linjc16/ctgov huggingface dataset:
Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery

Study Overview
=================
Brief Summary
-----------------
A one time oral dose of ALA is taken before surgery. The medication makes the tumor visible under ultraviolet light which allow the surgeon to see more of the tumor for a more complete removal.

Detailed Description
-----------------
Patients with primary neoplastic brain tumors (Grades II-IV) will participate in this trial. Each patient will have been evaluated and found to have such a tumor by history and recent imaging studies (MRI) and deemed a surgical candidate based on current neurosurgical standards of care.

Official Title
-----------------
A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Primary Glial Neoplasms of the Brain.

Conditions
-----------------
Glioblastoma

Intervention / Treatment
-----------------
* Drug: Aminolevulinic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected primary brain tumor 18 years of age or more Normal marrow and organ function Eastern Cooperative Group performance status ≤ 2 Women of childbearing potential must use adequate birth control Ability to understand and willingness to sign a written informed consent form Life expectancy not a consideration Exclusion Criteria: Receiving any other investigational agents History of allergic reactions to ALA Personal or family history of porphyrias Liver disease in the past year Uncontrolled intercurrent illness Pregnant or lactating women Inability to undergo MRI with contrast

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single-Arm<br>Single-Arm All subjects received 20mg/kg of Aminolevulinic Acid diluted in 50cc of water, orally, approximately 3 hours prior to surgery. | Drug: Aminolevulinic Acid<br>* 20 mg/kg mixed in 50cc water and taken orally 3 hours prior to surgery<br>* Other names: ALA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| More complete resection of malignant brain tumors |  | 3-7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of drug |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain tumor, glioma, surgical resection, ALA, ultraviolet light
Study Evaluating Tigecycline in Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of tigecycline in the treatment of selected serious infections caused by VRE. The primary efficacy endpoint will be the clinical response for all subjects.

Official Title
-----------------
A Clinical Research Study to Evaluate the Safety and Efficacy of Tigecycline in the Treatment of Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)

Conditions
-----------------
Gram-Positive Bacterial Infections, Staphylococcus Infections, Vancomycin Resistance, Methicillin Resistance

Intervention / Treatment
-----------------
* Drug: Tigecycline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects aged 18 years or older Isolation of one of the following multi-antibiotic resistant bacteria: vancomycin-resistant Enterococcus faecium, vancomycin-resistant Enterococcus faecalis, or methicillin-resistant Staphylococcus aureus, alone or as part of a polymicrobial infection Have a confirmed diagnosis of a serious infection (eg, bacteremia [unless due to an excluded infection], complicated intra-abdominal infection, complicated skin and skin structure infection, or pneumonia) requiring administration of intravenous (IV) antibiotic therapy Exclusion Criteria: Subjects with any concomitant condition or taking any concomitant medication that, in the opinion of the investigator, could preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up assessment will be completed or that will substantially increase the risk associated with the subject's participation in this study Anticipated length of antibiotic therapy less than 7 days For subjects with VRE, known or suspected hypersensitivity to tigecycline or linezolid, or other compounds related to these classes of antibacterial agents (eg, oxazolidinones, tetracyclines, minocycline, doxycycline). For subjects with MRSA, known or suspected hypersensitivity to tigecycline or vancomycin, or other compounds related to these classes of antibacterial agents (eg, tetracyclines, minocycline, doxycycline)

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tigecycline|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
-----------------
Staphylococcus aureus, Bacterial Infections
GLP-1's Effect on Cardiac Parameters and Mesenteric Blood Flow

Study Overview
=================
Brief Summary
-----------------
to investigate the effect of the human incretin hormone GLP-1 on mesenteric blood flow and cardiac parameters

Detailed Description
-----------------
to investigate the effect of the human incretin hormone GLP-1 on mesenteric blood flow and cardiac parameters, in healthy subjects, 4 arms, task force monitor

Official Title
-----------------
GLP-1's Influence on Intestinal Blood Flow

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

Intervention / Treatment
-----------------
* Other: 1,5 nmol/kg,GLP-1 sc injection
* Other: 1,5 nmol/kg GLP-1 9-36amide, sc injection
* Other: Exendin-4 ;10 ug,sc injection
* Other: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects Exclusion Criteria: medical conditions

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GLP-1<br>1,5 nmol/kg,GLP-1 sc injection | Other: 1,5 nmol/kg GLP-1 9-36amide, sc injection<br> <br> Other: Exendin-4 ;10 ug,sc injection<br> <br> |
| Active Comparator: GLP-1 9-36amide<br>1,5 nmol/kg GLP-1 9-36amide, sc injection | Other: 1,5 nmol/kg,GLP-1 sc injection<br> <br> * Other names: native GLP-1;Other: Exendin-4 ;10 ug,sc injection<br> <br> |
| Active Comparator: Exendin-4<br>Exendin-4 ;10 ug,sc injection | Other: 1,5 nmol/kg,GLP-1 sc injection<br> <br> * Other names: native GLP-1;Other: 1,5 nmol/kg GLP-1 9-36amide, sc injection<br> <br> |
| Placebo Comparator: isotonic saline<br>2 ml of isotonic saline, sc injection | Other: 1,5 nmol/kg,GLP-1 sc injection<br> <br> * Other names: native GLP-1;Other: 1,5 nmol/kg GLP-1 9-36amide, sc injection<br> <br> Other: saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood flow | blood flow change measured by ultra sound | with in 120 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GLP-1, blood flow, cardiac out put, stroke volume, beat to beat, effect of GLP-1 on cardiac parameters and blood flow
Plaque Stratification Using Ccta in Coronary ARtery Disease (PoSTCARD)

Study Overview
=================
Brief Summary
-----------------
Develop time-to-event prediction and plaque phenotype classification models for patients with known or suspected coronary artery disease.

Detailed Description
-----------------
Develop time-to-event prediction and plaque phenotype classification models using plaque morphology and composition assessment of CTA which has been validated by histology, applied to representative cohort of patients. Generalizability of models is enhanced by using validated rather than only raw image inputs. Demographic, clinical, and outcome data is collected for enrolled patients as well as last known well dates.

Official Title
-----------------
Plaque Stratification Using Ccta in Coronary ARtery Disease (PoSTCARD)

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

Intervention / Treatment
-----------------
* Device: vascuCAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must have successfully completed at least one (possibly multiple) CCTA for known or suspected coronary artery disease, which was positive for coronary atherosclerotic changes. Subject must have been ≥ 18 years of age at the time of the CCTA Exclusion Criteria: Subject has a history of percutaneous coronary intervention (PCI) with stent implantation and/or coronary artery bypass grafting (CABG) CCTA taken less than 3 months after deployment of new scanner Subject with insufficient CCTA image quality

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Development / training<br>Selected by stratified partitioning | Device: vascuCAP<br>* time to event and phenotype classification model<br>|
| Sequestered / test<br>Selected by stratified partitioning | Device: vascuCAP<br>* time to event and phenotype classification model<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to adverse outcome | Develop time-to-event model for major adverse cardiac events (MACE) prediction on large retrospective cohort (and enable a prospective collection subsequent to this study). Consistent with this primary endpoint is the evaluation of all imaging-derived data that has a bearing on the diagnosis and prognosis of the subject. | >= 2 years |
Identification of Risk Allels for Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Identification of Risk Allels for Prostate Cancer

Detailed Description
-----------------
As above.

Official Title
-----------------
Identification of Risk Allels for Prostate Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with prostate cancer.
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
Endodontic Root-canal Treatments Evaluated After Long-term Time

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to evaluate the root canal treatments performed from 1989 to 1995. Type of complication, success, new endodontic diseases and number of success were reported. Mean clinical parameters were clinical symptoms and presence/absence of apical radiolucency.

Detailed Description
-----------------
See previous papers (Pirani et al., Odontology, 2015)

Official Title
-----------------
Long-term Evaluation of Endodontic Root Canal Treatments: Complication, Factors Affecting Failure, New Disease and Success

Conditions
-----------------
Root Canal Treatment, Endodontic Disease

Intervention / Treatment
-----------------
* Procedure: Root canal orthograde treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients affected by endodontic disease and able to attend a recall hygien program Exclusion Criteria: Sistemic disease Cancer Inability to attend a recall hygien program

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Root canal treatment<br> | Procedure: Root canal orthograde treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Patients | patients with periapical disease and/or pulpal disease | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endodontology, Endodontics
The Effects of PG102, a Water Soluble Extract From Actinidia Arguta, on Serum Total IgE Levels

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the efficacy of PG102 at lowering levels of total IgE in asymptomatic subjects with atopy.

Official Title
-----------------
The Effects of PG102 on Allergy-related Risk Factors: A Randomized, Double Blind, Placebo Controlled Study

Conditions
-----------------
Asymptomatic Subjects With Atopy and Elevated Serum IgE

Intervention / Treatment
-----------------
* Dietary Supplement: PG102, a water soluble extract from Actinidia arguta
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects who have atopy but no allergy-related symptoms subjects with total IgE levels of 300IU/ml or more acquisition of written informed consent prior to commencement of study no serious clinical symptoms and normal laboratory test results; in case of abnormal finding, subjects whose conditions are not deemed severe from the judgement of investigators Exclusion Criteria: individuals with normal levels of total serum IgE ue of one or more allergic drugs serious clinical conditions (such as malignancies, severe cardiovascular disease etc.) serious mental disorder pregnant woman or woman of childbearing potential within 3 months subjects who participated in other clinical trials in the past 6months individuals who have a plan to participate in another clinical trials during this trial subjects with a history of kiwi allergy subjects whose conditions are inappropriate by investigators

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PG102 group<br> | Dietary Supplement: PG102, a water soluble extract from Actinidia arguta<br>* PG102 two tables(Actinidia arguta extract:Microcrystalline cellulose(1:1)mixed powder 1120mg) twice a day for 8weeks<br>|
| Placebo Comparator: placebo group<br> | Other: placebo<br>* placebo two tables(equivalent dose of Microcrystalline cellulose) twice a day for 8weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum total IgE level |  | 8weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum level of allergy-related factors, such as eosinophilic cation protein(ECP), eotaxin, thymus, and activation-regulated chemokine (TARC), IL-4, IL-5, and IL-13, skin test(atopy score), and adverse reactions |  | 8weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atopy, IgE
Daptomycin Concentration in Drainage Fluid and Blood Samples of ICU Patients

Study Overview
=================
Brief Summary
-----------------
10 patients with chronic heart failure receiving daptomycin therapy after implantation of a left ventricular heart assist system. Measurement of daptomycin levels in drainage fluids (mediastinal and pleural drainage systems) and in blood samples.

Official Title
-----------------
Daptomycin Concentration in Drainage Fluid and Blood Samples of ICU Patients

Conditions
-----------------
Heart Assist Device

Intervention / Treatment
-----------------
* Drug: Daptomycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written consent heart assist device implantation wound drainage daptomycin therapy Exclusion Criteria: pregnancy no written consent possible absence of wound drainage allergy to study medication acute rhabdomyolysis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Daptomycin|standard care|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| levels of Daptomycin in drainage fluid | Pharmacokinetics of Daptomycin in intensive care patients with wound drainage after surgery (LVAD implantation) | 4 days | 
| levels of Daptomycin in blood samples | Pharmacokinetics of Daptomycin in intensive care patients after surgery (LVAD implantation) | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infections | incidence of gram-positive infections | 14 days |
First in Man Study With SLV342

Study Overview
=================
Brief Summary
-----------------
First in man study with single and multiple rising doses with SLV342

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV342 in Young Healthy Male Subjects

Conditions
-----------------
Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: SLV342
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Healthy Exclusion Criteria Not healthy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>SLV342 suspension or capsule | Drug: SLV342<br>* 25 mg once daily - Maximal Tolerated Dose<br>|
| Placebo Comparator: B<br>matching placebo | Drug: placebo<br>* matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability parameters: adverse event, vital signs, 12-Lead ECG, continuous lead II ECG monitoring, laboratory safety variables and physical examination |  | 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, λz, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR |  | 28 days | 
| Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring |  | 28 days | 
| Midazolam PK parameters |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
First in Man, SLV342, Atherosclerosis
Position Of The Tip Of The Inner Catheter And Air Bubbles As Predictors Of Pregnancy During ICSI Cycles

Study Overview
=================
Brief Summary
-----------------
Position of the tip of the inner catheter and air bubbles detection (at time,5min 10min)during embryo transfer influence the pregnancy rate in ICSI cycles .

Detailed Description
-----------------
The aim of this study is to assess the relationship between the position of the tip of the inner catheter, the position of the air bubbles (at time , 5 min ,10 min )after embryo transfer and pregnancy rate outcome in ICSI cycles. Most IVF teams consider not touching the endometrium and the uterine fundus with replacement of the embryos in the lumen of the endometrial cavity the most important factors for successful embryo transfer, it is highly recommended to use agents that can facilitate a smooth embryo transfer and reduce unintended stimulation of the fundus, for example the application of soft-tipped catheters, which can improve pregnancy rate. The advantage of using the air and liquid content for catheter loading is to prevent the embryo from adhering to the wall of the catheter at the time of injection.The presence of two air bubbles on both sides of the medium that contains the embryo prevents the transfer of the embryo within the catheter and beside, in the transfer under ultrasonographic guidance, the air bubbles are often considered a marker for the embryo's position in the uterus.

Official Title
-----------------
Position Of The Tip Of The Inner Catheter And Air Bubbles As Predictors Of Pregnancy During ICSI Cycles:Prospective Observational Study

Conditions
-----------------
Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI < 30 kg/ m2. Between 20 and 35years old. FSH levels on cycle day 3 of <12 mIU/mL. Both ovaries present deprived of morphological abnormalities and adequately visualized in Transvaginal ultrasound. Grade one or two embryo quality. Exclusion Criteria: Hydrosalpinx. Intrauterine lesion. Patients undergoing ET after cryopreservation. Blood present on the catheter during the transfer procedure. A difficult transfer or with a suspicion of touching the fundus. Endometrial thickness less than 8mm. Known allergic reaction against one of the ingredient of the medications used during the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate |  | one and half year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clinical pregnancy rate after embryo transfer