linjc16/ctgov huggingface dataset:
Modeling Stress-precipitated Smoking Behavior for Medication Development

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether guanfacine will attenuate the ability of stress to precipitate smoking lapse behavior in treatment seeking and non-treatment seeking daily smokers.

Official Title
-----------------
Modeling Stress-precipitated Smoking Behavior for Medication Development

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Drug: guanfacine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 18-60 able to read and write in English smokers Exclusion Criteria: any significant current medical conditions that would contraindicate smoking current Diagnostic and Statistical Manual IV (DSM-IV) abuse or dependence of other substances, other than nicotine (or caffeine) dependence positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines women who are pregnant or nursing suicidal, homicidal or evidence of severe mental illness participants prescribed any psychotropic drug in the 30 days prior to study enrollment blood donation within the past 6 weeks participants who have engaged in a quit attempt in the past 3 months specific exclusions for administration of guanfacine not already specified include: Hypotensive individuals with sitting blood pressure below 90/50 mmHG; EKG evidence at baseline screening of any clinically significant conduction abnormalities, including a Bazett's corrected QT interval (QTc) >450 msec for men and QTc>470 msec for women; known intolerance for guanfacine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guanfacine<br>guanfacine 3mg/day | Drug: guanfacine<br>* 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study.<br>* Other names: Tenex;|
| Placebo Comparator: Placebo<br>placebo control | Drug: placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Latency to Initiate Ad-lib Smoking Session | latency to initiate smoking (in minutes) during a 50-minute period. | 50 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking lapse behavior, guanfacine
Evaluation of COVA™+ CARD in Adult Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this observational study is to evaluate the safety of the guided healing and adhesion prevention membrane, COVA™+ CARD, in adult cardiac surgery. The causality of the collagen membrane according to the occurrence of peri and post-operative complications will be evaluated.

Detailed Description
-----------------
Assessment of the safety of COVA™+ CARD, collagen membrane to prevent adhesion appearance, in cardiac surgery in adult patients: collection of post-operative complications, causality of the membrane collection of complications in the 3-month period after the surgery, causality of the membrane collection of peri-operative complications, causality of the membrane collection of complications, 3 months after the surgery assessment of the efficacy of COVA™+ CARD if re-operation assessment of the surgeon's satisfaction

Official Title
-----------------
Evaluation of the Tolerance and Efficacy of COVA™+ CARD in Adult Cardiac Surgery. A Prospective, Observational and Single Center Study.

Conditions
-----------------
Safety, Tolerance

Intervention / Treatment
-----------------
* Device: cardiac surgery requiring a collagen membrane COVA™+


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Cardiac surgery using COVA™+ CARD Exclusion Criteria: In accordance with the instruction for use (IFU) of the medical device. Refusal of participation to the study

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: cardiac surgery requiring a collagen membrane COVA™+|At the end of the cardiac surgery, the collagen membrane is implanted on the dissection area in order to prevent the formation of postoperative adhesions.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the tolerance of COVA™+ CARD in cardiac surgery | Recording of complications reported in the 3-month postoperative period and determination of the causality of the collagen membrane. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the tolerance of COVA™+ CARD in cardiac surgery | Recording of the immediate postoperative complications and determination of the causality of the collagen membrane. | Hospitalization stay (up to 30 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Collagen membrane, Cardiac surgery, Postoperative complication
The Study on the Pharmacokinetics of PEG-rhG-CSF in Children and Adolescents

Study Overview
=================
Brief Summary
-----------------
The purpose of the trail is to study the pharmacokinetics of Pegylated Recombinant Human Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents

Official Title
-----------------
The Study on the Pharmacokinetics of Pegylated Recombinant Human Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents

Conditions
-----------------
Acute Lymphoid Leukemia

Intervention / Treatment
-----------------
* Drug: PEG-rhG-CSF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age≤18 years old, gender no limited. Patients with acute lymphoblastic leukemia diagnosed by bone marrow pathology or cytology. Plan to receive CAM (cyclophosphamide,cytarabine,6-MP)chemotherapy regimen. Previously not received radiotherapy. Karnofsky Performance Scores ( KPS)≥60. The expected survival time was >3 months. Neutropenia or agranulocytosis, no bleeding tendency. No significant cardiac dysfunction or metabolic disease. TBIL(total bilirubin ), ALT（alanine aminotransferase）,AST（glutamic-oxalacetic transaminase） < 2.5×ULN（upper limit of normal）. BUN（blood urine nitrogen），Cr（creatinine），UA（uric acid）<1.5×ULN. Written informed consent are acquired. Exclusion Criteria: With a history of systemic radiotherapy. Infection difficult to control, the body temperature ≥ 38℃. Other situation that investigators consider as contra-indication for this study.

Ages Eligible for Study
-----------------
Maximum 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG-rhG-CSF<br> | Drug: PEG-rhG-CSF<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak concentration(Cmax) |  | 1 year | 
| elimination half life(t 1/2kel) |  | 1 year | 
| area under the curve(AUC) |  | 1 year |
Energy Expenditure Pre and Post Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
Obese patients are going to be submitted to indirect calorimetry pre-operatively and we are going to repeat the same exam 6 months after bariatric surgery (post Roux-en-Y gastric Bypass surgery). They are going to do also body composition analysis in both moments. The investigators are going to compare the results to see if the bariatric surgery increases their energy expenditure.

Official Title
-----------------
Energy Expenditure in Patients Pre and Post Bariatric Surgery

Conditions
-----------------
Bariatric Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obese patients that will be submitted to bariatric procedure Exclusion Criteria: patients that don´t have clinical conditions to be submitted to a bariatric procedure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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
-----------------
energy expenditure, morbid obesity, bariatric surgery, nutritional follow-up
Retinal Nerve Fiber Layer Thickness Measurement on Parapapillary Atrophy With the Cirrus High-Definition (HD) Optical Coherence Tomography (OCT)

Study Overview
=================
Brief Summary
-----------------
Retinal nerve fiber layer (RNFL) thickness measurement on the parapapillary atrophy is incorrect. Because a new spectral domain OCT, the Cirrus HD OCT, uses a movable circle to analyze the RNFL thickness, we may suggest a new analysis strategy for the parapapillary atrophy.

Detailed Description
-----------------
Recently, the retinal nerve fiber layer (RNFL) thickness measurement using the optical coherence tomography (OCT) becomes very useful to detect such a glaucomatous damage. However, there are some difficult cases including parapapillary atrophy to perform this measurement. Because the RNFL thickness is so sensitive to the position of measurement and the measurement of RNFL thickness on parapapillary atrophy is incorrect, it is difficult to determine exact RNFL thickness in patients with a large parapapillary atrophy. In the present study, we want to find the proper method to analyze the RNFL thickness on parapapillary atrophy. The previous OCT used a fixed circle to measure the RNFL thickness, but the new spectral domain OCT, the Cirrus HD OCT, uses a movable one. Therefore, we may suggest a new analysis strategy for the parapapillary atrophy.

Official Title
-----------------
Retinal Nerve Fiber Layer Thickness Measurement on Parapapillary Atrophy With

Conditions
-----------------
Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Qualified OCT images (signal strength > or = 8) Exclusion Criteria: Previous intraocular surgery history Media opacity DM

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>No parapapillary atrophy | |
| 2<br>Parapapillary atrophy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal nerve fiber layer thickness |  | when the OCT images are taking | 
| Size of parapapillary atrophy |  | when the OCT images are taking | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parapapillary atrophy, Retinal nerve fiber layer thickness, Glaucoma, Cirrus OCT
Demonstrate the Superiority of the Immune Response of Adjuvanted Influenza Vaccine Induced in an Adult Population

Study Overview
=================
Brief Summary
-----------------
The study is designed to demonstrate a meaningful difference in immunogenicity between the candidate adjuvanted vaccine compared to the licensed Fluarix vaccine in subjects aged 50 years and above. A control group in younger adults aged 18 to 40 years was included.

Detailed Description
-----------------
This is a study to demonstrate the superiority of the immune response of adjuvanted influenza vaccine induced in an adult population.

Official Title
-----------------
A Phase II/III, Observer-blind, Multi-Country, Multi-Centre, Randomized Study to Demonstrate the Superiority in Terms of Immunogenicity of Adjuvanted Influenza Vaccine Administered in Adults Aged 50 Years and Older Compared to Fluarix™

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: Fluarix
* Biological: adjuvanted influenza vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subjects must be healthy adults 18-40 years or >/= 50 years. Exclusion Criteria: Subjects will be excluded if they take/have taken chronically high doses of immunosuppressants or other immune modifying drugs within six months before vaccination, or immunoglobulins or blood products within three months before vaccination, or any investigational product within 30 days before vaccination, or a licensed vaccine within 2 (inactivated) to 4 (live) weeks before vaccination, if women are pregnant or lactating, or if subjects have acute clinically significant disease or an immunosuppressive/deficient condition, or have contra-indications to influenza vaccination.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Fluarix|nan|
|Biological: adjuvanted influenza vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate that the immune response induced by the adjuvanted influenza vaccine in the elderly is superior to that induced by Fluarix, for each vaccine strain |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate in all subjects, the safety, the humoral response and the cell-mediated immune (CMI) response of the adjuvanted influenza vaccine and Fluarix |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elderly, Improved vaccine, Influenza, Influenza disease
Ramucirumab Use in Combination With Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma; Temporary Authorization for Use (ATU) in France

Study Overview
=================
Brief Summary
-----------------
The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the ATU.

Official Title
-----------------
Ramucirumab Use in Combination With Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma; Temporary Authorization for Use (ATU) in France

Conditions
-----------------
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: Ramucirumab
* Drug: Paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participant has histologically or cytologically confirmed gastric adenocarcinoma, including gastroesophageal junction (GEJ) adenocarcinoma (Participants with adenocarcinoma of the distal esophagus are eligible if the primary tumor involves the GEJ.) after prior chemotherapy. Acceptable prior chemotherapy regimens for this protocol are combination chemotherapy regimens that include platinum or fluoropyrimidine components (acceptable prior platinum agents are cisplatin, carboplatin, or oxaliplatin; acceptable prior fluoropyrimidine agents are 5-fluorouracil (5-FU) and capecitabine). Prior trastuzumab use in human epidermal growth factor receptor 2 positive (HER2+) participants is accepted too. The participant is eligible for treatment by chemotherapy and has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1. Exclusion Criteria: Participant has a known allergy to any of the treatment components.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ramucirumab|Administered intravenously (IV)|
|Drug: Paclitaxel|Administered IV|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Presep and Vascath Interaction Study

Study Overview
=================
Brief Summary
-----------------
This is a prospective, observational study to compare presep(tm) catheter central vein mixed venous oxygen saturation before and after dialysis is initiated via the vascath(tm) central venous dialysis catheter to evaluate device interaction.

Detailed Description
-----------------
The central venous oxygen saturation catheter measurement may be influenced by close approximation to the tip of the central venous hemodialysis catheter when hemodialysis is ongoing.

Official Title
-----------------
A Pilot Study to Compare the Interaction Between Central Venous Mixed Venous Oxygen Saturation Catheters and Central Venous Hemodialysis Catheters

Conditions
-----------------
Hemodynamics, Renal Dialysis, Sepsis, Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted to the MICU PreSep venous oxygen saturation central venous catheter already in place VasCath central venous dialysis catheter already in place Planned hemodialysis Exclusion Criteria: Patient unable to undergo hemodialysis Contraindication for PreSep or VasCath catheters

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 |
| --- | --- | --- |
| change in SvO2 |  | before and afer initiation of dialysis via a vascath | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemodynamics, oxygen, renal dialysis, shock, sepsis, hypotension, lactic acidosis
To Demonstrate the Relative Bioequivalency of Cord's 100 mg Desipramine HCL Tablets To Merrell Dow's 100 mg Norpramin Tablets

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioequivalency of Cord's 100 mg Desipramine HCl tablets to Merrell Dow's 100 mg Norpramin tablets.

Official Title
-----------------
A Two-Way Single Dose Crossover Bioequivalency of Cord's 100 mg Desipramine HCL Tablets To Merrell Dow's 100 mg Norpramin Tablets

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: Desipramine HCL 100 mg Tablets Cord Laboratories
* Drug: Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, Inc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Desipramine HCL 100 mg Tablets Cord Laboratories | Drug: Desipramine HCL 100 mg Tablets Cord Laboratories<br> <br> |
| Active Comparator: 2<br>Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, Inc | Drug: Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, Inc<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 24 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antidepressant
Novel Quantitative Magnetic Resonance Imaging (MRI) Measures in the Assessment and Follow-up of Patients With Pulmonary Hypertension (PH)

Study Overview
=================
Brief Summary
-----------------
A prospective study of the use of two novel MRI techniques (oxygen-enhanced and fourier decomposition MRI) in the initial diagnosis and follow-up of patients with Pulmonary Hypertension. The investigators believe these techniques may present a novel set of imaging biomarkers that may be used for risk stratification, prediction of treatment response and longitudinal disease monitoring. The reserach MRI is in addition to standard of care and will not affect treatment decisions.

Official Title
-----------------
Novel Quantitative Magnetic Resonance Imaging (MRI) Measures in the Assessment and Follow-up of Patients With Pulmonary Hypertension (PH)

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Diagnostic Test: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of Pulmonary Hypertension. Age 18 and over. Exclusion Criteria: Standard contra-indications to MRI (as per NHS MRI safety questionnaire). Not medically fit for transfer to MRI. Patient judged inappropriate for involvement in study by clinical team e.g. secondary to emotional burden of recent diagnosis.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: MRI|Oxygen enhanced and fourier decomposition MRI|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delta pO2 max (mmHg) |  | Baseline and 3-6 months | 
| Wash in and wash out time constants (min) |  | Baseline and 3-6months | 
| Signal Intensity Change (%) |  | Baseline and 3-6months | 
| Fractions (% area of lung imaged) |  | Baseline and 3-6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, oxygen enhanced, fourier decomposition