linjc16/ctgov huggingface dataset:
A Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients With HIV-Associated Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and effectiveness of saquinavir SGC plus stavudine (d4T) plus lamivudine (3TC) with that of saquinavir SGC plus nelfinavir plus d4T in patients with HIV-associated kidney disease. This study examines whether these drug combinations are effective in preventing kidney disease from progressing to a stage where it is immediately life threatening. This study also examines the effect these drug combinations have on the level of HIV detected in these patients. Finally, this study evaluates the drug level (the amount of drug found in the body) of these two combinations in patients with kidney disease.

Detailed Description
-----------------
This is an open-label, non-comparative, randomized, single center, 24-week study. Patients are stratified into 3 groups (8 patients in each group) based on kidney function: Group 1: Serum creatine less than 2 mg/dL. Group 2: Serum creatine 2-5 mg/dL. Group 3: Serum creatine greater than 5 mg/dL. All 24 patients are randomized 1:1 to receive 1 of 2 study regimens: Arm A: Saquinavir SGC plus d4T plus 3TC. Arm B: Saquinavir SGC plus nelfinavir plus d4T. Patients are seen at Weeks 4, 8, 12, and 24. At Week 24, a kidney biopsy is performed with patient consent.

Official Title
-----------------
An Exploratory Study of Fortovase (Saquinavir) Soft Gelatin Capsules (SGC) Plus d4T and 3TC or Fortovase (Saquinavir) SGC Plus Nelfinavir and d4T in Patients With HIV-1 Associated Nephropathy

Conditions
-----------------
HIV Infections, AIDS-Associated Nephropathy

Intervention / Treatment
-----------------
* Drug: Nelfinavir mesylate
* Drug: Saquinavir
* Drug: Lamivudine
* Drug: Stavudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Detectable HIV-1 RNA by Amplicor assay. Biopsy-proven nephropathy. Exclusion Criteria Prior Medication: Excluded: Saquinavir and nelfinavir. d4T or 3TC within the past 4 months. Required: Stable antiretroviral therapy for more than 4 weeks.

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nelfinavir mesylate|nan|
|Drug: Saquinavir|nan|
|Drug: Lamivudine|nan|
|Drug: Stavudine|nan|

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
-----------------
Viral Load, Kidney Failure, Chronic, HIV-1, Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Lamivudine, Saquinavir, AIDS-Associated Nephropathy, Reverse Transcriptase Inhibitors, Nelfinavir
A Study To Compare the Effect of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 12-week clinical study is to evaluate the effect of vildagliptin 50mg qd, 50mg bid or 100mg qd compared to placebo in patients with type 2 diabetes.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 12 Weeks Treatment With Vildagliptin (50mg qd, 50mg Bid, 100mg qd) to Placebo in Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of type 2 diabetes Patients who have been placed on dietary therapy/exercise therapy without achievement of glycemic control Outpatients Exclusion Criteria: Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes Significant cardiovascular disease Significant diabetic complications Other protocol-defined inclusion/exclusion criteria may apply

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vildagliptin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on HbA1c at 12 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on fasting plasma glucose at 12 weeks |  |  | 
| Change from baseline on HOMA B at 12 weeks |  |  | 
| Change from baseline on HOMA IR at 12 weeks |  |  | 
| Change from baseline in body weight at 12 weeks |  |  | 
| Change from baseline on fasting lipids at 12 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, Vildagliptin, Hemoglobin A1c
Validation of a Dermatology-Specific Treatment Satisfaction Instrument

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to validate a dermatology-specific questionnaire that assesses patient satisfaction with their treatments across various inflammatory dermatology diseases.

Official Title
-----------------
Validation of a Dermatology-Specific Treatment Satisfaction Instrument

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Other: Dermatology-Specific Treatment Satisfaction Instrument


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (≥ 18 years) Psoriasis patients undergoing some form of treatment

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 |
| --- |
|Other: Dermatology-Specific Treatment Satisfaction Instrument|Study subjects will also be administered a dermatology-specific treatment satisfaction questionnaire, as well as other questionnaires including the generic validated Treatment Satisfaction Questionnaire for Medication (TSQM-9) and the validated Dermatology Life Quality Index (DLQI). Study participants will also self-report their disease severity using PGA. Depending on patients' preferred method of interacting with the study team, the investigators will collect their responses to these questionnaires either in-person, over the phone, or electronically via secure research platforms.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity and reliability of a dermatology-specific treatment satisfaction instrument in patients with psoriasis | For this survey study, the investigators will gather descriptive statistics for each item in the questionnaire. The investigators will also measure the following psychometric properties: measurement error, reliability and construct validity, as measured by convergent and known-groups validity | 8 months |
A Novel MSE Score to Predict rHCC Patients

Study Overview
=================
Brief Summary
-----------------
Develop and validate a novel scoring system based on pathological factors to predict the postoperative survival of patients with rHCC.Patients with rHCC who underwent hepatectomy were recruited from two hospitals.Exploring whether this scoring system is related to prognosis

Official Title
-----------------
A Novel MSE Score to Predict the Postoperative Prognosis of Patients With Ruptured Hepatocellular Carcinoma

Conditions
-----------------
HCC

Intervention / Treatment
-----------------
* Procedure: hepatectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a diagnosis of ruptured tumor confirmed by enhanced computed tomography (CT) and/or abdominal magnetic resonance imaging (MRI), a diagnosis of HCC made by two experienced pathologists Exclusion Criteria: extrahepatic HCC metastasis death within 1 month after surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Training cohort<br> | Procedure: hepatectomy<br> <br> |
| Validation cohort<br> | Procedure: hepatectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | Time from the first postoperative day to survival at the last follow-up | 2010-2022 |
Analysis of Sublingual Glycocalyx Damage at ICU Admission to Predict Risk of Death

Study Overview
=================
Brief Summary
-----------------
The aim of this observative, prospective study is to evaluate if and to what extent glycocalyx damage/microcirculation data at admission in the ICU as well as during ICU stay can be predictive of mortality and clinical course in patients presenting with the suspicion of sepsis/septic shock. Therefore, the enrollment of ca 100 ICU patients is planned.

Official Title
-----------------
Analysis of Sublingual Glycocalyx Damage at ICU Admission to Predict Risk of Death - the ASGARD Study

Conditions
-----------------
Sepsis, Septic Shock, Endothelial Dysfunction

Intervention / Treatment
-----------------
* Other: Endothelial Glycocalyx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU patients admitted to the ICU with the clinican suspicion of sepsis/septic shock. Exclusion Criteria: Underage persons, pregnant women, patients with inflammation or trauma of sublingual mucosa.

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<br>Patients admitted in the ICU with the clinical suspicion of infection/sepsis. | Other: Endothelial Glycocalyx<br>* Non-invasive assessment of endothelial glycocalyx dimensions.<br>|
| Non-sepsis Patients (control group)<br>Patients admitted in the ICU with other conditions apart from infection/sepsis. | Other: Endothelial Glycocalyx<br>* Non-invasive assessment of endothelial glycocalyx dimensions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of glycocalyx thickness regarding clinical course. | Glycocalyx thickness measured with the use of GlycoCheck System (Perfused Boundary Region - PBR, in µm). Clinical course will be estimated with the use of e.g. Sequential Organ Failure Assessment (SOFA) score (in points). | Hospital stay, an expected time of 4 weeks. | 
| Predictive value of glycocalyx thickness regarding mortality. | Glycocalyx thickness measured with the use of GlycoCheck System (Perfused Boundary Region - PBR, in µm). | Hospital stay, an expected time of 4 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of glycocalyx thickness with disease severity. | Glycocalyx thickness will be measured with the use of GlycoCheck System (Perfused Boundary Region - PBR, in μm). Disease severity will be assessed with ICU scores (e.g. SOFA Score - pts) | Hospital stay, an expected time of 4 weeks. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
perfused boundary region, PBR, Sepsis, endothelial glycocalyx, ICU
Mutation Analysis and Copy Number Changes of KRAS and BRAF Gene in Taiwanese Cases of Biliary Tact Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
Cholangiocarcinoma is a fatal malignant neoplasm originating from biliary tracts and constitutes about 5-10% of primary liver cancers, characterized by a poor prognosis. High prevalence in southeast and eastern Asia has been observed. At present, the cellular and molecular mechanisms leading to oncogenesis of cholangiocarcinoma remain unclear. The RAS gene product has a key role in controlling cell growth and differentiation through its intrinsic GTPase activity. Point mutations that activate the RAS protein and its downstream cascade have been observed in human tumors. Both KRAS and BRAF are members of the RAS-RAF-MEK-ERK-MAP kinase pathway which mediates cellular response to growth signals. Somatic KRAS mutations are found at high rates in leukemia, colon cancer, pancreatic cancer and lung cancer. Studies from European and Japanese groups have recently described that activating KRAS/ BRAF mutations may play a role in the carcinogenesis of cholangiocarcinoma of the biliary tracts, but our preliminary data demonstrated low frequency of KRAS and BRAF mutation in the same tumor as well as the results from Thailand. In this study, the investigators hypothesize copy number changes rather than genetic mutation of either KRAS or BRAF genes may be the key findings of Taiwanese cases of the adenocarcinoma from the biliary tracts.

Official Title
-----------------
Mutation Analysis and Copy Number Changes of KRAS and BRAF Gene in Taiwanese Cases of Biliary Tact Adenocarcinoma

Conditions
-----------------
Biliary Tract Adenocarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients diagnosed as biliary tact adenocarcinoma.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Lung Cancer

Study Overview
=================
Brief Summary
-----------------
platinum-based albumin-bound paclitaxel regimen in advanced non-small cell lung cancer (NSCLC) especially in lung squamous cell carcinoma has a better tumor response rate and safety than solvent-based paclitaxel.However, the safety and efficacy is uncertain in neoadjuvant therapy.

Detailed Description
-----------------
The main purpose of this study is to observe the safety and efficacy of platinum-based albumin-bound paclitaxel regimen in the treatment of non-small cell lung cancer (NSCLC) of stage Ⅱ B and IIIA .

Official Title
-----------------
Phase II Study of Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel Plus Carboplatin/Cisplatin in Stage Ⅱ B and IIIA Non-small Cell Lung Cancer Patients

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: nanoparticle albumin-bound paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Histological or cytological diagnosis of NSCLC of Stage Ⅱ B and IIIA . 2.18 years or older 3.Performance Status 0 to 2; 4.Appraisable disease; 5.patients can tolerant chemotherapy; 6.Total bilirubin 1.5 x upper limit of normal (ULN); 7.Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula). Exclusion Criteria: 1.Any systemic anticancer treatment for NSCLC；2.Local radiotherapy for NSCLC；3.In this study within five years prior to the start of treatment with other than NSCLC patients with other cancers.4.Any instability in systemic disease; 5.Allergic to paclitaxel or Platinum;6.Pregnant or lactating women;7.Other researchers believe that does not fit into the group

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: nanoparticle albumin-bound paclitaxel<br>Neoadjuvant chemotherapy of platinum-based nanoparticle albumin-bound paclitaxel in stage Ⅱ B and IIIA non-small cell lung cancer | Drug: nanoparticle albumin-bound paclitaxel<br>* Neoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel in stage Ⅱ B and IIIA non-small cell lung cancer<br>* Other names: nab-paclitaxel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response rate and Number of Adverse Events |  | From date of randomization until the date of progression, assessed up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival |  | From date of surgery until the date of first documented progression, assessed up to 36 months |
Qing'E Formula Therapy on Menopausal Symptoms (Healthy Volunteers Recruitment for Control Study)

Study Overview
=================
Brief Summary
-----------------
This study will recruit 50 healthy women with normal menstrual cycles aged 40-50, to investigate the expression of their NEI network and urine metabolomics.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women with normal menstrual cycles aged 40-50. The score of Kupperman index is less than 15. Not alcoholics or smokers (past or smoking). Get subjects informed consent process should comply with GCP requirements. Exclusion Criteria: Volunteers with heart, liver, kidney disease or acute or chronic gastrointestinal diseases, or with diseases of blood, endocrine, neurological and other systems. Volunteers are participating in other clinical trials within 3 months. Volunteers who donated blood or loosed blood heavily within 3 months. Volunteers with previous history of mental illness, drug abuse or drug dependence. Volunteers who took drugs within 14 days before the trail.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No drug intervention<br>The objective of this study is to investigate the expression of NEI network and urine metabolomics of healthy women with normal menstrual cycles. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The expression of NEI network and Urine metabolomics | The indices of NEI network include: Hypothalamic-pituitary-adrenal axis: CRH, ATCH, CORT Hypothalamic-pituitary-thyroid axis: TRH, T3, T4 Renin - angiotensin - aldosterone system: PRA, Ang2, ALD Sex hormones: E2, FSH Immune factors: TNF-α、IL-6、IL-1 Cardiovascular indicators: ET, NO, Hcy, Folic acid | 2-5 days after menstruation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy, normal menstrual cycles
Liver Transplantation and Uveal Malignant Melanoma

Study Overview
=================
Brief Summary
-----------------
Patients with uveal malignant melanoma with liver metastases have median survival of less than 12 months. There is no established treatment showing increased overall survival. The study will determine if liver transplantation will result in long term survival in patients with liver metastases from uveal malignant melanoma.

Official Title
-----------------
Open Non-randomized Study to Assess the Benefit of Liver Transplantation in Patients With Liver Metastasis After Ocular Malignant Melanoma (Uveal Melanoma)

Conditions
-----------------
Uveal Malignant Melanoma

Intervention / Treatment
-----------------
* Procedure: Liver transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Uveal malignant melanoma Liver metastases ECOG 0-1 Exclusion Criteria: Extra hepatic disease Previous other malignancy Previous organ transplantation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liver transplantation<br>The liver transplantation will be performed as described by the standard protocol, Liver Transplantation Protocol (Version 2006) at the Oslo University Hospital | Procedure: Liver transplantation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Over all survival | Patient survival after livertransplantation | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver transplantation, Overall survival