linjc16/ctgov huggingface dataset:
Observational Study of Effect of Radiation Therapy to Immuno Status in HIV-cancer Patients

Study Overview
=================
Brief Summary
-----------------
Objectives: To study immunostatus (CD4) and HIV viral load in HIV-cancer patients before RT and last weeks of RT .

Official Title
-----------------
Observational Study of Effect of Radiation Therapy to Immuno Status in HIV-cancer Patients

Conditions
-----------------
To Study Immunostatus of HIV-cancer Patients Who Recived RT Befor RT and Last Week of RT, To Study HIV Viral Load of HIV-cancer Patients Who Recived RT Befor RT and Last Week of RT

Intervention / Treatment
-----------------
* Radiation: Radiation therapy
* Other: Venepuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-65 years HIV positive cancer patients Photon beam RT, conventional fraction >= 4000 cgy in 4 weeks Exclusion Criteria: CD4 count < 200 cell/ml and not received anti retro viral

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| HIV-cancer patients who recived RT<br> | Radiation: Radiation therapy<br>* External photon beam radiation therapy dosage 4000-7000 CGy<br>Other: Venepuncture<br>* Venepuncture for CD4 and viral load count at Week 0, Last week of Radiation, and 12, 24 Week follow up<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study of the Safety and Efficacy of an Investigational Drug in Adult Patients With Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
The primary goal of the study is to determine the best dose of an investigational drug to give to patients with multiple myeloma and to evaluate the investigational drug's effectiveness as a treatment for multiple myeloma.

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Investigational drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary. Inclusion Criteria: Eligible patients must be at least 18 years of age with a diagnosis of multiple myeloma including elevated M-blood/urine protein or a tumor that can be evaluated by the doctor during the investigational drug's treatment. The patient's multiple myeloma must have gotten worse during/after previous chemotherapy was given. Any side-effects from prior chemotherapy must have subsided Blood and urine tests must show adequate bone marrow, liver, and kidney function. Exclusion Criteria: Any of the following will exclude patients from study participation: indolent or smoldering myeloma or localized plasmacytoma hyperviscosity syndrome irradiation to 25% or more of bone marrow prior high dose chemotherapy with bone marrow or stem cell support current participation in other clinical trials pregnant or breast-feeding women known HIV-positive or AIDS-related illness patients planning to have radiation therapy or surgery that would interrupt study therapy in the next 6 months.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Investigational drug|nan|

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
-----------------
Pharmacia
Primary Upper Limb Deep Vein Thrombosis. Is First Rib Resection Necessary?

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare outcome of patients with effort thrombosis who were treated operatively to those treated nonoperatively

Official Title
-----------------
Primary Upper Limb Deep Vein Thrombosis. Is First Rib Resection Necessary?

Conditions
-----------------
Paget Schroetter Syndrome

Intervention / Treatment
-----------------
* Device: iu22 ultrasound system - phillips


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:\ * patients treated for upper extremity DVT 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 |
| --- | --- |
| operative<br>operative | Device: iu22 ultrasound system - phillips<br>* iu22 ultrasound system - phillips<br>|
| non operative<br>non operative | Device: iu22 ultrasound system - phillips<br>* iu22 ultrasound system - phillips<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical differences | clinical differences between the 2 groups Patients will be evaluated by the  Villata post thrombotic syndrome (PTS) scoring system. The sum of each parameter will be used to compare he groups Vilata PTS scoring system: ( 0- ABSENT , 3 SEVERE ) Symptoms/clinical signs None Mild Moderate Severe Symptoms Pain Cramps Heaviness Pruritus Clinical signs edema Skin induration Hyperpigmentation Redness Venous ectasia Pain on calf compression | 10years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vein patency | patency of SCV based on duplex | 10 years |
Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude

Study Overview
=================
Brief Summary
-----------------
To demonstrate sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at sub-perception amplitude

Detailed Description
-----------------
To demonstrate sustained clinically significant pain relief in patients when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at sub-perception amplitude

Official Title
-----------------
WHISPER - A Randomized Controlled Study to Evaluate the Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Device: Precision or Precision Spectra Spinal Cord Stimulator System


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Complaint of chronic pain of the trunk and/or limbs Willing and able to comply with all protocol-required procedures and assessments/evaluations; able to independently read and complete all questionnaires and assessments provided in English Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) provided in English Key Exclusion Criteria: Meets any contraindication in the Precision SCS system per locally applicable Directions for Use (DFU) Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes

Ages Eligible for Study
-----------------
Minimum Age: 22 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SCS starting with supra-perception<br>Precision or Precision Spectra Spinal Cord Stimulator System programmed at supra-perception followed by sub-perception SCS | Device: Precision or Precision Spectra Spinal Cord Stimulator System<br> <br> |
| Experimental: SCS starting with sub-perception amplitude<br>Precision or Precision Spectra Spinal Cord Stimulator System programmed at sub-perception followed by supra-perception SCS | Device: Precision or Precision Spectra Spinal Cord Stimulator System<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline | Proportion of subjects with 50% or greater reduction in overall pain intensity from baseline with supra and sub perception amplitude with no increase in average daily medication intake to treat pain | 90 days post activation |
Efficacy Study of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints

Study Overview
=================
Brief Summary
-----------------
The objectives of the investigation will be to assess the effect of the repeated usage of a new eye drop on the tear film characteristics of silicone hydrogel contact lens wearers with contact lens related comfort problems and to quantify any potential benefit.

Official Title
-----------------
Evaluation of the Effect of Repeated Usage of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints

Conditions
-----------------
Contact Lens Related Dry Eye Syndrome

Intervention / Treatment
-----------------
* Device: OPTIVEtm Plus
* Procedure: No treatment
* Device: Blink Contacts® Eye Drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Current silicone hydrogel contact lens wearer Complaints of contact lens related dry eye (Symptoms and reduced comfortable wearing time) Exclusion criteria: Known allergy or sensitivity to the study product(s) or its components Systemic or ocular allergies Use of systemic medication which might have ocular side effects. Any ocular infection. Use of ocular medication. Significant ocular tissue anomaly

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: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: New study eye drop<br>One month of contact lens wear with use of the Test study eye drops | Device: OPTIVEtm Plus<br>* 1 drop in each eye four times a day for a period of 30 (± 3) days<br>|
| Placebo Comparator: No Eyedrop<br>One month of contact lens wear with no eye drop use | Procedure: No treatment<br>* One month of contact lens wear with no eye drop use<br>|
| Active Comparator: BLINK Contacts Lubricating eye drop<br>One month of contact lens wear with use of the Control study eye drops | Device: Blink Contacts® Eye Drops<br>* 1 drop in each eye four times a day for a period of 30 (± 3) days<br>* Other names: Blink Contacts®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Break up Time |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival staining measurement |  | 30 days | 
| Tear film evaporation rate |  | 30 days | 
| Ocular Surface Disease Index questionnaire |  | 30 days | 
| Comfort, vision and ocular symptoms questionnaire |  | 30 days | 
| Post wear contact lens deposition and lipid uptake assessment |  | 30 days |
DxFLEX 10C Clinical Study

Study Overview
=================
Brief Summary
-----------------
A multi-center method comparison study is designed per CLSI-EP09 A3. This study compares the qualitative immunophenotype agreement between DxFLEX and Navios EX to demonstrate the accuracy of the DxFLEX-10C system. A series of precision studies will be conducted with each focusing on different aspects of the DxFLEX-10C system.

Official Title
-----------------
DxFLEX ClearLLab 10C US-IVD Clinical Study Protocol - Clinical Laboratory

Conditions
-----------------
Hematological Malignancy

Intervention / Treatment
-----------------
* Device: DxFLEX 10C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient specimens targeted for this study will be residual samples with sufficient volume from whole blood, bone marrow, and lymph node meeting the following criteria: Specimens from new cases or follow up patients for myeloid/lymphoid FCI testing. Hematologically abnormal specimens Subjects of any range, ethnicities, and racial backgrounds Specimens from patients with the following medical indications presenting for testing by flow cytometry based on the Bethesda Consensus Guidelines. Exclusion Criteria: There are two (2) groups of exclusion criteria to detail the specimens that should not be counted for the study: Pre-analytical/Pre-screen exclusion criteria Post-acquisition exclusion criteria.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hematologically normal<br>Based on immunophenotyping | Device: DxFLEX 10C<br>* A device combining flow cytometry and reagents for immunophenotyping analysis<br>|
| Hematologically abnormal<br>Based on immunophenotyping | Device: DxFLEX 10C<br>* A device combining flow cytometry and reagents for immunophenotyping analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow immunophenotyped normal and abnormal | Based on WHO guidelines for Leukemia & Lymphoma | immediately after the analysis |
Combined Administration of Intravenous and Topical Tranexamic Acid in Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
This prospective randomized controlled trial was conducted To compare the efficacy of TNA in terms of total blood loss and the allogenic transfusion rate among the three study groups; intravenous alone, combined intravenous and low dose topical TNA and combined intravenous and high dose topical TNA. To evaluate the safety of each regimen in view of deep vein thrombosis and venous thromboembolism.

Official Title
-----------------
Combined Administration of Intravenous and Topical Tranexamic Acid in Total Knee Arthroplasty: Is it the Most Effective Regime? A Randomized Controlled Trial.

Conditions
-----------------
Degenerative Arthritis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with diagnosis of primary osteoarthritis Exclusion Criteria: patients with diagnoses other than primary OA patients on anticoagulation therapy patient with chronic renal failure patient with CVA Hx Patient with seizure Hx Patient with severe CHF Patient with acquired or congenital coagulopathy

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Only Intravenous Group<br>Only Intravenous Injection During Operation, 10mg/kr | Drug: Tranexamic Acid<br> <br> |
| Active Comparator: Intravenous + Topical 1g Group<br>Intravenous Injection During Operation, 10mg/kr After Capsule Closure, Tranexamic acid Topical Injection 1g | Drug: Tranexamic Acid<br> <br> |
| Active Comparator: Intravenous + Topical 2g Group<br>Intravenous Injection During Operation, 10mg/kr After Capsule Closure, Tranexamic acid Topical Injection 2g | Drug: Tranexamic Acid<br> <br> |
| Active Comparator: No Intravenous, Only Topical 2g Group<br>Only Topical Injection 2g | Drug: Tranexamic Acid<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin | Blood loss reduce | baseline and 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tranexamic acid
Effectiveness of MIRT on Hand and Finger Dexterity in PD Patients

Study Overview
=================
Brief Summary
-----------------
Aims of the study are (1) to evaluate the effectiveness of a specific OT treatment aimed to enhance finger and hand dexterity and (2) its impact on daily living autonomy of PD patients.

Detailed Description
-----------------
Reduction in hand functionality and finger dexterity are significant, but often overlooked, symptoms of Parkinson's Disease (PD). They are strictly correlated with loss of patient's autonomy, due to their significant impact on Activities of Daily Living (ADL) and, consequently in patient's Quality of life (QoL). No studies investigated the effectiveness of a specific and functional-based Occupational Therapy (OT) treatment in improving hand functionality and finger dexterity in PD patients. Aims of tthe study are to evaluate the effectiveness of a specific OT treatment aimed to enhance finger and hand dexterity and its impact on daily living autonomy of PD patients. Retrospectively, 482 PD patients, hospitalized for a 4-week Multidisciplinary Intensive Rehabilitation Treatment (MIRT) between January 2015 and January 2018 were identified. All patients underwent 1h/day OT treatment. The outcome measure was the O'Connor finger dexterity test; secondary outcome measures were Minnesota dexterity test, UPDRS II and SPDDS scale. These measures were assessed at admission (T0) and discharge (T1).

Official Title
-----------------
Effectiveness of MIRT on Hand and Finger Dexterity in PD Patients

Conditions
-----------------
Parkinson Disease, Dexterity, Rehabilitation

Intervention / Treatment
-----------------
* Behavioral: MIRT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of Parkinson's Disease Exclusion Criteria: other neurological disease psychosis auditive or visual deficit
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PD patients<br>PD patients at 1-5 H&Y stage undergoes 4week Multidisciplinary Intensive Rehabilitation Treatment | Behavioral: MIRT<br>* 4 week MIRT provide: front to front treatment (1 hour/day for 5 days/week) treatment with robotic devices (1 hour/day for 5 days/week) occupational therapy (1 hour/day for 5 days/week)<br>* Other names: Multidisciplinary Intensive Rehabilitation Treatment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| O'Connor Finger Dexterity Test | peg-placement test aimed to evaluate the ability to manipulate small objects | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minnesota Manual Dexterity Test | test aimed to evaluate the reach-to-grasp movements, gros manual dexterity and left vs right manual impairment | 4 weeks |
Renal Function Determination in Patients With Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
We have several ways to appropriately determine renal function in healthy patients and in several diseases, in cirrhotic population we dont have a precise tool that has sufficient precision that reflects glomerular function, although it has been reported that cystatin C, because of its nature could improve diagnostic accuracy to determinate the renal function in this population. The investigators hypothesize that glomerular filtration obtained from cystatin-C-derived formulas are more accurate when compared to creatinine-derived formulas with DTPA-Tc99 (diethylene-triamine-pentaacetate- technetium-99) as gold standard.

Detailed Description
-----------------
The aim of the study is to determine if the formulas for glomerular filtration are close to the estimation of actual renal function in mexican cirrhotic patients of different etiologies.

Official Title
-----------------
Renal Function Determination With Creatinine and Cystatin C Dependent Formulas Compared to Gold Standard DTPA-TC-99 (Diethylene-triamine-pentaacetate- Technetium-99) in Mexican Cirrhotic Patients

Conditions
-----------------
Liver Cirrhosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver cirrhosis Stability in creatinine levels in the previous three months (variation <0.3 mg/dL) Signed informed consent Exclusion Criteria: Pregnancy Hepatocellular carcinoma Cerebrovascular events Decompensated heart failure Drugs that modify serum creatinine levels Renal replacement therapy

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of glomerular filtration through several formulas in cirrhotic patients | Determination of glomerular filtration through several formulas dependent of creatinine and cystatin C and the gold standard | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver cirrhosis, glomerular filtration, cystatin C