linjc16/ctgov huggingface dataset:
Nasonex® Nasal Suspension 50 μg Long-term Designated Drug Use Investigation (Study P05876)

Study Overview
=================
Brief Summary
-----------------
The investigation will be conducted to define safety and efficacy under the conditions of post-marketing use of this drug in subjects with allergic rhinitis. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Official Title
-----------------
Nasonex® Nasal Suspension 50 μg Long-term Designated Drug Use Investigation

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: mometasone furoate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are treated with Nasonex for perennial or seasonal allergic rhinitis. Exclusion Criteria: Patients with an infection for which there is no effective antimicrobial drug or systemic fungal infection [symptoms may exacerbate] Patients with a history of hypersensitivity to any ingredient of this drug
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 perennial allergic rhinitis | Drug: mometasone furoate<br>* Metered-dose spray type suspension containing 50 μg mometasone furoate per spray. 2 sprays per nostril twice daily (total daily dose 200 μg) Duration: up to 6 months<br>* Other names: Nasonex;|
| 2<br>Patients with seasonal allergic rhinitis (including patients who also have perennial allergic rhinitis) | Drug: mometasone furoate<br>* Metered-dose spray type suspension containing 50 μg mometasone furoate per spray. 2 sprays per nostril twice daily (total daily dose 200 μg) Duration: up to 6 months<br>* Other names: Nasonex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the incidence of Adverse Drug Reactions (ADRs) |  | After 6 months of observation |
The Study of Immune Cell (T Cell) Activity in Patients With Paraneoplastic Neurologic Syndromes

Study Overview
=================
Brief Summary
-----------------
The investigators believe that T cells, cells that are a part of the immune system, are what are causing the neurological problems while also attacking tumor cells. This protocol studies the clinical status of patients with paraneoplastic neurological disorder (PND) as well as their blood to understand the relationship between their neurological disease, their cancer, and their immune system.

Detailed Description
-----------------
Patients with paraneoplastic neurological disorders (PNDs) provide a unique model for studying tumor immunity and neuronal autoimmunity. We hypothesize that T lymphocyte autoimmune dysfunction is involved in the pathogenesis of the paraneoplastic neurological syndromes, and that killer T cells are involved in the targeting and successful killing of tumor cells in these cancer patients. Furthermore, we postulate that this activity may provide a model for autoimmune brain disease. We will assess the immune responses in PND patients, correlate these with the clinical data (time course of disease, symptoms and signs, disability), and collect and archive clinical data, serum and cells from PND patients for current and future studies into the basic immune system phenomenon present in PND patients.

Official Title
-----------------
Killer T Cell Activity in the Paraneoplastic Neurologic Syndromes

Conditions
-----------------
Paraneoplastic Syndromes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neurological disease which is suspected to be paraneoplastic No known active additional malignancy other than non-melanoma skin cancer Exclusion Criteria: Known central nervous system (CNS) metastasis Known active additional malignancy No pulmonary disease which limits daily activities if leukapheresis: must be 14 or older no known hepatitis B or C, HIV, or syphilis (by history or prior negative tests) no known IV drug users HgB > 8.5 WBC > 3,500 platelets > 100,000 INR < 2 if large blood draw (1/2 to 1 unit; children 3 ml/kg) in lieu of leukapheresis: no known IV drug users HgB > 10 WBC > 3,500 platelets > 100,000 INR < 2 if lumbar puncture: platelets > 120,000 INR < 1.2 must be 14 or older

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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 |
| --- | --- | --- |
| Immunologic responses to tumor antigens in vitro | ELISPOT | throughout study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Paraneoplastic Neurologic Syndromes
An Examination of Predictors of Indicators of Response to Letrozole 2.5 mg

Study Overview
=================
Brief Summary
-----------------
To assess the quantitative real time PCR results of oligonucleotide probes for a number of gene transcription products that may be useful as predictors or indicators of response to letrozole

Detailed Description
-----------------
To assess the quantitative real time PCR results of oligonucleotide probes for a number of gene transcription products (PCNA, cyclin-D1, ER alpha, PR, pS2, 450 aromatase, bcl-2, bax, caspase-3, and VEGFR) that may be useful as predictors or indicators of response to letrozole

Official Title
-----------------
Quantitative Real Time PCR in Cytolytic Formalin Fixed Breast Cells Obtained by Periareolar Fine Needle Aspiration. An Ancillary Protocol to a Chemoprevention Trial of Letrozole

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: letrozole 2.5 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: evidence of hyperplasia with/without atypia upon random periareolar fine needle aspiration of breast on hormone replacement therapy postmenopausal increased risk of developing breast cancer based on personal or family history never have taken aromatase inhibitors or selective estrogen receptor modulators in last six months women who have a high risk of breast cancer older than 18 years Exclusion Criteria: no anticoagulants no marked breast tenderness not pregnant or within twelve months of breast feeding/childbirth

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: letrozole 2.5 mg|nan|

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
-----------------
breast atypia, breast epithelial hyperplasia, Ki-67, RTPCR, microdissection
Study on the Effects of an AMP Challenge on Asthmatic Patients Following Treatment With Fluticasone Propionate

Study Overview
=================
Brief Summary
-----------------
Inhaling AMP causes an inflammatory response in the lung. This study will investigate whether 5-days of treatment with fluticasone propionate protects the lung from responding to the AMP in this way.

Detailed Description
-----------------
A randomised, double-blind, placebo-controlled, incomplete block, 4-period crossover study to investigate the effects of 5-day repeat inhaled doses of fluticasone propionate (BID, 50-2000 mcg) on airway responsiveness to adenosine-5'-monophosphate (AMP) challenge when delivered after the last dose in mild asthmatic subjects

Official Title
-----------------
A Randomised, Double-blind, Placebo-controlled, Incomplete Block, 4-period Crossover, Study to Investigate the Effects of 5-day Repeat Inhaled Doses of Fluticasone Propionate (BID, 50-2000 mcg) on Airway Responsiveness to Adenosine 5-monophosphate (AMP) Challenge When Delivered After the Last Dose in Mild Asthmatic Subjects.

Conditions
-----------------
Asthma

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female of non-childbearing potential Using appropriate contraception. Mild asthmatic, non (or ex) smokers. Has inflammatory response to AMP. Otherwise healthy, not using any steroids. Exclusion Criteria: Have a history of life-threatening asthma, defined as an asthma episode, which required intubation and/or was associated with either hypercapnea, respiratory arrest or hypoxia seizures. Have a known sensitivity to corticosteroids. Have a history of milk protein allergy. Test positive at the screening visit for hepatitis B or C or HIV

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>study drug | Drug: Fluticasone propionate<br>* Study drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterise the dose response curve following repeat inhaled doses of FP for 5 days in the AMP challenge model. |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety following multiple AMP challenges: Adverse events |  | 5 days | 
| Plasma concentrations of FP and derived pharmacokinetic parameters |  | 5 days | 
| Exhaled nitric oxide concentrations |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, AMP challenge
Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of KWA-0711, and to determine its optimal dose in Chronic Constipation (CC) patients.

Official Title
-----------------
Phase II, Randomized, Placebo-controlled, Double-blind, Parallel-group Study of KWA-0711 Administered Orally for 4 Weeks to Evaluate Its Efficacy and Safety, and to Determine Its Optimal Dose in Patients With Chronic Constipation (CC)

Conditions
-----------------
Chronic Constipation

Intervention / Treatment
-----------------
* Drug: KWA-0711
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who experienced fewer than three SBMs per week for more than 6 months prior to the enrollment. The patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation. Exclusion Criteria: Patients who have secondary constipation caused by systemic disorder. Patients who have organic constipation. Patients who received intestinal resection.

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

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

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: KWA-0711 High dose<br> | Drug: KWA-0711<br> <br> |
| Experimental: KWA-0711 Low dose<br> | Drug: KWA-0711<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the weekly number of Spontaneous Bowel Movements (SBMs) at Week 1 |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete SBM (CSBM) frequency and responder rate |  | 4 weeks | 
| SBM frequency and responder rate |  | 4 weeks | 
| Time to first SBM after the initial dose |  | 4 weeks | 
| Stool consistency |  | 4 weeks | 
| Degree of straining |  | 4 weeks | 
| Abdominal bloating and discomfort |  | 4 weeks | 
| Use of rescue medications |  | 4 weeks | 
| Global assessment of constipation severity |  | 4 weeks | 
| Japanese version of IBS-QOL |  | 4 weeks | 
| Global assessment of treatment effectiveness |  | 4 weeks | 
| Satisfaction rating for the condition of bowel movements |  | 4 weeks | 
| Adverse events, ECGs, vital signs, and clinical labs |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Constipation, CC
The Impact Of Platelet Function on 1-year Outcome in Complex PCI Patients

Study Overview
=================
Brief Summary
-----------------
To identify the optimal cut-off values in different platelet function testing to predict MACCE at 12-months in complex PCI patients of China

Detailed Description
-----------------
This study will observe the relationship between platelet function testing and clinical outcomes. Meanwhile we aim to identify optimal cut-off values in different platelet function testing, including IPF, TEG and VerifyNow, to predict MACCE during12-months in complex PCI patients.

Official Title
-----------------
The Impact Of Platelet Function on 1-year Outcome in Complex PCI Patients

Conditions
-----------------
Percutaneous Coronary Intervention, Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented undergoing complex PCI in 1 year prior to enrollment. Exclusion Criteria: Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language where interpreter services are not reliably available, psychiatric disturbances, alcohol or drug abuse). Presence of serious/severe co-morbidities in the opinion of the investigator which may limit life expectancy (<1 year). Current participation in a blinded randomized clinical trial.
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 |
| --- | --- | --- |
| Optimal cut-off values in different platelet function testing to predict MACCE at 12-months in complex PCI patients of China |  | Within 12 months of patient enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness and sensitivity of predicting between different platelet function testing |  | Within 12 months of patient enrolled | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Percutaneous coronary intervention, platelet function, prognosis, antiplatelet
Efficacy and Safety of CDP870 and Methotrexate Compared to Methotrexate Alone in Subjects With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The main purpose of the study was to determine the efficacy of CDP870 in treating RA signs/symptoms in patients who were partial responders to MTX. Other purposes were to show additional efficacy without increased toxicity and the immunogenic response to CDP870 during combined CDP870 and MTX therapy.

Official Title
-----------------
Efficacy and Safety of CDP870 400 mg in Combination With Methotrexate Compared to Methotrexate Alone in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Are Partial Responders to Methotrexate

Conditions
-----------------
Arthritis, Rheumatoid

Intervention / Treatment
-----------------
* Drug: CDP870


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male/female, 18-75 years old, inclusive diagnosis of adult-onset RA had active disease had received methotrexate on a stable dose of folic acid Exclusion Criteria: contraindication for methotrexate or anti-TNF

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CDP870|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American college of Rheumatolofy (ACR)-20 responder rate at Week 24 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  |  | 
| health outcomes measures |  |  | 
| immunogenic profile of CDP870 plus methotrexate |  |  | 
| systemic exposure of CDP870 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CDP870, Certolizumab pegol
Opicapone Treatment Initiation Open-Label Study

Study Overview
=================
Brief Summary
-----------------
This is an observational study to describe the treatment patterns and clinical outcomes observed with use of ONGENTYS as adjunctive treatment to levodopa/carbidopa in Parkinson's disease patients experiencing off episodes with motor fluctuations

Official Title
-----------------
Opicapone Treatment Initiation Open-Label Study

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Drug: Opicapone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be able to complete electronic patient-reported outcome instruments Parkinson's disease patients experiencing off episodes Patient receiving concomitant levodopa/carbidopa, and as deemed appropriate by the physician, newly initiating ONGENTYS as adjunctive treatment Exclusion Criteria: Patient is not cognitively able to complete the study requirements Patient is not able to complete the study duration of 6 months History of moderate or severe hepatic impairment Patient has end-stage renal disease Concomitant use of non-selective monoamine oxidase (MAO) inhibitor or catechol-O-methyltransferase (COMT) inhibitors (patients entering study may switch from other COMT inhibitors to ONGENTYS) History of pheochromocytoma, paraganglioma, or other catecholamine-secreting neoplasms Currently enrolled in an interventional clinical trial Currently or previously received ONGENTYS

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 |
| --- | --- |
| ONGENTYS<br>Opicapone 50 mg capsule once daily for 6 months | Drug: Opicapone<br>* Opicapone as adjunctive treatment to levodopa/carbidopa over a 6-month period<br>* Other names: ONGENTYS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ONGENTYS treatment patterns | Reason for initiating treatment and discontinuation | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD Status | PD Status Questionnaire | 6 months | 
| CGI-C | Clinical Global Impression of Change Scale | 6 months | 
| MDS-UPDRS Parts I, II, and IV | Movement Disorder Society-Unified Parkinson's Disease Rating Scale | 6 months | 
| PDQ-8 | Parkinson's Disease Questionnaire-8 | 6 months | 
| PGI-C | Patient Global Impression of Change Scale | 6 months | 
| NoMoFa | Non-Motor Fluctuation Assessment | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Motor Fluctuations, Parkinson's disease (PD), Levodopa, Carbidopa, Non-Motor Fluctuations, Adjunctive treatment, COMT inhibitor
Detection of Phrenic Nerve Stimulation Using Sensors' Signals

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect sensor data from patients with implanted cardiac resynchronization devices who exhibit phrenic nerve stimulation.

Official Title
-----------------
Detection of Phrenic Nerve Stimulation Using Accelerometer and Electrogram Signals Study

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and capable of providing informed consent and of participating in all testing Age 18 or above or of legal age to give informed consent specific to national law Implanted with a Boston Scientific COGNIS™ family device Geographically stable and is available for follow-up procedures at a study centre Exclusion Criteria: Patients that are pacemaker-dependent Women who are pregnant or plan to become pregnant during the study (method of assessment upon physician's discretion) Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry Patients who are not expected to support approximately 30 minutes of study testing procedures Patients who are not mentally competent enough to provide feedback on PS during study procedures

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 |
| --- | --- |
| All study patients (single arm study)<br>All eligible patients will be included in the only study arm and will undergo study testing. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data collection | Collect sensor data in patients with implanted CRT-D devices who exhibit phrenic nerve stimulation. | 3 months follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phrenic nerve stimulation, Cardiac Resynchronization Therapy, Heart Failure, Heart Diseases