linjc16/ctgov huggingface dataset:
Neonatal Hearing Screening at Neonatal Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
Hearing loss is one of the most common congenital anomalies . It has been shown to be greater than that of most other diseases and syndromes (eg, phenylketonuria, sickle cell disease) screened at birth. Data from the newborn hearing-screening programs in Rhode Island, Colorado, and Texas showed that 2-4 of every 1000 neonates have hearing loss. Early Intervention at or before 6 months of age allows a child with impaired hearing to develop normal speech and language, alongside his or her hearing peers and can prevent severe psychosocial, educational, and language impairment. One of the most high risk population are neonates who spend time in the newborn intensive care unit , exposed to high frequency ventilation, hyperbilirubinemia, low birth-weight, and exposed to ototoxic medications. Auditory brainstem response , otoacoustic emissions , and automated Auditory brainstem response testing have all been used in newborn hearing-screening programs. otoacoustic emissions are fast objective, efficient, and frequency-specific measurements of peripheral auditory sensitivity are used to assess response of the outer hair cells to acoustic stimuli. To measure otoacoustic emissions, a probe assembly is placed in the ear canal, tonal or click stimuli are delivered, and the otoacoustic emissions generated by the cochlea is measured with a microphone .

Official Title
-----------------
Neonatal Hearing Screening at Neonatal Intensive Care Unit of Assiut University Hospital

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Device: Otoacoustic emissions device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonates of both sexes. Neonates with In utero infection such as cytomegalovirus, rubella, toxoplasmosis, or herpes. Neonatal indicators, specifically hyperbilirubinemia at a serum level requiring exchange transfusion. Exclusion Criteria: neonates whose parent refuse to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 1 Week
Maximum Age: 4 Weeks

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neonates who will be admitted at Neonatal Intensive Care Unite<br> | Device: Otoacoustic emissions device<br>* as a screening tool for Auditory brainstem response<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of hearing loss in all neonates in Neonatal Intensive Care Unit |  | 1 year |
Effect of Gastric Bypass on Patients With Type 2 Diabetes and/or Dyslipidemia

Study Overview
=================
Brief Summary
-----------------
This is a retrospective review of patients who have undergone bariatric surgery at VUMC and who have type 2 Diabetes and/or dyslipidemia. The investigators have previously found that gastric bypass significantly improves diabetes 6-12 months after surgery. The investigators are interested in looking at the longer term results after surgery.

Detailed Description
-----------------
Review and record changes in the subject's medication. subjects vitals: weight, blood pressure, and fasting blood values, which include: HbA1c Fasting blood glucose Fasting Insulin Lipid Panel ( total cholesterol, LDL, HDL and triglycerides) were obtained.

Official Title
-----------------
Effect of Gastric Bypass on Type 2 Diabetes and/or Dyslipidemia

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have had diabetes and/or dyslipidemia prior to gastric by-pass. - Exclusion Criteria:Patients who have had type 2 diabetes that was diet controlled at time of surgery; and debilitated patients who are unable to come in for a physical exam. -

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 66 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 |
| --- | --- | --- |
| glycemic control |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correction of lipid profiles |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric by-pass on patients with T2DM
Use of Diffuse Optical Spectroscopy for Evaluation of the Trauma/Critically Care Patients

Study Overview
=================
Brief Summary
-----------------
Trauma remains the leading cause of death and disability for Americans age 1-44. Trauma can cause internal bleeding, and this bleeding is often hard to detect without sophisticate tests that take time to complete and analyze. In addition, internal bleeding, including bleeding into the lung and chest cavity, as well as other blood loss, happens in many critically ill patients. For example, for hemorrhage, it is very difficult to detect active hemorrhage and to determine optimal rates of fluid and blood resuscitation. Diffuse optical spectroscopy has the potential to accurately assess adequacy of tissue perfusion, oxygenation, tissue oxygen extraction, and cytochrome oxidation states that may be critical to optimal treatment, end- organ preservation, and survival.

Detailed Description
-----------------
The research' want to monitor tissue perfusion and indicators of tissue damage and viability in critically ill patients by using DOS. Non-invasive Optical Techniques DOS,near-infrared diffuse optical spectroscopy (NIR-DOS. NIR-DOS provides functional physiologic tissue/organ information without ionizing radiation and without withdrawing any blood, in a cost-effective and rapid manner. The application of frequency-domain photon migration analysis (FDPM) to NIRS allows independent measurements of tissue absorption and scattering properties at depths of 1 cm or more below the skin surface. Such capabilities will improve early diagnosis, detection, optimization of therapy, assessment of adequacy of resuscitation, and alteration in management plans for all of these critical conditions.

Official Title
-----------------
Use of Diffuse Optical Spectroscopy for Evaluation of the Trauma/Critically Care Patients

Conditions
-----------------
Trauma

Intervention / Treatment
-----------------
* Device: Diffuse optical spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult age 18 years or older, male or female Trauma/Critical Care patient Exclusion Criteria: Subject is not Trauma/Critical Care patient

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 |
| --- | --- |
| trauma<br>Diffuse optical spectroscopy measurment | Device: Diffuse optical spectroscopy<br>* Diffuse optical spectroscopy measurment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ability to noninvasively diagnose conditions in the intensive care unit, or in battlefield conditions. |  | 5 to 60 seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
internal bleeding, changes in tissue perfusion
Use of in Vivo 3T MR to Characterize Carotid Plaque in Patients and Correlate MR Findings With Symptoms

Study Overview
=================
Brief Summary
-----------------
To compare two competing newly designed 3D sequences for black blood carotid plaque imaging techniques with the industry standard 2D sequnce for black blood.

Detailed Description
-----------------
To utilize a 3D sequence instead of the usual 2D commonly standard industry sequence that is supplied by the various manufacturers. Patients with greater than 50% stenosis that are 3T compatible are imaged using the two sequences to compare which sequences better visualize the plaque and it's characteristics The purpose is to validate the ability of the new 3D sequence to detect and measure any plaque hemorrhage as well as to identify region sof Type 1 hemorrhage.

Official Title
-----------------
Use of in Vivo 3T MR to Characterize Carotid Plaque in Patients and Correlate MR Findings With Symptoms

Conditions
-----------------
Carotid Plaque Hemorrhage Appearance

Intervention / Treatment
-----------------
* Other: there is no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with 50% stenosis of the carotid arteries that are safe to undergo MRI imaging Exclusion Criteria: Patients that are determined to no be safe to undergo MR imaging due to implants

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: there is no intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appearance of intraplaque hemorrhage | what radiologist interperts | 1 day of scan |
Transcatheter Aortic Valve Replacement (TAVR)-Pilot Trial

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this this randomized interventional study is to determine if increased level of home-based rehabilitation coupled with a pre-TAVR consultation visit in transcatheter aortic valve replacement patients will improve functional status and quality of life and will decrease hospital readmission.

Official Title
-----------------
Intensive Versus Usual Home-based Physical Therapy to Promote Functional Recovery After Transcatheter Aortic Valve Replacement (TAVR): A Pilot Randomized Trial

Conditions
-----------------
Transcatheter Aortic Valve Replacement (TAVR)

Intervention / Treatment
-----------------
* Procedure: Prehabilitation visit/increased physical therapy post-TAVR
* Procedure: Standard of Care Arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of severe aortic stenosis (AS) as determined by echocardiography, who are deemed eligible for TAVR by the NYULMC Heart Valve Team Exclusion Criteria: Decisional impairment as assessed by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) Non-English/non-Spanish speaking.

Ages Eligible for Study
-----------------
Minimum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation Visit/Increased Physical Therapy post-TAVR<br> | Procedure: Prehabilitation visit/increased physical therapy post-TAVR<br>* Prior to TAVR, patients randomized to the intervention arm will meet with a licensed physical therapist for a 30-minute session in the ambulatory setting. Following TAVR, patients randomized to the intervention arm will receive 4 days per week of home-based physical therapy by a licensed physical therapist working for Revival Home Health Care<br>|
| Active Comparator: Control<br>Standard of care physical therapy post-TAVR | Procedure: Standard of Care Arm<br>* Patients randomized to the usual care arm will receive home-based physical therapy for 2 days per week by Revival Home Health Care, which is the current standard of care.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in level of Activity measured by activity monitor called the ActiGraph wGT3X-BT. |  | Baseline, 2 Weeks | 
| Change in self-perceived physical health |  | Baseline, 2 Weeks | 
| Change in Independence in activities of daily living (ADLs). |  | Baseline, 2 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in hospital readmissions following intensive home-based physical therapy reduces |  | Baseline, 2 Weeks |
FLEX-Trial: Prospective Sonographic Assessment Of Healing Process Following Suture of Profound Flexor Tendon Due to Traumatic Rupture of FDP-Tendon in Zone II.

Study Overview
=================
Brief Summary
-----------------
To prospectively assess the healing process following suture of profound fexor tendon due to traumatic rupture of FDP-Tendon in Zone II by ultrasound.

Conditions
-----------------
Tendon Injury

Intervention / Treatment
-----------------
* Other: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: All patients with traumatic rupture of FDP-tendon in zone II. Exclusion criteria: < 18years; Fracture; crush injury; (partial) amputation; RA; CPPD; CP;

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: Ultrasound|Ultrasound will be used to evaluate tendons.|

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
-----------------
Traumatic Rupture of Tendon
Significant Pathology Associated With Crossed Leg Sign

Study Overview
=================
Brief Summary
-----------------
By determining the correlation of a Crossed Leg Sign with signifcant pathology, a clinician would then be able to use this correlation to risk stratify his/her patients for significant pathology.

Detailed Description
-----------------
By determining the correlation of a Crossed Leg Sign with signifcant pathology, a clinician would then be able to use this correlation to risk stratify his/her patients for significant pathology. Therefore, by determining the sensitivity and specificity of this physical exam finding, the clinician would have a better idea of the patients clinical management, including diagnostic testing and ultimate treatment of the patient. Crossed Leg Sign will be defined in this study as: any patient observed in the Emergency Department with sustained crossed legs. To my knowledge, crossed legs have never been evaluated in regards to it's correlation with significant pathology. This could potentially add another physical exam finding to be used by the clinician.

Official Title
-----------------
Crossed Leg Sign and it's Correlation With Significant Pathology

Conditions
-----------------
Pathology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient observed in the Emergency Department with sustained crossed legs. Exclusion Criteria: Any patient not observed to have sustained crossed legs and is not being used as a control.
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 |
| --- | --- | --- |
Photodynamic Lasertherapy (PDT) in Periodontal Treatment (in Vivo)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the effect of the photodynamic therapy in periodontal patients

Detailed Description
-----------------
The purpose of the study is to evaluate the effect of the photodynamic therapy in periodontal pockets and to assess the reduction of subgingival bacteria. The first step will include the evaluation of the quantity of the light which will activate the photosensitizer in the various niches in the periodontal pocket. The second step will evaluate the distribution of the photosensitizer in the periodontal pocket. The third step will assess the woundhealing of the the photodynamic therapy compared to conventional periodontal therapy with an ultrasonic device.

Official Title
-----------------
Photodynamic Lasertherapy (PDT) in Periodontal Treatment (in Vivo)

Conditions
-----------------
Periodontal Disease

Intervention / Treatment
-----------------
* Procedure: photosensitisation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: systemic healthy >15 teeth ≤ 6 mm >2 teeth age > 35 years Exclusion Criteria: - systemic ill cardiac pacemaker < 15 teeth

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: photosensitisation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pocket depth reduction |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| attachmentlevel loss |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Photodynamic lasertherapy, Periodontol disease
In-Hospital Portable Sleep Monitoring for the Evaluation of Obstructive Sleep Apnea (OSA)

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Portable sleep testing of hospitalized medical inpatients suspected of having OSA is accurate in determining the need for positive airway pressure (PAP) therapy when compared to outpatient laboratory-based polysomnography. Hospitalized medical inpatients referred for suspected OSA will be tested with a portable sleep apnea testing device during hospitalization. These patients will then undergo an outpatient laboratory-based attended polysomnography after hospital discharge. Results of the inpatient portable sleep apnea test will be compared to the outpatient laboratory-based polysomnography in terms of diagnostic accuracy.

Official Title
-----------------
Inpatient Portable Sleep Apnea Testing of Hospitalized Medical Patients for the Evaluation of Obstructive Sleep Apnea Prospectively Compared to Outpatient Laboratory-based Polysomnography

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Testing with a portable sleep apnea monitor .


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Hospitalized inpatients referred for evaluation of suspected obstructive sleep apnea Exclusion Criteria: Patients admitted to surgical or obstetrics/gynecology services Patients with certain medical conditions (altered mental status not related to respiratory failure, septicemia, unstable psychiatric disorder, narcotic abuse and prior diagnosed sleep apnea) Patients with certain social histories (prisoners) Patients unable to use CPAP (facial deformity and traumatic facial injuries).

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 |
| --- | --- |
| Study Group<br>Hospitalized inpatients referred by a general medicine service for evaluation of obstructive sleep apnea. | Device: Testing with a portable sleep apnea monitor .<br>* Portable sleep apnea testing will performed on referred patients.<br>* Other names: Alice PDx portable sleep testing system (Philips Respironics, Murraysville, PA);|

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
-----------------
Portable sleep apnea testing, Positive airway pressure therapy, Polysomnography
Safety and Effects of SLx-2101 Taken for up to 14 Days on Blood Pressure in Patients With Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose is to determine the effective dosage and to study the effects of this dosage taken for 12 days on systolic and diastolic blood pressure in patients with hypertension.

Detailed Description
-----------------
Office seated peripheral systolic and diastolic blood pressure Adverse events and vital signs Plasma concentrations of SLx-2101

Official Title
-----------------
A Pilot Phase IIa Randomised, Double-blind, Placebo-controlled, Crossover Study to Examine the Safety, Tolerability and Pharmacodynamic Effects on Blood Pressure of Repeat Oral Doses of SLx-2101 5, 10 or 20 mg Once Daily for up to 14 Days in Patients With Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: SLx-2101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or females between 18 and 80 years, inclusive Moderate to severe hypertension Body weight within a body mass index range of 18 - 32 kg/m2 Exclusion Criteria: Subject is receiving more than four antihypertensive agents History of drug abuse Exposure to a new chemical entity within 3 months prior to the first day of dosing

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>SLx-2101 | Drug: SLx-2101<br> <br> |
| Placebo Comparator: 2<br>Matching Placebo Dose | Drug: SLx-2101<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Office seated peripheral systolic and diastolic blood pressure |  | 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and changes in vital signs |  | 12 days |