linjc16/ctgov huggingface dataset:
A Study of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs in HIV-1 Infected Patients

Study Overview
=================
Brief Summary
-----------------
To examine the efficacy of saquinavir SGC (soft gel capsules) in combination with other antiretrovirals in HIV-1 infected patients currently treated with saquinavir HGC (hard gel capsules) measured by the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment.

Detailed Description
-----------------
Eligible patients will be stratified by HIV-1 RNA level into 2 populations: 1) >= 5,000-30,000 HIV-1 RNA, 2) > 30,000 HIV-1 RNA. All patients will be randomized to 1 of 3 treatment arms: Arm A - Saquinavir soft gel capsules (SQV SGC) + 2 new nucleoside analogs (reverse transcriptase inhibitors [RTIs]), Arm B - SQV SGC + nelfinavir + stavudine (d4T) or a new RTI, or Arm C - SQV SGC + ritonavir + d4T or a new RTI. All patients will undergo plasma HIV-1 RNA determinations, CD4 lymphocyte counts, hematology and chemistry blood work at baseline, weeks 4, 8, 12, 16 and 24.

Official Title
-----------------
A Phase IIIB Open-Label Trial Replacing Saquinavir HGC (Ro 31-8959) With Saquinavir SGC (Ro 31-8959) in Combination With Other Antiretroviral Drugs in Patients With HIV-1 Infection

Conditions
-----------------
HIV Infections

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Documented HIV infection. CD4 > 100 cells/mm3. Saquinavir HGC-experienced patients (>= 3 months cumulative therapy). Required: >= 3 months cumulative saquinavir HGC therapy.

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Ritonavir|nan|
|Drug: Nelfinavir mesylate|nan|
|Drug: Saquinavir|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
-----------------
HIV-1, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, HIV Protease Inhibitors, RNA, Viral, Saquinavir, Anti-HIV Agents, Viral Load
Changes of Cerebral Oxygenation During Anesthesia Induction

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to investigate the changes of cerebral oxygen saturation (rSO2) during anesthesia induction.

Detailed Description
-----------------
The aim of this study was to investigate the relationship between the cerebral oxygen saturation (rSO2) and pressure of carbon dioxide (PaCO2) and oxygen (PaO2) in arterial blood and to identify the covariates between rSO2 and PaCO2 and PaO2 during the period of anesthesia induction.

Official Title
-----------------
Changes of Cerebral Oxygenation During Anesthesia Induction

Conditions
-----------------
Cerebral Oxygen Saturation

Intervention / Treatment
-----------------
* Drug: 100% Oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients were included in the study if they were ethnic Chinese, between 18 and 65 years old, American Society of Anesthesiologists (ASA) physical status I or II, and undergoing a radical operation for mastocarcinoma. Exclusion Criteria: Patients were excluded if they had a body mass index exceeding 30 kg/m2, had a history of hypertension or diabetes mellitus, or were allergic to anesthesia drugs used in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Standard general anesthesia induction<br>Patients scheduled for elective surgery at the First Hospital of China Medical University will be recruited for the study beginning in February 2016.We will investigate the changes of cerebral oxygenation during anesthesia induction of standard general anesthesia | Drug: 100% Oxygen<br>* We will investigate the changes of cerebral oxygenation during anesthesia induction of standard general anesthesia with 100% oxygen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of cerebral oxygen saturation | the relationship between the cerebral oxygen saturation (rSO2) and pressure of carbon dioxide (PaCO2) and oxygen (PaO2) in arterial blood | Baseline and 30 minutes |
The Efficacy of Computerized Alcohol Screening and Intervention (CASI) in At-Risk Emergency Department and Trauma Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to examine the effectiveness of computerized alcohol screening and brief intervention in the UC Irvine Medical Center Emergency Department (ED) and Trauma Patients. Brief interventions have a high potential impact in ED and Trauma populations. Computerized alcohol screening and brief intervention (CASI) is a fast and easy to use tool for patients and healthcare providers. CASI mitigates barriers to proper screening and intervention, including time, availability of trained personnel, patient comfort, and language barriers. CASI provides the Alcohol Use Disorders Identification Test (AUDIT) followed by a brief intervention and customized alcohol intake recomendations for the patient. The intervention of this study will be the addition of a brief CASI questionnaire to the standard of care for a random subset of subjects. All subjects who screen positive for hazardous alcohol use will be followed up and reassessed for alcohol use. The researchers hypothesize that the addition of CASI will lead to a decrease in alcohol intake within three months. The basis of this research is evidence of the effectiveness in the CASI system, the growing public health issue of alcohol abuse, the need to be able to provide effective screening and brief intervention in the high volume ED settings, and findings that the primary method to reduce traumatic death is prevention.

Conditions
-----------------
Alcohol Consumption

Intervention / Treatment
-----------------
* Behavioral: CASI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Trauma and ED patients Exclusion Criteria: Under the age of 18 Intoxicated Psychiatric

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| At Risk Adult Drinkers<br>CASI | Behavioral: CASI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Bronchoscopy Assisted Sampling of Cells and Fluid From the Lower Respiratory Tract of Human Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to collect cells and liquid from the air passages of healthy adults, both smokers and non-smokers. These samples will be used for test-tube studies to explore mechanisms of diseases of the respiratory tract, and to compare the samples between people who smoke cigarettes and people who don't. Obtaining these samples requires an invasive procedure called bronchoscopy.

Official Title
-----------------
Bronchoscopy-Assisted Sampling of Cells and Fluid From the Lower Respiratory Tract of Human Subjects

Conditions
-----------------
Respiratory Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current cigarette smokers Must be otherwise healthy with no chronic illness Exclusion Criteria: Asthma Smoking related lung disease (including bronchitis)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Current smokers<br>Current cigarette smokers with no other illness | |
| Healthy controls<br>Healthy non smokers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The goal of this project is to define the effect of smoking on key aspects of airway biology. These studies will also provide crucial & novel definition of airway biology in smokers against which COPD & CF patients will be compared. |  | At the time of bronchoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy smokers, Current cigarette smokers, No lung disease
Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
This is a phase I study to analyze the effect of water and food intake on the bioavailability and pharmacodynamic of oral salmon calcitonin (SMC021) and salmon calcitonin nasal spray in post-menopausal women.

Official Title
-----------------
A Partially-Blind, Randomized, Single-Dose, Placebo-Controlled Crossover Phase I Study Assessing the Effect of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of SMC021 0.8 mg in Healthy Postmenopausal Women

Conditions
-----------------
Postmenopausal Osteoporosis

Intervention / Treatment
-----------------
* Drug: Oral salmon calcitonin, salmon calcitonin nasal spray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy postmenopausal women Exclusion Criteria: Previous treatment with other osteoporosis medication Other protocol defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oral salmon calcitonin, salmon calcitonin nasal spray|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK) profile of oral salmon calcitonin taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic (PD) profile of oral salmon calcitonin taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal |  |  | 
| PK profile of the carrier of oral salmon calcitonin, taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal |  |  | 
| PK profile of salmon calcitonin nasal spray |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postmenopausal, osteoporosis, Pharmacokinetics/dynamics, Calcitonin
Citrulline Allo. Evaluation of Citrullinemia as a Marker of Bowel Damage After Allogeneic Bone Marrow Transplantation in Children

Study Overview
=================
Brief Summary
-----------------
determine the interest of the dosage of citrullinemia to monitor the bowel damage after allogeneic bone marrow transplantation in children.

Detailed Description
-----------------
30 children included. Dosage of citrullinemia on day -7, day 0 and every week up to 100 days after BMT. Histological examination and extensive infectious screening in case of persistent digestive symptoms (more than 3 days). Two groups of patients regarding on digestive involvement. Comparison of the values of citrullinemia between these two groups.

Official Title
-----------------
Evaluation of Citrullinemia as a Marker of Bowel Damage After Allogeneic Bone Marrow Transplantation in Children

Conditions
-----------------
Benign Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 0 to 18 years allogeneic bone marrow transplantation for malignant or benign disease affiliation to French sécurité sociale parent's consent Exclusion Criteria: severe gastro-intestinal involvement before transplant previous digestive surgery

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| 1<br> | |
| 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Citrullinemia (weekly) |  | weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastro-intestinal complications in children following allogeneic bone marrow transplantation |  | following allogenic bone marrow transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children, Allogeneic bone marrow transplantation, Intestinal damage, Citrulline, Graft versus Host Disease, 0 to 18 years old
Establishment of a Non-invasive and Indirect Measure of Volitional Pimax

Study Overview
=================
Brief Summary
-----------------
Respiratory failure is the main death cause in muscular diseases. Non-invasive and volitional measures of inspiratory muscles strength include the nasal pressure with an occluded nostril and the maximal inspiratory pressure (PImax).Unfortunately, volitional maneuvers depend of patient effort. The mean of this reseach is to validate a non-invasive and non-volitional technique to evaluate diaphragm strength at muscular diseases patients.The methdology consist to compar PImax measure to nerves magnetical stimulation maneuvers measure.

Official Title
-----------------
Establishment of a Non-invasive and Indirect Measure of Volitional Pimax

Conditions
-----------------
Neuromuscular Diseases, Respiratory Failure

Intervention / Treatment
-----------------
* Procedure: phrenic nerves magnetic stimulations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neuromuscular disease Pimax evaluation indication Exclusion Criteria: pregnant women usual contre-indications for nuclear magnetic resonance

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| neuromuscular diseases<br> | Procedure: phrenic nerves magnetic stimulations<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| magnetic stimulation pressure measure( Pstim) | phrenic nerves magnetic stimulations | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
phrenic nerves magnetic stimulations
Suitability of PICC for Transpulmonary Thermodilution Compared to CICC

Study Overview
=================
Brief Summary
-----------------
Peripherally inserted central catheters (PICCs) are increasingly used in intensive care unit (ICU) as an alternative to centrally inserted central catheters (CICCs) for intravenous infusion. In the present study we try to assess their reliability for measuring cardiac index (CI) with trans-pulmonary thermodilution (TPTD) technique.

Official Title
-----------------
Are Peripherally Inserted Central Catheters (PICC) Suitable for Cardiac Output Assessment With Trans-pulmonary Thermodilution

Conditions
-----------------
CVC, Peripherally Inserted Central Catheters, Transpulmonary Thermodilution, Hemodynamic Monitoring

Intervention / Treatment
-----------------
* Diagnostic Test: transpulmonary thermodilution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients (≥18 years) admitted to the ICU Patients requiring hemodynamic monitoring using EV1000TM Patients having both PICC and CICC in place (these patients had their PICC replaced with a CICC, usually at the time of ICU admission, or vice versa, usually at the end of their ICU stay, and were enrolled immediately after the placement of the new device before the previous one was removed) Exclusion Criteria: body weight <40 kg severe aortic regurgitation or intra-cardiac shunt treatment with an intra-aortic balloon pump contraindication for placement of PICC, CICC or a femoral arterial catheter abdominal aneurism extracorporeal circulation pregnancy lack of informed consent

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: Other
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: transpulmonary thermodilution|Thermodilution was attempted via PICC and via CICC|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Index comparison via PICC | comparison of hemodynamic measurements made by the TPTD from the VolumeView/EV1000TM system via PICC vs. CICC. | One hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison 4Fr PICCs to CICC | Comparison of single-lumen 4 Fr PICCs to CICC in their reliability of assessing cardiac output | one hour | 
| Comparison 5Fr PICCs to CICC | Comparison of dual-lumen 5 Fr PICCs to CICC in their reliability of assessing cardiac output | one hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PICC, shock, cardiac output
Acute Appendicitis: The Influence of C-reactive Protein and Leucocytes on Clinical Decision-making

Study Overview
=================
Brief Summary
-----------------
Aim: To investigate if the results of CRP and leucocytes had any positive or negative influence on the surgeon's decision-making when handling patients with suspected AA.

Detailed Description
-----------------
A prospective observational cohort study including patients (≥15 years of age) admitted on suspicion of AA. The surgeons were instructed to perform their physical examination and register whether they found the patient more or less than 50% likely to have AA. Thereafter, the surgeons had to assess the blood results and reevaluate their diagnosis. The surgeon's diagnosis before and after was compared to the final diagnosis defined by surgical findings or follow up. Gold standard was any degree of appendicitis on histology.

Official Title
-----------------
Acute Appendicitis: The Influence of C-reactive Protein and Leucocytes on Clinical Decision-making

Conditions
-----------------
Acute Appendicitis

Intervention / Treatment
-----------------
* Other: Clinical descision making


Participation Criteria
=================
Eligibility Criteria
-----------------
Acutae abdominal pain Suspect for acute appendicites

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Clinical descision making|Chage in diagnosis before and after the presentation of the reults of CRP and Leucocytes|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in diagnosis |  | Two hours |
Temporal Intervention Trial of a CPR Video in the ICU

Study Overview
=================
Brief Summary
-----------------
To compare the decision making of family members of patients admitted to the ICU in regards to their CPR preferences for their loved ones with and without the use of a video decision aid.

Detailed Description
-----------------
Surrogate decision makers of patients admitted to an ICU and UNABLE to make decisions for themselves will be asked their choice for CPR preferences for their loved ones. This will occur during the first six months of the study. After six months, surrogate decision makers of patients admitted to an ICU and unable to make decisions for themselves will view a video decision aid for CPR and then asked their choice for CPR preferences for their loved ones.

Official Title
-----------------
A Temporal Intervention Trial of a CPR Video in the ICU

Conditions
-----------------
Admission to ICU

Intervention / Treatment
-----------------
* Behavioral: video decision aid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient admitted to ICU and unable to make decisions with a known surrogate decision maker Exclusion Criteria: Cannot speak English

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: verbal description of CPR<br>verbal description of CPR | |
| Experimental: Video decision aid<br>Video decision aid of CPR | Behavioral: video decision aid<br>* video of CPR<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPR preferences | CPR preferences for patients admitted to the ICU | within 48 hours of ICU admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CPR