linjc16/ctgov huggingface dataset:
Efficacy of Prolotherapy and Hydrodilatation for Frozen Shoulder

Study Overview
=================
Brief Summary
-----------------
Objective: To determine whether ultrasound-guided Intra-Articular Hypertonic Dextrose and hydrodilatation improves pain and function in patients with frozen shoulder(FS)

Detailed Description
-----------------
Setting: a medical center hospital. Participants: Subjects with primary FS with shoulder pain more than 3 months. Interventions: Participants randomly be assigned into A and B group: group A received ultrasound-guided hydrodilatation with hypertonic Dextrose with a mixture of 2mL of 50%, 1mL of 2% lidocaine, and 6ml normative saline ; group B : ultrasound-guided hydrodilatation with 9 mL of normative saline and 1 mL of 2% lidocaine. Main Outcome Measures: The primary outcome measure was the Shoulder Pain and Disability Index score. Secondary outcomes were the VAS of shoulder pain level, muscle power and angles of shoulder passive range of motion, including flexion, abduction, extension, external rotation, and internal rotation at pretreatment and weeks 2, 4, 8, 12 and 24 of post-treatment.

Official Title
-----------------
Efficacy of Ultrasound-guided Intra-Articular Hypertonic Dextrose(Prolotherapy) and Hydrodilatation for Frozen Shoulder

Conditions
-----------------
Frozen Shoulder

Intervention / Treatment
-----------------
* Other: injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Participants diagnosed with primary FS who had experienced shoulder pain for more than 6 months and a reduction > 30° in passive ROM of the affected shoulder in at least two directions (forward flexion, abduction, or external rotation) compared with the contralateral side were evaluated for eligibility. 23 Subjects with any degree of tear or calcified tendinitis of rotator cuff tendons, previous shoulder surgery, previous intra-articular injection for the affected shoulder within 3 months of the study; or any secondary FS caused by metabolic, rheumatic, infectious arthritis, stroke, tumor, shoulder fracture/dislocation, or acute cervical radiculopathy were excluded. 23 -

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 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: evaluation prolotherapy for frozen shoulder<br>This pilot study highlighted that prospective studies are required to prove its clinical application for FS and other conditions. | Other: injection<br>* ultrasound-guided hydrodilatation with hypertonic Dextrose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Shoulder Pain and Disability Index score |  | 2 weeks |
Post-Marketing Clinical Follow-Up of a Spine Implant

Study Overview
=================
Brief Summary
-----------------
Post-Marketing Clinical Follow-up of an Anular Closure System (Barricaid®) to Confirm Comparability of Outcome between Devices with Subcomponents from Two Different Suppliers

Detailed Description
-----------------
Comparison of device integrity (anchor fracture and/or mesh detachment) and device movement/migration in patients implanted with the Barricaids with anchors from two different suppliers.

Official Title
-----------------
Post-Marketing Clinical Follow-up of an Anular Closure System (Barricaid®) to Confirm Comparability of Outcome Between Devices With Subcomponents From Two Different Suppliers

Conditions
-----------------
Lumbar Disc Herniation, Annular Tear of Lumbar Disc

Intervention / Treatment
-----------------
* Other: Follow up per standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Each site will enroll all patients who were implanted with a Barricaid with an anchor manufactured by the second manufacturer. Patients must be 18 years of age or older and able to understand and consent to participate in the study. Exclusion Criteria: Not defined

Ages Eligible for Study
-----------------
Minimum Age: 18 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 implanted with vendor B anchor<br> | Other: Follow up per standard of care<br>* Patients will come in 2 years post implantation and receive standard examinations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device failures | Device failures and movement/migration will be assessed by a radiographic core laboratory. | 22+ months post implantation |
Intermediate-size IND for Treatment of KRAS G12V-mutant Tumors

Study Overview
=================
Brief Summary
-----------------
This intermediate-size IND will treat participants with incurable, advanced or metastatic cancer, harboring KRAS G12V mutation and appropriate HLA class II match (HLA-DRB1*07:01).

Detailed Description
-----------------
This study will treat two identified patients with metastatic pancreatic adenocarcinoma and metastatic pancreatic cancer who have both been treated with standard of care therapies and found to have disease progression. Both of these patients have KRAS G12V mutations in their cancers and express the HLA-DRB1*07:01 HLA class II molecule. As such, they are candidates for adoptive cell therapy with autologous gene-engineered T cells expressing HLA-DRB1*07:01-restricted KRAS G12V reactive T-cell receptors (TCR). Adoptive T-cell therapy is a type of immunotherapy which involves isolation of T cells from a patient, followed by an amplification of those T cells in the lab to large numbers, and reinfusion of the T cells back to the patient. In addition to the two identified patients, the protocol will remain open for additional participants with incurable, advanced or metastatic cancer, harboring KRAS G12V mutation, and appropriate HLA class II match (DRB1*07:01).

Official Title
-----------------
Intermediate-size Patient Population IND for Treatment of KRAS G12V-mutant Tumors With Gene-engineered KRAS G12V-reactive T Cells

Conditions
-----------------
KRAS G12V Mutant Advanced Epithelial Cancers

Intervention / Treatment
-----------------
* Drug: Cyclophosphamide
* Drug: Gemcitabine
* Drug: Pembrolizumab
* Biological: Cell Infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with incurable, advanced or metastatic cancer, harboring KRAS G12V mutation, and appropriate HLA class II match (HLA-DRB1*07:01)

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cyclophosphamide|Patients will receive a single dose of cyclophosphamide 60 mg/kg IV in 250 ml D5W over 2 hours on Day -3.|
|Drug: Gemcitabine|Patients will receive a single dose of gemcitabine 600 mg/mg2 IVPB over 30 minutes on Day -2.|
|Drug: Pembrolizumab|Patients will receive the anti-PD-1 immune checkpoint inhibitor pembrolizumab 200 mg IV over 30 minutes on Day -1 and will be dosed every 3 weeks.|
|Biological: Cell Infusion|Patient's T cells will be administered at a dose of between 1 x 10^9 to 5.0 x 10^10 TCR-transduced lymphocytes, which is a dose of genetically modified T cells that can be safely administered and is capable of mediating tumor regression in some patients with metastatic cancers. The cells are to be infused intravenously over approximately 30 minutes via non-filtered tubing, gently agitating the bag during infusion to prevent cell clumping.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Clemastine Fumarate on Color Vision in Healthy Controls

Study Overview
=================
Brief Summary
-----------------
In a1972 study in the French Annals of Pharmaceuticals, Laroche and Laroche reported that the drug clemastine has a negative effect on patients' color discrimination, which is the ability to distinguish different hues and arrange them in the correct order. In an upcoming clinical trial studying the effect of clemastine on vision outcomes, our lab aims to assess color visual performance adding assessment of color defectiveness as a clinical endpoint. Color defectiveness is the ability to see certain colors, and is commonly referred to as color-blindness. Color discrimination and defectiveness can be related, but do not always correlate. This study aims to detect the effect, if any, that clemastine has on color defectiveness in healthy controls, which could confound its use as an outcome endpoint in future clinical trials relating to clemastine.

Detailed Description
-----------------
Additional evaluation of pharmacokinetic data will be performed to confirm pharmacokinetic measures and correlate blood levels of drug to color performance if seen.

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Clemastine fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy control Exclusion Criteria: Preexisting ophthalmologic conditions such as optic neuritis, macular star, glaucoma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clemastine<br>This group will receive 8mg of clemastine daily. | Drug: Clemastine fumarate<br>* 4mg 2x day clemastine fumarate orally.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline cone contrast test score at 3 weeks | Cone contrast and color vision testing to be performed at all 3 study visits | baseline, 3 day, 3 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Lanthany D15 score at 3 weeks | Lanthany D15 test to be administered at all 3 study visits. Score determined by number of crossings as outlined in the following link http://www.richmondproducts.com/files/8113/1550/0538/FR_15_Farnsworth_and_LanthonyD15_Instructions_Rev_1.7_0506.pdf | baseline, 3 day, 3 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
volunteers
EMDR in the Treatment of Specific Phobia.

Study Overview
=================
Brief Summary
-----------------
The purpose for this study is to determine whether EMDR is effective in the treatment of specific (animal) phobia.

Detailed Description
-----------------
Aims: To test the hypothesis that one session EMDR is more effective for the treatment of specific (animal) phobia than relaxation immediately after treatment and at follow-up. Secondly to test whether an additional one-session exposure therapy offered to both treatment groups (EMDR patients and relaxation patients) improves outcome in the EMDR-group and results in equal outcome for both treatment groups.

Official Title
-----------------
EMDR (Eye Movement Desensitization and Reprocessing) in the Treatment of Specific Phobia. A Randomised Controlled Trial.

Conditions
-----------------
Specific Phobia

Intervention / Treatment
-----------------
* Other: EMDR (Eye Movement Desensitization and Reprocessing)
* Other: Exposure therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Specific (Animal) Phobia Exclusion Criteria: Current or past psychotic disorder Current substance dependence or abuse Serious physical illness Active suicidal behavior Bipolar affective disorder Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 15 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMDR<br>The experimental group was treated for animal phobia by EMDR, control group received an attention placebo (relaxation plus breathing exercises). Afterwards, both groups were treated by exposure therapy (therapy of choice for animal phobia). | Other: EMDR (Eye Movement Desensitization and Reprocessing)<br>* Psychotherapy which is approved for PTSD.<br>Other: Exposure therapy<br>* All participants in the study received exposure therapy som second treatment. Exposure therapy is the therapy of choice for animal phobia.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral Approach Test towards the feared animal. |  | Before and after each treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on self-report questionnaires on phobic symptoms |  | Before and after both treatments | 
| Neuropsychological function |  | Before first treatment, some measures also before second treatment | 
| Cognitive strategies |  | Before both treatments | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Specific (Animal) Phobia, EMDR, Exposure therapy
Personality Characteristics and Compliance With Antiglaucoma Medication

Study Overview
=================
Brief Summary
-----------------
Personality traits may influence to the drug compliance in glaucoma patients.

Detailed Description
-----------------
In chronic diseases, especially asymptomatic at early stage, drug compliance has been reported as an important factor to control them. And personality traits are associated with the drug compliance. However, there was few study to consider this relationship. We want to find the association the personality characteristics and drug compliance in glaucoma patients.

Official Title
-----------------
Personality Characteristics and Compliance With Antiglaucoma Medication

Conditions
-----------------
Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic glaucoma Topical anti-glaucoma medications Exclusion Criteria: Oral glaucoma medications

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Drug compliance, Personality
SUBSUS (SUBglottic Secretion at Ultrasound Score)

Study Overview
=================
Brief Summary
-----------------
To compare the performance of ultrasound in detecting subglottic secretion above the ETT tube cuff in comparison to computed tomography (CT) scan.

Detailed Description
-----------------
Airway ultrasound will be performed at the bedside prior to CT scan in all intubated patients who fulfiled the criteria. The image of subglottic secretion was then compared to the plain CT cervical. The findings of the CT was examined by a radiologist.

Official Title
-----------------
Prospective Study On Novel Usage of Airway Ultrasound To Detect Subglottic Secretion Above Endotracheal Tube(ETT) Cuff

Conditions
-----------------
Ventilator Associated Pneumonia

Intervention / Treatment
-----------------
* Procedure: Airway Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age more than 18 years old ETT in situ indicated for CT cervical scan Exclusion Criteria: neck subcutaneous emphysema neck scar or surgical dressing around the neck which can lead to difficulty in obtaining an optimal ultrasound image.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound Airway<br>Ultrasound Airway for subglottic secretion | Procedure: Airway Ultrasound<br>* Comparison between Airway ultrasound and CT cervical<br>* Other names: Cervical CT plain;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prospective Study on Novel Usage of Airway Ultrasound To Detect Subglottic Secretion Above Endotracheal Tube Cuff | Compare the performance of airway ultrasound and cervical CT scan to diagnose subglottic secretion. | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
subglottic secretion, airway ultrasound, ventilator associated pneumonia
Management of Nausea and Vomiting Chemotherapy-induced in Normandy

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to evaluate the various parameters involved in the occurrence of nausea / vomiting during the first cycle of chemotherapy for solid tumors or hematologic among a group of chemotherapy-naive patients, despite anti standardized-emetics protocols.

Official Title
-----------------
Management of Nausea and Vomiting Chemotherapy-induced in Normandy

Conditions
-----------------
Cancer, Nausea, Vomiting

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged over 18 years With solid tumors or hematologic in first line chemotherapy, administered intravenously, Able to understand the meaning of the questions Having given their written consent to participate in the survey. Exclusion Criteria: This does not concern patients who: Do not give their consent for participation Do not speak French Suffer from cognitive deficits Are under therapy Must receive a combination of radio-chemotherapy Present an occlusive syndrome Metastases (s) brain (s) clinically symptomatic (s) or radiologically proven (s) or a (of) tumor (s) brain (s) Have been previously treated with chemotherapy Present a cons-indication to corticosteroids, with anti-serotonin or NK1 receptor inhibitors Pregnant or breastfeeding.

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 |
| --- | --- | --- |
| acute nausea and vomiting | acute nausea and vomiting and / or delayed measured by the tool of anti emetic MAT MASCC. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chemotherapy, cancer, nausea, vomiting
A Study of Capecitabine (Xeloda) in the Adjuvant Treatment of Participants With Resected Colon Cancer

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and tolerability of capecitabine (Xeloda) in participants who have undergone surgery for colon cancer. Oral Xeloda will be administered twice daily in 3-week cycles for a total of up to 8 cycles. The anticipated time on study treatment is 24 weeks, and the target sample size is 70 individuals.

Official Title
-----------------
Phase IV Clinical Study of Safety and Tolerability of Oral Xeloda (Capecitabine) in Adjuvant Treatment of Resected Cancer of the Colon

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults at least 18 years of age Curative surgery for Stage III colon cancer, performed 4 to 8 weeks before study entry Exclusion Criteria: Macroscopic or microscopic residual tumor Evidence of metastatic disease including tumor cells in ascites Previous cytotoxic chemotherapy, radiotherapy, or immunotherapy for colon cancer Active cardiovascular disease Other malignancy within the last 5 years, other than curatively treated basal cell cancer of the skin or in situ cancer of the cervix Malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capecitabine<br>Participants will receive capecitabine for up to approximately 6 months. | Drug: Capecitabine<br>* Participants will receive oral capecitabine, 1250 miligrams per meter-squared (mg/m^2) twice daily, in 3-week treatment cycles for up to 8 cycles. Treatment will be administered for 2 weeks followed by 1 week of rest without medication.<br>* Other names: Xeloda;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) |  | Up to approximately 6 months | 
| Incidence of treatment discontinuation due to AEs |  | Up to approximately 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of toxocity-related dose reductions |  | Up to approximately 6 months |