linjc16/ctgov huggingface dataset:
Efficacy and Long-Term Safety of Vildagliptin as Monotherapy in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as monotherapy.

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at least 18 years of age at Visit 1 Drug naïve patients with T2DM diagnosed at least 2 months prior to Visit 1 HbA1c ≥ 7.0 % and ≤ 10.0% at Visit 1 Body Mass Index (BMI) in the range of 22-45 kg/m2 at Visit 1 Exclusion Criteria: Pregnant or lactating female FPG ≥ 270 mg/dL (≥15 mmol/L) Other protocol-defined inclusion/exclusion criteria may apply

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin Dose 1<br> | Drug: Vildagliptin<br> <br> |
| Experimental: Vildagliptin Dose 2<br> | Drug: Vildagliptin<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM by assessing changes in HbA1c from baseline to 24 weeks. |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM as measured by changes in fasting plasma glucose from baseline to 24 weeks |  | 24 weeks | 
| Measure: To evaluate the safety and tolerability of vildagliptin compared to placebo over 24 weeks of treatment as monotherapy in patients with T2DM |  | 24 weeks | 
| Measure: To evaluate the long-term safety and tolerability of vildagliptin over the entire study duration as monotherapy in patients with T2DM |  | 76 weeks | 
| Measure: To evaluate the body weight change from baseline with vildagliptin compared to placebo after 24 weeks of treatment as monotherapy in patients with T2DM |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes, Vildagliptin
Phase I Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With Solid Tumors.

Study Overview
=================
Brief Summary
-----------------
This study is to define the pharmacokinetics and to evaluate the safety of BAY73-4506, 160 mg once daily administered orally as a single agent in Japanese patients with advanced solid tumors.

Official Title
-----------------
Phase I, Uncontrolled, Open-label, Non-randomized Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With Advanced, Refractory Solid Tumors

Conditions
-----------------
Tumors

Intervention / Treatment
-----------------
* Drug: Regorafenib (BAY73-4506)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Japanese patients >/= 18 years Histologically or cytologically confirmed solid tumors ECOG-PS 0 - 1 Adequate bone marrow, liver and renal function Exclusion Criteria: Uncontrolled hypertension Patients with severe renal impairment or on dialysis Patients with seizure disorder requiring anticonvulsant medication Known or suspected allergy to the investigational agent.

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: Arm 1<br> | Drug: Regorafenib (BAY73-4506)<br>* The patients will be treated on Day 1 of the first week followed by 6 days off treatment (Cycle 0, single dosing period). After Cycle 0, the patients will be treated with BAY 73-4506 (160 mg once daily orally, 21 days on/ 7 days off schedule). Dose level : 160 mgDose level-1: 120 mgDose level-2: 60 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade 4 neutropenia for >/= 7 days, febrile neutropenia with Grade 4 neutropenia, Grade 4 thrombocytopenia, Grade 3 or 4 non-hematologic toxicity, hypertension and skin toxicity of Grade 3 or 4 which are not manageable and pharmacokinetics |  | After 5 weeks (after Cycle 1). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker |  | At screening | 
| Response rate |  | Every 8 weeks for the first 6 cycles. After Cycle 6, every 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Solid Tumors
Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Study Overview
=================
Brief Summary
-----------------
The investigators will test whether hypotonic (diluted) remodulin solution causes less pain than the eutonic (undiluted) solution supplied by the manufacturer.

Official Title
-----------------
Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: HypotonicTreprostinil Solution
* Drug: Eutonic Treprostinil Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PAH by standard criteria Treatment with subcutaneous remodulin infusion for at least 3 months, with stable dose for 1 month Pain at infusion site (defined as > 8 on McGill Pain Questionnaire) Exclusion Criteria: Known pregnancy or breastfeeding

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypotonic Treprostinil Solution<br>Hypotonic Treprostinil Solution | Drug: HypotonicTreprostinil Solution<br>* Hypotonic Treprostinil Solution<br>* Other names: Hypotonic Remodulin Solution;|
| Active Comparator: Eutonic Treprostinil Solution<br>Eutonic Treprostinil Solution | Drug: Eutonic Treprostinil Solution<br>* Eutonic Treprostinil Solution<br>* Other names: Eutonic Remodulin Solution;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Pain Diary |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| McGill Pain Questionnaire |  | 2 weeks | 
| CAMPHOR quality of life questionnaire |  | 2 weeks | 
| 6 minute walk distance |  | 2 weeks | 
| NT-proBNP level |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subcutaneous Treprostinil
Intraoperative Pathway in DIEP Flap Breast Reconstruction

Study Overview
=================
Brief Summary
-----------------
Efficiency in the operating room can be difficult in long cases with multiple surgeons. We used a team based approach to develop an intraoperative pathway for microsurgical breast reconstruction with a deep inferior epigastric perforator flap.

Detailed Description
-----------------
A team based approach was developed with an intraoperative pathway for microsurgical breast reconstruction with a deep inferior epigastric perforator flap.

Official Title
-----------------
Intraoperative Pathway in DIEP Flap Breast Reconstruction

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: pathway


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All cases prior to pathway Exclusion Criteria: None
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 |
| --- | --- |
| Pre pathway<br>Pre pathway | |
| Post pathway<br>Post pathway | Other: pathway<br>* Comparison of pre and post pathway<br>* Other names: intraoperative pathway;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Time | Length of Time in surgery | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intraoperative Pathway, Breast Reconstruction, DIEP flap
Accuracy of a CAD/CAM Surgical Template for Mandible Distraction

Study Overview
=================
Brief Summary
-----------------
The purpose was to assess the accuracy and clinical validation of virtual planning and surgical template in mandible distraction osteogenesis. Patients with hemifacial microsomia were enrolled. Virtual planning and simulation were performed on three-dimensional models. Distraction was simulated on virtual model and the new morphology of the mandible was predicted. The position and direction of the distractor was determined to achieve the optimal morphology. The templates were designed based on virtual planning and manufactured using three-dimensional printing technique. The template is designed to assist the surgeon to perform the osteotomy and predrill the screw holes to guide the distractor position. The outcome evaluation was completed by comparing planned outcomes with postoperative outcomes. Linear and angular differences for the distractor was measured.

Official Title
-----------------
Accuracy Evaluation of A CAD/CAM Surgical Template for Mandible Distraction

Conditions
-----------------
Facial Asymmetry, Mandible; Hypoplasia, Unilateral Condylar, Distraction of Bone

Intervention / Treatment
-----------------
* Device: CAD/CAM Surgical Template


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were scheduled to undergo mandibular DO via intraoral approach Patients who were scheduled to undergo CT scan as a part of their diagnosis and treatment Patients who agreed to participate in this study Exclusion Criteria: Patients requiring more than one distractor of the mandible Patients with mandible defect Patients with previous mandibular trauma

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 60 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

| Intervention/Treatment |
| --- |
|Device: CAD/CAM Surgical Template|The templates were designed based on virtual planning and manufactured using three-dimensional printing technique. The template is designed to assist the surgeon to perform the osteotomy and predrill the screw holes to guide the distractor position.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linear differences of the distractor position |  | within latency period (5-7 days after the surgery) | 
| angular differences of the distractor vector |  | within latency period (5-7 days after the surgery) |
Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Drugs in Patients With Elevated Cholesterol Levels (0653A-058)

Study Overview
=================
Brief Summary
-----------------
A 10-week study to compare the reduction in cholesterol following treatment with two different marketed drugs in patients with hypercholesterolemia.

Detailed Description
-----------------
The duration of treatment is 6 weeks.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind Study to Evaluate the Lipid-Altering Efficacy and Safety of the Ezetimibe/Simvastatin Combination Tablet Versus Rosuvastatin in Patients With Primary Hypercholesterolemia

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: MK0653A, ezetimibe (+) simvastatin
* Drug: Comparator: Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Men and women aged 18 to 69 years, with elevated cholesterol levels may be eligible to participate in a research study to assess the efficacy and safety of two marketed drugs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 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: MK0653A, ezetimibe (+) simvastatin|nan|
|Drug: Comparator: Rosuvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-C lowering efficacy after 6 weeks. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety;changes in TC, non-HDL-C, TG, HDL-C, Apo B, LDL-C/HCL-C ratio. |  |  |
SOLIACS: Solian Solution in the Acute Setting

Study Overview
=================
Brief Summary
-----------------
During this study the efficacy and safety profile will be evaluated of the use of amisulpride in the form of a solution in schizophrenic patients with an acute episode. The main purpose of the study is to observe the anti-psychotic effect of amisulpride as a solution during the first days of an acute episode of schizophrenia.

Official Title
-----------------
Solian Solution to Treat Schizophrenic Patients During an Acute Episode

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: amisulpride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: schizophrenic in-patients with an acute episode aged between 18 and 65 years written informed consent Exclusion Criteria: pregnancy and breast-feeding breast cancer, prolactinoma, pheochromocytoma hypersensitivity to amisulpride or one of the other excipients contra-indications when using amisulpride as per the SmPC

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| *analyze the antipsychotic efficacy of amisulpride solution in the first days of an acute schizophrenic episode. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| *analyse the safety profile of amisulpride solution in treatment of schizophrenics with an an acute episode. |  |  |
A Relative Bioavailability Study of Moexipril HCl 15 mg Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the relative bioavailability of Moexipril HCl 15mg tablets (by Paddock Laboratories, Inc.) with that of Univasc® 15mg tablets (by Schwarz Pharma) following a single oral dose (1 x 15mg tablet) in healthy, adult subjects under fasting conditions.

Official Title
-----------------
A Relative Bioavailability Study of Moexipril HCl 15mg Tablets Under Fasting Conditions

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

Intervention / Treatment
-----------------
* Drug: Moexipril HCl 15mg Tablets, Paddock Laboratories, Inc.
* Drug: Univasc® 15mg Tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening Exclusion Criteria: Positive test results for HIV or Hepatitis B or C History of allergy or sensitivity to Moexipril HCl or related drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moexipril HCl 15mg Tablets<br> | Drug: Moexipril HCl 15mg Tablets, Paddock Laboratories, Inc.<br> <br> |
| Active Comparator: Univasc® 15mg Tablets<br> | Drug: Univasc® 15mg Tablets<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence according to US FDA guidelines |  |  |
Non Invasive Ventilation Comfort Study

Study Overview
=================
Brief Summary
-----------------
Patients who are suffering from a variety of respiratory conditions benefit from continuous positive airway pressure (CPAP) which is a form of Non-Invasive Ventilation (NIV). Some patients find the temperature of the breathing gas difficult to tolerate. The aim of this study is to compare comfort of healthy volunteer participants while being given CPAP at different temperatures.

Detailed Description
-----------------
Patients who are suffering from a variety of respiratory conditions benefit from continuous positive airway pressure (CPAP) which is a form of Non-Invasive Ventilation (NIV). Some patients find the temperature of the breathing gas difficult to tolerate. The aim of this study is to compare comfort of healthy volunteer participants while being given CPAP at different temperatures. Healthy volunteers will be given two different levels humidity and temperature and asked about preference.

Official Title
-----------------
Non Invasive Ventilation Comfort Study

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

Intervention / Treatment
-----------------
* Device: CPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any employee of FPH willing to take part in the study following review of the Participant Information Sheet and who has provided affirmative answers to the questions / statements included on the Consent Form Exclusion Criteria: Any employee of FPH not willing to take part in the study following review of the Participant Information Sheet. Any employee of FPH who has not provided affirmative answers to the questions / statements included on the Consent Form

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>In random order, CPAP via a standard humidifier with chamber output temperature of 31°C, or CPAP with a prototype humidifier with chamber output temperature of 31°C. | Device: CPAP<br> <br> |
| Experimental: Group 2<br>In random order, CPAP via a standard humidifier with chamber output temperature of 31°C, or CPAP with a prototype humidifier with chamber output temperature of 27°C. | Device: CPAP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Comfort Questionnaire | Participant answers questions to indicate comfort | 30 Minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CPAP
Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and tolerability of escalating doses of CSL112 after single intravenous infusions in healthy volunteers and to measure the pharmacokinetics of CSL112 after single intravenous infusions in healthy volunteers.

Official Title
-----------------
An Adaptive, Phase I, Single-Centre, Randomised, Double-blind, Placebo-controlled Single Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics, of Intravenous CSL112 in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Biological: CSL112 (reconstituted HDL)
* Biological: normal saline (0.9%)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males and females aged 18 years to less than 55 years Body weigh 45 kg or greater Exclusion Criteria: Evidence of a clinically significant medical condition, disorder or disease Evidence of clinically relevant abnormal laboratory test result Evidence of history of alcohol or substance abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 54 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: normal saline (0.9%)<br> | Biological: normal saline (0.9%)<br>* Single intravenous dose of normal saline (0.9%)<br>|
| Experimental: CSL112<br> | Biological: CSL112 (reconstituted HDL)<br>* Single escalating intravenous doses of CSL112<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as measured by the frequency of drug-related clinical adverse events. |  | Up to 14 days after infusion of CSL112 | 
| Safety and tolerability as measured by liver function tests. |  | Up to 14 days after infusion of CSL112 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of lipoprotein. | Plasma levels of lipoprotein. | Up to 10 days after infusion of CSL112 |