linjc16/ctgov huggingface dataset:
Clinical Characteristics, Management Patterns and Outcomes of Type A Aortic Dissection: A Sino-US Comparative Cohort Analysis

Study Overview
=================
Brief Summary
-----------------
This study constructed a retrospective cohort study by retrospectively analyzing the data of all patients with aortic dissection from January 1, 2012 to December 31, 2021 from the Cardiovascular Disease Registration System of Jiangsu Province in China and the data of similar diseases in recent years from National Inpatient Sample database in the United States

Official Title
-----------------
Clinical Characteristics, Management Patterns and Outcomes of Type A Aortic Dissection: A Sino-US Comparative Cohort Analysis

Conditions
-----------------
Aortic Dissection

Intervention / Treatment
-----------------
* Procedure: surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Clinical diagnosis of type A Aortic Dissection Exclusion Criteria: age<18, age unknown, diagnosis of aortic aneurysm, transfer out within 1 day, unknown vital status at discharge; unknown treatment type: cardioplegia, valve or cardiac repair only without aortic repair or two types of treatments on different days

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 |
| --- | --- |
| Chinese patients with aortic dissection<br>Clinical characteristics, management patterns and outcomes of type A aortic dissection in China. | Procedure: surgery<br>* surgery on patients with aortic dissection<br>|
| American patients with aortic dissection<br>Clinical characteristics, management patterns and outcomes of type A aortic dissection in the United States. | Procedure: surgery<br>* surgery on patients with aortic dissection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline data of patients with type A aortic dissection was assessed by SPSS 17.0 | Baseline data of patients with type A aortic dissection included gender, age,height, weight, past medical history, family history, hospital costs, etc. | from 2015 to 2019 | 
| The main efficacy indicators was assessed by SPSS 17.0. | The main efficacy indicators included surgical procedures, surgical outcome (postoperative bleeding, ICU stay, extubation time), perioperative complications (including infection, bleeding, neurological complications, cardic complications, renal insufficiency, etc.), and postoperative mortality. | from 2015 to 2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
China, Aortic Dissection, the United States
ProSat - Long Term Effect of Probiotics on Satiety

Study Overview
=================
Brief Summary
-----------------
The aim of the ProSat study is to examine the effects of a probiotic capsule containing Lb. Casei on subjective appetite sensation, ad libitum energy intake, and appetite hormone response in a single meal test and to determine whether the acute effects persist after daily supplementation of the probiotic capsule.

Official Title
-----------------
Probiotics and Satiety - Acute Effects and Persistence of Acute Effects

Conditions
-----------------
Obesity, Appetite Regulation

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women Normal to slight overweight (BMI: 22-28 kg/m2) 20-45 years of age Exclusion Criteria: Smoking Daily medicine use (oral contraceptives excluded) Use of pre- and probiotic supplements and foods Blood donation 3 months prior to the study Hb < 7,5mmol/l Chronic illnesses such as hyperlipidemia, diabetes inflammatory diseases Pregnancy or breastfeeding Elite athletes (>10 hours hard exercise/week) Vegetarians

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Probiotic<br>* Parallel, randomized, controlled 2 arms study.<br>|
| Active Comparator: High dose Lb. casei<br> | Dietary Supplement: Probiotic<br>* Parallel, randomized, controlled 2 arms study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose, insulin, GLP-1, GLP-2, CCK, PYY, PP, ghrelin, amylin, LPS, TNF-alfa, CRP, fibrinogen. |  | June 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective appetite measurements, spontaneous food intake. |  | June 2011 |
Normoxic Challenges Utility to Evaluate Blood Loss

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the impact of repeated normoxic challenges on cerebral oxygenation as a measure of the effect of blood loss on DO2 during surgical procedures.

Official Title
-----------------
Normoxic Challenges Utility to Evaluate Blood Loss Through Cerebral Oxygenation

Conditions
-----------------
Hemorrhage

Intervention / Treatment
-----------------
* Device: Cerebral oxygenation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective surgery High risk of intraoperative blood loss General anaesthesia Exclusion Criteria: Respiratory insufficiency Ischemic heart disease Stroke ASA classification > 3 Laparoscopic surgery

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cerebral oxygenation|Evaluate cerebral oxygenation using normoxic challenges|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cerebral regional oxygen saturation |  | Before and 3 minutes after normoxic challenges |
Comparison Study of Letrozole Alone or Letrozole With Zoledronic Acid in Early Breast Cancer, Neoadjuvant Therapy

Study Overview
=================
Brief Summary
-----------------
This study is to measure the extent of tumor shrinkage when Letrozole and Zoledronic Acid are given before surgery to newly diagnosed post-menopausal women with early breast cancer

Official Title
-----------------
Randomized Multi-Center Study Comparing Prolonged Primary Systemic Endocrine Therapy With Letrozole Alone or in Combination With Zoledronic Acid in Early Breast Cancer (NEOadjuvant Study in CANada)

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

Intervention / Treatment
-----------------
* Drug: Zoledronic Acid; Letrozole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Postmenopausal women Newly diagnosed with non metastatic breast cancer Candidate for mastectomy or breast-conserving surgery Exclusion Criteria Patients with invasive tumors Patients receiving anti-cancer treatment Patients who have undergone surgery Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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: Zoledronic Acid; Letrozole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response at 24 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response at 16 weeks |  |  | 
| Clinical benefit at 16 weeks |  |  | 
| Clinical benefit at 24 weeks |  |  | 
| Rate of breast conserving surgery in both arms |  |  | 
| Rate of complete pathological response |  |  | 
| Biomarkers |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neoadjuvant, postmenopausal women, breast cancer, hormonal therapy, bisphosphonate
Biomarkers Predicting Response in Patients With Non-Small Cell Lung Cancer Previously Treated With Erlotinib Hydrochloride

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of blood in the laboratory from patients receiving erlotinib hydrochloride may help doctors learn more about the effects of erlotinib hydrochloride on cells. It may also help doctors understand how well patients respond to treatment. PURPOSE: This research study is studying biomarkers predicting response in patients with non-small cell lung cancer previously treated with erlotinib hydrochloride.

Detailed Description
-----------------
OBJECTIVES: To evaluate whether serum NGAL, MMP-9, NGAL/MMP-9 complex, and soluble E-cadherin can be utilized as biomarkers to predict response in patients with non-small cell lung cancer treated with erlotinib hydrochloride. OUTLINE: Serum samples are analyzed for NGAL, MMP-9, NGAL/MMP-9, and soluble E-cadherin by ELISA and Luminex assays.

Official Title
-----------------
Measurement of Potential Biomarkers Predicting Erlotinib Response

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Other: enzyme-linked immunosorbent assay
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of non-small cell lung cancer Received erlotinib hydrochloride on clinical trial ECOG-E3503 PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: enzyme-linked immunosorbent assay|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline serum NGAL, MMP-9, NGAL/MMP-9 complex, and soluble E-cadherin levels as predictors of erlotinib hydrochloride response |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-small cell lung cancer
Evaluation of D-chiro-inositol Treatments

Study Overview
=================
Brief Summary
-----------------
Healthy women will take tablets containing 600 mg D-chiro-inositol twice per day for one month. We will evaluate metabolic and hormonal.parameters, as insulienmia, glycemia, estradiol, testosterone.

Official Title
-----------------
Evaluation of the Effects of D-chiro-inositol in Female Healthy Volunteer

Conditions
-----------------
Inositol, Testosterone, Insulin, Ovulation, Asprosin

Intervention / Treatment
-----------------
* Dietary Supplement: D-chiro-inositol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good state of health; Regular menstrual cycle. Exclusion Criteria: pregnancy; delivery in the previous 6 months; currently breastfeeding; menopause; alcohol or drug abuse; insulin resistance defined as HOMA-IR index greater than or equal to 2.5; other medical morbidities, such as hypertension, PCOS, or diabetes; oligomenorrhea or amenorrhea; current treatment with corticosteroids or hormones (oral contraceptives, estrogensic, progestogensin); use of GnRH analogues, SERMs, or SPRMs within the previous 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Human healthy women
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D-chiro-inositol<br>Patients will take D-chiro-inositol. We will make two blood sampling, at the baseline and after one-month treatment | Dietary Supplement: D-chiro-inositol<br>* D-chiro-inositol 600 mg twice per day on an empty stomach for one month<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Testosterone | Serum values of testosterone | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | body-mass index | 30 days | 
| Glycemia | Serum values of glucose | 30 days | 
| Insulinemia | Serum values of insulin | 30 days | 
| HOMA-IR index | Model of assessment for insulin resistance | 30 days | 
| FSH | Serum values of FSH | 30 days | 
| LH | Serum values of LH | 30 days | 
| Estradiol | Serum values of estradiol | 30 days | 
| DHEAS | Serum values of DHEAS | 30 days | 
| Asprosin | Serum values of asprosin | 30 days |
Arimidex Observational: Reason for and Effect of Change From Tamoxifen

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyse the effect on quality of life after 3 months of treatment after changing adjuvant therapy from tamoxifen to Arimidex.

Official Title
-----------------
Arimidex: Reason for and Effect of Change From Tamoxifen

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal Hormone sensitive breast cancer Patient uses tamoxifen or has stopped taking tamoxifen less than 7 days ago Exclusion Criteria: Visceral metastases Patients with signs of progression at the moment of changing therapy Patients who have used other endocrine treatments for breast cancer besides tamoxifen

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
-----------------
Adjuvant
DYSPORT™ Clinical & Health Economics Outcomes Registry in Cervical Dystonia

Study Overview
=================
Brief Summary
-----------------
The purpose of the protocol is to determine typical patient response to Dysport in the treatment of adult cervical dystonia (CD).

Official Title
-----------------
DYSPORT™ for Injection AbobotulinumtoxinA Neurotoxin Clinical & Health Economics Outcomes Registry in Cervical Dystonia (ANCHOR-CD)

Conditions
-----------------
Cervical Dystonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of idiopathic CD as determined by the enrolling investigator If previously treated with a neurotoxin for CD, at least a 12-week interval must have elapsed between the last injection of Botulinum toxin A (BoNT-A) or Botulinum toxin B (BoNT-B) and the first dose of Dysport injected in this study Patient is able to comply with the protocol (e.g., can visit the clinic as required and can complete questionnaires/telephone interviews) Provision of written informed consent prior to enrollment Exclusion Criteria: Contraindications to treatment with any BoNT-A or BoNT-B preparations Based on Investigator opinion, patients in whom previous BoNT-A or BoNT-B therapy has failed to produce a clinical response or produced an intolerable adverse reaction Anticipated concomitant treatment with BoNT for other than cervical dystonia Secondary cervical dystonia

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 |
| --- | --- | --- |
| Proportion of treatment responders using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity scale score |  | Cycle 1 - Baseline and week 4 | 
| Patient Global Impression of Change using the 7-point Likert scale |  | Cycle 1 - Baseline and week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression of Change using the 7-point Likert scale |  | Cycle 1 - Week 4 and early termination visit | 
| Patient Global Impression of Change using the 7-point Likert scale |  | Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visits | 
| Time to Waning Effect of Dysport treatment/symptom re-emergence |  | Cycles 1 to 4 - Week 8 and at study termination visits | 
| Patient-self-administered questionnaire (Cervical Dystonia Impact Profile-58) |  | Cycles 1 & 3: Baseline | 
| Patient-reported assessment of pain using the Pain Numeric Rating Scale (NRS) |  | Cycles 1 to 4 - Baseline, week 4 and at study termination visits | 
| Treatment Satisfaction Questionnaire for Medication (TSQM) |  | Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visit |
Anticoagulation in Blunt Cerebrovascular Injuries

Study Overview
=================
Brief Summary
-----------------
Originally thought to be a rare occurrence, BCVI are now diagnosed in approximately 1% of blunt trauma patients. Initially BCVI were thought to have unavoidable devastating neurologic outcomes. But early reports suggested anticoagulation might decrease these events. If untreated, carotid artery injuries (CAI) have a stoke rate up to 50% depending on injury grade, with increasing stroke rates correlating with increasing grades of injury. Current studies report early treatment with antithrombotics - either heparin or anti-platelet agents - in patients with BCVI markedly reduces stroke rates and resultant neurologic morbidity. As reports of bleeding complications have altered heparin protocols in these patients, the use of antiplatelet agents is attractive. Although heparin has been has been proposed as the gold standard treatment due to its initial empiric use, no comparative studies of antithrombotic agents has been performed. In sum, Grade I-III blunt carotid and vertebral arterial injuries (BCVI) have the potential for stroke, and should be treated. Heparin has not been shown to clearly improve healing rates compared with antiplatelet therapy. The purpose of this study is to determine whether systemic anticoagulation alters the course of Grade I-III BCVI compared with antiplatelet therapy. The investigators study hypothesis is that Grade I-III BCVI will heal or progress to pseudoaneurysm formation, independent of systemic antithrombotic regimen, and that the combination of aspirin and clopidogrel is equally efficacious in preventing neurologic symptoms compared to systemic heparin associated with Grade I-III BCVI.

Official Title
-----------------
Anticoagulation in the Management of Grade I-III Blunt Cerebrovascular Injuries

Conditions
-----------------
Carotid Artery Injury, Vertebral Artery Injury

Intervention / Treatment
-----------------
* Drug: heparin
* Drug: aspirin and clopidogrel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients greater than 18 years old with documented grade I-III blunt cerebrovascular injuries. Exclusion Criteria: Pregnancy Nasal polyps Previous gastrointestinal bleeding secondary to antiplatelet medications Contraindication to systemic anticoagulation.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: heparin|nan|
|Drug: aspirin and clopidogrel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurologic sequelae |  | during hospital visit |
Safety and Pharmacokinetic Characteristics of HD203 in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is compare the safety and pharmacokinetic characteristics of HD203 with those of etanercept after subcutaneous injection in healthy male volunteers.

Official Title
-----------------
A Randomized, Double-blind, Single-dosing, Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of HD203 25 mg With Those of Enbrel® Injection 25 mg After Subcutaneous Injection in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Biological: HD203


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 to 40 years of healthy volunteers

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etanercept<br> | Biological: HD203<br>* Injectable form<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Etanercept levels in blood |  | 21 days | 

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