linjc16/ctgov huggingface dataset:
Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application

Study Overview
=================
Brief Summary
-----------------
This study is designed to explore the efficacy and safety of DA-4001 after topical application in male patients with androgenetic alopecia Design : Randomized, double-blind, active-controlled study Investigational Product : Finasteride, minoxidil

Official Title
-----------------
A Single-center, Active-controlled, Randomized, Double-blind, Proof of Concept Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application in Male Patients With Androgenetic Alopecia

Conditions
-----------------
Androgenetic Alopecia

Intervention / Treatment
-----------------
* Drug: DA-4001C
* Drug: 5% minoxidil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Basic and specific(BASP) classification : basic type is M2 or C2 and specific type is V1,V2 or F1,F2 Exclusion Criteria: Evidence of hair loss other than androgenetic alopecia Use of finasteride, dutasteride within previous 12 months Use of minoxidil within previous 6 months Use of androgenic or anti-androgenic agents within previous 6 months Use of steroid agents for local application to scalp or systemic application within previous 1 month History of hair transplantation, scalp reduction Coronary artery disease, arrhythmia, congestive heart failure, valvular haert disease, angina pectoris

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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: DA-4001C<br>DA-4001C is administered | Drug: DA-4001C<br>* 1ml by topical application twice a day<br>|
| Active Comparator: 5% minoxidil<br>5% minoxidil is administered | Drug: 5% minoxidil<br>* 1ml by topical application twice a day<br>* Other names: minoxyl;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in target area hair count per cm2 at week 24, as assessed by phototrichogram |  | baseline and week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in target area hair count per cm2 at week 16, as assessed by phototrichogram |  | Baseline and week 16 | 
| Improvement rate of target area hair count per cm2 at week 16 and week 24, as assessed by phototrichogram |  | Baseline, week 16,and week24 | 
| Improvement rate of target area mean hair diameter at week 16 and week 24, as assessed by phototrichogram |  | Baseline, week 16, and week 24 |
Comparison of Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq) in Cancer Breakthrough Pain (FT-019-IM)

Study Overview
=================
Brief Summary
-----------------
Primary: • To compare the efficacy of nasal fentanyl (NF) to oral transmucosal fentanyl (Actiq®) (hereafter Actiq) in the management of breakthrough pain in cancer patients. Secondary: To compare patients' general impression and preference of NF and Actiq To explore the relationship between NF doses and dose of current opioid for breakthrough pain (BTP) and the relationship between dose of NF and of background opioid To assess safety and tolerability of NF

Official Title
-----------------
An Open Label, Comparative, Randomised, Balanced Crossover Trial Comparing Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq®) in Breakthrough Pain in Patients With Cancer

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Nasal fentanyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult in- or out patient with cancer and breakthrough pain; using a stable, chronic opioid treatment for background pain. Minimum three BTP episodes per week and maximum four per day. Life expectancy of at least three months. Chemotherapy and palliative radiotherapy (except facial radiotherapy) are allowed. Randomisation in previous studies with NF, i.e. FT-016-IM, FT-017-IM or FT-018-IM, is not allowed. Previous use of Actiq is accepted.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nasal fentanyl|Breakthrough pain in patients with breast or prostate cancer|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint: Time to onset of meaningful pain relief recorded by stopwatch |  | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Pain Intensity Differences (PID) at 10 and 30 min derived from Pain Intensity (PI) scores • Sum of Pain Intensity Differences (SPID) 0-15 and 0-60 derived from PI scores • Time to 50% reduction in PI scores • General impression (GI) of the t |  | 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breakthrough pain in patients with cancer
Evaluation of the Zilver Vascular Stent in the Iliac Arteries (ZIPS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the ability of a vascular stent to maintain an open iliac (leg) artery. The Zilver Vascular Stent is made of nitinol, a flexible metal with a long history of use in medical devices. The stent self-expands once inside the artery where it is intended to hold the vessel wall open. Within a few weeks, a layer of cells will grow over the stent helping to hold it in place.

Conditions
-----------------
Peripheral Arterial Disease (PAD)

Intervention / Treatment
-----------------
* Device: Peripheral Vessel Stenting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has documented stenotic or occluded atherosclerotic lesions of the external iliac or common iliac artery. Patient has a de novo or restenotic lesion(s) with no prior stent in the target lesion. Patient has given informed consent. Exclusion Criteria: Patient is less than 50 years of age Patient is participating in another investigational drug or device study. Patient has multiple lesions (ipsilateral or in the aorta) that would require a staged procedure. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions. Patient has a known hypersensitivity or contraindication to aspirin, clopidogrel, nitinol, or contrast dye that cannot be adequately premedicated. Patient is pregnant or breast-feeding.

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Peripheral Vessel Stenting|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of the study is major adverse event (MAE) rate at the 9-month follow-up. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional endpoints include acute procedure and hemodynamic success, secondary patency, 9-month restenosis rate based on ultrasound examination, and 9-month functional status improvement. |  |  |
Use of TpCO2 (Transcutaneous CO2 Measurement) as PaCO2 Predictor During NIV in Case of Acute Hypercapnic Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
In patients suffering from hypercapnic respiratory failure and treated by non invasive ventilation (NIV), the interest of using transcutaneous CO2 measurement to evaluate PaCO2 and PaCO2 variation over time is unknown and will be evaluated in this study. Measurements will be done during one-hour NIV treatments.

Official Title
-----------------
Use of TpCO2 (Transcutaneous CO2 Measurement)as PaCO2 Predictor During Non Invasive Ventilation (NIV) in Case of Acute Hypercapnic Respiratory Failure

Conditions
-----------------
Hypercapnic Respiratory Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU patient equipped with an arterial line NIV treatment prescribed by the clinician in charge Hypercapnia defined by PaCO2> 42mmHg Exclusion Criteria: Severe hemodynamic instability Severe psychiatric disorders Denied consent Age < 18 years

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 |
| --- | --- | --- |
| Comparison between TpCO2 (transcutaneous non invasive CO2 partial pressure measurement) and PaCO2 (obtained by blood gas analysis) values during NIV treatment. |  | sixty minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute respiratory failure, Hypercapnia, Non invasive ventilation, Transcutaneous CO2 measurement
Observational Study to Evaluate the Safety of Levemir® in Diabetes

Study Overview
=================
Brief Summary
-----------------
This observational study is conducted in North America. The aim of this observational study is to evaluate the incidence of adverse events while using Levemir® under normal clinical practice conditions.

Official Title
-----------------
Observational, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 or 2 diabetes Including newly diagnosed not on insulin or insulin analogue treatment Selection at the discretion of the physician Adult patients with type 1 and 2 diabetes mellitus, and type 1 patients 6 years and older Exclusion Criteria: Current treatment with Levemir® Previously enrolled in the study Hypersensitivity to Levemir®
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> | Drug: insulin detemir<br>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>* Other names: Levemir®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of SADR (serious adverse drug reactions ) incl major hypo (hypoglycaemic events) |  | during treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose control measures |  | during treatment | 
| Weight |  | during treatment |
Behavioral and Immunological Factors in Coronary Disease

Study Overview
=================
Brief Summary
-----------------
To explore the immune/inflammatory processes as pathways between depression/exhaustion and coronary artery disease (CAD) progression.

Detailed Description
-----------------
BACKGROUND: Recent studies demonstrate that the immune system plays an important role in coronary artery disease (CAD). Research also shows that psychological factors such as major depression and acute mental stress are involved in the clinical progression of CAD. Depression is associated with higher levels of immune parameters that play a role in CAD (cytokines, markers of low grade inflammation, infectious pathogen burden, and adhesion molecules), and most of these measures also increase in response to acute physical and mental stress. The pathophysiological mechanisms linking depression and mental stress with adverse cardiovascular outcomes may therefore be mediated by immunological factors. DESIGN NARRATIVE: The study examines clinical outcomes in patients who undergo percutaneous coronary revascularization, because a major problem remains the frequent (20 percent-40 percent) occurrence of coronary restenosis and new cardiac events in the six months after the intervention. These adverse outcomes have substantial impact on the costs of medical care and patients' quality of life. Since previous research has not examined the role of behaviorally-induced changes in immune parameters in the prediction of CAD progression, the following immunological measures will be examined: cytokines (IL-1B, IL-4, IL-6, IFNy, TNFa), acute phase proteins (CRP, fibrinogen), lymphocyte counts and differential, adhesion molecules (ICAM-1, LFA, L-selectin), and a composite measure of pathogen burden (CMV, H. pylori, C. pneumoniae). Using a longitudinal design, this project will determine the time course of changes in depression and changes in immune parameters. Moreover, the present study will determine the contribution of behavioral and immunological factors in the clinical progression of coronary disease following coronary angioplasty. These data may therefore improve the identification of patients at risk for recurrent cardiac events and restenosis after coronary angioplasty, and provide further understanding of the pathophysiological mechanisms involved in coronary disease progression.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Cortical Neuromodulation in Post Stroke Dysphagia

Study Overview
=================
Brief Summary
-----------------
The investigators aim is to try to rehabilitate post stroke dysphagia using electrical stimulation of the mylohyoid muscles.

Detailed Description
-----------------
Aspiration could have fatal complication especially in post stroke dysphagia. The aim of this study is to improve post stroke dysphagia using electrical stimulation of mylohyoid muscles. The investigators measure swallowing time before and after electrical stimulation, performed one hour per day, 5 consecutive days during paste consistency swallowing

Official Title
-----------------
Neuromodulation in Post Stroke Dysphagia

Conditions
-----------------
Dysphagia

Intervention / Treatment
-----------------
* Procedure: electrical stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: post stroke dysphagia Exclusion Criteria: contraindication to magnetic stimulation, unability to accept the study

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electrical stimulation<br>stroke patients | Procedure: electrical stimulation<br>* sub motor threshold stimulation of mylohyoid muscles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| videofluoroscopy | measure swallowing time before and after electrical stimulation, performed one hour per day, 5 consecutive days during paste consistency swallowing | before and after (once a day for 5 consecutive days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
swallowing, stroke, aspiration, human, electrical stimulation, post stroke dysphagia
A Multi-centre, Prospective Surveillance to Assess Mid-term Performance of the Mpact Cup

Study Overview
=================
Brief Summary
-----------------
This is a multi-centre, prospective post marketing surveillance study to assess mid-term performance of the Mpact cup in subjects requiring primary total hip arthroplasty.

Official Title
-----------------
A Multi-centre, Prospective Post Marketing Surveillance Study to Assess Mid-term Performance of the Mpact Cup in Subjects Requiring Primary Total Hip Arthroplasty

Conditions
-----------------
Osteoarthritis, Arthritis, Avascular Necrosis, Fracture of the Femoral Neck or Head, Congenital Hip Dysplasia

Intervention / Treatment
-----------------
* Device: Mpact Acetabular Shell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery. Those presenting with disease that meets the indications for use for Medacta USA implants defined by this study (on-label use). Patients must be willing to comply with the pre and post-operative evaluation schedule. Exclusion Criteria: Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mpact Acetabular Shell<br>Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement. | Device: Mpact Acetabular Shell<br>* Total Hip Replacement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Kaplan-Meier analysis as a measure of implant performance. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Harris Hip Score. |  | pre-op, 3/6 months, 1,2 and 5 years | 
| Radiological analysis as a meausure of safety. |  | 3/6 months, 1,2 and 5 years |
Acute Anterior or Posterior Cerebral Artery Occlusion Recanalization Therapy and Relationships With Clinical Outcome (ACAPULCO)

Study Overview
=================
Brief Summary
-----------------
Nearly 3% of patients with ischaemic stroke (IS) have an isolated occlusion of the anterior or posterior cerebral artery in the acute phase of the disease. In those patients, intravenous thrombolysis (IT) is indicated for 4.5 hours after symptoms onset. Due to a lack of data, mechanical thrombectomy (MT) is not considered as a gold standard to treat IS alone or in addition with IT. Therefore, observational studies are needed to understand the clinical evolution of patients with IS treated with IT and/or MT. The ACAPULCO retrospective observational study aims to highlight potential benefits of MT in those patients to improve their management and to propose targeted therapies in the future.

Official Title
-----------------
Acute Anterior or Posterior Cerebral Artery Occlusion Recanalization Therapy and Relationships With Clinical Outcome (ACAPULCO)

Conditions
-----------------
Ischemic Stroke, Thrombi

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 and < 96 Clinical signs consistent with acute ischemic stroke Patients who presented within 6 hours of stroke symptoms onset Isolated occlusion of the anterior or the posterior artery Exclusion Criteria: Administration of recanalization treatment before hospital admission

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- | --- |
| Clinico-radiological evolution of IS patients with isolated occlusion of the anterior or posterior cerebral artery. | Good Neurological Condition Good neurological outcome (GNO) at 3 months will defined using the modified Rankin Scale (mRS). A normal/near normal outcome after procedure is associated with a mRS Scale score = 0-1 and severe disability/death is associated with a mRS Scale score = 5-6 | 90 days |