linjc16/ctgov huggingface dataset:
The Efficacy of Metformin Produced by Pars Mino Co in Comparison With Canadian Apotex Co.

Study Overview
=================
Brief Summary
-----------------
Background: Metformin is usually using for glycemic control in type 2 diabetes mellitus. Different pharmaceutical types of metformin are available. As a clinical trial, we compared the efficacy and complications of metformin produced by Pars Mino pharmaceutical company, Iran with Apotex pharmaceutical company, Canada, in type 2 diabetic patients. Method: 18 eligible women with type 2 diabetes were given metformin Pars Mino or Apotex (500 mg twice a day) each for 6 weeks period in a randomized, double blind, crossover study. These two groups randomly under treatment with generic metformin (manufactured by Pars Mino company) or non-generic (manufactured by Apotex Canada). After 2 weeks washout period another 6 weeks period with another Brand of metformin was prescribed. FBS, HbA1C, lipid profile (Cholesterol, TG, HDL, and LDL), weight, and BMI were assessed before and after each treatment phase. The results were compared with each other by paired sample T-test, Independent sample T-test.

Official Title
-----------------
The Efficacy of Metformin Produced by Pars Mino Co in Comparison With Canadian Apotex Co.

Conditions
-----------------
Diabetes Mellitus, Type 2 AND Metformin

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild hyperglycemia, no contraindication for metformin, poor controlled diabetes Exclusion Criteria: Creatinine more than 1.5, severe organ damage

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin, Apo-metformin<br>Participants under treatment with non-generic Metformin (manufactured by Apotex Canada). | Drug: Metformin<br> <br> |
| Active Comparator: Metformin, Pars Minoo<br>Participants under treatment with generic Metformin (manufactured by Pars Minoo). | Drug: Metformin<br> <br> |

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
-----------------
Diabetes mellitus, type 2, Metformin, Generic, Efficacy
Clinical Procedures to Support Research in ALS

Study Overview
=================
Brief Summary
-----------------
The purpose of the Clinical Procedures To Support Research (CAPTURE) study is to utilize information collected in the medical record to learn more about a disease called amyotrophic lateral sclerosis (ALS) and related disorders.

Detailed Description
-----------------
The study will consent patients with ALS or related disorders that are receiving care at a clinical center in the CReATe consortium that uses Epic as its electronic health record (EHR) system. The study aims to systematically gather a clinical dataset through the EHR using a standardized approach to characterize the natural history of ALS and related diseases.

Official Title
-----------------
Clinical Procedures to Support Research in ALS (CAPTURE-ALS)

Conditions
-----------------
Amyotrophic Lateral Sclerosis, ALS-Frontotemporal Dementia, Primary Lateral Sclerosis, Progressive Muscular Atrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of ALS or a related disorder (e.g. primary lateral sclerosis, progressive muscular atrophy). Receiving care at a clinical center that uses Epic as its EHR. Able and willing to provide informed consent (or informed consent obtainable from a designated proxy). Exclusion Criteria: Inability to understand English and/or Spanish

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 |
| --- | --- |
| Affected<br>Affected with ALS or a related disorder. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Using the ALS Toolkit for collecting and using electronic health record data for research purposes |  | 12 months |
Universal Genetic Testing Versus Guidelines-Directed Testing for Germline Pathogenic Variants Among Non-Western Patients With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The study aims to examinethe pattern and frequency of pathogenic variants among all newly diagnosed breast cancer patients in a genetically distinct population. Additionally, the uptake rate of cascade family screening , frequency of pathogenic variants and barriers against testing will be studied.

Official Title
-----------------
Universal Genetic Testing Versus Guidelines-Directed Testing for Germline Pathogenic Variants Among Non-Western Patients With Breast Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient, age ≥ 18 years at time of cancer diagnosis Pathology proven diagnosis of breast cancer (including DCIS); any stage. (prior history of cancer is allowed) Willingness to participate Signed consent form. Exclusion Criteria: - Major psychiatric disorder (defined as: patients followed by a psychiatrist and on antipsychotic medications

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 |
| --- | --- |
| Breast cancer patients<br>All adult patients with a confirmed diagnosis of breast cancer, aged 18 or older at time of cancer diagnosis, will be invited to participate. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of pathogenic or likely pathogenic germline variants among newly diagnosed breast cancer patients tested by universal multigene panel testing or guideline-based targeted testing |  | 2021-2023 | 
| Number of participants with variants of uncertain significance (VUS) as assessed by universal multigene panel testing versus guideline-based targeted testing |  | 2021-2023 | 
| The reasons/ Barriers for refusal of genetic cascade testing among newly diagnosed cancer patients |  | 2021-2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of cascade testing of family members of the participants with positive pathogenic mutation | The family of the positive patients will be offered the genetic testing. | 2021-2023 | 
| Prevalence of pathogenic or likely pathogenic mutations among family members of the patients with pathogenic mutations using the universal multigene panel |  | 2021-2023 | 
| Prevalence of variants of uncertain significance (VUS) among tested family members of participants with pathogenic mutations as assessed by universal multigene panel testing |  | 2021-2023 | 
| The reasons/ Barriers for refusal of genetic cascade testing among family members of the tested patients with pathogenic mutations |  | 2021-2023 |
Study to Evaluate Anxiety Sensitivity and Somatic Symptoms as Risk Factors for PONV

Study Overview
=================
Brief Summary
-----------------
This prospective observational study aims to evaluate the influence of somatic symptom load and anxiety sensitivity as risk factors for the occurrence of postoperative nausea and vomiting (PONV). Physiological and psychological variables are assessed in female patients with an increased risk for PONV prior to a planned surgical intervention with a 33-item questionnaire composed of the ASI-3 and the PHQ-15. Postoperative evaluation includes the occurrence of nausea and vomiting in the first 24 hours after surgery. It is hypothesized that patients with high sum scores for somatic symptom load (measured with the Patient Health Questionnaire, PHQ-15) and with increased levels for anxiety sensitivity (measured with the Anxiety Sensitivity Index, ASI-3) experience more frequently postoperative nausea and vomiting (PONV) than patients with low scores in both self-rating instruments.

Official Title
-----------------
Prospective Observational Study to Evaluate Somatic Symptom Load and Anxiety Sensitivity as Risk Factors for Postoperative Nausea and Vomiting (PONV)

Conditions
-----------------
Postoperative Nausea and Vomiting

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female patients 18-75 years non-smokers must be able to give written informed consent planned surgical intervention requiring hospitalisation not included in another clinical trial Exclusion Criteria: emergency intervention total intravenous anesthesia (TIVA) with propofol disability to give written informed consent physical or psychic disorders requiring permanent psycho-social care no German language skills

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Female patients with increased risk to experience PONV.<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of postoperative nausea and vomiting (PONV). |  | PONV is assessed in the first 24 hours after surgery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anxiety, Somatoform Disorders
A Study to Isolate and Test Circulating Tumor Cells Using the ClearCell® FX EP+ System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to isolate and measure circulating tumor cells in the blood stream to advance detection of cancer and treatment monitoring. In this study, the investigators will utilize the novel technology for circulating tumor cell detection in order to evaluate their presence in patients with lung cancer.

Detailed Description
-----------------
The plan is to collect both blood and tumor samples from the patient's lung cancer in order to validate this technology in detecting circulating tumor cells. The investigators will also obtain a postoperative blood sample to see if there is a decrease in the overall circulating tumor cell measurement once the tumor has been surgically removed.

Official Title
-----------------
A Pilot Study to Isolate and Test Circulating Tumor Cells Using the ClearCell® FX EP+ System

Conditions
-----------------
Cancer of Lung, Lung Cancer, Lung Neoplasms, Cancer of the Lung, Neoplasms, Lung, Neoplasms, Pulmonary, Pulmonary Cancer, Pulmonary Neoplasms, Carcinoma, Non-small-cell Lung, Adenocarcinoma, Squamous Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage IB and above non-small cell lung cancer or metastatic lung cancer Age >18 years old Willing and able to consent to study No prior history of neoadjuvant therapy. Exclusion Criteria: Age <18 years old Unable to provide consent

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| Number and types of mutations in the primary tumor. |  | Within 1 year | 
| Number and type of mutations detectable in the matched circulating tumor cell samples. |  | Within 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance of mutations detected by either method. |  | Within 1 year |
Adipose Tissue Content of Fatty Acids Present in Dairy Fat and Risk of Stroke. The Danish Diet, Cancer and Health Cohort

Study Overview
=================
Brief Summary
-----------------
Background: Although low-fat dairy products are an integral part of a diet recommended for stroke prevention, the role of dairy fat in relation to the risk of stroke is not yet clear. Objective: Therefore the association of adipose tissue content of fatty acids, for which dairy products are a major source (12:0, 14:0, 14:1 cis-9, 15:0, 17:0, 18:1 trans-11 and 18:2 cis-9, trans-11), with incident total stroke and stroke subtypes will be investigated. Design: The study is a case-cohort study nested within the Danish Diet, Cancer and Health cohort, including all incident stroke cases and a random sample of the total cohort.The fatty acid composition of adipose tissue biopsies was determined by gas chromatography and the content of specific fatty acids was expressed as percentage of total fatty acids. Stroke cases were identified in the Danish National Patient Registry and the diagnoses were individually verified. Cox proportional hazard regression will be used to estimate the association between fatty acids and stroke.

Official Title
-----------------
Adipose Tissue Content of Fatty Acids Present in Dairy Fat and Risk of Stroke. The Danish Diet, Cancer and Health Cohort

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: Fatty acids present in adipose tissue samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Born in Denmark, aged 50-64 years, residing in the urban and suburban areas of Copenhagen and Aarhus, Denmark. - Exclusion Criteria: Pre-existing cancer diagnosis. Previous stroke. -

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 64 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Fatty acids present in adipose tissue samples|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke, including validated subtypes |  | From baseline until 30 November 2009 |
Monitoring Of Helsingborg Acute Knee Injuries (MOHAK)

Study Overview
=================
Brief Summary
-----------------
Using magnetic resonance imaging (MRI), laboratory analyses and patient reported outcomes, the overall aim of this study is to investigate structural injuries and biochemical alterations in the acutely injured knee and to relate these findings to clinical outcomes at various time points.

Official Title
-----------------
Monitoring Of Helsingborg Acute Knee Injuries (MOHAK) to Understand Osteoarthritis Development After Injury.

Conditions
-----------------
Knee Injury, Knee Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 12-40 years at inclusion (inclusion of patients younger than 18 will require parental approval) A history of knee injury not more than 4 weeks prior to inclusion Agreement and informed consent to participate in the study Exclusion Criteria: Any MRI contra-indications (such as extreme obesity, metal implants, claustrophobia etc.) Pregnancy A history of deep vein thrombosis (DVT) or a disorder of the coagulative system General disease that effects physical function or systemic medication/abuse of steroids Any other condition or treatment interfering with the completion or assessment of the trial.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 40 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 |
| --- | --- | --- |
| Knee injury and Osteoarthritis Outcome Score (KOOS) |  | 5 yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic osteoarthritis |  | 5 yrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee injury, Osteoarthritis, Anterior Cruciate Ligament injury, Patellar dislocation
Evaluation of Double Tract Reconstruction After Total Gastrectomy in Patients With Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the double tract reconstruction after total gastrectomy in patients with gastric cancer. A prospective randomized controlled trial was conducted to compare double tract method with Roux-en-Y method

Detailed Description
-----------------
Patients with gastric cancer were intraoperatively randomized for R-Y reconstruction or DT reconstruction after total gastrectomy.

Official Title
-----------------
A Prospective Randomized Controlled Trial Comparing Double Tract Method With Roux-en-Y Method After Total Gastrectomy in Patients With Gastric Cancer

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: Reconstruction after total gastrectomy
* Procedure: Reconstruction after total gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven adenocarcinoma without esophageal invasion, tumor status T1-2 Age 80 years or younger No distant metastasis Exclusion Criteria: Carcinoma in the remnant stomach Stage intravenous (IV) History of laparotomy History of serious heart disease Liver cirrhosis or chronic liver disease with indocyanine green excretion test at 15 min of 15% or more Absence of informed consent

Ages Eligible for Study
-----------------
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Roux-en-Y | Procedure: Reconstruction after total gastrectomy<br>* Roux-en-Y<br>|
| Experimental: 2<br>double tract reconstruction | Procedure: Reconstruction after total gastrectomy<br>* double tract reconstruction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The %body weight ratio |  | 12 months after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preoperative complication, PNI and QOL score |  | within one month, and 3 and 12months after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
total gastrectomy, double tract reconstruction, gastric cancer, Total gastrectomy in patients with gastric cancer
Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With Chemotherapy

Study Overview
=================
Brief Summary
-----------------
This study was a single-arm, multi-center, prospective, phase 3 trial aimed to evaluate the efficacy and safety of icotinib in patients with locally advanced or metastatic NSCLC after failure of at least one platinum-based chemotherapy regimen.

Official Title
-----------------
Safety and Efficacy of Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With Chemotherapy: a Single-arm, Phase 3 Study

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: icotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed locally advanced/metastatic (stage IIIB/stage IV, using the American Joint Committee on Cancer [AJCC] 6th edition of tumor-node-metastasis [TNM] staging system) NSCLC patients Progressed after at least one platinum-based chemotherapy regimen at entry Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 At least one measurable lesion by Response Evaluation Criteria in Solid Tumors version 1.0 Adequate hematologic and biochemical values Exclusion Criteria: Patients with symptomatic brain metastases Malignant tumor within the previous five years Severe infection; congestive heart failure Previous treatment with drugs targeting EGFR History of interstitial lung disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: icotinib<br>Patients were administered with oral icotinib (tablet form, 125 mg) three times daily within two days after enrollment until disease progression or unacceptable toxicity. | Drug: icotinib<br>* Patients were administered with oral icotinib (tablet form, 125 mg) three times daily within two days after enrollment until disease progression or unacceptable toxicity.<br>* Other names: Conmana;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 12 months | 
| objective response rate |  | 2 months | 
| number of patients suffered adverse events |  | 15 months |