linjc16/ctgov huggingface dataset:
A Phase-1 Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
To assess the multiple-dose pharmacokinetics (PK), safety and tolerability of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) in healthy volunteers.

Official Title
-----------------
A Phase 1, Single-center, Randomized, Open-label Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide/Quinidine Sulfate) in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: AVP-786
* Drug: AVP-923


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult males 18 - 45 years of age BMI 18 - 30 kg/m2 Exclusion Criteria: History or presence of significant disease History of substance abuse and/or alcohol abuse with the past 3 years Use of tobacco-containing or nicotine-containing products within 6 months Use of any prescription or the over-the-counter medications within 14 days

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A - Period 1<br>Twice daily dosing orally for 7 days | Drug: AVP-786<br> <br> |
| Active Comparator: Cohort A - Period 2<br>Twice daily dosing orally for 7 days | Drug: AVP-923<br> <br> |
| Experimental: Cohort A - Period 3<br>Twice daily dosing orally for 7 days | Drug: AVP-786<br> <br> |
| Experimental: Cohort B - Period 1<br>Twice daily dosing orally for 7 days | Drug: AVP-786<br> <br> |
| Active Comparator: Cohort B - Period 2<br>Twice daily dosing orally for 7 days | Drug: AVP-923<br> <br> |
| Experimental: Cohort B - Period 3<br>Twice daily dosing orally for 7 days | Drug: AVP-786<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of AVP-786 |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) for AVP-786 |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Healthy Volunteers, deuterated dextromethorphan, deuterated dextromethorphan with quinidine
Effects of Palatinose™ on Weight Management and Body Composition

Study Overview
=================
Brief Summary
-----------------
The study aims to assess body weight and body composition changes in overweight and obese persons consuming an energy-reduced diet containing foods with either sucrose or isomaltulose (Palatinose(TM)) over a period of 3 months.

Official Title
-----------------
The Effects of Palatinose™ on Weight Management and Body Composition in Overweight and Obese Individuals

Conditions
-----------------
Overweight and Obesity, Diet Modification, Body Weight

Intervention / Treatment
-----------------
* Other: isomaltulose (Palatinose(TM)
* Other: Sucrose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is healthy at the time of pre-examination Subject has a BMI of 25 - 35 kg/m² and motivated to lose weight Subject is aged 18 - 60 years at the time of pre-examination Exclusion Criteria: Person suffers from an acute or chronic disease Person has known dietary restrictions or allergies to Foods Intake of medications which interfere with body composition, appetite, satiety or food intake

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sucrose<br>Test products i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals containing sucrose | Other: Sucrose<br>* sucrose containing food products, i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals, consumed within an energy-reduced diet<br>|
| Experimental: Palatinose(TM)<br>Test products i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals containing isomaltulose (Palatinose™) | Other: isomaltulose (Palatinose(TM)<br>* isomaltulose containing food products, i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals, consumed within an energy-reduced diet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight Change | Body weight Change over a 12-week period | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fat percentage | Body fat percentage measured using the BodPod | 12 weeks | 
| postprandial respiratory quotient (RQ) | postprandial energy metabolism, i.e. respiratory quotient (RQ) and fat oxidation measured by indirect calorimetry | 120 minutes postprandial | 
| BMI | Body mass index (kg/m2) | 12 weeks | 
| Waist circumference | Waist circumference assessed using a measuring tape | 12 weeks |
Heparin Solution and INTEM/HEPTEM Analysis

Study Overview
=================
Brief Summary
-----------------
Heparinized solution has been used for maintenance of arterial catheter during perioperative period. Although the infused dose of heparin is very low, the investigators examine whether the heparin effect is remained or not in blood using rotational thromboelastometry (ROTEM) analysis.

Official Title
-----------------
Influence by Heparinized Flush Solution of the Radial Artery Catheter: INTEM and HEPTEM Analysis.

Conditions
-----------------
Brain Tumor, Spinal Stenosis, Cerebral Artery Anuerysm

Intervention / Treatment
-----------------
* Drug: Heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients requiring continuous invasive arterial pressure monitoring during operation for anesthetic management. Exclusion Criteria: heparin hypersensitivity hematologic disease anticoagulant medication

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Heparin<br> | Drug: Heparin<br>* Heparinized flush solution contained heparin concentration of 2 unit/ml and continuous flow of the flush solution was 5 ml/h at 300 mmHg.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| INTEM test | INTEM is not an abbriviation. INTEM is one of the ROTEM test and it is an coagulation test name (such as prothrombin time test) using patient's whole blood. We put the blood sample of patinet into the machine, so the result comes out automatically. It will be checked twice at pre- and postopertive 30 minute and it'll be analyzed and compared. | at 30 min before operation and 30 min after operation | 
| HEPTEM test | HEPTEM is not an abbriviation. HEPTEM is one of the ROTEM test and it is an coagulation test name (such as prothrombin time test) using patient's whole blood. We put the blood sample of patinet into the machine, so the result comes out automatically. It will be checked twice at pre- and postopertive 30 minute and it'll be analyzed and compared. | at 30 min before operation and 30 min after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total infused units of heparin |  | periond from starting operation to finishing operation (espected average of 5 hours). |
Study of the Clinical Utility of PSMA Imaging in the Evaluation of Men With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
In this study we aim to more precisely define the clinical utility of PSMA imaging across a range of clinical indications in men with prostate cancer. To accomplish this, we will make the 18F-DCFPyL PET/CT scan available to urologists, medical oncologists, and radiation oncologists at Johns Hopkins and survey physicians as to the indication for ordering the PET/CT and if a change in management occurred as the result of new information gained from the scan. We believe these data will prove critical for planning future studies aimed at evaluating the efficacy of this test for improving patient outcomes.

Official Title
-----------------
Study of the Clinical Utility of PSMA Imaging in the Evaluation of Men With Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: 18F DCFPyL- Radiopharmaceutica


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Willingness to signed informed consent Histologically confirmed adenocarcinoma of the prostate PSA measurement ≤60 days prior to study enrollment Completed radiographic evaluation with whole-body bone scan (99mTc-MDP or Na18F) and cross-sectional imaging (CT or MRI) of the abdomen and pelvis ≤60 days prior to study enrollment Exclusion Criteria: Administered a radioisotope within 5 physical half-lives prior to study enrollment History of other malignancy diagnosed within the last 5 years (exceptions: low grade urothelial carcinoma of the bladder, squamous cell carcinoma or basal cell carcinoma of the skin).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| adenocarcinoma of the prostate<br> | Drug: 18F DCFPyL- Radiopharmaceutica<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician responses to a questionnaire | The Post-PET/CT questionnaire will determine if the PET/CT scan results in changes to clinical management of patient illness. | less than 1 year |
Study of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia

Study Overview
=================
Brief Summary
-----------------
This is a Phase 3, multicenter, prospective, randomized, open-label, study to compare the safety and efficacy of intravenous (IV) ceftolozane/tazobactam with that of IV piperacillin/tazobactam in the treatment of ventilator-associated pneumonia (VAP) in adult participants .

Official Title
-----------------
A Multicenter, Open-Label, Randomized Study to Compare the Safety and Efficacy of Intravenous Ceftolozane/Tazobactam With That of Piperacillin/Tazobactam in Ventilator Associated Pneumonia

Conditions
-----------------
Ventilator-Associated Pneumonia (VAP)

Intervention / Treatment
-----------------
* Drug: Ceftolozane/Tazobactam
* Drug: Piperacillin/Tazobactam


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Participant has received mechanical ventilation for > 48 hours Acute Physiology and Chronic Health Evaluation (APACHE) II score of 11-35 Presence of a new or progressive infiltrate on chest x-ray Presence of clinical criteria consistent with VAP Key Exclusion Criteria: History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics Known end stage renal disease or requirement for dialysis

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ceftolozane/Tazobactam<br>3000 milligrams (mg) ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered intravenously (IV), every 8 hours for 8 days | Drug: Ceftolozane/Tazobactam<br> <br> |
| Active Comparator: Piperacillin/Tazobactam<br>4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days | Drug: Piperacillin/Tazobactam<br> <br> * Other names: Zosyn;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response at the End of Therapy Visit |  | 24 hours after last dose of study drug |
Corneal Crosslinking for Treatment of Corneal Neovascularization

Study Overview
=================
Brief Summary
-----------------
The study objective is to assess safety and efficacy of photo-activation of riboflavin for treatment of corneal neovascularization with or without concomitant inflammation and/or infection.

Official Title
-----------------
Randomized Comparison of Standard vs. Accelerated Corneal Crosslinking for Treatment of Corneal Neovascularization With or Without Concomitant Inflammation and/or Infection

Conditions
-----------------
Corneal Neovascularization

Intervention / Treatment
-----------------
* Combination Product: 30 minute photoactivation of riboflavin 0.1%
* Combination Product: 10 minute photoactivation of riboflavin 0.1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older With active inflammation or infection causing vascularization and possibly melting of the cornea, or vessels extending into the cornea causing lipid deposition, or vascularization that could significantly increase the risk of rejection of a current or planned corneal transplant, or vessels that continue to extend into the cornea despite topical treatment with corticosteroids. Signed written informed consent. Exclusion Criteria: Known sensitivity to treatment medications Current condition that in the investigator's opinion could compromise safety or data integrity. Pregnancy (including plan to become pregnant) or lactation during the course of 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 30 minute photoactivation<br>photoactivation of riboflavin 0.1% using 365-nm UV light, 3mW/cm2 for 30 minutes | Combination Product: 30 minute photoactivation of riboflavin 0.1%<br>* Use of riboflavin 0.1% eye drops and 3mW/cm2 UVA light for 30 minutes<br>|
| Active Comparator: 10 minute photoactivation<br>photoactivation of riboflavin 0.1% using 365-nm UV light, 9mW/cm2 for 10 minutes | Combination Product: 10 minute photoactivation of riboflavin 0.1%<br>* Use of riboflavin 0.1% eye drops and 9mW/cm2 UVA light for 10 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corneal neovascularization as a proportion of the total corneal area | the cornea will be photographed and morphometric image analysis software will be used to measure corneal neovascularization as a proportion of the total corneal area. The proportion measured at baseline will be compared with the proportion measured at 6 months after treatment. | 6 months |
Reliability and Diagnostic Accuracy of an Alternate Lachman's Test Performed in a Prone Position

Study Overview
=================
Brief Summary
-----------------
This study is investigating the reliability and diagnostic accuracy of a Lachman's test conducted in a prone position to detect the presence of a torn anterior cruciate ligament.

Official Title
-----------------
Reliability and Diagnostic Accuracy of an Alternate Lachman's Test Performed in a Prone Position

Conditions
-----------------
Anterior Cruciate Ligament Stability

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: current knee pain complaint in subjects between 15 and 60 years old Exclusion Criteria: the inability to assume the prone testing position evidence of a fracture by application of the Ottawa Fracture rule previous knee joint arthroplasty suspicion of posterior cruciate involvement knee surgery in the previous six months presence of serious underlying non-mechanical pathology systemic illness

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 60 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
-----------------
accuracy, anterior cruciate ligament, diagnostic value, examination, knee, Lachman test, sensitivity, specificity
Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls

Study Overview
=================
Brief Summary
-----------------
This is a phase IV study to evaluate the body's immune response of participants to the Cervarix and Gardasil vaccines against the Human Papilloma Virus (HPV) types associated with increased risk of cervical cancer.

Detailed Description
-----------------
This study looks at possible cross reactivity between different HPV serotypes and both peripheral antibodies and mucosally-secreted antibodies.

Official Title
-----------------
A Phase IV, Randomised Study to Evaluate the Immune Responses of UK Adolescent Girls Receiving CervarixTM or GardasilTM Human Papillomavirus Vaccines

Conditions
-----------------
HPV Infections

Intervention / Treatment
-----------------
* Biological: Cervarix
* Biological: Gardasil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 13 and 15 years at the time of the first immunisation Female No contraindications to vaccination as specified in the Green Book - Immunisation Against Infectious Disease, HMSO. Written informed consent obtained from parent or guardian of subject Exclusion Criteria: Pregnant or become pregnant during the course of the trial (no contraindications to vaccination for those taking the contraceptive pill). Breast-feeding mothers Allergic to vaccine components

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cervarix<br>Three doses of Cervarix at month 0, 1 and 6. Blood sample at month 0, 2, 7 and 12. Optional vaginal sponge sample at month 7. | Biological: Cervarix<br>* Three doses of Cervarix at month 0, 1 and 6.<br>|
| Active Comparator: Gardasil<br>Three doses of Gardasil at month 0, 1 and 6. Blood sample at month 0, 2, 7 and 12. Optional vaginal sponge sample at month 7. | Biological: Gardasil<br>* Three doses of Gardasil at month 0, 1 and 6.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurable antibody mediated neutralisation of HPV serotype 6, 11, 16, 18 and genetically related serotypes, especially 45 |  | 18 months from enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine differences in vaccine formulation and their impact on cross protection. |  | 24 months from enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HPV, Human Papilloma Virus, Cervical cancer vaccine
Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to assess the activity of ZD1839 250 mg once daily in addition to the standard chemotherapy in patients with advanced or metastatic transitional cell carcinoma of the urothelium by estimating the time to progression.

Official Title
-----------------
An Open Randomised Phase II Study Of Gemcitabine Plus Cisplatin +/- Concomitant or Sequential ZD1839 in Patients With Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Drug: Gemcitabine
* Drug: Cisplatin
* Drug: Gefitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically-confirmed transitional cell carcinoma of the urothelium Locally advanced or metastatic disease At least one measurable lesion as defined by RECIST Chemotherapy-naiv Exclusion Criteria: Previous chemotherapy or other systemic antitumour therapy Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma, cervical cancer in situ or locally limited prostate cancer

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Cisplatin + Gemcitabin | Drug: Gemcitabine<br>* intravenous<br>Drug: Cisplatin<br>* intravenous<br>|
| Experimental: 2<br>Cisplatin + Gemcitabin + Gefitinib | Drug: Gemcitabine<br>* intravenous<br>Drug: Cisplatin<br>* intravenous<br>Drug: Gefitinib<br>* oral<br>* Other names: ZD1839;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression (TTP) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Response rate |  |  | 
| 2. Overall survival time |  |  | 
| 3. Time to treatment failure |  |  | 
| 4. Disease control rate |  |  | 
| 5. Duration of response |  |  | 
| 6. Safety and tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bladder cancer, Transitionel cell cancer of the urothelium