linjc16/ctgov huggingface dataset:
Red Yeast Rice and Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of red yeast rice on subclinical atherosclerosis in patients with rheumatoid arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Dietary Supplement: Tea
* Dietary Supplement: RYR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with a definite diagnose of rheumatoid arthritis(RA) were included if they met the classification criteria for RA established by the American Rheumatism Association (ACR) and European League Against Rheumatism (EULAR) in 2010 aged from 18 to 75 years without conflict to the written, informed consent signed prior to the enrollment no severe hepatic or renal disorders no known carotid artery stenosis no coagulation disorders no hypertension Exclusion Criteria: being in pregnancy, lactation period or under a pregnancy plan being allergic to the test drug not compatible for the trial medication without full legal capacity

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RYR<br>Patients under the treatment of red yeast rice | Dietary Supplement: RYR<br>* red yeast rice<br>|
| Sham Comparator: Control<br>Patients under the treatment of tea | Dietary Supplement: Tea<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in Carotid intima-media thickness at 24 weeks |  | At 0 week, 12 weeks, 24 weeks |
Anastrazole Plus GnRH-agonist in the Treatment of Endometriosis Recurrence

Study Overview
=================
Brief Summary
-----------------
The aromatase inhibitor (anastrazole) plus long acting GnRH agonist leuprolide acetate will be tested for the treatment of women with endometriosis recurrence compared with classical GnRH analog treatment. Pain symptom disappearance and disease free time during follow-up will be the outcomes for establishing which medical treatment is the best in endometriosis recurrence treatment.

Detailed Description
-----------------
Endometriosis is a chronic disease affecting 5-10% of women in reproductive age, showing recurrence after surgery at least in 20-50% after 5 years of follow-up. Aromatase inhibitor plus GnRH analog may be more effective than GnRH agonist alone in the treatment of endometriosis recurrence.

Official Title
-----------------
Treatment of Patients With Endometriosis Recurrence With Aromatase Inhibitor (Anastrazole) Plus GnRH-agonist (Luprolide).

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Drug: anastrazole
* Drug: GnRH analog alone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women affected by endometriosis showing recurrence of pain symptoms, previous surgery for endometriosis Exclusion Criteria: presence of other systemic diseases

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anastrazole<br>women with endometriosis recurrence will be treated with Leuprolide acetate 11,25mg plus anastrazole 1mg/day for three months | Drug: anastrazole<br>* combined treatment with aromatase inhibitor (anastrazole) plus GnRH analog (leuprolide acetate) for three months<br>|
| Active Comparator: GnRH analog alone<br>women with endometriosis recurrence will be treated with leuprolide acetate 11.25mg | Drug: GnRH analog alone<br>* treatment for three months with GnRH analog (leuprolide acetate) alone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free time | time without pain symptoms due to the disease recurrence | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of pain disappearance | time needed during treatment to improve pain symptoms | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endometriosis recurrence, pelvic pain, aromatase inhibitor
Intubation With McGrath Video Laryngoscope and Boedeker Intubation Foreceps in a Population of Patients With Predictors of Difficult Airway

Study Overview
=================
Brief Summary
-----------------
Tracheal intubation with videolaryngoscopes have been widely studied, and is now often used in the management of difficult airways. Videolaryngoscopes with angulated blades can improve laryngeal view, however this does not always match with a higher intubation succes. To adress this matter the aim of this study is gathering experience with intubation with mcgrath videolaryngoscope and a blade-shape intubation foreceps (Boedeker intubation foreceps, Karl Storz, Germany). The hypothesis is that intubation with this combination is easy and can be a good alternative when using the McGrath videolaryngoscope in patients with predictors of difficult airway.

Official Title
-----------------
Intubation With McGrath Video Laryngoscope and Boedeker Intubation Foreceps in a Population of Patients With Predictors of Difficult Airway, an Observational Pilot Study

Conditions
-----------------
Patients With One or More Predictors of Difficult Airway

Intervention / Treatment
-----------------
* Device: Intubation with mcgrath videolaryngoscope and Boedeker intubation foreceps


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for elective surgery age over 18 or more planned intubation with mcgrath videolaryngoscope informed conscent obtained patients are patients shall be able to read and understand Danish Exclusion Criteria: Patients planned to awake intubation stridor hypoxia defined by saturation under 90% without oxygen supply patients with oxygentreatment at home patients that need a wired tube patients that need a preshaped tube patients that need crash induction use of gastric tube

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 |
| --- | --- |
| airway<br>Patients with one or more predictors of diffucult airway | Device: Intubation with mcgrath videolaryngoscope and Boedeker intubation foreceps<br>* Patients will be intubated with the Mcgrath videolaryngoscope and a tracheal tube placed by Boedeker intubation foreceps<br>* Other names: Karl Storz Boedeker intubation foreceps;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to intubation |  | within one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sore throat |  | within 2 days | 
| succesful intubation |  | within one day | 
| Damage on teeth |  | 2 days | 
| Intubation difficulty | Intubation difficulty scale | within one day | 
| Intubation conditions | a.m fuchs-buder | within one day | 
| Intubation attempts |  | within one day |
Clinical Features and Outcome in Patients With Osseomuscular Type of Wilson's Disease

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to observe the clinical features and outcome in patients with osseomuscular type of Wilson's disease from a large cohort during long-term follow-up

Official Title
-----------------
Clinical Features and Outcome in Patients With Osseomuscular Type of Wilson's Disease

Conditions
-----------------
Clinical Features and Outcome

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: genetically diagnosed WD patients Exclusion Criteria: Deny follow-up

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum ceruloplasmin | Serum ceruloplasmin levels were collected among patients with wilson disease. After confirming a non-Gaussian distribution, the reference range of serum ceruloplasmin level was determined. | From 2004 through 2030 | 
| Urinary Copper Excretion | The measurement of 24-hour urine copper excretions were collected and measured. | From 2004 through 2030 |
Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two(Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines in Non-Elderly Adult and Elderly Subjects

Study Overview
=================
Brief Summary
-----------------
The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, in non-elderly adult and elderly subjects.

Official Title
-----------------
A Phase II, Randomized, Controlled, Observer-Blind, Multi-Center Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two (Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines Containing 7.5 mg or 15 mg of H5N1 Influenza Antigen, in Non-Elderly Adult and Elderly Subjects

Conditions
-----------------
Pandemic Influenza Disease

Intervention / Treatment
-----------------
* Biological: Influenza vaccine surface antigen adjuvanted with MF59


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female volunteers 18 years of age or older Exclusion Criteria: any auto-immune disease or other serious acute, chronic or progressive disease hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine. history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine. within the past 7 days, they have experienced: any acute disease, infections requiring systemic antibiotic or antiviral therapy.

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Influenza vaccine surface antigen adjuvanted with MF59|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPMP criteria for evaluation of flu vaccines e.g. Seroprotection, GMT's and Seroconversion rate at day 0 and day 22 and day 43 following vaccination |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Thought the Study. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
influenza, pandemic influenza, influenza vaccine, adjuvanted influenza vaccine
The Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tube

Study Overview
=================
Brief Summary
-----------------
Single-center prospective randomized trial to evaluate the effect of thermal damage of Ligasure® to destroy cornual portion of fallopian tube tisse. Right of Left side of fallpian tube is randomized and coagulated one more time than other side before cut off. The pathologist evaluate the amount of fallopian tube tissue left at both cornual portion of cut off specimen.

Detailed Description
-----------------
When investigators perform salpingectomy, both side of cornual portion of the uterus are coagulated by Ligasure®. The randomized, the same word selected side of the fallopian tube is coagulated one more time at the cornual portion than unselected other side of fallopian tube. Hypothesis is that the side selected and coagulated twice would have less fallopian tube tisse left at fianl pathology than the side only once coagulated by Ligasure®.

Official Title
-----------------
The Effect of Thermal Damage of Ligasure® to Destroy Cornual Portion of Fallopian Tube Tissue

Conditions
-----------------
Recruiting, Completed

Intervention / Treatment
-----------------
* Device: The Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female 35-50 premenopausal plan to perform hysterectomy Exclusion Criteria: disease in fallopian tube before surgery has history of pelvic inflammatory disease

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: twice coagulated side of fallopian tube<br>twice coagulated side of fallopian tube once coagulated sied of fallopian tube | Device: The Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tube<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remnant fallopian tube tissue after coagulation wiht Ligasure® |  | 1 day |
Effect of Alendronate 70mg Formulation on Bone Turnover Markers and Patient Reported Outcomes

Study Overview
=================
Brief Summary
-----------------
Compare the data obtained with two formulations of alendronate 70 mg (tablets vs effervescent tablet for buffered solution) on the change in bone turnover markers, on gastric tolerance and on treatment adherence (including compliance and persistence).

Official Title
-----------------
A Non-interventional Two-arm Two-centre, Retrospective/Prospective Study to Compare the Effect of Alendronate 70mg Formulation (Tablet vs Effervescent Tablet) on Bone Turnover Markers and Patient Reported Outcomes

Conditions
-----------------
Osteoporosis, Postmenopausal

Intervention / Treatment
-----------------
* Drug: Binosto 70Mg Effervescent Tablet
* Drug: Fosamax 70Mg Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-menopausal women (at least 5 years after natural / surgical menopause). Patients on treatment with alendronate 70mg tablets or alendronate 70mg effervescent tablets for 6-8 months and who will be continued to be treated for a minimum of 12 months. Available BTMs (s-CTX), biochemistry (calcium, phosphate, 25-OH vit D, PTH, creatinine) and DXA (lumbar spine, total hip and femoral neck) at the initiation of the treatment. Ability to sign an informed patient consent Exclusion Criteria: Patients who had received a prior osteoporosis treatment with anti-resorptive drugs (bisphosphonate or denosumab) or teriparatide before starting alendronate 70 mg. Any secondary cause of osteoporosis including current treatment with glucocorticoids or aromatase inhibitors, inflammatory disorders, malabsorption Metabolic or cancer bone disease Contra-indications to bisphosphonates according to product labelling Known or suspected allergy to study product(s) or related products Inability to sign an informed consent Previous participation in this study

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 90 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 |
| --- | --- |
| Fosamax®<br>1 group will be treated with alendronate 70 mg tablets (Fosamax®) | Drug: Fosamax 70Mg Tablet<br>* Assess the effect of alendronate 70mg tablet on bone turnover markers and patient reported outcomes.<br>|
| Binosto®<br>1 group will be treated with alendronate 70 mg effervescent tablets for buffered solution (Binosto®) | Drug: Binosto 70Mg Effervescent Tablet<br>* Assess the effect of alendronate 70mg effervescent tablet on bone turnover markers and patient reported outcomes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| s-CTX | Decrease in the rate of the bone resorption marker s-CTX | Change at 6 months, 12 months, 18 months after treatment start |
Comparison of Simultaneous Laparoscopic and Open Operations for Synchronous Liver Metastases With Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
retrospective analysis of medical records of patients with synchronous liver metastatic colorectal cancer, who underwent simultaneous operations on the intestine and on the liver, from January 2011 to November 2020 at the Russian Scientific Center for Roentgenoradiology. 2 groups of 21 patients each were formed: group 1 included a patient with simultaneous laparoscopic operations, group 2 included a patient with simultaneous open operations.

Conditions
-----------------
Optimization of Treatment

Intervention / Treatment
-----------------
* Procedure: simultaneous operations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with synchronous metastatic liver lesions with colorectal cancer Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patient with simultaneous laparoscopic operations<br> | Procedure: simultaneous operations<br>* simultaneous operations<br>|
| patient with simultaneous open operations<br> | Procedure: simultaneous operations<br>* simultaneous operations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | three years |
A Study of ABT-751 in Patients With Recurrent Breast Cancer After Taxane (Taxol or Taxotere) Therapy.

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with breast cancer after having had taxol or taxotere. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.

Official Title
-----------------
A Phase II Study of ABT-751 in Patients With Breast Cancer Refractory to Taxane Regimens

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

Intervention / Treatment
-----------------
* Drug: ABT-751


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Stage IIIB or IV breast cancer. Recurrent tumor after or while on taxane therapy (taxol or taxotere). Able to tolerate normal activities of daily living. Adequate bone marrow, kidney and liver function. Exclusion Criteria Pregnant or breast feeding. No anti-tumor therapy (including hormonal therapy or Herceptin) within 4 weeks of the start of ABT-751 administration.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ABT-751|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate in subjects with Breast cancer |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Tumor Progression (TTP) |  | 1 year | 
| Survival |  | 2 years | 
| Toxicities associated with treatment administration |  | 1 year |