linjc16/ctgov huggingface dataset:
NW500 Non-Mydriatic Retinal Camera Clinical Performance Study

Study Overview
=================
Brief Summary
-----------------
Comparison of color fundus images acquired by the Topcon NW500 non-mydriatic retinal camera (investigational device) and the Topcon TRC-NW400 (predicate device)

Official Title
-----------------
NW500 Non-Mydriatic Retinal Camera Clinical Performance Study

Conditions
-----------------
Fundus Photography

Intervention / Treatment
-----------------
* Device: fundus photography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are 18 years of age or older on the date of informed consent. Subjects who are able to understand the written informed consent and are willing to participate as evidenced by signing the informed consent. Exclusion Criteria: Subjects who are unable to tolerate ophthalmic imaging. Subjects with poor fixation or ocular media not sufficiently clear to obtain acceptable images. Subjects who cannot follow instructions to complete the required testing.

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 |
| --- | --- |
| Adults 18 years old or older<br> | Device: fundus photography<br>* color fundus photography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fundus photo image quality |  | 1 day |
Validation of the Rhinitis Control Scoring System (RCSS)

Study Overview
=================
Brief Summary
-----------------
Many patients suffering from allergic rhinitis do not recognize or perceive their symptoms. Instruments have been developed to assess quality of life in rhinitis, asthma or both, but there is a need to develop validated tools or methods to assess rhinitis control among rhinitis and/or asthmatic patients. The aim of this study is to assess the discriminative and evaluative properties of the RCSS in asthmatic patients with allergic rhinitis.

Detailed Description
-----------------
Allergic asthmatic subjects showing seasonal rhinitis symptoms will be recruited. The discriminative (internal consistency, cross sectional construct validity and reliability) and evaluative (responsiveness and longitudinal construct validity) properties of the RCSS will be evaluated as well as the relationship between rhinitis control and asthma control. RCSS will be completed at various time points during the seasonal allergic period.

Official Title
-----------------
Validation of a Rhinitis Control Tool : the Rhinitis Control Scoring System (RCSS)

Conditions
-----------------
Asthma, Rhinitis

Intervention / Treatment
-----------------
* Drug: Medication Mometasone furoate and desloratadine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: asthma seasonal allergic rhinitis Exclusion Criteria: smoking nasal polyposis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Mometasone furoate and desloratadine<br>Mometasone and desloratadine treatment | Drug: Medication Mometasone furoate and desloratadine<br>* One month treatment with both drugs<br>* Other names: Aerius;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discriminative (internal consistency, cross sectional construct validity and reliability) and evaluative (responsiveness and longitudinal construct validity) properties of the RCSS. |  | March to November 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship between rhinitis control and asthma control. |  | March to November 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
control, symptoms
The Foley's Catheter Balloon to the Bleeding From Placenta Previa

Study Overview
=================
Brief Summary
-----------------
Post-partum haemorrhage due to placenta previa is usually from the placental bed at the lower uterine segment and it occurs after the placenta separation. Although, nowadays the obstetrician can diagnose placenta previa before delivery, it is still one of the important causes of maternal mortality . Hysterectomy can be the only effective action to take, although it carries many morbidities for the women especially those with low parity. Uterine packing considers as a line of treatment before performing surgical procedures in postpartum hemorrhage resulting from placental site bleeding. It can save life, avoid laparotomy and save uterus. Nowadays, the use of intrauterine balloons have been developed and become effective for the control of placental site bleeding not responding to medical treatment. The 2-way Foley's Cather has many advantages over the gauze packing; First, it allows drainage of blood so no occult bleeding could be accumulated inside the uterus as in uterine gauze, second the removal of the Foley's Cather balloon is easy and not a painful, third, the removal of 2-way Foley's Cather could be gradually as a test of its effectiveness before complete removal .

Official Title
-----------------
Use of Foley's Catheter Balloon Tamponade to Control Placental Site Bleeding Resulting From Placenta Previa During Cesarean Section

Conditions
-----------------
Postpartum Hemorrhage

Intervention / Treatment
-----------------
* Device: Foley's cather ballon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with placenta previa Delivered by cesarean section Exclusion Criteria: Patients with sever uncontrolled uterine bleeding after delivery Placenta accreta

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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: Foley's cather tamponade<br>Balloon tamponade with 2-way Foley's Cather was successfully used during cesarean section due to sever postpartum haemorrhage after failure of medical treatment. | Device: Foley's cather ballon<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of blood loss (mL) |  | 6 months |
Effect of Curcumin on Iron Metabolism in Healthy Volunteer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the impact of curcumin, administrated orally, on iron metabolism in healthy volunteers. Iron metabolism will be describe by hepcidin expression that the investigators observed in vitro and serum hepcidin levels.

Official Title
-----------------
Effect of Curcumin on Iron Metabolism in Healthy Volunteer

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: curcuma longa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index between 18 et 25 Kg/m² Non smoker No swallowing disorders Normal clinical exam Normal ECG Normal values for routine biological tests : serum iron, transferrin saturation,, hemogram ferritin, C Reactive Protein, AST, ALT, HDL and LDL cholesterol, triglycerides No C282Y mutation within the HFE gene Affiliation to social security Written informed consent obtained Exclusion Criteria: Chronic or evolutive disease Infection during the 7 days before each sequence Drug or alcohol (>30g) abuse Current treatment Known food allergy stay at altitude (> 1500m) in 2 months Positive serology for hepatitis B or C virus or HIV. Transfusion or blood donation during the last three months. Exclusion period on the healthy volunteer National File.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: curcumin<br>oral administration of 6g of curcumin | Drug: curcuma longa<br>* oral administration of 6 grams of curcumin<br>|
| Placebo Comparator: placebo<br>oral administration of 12 sugar pill | Drug: curcuma longa<br>* oral administration of 6 grams of curcumin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal variation of serum hepcidin level after oral administration of curcumin |  | within 48 hours after administration of curcumin | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasmatic iron bioavailability | Iron, ferritin, transferrin, transferrin saturation | 30min, 1H, 2H, 3H, 4H, 6H, 8H, 12H, 24H et 48H | 
| Evaluation of the inhibitory activity of volunteers's serum on hepcidin expression by hepatocytes | In vitro: the coculture model that we previously developed to analyze endogenous hepcidin expression, and human hepatic cells line (HepG2) stimulated or not by IL-6 which governs the STAT3 pathway, transfected with gene reporter constructs containing hepcidin promoter. | 30min, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h |
Analgesia for Thyroidectomy Using Bilateral Superficial Cervical Plexus Block With Bupivacaine Only or Adding Ketorolac to it.

Study Overview
=================
Brief Summary
-----------------
Thyroidectomy is considered a common operation with moderate to severe postoperative pain in some patients. Patients are divided into two groups. Bupivacaine group received bilateral superficial cervical plexus block (BSCPB) with 10 ml of bupivacaine (0.25%) and 1 ml of normal saline on each side and the Bupivacaine Ketorolac group received (BSCPB) with 10 ml of bupivacaine (0.25%) and 1 ml of ketorolac (15 mg) on each side.

Official Title
-----------------
The Effect of Adding Ketorolac to Bupivacaine in Superficial Cervical Plexus Block in Thyroid Surgery.

Conditions
-----------------
Thyroid Goiter, Thyroid Nodule

Intervention / Treatment
-----------------
* Drug: Bupivacain
* Drug: Ketorolac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 20-50 years ASA I-II patients Patients going to do thyroid surgeries under general anesthesia Exclusion Criteria: Patient refusal Known history of sensitivity to the drug used in the study Drug abuse Infection at the site of the block Presence of coagulopathy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bupivacaine<br> | Drug: Bupivacain<br>* analgesic<br>|
| Active Comparator: bupivacaine and ketorolac<br> | Drug: Bupivacain<br>* analgesic<br>Drug: Ketorolac<br>* analgesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1st analgesic requirement | The first time of supplemental analgesic need postoperatively | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic consumption | total analgesic consumption | 24 hours | 
| postoperative pain | visual analogue scale(0-10) 0=no pain and 10=severe intolerable pain | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ketorolac, superficial cervical plexus block, thyroidectomy
Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients

Study Overview
=================
Brief Summary
-----------------
Patients with Parkinson's disease who completed the prior double-blind study 6002-009 are eligible to enter into this long-term study. The purpose of this study is to evaluate the safety and efficacy of KW-6002 administered long-term in patients with advanced Parkinson's disease treated with levodopa.

Official Title
-----------------
Long-Term Safety Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Istradefylline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be willing and able to give written informed consent Completion of the study 6002-009 Exclusion Criteria: Mini-mental status examination score of 23 or less Less than 70% of compliance in the study 6002-009 Emergency deviation in the study 6002-009 Pregnant females

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Istradefylline<br> | Drug: Istradefylline<br>* Oral istradefylline (KW-6002) 20 or 40 mg once daily<br>* Other names: KW-6002;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing the mean total hours of awake time per day spent in the OFF state |  |  | 
| Reducing the mean percentage of awake time per day spent in the OFF state |  |  | 
| Mean change in the total hours and the percentage of awake time per day spent in the ON state (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia) |  |  | 
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) |  |  | 
| Change in the Clinical Global Impression - Improvement scale (CGI-I) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease, levodopa, end of dose wearing off, OFF time
Monitoring of Donor-specific Antibodies After Treatment With Immunoglobulins, Plasmapheresis and Rituximab in Lung Transplantation

Study Overview
=================
Brief Summary
-----------------
Single-arm, prospective observational study

Detailed Description
-----------------
This is an observational study to monitor the treatment of donor-specific antibodies in lung transplant recipients with detection of donor-specific antibodies. All consented subjects will be approached for participation. The study will evaluate the effectiveness of the treatment protocol of donor-specific antibodies with Immunoglobulins or combined treatment with Immunoglobulins, Plasmapheresis and Rituximab after lung transplantation.

Official Title
-----------------
Monitoring of Donor-specific Antibodies (DSA) After Combined Treatment With Immunoglobulin A and Immunoglobulin M-enriched Intravenous Human Immunoglobulins and Plasmapheresis and Rituximab in Lung Transplantation

Conditions
-----------------
Lung Transplantation, Donor-specific Anti-human Leukocyte Antigen(HLA) Antibodies

Intervention / Treatment
-----------------
* Diagnostic Test: blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients after lung transplantation with detection of donor-specific antibodies Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: blood samples|For performing the Luminex solid phase assay (SPA) test, 7.5 ml of patient whole blood are collected from a peripheral vein.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Donor-specific Antibodies Clearance | The DSA clearance is defined as absence of DSA in the Luminex test, which is performed every 6 months after treatment end. | 6, 12, 18, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft survival | Graft survival is defined as freedom from mortality and re-transplantation | 1, 3, 5 years | 
| Incidence of acute cellular and humoral rejections and chronic lung allograft dysfunction (CLAD) |  | 1, 3, 5 years |
Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of PGE2

Study Overview
=================
Brief Summary
-----------------
Before, during and after intravenous administration of PGE2 we score/measure headache, rCBF, blood flow in the middle cerebral artery and diameter of superficial temporal artery and correlate that to known pathophysiology of headache to see if PGE2 is involved in headache pathophysiology.

Official Title
-----------------
Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of PGE2

Conditions
-----------------
Headache, Migraine

Intervention / Treatment
-----------------
* Drug: PGE2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Exclusion Criteria: Primary Headache, headache on the day of the investigation, hypertension, hypotension, pregnant/nursing, daily intake of medication (except oral contraceptives), Cardiovascular or CNS disease, drug/alcohol abuse, psychiatric disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PGE2|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rCBF, blood flow, diameter of STA/RA, HR, BP |  |  |
Effectiveness of the Cytokine Hemadsorption on Sepsis

Study Overview
=================
Brief Summary
-----------------
In this prospective study, we aimed to compare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in ICU patients diagnosed with sepsis or septic shock.

Official Title
-----------------
Effectiveness of the Cytokine Hemadsorption on the Clinical Progression and Mortality of Intensive Care Patients With Sepsis

Conditions
-----------------
Interleukin-6

Intervention / Treatment
-----------------
* Procedure: cytokine hemadsorption


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the patients were the available data of clinical and laboratory diagnosis of sepsis and septic shock detection of gram-negative bacterial agent in blood or sputum culture. patients who had the shock symptoms such as hypotension, tachycardia or fever during the course of sepsis. Exclusion Criteria: had uncontrolled hemorrhage, diagnosed with cardiac failure at stage 4 or renal failure at stage 4 or hepatic liver failure at stage 4 cancer at the end stage or admitted with acute coronary syndrome.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| ICU patients diagnosed with sepsis or septic shock<br>compare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in ICU patients diagnosed with sepsis or septic shock. | Procedure: cytokine hemadsorption<br>* the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in ICU patients diagnosed with sepsis or septic shock.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-6 | levels of IL-6 | 1 YEARS |