linjc16/ctgov huggingface dataset:
Inferior Vena Cava Index in Patients Undergoing Liver Resection

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate whether IVC index measured intraoperatively was affected by fluid administration and could add any helpful information about the hemodynamics during hepatic resection. In addition, the investigators evaluated whether IVC index was somehow correlated with the risk of postoperative complication.

Official Title
-----------------
Does Inferior Vena Cava Collapsibility Correlate With Fluid Regimen and Outcome in Patients Undergoing Liver Resection?

Conditions
-----------------
Liver Neoplasms

Intervention / Treatment
-----------------
* Other: IVC diameters evaluation by intraoperative ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent hepatectomy for primary and secondary liver tumors Exclusion Criteria: Patients with tumoral thrombosis or full tumoral involvement/compression of IVC were excluded. Patients unresectable at laparotomy for any extra-hepatic or intrahepatic reason and patients previously submitted to hepatectomy were not included

Ages Eligible for Study
-----------------
Minimum Age: 34 Years
Maximum Age: 85 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 |
| --- | --- |
| Patients with liver tumors candidate to hepatectomy<br> | Other: IVC diameters evaluation by intraoperative ultrasound<br>* Out of consecutive patients who underwent hepatectomy for primary and secondary liver tumors, patients in whom IVC diameters were intraoperatively measured for clinical reasons were retrospectively selected and analyzed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to investigate the influence of the liver resection on hemodynamic status in terms of hemodynamic indexes changes |  | 4 weeks |
Analysis of Expression of Specific Markers and Their Prognostic Significance in Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
Hepatocellular carcinoma is an aggressive disease with limited therapeutic options. Therefore, new approaches to treat this type of cancer are needed with immunotherapy potentially being one of these. As a first step in the development of novel therapies, expression analysis of specific markers, including tumor antigens will be carried out, and the correlation of expression with disease variables and clinical outcome will be assessed. This will be done retrospectively using archived hepatocellular carcinoma tissue samples.

Official Title
-----------------
Analysis of the Incidence of Expression of Tumor Antigens and Tumor Marker in Cancer Tissue From Asian Patients With Hepatocellular Carcinoma and Evaluation of Prognostic Significance of These Tumor Antigens.

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Other: Retrospective analysis of already archived samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has pathologically proven hepatocellular carcinoma (any stage) All the data required are available from patient's records Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br> | Other: Retrospective analysis of already archived samples<br>* Analysis using RNA extracted from tissue samples already archived; Analysis by Fluorescent in situ hybridization (FISH) using tissue samples already archived.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of hepatocellular carcinoma patients whose tumor tissue expresses specific tumor antigens. |  | At the time of analysis | 
| The prognostic character of the expression of the tumor antigens |  | At the time of analysis | 
| Expression of c-MET in the same hepatocellular carcinoma tumor samples |  | At the time of analysis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prognosis, Markers, Expression analysis, Hepatocellular carcinoma
Optimizing Abiraterone Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore whether early abiraterone exposure is related to treatment response in patients with metastatic castration resistant prostate cancer. Furthermore to explore the relation between biomarkers and treatment response and drug exposure.

Official Title
-----------------
Optimizing Abiraterone (Zytiga®) Therapy by Exploring the Relation Between an Early Biomarker - Drug Exposure - as a Predictor for Drug Response in Patients With mCRPC

Conditions
-----------------
Metastatic Castration Resistant Prostate Cancer

Intervention / Treatment
-----------------
* Other: Abiraterone Acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with metastatic castration resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated Age ≥18 years Feasible to collect blood samples from Life expectancy of > 6 months Measurable disease Able and willing to give written informed consent prior to screening and enrollment Exclusion Criteria: other anticancer therapies potent CYP3A4 inducers herbal medicine that could interfere with abiraterone exposure

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Abiraterone Acetate<br>abiraterone treatment, 1000mg, tablets, once daily, treatment is not adapted for the study | Other: Abiraterone Acetate<br>* Exclusively determine pharmacokinetics and pharmacodynamics of abiraterone for the indication according to the drug label (CRPC)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abiraterone AUC |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biomarkers: relation between biomarkers and treatment response | relation between biomarkers and treatment response | 6 months | 
| biomarker reduction | To explore the if reduction in biomarkers is related to treatment response after three and six months | 6 months |
An Evaluation of the Safety and Efficacy of LIPO-102 for the Reduction of Subcutaneous Abdominal Adiposity

Study Overview
=================
Brief Summary
-----------------
This is a double-masked evaluation of the safety and efficacy of LIPO-102 for the reduction of subcutaneous abdominal adiposity.

Official Title
-----------------
A Double-Masked, Evaluation of the Safety and Efficacy of LIPO-102 for the Reduction of Subcutaneous Abdominal Adiposity

Conditions
-----------------
Subcutaneous Abdominal Adiposity

Intervention / Treatment
-----------------
* Drug: LIPO-102
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or non pregnant female Good general health Sufficient abdominal fat for injections Signed informed consent BMI greater than or equal to 18 and less than 28 kg/m2 History of stable weight in past 3 months Exclusion Criteria: Known hypersensitivity to study drugs Treatment with an investigational agent within 30 days of first dose

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LIPO-102, High<br>LIPO-102, High | Drug: LIPO-102<br>* subcutaneous injection<br>|
| Experimental: LIPO-102, Low<br>LIPO-102, Low | Drug: LIPO-102<br>* subcutaneous injection<br>|
| Experimental: Placebo<br>Pbo | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Vital signs, injection site assessment, clinical laboratory tests (hematology, serum chemistry, lipid panel including FFA, and urine dipstick analysis) and adverse events. | 8 weeks | 
| Reduction in abdominal adiposity |  | 8 weeks | 
| Waist circumference |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photographic assessments | Abdominal volume reductions | 8 weeks | 
| Skin-fold caliper measurements |  | 8 weeks | 
| Patient and clinician Global Impression of severity survey |  | 8 weeks | 
| Patient and clinician global impression of change questions |  | 8 weeks | 
| Abdominal appearance questionnaire |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subcutaneous Adipose Tissue Reduction
Molecular Characterization of Candida Auris

Study Overview
=================
Brief Summary
-----------------
Candida auris is emerging fungal opportunistic pathogen in developing countries. Much studies has been conducted on Candida albicans. there was a dire need to investigate this alarming threat. Our hypothesis is that by recording the patients diagnosed with oropharygneal candidiasis and collecting clinical swab samples from these patients will be fruitful if microbiological isolation, identification and molecular characterization will be done. So this is the first study on C. auris in south punjab, Pakistan. Aim of this study is to collect epidemiological data of C. auris.

Official Title
-----------------
Formulation Development and In-Vitro Studies of Efficacy of Botanical Extracts Against Candida Auris

Conditions
-----------------
Oral Fungal Infection

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-diagnosed Patients of both gender from pre-selected localities Exclusion Criteria: Healthy individuals or individuals having no oral fungal infection individuals above 100 years of age

Ages Eligible for Study
-----------------
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: No intervention|Not required|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of C. auris | patients from selected localities will be recorded along with total patients in that category, prevalence will be calculated on the record collected from specified duration of study | From November 15, 2019 to February 29, 2020 | 
| Seasonality of C. auris infection | Number of patients recorded during different months will be the source of calculation of seasonality index of the C. auris infection | From November 15, 2019 to February 29, 2020 | 
| Drug susceptibility | Antifungal drug discs will be used for assessing the antfungal drugs susceptibility | From November 15, 2019 to February 29, 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Candida auris, Oral Fungal Infection, Candidiasis
Diagnostic Accuracy in Sepsis

Study Overview
=================
Brief Summary
-----------------
The sepsis syndrome has recently been more stringently defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. Clinical and paraclinical tools are investigated for their ability to adequately recognize sepsis early.

Official Title
-----------------
Diagnostic Accuracy of Clinical and Paraclinical Tools in Sepsis

Conditions
-----------------
Sepsis Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients >18 years old with suspected sepsis in the Emergency Department of Oslo University Hospital Oslo Exclusion Criteria: Non

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 |
| --- | --- |
| Patients with suspected sepsis in Emergency Department<br>Patients with suspected sepsis treated by the sepsis emergency team or the medical emergency team in the Emergency Department of Oslo University Hospital Oslo are included prospectively. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy in sepsis | Sensitivity, specificity, predictive values, AUC of clinical criteria of sepsis in the Emergency department, compared to post hoc assesment | within 90 days after inclusion | 
| Prognostic accuracy in sepsis | Sensitivity, specificity, predictive values, AUC of clinical criteria of sepsis in the Emergency department, compared to in hospital, 30 and 90 days mortality | 90 days after inclusion |
3D Ultrasound in Women With Vacuum or Forceps Deliveries

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate of the differences in pelvic floor anatomy and function in women who have undergone a vacuum assisted vaginal delivery (VAVD) versus a forceps assisted vaginal delivery (FAVD) using three-dimensional ultrasound imaging. Women within 1-5 years after first delivery who did not have an internal delivery will be included. The total number of subjects is forty. This will include ten primiparous subjects who have undergone vacuum delivery, ten who have undergone forceps delivery, ten who had spontaneous vaginal delivery and ten who have undergone primary elective cesarean section.

Official Title
-----------------
3-Dimension Ultrasound Findings in Women Who Have Undergone Vacuum Versus Forceps-Assisted Vaginal Deliveries

Conditions
-----------------
Pelvic Floor Injury, Urinary Incontinence, Stool Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females age >18 and <45. Primiparous females with singleton pregnancy who have undergone a term vacuum assisted vaginal delivery, forceps assisted vaginal delivery, spontaneous vaginal delivery, or elective primary cesarean section or spontaneous vaginal delivery. Birth weight >2500g and <4500g. Delivery should have occurred more than one year ago, but less than five years ago. Pregestational BMI <35kg40kg/m2. Exclusion Criteria: Presence of interim delivery. Presence of both vacuum and forceps use during delivery. Presence of pregestational or A2 gestational diabetes mellitus. Presence of neuromuscular disorder (i.e., spinal cord disease, Multiple Sclerosis, Myasthenia Gravis) or connective tissue disorder (i.e., Lupus and Sjogren's disease).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Forceps assisted vaginal delivery<br>Forceps assisted vaginal delivery within 1-5 years without any interval delivery | |
| Vacuum assisted vaginal delivery<br>Vacuum assisted vaginal delivery within 1-5 years without any interval delivery | |
| Elective cesarean delivery<br>Elective cesarean vaginal delivery within 1-5 years without any interval delivery done prior to labor | |
| Spontaneous vaginal delivery<br>Spontaneous vaginal delivery within 1-5 years without any interval delivery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levator ani injury on 3D ultrasound | Assessment of levator ani injury on trasnperineal 3D ultrasound images | 1-5 years after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pelvic floor injury, Levator ani muscle
Treatment-related Quality of Life and Patient-Centred Care With Infertility

Study Overview
=================
Brief Summary
-----------------
This study was conducted in a cross-sectional descriptive type with 160 infertile women who were treated in the IVF Clinic of a university hospital between July - October 2020 in order to evaluate the effect of patient-centered care approach in infertility on treatment-related quality of life. The data of the study were collected face to face through the Introductory Information Form Patient Centered Care Form for Infertile Women and FertiQol Treatment Module.

Official Title
-----------------
Patient-Centred Care and Treatment-related Quality of Life With Infertility

Conditions
-----------------
Patient Centred Care, Compliance, Treatment, Infertility, Female, Quality of Life

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with infertility Has no commnunication problems Exclusion Criteria: Communication problems (e.g language) Diagnosed by diseases with reproductive problems but not infertility

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-related quality of life | FertiQol Treatment Module was used to evaluate treatment-related quality of life. This module is a sub-module within FertiQol Scale which developed by Boivin et al. (2011). Module has 10 questions about treatments physical and emotional effects. Module has two subdimensions called Environment and Tolerability and each subdimensions and total scale score can between 0-100 points. | from obtaining ethical permission to reaching sampling (approximately 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Centred Care | Patient Centred Care Questionnaire Form for Infertile Women was used to evaluate patient centred care approach. This questionnaire was prepared by researchers according to literature (IOM, 2001; Picker, 2001).There is no scoring for this tool. | from obtaining ethical permission to reaching sampling (approximately 6 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patient centred care, FertiQol, infertility, quality of life, nursing
The Study of p62/SQSTM1 as a Malignant Transformation Marker for Oral Potentially Malignant Disorders and a Prognostic Marker for Oral Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
The mortality rate of oral cancer in Taiwan is still high with no decrease. One of the reasons result in these situations is the patent visits hospital for treatment in late stage of oral cancer. Recently, the government makes effort in oral cancer screening to find oral potentially malignant disorders (OPMD) early. However, there is no conscience in treatment strategies of OPMD up to now. In this study, we will set a OPMD data bank, and use the cases to find out the potential biomarker, which is able to predict the oral cancer malignant transformation. Sixty OPMD with oral cancer transformation will be recruited, and 60 OPMD with no oral cancer malignant transformation will also be enrolled as the disease control group. Besides, 20 normal cases and 60 oral cancer cases resulting from previous OPMD will be collected. All those groups will detect the expression of p62/SQSTM1 to investigate the possibility that p62/SQSTM1 as a biomarker to predict the malignant transformation of OPMM, and a guideline to treat or not to treat OPMD.

Official Title
-----------------
The Study of p62/SQSTM1 as a Malignant Transformation Marker for Oral Potentially Malignant Disorders and a Prognostic Marker for Oral Squamous Cell Carcinoma

Conditions
-----------------
Oral Potentially Malignant Disorder, Oral Cancer, Malignant Disorder, p62/SQSTM1

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study group was oral precancerous lesions in patients with malignant transformation; control group was generally no precancerous disease and orthodontic surgery volunteer Exclusion Criteria: Oral mucosa of subjects is too thin

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The study of p62/SQSTM1 as a Malignant Transformation Marker for Oral Potentially Malignant Disorders and a Prognostic Marker for Oral Squamous Cell Carcinoma |  | two year |