linjc16/ctgov huggingface dataset:
Simvastatin Metabolism as a Test for CD Activity (IRB 15-007568]

Study Overview
=================
Brief Summary
-----------------
To study the correlation between simvastatin metabolism by the enterocyte and the histologic state of the intestine in treated celiac disease.

Detailed Description
-----------------
A cross sectional design incorporating subjects with active celiac disease and healed celiac disease (based on clinically-obtained biopsies); and healthy individuals.

Official Title
-----------------
Simvastatin Metabolism as a Test for Celiac Disease Activity

Conditions
-----------------
Celiac Disease

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gluten-free diet for at least 1 year Clinical endoscopy within the past month Biopsies must show no villous atrophy or villous blunting Villous height to crypt depth (VHCD) ratio measurement should be 2.5:1 or greater Exclusion Criteria: 1st degree relative with Celiac Disease Positive tTG IgA, already on simvastatin or statin agent Unable to stop non-steroidal or anti-inflammatory drugs Prior history of GI surgery other than appendectomy or cholecystectomy Taking drugs know to inhibit or activate CYP3A4 Unable to avoid food known to inhibit CYP3A4 History of a reaction to statin drugs in the past Pregnant or nursing women

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simvastatin<br>Simvastatin tablet, 20 mg, one time by mouth | Drug: Simvastatin<br>* 20 mg Simvastatin given, Blood draw, Urine collection, Celiac serology testing, DNA sampling, Dietary review<br>* Other names: Zocor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare simvastatin metabolism with intestinal biopsies |  | Within one month of visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Villous height and crypt depth | As measured in intestinal biopsies | Within 1 month of visit | 
| Dietary interview | To determine whether the patient is strictly adherent, mostly adherent or non-adherent to a gluten-free diet | At initial visit | 
| Urinalysis | Looking for traces of gluten peptides | Prior to administration of simvastatin and at the 3-hour mark | 
| Serologic testing | tTG IgA titer level determination | Prior to administration of simvastatin | 
| DNA sampling | Genetic testing associated with celiac disease (DQ2 and DQ8) | Prior to administration of simvastatin |
Resistant Starch on Glucose and Insulin Sensitivity in Individuals With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study will test the effects of resistant starch type 4 on blood sugar and hunger in adults with Type 2 diabetes.

Detailed Description
-----------------
To measure the blood glucose response, after an overnight fast, blood samples will be collected before eating and 15, 30, 45, 60, 90, and 120 minutes after eating each bar. The incremental area under the curve was used to calculate glycemic index. The investigators will also measure the second meal effect by measuring the metabolic response (glucose, insulin, and gut hormones) after a standardized lunch two hours following the first assessment.

Official Title
-----------------
Resistant Starch on Glucose and Insulin Sensitivity in Individuals With Type 2 Diabetes

Conditions
-----------------
Hyperglycemia

Intervention / Treatment
-----------------
* Dietary Supplement: Resistant Starch Type 4-Raw
* Dietary Supplement: Resistant Starch Type 4-Raw
* Dietary Supplement: Resistant Starch Type 4-Cooked
* Dietary Supplement: Resistant Starch Type 4-Cooked
* Dietary Supplement: Shredded Wheat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetics Exclusion Criteria: Diagnosed with other metabolic disorders Allergies to wheat Non-smokers
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Resistant starch type 4-Raw | Dietary Supplement: Resistant Starch Type 4-Raw<br>* Low Dose- 70g bar<br>|
| Experimental: 2<br>Resistant starch type 4-Raw | Dietary Supplement: Resistant Starch Type 4-Raw<br>* High Dose- 100g bar<br>|
| Experimental: 3<br>Resistant starch type 4-Cooked | Dietary Supplement: Resistant Starch Type 4-Cooked<br>* Low Dose- 70g bar<br>|
| Experimental: 4<br>Resistant starch type 4-Cooked | Dietary Supplement: Resistant Starch Type 4-Cooked<br>* High dose: 100g bar<br>|
| Placebo Comparator: 5<br>Shredded wheat | Dietary Supplement: Shredded Wheat<br>* 70g bar<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Prandial metabolism |  | Acute -- fasting, 15, 30, 45, 60, 90 and 120 minutes post-ingestion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satiety |  | Early morning - Midafternoon | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Diet, Fiber
Double-Blind Trial of Miglitol in Type 2 Diabetic Patients With Insulin Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is evaluate the clinical efficacy and safety of Miglitol in patients with Type2 Diabetes Mellitus with treated insulin.

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

Intervention / Treatment
-----------------
* Drug: Miglitol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type2 diabetes Criteria of postprandial plasma glucose and HbA1c are met Exclusion Criteria: Type1 diabetes Patients with antidiabetic drugs The other exclusion criteria are met

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: Double


Arms and Interventions

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

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
-----------------
alpha-glucosidase inhibitor,Insulin
Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia

Study Overview
=================
Brief Summary
-----------------
Comparison between the analgesic effect of local infiltration of either Bupivacaine or ketamine in the peritonsillar area before the incision of tonsillectomy to achieve postoperative analgesia

Official Title
-----------------
Comparison Between Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia

Conditions
-----------------
Post Operative Pain

Intervention / Treatment
-----------------
* Drug: Ketamine.
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria 3-20 years old patients elective tonsillectomy or adenotonsillectomy with or without ventilation tube application. Exclusion criteria allergy to bupivacaine or ketamine coagulopathy endocrine, neuropsychiatric or cardiopulmonary dysfunction increase intracranial pressure (ICP) psychiatric illness, history of seizure, patients under chronic analgesic treatment history of peritonsillar abscess, tonsillar malignancy.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group K1 Ketamine<br>pre-incisional submucosal infiltration of ketamine .5 mg/kg in the Peritonsillar area | Drug: Ketamine.<br>* Peritonsillar infiltration of ketamine<br>|
| Active Comparator: Group B1 Bupivacaine<br>pre-incisional submucosal infiltration of Bupivacaine .25 % in the Peritonsillar area | Drug: Bupivacaine<br>* peritonsillar infiltration of Bupivacaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | The pain will be assessed using modiﬁed Hannallah pain scale which includes blood pressure, movement, agitation and posture where zero is the least pain and 2 is the worest necessitating rescue analgesia | 60 minutes postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ketamine, Bupivacaine, tonsillectomy, analgesia
Chemoradiation Plus Weekly c225 Against Locoregionally Advanced Nasopharyngeal Carcinoma (NPC)

Study Overview
=================
Brief Summary
-----------------
The investigators will add weekly cetuximab (c225) to the standard care of chemoradiation against locoregionally advanced Nasopharyngeal Carcinoma (NPC), and evaluate the toxicity and efficacy of this new regimen.

Official Title
-----------------
IMRT With Concurrent Chemotherapy and Cetuximab Against Locoregionally Advanced NPC: a Phase 1 Study

Conditions
-----------------
Nasopharyngeal Carcinoma

Intervention / Treatment
-----------------
* Radiation: Intensity-modulated radiotherapy
* Drug: Concurrent chemotherapy with paclitaxel and nedaplatin
* Biological: Cetuximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically confirmed untreated NPC patients locoregionally advanced (T3-4 or N2-3 M0) 18-65 years with MRI examinations ECOG ≤ 2 With written consent Exclusion Criteria: Without a second cancer Pregnancy With other severe diseases (blood,liver ,kidney or heart diseases) Could not be staged properly Without written consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cetuximab<br>Patients will be given intensity-modulated radiotherapy,2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin,and weekly cetuximab during radiation therapy. | Radiation: Intensity-modulated radiotherapy<br>* Patients will be given intensity-modulated radiotherapy(IMRT)<br>Drug: Concurrent chemotherapy with paclitaxel and nedaplatin<br>* Patients will be given 2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin<br>Biological: Cetuximab<br>* Patients will be given cetuximab weekly during radiation therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety |  | 6 months | 
| Number of Participants with Adverse Events as a Measure of Safety and tolerability |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Locoregionally advanced nasopharyngeal carcinoma, cetuximab, chemoradiation
Screening for Cervical Intraepithelial Neoplasia Using Self-collected Menstrual Blood

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the feasibility and efficacy of assessing HR-HPV DNA and HPV E6/E7 mRNA via self-collected menstrual blood in a smart menstrual pad. In other words, can the investigators detect the high risk strains of the human papilloma virus (HPV) that are associated with cervical cancer in self-collected menstrual blood, as an alternative to collecting vaginal swabs.

Official Title
-----------------
Screening for Cervical Intraepithelial Neoplasia Using Self-collected Menstrual Blood

Conditions
-----------------
HPV - Anogenital Human Papilloma Virus Infection

Intervention / Treatment
-----------------
* Diagnostic Test: Menstrual Blood Analysis (Menstrual Blood Analysis)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: There will be two study groups: 1) menstruating women over the age of 18 who have previous history of HR-HPV in the last 18 months and 2) menstruating women over the age of 18 who do not have a previous history of HR-HPV. Exclusion Criteria: Women younger than 18 years old or are not menstruating regularly

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High Risk HPV Positive Cohort<br>This group of women have tested positive for HR-HPV at annual cervical cancer screening and have been invited to participate in the study. They will be asked to use a menstrual pad we provide that collects a sample of their menstrual blood (strip). The strip will be mailed back to us for analysis (Menstrual Blood Analysis). These women will also be asked to conduct a self-swab vaginally to be sent back to us for analysis. These women will return 6-months after their positive HR-HPV for standard of care testing. All results of the standard of care tests, menstrual blood tests, and self-swab tests will be compared. | Diagnostic Test: Menstrual Blood Analysis (Menstrual Blood Analysis)<br>* We will be testing women's menstrual blood to investigate the feasibility and efficacy of assessing HR-HPV DNA and HPV E6/E7 mRNA via self-collected menstrual blood from a menstrual pad.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of HR-HPV DNA or HPV E6/E7 mRNA | Binary (yes, no) | 2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
menstrual blood, high risk HPV
Circular Cyclocoagulation Using HIFU With EYEOP1 Device in Glaucoma Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation using HIFU in glaucoma patients

Official Title
-----------------
Efficacy and Safety of Circular Cyclocoagulation Using High Intensity Focused Ultrasound With EYEOP1 Device in Glaucoma Patients. Prospective Multicenter Clinical Trial.

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Device: Ultrasound glaucoma treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary Open-angle glaucoma included pseudo-exfoliative glaucoma and pigmentary glaucoma IOP > 21 mm Hg on glaucoma medications, and indicated for filtering glaucoma surgery Patient must be aged 18 years and more No previous cyclophotocoagulation procedure in the eye No previous laser treatment in the eye during the 3 months before HIFU procedure Exclusion Criteria: History of previous glaucoma surgery with implantation of glaucoma drainage device in the study eye History of ocular or retrobulbar tumor retinal detachment, choroidal hemorrhage or detachment Ocular infectious diseasee within 14 days before HIFU procedure

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound Glaucoma treatment<br>Cyclocoagulation using High Intensity Focused Ultrasound (HIFU) | Device: Ultrasound glaucoma treatment<br>* Ultrasound glaucoma treatment with EYEOP1 device<br>* Other names: UCP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate : Proportion of eyes that achieve an IOP of > 5 mmHg and <21 mmHg or an IOP reduction > 20% | Success rate = complete success rate (achieved without ocular hypotensive medication) + qualified success (achieved with ocular hypotensive medication) | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average change in IOP (mm Hg) |  | 3, 6 and 12 months | 
| Percentage change in IOP from baseline |  | 3, 6 and 12 months | 
| Average change in glaucoma hypotensive medications |  | 3, 6 and 12 months | 
| Incidence of device and procedure-related complications during follow-up |  | 3, 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Cyclocoagulation, HIFU - High Intensity Focused Ultrasound, Ciliary Body
Systemic Variables in the Saliva of Children Undergoing Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Saliva is used nowadays as a significant diagnostic tool due to the latest technological developments. The research compares two experimental groups; children after liver transplantation and a control group. Our objective is to identify from all the parameters that are evaluated, the ones that differ between the two groups. If such parameters will be found and differ statistically, it will be possible to create a non invasive medical examination protocol, which will probably be much more complaint, and being so would help locate individuals in risk groups with the tendency to develop an end-organ liver disease.

Official Title
-----------------
Systemic Variables in the Saliva of Children Undergoing Liver Transplantation

Conditions
-----------------
Liver Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children after a successful liver transplantation

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
saliva, liver transplantation, children, In this prospective study 60 subjects will be examined, children and adolescents, after a successful liver transplantation, informed consent forms signed be the examinees parents
Influence of Didgeridoo Practice on UA Obstruction Levels in Moderate OSA

Study Overview
=================
Brief Summary
-----------------
Didgeridoo practice has been shown to improve OSA severity. The aim of our study is to assess the changes in upper airways obstruction levels before and after Didgeridoo practice in moderate OSA patients.

Detailed Description
-----------------
Didgeridoo practice has been shown to improve Obstructive Sleep Apnea (OSA) severity. The aim of our study is to assess the changes in upper airways obstruction levels, evaluated by sleep endoscopy, before and after 3 months of Didgeridoo practice in moderate non obese OSA patients. Severity of OSA will also be documented by polysomnography.

Official Title
-----------------
Influence of Didgeridoo Practice on Upper Airways Obstruction Levels in Moderate Obstructive Sleep Apnea Patients

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

Intervention / Treatment
-----------------
* Other: didgeridoo practice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: moderate OSA, non obese Exclusion Criteria: not willing play didgeridoo age<18 significant lung, cardiac disease neuromuscular disease psychiatric disorders drugs with influence on respiratory drive

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: didgeridoo practice<br> | Other: didgeridoo practice<br>* instrument lessons, 1X/w and daily practice, 20 min /d<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| upper airways obstruction levels | assessed by drug-induced sleep endoscopy | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| apnea-hypopnea index | assessed by polysomnography | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
didgeridoo, sleep apnea, drug induced sleep endoscopy