Official Title
-----------------
Determine the Feasibility of Detecting Endometriosis During Surgery Using a Molecular Targeted Fluorescent Imaging Tracer

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Drug: Bevacizumab-800CW


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females aged ≥ 18 years Scheduled for surgery for the treatment of endometriosis WHO performance score of 0-2 Written informed consent For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post-menopausal: A negative serum pregnancy test prior to receiving the tracer Willing to ensure that she or her partner uses effective contraception during the trial and for 6 months thereafter. Exclusion Criteria: Medical or psychiatric conditions that compromise the patient's ability to give informed consent Pregnancy History of infusion reactions to Bevacizumab or other monoclonal antibody therapies Significant renal, cardiac, or pulmonary disease (ASA III-IV)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>4.5mg Bevacizumab-800CW intravenously | Drug: Bevacizumab-800CW<br>* 4.5mg Bevacizumab-800CW will be administered intravenously three days prior to surgery<br>* Other names: Bevacizumab-IRDye800CW;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tracer accumulation of bevacizumab-800cw in endometriosis lesions assessed by ex vivo measurement of the mean fluorescent intensity correlated to histopathology |  | within 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events |  | within two weeks after tracer injection |
Spread of Dermatophytes Among Families

Study Overview
=================
Brief Summary
-----------------
The objective is to demonstrate person-to-person spread of dermatophytes of the skin and nails among family members, as measured by fungal culture and DNA typing of the dermatophytes isolated.

Detailed Description
-----------------
Enrolled families consist of at least two members over the age of 14. Once the index person is examined and a dermatophyte is isolated from either toenail or foot scale, other family members are examined and cultured. All dermatophyte isolates obtained from each family unit are compared using DNA typing and restriction length polymorphism (RFLP) to determine whether family members share the same organism or were infected by an outside source.

Official Title
-----------------
Demonstration of the Spread of Dermatophytes Through Casual Contact Among Family Household Members

Conditions
-----------------
Onychomycosis, Tinea Pedis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: positive dermatophyte culture - Exclusion Criteria: use of antifungal agents, either oral or topical

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dermatophytes
Study of the Incidence of Cilioretinal Arteries in the Hungarian Population

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze the retinal arteries, to investigate the incidence, number, types, distribution and localization of cilioretinal arteries in the Hungarian Caucasian population.

Official Title
-----------------
Study of the Incidence of Cilioretinal Arteries in the Hungarian Population

Conditions
-----------------
Cilioretinal Arteries

Intervention / Treatment
-----------------
* Device: Fundus photography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caucasian race Signed informed consent Exclusion Criteria: Optical media opacities of the eye

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy subjects<br>Healthy subjects | Device: Fundus photography<br>* Non-mydriatic fundus photographs<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of cilioretinal arteries |  | Through study completion, 4 years |
Improving Outcomes in Cleft Palate Surgery

Study Overview
=================
Brief Summary
-----------------
This is a pilot study to determine if an audit and feedback intervention decreases complication rates after cleft palate surgery.

Detailed Description
-----------------
This study will determine whether a surgeon-directed audit and feedback intervention reduces rates of oro-nasal fistula after cleft palate repair. Fistula is an important potential complication of cleft palate repair. The study also evaluates feasibility of standardized outcome measurement in the care of children with cleft lip and palate, acceptability of standardized measurement, and acceptability of the audit and feedback intervention among surgeons. The results of this research will improve child health by enabling cleft surgeons to critically evaluate and improve their patient's outcomes.

Official Title
-----------------
Improving Outcomes in Cleft Palate Surgery Through an Audit and Feedback Intervention Directed at Surgeons

Conditions
-----------------
Cleft Palate

Intervention / Treatment
-----------------
* Behavioral: Intensive Feedback
* Behavioral: Routine Feedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active surgeon performing cleft palate repair in the US or Canada. Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive Feedback<br>Participants in this arm will receive intensive feedback on their complication rates, surgical technique, and peri-operative surgical management from peer surgeons participating in the study. | Behavioral: Intensive Feedback<br>* (1) receive feedback regarding their individual fistula rate and those of all other participants in the trial, (2) receive an analysis of their video-recorded operative technique by surgeon peers, (3) directly observe a peer surgeon with lower fistula rate, and (4) develop a personalized action plan with a target for improvement.<br>|
| Active Comparator: Routine Feedback<br>Participants in this arm will receive routine feedback on their complication rates. | Behavioral: Routine Feedback<br>* (1) receive feedback regarding their individual fistula rate and those of all other participants in the trial<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oro-nasal Fistula | Presence or absence of fistula of the palate | 12 weeks |
A Pilot Test for Newly Developed Synoptic Operative Template for Ovarian Cancer (SOTOC): National Cancer Center - Peritoneal Carcinomatosis Index

Study Overview
=================
Brief Summary
-----------------
objectives: To development of NCC-PCI-Operative Template (NPOT) for the objective description of perioperative tumor burden and surgical approaches in the management of ovarian cancer, tubal cancer, and primary peritoneal cancer

Detailed Description
-----------------
Informed consent Digital photography & Checking PCI (tumor size& location ) Postoperative surveillance(tumor marker, image and physical examination) Developing the best fitting NCC-PCI template to reflect recurrence and survival pattern

Conditions
-----------------
Ovarian Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preoperative clinical diagnosis of ovarian cancer, tubal cancer, and primary peritoneal carcinoma Available preoperative image study (CT and/or MRI and/or PET) Patients who gave a written informed consent Patients must be surgical candidate considering medical and psychological condition Exclusion Criteria: Patients who refuse to participate or want to withdraw at anytime.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of Clinical Applicability about Synoptic Operative Template for Ovarian Cancer (SOTOC) |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCI,SOTOC, Ovarian cancer
Sleep, Insulin Sensitivity, and Weight in Adolescents Post-bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
Assessing sleep and circadian health in severely obese adolescents undergoing bariatric surgery and examine relation to health outcomes including insulin sensitivity and percent weight loss to date at 1-year and evaluate the impact of sleep extension on health outcomes in this population.

Official Title
-----------------
Sleep, Insulin Sensitivity, and Weight in Adolescents Post-bariatric Surgery

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Behavioral: PBS Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 12-21 years attending high school or middle school (peak period for insufficient and delayed sleep) completion of bariatric surgery procedure (i.e., vertical sleeve gastrectomy) within the past 2 years but not less than 6 months prior to study participation All must also be Tanner Stage 5 Exclusion Criteria: regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin or other sleep aids) or insulin resistance (systemic steroids, other oral diabetes medications) HbA1c ≥6.5% intelligence quotient (IQ) <70 or severe mental illness

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep Extension<br>Participants will be asked to extend their time in bed with the goal of improving the total time they sleep each night. | Behavioral: PBS Study<br>* Sleep extension intervention<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep duration | Total sleep time at night in hours | 1 week |
EMG Finding According to the Type of Lumbar Disc Herniation

Study Overview
=================
Brief Summary
-----------------
Disc herniation is a common cause of low back pain and leg pain. Electromyography is the only test that can objectively examine nerve damage caused by a lumbar disc herniation. This study aimed to compare the MRI findings of disc herniation and the aspects of electromyography.

Official Title
-----------------
A Study for Electrodiagnostic Finding According to the Type of Lumbar Disc Herniation on MRI

Conditions
-----------------
Intervertebral Disc Displacement, Electromyography

Intervention / Treatment
-----------------
* Diagnostic Test: electromyography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Radicular pain within 6 months Disc herniation confirmed by lumbar MRI undergoing electromyography Exclusion Criteria: Patients who refused electromyography Patients taking warfarin Lower limb amputation patient Pregnant women Patients who have undergone surgical treatment for disc herniation Patients with peripheral neuropathy ( AIDP, CIDP, diabetic amyotrophy, peroneal pals et al.)

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lumbar disc herniation<br>Patients are complaining of lower extremity radiating pain due to lumbar disc herniation. | Diagnostic Test: electromyography<br>* Electromyography (EMG) is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Denervation pattern of muscles in lower extremity | The location of the lower limb muscles where spontaneous activity occurs | 1 day During the examination of Electromyogram | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disc herniation findings of lumbar MRI | Anatomical location of disc herniation | 1 day During the examination of lumbar MRI |
Tranexamic Acid in Orthopaedic Trauma Surgery

Study Overview
=================
Brief Summary
-----------------
Tranexamic acid is an antifibrinolytic drug that has been used to decrease post-operative blood loss. This study is a prospective, randomized controlled trial investigating the use of tranexamic acid in fracture surgery around the hip and knee, in which significant blood loss (>300mL) is expected. The hypothesis of this study is that tranexamic acid will be associated with a decrease in post-operative blood loss, as well as a decreased need for allogenic blood transfusion, in patients who have fracture surgery around the hip and knee.

Official Title
-----------------
Tranexamic Acid in Orthopaedic Trauma Surgery

Conditions
-----------------
Blood Loss, Trauma, Fracture, Surgery

Intervention / Treatment
-----------------
* Drug: Tranexamic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with isolated fractures of the pelvic ring, acetabulum, femur or tibia that will require open reduction and internal fixation Expected blood loss is greater than 300 mL Age ≥ 18 Skeletal maturity Exclusion Criteria: Pregnant or breastfeeding Patients taking oral contraceptives Contraindication to venous thromboembolic event (VTE) prophylaxis (intracranial, intrathoracic, intra-abdominal bleeding or spine fractures) Patients requiring operative intervention for other injuries (orthopaedic or non-orthopaedic) Known hypercoagulable state including history of prescribed anti-coagulation (warfarin, plavix, low molecular weight heparin) Renal Insufficiency (creatinine greater than 1.5mg/dL) Open fractures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No tranexamic acid given | |
| Experimental: Tranexamic Acid<br>15 mg/kg preoperative IV dose followed by another 15 mg/kg IV dose three hours after the initial dose | Drug: Tranexamic Acid<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin value |  | through postoperative day four | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hematocrit value |  | through postoperative day four | 
| number of units of allogenic blood transfused |  | through postoperative day four | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tranexamic acid, orthopaedic trauma, pelvic fracture, hip fracture, femur fracture, blood loss
The Indiana Myeloma Registry

Study Overview
=================
Brief Summary
-----------------
This is a prospective, non-interventional, observational study. The purpose of this study is to collect data and bio-specimens that will support future research

Official Title
-----------------
Collection of Specimens and Clinical Data to Create A Bio-repository for the Multiple Myeloma Program: The Indiana Myeloma Registry

Conditions
-----------------
Plasma Cell Dyscrasias

Intervention / Treatment
-----------------
* Other: This is a non-interventional trial


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients ≥ 18 years of age at the time of informed consent Has been diagnosed with or is suspected to have one of the following: Monoclonal Gammopathy of Undetermined Significance (MGUS) Smoldering Multiple Myeloma Multiple Myeloma Bony or Soft Tissue Plasmacytoma Primary Amyloidosis Exclusion Criteria: < 18 years of age Have not been diagnosed with one of the following: Monoclonal Gammopathy of Undetermined Significance (MGUS) b.Smoldering Multiple Myeloma c.Multiple Myeloma d.Bony or Soft Tissue Plasmacytoma e.Primary Amyloidosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: This is a non-interventional trial|This is a non-interventional trial|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Create a repository | The primary objective of this study is to provide a mechanism to store comprehensive clinical, genomic, demographic, social, environmental and quality of life data from subjects with plasma cell dyscrasias | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data collection | To collect data related to clonal evolution, tumor microenvironment, clinical outcomes, adverse events, environmental factors and quality of life that will provide the foundation to create hypotheses for future confirmatory studies. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Plasmacytoma, Multiple myeloma, Monoclonal gammopathy of undetermined significance, Smoldering multiple myeloma
Pharmacokinetic Study on the Combination of Everolimus-Tacrolimus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to address the pharmacokinetic (PK) profiles of everolimus and tacrolimus in combination in de novo kidney transplant recipients, comparing 1.5 and 3 mg per day of everolimus in fixed doses. For comparison purposes, pharmacokinetic profiles will be performed at first dose (abbreviated), 4th day, 14th day, and 42nd day post-transplantation.

Detailed Description
-----------------
To address the pharmacokinetic profiles of everolimus and tacrolimus in combination in de novo kidney transplant recipients, comparing 1.5 and 3 mg per day of everolimus in fixed doses. For comparison purposes, pharmacokinetic profiles will be performed at first dose (abbreviated), 4th day, 14th day, and 42nd day post-transplantation. Patients will receive triple therapy steroids, tacrolimus and everolimus. Tacrolimus will be administered at a dose of 0.15 mg/kg/day to achieve 10-15 ng/ml 14 days, and 5-10 thereafter. During the first 6 weeks (the PK study period) everolimus will be assigned to fixed dose of 0.75 or 1.5 mg bid. After day 42, everolimus will be adjusted for 3-8 ng/ml and tacrolimus minimized to optimize graft function. Efficacy and safety parameters at 6 months post-transplantation will be secondary endpoints.

Official Title
-----------------
A Pilot Study to Investigate Pharmacokinetic Characteristics of Everolimus in Patients Treated With Tacrolimus-Based Immunosuppression in De Novo Kidney Transplantation

Conditions
-----------------
Kidney Diseases

Intervention / Treatment
-----------------
* Drug: everolimus and tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney transplant recipients aged 18-65 years old with a presumed immediately functioning graft Exclusion Criteria: Non-functioning kidneys

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: everolimus and tacrolimus|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-hour PK profiles of everolimus and tacrolimus on day 14 post-transplantation with everolimus 1.5 mg versus 3 mg per day |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney Transplantation