linjc16/ctgov huggingface dataset:
Elotuzumab Safety Surveillance In Japanese Patients With Relapse Or Refractory Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
BMS will conduct a regulatory postmarketing surveillance (PMS) to evaluate the safety of elotuzumab in clinical practice in Japan.

Official Title
-----------------
Elotuzumab Safety Surveillance In Japanese Patients With Relapse Or Refractory Multiple Myeloma

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with relapsed or refractory multiple myeloma who are beginning to receive elotuzumab at the selected sites will be included in this surveillance study Exclusion Criteria: Not Applicable
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MM patients receiving elotuzumab<br>Non-Interventional Study of all patients with relapsed or refractory multiple myeloma (MM) who are beginning to receive elotuzumab at the selected sites. | Other: No Intervention<br>* No Intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all adverse events(AE) to elotuzumab in real-world practice in Japan |  | Up to 72 weeks | 
| Incidence of immune-related (IR) adverse events to elotuzumab in real-world practice in Japan | immune-related (IR) adverse events are defined as: 1) AEs that are related to elotuzumab per investigator and 2) are consistent with an inflammatory process. | Up to 72 weeks | 
| Number of patients who achieve a Stringent complete response (sCR) as measured by International Myeloma Working Group (IMWG) criteria |  | Up to 72 weeks | 
| Number of patients who achieve a Complete response (CR) as measured by International Myeloma Working Group (IMWG) criteria |  | Up to 72 weeks | 
| Number of patients who achieve a Very good partial response (VGPR) as measured by International Myeloma Working Group (IMWG) criteria |  | Up to 72 weeks | 
| Number of patients who achieve a Partial response (PR) as measured by International Myeloma Working Group (IMWG) criteria |  | Up to 72 weeks | 
| Number of patients who achieve a Progressive Disease (PD) as measured by International Myeloma Working Group (IMWG) criteria |  | Up to 72 weeks | 
| Number of patients who achieve a Relapse from complete response as measured by International Myeloma Working Group (IMWG) criteria |  | Up to 72 weeks |
12 Weeks of Resistance Band Exercise Impacts on Adiposity, Hormones, and Blood Pressure in Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to examine the impacts of a 12-week resistance band exercise program on body composition, aging-related hormones, and blood pressure in postmenopausal women with stage 1 hypertension. Twenty postmenopausal women with hypertension participated in this study. Participants were randomly allocated into the resistance band training group (EX, n = 10) or the control group (CON, n = 10). The EX group performed a resistance band exercise training program at jump rope training program at 40-70% of their heart rate reserve (HRR) 5 days/week for 12 weeks (sessions 60 minutes in duration). The CON group did not participate in any exercise, dietary, or behavioral intervention. Body composition, aging-related hormones (growth hormone, insulin-like growth factor 1, dehydroepiandrosterone, and estradiol), and blood pressure were measured before and after the 12-weeks study.

Official Title
-----------------
Impacts of 12 Weeks of Resistance Band Exercise Training on Body Composition, Aging-related Hormones, and Blood Pressure in Postmenopausal Women With Hypertension

Conditions
-----------------
Hypertension, Hormone Disturbance, Adiposity

Intervention / Treatment
-----------------
* Other: Resistance band exercise intervention
* Other: No exercise intervention group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: postmenopausal hypertensive sedentary (no regular exercise training or physical activity within previous year) Exclusion Criteria: premenopausal renal, pulmonary, and/or heart disease regularly physically active
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: exercise intervention group, control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control group<br>No exercise intervention | Other: No exercise intervention group<br>* Control group: no exercise intervention<br>|
| Experimental: Resistance band exercise intervention<br>Exercise intervention group (resistance band exercise training for 12 weeks, 5x per week, for 60 minutes per day). | Other: Resistance band exercise intervention<br>* Resistance band exercise intervention (12 weeks, 5x per week, 60 minutes per day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estradiol | Estradiol levels were measured pre- and post-exercise in picograms per milliliter (pg/mL) | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postmenopausal, exercise
AZD3355 Dose-escalation Study in Healthy Males

Study Overview
=================
Brief Summary
-----------------
The aim is to establish the maximal tolerated dose of AZD3355 for the selection of doses in the up-coming studies. This will be done by comparing single and repeated doses of AZD3355 to placebo (inactive substance). Safety and tolerability variables will be closely monitored throughout the study.

Official Title
-----------------
A Phase 1 Single Centre Single-blind Randomised Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD3355 After Administration of Single Ascending Doses and Multiple Repeated Doses in Healthy Male Volunteers

Conditions
-----------------
Reflux Disease

Intervention / Treatment
-----------------
* Drug: AZD3355
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects without concurrent diseases who do not require any medical treatments Provision of signed informed consent. Exclusion Criteria: History of somatic disease/condition, which may interfere with the objectives for the study, as judged by the investigator. Clinically significant illness or clinically relevant trauma within the 2 weeks prior to the administration of the investigational product, as judged by the investigator. History of clinically significant orthostatic reaction or syncope Clinically important abnormalities related to the heart function

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD3355<br>* capsules, oral, single or twice daily dose<br>* Other names: Lesogaberan;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* To match dosing of AZD3355<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (Adverse event reporting, ECG, blood pressure, pulse rate, urine weight and osmolality, body temperature, blood and urine laboratory values) |  | During the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables |  | Several occasions during the study days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, tolerability, healthy subjects
Drug-Drug Interaction Study of MRA in Patient With Rheumatoid Arthritis (RA)

Study Overview
=================
Brief Summary
-----------------
This is an open-label, clinical pharmacology study to investigate drug-drug interaction in patients with RA.

Official Title
-----------------
An Open-Label, Clinical Pharmacology Study to Investigate Drug-Drug Interaction in Patients With RA

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: MRA(Tocilizumab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Patients who are diagnosed with RA according to the 1987 American College of Rheumatology (ACR) classification criteria Patients who contracted RA at least 6 months prior Exclusion criteria Patients with Class IV Steinbrocker functional impairment at enrollment. Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept and have been receiving treatment with leflunomide, within 12 weeks before initiation of treatment with the probe drug

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MRA(Tocilizumab)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 20% improvement based on the ACR criteria compared with the baseline value. |  | throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable. |  | Week 0,Week 1, Week 2 |
The Experiences of Patients With Greater Trochanteric Pain Syndrome.

Study Overview
=================
Brief Summary
-----------------
Greater Trochanteric Pain syndrome (GTPS) is a debilitating condition causing pain on the outside of the hip. This study aims to explore the experiences, beliefs and expectations of patients with GTPS, using semi-structured interviews.

Detailed Description
-----------------
Greater Trochanteric Pain syndrome (GTPS) is a debilitating condition causing pain on the outside of the hip. There is growing evidence to suggest that psychological barriers to recovery are present in patients with peripheral pain. The experiences and beliefs of patients suffering with GTPS are unknown. This study aims to explore the experiences, beliefs and expectations of patients with GTPS, using semi-structured interviews to inform the development of interventions for evaluation in future research.

Official Title
-----------------
The Experiences of Patients With Greater Trochanteric Pain Syndrome.

Conditions
-----------------
Greater Trochanteric Pain Syndrome

Intervention / Treatment
-----------------
* Other: Semi-structured interviews


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults > 16 Able to speak and understand the English language Patients seen in a Specialist Consultant lead clinic who have been given the diagnosis of lateral hip pain, Greater Trochanteric Pain Syndrome (GTPS), Trochanteric Bursitis or Gluteal Tendinopathy. Exclusion Criteria: Inflammatory conditions Systemic / Infective disease Previous diagnosis of Fibromyalgia or persistent multi-joint pain.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Semi-structured interviews|Semi-struuctured telephone interviews|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Framework Method of data analysis. | A systematic approach to qualitative analysis specifically used when the objectives of a study are known, prior to analysis | 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GTPS, Gluteal tendinopathy, Lateral hip pain, Trochanteric bursitis
DV2-HBV-27: Observational Pregnancy Registry

Study Overview
=================
Brief Summary
-----------------
Purpose of the study is to evaluate pregnancy outcomes among women who received a dose of HEPLISAV-B within 28 days prior to conception or at any time during pregnancy

Official Title
-----------------
HEPLISAV-B Pregnancy Registry: An Observational Study on the Safety of HEPLISAV-B Exposure in Pregnant Women and Their Offspring

Conditions
-----------------
Pregnant

Intervention / Treatment
-----------------
* Biological: HEPLISAV-B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older HEPLISAV-B exposure within 28 days prior to conception or at any time during pregnancy Exclusion Criteria: Less than 18 years of age HEPLISAV-B exposure greater than 28 days prior to conception

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult Pregnant Women Exposed to HEPLISAV-B<br>Adult women who received a dose of HEPLISAV-B within 28 days prior to conception or at any time during pregnancy. | Biological: HEPLISAV-B<br>* This study is strictly observational. Administration of HEPLISAV-B, the schedule of office visits and all treatment regimens will be determined by the treating health care provider in the context of routine clinical care.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Major Congenital Malformations in Live-Born Infants. |  | Live-born infants will be followed to 12 months of age | 
| Rate of Still Births, Pre-Term, or Fetal Loss (Including Spontaneous Abortion) of any Gestational Age |  | Follow-up will end at the time of pregnancy outcome up to 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnant, Conceived, HBV Vaccine, Hepatitis B, Hepatitis B vaccine, HBV, Hepatitis, Registry, Prevention, Female volunteers
Changes in Seroprevalence and Wellness Over Time in Healthcare Workers (CONSERVE-HCW)

Study Overview
=================
Brief Summary
-----------------
The Investigators propose a multi-center, observational, longitudinal, cohort study of the serology and wellness of HCWs over a year of the COVID-19 pandemic.

Detailed Description
-----------------
All consenting participants will undergo survey assessment and diagnostic testing with the Abbott Architect SARS-CoV-2 IgG assay (IgG) every three months for a one year period. Clinical outcomes and related data capture will be performed at this same interval.

Official Title
-----------------
Changes in Seroprevalence and Wellness Over Time in Healthcare Workers (CONSERVE-HCW)

Conditions
-----------------
COVID-19 Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 years; and Be an active member of the CommonSpirit Health workforce or medical staff during the COVID-19 pandemic and at the time of enrollment; and Have access to the Internet; and The ability to provide informed consent. Exclusion Criteria: Subjects that lack the ability for longitudinal follow-up; and/or Subjects that do not meet the above inclusion criteria. -

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline IgG Assay Information | Seroprevalence of anti-SARS-CoV-2 IgG antibodies in HCWs | Baseline | 
| Change in IgG Assay Information | The change in the seroprevalence of anti-SARS-CoV-2 IgG antibodies in HCWs over one year. | From Baseline to 3 months, 6 months, 9 months, & 12 months | 
| Compare seroprevalence of anti-SARS-CoV-2 IgG antibodies between groups | Compare seroprevalence of anti-SARS-CoV-2 IgG antibodies in 'front-line' workers and non-'front-line' HCWs | From Baseline to 3 months, 6 months, 9 months, & 12 months | 
| Impact of COVID-19 Pandemic on Perceived Wellness and Job Satisfaction | Over the 12 months of the study, evaluate the impact of the COVID-19 pandemic on HCW wellness using the Perceived Wellness Survey. Job satisfaction will be measured using a locally developed questionnaire. | Baseline to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Serology, Wellness, SARS-CoV-2 IgG, Seroprevalence, Healthcare Workers
Connectivity and Social Cognition in Adolescent Girls With Borderline Personality Disorder, a Pilot Study

Study Overview
=================
Brief Summary
-----------------
The disruption of social cognition associated with borderline personality disorder (BPD), and more specifically categorization of facial emotions, remains largely under-studied, despite the high frequency of this pathology in the clinical population. The first results differ from the observations made in adults and this confirms the relevance of studying this theme specifically in adolescence. On the cognitive level, there is a disturbance of the detection and the categorization of the facial emotions in the TPL. The characteristics of this disturbance and its possible association with an attack on the connectivity of the brain remain unknown in adolescence. No functional imaging studies are published in adolescent TPL. This pilot bimodal functional imaging study EEG-NIRS aims to collect preliminary and feasibility data to support a response to upcoming PHRC competitions and eventually offer a science thesis opportunity.

Official Title
-----------------
Connectivity and Social Cognition in Adolescent Girls With Borderline Personality Disorder, a Pilot Study

Conditions
-----------------
Adolescent Behavior, Borderline Personality Disorder

Intervention / Treatment
-----------------
* Other: Exploring the feasibility of learning during cognitive tasks (EEG-NIRS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescents 14-17 years of age with suicidal behavior and a borderline personality disorder for whom consent is obtained from parental authority, Affiliation to Social Security Exclusion Criteria: Intellectual disability, psychopathy, delusional or concomitant major depression

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 17 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 |
| --- | --- |
| Other: Adolescent with suicidal behavior and personality disorder<br> | Other: Exploring the feasibility of learning during cognitive tasks (EEG-NIRS)<br>* Exploring the feasibility of the study in its aspects of recruitment and tolerability of tasks and acquisition of electrical and hemodynamic data that can be used during cognitive tasks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis by functional imaging study of the characteristics of disorders of personalities and its possible association with an attack on connectivity of the brain |  | 3 hours |
RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole

Study Overview
=================
Brief Summary
-----------------
Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks

Official Title
-----------------
A 12-Week, Randomized, Double-Blind, Parallel Group, Multicentre Study to Assess the Tolerability and Clinical Benefits of Ropinirole Extended Release (XR) Tablets Compared With Ropinirole Immediate Release (IR) Tablets in Subjects With Restless Legs Syndrome (RLS)

Conditions
-----------------
Restless Legs Syndrome, Restless Legs Syndrome (RLS)

Intervention / Treatment
-----------------
* Drug: ropinirole Extended Release (XR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of primary RLS according to RLS Diagnostic Clinical Interview and International Restless Legs Syndrome Study Group Diagnostic Criteria. Disturbed sleep, with both evening (between 5:00 pm and 8:00 pm) and night time (between 8:00 pm and 8:00 am) symptoms requiring treatment. Exclusion criteria: Signs of secondary RLS. Primary sleep disorder or movement disorder other than RLS. Unstable medical conditions. Inability to tolerate dopamine agonists or dopamine antagonists. Unwilling to discontinue any medications currently being taken to treat RLS symptoms.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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: ropinirole Extended Release (XR)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the superior tolerability of ropinirole extended release compared to ropinirole immediate release in adult subjects with RLS requiring evening and night-time coverage of RLS symptoms |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the safety profile and to evaluate the clinical benefits (as assessed by efficacy endpoints and patient-reported outcomes) of ropinirole extended release compared to ropinirole immediate release in subjects with RLS. |  | 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Restless Legs Syndrome