linjc16/ctgov huggingface dataset:
Pilot Community Clinical Study of Hypothermia in Cardiac Arrest

Study Overview
=================
Brief Summary
-----------------
The overall goal of this study is to determine the feasibility of initiating hypothermia in cardiac arrest patients as soon as possible in the field. In this pilot study we will randomize 125 patients after return of spontaneous circulation (ROSC) to hypothermia with rapid infusion of 2 liters of 4oC Normal Saline IV solution over 20 to 30 minutes, IV sedation and muscle paralysis or to standard of care following ROSC. The primary objectives of this study will be to determine whether temperature of 33-34oC can be achieved and maintained using this strategy. The primary outcome measures will include: temperature changes of the patients at time of admission to the hospital. Secondary analysis will include determining if the proportion of patients discharged from the hospital is increased in the group receiving hypothermia. If this initial pilot study can demonstrate feasibility in achieving and maintaining hypothermia, a larger randomized clinical trial to test the hypothesis that hypothermia initiation in the field will increase the proportion of patients surviving following cardiac arrest will be planned.

Official Title
-----------------
Pilot Community Clinical Study of Hypothermia in Cardiac Arrest

Conditions
-----------------
Cardiac Arrest

Intervention / Treatment
-----------------
* Drug: Up to 2 liter infusion of cold 4 degree C normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resuscitated out-of-hospital cardiac arrest defined as having a palpable pulse comatose IV access Intubated Exclusion Criteria: age less than 18 traumatic cause of cardiac arrest

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: Cold fluid<br> | Drug: Up to 2 liter infusion of cold 4 degree C normal saline<br>* Patients randomized to field cooling will receive up to 2 liters of 4oC normal saline. Control patients will receive standard of care following resuscitation.<br>|
| No Intervention: control, standard of care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature difference between first field temperature and hospital arrival temperature |  | less than 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival to discharge from hospital |  | Between 2 -30 days | 
| Awakening in the hospital |  | between 2-30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Arrest, Hypothermia
A Study to Determine the Safety and Tolerability of Herceptin as an Adjuvant Therapy of Early Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This was an open-labeled, multi-center, prospective, non-comparative study of the safety of Herceptin (trastuzumab) used as an adjuvant therapy in patients with early breast cancer who had previously received antracycline therapy before or after surgery.

Conditions
-----------------
Breast Cancer, Early Breast Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients > or = 18 years of age Human Epidermal Growth Factor Receptor 2 (HER2)-neu overexpression Previously treated with adjuvant antracycline containing chemotherapy Left Ventricular Ejection Fraction (LVEF) > 50% Eastern Cooperative Oncology Group (ECOG) score < or = 2 Life expectancy > or = 12 weeks Exclusion Criteria: Left Ventricular Ejection Fraction (LVEF) < 50% Advanced pulmonary disease Severe dyspnea Abnormal laboratory results within 14 days prior to registration Peripheral neuropathy Presence of Central Nervous System (CNS) metastasis

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 |
| --- | --- |
| HER2-positive early breast cancer<br>Human Epidermal Growth Factor Receptor 2 (HER2)-positive early breast cancer treated with loading dose of Herceptin (trastuzumab) administered as 6 mg/kg followed by once in 3 weeks administration at 4 mg/kg up to 12 months of treatment | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with adverse events |  | Up to 3 years | 
| Percentage of participants with serious adverse events |  | Up to 3 years |
D2 Dopamine Receptor Occupancy After Oral Dosing of Lu AF35700 in Healthy Men Using [11C]-PHNO as Tracer Compound

Study Overview
=================
Brief Summary
-----------------
To investigate the relationship between the combined Lu AF35700 and Lu AF36152 plasma concentration and D2 dopamine receptor occupancy up to 172 hours after oral dosing of Lu AF35700

Official Title
-----------------
Interventional, Open-label, Positron Emission Tomography (PET) Study Investigating D2 Dopamine Receptor Occupancy After Oral Dosing of Lu AF35700 in Healthy Men Using [11C]-PHNO as Tracer Compound

Conditions
-----------------
Healthy Men

Intervention / Treatment
-----------------
* Drug: Part A: Lu AF35700
* Drug: Part B: Lu AF35700


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy young men >=25 and <=45 years of age with a Body Mass Index (BMI) >=18.5 kg/m2 and <=30 kg/m2. Other protocol-defined Inclusion and Exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: Lu AF35700<br> | Drug: Part A: Lu AF35700<br>* One 30 mg single dose for one day; orally<br>|
| Experimental: Part B: Lu AF35700<br> | Drug: Part B: Lu AF35700<br>* Daily dosing: 10 mg for 3 days, 20 mg for 3 days, 45 mg on Day 7; orally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between plasma concentrations and pharmacodynamic (PD) measures specified as binding potential at each scanning time point |  | Up to 172 hours after dosing | 
| Relationship between plasma concentrations and PD measures specified as plasma concentrations of Lu AF35700, Lu AF36152 and Lu AF35700 + Lu AF36152 at each scanning time point |  | Up to 172 hours after dosing | 
| Relationship between plasma concentrations and PD measures specified as occupancy in relation to plasma concentrations of Lu AF35700, Lu AF36152 and Lu AF35700 + Lu AF36152, respectively |  | Up to 172 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | Up to Week 12 | 
| Columbia Suicide Severity Rating Scale (C-SSRS) (Part B only) |  | Up to Week 12 | 
| Area under the curve (AUC), maximum observed concentration (Cmax), oral clearance (CL/F), and apparent elimination half-life (t½) |  | Up to 168 hours after dosing |
Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT

Study Overview
=================
Brief Summary
-----------------
This is a single arm, open-label, multi-center, phase 1-2a study to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose and the safety of CARCIK-CD19 in adult and pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Official Title
-----------------
Phase 1-2a Trial to Determine the Feasibility and Safety of a Single Dose of Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Adult and Pediatric Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, After Hematopoietic Stem Cell Transplantation

Conditions
-----------------
Acute Lymphoblastic Leukemia, in Relapse

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children (1-17) and adults (18-75 years old); Relapsed or refractory adult and pediatric B-cell precursor ALL after HSCT; Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry; Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening; No evidence of overall aGVHD > Grade I or chronic GVHD (cGVHD) greater than mild at time of enrollment and in the previous 30 days; No longer taking immunosuppressive agents for at least 30 days prior to enrollment; Exclusion Criteria: Patients with GVHD Grades II-IV; Any cell therapy in the last 30 days;

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CARCIK-CD19<br> | Biological: CARCIK-CD19<br>* Allogeneic (donor-derived) Cytokine Induced Killer (CIK) cells transduced with a transposon CD19 Chimeric Antigen Receptor (CAR) gene<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose Limiting Toxicities (DLT): | rate and severity of the cytokine release syndrome (CRS) | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Lymphoblastic Leukemia, CAR-T, CARCIK, Transposon
Accuracy of eDiagEPU, a Medical Computerized Tool for EPU

Study Overview
=================
Brief Summary
-----------------
In a recently published study, a poor knowledge of guidelines in the field of early pregnancy was observed in France, Belgium and Switzerland. To improve the respect of the most recent criteria of diagnoses, a computerized tool was developped.

Detailed Description
-----------------
In December 2018, the investigators published an prospective multinational survey, with 17 questions that assessed the participants' knowledge, interest, and management of early pregnancy in France, Belgium and Switzerland1. Knowledge about early management of pregnancy was limited among the practitioners surveyed ; 211/306 (69.0%) participants reported incorrect management when they visualized a gestational sac without embryo and 265/306 (86.6%) misinterpreted changes in serum levels of chorionic gonadotropin during early pregnancy. To fill this gap, the investigators developped a computerized tool who is following strictly the most recent criteria of diagnoses in the field of early pregnancy. This tool should be evaluated in an observational study, using data of real patients without modification of their management.

Official Title
-----------------
eDiagEPU, a Computerized Help to Diagnosis for Early Pregnancy Unit : a Retrospective Study

Conditions
-----------------
Pregnant Women Less Than 14 Weeks of Gestation

Intervention / Treatment
-----------------
* Other: Help to diagnosis software


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Pregnancy of unknown location (hCG + without gestational sac found in ultrasound) Viable pregnancy with embryo less than 14 weeks of gestation Non-viable pregnancy ; ectopic pregnancy, complete, incomplete or missed miscarriage Exclusion criteria: - Incomplete follow up and no diagnosis and lack of data to establish a diagnosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Patients attending the Obstetrical Emergency Unit<br>Patients attending the Obstetrical Emergency Unit of CHU Montpellier during 2018 | Other: Help to diagnosis software<br>* Help to diagnosis software<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tyde of Medical diagnosis (senior physician) | Medical diagnosis retained by senior physician at the end of the management of the patient | 1 week | 
| tyde of Medical diagnosis (diagnosis tool) | Medical diagnosis proposed by the diagnosis tool | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Viable pregnancy, miscarriage, ectopic pregnancy, early pregnancy
Skin Sparing Mastectomy and Immediate Breast Reconstruction With Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy (M-RIC)

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the feasibility and morbidity of skin sparing mastectomy and immediate breast reconstruction with latissimus dorsi flap after neoadjuvant chemotherapy and radiotherapy in invasive breast carcinoma.

Official Title
-----------------
Phase II Study: Assessing the Feasibility and Morbidity of Skin Sparing Mastectomy and Immediate Breast Reconstruction With Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy in Invasive Breast Carcinoma.

Conditions
-----------------
Breast Carcinoma

Intervention / Treatment
-----------------
* Procedure: Mastectomy, preservation of the skin envelope,followed by immediate reconstruction with autologous latissimus dorsi flap.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women < 75 year old Invasive breast carcinoma, indication for mastectomy Women Health Organization (WHO) score of 0 and 1, primary chemotherapy, external radiotherapy performed less than 8 week earlier... Exclusion Criteria: Women older than 75 Metastatic breast carcinoma Antecedents of previously treated homolateral breast carcinoma Documented cancer progression Smoker at the moment of the indication surgery Known diabetes, neoadjuvant hormonal treatment...

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Mastectomy, preservation of the skin envelope,followed by immediate reconstruction with autologous latissimus dorsi flap.|Mastectomy, preservation of the skin envelope, removal of the nipple-areolar complex and dissection of the axillary lymph nodes followed by immediate reconstruction with autologous latissimus dorsi flap with or without prosthesis.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of skin necrosis | To evaluate the incidence of skin necrosis in case of treatment with skin sparing mastectomy and immediate breas reconstruction with latissimus dorsi myocutaneous flap after neoadjuvant chemotherapy and radiotherapy. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of histological remission of the surgical specimen based on the anatomopathological examination |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Invasive breast carcinoma
Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan

Study Overview
=================
Brief Summary
-----------------
To provide continued treatment to Pulmonary Arterial Hypertension (PAH) patients who are benefitting from treatment with QTI571.

Detailed Description
-----------------
This was a multi-center open label study to provide continued supply of QTI571 to patients in Japan who were treated in the extension study (A2301E1) and were judged by the investigator to benefit from continued QTI571 treatment.

Official Title
-----------------
An Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan and Are Judged by the Investigator to Benefit From Continued QTI571 Treatment

Conditions
-----------------
Severe Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: QTI571


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient is receiving QTI571 for the treatment of Pulmonary Arterial Hypertension (PAH) and is currectly enrolled in a long-term extension study (CQTI571A2301E1) in Japan. Patient is currently benifitting form the treatment with QTI571 in the opinion of the investigator. Exclusion Criteria: Patient has been permanently discontinued from QTI571 study treatment in the parent study. Concomitant use of oral vitamin K antagonist medication.

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
Interventional Model Description: This was a multi-center open label study to provide continued supply of QTI571 to patients in Japan who were treated in the extension study (A2301E1) and were judged by the investigator to benefit from continued QTI571 treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QTI571<br>Participants will receive QTI571 during 3 years. | Drug: QTI571<br>* QTI571 200mg up to 400mg (depending on tolerability) taken orally, once a day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events | All Serious Adverse Events were evaluated and reported for all participants receiving QTI571. 16 individual SAEs were observed in 5 subjects. | Approximately 2.9 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary arterial hypertension, QTI571, open label study
Definitive CCRT Combined With Durvalumab and Tremelimumab for Inoperable Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
This is a single arm phase II study, in which 2 cycles of chemotherapy (5FU/CDDP) and immunotherapy (durvalumab and tremelimumab) are administered every 3 weeks with concurrent radiotherapy for inoperable locally advanced esophageal squamous cell carcinoma. Four weeks after completion of CCRT combined with immunotherapy, 2 cycles of durvaluma and tremelimumab will be administered every 4 weeks and thereafter durvalumab monotherapy Q4W will be maintained until unacceptable toxicity or disease progression, or for maximum 2 years after enrollment.

Official Title
-----------------
Phase II Trial of Durvalumab (MEDI4736 )/Tremelimumab Combined With Definitive Concurrent Chemo-radiotherapy for Inoperable Esophageal Squamous Cell Carcinoma

Conditions
-----------------
Esophageal Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: Durvalumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed squamous esophageal cancer The clinical stage T2-3N0M0 or T1-3N1-3M0 Inoperable case: it refers to medically inoperable status and/or patient's refusal to surgery and/or cervical location and/or locoregionally recurrent tumor after primary surgery ECOG PS of 0 to 1 Exclusion Criteria: clinical T4 disease (for example, invasion to aorta, vertebral body, or trachea/bronchus) or distant metastasis (M1) previously received radiotherapy for esophageal cancer

Ages Eligible for Study
-----------------
Minimum Age: 19 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: study arm<br>Concurrent radiotherapy with chemotherapy (5FU/CDDP) and immune checkpoint inhibitors (durvalumab/tremelimumab), and followed by consolidation immune checkpoint inhibitors | Drug: Durvalumab<br>* concurrent radiotherapy<br>* Other names: Cisplatin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Time interval from enrollment to disease progression or death | 1 year |