linjc16/ctgov huggingface dataset:
Alginate-based Reflux Suppressant and Magnesium-aluminium Antacid Gel for Treatment of Heartburn in Pregnancy

Study Overview
=================
Brief Summary
-----------------
This study evaluates the efficacy of alginate-based reflux suppressant and magnesium-aluminium antacid gel for treatment of heartburn in pregnancy. Half of the participants will receive alginate-based reflux suppressant, while the other half will receive magnesium-aluminium antacid gel.

Official Title
-----------------
Comparison of the Efficacy of Alginate-based Reflux Suppressant and Magnesium-aluminium Antacid Gel for Treatment of Heartburn in Pregnancy : A Randomized Double-Blind Controlled Trial

Conditions
-----------------
Heartburn in Pregnancy

Intervention / Treatment
-----------------
* Drug: Alginate-based reflux suppressant
* Drug: magnesium-aluminium antacid gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women gestational age less than 36 weeks with heartburn Exclusion Criteria: Having medical disease that contraindicated to use study drug Allergic to alginate-based reflux suppressant and magnesium-aluminium antacid gel

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Active Comparator: Alginate-based reflux suppressant<br>Alginate-based reflux suppressant 15 ml oral every 6 hours for 2 weeks | Drug: Alginate-based reflux suppressant<br> <br> |
| Sham Comparator: magnesium-aluminium antacid gel<br>magnesium-aluminium antacid gel 15 ml oral every 6 hours for 2 weeks | Drug: magnesium-aluminium antacid gel<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of heartburn as measured by diary chart |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of hearburn as measured by visual analog scale |  | 2 weeks | 
| satisfaction as measured by questionnaire |  | 2 weeks | 
| quality of life as measured by questionnaire SF-8 |  | 2 weeks | 
| Number of participants with side effects |  | 2 weeks | 
| fetal outcomes as measured by birth weight and Apgar scores |  | at birth |
Danish Carvedilol Study in Portal Hypertension

Study Overview
=================
Brief Summary
-----------------
Patients with large esophageal varices who have not yet experienced bleeding, are normally treated with propranolol, a beta blocking agent that reduces the portal pressure and thereby diminish the risk of bleeding. 20-40% of the patients do not respond to this treatment or have to discontinue the treatment because of side effects. The aim of this study is to evaluate if carvedilol (a combined alfa -beta blocker) has better efficacy and safety than propranolol in lowering the portal pressure in patients with cirrhosis.

Official Title
-----------------
Danish Carvedilol Study in Portal Hypertension. Carvedilol in the Prevention of Bleeding in Portal Hypertension and Esophageal Varices

Conditions
-----------------
Cirrhosis, Portal Hypertension

Intervention / Treatment
-----------------
* Drug: carvedilol
* Drug: propranolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhosis HVPG > 12 mmHg Exclusion Criteria: Respiratory disease that contradict endoscopy Hepatic encephalopathy Hepatorenal syndrome COPD or Asthma Treatment with vasoactive drugs within 1 week of inclusion Heart disease that contradict treatment with beta-blocking agents IDDM Pregnancy

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: carvedilol<br> | Drug: carvedilol<br>* 6.25 mg of carvedilol for 12 weeks, to achieve a satisfactory pulse reduction the doses are doubled weekly up to a maximum of 25 mg carvedilol daily.<br>|
| Active Comparator: propranolol<br>Cirrhotic patients treated with propranolol | Drug: propranolol<br>* 80 mg of propranolol for 12 weeks, to achieve a satisfactory pulse reduction the doses are doubles weekly up to a maximum of 360 mg propranolol daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| If carvedilol is better than propranolol in lowering portal pressure after 3 months of treatment |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| If the effect of a single dose of propranolol can predict the long term effect of propranolol or carvedilol |  | 3 months |
Effect of Bevacizumab and VEGF on Platelet Clustering in Patients Who Are Receiving Bevacizumab for Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about the effect of bevacizumab and VEGF on platelet clustering. PURPOSE: This research study is looking at the effect of bevacizumab and VEGF on platelet clustering in patients with cancer who are receiving bevacizumab.

Detailed Description
-----------------
OBJECTIVES: To determine the influence of bevacizumab on platelet aggregation in patients receiving bevacizumab for cancer. To determine the influence of VEGF on platelet aggregation. To determine the influence of VEGF or bevacizumab on cyclooxygenesis. To determine if the sequence of medication plays a role in platelet aggregation. OUTLINE: Blood samples are collected before and after bevacizumab infusion. Samples are analyzed for measurements of platelet aggregation, coagulation parameters, and endothelial activation (e.g., fibrin fragment F1 and 2, thrombin and antithrombin complex, soluble P-selectin, Von Willebrand factor and factor VIII, tissue factor, and endothelin 1).

Official Title
-----------------
Influence of Bevacizumab and VEGF on Platelet Aggregation

Conditions
-----------------
Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific

Intervention / Treatment
-----------------
* Biological: bevacizumab
* Other: coagulation study
* Other: laboratory biomarker analysis
* Other: platelet aggregation test


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Receiving bevacizumab for cancer PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: bevacizumab|nan|
|Other: coagulation study|nan|
|Other: laboratory biomarker analysis|nan|
|Other: platelet aggregation test|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of bevacizumab on platelet aggregation |  |  | 
| Influence of VEGF on platelet aggregation |  |  | 
| Influence of VEGF or bevacizumab on cyclooxygenesis |  |  | 
| Correlation between medication sequence and platelet aggregation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific
Diurnal Curves With Bimatoprost 0.03% Versus Travoprost 0.004%

Study Overview
=================
Brief Summary
-----------------
To compare the diurnal curves in patients using bimatoprost 0.03% versus travoprost 0.004% for the treatment of glaucoma or ocular hypertension.

Official Title
-----------------
Diurnal Curves With Bimatoprost 0.03% Versus Travoprost 0.004%

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

Intervention / Treatment
-----------------
* Drug: Bimatoprost 0.03%, Travoprost 0.004%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: · Male or female > 18 years of age Naive to treatment or washed off any ocular hypotensive agents Untreated IOP >19 mm Hg Diagnosis of open-angle glaucoma or ocular hypertension Ability to provide informed consent and likely to complete study Exclusion Criteria: · Known contraindication to bimatoprost or travoprost, or any component of any study medication Uncontrolled systemic disease Active ocular disease other than glaucoma or ocular hypertension Required use of ocular medications other than the study medications during the study History of intraocular surgery within the last 3 months Prior discontinuation of any of the study medications for reasons related to efficacy or safety

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bimatoprost 0.03%, Travoprost 0.004%|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Impact of Histologic Concordance Between Biopsies and the Endoscopic Resection Specimen, in the Treatment of Barrett's Esophagus in Dysplasia, on the Recurrence of Dysplasia

Study Overview
=================
Brief Summary
-----------------
Influence of histological concordance on the risk of recurrence: the histological concordance being the comparison between the biopsies and the endoscopic resection piece and its concordant response rate.

Detailed Description
-----------------
Influence of histological concordance on the risk of recurrence: the histological concordance being the comparison between the biopsies and the endoscopic resection piece and its concordant response rate.

Official Title
-----------------
Impact of Histologic Concordance Between Biopsies and the Endoscopic Resection Specimen, in the Treatment of Barrett's Esophagus in Dysplasia, on the Recurrence of Dysplasia

Conditions
-----------------
Barretts Esophagus With Dysplasia

Intervention / Treatment
-----------------
* Diagnostic Test: Pathological revision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with DHG on Barrett's esophagus on endoscopic biopsies followed by endoscopic resection. Exclusion Criteria: -

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DHG on Barrett's esophagus<br>patients with DHG on Barrett's esophagus on endoscopic biopsies followed by endoscopic resection | Diagnostic Test: Pathological revision<br>* Pathological revision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of histological concordance on the risk of recurrence | the histological concordance being the comparison between the biopsies and the endoscopic resection piece and its concordant response rate. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of histological factors of recurrence. | Identification of histological factors of recurrence. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Barretts Esophagus, Dysplasia
Intensive Insulin Therapy for Strict Glycemic Control in Neurosurgical Patients: Safety and Efficacy

Study Overview
=================
Brief Summary
-----------------
Strict glycemic control improves mortality and morbidity of patients admitted to the postoperative intensive care unit (ICU). The investigators would like to know if this therapy could improve the long term neurologic and cognitive outcomes of patients treated for acute subarachnoid hemorrhage with either a surgical or intravascular approach.

Detailed Description
-----------------
Intensive Insulin Therapy and Strict Glycemic Control (80-120 mg/dL) Versus Standard Insulin Therapy in Neurosurgical Intensive Care Patients (Subarachnoid Hemorrhage, Traumatic Brain Injury, Intracranial Expanding Lesion): Safety, and Efficacy (Mortality, Morbidity, Long Term Neurologic Outcome).

Official Title
-----------------
Effects of Intensive Insulin Therapy on Mortality, Morbidity and Long Term Neurologic Outcome in Neurosurgical Intensive Care Patients

Conditions
-----------------
Subarachnoid Hemorrhage, Traumatic Brain Injury, Intracranial Hemorrhage

Intervention / Treatment
-----------------
* Drug: Insulin (Actrapid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subarachnoid hemorrhage Traumatic brain injury Intracranial hemorrhage

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Insulin infusion rate titrated to maintain glycemia between 80 and 100 mg/dl | Drug: Insulin (Actrapid)<br>* 50 UI Actrapid diluted in 50 ml of saline<br>|
| Active Comparator: B<br>Insulin infusion rate titrated to maintain glycemia between 80 and 220 mg/dl | Drug: Insulin (Actrapid)<br>* 50 UI Actrapid diluted in 50 ml of saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Episodes of hypoglycemia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection rate |  | during the study | 
| Vasospasm rate |  | during the study | 
| Mortality |  | 6 months follow up | 
| Neurologic status |  | 6 months follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neurointensive care, Intensive insulin infusion, Hypoglycemia, Postoperative Mortality, Postoperative Morbidity, Neurologic outcome
Prophylactic Mesh in Cytoreductive Surgery

Study Overview
=================
Brief Summary
-----------------
Evaluate the effectiveness of mesh reinforcement in high-risk patients to prevent incisional hernia.

Detailed Description
-----------------
Based on the hypothesis that oncological cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC) is associated with an increased risk of developing Incisional Hernia in the postoperative period, with an expected incidence of 50% at 24 months, we designed a prospective, multicenter and randomized clinical study to demonstrate the utility of the meshes in the prevention of Incisional Hernia, hoping to reduce the incidence to 15% at 24 months.

Official Title
-----------------
Prevention of Incisional Hernia With Prophylactic Mesh in Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy. A Multicentre, Prospective, Randomised Controlled Trial

Conditions
-----------------
Incisional Hernia

Intervention / Treatment
-----------------
* Procedure: Prophylactic Mesh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completeness of cytoreduction after surgery (CC-SCORE) CC-0, CC-1 Exclusion Criteria: Completeness of cytoreduction after surgery (CC-SCORE) CC-2, CC-3

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: without mesh<br>Patients undergo to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy without prophylactic mesh | |
| Other: with mesh<br>Patients undergo to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with prophylactic mesh | Procedure: Prophylactic Mesh<br>* Prophylactic Mesh after closure of the abdominal wall after Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Incisional Hernia | Prevention of Incisional Hernia | four years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hyperthermic intraperitoneal chemotherapy, cytoreduction surgery, prophylactic mesh
OptiGon - Optimising Laboratory Assays for Immune Responses to Gonococcus

Study Overview
=================
Brief Summary
-----------------
This is an observational study. Blood from otherwise healthy patients presenting with confirmed N.gonorrhoea infection, prior to treatment, will be collected to (i) allow the optimisation of assays assessing the immune response to gonococcus and (ii) assess whether N. gonorrhea specific responses can be detected on ELIspot +/- flow cytometry. The investigators plan to recruit up to 30 adults (men and women, aged 18-50 years) who have been diagnosed with confirmed N.gonorrhoea infection at the Sexual Health Clinic at the Oxford University Hospitals NHS Foundation Trust. The investigators will collect blood samples from consenting participants prior to them receiving curative antibiotic treatment.

Detailed Description
-----------------
On the day the patient attends the Sexual Health Clinic, they will be given the PIS to consider participation to the study following a confirmed positive result for N. gonorrhoea infection. Following written informed consent, a venous blood sample will be collected (up to 26 ml) on the same day. This will conclude that participant's involvement to the study. The blood sample will be transported to the laboratory at the Jenner Institute, University of Oxford for further analysis.

Official Title
-----------------
Optimising Laboratory Assays for Immune Responses to Gonococcus

Conditions
-----------------
Gonorrhea

Intervention / Treatment
-----------------
* Other: Blood sample collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (18-50 years) attending Oxford University Hospitals NHS Foundation Trust with untreated confirmed N. gonorrhoea infection confirmed by either: Nucleic acid test Microscopy of urethral discharge Exclusion Criteria: Have already received antimicrobial therapy to treat the N. gonorrhoea infection Have not provided written, informed consent. Presence of any known medical condition which, in the opinion of the local investigator, makes the donation of 26 mls of blood unsafe.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Blood sample collection|Blood sample collection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cellular immune response | Cellular immune response detected by ELISpot +/- Flow cytometry from PBMCs collected from the blood of patients presenting with confirmed N.gonorrhoea infection. | Blood sampling at enrolment |
Epidemiologic Registry PETHEMA LMA 2015

Study Overview
=================
Brief Summary
-----------------
Epidemiologic and retrospective multicenter registry of all patients diagnosed with de novo or secondary acute myeloid leukemia (AML) in the PETHEMA Group institutions. This study is a non-interventional research regarding diagnosis and therapeutic approach

Detailed Description
-----------------
To perform this registry, every patient diagnosed with AML in the participant institutions, regardless type of AML and treatment administered, must be reported. It will be required to registry the main characteristics of the patients and AML at diagnosis, as cytomorphologic, immunophenotypic, and cytogenetic results, according to the habitual practice of the centers. The treatment which has been administered by every center of the PETHEMA Group, even when it is considered as supportive care, and evolution of the disease will also be reported (relapse o death). PETHEMA Group will input all the reported information in data bases

Official Title
-----------------
Epidemiologic Registry of Patients Diagnosed With Acute Myeloid Leukemia (PETHEMA LMA 2015)

Conditions
-----------------
AML

Intervention / Treatment
-----------------
* Other: Registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with acute myeloid leukemia Exclusion Criteria: No exclusion criteria

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Registry|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| characteristics of the patients diagnosed of AML |  | 3 years |