linjc16/ctgov huggingface dataset:
Effect of Prophylactic Tranexamic Acid on Bleeding Outcomes for Dilation and Evacuation

Study Overview
=================
Brief Summary
-----------------
Prophylactic tranexamic acid has shown been shown to reduce maternal mortality from postpartum hemorrhage with no adverse effects, but has not been studied to reduce bleeding complications with dilation and evacuation (D&E). We propose a randomized, double-blinded, placebo-controlled pilot study to determine whether routine use of intravenous (IV) tranexamic acid will decrease the need for interventions to control bleeding at the time of D&E at 16 to 24 weeks gestation.

Official Title
-----------------
Effect of Prophylactic Tranexamic Acid on Bleeding Outcomes for Dilation and Evacuation

Conditions
-----------------
Abortion, Dilation and Evacuation, Hemorrhage, Blood Loss

Intervention / Treatment
-----------------
* Drug: Tranexamic acid
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Requesting pregnancy termination Intrauterine pregnancy at 16 to 24 weeks gestation Participants must be willing and capable of giving informed consent and able to understand and sign written consents in English. Exclusion Criteria: History of thromboembolic events (i.e. deep vein thrombosis, stroke, pulmonary embolism)

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

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

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: Placebo<br>100mL saline or lactated ringer without tranexamic acid added given intravenously over 10 minutes at start of procedure | Drug: Placebo<br>* 100mL saline or lactated ringers<br>|
| Active Comparator: Active Comparator<br>1g tranexamic acid mixed in 100mL saline or lactated ringer given intravenously over 10 minutes at start of procedure | Drug: Tranexamic acid<br>* 1g tranexamic acid mixed in 100mL saline or lactated ringer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention to control blood loss | Rate at which providers perform interventions to control blood loss during D&E procedures | At time of procedure |
Surgical Field Bacterial Contamination in Primary Total Hip (THA) and Knee (TKA) Arthroplasty

Study Overview
=================
Brief Summary
-----------------
In Denmark, approximately 13,000 operations are carried out every year. Prosthetic infection is a very serious condition and despite extensive prophylactic measures, prosthetic infections appear in 1-2 percent of the operated patients. It is difficult to diagnose prosthetic infection with the techniques applied so far and incorrect diagnosis might imply unnecessary reoperations as well as unnoticed infections might lead to prolonged pain and invalidity. The purpose of this study is to examine the value of these three techniques applied as a supplement to the existing technology and on this basis to prepare an algorithm for the examination of joint prosthesis infection.

Official Title
-----------------
Surgical Field Bacterial Contamination in Primary Hip and Knee Replacement Surgery

Conditions
-----------------
Prosthetic Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have been through an alloplastic operation in hip og knee. Exclusion Criteria: Patients with cancer or a bilateral disease Former patients who have been through an operation with implants in hip or knee. Patients who might be infected in the joint due to operation in hip or knee. Lack of informed consent or inability to read/understand Danish

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 |
| --- | --- | --- |
| Contamination of the operation area | We want to examine the existence of contamination before an operation in hip and knee. Furthermore, we want to examine the contamination to achieve better knowledge of the bacterial combination. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the bacterial culture | We want to describe the bacterial culture to achieve better knowledge of the bacterial combination. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contamination, hip operation, knee operation
Identifying Changes in Blood (Potential Biomarkers) in Individuals With Drug-Induced Liver Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to try to develop new blood tests that may help doctors identify if a drug is hurting a person's liver.

Detailed Description
-----------------
Our hypothesis is that there are liver-specific particles, called mRNA, that are identifiable in a person's blood sample during liver injury caused by some drugs. The purpose of this study is to try to develop new blood tests that may help doctors identify if a drug is hurting a person's liver, perhaps early in the process before significant injury or illness have occurred.

Official Title
-----------------
Identification of New Biomarkers of Drug Induced Liver Injury

Conditions
-----------------
Drug Induced Liver Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ALT > 200 IU/L at presentation to UNC Hospitals Drug induced liver injury considered likely by admitting medical staff

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Acute drug-induced liver injury<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Predict the Risk of Axillary Metastases in Breast Cancer Patients With Axillary Ultrasound

Study Overview
=================
Brief Summary
-----------------
Axillary lymph node status is a vital prognostic factors in breast cancer patients and provides crucial information for making treatment decisions.This projective observational study is planned to identify risk factors for axillary metastases in breast cancer patients with axillary ultrasound and to construct a nomogram to predict the risk of axillary metastases in these patients.

Detailed Description
-----------------
Breast carcinoma is the most common malignancy in women, accounting for 25% of all female cancer cases and 15% of all cancer-related deaths in the world.Lymph node metastasis is a multifactorial event. Among patients with a preoperative axillary ultrasound, almost 40% of patients are pathologically proved to be free from axillary metastasis.The purpose of this study is to develop a nomogram to evaluate the probability of axillary metastasis as a tool to support clinical decision-making.

Official Title
-----------------
A Nomogram to Predict the Risk of Axillary Metastases in Breast Cancer Patients With Axillary Ultrasound

Conditions
-----------------
Breast Cancer Female

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female patients with primary breast cancer receiving a successful SLNB or ALND pathological diagnosed, without distant metastasis a clinically negative axilla Exclusion Criteria: pregnancy neoadjuvant therapy previous ipsilateral axillary surgery inflammatory breast cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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 |
| --- | --- | --- |
| Axillary Metastases | Surgical treatment for breast cancer patients include breast-conserving surgery or mastectomy with or without breast reconstruction. Intraoperative ALND is carried out when the SLNs are positive by intraoperative frozen section. Post-operative H&E permanent staining is administered to confirm the results of the frozen section. Serial H&E and immunohistochemistry stain (IHC) are only carried out when axillary metastases are not visible after H&E staining. | 4 months to 1.5 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Nomogram, Ultrasound, Axillary Metastases
Oral Health Status and Diet History Analysis Among Orphan House Children From 10-14 Years in Cairo Governorate.

Study Overview
=================
Brief Summary
-----------------
the purpose of study to determine oral health status and dietary habits among group of orphan children from 10-14 years in Cairo Governorate.

Detailed Description
-----------------
The study's investigators will record all data related to oral health status of orphan children from 10-14 years and their dietary habits to describe usual food intake and its variation over a long period of time . the OHI-S will also recorded which has 2 components the Debris index and Calculus index .

Official Title
-----------------
Oral Health Status and Diet History Analysis Among Orphan House Children From 10-14 Years in Cairo Governorate : A Cross Sectional Study

Conditions
-----------------
Gingival Disease Due to Bacteria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Egyptian children aged from 10-14 years Cooperative children Exclusion Criteria: Children with systemic disease , genetic disorders , or any disabilities

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 14 Years

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

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 |
| --- | --- | --- |
| oral health status | Debris index | 3 months | 
| oral health status | Calculus index | 3 months | 
| Diet history analysis | Diet history chart | 3 months |
Special Drug Use Investigation for Relenza® (Zanamivir) (Prophylaxis)

Study Overview
=================
Brief Summary
-----------------
The purpose of this post-marketing surveillance study is to collect information on efficacy and safety for prophylactic administration of zanamivir in clinical practice in family or persons living with patients with influenza virus infection.

Official Title
-----------------
Special Drug Use Investigation for Relenza® (Zanamivir) (Prophylaxis)

Conditions
-----------------
Influenza, Human

Intervention / Treatment
-----------------
* Drug: Zanamivir hydrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who meet the study population criteria Exclusion Criteria: Subjects with a history of hypersensitivity to the ingredients of zanamivir
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects prescribed zanamivir<br>Subjects prescribed zanamivir during study period | Drug: Zanamivir hydrate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of incidence of adverse events in subjects treated with zanamivir |  | 11 days | 
| Occurrence of influenza virus infection |  | 11 days |
Effects of Excess Energy Intake on Metabolic Risk

Study Overview
=================
Brief Summary
-----------------
The prevalence of obesity has reached epidemic proportions and is associated with the development of insulin resistance and type 2 diabetes (T2DM). A unifying theme has emerged over the past few years suggesting that lipid oversupply to metabolic organs responsible for glucose regulation leads to insulin resistance. Fitting with this, we and others have shown that increased lipid accumulation within skeletal muscle and/or liver is associated with impaired glucose uptake. However, the underlying mechanisms that mediate changes in muscle lipid metabolism are not yet known. The overall aim of this project is to examine metabolic effects of experimental weight gain in lean and overweight individuals with and without a genetic predisposition to type 2 diabetes. We hypothesise that lean subjects will increase fatty acid oxidation and upregulate mitochondrial oxidative capacity in muscle following overfeeding to protect against body weight gain and insulin resistance, but overweight subjects with a genetic predisposition to T2DM will have a defect in this ability.

Official Title
-----------------
Effects of Excess Energy Intake on Metabolic Risk

Conditions
-----------------
Insulin Resistance

Intervention / Treatment
-----------------
* Other: Nutritional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sedentary (<60 min formal exercise per week) Aged 20-65 years Exclusion Criteria: Personal history of diabetes, cardiovascular disease or hypertension Recent weight change (larger than 4kg in the past 3 months) Smoking Regular use of medications, except oral contraceptives Individuals with alcoholism or other substance abuse Pregnancy or lactation, women who are planning to become pregnant or who are not using adequate measures of birth control.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Basic Science
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Overfeeding<br>4 weeks of 1250 kcal added daily | Other: Nutritional<br>* Overfeeding high fat diet for 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitiviy by hyperinsulinemic clamp |  | 28-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat oxidation (whole body RQ and C-14 palmitate), mitochondrial function |  | 28-days |
PFx Closure System in Subjects With Cryptogenic Stroke, TIA, Migraine or Decompression Illness

Study Overview
=================
Brief Summary
-----------------
The primary object of this study is to demonstrate the continued safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic attack, migraine or decompression illness.

Official Title
-----------------
The Paradigm IV Trial - PFx Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness

Conditions
-----------------
PFO, Stroke, Transient Ischemic Attack, Migraine, Decompression Illness

Intervention / Treatment
-----------------
* Device: PFx Closure System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 65 years old PFO with one or more of: Cryptogenic stroke, TIA or embolism, History of severe migraine headaches, or History of severe decompression illness. Exclusion Criteria: In appropriate anatomy (vascular or cardiac) or inappropriate medical condition for PFO closure and study medications.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PFx Closure System|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFO closure at 6 months post procedure. |  | 6 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFO closure at 30 days and 12 months post procedure. AE event rate for all subjects. Measurement of migraine severity or frequency at 6 and 12 months post procedure for subjects enrolled due to diagnosis of migraine. |  | 30 days; 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PFO, Stroke, Transient Ischemic Attack, Migraine, Decompression Illness
Clinical Evaluation of Glass Ionomer With Glass Hybrid Technology Versus Conventional High Viscosity Glass Ionomer in Class I Cavities of High Caries Risk Patients

Study Overview
=================
Brief Summary
-----------------
PICOTS: P: High Caries Risk Patients with bilateral class I cavities. I: Glass Ionomer with Glass Hybrid Technology. C: Conventional High Viscosity Glass Ionomer. O: Clinical performance (Functional properties Biological properties) using (World Dental Federation) Fédération dentaire internationale (FDI) criteria for dental restorations. T: 1 year. S: Randomized controlled Trial (split mouth design). Research question:In high caries risk patients with class I cavities will glass ionomer with glass hybrid technology has similar clinical performance as conventional high viscosity glass ionomer

Official Title
-----------------
Clinical Evaluation of Glass Ionomer With Glass Hybrid Technology Versus Conventional High Viscosity Glass Ionomer in Class I Cavities of High Caries Risk Patients: Randomized Controlled Trial

Conditions
-----------------
Class I Cavities in High Caries Risk

Intervention / Treatment
-----------------
* Other: Conventional high viscosity glass ionomer
* Other: Glass ionomer with glass hybrid technology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bilateral class I carious lesions in their occlusal pits and fissures. High caries risk patients who has 1 or more cavitated lesion with risk factor declared by Caries Management By Risk Assessment (CAMBRA) Co-operative patients approving to participate in the trial. Exclusion Criteria: Disabilities. Systemic diseases or severe medically compromised. Lack of compliance. Evidence of severe bruxism, clenching or temporomandibular joint disorders

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glass Ionomer with Glass Hybrid technology<br>Intervention | Other: Glass ionomer with glass hybrid technology<br>* Dental restorative material<br>* Other names: GC EQUIA Forte;|
| Active Comparator: Conventional high viscosity Glass Ionomer<br>Comparator | Other: Conventional high viscosity glass ionomer<br>* Dental restorative material<br>* Other names: GC EQUIA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance using FDI criteria for dental restorations (functional properties and biological properties) |  | 1 year |
CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy

Study Overview
=================
Brief Summary
-----------------
This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)

Official Title
-----------------
A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Drug: dacarbazine
* Drug: CP-675,206
* Drug: temozolomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgically incurable melanoma, either Stage IV or IIIC with N3 status for regional lymph nodes and in-transit or satellite lesions. Serum lactic acid dehydrogenase (LDH) <= 2 x ULN ECOG performance status of 0 or 1 Exclusion Criteria: Received any systemic therapy for metastatic melanoma except post-surgical adjuvant treatment with cytokines (eg, alpha-interferon or GM-CSF) or with vaccines after complete resection of melanoma. History of brain metastases

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: B<br>Choice of one or the other Dacarbazine or Temozolomide(CP-675,206) (choice) | Drug: dacarbazine<br>* decarbazine 1000 mg/m2 IV Q 21 days x 12<br>Drug: temozolomide<br>* temozolomide 200 mg/m2 orally on Days 1-5 every 28 days x 12<br>|
| Experimental: A<br> | Drug: CP-675,206<br>* CP-675,206 15 mg/kg IV Q 90 days x 4<br>* Other names: anti-CTLA4 human monoclonal antibody;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | August 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events |  | 1 year | 
| PFS at 6 months |  | 6 months | 
| objective tumor response |  | 1 year | 
| Durable response |  | 6 months | 
| pharmacokinetics endpoints |  | 15 months | 
| pharmacogenomic endpoints |  | 1 year | 
| HQol |  | 1 year | 
| healthcare resource utilization and loss of productivity |  | 1 year | 
| human antihuman antibody response for patients in Arm A |  | 15 months |