linjc16/ctgov huggingface dataset:
Does the Invitation by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening?

Study Overview
=================
Brief Summary
-----------------
The propose of this study is to assess the effect of general practitioner's involvement on first patients' solicitation in screening for colorectal cancer by testing for faecal occult blood (FOBT).

Official Title
-----------------
Does the Invitation by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening? A Cluster Randomised Controlled Study.

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Other: Co-signed letter
* Other: Classical Letter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged : 50 to 74 years. Not having ever been invited to participate in colorectal screening. Exclusion Criteria: Patients who have a Fecal Occult Blood Test for less than 2 years or a colonoscopy within the past 5 years or excluded for medical reasons (according to information known from ADECA).

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | Other: Classical Letter<br>* Patients receive classical letter signed by the coordinator doctor of ADECA<br>|
| Experimental: Co-signed Letter<br> | Other: Co-signed letter<br>* Patients receive a personalized letter co-signed by their general practitioner and the medical coordinator of ADECA.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of Fecal Occult Blod Test | Increased number of patients who completed the test for faecal occult blood following the first solicitation with the letter co-signed by general practitioner, compared with the conventional solicition(including replies exclusions). | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the impact of co-signing on deadline for completion of the test after the mailing. |  | 7 months | 
| Compare the proportion of uninterpretable tests. |  | 7 months | 
| Compare the rate of completion of colonoscopy after a positive test (information received by ADECA in the follow-up), according to the specifications. |  | 7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal Cancer, Screening, General Practitioner, Fecal Occult Blood Tests
Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV

Study Overview
=================
Brief Summary
-----------------
This is non-interventional study of voriconazole IV formulation in clinical use, which was mandated by the Korean government agency following the approval of Vfend in the Republic of Korea.

Official Title
-----------------
Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV

Conditions
-----------------
Serious Fungal Infections

Intervention / Treatment
-----------------
* Drug: voriconazole IV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Invasive aspergillosis and other serious fungal infections. Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A.<br>Patients who are indicated for VFEND according to drug package insert. | Drug: voriconazole IV<br>* 6 mg/kg iv q 12 hours (loading) then maintenance<br>* Other names: Vfend;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable | Clinical response defined as: Cure=resolution of all baseline signs and symptoms of fungal infection(s); Improvement=lessening of baseline signs and symptoms or absence of one or more, but not all baseline findings; Failure=no improvement or deterioration of baseline condition; Unevaluable=incomplete therapy (efficacy could not be evaluated or discontinuation was not followed up). | Baseline (Day 1) up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable | In case cultivation performed, cultivated strain before and after Vfend administration recorded, and the improvement of mycological outcomes after administration evaluated. Mycological response defined as: Eradication=absence of signs and symptoms of fungal infection; Persistence=(no eradication) presence of fungal infection; Superinfection=existence of different strains from strains separated prior to study medication; Not evaluable=a follow-up mycological cultivation is not performed. | Baseline (Day 1) up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
voriconazole, Korea, invasive fungal infection
Acute-On-Chronic Liver Failure in Zagazig University Hospitals

Study Overview
=================
Brief Summary
-----------------
Rationale: To identify the prevalence of Acute-on-chronic liver failure in Zagazig University Hospitals. The question of the research: How much the prevalence of Acute-on-chronic Liver Failure in Zagazig University Hospitals? The aim of the work: The aim of the study is to identify the presence of Acute-on-chronic Liver Failure in Zagazig University Hospitals Objectives: To estimate the prevalence of Acute-on-chronic Liver Failure in Zagazig University Hospitals. Subjects and Methods: I . Technical Design: Site of the study: Gastroenterology and Hepatology Unit- Zagazig University Hospitals Sample size: ''all patients admitted to Gastroenterology and Hepatology Unit with the criteria of ACLF according to EASL-AASLD from June 2017 to December 2017 were included in this study''. II . OPERATIONAL DESIGN: Type of the study: a prospective study. Full medical history - taking. Full clinical examination. Laboratory investigations including Routine laboratory investigation  CBC, Liver functions test, kidney functions test and prothrombin time  III. Administrative Design: Approvals obtained for performing the study from the official or governmental department. An ethical committee from the faculty of medicine and patients included in the study. Results: Collected data will be presented in tables and suitable graphs and analyzed according to standard statistical methods

Official Title
-----------------
ACLF in Zagazig University Hospitals

Conditions
-----------------
Acute-On-Chronic Liver Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients admitted to Gastroenterology and Hepatology Unit with the criteria of ACLF according to EASL-AASLD will be included in this study. Exclusion Criteria: no any exclusion criteria
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 |
| --- | --- | --- |
| improvement of the patients score according to SOFA score (AASLD and EASL guidelines) | follow up of participants until the patients recover | 24 weeks from first recruiting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death of the patient | due to the severity of acute on chronic failure, the death of patients is expected | 24 weeks from first recruiting | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ACLF, SOFA, Zagazig university
Clinical Study to Investigate the Safety and Efficacy of MLC601 in 150 Iranian Patients After Stroke

Study Overview
=================
Brief Summary
-----------------
To investigate the safety and efficacy of MLC601 (NeuroAideTM) as a Traditional Chinese Medicine on motor recovery after ischemic stroke.

Detailed Description
-----------------
This is a double-blind, placebo-controlled clinical trial study on 150 patients with a recent (less than 3 month) ischemic stroke. All patients will give either MLC601 (100 patients) or placebo (50 patients), 4 capsules 3 times a day, as an add-on to standard medication of post stroke for 3 months. Motor improvement will be monitored using Fugl-Meyer Assessment FMA.

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Drug: MLC601
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 30-72 yars, < one month after stroke, ischemic cerebral stroke, signed informed consent form. Exclusion Criteria: treatment with thrombolytic after stoke, ischemic stroke combined with hemorrhage, severe renal or liver failure, dementia, psychosis and history of seizure disorder, history of previous stroke, and hemoglobin level less than 10mg/dl on admission.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 72 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MLC601<br>MLC601 (NeuroAideTM) is a TCM which is used extensively in China to improve recovery after stroke. It combines several herbal and animal components. | Drug: MLC601<br>* group A (100 patients; NeuroAid 400mg, 4 capsules 3 times daily) or for 3 month<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* group B (50 patients; placebo, 4 capsules 3 times daily) for 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the Safety and Efficacy of MLC601 | Patients showed a good tolerability to treatment and adverse events were mild and transient. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor recovery of MLC601 in 150 Iranian Patients after Stroke | Repeated measured analysis showed statistically difference in Fugl-Meyer Assessment FMA score during 12 months between two groups | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Efficacy, MLC601, motor recovery
Bioavailability Study Comparing Two New Nilotinib Tablet Formulations to an Established Nilotinib Capsule Formulation in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Bioavailability study comparing two new nilotinib tablet formulations to an established nilotinib capsule formulation in healthy volunteers

Official Title
-----------------
A Randomized, Open Label, Two-arm, Three Period Crossover Bioavailability Study Comparing Two New Nilotinib Tablet Formulations to an Established Nilotinib Capsule Formulation in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: Nilotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Healthy adult male (18 - 55 yrs) and sterile or post menopausal female subjects Body weight must be ≥50 kg and <100 kg, with a body mass index (BMI) >18 but <33. Laboratory parameter values must fall within the normal range Exclusion Female who is pregnant or breast feeding. Contraindication to receiving nilotinib. Smokers or user of tobacco products A past medical history of clinically significant Electrocardiogram abnormalities, or a history/family history of long QT-interval syndrome. Other protocol-defined inclusion/exclusion criteria may apply

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nilotinib Tablet Formulations<br> | Drug: Nilotinib<br> <br> |
| Active Comparator: Established Nilotinib Capsule Formulation<br> | Drug: Nilotinib<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioavailability of nilotinib |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nilotinib, bioavailability, tablet, capsule, PK, healthy, subject(s),
Relation Between MicroRNA 203 and 210 and Sparing the Laparoscopic Examination in Cases of Unexplained Infertility

Study Overview
=================
Brief Summary
-----------------
The study targets to evaluate the role of estimation of plasma expression levels of gene of microRNAs 203 and 210 in helping to diagnose and grade endometriosis. The study included women with unexplained infertility and clinical picture suggestive of presence of endometriosis were divided randomly into two groups: Control and study groups. All patients underwent exploratory laparotomy for diagnosis and grading of endometriosis if present. Patients of study group gave blood samples for estimation of plasma expression levels of microRNA 203 and 210 using qRT-PCR procedure.

Official Title
-----------------
Plasma Levels of Micro RNA 203 and 210 Might Spare the Exploratory Laparoscopy in Case of un Explained Infertility With Suspected Endometriosis

Conditions
-----------------
Infertility Unexplained, Endometriosis

Intervention / Treatment
-----------------
* Procedure: Laparoscopic Exploration
* Diagnostic Test: Estimation of Plasma Expression level of MICRO RNA 203 & 210


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 30-45 years old Unexplained infertility Exclusion Criteria: Presence of other causes of infertility, age out of the predetermined range, the presence of immune disorders, maintenance on immunosuppressive drugs

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study group<br>Study group Patients with unexplained infertility had estimated their Plasma Expression level for GeneMicro RNA 203 & 210 by qRT-PCR followed by laparoscopic exploration | Procedure: Laparoscopic Exploration<br>* Laparoscopic Exploration to diagnose & grade endometriosis<br>Diagnostic Test: Estimation of Plasma Expression level of MICRO RNA 203 & 210<br>* estimation of Plasma Expression level for GeneMicro RNA 203 & 210 by qRT-PCR<br>|
| Active Comparator: Control Group<br>Control group Patients with unexplained infertility underwent laparoscopy only | Procedure: Laparoscopic Exploration<br>* Laparoscopic Exploration to diagnose & grade endometriosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| grading of endometriosis | The diagnostic performance of estimated plasma levels of microRNA for diagnosis and grading endometriosis | 8 months |
Thermography of the Foot With Plantar Orthosis Liners

Study Overview
=================
Brief Summary
-----------------
Objetive: To analyze the thermal effects of the types of liners used in the manufacture of the foot orthoses, as well as to establish the thermal differences among them. Design: Quantitative, experimental, longitudinal and prospective study. Subjects: 47 individuals selected randomly, over 20 years of age Methods: 4 types of liner were studied: natural skin, synthetic leather, perforated E.V.A and E.V.A. without perforation.

Official Title
-----------------
Foot Thermography With the Use of Different Plantar Orthosis Lining Materials

Conditions
-----------------
Foot Orthosis, Temperature

Intervention / Treatment
-----------------
* Other: Thermographic photo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People wearing sanitary footwear. 20-35 years Not having smoked or taken alcohol or exciting drinks before evaluation Without cream on the sking and not being exposed to UV rays. Exclusion Criteria: young or old people with respect to the age of study smokers or drinkers

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Termography PRE<br>Foot thermography before lining test | Other: Thermographic photo<br>* Barefoot patient, thermographic photo of the sole of the feet is taken<br>|
| Experimental: Termography POST<br>Foot thermography after wearing 2 types of liner for three hours (one on each foot) | Other: Thermographic photo<br>* Barefoot patient, thermographic photo of the sole of the feet is taken<br>|
| Active Comparator: Thermographic comparations<br>Thermographic comparations between PRE and POST measurements | Other: Thermographic photo<br>* Barefoot patient, thermographic photo of the sole of the feet is taken<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot temperature measurement PRE | The camera Flir E60BX was used, placed on a tripod one meter away from the feet. A photo of the sole of the foot was taken. | for a month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot temperature measurement POST | Photo after the use of linings inside the shoe | for a month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infrared thermography, orthopodia, thermometry
Immediate Implant Placement With Platlet Rich Fibrin as Space Filling Material Versus the Use of Deprotienized Bovine Bone (Tutogen) in Maxillary Premolars.

Study Overview
=================
Brief Summary
-----------------
20 subjects suffering from non restorable maxillary premolar teeth will be randomly devided into two groups. the selected teeth will be extracted and immeiate implants will be placed in all subjects. the first group will recieve deprotienized bovine bone (tutogen) to fill the buccal space between the implant and the bone, the second group will recieve platlet rich fibrin to fill the buccal space between the implant and the bone

Official Title
-----------------
Immediate Implant Placement With Platlet Rich Fibrin as Space Filling Material Versus the Use of Deprotienized Bovine Bone (Tutogen) in Maxillary Premolars. A Randomized Controlled Clinical Trial

Conditions
-----------------
Immediate Dental Implant

Intervention / Treatment
-----------------
* Procedure: deprotienized bovine bone (tutogen)
* Procedure: platelet rich fibrin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non restorable maxillary premolars non smoker free from any systemic disease or medication that could impair normal bone healing Exclusion Criteria: any systemic disease that could affect bone healing patient with lesion related to the surgical site

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: platelet rich fibrin<br>immediate implant grafting | Procedure: deprotienized bovine bone (tutogen)<br> <br> |
| Active Comparator: deprotienized bovine bone (tutogen)<br>immediate implant grafting | Procedure: platelet rich fibrin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient morbidity | patient pain level on pain scale using pain chart | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| crestal bone loss | radiographic analysis computing amount of crestal bone loss around implants using cone beam computed tomography | 3 months | 
| implants stability quotient | implant stability measured using resonance frequency analysis | 3 months |