linjc16/ctgov huggingface dataset:
Prevalence of Osteoporosis in Patients Who Uses Inhaled Steroids

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to determine whether the prevalence of osteoporosis is greater in patients who suffer from Chronic obstructive pulmonary disease (COPD) or Asthma disease and uses inhaled steroids.

Official Title
-----------------
Prevalence of Osteoporosis in Patients Who Uses Inhaled Steroids

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Device: Dual energy X-ray absorptiometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man at the minimum age of 60 years. Diagnosed with Chronic Obstructive Pulmonary disease (COPD) or Asthma disease. Usage of the following corticosteroids at the minimal doses indicated, for at least 3 years: Seretide 250/50 mcg Symbicort 320/9 mcg 5.No Diagnosis of thyroid irregularity 6.No diagnosis/treatment for Osteoporosis. Exclusion Criteria: Usage of systemic steroids more than once during the 12 months prior to the study. Usage of systemic steroids during the month prior to the study. Usage of inhaled steroids in order to treat any other disease except Chronic Obstructive Pulmonary Disease (COPD) or Asthma.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Dual energy X-ray absorptiometry|Device which measures bone density|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of Osteoporosis |  | 3 month | 
| Diagnosis of Osteoporosis |  | 3 |
Fasting Study of Alendronate Sodium Tablets (70 mg) and Fosamax Tablets (70 mg)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate the bioequivalence of Mylan's alendronate sodium 70 mg tablets to Merck's Fosamax 70 mg tablets following a single, oral 70 mg (1 x 70 mg) dose administration under fasting conditions.

Official Title
-----------------
Single-Dose Fasting In Vivo Bioequivalence Study of Alendronate Sodium Tablets (70 mg; Mylan) and Fosamax Tablets (70 mg; Merck) in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: Alendronate Sodium Tablets, 70 mg
* Drug: Fosamax Tablets, 70 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, adult subjects, 18 years and older able to swallow medication Exclusion Criteria: institutionalized subjects history of any significant disease use of any prescription or OTC medications within 14 days of start of study received any investigational products within 30 days prior to start of study

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Alendronate Sodium Tablets, 70 mg | Drug: Alendronate Sodium Tablets, 70 mg<br>* 1 x 70 mg, single-dose fasting<br>|
| Active Comparator: 2<br>Fosamax Tablets, 70 mg | Drug: Fosamax Tablets, 70 mg<br>* 1 x 70 mg, single-dose fasting<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. |  | urine collection up to 36 hours |
Use of Bone Scintigraphy, CT and MRI in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
A new imaging modality combining CT and tomographic bone scintigraphy (SPECT/CT) has enabled the combination of functional and anatomical imaging. Its use in cancer patients has not yet been evaluated or validated against a relative gold stand or clinical follow up. The purposes of this study are: 1: to validate the use of conventional planar bone scintigraphy and SPECT combined with low-dose or diagnostic CT and compare this to 3 Tesla MRI and clinical follow up. 2: to compare the specificity of low-dose and diagnostic CT, respectively, combined with bone SPECT. 3: to construct an algorithm for optimal evaluation of disease dissemination in breast cancer patients

Official Title
-----------------
Use og Bone Scintigraphy, CT and MRI for Detection of Metastases in Patients With Breast Cancer

Conditions
-----------------
Breast Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological verified breast cancer Age 18-80 years Investigation for metastases using imaging modality/modalities planned Written consent to participate in trial Exclusion Criteria: Overweight limiting the use of MRI Metal parts in body Claustrophobia Allergy to contrast agents used in trial Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SPECT/CT, MRI, Breast neoplasms
Impairment in Glucose Homeostasis Among Obese Adolescents in High Risk Diabetes Prone Population - Jisr Az-Zarqa Village

Study Overview
=================
Brief Summary
-----------------
Obesity is increasing all over the world in adults, adolescents and children,and is followed by morbidity, including the metabolic syndrome. Hypothesis: Among obese adolescents there is a subgroup with impaired glucose homeostasis The aim of the study is to identify adolescents with impaired glucose metabolism, 12-18 years, among high risk diabetes prone population, for diagnosis and treatment.

Conditions
-----------------
Glucose Metabolism Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of obesity Exclusion Criteria: History of disease or drug therapy affecting glucose metabolism

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum 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 |
| --- | --- |
| Obese Adolescents<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Impaired Glucose Homeostasis among obese adolescents in high risk diabetes prone population |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the metabolic profile in obese adolescents |  | One year |
Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms

Study Overview
=================
Brief Summary
-----------------
A national multicenter prospective study to investigate the feasibility and efficacy of endoscopic ultrasound guided radiofrequency ablation of neuroendocrine pancreatic tumors, WHO Grade 1-2 of 3 cm or less in diameter.

Official Title
-----------------
Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms

Conditions
-----------------
Pancreatic Neuroendocrine Tumors, WHO Grade I-II

Intervention / Treatment
-----------------
* Device: Radio frequency ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 18 EUS fine needle biopsy (FNB) proven pancreatic neuroendocrine tumor (PNET), WHO 2019 Grade 1-2 in patients with functioning or non-functioning tumors. Also MEN1 patients are eligible: PNET 2-3 cm in largest diameter (Based on MRI or CT) with a Ki-67 <5%, or: PNET < 2cm with Ki-67 <10% that has shown progression during surveillance, or: PNET 1.5-2 cm with Ki-67 <10% in patients age < 60 years of age, whether progression is detected or not. Distance from the main pancreatic duct ≥2 mm, or <2mm with a prophylactic stent in the main pancreatic duct. Patient in good general condition, ECOG performance status 0-2 (see Appendix) Signed written informed consent Exclusion Criteria: Pregnancy. Life expectancy < 1 year Severe hemostasis disorders Pancreatic and/or biliary ductal dilation Evidence of active pancreatitis Metastatic disease, including local lymph node metastases Use of anticoagulants that cannot be discontinued INR >1.5 or platelet count <50.00 Distance from the main pancreatic duct <1 mm, and placement of a pancreatic stent is not possible Patient being managed for another malignant lesion which is progressive or under treatment

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Historical controls<br>Historical controls | Device: Radio frequency ablation<br>* Radio frequency ablation of pancreatic neuroendocrine tumors<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | To register number of patient experiencing adverse events to the radiofrequency ablation procedure | Up to 12 months | 
| Residual disease | To register number of patient who develop residual disease in the area of the tumor that has been treated with radiofrequency ablation | Up to 5 years | 
| Metastatic disease | To register number of patient who develop of local or distant metastases | Up to 10 years |
A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the bioequivalence of Indomethacin ER Capsules.

Official Title
-----------------
A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules Under Fasting Conditions

Conditions
-----------------
Inflammation

Intervention / Treatment
-----------------
* Drug: Indomethacin 75mg Extended-Release Capsules, Sandoz
* Drug: Indocin 75mg SR Capsules


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on physical exam, medical history or clinical laboratory results on screening Exclusion Criteria: Positive test results for HIV or hepatitis B or C No allergies to indomethacin or related drugs

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Indomethacin 75mg ER Capsules | Drug: Indomethacin 75mg Extended-Release Capsules, Sandoz<br> <br> |
| Active Comparator: 2<br>Indocin 75mg SR Capsules | Drug: Indocin 75mg SR Capsules<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence according to US FDA guidelines. |  | 8 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anti-inflammatory
Effect of Preoperative MRI Virtual Reality in Patients Undergoing Knee Arthroscope Surgery

Study Overview
=================
Brief Summary
-----------------
Knee MRI is difficult for patients to understand as the image offers a single plane image. Accordingly,investigators sought to transfer the MRI image to 3-dimensional virtual reality system by Mesh rendering technique.

Detailed Description
-----------------
The primary outcome of the study is APAIS score assessed at 24 hours postoperation. Experimental VR group will be applied with virtual reality transformed knee MRI whereas no interverntion group will be applied with traditional knee MRI. MRI will be transformed to virtual reality images by Mesh rendering technique.

Official Title
-----------------
Effect of Preoperative MRI Virtual Reality in Patients Undergoing Knee: a Randomized Controlled Trial

Conditions
-----------------
Knee Injuries

Intervention / Treatment
-----------------
* Device: Virtual reality


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing elective knee arthroscopy surgery Exclusion Criteria: Infection, not willing to undergo study, mentally ill, severe osteoarthritis (KL grade III or more)

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR group<br>Application of virtual reality 12 hours before arthroscopic surgery | Device: Virtual reality<br>* Application of knee MRI transformed virtual reality system<br>|
| No Intervention: Non-VR group<br>Application of knee MRI 12 hours before arthroscopic surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Amsterdam perioperative anxiety and information scale (APAIS) score | surgery related anxiety and information score Interpretation: minimum subscale scores: 2 minimum combined anxiety component: 4 maximum subscale scores: 10 maximum combined anxiety component: 20 The higher the scores the greater the degree of anxiety or need for additional information. | postoperatively at 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (VAS) for satisfaction | Satisfaction scale with a range of scores from 0-100. A higher score indicates greater satisfaction. | postoperatively at 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
virtual reality, knee
Test of Digital Breast Tomosynthesis vs. Common Mammography to Detect Breast Cancer for Women Undergoing Breast Biopsy

Study Overview
=================
Brief Summary
-----------------
Comparison of the ability of DBT and FFDM to detect breast cancer.

Detailed Description
-----------------
Enrolled women will undergo bilateral DBT. Prior breast imaging data (screening and diagnostic mammography) must have been conducted on GE equipment and the images must be available (or imaging must be repeated). DBT images will be read on-site by one or more qualified radiologists. All subjects who undergo biopsy will be asked to return in approximately 1 year for a follow-up mammogram. Images will be processed and evaluated by independent readers.

Official Title
-----------------
A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 3. Women Undergoing Breast Biopsy

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women ≥18 years or older and has underwent screening/diagnostic mammography and referred for breast biopsy Able and willing to comply with study procedures, and have signed and dated the informed consent form Surgically sterile or postmenopausal Exclusion Criteria: Pregnant or trying to become pregnant Has signs or symptoms of breast cancer Has been previously included in this study Has breast implants Has a history of breast cancer and is in active treatment Has breasts too large to be adequately positioned for the DBT examination

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mammography, mammogram, breast, Abnormal and normal breast tissue
Validation of the French Adaptation of the MSWDQ-23 Questionnaire

Study Overview
=================
Brief Summary
-----------------
MS is an autoimmune disease of the central nervous system that affects more than 120,000 people in France. The average age of onset of the disease is between 25 and 35 years. Given the wide range of ages of the patients, from 4 to 80 years, the ethical and socio-economic stakes are high in order to maintain their autonomy, sociability, family and intimate life, and their employment in the best possible conditions and for as long as possible. However, to date, there are no evaluation tools in French that allow us to understand the difficulties at work of MS patients. The Multiple Sclerosis Work Difficulties Questionnaire (MSWDQ-23) was developed specifically for MS patients and validated in English [1]. There is a short version of this questionnaire that facilitates its use in clinical practice [2]. It has been translated and validated in Spanish through a multicenter study, and is currently being validated in German, but does not currently exist in French [3]. The main objective of the WORKSEP project is to validate the French version of this questionnaire through a multicenter population-based cohort within the framework of the French-speaking Multiple Sclerosis Society (SFSEP). This validation study will involve the inclusion of 206 French-speaking MS patients, regardless of their professional status, all forms of MS combined, from the early stage (Clinically Isolated Syndrome) to the more advanced stages (primary and secondary progressive forms).

Official Title
-----------------
Validation Study of the French Adaptation of the MSWDQ-23 Questionnaire, a Tool Assessing the Work Difficulties of Patients With Multiple Sclerosis.

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 65 years old. Native French speaker. A diagnosis of Clinically Isolated Syndrome or MS defined according to the 2017 McDonald criteria. Be affiliated with the social security system. Agree to participate in the study. Exclusion Criteria: Opposition to the use of the data

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multiple Sclerosis patients<br> | Other: questionnaires<br>* Patients will complete the MSWDQ-23 in French, as well as the DEX, questionnaire for the evaluation of executive dysfunction in daily life, to evaluate their cognitive complaints and the SF36 questionnaire to evaluate their quality of life<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MSWDQ-23 score | total score out of 100 | 1 day |
Detection of CTC and ctDNA in the Diagnosis of Metastasis in Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
To investigate the value of CTCs and ctDNA in the diagnosis of metastasis in ascites/peritoneal flushing fluid and blood; To investigate the influence of laparoscopic CO2 pneumoperitoneum establishment on peritoneal and hematogenous metastasis of advanced gastric cancer; To explore the influence of the number and type of CTCs and ctDNA on metastasis and prognosis.

Official Title
-----------------
Application of the Detection of Circulating Tumor Cell and Circulating Tumor DNA in the Diagnosis of Metastasis in Gastric Cancer

Conditions
-----------------
Metastasis, Stomach Neoplasms

Intervention / Treatment
-----------------
* Diagnostic Test: CTC test
* Diagnostic Test: ctDNA test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who sign informed consent. Gastric cancer is determined by more than 2 pathologists. Patients with Borrmann III/IV gastric cancer. Exclusion Criteria: Patients who complicate with other malignant tumors. Patients who complicate with other serious heart and lung diseases. Patients who receive preoperative neoadjuvant chemotherapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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 |
| --- | --- |
| Laparotomy group<br>Patients who undergo radical laparotomy for gastric cancer. | Diagnostic Test: CTC test<br>* Circulating tumor cells test of ascites and blood for patients with gastric cancer.<br>Diagnostic Test: ctDNA test<br>* Circulating tumor DNA test of ascites and blood for patients with gastric cancer.<br>|
| Laparoscopy group<br>Patients who undergo laparoscope-assisted radical gastrectomy for gastric cancer. | Diagnostic Test: CTC test<br>* Circulating tumor cells test of ascites and blood for patients with gastric cancer.<br>Diagnostic Test: ctDNA test<br>* Circulating tumor DNA test of ascites and blood for patients with gastric cancer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of CTCs | To count the circulating tumor cells in ascites and blood. | 1 day | 
| Classification of CTCs | To classify the circulating tumor cells in ascites and blood. | 1 day | 
| Expression of ctDNA | To assess the expression of circulating tumor DNA in ascites and blood, including YAP1, LAMC1 and DDIT4. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnosis