linjc16/ctgov huggingface dataset:
Breastfeeding Preterm Infants - The Efficacy of Internet-based Peer Support

Study Overview
=================
Brief Summary
-----------------
This study examines if the internet-based peer support has an effect on the breastfeeding attitude or the duration of breastfeeding in preterm infants and their mothers compared with mothers with routine care. The factors associated with the initiation of breastfeeding in the neonatal intensive care unit will be determined. In addition, the perceptions of the mothers of preterm infants about their needs and problems when breastfeeding their preterm infants are described.

Conditions
-----------------
Breast Feeding, Infant, Premature

Intervention / Treatment
-----------------
* Behavioral: Breastfeeding peer support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mothers giving birth before full 35 gestational weeks in a study hospital Exclusion Criteria: The mother not able to speak Finnish The infant's condition is critical (based on the paediatrician), The mother has a syndrome or illness preventing breastfeeding
Sexes Eligible for Study
-----------------
Female

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

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 |
| --- | --- |
| Experimental: Breastfeeding peer support<br>Internet-based breastfeeding peer-support group in social media (Facebook). The mothers are allowed to use the group based on their individual needs from the recruitment to the first birthday of their child. Peer support is provided by three voluntary mothers. The mothers can discuss breastfeeding-related issues and ask questions. A midwife will moderate the group. | Behavioral: Breastfeeding peer support<br> <br> |
| No Intervention: Routine breastfeeding support<br>Routine breastfeeding support provided in the hospital and in the maternal and child health clinics | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of breastfeeding |  | 12 months | 
| Breastfeeding attitude with Iowa Infant Feeding Attitude Scale | Iowa Infant Feeding Attitude Scale (IIFAS) is used to measure breastfeeding attitude | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initiation of breastfeeding (postnatal age of the preterm infant) | The postnatal age (days), when the preterm infant initiates breastfeeding for the first time, is measured | 2 months | 
| Duration of expressing milk |  | 12 months |
An Evaluation of the Safety and Efficacy of FID 114657

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of FID 114657 in comparison to Soothe XP in a specified population of dry eye patients.

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Other: FID 114657
* Other: Soothe XP Lubricant Eye Drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of dry eye NaFl Corneal Staining sum score ≥ 3 in either eye Exclusion Criteria: Must not have worn contact lenses for 1 week preceding enrollment

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FID 114657<br>FID 114657 | Other: FID 114657<br>* 1 drop both eyes four times a day for 6 weeks<br>|
| Active Comparator: Soothe XP Lubricant Eye Drops<br>Soothe XP Lubricant Eye Drops | Other: Soothe XP Lubricant Eye Drops<br>* 1 drop both eyes four times a day for 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Break-Up Time (TBUT) |  | measured at Days 0, 7, 14, 28 and 42 | 
| Corneal Staining |  | measured at Days 0, 7, 14, 28 and 42 | 
| Conjunctival Staining |  | measured at Days 0, 7, 14, 28 and 42 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye, artificial tears
Amikacin Penetration Into the Cerebrospinal Fluid

Study Overview
=================
Brief Summary
-----------------
The limited available data precludes establishing an antibiotic regimen in patients suffering from bacterial meningitis after head trauma, or spontaneous bleeding Understanding the disposition of Amikacin administered intrathecally will enable to propose rational treatment of these patients.

Detailed Description
-----------------
The limited available data precludes establishing an antibiotic regimen in patients suffering from bacterial meningitis after head trauma, or spontaneous bleeding Understanding the disposition of Amikacin administered intrathecally will enable to propose rational treatment of these patients.

Official Title
-----------------
Amikacin Penetration Into the Cerebrospinal Fluid: Pharmacokinetic/Pharmacodynamic Analysis in Adults With Hospital Acquired Gram-negative Meningitis Associated With Intracranial Pressure Monitoring and Draining Devices

Conditions
-----------------
Gram Negative Meningitis, Post Traumatic Bacterial Meningitis

Intervention / Treatment
-----------------
* Drug: Systemic and Intra-Thecal Amikacin Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Culture proved bacterial meningitis where the prescribed therapy includes the use of systemic and intraventricular amikacin therapy. The included patient should have an intraventricular catheter placed for intraventricular pressure measurement and admitted to an intensive care unit. Blood creatinine concentration up to 1.49 mg/dL measured at the inclusion day. Exclusion Criteria: Patients or legal guardians who refuse to participate in the study. Known allergy to amikacin. Blood creatinine concentration of 1.5 mg/dL or higher. Subjects without intraventricular catheter who will need repeated lumbar punctures for CSF amikacin determinations. Patients suffering from known chronic liver disease.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Systemic and Intra-Thecal Amikacin Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bactericidal effect on the causative bacteria |  |  | 
| Blood and CSF AUC/MIC relationship |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amikacin, Pharmacokinetics, Pharmacodynamics, Intra-Thecal injection
Prevention of Weight Gain in University Students

Study Overview
=================
Brief Summary
-----------------
This study assess whether a small-group seminar intervention to prevent weight gain is effective in a general university student population, and to address the relative role of biological vs. lifestyle factors in predicting weight gain in humans.

Official Title
-----------------
Prevention of Weight Gain in University Students

Conditions
-----------------
Prevention, Weight Gain

Intervention / Treatment
-----------------
* Behavioral: Lifestyle intervention seminars


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First year students at the Université de Sherbrooke. Exclusion Criteria: Presence of diseases or medications that would be expected to affect weight (cystic fibrosis, diabetes, inflammatory bowel diseases, anorexia nervosa, bulimia, etc.). Pregnancy or planning a pregnancy in the next two years. Unable to give an informed consent.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Small-group seminar for 2 years<br> | Behavioral: Lifestyle intervention seminars<br>* The first sessions emphasize acquisition of new knowledge during interactive group seminars designed to maximize attendant's participation by adapting wellknown quiz-show or parlour games to deliver key concepts. A number of sessions are aimed at increasing self-efficacy through problem-solving, time-management strategies, individual self monitoring and goal-setting.During the second year, the intervention focuses on maintenance of healthy behaviour with empowerment of the participants using problem-solving, goal-setting, planning, and self-monitoring skills.<br>|
| Experimental: Small-group seminars for 1 year followed by email intervention<br> | Behavioral: Lifestyle intervention seminars<br>* The first sessions emphasize acquisition of new knowledge during interactive group seminars designed to maximize attendant's participation by adapting wellknown quiz-show or parlour games to deliver key concepts. A number of sessions are aimed at increasing self-efficacy through problem-solving, time-management strategies, individual self monitoring and goal-setting.During the second year, the intervention focuses on maintenance of healthy behaviour with empowerment of the participants using problem-solving, goal-setting, planning, and self-monitoring skills.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change |  | 2 years |
Early Dehiscence Markers in Ovarian Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
EDMOCS trial pretends to evaluate if C-reactive protein (CRP) and procalcitonin (PCT) can predict intestinal anastomotic leaks before early discharge in advanced ovarian cancer surgery requiring intestinal resection. These markers have already been positively tested in colorectal cancer surgery, but not yet in ovarian surgery. Patients undergoing intestinal resection in ovarian cancer surgery will be included. C-reactive protein and PCT will be measured pre-operatively, and on the second, fourth and sixth postoperative day. Thirty-day readmissions, re-operations and mortality will be recorded.

Official Title
-----------------
Procalcitonin and C-Reactive Protein as Early Anastomotic Dehiscence Markers in Ovarian Cancer Surgery

Conditions
-----------------
Ovarian Neoplasms Malignant, Anastomotic Leak

Intervention / Treatment
-----------------
* Diagnostic Test: Blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ovarian cancer stage III-IV Intestinal resection needed Exclusion Criteria: Infection diagnosed at time of surgery. Urgent surgery

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Blood test|C-reactive protein and PCT measured preoperatively, and on the second, fourth and sixth postoperative days.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with anastomotic leak detected by elevation of C-reactive protein and procalcitonin levels | To evaluate whether C-reactive protein (CRP) and procalcitonin (PCT) can predict anastomotic leak before early discharge. | Within the first 30 days after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein and procalcitonin measures in patients without complications in ovarian surgery. | Defining normal range values of C-Reactive Protein and Procalcitonin during postoperative ovarian cancer surgery. | Within the first six days after the surgery |
The Effect of an Antibiotic on the Production of Uremic Toxins by the Gut Microbiome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if multiple doses of vancomycin over the course of 3 months will perturb the intestinal flora (microbiome) and result in reduced serum concentration of the uremic toxin indoxyl sulfate and p-cresyl sulfate. The design of the study will permit investigators to assess the variability of serum uremic retention solute concentrations with and without antibiotic over a three-month period.

Official Title
-----------------
The Effect of an Antibiotic on the Production of Uremic Toxins by the Gut Microbiome

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Drug: Vancomycin
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with stable chronic kidney disease on hemodialysis with a fistula or an AV graft. Exclusion Criteria: Antibiotics received within the last 3 months; recent diarrhea known allergy to vancomycin history of C. difficile infection elevation of white blood cell count or fever within one week of enrollment.

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: Crossover Assignment
Interventional Model Description: randomized double-blinded placebo-controlled crossover study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 250mg of oral vancomycin First<br>After 3 months, initial experimental group will be switched to placebo for 3 months. | Drug: Vancomycin<br>* Oral vancomycin 250mg capsules<br>* Other names: vancomycin hydrochloride capsules;Other: Placebo<br>* Placebo Pills distributed by Research Pharmacy labeled placebo.<br>|
| Placebo Comparator: Placebo First<br>After three months, the control group will be crossed over to weekly oral vancomycin (250mg) | Drug: Vancomycin<br>* Oral vancomycin 250mg capsules<br>* Other names: vancomycin hydrochloride capsules;Other: Placebo<br>* Placebo Pills distributed by Research Pharmacy labeled placebo.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Plasma Concentration Measure of Indoxyl Sulphate (IS) | Plasma concentrations of IS were measured by HPLC (high pressure liquid chromatography). Assessed weekly between day 0 and Week 4; change from baseline/day 0 to Week 4 reported | 4 weeks | 
| Change in Plasma Concentration Measure P-Cresyl Sulphate (PCS) | Plasma concentrations of P-Cresyl Sulphate (PCS) were measured by HPLC (high pressure liquid chromatography) Assessed weekly between day 0 and Week 4; change from baseline/day 0 to Week 4 reported | 4 weeks |
Mercury II - Compare the Efficacy and Safety of Lipid Lowering Agents Atorvastatin and Simvastatin With Rosuvastatin in High Risk Subjects With Type IIa and IIb Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether treatment with rosuvastatin following atorvastatin or simvastatin treatment will improve health outcomes for patients at high risk of Coronary heart disease compared to atorvastatin and simvastatin alone.

Official Title
-----------------
An Open Label, Randomized, Multi-Center, Phase IIIB, Parallel Group Switching Study to Compare the Efficacy and Safety of Lipid Lowering Agents Atorvastatin and Simvastatin With Rosuvastatin in High Risk Subjects With Type IIa and IIb Hypercholesterolemia.

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Rosuvastatin
* Drug: Atorvastatin
* Drug: Simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Discontinuation of all cholesterol lowing drugs, including dietary supplements. Documented history of, or high risk of coronary heart disease or other established atherosclerotic disease. Exclusion Criteria: The use of lipid lowering drugs or dietary supplements after Visit 1. Active arterial disease eg Unstable angina, or recent arterial surgery Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse. Abnormal laboratory parameters as defined in the protocol.

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 |
| --- | --- |
| Experimental: 1<br>Rosuvastatin | Drug: Rosuvastatin<br> <br> * Other names: Crestor;|
| Active Comparator: 2<br>Atorvastatin | Drug: Atorvastatin<br> <br> * Other names: Lipitor;|
| Active Comparator: 3<br>Simvastatin | Drug: Simvastatin<br> <br> * Other names: Zocor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low density Lipoprotein cholesterol level - reaching internationally recognised LDL cholesterol goal levels. |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in other cholesterol & triglyceride measures |  | 16 weeks | 
| Safety evaluation |  | 8 & 16 weeks | 
| To compare the efficacy of rosuvastatin with atorvastatin and simvastatin |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholesterol, hypercholesterolemia, Coronary Heart disease, low density lipoproteins, Rosuvastatin, Atorvastatin, simvastatin
Trial of Myocet in Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to examine the safety and effectiveness of the drug combination of Myocet, paclitaxel and trastuzumab compared to paclitaxel and trastuzumab without Myocet, as first line treatment for patients with metastatic HER2+ breast cancer.

Official Title
-----------------
A Phase III Randomized, Controlled Trial of Myocet, Trastuzumab and Paclitaxel Versus Trastuzumab and Paclitaxel for First-Line Therapy of Metastatic Breast Cancer

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

Intervention / Treatment
-----------------
* Drug: Myocet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic Her2+ Breast cancer by FISH analysis No prior chemotherapy for metastatic disease Measurable disease normal left ventricular ejection fraction Exclusion Criteria: prior doxorubicin treatment exceeding 300 mg/m2 or epirubicin exceeding 600 mg/m2 relapse within 12 months of completion of adjuvant trastuzumab, taxane or anthracycline therapy

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

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

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

| Intervention/Treatment |
| --- |
|Drug: Myocet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  |  | 
| Safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic Her2+ Breast cancer, Myocet, liposomal doxorubicin, trastuzumab
Study of a Flu Vaccine in Children

Study Overview
=================
Brief Summary
-----------------
This study tests the safety and effectiveness of a flu vaccine in school children. School children are usually the first members of a community to come down with the flu, and they often give the flu to their younger siblings, parents, and grandparents. It is hoped that giving school children a flu vaccine can help prevent the spread of the flu to other members of the community.

Detailed Description
-----------------
This is a Phase III trial (an advanced study with a large number of patients). Your child will receive a single dose of flu vaccine, which is given by a nasal spray.

Official Title
-----------------
Study of the Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) in a Community-Based, Non-Randomized, Open-Label Trial in Children to Assess Safety and Herd Immunity for the Control of Epidemic Influenza

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: Influenza virus vaccine (CAIV-T)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Your child may be eligible for this study if he/she: Is between the ages of 18 months and 18 years, with consent of parent or guardian. Is a resident of the Temple-Belton, Texas area. Exclusion Criteria: Your child will not be eligible for this study if he/she: Has had a fever within 3 days before vaccination. Has symptoms of a weakened immune system. Has had a wheezing episode within the past 2 weeks. Has moderate to severe asthma. Is allergic to eggs. Needs to take aspirin on a regular basis. Has received another vaccine or study drug in the past month.

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

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

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

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

Design Details

Primary Purpose: Prevention
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Influenza virus vaccine (CAIV-T)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |