linjc16/ctgov huggingface dataset:
Sitosterolemia Metabolism

Study Overview
=================
Brief Summary
-----------------
Ezetimibe has become the treatment choice for patients with sitosterolemia. Ezetimibe is an inhibitor of cholesterol absorption from the gastrointestinal tract. The purpose of this study is to determine if ezetimibe improves whole body plant sterol and cholesterol homeostasis.

Official Title
-----------------
Assessment of Sterol Metabolism in Sitosterolemia: A Pilot Study of Patients Treated With Ezetimibe

Conditions
-----------------
Sitosterolemia

Intervention / Treatment
-----------------
* Drug: Ezetimibe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed diagnosis of homozygous sitosterolemia as established by genotyping and clinical parameters Exclusion Criteria: pregnant intellectual disability major infectious diseases immunodeficiency cancer renal failure diabetes

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 99 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ezetimibe<br>Compare on and off ezetimibe | Drug: Ezetimibe<br>* 10mg ezetimibe/day, at least 4 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma cholesterol level | Plasma cholesterol level will be assessed by GC | 8 months | 
| Plasma sitosterol level | Plasma plant sterol assessment using GC | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cholesterol absorption | Use stable isotope technique to assess cholesterol absorption | 4 month | 
| Cholesterol synthesis | Use of stable isotope to assess cholesterol synthesis. | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sitosterolemia, Ezetimibe, Plant sterol, Cholesterol
Pico-Salax Colonic Preparation Study: Quantifying Electrolyte and Volume Status Changes

Study Overview
=================
Brief Summary
-----------------
Twenty adult volunteers will be administered Pico-Salax in the usual fashion for colonoscopy with intense monitoring of serum and urine chemistry and hemodynamics.

Official Title
-----------------
Pico-Salax Colonic Preparation Study: Quantifying Electrolyte and Volume Status Changes

Conditions
-----------------
Hemodynamics, Hyponatremia

Intervention / Treatment
-----------------
* Drug: Pico-Salax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers older than 45 Exclusion Criteria: impaired renal function congestive heart failure ascites known electrolyte abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Pico-Salax<br> | Drug: Pico-Salax<br>* Two sachets of Pico-Salax given 5 hours apart<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum electrolytes |  | 48 hours | 
| patient hemodynamics |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonoscopy, preparation
Shared Decision-Making Tool for Opioid Prescribing After Ambulatory Hand Surgery in Veterans

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if an educational patient-centered presentation reduced the amount of opioid pills requested and utilized by patients compared to standard of care group.

Official Title
-----------------
Shared Decision-Making Tool for Opioid Prescribing After Ambulatory Orthopedic Surgery in Veterans - A Randomized Controlled Clinical Trial

Conditions
-----------------
Opioid Use, Surgery

Intervention / Treatment
-----------------
* Behavioral: Educational Shared-Decision Making Tool


Participation Criteria
=================
Eligibility Criteria
-----------------
1. Inclusion Criteria: a. 18-89 years of age b. Patient at the Orthopedic Department at the Veterans Health Administration c. Indicated for upper extremity surgeries: E.g., Carpal Tunnel Release, Trigger Finger Release, Cubital Tunnel Release, Ganglion Cyst Excision 2. Exclusion Criteria: a. History of opioid use disorder b. Had any recent surgery within four weeks of upper extremity procedure c. Taking opioids prior to surgery d. Returning to an institutionalized setting e. Pregnancy f. Unable to communicate in the English language g. Allergy to any medication recommended for post-operative analgesia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- |
| Experimental: Shared-Decision Making Tool Group<br> | Behavioral: Educational Shared-Decision Making Tool<br>* Patients received a short video presentation on pain management, use of over the counter medication, side effects of opioids and over-the-counter medications and ability to choose the amount of opioid pills up to the standard care amount.<br>|
| No Intervention: Standard of Care Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Opioid Pills Dispensed |  | 1 day (Once after surgery) | 
| Number of Opioid Pills Consumed |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes Measurement Information System Pain Interference Score | Lower scores are better | Once a week for 4 weeks after surgery | 
| Patient-Reported Outcomes Measurement Information System Pain Intensity Score | Lower scores are better | Once a week for 4 weeks after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
orthopedics, hand surgery, opioid use, counseling, education
Determination of Optimal Cutoff Value for Screening Severe Hypoxemic OSA (Obstructive Sleep Apnea) Patients

Study Overview
=================
Brief Summary
-----------------
The 4 following scores have been proposed to detect OSA (Obstructive Sleep Apnea): DES-OSA, STOP-Bang, P-SAP, and OSA50. The aim of this study is to evaluate the optimal cutoff value of these four scores to detect specifically serve OSA patients with hypoxemia.

Official Title
-----------------
Determination of Optimal Cutoff Value of 4 Tests (DES-OSA, STOP-Bang, OSA50, P-SAP) for Screening Severe Hypoxemic OSA (Obstructive Sleep Apnea) Patients

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

Intervention / Treatment
-----------------
* Diagnostic Test: Determination of optimal cutoff values.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients scheduled to have a PSG in the sleep laboratory center. Exclusion Criteria: Patients < 18 years

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 |
| --- | --- |
| All patients<br>All patients included in the present study | Diagnostic Test: Determination of optimal cutoff values.<br>* The results of the four scores will be compared with the results of the polysomnography (PSG). A statistical analysis will be performed to determine the optimal cutoff value of each of the four scores to detect severe OSA patient with hypoxemia.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequacy of STOP-Bang to detect severe hypoxemic OSA patients | Adequacy of STOP-Bang after comparison with the results of the PSG. | One week. | 
| Adequacy of P-SAP to detect severe hypoxemic OSA patients | Adequacy of P-SAP after comparison with the results of the PSG. | One week | 
| Adequacy of OSA50 to detect severe hypoxemic OSA patients | Adequacy of OSA50 after comparison with the results of the PSG. | One week | 
| Adequacy of DES-OSA to detect severe hypoxemic OSA patients | Adequacy of DES-OSA after comparison with the results of the PSG. | One week |
Efficacy of Prophylactic Glycerin Suppositories for Feeding Intolerance in Very Low Birth Weight Preterm Infants: a Randomized Trial

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of prophylactic glycerin suppositories will accelerate the elimination of meconium from the large intestine and thus reduce the incidence of feeding intolerance in very low birth weight (VLBW) infants

Official Title
-----------------
Efficacy of Prophylactic Glycerin Suppositories for Feeding Intolerance in Very Low Birth Weight Preterm Infants: a Randomized Trial

Conditions
-----------------
Infant, Very Low Birth Weight

Intervention / Treatment
-----------------
* Drug: Glycerin suppositories


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infants with birth weight < 1250g. Inborn or outborn infants Less than 72 hours of age. Exclusion Criteria: Congenital malformations. Acute abdomen needing surgical intervention. Severity of illness such that death is likely in the first few days after birth. Inability to get the parental consent.

Ages Eligible for Study
-----------------
Maximum Age: 1 Month

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Intervention group will receive the glycerin suppository | Drug: Glycerin suppositories<br> <br> |
| No Intervention: Control<br>Normal care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| days to achieve full tolerated feeding (breast milk or formula) by NGT or by mouth (140cc/kg/day) |  | 2years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of feeding intolerance | which is defined by the presence of GRVs > 50 % of the previous feed for two consecutive feeds in addition to two of the following: I. Abdominal distention > 1 cm in 12 hour. II. Abdominal tenderness. III. Vomiting. IV. Bile stained aspirate. | 2years | 
| Incidence of necrotizing enterocolitis (NEC) |  | 2years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glycerin suppositories, Feeding intolerance, preterm infants, prophylactic use, elimination of meconium
European Pediatric Catheter Ablation Registry

Study Overview
=================
Brief Summary
-----------------
The main objective of the European Pediatric Catheter Ablation Registry is to collect data on ablation procedures in the European pediatric population in order to improve the management of this subset of patients.

Detailed Description
-----------------
Catheter ablation has revolutionized the management of cardiac arrhythmias in patients and has become first-line therapy for managing many pediatric patients with atrioventricular accessory pathway or atrioventricular nodal-mediated supraventricular tachycardia. Cardiac ablation in children is not a standardized procedure as in adults as evidence gaps still have to be filled. On a European perspective, lack of a dedicated scientific society has limited so far the collection and sharing of data among the most experienced centers. Actually there are no sufficient data available about the management of pediatric patients undergoing ablation in clinical practice, in particular regarding indications, methodology and clinical follow-up.

Official Title
-----------------
European Pediatric Catheter Ablation Registry

Conditions
-----------------
Cardiac Arrhythmias

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients scheduled to any kind of an ablation procedure; Patient´s age between 0 and 18 years; Legal guardians understand the nature of the procedure, are willing to comply with study follow-up evaluations, and provide written informed consent prior to the procedure. Exclusion Criteria: Patient unable to comply with follow-up schedule; Patient has medical conditions that preclude protocol compliance or limit study participation; Legal guardian or patient unwilling or unable to provide informed consent.

Ages Eligible for Study
-----------------
Maximum Age: 18 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 |
| --- | --- | --- |
| To collect data on ablation procedures in the European pediatric population. | Primary outcome will be a combination of efficacy (arrhythmia recurrency) and safety (procedural and late complications) | After 12 months from the ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe and compare different ablation methodologies | Rate of index arrhythmia recurrence and rate of complications will be compared for different ablation technology (electroanatomical mapping system vs standard mapping) and for different energy source(radiofrequency vs cryo) | After 12 months from the ablation procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ablation, procedure, pediatric, european, cardiac, arrhythmias, registry, observational, prospective, catheter, cryoablation, atrioventricular
Adult Intensive Care Units Database of National Taiwan University Hospital

Study Overview
=================
Brief Summary
-----------------
Australian and New Zealand Intensive Care Society (ANZICS) has built an Center of Outcome and Resource Evaluation (CORE) adult patients database (APD) of adult critically ill patients. ANZICS CORE APD has built an international collaboration of intensive care unit (ICU) database. National Taiwan University Hospital has joined this international collaboration and built the data according to the APD data dictionary with same value domain attributes and data element attributes. This database also add expansion of data include hourly vital signs data, more laboratory data, more diagnoses at admission and discharge, data after 24 hours till discharge, and extended information of clinical outcomes more than 30 days after admission to ICU . This database will retrospectively collect the data of patients discharged from intensive care after March 1, 2019 and will prospectively continue the retrospective collection of data till the patients discharged before June 30, 2043. The data will be used for the evaluation of quality and resource allocation, quality improvement, education of data science, datathon, and research to predict the clinical outcomes and assist the treatment strategies.

Official Title
-----------------
Adult Intensive Care Units Database of National Taiwan University Hospital

Conditions
-----------------
Critical Illness

Intervention / Treatment
-----------------
* Other: Intensive care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Critically ill patients admitted to intensive care units Exclusion Criteria: Patients aged less than 20 years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critically ill patients<br> | Other: Intensive care<br>* intensive care for critically ill patients in the intensive care units<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality | Survival status at 30 days after ICU admission | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in intensive care unit | Length of stay (days) in intensive care unit | Time to discharge from intensive care unit, a median of 2-7 days |
Long Term Follow-up of Pegylated-Interferon Alpha-2b

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to investigate the long term outcome of Peginterferon alpha-2b with or without the addition of lamivudine in patients with chronic hepatitis B

Detailed Description
-----------------
Interferon alpha therapy is a generally accepted agent for the treatment of chronic HBV infection and effective in about one third of patients. Recently, in the HBV 99-01 study, pegylated interferon alpha-2b (PEG-IFN) has been shown to be effective in HBeAg-positive patients with chronic hepatitis B. In this study, 266 patients were randomized to receive PEG-IFN in combination with either lamivudine or placebo for 52 weeks. Thirty-six percent of patients receiving monotherapy and thirty-five percent receiving combination therapy had lost serum HBeAg at the end of the 26 week post-treatment follow-up period and there was no difference between treatment groups (P = 0.91). More patients on combination therapy initially seroconverted (44% of patients, compared with 29% on monotherapy; P = 0.01) at the end of treatment but relapsed during follow-up. Similar response patterns were seen when response was assessed by DNA suppression and change in ALT levels. In contrast to nucleoside analogues, such as lamivudine and adefovir dipivoxil, the virological and biochemical response to standard alpha-interferon has been shown to be durable after treatment discontinuation.In addition, standard alpha-interferon leads to improved survival and reduction of hepatocellular carcinoma in chronic hepatitis B patients.Pegylated interferons have shown to be effective in HBeAg-positive chronic hepatitis B patients, but the durability of the response and long-term outcome of treatment have yet to be established.

Official Title
-----------------
Long Term Follow-up of Pegylated-Interferon Alpha-2b and Lamivudine Combination Therapy in Patients With Chronic HBV Infection

Conditions
-----------------
Chronic Hepatitis B

Intervention / Treatment
-----------------
* Procedure: blood samples are taken once


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic Hepatitis B who participated in the HBV 99-01 study

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 |
| --- |
|Procedure: blood samples are taken once|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
-----------------
chronic HBV, Peginterferon, long term follow-up
DAHANCA 33: Image Guided Dose-escalated Radiotherapy to Patients With Hypoxic HNSCC

Study Overview
=================
Brief Summary
-----------------
Aim: To improve curability of radiotherapy in HNSCC patients identified by hypoxic FAZA-PET scanning

Detailed Description
-----------------
Prospective phase II study aiming to improve the outcome in hypoxic resistent patients identified by FAZA-PET. Inclusion: Patients must fulfill the following: Positive hypoxic FAZA-PET Scanning (as described in DAHANCA 24 - see citation) Stage III-IV, Squamous cell carcinoma of the larynx, pharynx or oral cavity (HPVneg (oropharynx) Indication for hyperfractionated accelerated radiotherapy with concommitant cis-platin and nimorazole

Official Title
-----------------
DAHANCA 33: Functional Image Guided Dose-escalated Radiotherapy to Patients With Hypoxic Squamous Cell Carcinoma of the Head and Neck

Conditions
-----------------
Locally Advanced Head and Neck Cancer, Radiotherapy, Hypoxic Radioresistance

Intervention / Treatment
-----------------
* Radiation: HART-CN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage III-IV larynx, pharynx, oral cavity Hypoxic FAZA-PET positive Indication for primary radio-chemotherapy Informed consent Exclusion Criteria: HPV positive oropharynx cancer Primary surgery

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: Treatment with HART-CN<br>HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cisplatin and nimorazole | Radiation: HART-CN<br>* HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cis-platin and daily nimorazole<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loco-regional failure | loco-regional failure defined as persistent or recurrent disease in tumor and/or regional lymphnode sites (within the radiotherapy treated volume). The primary endpoint did not include the effect of a successful procedure with salvage surgery (no primary neck dissection was allowed). | Year 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Death from all causes | Year 3 | 
| Acute radiation related morbidity |  | Month 3 | 
| Late radiation related morbidity |  | Year 3 | 
| Disease-specific death | Disease-specific death is defined as death from or with the cancer in question; | Year 3 |