linjc16/ctgov huggingface dataset:
Phase II Trial of CHOP-R Followed by Zevalin and Rituxan in Follicular Lymphoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the complete response rate when CHOP-R chemotherapy in followed by Zevalin in previous untreated patients with follicular lymphoma

Detailed Description
-----------------
Patients with follicular lymphoma who require therapy and have been previously untreated are eligible for this non-randomized, phase II study evaluating up front therapy with CHOP-R x 3 cycles followed by zevalin and 4 additional weeks of rituxan.The complete response will be determined by combining IWC criteria and PET scanning.Secondary objectives include PET-CT conversion rate, frequency and severity of adverse events, duration of complete remission and time to next lymphoma therapy.

Official Title
-----------------
Phase II Trial of CHOP-R Followed by Zevalin and Rituxan in Follicular Lymphoma

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

Intervention / Treatment
-----------------
* Drug: Chemotherapy and Radioimmunotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Conformed diagnosis of follicular lymphoma, grades 1,2 or 3 No prior chemotherapy No prior monoclonal antibody therapy Bulky or symptomatic disease, stage II-IV Performance status 0-2 Exclusion Criteria: Impaired bone marrow reserve Presence of CNS lymphoma Serious nonmalignant disease or active infection

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

| Intervention/Treatment |
| --- |
|Drug: Chemotherapy and Radioimmunotherapy|CHOP-R x 3 cycles followed by zevalin and extended rituximab|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate |  | May 2007,May 2008, May2009, May 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PET-CT conversion rate |  | May2007 | 
| Frequency and severity of adverse events |  | May 2007 | 
| Duration of complete response |  | May 2007,May 2008, May 2009, May 2010 | 
| Time to next lymphoma therapy |  | May 2207,May2008,May2009, May2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-Hodgkin Lymphoma
Distributed Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test if a patient can be directly connected to a quality assurance (QA) database, traditionally known as a registry. Patient-reported outcomes (PRO) data will be entered into the database directly from a patient's mobile phone from their index procedure for 12 months. The investigators hope this study to be a proof of concept for such a distributed registry and evaluate 1) consistency of data acquisition, 2) engagement of patients, 3) overall value of patient-reported outcomes to enhance long term follow up.

Official Title
-----------------
Distributed Registry Study

Conditions
-----------------
Peripheral Arterial Disease, Intermittent Claudication, Arteriosclerosis, Atherosclerosis, Arterial Occlusive Diseases, Vascular Diseases, Cardiovascular Diseases, Peripheral Vascular Diseases, Signs and Symptoms, Patient Compliance

Intervention / Treatment
-----------------
* Behavioral: Patient reported outcomes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cardiovascular disease who are scheduled or have undergone either a) open or endovascular vascular procedure, or b) open or percutaneous cardiac procedure. Patients with smartphones (iOS or Android) with unlimited data plans. Patients who agree to remote surveillance Exclusion Criteria: Patients unwilling to download a research study app. Data plans which are not unlimited.

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 undergoing vascular surgery procedures<br>Patients will report outcomes via their smartphone. | Behavioral: Patient reported outcomes<br>* Patients will download the research app onto their phone and enter pertinent medical history and surgical history data similar to standard registries for specific procedures. Over the next 12 months the investigators will obtain patient-reported outcomes (PROs) using the patient's phone. Specifically, the investigators will obtain daily activity data, weekly 6-minute-walk tests, and quarterly quality of life surveys<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcomes (PROs) using mobile app | PROs are any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else | 1 Year |
Intelligent Operating Room (InOR) for Orthopaedic Surgery

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate the usefulness of digital technologies to support surgical teams before, during, and after an operation.

Official Title
-----------------
Intelligent Operating Room (InOR) for Orthopaedic Surgery

Conditions
-----------------
Knee Replacement, Musculoskeletal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients 18-99 years. All willing patients undergoing elective total and unicondylar knee replacement (both navigated and robotic-assisted). Exclusion Criteria: Patients/staff who are unwilling to participate in the study Patients/staff that withdraw from the study Two stage revisions for infected primary total knee replacements, multiple stage procedures for complex deformities, Single stage revision procedures with the need for special instruments and modified steps Patients with cognitive impairment/ special cognitive needs. <18 years old

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| Change in baseline scores of qualitative questionnaires (every 8 weeks in one surgical team). | To determine how digital technologies and advanced data analytics can improve team coordination, efficiency and performance intraoperatively through understanding and mapping of surgical workflows and instrumentation use. | 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Report the effect of presenting information intraoperatively through digital displays and augmented reality headsets. | Assessed through monitoring scores from qualitative questionnaires of the surgical team; | 14 months | 
| To provide automatic post-operative analytics after each surgical operation (up to 150 cases). | Including phase timings and instrumentation | 14 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgery
Studying Non-motor Symptoms in HSP

Study Overview
=================
Brief Summary
-----------------
Comparing the non-motor symptoms of patients with hereditary spastic paraplegia (HSP) to healthy controls (spouses, relatives or other healthy controls) by using the a number of specific questionaires

Detailed Description
-----------------
https://lamapoll.de/NMS_in_HSP

Official Title
-----------------
Studying Non-motor Symptoms in Patients With Hereditary Spastic Paraplegia (HSP) Compared to Healthy Controls

Conditions
-----------------
SPG4

Intervention / Treatment
-----------------
* Diagnostic Test: EuroQol five dimensions questionaire (EQ-5D)
* Diagnostic Test: Modified Fatigue Impact Scale (MFI)
* Diagnostic Test: Brief Pain Inventory (BPI)
* Diagnostic Test: Becks Depression Inventory (BDI)
* Diagnostic Test: Restless-leg Questionaire (RLS diagnostic criteria)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Group 1: Patients with HSP (hereditary spastic paraplegia) Group 2: Healthy controls Age 18 to 70 years Written, informed consent Exclusion Criteria: Lack of ability for a written, informed consent Presence of spastic gait disorder or other neurological condition (Group 2)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HSP patients<br>Patients with hereditary spastic paraplegia regardless of their genetic mutation | Diagnostic Test: EuroQol five dimensions questionaire (EQ-5D)<br>* Testing quality of life.<br>Diagnostic Test: Modified Fatigue Impact Scale (MFI)<br>* Screening for fatigue<br>Diagnostic Test: Brief Pain Inventory (BPI)<br>* Testing for pain<br>Diagnostic Test: Becks Depression Inventory (BDI)<br>* Screening for depression<br>Diagnostic Test: Restless-leg Questionaire (RLS diagnostic criteria)<br>* Testing for restless-legs<br>|
| Healthy controls<br>healthy controls (spouses, relatives, or other healthy controls) | Diagnostic Test: EuroQol five dimensions questionaire (EQ-5D)<br>* Testing quality of life.<br>Diagnostic Test: Modified Fatigue Impact Scale (MFI)<br>* Screening for fatigue<br>Diagnostic Test: Brief Pain Inventory (BPI)<br>* Testing for pain<br>Diagnostic Test: Becks Depression Inventory (BDI)<br>* Screening for depression<br>Diagnostic Test: Restless-leg Questionaire (RLS diagnostic criteria)<br>* Testing for restless-legs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of relevant non-motor symptoms in SPG4 | By using the five mentioned scales we try to identify relevant non-motor symptoms | day 1 |
Placebo Controlled Metformin and Sulfonylurea Combination Study in Patients With Type 2 Diabetes (0767-025)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare how MK0767 and metformin and sulfonylurea therapy lower blood glucose in patients with inadequate glycemic control This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: MK0767


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Type 2 diabetes wtih inadequate glycemic control on maximally effective/tolerated metformin and sulfonylurea therapy Non-pregnant females Exclusion Criteria: Patients with Type 1 Diabetes or history of ketoacidosis Patients who have been treated with insulin or other antihyperglycemic agents Patients with viral hepatitis, active liver or gallbladder disease, history of pancreatitis, heart disease, congestive heart failure, inadequately controlled hypertension, HIV positive, history hematologic disorders or neoplastic disease

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 78 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

| Intervention/Treatment |
| --- |
|Drug: MK0767|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Genetic Study of Atrial Fibrillation: Focusing on Renin-Angiotensin System and C-Reactive Protein Genes

Study Overview
=================
Brief Summary
-----------------
Multi-locus and multi-gene studies of atrial fibrillation, focusing on renin-angiotensin system genes and C reactive protein gene

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with atrial fibrillation Exclusion Criteria: Patients with atrial fibrillation who are reluctant for the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Dexamethasone on Fetal Heart Rate Variables In Case Of Imminent Preterm Labor

Study Overview
=================
Brief Summary
-----------------
Effect of dexamethasone on fetal heart rate variability in case of preterm labour: prospective cohort study

Detailed Description
-----------------
prospective cohort study on Effect of dexamethasone on fetal heart rate variability in case of preterm labour

Official Title
-----------------
Effect of Dexamethasone on Fetal Heart Rate Variables In Case Of Imminent Preterm Labor

Conditions
-----------------
Fetal Heart Rate or Rhythm Abnormality Affecting Fetus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm labor Exclusion Criteria: Twins

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 50 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fetal heart rate variability in relation to dexamethasone administration |  | Baseline |
A Study to Compare Two Ways of Completing Pain and Sleep Questions and to Evaluate a New Daily Questionaire for Assessing Fatigue in Fibromyalgia Patients

Study Overview
=================
Brief Summary
-----------------
The study has two goals. The first goal of the study is to compare two methods of administering questions about pain and sleep interference. The two methods being compared are a telephone based system and an electronic hand held diary. The second goal of the study is to evaluate a daily diary to evaluate fatigue symptoms in patients with fibromyalgia.

Official Title
-----------------
A Non-Drug Methodology Study To Explore The Psychometric Properties Of A Daily Diary Of Fatigue Symptoms And To Compare Two Modes Of Administration Of Pain And Sleep Interference Questions For Use With Fibromyalgia Patients

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Other: Interactive Voice Response System (IVRS)
* Other: Personal Digital Assisstant (PDA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fibromyalgia using ACR diagnosis Exclusion Criteria: Other confounding disease including other inflammatory disease, pain and depression

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Interactive Voice Response System<br> | Other: Interactive Voice Response System (IVRS)<br>* Telephone based system<br>|
| Other: Personal Digital Assisstant<br> | Other: Personal Digital Assisstant (PDA)<br>* Electronic Hand Held diary<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily questions about pain asked using a telephone based system and a hand held diary |  | 4 weeks | 
| Daily questions about sleep asked using a telephone based system and a hand held diary |  | 4 weeks | 
| Daily questions about fatigue asked hand held electronic diary |  | 2 weeks | 
| Questionaires about pain, fatigue, function, quality of life, patients impression of change and diary ease of use |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionaires about sleep, mood and fibromyalgia severity |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fibromyalgia methodology pain sleep fatigue
Zyprexa® Relprevv™ Patient Care Program

Study Overview
=================
Brief Summary
-----------------
The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS).

Detailed Description
-----------------
The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS) by: Ensuring Zyprexa Relprevv is prescribed only by certified prescribers, dispensed only by certified dispensers, and dispensed for use only in certified healthcare facilities with ready access to emergency response services, and dispensed for use only with documentation of safe use conditions; Informing health care providers and patients about the risks and the need for continuous observation of patients for at least 3 hours in certified healthcare facilities; and Establishing long-term safety and safe use of Zyprexa Relprevv through periodic monitoring for the risk of PDSS events and by enrolling all patients who receive Zyprexa Relprevv in the Zyprexa Relprevv Patient Care Program registry.

Official Title
-----------------
Zyprexa® Relprevv™ Patient Care Program

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patients receiving Zyprexa Relprevv enrolled in Zyprexa Relprevv Patient Care Program Exclusion Criteria: Any patient not receiving Zyprexa Relprevv

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 |
| --- | --- |
| Patients<br>All patients who will be receiving Zyprexa Relprevv must be enrolled into the Zyprexa Relprevv Patient Care Program | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence per injection and per patient of post-injection delirium/sedation syndrome (PDSS) events |  | Baseline to end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of post-injection delirium/sedation syndrome (PDSS) by clinical presentation and outcome |  | Baseline to end of study | 
| Potential risk factors of post-injection delirium/sedation syndrome (PDSS). |  | Baseline to end of study |
A Study to Evaluate SU-VEID™ for Improving Peripheral Venous Access Success in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if use of the SU-VEID™ in children facilitates an increase success rate of peripheral intravenous starts, in comparison to the conventional method of vein entry techniques.

Official Title
-----------------
Use of SU-VEID™ As An Adjunct to Vein Visualization Technology to Improve Peripheral Venous Access Success in Children

Conditions
-----------------
Intravenous Access

Intervention / Treatment
-----------------
* Device: Single Use Vein Entry Indicator Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient age < 18 years old. Pediatric patients in surgical pre-op (0-18 years old), requiring an I.V. catheter for surgery who are difficult venous access. Written informed consent/ assent from the patient or legal guardian. Exclusion Criteria: - Patient age > 18 years old.

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard IV Insertion<br>Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have standard IV insertion | |
| Other: SU-VEID assisted IV Insertion<br>Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have IV insertion using SU-VEID device | Device: Single Use Vein Entry Indicator Device<br>* Electronic pressure sensing device, integrated to a conventional needle catheter, and which indicates continuously during intravenous cannulation whether the tip of the needle is inside or outside of a vein, to assist a clinician in intravenous cannulation.<br>* Other names: SU-VEID;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IV Start first-attempt success rate | Total number of participants to have an IV access within the first attempt when using the SU-VEID Device in comparison to the conventional procedure | Baseline |