linjc16/ctgov huggingface dataset:
Assessment of NSAID-treated Patients Adherence to Co-prescribed Proton Pump Inhibitor (PPI)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this cross-sectional observational real life study is to investigate the patient reported adherence to PPI, when prescribed as prevention of NSAID associated GI Ulcers to patients prescribed a NSAID. Patients included have Osteoarthritis, Rheumatoid Arthritis or Ankylosing Spondylitis. Adherence will be assessed by patient questionnaires.

Detailed Description
-----------------
Cross-sectional, observational Real Life study on NSAIDs treated patients with Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis: Assessment of patient adherence to PPI treatment

Official Title
-----------------
Cross-sectional, Observational Real Life Study on NSAIDs Treated Patients With Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis: Assessment of Patient Adherence to PPI Treatment

Conditions
-----------------
Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis (documented in the medical record) of OA, RA or AS Prescription of oral NSAID treatment for OA, RA or AS, where low dose is not sufficient Prescription of PPI for prevention of NSAID associated GI ulcers, with instruction to take PPI same day as when taking NSAID. Exclusion Criteria: Participating in any clinical trial involving PPI or NSAID Patients prescribed PPI as acute treatment of GI events or symptoms within 8 weeks Inability to complete PROs

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis, 18 years or older | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported adherence to PPI treatment on actual days of NSAID treatment. |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with reported adherence ≤ 80%. |  | 7 days | 
| Patient adherence to prescribed ASA treatment. |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis
A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME)

Study Overview
=================
Brief Summary
-----------------
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME.

Official Title
-----------------
A Randomized, Sham-Injection Controlled, Double-Masked, Ascending-Dose, Dose-Range-Finding Trial of Microplasmin Intravitreal Injection for Non-Surgical Posterior Vitreous Detachment (PVD) Induction for Treatment of DME.

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: ocriplasmin
* Other: Sham injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria include: patients >18 years of age with Diabetic Macular Edema Exclusion Criteria include: PVD present at baseline Vitreous hemorrhage Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR) Patients who have had a vitrectomy in the study eye at any time

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: Ocriplasmin 25µg<br>25µg ocriplasmin intravitreal injection versus sham injection | Drug: ocriplasmin<br>* Intravitreal injection, single administration<br>* Other names: microplasmin;|
| Experimental: Ocriplasmin 75µg<br>75µg ocriplasmin intravitreal injection versus sham injection | Drug: ocriplasmin<br>* Intravitreal injection, single administration<br>* Other names: microplasmin;|
| Experimental: Ocriplasmin 125µg<br>125µg ocriplasmin intravitreal injection versus sham injection | Drug: ocriplasmin<br>* Intravitreal injection, single administration<br>* Other names: microplasmin;|
| Sham Comparator: sham injection<br>Sham injection | Other: Sham injection<br>* Sham intravitreal injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PVD Induction | The primary efficacy variable was the proportion of patients with total posterior vitreous detachment (PVD) on Day 14 as determined by a masked central reading center (CRC) using 4-quadrant B-scan and optical coherence tomography (OCT) | Day 14 post-injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic Macular Edema, PVD, DME, Diabetic Retinopathy
Monitoring System for the Wearing of Orthodontic Elastics

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to validate a novel sensor intended to measure the wearing time of orthodontic elastics in patients with multibracket appliances. The newly developped sensor will be tested in 42 patients over a period of 6 months

Detailed Description
-----------------
Fixed multibracket appliances are used to correct tooth and jaw malocclusions. Usually, elastics are inserted between the upper and lower jaws to adjust the position of the jaws in relation to each other. The wearing time of the elastics determines the duration of the treatment and the quality of the treatment results. While micro-sensors are increasingly used for removable appliances to monitor patient compliance, there is still no such possibility for fixed appliances. This gap is to be closed with the planned 'OrthoKontrol' (intraoral mini-sensor). This is intended to measure and record the wearing time of the elastics.

Official Title
-----------------
OrthoKontrol - System Zur Überwachung Der Tragedauer Von kieferorthopädischen Gummizügen

Conditions
-----------------
Medical Device Complication

Intervention / Treatment
-----------------
* Device: OrthoKontrol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Multibracket appliances (fixed braces) in both jaws Need for intermaxillary elastics on at least one side Minimum motor skills Exclusion Criteria: Patients with general diseases Patients with inflammatory oral diseases Patients with physical disabilities, which make it impossible to cooperate Independent insertion of the elastics is not possible Patients with impaired judgment Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 11 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: OrthoKontrol|Fixing OrthoKontrol Sensor on multibracket appliance to measure cooperation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comfort of the device | The wearing comfort for the patient is ok/not ok | 6 months | 
| Handling of the device | The handling for the therapist is ok/not ok | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cooperation | read on the sensors how long the patients followed the instructions | 6 months |
Intracytoplasmic Sperm Injection Preparation in Infertile Women

Study Overview
=================
Brief Summary
-----------------
Infertility is a common gynecological problem is women

Detailed Description
-----------------
Intracytoplasmic sperm injection is one of the aisted reproduction techniques that help to solve this problem

Official Title
-----------------
Intracytoplasmic Sperm Injection Preparation in Infertile Women With Unexplained Infertility

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: Doxycycline before ICSI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who have infertility with age between 20 -42 years Exclusion Criteria: women who has ovarian or endometrial factor of infertility

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 42 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized controlled study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Doxycycline before ICSI<br>extra medications (Doxycycline ) group before ICSI : in which Women who will receive the Doxyxycline before ICSI Intervention : Women will receive Doxycycline before ICSI | Drug: Doxycycline before ICSI<br>* Extra medication (Doxycycline ) group before ICSI :,women who will receive more medications (Doxycycline ) before starting the ICSI process<br>* Other names: Medical treatment with Doxycycline;|
| No Intervention: control group<br>control group : No intervention : in which Women willnot receive the extra medications (Doxycycline ) before ICSI | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of women who will have successful ICSI | The number of women who will get pregnant after ICSI with extra treatment | within 4 months |
Circulating Tumour Cells in Patients With Peritoneal Metastases

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the prognostic value of circulating tumour cells (CTC) in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy due to gastrointestinal cancers that have spread to the peritoneum.

Detailed Description
-----------------
CTCs har extracted by way of a new method at baseline, during surgery, and postoperatively. The occurence of such CTCs will be investigated for prognostic evaluation. Patients will be follow-up by Clinical routine. Disease recurrence and overall survival will be the endpoint used.

Official Title
-----------------
Cirkulerande Tumörceller Hos Patienter Med Bukhinnespridda tumörer

Conditions
-----------------
Circulating Tumor Cell, Peritoneal Metastases, Hyperthermic Intraperitoneal Chemotherapy

Intervention / Treatment
-----------------
* Diagnostic Test: iCellate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Peritoneal metastases being treated with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy Exclusion Criteria: None

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIPEC group<br>All patients undergoing HIPEC will asked to join this prospective study. | Diagnostic Test: iCellate<br>* New method of circulating tumour cell detection and capture.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognostic value | Prediction of survival and recurrence according to the occurrence of CTCs. | 2 year. |
DHA Supplementation in Patients With STGD3

Study Overview
=================
Brief Summary
-----------------
We have found that biomarkers of long-term elevated dietary intake of omega-3 fatty acids such as DHA and EPA are inversely associated with severity of disease phenotype in STGD3 patients. Therefore, the purpose of this study is to follow STGD3 patients as they supplement their diets with DHA/EPA.

Official Title
-----------------
Clinical Interventions Against Stargardt Macular Dystrophy: DHA Supplementation in Patients With STGD3

Conditions
-----------------
Dominantly Inherited Stargardt's Disease (STGD3)

Intervention / Treatment
-----------------
* Dietary Supplement: Over the counter DHA/EPA dietary supplementation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Moran Eye Center patients with STGD3 Exclusion Criteria: All others

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 105 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm, Open Label<br>Single Arm, Open Label | Dietary Supplement: Over the counter DHA/EPA dietary supplementation<br>* 1000 mg/day DHA/EPA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ERG |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | 1 year |
Efficacy and Safety of Aripiprazole in Patients With Schizophrenia or Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
This is a multicenter,open-label,prospective study of Aripiprazole use in patients with schizophrenia and bipolar disorder.

Detailed Description
-----------------
This is a multicenter,open-label,prospective study of Aripiprazole use in patients with schizophrenia and bipolar disorder. Qualified schizophrenia patients will be enrolled to an 12-week treatment phase of Aripiprazole by physician's assessment. Qualified bipolar disorder patients will be enrolled to an 8-week treatment phase of Aripiprazole by physician's assessment. This study will be continued for 6 years. The final report of Aripiprazole PMS will be submitted to KFDA on December 28, 2009.

Official Title
-----------------
Efficacy and Safety of Aripiprazole in Patients With Schizophrenia or Bipolar Disorder

Conditions
-----------------
Schizophrenia, Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with a schizophrenia or schizoaffective disorder or bipolar disorder according to DSM-IV criteria Age: more than 18 years of age Exclusion Criteria: Unqualified patients judged by study investigator(s)

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aripiprazole|The recommended starting and target dose for Abilify is 10 or 15mg/day administered on a once-a-day schedule without regard to meals. (Administer 10 to 30 mg/day according to the patient's condition)|

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
-----------------
Aripiprazole, Schizophrenia, Bipolar Disorder
The Effect of Concentrated Pomegranate Juice Consumption on Lipid Profile and Inflammatory Factors in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the effects of concentrated pomegranate juice on serum lipid profile and some inflammatory factors in patients with type 2 diabetes. Forty patients aged between 25-60 years old from both sexes are recruited. Patients consume 50gr/day concentrated pomegranate juice for 4 weeks. Anthropometric and blood pressure measurements, 3-days food-record questionnaire ,physical activity and fasting blood samples were collected at the beginning and at the end of the study. Fasting blood sugar, lipid profile, TNF- a, IL-6,hs -CRP and adiponectin levels are measured. LDL are calculated by formula. The participants are asked not to change their regular diet, medicine and activity during the study.

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Other: 50 gr concentrated pomegranate juice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female 25 to 60 years old having type 2 diabetes for at least 6 month Exclusion Criteria: pregnancy lactation cardiac disease hepatic disease respiratory disease chronic renal diseases acute or chronic inflammation retinopathy intake of antioxidant supplement insulin therapy sensitivity to concentrated pomegranate juice change oral drug for controlling blood glucose

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 Years

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

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: 50 gr concentrated pomegranate juice<br> | Other: 50 gr concentrated pomegranate juice<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride change |  | Baseline and after 4 weeks | 
| Total Cholesterol change |  | Baseline and after 4 weeks | 
| HDL- Cholesterol change |  | Baseline and after 4 weeks | 
| LDL- Cholesterol change |  | Baseline and after 4 weeks | 
| hsCRP change |  | Baseline and after 4 weeks | 
| TNF- α change |  | Baseline and after 4 weeks | 
| IL-6 change |  | Baseline and after 4 weeks | 
| adiponectin change |  | Baseline and after 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Blood Sugar change |  | baseline and after 4 weeks | 
| Blood Pressure change |  | Baseline and after 4 weeks | 
| Body Mass Index change |  | baseline and after 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, Pomegranate, Inflammation, lipid profiles
A Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours

Study Overview
=================
Brief Summary
-----------------
This is an open-label, phase 1 study to determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours.

Official Title
-----------------
Open-Label, Phase 1 Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours

Conditions
-----------------
Advanced or Metastatic Solid Tumours

Intervention / Treatment
-----------------
* Drug: LOR-253 HCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18 years of age or older. Histologically confirmed diagnosis of solid tumour for which no effective therapy is available or that is unresponsive to conventional therapy. Meet laboratory parameter requirements at study entry. Exclusion Criteria: Chemotherapy, radiotherapy, biologic therapy, immunotherapy or any other investigational drugs within 21 days of beginning study treatment with LOR-253 HCl. A hematologic malignancy. A history of brain or other central nervous system metastases. Have a presence of a significant infection. Clinically significant autoimmune disease. Uncontrolled intercurrent illness. With iron or copper overload syndromes. Pregnancy or breast feeding.

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: LOR-253 HCl<br>LOR-253 HCl will be given in ascending doses until the maximum administered dose or appropriate target dose is reached. A biomarker study of up to 10 patients will be conducted upon achieving appropriate dose level. | Drug: LOR-253 HCl<br>* LOR-253 HCl will be given in ascending doses starting from 20 mg/m2 until the maximum administered dose or appropriate target dose is reached. Patient will be treated on LOR-253 HCl for 2 cycles for the evaluation.<br>* Other names: No other names are used.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the safety profile of LOR-253 HCl when administered to patients with advanced or metastatic solid tumours. |  | 8 weeks |