linjc16/ctgov huggingface dataset:
Study of Chemotherapy With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
To access the effectiveness of cyclophosphamide combined thiotepa and carboplatin chemotherapy combined with adoptive cellular therapy with dendritic and cytokine-induced killer cells in triple negative metastatic breast cancer patients

Detailed Description
-----------------
Metastatic breast cancer patients should be definitively diagnosis based on histopathology, with ER-negative and PR-negative, FISH testing for her-2-negative All the patients enrolled will be given standard cyclophosphamide combined thiotepa and carboplatin chemotherapy and cellular therapy.Cellular therapy consisting of one cycle of chemotherapy followed by an apheresis and ex vivo cultures to generate DC and CIK, followed by low-dose Oral Cyclophosphamide . The response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines. Estimate time to progression, survival rates and clinical benefit response on patients. Find biomarkers associated with drug response.

Official Title
-----------------
Study of Chemotherapy Combined With Adoptive Cellular Therapy With Dendritic and Cytokine-induced Killer Cells in Triple Negative Breast Cancer Patients

Conditions
-----------------
Breast Neoplasms, Neoplasm Metastasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Failure to anthracycline and/or taxol chemotherapy; metastatic tumor is histologically confirmed by immunohistochemical staining to be ER-negative and PR-negative. FISH testing for her-2-negative; Metastatic tumor can not be removed through surgery procedure; An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; Normal cardiac, hepatic, renal and bone marrow functions; Life expectancy ≥3 months. Exclusion Criteria: Central nervous system metastases; Serious or uncontrolled concurrent medical illness; History of other malignancies; Having been enrolled in some other clinal trials within a month;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| progression-free survival | progression-free survivalis measured from the date therapy is initiated to the date of documented disease progression or death | six months to two year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical benefit response and overall survival | clinical benefit response include complete release(CR), partial release (PR), stable disease (SD). | six months to two year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast neoplasm, Neoplasm Metastasis, Drug Therapy
High-fidelity Simulation in Health Care Education

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the use of high-fidelity simulation in health care education is an effective training and evaluation model.

Detailed Description
-----------------
High-fidelity simulation has many advantages in medical education. Simulation-based critical care training is especially valuable due to error-prone work settings and the high cost of patient adverse events. This study was conducted to assess the effectiveness of implementing the high-fidelity simulation in critical care training, and the feasibility of high-fidelity simulation as an evaluation tool.

Official Title
-----------------
Prospective Study Focusing on Impact of High-fidelity Simulation in Health Care Education

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

Intervention / Treatment
-----------------
* Device: High-fidelity high-fidelity mannequin simulator (SimMan, Laerdal, Stavanger, Norway).


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthcare trainees, including medical students, nursing students, residents, nursing staff and emergency medical technicians. Exclusion Criteria: any trainees unwilling to receive simulation-based training

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: simulation group<br>the trainees in the simulation group receive simulation-based training | Device: High-fidelity high-fidelity mannequin simulator (SimMan, Laerdal, Stavanger, Norway).<br>* Critical care training using high-fidelity simulation. The case scenarios were simulated by a high-fidelity mannequin simulator (SimMan, Laerdal, Stavanger, Norway).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| performance of clinical reasoning and skills in simulated settings |  | before and after the simulation-based training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical performance of reasoning and skills |  | before and after the simulation-based training | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
simulation, medical education, performance of clinical reasoning and skills
Bioavailability of Prochlorperazine Suppositories, 25 mg

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare prochlorperazine plasma concentrations produced after administration of the test formulation with those produced after administration of a marketed reference product.

Official Title
-----------------
Bioavailability of Prochlorperazine Suppositories, 25 mg

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

Intervention / Treatment
-----------------
* Drug: Prochlorperazine suppositories, 25mg
* Drug: Compazine® suppositories, 25mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening Exclusion Criteria: Positive test results for HIV or Hepatitis B or C History of allergy or sensitivity to Prochlorperazine or related drugs

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prochlorperazine suppositories, 25mg<br> | Drug: Prochlorperazine suppositories, 25mg<br> <br> |
| Active Comparator: Compazine® suppositories, 25mg<br> | Drug: Compazine® suppositories, 25mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence according to US FDA guidelines |  |  |
The Life Experience of Young Women (Age 18-38) Who Live With Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
This research will focus on young women between the ages of 18-38 who underwent a heart operation and their life experiences. This research will focus on these life events and the paradigm of these women being raised as heart sick, and consequently lacking self-esteem (Frigiola, Bull, & Wray, 2014; Hickey et al., 2012). Most qualitative studies focusing on the quality of life compare men and women, completely ignoring women's body image and the experience of womanhood (Hickey et al., 2012; Hövels-Gürich et al., 2007; Sarikouch, et al., 2013). This study aims to focus on women's stories about their life experiences and the influence of surgery(ies) on their daily life using an the qualitative phenomenological approach.

Official Title
-----------------
The Life Experience of Young Women (Age 18-38) Who Live With Congenital Heart Disease

Conditions
-----------------
Women With Congenital Heart Diseases

Intervention / Treatment
-----------------
* Other: Observation and Interviwe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Atrial septal defect or ASD, Ventricle septal defect or VSD, Tetralogy of Fallot or TOF Translocation of great arteries or TGA underwent heart operation Hebrew speakers that are able to understand the meanings of the questions and tell their life stories. Exclusion Criteria: Non Hebrew speakers Did not underwent heart surgery.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observation and Interviwe|The research data will be conducted by using a semi structured interview of the participants in the study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interview about the life experience of young women (age 18-38) who live with congenital heart disease and overwent an open heart operation. |  | 1day, at the time of the interview |
Shunt Evaluation With ALPE System in Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
. The aim of this study, thus, is to evaluate shunt fraction and markers of alveolar distress during one lung ventilation (OLV) at different levels of positive end expiratory pressure (PEEP). Moreover, investigators will focus on predicting factors of high shunt levels during OLV.

Conditions
-----------------
Mechanical Ventilation, Thoracic Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for thoracoscopic lobectomy or thoracoscopic wedge resection in lateral decubitus. patients American Society of Anesthesiologists Physical Status Classiﬁcation score of 1-3 Exclusion Criteria: Patients with hemodynamic instability, Patients with severe chronic respiratory failure Patients with preoperative anemia (hemoglobin <10 g 100 ml-1) Patients requiring unplanned conversion to thoracotomy

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 |
| --- | --- |
| Low shunt group<br>patients with shunt less than 30% in one-lung ventilation at ZEEP | |
| High shunt group<br>Patients with shunt equal or more than 30% in one-lung ventilation at ZEEP | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary shunt evaluated with ALPE system |  | every 30 minutes after the start of surgery up to 3 evaluations, up to 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| predictors of high intraoperative shunt | All patients admitted to the study received a preoperative physiologic assessment with a cardiovascular evaluation and spirometry. After 15 minutes of one lung ventilation, the pulmonary shunt is evaluated. Therefore, all clinical variable evaluated during preoperative assessment will be compared with the pulmonary shunt | The outcome is assessed 15 minutes after one lung ventilation |
Long-term Follow-up of Study Participant Treated With Lentiviral-Based Genetically Modified Autologous Cell Product ,AGT103-T

Study Overview
=================
Brief Summary
-----------------
Long-term follow-up of study subjects who received AGT103-T product in HIV study. The AGT103-T is genetically modified cells that resist infection with HIV causing a depletion of HIV in HIV-infected study participants.

Detailed Description
-----------------
The primary objective of this study is to monitor study participant who receive the genetically modified gag specific CD4 T cells for the long term adverse event, evaluate sustained impact on immunity and the persistence of vector modified CD4 T cells.

Official Title
-----------------
A Long-Term Follow-Up Study of Participants Treated With the Lentiviral-Based Genetically Modified, Autologous Cell Product, AGT103-T

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Biological: Gene modified therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received the investigational product, AGT103-T, in the AGT-sponsored AGT-HC168 clinical trial Provided written informed consent, signed and dated by the study participant in the long-term follow-up study Exclusion Criteria: 1. Did not receive the investigational product, AGT103-T

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 |
| --- |
|Biological: Gene modified therapy|No investigational cell product will be administered|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the incidence of delayed adverse events (AE) to gene therapy | The presence of malignancies, incidence or exacerbation of pre-existing neurologic disorder, new incidence or exacerbation of a prior rheumatologic or other autoimmune disorder, the new incidence of a hematologic disorder post infusion with AGT103T | 1year to 15years post infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The persistence and the immunity impact of the vector-modified T cells | Evaluate sustained impact on immunity measured by CD4 T cell responses to Gag peptides Measure proportion of participants with absence of replication competent lentivirus (RCL) Measure persistence of vector-modified cells (transgene copies per CD4 T cell) | 1year to 15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Long term follow-up, Genetically modified CD4 T cells, Gene Therapy, Lentivirus vector
A Phase 3 Study of OPC-262 in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety of OPC-262 administered orally in combination with another oral antihyperglycemic agent

Official Title
-----------------
Long-term Co-administration Study of OPC-262 in Patients With Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: OPC-262


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) Patients who are capable of giving informed consent 2) Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner Exclusion Criteria: Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 20 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: OPC-262<br> | Drug: OPC-262<br>* Oral administration of tablets for 52 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, clinical laboratory tests |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcome HbA1c |  | 52 weeks |
Isolated Oligohydramnios Less Favorable Delivery and Neonatal Outcomes

Study Overview
=================
Brief Summary
-----------------
Oligohydramnios happens in 1-5% of term pregnancies. The clinical significance of isolated oligohydramnios been a matter of debate. We aimed in this study to investigate the impact of isolated oligohydramnios on the mode of delivery and risk of adverse perinatal outcome.

Detailed Description
-----------------
Retrospective study conducted in Armed Forces Hospitals of Southern Region, comparing cases with oligohydramnios (amniotic fluid level index <5) to normal amniotic fluid cases (amniotic fluid level index ≥ 8). Primary outcomes are the mode of delivery and adverse perinatal outcomes (including mortality, NICU admission, low Apgar score and sepsis)

Official Title
-----------------
Isolated Oligohydramnios is Associated With Less Favorable Delivery and Composite Neonatal Outcomes

Conditions
-----------------
Oligohydramnios, Delivered

Intervention / Treatment
-----------------
* Behavioral: observation of delivery and neonatal outcomes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Third trimester pregnancy Isolated oligohydramnios Exclusion Criteria: Multiple pregnancy less than 32 weeks medical disorders like DM HPN Fetal jeopardy

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Isolated oligohydramnios group<br>Cases with oligohydramnios (amniotic fluid index less than 5) without an overt underlying reason in the third trimester | Behavioral: observation of delivery and neonatal outcomes<br>* MONITORING THE DELIVERY MODE EITHER CESAREAN OR VAGINAL, BESIDE THE NEONATAL OUTCOME AND MORBIDITIES IN BOTH GROUPS<br>|
| Normal amniotic fluid group<br>Normal pregnancy cases with normal amniotic fluid index | Behavioral: observation of delivery and neonatal outcomes<br>* MONITORING THE DELIVERY MODE EITHER CESAREAN OR VAGINAL, BESIDE THE NEONATAL OUTCOME AND MORBIDITIES IN BOTH GROUPS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery mode | Either vaginal delivery or cesarean section | through study completion, an average of 1 year | 
| Composite neonatal outcomes | Risk of low Apgar score, transient tachypnea of newborn, ICU admission, etc | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction of labor rate | Comparing incidence of labor induction between both groups and between gestational age groups | through study completion, an average of 1 year |
Nutrition Status, BMD, and SSRIs

Study Overview
=================
Brief Summary
-----------------
The association between selective serotonin reuptake inhibitor (SSRI) use and bone mass density (BMD) has been debated. Some have suggested features of depression, which SSRIs are prescribed to treat, may be a cause of decreased BMD, such as poor overall food intake at the time of SSRI use. Our study seeks to determine whether SSRI use in adults is associated with lower than average BMD, and if there is an association between low micronutrient intake, SSRI use, and a low BMD.

Official Title
-----------------
Nutrition Status, Bone Mass Density, and Selective Serotonin Reuptake Inhibitors

Conditions
-----------------
BMD

Intervention / Treatment
-----------------
* Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Included adult NHANES participants are those who participated in the Dual-Energy X-ray Absorptiometry (DXA) femur-neck BMD test and responded in full to the demographic, pharmaceutical, and dietary surveys. Exclusion Criteria: Pregnancy, incomplete survey responses, incomplete DXA results

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

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 |
| --- | --- |
| SSRI long-term user<br>Adults, 655 with an SSRI prescription ≥180 days and identified in the National Health and Nutrition Examination Survey (NHANES) data. | Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA)<br>* BMD t-score derived from DXA scan<br>|
| Non-user<br>Adults, 12,372 non-users, were identified in the National Health and Nutrition Examination Survey (NHANES) data. | Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA)<br>* BMD t-score derived from DXA scan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMD t-score |  | NHANES DXA measurement taken 2005-2014 |