linjc16/ctgov huggingface dataset:
Pivotal Study for Validation of Philips Dx (PDx)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to show safety and effectiveness of the PDx for In Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital images of surgical pathology slides.

Official Title
-----------------
Pivotal Study for Validation of Philips Dx for Diagnosis in Surgical Pathology

Conditions
-----------------
Pathologic Processes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria All relevant coverslipped slide or slides, with human tissue obtained via surgical pathology of original case are available. Original sign-out diagnosis is available. The selected slide or slides fulfill the quality checks according to general clinical practice. Target enrollment of organs and subtypes according pre-specified list. Exclusion Criteria Cases, including sent out cases, for which any of the relevant slides used for the original sign-out diagnosis is no longer available at the site. The selected slide or slides do not match any subtype of the organ for which the case was selected. Relevant Clinical Information that was available to the sign-out pathologist in the pathology request form cannot be obtained. Selected slides contain indelible markings. Selected slides with damaged tissue. More than one case was selected for a patient (only one case may be enrolled per patient). Case consists of frozen section(s) only. Case consists of gross specimens only.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical pathology cases<br>Cases will be selected from the sites Laboratory Information Systems using the in- and exclusion criteria. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Discordance Rate | The primary endpoint was the difference in major discordance rates between Manual Optical (MO) and Manual Digital (MD). MO is defined as reading by using optical microscope whereas MD is defined as reading by using PIPS. MO major discordance rate is defined as the proportion of major discordances between the MO diagnosis and the main diagnosis from the total number of readings. MD major discordance rate is defined as the proportion of major discordances between the MD diagnosis and the main diagnosis from the total number of readings. | 6 months |
Diaphragmatic Reinnervation of Tetraplegic Patients With Respiratory Insufficiency

Study Overview
=================
Brief Summary
-----------------
This study evaluates the diaphragmatic reinnervation by inferior laryngeal nerve in tetraplegic patients with ventilatory insufficiency.

Official Title
-----------------
Phrenic Reinnervation in Central Ventilatory Paralysis Due to Medullary Trauma With Phrenic Motoneuron Destruction

Conditions
-----------------
Tetraplegia

Intervention / Treatment
-----------------
* Procedure: reinnervation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: tetraplegia c3-c4 respiratory insufficiency Exclusion Criteria: PM

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>Patients | Procedure: reinnervation<br>* anastomosis between right inferior laryngeal nerve and right phrenic nerve<br>* Other names: laryngeal reinnervation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recovery of spontaneous ventilation |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tetraplegia, reinnervation, phrenic nerve
Activating Transversus Abdominis Muscle

Study Overview
=================
Brief Summary
-----------------
Transversus abdominis (TrA) is an important muscle for spinal stabilization. Abdominal draw-in maneuver (ADIM) is a method that selectively activates TrA without activating external oblique (EO) and internal oblique (IO) muscles. Individuals with low back pain may have some troubles to understand proper contraction of TrA. Therefore, to contract the TrA, two different feedback techniques have been used to instruct. In this observational study we aim to investigate the effects of two different biofeedback methods to teach patients the proper activation of TrA muscle using ADIM. We aim to find out the differences between visual and traditional tactile biofeedback and decide which one is practical and easy to teach the patients in clinical environment.

Official Title
-----------------
Activating Transversus Abdominis Muscle: A Comparison Of Two Different Feedback Methods

Conditions
-----------------
Low Back Pain, Rehabilitative Ultrasound, Spinal Stabilization

Intervention / Treatment
-----------------
* Other: abdominal hallowing maneuver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers between ages of 18-25 Exclusion Criteria: Volunteers excluded if they had (1) history of LBP, (2) spinal or abdominal surgeries, (3) neuromusculer or romatologic diseases. Each volunteer gave their informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 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 |
| --- | --- |
| Group1<br>visual feedback | Other: abdominal hallowing maneuver<br>* abdominal hallowing maneuver includes tucking navel in and up. To be able to control the effect of breathing it was instructed to start the maneuver at the end of the expiration. During the maneuver it was instructed to focus on increasing the thickness of TrA without increasing the thickness of IO and EO<br>|
| Group2<br>traditional feedback | Other: abdominal hallowing maneuver<br>* abdominal hallowing maneuver includes tucking navel in and up. To be able to control the effect of breathing it was instructed to start the maneuver at the end of the expiration. During the maneuver it was instructed to focus on increasing the thickness of TrA without increasing the thickness of IO and EO<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thickness change in TrA muscle | thickness change in TrA muscle | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thickness change in EO muscle | thickness change in EO muscle | 1 month | 
| thickness change in IO muscle | thickness change in IO muscle | 1 month |
Hyper Baric Oxygen Therapy (HBOT) for Spontaneous Osteonecrosis of the Knee

Study Overview
=================
Brief Summary
-----------------
safety and efficacy of Hyper Baric Oxygen (HBO) in patients presenting with spontaneous osteonecrosis of the knee

Official Title
-----------------
Safety and Efficacy of Hyper Baric Oxygen Therapy (HBOT) in Patients Presenting With Spontaneous Osteonecrosis of the Knee

Conditions
-----------------
Spontaneous Osteonecrosis of the Knee

Intervention / Treatment
-----------------
* Biological: Weight reduction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age40-85 years Diagnosis of Spontaneous osteonecrosis of the knee (SONK)in last month, Stage 1 or 2 by MRI. Exclusion Criteria: Hyperbaric treatment (HBOT) in the last 2 years. Any contraindication for HBOT Pregnancy. Inability to sign inform consent Any contraindication for MRI

Ages Eligible for Study
-----------------
Minimum Age: 40 Months
Maximum Age: 85 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: Biological<br>6 weeks of HBO treatment as well as non weight bearing | Biological: Weight reduction<br> <br> |
| Active Comparator: Control<br>non weight bearing | Biological: Weight reduction<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Pain Reduction | 6 weeks | 
| Safety | Number of Participants with Adverse Events during HBOT | end of HBOT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction In AVN size by MRI |  | 6 weeks |
Evaluation of the Management of Tramadol Use Disorders

Study Overview
=================
Brief Summary
-----------------
In France, In recent years, there has been a steady increase in reports of abuse and dependence on tramadol. Over 50% of tramadol withdrawal syndromes involve taking tramadol in therapeutic doses, sometimes for short periods of less than a week. Physical dependence can develop when a therapeutic maintenance dose is prescribed for the treatment of mild to moderate pain. Due to its mixed mechanism of action, tramadol withdrawal syndromes are not only characterized by classic signs of opioid withdrawal (muscle pain, mydriasis, sweating, nausea and vomiting, tearing, rhinorrhea, yawning, fever, insomnia, etc.). The properties of this substance on serotonin explain the effects which are added to the morphine-mimetic withdrawal of tramadol. Analysis of spontaneous reports shows psychological and psychic signs of withdrawal. Currently, there is no validated protocol for the management of tramadol withdrawal. The main objective is to assess the different options for managing tramadol withdrawal: opioid maintenance therapy and symptomatic treatments, in relation to the addictive and psychiatric co-morbidities in patients. The study also provides insight into the different types of withdrawal syndromes experienced by patients in order to raise awareness among doctors when prescribing tramadol.

Official Title
-----------------
Evaluation of the Medical Management of Tramadol Use Disorders in Patients Hospitalized for Tramadol Withdrawal

Conditions
-----------------
Withdrawal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: >18 years old Tramadol actual misuse/addiction Patients hospitalized for Tramadol withdrawal Exclusion criteria: <18 years old History of misuse or addiction for tramadol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Patients hospitalized for tramadol withdrawal<br>Patients hospitalized for tramadol withdrawal in Montpellier University Hospital and Nîmes University Hospital from 01/01/2015 to 31/12/2019 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Management of Tramadol withdrawal syndrome | Management by substitution drugs, by therapeutic degrowth | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tramadol withdrawal syndrome experienced by patients | Description of classic cpioid withdrawal symptoms and atypical aymptoms apecific to | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Substance use disorder, Programme de Medicalisation des Systèmes d'Information, tramadol
A Clinical Trial Evaluating the Efficacy of a Skin Cream in Improving Facial Appearance and Skin Elasticity

Study Overview
=================
Brief Summary
-----------------
A Clinical Trial Evaluating Efficacy of a Skin Cream Targeting Dermal Fat in Improving the Skin Elasticity of Healthy Volunteers.

Detailed Description
-----------------
This is a single-arm study with subjects serving as their own controls. The study evaluates a face cream comprised of natural agents with adipogenic and lipolytic activities. The combination of adipogenic and lipolytic impulses is theorized to be more effective in promoting regeneration and healthy cell size in the dermal white adipose tissue than other approaches (e.g., adipogenic + lipogenic or anti-adipogenic + lipolytic). The health of the dermal white adipose tissue is reflected by the strength and elasticity of the skin and the distribution of volume in the face.

Official Title
-----------------
A Clinical Trial Evaluating the Efficacy of a Skin Cream Targeting Dermal Fat in Improving the Skin Elasticity of Healthy Volunteers

Conditions
-----------------
Atrophy, Hemifacial, Elastosis, Photoaging

Intervention / Treatment
-----------------
* Other: Adipeau face cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: Plans to undergo facial skin resurfacing (e.g. laser, chemical peel, microneedling) during the study period Plans to undergo injectable filler treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Adipeau face cream<br>Cosmetic cream | Other: Adipeau face cream<br>* Adipeau face cream contains the natural actives Carthamus Tinctorius (Safflower) Seed Oil and Kaempferia Parviflora Rhizome Extract (Black Ginger).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Skin Elasticity | Elasticity measured by DermaLab Skin Elasticity Meter. | Six months and 12 months.. | 
| Change in Skin Volume | Increases and decreases measured by Cherry Imaging 3D Scanning System. | Six months and 12 Months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FaceQ skin satisfaction surveys | Satisfaction With Skin, Appraisal of Lower Eyelids, Satisfaction with Cheeks, Adverse Effects | Two, Six and 12 Months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrophy, Sagging, Depletion, Photoaging
Gemcitabine in NK/T Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
We retrospectively review patients with refractory or relapsed ENKL who received a gemcitabine-containing regimen

Official Title
-----------------
Gemcitabine in Pretreated/Refractory NK/T Cell Lymphoma

Conditions
-----------------
NK/T Cell Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NK/T cell lymphoma relapse or refractory disease gemcitabine containing treatment Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| relapsed or refractory NK/T cell lymphoma with gemcitabine<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | 2012-May |
Opioid Use After Traumatic Injury in Adolescents

Study Overview
=================
Brief Summary
-----------------
Currently, 1 in 8 adolescents continue to receive prescription opioids a year or more after injury. By longitudinally surveying patients, we can identify risk factors and pathways to nonmedical opioid use. Furthermore, by assessing whether pain management and mental health treatment after injury moderates sustained opioid use and prescription opioid misuse, we can create targeted interventions to reduce future nonmedical opioid use in adolescents.

Detailed Description
-----------------
This is a prospective cohort study that will follow participants for 2 years and administer surveys to adolescents both traumatically injured and uninjured on prescription opioid usage, substance use, utilization of pain management and mental health services, and mental and physical health condition conditions.

Official Title
-----------------
A Prospective Survey of Opioid Use After Traumatic Injury in Adolescents

Conditions
-----------------
Opioid Use, Traumatic Injury, Adolescent Behavior, Substance Abuse Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is 12-20 years of age Adolescent admitted for trauma OR adolescent with no recent trauma English speaking Consent can be obtained from a parent or guardian Exclusion Criteria: - Patients with severe brain injuries or other injuries that prevent survey participation

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 20 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 |
| --- | --- |
| Traumatically Injured Adolescent<br> | |
| Not Traumatically Injured Adolescent<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prospectively determine drivers of sustained opioid use and prescription opioid misuse. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify patient-reported factors for sustained prescription opioid use, including chronic pain and mental health conditions such as PTSD, depression, anxiety, and sleep disorders. |  | 2 years | 
| Assess behavioral, social, and clinical predictors of prescription opioid misuse and nonmedical opioid use by longitudinally surveying injured adolescents. |  | 2 years | 
| Qualitatively determine patients' motives for continued opioid therapy, prescription opioid misuse, and nonmedical opioid use by interviewing injured adolescents. |  | 2 years | 
| Analyze genetic information, obtained via saliva sample and the company 23andMe, from each participant to determine if some people are more likely to use more pain medication than others or respond better to certain pain medications. |  | 2 years |
Positioning and the Spontaneous Breathing Test in Neonates

Study Overview
=================
Brief Summary
-----------------
The spontaneous breathing test (SBT) is routinely performed on all intubated patients in the NICU who are potential candidates for extubation from mechanical ventilatory support. For all parents who consent, the routine SBT will be performed on all infants. In addition to the routine SBT the following will occur: work of breathing indices: obtained non-invasively through respiratory inductive plethysmography (RIP). Performing the SBT in the prone position, in addition to the routine position (supine).

Official Title
-----------------
Evaluation of the Influence of Positioning and Time Duration on the Spontaneous Breathing Test in Neonates

Conditions
-----------------
Spontaneous Breathing Test, Infants, NICU

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants who qualify for SBT as part of their normal care Exclusion Criteria: Previous history of abdominal or chest surgery (i.e. chest tube, PDA ligation, surgical NEC) Congenital malformation of the chest of abdomen Neuromuscular disorder Current medications affecting neuromuscular tone (ex morphine) Unable to be positioned either prone or supine as determined by the attending neonatologist.

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intubated infants<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of prone vs supine positioning on whether an infant receives a passing score on the SBT test | SBT is a pass/fail test. The effect of prone vs supine positioning in intubated neonates on whether a spontaneous breathing test is scored pass or fail will be determined. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOB indices during SBT | Determination whether prone vs supine position alters the work of breathing indices in infants while receiving a SBT | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infants, NICU, intubated, ventilator