linjc16/ctgov huggingface dataset:
Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether N-acetylcysteine is effective in the prophylaxis of post-cardiopulmonary bypass acute renal impairment.

Detailed Description
-----------------
BACKGROUND Reactive oxygen species have been shown to cause contrast-induced nephrotoxicity (CIN). According to previous studies, the N-acetylcysteine has been proved to be advantageous in the avoidance of CIN. We seek to evaluate the efficacy of the antioxidant N-acetylcysteine in limiting the nephrotoxicity after cardiovascular surgery with cardiopulmonary bypass. METHODS We will prospectively study 60 patients who will receive a cardiovascular surgery with cardiopulmonary bypass. Patients will be randomly assigned to receive either N-acetylcysteine (600 mg orally twice daily for 4 doses) with 0.45% saline intravenously, before and after cardiopulmonary bypass, or placebo with 0.45% saline. Serum creatinine and blood urea nitrogen will be measured before, 48 h and 5 days after the operation procedure. Expected results Prophylactic oral administration of the antioxidant N-acetylcysteine, along with hydration, will significantly reduce the acute renal damage induced by CPB in patients with chronic renal insufficiency that need cardiovascular procedures.

Official Title
-----------------
N-Acetylcysteine Protects Against Acute Renal Insult in Patients With Abnormal Renal Function Undergoing Cardiopulmonary Bypass.

Conditions
-----------------
Cardiovascular Disease, Renal Insufficiency, Acute, Cardiopulmonary Bypass

Intervention / Treatment
-----------------
* Drug: N-Acetylcysteine 600mg/tab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who will received cardiac surgery with cardiopulmonary bypass Exclusion Criteria: Dialyzed patients Acute renal failure Advanced left ventricular systolic dysfunction defined as left ventricular ejection fraction ≦ 35%. Acute chronic obstructive lung disease or asthma exacerbation Allergy to N-acetylcysteine

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: N-Acetylcysteine 600mg/tab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine and blood urea nitrogen: before, 48 h and 5 days after the operation procedure. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acetylcysteine, cardiac surgery, cardiopulmonary bypass, acute renal insufficiency
Effectiveness of Rifabutin in the Treatment of Mycobacterium Avium Complex

Study Overview
=================
Brief Summary
-----------------
Treatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections who have failed or are intolerant of rifampin. Rifabutin may be a reasonable alternative agent in patients who fail rifampin or or intolerant of rifampin.

Detailed Description
-----------------
Rifabutin dosage 150-300 mg daily( depending upon age, and clinical conditions) in NTM patients who fail treatment with rifampin.

Official Title
-----------------
Clinical Efficacy of Rifabutin in the Treatment of Serious and Life Threatening Infections Due to Mycobacterium Avium Complex, or Drug Resistant Mycobacterium Tuberculosis, or Other Drug Resistant Mycobacterium

Conditions
-----------------
Nontuberculous Mycobacterial Infections

Intervention / Treatment
-----------------
* Drug: Rifabutin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults age 18 and older with positive acid-fast bacilli smears and cultures for drug-resistant mycobacteria Exclusion Criteria: Children less than 18 years of age Pregnancy Low platelet count, except with very serious disease

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 |
| --- | --- |
| Experimental: Rifabutin<br>Treatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections or other NTM disease who fail therapy with other drugs ( i.e., rifampin) | Drug: Rifabutin<br>* Rifabutin dosage dependent on clinical factors such as age, weight, and patient-specific health status<br>* Other names: mycobutin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and microbiological outcomes (e.g. clinical symptoms, laboratory cultures) | neg cultures X3( sputum conversion) | 6 mos | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological Cultures | neg cultures for 1 yr on treatment | 1year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MAC and NTM
Epidemiological Study About the Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis

Study Overview
=================
Brief Summary
-----------------
To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis.

Official Title
-----------------
Epidemiological Study About the Clinical and Microbiological Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis.

Conditions
-----------------
Candidiasis, Vulvovaginal

Intervention / Treatment
-----------------
* Other: Clotrimazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sexually active women between 18 and 50 years Patients attending to the gynecologist with acute vulvovaginal candidiasis. Patients requiring standard treatment with clotrimazole 500 single dose and that the decision to prescribe this treatment is prior to inclusion in the study. Women who agree to participate in the study and has signed the informed consent sheet. Exclusion Criteria: Use of any medication that may interfere significantly with study assessments. Pregnant or breastfeeding Women with signs of other genital infection Within 3 months after childbirth or abortion Patients that is expected not to attend follow-up visits

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Clotrimazole<br>Clotrimazole 500 mg | Other: Clotrimazole<br>* All patients receive standard antifungal treatment for this type of infections consisting Clotrimazole 500 Single dose (standard treatment).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal swab test | To verify diagnosis of vaginal candidiasis | Baseline | 
| Vaginal swab test | To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis | month 2 | 
| Vaginal swab test | To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis | month 3 | 
| Vaginal swab test | To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis, only those with a history of more than four episodes in a year | month 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Candidiasis
GARDASIL™ Post Marketing Surveillance in the Philippines (V501-077)

Study Overview
=================
Brief Summary
-----------------
This study will collect safety information on the use of GARDASIL™ in the Philippines.

Official Title
-----------------
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) Post Marketing Surveillance Protocol

Conditions
-----------------
Papillomavirus Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received GARDASIL™

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 46 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 |
| --- | --- |
| All Participants<br>Participants who were vaccinated with GARDASIL™ by their physician | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events following any dose of vaccine |  | At least 30 days following any vaccine dose |
Retrospective Collection of PillCam SB Movies

Study Overview
=================
Brief Summary
-----------------
Up to two hundred un-identified PillCam SB movies will be collected from 2 clinical sites, during up to 3 years and transferred to Given Imaging. Demographical data and medical history will be collected. Capsule transit time in the different sections of the GI will be evaluated.

Detailed Description
-----------------
Up to two hundred un-identified PillCam SB movies that were created between the year 2008 and the date the study was approved by the IRB, will be collected from 2 clinical sites, Sourasky and Sheba medical centers during up to 3 years and transferred to Given Imaging. Demographical data and medical history will be collected. Capsule transit time in the different sections of the GI will be evaluated by internal readers.

Official Title
-----------------
Retrospective Collection of PillCam SB Movies for Capsule Transit Time Analysis (OCEAN Study)

Conditions
-----------------
Inflammatory Bowel Disease, Crohn Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Videos collected from any PillCam SB procedure Exclusion Criteria: None
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 |
| --- | --- | --- |
| Transit time in the different sections of the GI according to PillCam SB movies (minutes) |  | Minutes |
Cabozantinib Real-life Use for Advanced Renal Cell Carcinoma in France: a Retrospective Descriptive Non-interventional Study of 2 Cohorts.

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to describe the real-life conditions of use and exposure of cabozantinib in France in two cohorts defined by their treatment initiation period.

Official Title
-----------------
Cabozantinib Real-life Use for Advanced Renal Cell Carcinoma in France: a Retrospective Descriptive Non-interventional Study of 2 Cohorts.

Conditions
-----------------
Renal Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any subjects from the participating sites (dead or alive) who have received at least one dose of cabozantinib within the ATU program or between 10/12/2016 and 16/02/2018 and for whom the medical file is available Exclusion Criteria: Patients alive at study initiation who have not received information notice who have opposed to data collection.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Subjects who received at least one dose of cabozantinib during the Authorization for Use (ATU) period (12/09/2016 to 09/12/2016) for the treatment of advanced Renal Cell Carcinoma (RCC). | |
| Cohort 2<br>Subjects who received at least one dose of cabozantinib during the first six months after the ATU period (10/12/2016 to 16/02/2018). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of treatment exposure |  | during the whole study period for a maximum of 28 to 31 months | 
| Dose prescribed at initiation |  | during the whole study period for a maximum of 28 to 31 months | 
| Average Daily Dose | average daily dose received by subject during the treatment exposure | during the whole study period for a maximum of 28 to 31 months | 
| Number of subjects with ≥1 temporary interruptions |  | during the whole study period for a maximum of 28 to 31 months | 
| Number of interruptions per subject |  | during the whole study period for a maximum of 28 to 31 months | 
| Number of subjects with ≥1 dose modification(s) |  | during the whole study period for a maximum of 28 to 31 months | 
| Number of subjects with permanent discontinuations |  | during the whole study period for a maximum of 28 to 31 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival of subjects since cabozantinib initiation |  | during the whole study period for a maximum of 28 to 31 months | 
| Overall survival of subjects since RCC diagnosis. |  | during the whole study period for a maximum of 28 to 31 months | 
| Overall survival of subjects since metastatic diagnosis |  | during the whole study period for a maximum of 28 to 31 months |
Thromboelastography-Guided Fluid Management in Spinal Surgery

Study Overview
=================
Brief Summary
-----------------
The Researchers are trying to evaluate whether using a blood test called thromboelastogram (TEG) to manage patients undergoing multi-level spinal fusion surgery will reduce complications after surgery compared with the standard practices.

Detailed Description
-----------------
Multi-level instrumented spinal fusions represent an important treatment modality for degenerative scoliosis and sagittal malalignment. These surgeries remain a significant physiologic burden with high blood loss and long operative times. Thromboelastography provides a quantitative measure for blood product transfusion surrounding procedures. We aim to utilize thromboelastography to guide transfusions for multi-level spinal instrumentation. This two-arm, randomized, non-blinded prospective analysis will clarify reduced transfusion requirements for TEG-arm compared to non-TEG arm. We will also evaluate postoperative outcomes at the 1 year time-point.

Official Title
-----------------
Thromboelastography-guided Fluid Management in Spinal Surgery: A Prospective Analysis

Conditions
-----------------
Spinal Fusion

Intervention / Treatment
-----------------
* Procedure: Intervention
* Other: Control Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients undergoing elective multi-level spinal fusion for sagittal malalignment, multi-level spondylolisthesis, multi-level lumbar spinal stenosis, and adult degenerative scoliosis with ages between 18-89 Exclusion Criteria: patients with tumors, infection, or trauma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- |
| Control Group<br>Traditional evaluation/standard-of-care evaluation of patients undergoing multi-level spinal fusion surgery. These patients will receive point-of-care laboratory testing. | Other: Control Group<br>* Laboratory analysis to guide transfusion<br>* Other names: Point of care testing;|
| Intervention arm<br>Utilization of TEG for decision-making regarding intra-operative transfusion in major spinal reconstruction surgery. | Procedure: Intervention<br>* We will utilize thromboelastography to discern when to transfuse blood products in the setting of multi-level spinal fusion<br>* Other names: Thromboelastography;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Blood Loss | Amount of blood loss measured in units of cc(mL) | post operative approximately 1 day | 
| Volume of transfused packed red blood cells | Amount of transfused packed red blood cells measured in units of cc(mL) | post operative approximately 1 day | 
| Adverse Events | Number of adverse events reported | One year |
CAM in Hospice Palliative Care in Taiwan

Study Overview
=================
Brief Summary
-----------------
The study aims to explore the effects of silver spike point (SSP) treatment on common symptoms including pain, breathlessness, nausea/vomiting, dry mouth etc. of terminal cancer patients.

Detailed Description
-----------------
The study aims to explore the effects of silver spike point treatment on common symptoms including pain, breathlessness, nausea/vomiting, dry mouth etc. of terminal cancer patients. We will conducted a pilot study to evaluate the effects on different symptoms and then a prospective study will be conducted after validation of major effects.

Official Title
-----------------
The Application of Evidence-Based Chinese Complementary and Alternative Medicine (CAM) in Hospice Palliative Care in Taiwan-The Second and Third Year Project.

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Device: SSP treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cancer patients Competent with clear consciousness With symptoms of pain, breathlessness, nause/vomiting, dry mouth, generalized discomfort Expected life span of at least 1 week Exclusion Criteria: With implanted devices Not having clear consciousness Expected life span less than 1 week Foreigner

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SSP treatment group<br>Case on SSP treatment | Device: SSP treatment<br>* SSP treatment 5 times a week<br>|
| Sham Comparator: Non-SSP treatment group<br>Sham SSP treatment | Device: SSP treatment<br>* SSP treatment 5 times a week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom severity score | Questionnaire for evaluating the severity of symptoms | One week after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Questionnaire for evaluating quality of life | One week after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Complementary and alternative medicine, Hospice Palliative Care
Population Pharmacokinetics in Benznidazole-treated Adults With Chronic With Chagas Disease

Study Overview
=================
Brief Summary
-----------------
o study population pharmacokinetics in Benznidazole-treated adult patients with Chronic Chagas Disease to get information to optimize drug doses.

Official Title
-----------------
Population Pharmacokinetics in Benznidazole-treated Adults With Chronic Chagas Disease. Benznidazole Pharmacokinetics and Adverse Reactions Relationship.

Conditions
-----------------
Chagas Disease

Intervention / Treatment
-----------------
* Drug: Benznidazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with Chronic Chagas Disease diagnosed by 2 different and positive serological tests. Patients with Chronic Chagas Disease who are going to start treatment with Benznidazole. Any gender. All the participants must agree to participate in the study and must sign the informed consent. Exclusion Criteria: Patients younger than 18. Patients with previous hypersensitivity to Benznidazole. Immunocompromised patients as AIDS, cancer, chemotherapy, longterm corticoids need, primary immunodeficiency, or any other. Hepatic dysfunction Renal dysfunction: serum creatinin higher than 3 mg/dl. Pregnancy or lactation. Low adhesion to treatment or check-up. Impossibility of follow-up. Severe adverse reaction to Benznidazole. Any other situation that could be risky for the patient.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Benznidazole<br> | Drug: Benznidazole<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Population pharmacokinetic parameters of Benznidazole | Population pharmacokinetic model development | 2 months (treatment period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse reactions | Number of participants with adverse events. Severity of adverse events. Relationship between adverse event and drug concentration. | 2 months (treatment period) |