linjc16/ctgov huggingface dataset:
Evaluation of A Morning Dosing Of A New Medicine And Its Effects On Sleep At Bedtime In Subjects With Primary Insomnia

Study Overview
=================
Brief Summary
-----------------
This study is designed to determine whether morning doses of GW679769, taken daily for 1 to 9 days, will promote sleep during the following night without significant post-dose thinking impairment and drowsiness in subjects with primary insomnia.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Effects of Morning Administration of GW679769 (10mg and 30 mg) on Polysomnograph Sleep Recordings, Subjective Sleep Assessment, Daytime Cognition and Psychomotor Function in Subjects With Primary Insomnia

Conditions
-----------------
Sleep Initiation and Maintenance Disorders, Insomnia

Intervention / Treatment
-----------------
* Drug: GW679769


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Difficulty going to sleep and/or staying asleep during at least the past 3 months. Insomnia must result in significant distress or impairment in functioning at home, socially or at work. Otherwise good health with no significant or unstable medical disorder including psychiatric, neurological, endocrine, heart, lung or gastrointestinal disorders, drug/alcohol abuse, cognitive impairment, cancer or chronic pain conditions such as arthritis. Exclusion criteria: History of other sleep disorders such as sleep apnea or restless leg syndrome; regular sleep habits, including bedtime between 9 PM and midnight, nightshift/rotating shift work, frequent napping or planned travel across >2 time zones. Use to moderate use of nicotine, caffeine and alcoholic products.

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW679769|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of GW679769 and placebo when taken daily in the morning, on the time needed to fall asleep at bedtime on Days 1/2 and 8/9 of treatment, as assessed at a sleep clinic. |  | 9 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of GW679769 and placebo on total sleep time and time awake after initial sleep onset on Days 1/2 and 8/9 of treatment, as assessed at a sleep clinic. Daily sleep questionnaires and mental functioning tests on Days 1 and 9 of treatment. |  | 9 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognition, Primary Insomnia, sleep, polysomnography
Exploratory Study on the Role of Somatic Modulation in Hyperacusis

Study Overview
=================
Brief Summary
-----------------
This study focuses on patients with a primary complaint of hyperacusis. Hyperacusis has been defined as 'abnormally reduced tolerance to sound' and is commonly associated with tinnitus. The effects of somatic modulation upon tinnitus have been studied, but not so for hyperacusis.. The effect of 9 somatic modulations (i.e. 3 jaw modulations and 6 cervical spine modulations) and 1 control movement (i.e. without any somatic modulation effect) in random order on the sound tolerance of a 1 kilohertz (kHz) broadband noise sound and the tinnitus experience will be investigated. More specifically, the perceived loudness and intrusiveness of this sound and the tinnitus sound will be evaluated before somatic modulation and during the somatic modulation.

Official Title
-----------------
Exploratory Study on the Role of Somatic Modulation in Hyperacusis

Conditions
-----------------
Hyperacusis

Intervention / Treatment
-----------------
* Diagnostic Test: Somatic modulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary complaint of hyperacusis Exclusion Criteria: Primary complaint of tinnitus

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 |
| --- | --- |
| Hyperacusis<br>Abnormally reduced tolerance to sound | Diagnostic Test: Somatic modulation<br>* Type of modulations: 3 jaw and 6 cervical spine modulations, 1 control movement (i.e. without any expected somatic modulation effect) Jaw modulations: laterotrusion to the left, laterotrusion to the right and protrusion Cervical spine modulations: isometric flexion, extension and left and right lateroflexion of the head against resistance of the investigator's hand, compression and traction of the cervical spine in sitting position. Control movement: the investigator's hand rests against the patient's forehead without any force application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in rating of hyperacusis (loudness and intrusiveness) after modulation | Change in hyperacusis loudness and intrusiveness rating by use of a visual analogue scale | Baseline (Before modulation), Immediately after modulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in rating of tinnitus (loudness and intrusiveness) after modulation | Change in tinnitus loudness and intrusiveness rating by use of a visual analogue scale | Baseline (Before modulation), Immediately after modulation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperacusis, Somatic, Modulation
Vital Sensor Monitors for CV19 Detection

Study Overview
=================
Brief Summary
-----------------
This study will monitor physical bio-markers such as heart rate, respiratory rate, and temperature to detect potential COVID-19 infections.

Detailed Description
-----------------
The purpose of this research is to assess the accuracy of wearable sensors at detecting and monitoring COVID-19 infections. Our small, wearable sensor can get data on your respiration, body temperature, heart rate, and blood oxygen level, which may help physicians better identify if a respiratory condition is worsening overtime. If successful, our sensor could help healthcare professionals detect early symptoms of COVID-19 respiratory infection and monitor recovery and treat people before their condition worsens significantly.

Official Title
-----------------
ICU-Grade Wearable Sensors With Novel Respiratory Biomarkers to Diagnose and Detect Pre- and Very Early Symptomatic COVID-19 Infection Using Predictive Machine Learning Algorithms

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Device: ANNE One


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18 years old or over Recent (within 1 week) occupational or home exposure to a newly diagnosed COVID-19 infected individual Able and willing to give written consent and comply with study procedures Exclusion Criteria: Inability to understand instructions and follow a three step command The subject is pregnant, nursing or planning a pregnancy Inability to provide written consent Past confirmed COVID-19 infection with resolution of symptoms Past confirmed COVID-19 active infection moderate or severe symptoms

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Adults<br>Adults 18 years or older | Device: ANNE One<br>* Wireless vital sign monitoring device<br>|
| COVID19<br>Adults 18 years or older diagnosed with COVID 19 | Device: ANNE One<br>* Wireless vital sign monitoring device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1.Efficacy of wearable device to detect respiratory infection parameters: cough count | Device data measuring cough count. Captured by analysis of peak acclerometer graphing and duration in meters per second squared (m/s2). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2.Monitoring of respiratory infection symptoms, WURSS-11 Survey | WURSS-11 survey. https://www.fammed.wisc.edu/files/webfm-uploads/documents/research/wurss-11.pdf The WURSS-11 survey will be conducted on a weekly basis by study subjects for the duration of the study (up to 52 weeks). | Time Frame: 1 year |
A Study to Evaluate Pneumococcal Polysaccharide Vaccine Effectiveness in Children With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if children with type 1 diabetes have adequate immune response to PPSV23 vaccination and to assess factors affecting immune response.

Official Title
-----------------
Vaccine Effectiveness and Seroconversion to 23 Valent Pneumococcal Polysaccharide Vaccination in Children With Type 1 Diabetes

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Biological: Pneumovax 23- pneumococcal polysaccharide
* Procedure: Blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children ages 3-18 years old. Clinical diagnosis of Type 1 diabetes. Exclusion Criteria: Newly diagnosed with Type 1 diabetes with in the past month of study date. Contraindications to receiving 23 valent pneumococcal vaccines. Other conditions associated with compromised immunity and vaccine response. Primary or Secondary Immune deficiency. Previous receipt of PPSV-23 vaccination.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Will study immunological response to vaccination
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pneumovax 23<br>Type 1 Diabetes subjects will receive Pneumovax 23-pneumococcal polysaccharide (PPSV23) | Biological: Pneumovax 23- pneumococcal polysaccharide<br>* PPSV23 is a vaccine to help protect against serious infection due to the Streptococcus pneumoniae bacteria. One dose administered intramuscularly or subcutaneously.<br>* Other names: PPSV23;Procedure: Blood draw<br>* 6 ml blood draw at baseline and 6 months post immunization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunoglobulin G (IgG) Antibodies | Serological response. Blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/mL | 6 months post vaccination |
ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon

Study Overview
=================
Brief Summary
-----------------
Study to evaluate efficacy of fingolimod in patients with neutralizing antibodies over 12 months

Official Title
-----------------
A 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Fingolimod in the Treatment of Relapsing-remitting Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Fingolimod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects aged 18-65 years Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5 Interferon-beta (IFN-β) treatment for at least 18 months. Positive IFN-NAb titer at screening or within 6 months prior to screening Patients with disease activity despite treatment with IFN-ß measured by gadolinium-enhancing lesions on T1-weighted images on MRI using a triple-dose gadolinium protocol and/or new or newly enlarging T2 lesions (T2 lesions: compared to a reference MRI performed within the last 18 months) Exclusion Criteria: patients with previous or current disease of immune system active infections cardiovascular risk patients Patients unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fingolimod<br> | Drug: Fingolimod<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with active MRI lesions | number of patients with neutralizing antibodies against IFN-ß with reduction of number of combined unique active lesions on brain MRI (CUAL) defined as those lesions that are new or recurrent or enlarging on T2-weighted scans or those that are new and taking Gd-enhancement on T1-weighted scans, avoiding double counting | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events | safety of fingolimod as measured by number of adverse events | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, MS, Fingolimod, Gilenya, Neutralizing Antibodies, NAb
Dexketoprofen and Etoricoxib in Patients Undergoing Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study was to determine the plasma and central nervious system pharmacokinetics of dexketoprofen and etoricoxib. The secondary aim was to asses their effect on the concentrations of interleukin 6, prostaglandin E2 and other proinflammatory markers both in plasma and cerebrospinal fluid. Thirdly, the investigators aimed to evaluate their efficacy in postoperative pain treatment.

Official Title
-----------------
The Central Nervous Penetration of Dexketoprofen and Etoricoxib and Their Effect on Pain and Inflammatory Reaction in Patients Undergoing Hip Arthroplasty

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: Dexketoprofen
* Drug: Etoricoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: agreed to participate the study American Society of Anesthesiologist s physical status classification 1-3 elective hip arthroplasty planned no contraindications to the study drugs no contraindication to lumbar puncture Exclusion Criteria: refused to participate the study age less than 40 or over 75 years Planned anesthesia method other than spinal anesthesia contraindications to the study drugs Contraindications to lumbar puncture

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etoricoxib<br>Etoricoxib 60mg if body weight≤ 60kg, 90mg if body weight 61-90kg and 120mg if body weight> 90kg by mouth | Drug: Etoricoxib<br>* After total hip replacement surgery patient were given either etoricoxib or dexketoprofen<br>|
| Active Comparator: Dexketoprofen<br>Dexketoprofen 0,5 mg/kg up to 50 mg intravenously | Drug: Dexketoprofen<br>* After total hip replacement surgery patient were given either etoricoxib or dexketoprofen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebrospinal fluid concentration dexketoprofen and etoricoxib | Cerebrospinal fluid concentration of dexketoprofen and etoricoxib | 0-24 hours | 
| Plasma concentration dexketoprofen and etoricoxib | Plasma concentration dexketoprofen and etoricoxib | 0-24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain assessed with numeral rating scale | 0-24 h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dexketoprofen, Etoricoxib, hip arthroplasty, pain
IFx-Hu2.0 Expanded Access Program

Study Overview
=================
Brief Summary
-----------------
Expanded access requests for IFx-Hu2.0 may be considered for the treatment of adult patients (greater than or equal to 18 years of age) with stage III through IV cutaneous melanoma, advanced Merkel cell carcinoma (MCC), or advanced cutaneous squamous cell carcinoma (cSCC) who have failed all available treatment options. To request access, use Responsible Party contact information provided in this record..

Official Title
-----------------
IFx-Hu2.0 Expanded Access Program

Conditions
-----------------
Cutaneous Melanoma, Stage III, Cutaneous Melanoma, Stage IV, Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Biological: IFx-Hu2.0


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To request more information use Responsible Party contact information provided in this record Exclusion Criteria: To request more information use Responsible Party contact information provided in this record

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: IFx-Hu2.0|The investigational drug product IFx-Hu2.0 is composed of the drug substance pAc/emm55 (pDNA) complexed with the two excipients in vivo-jetPEI® (linear polyethylenimine), a transfection reagent, and dextrose, a pDNA/polyethylenimine complex stabilizer. Therapeutic Classification: Immunomodulatory Agent Route of Administration: Intralesional (i.e. injection of cutaneous, subcutaneous or nodal lesions) Mechanism of Action: Injection of IFx-Hu2.0 into the lesion facilitates the expression of the immunogenic Emm55 protein by the tumor cells. Physiological Effect: Expression of the emm55 gene by the tumor cells triggers immune recognition of tumor-specific and -associated antigens which leads to innate and adaptive immune responses. In addition to priming anti-tumor immunity in immune checkpoint inhibitor (ICI)-naïve patients, this could re-sensitize patients with primary or secondary ICI clinical resistance.|

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
-----------------
CM, MCC, cSCC, pDNA, plasmid DNA, pAc/emm55, IFx-Hu.20, Immunotherapy, Gene Therapy, Immunology, Oncology, Immuno-Oncology
Efficacy of Potassium Sodium Hydrogen Citrate Therapy on Renal Stone Recurrence and/or Residual Fragments After Shockwave Lithotripsy and Percutaneous Nephrolithotomy in Calcium Oxalate Urolithiasis

Study Overview
=================
Brief Summary
-----------------
Extracorporeal shock wave lithotripsy (ESWL) and Percutaneous nephrolithotomy (PCNL) become the therapy of choice for renal stone. Although providing good results, stone recurrence is usually found as the therapies do not change the underlying metabolic abnormality. Among the metabolic disorders, hypocitraturia is an important risk factor for calcium nephrolithiasis. This study evaluate the preventive effects of potassium sodium citrate on stone recurrence as well as stone growth post ESWL or PCNL, in patients with calcium-containing stones.

Conditions
-----------------
Kidney Calculi

Intervention / Treatment
-----------------
* Drug: Potassium-sodium citrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years stone free or had residual calcium oxalate stone fragments with a less than 4 mm. diameter at eight weeks after ESWL or PCNL Exclusion Criteria: renal tubular obstruction serum creatinine > 2 mg/dl urinary tract infection (bacteria > 100,000 in urine culture) hypersensitive or contraindication to Potassium sodium hydrogen citrate insertion Double-J Stent history of arrhythmia, myocardial infarction or digitalis administration

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Potassium-sodium citrate|The treated group was given oral potassium-sodium citrate 81 mEq/day The control group received no treatment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of stone recurrence or stone growth | The patients were evaluated at 6 months after the initial treatment for serum chemistry and urinalysis. After 12 months, all patients were evaluated for serum chemistry, urinalysis, 24-hour urine study and plain KUB. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Potassium sodium citrate, stone recurrence, ESWL, PCNL, Hypocitraturia, intervention