linjc16/ctgov huggingface dataset:
Dexmedetomidine and Renal Transplants

Study Overview
=================
Brief Summary
-----------------
Investigators aim to retrospectively research patients undergoing renal transplants that received dexmedetomidine perioperatively to see if dexmedetomidine use protects renal function. Investigators hope to elucidate any association between renal transplant patients and perioperative dexmedetomidine administration, these include (but are not limited to) UOP, Cr/GFR, morbidity, mortality, in hospital complications and failure rate. Investigators will research both living and cadaveric renal transplants.

Official Title
-----------------
Dexmedetomidine and Renal Transplants

Conditions
-----------------
Renal Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients greater than or equal to 18 years old that underwent renal transplant at UC Davis Medical Center - Exclusion Criteria: Patients that did not undergo renal transplants and patients less than 18 years old will be excluded from the study. -

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

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

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 |
| --- | --- | --- |
| Cr/GFR improvement, postoperative mortality/morbidity (within 30 days) and overall complications |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft failure, length of hospital stay (LOS), length of ICU stay, re-admission rate, infections, pulmonary complications. |  | 5 years |
Development of Clinical Database of Individuals With Smith-Magenis Syndrome and Sleep Disturbances

Study Overview
=================
Brief Summary
-----------------
This database will be used to better understand the sleep problems of people with SMS. This clinical database will be a part of a larger Smith-Magenis Patient Registry used to create an awareness campaign around SMS and the sleep disturbances that are characteristic of the disorder.

Official Title
-----------------
Development of Clinical Database of Individuals With Smith-Magenis Syndrome

Conditions
-----------------
Sleep Disturbances in Smith-Magenis Syndrome

Intervention / Treatment
-----------------
* Other: Data collection of sleep disturbances in individuals with SMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parent or legal guardian of individual with Smith-Magenis Syndrome Exclusion Criteria: Not legal guardian of individual with SMS

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Data collection of sleep disturbances in individuals with SMS|Data related to Smith-Magenis syndrome and sleep disturbances are collected through a web or phone survey|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of individuals with Smith- Magenis syndrome |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Disturbances |  | Up to 100 weeks |
Comparison of Laboratory Test Results of Minimal-Residual Disease in Samples From Patients With Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Diagnostic procedures that find residual disease may help predict if the disease will come back in patients diagnosed with acute myeloid leukemia. PURPOSE: This research trial studies the comparison of laboratory test results for minimal residual disease in samples from patients with acute myeloid leukemia.

Detailed Description
-----------------
OBJECTIVES: To promote harmonization between Cooperative Group Reference Laboratories conducting minimal-residual disease (MRD) evaluation of acute myeloid leukemia by flow cytometry. OUTLINE: Archived bone marrow and blood samples, distributed to the Eastern Cooperative Oncology Group, Southwest Oncology Group, and Cancer and Leukemia Group B laboratories, are analyzed for leukemia-associated immunophenotype (LAIP) assays and minimal residual disease studies by flow cytometry. Results are then provided to the National Cancer Institute for assessment and comparability of test results.

Official Title
-----------------
Interlaboratory Comparability Study of Residual Disease in Acute Myelogenous Leukemia

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Other: diagnostic laboratory biomarker analysis
* Other: flow cytometry


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Non-identified cryopreserved samples of bone marrow and/or peripheral blood from patients with acute myeloid leukemia (AML) from the Children Oncology Group (COG) studies Baseline/diagnostic AML samples Samples collected after initial treatment and representing varying levels of residual blast counts PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: diagnostic laboratory biomarker analysis|nan|
|Other: flow cytometry|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of concordance in the MRD assay results between laboratories |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
childhood acute myeloid leukemia/other myeloid malignancies
Clinical Performance of Short Fiber Reinforced Flowable Resin Composite Restorations 2y RCT

Study Overview
=================
Brief Summary
-----------------
Clinical performance of short fiber reinforced flowable resin composite restorations versus conventional resin composite restorations will be tested in posterior teeth (2y randomized clinical trial).

Official Title
-----------------
Clinical Performance of Short Fiber Reinforced Flowable Resin Composite Restorations Versus Conventional Resin Composite Restorations in Posterior Teeth (2y Randomized Clinical Trial)

Conditions
-----------------
Decay, Dental, Caries Class II

Intervention / Treatment
-----------------
* Other: Short fiber reinforced flowable resin composite restorations
* Other: Conventional resin composite restoration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with large proximal carious cavities in molars. Pulp asymptomatic vital carious upper or lower molars. Good oral hygiene. Exclusion Criteria: Presence of signs and symptoms of irreversible pulpitis or pulp necrosis Severe medical complications. Allergic history concerning methacrylates Evidence of parafunctional habits.

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short fiber reinforced flowable resin composite restorations<br>(everX Flow, GC Europe) + (Gaenial posterior, GC Europe | Other: Short fiber reinforced flowable resin composite restorations<br>* reinforced flowable resin composite<br>* Other names: Ever X Flow;|
| Active Comparator: Conventional resin composite restoration.<br>(Gaenial posterior, GC Europe) | Other: Conventional resin composite restoration<br>* Microhybrid resin composite<br>* Other names: Gaenial posterior, GC Europe;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance (Alpha is the best score, bravo, charlie the worst score) | Modified USPHS criteria; . Post operative Hypersensitivity Secondary caries Gross fracture Color match Cavo-surface marginal discoloration Marginal integrity Proximal contact | Change from baseline at 6, 12 ,18, 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
short fiber reinforced flowable resin composite, Clinical performance, Ever X flow, Randomized clinical study
Follow-up of Anterior Cruciate Ligament Reconstruction

Study Overview
=================
Brief Summary
-----------------
Rupture of Anterior Cruciate Ligament (ACL) is a common pathology, but is subject to variability of associated lesions, surgical management and rehabilitation.

Detailed Description
-----------------
In this study, a collect data of patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction in order to evaluate the clinical, functional and morphological results of this intervention, in order to improve the management of the patient.

Official Title
-----------------
Follow-up of Anterior Cruciate Ligament Reconstruction

Conditions
-----------------
Anterior Cruciate Ligament Rupture

Intervention / Treatment
-----------------
* Other: datas collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction Exclusion Criteria: None

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction<br>Patients having undergone an ACL reconstruction will be included. | Other: datas collection<br>* data collection in history medical : operative report, clinical examination, questionnaires, imaging, isokinetic tests<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of Magnetic Resonance Imaging (MRI) results | Collected in medical records | Pre-operative and Month: 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of operative report results | Collected in medical records | Month: 12 | 
| Analysis of consultation report | Collected in medical records | pre-operative and Months: 1,5 , 3, 6, 12 | 
| Analysis of isokinetic tests | Collected in medical records | Months: 9, 12 | 
| Analysis of clinical surveys | Collected in medical records | pre-operative and Months: 3, 6, 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anterior Cruciate Ligament, reconstruction, Operative report, Consultation report, Isokinetic tests, Clinical surveys
Using a Novel Algorithm to Improve the Retrieval Rate of Inferior Vena Cava Filters (iRetrieve Study)

Study Overview
=================
Brief Summary
-----------------
Since 2003, that the first retrievable IVC filter was introduced in the U.S,improvements have been made in the filter design to resolve problems of structural integrity and increase the ability to remove the filter after longer periods of time.The FDA issued a communication in August 2010 advising physicians to remove retrievable filters whenever possible and updated that letter again in May 2014 due to concerns that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient's risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.

Detailed Description
-----------------
Several studies have shown that approximately 80% to 85% of optional IVC filters are never retrieved. The successful removal of retrievable filters requires diligent patient follow-up and interdepartmental cooperation, and even so, successful removal is not always possible. American College of Chest Physicians (ACCP) guidelines for IVCF placement indications advocates a close, structured follow-up of retrievable IVCFs to improve filter retrieval rates. Using a retrieval algorithm and pathway program, a score will trigger a secure email and text messages sent to both physician and patient at different timelines, for follow up so as to retrieve filter placed.

Official Title
-----------------
A Prospective Multi-center Study Using a Novel Algorithm to Improve the Retrieval Rate of Inferior Vena Cava Filters Placed Across the US

Conditions
-----------------
Venous Thromboembolism,, Pulmonary Embolism,, Deep Vein Thrombosis,

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Data obtained in line with good clinical practice, applicable laws and regulation Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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 |
| --- | --- | --- |
| Filter retrieval rate |  | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of major adverse event |  | 24 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inferior Vena Cava
White Matter in Pediatric Bipolar Disorder: A DTI Study

Study Overview
=================
Brief Summary
-----------------
Fourteen subjects with bipolar disorder and 14 matching healthy controls, aged 6-13, will receive a magnetic resonance imaging (MRI) scan on a 3 Tesla scanner. They will also have a clinical interview, including the KSADS-PL. All subjects must be right-handed.

Detailed Description
-----------------
We propose to investigate the connectivity of white matter tracts using diffusion tensor imaging (DTI) in children with very early onset bipolar disorder (BPD). We hypothesize that the connectivity between the prefrontal cortex and the temporal lobe and parietal lobe and limbic structures will be abnormal, indicating white matter and gray matter deficits in early onset BPD. We also hypothesize that the superior lateral fasciculus cingulum bundle and the inferior lateral fasciculus will have decreased fractional anisotropy in very early onset BPD relative to healthy controls.

Official Title
-----------------
White Matter Connectivity in Pediatric Bipolar Disorder: A Diffusion Tensor Imaging Study

Conditions
-----------------
Bipolar Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 6 to 13 Male or female Right-handed Exclusion Criteria: IQ less than 70 Learning disabilities History of autism, schizophrenia, anorexia or bulimia nervosa Substance abuse Claustrophobia Metal in body Pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 13 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 |
| --- | --- |
| BPD<br>Children with bipolar disorder | |
| HC<br>Healthy comparison children | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional anisotropy in brain white matter |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
children, bipolar disorder, magnetic resonance imaging, white matter, diffusion tensor imaging, adolescents
Second-Line Oxaliplatin and Irinotecan Versus Irinotecan Alone for Gemcitabine and S-1 Refractory Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
This study is a randomized, open-label, controlled study that will compare the efficacy of oxaliplatin in combination with irinotecan to irinotecan alone as second-line treatment for patients with gemcitabine and S-1 refractory pancreatic cancer.

Official Title
-----------------
Second-Line Oxaliplatin and Irinotecan Versus Irinotecan Alone for Advanced Pancreatic Cancer Patients Progressed After First-line Gemcitabine and S-1: A Randomized Controlled Study

Conditions
-----------------
Pancreatic Neoplasms

Intervention / Treatment
-----------------
* Drug: Irinotecan
* Drug: Oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically confirmed advanced pancreatic cancer who had experienced progression during first-line gemcitabine and S-1 were eligible for enrollment on this open-label, randomized study. Additional inclusion criteria were age 18 years or older Measurable reference cancer site(s) confirmed with computed tomography (CT) or magnetic resonance imaging (MRI) Karnofsky performance status (KPS) of at least 70% -Adequate renal function, adequate hepatic function, adequate bone marrow function Exclusion Criteria: The presence of any severe concomitant disease that could interrupt the planned treatment; intractable pain Hypersensitivity to study drugs Serious cardiovascular disease (eg, unstable coronary artery disease or myocardial infarction within 4 weeks of study start) National Cancer Institute CommonToxicity Criteria grade 3 or 4 sensory or motor neuropathy Prior or concurrent malignancy (other than pancreatic cancer) Female, pregnancy or breastfeeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxaliplatin + Irinotecan<br>Irinotecan：160 mg/m2，iv 120 min，d1 q2w oxaliplatin: 85 mg/m2，iv 120 min，d1 q2w | Drug: Irinotecan<br> <br> Drug: Oxaliplatin<br> <br> |
| Active Comparator: Irinotecan<br>Irinotecan：180 mg/m2，iv 120 min，d1 q2w | Drug: Irinotecan<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | 1 years |
A Study to Determine the Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Treatment of Dark Circles

Study Overview
=================
Brief Summary
-----------------
This is a multicentre, open label, randomized, pilot study to evalute safety and efficacy of Human Platelet Lysate (HPL) in subjects with Periorbital Hyperpigmentation. The study is being conducted at 2 centers in India.The primary endpoints are Physicians and Patient Self assessment score. The secondary endpoints are improvement in photographic assessment form randomization to end of study.

Official Title
-----------------
A Prospective Multicentric Open Label Randomized Bio-Interventional Phase I/II Pilot Study To Evaluate Safety & Efficacy Of Autologous Human Platelet Lysate (HPL) for Treatment of Periorbital Hyperpigmentation (Dark Circles)

Conditions
-----------------
Periorbital Hyperpigmentation (Dark Circles)

Intervention / Treatment
-----------------
* Other: Autologous Human Platelet Lysate
* Other: Standard Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects (male and female), aged 18 to 55 years (both inclusive) with Periorbital Hyperpigmentation. Subject willing to refrain from any other treatment of Periorbital Hyperpigmentation during entire study duration. Subjects who are willing to give informed consent and adhere to the study protocol. Exclusion Criteria: Subjects aged less than 18 and more than 55 years Subjects with history of connective tissue disease. Subjects with metabolic or hematopoietic disorders Subjects unwilling to or unable to comply with the study protocol. Subjects taking concomitant therapy that might interfere with the study results in the investigator's opinion or participating in another trial in the past 30 days.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study arm A<br>Subjects will receive one dose of 5 ml of Autologous Human Platelet Lysate with simultaneous micro-needling on day 2 | Other: Autologous Human Platelet Lysate<br>* Subjects will receive one dose of 5 ml of HPL with simultaneous micro-needling on day 2<br>|
| Other: Control Arm B<br>Topical Applications of the standard therapy as directed by the investigator | Other: Standard Therapy<br>* Topical Applications as directed by the investigator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photographic Assessment |  | Day 0, Month 1, Month 2, End of Study - 3 months |