linjc16/ctgov huggingface dataset:
Hepatic Impaired Subjects Compared to Healthy Subjects Receiving Multi-dose BMS-650032

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effects of hepatic impairment on the multiple dose pharmacokinetics of BMS-650032.

Official Title
-----------------
Multiple-Dose Pharmacokinetics of BMS-650032 in Subjects With Hepatic Impairment Compared to Healthy Subjects

Conditions
-----------------
Hepatic Insufficiency

Intervention / Treatment
-----------------
* Drug: BMS-650032


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects aged 18 to 70, with hepatic impairment conforming to Child-Pugh class A,B or C Each matched control subjects determined to be healthy Exclusion Criteria: History of esophageal and gastric bleeding within the past 6 months Primarily cholestatic liver disease Active alcoholic hepatitis Stable encephalopathy of ≥Stage 2 Presence of severe ascites or edema Presence of hepatopulmonary or hepatorenal syndrome Positive for HIV Positive for HCV, unless HCV RNA is undetectable

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BMS-650032 in Child-Pugh A<br> | Drug: BMS-650032<br>* Capsules, Oral, 200 mg, BID, 7 Days<br>|
| Active Comparator: BMS-650032 in Child-Pugh B<br> | Drug: BMS-650032<br>* Capsules, Oral, 200 mg, BID, 7 Days<br>|
| Active Comparator: BMS-650032 in Child-Pugh C<br> | Drug: BMS-650032<br>* Capsules, Oral, 200 mg, BID, 7 Days<br>|
| Active Comparator: BMS-650032 in Healthy Subjects<br> | Drug: BMS-650032<br>* Capsules, Oral, 200 mg, BID, 7 Days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics parameters including Cmax, Tmax,AUC(TAU),Vss/F, T-Half, CLT/F and AI |  | Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety and tolerability of BMS-650032 in subjects with hepatic impairment and in healthy subjects. This will be measured by: blood chemistries, hematology, urinalysis and ECGs |  | Day 10 | 
| Assess the relationship between the Child-Pugh classification (including its components) and BMS-650032 PK parameters. This will be measured by frequent pharmacokinetics blood samples. |  | Day 10 |
Booster Dose Trial

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to assess the safety and effectiveness of a COVID vaccine booster in patients with cancer who have not developed an antibody after the U.S. Food and Drug Administration (FDA) Emergency Use Authorized COVID vaccination series

Official Title
-----------------
Safety and Efficacy of Booster Doses of BNT162b2 Vaccine in Immunocompromised Patients With a Cancer Diagnosis

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

Intervention / Treatment
-----------------
* Biological: BNT162b2 vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above the age of 18 Known diagnosis of any malignancy- either active or completed therapy Underwent an in-person encounter at a study facility during the study period Have a negative SARS-CoV-2 spike IgG at least 14 days after the second dose of the mRNA-based vaccines (Moderna or Pfizer/BioNTech) or 28 days after a single dose of the adenovirus-based Johnson & Johnson vaccine. Exclusion Criteria: Patients who have had a serious adverse reaction to any prior COVID-19 vaccines resulting in emergency room visit or hospitalization, had events related to myocarditis, thrombosis and thrombocytopenia syndrome or anaphylaxis to any prior dose of the COVID-19 vaccines. Patients who have had a documented COVID-19 infection in the 90 days prior to starting the study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Booster dose<br> | Biological: BNT162b2 vaccine<br>* administer an additional dose of the BNT162b2 mRNA vaccine to patients with cancer who have a negative SARS-CoV-2 Spike IgG at least 14 days after 2 doses of the mRNA vaccines (BNT162b2/mRNA-1273) or 28 days after the adenoviral based Ad26CoV2.S vaccine.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of seroconversion for SARS-CoV-2 spike antibody |  | 4 weeks after booster dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Booster
Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy

Study Overview
=================
Brief Summary
-----------------
Patients with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 3 arms with different vagus nerve stimulation paradigms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.

Official Title
-----------------
Prospective Randomized Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Procedure: Vagus nerve stimulation paradigm #1
* Procedure: Vagus nerve stimulation paradigm #2
* Procedure: Vagus nerve stimulation paradigm #3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 16 years or older At least 1 seizure/month with alteration of consciousness Documented seizure diary, at least 3 months prior to implantation (baseline) No change in anti-epileptic drugs 1 month before implantation At least one or more AEDs Exclusion Criteria: Active cardiac, pulmonary or gastrointestinal disease Vagotomy Concomitant use of an investigational drug Unstable medical condition Unstable psychiatric condition

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Vagus nerve stimulation paradigm #1 | Procedure: Vagus nerve stimulation paradigm #1<br>* Vagus nerve stimulation parameters #1<br>|
| Experimental: 2<br>Vagus nerve stimulation paradigm #2 | Procedure: Vagus nerve stimulation paradigm #2<br>* Vagus nerve stimulation parameters #2<br>|
| Experimental: 3<br>Vagus nerve stimulation paradigm #3 | Procedure: Vagus nerve stimulation paradigm #3<br>* Vagus nerve stimulation parameters #3<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of vagus nerve stimulation: responder rates and mean monthly seizure frequency reduction, mean seizure free interval, seizure severity and seizure type |  | After 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VNS-related side effects |  | After 6 and 12 months | 
| Battery life |  | After 6 and 12 months | 
| Quality of life: changes in QOLIE 89 score |  | After 12 months | 
| Mood assessment: changes in Beck depression scale scores |  | After 12 months |
Blood Transfusion by Boston MedFlight Registry

Study Overview
=================
Brief Summary
-----------------
The primary aim of this observational registry is to study the outcomes of patients with hemorrhagic shock transported by Boston MedFlight receiving blood products during transport.

Detailed Description
-----------------
Boston MedFlight, a critical care transport organization, based on a consortium of the academic medical centers in Boston, will begin carrying PRBC in 2019. The program is intended to provide BMF clinicians with 24-hour immediate access to appropriate blood products to be utilized if needed for patients following life-threatening illness or injury. The four fundamental goals of this program are: save lives' ensure transfusion safety; minimize blood product waste; and conduct continuous quality assurance. Our goal is to observationally evaluate this new protocol of administering blood products in the pre-hospital setting. We will collect data on patients with hemorrhagic shock being transported by Boston MedFlight, who receive or would have been eligible to receive pre-hospital blood transfusion by the inclusion criteria.

Official Title
-----------------
Blood Transfusion by Boston MedFlight Registry

Conditions
-----------------
Hemorrhagic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult patients who would be eligible to receive blood products; systolic blood pressure <90 mmHg a shock index of > 0.9 clinical signs of shock as determined by the transport clinicians. Exclusion Criteria: Age < 18 years old

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 |
| --- | --- |
| Blood products during transport<br>Administration of appropriate blood products during transport | |
| Standard of Care<br>Receiving standard prehospital air medical care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality | 30-day all cause mortality | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood transfusion, Pre-hospital care
Trend Analysis of the Service of Pediatric Palliative Care

Study Overview
=================
Brief Summary
-----------------
Palliative care has received considerable attention in Taiwan in recent years. The relevant research has been widely conducted for palliative care in adult population. However, the research in children population is relatively insufficient. In the limited studies, most of them are the experiences generated from individual institutions. This study is going to retrieve the data from 2008-2017 National Health Insurance Research Database, Cancer Registry Database, Death Registry Database and other relevant materials in order to analyze the trends of using pediatric palliative care service, the types of services, the timing of initiating palliative care, and the preference of using palliative care service among different life span in the past decade. In addition, the study will examine the differences of the timing of initiating of pediatric palliative care service and the types of diseases among different characteristics of children and healthcare providers. And the study will discuss how pediatric palliative care services affect medical costs.

Official Title
-----------------
The Trend Analysis and Associated Factors of Initiating the Service of Pediatric Palliative Care

Conditions
-----------------
Nursing Caries, Palliative Care, Pediatric Population, Pediatric Cancer, Oncology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals died from cancer between 2008 and 2017. Exclusion Criteria: -
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 |
| --- | --- | --- |
| Taiwan Health and Welfare Data | The study will use the National Health Insurance Database, Cancer Registry Database and other relevant materials from Ministry of Health and Welfare in Taiwan to conduct research. | 2008-2017 |
18612 - Sun Protection Factor Assay

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment-Darkening Dose

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY 987521


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing; Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female. Aged between 18-70 years old. Good health as determined from the HRL SHF (Subject History Form). Signed and dated Informed Consent Form. Signed and dated HIPAA Form (Health Insurance Portability and Accountability Act). An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose). Exclusion Criteria: Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma, diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

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

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

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

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: BAY 987521<br>Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: BAY 987521<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
The Initial Assessment of Daily Insulin Dose in Newly Diagnosed Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
To investigate the daily dose of insulin in newly diagnosed Chinese type 2 diabetic patients who use the continuous subcutaneous insulin infusion (CSII) as the initial therapy.

Official Title
-----------------
The Initial Assessment of Daily Insulin Dose in Newly Diagnosed Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes.

Intervention / Treatment
-----------------
* Behavioral: The initial assessment of daily insulin dose.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All participants with type 2 diabetes, diagnosed by World Health Organization criteria, were recruited from outpatient of the Endocrinology Department in Shanghai Renji Hospital. Exclusion Criteria: Patients who had a history of coronary heart disease, abnormal renal function, active liver disease, chronic metabolic acidosis (including diabetic ketoacidosis), or severe chronic gastrointestinal disease.

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Newly diagnosed type 2 patients<br>The initial assessment of daily insulin dose. | Behavioral: The initial assessment of daily insulin dose.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| When the glucose level decreased to about 10 mmol/L |  | 72-96 hours |
Postoperative Pain After Endoscopic TEP vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair

Study Overview
=================
Brief Summary
-----------------
Immediate pain reaction and return to work after TEP or Lichtenstein hernia repair have not been studied. In this multicenter trial the patients are allocated to surgery using TEP (n=50) or Lichtenstein (n=50) technique. Pain and return to work are recorded postoperatively up to one month. Immediate and late complications are also analyzed.

Detailed Description
-----------------
Patient characteristics are recorded before surgery. The adult patients with inguinal hernia are randomized into endoscopic totally extraperitoneal hernioplasty (TEP) or open Lichtenstein hernioplasty. Pain reaction to surgery and return to work are asked many times using questionnaire and pain diary (pain scores from 1h to 30 days after surgery). Surgical complications and use of pain killers are carefully recorded. Clinical examination is performed if necessary.

Official Title
-----------------
Early Postoperative Pain After Totally Extraperitoneal Endoscopic Technique (TEP) vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair: a Prospective Randomized Multi-center Study

Conditions
-----------------
Inguinal Hernia, Hernia

Intervention / Treatment
-----------------
* Procedure: Tep surgery for inguinal hernia
* Procedure: Lichtenstein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of symptomatic inguinal hernia Age 18-80 Exclusion Criteria: Large scrotal hernia Bilateral hernia Symptom-free hernia Inguinal pain without clinical evidence of hernia Asa class≥3

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endoscopic TEP surgery<br>Routine total extraperitoneal technique surgery for inguinal hernia | Procedure: Tep surgery for inguinal hernia<br>* TEP surgery<br>|
| Active Comparator: Open Lichtenstein hernioplasty<br>Routine lichtenstein surgery for inguinal hernia | Procedure: Lichtenstein<br>* Lichtenstein surgery for inguinal hernia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores (0-100) after surgery | Patients report pain after the operation at rest, during exercise and coughing. Higher scores means worse outcome | from day 1 to 1 month postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of operative complications | Any minor or major complication | from day 1 to 1 month postoperatively | 
| Number of re-operations | Any re-operation | 1 month after the operation |
Improving COVID-19 Vaccine Uptake Among Black and Latino Youth

Study Overview
=================
Brief Summary
-----------------
Black and Latino youth may be less likely to get the COVID-19 vaccine than White youth. In this study we will work with community members to come up with ways to help Black and Latino families learn more about the COVID-19 vaccine and get the COVID-19 vaccine. We will test these ideas out in pediatric primary care clinics. This study will help us make sure that all youth have an equal chance of getting the COVID-19 vaccine.

Official Title
-----------------
Improving Pediatric COVID-19 Vaccine Awareness, Access, and Accountability in Underrepresented Communities

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

Intervention / Treatment
-----------------
* Behavioral: Culturally-Tailored COVID-19 Vaccine Uptake Intervention
* Behavioral: Standard Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Youth 0-21 years of age and their caregiver Receiving care at one of four Nemours primary care practices selected for this study Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Culturally-Tailored COVID-19 Vaccine Uptake Intervention<br> | Behavioral: Culturally-Tailored COVID-19 Vaccine Uptake Intervention<br>* This is a multi-component intervention to increase COVID-19 vaccine uptake among youth that was co-created with community partners and refined with qualitative feedback from Black and Latino youth and parents. The intervention consists of culturally-tailored educational materials to increase awareness about the COVID-19 vaccine, culturally-sensitive communication strategies employed by pediatric primary care providers and community health workers, and strategies to facilitate and standardize access to the COVID-19 vaccine in the primary care clinic.<br>|
| Active Comparator: Standard Care<br> | Behavioral: Standard Care<br>* Standard care includes routine offer of the COVID-19 vaccine and counseling about the COVID-19 vaccine by pediatric primary care providers.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 Vaccination Rate for Eligible Children | Percent of patients who received a COVID-19 vaccine among all children who were eligible for and had not yet been vaccinated for the COVID-19 vaccine during the time of their visit to one of the four participating primary care clinics. | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthcare disparities, Vaccine hesitancy