linjc16/ctgov huggingface dataset:
Randomized Study of Midodrine, an Alpha Adrenergic Agonist, in Patients With Neurally Mediated Syncope

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: Determine the efficacy of midodrine, a selective alpha 1 adrenergic agonist, in preventing neurally mediated syncope.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double-blind, crossover, placebo-controlled study. On day one, patients receive either midodrine or placebo. On day three, patients receive the opposite drug.

Conditions
-----------------
Syncope

Intervention / Treatment
-----------------
* Drug: midodrine


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of neurally mediated syncope (vasovagal fainting) Sudden fall in blood pressure AND Slowing of the heart AND Temporary loss of consciousness AND Hemodynamic response to head up tilt --Prior/Concurrent Therapy-- No other concurrent adrenergic agonist or antiagonist --Patient Characteristics-- Fertile patients must use effective birth control

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: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: midodrine|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
-----------------
syncope, neurologic and psychiatric disorders, rare disease
Study Evaluating Local Susceptibility Patterns Associated With Tigecycline in Comparison to Other Antibiotics

Study Overview
=================
Brief Summary
-----------------
Various bacterial organisms will be tested in order to compile information regarding the effectiveness of tigecycline against certain bacteria seen in local communities.

Detailed Description
-----------------
This is a prospective, microbiologic in vitro evaluation which will study the susceptibility of tigecycline in disk diffusion on clinical bacterial isolates collected from inpatients and outpatients. Fourteen hospital centers participated in the program. In vitro efficacy of tigecycline will be determined through the in vitro disk diffusion activity, using FDA breakpoints.

Official Title
-----------------
Evaluation of the Antimicrobial Activity In Vitro of Tigecycline in Comparison to Other Broad Spectrum Antibiotics in Isolates Collected From Patients

Conditions
-----------------
Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any protocol-specified microorganism isolated from the samples collected from hospitalized patients and outpatients
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>A listing of all isolates meeting the inclusion criteria will be maintained. | |

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
-----------------
Susceptibility of tigecycline, Drug Resistance, Bacterial
Nasogastric Tube in Premature Babies - Pain and Treatment

Study Overview
=================
Brief Summary
-----------------
Does sucrose or pacifier influence pain in premature babies when a nasogastric tube is inserted?

Detailed Description
-----------------
A total of 24 premature babies are randomised to receive either placebo (sterile water), 30 % sucrose, or pacifier in a complete factorial, cross-over design. Pain is rated on the PIPP scale by observers blinded to the procedure other than use of pacifier.

Official Title
-----------------
Nasogastric Tube in Premature Babies - Pain and Treatment. A Randomised, Partly Blinded, Placebo-controlled Factorial Clinical Trial of Sucrose and Pacifier

Conditions
-----------------
Infant, Premature

Intervention / Treatment
-----------------
* Drug: Sucrose
* Device: Pacifier
* Other: sterile water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 28 - 32 weeks gestational weeks not on mechanical ventilation Exclusion Criteria: high risk group regarding cerebral prognosis

Ages Eligible for Study
-----------------
Minimum Age: 3 Days
Maximum Age: 8 Weeks

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>no fluid, no pacifier | |
| Experimental: water<br>water, no pacifier | Other: sterile water<br> <br> |
| Experimental: sucrose<br>Sucrose, no pacifier | Drug: Sucrose<br>* 30 % sucrose<br>|
| Experimental: pacifier<br>No fluid, pacifier | Device: Pacifier<br> <br> |
| Experimental: water and pacifier<br>water, pacifier | Device: Pacifier<br> <br> |
| Experimental: sucrose and pacifier<br>sucrose, pacifier | Drug: Sucrose<br>* 30 % sucrose<br>Device: Pacifier<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measured on PIPP (Premature Infant Pain Profile) scale |  | 4 week to complete | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, infant, premature, intubation, gastrointestinal, Neonatal nursing
the Effect of Carbetocin in Decreasing Intraoperative Blood Loss in Abdominal Myomectomy

Study Overview
=================
Brief Summary
-----------------
To investigate the effectiveness of carbetocin on reducing intraoperative blood loss during abdominal myomectomy

Official Title
-----------------
the Effect of Carbetocin in Decreasing Intraoperative Blood Loss in Abdominal Myomectomy: a Randomized Controlled Trial

Conditions
-----------------
Abdominal Myomectomy

Intervention / Treatment
-----------------
* Drug: carbetocin 100 mcg
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging Age ≥ 25 years and ≤ 50 years Pre-operative hemoglobin >10 g/dl Ability to understand and the willingness to sign a written informed consent. Admissible medical/surgical history Five or less symptomatic uterine myomas symptomatic stage 3 to 6 fibroids, according to FIGO staging Exclusion Criteria: • Post-menopausal women Patients with known bleeding/clotting disorders Patients with a history of gynecologic malignancy Hypertension. Cardiac and Pulmonary diseases. History of allergic reactions attributed to carbetocin

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: carbetocin<br>100microgram in 10 cm syringe carbetocin IV just before skin incision of myomectomy. | Drug: carbetocin 100 mcg<br>* a 10 cm syringe containing 100 mcg carbetocin just before skin incision of myomectomy.<br>|
| Placebo Comparator: placebo<br>10 cm syringe normal saline IV given just before skin incision of myomectomy. | Drug: placebo<br>* a 10 cm syringe normal saline IV given just before skin incision of myomectomy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean amount of intraoperative blood loss | Mean amount of intraoperative blood loss in ml | intraoperative |
A Bioequivalence Study of Two Azithromycin Tablet Formulations in Indonesian Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the bioequivalence of 500 mg Azithromycin FC tablets (Azivol) produced by PT. Novell Pharmaceutical Laboratories, compared to the reference product Zithromax 500 mg FC tablet produced by Pfizer Australia Pty, Ltd

Conditions
-----------------
Fasting

Intervention / Treatment
-----------------
* Drug: Azithromycin
* Drug: Azithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects, both sexes, age between 18 to 55 years old Weight with normal range according to accepted normal values for BMI (18-25 kg/m2) Give a written informed consent Acceptable medical history and physical examination Normal hematology values including hemoglobin, hematocrit, WBC, platelets, WBC differential Normal laboratory test including : Blood urea nitrogen, sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, fasting glucose, albumin and creatinine Normal urinalysis results including: specific gravity, color, pH, sugar, albumin, bilirubin, RBC, WBC and casts Acceptable electrocardiogram (ECG) result Negative result for serological tests of Hepatitis B, Hepatitis C and HIV Negative result for pregnancy test Exclusion Criteria: Smoker or alcoholism Pregnant woman or nursing mother Have history of hepatic, cardiovascular, gastrointestinal or renal disease Potentially sensitive to azithromycin or other related drugs Received any investigation drug within four weeks Donation or loss more than 450 mL of blood within 3 months prior to the screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azivol<br> | Drug: Azithromycin<br>* Single dose 500 mg of film coated tablet<br>|
| Active Comparator: Zithromax<br> | Drug: Azithromycin<br>* Single dose 500 mg of film coated tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of azithromycin until 120 h after oral administration of 500 mg Azithromycin tablet (ng/mL) |  | 30 days |
The Effect of Two Different Endoscopic Entry Techniques on Postoperative Gastrointestinal Function

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine effect of veres needle entry and direct trocar entry on postoperative gastrointestinal functions.

Detailed Description
-----------------
Women planned to have laparoscopic surgery will be randomized into two groups, in first group pneumoperitoneum will be provided by veres needle, in other group direct trocar entry will be used to provide pneumoperitoneum. After surgery gastrointesitinal functions, shoulder pain, blood loss will be compared between groups.

Official Title
-----------------
The Effect of Two Different Endoscopic Entry Techniques on Postoperative Gastrointestinal Function

Conditions
-----------------
Gastrointestinal Disorder Postoperative

Intervention / Treatment
-----------------
* Other: direct trocar entry
* Other: veres needle entry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laparoscopic surgery for benign or malignant disease Exclusion Criteria: Patients with gastrointestinal intervention Patients who had undergone previous operations Patients with gastrointestinal intervention dysfunction
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: veres needle entry arm<br>Vere needle will be used to provide penumoperiteum than postoperative gastrointestinal functions will be compared | Other: veres needle entry<br>* veres needle entry to provide pneumoperitoneum<br>|
| Active Comparator: direct trocar entry arm<br>Direct trocar entry will be used to provide penumoperiteum than postoperative gastrointestinal functions will be compared | Other: direct trocar entry<br>* direct trocar entry to provide pneumoperitoneum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel sound (first bowel sound) | time from surgery to first bowel sound as hours | Postoperative first 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gas discharge | time from surgery to first bowel sound as hours | Postoperative first 72 hours |
Lifestyle Intervention in Patients With New Onset Type 2 Diabetes.

Study Overview
=================
Brief Summary
-----------------
The study seeks to establish if weight loss achieved through a program of intensive lifestyle management can result in improvements in GLP-1 and glycaemic control, in patients with newly diagnosed type 2 diabetes mellitus.

Official Title
-----------------
Effect of Intensive Lifestyle Intervention on Hormonal Factors Regulating Food Intake and Blood Glucose Control in Patients With New Onset Type 2 Diabetes.

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Group lifestyle programme


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New onset type 2 Diabetes Body mass index 25 and above Able to give informed consent Exclusion Criteria: Hypoglycaemic and antiobesity agents, or any other prescription medication that may interfere with study results

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: Lifestyle intervention group.<br> | Behavioral: Group lifestyle programme<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lifestyle impact on GLP-1, HbA1c and fasting glycaemia. |  | 8 months following commencement of study. |
Post-Approval Study of the NexStent Carotid Stent System and the FilterWire EZ Embolic Protection System: SONOMA

Study Overview
=================
Brief Summary
-----------------
The primary objective of the SONOMA Registry is to confirm the safety of the NexStent® Carotid Stent System and FilterWire EZ™ Embolic Protection System in routine clinical practice and to identify rare or unanticipated device-related events that might occur.

Detailed Description
-----------------
The SONOMA Registry will enroll approximately 300 subjects at a maximum at 78 study centers.

Official Title
-----------------
The NexStent® Carotid Stent System: A Post Market Approval Evaluation Study In Conjunction With the FilterWire EZ™ Embolic Protection System

Conditions
-----------------
Carotid Stenosis

Intervention / Treatment
-----------------
* Device: NexStent Carotid Stent System (Monorail Delivery System)
* Device: FilterWire EZ™ Embolic Protection System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidates must be indicated for carotid stent placement as per NexStent Carotid Stent labeling located in the Directions for Use (DFU). Exclusion Criteria: Subjects with contraindications as outlined in the DFU should be excluded from this registry.

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

| Intervention/Treatment |
| --- |
|Device: NexStent Carotid Stent System (Monorail Delivery System)|Self-expanding carotid stent for treating patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.|
|Device: FilterWire EZ™ Embolic Protection System|Used as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE) | 30-day major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure. | 30 Days | 
| Number of Participants Who Experienced a 12-Month Major Adverse Event (MAE) | 12-month major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure (see 30-Day MAE above), and ipsilateral stroke events that occur within 31-365 days post-procedure. | 12 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NexStent, FilterWire EZ, Boston Scientific, Carotid Artery, Carotid Endarterectomy, Carotid Revascularization
Evaluation of Platelet Function in Pregnancy With Multiple Electrode Aggregometry

Study Overview
=================
Brief Summary
-----------------
Establishment of a range of normal values in pregnancy with the Multiple Electrode Aggregometry (Multiplate@) device, a device that allows measurement of not only platelet count but platelet function. This has not been studied in ths special patient group. Results from this trial will be used as a basis for further investigation of abnormal platelet function in pregnancy.

Official Title
-----------------
Multiple Electrode Aggregometry and Platelet Function in Pregnancy

Conditions
-----------------
Platelet Function, Pregnancy

Intervention / Treatment
-----------------
* Other: Platelet function during pregnancy Multiple Electrode Aggregometry (Multiplate@) device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnancy Exclusion Criteria: Rejection of informed consent

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Platelet function during pregnancy Multiple Electrode Aggregometry (Multiplate@) device|Observation of platelet function in pregnancy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of platelet function | Measurement of change of platelet function by the Multiplate® device. First measurement (baseline measurement) at enrollment into the trial. Second measurement during government-mandated gynaecological evaluation, around the 20th week of pregnancy. Third measurement immediately prior to delivery. Last measurement one week after delivery. 2nd, 3rd and 4th measurement for assessment of change from baseline. | 4x, as specified below | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet-associated complications | Record of bleeding events, preeclampsia, HELLP (hemolysis, elevated liver enzymes, and low platelet count) syndrome. Time points: at every assessment of primary outcome measure, as described above. | 4x, as specified below (baseline, 20th week) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy, platelet function, monitoring, multiple electrode aggregometry
Anastomotic Leakage After Anterior Resection for Rectal Cancer - Predictive Biomarkers and Rectal Blood Flow

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether reduced rectal blood flow is associated with the extent of surgery when performing an operation to remove rectal cancer. The investigators also aim to describe any relation of reduced rectal blood flow, as well as raised inflammatory biomarkers in blood and tissue, to the occurrence of anastomotic leakage. The patients will be recruited at Umeå University Hospital and all patients who are planned to undergo anterior resection for rectal cancer and able to consent are eligible for this study. Rectal blood flow measurements will be conducted with Laser-Doppler technology using noninvasive measuring probes. Preoperative and postoperative blood sampling as well as postoperative drain fluid collection will take place. Perianastomotic tissue will also be collected. In the postoperative period, any occurrence of surgical complications especially anastomotic leakage, will be noted. Blood flow and biomarkers will be assessed in relation to type of mesorectal excision (total or partial) and correlated to anastomotic leakage. Standard statistical tools will be utilized, such as parametric, non-parametric tests and logistic regression, as appropriate. The study will recruit approximately 40 patients during three consecutive years.

Official Title
-----------------
Anastomotic Leakage After Anterior Resection for Rectal Cancer - Predictive Biomarkers and Rectal Blood Flow

Conditions
-----------------
Anastomotic Leak

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned anterior resection for rectal cancer Willing to participate Exclusion Criteria: Not willing to participate Unable to consent
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 |
| --- | --- | --- |
| Blood flow measurements | Laser-Doppler blood flow measurements of the rectal mucosa perfusion below and distal to the anastomosis. | Start and end of operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomotic leakage | The occurrence of anastomotic leakage, as defined by the International Study Group for Rectal Cancer (ISREC). | 90 days postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rectal Neoplasms