linjc16/ctgov huggingface dataset:
Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus Receiving Background Treatment With Glimepiride Alone or in Combination With Metformin or With Pioglitazone Alone

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the long-term safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM).

Official Title
-----------------
A Phase III, Multicenter, Double-blind, Active-Controlled, 52 Week Extension Study to Evaluate the Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus Receiving Background Treatment With Glimepiride Alone or in Combination With Metformin or With Pioglitazone Alone

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

Intervention / Treatment
-----------------
* Drug: Dutogliptin
* Drug: Sitagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have successfully completed all required visits of a qualifying Phase 3 core protocol Be currently receiving treatment for T2DM as set forth in the qualifying Phase 3 core protocol Exclusion Criteria: Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 86 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Dutogliptin<br>* 400 mg tablet, once daily<br>* Other names: PHX1149;|
| Active Comparator: 2<br> | Drug: Sitagliptin<br>* 100 mg capsule (each capsule contains two 50-mg tablets), once daily<br>* Other names: Januvia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose. |  | 52 weeks |
Implant Site Preparation With Piezosurgery vs Conventional Drills in Terms of Operation Time, Implant Stability and Bone Density

Study Overview
=================
Brief Summary
-----------------
The preparation of the implant site has a major influence on the success rate and long-term survival of dental implants. Piezoelectric devices and special implant drilling inserts are now emerging to replace conventional drills.

Official Title
-----------------
Evaluation of Implant Site Preparation With Piezosurgery vs Conventional Drills in Terms of Operation Time, Implant Stability and Bone Density. (Randomized Controlled Clinical Trial- Split Mouth Design)

Conditions
-----------------
Implant Osteotomy

Intervention / Treatment
-----------------
* Procedure: Piezosurgery assisted osteotomy
* Procedure: Conventional drilling osteotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with bilateral missing premolars Remaining bone height more ≥ 10mm. Remaining bone width ≥ 6mm Exclusion Criteria: patients that smoke more than 10 cigarettes/day Patients with uncontrolled systemic disease. Presence of bone pathology within the future osteotomy site

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 50 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
Interventional Model Description: Split mouth
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study<br> | Procedure: Piezosurgery assisted osteotomy<br>* Sequential osteotomy drilling was done using mectron piezosurgery implant drilling protocol<br>|
| Active Comparator: Control<br> | Procedure: Conventional drilling osteotomy<br>* bone osteotomy for implant placement was done following the BEGO Semados RS/RSX TrayPlus conventional drilling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of surgery | Average surgical times for implant site was estimated | through operation completion | 
| Change in implant stability | ISQ was measured using ostell device | at baseline and 4 months | 
| Change in bone density | Mean bone density using CBCT | at baseline and 4 months |
Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). The aim of this trial is to compare biphasic insulin aspart 30 plus metformin in a standard injection regimen to a standard dosing of insulin glargine plus metformin on blood glucose control in subjects with type 2 diabetes who are insulin naive and failing OAD therapy.

Official Title
-----------------
Biphasic Insulin Aspart 70/30 + Metformin Compared to Insulin Glargine + Metformin in Type 2 Diabetes Failing OAD Therapy

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

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart
* Drug: insulin glargine
* Drug: metformin
* Drug: pioglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Insulin naive Type 2 diabetes Currently treated with OADs alone or combined with other treatment for at least 3 months BMI below 40 kg/m2 and body weight below 125 kg HbA1c greater than or equal to 8% Exclusion Criteria: Inability to tolerate metformin or contradictions to its use Pregnant, breastfeeding or intention of becoming pregnant Allergy to any of the trial products Inability or unwillingness to perform SMBG

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: biphasic insulin aspart|nan|
|Drug: insulin glargine|nan|
|Drug: metformin|nan|
|Drug: pioglitazone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 28 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glucose by 8-point SMBG |  |  | 
| Number of subjects achieving HbA1c below 7% |  |  | 
| Number of hypoglycemic episodes and adverse events |  |  | 
| Weight change |  |  | 
| Insulin dose |  |  |
Effect Of Treadmill Based Aerobic Exercise Intervention On Menstruation And Quality Of Life In Women With Polycystic Ovarian Syndrome

Study Overview
=================
Brief Summary
-----------------
this study will be carried to investigate the effect of aerobic exercise on menstrual regularity and quality of life in pco women

Detailed Description
-----------------
This study will be carried out on sixty females with polycystic ovarian syndrome (PCOS) patients will be randomly assigned into two equal groups: control group (30 women) will receive low caloric diet 1200 Cal/day) while study group (30 women) will receive the same diet regime and treadmill aeobic exercise

Official Title
-----------------
Effect Of Treadmill Based Aerobic Exercise Intervention On Menstruation And Quality Of Life In Women With Polycystic Ovarian Syndrome

Conditions
-----------------
Polycystic Ovary Syndrome, Irregular Menses

Intervention / Treatment
-----------------
* Device: Treadmill exercise
* Other: low caloric diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with pco age from17 to 28 years BMI 25- 30 Exclusion Criteria: Asthma and chronic respiratory disease congenital spinal problems cardiopulmonary disease physical impairments

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 28 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: control group receive low caloric diet study group receive high intensity interval training
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: low caloric diet<br>low caloric diet 1200cal/day | Other: low caloric diet<br>* low caloric diet (1200ca/lday)<br>|
| Experimental: treadmill<br>treadmill aerobic exercise training | Device: Treadmill exercise<br>* high intensity interval training<br>Other: low caloric diet<br>* low caloric diet (1200ca/lday)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| menstrual regularity | Oligomenorrhea (menses every 6 weeks to 6 months), amenorrhea (menses greater than every 6 months apart or their absence), regular ( menses every 28-35 days) | 3 months | 
| quality of life questionnaire (QOLQ) | a total of 26 items for the Polycystic Ovary Syndrome Questionnaire, each question is associated with a 7-point scale in which 7 represents optimal function and 1 represents the poorest function | 3 months |
Anatomic Characteristics of Lisfranc Ligament in Vietnamese Adult

Study Overview
=================
Brief Summary
-----------------
Goal: the aim of this study is to determine the anatomic characteristic of lisfranc ligament

Detailed Description
-----------------
Goal: the aim of this study is to determine the anatomic characteristic of lisfranc ligament, including components, thickness, height, and width, origins as well as relationship of center point of origin with neighbor structures in Vietnamese adults

Official Title
-----------------
Anatomic Characteristics of Lisfranc Ligament in Vietnamese Adult

Conditions
-----------------
Lisfranc Injury

Intervention / Treatment
-----------------
* Other: dissection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: above ankle amputation samples at Cho Ray hospital, HCM city, Vietnam Exclusion Criteria: foot injuries foot infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: dissection|Dissection of lisfranc ligament from 30 aldult Vietnamese cadavers's foot|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Some anatomic characteristic of lisfranc ligament | lenght, width | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relative position with neighbor structures | cm | 2 years |
Technical Optimization of Detection of KRAS, BRAF and NRAS Mutations on Tumor DNA Circulating in Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to optimize the search by next-generation sequencing (NGS) mutations in the KRAS, BRAF and NRAS on circulating tumor DNA and compare the genetic profiles obtained with those from tumors embedded in paraffin

Official Title
-----------------
Prospective Study of Technical Optimization of the Detection of KRAS Mutations, BRAF and NRAS by Next Generation Sequencing on Tumor DNA Circulating in Metastatic Colorectal Cancer.

Conditions
-----------------
Metastatic Colorectal Cancer

Intervention / Treatment
-----------------
* Other: KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with metastatic or locally advanced colorectal carcinoma with a KRAS, BRAF or NRAS mutation Age ≥ 18 years Patient information and written informed consent form signed Patient must be affiliated to a social security system Exclusion Criteria: Patients whose health-cons indicates a blood sample 10mL Age < 18 years Pregnant or breast feeding females Persons deprived of liberty or under supervision

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CircuLOR-1<br>KRAS (exons 2, 3 et 4), NRAS (exons 2, 3 et 4) and BRAF (exon 15) mutations | Other: KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA<br>* 10 ml blood sample<br>* Other names: NGS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Optimization of KRAS, BRAF and NRAS mutations detection | Optimize the detection of mutations of KRAS (exons 2, 3 et 4), NRAS (exons 2, 3 et 4) and BRAf (exon 15) genes, using the next-generation sequencing technology from circulating tumor DNA in patients with metastatic colorectal cancer. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KRAS, NRAS et BRAF mutational status | Compare the results of KRAS NRAS and BRAF genes genotyping obtained from circulating tumor DNA to that achieved by the current gold standard (paraffin-embedded). | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colorectal cancer, Kras mutation, Nras mutation, Braf mutation
The Effect of CQI on the Outcome of Patients Supported With ECMO

Study Overview
=================
Brief Summary
-----------------
This was a prospective observational study in comparison with a retrospective control group(Jan 2015 to Jun 2019). Two ICUs in China were included. The continuous quality improvement (CQI)strategies were implemented from Jul 2019 to Jun 2021(CQI group). The mortalities of ECMO patients was compared between the CQI group and the control group.

Official Title
-----------------
The Effect of Continuous Quality Improvement on the Outcome of Patients Supported With Extracorporeal Membrane Oxygenation in ICU

Conditions
-----------------
Respiratory and Circulation Failure

Intervention / Treatment
-----------------
* Other: continuous quality improvements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years old who received ECMO support in the centers Exclusion Criteria: patients waiting for transplantation with ECMO.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control group<br> | |
| CQI group<br> | Other: continuous quality improvements<br>* We implement the continuous quality improvement strategy in CQI group, and observe the effect of the strategy on the mortality of patients supported with ECMO .<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mortality of patients supported with ECMO |  | January, 2021 to July, 2021 |
Study of Febrile Syndromes After Tick Bite

Study Overview
=================
Brief Summary
-----------------
Febrile syndromes after tick bites can be caused by different microorganisms: bacteria (B. miyamotoi, A. phagocytophilum, R. helvetica…), parasites (Babesia spp) and viruses (TBE virus). The clinical picture is not specific but complications may appear depending on the microorganism identified (thrombosis with N. mikurensis, meningoencephalitis with B. miyamotoi and the TBE virus). Thus, in order to provide appropriate treatment and monitoring, the infection should be documented.

Official Title
-----------------
Study of Febrile Syndromes After Tick Bite

Conditions
-----------------
Febrile Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject (≥18 years old) Subject whose sample was sent to the bacteriology laboratory for research on Anaplasma phagocytophilum between 2009 and August 2020 Exclusion criteria: Subject having expressed his opposition to his medical data and biological resources not being reused for scientific research. Subject under guardianship or guardianship Subject under safeguard of justice

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective search for the presence of an emerging pathogen in the cohort of patients with febrile syndrome after tick bite |  | Files analysed retrospectively from January 01, 2009 to August 31, 2020 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Febrile syndrome, Tick bite, Anaplasma phagocytophilum
Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe and the United States of America (USA). The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics (the determination of the concentration of the administered medication in blood over time) and pharmacodynamics (the determination of the effect over time and the duration of action) of multiple doses of liraglutide in the pediatric population (children).

Official Title
-----------------
Liraglutide: A Randomized, Double-blind, Placebo Controlled Trial to Assess Safety/Tolerability, Pharmacokinetics & Pharmacodynamics of Liraglutide in Pediatric (10-17 Years Old) With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: liraglutide
* Drug: placebo
* Drug: liraglutide
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI greater than 85th percentile for age and gender Currently being treated with diet and exercise or metformin alone HbA1c (glycosylated haemoglobin) between 6.5 and 11.0% Exclusion Criteria: Any clinically significant disease other than type 2 diabetes, as judged by the trial physician Previous treatment with any anti-diabetic drug other than metformin (except for prior short term treatment, at the discretion of the trial physician)

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 17 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I.a<br> | Drug: liraglutide<br>* Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)<br>|
| Placebo Comparator: I.b<br> | Drug: placebo<br>* Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)<br>|
| Experimental: II.a<br> | Drug: liraglutide<br>* Increasing dose for self-injection subcutaneously (under the skin) daily over 3 to 4 weeks (0.6 - 1.8 mg).<br>|
| Placebo Comparator: II.b<br> | Drug: placebo<br>* Increasing dose for self-injection subcutaneously (under the skin) daily over 3 to 4 weeks (0.6 - 1.8 mg).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and type of adverse events |  | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Area under the plasma concentration vs. time curve |  | within dosing interval | 
| Pharmacodynamics: Fasting Plasma Glucose (FPG) and insulin |  | throughout study duration (pre-, during and post-treatment) |