linjc16/ctgov huggingface dataset:
Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depression

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program intended to provide access to ZULRESSO™ (brexanolone) injection for the treatment of a limited number of eligible women with postpartum depression during the period prior to commercial availability. Requests for access must be made by a healthcare provider for a specific patient based on a determination with patient that the benefits of treatment outweigh the risks and an assessment of eligibility based on program criteria. Sites with eligible patients must apply and meet requirements for participation in the expanded access program.

Official Title
-----------------
Expanded Access Protocol of ZULRESSO for Adult Patients With Postpartum Depression

Conditions
-----------------
Postpartum Depression

Intervention / Treatment
-----------------
* Drug: ZULRESSO (brexanolone) injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has signed an informed consent form prior to any study-specific procedures being performed Subject is an ambulatory female at least 18 years of age Subject agrees to adhere to the study requirements Subject agrees not to be the primary caregiver of any dependents during the infusion Subject must have a negative pregnancy test on Day 1 prior to the start of the ZULRESSO infusion Subject has a current diagnosis of PPD, as assessed by the Investigator Exclusion Criteria: Subject has end stage renal disease Subject has a known allergy to progesterone or allopregnanolone

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ZULRESSO (brexanolone) injection|ZULRESSO|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Expanded Access
Noninvasive Hemoglobin Testing, Prospective Blood Donors

Study Overview
=================
Brief Summary
-----------------
The objective of this clinical investigation is to evaluate the pulse oximeter devices for screening prospective blood donors. The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer in a blood donation setting.

Official Title
-----------------
Noninvasive Hemoglobin Testing in Prospective Blood Donors

Conditions
-----------------
Healthy, Anemia

Intervention / Treatment
-----------------
* Device: Rad-67 Pulse oximeter & DCI Mini sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age Weight at least 110 pounds Subjects with the intention of being screened for eligibility to donate blood The subject has given written informed consent to participate in the study Exclusion Criteria: Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, infections, abnormalities, etc. Subjects unwilling and/or unable to remove nail polish or acrylic nails Subjects with blood cancers such as leukemia Subjects with hemoglobin disorders such as sickle-cell anemia and thalassemia Subjects with known history of infectious diseases such as HIV/AIDS, syphilis, hepatitis, etc. Subjects with self-disclosed/known pregnancy at the time of enrollment Subjects deemed not suitable for the study at the discretion of the investigator Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test subjects<br>All subjects are enrolled and receive Rad-67 Pulse oximeter & DCI Mini sensor for measurement of hemoglobin. | Device: Rad-67 Pulse oximeter & DCI Mini sensor<br>* Noninvasive pulse oximeter that measures hemoglobin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rad-67 Sensitivity | Sensitivity of the the Rad-67 will be determined for its use in a blood donation center | Up to one hour per subject | 
| Rad-67 Specificity | Specificity of the the Rad-67 will be determined for its use in a blood donation center | Up to one hour per subject |
Gender Bias in the Overuse Studies Conducting in Primary Care

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze whether the differences between men and women in the frequency of adverse events due to ignoring Do not do recommendations in primary care setting are due to biological causes or gender bias.

Detailed Description
-----------------
First, using the Delphi technique, a consensus will be reached on those Do Not Do recommendations that should be included in the retrospective analysis study. The selection criteria for these recommendations will be if they are considered to persist in clinical practice in primary care, their relationship with factors associated with sex and gender, and if ignoring the Do not do recommendation could cause a serious adverse event. Second, a retrospective cohort study will be carried out in which a random selection of medical records will be reviewed to identify the frequency of adverse events due to ignoring the Do not do recommendations previously selected by consensus. Investigators will review a total of 1538 medical records of patients (50% of women) who attended primary care consultation from 1st January 2022 to 31st December 2022. Data source will be the electronic record management system of the autonomous community of Valencia, named ABUCASIS. Adverse events will be identified by using an activation tool used in a previous study (SOBRINA study).

Official Title
-----------------
A Framework to Analyze Gender Bias in the Overuse Studies Conducting in Primary Care

Conditions
-----------------
Severe Adverse Event

Intervention / Treatment
-----------------
* Other: Do not do recommendation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Attending primary care consultation from 1 January 2017 to 31 December 2019. Adult Exclusion Criteria: - None

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Do not do recommendation|A drug prescription or procedure included in 'do not do' recommendations|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of severe adverse events | Number of severe adverse events due to ignore do not do recommendations | From date of prescription until the date of first documented severe adverse event or date of death from any cause, whichever came first, assessed up to 12 months | 
| Number of female patients who were recommended do not do | Number of female patients who were recommended do not do | From 1st January 2022 to 31 December 2022 | 
| Number of male patients who were recommended do not do | Number of male patients who were recommended do not do | From 1st January 2022 to 31 December 2022 |
Increasing Walking Following Cardiac Rehabilitation

Study Overview
=================
Brief Summary
-----------------
The purpose of the project was to test the widely endorsed assumption that pedometers produce or encourage more physical activity participation in the form of walking. The investigators hypothesized that pedometers would not increase the amount of walking cardiac patients participated in after their cardiac rehabilitation program compared to patients without pedometers.

Detailed Description
-----------------
As evidenced by the media attention given to pedometers and recent physical activity promotional efforts focused on pedometers, people seem to think that owning a pedometer will influence activity levels. However, an examination of a few social cognitive theories produces no theoretical rationale that would support any sustained positive influence of pedometers in the absence of some other conditional factor, such as a behavioural goal or a social support system. We believe that once people determine how many steps their usual routes and daily activity typically amounts to, that the pedometer will no longer be used. We based our contentions on two theories: self efficacy theory (Bandura, 1986;1997) and self-determination theory (Deci & Ryan, 2000).

Official Title
-----------------
Increasing Walking Following Completion of Cardiac Rehabilitation

Conditions
-----------------
Cardiac Diseases, Walking

Intervention / Treatment
-----------------
* Device: pedometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients referred to the Northern Alberta Cardiac Rehabilitation Program Patients who are willing to participate Are able to read English Patients who are able to walk at 2.0 mph based on their exercise stress test results Exclusion Criteria: patients unable to walk or walking contra-indicated unwilling do not read English
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 |
| --- | --- |
| No Intervention: control<br>no pedometer | |
| Experimental: pedometer<br>given pedometer | Device: pedometer<br>* gave pedometer and info<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity behaviour |  | months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise adherence, cardiac patients, walking
TIII Over TI in Subjects With Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Study was performed to identify ECG criteria for unmasking of subjects with NSTEMI at elevated risk.

Detailed Description
-----------------
In the present study the investigators assessed the value of T wave changes in subjects with NSTEMI (TIII>TI).

Official Title
-----------------
Assessment of T Wave Changes of Patients With Acute Non-ST-elevation Myocardial Infarction

Conditions
-----------------
NSTEMI - Non-ST Segment Elevation MI

Intervention / Treatment
-----------------
* Other: Non interventional study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NSTEMI and PCI Exclusion Criteria: NSTEMI without percutaneous intervention
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TIII>TI<br>Subjects with TIII>TI in initial ECG | Other: Non interventional study<br>* retrospective noninterventional study<br>|
| Non TIII>TI<br>Subjects without TIII>TI in initial ECG | Other: Non interventional study<br>* retrospective noninterventional study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial infarction size | Assessment of myocardial damage using biomarkers | 5 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation with coronary artery | Assessment of association of infarct related artery and ECG changes | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSTEMI, ECG
Cancer Center Trials: Reasons for Low Accrual Rates at One Academic Institution Vs. The Community Setting

Study Overview
=================
Brief Summary
-----------------
To identify reasons for low patient recruitment numbers to clinical trials in a cancer research center setting (and a community setting) in order to attempt to increase accrual rates. To review the screening sheet for women who considered participating in the study of Tamoxifen and Raloxifene (STAR) for the prevention of breast cancer in high risk women through the University of New Mexico in Albuquerque from 1999 through 2004

Detailed Description
-----------------
Objective 1: All new cancer patients seen for a four month period at the University of New Mexico Cancer Research and Treatment Center (UNM CRTC) (academic population) and for a six month-period at the New Mexico Cancer Care Alliance (NMCCA) (community setting). A careful screening log will be kept during this period with the research nurses cooperation in documenting 1) whether patients seen were accrued to a clinical trial, 2) what available trials the patient might possibly be eligible for, and 3) the reason for not registering on to a clinical trial. Objective 2: To compare the responses to questions on the entry forms of those women who were eligible and declined participation to those who participated by Hispanic versus non-Hispanic ethnicity, we will access, copy, and analyze all the risk assessment profiles otherwise known as entry or eligibility forms completed by women who considered participating in the study of Tamoxifen and Raloxifene (STAR). Patterns of eligibility criteria and risk assessment will be described by ethnicity of women considered for entry into this chemopreventive randomized trial without the use of personal identifying data in accordance with the Health Insurance Portability Accountability Act of 1996 to maintain patient confidentiality

Official Title
-----------------
Cancer Center Trials: Reasons for Low Accrual Rates at One Academic Institution Vs. The Community Setting

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who considered participating in the study of Tamoxifen and Raloxifene (STAR) for the prevention of breast cancer in high risk women through the University of New Mexico in Albuquerque from 1999 through 2004 Exclusion Criteria: Not specified.

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

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

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 |
| --- | --- | --- |
Intrathecal Morphine for Postoperative Analgesia Following Laparoscopic Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
this study compares the use of intrathecal morphine, to multimodal analgesic techniques for postoperative pain management following laparoscopic bariatric surgery.

Official Title
-----------------
Intrathecal Morphine for Postoperative Pain Management in Patients Undergoing Laparoscopic Bariatric Surgery

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

Intervention / Treatment
-----------------
* Drug: intrathecal morphine
* Drug: intrathecal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesia (ASA) II-III patients. Aged 30-50 years. The body mass index (BMI) of the patients needed to be over 40 kg/m² or over 35 kg/m² with at least one comorbidity. Exclusion Criteria: Patients with a known allergy to the study drugs. Advanced cardiac, respiratory, renal or hepatic disease. Coagulation disorders. Infection at or near the site of intrathecal injection. Drug or alcohol abuse. Psychiatric illnesses that may interfere with perception and assessment of pain.

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group I: morphine group<br>received 0.3mg morphine (0.3ml) added to 1.2ml of bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia. | Drug: intrathecal morphine<br>* received 0.3mg morphine (0.3ml) added to 1.2ml of bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia.<br>|
| Placebo Comparator: group II: control group<br>received 0.3ml saline added to 1.2mlof bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia. | Drug: intrathecal saline<br>* received 0.3ml saline added to 1.2mlof bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total postoperative analgesic consumption. | the efficacy of the studied dose of intrathecal morphine in reducing postoperative analgesic consumption. | 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (VAS) scores | postoperative pain scores | 24 hours postoperative | 
| Time to first request of rescue analgesia. |  | 24 hours postoperative | 
| Tolerability as assessed by the incidence of side effects | the incidence of side effects | 24 hours postoperative |
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis (CF) Participants 2 Years and Older

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long term safety, tolerability, efficacy and pharmacodynamics of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) in CF participants 2 years of age and older.

Official Title
-----------------
A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Years and Older

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: ELX/TEZ/IVA
* Drug: IVA


Participation Criteria
=================
Eligibility Criteria
-----------------
key Inclusion Criteria: Completed study drug treatment in the parent study (VX20-445-111 Part B, NCT04537793), or had study drug interruption(s) in the parent study, but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period of the parent study Key Exclusion Criteria: History of study drug intolerance in the parent study History of poor compliance with ELX/TEZ/IVA and/or procedures in the parent study Other protocol defined Inclusion/Exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 2 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: ELX/TEZ/IVA<br>Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening. | Drug: ELX/TEZ/IVA<br>* Fixed-dose combination granules or tablets for oral administration.<br>* Other names: elexacaftor/tezacaftor/ivacaftor;Drug: IVA<br>* Granules or tablets for oral administration.<br>* Other names: ivacaftor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | From Day 1 up to Week 196 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change in Sweat Chloride (SwCl) |  | From Baseline up to Week 192 | 
| Absolute Change in Lung Clearance Index (LCI) 2.5 |  | From Baseline up to Week 192 |
Pilot Study- Treat to Target Vitamin D in End Stage Renal Disease

Study Overview
=================
Brief Summary
-----------------
Feasibility of dose adjustment to reach a 6 month 25-hydroxy vitamin D level of 35-50 ng/ml in end stage renal disease patients

Detailed Description
-----------------
Pilot study to test the feasibility of adjusting doses based on a prespecified algorithm to reach a 6 month 25(OH)D level of 35-50 ng/ml in end stage renal disease patients.

Official Title
-----------------
Pilot Study- Treat to Target Vitamin D in End Stage Renal Disease

Conditions
-----------------
Chronic Kidney Diseases

Intervention / Treatment
-----------------
* Dietary Supplement: Cholecalciferol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: likely be able to complete the study, >3 months on hemodialysis, receiving standard of care through their nephrologist. Exclusion Criteria: on peritoneal dialysis, allergy to vitamin D, liver disease, intestinal disorders that interfere with vitamin D absorption, taking vitamin D >800 IU per day, 25(OH)D level >30 ng/ml, glucocorticoids, anticonvulsants or drug therapies for osteoporosis, pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Subjects will be started on Vitamin D3 4000 per day or 2400 IU per day at baseline and based on 3 month 25(OH)D levels, will be adjusted to a different vitamin D dose if needed
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D 4000<br>At baseline, if subjects 25(OH)D levels are 12-19.9, they will be started on 4000 IU per day. | Dietary Supplement: Cholecalciferol<br>* Vitamin D<br>* Other names: Vitamin D3;|
| Active Comparator: Vitamin D 2400<br>At baseline, if subjects 25(OH)D levels are 20-30, they will be started on 2400 IU per day. | Dietary Supplement: Cholecalciferol<br>* Vitamin D<br>* Other names: Vitamin D3;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 25(OH)D level | 25(OH)D level | 6 months |