linjc16/ctgov huggingface dataset:
Efficacy and Safety of Pimecrolimus for the Treatment of Vitiligo Vulgaris

Study Overview
=================
Brief Summary
-----------------
Patients with vitiligo vulgaris are treated with Pimecrolimus twice a day during 6 months. After a baseline visit, patient returns for a control visit after 3 and 6 months of treatment. One reference lesion is clinically evaluated with pictures.

Official Title
-----------------
Efficacy and Safety of Pimecrolimus for the Treatment of Vitiligo Vulgaris

Conditions
-----------------
Vitiligo Vulgaris

Intervention / Treatment
-----------------
* Drug: Application of pimecrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active or stable vitiligo vulgaris lesions at head or neck + maximum 10% lesions at the rest of the body Exclusion Criteria: Topica during last 2 weeks Photo(chemo)therapy during last 4 weeks Segmentary vitiligo

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Application of pimecrolimus|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repigmentation percentage of the reference lesion after 6 months. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with repigmentation after 3 and 6 months. |  |  | 
| Repigmentation percentage of the reference lesion after 3 months. |  |  | 
| Adverse events (month 3 and 6). |  |  |
The BALANCED Anaesthesia Study

Study Overview
=================
Brief Summary
-----------------
General anaesthesia is a reversible drug-induced coma. Too little can result in patients being partially conscious during surgery; too much can slow recovery after surgery. There is a range of drug doses that can be used and some anesthesiologists use more than others. There is no convincing evidence that any particular dose within the usual range is better. Consequently, there are no guidelines on the best depth of anaesthesia. This study will determine whether general anesthetic concentrations at the low end of the usual range are better than those at the high end. Participants will randomly be assigned to lighter or deeper general anesthesia. The first day after surgery, two short questionnaires about recovery and memories of the surgery will be completed. During the rest of the participant's hospital stay, a survey about how one feels will be completed. There will be two telephone contacts after discharge from the hospital. One month after surgery three questionnaires will be completed about performing daily tasks, how you feel and memories of the surgery. Then one year after surgery pain will be assessed.

Official Title
-----------------
The BALANCED Anaesthesia Study A Prospective, Randomised Clinical Trial of Two Levels of Anaesthetic Depth on Patient Outcome After Major Surgery

Conditions
-----------------
Effect of General Anesthetic Dose on Recovery From Surgery

Intervention / Treatment
-----------------
* Procedure: Light general anaesthesia (BIS = 50)
* Procedure: deep general anaesthesia (BIS = 35)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥60 years ASA physical status 3 or 4 surgery expected to last ≥2 hours post-operative hospital stay expected to be ≥2 nights general anaesthesia with or without major regional block able to monitor BIS throughout anaesthesia Exclusion Criteria: Unable to monitor BIS (e.g. cranial or intracranial surgery) unable to consent surgery with 'wake-up' test propofol infusion for part or all of maintenance of anaesthesia ('total intravenous anaesthesia') previous enrolment in Balanced study

Ages Eligible for Study
-----------------
Minimum Age: 60 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Light general anaesthesia (BIS = 50)<br>Light general anaesthesia | Procedure: Light general anaesthesia (BIS = 50)<br> <br> |
| Experimental: deep general anaesthesia (BIS = 35)<br>deep general anaesthesia | Procedure: deep general anaesthesia (BIS = 35)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One-year all-cause mortality |  | One year |
A Pilot Study to Evaluate the Systemic Inflammatory Response of Thoracoabdominal Aortic Aneurysm Repair.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at the systemic inflammatory response caused when patients undergo thoracoabdominal aortic aneurysm repair (TAAA). In addition, this study will look at how the inflammatory response affects the post operative healing process and post operative complications.

Detailed Description
-----------------
Patients will be invited to participate in this study prior to the TAAA repair procedure. Prior to the surgery, baseline blood and saliva samples will be collected. Following the surgery, blood and saliva samples will be collected for 48 hours. In addition, hemodynamic data (i.e. vital signs) will be collected for the first 48 hours. The patient data will be reviewed for the first 30 days for morbidity and mortality assessment.

Official Title
-----------------
A Pilot Study to Evaluate the Systemic Inflammatory Response of Thoracoabdominal Aortic Aneurysm Repair.

Conditions
-----------------
Aortic Aneurysm, Thoracic, Systemic Inflammatory Response Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective TAAA repair Exclusion Criteria:

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 |
| --- | --- | --- |
| to evaluate the effects of TAAAA repair on pro-inflammatory mediators and the anti-inflammatory mediators IL-1 receptor antagonist and IL-10. |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the inflammatory response after TAAA repair and delineate any association to post-operative morbidity |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elective TAAA repair
Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement

Study Overview
=================
Brief Summary
-----------------
Prospective randomized study in cemented primary total knee arthroplasty. In one group the cement used was standard cement, without any antibiotics and in the other group the cement used was loaded with 0.5 g of erythromycin and 3 million units of colistin in 40 g of cement. In all cases intravenous antibiotics prophylaxis against infection was used. In both groups the cement was mechanically mixed in a vacuum. One deep drain tube was placed for 24 hours in all cases. The main variable was the presence of infection according to the Center of Disease Control criteria with a minimum of 12 months follow-up.

Official Title
-----------------
Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement

Conditions
-----------------
Infection After Primary Total Knee Arthroplasty

Intervention / Treatment
-----------------
* Procedure: Cement without antibiotic.
* Procedure: Cement with erytromycin and colistin.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary total knee replacement. Both genders. No age limits. Exclusion Criteria: Allergy to erythromycin or colistin. Previous infection in the knee.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cement with erytromycin and colistin<br>In this group the knee arthroplasty was fixed with cement with erythromycin and colistin. | Procedure: Cement with erytromycin and colistin.<br> <br> |
| Placebo Comparator: Cement without antibiotic<br>In this group the knee arthroplasty was fixed with standard cement, without any antibiotics. | Procedure: Cement without antibiotic.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection | Presence or absence of infection, according to the Center for Disease Control's criteria. The infection cases are classified as superficial of deep infection. | The minimum follow-up is 12 months. |
Evaluation of the GTX™ 5126 DES Coronary Stent System in the Treatment of Patients With a Lesion in the Coronary Artery

Study Overview
=================
Brief Summary
-----------------
The GTX™ Drug Eluting Coronary Stent System is intended for the treatment of patients with a lesion in the coronary artery.

Official Title
-----------------
Silencing the c-Myc Gene Using Third Generation Antisense Restenosis Therapy

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: GTX™ Drug Eluting Coronary Stent System


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Patient has discrete de novo lesion of a coronary artery with symptomatic ischemic heart disease Planned treatment of one lesion with a single stent Denovo type A, B1 lesions with a Reference diameter between 3.0 and 3.5mm and a lesion length between 5 and 16mm Key Exclusion Criteria: Diabetic (HbA1C >6.0) Platelet count < 100000 cells/mm3 or > 700000 cells/mm3; WBC < 3000 cells/mm3; or a hemoglobin < 10 g/dl Renal dysfunction with creatinine > 2.0 mg/dl Patient has a known pre-dilatation ejection fraction (EF) less than forty five (<45%) Myocardial infarction (MI) less than 3 months prior to intervention Patient has type B2, C lesion Reference artery diameter <3.0 or >3.6 mm Target lesion length < 5mm and >16 mm Other stenosis >50% in target vessel Known hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine, or cobalt chromium, or a sensitivity to contrast agent that, in the opinion of the investigator, cannot be adequately premedicated.

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: 1<br>Device | Device: GTX™ Drug Eluting Coronary Stent System<br>* Drug eluting stent<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vessel Lumen Patency |  | 6 months |
Brand Level Nutrient Information Compared to Generic Food Codes

Study Overview
=================
Brief Summary
-----------------
Measuring diet is difficult. This is the first time that brand level foods and nutrient values have been compared with generic food codes to explore the difference this might make to estimated nutrient intakes.

Detailed Description
-----------------
Background Traditional dietary assessment methods lack precision. myfood24 is an online 24-hour dietary assessment tool, aiming to reduce the burden of dietary assessment; providing data entry by participants using automated coding of food items. myfood24 includes a large branded food database. Objective To assess the effect of using brand level nutrient information compared to generic food codes on estimated nutrient intakes. Design A 24 hour recall was collected using myfood24, which contains a food and nutrient database of over 40,000 items with both branded and generic foods. Participants freely selected their foods generating the 'free choice recall'. After the online recall was completed, they provided further details of brands consumed. The free choice recalls were recoded forming an 'all branded' and an 'all generic' recall. Estimated nutrient intakes from the three different methods of food coding were compared to assess the impact of brand-level information.

Official Title
-----------------
Brand Level Nutrient Information Compared to Generic Food Codes: Impact on Results From Dietary Recalls

Conditions
-----------------
Diet Records, Diet Surveys

Intervention / Treatment
-----------------
* Other: no intervention - recoding of food recall only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: students University of Leeds convenience sample of general public adults Exclusion Criteria: none defined
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Food code group<br>The participants freely selected foods from the online dietary assessment tool to record what they had eaten over the last 24h. They then provided information on brand details. The recalls were recoded to take into account all branded items and then recoded again to take represent all generic (ie. no brands) foods. | Other: no intervention - recoding of food recall only<br>* recoding of food recall<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutrient intakes by food coding | comparison of nutrient intakes as a result of the recoding process with brand level data | 24hour recall |
Patient Perceptions and Physician Assessment of Benefits and Risks of Oral Anticoagulation Due to Non-valvular AF

Study Overview
=================
Brief Summary
-----------------
The risk of stroke is markedly elevated in patients with atrial fibrillation (AF). Oral anticoagulation (OAC) is indicated in individuals with moderate and high risk of stroke to the disadvantage of an increased burden from bleeding. Adequate knowledge of this disorder and understanding the benefits and hazards of antithrombotic treatment are essential to incorporate patient´s values and preferences in these decisions. This will further improve acceptance of recommended therapy and augment compliance with OAC. The objective of this investigation is to compare patient´s perceptions and physician´s assessments of benefits and risks of OAC.

Official Title
-----------------
Patient Perceptions and Physician Assessment of Benefits and Risks of Oral Anticoagulation Due to Non-valvular Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation, Health Literacy

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed and ECG-documented non-valvular atrial fibrillation New indication for oral anticoagulation (OAC) Ability of informed consent Exclusion Criteria: Existing OAC therapy Valvular heart disease History of valve surgery

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaire|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of subjective stroke risk perception with CHA2DS2-VASc score |  | Baseline | 
| Comparison of subjective bleeding risk perception with HAS-BLED score |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between accurate perception of stroke and bleeding risks and baseline parameters (highest completed level of education, subjective level of information) |  | Baseline |
A Novel Appendicitis TriMOdal Prediction Score (ATMOS) for Acute Appendicitis in Pregnancy: a Retrospective Observational Study

Study Overview
=================
Brief Summary
-----------------
Acute appendicitis (AA) is a disease of younger age, but it occurs in 1 out of 500-2000 pregnancies. The current treatment of choice for AA in pregnancy is surgical. Even with standard clinical examination, serum inflammatory markers, and transabdominal ultrasound, the decision on surgical treatment of acute appendicitis (AA) and the rate of negative appendectomy in pregnancy are still unsatisfactory. There are several scoring systems (Alvarado, Tzanakis) that help making decision on operating more easier, however their specificity is either high with low sensitivity, or the other way around. In addition, all scores are based on adult non-pregnant population. We are making an observational study to develop a scoring system that would include ultrasonic imaging with clinical-biochemical parameters while not compromising sensitivity and specificity.

Detailed Description
-----------------
The study includes extraction of medical data for pregnant women, age 18 years or older, admitted to the University Hospital Centre Zagreb, Zagreb, Croatia, with the suspicion of AA, from January 2010 to December 2020. The aim of this study is to develop a scoring system that would include ultrasonic imaging with clinical-biochemical parameters while not compromising sensitivity and specificity.

Official Title
-----------------
A Novel Appendicitis TriMOdal Prediction Score (ATMOS) for Acute Appendicitis in Pregnancy: a Retrospective Observational Study

Conditions
-----------------
Appendicitis in Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women, age 18 years or older, admitted to the University Hospital Centre Zagreb, Zagreb, Croatia, with the suspicion of acute appendicitis, from January 2010 to December 2020. Exclusion Criteria: non-pregnant patients pregnant patients younger than 18 years diagnosis made with CT or MRI pregnant patients with the acute abdomen (intraoperative diffuse peritonitis) from acute appendicitis

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 |
| --- | --- | --- |
| Predictive factors of acute appendicitis in pregnancy | Detection of predictive factors of acute appendicitis in pregnancy | January 2010 to December 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
appendicitis, pregnancy, score, ultrasound, neutrophil-lymphocyte ratio, CRP-platelet ratio
Neoadjuvant Treatment With Palbociclib and Exemestane Plus Trastuzumab and Pyrotinib in Estrogen Receptor (ER)-Positive, HER2-positive Breast Cancer

Study Overview
=================
Brief Summary
-----------------
neoPEHP is a multicohort, open-label, exploratory, phase 2 study. Patients were eligible if they had previously untreated, histologically confirmed, unilateral, invasive, HER2-positive, ER-positive breast cancer and were suitable for neoadjuvant therapy. Patients were treated every 3 weeks with intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg) and oral pyrotinib (400 mg po QD) for six cycles plus oral palbociclib (125 mg once a day for 21 days in a 4-week cycle) and oral exemestane (25 mg po QD) every 4 weeks for 24 weeks. The primary endpoints was pathological complete response.

Official Title
-----------------
Neoadjuvant Treatment With Palbociclib and Exemestane Plus Trastuzumab and Pyrotinib in ER-positive, HER2-positive Breast Cancer (neoPEHP): an Exploratory, Open-label, Multi-center Phase 2 Study

Conditions
-----------------
Neoadjuvant Treatment for HER2-positive, ER-positive Breast Cancer

Intervention / Treatment
-----------------
* Drug: palbociclib and exemestane plus trastuzumab and pyrotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: We judged patients eligible for the first study cohort if they had previously untreated, histologically confirmed, unilateral, invasive, HER2-positive (3+ on immunohistochemistry or neu-amplified) and ER-positive (>10% of cells in the tumour expressing ER) breast cancer. Other inclusion criteria were age 18 years or older, Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less, and tumour classified between cT1c and cT4a-d. Exclusion Criteria: metastatic disease, bilateral breast cancer, other malignant disease, inadequate bone marrow or renal function, impaired liver function, impaired cardiac function, uncontrolled hypertension, pregnancy, and refusal to use contraception.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neoadjuvant treatment with palbociclib and exemestane plus trastuzumab and pyrotinib<br> | Drug: palbociclib and exemestane plus trastuzumab and pyrotinib<br>* Neoadjuvant treatment with palbociclib and exemestane plus trastuzumab and pyrotinib in ER-positive, HER2-positive breast cancer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological complete response(ypT0/is,ypN0, pCR) | defined as the absence of invasive tumor cells in breast and axilla, ypT0/is ypN0 | 24 weeks |