linjc16/ctgov huggingface dataset:
Safety/Tolerability, Immunological and Clinical Activity of a Boost Immunization With AFFITOPE AD02

Study Overview
=================
Brief Summary
-----------------
This is a phase IB follow-up study to assess a boost immunization with AFFITOPE AD02 with regard to safety/tolerability, immunological and clinical activity in Alzheimer patients who have received the vaccine within the clinical study AFF002.

Official Title
-----------------
Phase IB Follow-up Study to Assess a Boost Immunization With AFFITOPE AD02 With Regard to Safety/Tolerability, Immunological and Clinical Activity in Alzheimer Patients Who Have Received the Vaccine Within the Clinical Study AFF002

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Biological: AFFITOPE AD02


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in AFF002 and AFF004 Exclusion Criteria: Presence or history of allergy to components of the vaccine, if considered relevant by the investigator Contraindication for MRI imaging History and/or presence of autoimmune disease, if considered relevant by the investigator Active infectious disease (e.g., Hepatitis B, C) Presence and/or history of Immunodeficiency (e.g., HIV) Significant systemic illness

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 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: AFFITOPE AD02<br> | Biological: AFFITOPE AD02<br>* s.c. injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability | Withdrawal criteria (continuation decision) Number of patients who withdraw due to AEs Reason for withdrawal Adverse events (AEs) Serious adverse events (SAEs) Physical and neurological examination Concomitant medication Vital signs (blood pressure, heart rate, respiratory rate, body temperature) Body mass (weight and height) MRI of brain ECG Laboratory assessment (haematology, biochemistry, coagulation, serology and urinalysis) | July 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological and clinical activity | Immunological parameters: - Assessment of the immune response triggered by the vaccine (titre of IgG antibodies specific for the immunizing peptide, N-terminal part of Aβ, (irrelevant peptide serves as specificity control), Aβ itself and KLH as assessed by ELlSA as well as the results of the biacore affinity measurements towards the immunizing peptide and Aβ) Clinical efficacy variables: Cognitive and functional tests, behavioural scales Measurement of quality of life in patients with Alzheimer's disease Investigator's global evaluation scale | July 2010 |
The Real World Study of Apatinib for Gastric Cancer Treatment in Anhui Province

Study Overview
=================
Brief Summary
-----------------
The investigators conduct the real world study to explore the efficacy and safety of Apatinib in gastric cancer .

Official Title
-----------------
The Real World Study of Apatinib for Gastric Cancer Treatment in Anhui Province

Conditions
-----------------
Gastric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients . Confirmed by Pathology or histology of Gastric cancer Patients should be voluntary to the trial and provide with signed informed consent The researchers believe patients can benefit from the study. Exclusion Criteria: Patients with a known history of allergic reactions and/or hypersensitivity attributed to apatinib or its accessories Pregnant or lactating women Patients with Apatinib contraindications Patients of doctors considered unsuitable for the trial

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

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 |
| --- | --- | --- |
| Progress free survival | Progress free survival is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease control rate | Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1 | 1year | 
| Objective tumor response rate | Objective tumor response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments | 1year | 
| overall survival | overall survival is defined as the length of time from random assignment to death or to last contact. | 3year | 
| Disease-free survival | Disease-free survival is defined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
apatinib
Safety of the PET-512MC Transesophageal Transducer

Study Overview
=================
Brief Summary
-----------------
The objective of this Study is to demonstrate the safety of the PET-512MC TEE transducer as it is inserted and transitioned into the esophagus through the mouth.

Detailed Description
-----------------
The PET-512MC is a multiplane transesophageal transducer designed for use with Toshiba Diagnostic Ultrasound Systems for the visualization of the heart (and other organs) as a real-time ultrasound image. It is inserted into the esophagus through the mouth to visualize a plane of the heart through the esophageal wall. The purpose of this Study is to demonstrate the safety of the PET-512MC TEE transducer and gather feedback from the investigators related to the insertion of the transducer. The data will be used to determine the usability of the transducer in the clinical environment.

Official Title
-----------------
Safety of the PET-512MC Transesophageal Transducer (TEE)

Conditions
-----------------
Transesophageal Transducer

Intervention / Treatment
-----------------
* Device: PET-512MC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male and female patients ages 18 and above who have been scheduled for a TEE procedure by their physician Informed consent understood and signed Compliance with post-treatment and follow-up protocol requirements Exclusion Criteria None

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TEE Procedure<br>patients requiring TEE procedure by their physician | Device: PET-512MC<br>* Transesophageal Transducer<br>* Other names: TEE Probe;|

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
-----------------
TEE, Transesophageal, Transducer, Esophagus, Ease of passage and during transitioning into and down the esophagus to complete a normal TEE study
Intravitreal Bevacizumab for Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
Diabetic macular edema is a common cause of visual loss among diabetic patients. Studies have demonstrated the role of vascular endothelial growth factor (VEGF) in the pathogenesis of edema. This study designed to evaluate the effect of Intravitreal injection of a recombinant monoclonal anti-VEGF antibody, Bevacizumab, for treatment of diabetic macular edema.

Conditions
-----------------
Macular Edema, Diabetic Retinopathy

Intervention / Treatment
-----------------
* Drug: Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus Clinically significant macular edema Possibility of performing macular OCT Consent of patient for inclusion in the study Exclusion Criteria: History of macular photocoagulation in less than 6 months of inclusion in the study Necessity of surgical intervention Rejection of the remaining in the study by patient
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Performance Evaluation of AMH Assay

Study Overview
=================
Brief Summary
-----------------
The Access AMH Assay is an in vitro diagnostic assay intended as an aid for fertility assessment. The purpose of the study is to evaluate the clinical performance of the Access AMH Assay in the intended use population.

Detailed Description
-----------------
same as brief summary

Official Title
-----------------
Clinical Performance Evaluation of AMH Assay

Conditions
-----------------
Anti-Mullerian Hormone

Intervention / Treatment
-----------------
* Diagnostic Test: Access AMH Assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 21 and < 46 years of age Regular menstrual cycle Both ovaries present Exclusion Criteria: Evidence of PCOS Confirmed ovarian endometrioma Ovarian surgery prior to enrollment Being treated for cancer Hormonal contraceptive use prior to enrollment Currently pregnant

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Access AMH Assay|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of AMH as an aid for fertility assessment | Comparison of AMH levels in women at different levels of AFC to aid in assessing ovarian reserve | Day 2 to 4 of menstrual cycle |
IGF-1, IGFBP3, ALS Normative Ranges in Healthy Pediatric Spanish Population

Study Overview
=================
Brief Summary
-----------------
To determine the normative ranges of the Insulin-like Growth Factor 1 (IGF-1), Insulin-like growth factor-binding protein 3 (IGFBP-3), Acid-Labile Subunit (ALS) according to age, sex and pubertal stage of a healthy paediatric Spanish population.

Official Title
-----------------
An Epidemiologic, Descriptive and Cross-sectional Study of the IGF-1, IGFBP-3 and ALS Normative Ranges in a Healthy Paediatric Spanish Population, Divided Into Chronological Age, Sex and Pubertal Stage

Conditions
-----------------
IGF-1 Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children of either sex of Caucasian parents Age: newborns up to and including 18 years of age Length/height, weight and body mass index (BMI) within the mean +/- 2SD (Standard Deviation) and in accordance with the growth charts of the 2010 Spanish cross-sectional growth study (Carrascosa Lezcano et al 2010) Signed consent by at least one parent or legal guardian (if subject is ≤18 years) and by subject if ≥12 years Exclusion Criteria: Early or advanced puberty (pubertal signs: between 8 and 9 years old in girls, and between 9 and 10 years old in boys), or delayed puberty (no puberty onset in ≥ 13 year-old girls, and in ≥ 14 year-old boys) Chronic diseases including, but not limited to, endocrinologic diseases, chromosomal diseases, chronic diseases of renal, hepatic and/or cardiac aetiology, and tumour processes An acute disease during the last two weeks prior to recruitment Any clinically significant out-of-range lab value Healthy paediatric volunteers who are under medical treatment (contraception permitted) A family history of short stature (either parent < P3) Children born small for gestational age (birth weight, length, or head circumference < P10) Adopted children or conceived through in vitro fertilization ( IVF ) Subjects who are unwilling or unable in the opinion of the investigator or sponsor to undergo all the study procedures

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGF-1 levels according to age, sex and pubertal stage in healthy paediatric volunteers |  | At the time of participant's single study visit (day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGFBP-3 levels according to age, sex and pubertal stage in healthy paediatric volunteers |  | At the time of participant's single study visit (day 1) | 
| ALS levels according to age, sex and pubertal stage in healthy paediatric volunteers |  | At the time of participant's single study visit (day 1) |
Effects of Kinesio Taping on Postural Stability in Young Soccer Players

Study Overview
=================
Brief Summary
-----------------
The purpose of our study is to investigate the effects of Kinesio Taping application, which is applied before the training period, on postural stability in young soccer players.

Official Title
-----------------
Effects of Kinesio Taping on Postural Stability in Young Soccer Players

Conditions
-----------------
Increasing Performance of Healthy Athlete

Intervention / Treatment
-----------------
* Device: Kinesio Taping application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Soccer players aged between 12-16 Exclusion Criteria: - Players who had lower extremity injury previously

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 16 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KT<br>Kinesio Taping Application | Device: Kinesio Taping application<br>* Therapeutic taping application applied to skin affecting muscle, fascia, circulation, ligaments, tendons and joints.<br>* Other names: Kinesio Tex Gold, Kinesio Tex FP;|
| No Intervention: CONTROL<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tetrax interactive balance system results | Postural Stability of soccer players | 45 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Flir E5 Thermographic Camera results | Skin temperature measurement of soccer players | 45 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
soccer
Characterization of Laryngeal Contact Granulomas: Retrospective Analysis of Symptoms, Promotive Factors and Therapy

Study Overview
=================
Brief Summary
-----------------
Retrospective analysis of data from patients with laryngeal contact granulomas in order to identify possible differences and/or similarities between the cases and in order to determine whether and which conclusions can be drawn on disease and therapy.

Detailed Description
-----------------
This is a retrospective analysis of data from patients with laryngeal contact granulomas in order to identify possible differences and/or similarities between the cases and in order to determine whether and which conclusions can be drawn on disease and therapy.

Official Title
-----------------
Characterization of Laryngeal Contact Granulomas: Retrospective Analysis of Symptoms, Promotive Factors and Therapy

Conditions
-----------------
Laryngeal Contact Granuloma

Intervention / Treatment
-----------------
* Procedure: Retrospective analysis of data


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Laryngeal contact granuloma in adults with documentation of symptoms, possible causes, therapy and outcome Exclusion criteria: Incomplete information on the diagnosis laryngeal contact granuloma (symptoms, promotive factors, findings)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Retrospective analysis of data|Retrospective data analysis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with similar therapy outcome as a measure of therapy predictability | Data from patients with laryngeal contact granuloma are analyzed retrospectively as to wether similar pathologies and treatment lead to similar outcome. | 4 to 6 months after finishing the therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laryngeal contact granuloma, Treatment type, Outcome
A Study of Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
This is a study of bimatoprost as initial, replacement, or adjunctive intraocular pressure (IOP)-lowering therapy in patients with primary open angle glaucoma and ocular hypertension.

Conditions
-----------------
Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Bimatoprost 0.03%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of open-angle glaucoma or ocular hypertension No use of Lumigan® in the past 3 months Exclusion Criteria: Received laser therapy, glaucoma surgery, cataract surgery, or other ocular surgery within the past 3 months

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: Bimatoprost 0.03%<br>Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months. | Drug: Bimatoprost 0.03%<br>* Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.<br>* Other names: LUMIGAN®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) in the Study Eye | IOP is a measure of the fluid pressure inside the study eye. Patients were categorized by pre-study therapies and the bimatoprost-containing study therapy into the following 5 groups: Group A (pre-study: treatment naïve; during study: bimatoprost monotherapy); Group B (pre-study: prostaglandin analog [PGA] monotherapy, excluding bimatoprost; during study: bimatoprost monotherapy); Group C (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost monotherapy); Group D (pre-study: combination therapy including PGA, without bimatoprost; during study: pre-study combination therapy with PGA switched to bimatoprost); and Group E (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost adjunctive to pre-study therapy). | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With an Adverse Event of Conjunctival Hyperemia | Conjunctival hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. | 3 Months |