linjc16/ctgov huggingface dataset:
An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Follicular Lymphoma

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate the safety and efficacy of MabThera/Rituxan (rituximab) in previously untreated patients with follicular lymphoma. Data will be collected for 3 years

Official Title
-----------------
An Observational Phase IV Non Interventional Study in Patients With Advanced Follicular Lymphoma (III-IV) Evaluating the Safety of Maintenance Therapy With Rituximab After 8 Cycles of Rituximab in Combination With Chemotherapy as Induction Therapy in Previously Untreated Patients in Greece.

Conditions
-----------------
Lymphoma, Follicular

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/=18 years Patients with previously untreated follicular lymphoma (stage III-IV) according to the approved summary of product characteristics (SPC) Exclusion Criteria: Contraindications to MabThera/Rituxan therapy according to the approved SPC

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 3 years | 
| Event-free survival |  | 3 years | 
| Overall survival |  | 3 years |
Comparison Between Early and Late Mobilization After Cardiac Device Implantation

Study Overview
=================
Brief Summary
-----------------
Mobilization after cardiac implantable electronic devices (CIED) implantation is highly variable between centers, some discharging home after 3-4 hours while others request bed restriction for 24 hours. Concern about lead dislodgements due to early mobilization are probably not justified. Bed restriction may result in considerable inconvenience to the patients.

Detailed Description
-----------------
Mobilization after cardiac implantable electronic devices (CIED) implantation is highly variable between centers, some discharging home after 3-4 hours while others request bed restriction for 24 hours. Concern about lead dislodgements due to early mobilization are probably not justified. Bed restriction may result in considerable inconvinience to the patients. Patients will be randomally assigned to early mobilization (after 4 hours) or bed restriction till the morning after the procedure. Primary outcome: lead malfunction, patients' satisfaction

Official Title
-----------------
Comparison Between Early and Late Post-operative Mobilization Following Implantation of Cardiac Pacemaker or Defibrillator

Conditions
-----------------
Pacemaker, Artificial

Intervention / Treatment
-----------------
* Other: mobilization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing device implantation and are hemodynamically stable Exclusion Criteria: hemodincamically unstable patient's request

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: early mobilization after cardiac device implantation<br>mobilization after 4 hours | Other: mobilization<br>* Early mobilization after CIED implantation<br>|
| Active Comparator: Late mobilization after cardiac device implantation<br>Mobilization after 24 hours | Other: mobilization<br>* Early mobilization after CIED implantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lead dislodgement | incidence of device lead dislodgement | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' comfort level | comfort level based on immobilization comfort questionnaire | one month |
Management and Healthcare Utilization of Patients With Chronic Airway Disease During the COVID-19 Epidemic

Study Overview
=================
Brief Summary
-----------------
During the COVID-19 epidemic, the medical treatment, disease status, and medication status of patients with chronic airway disease have not been studied. The purpose of this study is to investigate the management and healthcare utilization of patients with chronic airway disease and the influencing factors during the COVID-19 epidemic.

Detailed Description
-----------------
During the COVID-19 epidemic, the medical treatment, disease status, and medication status of patients with chronic airway disease have not been studied. The purpose of this study is to investigate the management and healthcare utilization of patients with chronic airway disease and the relevant factors during the COVID-19 epidemic. Using cross-sectional research methods, telephone interviews and questionnaire surveys were used to investigate the management and healthcare utilization of patients with chronic airway disease （COPD and asthma）during the COVID-19 epidemic.

Official Title
-----------------
Management and Healthcare Utilization of Patients With COPD and Asthma During the COVID-19 Epidemic in Beijing

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive, Asthma

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD patients and asthma patients in the Chronic Airway Disease Database in Peking University Third Hospital. Exclusion Criteria: Refusal to participate in this study; cognitive dysfunction.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory symptoms | COPD Assessment Test (CAT) | through study completion, an average of 2 week. | 
| Frequency of exacerbation during the COVID-19 epidemic | Frequency of exacerbation during the COVID-19 epidemic | through study completion, an average of 2 week. |
Preoperative Inspiratory Muscle Training Effects on the Perioperative Inflammatory Reaction in Cardiac Surgery.

Study Overview
=================
Brief Summary
-----------------
This study evaluates the impact of preoperative high-intensity inspiratory muscle training (IMThi) before cardiac surgery on perioperative inflammatory response. Half participants will receive high intensity inspiratory muscle training and the others a sham inspiratory muscle therapy.

Official Title
-----------------
High Intensity Preoperative Inspiratory Muscle Training (IMTHi) Effects on the Perioperative Inflammatory Reaction in Cardiac Surgery With an Associated Biocollection.

Conditions
-----------------
Thoracic Surgery, Prehabilitation, Respiratory Therapy

Intervention / Treatment
-----------------
* Other: Prehabilitation with inspiratory muscle training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Waiting for thoracic surgery with valve replacement Preoperative surgeon consultation between 3 and 6 weeks before surgery Exclusion Criteria: Patient with antecedent of lung surgery Patient with neuromuscular or neurovascular disease Non anticipated surgery with a time between surgeon consultation and surgery inferior to 3 weeks. Inhability to do the preoperative exercises

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: sham IMT<br>Preoperative Inspiratory muscle training at low intensity (15% Pimax) which is considered as a no effect training. | Other: Prehabilitation with inspiratory muscle training<br>* 3 to 6 weeks of two times a day inspiratory muscle training at 80% of the Maximum Inspiratory Pressure.<br>|
| Experimental: Hi Intensity IMT<br>High intensity muscle training in the preoperative period at 80% of the maximal inspiratory muscle pressure. | Other: Prehabilitation with inspiratory muscle training<br>* 3 to 6 weeks of two times a day inspiratory muscle training at 80% of the Maximum Inspiratory Pressure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative STNFr1 level | Post training and preoperative Serum concentration of the SRNFr1 cytokine. | Outcome is evaluated at the training initiation and re evaluated 24hours before the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inspiratory muscle training, Systemic Inflammatory Response Syndrome
Nalbuphine as an Adjuvant to Intravenous Regional Anesthesia

Study Overview
=================
Brief Summary
-----------------
The effect of addition of nalbuphine to lidocaine in intravenous regional anesthesia

Official Title
-----------------
Nalbuphine as an Adjuvant to Intravenous Regional Anesthesia

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Nalbuphine
* Drug: Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients American Society of Anesthesiologists (ASA) physical status I-II age between 20 and 50 years old scheduled for elective unilateral short hand surgery Exclusion Criteria: allergy to study medications body mass index > 35 kg/m2 patients with sickle cell disease or Reynaud disease patient refusal

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nalbuphine<br>53 patients received intravenous regional lidocaine plus Nalbuphine | Drug: Nalbuphine<br>* 53 patients received intravenous regional lidocaine plus nalbuphine<br>|
| Other: Control group<br>53 patients received intravenous regional lidocaine | Drug: Lidocaine<br>* 53 patients received intravenous regional lidocaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tourniquet and postoperative pain measured by visual analogue scale |  | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortisol level |  | 4 hours |
SVV and PPV Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia

Study Overview
=================
Brief Summary
-----------------
Although individualized or goal-directed approach has been advocated, a reliable index is still required to help monitor the volume status timely and efficiently. Dynamic indexes, such as pulse pressure variation (PPV) and stroke volume variation (SVV), have been shown to be clearly superior to more commonly measured static preload variables, such as pulmonary artery occlusion pressure (PAOP) and central venous pressure (CVP). The reliability of dynamic indexes in monitoring the volume status and predicting fluid responsiveness have been validated. Fluid optimization guided by SVV and PPV is beneficial to hemodynamic stability and can decrease mortality and reduce postoperative complications. However, the usefulness of dynamic indexes in elderly patients has not been previously investigated. This study aimed to evaluate whether dynamic indexes PPV and SVV can reliably predict fluid responsiveness in elderly patients, and to determine their thresholds in elderly patients.

Official Title
-----------------
Stroke Volume Variation and Pulse Pressure Variation Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia

Conditions
-----------------
Stroke Volume Variation, Pulse Pressure Variation, Fluid Responsiveness, Fluid Therapy

Intervention / Treatment
-----------------
* Diagnostic Test: volume expansion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Patients undergoing gastrointestinal surgery 2.Age between 18 and 80 3.ASA I  II. 4.BMI 18   24 kg/m2 Exclusion Criteria: 1.arrhythmias 2.intracardiac shunts 3.severe hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg) 4.pulmonary hypertension 5.chronic obstructive pulmonary disease 6.peripheral vascular obstructive disease 7.receiving long-term treatment with vasopressors.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 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: observed patients<br> | Diagnostic Test: volume expansion<br>* volume expansion with 6% hydroxyethyl starch (7 mL/kg) at a rate of 0.4 mL/kg/min<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid responsiveness | Fluid responsiveness was defined as an increase in CI ≥15% | immediately after the fluid therapy |
Receiving Radiation Therapy in the MRgRT Research Facility

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the technical performance of magnetic-resonance guided radiotherapy (MRgRT) facility at the Princess Margaret Cancer Centre and the impact on the workflow of the clinical team in this facility.

Official Title
-----------------
Receiving Radiation Therapy in the MRgRT Research Facility

Conditions
-----------------
Solid Tumors and Metastatic Lesions

Intervention / Treatment
-----------------
* Radiation: Magnetic resonance - guided radiation therapy (MRgRT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide informed consent Planned to receive clinical intervention (imaging or treatment) in the MRgRT facility At least 18 years of age Exclusion Criteria: -

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: Magnetic resonance - guided radiation therapy (MRgRT)<br>Magnetic resonance (MR) - guided radiation therapy | Radiation: Magnetic resonance - guided radiation therapy (MRgRT)<br>* Use of magnetic resonance (MR) visualization for interventional radiotherapy in cancer patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of planned patients receiving treatment in the MRgRT facility |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure tumor size before, during and after radiotherapy | Collect and analyze imaging data before, during and after radiotherapy, and the related treatment data | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
magnetic resonance, external beam radiotherapy, brachytherapy, radiotherapy
An Assessment of the Glider Balloon in Complex Lesions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect data from real-world use with the Glider Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to support the effectiveness of the Glider PTCA Balloon for crossing into complex coronary lesions.

Detailed Description
-----------------
Observational Study collecting data on commercial cases in which the Glider PTCA Balloon Catheter is used in accordance with the instructions for use. This study includes up 500 patients at up to 50 study sites.

Official Title
-----------------
An Assessment of the Glider Balloon in Complex Lesions

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: PTCA Balloon Angioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lesion must be successfully crossed with a guidewire without complication (including Chronic Total Occlusions (CTOs)) The Glider balloon may only be used at one lesion during the procedure The lesion in which the Glider balloon is used must be completed first The primary lesion treated during the procedure must be treated with the Glider balloon Intended treatment of a protocol-defined complex lesion that has at least one of the following factors: Significant vessel tortuosity Failed balloon crossing with another balloon Tight stenosis Heavy calcification Side branch present Exclusion Criteria: Patient < 18 years of age Lesion longer than 40mm Device use not consistent with Instructions for Use Patient has not given consent for their data to be submitted to this registry

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 |
| --- |
|Device: PTCA Balloon Angioplasty|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success Rate | Percentage of lesions successfully crossed among those attempted with the Glider PTCA catheter. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from Balloon Slippage | Percentage of inflations with the Glider balloon in which the physician user reports no slippage. | 1 hour | 
| Lesion Success Rate | Percentage of lesions with <50% diameter stenosis, or Thrombolysis In Myocardial Infarction (TIMI) 3 flow if side branch is present, without development of MACE during hospital stay. | 48 hours |
Factors Associated With the Use of a High Volume Cancer Center by Black Women With Ovarian Cancer: A Qualitative Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the experiences of Black women who receive care for ovarian cancer at Memorial Sloan Kettering Cancer Center, or MSK for short. The study consists of interviews with Black women who recently obtained some part of their ovarian cancer care at MSK.

Official Title
-----------------
Factors Associated With the Use of a High Volume Cancer Center by Black Women With Ovarian Cancer: A Qualitative Study

Conditions
-----------------
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

Intervention / Treatment
-----------------
* Behavioral: semi-structured interviews


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant must have been diagnosed with ovarian, fallopian tube or primary peritoneal cancer and treated by an MSK physician. Participants must be able to provide verbal informed consent. Participants must be 18 years of age or older. Participants must self-identify as Black/African American. Participant must be able to understand and speak in English Exclusion Criteria: Inability or refusal to identify race/ethnicity. Presence or development of a physical, cognitive or psychiatric deficit resulting in an inability to provide meaningful informed consent or to understand the study or complete the interview.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Black Women with Cancer<br>In this formative qualitative research study we aim to use one-on-one semi-structured interviews with Black women diagnosed with ovarian cancer to learn about their experiences and their journey to accessing care at a high-volume ovarian cancer care center (HVC). | Behavioral: semi-structured interviews<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accessing care | The study team will review and code the interview transcripts through a process of independent and collaborative thematic content analysis,[15-18] using ATLAS.ti (a qualitative data analysis software package) to facilitate the analysis process. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
interviews, 16-1378