linjc16/ctgov huggingface dataset:
Effects Of Lapatinib (GW572016) In Patients With Relapsed Adenocarcinoma Of The Esophagus

Study Overview
=================
Brief Summary
-----------------
This Phase II study will assess the efficacy, safety, and pharmacodynamics and pharmacokinetics of 1000 mg and 1500 mg lapatinib administered once daily in patients with relapsed adenocarcinoma of the esophagus, including tumors of the GE junction and gastric cardia.

Official Title
-----------------
A Phase II, Open-Label Study Evaluating Clinical Efficacy, Safety, Pharmacokinetic and Pharmacodynamic Effects of Lapatinib (GW572016) in Patients With Relapsed Adenocarcinoma of the Esophagus, Including Tumors of the Gastroesophageal Junction and Gastric Cardia

Conditions
-----------------
Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: Lapatinib (GW572016) oral tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Has a histologically confirmed adenocarcinoma of the esophagus. GE (gastroesophageal) junction or gastric cardia. Must be of non-child-bearing potential or is of child-bearing potential. Have a negative serum pregnancy test and agree to an approved form of birth control. Have an ECOG (Eastern Cooperative Oncology Group) Performance status less than or equal to 2. Have a life expectancy of at least 12 weeks. Have provided written informed consent. Investigator considers patient to be fit for study from lab test results and interview. Exclusion criteria: Pregnant or lactating female. Prior resection of the small bowel. Received major surgery. Received prior radiation therapy to the mediastinum or abdomen. Has a known immediate or delayed hypersensitivity reaction. Idiosyncrasy to drugs chemically related to the study drug.

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

| Intervention/Treatment |
| --- |
|Drug: Lapatinib (GW572016) oral tablets|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) of treatment with daily lapatinib at two different doses (1000 mg and 1500 mg per day) |  | daily throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and clinical benefit of lapatinib therapy, progression-free survival, and response duration in the two dose levels combined as well as for the two doses separately. |  | throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
relapsed adenocarcinoma, esophagus, tumors, GE junction, cancer, lapatinib, gastric cardia
The Pharmacokinetic Study of Saquinavir New Tablet Formulation in HIV-infected Pregnant Women.

Study Overview
=================
Brief Summary
-----------------
Pharmacokinetic study of Saquinavir and Ritonavir in HIV-infected pregnant women

Detailed Description
-----------------
It is generally accepted that HIV-infected pregnant women should receive treatment to prevent the transmission of HIV from mother-to-child.The (relative) contra-indications for the NNRTIs during pregnancy make a PI based regimen the most rational choice. Based on several experiences and investigations it is expected that saquinavir will play a role as a component of tripe drug regimens for HIV-infected pregnant women. Since the bid dose regimen of 1,000mg saquinavir and 100mg ritonavir is approved by the regulatory authorities and with the availability of a new 500mg tablet formulation of saquinavir,there is a need for a well-designed pharmacokinetic trial using the new 500mg saquinavir tablet formulation in the above mentioned dose.

Official Title
-----------------
The Pharmacokinetics of SAquinavir (Invirase New Tablet Formulation) 1,000mg + Ritonavir (Norvir) 100mg q12h in HIV-infected Pregnant Women (SARA)

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

Intervention / Treatment
-----------------
* Drug: Saquinavir and Ritonavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infected woman 18 - 40 years of age able and willing to sign Informed Consent pregnant for a maximum of 31 weeks Exclusion Criteria: history of sensitivity/idiosyncrasy to the drug relevant history of interference with drug metabolism inability to understand trial procedures abnormal specific serum levels use of specific concomitant medications active hepatobiliary or hepatic disease previous failure of saquinavir/ritonavir regimen

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Saquinavir and Ritonavir|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetics at week 20 and 33 of gestation and 6 weeks post partum |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antiviral activity |  |  | 
| safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV
Vis-Rx Post-Market Evaluation

Study Overview
=================
Brief Summary
-----------------
Post-market clinical evaluation of the Gentuity High-Frequency Optical Coherence Tomography (HF-OCT) System and the Vis-Rx Micro-Imaging Catheter for use in Percutaneous Coronary Intervention (PCI) procedures.

Detailed Description
-----------------
Prospective, single-arm, unblinded, multi-center, post-market clinical evaluation assessing the imaging capabilities of the Gentuity HF-OCT System and the Vis-Rx Micro-Imaging Catheter for use in PCI procedures. Objectives are to evaluate the clinical and technical performance in the target patient population.

Official Title
-----------------
Post-Market Clinical Evaluation of the Gentuity High-Frequency Optical Coherence Tomography Imaging System and Vis-Rx Micro-Imaging Catheter

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Willing and able to provide written informed consent to participate Transluminal interventional procedure for their coronary arteries General Exclusion Criteria: Bacteremia or sepsis Major coagulation system abnormalities Severe hemodynamic instability or shock Acute renal failure Disqualified for Coronary Artery Bypass Graft (CABG) surgery Disqualified for PCI procedure Currently enrolled in another study to evaluate an investigational device or medication Lesion-Specific Exclusion Criteria: Total occlusion Coronary artery spasm Large thrombus (visible under angiography) Any target vessel which has undergone a bypass procedure

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 |
| --- | --- |
| HF-OCT imaging<br>Enrolled subjects who meet lesion-specific eligibility criteria and undergo HF-OCT imaging | Device: HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter<br>* Intracoronary HF-OCT imaging of the target lesion(s) during the procedure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance | Operator evaluation of performance via Likert scale | Immediately after the procedure | 
| Technical performance | Objective measurement of image clarity of the HF-OCT images by an independent core lab | Up to 3 months following the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete pullbacks | Percentage of HF-OCT images with maximum clear image length | Up to 3 months following the procedure |
Long-term Beneficial Metabolic Effects of Adrenalectomy in Subclinical Cushing's Syndrome of Adrenal Incidentaloma

Study Overview
=================
Brief Summary
-----------------
Objective: To determine the metabolic effects of the adrenalectomy in subclinical Cushing's syndrome of adrenal incidentaloma. Methods: 234 subclinical cushing syndrome and adrenal incidentaloma will be randomly assigned into two groups(e.g adrenalectomy group and conservative treatment group).

Official Title
-----------------
Long-term Effects of Adrenalectomy on Metabolic Syndrome, Glucose Metabolism, Lipid Metabolism, and Bone Metabolism in Subclinical Cushing's Syndrome of Adrenal Incidentaloma

Conditions
-----------------
Cushing Syndrome

Intervention / Treatment
-----------------
* Procedure: surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with both unilateral adrenal incidentaloma and hypercortisolism definition of hypercortisolism overnight dexamethasone suppression test, serum cortisol>1.8ug/dL 24hr urine cortisol > upper reference limit Exclusion Criteria: patients who took medication influencing cortisol secretion patients with definite clinical feature of cushing syndrome moon face abdominal striae skin or proximal muscle atrophy metabolic syndrome, hyperthyroidism, hyperparathyroidism, chronic renal failure, rheumatic disease, hematologic disease patients who took following medication insulin oral hypoglycemic agent thyroid hormone anti-hyperlipidemic drug sex hormone patients who taking steroid hormone or who took steroid hormone more than 2 weeks within 1 year psychiatric disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| Active Comparator: Adrenalectomy group<br>patients who undergo adrenalectomy | Procedure: surgery<br>* adrenalectomy<br>|
| No Intervention: Control group<br>patients who receive conservative treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of lipid profile between two groups | lipid profile with LDL,apo B | 4 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of obesity between two groups | measurement of body weight, height | 4Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
subclinical cushing syndrome, hypercortisolism, adrenal incidentaloma, adrenalectomy
Impact of the Eurékoi Serious Game on Family Caregivers of Patients With a Major Neurocognitive Disorder

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the effectiveness of serious EUREKOI gambling on the anxiety of family caregivers of patients with newly diagnosed Alzheimer's disease.

Official Title
-----------------
Impact of the Eurékoi Serious Game on Family Caregivers of Patients With a Major Neurocognitive Disorder

Conditions
-----------------
Family Caregiver of Patient With Alzheimer Disease

Intervention / Treatment
-----------------
* Behavioral: Serious game Eurekoi intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women over 18 years old; Primary caregiver of a patient with a mild-stage major neurocognitive disorder newly diagnosed according to the DSM 5 criteria; Signature of informed consent. Exclusion Criteria: Subject not speaking French, not reading French Subject with visual impairment Subject under tutorship or curatorship.

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?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Serious Game Eurekoi intervention<br>1 session in group using the serious game eurekoi | Behavioral: Serious game Eurekoi intervention<br>* 1 session in group using the serious game eurekoi<br>|
| No Intervention: Control group<br>no intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacity of the serious game Eurekoi on anxiety of familial caregiver of patient with Alzheimer Disease | Auto-evaluation of anxiety using Spielberger inventory (score between 20 and 80 ; the higher the score, the greater the anxiety) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of knowledge of familial caregiver about cognitive troubles | Multiple choice questionary | 3 months | 
| Evaluate satisfaction of the familial caregivers about the session with the game EUREKOI | questionary of satisfaction | 3 months |
Stress Management on Nursing Students

Study Overview
=================
Brief Summary
-----------------
In this study, it was aimed to determine the effect of the stress management program on the clinical stress of first year nursing students. This research will be carried out in a randomized controlled experimental design. The data of the research; The descriptive characteristics form will be collected using the Perceived Stress Scale for Nursing Students, the Bio-Psycho-Social Response Scale for Nursing Students, and the Stress Coping Behaviors Scale for Nursing Students. students will be assigned as experiment (32) and control (32) by randomization. A four-session stress management program will be applied to the experimental group students. No intervention will be made on the control group.

Official Title
-----------------
The Effect of Stress Management Program on Clinical Stress of First Year Nursing Students

Conditions
-----------------
Stress, Clinical Anxiety

Intervention / Treatment
-----------------
* Behavioral: stress managment program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The first to enroll in the Nursing Fundamentals course, Exclusion Criteria: Have previously taken nursing fundamentals course

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?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stress management program<br> | Behavioral: stress managment program<br>* A four-session stress management program will be applied to the experimental group students.<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Scale for Nursing Students | It measures the perceived stress of nursing students. It is a Likert type scale and consists of 29 items. Total score; 0 - 116. A high score indicates a higher level of stress. | 15 minute | 
| Bio-Psycho-Social Response Scale for Nursing Students | It consists of 21 items related to the symptoms related to the physical, psychological and social health of students. It is a Likert type scale and consists of 21 items. Total score; It ranges from 0 to 84. A high score indicates more symptom presence and poor bio-psycho-social status. | 20 minute | 
| Stress Coping Behaviors Scale for Nursing Students | It measures the stress coping behaviors of students. It consists of 19 items in total. A higher score on a factor indicates that this coping type is used more frequently. | 15 minute |
Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer.

Study Overview
=================
Brief Summary
-----------------
Rivaroxaban or placebo for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer: a randomized, double blind, placebo-controlled study.

Official Title
-----------------
Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer: a Randomized, Double Blind, Placebo-controlled Study.

Conditions
-----------------
Prevention of Venous Thromboembolism

Intervention / Treatment
-----------------
* Drug: Rivaroxaban
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Objective diagnosis of colorectal cancer; Elective laparoscopic surgery for colorectal cancer Whatever the stage of cancer Antithrombotic prophylaxis with LMWH administered for 7±2 days after surgery Exclusion Criteria: Age < 18 years Surgery for non-cancer disease Duration of surgery < 45 min Conversion to open surgery Other indication for anticoagulant therapy Known cerebral metastases Kidney or liver failure Known hemorrhagic diathesis or high risk for bleeding History of intracerebral bleeding or neurosurgery within 6 months History of heparin induced thrombocytopenia Pregnancy or lactation Refusal 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rivaroxaban<br>Orally administered, at the dose of 10 mg OD for 3 weeks (extended prophylaxis) | Drug: Rivaroxaban<br>* Tablets<br>|
| Placebo Comparator: Placebo<br>Orally administered, OD for 3 weeks (extended prophylaxis) | Drug: Placebo<br>* Tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous thromboembolism | The primary study outcome is a composite of symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death. | 28±2 days from planned laparoscopic surgery for colorectal cancer in patients randomized to rivaroxaban or placebo. |
A Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two different anti-HIV drug combinations, one that contains nelfinavir (NFV) and one that does not. The best dosing schedule for indinavir (IDV) also will be studied.

Detailed Description
-----------------
Patients are stratified by screening plasma viral RNA results (50,000 copies/ml or below vs above 50,000 copies/ml) and randomized to 1 of 2 treatment arms. Group 1 receives IDV 3 times daily plus d4T/3TC twice daily. Group 2 receives IDV/NFV/d4T/3TC twice daily. Patients remain on study medications for 24 weeks and are seen at the clinic once every 4 weeks after entering the study. At each clinic visit, blood samples are taken to evaluate CD4 cell count and plasma HIV RNA levels.

Official Title
-----------------
A Multicenter, Open-Label, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate/d4T/3TC Versus Indinavir Sulfate/Nelfinavir Mesylate/d4T/3TC in HIV-Infected Individuals

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

Intervention / Treatment
-----------------
* Drug: Indinavir sulfate
* Drug: Nelfinavir mesylate
* Drug: Lamivudine
* Drug: Stavudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria You may be eligible for this study if you: Are HIV positive. Have a viral load (level of HIV in your blood) of at least 10,000 copies/ml within 45 days of study entry. Have a CD4 cell count of at least 100 cells/mm3 within 45 days of study entry. Have a normal chest X-ray. Have never taken protease inhibitors or 3TC. Are 16 years of age or older. Agree to practice sexual abstinence or use barrier methods of birth control (e.g., condoms). Exclusion Criteria You will not be eligible for this study if you: Have an active opportunistic (AIDS-related) infection or cancer. Have certain types of Kaposi's sarcoma. Have hepatitis. Have chronic diarrhea. Have a history of certain medical conditions. Are allergic to any of the study medications. Are taking certain medications. Are pregnant or breast-feeding.

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: Indinavir sulfate|nan|
|Drug: Nelfinavir mesylate|nan|
|Drug: Lamivudine|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
-----------------
Drug Therapy, Combination, HIV Protease Inhibitors, Lamivudine, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Nelfinavir