linjc16/ctgov huggingface dataset:
Prospective Registry of the Current Status of Care for Patients With Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
The study will estimate the current status of care for participants with coronary artery disease

Official Title
-----------------
A Multi-center, Prospective, Registry Study to Estimate the Current Status of Care for Patients With Coronary Artery Disease

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patients with discharge diagnosis as coronary artery disease (including atherosclerosis or non-athrosclerosis) Exclusion Criteria: None

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 |
| --- | --- | --- |
| The overall composite of 10 performance measures for CAD care | Performance measures for CAD care including: Proportion of patients received fibrinolytic therapy within 30 mins (STEMI) Proportion of patients received primary percutaneous coronary intervention within 90 mins (STEMI) Proportion of patients received reperfusion therapy (STEMI, high or moderate risk NSTE-ACS) Proportion of patients with aspirin prescribed at discharge Proportion of patients with P2Y12 inhibitors prescribed at discharge Proportion of patients with beta-blocker prescribed at discharge Proportion of patients with statin prescribed at discharge Proportion of left ventricular systolic dysfunction patients with ACEI or ARB prescribed at discharge Proportion of patients received evaluation of left ventricular systolic function Proportion of patients with a diagnosed non-obstructive coronary artery disease at discharge | Duration of hospital stay, an expected average of 1 week |
Verification Study and Reactivity Study for the Validity of QuQu Scale

Study Overview
=================
Brief Summary
-----------------
Examine the construct validity, the test-retest reliability, the concurrent validity with the standard dementia rating scales and the reactivity of a novel dementia rating scale QuQu scale: QUick QUestion scale final for the evaluation of patients with Alzheimer's Disease Dementia and Mild Cognitive Impairment.

Official Title
-----------------
Verification Study and Reactivity Study for the Validity of a Novel Dementia Rating Scale QUick QUestion Scale for Alzheimer's Disease Dementia

Conditions
-----------------
Alzheimer's Disease Dementia, Cognitive Concern Without Dementia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alzheimer's Disease Dementia and patients with cognitive concern without Dementia Written Informed consent by each subject and/or a legal representative, and study informant. If the doctor decides that the patient has no trouble in understanding this study, the written informed consent of a legal representative may be exempted. If not, this study needs a written informed consent by a legal representative and the patient except the case where the consent is hardly obtained due to the progression of the disease. Exclusion Criteria: patients with other types of dementia (e.g. vascular dementia, Levy body dementia, frontotemporal dementia) patients with other diseases which cause secondary dementia prior to Alzheimer's Disease Dementia patients with other severe neurological disease or psychiatric disorder without Alzheimer's Disease Dementia patients with other medical conditions where the investigators determine that it is inappropriate for the subject of this study (e.g. inappropriate for the evaluation of dementia rating scale)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alzheimer's Disease Dementia<br> | |
| non-Dementia<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QuQu scale candidate |  | 12 weeks | 
| Mini-Mental State Examination (MMSE) |  | 12 weeks | 
| NPI-Caregiver Distress. Scale(NPI-D) |  | 12 weeks | 
| Disability Assessment for Dementia (DAD) |  | 12 weeks | 
| Clinical Dementia Rating |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's Disease Dementia
Association of Intrahepatic Cholestasis of Pregnancy and Chronic Placental Inflammation

Study Overview
=================
Brief Summary
-----------------
This observational prospective study will help to determine if an immune process similar to allograft rejection is responsible for the occurrence of an intrahepatic cholestasis of pregnancy (ICP). If so, it would suggest the potential benefit of immunomodulatory therapeutics.

Detailed Description
-----------------
This observational study will include 322 pregnant women at delivery: 161 women diagnosed with an intrahepatic cholestasis of pregnancy, and 161 control women. A blood test will be performed at delivery for each woman and each newborn, in order to measure several biological parameters involved in inflammation processes, allograft rejection and angiogenesis. Placenta will also be analysed. In particular, we will look for chronic inflammation in placenta. Biological parameters and placental parameters will be compared between the two groups: cases with ICP and controls.

Official Title
-----------------
Inflammation in Intrahepatic Cholestasis of Pregnancy

Conditions
-----------------
Cholestasis of Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult pregnant woman with singleton For cases: diagnosis of intrahepatic cholestasis of pregnancy For controls: no diagnosis of ICP Exclusion Criteria: Women under 18 years old Women under legal protection Gemellar pregnancies Delivery before 22 Weeks of gestation Medical termination of pregnancy Acute chorioamniotitis, in particular those due to the following pathogens: toxoplasmosis, rubella, CMV, herpes virus Premature rupture of membranes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>Women with intrahepatic cholestasis of pregnancy | |
| Controls<br>Women without intrahepatic cholestasis of pregnancy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of placental chronic inflammation |  | At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of several biological parameters involved in inflammation processes |  | At delivery | 
| Levels of several biological parameters involved in allograft rejection |  | At delivery | 
| Levels of several biological parameters involved in angiogenesis |  | At delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
placenta, cholestasis, pregnancy, inflammation
A Study of TRS01 in Participants With Post-surgical Ocular Inflammation

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and preliminary efficacy of TRS01 eye drops as compared to placebo on participants with ocular inflammation after cataract surgery.

Official Title
-----------------
A Multicenter, Double-Masked, Randomized, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety of TRS01 Eye Drops in Participants With Post-surgical Inflammation

Conditions
-----------------
Post Surgical Ocular Inflammation

Intervention / Treatment
-----------------
* Drug: TRS01 eye drops
* Drug: TRS01 eye drops
* Drug: TRS01 eye drops
* Drug: Placebo eye drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-operatively, individuals of either gender or any race will be eligible for study participation if they are: 18 years of age or older. Able to provide informed consent, follow instructions and complete all required study visits for the duration of the study. Scheduled for routine cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens (IOL) implantation, and not combined with any other surgery. Have vision ≥ 20/200 in the non-study eye. Able to self-administer eye drops (tested during screening by self-administration of artificial tears), or have a care provider that can administer the drops. Have no known sensitivity /allergy to the TRS01 or formulation excipients. Using adequate birth control by men and women, if of reproductive potential and sexually active, as specified per protocol Randomization inclusion criteria as specified per protocol. Exclusion Criteria: Scheduled to undergo cataract surgery in the non-study eye for the duration of the study. Receiving specific medication/interventions as specified per protocol

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRS01 low dose<br> | Drug: TRS01 eye drops<br>* Dosed 4 times a day (QID)<br>|
| Experimental: TRS01 medium dose<br> | Drug: TRS01 eye drops<br>* Dosed QID<br>|
| Experimental: TRS01 high dose<br> | Drug: TRS01 eye drops<br>* Dosed QID<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo eye drops<br>* Dosed QID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Both Systemic and Ocular Adverse Events | Number of adverse events that occurred during the study | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative, postsurgical, ocular, inflammation, pain
Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Patients With Dry Eye

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of rebamipide 2% suspension for the treatment of patients with dry-eye.

Official Title
-----------------
A Phase II, Prospective, Randomized, Double-masked, Parallel Group, Multi-center Study Assessing the Safety and Efficacy of 2% Rebamipide (OPC-12759) Compared to Placebo for the Treatment of Keratoconjunctivitis Sicca (Dry Eye)

Conditions
-----------------
Dry Eye Syndromes, Keratoconjunctivitis Sicca

Intervention / Treatment
-----------------
* Drug: rebamipide 2% ophthalmic suspension
* Drug: placebo eye drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years and older Diagnosis of dry eye as defined by the protocol Exclusion Criteria: Ongoing ocular disease that may interfere with study parameters. Inability to stop using topical ophthalmic medications throughout the duration of the study Inability to stop the use of contact lenses for the duration of the study.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rebamipide 2% ophthalmic suspension<br> | Drug: rebamipide 2% ophthalmic suspension<br>* Instill one drop in each eye four times daily for 12 weeks.<br>|
| Placebo Comparator: Placebo eye drops<br> | Drug: placebo eye drops<br>* Instill one drop in each eye four times daily for 12 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total fluorescein corneal staining score |  | 4 weeks | 
| Primary ocular discomfort |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dry eye symptoms |  | 12 weeks | 
| Ocular staining |  | 12 weeks |
Sarcopenia and Aging

Study Overview
=================
Brief Summary
-----------------
Objective: Evaluate the muscular strength in the ageing process and identify the changes between the abdominal muscles, upper and louver edges. Method: 48 individuals participated in this study, being divided into four groups according to the age: (G1) 11to 18 years old, (G2) 20 to 26 years old, (G3) 45 to 60 years old and (G4) 66 - 82 years old. The excluding criterion included people who work out more than three times a week, severe arthrosin, stroke, significant cognitive deficit , obesity, use of ortheses for louver members or any break, with or without metallic implant. The evaluation instruments used were: (1) Esfigmomanômetro (EM), (2) Trunk flexor in the supine position,, (3) Jamar Dinamômetro and (4) Preston Pinch Gauge Dinamômetro.

Detailed Description
-----------------
Forty-eight subjects participated voluntarily in this work and is divided into four groups of 12 participants with 6 men and 6 women: (G1) 11 to 18 years (G2) 20 to 26 years (G3) from 45 to 60 and (G4) 66 to 82 years, selected in dependency of Unifran and residences of the city of Franca, Sao Paulo - Brazil. To evaluate muscle strength, a BD sphygmomanometer was used to analyze the strength of flexors and extensors of the knee. The Jamar Dynamometer was used to assess the functional integrity of the upper and Preston Pinch Gauge Dynamometer for evaluation of gripper hands.

Official Title
-----------------
Sarcopenia and Aging

Conditions
-----------------
Sarcopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: absence of the basic pathology that interferes directly in the muscle Exclusion Criteria: people who work out more than three times a week severe arthrosin stroke significant cognitive deficit obesity use of ortheses for louver members or any break with or without metallic implant

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 82 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 |
| --- | --- |
| Group I<br>11 to 18 years - composed of 12 adolescent with six women and six men | |
| Group II<br>20 to 26 years - composed of 12 young with six women and six men | |
| Group III<br>45 to 60 years - composed of 12 adult with six women and six men | |
| Group IV<br>66 - 82 years - composed of 12 aged with six women and six men | |

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
-----------------
Ageing, Sarcopenia, Muscular contraction
Bioequivalence Trial of a New Opioid Combination Compared to Reference

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate bioequivalence of a new formulation to a reference

Official Title
-----------------
Phase 1 Single Center Trial to Demonstrate the Bioequivalence of a New Combination Analgesic Formulation as Compared to an Equimolar Marketed Formulation

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

Intervention / Treatment
-----------------
* Drug: Opioid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Standard Phase I Cyp 2D6 extensive metabolizers Exclusion Criteria: Standard Phase I Contraindications of current reference tablet SmPC

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence acceptance range of 90CI of T/R ratios of AUC and Cmax. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive, e. g. safety/tolerability of Test comparable to Reference |  |  |
New Serological Markers for Eosinophilic Esophagitis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate if serological parameters such as extracellular Serum-Tryptase (ST) and eosinophilic cationic protein (ECP) are useful for the diagnosis and surveillance of the eosinophilic esophagitis (EE).

Detailed Description
-----------------
The eosinophilic esophagitis (EE) is chronic inflammatory and immunological disease. The diagnosis of EE is based upon large numbers of eosinophils in the esophagus on histopathologic examination (> 20 eosinophils per high powered field in at least one specimen) despite acid suppression with a Proton-Pump-Inhibitor (PPI) for at least two weeks. There are no diagnostic serological markers for EE so far, so that the purpose of the study is to investigate serological markers which are established in other allergic diseases.

Conditions
-----------------
Eosinophilic Esophagitis

Intervention / Treatment
-----------------
* Drug: Fluticasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histopathological defined eosinophilic esophagitis Age: 18-80 Exclusion Criteria: missing consent form contraindications for performing esophagogastroscopy/taking biopsies of the esophagus

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 |
| --- | --- |
| eosinophilic esophagitis<br>patients with histopathological defined eosinophilic esophagitis | Drug: Fluticasone<br>* Guideline-based treatment with fluticasone 0,5 ml (1-0-1), step-up or step-down after 3 months based on the histopathological findings<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Lymphoma and T Helper 2 Cytokines Relationship With Prognostic Markers

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized that Non Hodgkin lymphoma is using T helper 2 pathways. So that the investigators decided to study of cytokines related to T helper 2 pathways. It is well known that parasites and allergic situations also use T helper 2 pathways. Because that the investigators excluded the patients have parasites and allergic situations. All the patients were over 18. The investigators included the patients with non Hodgkin lymphoma which new diagnosed. It is observational study. The investigators took blood before chemotherapy and four months later. The investigators did not interfere with which chemotherapy will be given to patients. This decision was belong to hematologist or oncologist who will treat the patient.

Official Title
-----------------
Aggressive Non-Lymphoma and T Helper 2 Cytokines Relationship With Prognostic Markers

Conditions
-----------------
Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly diagnosed non hodgkin lymphoma Diffuse large B cell lymphoma and T cell lymphoma patients Exclusion Criteria: under 18 age parasitosis allergic status

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Lymphoma group<br> | |
| healthy group<br> | |
| IL-10 high<br> | |
| IL-10 low<br> | |
| IL-4 high<br> | |
| IL-4 low<br> | |
| lymphopenia<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin 4 and Interleukin 10 levels as pg/mL in non hodgkin lymphoma | We will measure 31 patients and 27 healthy person's Interleukin 4 and Interleukin 10 levels as pg/mL at the beginning of the study. We determined all of the patients IPI score, LDH (U/L), crp (mg/L), erythrocyte sedimentation rate, hemoglobin (gr/dL), lymphocyte count in per µL, albumin (gr/dL) before the treatment. We wanted to check whether there is any correlation between well known prognostic markers (LDH, crp, albumin, stage, ECOG performance status) and Interleukin-4 and interleukin-10 levels. | This study ended within 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survey as months | Our secondary goal was to determine the survey time as month from diagnoses to die from any reason or last evaluation during our study which was 13 months. | During study which was 13 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Survey, interleukin status