linjc16/ctgov huggingface dataset:
Autologous TAC T Cells Targeting CD19 in R/R Large B-Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
Phase I/II study to evaluate TAC01-CD19 in subjects with relapsed or refractory B-cell lymphomas. TAC technology is a novel way to genetically modify T cells and to redirect these T cells to target cancer antigens by co-opting the natural T cell receptor. The dose finding portion of this study will evaluate the safety and tolerability of increasing dose levels of TAC01-CD19 to identify a Maximal Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D). The dose expansion portion of the study will further evaluate the safety, efficacy and pharmacokinetics of TAC01-CD19 at the RP2D.

Official Title
-----------------
A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC T Cells Targeting CD19 in Relapsed or Refractory Large B-Cell Lymphoma

Conditions
-----------------
Lymphoma, B-Cell

Intervention / Treatment
-----------------
* Biological: TAC01-CD19


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed CD19+ Large B-Cell Lymphoma including Diffuse Large B-cell Lymphoma (DLBCL) not otherwise specified (including de novo and transformed lymphoma), Primary Mediastinal Large B-cell Lymphoma, High-Grade B-cell Lymphoma with MYC and BCL2 and/or BCL6 rearrangement per WHO 2016 classification. Relapsed or refractory disease after greater than 2 lines of therapy including anthracycline and anti-CD20 therapy and either having failed autologous stem cell transplant (ASCT) or being ineligible for ASCT. ECOG 0-1. Adequate organ function. Exclusion Criteria: Prior treatment with any of the following: allogeneic bone marrow transplantation, gene therapy, adoptive cell transfer of any kind, including CAR T cells. Active central nervous system (CNS) lymphoma involvement. History or presence of clinically relevant CNS pathology. Active inflammatory neurological disorders, autoimmune disease, or infections.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAC01-CD19<br>TAC01-CD19, Autologous TAC (T cell antigen coupler) T cells, single infusion, multiple dosage levels. | Biological: TAC01-CD19<br>* Dose-escalating cohorts plus expansion groups<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dose-limiting toxicities (DLTs) | Measurement of occurrence of study-defined DLTs | First 28 days after dosing | 
| Incidence of adverse events (AEs) | Type, frequency, and severity of adverse events (AEs) and laboratory abnormalities | Informed consent through 2 years after dosing |
Randomized Controlled Trial of TCRFVR and LAUP in Snorers

Study Overview
=================
Brief Summary
-----------------
We hypothesis that radiofrequency will cause less post-operative discomfort when compared with laser assited uvulopharyngoplasty. 40 patients with primary snore will be enrolled into this study. After overnight sleep test confimred that no obstructive sleep apnea existed, cases were informed consented. Then they were randomized into two groups. Post-operative pain, duration of analgesics were recorded.

Detailed Description
-----------------
Although Rf group was less effective, they felt less discomfort.

Official Title
-----------------
Comparison of Clinical Effect Between Temperature-Controlled Radio-Frequency Uvuloplasty and Laser Assisted Uvulo-Pharyngoplasty in Patients Who Snore

Conditions
-----------------
Snorer

Intervention / Treatment
-----------------
* Procedure: TCRFVR and LAUP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: RDI < 5/h Exclusion Criteria: Previous treated snoring, coagulation disorder

Ages Eligible for Study
-----------------
Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: TCRFVR and LAUP|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LAUP is more effective in eliminating snoring |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| However, Rf cause less post-operative discomfort |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TCRFVR, LAUP, Snorer
A Training Set for the HRD Model in EOC

Study Overview
=================
Brief Summary
-----------------
A homologous recombination deficiency (HRD) scoring model based on loss of heterozygosity (LOH) is little explored in epithelial ovarian cancer (EOC) patients. This study would recruit 200 Chinese EOC patients with known BRCA1/2 mutation status and resistance to platinum-based chemotherapy. A LOH-HRD model is to be constructed based on the genetic testing in these patients. The mutated genes, HRD score model and their relationship with the prognosis, would provide a full description of for the Chinese EOC patients, and a potential explanation of platinum-resistance in such population.

Official Title
-----------------
A Training Set for the Homologous Recombination Deficiency Scoring Model With Loss of Heterozygosity Status in Epithelial Ovarian Cancer

Conditions
-----------------
Epithelial Ovarian Cancer, BRCA Mutation, Loss of Heterozygosity, Prognosis, Platinum Resistance, Homologous Recombination Deficiency

Intervention / Treatment
-----------------
* Genetic: Homologous recombination deficiency model


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years or older Pathological confirmation of epithelial ovarian cancer With available tumor tissues Given consents to participate the study Exclusion Criteria: • Not meeting all of the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Epithelial ovarian cancer patients sensitive to platinum based chemotherapy<br> | Genetic: Homologous recombination deficiency model<br>* A homologous recombination deficiency (HRD) scoring model based on loss of heterozygosity (LOH)<br>|
| Epithelial ovarian cancer patients resistant to platinum based chemotherapy<br> | Genetic: Homologous recombination deficiency model<br>* A homologous recombination deficiency (HRD) scoring model based on loss of heterozygosity (LOH)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homologous recombination deficiency (HRD) score | The HRD score for individual patient is a scale describing her HRD status. The score model is calculated by the analysis for loss of heterozygosity (LOH), and the minimum value is 0, but the maximun value is not available. Higher scores mean more sensitivity to poly-ADP-ribose polymerase inhibitor | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Progression-free survival in recruited patients | Five years | 
| Overall survival | Overall survival in recruited patients | Five years |
Study Evaluating DVS-233 in Adult Outpatients With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
Primary: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo. Secondary: To assess the response of subjects receiving DVS-233 SR for the clinical global evaluation, functionality, general well-being, pain, and remission (Hamilton Psychiatric Rating Scale for Depression, 17-item [HAM-D<sub>17</sub>] < 7) versus those subjects receiving placebo.

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of a Flexible Dose of DVS-233 SR in Adult Outpatients With Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: DVS-233 SR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have a primary diagnosis of major depressive disorder (MDD) Depressive symptoms for at least 30 days prior to the screening visit Minimum screening and study day -1 (baseline) scores of 20 on the Hamilton Psychiatric Rating Scale for Depression (HAM D<sub>17</sub>) Exclusion Criteria: Treatment with DVS-233 SR at any time in the past Treatment with venlafaxine (immediate release [IR] or extended release [ER]) within 90 days of study day 1 Known hypersensitivity to venlafaxine (IR or ER)

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DVS-233 SR|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
-----------------
Depressive Disorder, Major, Depression, Involutional
Trial of Pemetrexed in Combined With Cisplatin for the Treatment of Advanced Breast Cancer

Study Overview
=================
Brief Summary
-----------------
For patients resistant to enthrycycline and taxanes, there is no standard regimen. Pemetrexed alone had certain efficacy in treatment of advance breast cancer. Platin was also a effective drug for advanced breast cancer. The combination of these two drug may have a synergy with each other in treatment of advanced breast cancer.

Detailed Description
-----------------
combination of pemetrexed and cisplatin to treat advanced breast cancer. Previous regimen no more than 3 which including enthrycycline and taxanes(paclitaxel and/or docetaxel)

Official Title
-----------------
Trial of Pemetrexed in Combined With Cisplatin for the Treatment of Advanced Breast Cancer

Conditions
-----------------
Locally Advanced Malignant Neoplasm

Intervention / Treatment
-----------------
* Drug: pemetrexed plus cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-70 years old Resistant to enthracycle and taxanes Has measurable disease Exclusion Criteria: Has more than 3 previous chemotherapy regimens

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: PC Regimen<br> | Drug: pemetrexed plus cisplatin<br>* pemetrexed 500mg/m2 plus cisplatin 80mg/m2 on day1 of each 21 day cycle, until progression<br>* Other names: Alimta;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS (progression free survival) |  | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Assessing for Hematology and Non-hematology toxicities, including all SAEs. | 2 years | 
| Response Rate |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
progress free survival, response rate, safety
A Study in People With Abnormal Fat Levels in the Blood

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to determine: The safety of the study medication and any side effects that might be associated with it; Whether the study medication can help patients with low levels of 'good' cholesterol (HDL-C) and high blood fats or triglycerides (TG); How much of the study medication should be given to patients; How the study medication compares to fenofibrate (Lofibra), a drug used for people with low levels of HDL-C and high levels of TG.

Official Title
-----------------
PPAR Alpha: A Phase 2 Dose-Finding and Safety Study for Atherogenic Dyslipidemia by Eli Lilly

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Drug: PPAR alpha
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women between 18 and 80 years of age People with abnormal fat levels in the blood (low HDL, high TG) Exclusion Criteria: People with diabetes People whose blood pressure is greater than 160/95 mm Hg, on or off blood pressure medicine People who have had frequent chest pain or unstable angina, a heart attack or a heart procedure, including stent placement, within the past 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PPAR alpha|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on HDL-C and Triglycerides after 12 weeks |  |  | 
| Safety after 12 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on LDL-C after 12 weeks |  |  | 
| Effects on biomarkers of atherosclerosis after 12 weeks |  |  | 
| Effects on factors of metabolic syndrome after 12 weeks |  |  |
Nexium Capsules RE Maintenance Specific Clinical Experience Investigation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect following data in patients given Nexium capsule (Nexium) in usual post-marketing use as the maintenance therapy for repeatedly recurring/relapsing reflux oesophagitis.

Detailed Description
-----------------
Nexium capsules Specific Clinical Experience Investigation for Maintenance Therapy for Repeatedly Recurring/Relapsing Reflux Oesophagitis

Official Title
-----------------
Nexium Capsules Specific Clinical Experience Investigation for Maintenance Therapy for Repeatedly Recurring/Relapsing Reflux Oesophagitis

Conditions
-----------------
Repeatedly Recurring Esophagitis, Relapsing Reflux Esophagitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with repeatedly recurring/relapsing reflux oesophagitis who will be given Nexium for the first time as a maintenance therapy. Exclusion Criteria: Patients having reflux oesophagitis when Nexium is started (Grade A, Grade B, Grade C or Grade D of Los Angeles Classification (Hoshihara's modification) on endoscopy) Patients having previous history of maintenance therapy for repeatedly recurring/ relapsing reflux oesophagitis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nexium<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Drug Reactions | Adverse event incidence | 6 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-recurrence rate of reflux oesophagitis |  | 6 Month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
maintenance therapy,, repeatedly recurring,, relapsing reflux oesophagitis,, Nexium
Comparing Health Services Interventions for the Prevention of HPV-related Cancer

Study Overview
=================
Brief Summary
-----------------
The study aims to identify global and local determinants of HPV vaccine acceptability, HPV vaccine uptake and compliance as well as identify logistics and programmatic issues in each country to offer the HPV vaccine, as a potential cervical cancer prevention strategy, to mid-aged women attending screening.

Detailed Description
-----------------
3000 women aged within the age range of 25-45 years old will be recruited; 250-300 women per country. These women will be identified by means of screening registry lists or screening clinical visits. Eligible women will receive a study questionnaire on the HPV vaccine. Additionally, and independently of participating in the study questionnaire, those who accept will get 3 HPV vaccine doses. Depending on country preferences, either Cervarix® (Glaxosmithkline Biologicals, S.A.) at month 0, 1 and 6 or Gardasil® (Sanofi Pasteur MSD SNC) at month 0, 2 and 6, will be administered. Safety data and HPV vaccine compliance will be assessed. A sub study in Spain will also analyze acceptability of HPV vaccination in a sample of women aged 35-40 yrs identified as poor screening attenders. Two independent informed consent forms will be provided; one for the study questionnaire participation and another for HPV vaccine administration.

Official Title
-----------------
Work Package 4: HPV Vaccination of Women in Screening Ages

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Other: questionnaire
* Biological: Gardasil vaccine
* Biological: Cervarix®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women within the age range of 25-45 attending cervical cancer screening Exclusion Criteria: previous history of HPV vaccine administration

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: women attending for cervical cancer screening<br> | Other: questionnaire<br> <br> Biological: Gardasil vaccine<br> <br> Biological: Cervarix®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of vaccinated patients |  | up to 3 years |
Haemodynamic Changes During Robotic Prostatectomy

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to analyse the haemodynamic and ventilatory changes in patients undergoing robotic prostatectomy, compared to standard laparoscopic prostatectomy.

Detailed Description
-----------------
Prostatectomy is a standard operation, increasingly performed using robotic assistance. During robotic assisted procedures, the intraabdominal pressures are usually higher than in standard laparoscopic operations which can pose a risk of cardiovascular and respiratory adverse effects. The aim of this study is to investigate the haemodynamic and ventilatory effects of robotic assisted prostatectomy, compared to standard laparoscopic prostatectomy.

Official Title
-----------------
Analysis of Haemodynamic Parameters of Patients Undergoing Robotic Prostatectomy

Conditions
-----------------
Robotic Surgical Procedures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing prostatectomy in University Hospital in Motol between 1st December 2019 and 30th April 2020 Exclusion Criteria: body mass index over 35 regular use of beta-blocking drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Robotic prostatectomy<br>All patients undergoing robotic assisted prostatectomy in University Hospital in Motol during the project period. Monitored using standard non-invasive monitoring. | |
| Laparoscopic prostatectomy<br>All patients undergoing standard laparoscopic prostatectomy in University Hospital in Motol during the project period. Monitored using standard non-invasive monitoring. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemodynamic changes | Changes in mean arterial pressure. | Through study completion, an average of 1 year | 
| Ventilatory changes | Changes in peak airway pressure and mean airway pressure. | Through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ventilatory changes, robotic surgical procedures, laparoscopic surgical procedures, prostatectomy, haemodynamic changes