linjc16/ctgov huggingface dataset:
CXCL9 and EASIX for Prediction of Acute Graft Versus Host Disease

Study Overview
=================
Brief Summary
-----------------
The prediction of severe acute GVHD before it occurs is of high importance for ensuing clinical decisions and overall success of allogeneic SCT. The key immunologic signatures associated with clinical outcomes after different graft versus host disease prophylaxis methods or peripheral blood stem cell transplant are largely unknown.

Official Title
-----------------
CXC-chemokine Ligand 9 (CXCL9) and Endothelial Activation and Stress Index (EASIX) for Prediction of Acute Graft Versus Host Disease

Conditions
-----------------
GVHD,Acute

Intervention / Treatment
-----------------
* Diagnostic Test: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients >18 year old admitted for allo SCT PB for malignant disease.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: blood sample|blood sample to check CXCL9 and EASIX at day 28 post stem cell transplant|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| predictors of acute GVHD | CXCL9 combined with EASIX can be used as predictors of acute GVHD | CXCL9 combined with EASIX calculated at day 28 +/- 2 post SCT can be used as predictors of acute GVHD by day 100. |
Accuracy of Extra-oral Bite-wing Radiography in Detecting Calculus and Crestal Bone Loss

Study Overview
=================
Brief Summary
-----------------
To compare the diagnostic accuracy of extra-oral x-rays with intra-oral x-rays, in contrast to clinically observed measurements, for the detection of calculus and bone loss of either the suprabony or infrabony types in patients undergoing periodontal surgery.

Official Title
-----------------
Accuracy of Extra-oral Bite-wing Radiography in Detecting Calculus and Crestal Bone Loss

Conditions
-----------------
Periodontitis, Calculus, Dental, Bone Loss, Alveolar

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be active patients of record at CU School of Dental Medicine Patients will have an active treatment plan for periodontal open flap surgery Patients will be classified as either ASA I or ASA II Patients must have periodontal probing depths >/= 5mm and radiographic sings of marginal bone loss (supra or infra bony) Exclusion Criteria: Less than 18 years of age ASA III or above Emergency patients Pregnant patients Patients who are not patients of record at the CU School of Dental Medicine Patients with a recent panoramic radiograph that contraindicates the need for new imaging in the form of extra-oral bitewings

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Radiographic evidence of calculus | Radiographic evidence of calculus | Baseline - Yes or No | 
| Radiographic measure of alveolar bone loss | Radiographic measure (mm) of alveolar bone loss, as measured from the Cemento-enamel-junction to base of defect | Baseline - measured in mm | 
| Clinical evidence of calculus | Clinical evidence of calculus | Baseline - Yes or No | 
| Clinical measure of alveolar bone loss | Clinical measure (mm) of alveolar bone loss, as measured from Cemento-enamel-junction to base of defect using a periodontal probe | Baseline - measured in mm |
LDCT Chest In Assessment Of Apparently Healthy Smokers

Study Overview
=================
Brief Summary
-----------------
To evaluate the effectiveness of LDCT screening in detecting early-stage lung cancers among smokers who do not have symptoms of lung disease.

Detailed Description
-----------------
Tobacco smoking is the leading preventable cause of death worldwide .Chronic Obstructive Pulmonary Disease (COPD), lung cancer, and cardiovascular disease will be responsible for the majority of deaths in the developed world in the coming decades . COPD is characterised by chronic airflow limitation caused by a combination of small airway inflammation and parenchymal destruction (emphysema) . Since computed tomography (CT) has been validated as a non-invasive technique capable of identifying areas of lung parenchyma with emphysema , several studies have identified a subgroup of apparently healthy smokers who have emphysema but no airway obstruction Furthermore, this subgroup has the highest risk of developing lung cancer among smokers .It has been proposed that systemic inflammation may play an important pathogenic role in carcinogenesis . We will conducted this cross sectional study between. current and former smokers without airway obstruction participating in a lung cancer screening study: a study group of smokers with emphysema on the CT, and a control group of smokers without emphysema.

Official Title
-----------------
Role Of LDCT Chest In Assessment Of Apparently Healthy Smokers

Conditions
-----------------
Smoking

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Participants have at least 45years old had smoked 10 pack-years or more Exclusion Criteria: Age: less than 45 years. Non smoker Evidence of airway obstruction by Pulmonery Function Test

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| • Prevalence of Emphysema in apparently healthy smoker • Association between lung cancer and emphysema • Rate of early-stage lung cancer detection (Stage I/II) • Lung cancer mortality rate | from LDCT Chest | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy and performance of LDCT • Positive predictive value of LDCT screening • Rate of incidental findings on LDCT requiring follow up • Rate of unnecessary invasive procedures due to false positives | by Statistical tests and anylasis | baseline |
IMOvifa Perimeter Reference Database

Study Overview
=================
Brief Summary
-----------------
This study will collect data to establish a reference database for the IMOvifa perimeter.

Detailed Description
-----------------
This study will collect data from a reference population to be used as inputs to the calculation of age corrected significance limits for expected visual function sensitivity to establish reference limits for key output parameters for select test patterns of the IMOvifa perimeter device.

Official Title
-----------------
IMOvifa Perimeter Reference Database

Conditions
-----------------
Normal Eyes

Intervention / Treatment
-----------------
* Device: Visual field


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 22 years of age or older on the date of informed consent Able to understand the written informed consent and willing to participate IOP ≤ 21 mmHg (each eye) BCVA 20/40 or better (each eye) Both eyes free of ocular conditions that may affect visual function (at doctor's discretion) Exclusion Criteria: Unable to tolerate ophthalmic imaging and/or VF testing History of conditions known to adversely affect visual function (at doctor discretion) Spherical Equivalent refractive error outside the range from +6 Diopters Cylindrical refractive error outside the range +2.5 Diopters

Ages Eligible for Study
-----------------
Minimum Age: 22 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 |
| --- | --- |
| Normal<br>Subjects with normal visual function | Device: Visual field<br>* test for detecting loss in visual function<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reference limit for mean deviation | Visual sensitivity level in decibels | Day 1 |
Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU

Study Overview
=================
Brief Summary
-----------------
This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.

Detailed Description
-----------------
This is a non-therapeutic study design. After successful screening, subjects will be monitored for potential gene therapy-related adverse events for up to 15 years post MB-CART2019.1 infusion. Subjects will be assessed yearly for the occurrence of delayed adverse events (AEs), monitored for replication competent lentivirus (RCL) and assessed for long term efficacy as well as CAR-T persistence.

Official Title
-----------------
A Prospective, Observational, Long-term Follow-up Study for Subjects Who Previously Received Zamtocabtagene Autoleucel in a United States Miltenyi Biomedicine-Sponsored Clinical Study

Conditions
-----------------
Non Hodgkin Lymphoma

Intervention / Treatment
-----------------
* Other: Long-term Follow-Up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received zamtocabtagene autoleucel in a Miltenyi Biomedicine-sponsored clinical study and have either completed the study or have discontinued early from the study. Provided written informed consent to participate in this study. 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 |
| --- | --- |
| Long-term Follow-Up<br>No intervention | Other: Long-term Follow-Up<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of serious and non serious adverse events of special interest | AESIs will be collected | Up to 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with measurable replication competent lentivirus in peripheral blood (if positive at study entry) | Peripheral blood samples may be collected for RCL assessment | Up to 15 years | 
| Duration of zamtocabtagene autoleucel persistence | Peripheral blood samples will be collected to test for CAR T cells | Up to 5 years | 
| Objective response rate | ORR | Up to 15 years | 
| Overall Survival | OS | Up to 15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chimeric antigen receptor, CAR T, CD19, CD20
Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter Syndrome

Study Overview
=================
Brief Summary
-----------------
This post-trial access program is to allow continued access for people who participated and are benefitting from treatment on the HGT-HIT-046 (NCT01506141) or SHP609-302 (NCT02412787) studies, which will be closed down. Idursulfase-IT also known as TAK-609, is a medicine to help treat Hunter Syndrome and issues with remembering, learning new things, and concentrating, also called cognitive impairment.

Official Title
-----------------
Post-trial Access Program: Idursulfase-IT (HGT-2310) in Conjunction With Intravenous Elaprase in Pediatric Patients With Hunter Syndrome and Cognitive Impairment

Conditions
-----------------
Hunter Syndrome

Intervention / Treatment
-----------------
* Drug: Idursulfase-IT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants will have completed the treatment period of the HGT-HIT-046 (NCT01506141) or SHP609-302 (NCT02412787) study prior to the first dose on this program. Participant and/or a parent(s)/legal guardian is informed of the nature of this compassionate post-trial access program and can provide written informed consent for themselves or the child to participate (with assent from the child when appropriate prior to treatment). Exclusion Criteria: Participant has a condition that in the opinion of the treating physician may compromise their safety. Participant has a known hypersensitivity to idursulfase-IT or its components.
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Idursulfase-IT|Participants will continue to receive the same dose of idursulfase-IT, once monthly, that was administered during the HGT-HIT-046 [NCT01506141] or SHP609-302 [NCT02412787] study [10mg or 30mg] along with intravenous (IV) infusions of standard-of-care therapy Elaprase via intrathecal drug delivery device (IDDD) or lumbar punctures.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Therapeutic Recommendations Based on Clinical History and Video Documented PBS-Score

Study Overview
=================
Brief Summary
-----------------
Determine the relationship between the PBS-score and treatment recommendations provided by senior pediatric orthopedic surgeons.

Detailed Description
-----------------
In conjunction with the assessments of video documented PBS-score items (described in Study I), treatment recommendations from six to eight experienced pediatric orthopedic surgeons from four different countries will be collected. Their recommendations will be based on the included items of the PBS-score, and patient history including age of the child, Pirani score, initial treatment (need for tenotomy), and reported compliance to orthotic use.

Official Title
-----------------
Therapeutic Recommendations Based on Clinical History and Video Documented PBS-Score, an International Cross-sectional Multicenter Study

Conditions
-----------------
Clubfoot

Intervention / Treatment
-----------------
* Other: Treatment recommendations will be based on video documented PBS-Score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in Swedish, English, Portuguese, Urdu, or Pashto. Exclusion Criteria: syndromic clubfoot

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 14 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Treatment recommendations will be based on video documented PBS-Score|Therapeutic recommendations from orthopedic surgeons, will be summarized and described|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment | Treatment recommendations from eight to ten experienced pediatric orthopedic surgeons will be collected. Their recommendations will be based on the included items of the PBS-score, and patient history including age of the child, Pirani score, initial treatment (need for Achilles tenotomy), and reported compliance to orthotic use. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PBS-score, PEVA, Treatment clubfoot
Can Virtual Reality Technology Improve the Patient Experience in Oocyte Retrieval?

Study Overview
=================
Brief Summary
-----------------
A non-pharmacological, non-blinded, randomized cohort study that will investigate the effect of Virtual Reality technology on the patient experience during oocyte retrieval. The primary objective of the trial is to investigate the impact of Virtual Reality technology on the patient experience

Official Title
-----------------
Can Virtual Reality Technology Improve the Patient Experience in Oocyte Retrieval?

Conditions
-----------------
Infertility, Female

Intervention / Treatment
-----------------
* Device: Virtual reality technology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing oocyte retrieval Understanding and speaking Danish Exclusion Criteria: Previous participation in the trial Acupuncture as pain relief during oocyte retrieval

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

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality<br>The intervention group receives stimuli in the form of Virtual Reality technology before and during oocyte retrieval. In addition, patients receive standard treatment | Device: Virtual reality technology<br>* Participants who are randomized to group 1 will receive the Virtual Reality glasses on the day of oocyte retrieval in the recovery room. The participant chooses which animation she wants to experience.<br>|
| No Intervention: Control<br>The control group, does not receive stimuli in the form of Virtual Reality technology, but only the standard treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaires regarding impact on patient experience | The impact of Virtual Reality technology on the patient experience during oocyte retrieval through questionnaires. A visual analog scale (VAS) from 1-10 will be used for this measurement. | 30-60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaires reagarding the impact on the consumption of analgesic medication | The effect of Virtual Reality technology on the consumption of analgesic medication. A visual analog scale (VAS) from 1-10 will be used for this measurement. | 30-60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infertility, Virtual reality
Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease

Study Overview
=================
Brief Summary
-----------------
This is an open-label, Phase 2 study designed to evaluate the safety and efficacy of belumosudil and rituximab as primary treatment of cGVHD.

Official Title
-----------------
Phase II Trial of Belumosudil and Rituximab for the Primary Treatment of Extensive Chronic Graft-versus-host Disease

Conditions
-----------------
Chronic Graft Versus Host Disease

Intervention / Treatment
-----------------
* Drug: Belumosudil
* Drug: Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First episode of systemic immunosuppression-requiring cGVHD, defined as classic cGVHD by the NIH consensus criteria (without features or characteristics of aGVHD) Previously untreated, defined by having received <10 days of corticosteroids or alternative systemic immunosuppressive agent started specifically for a new diagnosis of cGVHD KPS >/= 70% Adequate hematologic function independent of platelet transfusion and G-CSF for at least 7 days prior to study entry: ANC >750 cells/mm3; Platelets >30,000 cells/mm# Exclusion Criteria: Late persistent or recurrent aGVHD Active uncontrolled infection History of HIV infection Active HBV or HCV infection. Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative PCR result before enrollment. Those who are PCR positive will be excluded. Calculated CrCl <30mL/min AST and/or ALT >5x ULN or direct bilirubin >3x ULN Cardiac ejection fraction <40% or history of uncontrolled cardiac arrhythmias Has received more than one allogeneic transplant prior to the occurrence of cGVHD

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Belumosudil Plus Rituximab<br>Belumosudil plus Rituximab | Drug: Belumosudil<br>* 200mg PO QD x 24 cycles (28-day cycle)<br>Drug: Rituximab<br>* 375mg/m2 IV Q1 week x 4 weeks, then Q3 months x4 doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who achieve partial and complete responses after treatment |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of time patients remain on corticosteroid treatment |  | 2 years | 
| Number of patients who had treatment-related adverse events using CTCAE v5 |  | 2 years |