linjc16/ctgov huggingface dataset:
LUCY: A Study for the Treatment of Non-Small Cell Lung Cancer (NSCLC) in Patients Previously Treated With Chemotherapy

Study Overview
=================
Brief Summary
-----------------
A study for the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients previously treated with chemotherapy.

Conditions
-----------------
Lung Cancer, Cancer of Lung, Cancer of the Lung, Non-Small Cell Lung Carcinoma, Carcinoma, Non-Small Cell Lung

Intervention / Treatment
-----------------
* Drug: YM155


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed non-small cell lung cancer. Prior chemotherapy regimen(s) for lung cancer Exclusion Criteria: History of other malignancy in the last 5 years Major surgery within the past 21 days

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>7 days continuous infusion | Drug: YM155<br>* IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response rate (CR+PR) |  | In first 6 cycles | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment Efficacy, Treatment Effectiveness, Disease Management, Treatment, Safety
Digital Glucose Monitoring in Gestational Diabetes

Study Overview
=================
Brief Summary
-----------------
Assessing blood glucose control in women with gestational diabetes can be challenging. The standard of care remains visual inspection of blood glucose paper diaries of self-performed capillary monitoring during regular meeting in High Risk pregnancy clinics. The researchers are interested in preforming a randomized control trial comparing women with the diagnosis of gestational diabetes with regular High-Risk clinic surveillance to digital monitoring using an application in a Smart-phone and submitting those values via email in addition to the regular clinic appointments. The Primary outcome of the trial is to assess the compliance of the research group as compared to the control group.

Official Title
-----------------
Improvement of Compliance by Digital Blood Glucose Monitoring of Women With Gestational Diabetes

Conditions
-----------------
Gestational Diabetes

Intervention / Treatment
-----------------
* Other: glucose buddy application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gestational diabetes Exclusion Criteria: pre-gestational diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: glucose application<br>Regular high risk pregnancy clinic surveillance in addition to a Smart phone application for registering the Blood glucose levels and submitting via email every 3-5 days to the High risk Doctor involved in the trial. | Other: glucose buddy application<br> <br> |
| No Intervention: Regular monitoring<br>Regular high risk pregnancy clinic surveillance | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing the compliance of the research group compared to the control group. | By calculating the amount of daily glucose measurements in the research group compared to the number of glucose measurements in the control group | 18 month |
Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Carbon Monoxide Poisoning

Study Overview
=================
Brief Summary
-----------------
That SPECT brain imaging tracks and is consistent with clinical history and physical exam as well as cognitive testing.

Detailed Description
-----------------
The study is a retrospective review of the PI's experience using SPECT brain imaging and hyperbaric oxygen therapy in the diagnosis and treatment of non-acute phases of carbon monoxide poisoning. The purpose is to see if the SPECT brain imaging is consistent with the clinical condition and cognitive testing on the patients.

Official Title
-----------------
Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Carbon Monoxide Poisoning

Conditions
-----------------
Neuropsychiatric Sequelae of Carbon Monoxide Poisoning

Intervention / Treatment
-----------------
* Drug: HBOT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults and children with non-acute carbon monoxide poisoning who underwent SPECT brain imaging as part of their evaluation and treatment Exclusion Criteria: None.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>HBOT | Drug: HBOT<br>* total body exposure to greater than atmospheric pressure oxygen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPECT brain imaging |  | after completion of HBOT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical history and physical exam |  | after completion of HBOT | 
| Neuropsychological testing | Neuropsychological testing performed after the final HBOT in those who had neuropsychological testing before HBOT | After the final HBOT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carbon monoxide poisoning, brain injury
Prospective Review of Procalcitonin After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
This study is designed to demonstrate the value of Procalcitonin (PCT) in assisting the rapid diagnosis of post- operative infection that includes elevation of Procalcitonin above and beyond the changes seen with the acute and inflammatory response induced by cardio-pulmonary bypass. Procalcitonin is an innovative and highly specific biomarker for clinically relevant severe bacterial infections and sepsis. PCT supports early diagnosis and clinical decision making.This is a prospective single center study designed to assess the normal change in PCT levels following major surgery and the utilization of PCT regarding the diagnosis of infection and the response to treatment, following major cardiac surgery

Detailed Description
-----------------
Inclusion Criteria: Elective CABG + / - Aortic / Mitral valve patients Off pump and on pump cases Exclusion Criteria: Patients with recent infection in last week and / or Antibiotics in last 1 week or pre op fever > 99.5f / 38C in 24hrs prior to surgery Patients on oral or IV corticosteroids within 1 week of being on them. Known immune dysfunction Active congestive heart failure / Recovering from cardiogenic shock\ Intra aortic balloon pump pre - op No CABG patients with CRYO MAZE, or Ablation

Official Title
-----------------
Prospective Review of Procalcitonin After Cardiac Surgery

Conditions
-----------------
Procalcitonin, Coronary Artery Bypass Grafting

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective CABG + / - Aortic / Mitral valve patients Off pump and on pump cases Exclusion Criteria: Exclusion Criteria: Check any box that applies: Patients with recent infection in last week and / or Antibiotics in last 1 week or pre op fever > 99.5f / 38C in 24hrs prior to surgery Patients on oral or IV corticosteroids within 1 week of being on them. Known immune dysfunction Active congestive heart failure / Recovering from cardiogenic shock\ Intra aortic balloon pump pre - op No CABG patients with CRYO MAZE, or Ablation

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
utilization of Procalcitonin in the cardiac setting
A Comparative Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, open-labeled study to examine the non-inferiority of ASP1585 to sevelamer hydrochloride in chronic kidney disease patients with hyperphosphatemia on hemodialysis.

Official Title
-----------------
A Phase 3, Multicenter, Open-label, Sevelamer Hydrochloride-controlled Study in Chronic Kidney Disease (CKD) Patients With Hyperphosphatemia on Hemodialysis

Conditions
-----------------
Chronic Kidney Disease, Renal Dialysis, Renal Insufficiency

Intervention / Treatment
-----------------
* Drug: ASP1585
* Drug: Sevelamer hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic kidney disease patients on hemodialysis Hyperphosphatemia Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not been changed within 28 days Written informed consent Exclusion Criteria: Patients with gastrointestinal surgery or enterectomy Patients with severe cardiac diseases Patients with severe constipation or diarrhea Patients with a history or complication of malignant tumors Patients with uncontrolled hypertension Patients treated with parathyroid intervention

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP group<br> | Drug: ASP1585<br>* oral<br>* Other names: AMG223;|
| Active Comparator: Sevelamer group<br> | Drug: Sevelamer hydrochloride<br>* oral<br>* Other names: phosbloc;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum phosphorus level at the end of treatment |  | After 12-week or at the treatment discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum phosphorus level |  | After 12-week or at the end of treatment | 
| Time-course changes in serum phosphorus levels |  | During Treatment | 
| Changes in serum Ca x P |  | During treatment | 
| Changes in intact PTH levels |  | During Treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperphosphatemia, hemodialysis, CKD, ASP1585
Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of TLK199 in patients with myelodysplastic syndrome (MDS).

Official Title
-----------------
Phase 1-2a Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

Conditions
-----------------
Myelodysplastic Syndromes

Intervention / Treatment
-----------------
* Drug: TLK199 HCl Liposomes for Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed diagnosis of MDS Adequate liver and kidney function Ineligible for, or refusing, allogeneic bone marrow transplant At least 18 years of age Discontinuation of growth factors (e.g., G- CSF) at least 2 weeks prior to study entry Exclusion Criteria: Failure to recover from any prior surgery, or any major surgery within 4 weeks of study entry Pregnant or lactating women History of allergy to eggs Other investigational drugs within 14 days of study entry Chemotherapy, radiotherapy or immunotherapy within 14 days of study entry Concomitant steroids or hormones for the treatment of neoplasms

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: TLK199 HCl Liposomes for Injection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-068)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
A clinical study to determine the efficacy and safety of an investigational medication (MK0869) in the treatment of depression.

Detailed Description
-----------------
The duration of treatment is 10 weeks.

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Multicenter Study of the Long-Term Efficacy of MK0869 in the Maintenance of Antidepressant Effect in Geriatric Outpatients With Major Depressive Disorder

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

Intervention / Treatment
-----------------
* Drug: aprepitant
* Drug: Comparator: placebo (unspecified)


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with Major Depressive Disorder

Ages Eligible for Study
-----------------
Minimum Age: 65 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: aprepitant|nan|
|Drug: Comparator: placebo (unspecified)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAMD-17 score </= 10 after 10 weeks; maintenance of antidepressant effect for 6-10 months; tolerability |  | After 10 weeks & 6-10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-S score change from Week 10 at Month 6; HAMD-17 total score change from Week 10 at Month 6; MADRS total score change at Month 6, HAMA total score change at Month 6 |  | 6 Months |
Influence of Dexmedetomidine on a Closed-Loop Anesthesia System

Study Overview
=================
Brief Summary
-----------------
The main objective if to evaluate the sparing effect of dexmedetomidine on the doses of propofol and remifentanil.

Official Title
-----------------
Closed-Loop Delivery of Propofol and Remifentanil: Sparing Effect of Dexmedetomidine

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: NaCl 9/00
* Drug: dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male patients scheduled for a general anesthesia Exclusion Criteria: age lower than 18 years allergy to propofol, or to soja or to peanuts, or to sufentanil, to remifentanil, or to morphine,or to a myorelaxant or to an excipient, hypersensibility to sufentanil, or to remifentanil, or to other derivate of fentanyl, history of central nervous system disease, patients receiving a psychotropic treatment or an agonist-antagonist opiate, hypovolemic patients, patients receiving a cardio-vascular treatment, expected bleeding surgical procedure, simultaneous general and loco-regional anesthesia, severe hepatic insufficiency.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo | Drug: NaCl 9/00<br>* Same volume as in the dexmedetomidine group<br>|
| Experimental: dexmedetomidine<br>patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and dexmedetomidine | Drug: dexmedetomidine<br>* 1 mcg/kg administered in 10 minutes followed by a continuous infusion of 0,5 mcg/kg/hr<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| administered doses of propofol and of remifentanil during anesthesia |  | end of anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delay before recovery |  | at the end of anesthesia | 
| hemodynamic abnormalities requiring a treatment |  | end of anesthesia | 
| postoperative morphine requirement |  | Third post-anesthetic hour | 
| explicit memorisation |  | Second postoperative day |
Preoperative Warm-up in Gynecologic Surgery

Study Overview
=================
Brief Summary
-----------------
Background and Objectives: All modern surgical procedures require a high level of cognitive and psychomotor skills achieved using different training methods, but could be influenced by fatigue and other psychological factors. We evaluate the effect of warm-up exercises on operative laparoscopic performances in gynecologic laparoscopic procedures. Methods: The surgical team operates on a consecutive series of 20 patients and perform laparoscopic salpingo-oophorectomy. Patients are randomly allocated in 2 groups: group A to be operated on without warm-up exercises and group B to be operated on after a short-term warm-up. All patients are operated on by the same surgical team. The full-time records of the operation were analyzed by 2 independent reviewers. Laparoscopic procedures are recorded and assessed by 2 independent observers using the generic OSATS rating scale. A training module using the Lap Sim simulator was designed for the warm-up.

Official Title
-----------------
Preoperative Warm-up in Gynecologic Surgery Using a Virtual Reality Simulator.

Conditions
-----------------
Gynecologic Disorders

Intervention / Treatment
-----------------
* Other: Preoperative Warm-Up training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: residents or faculty at the Dept. of Gynecology and Obstetrics completed skills training Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Warm-Up<br>Surgery after warm-up task Preoperative Warm-Up training | Other: Preoperative Warm-Up training<br>* Preoperative Warm-Up training<br>|
| No Intervention: No Warm-up<br>Surgery without warm-up exercise | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical performance | Surgical Performance will be assessed using Objective structured assessment of technical skills (OSATS) | During surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopy, surgery, warm-up, preoperative, surgical skills
Intrathecal Clonidine Addiction for Combined Spinal Epidural Analgesia During Labor

Study Overview
=================
Brief Summary
-----------------
The study aims to evaluate the impact of the addition of 20 mcg of intrathecal clonidine in combined spinalepidural for labor analgesia on the local anesthetic consumption, on labor performance and on maternal fetal well-being.

Official Title
-----------------
Impact on Maternal and Fetal Wellbeing and on Labor Curve of Intrathecal Clonidine Addiction for Labor Analgesia. A Randomized Controlled Trial.

Conditions
-----------------
Labor Pain

Intervention / Treatment
-----------------
* Drug: Clonidine
* Drug: Sufentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written maternal informed consent Singleton pregnancy Gestational age ≥ 37 weeks, ASA I BMI < 30 fetus in cephalic presentation Exclusion Criteria: Suspect or certainty of fetal malformation, Presence of conditions such as preeclampsia, multiparity, preterm labor History of adverse reaction to α-2 adrenergic agonists Nicotine addiction Chronic use of opioid

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SC<br>this arm will receive intrathecal clonidine addiction to sufentanil during combined spinal epidural analgesia for labor | Drug: Clonidine<br>* Intrathecal clonidine addiction<br>|
| Active Comparator: S<br>this arm will receive intrathecal sufentanil during combined spinal epidural analgesia for labor | Drug: Sufentanil<br>* Intrathecal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local anesthetic consumption reduction |  | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clonidine, spinal injections