linjc16/ctgov huggingface dataset:
A Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients Switched From EC-MPS.

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety, efficacy and effect on quality of life of switching kidney transplant patients from reduced dose EC-MPS treatment due to gastrointestinal problems to a higher than the equimolar dose of CellCept. Patients will be switched, initially, from EC-MPS (<1440g/day) to an equimolar dose of CellCept, and at the next visit (day 10 +/- 5) the CellCept dose will be increased by 250mg/day, and the daily dose will be split into 3-4 doses. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Official Title
-----------------
An Open-Label Study to Evaluate the Effect on Quality of Life of Switching Kidney Transplant Patients From Reduced Dose EC-MPS to a Higher Than the Equimolar Dose of CellCept

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: mycophenolate mofetil [CellCept]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >=18 years of age; first or second kidney transplant; EC-MPS therapy for >=6 months, with a stable dose for >=2 months; lower than recommended dose of EC-MPS (<1440g/day) due to gastrointestinal complaints. Exclusion Criteria: patients who have participated in this study before; patients currently participating in another clinical trial, or who participated in one during the last 30 days.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: mycophenolate mofetil [CellCept]|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Quality of Life index, and Gastrointestinal Symptom Rating Scale, at 3 months. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Mean dose increase of CellCept. Pharmacokinetics: Comparison of pharmacokinetic parameters under EC-MPS and CellCept therapy. Safety: AEs; acute rejection episodes. |  |  |
Nutrition Protocol and Premature Infants' Growth

Study Overview
=================
Brief Summary
-----------------
Nutrition is a major issue for premature infants. Inappropriate nutritional intake during the first weeks of life is responsible for postnatal growth restriction and adverse long-term outcomes. This study aimed at evaluating the impact of the introduction of an updated, standardized, nutrition protocol on very premature infants' growth and morbidity, and the care givers' compliance to the new protocol.

Official Title
-----------------
Impact of Introducing a Standardized Nutrition Protocol on Very Premature Infants' Growth and Morbidity

Conditions
-----------------
Premature Infants, Nutrition Deficiency Due to Insufficient Food, Growth Retardation

Intervention / Treatment
-----------------
* Other: nutrition protocol introduction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All surviving infants born between 26 and 32 weeks gestation in our Level III NICU Exclusion Criteria: Death Any congenital malformation

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 77 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Before Protocol<br>72 premature infants born between 26 and 32 weeks gestation, over 6 months period, and involved before the introduction of a strict nutrition protocol | Other: nutrition protocol introduction<br>* Growth comparison of 2 cohorts of infants evaluated in a before-after design<br>|
| After Protocol<br>86 premature infants born between 26 and 32 weeks gestation, over 6 months period, and involved after the introduction of a strict nutrition protocol and a washout period of 6 months | Other: nutrition protocol introduction<br>* Growth comparison of 2 cohorts of infants evaluated in a before-after design<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight | longitudinal weight evaluation | weekly recording from Day 0 up to Day 77 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Necrotizing enterocolitis | Necrotizing enterocolitis | Day 77 postnatal age | 
| late onset sepsis | Incidence of late onset sepsis | Day 77 postnatal age | 
| patent ductus arteriosus | Incidence of patent ductus aretriosus requiring treatment | Day 77 postnatal age | 
| Bronchopulmonary dysplasia | Incidence of Bronchopulmonary dysplasia | Day 77 postnatal age | 
| Central venous catheters. | Duration of central venous catheters | Day 77 postnatal age | 
| Compliance to the protocol | comparison between expected prescription and actual nutrition intake | weekly recording from Day 0 up to Day 77 |
Antibiotic Prophylaxis in Mesh Repair of Inguinal Hernias

Study Overview
=================
Brief Summary
-----------------
Inguinal hernia repairs is clean surgical procedures. However infection may be a concern when prosthetic materials are used. This prospective randomized study has been set to observe if antibiotic prohylaxis is of benefit in mesh repair of inguinal hernias.

Detailed Description
-----------------
There are two group in the study. Control group received no antibiotic prohylaxis, whereas a single dose 1 gr. intravenous cefazoline is given to the patient in prophylaxis arm of the study. 30-days surgical site infection rates and 1 year prosthetic intervention late infection rates are observed and recorded. Side effects of antibiotic used are also recorded.

Official Title
-----------------
Single Dose Antibiotic Prophylaxis in Lihtenstein Repair for Primary Inguinal Hernias

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Drug: sefazolin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: inguinal hernia repair - Exclusion Criteria: uncontrolled diabetes mellitus, -

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Antibiotic prohylaxis / Lichtenstein repair | Drug: sefazolin<br>* In prophylaxis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection |  | 30 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug side effects |  | 5 days postoperatively | 
| 1-year prosthetic repair surgical site late infection rate |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inguinal hernia, antibiotic, prophylaxis
Prophylaxis of Ventilator Associated Pneumonia by Continuous Lateral Rotation Therapy

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Ventilator associated pneumonia (VAP) in critically ill patients may be prevented by continuous lateral rotation therapy (CLRT) using specially designed, motor driven beds. Patients are randomized to CLRT or supine position if mechanically ventilated and not suffering from pneumonia or ARDS within 48 hours after intubation. Prophylaxis of VAP is standardized in both groups. Primary endpoint is incidence of VAP, secondary endpoints are length of ventilation, length of stay and mortality.

Official Title
-----------------
Prophylaxis of Ventilator Associated Pneumonia by Continuous Lateral Rotation Therapy

Conditions
-----------------
Pneumonia, Ventilator-Associated

Intervention / Treatment
-----------------
* Procedure: Continuous lateral rotation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mechanically ventilated Intubated not longer than 48 h Medical cause for ICU admission Expected to be ventilated for > 48 hours Exclusion Criteria: Pneumonia or ARDS present Postoperative patient

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Continuous lateral rotation therapy | Procedure: Continuous lateral rotation therapy<br> <br> |
| No Intervention: 2<br>Standard manual positioning (Supine position) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator associated pneumonia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  |  | 
| Length of mechanical ventilation |  |  | 
| ICU and hospital Mortality |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevention of ventilator associated pneumonia
Prospective Trial on Trochanteric Femur Fractures Treated With or Without a Trochanter Support Plate

Study Overview
=================
Brief Summary
-----------------
Fractures just below the hip often are treated with a so called Gliding Screw and Plate (DHS). Recently a new additional plate called a Trochanter Support Plate (TSP) which attaches to the DHS has become available which is claimed to give extra support to the fracture. In a prospective randomised study we wish to test the hypothesis that the TSP does not give any additional stability to the fracture treated with the DHS.

Official Title
-----------------
A Prospective Randomised Study of Unstable Trochanteric Femur Fractures Treated With Dynamic Hip Screw With and Without a Trochanter Support Plate

Conditions
-----------------
Femoral Fractures

Intervention / Treatment
-----------------
* Procedure: Addition of TSP to DHS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of unstable trochanteric femur fracture.(Evans-Jensen class.3-5) (can include; Patients with cognitive problems (ie. dementia etc) Exclusion Criteria: Patients with pathological fractures Multitrauma patients Patients not able to walk before the fracture Under 19 years old. Patients with fractures needing other treatments than gliding hip screws Reverse oblique fractures.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: -TSP<br>Patients operated without TSP | Procedure: Addition of TSP to DHS<br>* All patients operated with DHS. Of these two groups. One operated with TSP and one without.<br>|
| Active Comparator: +TSP<br>Patients operated with TSP | Procedure: Addition of TSP to DHS<br>* All patients operated with DHS. Of these two groups. One operated with TSP and one without.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture movement postoperatively |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation |  | One year | 
| Pain postoperatively |  | one year | 
| Hip function postoperatively |  | one year | 
| Fracture healing |  | one year | 
| complications postoperatively |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trochanter, Femur, Fracture
Early Increase in Blood Supply in Patients With Barrett's Esophagus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if early Barrett's specialized intestinal metaplasia can be detected by measuring early increased blood supply of the esophageal tissue, with 4 Dimensional Elastic Light-Scattering Fingerprinting, (4D-ELF) technology in real time.

Official Title
-----------------
Detectable Esophageal Early Increase in Blood Supply (EIBS) in Patients With Barrett's Esophagus

Conditions
-----------------
Barrett's Esophagus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 years or older, informed written consent, patient scheduled for previously planned upper endoscopy Exclusion Criteria: liver disease; gastric antral vascular ectasia (GAVE);any known non-esophageal aerodigestive malignancy; severe cardiopulmonary disease precluding endoscopy; presence of conditions not allowing biopsy (e.g. coagulation disorder); known familial polyposis syndrome (FAP, HNPCC, Juvenile polyposis, etc.); known pregnancy or sexually active females of childbearing age who are not practicing an accepted form of birth control.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NoBE (control)<br> | |
| BE without dysplasia<br> | |
| BE with dysplasia<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine if early increase blood supply (EIBS)can predict presence of Dysplasia | To determine if early increase blood supply (EIBS), as measured in Barrett's glandular mucosa segment, can predict the presence of Dysplasia in patients with known diagnosis of Barrett's esophagus (BE). | 10 minutes during standard upper endoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine if EIBS can predict presence of BE in patients undergoing upper endoscopy | EIBS measurements taken from buccal mucosa and esophagus will be compared in patients without BE, patients with BE without dysplasia, and patients with BE dysplasia. EIBS measurements will be obtained from normal squamous mucosa in the mouth, proximal esophagus, areas of BE in the distal esophagus, and measurements from the gastric cardia/hiatal hernia (at least 4 cm below the Z line. | 10 minutes |
Hematopoietic Stem Cell Transplantation for the Treatment of Limb Ischemia and Diabetic Neuropathy

Study Overview
=================
Brief Summary
-----------------
Several pathophysiological theories have been proposed for the development of diabetic chronic complications. In recent years, the use of stem cells (totipotential, hematopoietic or endothelial lineages) has been reported as an adjunctive modality of treatment for ischemia models in animals and humans. Nevertheless, there are no reports in the use of stem cells for the treatment of human sensorimotor peripheral diabetic neuropathy. We performed this study to evaluate the effect of autologous hematopoietic CD34+ cell transplantation on nerve conduction velocity in patients with type 2 diabetes mellitus.

Official Title
-----------------
Autologous Hematopoietic Stem Cell Transplantation for the Treatment of Limb Ischemia and Diabetic Neuropathy in Patients With Diabetes Mellitus Type 2:A Randomized Controlled Trial.

Conditions
-----------------
Limb Ischemia, Diabetic Neuropathy

Intervention / Treatment
-----------------
* Biological: Hematopoietic stem cell transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ambulatory patients with type 2 diabetes mellitus and ischemia of one or both lower limbs, defined as lack of limb improvement with conventional care (medications, debridements) after a recent amputation or a patient graded III or IV in the Leriche-Fontaine functional classification. Exclusion Criteria: Patients older than 75 years Hypercoagulable states Cardiac ejection fraction < 30% Active vasculopathy in brain, kidneys or heart Neoplastic disease Active infection Diabetic ketoacidosis or hyperosmolar hyperglycemic state Gangrene of the extremity requiring immediate surgery.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 74 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br> | |
| Experimental: 2<br>Hematopoietic stem cell transplantation | Biological: Hematopoietic stem cell transplantation<br>* Intramuscular application of CD34+ hematopoietic stem cells (with a minimum of 2 million CD34+ cells/kg) into the gastrocnemius muscles after stimulation with subcutaneous filgrastim 600 micrograms/kilogram a day for 4 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nerve conduction velocity |  | Three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nerve conduction velocity, hematopoietic stem cell transplantation
Mobile Technology for Improved Family Planning

Study Overview
=================
Brief Summary
-----------------
An individual randomised controlled trial (RCT) to evaluate the effectiveness of a voice-based mobile phone health (mHealth) intervention to support post-abortion family planning (PAFP) at four Marie Stopes International clinics in Cambodia. The study seeks to address the research question: does a PAFP mHealth intervention increase use of contraception in Cambodia? STUDY RESULTS: http://www.who.int/bulletin/online_first/en/

Conditions
-----------------
mHealth, Contraception, Post-abortion Family Planning

Intervention / Treatment
-----------------
* Behavioral: Mobile phone-based intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Client attending for abortion Client does not want to have a child at the current time Client aged 18 or over Client owns a mobile phone Client willing to receive simple voice messages relating to contraception from Marie Stopes in Khmer language Exclusion Criteria: Not meeting inclusion criteria Declined to participate

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile phone-based intervention<br>Standard care plus automated voice message to support post-abortion contraception use every two weeks for total of three months and direct follow up phone call by family planning counsellor depending on response to voice message. | Behavioral: Mobile phone-based intervention<br>* Automated voice message to support post-abortion contraception use every two weeks for total of three months. Direct follow up phone call by family planning counsellor depending on response to voice message.<br>|
| No Intervention: Standard care<br>Face-to-face post-abortion family planning (PAFP) counselling, follow-up at one or two weeks, clinic phone number, existing 'Hotline' phone number. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of a Effective Contraceptive Method at Four-months Post-abortion | Self-reported use of pill, coil, implant or injection for all participants. Objective measurement of contraceptive use for participants from one clinic. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy |  | 4 months | 
| Repeat Abortion |  | 4 months | 
| Contraceptive Discontinuation |  | 4 months |