linjc16/ctgov huggingface dataset:
A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease

Study Overview
=================
Brief Summary
-----------------
This 2 arm study will compare the efficacy of intravenous Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 and then every 3-4 weeks) or zoledronic acid (4mg iv on day 1 and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.

Official Title
-----------------
A Randomized, Placebo-controlled, Double-blind Study of the Effect of Bondronat Compared With Zoledronic Acid on Pain in Patients With Malignant Bone Disease Experiencing Moderate to Severe Pain

Conditions
-----------------
Pain, Bone Neoplasm, Neoplasm Metastasis

Intervention / Treatment
-----------------
* Drug: ibandronate [Bondronat]
* Drug: zoledronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with malignant bone disease; patients with moderate to severe pain. Exclusion Criteria: patients who have received a bisphosphonate within 3 weeks from the signing of the informed consent; patients receiving concurrent investigational therapy, or who have received investigational therapy within 30 days of the first scheduled day of dosing; untreated esophagitis or gastric ulcers; recent or pre-scheduled radiotherapy to bone; patients who are pregnant or breast-feeding.

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: ibandronate [Bondronat]<br>* 6mg iv on days 1-3, and every 3-4 weeks<br>|
| Active Comparator: 2<br> | Drug: zoledronic acid<br>* 4mg iv on day 1 and every 3-4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain, as measured by Brief Pain Inventory and analgesic use |  | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance score and QoL measures |  | Week 24 | 
| AEs and laboratory parameters |  | Throughout study | 
| Opioid side effects |  | Throughout study | 
| Skeletal-related events |  | Throughout study |
Comparison of SureCALL® EMG Labor Monitor® and Tocodynamometer to Intrauterine Pressure Catheter Measurement (IUPC) Measurement in Pregnant Women

Study Overview
=================
Brief Summary
-----------------
This measurement study was designed to evaluate the performance of SureCALL® EMG Labor Monitor® (SureCALL®) to the predicate Tocodynamometer device (TOCO) using the performance of an Intrauterine Pressure Catheter device (IUPC) as the gold standard.

Detailed Description
-----------------
The SureCALL® EMG Labor Monitor® (SureCALL®) is a transabdominal electromyography monitor intended to measure intrapartum uterine activity. It is intended for use on term pregnant women who are in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. The device is intended for use by healthcare professionals in a clinical setting. This measurement study was designed to evaluate the performance of SureCALL® to the predicate Tocodynamometer device (TOCO) using the performance of an Intrauterine Pressure Catheter device (IUPC) as the gold standard. This study involved 20 women at term, in labor, at three clinical sites. Each study subject was instrumented with three technologies for measuring uterine activity: a tocodynamometer attached to the maternal abdomen a set of abdominal surface electrodes for uterine electromyography, and an intrauterine pressure catheter. Using IUPC as the gold standard, this study methodology allowed a three way comparison for evaluating how well the SureCALL® system performed compared to the TOCO technology.

Official Title
-----------------
Comparison of SureCALL® EMG Labor Monitor® and Tocodynamometer to Intrauterine Pressure Catheter Measurement in Pregnant Women

Conditions
-----------------
Pregnancy - Labor Monitoring

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton Pregnancy Indicated for IUPC Gestational ages from 37 to 41 weeks Informed consent required Exclusion Criteria: Multifetal Pregnancy Not Indicated for IUPC Gestation ages below 37 or above 41 weeks Informed consent not given

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant, In Labor<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC | Contraction timing as measured by the SureCALL® and contraction timing as measured by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of SureCALL® and TOCO were then compared. | 9 - 42 Minutes |
A Pilot Implementation Study of GLA:D Back

Study Overview
=================
Brief Summary
-----------------
GLA:D Back is a program developed in Denmark to help people with persistent low back pain. This pilot study will assist in contextualizing Danish content into an English version of the program.

Detailed Description
-----------------
GLA:D Back is a program developed in Denmark to help people with persistent low back pain. Unfortunately, all materials developed for the program are in Danish. In this pilot, the investigators will translate the Danish materials into English, then use them to conduct an English training session for community clinicians in Edmonton, Alberta, Canada. Interested clinicians will then implement the program in their communities and provide feedback to contextualize the program for use in English. Specifically, surveys, interviews and focus groups will be used to help fine-tune the printed content of the course (e.g. manuals), it's training materials (e.g. lectures) and processes related to REDCap data collection (e.g. surveys).

Official Title
-----------------
A Pilot Implementation Study of GLA:D Back

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Behavioral: GLA:D Back


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have persistent low back pain of at least 1 month's duration. Exclusion Criteria: Participating currently in a supervised exercise or rehabilitation program or enrolled in another interventional clinical trial. Patients with nerve root involvement, suspected serious pathology, unstable trauma to the spine, aspects of pregnancy or other conditions that would prevent participation or disallow trial completion within the prescribed time period. Persons with conditions that require a specialist consult are suspected of needing a specialist consult, or have conditions that would be aggravated or worsened if treated by the interventions in this 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: GLA:D Back|GLA:D Back is a 10-week program based on first-line recommendations of patient education and structured exercise taught in a group format.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation | Number of clinicians who implement the program | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients enrolled | Number of patients trained by each GLA:D clinician | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low Back Pain
Corneal Endothelium Cell Loss After Cataract Extraction in Patients Taking Tamsulosin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether corneal endothelium cell loss during cataract surgery is higher in patients taking Tamsulosin.

Detailed Description
-----------------
Cataract surgery in patients taking Tamsulosin is regarded as more challenging for the surgeon because Intraoperative Floppy Iris Syndrome (IFIS) might occur. However, the question is whether this has any practical implication for the outcomes of surgery. In this study we investigate whether cornea is damage during surgery on Tamsulosin patient. In an observational study 30 cataract patients taking Tamsulosin is compared to 30 patients not taking Tamsulosin, but otherwise similar. Number of patients is based on power calculation. Cornea is examined by specular microscopy.

Official Title
-----------------
Corneal Endothelium Cell Loss After Cataract Extraction in Patients Taking Systemic Sympathetic Alfa-1-a-antagonist Medication (Tamsulosin)

Conditions
-----------------
Cataract

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cataract needing surgery Exclusion Criteria: glaucoma corneal scarring diabetes uveitis
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tamsulosin<br>Patients taking tamsulosin | |
| Non-tamsulosin<br>Patients not taking tamsulosin. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corneal endothelium cell loss | Corneal endothelium cells was evaluated by specular microskopy before and 3 month post-operatively. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract surgery, tamsulosin, endothelium cell
Eye Movement Recordings in the Diagnosis of Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
The study investigates whether the use of eye movement recordings can provide a reliable diagnostic of previously undiagnosed mild traumatic brain injury (blast and impact) in Operations Enduring Freedom or Iraqi Freedom (OIF/OEF) veterans.

Detailed Description
-----------------
Eye movements are recorded for Operations Enduring Freedom or Iraqi Freedom (OIF/OEF) veterans with mild traumatic brain injury (mTBI) and compared to the eye movements of those without mTBI. By analyzing and characterizing the differences between the two groups, a diagnostic measure of mTBI through the use of eye movements can be developed.

Official Title
-----------------
Eye-movement Recordings in the Diagnosis of Traumatic Brain Injury

Conditions
-----------------
Traumatic Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OIF/OEF Veteran; Neuropsych diagnosis of MTBI Exclusion Criteria: chronically abusing alcohol or illicit drugs. uncorrected vision prevents subject from effectively viewing the stimuli, unless they can wear contact lenses during the recording session. inability to make normal eye movements (i.e.: saccades, smooth pursuit) required by study paradigms. Note: Deficit can be caused by taking medications that can potentially affect eye movements or any neurological condition that can interfere with making normal eye movement. psychological or psychiatric conditions that preclude sustained concentration or ability to perform the tasks.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Control<br>Control subjects with no Mild Traumatic Brain Injury (MTBI) and no Post-Traumatic Stress Disorder (PTSD) | |
| MTBI<br>Subject with a diagnosis for Mild Traumatic Brain Injury (MTBI) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability of Fixation | The ability to keep eye position fixed on a visual target, measured by the distance between the target and eye fixation point averaged over 20 sec. | During eye movement recording session (20 sec). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Traumatic Brain Injury, Eye movement recording
Effectiveness of Exercise in the Treatment of Depression

Study Overview
=================
Brief Summary
-----------------
The main objective is to test the non-inferiority of supervised exercise versus antidepressant treatment in reducing depressive symptoms in patients with clinical criteria for depression (according to ICD 10) over a period of 6 months follow-up.

Detailed Description
-----------------
This is a randomized clinical trial in primary care in which a total of 312 patients over 65 years with clinically significant depression will be randomly assigned to an exercise program supervised or receive treatment with antidepressant drugs commonly used in clinical practice. At baseline physical fitness of the participants will be checked, and assessments will be made after 15 days and 1, 3 and 6 months. The supervised exercise program will consist of 2 sessions per week in groups of 10-12 patients over a 6 month period in which a sports instructor will train patients to perform at least 30 minutes of regular, moderate-intensity activity with a frequency almost daily, including aerobic exercise and strength training, flexibility and balance. In both groups will be evaluated periodically, among other variables, the state of depressive symptoms, level of physical activity, self-rated health, occurrence of adverse effects and adherence to exercise program or antidepressant treatment. The main outcome measure is the reduction of the baseline score on the scales of depressive symptoms (Montgomery-Asberg Depression Rating Scale and Geriatric Depression Scale).

Official Title
-----------------
Effectiveness of Exercise in the Treatment of Depression in Older People as an Alternative to Drugs Antidepressants in Primary Care

Conditions
-----------------
Depression, Primary Care, Exercise

Intervention / Treatment
-----------------
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People with depression Exclusion Criteria: Contraindication to exercise

Ages Eligible for Study
-----------------
Minimum 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br> | Other: Exercise<br> <br> * Other names: Antidepressants;|
| Active Comparator: Antidepressants<br> | Other: Exercise<br> <br> * Other names: Antidepressants;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in depressive symptoms |  | 6 months |
Clinical Evaluation of LifeScan Blood Glucose Monitoring Systems

Study Overview
=================
Brief Summary
-----------------
Study to determine the performance of the LifeScan BGMS when conducted at MAC clinical site.

Detailed Description
-----------------
This study will evaluate the performance of the MAC clinical site to evaluate accuracy performance of LifeScan blood glucose monitoring systems as it is conducted at other LifeScan UK affiliated clinic sites. Multiple LifeScan Blood Glucose Monitoring System (BGMS) will be tested with production lots which have passed release testing.

Official Title
-----------------
Clinical Evaluation of LifeScan Blood Glucose Monitoring Systems

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: OneTouch Verio
* Device: OneTouch Select Plus
* Device: OneTouch Ultra


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be enrolled in LifeScan Patient Registry. Participants must have read the Information sheet and signed an informedconsent form >prior to study participation. Participants must be 16 years or older. Participants must be diagnosed with Diabetes Exclusion Criteria: > Participants not enrolled in the LifeScan Patient Registry

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LifeScan BGMSs<br>OneTouch Verio, OneTouch Select Plus and OneTouch Ultra Blood Glucose Monitoring Systems (BGMSs) tested using subject capillary blood and compared to a reference instrument (YSI 2900). | Device: OneTouch Verio<br>* OneTouch Verio Blood Glucose Monitoring System.<br>Device: OneTouch Select Plus<br>* OneTouch Select Plus Blood Glucose Monitoring System.<br>Device: OneTouch Ultra<br>* OneTouch Ultra Blood Glucose Monitoring System.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Evaluation of Blood Glucose result (mg/dl) from LifeScan Blood Glucose Monitoring Systems by comparison of a blood glucose result (mg/dl) obtained from a reference instrument (YSI2900) to demonstrate accuracy (%). | Clinical Evaluation of Blood Glucose result (mg/dl) from LifeScan Blood Glucose Monitoring Systems by comparison of a blood glucose result (mg/dl) obtained from a reference instrument (YSI2900) to demonstrate accuracy (%). | Less than 30 minutes |
Resminostat (YHI-1001) in Combination With Sorafenib in Asian Patients With Advanced Hepatocellular Carcinoma (HCC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess efficacy and safety in combination of resminostat and sorafenib in Asian patients with advanced HCC previously untreated with systemic chemotherapy.

Official Title
-----------------
A Phase I/II Study in Combination of Resminostat and Sorafenib in Patients With Advanced Hepatocellular Carcinoma Previously Untreated With Systemic Chemotherapy

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: Resminostat
* Drug: Sorafenib


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Patients with advanced or metastatic hepatocellular carcinoma Patients with ECOG PS of 0-1 Patients who can be treated with oral medications and have no gastrointestinal function disorder which is considered to affect the absorption of medications Main Exclusion Criteria: Patients with a history of treatment with HDAC inhibitors Pregnant women and lactating mothers Patients with brain metastases or suspected brain metastases based on the clinical symptoms

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Resminostat + Sorafenib<br>oral administration | Drug: Resminostat<br> <br> Drug: Sorafenib<br> <br> |
| Active Comparator: Sorafenib<br>oral administration | Drug: Sorafenib<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1 : Number of participants with dose limited toxicities as measure of safety and tolerability |  | 6 months | 
| Phase 2 : Time To Progression (TTP) |  | 12 months |