linjc16/ctgov huggingface dataset:
Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease

Study Overview
=================
Brief Summary
-----------------
Provide patients with serious AdV infection or disease access to treatment with BCV.

Official Title
-----------------
An Intermediate-size, Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease

Conditions
-----------------
Adenovirus

Intervention / Treatment
-----------------
* Drug: Brincidofovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed serious AdV infection based on clinical symptoms and laboratory testing showing AdV in the blood or other bodily fluids Able to swallow medication, either tablet or liquid Exclusion Criteria: Previous dosing with Brincidofovir If female, not pregnant or trying to become pregnant

Ages Eligible for Study
-----------------
Minimum Age: 2 Months

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Brincidofovir|Up to 100mg Brincidofovir twice weekly, not to exceed a total dose of 200mg each week|

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
-----------------
Adenovirus Brincidofovir
Patient Registry: Partial Breast Irradiation

Study Overview
=================
Brief Summary
-----------------
This is an Aurora Health Care system registry of patients receiving accelerated partial breast irradiation and external beam.

Official Title
-----------------
Patient Registry: A Study of the Use of Accelerated Partial Breast Irradiation to Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aurora patients who decide to undergo PBI treatment in the next 5-years or who have had PBI Treatment in the last ten-years. All such patients are female. Exclusion Criteria: Patients not seen in an Aurora facility

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The collection and analysis of sufficient data to determine 5 and 10-year local recurrence rates is collection and analysis of sufficient data to determine 5 and 10-year local recurrence rates | The primary endpoint of this registry trial is collection and analysis of sufficient data to determine 5 and 10-year local recurrence rates for each PBI type used and for the overall Aurora population. The following endpoints will also be reported and analyzed: Disease Free Survival Regional Recurrence Distant Metastasis Combined Recurrence | 5 and 10-year local recurrence rates | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| collection and analysis of data to evaluate and compare cosmetic outcome | The secondary endpoint is the collection and analysis of data to evaluate and compare cosmetic outcome (per Harvard Score) and toxicities/complications for each PBI type (per Common Terminology Criteria for Adverse Events (referred to as CTC or CTCAE)) | 5 and 10-year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients, receiving, irradiation, device, External Beam
Evaluation of Continuous Non Invasive Blood Pressure With Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
A study to collect data recorded by devices for cNIBP evaluation purposes.

Detailed Description
-----------------
The study is going to be conducted to collect data from the devices used in the study for future AMS engineering purposes as deemed appropriate by the Sponsor.

Official Title
-----------------
Clinical Evaluation of Continuous Non-Invasive Blood Pressure Monitors With Adult Volunteers

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Device: measuring blood pressure with noninvasive blood pressure device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female, aged 18 years or older (≥18 years); Willing and able to give informed consent for participation in the study; Able and willing to comply with all the study requirements. Exclusion Criteria: Who is pregnant or lactating; Who is a smoker; Who has consumed alcohol in the last 24 hours; Who has been previously diagnosed with Ataxia or balance disorder; Who has been previously diagnosed with Raynaud's disease/ syndrome/ phenomenon; Who has been previously a diagnosed cardiovascular condition requiring medication or has an internal pacemaker; Who has an injury, deformity, A-V fistula, or other characteristic limiting the placing of cuffs on arms/fingers;

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ambulatory monitoring solution<br>this study has only one arm | Device: measuring blood pressure with noninvasive blood pressure device<br>* To measure blood pressure in different circumstances with noninvasive blood pressure device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data collection of NIBP measurement | To collect data recorded by devices for cNIBP evaluation purposes. | through study completion, average of one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect number of adverse events (AEs), serious adverse events (SAEs), and device issues | The safety objective is to collect safety information, including type and number of adverse events (AE), serious adverse events (SAE), and device issues. | through study completion, an average of one day |
Gestational Diabetes and Sleep-Disordered Breathing

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the amount of heart rate variability (HRV) for women with gestational diabetes mellitus (GDM) and to determine whether women with GDM have transient sleep-disordered breathing (SDB) during pregnancy.

Official Title
-----------------
A Pilot Study to Evaluate the Association Between Gestational Diabetes, Heart Rate Variability and Sleep-Disordered Breathing

Conditions
-----------------
Gestational Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Determining a change in heart rate variability post delivery of the baby


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women aged 18-40 years old. Pregnant women at gestational age 30 to 34 weeks. Exclusion Criteria: Pregnant women with known type 1 or type 2 diabetes mellitus. Pregnant women carrying more than one fetus. Pregnant women with pre-gestational hypertension. Pregnant women with pre-eclampsia during current pregnancy. Pregnant women with a history of coronary artery disease or acute ischemia. Pregnant women who currently smoke. Pregnant women without results for the 3 hour 100 gram oral glucose tolerance test. Pregnant women with preterm labor, cervical shortening, premature rupture of membranes or any other obstetric complications that may predispose to preterm labor. Pregnant women using 17-P (progesterone) to prevent recurrent pre-term labor. Pregnant women with known SDB.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Gestational Diabetes Mellitus (GDM)<br> | Other: Determining a change in heart rate variability post delivery of the baby<br>* Determining a change in heart rate variability post delivery of the baby<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in heart rate control post-GDM |  | Two months after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in SDB post-GDM |  | Two months after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GDM
Use of Laser Speckle to Study Post Occlusive Reactive Hyperhemia in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The investigators aim to test the hypothesis that Laser speckle contrast imaging allows for the measurement of cutaneous blood flow following various durations of tourniquet ischemia.

Detailed Description
-----------------
Ischemia and post occlusive reactive hyperemia in the skin is tested in healthy normal subjects for tourniquet ischemias of 1, 2 & 3 minutes at rest.

Official Title
-----------------
Evaluation Chez Des Sujets Volontaires Sains de l'ischémie-reperfusion cutanée

Conditions
-----------------
Microcirculation

Intervention / Treatment
-----------------
* Other: tourniquet ischemia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Affiliation to the French health system Exclusion Criteria: Any disease or chronic treatment

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy volunteers<br> | Other: tourniquet ischemia<br>* Recording of cutaneous blood flow on the forearm at rest before and following tourniquet ischemias of 1 , 2 & 3 minutes<br>* Other names: Plethysmography;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laser speckle | Peak value of laser speckle signal | with 2 minutes of ischemia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microcirculation, laser flowmetry, Skin, Physiology
Prostaglandins Before Caserean Section

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to assess the value of administration of prostaglandins before cesarean section to reduce the amount of blood loss

Detailed Description
-----------------
160 full term pregnant patients candidate for elective cesarean section were randomly allocated into 2 groups ,80 patients will receive 200mcg of rectal prostaglandins before cesarean section and 80 patients are used as control receiving placebo

Official Title
-----------------
Does the Administration of Prostaglandins Before Cesarean Section Reduce the Amount of Blood Loss ?

Conditions
-----------------
Intrapartum Hemorrhage

Intervention / Treatment
-----------------
* Drug: Misoprostol 200Mcg Tab
* Procedure: elective cesarean section


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:pregnant patients full term elective cesarean section - Exclusion Criteria: medical disorder with pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (Misoprostol group)<br>200 mcg rectal Misoprostol administration before cesarean section | Drug: Misoprostol 200Mcg Tab<br>* administration of 200 Mcg of misoprotol rectal<br>Procedure: elective cesarean section<br>* elective cesarean section for full term patients<br>|
| Placebo Comparator: Group B (control group)<br>No prostaglandins administration before cesarean section | Procedure: elective cesarean section<br>* elective cesarean section for full term patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of intraoperative blood loss | number of soaked towels | during cesarean section | 
| postpartum hemorrhage | blood loss after cesarean section | 24 hour after cesarean section | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fetal condition | apgar score | 5 minutes after cesarean section |
Brief Interventions With Text Messaging to Reduce Adolescent Alcohol and Marijuana Use

Study Overview
=================
Brief Summary
-----------------
This study tests the feasibility of an intervention to prevent risky alcohol or marijuana use that adds a 4-week course of tailored text messaging to a brief motivational intervention for 13-18-year-old adolescents.

Official Title
-----------------
Feasibility of Augmenting Brief Interventions With Text Messaging to Reduce Adolescent Alcohol and Marijuana Use

Conditions
-----------------
Alcohol Drinking, Marijuana

Intervention / Treatment
-----------------
* Behavioral: Text Messaging and Brief Negotiation Interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 13 to 18 years old Able to provide consent or assent and parental permission have a functioning cell phone without pay-as-you-go text messaging Exclusion Criteria: currently enrolled in any substance abuse program; have medical/psychiatric condition that precludes participation

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: A brief motivational interview and four weeks of text messaging.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Text messaging and brief intervention<br>Brief motivational interview and 4-weeks of text messaging. | Behavioral: Text Messaging and Brief Negotiation Interview<br>* An in-person brief motivational intervention coupled with 4 weeks of motivational text messages<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment | Number of participants per month that enroll in the study | Baseline | 
| Retention | % of enrolled participants that complete the 4-week follow up assessments | 4 weeks | 
| Satisfaction | Participant's rating of how much they like the intervention (Likert scale) | 4 weeks |
Birth Ball Versus Meperidine and Haloperidol Injection for Pain Relief During First Stage of Labour

Study Overview
=================
Brief Summary
-----------------
The study was performed at Gregorio Marañón Hospital birth centre. A Randomised Clinical Trial comparing the two methods of pain relief in the first time of labour was carried out. In this study, 110 women in the first stage of labour were allocated in two study groups by a randomised block design. One of them used the birth ball as a pain relief method,and the other one used pethidine and haloperidol injection.

Conditions
-----------------
Parturition, Humanizing Deliver, Labor Pain, Natural Childbirth, Labor Onset, First Labor Stage

Intervention / Treatment
-----------------
* Drug: pethidine and haloperidol injection
* Other: birth ball


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy pregnant women women in the first stage of labour or women at induction of labour fetal head in pelvis or whole amniotic membranes must be able to understand spanish Exclusion Criteria: intrapartum meconium needed of continuous fetal monitoring suspecte/compromise fetal wellbeing morbidly obese women unaccompanied women

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Meperidine<br>Use pethidine and haloperidol injection as a pain relief. | Drug: pethidine and haloperidol injection<br> <br> * Other names: meperidine and haloperidol injection;|
| Experimental: birth ball<br>Use birth ball as a pain relief. | Other: birth ball<br> <br> * Other names: fit ball, swiss ball;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | We use a numeric scale, since 0 ( no pain) to 10 (the greatest pain), to measure this item. We use it with women in the first stage of labour, with labor pain | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baby´s apgar | We use the apgar Test to measure this item. Since 0 to 10.We use it after birth, with babies of women who are in our study. | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parturition, Humanizing Deliver, Labor Pain, Natural Childbirth, Labor Onset, First Labor Stage, Birth ball, meperidine, pethidine
Respiration Patterns With Impedance in LINQ

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the use of subcutaneous impedance measured with an implanted Medtronic Reveal LINQ™ insertable cardiac monitor (ICM) as respiratory rate monitor.

Official Title
-----------------
REspiration Patterns in REVEAL LINQ Insertable Cardiac Monitor

Conditions
-----------------
Breathing Exercises

Intervention / Treatment
-----------------
* Device: respiration assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected arrhythmia Diastolic Heart Failure and/or in Renal Failure. Chronic Kidney Disease (CKD) in Stage 5 (GFR = <15 mL/min). Diastolic Heart Failure in class II and class III (class IV to be considered in end stage and non-reversible). Willing to sign the informed consent form. Greater than 18 years of age. Exclusion Criteria: Enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager. Significant respiratory diseases such as COPD or pulmonary hypertension. Frequent arrhythmias, including PVC's. Known systolic heart failure. Recent infection. Allergenic or rejection reaction to materials used in incision/insertion tools, Reveal LINQ™ ICM exterior or incision closure method. Active implanted cardiac medical device (e.g. IPG, ICD, CRT, etc). Not suitable for Reveal LINQ™ implantation (e.g., severe cachexia, dermatologic conditions of the skin) or any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study. Body conditions that would complicate accurate measurement of respiratory efforts with an external device deployed around the chest. Not able to take the postures as necessary for the study protocol and not able to walk continuously for a period of 6 minutes. Any concomitant condition which in the opinion of the investigator would not allow a safe participation in 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Respiration assessment<br> | Device: respiration assessment<br>* Respiration Breathing Exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of respiration detection | Respiratory Maneuvers and Device interrogation | up to 18 months |