linjc16/ctgov huggingface dataset:
The Evaluation of a New Sleep Algorithm

Study Overview
=================
Brief Summary
-----------------
A new device is being developed to screen for sleep-breathing disorders. Within this device is a new software algorithm which will determine sleep/wake states. The aim of this study is to evaluate the performance of this new algorithm. This prototype will be compared against a commercially available device which monitors sleep/wake patterns. Volunteers will be asked to wear the prototype and comparative devices for 1-2 nights. The data from both devices will be downloaded after the completion of the study and analysis wil be performed to compare the two recordings.

Official Title
-----------------
The Evaluation of a New Sleep/Wake State Algorithm

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: Screening device
* Device: Comparative product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: => 18yrs old can read and write English Provide informed written consent Exclusion Criteria: Unable to participate for the full duration of the study An individual who is deemed unsuitable to participate in the opinion of the investigator

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Comparative product<br>A device which monitors sleep/wake states | Device: Comparative product<br>* A non-invasive device worn on the arm or leg. It monitors body movement and sleep/wake states<br>* Other names: Actigraphy;|
| Screening device<br>This device will screen for sleep-breathing disorders | Device: Screening device<br>* Non-invasive device worn over clothes during sleep. Used to screen for sleep-disordered breathing conditions.<br>* Other names: Actigraphy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total sleep time | To measure the total sleep time recorded and analysed on the device using the new algorithm | 12 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of arousals during sleep | To compare the data acquired of the new device's algorithm against a pre-existing device detailing the frequency of sleep and wake periods | 12 hrs | 
| Duration of arousals during sleep | To compare the data acquired of the new device's algorithm against a pre-existing device detailing the duration of sleep and wake | 12 hrs | 
| Occurrence of arousals during sleep | To compare the data acquired of the new device's algorithm against a pre-existing device detailing when sleep and wake periods occurred | 12 hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Observational, Sleep, Algorithm
Specific Autoantibody Testing in Patients With Interstitial Lung Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the clinical utility of specific autoantibody testing in unmasking an underlying connective tissue disorder in patients who present with interstitial lung disease and found to have weak positive ANA (1:400 titre) with no overt connective tissue disease manifestations OR borderline/negative ANA with some clinical suggestion of connective tissue disease.

Detailed Description
-----------------
It has been well established that patients with connective tissue disease associated interstitial lung disease respond better to immunosuppressive therapy, and have a better outcome compared to patients with idiopathic interstitial pneumonias. This makes it imperative to identify this group of patients for management and prognostication. Unfortunately some of these patients do not demonstrate overt clinical manifestations of connective tissue disease and our current available autoantibody screen does not detect all potential autoantibodies present. We would like to test for specific autoantibodies in this group of patients to evaluate its clinical utility in identifying covert connective tissue diseases associated with interstitial lung disease.

Official Title
-----------------
To Evaluate the Clinical Utility of Specific Autoantibody Testing in Patients With Interstitial Lung Disease

Conditions
-----------------
Interstitial Lung Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 21 years old and older Patients with interstitial lung disease who have been found to have weak positive ANA (1:400 titre) with no overt connective tissue disease manifestations OR borderline/negative ANA with some clinical suggestion of connective tissue disease will be offered specific autoantibody testing Exclusion Criteria: Inability and unwillingness to sign informed consent Patients who are pregnant or have underlying malignancy

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Clinical utility of specific autoantibody testing | Utility of specific autoantibodies to diagnose underlying connective tissue disease in patients presenting with interstitial lung disease who do not demonstrate overt clinical manifestations of connective tissue disease and our current available autoantibody screen does not detect all potential autoantibodies present. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
interstitial lung disease, idiopathic pulmonary fibrosis
The Use of DPP-4 Inhibitors in Short Bowel Syndrome

Study Overview
=================
Brief Summary
-----------------
The inhibition of Dipeptidyl peptidase-4 should increase the concentration of glucagone-like peptide 1 and 2, and the increase of the latter should increase the absorptive capacity of the intestine.

Detailed Description
-----------------
The only effective (to some extend drug) in short bowel syndrome is Glucacone-like peptide 4. Its price is, however, to high to really change the treatment strategy for intestinal failure. The Dipeptidyl peptidase-4 inhibitor, which a drug which is commonly used in the treatment of diabetes mellitus type II, should increase the concentration of glucagone-like peptide 1 and 2, and the increase of the latter should increase the absorptive capacity of the intestine.

Official Title
-----------------
The Use of Dipeptidyl Peptidase-4 Inhibitor Influences the Absorption of Intestine in Short Bowel Syndrome

Conditions
-----------------
Short Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: Dipeptidyl peptidase-4 inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients receiving home parenteral nutrition (HPN) because of short bowel syndrome for at least 12 months stable metabolic status benign disease Exclusion Criteria: HPN < 12 months metabolically unstable cancer as the reason for intestinal failure

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DPP-4<br>The administration of the DPP-4 inhibitor in the form of a pill once per day | Drug: Dipeptidyl peptidase-4 inhibitor<br> <br> * Other names: Sitagliptin;|
| No Intervention: NO DPP<br>no therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of intestinal absorption | the use of DPP-4 inhibitor results in the better intestinal absorption | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Short bowel syndrome
IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effects on the kidney of rosuvastatin and simvastatin in subjects with Fredrickson Type IIa & Type IIb Dyslipidaemia

Official Title
-----------------
A 6-wk Open-Label, Randomised, Multicentre, Phase IIIb, Parallel-Group Study, Which Describes the Renal Effects of the Lipid-Regulating Agents Rosuvastatin and Simvastatin in the Treatment of Sub's With Fredrickson Type IIa & Type IIb Dyslipidaemia, Inc. Heterozygous Familial Hypercholesterolaemia

Conditions
-----------------
Fredrickson Type IIa & Type IIb Dyslipidaemia

Intervention / Treatment
-----------------
* Drug: Rosuvastatin
* Drug: Simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fasting low density lipoprotein level as defined by the protocol. Fasting triglyceride level as defined by the protocol. Exclusion Criteria: The use of lipid lowering drugs or dietary supplements after Visit 1. Active arterial disease eg Unstable angina, or recent arterial surgery Blood creatine levels above the limits defined in the protocol or +4 proteinuria during dietary lead in period. Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Rosuvastatin | Drug: Rosuvastatin<br> <br> * Other names: Crestor;|
| Active Comparator: 2<br>Simvastatin | Drug: Simvastatin<br> <br> * Other names: Zocor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of Proteinuria |  | 2 weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal effects of rosuvastatin and simvastatin |  | 2 weekly | 
| Low density lipoproteins cholesterol levels |  | 2 weekly | 
| Safety: adverse events & abnormal laboratory markers |  | 2 weekly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholesterol, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor, Simvastatin, Zocor, Renal, kidney
Type Distribution of Human Papillomavirus in Adult African Women Diagnosed With Invasive Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the distribution of the most frequent types of human papillomavirus in African women diagnosed with invasive cervical cancer.

Official Title
-----------------
Human Papillomavirus (HPV) Type Distribution in Adult African Women Diagnosed With Invasive Cervical Cancer

Conditions
-----------------
Infections, Papillomavirus, Cervical Cancer

Intervention / Treatment
-----------------
* Procedure: Collection of cervical cancer tissue samples
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A female aged 21 years or more, presenting with a lesion macroscopically suggestive of invasive cervical cancer. Scheduled for cervical biopsy as per routine procedure at the participating institution on the day of the visit or on a later date. Written or oral-witnessed informed consent obtained from the subject prior to any study procedure. No prior chemo- or radiotherapy for cervical cancer. Exclusion Criteria: Not applicable

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Subjects diagnosed with invasive cervical cancer | Procedure: Collection of cervical cancer tissue samples<br>* Cervical samples will be tested for histopathology diagnosis and human papillomavirus DNA testing.<br>Other: Data collection<br>* Questionnaire completion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of any of the human papillomavirus types (HPV-16, 18, 31, 33, 35, 45, 52 and 58) among the women diagnosed with invasive cervical cancer |  | Average time frame: 6-12 months | 
| Occurrence of any of the human papillomavirus types (human papillomavirus-16, 18, 31, 33, 35, 45, 52 and 58) among the women diagnosed with squamous cell carcinoma |  | Average time frame: 6-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of squamous cell carcinoma cases versus adenocarcinoma and other histologic tumour types of invasive cancer among the women diagnosed with invasive cervical cancer |  | Average time frame:6-12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Human papillomavirus
Genetic Polymorphism and Parkinson's Disease in Taiwanese

Study Overview
=================
Brief Summary
-----------------
To observe and analyze the correlation between Single Nucleotide polymorphisms (SNPs) and the incidence of Parkinson's disease in Taiwanese.

Official Title
-----------------
Association Analysis of Single Nucleotide Polymorphisms and the Incidence of Parkinson's Disease in a Hospital-based Case-control Study in Taiwan

Conditions
-----------------
Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Parkinson's disease (case subjects are diagnosed by the presence of at least three of the five following primary signs: rest tremor, bradykinesia, rigidity, impaired postural refluxes, and the presence of a sustained L-dopa response.) Healthy volunteers without Parkinson's disease Exclusion Criteria: Cases showing atypical features, including multiple system atrophy and progressive supranuclear gaze palsy, or secondary causes of Parkinsonism, such as neuroleptic drugs, infection, tumor, previous cerebrovascular accident and known toxins
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 |
| --- | --- |
| Case (Parkinson's disease patients)<br>Clinical diagnosis of Parkinson's disease (cases are diagnosed by the presence of at least three of the five following primary signs: rest tremor, bradykinesia, rigidity, impaired postural refluxes, and the presence of a sustained L-dopa response.) | |
| Control (Healthy volunteers)<br>Healthy volunteers without Parkinson's disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| single nucleotide polymorphisms in certain candidate genes |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease, Genetic Polymorphism
Measurement of the Oxygen Saturation in the Retinal Vessels With Oxymap

Study Overview
=================
Brief Summary
-----------------
Retinal oximetry can be measured with newly developed Oxymap (Oxymap ehf, Reykjavik, Iceland). Briefly, the device simultaneously acquires digital images at two wavelengths and automatically tracks retinal vessels on both images. Retinal vessel oxygen saturation is estimated by spectrophotometric analysis of light reflected from retinal vessels and from the immediately surrounding retina. Oxygen saturation measurements are made on major temporal arteries and veins. Briefly, the first and second degree vessels are used, with the addition of third degree vessels in images where peripapillary haemorrhage prevented analysis close to the optic disc. Vessel segments chosen for analysis are used consistently for consecutive measurements in the same retina.

Detailed Description
-----------------
Retinal oximetry can be measured with newly developed Oxymap (Oxymap ehf, Reykjavik, Iceland). Briefly, the device simultaneously acquires digital images at two wavelengths and automatically tracks retinal vessels on both images. Retinal vessel oxygen saturation is estimated by spectrophotometric analysis of light reflected from retinal vessels and from the immediately surrounding retina. Oxygen saturation measurements are made on major temporal arteries and veins. Briefly, the first and second degree vessels are used, with the addition of third degree vessels in images where peripapillary haemorrhage prevented analysis close to the optic disc. Vessel segments chosen for analysis are used consistently for consecutive measurements in the same retina. Retinal oximetry in various chorioretinal diseases will be measured with Oxymap.

Official Title
-----------------
Measurement of the Oxygen Saturation in the Retinal Vessels With Oxymap

Conditions
-----------------
Chorioretinal Disorders in Diseases Classified Elsewhere

Intervention / Treatment
-----------------
* Device: oximetry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy eyes and eyes with various chorioretinal diseases, including diabetic retinopathy, retinal vein occlusion, epiretinal membrane, macular hole, inherited chorioretinal diseases, glaucoma, retinal detachment, etc. Exclusion Criteria: Eye with medial opacity.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: oximetry|Retinal oximetry will be performed with Oxymap.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of retinal oxygen saturation from baseline at 6 months |  | Six months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oxygen consumption, retinal oximetry
Quantitative MRI for Patients With Sickle Cell Disease Undergoing Hematopoietic Cell Transplant

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this research is to determine if it is feasible to perform serial magnetic resonance imaging (MRI) to evaluate the amount of bone marrow cells (also called cellularity) and iron stores before and after bone marrow transplantation for severe sickle cell disease.

Official Title
-----------------
Quantitative MRI for Patients With Sickle Cell Disease Undergoing Hematopoietic Cell Transplant

Conditions
-----------------
Sickle Cell Disease

Intervention / Treatment
-----------------
* Diagnostic Test: serial functional magnetic resonance imaging (MRI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 5 years. Diagnosis of SCD ([Hemoglobin SS (Hb-SS), Hemoglobin SC (Hb-SC) or Hemoglobin S-Beta thalassemia (Hb-Sβ) genotype]. Patient is a candidate for an allogeneic HCT. Subject or guardians have given informed consent. Exclusion Criteria The need for general anesthesia for MRI. Subjects with implanted magnetic devices (e.g. pacemakers) that may malfunction or move in the strong magnetic field. A subject who is pregnant. Previous HCT.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI arm<br>Subjects with sickle cell disease undergoing bone marrow transplantation will undergo serial functional MRI (up to 4 scans). | Diagnostic Test: serial functional magnetic resonance imaging (MRI)<br>* All subjects with sickle cell disease undergoing bone marrow transplantation will undergo up to 4 functional MRI scans.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of obtaining serial scans in patients with sickle cell undergoing marrow transplant | Feasibility will be measured by the number of subjects who undergo at least 2 of 4 scheduled functional MRI's | 110 days post transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI and hemoglobin S. | Correlation between functional MRI result and hemoglobin S level. | 1 year post transplant | 
| MRI and neutrophil engraftment | Correlation between functional MRI result and time to neutrophil engraftment | 1 year post transplant | 
| MRI and chimerism | Correlation between functional MRI result and time to donor/ recipient chimerism | 1 year post transplant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone marrow cellularity, bone marrow transplant