linjc16/ctgov huggingface dataset:
Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant

Study Overview
=================
Brief Summary
-----------------
The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.

Official Title
-----------------
Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant

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

Intervention / Treatment
-----------------
* Drug: FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids
* Drug: FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
* Drug: MMF 2 g + full-dose Neoral (FDN) + corticosteroids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First kidney transplantation Male and female patients Between 18 and 65 years old Exclusion Criteria: Patients in need of multiple organ transplants

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids,<br> | Drug: FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids<br>* FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids<br>|
| Experimental: FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids<br> | Drug: FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids<br>* FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids<br>|
| Experimental: MMF 2 g + full-dose Neoral (FDN) + corticosteroids<br> | Drug: MMF 2 g + full-dose Neoral (FDN) + corticosteroids<br>* mycophenolate mofetil (MMF) + full-dose Neoral (FDN) + corticosteroids<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant |  |  | 
| permanent resumption of dialysis within 12 months post transplant |  |  | 
| surgical removal of graft within 12 months post transplant |  |  | 
| death within 12 months post transplant |  |  | 
| withdrawal of consent, death, or lost to follow up within 12 months post transplant |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12 |  |  | 
| serum creatinine |  |  | 
| cystatin C at months 3, 6, and 12 |  |  | 
| proteinuria at day 28, months 6 and 12 |  |  | 
| absolute lymphocyte count at screening, baseline, day 1, 7, 14, and 28, months 2, 3, 6, 9, and 12 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney, transplantation, rejection, immunosuppression
Study in Children Who Have Switched to Isosource Junior Mix Formula

Study Overview
=================
Brief Summary
-----------------
A Retrospective study In Children who have switched to Isosource Junior Mix formula (RICIMIX study) will review paediatric children > 12 months of age who require Isosource Junior Mix as an enteral tube feeding formula and have consumed the formula for at least 1 month. The purpose of this study is to understand If there has been an improvement in outcomes/ experiences The current usage of ISJMIX formula in children who require blended diets Improved feeding intolerances Improved patient outcomes/ experiences

Detailed Description
-----------------
Retrospective data will be collected using questionnaire by the dietitians at the nutrition and dietetic department. All completed questionnaires will be sent back to Nestle Health Science/ CRO company. The primary objectives: The following measures will be collected retrospectively after 1 month use of ISJMIX Feeding tolerance [no change, tolerance improved, tolerance worsened]: gastric residuals, gagging/retching, vomiting, abdominal distention/ gas, stool consistency issues (too hard, too loose) Volume of formula consumed in a day The secondary objective is to collect restropective data on: Any improved patient outcomes noted Calculate the potential cost savings made when using ISJMIX to help manage the feeding intolerances Calculate the potential costs benefit of using ISJMIX over other standard formulas

Official Title
-----------------
A Retrospective Study In Children Who Have Switched to Isosource Junior Mix Formula (RICIMIX Study)

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Dietary Supplement: Isosource Junior Mix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children who are using Isosource Junior Mix as tube feed formula Exclusion Criteria: All children who did not switch to Isosource Junior Mix feed formula

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 14 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Isosource Junior Mix|Single arm study, collecting data on those who have been on Isosourcr Junior mix tube feed formula for 30 days|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeding tolerance | The following measures will be collected retrospectively after 1 month use of ISJMIX • Feeding tolerance [no change, tolerance improved, tolerance worsened]: gastric residuals, gagging/retching, vomiting, abdominal distention/ gas, stool consistency issues (too hard, too loose) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume consumed | Average volume consumed over month period | 30 days | 
| Weight in Kg |  | 1 month |
Low Molecular Weight Heparin on the Adenomyosis Patients'IVF-ET Outcome

Study Overview
=================
Brief Summary
-----------------
In assisted reproductive technology, adenomyosis patients are characterized by lower clinical pregnancy rate, lower implantation rate and higher abortion rate. The purpose of this study is to explore whether low molecular weight heparin can reduce the abortion rate of adenomyosis patients in frozen thawed embryo transfer cycles.

Official Title
-----------------
To Study the Effect of Low Molecular Weight Heparin on the Adenomyosis Patients'Outcome of in Vitro Fertilization-embryo Transplantation

Conditions
-----------------
Adenomyosis, Assisted Reproductive Technology

Intervention / Treatment
-----------------
* Drug: Low molecular weight heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The basal serum level of FSH was less than 10 IU / L Diagnosed with adenomyosis by ultrasound The first frozen thawed embryo transfer cycle, by hormone replacement protocol Transfer at least one high quality frozen embryo; Patients agreed to use low molecular weight heparin after FET, and they were able to sign informed consent in person. Exclusion Criteria: With abnormal karyotype; Accompanied with other uterine diseases: intrauterine adhesion, intramural myoma, moderate to severe endometriosis, congenital uterine malformation, endometrial tuberculosis, thin endometrium < 8mm on the day of transformation, etc; PCOS, RIF patients; There are indications of conventional anticoagulation or antiplatelet therapy, such as antiphospholipid syndrome, autoimmune diseases, coagulation dysfunction, etc; There were contraindications to hormone replacement therapy and low molecular weight heparin; Participating in other clinical studies; Unable to follow-up

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 38 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Adenomyosis patients in control group have normal luteal progesterone support. | |
| Experimental: Low molecular weight heparin Group<br>Adenomyosis patients in Low molecular weight heparin group have Low molecular weight heparin in addition to normal luteal progesterone support. | Drug: Low molecular weight heparin<br>* Patients with adenomyosis were treated with low molecular weight heparin after frozen embryo transfer in addition to routine luteal support.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early spontaneous abortion rate |  | Within three months after frozen embryo transfer |
Drug Interaction Study to Asses Multiple Doses of ZD4054 (Zibotentan)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to to assess the effect of multiple oral doses of ZD4054 (Zibotentan) on the pharmacokinetics of a CYP450 3A Probe (midazolam) in healthy male subjects.

Official Title
-----------------
A Randomised, Open-label, Crossover, Phase I Study to Assess the Effect of Multiple Oral Doses of ZD4054 (Zibotentan) on the Pharmacokinetics of a CYP450 3A Probe (Midazolam) in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: midazolam
* Drug: ZD4054


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 18 and 30 kg/m2 Medical and surgical history and physical examination without any clinically significant findings Normal resting ECG with QTcB interval <450ms Exclusion Criteria: Definite or suspected personal history or family history of hypersensitivity to drugs that are endothelin antagonists; ie, ambrisentan, artrasentan, sitaxsetan and bosentan Healthy volunteer has a known hypersensitivity to midazolam or any of the excipients of the midazolam tablet Medical diagnosis of migraine with an attack during the 12 months prior to Screening

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>midazolam, one single dose of 705mg | Drug: midazolam<br> <br> * Other names: Dormicum®;|
| Experimental: 2<br>ZD4054(Zibotentan)- 10mg od, 7 days + midazolam (one single dose of 7.5 mg on day 6 ) | Drug: midazolam<br> <br> * Other names: Dormicum®;Drug: ZD4054<br>* ZD4054 10 mg od<br>* Other names: Zibotentan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK variables |  | Frequent sampling occasions during study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, ECG, blood pressure, pulse, safety lab) |  | During the whole treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ZD4054, Healthy Volunteers
B-Thalasaemia Trait and Its Possible Cardioprotective Role

Study Overview
=================
Brief Summary
-----------------
Our purpose is to investigate whether thallasaemia trait offers protection against cardiovascular events and whether this can be applied to specific characteristics of these people ( better lipid profile , better blood pressure profile) as scientific literature suggests.

Detailed Description
-----------------
Thallasaemia is a major problem , especially in countries around the Mediterranean sea.On the other hand ,thallasaemia trait has been shown ,in a small number of studies , to have a possible protective role against CAD and stroke.These kind of studies have been contacted in Greece also ,and usually they enroll a small number of participants. In the study, investigators will enroll 2500 subjects who serve in military units in Thesally Greece. Firstly investigators will estimate the prevalence of thallasaemia trait in this population , as it is very high in this region and at the same time investigators will retrospectively record data from their personal files (which are annually recorded).

Official Title
-----------------
B-Thalasaemia Trait and Its Possible Cardioprotective Role

Conditions
-----------------
Beta-Thalassemia Trait, Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: voluntary participation, Subjects with Thalassemia treat will be confirmed of their treat by electrophoresis - Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 57 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 |
| --- | --- |
| GrThalasaemia<br>estimation of IMT of the carotides arteries and calcium scoring | |
| GrNormal<br>estimation of IMT of the carotides arteries and calcium scoring | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardioprotective role of Thalassemia Treat | Cardioprotective role of Thalassemia Treat | 1 YEAR | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thalassemia, coronary, stroke, trait
Automatic Stop Orders for Urinary Catheters

Study Overview
=================
Brief Summary
-----------------
Urinary tract infections are the most common type of hospital-acquired infection. The majority of these infections result from the use of indwelling urinary catheters. Often caregivers leave them in unnecessarily. The purpose of this study is to assess the effectiveness of an automatic stop order (automatic removal or urinary catheters when they no longer needed) in reducing urinary infections.

Detailed Description
-----------------
We will randomize patients with urinary catheters to either automatic stop orders or to usual care. The primary outcome will be urinary tract infection. Secondary outcomes will include days of indwelling urinary catheterization, symptomatic urinary tract infection, isolation of antimicrobial-resistant bacteria from catheterized urine, antimicrobial use, bacteremia (blood-stream) infection secondary to urinary tract infection, and cost. We hypothesize that use of the automatic stop order will significantly reduce hospital-acquired urinary tract infection.

Official Title
-----------------
A Randomized Controlled Trial of Automatic Stop Orders for Urinary Catheterization in Hospitalized Patients

Conditions
-----------------
Urinary Tract Infections

Intervention / Treatment
-----------------
* Behavioral: Automatic stop order


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Urinary catheter for less than 48hrs Exclusion Criteria: Patient with symptomatic urinary tract infection Latex allergy

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Automatic stop order|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary tract infections |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| days of indwelling urinary catheterization, |  |  | 
| symptomatic urinary tract infection, |  |  | 
| isolation of antimicrobial-resistant bacteria from catheterized urine, |  |  | 
| antimicrobial use, |  |  | 
| bacteremia (blood-stream) infection secondary to urinary tract infection, |  |  | 
| cost |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urinary infections, catheters, bacteriuria, trial
Somatuline® Depot (Lanreotide) for Acromegaly Post-Marketing Observational Study

Study Overview
=================
Brief Summary
-----------------
To assess the safety and effectiveness of Somatuline® Depot (lanreotide) Injection when administered by a health care professional (HCP), the patient, the patient's partner or parent/guardian as part of their routine acromegaly care.

Detailed Description
-----------------
The objectives of this post-marketing observational study are to assess the safety and effectiveness, as measured by insulin-like growth factor-1 (IGF-1) and growth hormone (GH) levels, of Somatuline® Depot (lanreotide) Injection when administered by a health care professional (HCP), the patient, the patient's partner or parent/guardian as part of their routine acromegaly care. Treatment convenience and acromegaly symptom relief will also be assessed through questionnaires, and demographic and medical history information will be collected.

Official Title
-----------------
Somatuline® Depot (Lanreotide) Injection for Acromegaly (SODA): A Post-marketing Observational Study

Conditions
-----------------
Acromegaly

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must have a clinical diagnosis of acromegaly The patient must be treated with Somatuline® Depot (including patients newly prescribed Somatuline® Depot) The patient or legally authorized representative must be able to understand the protocol and give signed informed consent. Assent from the patient should also be obtained, where appropriate. Signed informed consent and assent must be obtained before any study-related activities are conducted. Exclusion Criteria: Symptomatic, untreated biliary lithiasis Known hypersensitivity to somatostatin analogs or related compounds (e.g., octreotide)
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 |
| --- | --- | --- |
| Assess the safety & effectiveness, as measured by IGF-1 & GH levels, of Somatuline® Depot Injection when administered by a health care professional, the patient, the patient's partner or parent/guardian as part of their routine acromegaly care. |  | 2 - 4 years/patient | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acromegaly
Early Oral Intake Following Cesarean Surgery

Study Overview
=================
Brief Summary
-----------------
In this study we are trying to compare the safety and financial benefit of starting the realimentation early versus conventional oral intake following the Cesarean surgery in Iran.

Detailed Description
-----------------
Cesarean delivery is announced to constitute 50% of deliveries in the Capital and 39% of all the deliveries nationwide, which is far beyond the acceptable international normal range, according to the official site of the Ministry of Health and Medical Education of the Islamic Republic of Iran [http://www.mohme.gov.ir/HNDC/Indicators/Simaye_Salamt/Simaye_Salamat.htm]. This high rate of elective cesarean deliveries might be due to several reasons which are far beyond the scope of this study. Here we tried to see whether the reduction in the time of hospitalization for these patients is safe at the expense of earlier oral realimentation and to see whether this strategy increases the patients' satisfaction or not.

Official Title
-----------------
Early Oral Intake Following Elective Cesarean Surgery in Iranian Women; the Economic Burdens and Patient Satisfaction

Conditions
-----------------
Obstetrics, Surgery

Intervention / Treatment
-----------------
* Procedure: Oral Intake following admittance to the postpartum ward


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who had elective cesarean deliveries under regional anesthesia Exclusion Criteria: Receiving general anesthesia, magnesium sulfate or insulin. Coming across an intraoperative bowel injury. Having any medical or gastrointestinal problem that prohibits early feeding

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Oral Intake following admittance to the postpartum ward|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance of Oral Intake |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cesarean, Oral, Intake