linjc16/ctgov huggingface dataset:
In Utero Magnesium Sulfate Exposure: Effects on Extremely-Low-Birth-Weight Infants

Study Overview
=================
Brief Summary
-----------------
This study examined the effect of magnesium sulfate (MgSO4) exposure on adverse outcome in extremely low birth weight (ELBW) infants. For infants included in the NICHD Neonatal Research Network Generic Database whose mothers were given prenatal MgSO4, data were prospectively collected on maternal/infant conditions and magnesium exposure (including indications, timing and duration of exposure).

Detailed Description
-----------------
Retrospective studies suggested that the risk of cerebral palsy and intraventricular hemorrhage (IVH) in extremely premature infants of mothers given magnesium sulfate (MgSO4) may be reduced. The purpose of this study was to examine the effects of MgSO4 exposure on adverse outcomes in extremely low birth weight (ELBW) infants. For infants included in the NICHD Neonatal Research Network Generic Database, data were prospectively collected on maternal/infant conditions and MgSO4 exposure (including indications, timing and duration of exposure).

Official Title
-----------------
In Utero Magnesium Sulfate Exposure: Effects on Extremely-Low-Birth-Weight (ELBW) Infants

Conditions
-----------------
Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Intracranial Hemorrhages, Leukomalacia, Periventricular, Cerebral Palsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants born in NRN Centers with a birth weight of 401-1,500g Exclusion Criteria: None

Ages Eligible for Study
-----------------
Maximum Age: 14 Days

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 |
| --- | --- | --- |
| Incidence of Intraventricular Hemorrhage |  | Hospital discharge 120 days of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of cerebral palsy |  | 18-22 months corrected age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Prematurity, Antenatal Magnesium sulfate
Effect of PF-00734200 in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
To determine the effect of PF-00734200 on HbA1c in type 2 diabetic subjects receiving metformin

Official Title
-----------------
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of 12-Week Administration Of PF-00734200 To Subjects With Type 2 Diabetes Mellitus And Insufficient Glycemic Control On Metformin Treatment

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: PF-00734200 30 mg QD
* Drug: PF-00734200 20 mg QD
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women between 18-80 years of age with poorly controlled Type 2 diabetes Exclusion Criteria: Type 1 or secondary forms of diabetes Currently using insulin

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 30 mg QD<br> | Drug: PF-00734200 30 mg QD<br>* 30 mg QD<br>|
| Experimental: 20 mg QD<br> | Drug: PF-00734200 20 mg QD<br>* 20 mg QD<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Glucose |  | 12 weeks | 
| Fasting Insulin |  | 12 weeks |
3D Evaluation of Powerscope Appliance in Treatment of Skeletal Class 2 Malocclusion

Study Overview
=================
Brief Summary
-----------------
The study is aiming to evaluate the efficacy of Powerscope appliance in treatment of skeletal Class 2 malocclusion by three-dimensional image. Powerscope appliance is a hybrid fixed functional appliance used for treatment of Class II malocclusion with a retruded mandible.

Official Title
-----------------
Three-dimensional Evaluation of the Efficacy of Powerscope Appliance in Treatment of Skeletal Class 2 Malocclusion: A Prospective Clinical Study

Conditions
-----------------
Class II Malocclusion, Division 1

Intervention / Treatment
-----------------
* Device: Powerscope group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy post pubertal female patients of age range 14 to 16 years old, manifesting features of post pubertal cervical vertebrae maturational stages 4, 5 and 6 (deceleration, maturation, and completion). Skeletal class 2 malocclusion of ANB angle greater than 4° with retrognathic mandible. Class II division 1 malocclusion with at least an end-on Class II molar relationship. Presence of all permanent dentition excluding third molars. Good oral hygiene. Exclusion Criteria: History of previous orthodontic treatment. Any systemic disease that could affect the orthodontic treatment. Patients with periodontal diseases. Patients with temporomandibular disorders.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 16 Years

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

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: Powerscope group<br>Class II patients which will receive treatment using Powerscope appliance | Device: Powerscope group<br>* Treatment of Class II malocclusions using Powerscope appliance<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Condylar head volumetric changes | The change in Condylar head volume before and after usage of Powerscope appliance | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mandibular length | The change in the length of the mandible | six months |
Phase 2b/3 Study of XAF5 Ointment for Steatoblepharon (Undereye Bags)

Study Overview
=================
Brief Summary
-----------------
This randomized, placebo-controlled, double-masked, Phase 2b/Phase 3 study will assess the efficacy of two different concentrations of XAF5 Ointment for reduction of lower lid steatoblepharon (undereye bags).

Official Title
-----------------
A Phase 2b/3, Multicenter, Dose-ranging, Randomized, Double-masked, Placebo-controlled Study of XAF5 Ointment for Reduction of Lower Lid Steatoblepharon

Conditions
-----------------
Steatoblepharon

Intervention / Treatment
-----------------
* Drug: XAF5 (concentration A: 0.1%)
* Drug: XAF5 (concentration B: 0.035%)
* Drug: Matching placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe, bilateral lower eyelid steatoblepharon Must understand and provide informed consent Healthy facial skin Exclusion Criteria: Pregnant or lactating women Clinically significant eye disease Best corrected visual acuity worse than 20/40 in either eye History of eye surgery in past 6 months History of lower eyelid surgery

Ages Eligible for Study
-----------------
Minimum Age: 40 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XAF5 (concentration A: 0.1%)<br>Participants will apply XAF5 Ointment (concentration A: 0.1%) to the lower eyelids once daily. | Drug: XAF5 (concentration A: 0.1%)<br> <br> |
| Experimental: XAF5 (concentration B: 0.035%)<br>Participants will apply XAF5 Ointment (concentration B: 0.035%) to the lower eyelids once daily. | Drug: XAF5 (concentration B: 0.035%)<br> <br> |
| Placebo Comparator: Placebo<br>Participants will apply Placebo Ointment to the lower eyelids once daily. | Drug: Matching placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LESS score (Clinician-Reported) |  | 16 weeks |
Tissue Perfusion and Blood Flow Monitoring Technology

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety and efficacy of an optical device designed and developed to quantitatively monitor blood flow velocity of wound sites. The hypothesis is that the blood flow velocity of the wound site will provide critical information on the efficacy of hyperbaric oxygen therapy.

Official Title
-----------------
Tissue Perfusion and Blood Flow Monitoring Technology

Conditions
-----------------
Wounds and Injuries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Subjects age 21 or older with the following types of wounds and who are able to comply with the study requirements: neuropathic diabetic foot ulcer soft tissue radiation necrosis crush injury compromised/failed skin grafts and flaps Subjects must have signed the Informed Consent Forms. Exclusion Criteria Subjects who are not candidates for HBO therapy for any reason, including but not limited to: untreated pneumothorax, uncontrolled congestive heart failure, seizure disorder, neoplastic tumors, claustrophobia (for those in the HBO Group). Female subjects who are pregnant or nursing. Anyone who is unable to give written informed consent. Subjects with end-stage renal disease or who require peritoneal or hemodialysis. Subjects with current malignancies.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Standard Care Group<br>Subjects who will undergo only standard wound care management. | |
| Hyperbaric Oxygen Therapy Group<br>Subjects who are selected for adjunctive hyperbaric oxygen therapy in addition to standard wound care intervention. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of blood flow velocity measurements of wound sites to assess tissue viability with a novel optical device. Comparison between the responses of patients treated with hyperbaric oxygen therapy and those treated by other means will be made. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic Wounds, Hyperbaric Oxygen, Laser Speckle Imaging, Hyperbaric Oxygenation
MRI-guided Bone Marrow Biopsies of Prostate Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to target lesions of the prostate in the bone and to biopsy these lesions using MRI to identify the areas.

Detailed Description
-----------------
This study involves a one-time, MRI-guided bone marrow biopsy. Prior to this procedure, patients will need to have a bone scan performed within the last three months and a PSA blood test drawn within one month of registration to the study. Patients are also required to participate in the DFCI research study Collection of Specimens and Clinical Data for Patients with Prostate Cancer or at High Risk for Prostate Cancer.

Official Title
-----------------
MRI-guided Bone Marrow Biopsies of Advanced CaP Patients

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: Magnetic Resonance Imaging
* Procedure: Bone Marrow Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic diagnosis of prostate cancer Bone scan consistent with or suspicious of metastatic prostate cancer within last three months Platelet count > 50,000/ul PT and aPTT < 1.5 x control At least one week removed from taking aspirin or coumadin Currently participating in protocol Collection of Specimens and Clinical Data for Patients with Prostate Cancer or at High Risk for Prostate Cancer Exclusion Criteria: Devices incompatible to MR studies (e.g. pacemakers, ear implants, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Magnetic Resonance Imaging|nan|
|Procedure: Bone Marrow Biopsy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the yield of detecting metastatic prostate cancer tissue using MRI-guided bone marrow needle biopsies to that of historical controls obtained through unguided biopsies. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the sensitivity of radiographic bone marrow changes detected by MRI for prostate cancer, as determined by the pathologic findings from bone marrow biopsy. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI-guided bone marrow biopsy
Increasing Viral Testing in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a brief intervention delivered to emergency department patients increases the uptake of rapid HIV and hepatitis C testing in comparison to no brief intervention.

Official Title
-----------------
Phase 2/3 Clinical Trial of the Effect of a Brief Intervention on Uptake of Rapid Testing for HIV and Hepatitis C Among Emergency Department Patients

Conditions
-----------------
Drug Use, HIV, Hepatitis C

Intervention / Treatment
-----------------
* Behavioral: Brief motivational intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Emergency department patient. Does not know HIV or hepatitis C status. Has an ASSIST V3 score that indicates recent illicit and/or prescription drug use. Fluency in English or Spanish. Exclusion Criteria: Critically ill or injured. Homicidal and/or suicidal intention. Age < 18 years or > 64 years. Does not speak English or Spanish.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief Intervention<br>This arm of the study will receive an assessments survey followed by a brief intervention concerning the relationship between the participants use of drugs and/or sexual risk and rik for HIV and hepatitis C infections. Following the intervention the participants will be offered free rapid testing for HIV and hepatitis C. | Behavioral: Brief motivational intervention<br>* A 20-30 minute motivational based discussion<br>|
| No Intervention: Standard Care<br>This arm of the study will receive an assessments survey. Following the assessment the participants will be offered free rapid testing for HIV and hepatitis C. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The agreement of the participant to be tested for HIV and hepatitis C | We will measure the acceptance of free rapid testing for HIV and hepatitis C among the intervention and control groups | Within four hours of being consented into the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identifying risky sexual behaviors of study participants | Identify factors that influence the relationship of BI and risk assessment vs. risk assessment alone on uptake of combined HIV and hepatitis C screening in the ED. | Within four hours of being consented into the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brief intervention, Rapid testing
Investigating Immune Escape by SARS-CoV-2 Variants

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to investigate the ability of pre-existing immunity by natural infection or vaccination to prevent infections by emerging SARS-CoV-2 variants.

Detailed Description
-----------------
Several variants of the SARS-CoV-2 virus were identified in 2020 including the United Kingdom variant (known as 20I/501Y.V1, VOC 202012/01, or B.1.1.7), South Africa variant (known as 20H/501Y.V2 or B.1.35), and Brazil variant (known as P.1), with more variants still being discovered. There is concern that these variants, due to mutations in spike protein and receptor-binding domain of the spike protein, can be more infectious, lethal, and potentially escape the immune responses from vaccination or prior infection. Research is needed to understand the risks associated with currently known variants of SARS-CoV-2 as well as investigate if there is potential for new mutations to form that would allow SARS-CoV-2 variants to partially or entirely escape the immune mechanisms developed from vaccination and/or prior infection from the wild-type strain of SARS-CoV-2.

Official Title
-----------------
Investigating Immune Escape by SARS-CoV-2 Variants

Conditions
-----------------
COVID-19; Immunity

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People who have been fully vaccinated for COVID-19 2-12 weeks prior to enrollment or individuals <3 months post-COVID-19 infection. Collection of samples for blood samples will be done only from healthy, nonpregnant adults who weigh at least 110 pounds. Participants must be able to provide informed consent. Exclusion Criteria: -Subjects considered vulnerable including children, pregnant women, nursing home residents, or other institutionalized persons, fetuses, prisoners, and persons without decisional capacity.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention, prospective, cohort study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing immunity | Assess immune escape among people with vaccination or natural immunity | 1 year |
Automated Breast Radiation Therapy Using an MR-Guided Process

Study Overview
=================
Brief Summary
-----------------
In the proposed research study, we are investigating the feasibility of integrating automated planning tools to MR images acquired using a novel MR-guided linac, for on-line adaptive radiation treatment. However, these on-line automation tools require further technical refinement and clinical validation. The goal of this research proposal is to develop an on-line MR-guided radiation therapy process for adapting breast IMRT treatment. Such an approach will provide early stage breast cancer patients timely access to high-quality adaptive treatments without exposure to additional ionizing radiation.

Official Title
-----------------
Automated Breast Radiation Therapy Using an MR-Guided Process

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

Intervention / Treatment
-----------------
* Other: IMRT + CT + MR scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who will receive standard two-field tangential whole breast radiation therapy with dose prescription of 4240 cGy in 16 fractions, 5000 cGy in 25 fractions or 4000 cGy in 16 fractions. Female patients with any stage of breast cancer. Patients with prior treatment such as surgery or chemotherapy for any type of cancer. Able to provide a written informed consent. ≥ 18 years of age. Exclusion Criteria: Patients who will not receive 4240 cGy in 16 fractions, 5000 cGy in 25 fractions, or 4000 cGy in 16 fractions Males. Patients who received partial breast radiation and not the standard dose. Patients who are unable to provide informed consent. < 18 years of age.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMRT + CT + MR scan<br> | Other: IMRT + CT + MR scan<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time between planning of Radiation treatment and the start of radiotherapy |  | 3 years | 
| The effect of breathing on the position of the heart and lung in treatment plans |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast RT, Breast radiation therapy