linjc16/ctgov huggingface dataset:
Music and Feeding in NICU

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of classical music exposure on improved time to regain birth weight and improved feeding readiness in healthy premature infants in the NICU.

Official Title
-----------------
The Mozart Effect and the Assessment of Weight Gain and Development of Feeding Skills in the NICU.

Conditions
-----------------
Feeding, NICU, Preterm Infants, Mozart, Weight Gain

Intervention / Treatment
-----------------
* Other: Music
* Other: No music.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Neonates between the gestational ages of 28 weeks and 32 weeks and 6 days Parents ≥18 years of age English speaking parents Breastmilk as intended primary form of nutrition Exclusion Criteria: Congenital anomalies affecting hearing or feeding skills Patients requiring HFOV or HFJV

Ages Eligible for Study
-----------------
Minimum Age: 28 Weeks
Maximum Age: 31 Weeks

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music<br>Exposure to music, twice per day for the study period | Other: Music<br> <br> |
| Other: Control<br>No intervention; standard care. | Other: No music.<br>* This is the control group.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is time to regain birth weight | We will track weight gain and will monitor how long it takes for the babies to regain their birth weight. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Feeding Cues | At 33 weeks corrected gestational age; a speech therapist will assess feeding cues daily using an objective oral feeding assessment tool | 2 weeks |
Evaluation of an Analgosedation Protocol in Mechanically Ventilated Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate how the investigators provide sedation (medicine that make you sleepy) in the investigators intensive care unit (ICU). This study will look at a new way of using sedation in the ICU to see what effect it has on patients and if it decreases the amount of time spent on mechanical ventilation (machine that breathes for you), and in the ICU.

Official Title
-----------------
Evaluation of an Analgosedation Protocol in Mechanically Ventilated Patients

Conditions
-----------------
Effect of Protocolized Sedation on Days of Mechanical Ventilation in the ICU

Intervention / Treatment
-----------------
* Other: Sedation protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years of age and older Patients expected to require mechanical ventilation for greater than 48 hrs Exclusion Criteria: Need for continuous neuromuscular blockade Severe chronic neurocognitive dysfunction Tracheostomy at the time of study enrollment Alcohol withdrawal risk or symptoms Drug overdose Chronic use of narcotics Active seizures

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sedation protocol<br>Sedation protocol is a document that will be used to guide the adjustment of sedation in the ICU. | Other: Sedation protocol<br>* Nursing driven sedation protocol<br>* Other names: The sedation protocol is a document that wil lbe used by healthcare providers to guide sedation used in the ICU;|
| Active Comparator: Standard of care<br>Current practices | Other: Sedation protocol<br>* Nursing driven sedation protocol<br>* Other names: The sedation protocol is a document that wil lbe used by healthcare providers to guide sedation used in the ICU;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days on mechanical ventilation |  | Participants will be assessed daily for the duration of their stay in the ICU, an expected average of 4-5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU Length of stay |  | Participants will be followed for the entire length of their ICU stay, expected average of 4-7 days | 
| 28 day mortality |  | Participants will be followed for 28 days from enrollment into the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sedatives, analgesics, protocol, mechanical ventilation, analgosedation
Near Infrared Spectroscopy to Determine Patent Ductus Arteriosus Closure

Study Overview
=================
Brief Summary
-----------------
Using cerebral and renal near infrared spectroscopy monitoring to determine PDA closure in preterm infants after completing medical treatment for a hemodynamically significant PDA.

Official Title
-----------------
Use of Near Infrared Spectroscopy in Preterm Infants to Determine Patent Ductus Arteriosus Closure Following Medical Treatment

Conditions
-----------------
Patent Ductus Arteriosus

Intervention / Treatment
-----------------
* Device: near infrared spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preterm infants less than 32 weeks gestation Exclusion Criteria: infection, congenital heart disease, syndromic anomalies, and perinatal asphyxia.

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 1 Week

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 |
| --- | --- |
| no PDA<br>These are infants who do not have a patent ductus arteriosus (PDA) as determine by echocardiography | Device: near infrared spectroscopy<br>* Near infrared spectroscopy will be placed on infants both with and without hsPDA<br>|
| hsPDA<br>These are infants who have a hemodynamically significant PDA (hsPDA) as determined by echocardiography | Device: near infrared spectroscopy<br>* Near infrared spectroscopy will be placed on infants both with and without hsPDA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in NIRS readings |  | 3 days |
Effects of Vitamin D Supplement Before and During Pregnancy on Birth Weight

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a daily supplement of vitamin D, taking before and during pregnancy, effects child birth weight, pre- and postpartum complication and bone mineral density during lactation.

Official Title
-----------------
Effects of Vitamin D Supplement Before and During Pregnancy on Complications, Birth Weight and Bone Mineral Density During Lactation

Conditions
-----------------
Birth Weight, Vitamin D Deficiency, Pregnancy

Intervention / Treatment
-----------------
* Dietary Supplement: Cholecalciferol 35 µg per day
* Other: placebo tablet
* Dietary Supplement: Cholecalciferol (Vitamin D3) 70 µg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: P-OH25-vitamin D < 50 nmol/l Woman age 30-35 years In good general health Exclusion Criteria: Infertility Intake of 400 IU or more Vitamin D/day Cancer Alcohol or drug abuse Calciummetabolic disturbances Spontaneous abortion within last 6 month

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cholecalciferol (Vitamin D3) 35 µg<br>Dietary Supplement: Cholecalciferol (Vitamin D3) 35 µg per day | Dietary Supplement: Cholecalciferol 35 µg per day<br>* Cholecalciferol (Vitamin D3) oral 1 tablet 35 µg per day. Placebo oral 1 tablet per day. In total 35 µg per day. In total 2 tablets per day per participant from Baseline to 16 weeks after delivery.<br>|
| Active Comparator: Cholecalciferol (Vitamin D3) 70 µg<br>Dietary supplement: Cholecalciferol (Vitamin D3) 70 µg per day | Dietary Supplement: Cholecalciferol (Vitamin D3) 70 µg<br>* Cholecalciferol (Vitamin D3) oral 2 tablets each containing 35 µg. In total 70 µg per day. In total 2 tablets per day per participant from Baseline to 16 weeks after delivery.<br>|
| Placebo Comparator: placebo<br> | Other: placebo tablet<br>* placebo 2 tablet, once a day,<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birth Weight |  | 0-24 hours after delivery of the child | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-partum effects of vitamin D supplement on maternal bone mineral density (BMD). |  | Day 1 to 4 months after delivery. | 
| Infections of the newborn |  | Day 1 of the child to 16 weeks after birth. | 
| Growth of the newborn measured by weight, crown-heel length and head circumference |  | Day 1 of the child to 16 weeks after birth | 
| Time to accomplish pregnancy |  | 0-12 months |
Safety and Feasibility Study of Dapivirine (TMC120) Vaginal Ring in Belgium

Study Overview
=================
Brief Summary
-----------------
This Phase I trial will assess the feasibility of using a vaginal ring to deliver the candidate microbicide dapivirine (TMC120) for 7 days. The study population will consist of 13 healthy, sexually abstinent women. Safety and tolerability will be assessed through clinical and laboratory assessments. Feasibility of drug delivery will be assessed by measuring dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma.

Official Title
-----------------
Double-blind, Randomized, Placebo Controlled Trial to Study Safety, Local and Systemic Availability of TMC120 From a Vaginal Ring.

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: dapivirine (TMC120) vaginal ring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, age 18-50 years Willing and able to provide written informed consent HIV-uninfected and otherwise healthy Willing to abstain from sexual activity and from use of vaginal products while participating in the study Currently using oral contraceptives for pregnancy prevention Willing to use oral contraceptives as needed to avoid menstruation while taking part in this study Exclusion Criteria: History of allergy to TMC120 or to the constituents of the vaginal ring History of diagnosis of and/or treatment for a sexually transmitted disease within the last three months History of genital tract surgery within the last month Currently pregnant or breastfeeding, or within two months of last pregnancy outcome Currently or within one month of participating in any other clinical research study Current vulvar or vaginal symptoms / abnormalities that could influence the study results Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption Current diagnosis of any genital infection Smoking more than 10 cigarettes / day

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dapivirine (TMC120) vaginal ring|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of seven-day use of a vaginal ring containing dapivirine (TMC120). |  |  | 
| Assess dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma during and after seven-day use of a vaginal ring containing dapivirine (TMC120). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV Seronegativity
Electroclinical Features of Sudden Unexpected Death in Epilepsy (SUDEP) : a Multi-center Observational Study

Study Overview
=================
Brief Summary
-----------------
Sudden unexpected death in epilepsy (SUDEP) is regarded as a leading cause of premature death in epilepsy patients. We aim to capture the whole process of SUDEP and near-SUDEP occurrence in patients with epilepsy, and expolre video-electroencephalograph (V-EEG) changes and marker. A Chinese multicenter study was carried out to determine electroencephalo-graph marker related to SUDEP to provide a scientific basis for the prevention of SUDEP in patients with epilepsy.

Official Title
-----------------
Electroclinical Features of Sudden Unexpected Death in Epilepsy (SUDEP) : a Multi-center Observational Study

Conditions
-----------------
Sudden Unexpected Death in Epilepsy, Near-Sudden Unexpected Death in Epilepsy

Intervention / Treatment
-----------------
* Diagnostic Test: Video-Electroencephalography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with epilepsy who meet SUDEP or near-SUDEP diagnosis, Giving written informed consent to participate in the study from relatives or caregivers. Exclusion Criteria: Refusing to recruitment from relatives or caregivers.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Video-Electroencephalography|Three types of video EEG monitoring equipment produced by Nicolet, Bio-logic and Nihon Kohden were used to collect data in the multi-center. The 19-lead recording electrode was placed according to the international 10-20 system, and the average lead was used. The recording time was 24h. All patients underwent eyes open and closed test, intermittent photic stimulation and hyperventilation induction test.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of SUDEP or near-SUDEP | Baseline, clinical characteristics and EEG markers of SUDEP patients were collected. | 2022.04.01-2024.04.01 |
Assessment of Complete Response MRI Criterion After Neoadjuvant Therapy in Locally Advanced Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
Standard care for locally advanced rectal cancer consists in a neoadjuvant therapy followed by surgery. Morbidity and mortality remain high after rectal surgery, and often linked with quality of life impairment. 10 to 30% present a pathological complete response after neoadjuvant therapy. Some surgical teams propose watch and wait approach for patients selected with clinical complete responses criterion. The problem is to be sur the response is complete. MRI seems to be accurate to select complete responders. We will try to find MRI criterion of complete responses.

Official Title
-----------------
Assessment of Complete Response MRI Criterion After Neoadjuvant Therapy in Locally Advanced Rectal Cancer

Conditions
-----------------
Rectal Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rectal adenocarcinoma Locally advanced Neoadjuvant therapy MRI restaging Rectal surgery Definitive anatomopathology study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Pathological complete response<br>Patients with a complete response to the neoadjuvant therapy on the definitive anatomopathology study. | |
| Non pathological complete response<br>Patients without complete response to the neoadjuvant therapy on the definitive anatomopathology study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response MRI criterion | We selected several objective MRI criterion among literature and compared them between the two groups. | Day 0: immediately after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI accuracy | Calculated Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value. | Day 0: immediately after the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, Complete response
Dynamic PET acquisition-a Quantitative Technique for Grading of Malignant Tumors and Prediction of Response to Treatment

Study Overview
=================
Brief Summary
-----------------
To assess a quantitative kinetic model of FDG uptake measurement using PET in patients with aggressive Non-Hodgkin's lymphoma and cancer of the pancreas, malignancies with known variability in disease aggressiveness and prognosis, for optimized tailoring of the therapeutic strategy in the individual patient.

Official Title
-----------------
Dynamic FDG-PET in Aggressive Lymphoma and Pancreas Cancer

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Device: PET-CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age>18 newly diagnosed untreated aggressive NHL newly diagnosed untreated cancer of pancreas Exclusion Criteria: none

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PET-CT|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of the imaging modality on patient management |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient management |  | 10 years |
Clinical Trial for GNX80 in Intermittent Claudication

Study Overview
=================
Brief Summary
-----------------
This is a Phase 4, randomized clinical trial to evaluate whether GNX80 vs. placebo, prescribed for 6 months to patients with Intermittent Claudication(IC) would lead to an improvement in the walking distance.

Detailed Description
-----------------
A Prospective, Randomized, Placebo-controlled, Double-blinded, Multi-center, Phase IV, Exploratory Clinical Trial to Demonstrate the Effect of Improving the Walking Distance by GNX80 in Patients with Intermittent Claudication

Official Title
-----------------
A Prospective, Randomized, Placebo-controlled, Double-blinded, Multi-center, Phase IV, Exploratory Clinical Trial to Demonstrate the Effect of Improving the Walking Distance by GNX80 in Patients With Intermittent Claudication

Conditions
-----------------
Intermittent Claudication

Intervention / Treatment
-----------------
* Drug: GNX80
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of at least 20 years Angiographically confirmed peripheral arterial disease Intermittent claudication for more than 6 months Exclusion Criteria: Severe impairment of heart, liver, or kidney function Limitation of walking ability due to respiratory insufficiency or to an orthopaedic condition Poorly controlled diabetes mellitus Positive pregnancy test Planned surgical or endovascular procedures other than for the treatment of IC

Ages Eligible for Study
-----------------
Minimum Age: 20 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: GNX<br>GNX / 80mg / BID / PO | Drug: GNX80<br>* GNX80 oral intake(BID) for 24 weeks<br>* Other names: Test;|
| Placebo Comparator: Placebo<br>Placebo / BID / PO | Drug: Placebo<br>* Placebo oral intake(BID) for 24 weeks<br>* Other names: Control;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking Distance in comparison with the findings from at baseline | walking distance evaluated by a constant treadmill test | 24 weeks |