linjc16/ctgov huggingface dataset:
Surgical Approach for Primary Hyperparathyroidism in the Elderly

Study Overview
=================
Brief Summary
-----------------
Following a personal observation and a retrospective analysis of the data, the investigators hypothesise that there is increased frequency of multiple gland disease in primary hyperparathyroidism in the elderly. This study will include patients over the age of 65, diagnosed with primary hyperaprathyroidism, referred for surgery and suspected to have a single adenoma according to preoperative imaging. Surgery will begin with a focal parathyroid exploration as suspected followed by an exploration of the other gland at the same time. Data will be analysed to determine the frequency of multigland disease in this population.

Official Title
-----------------
Surgical Approach for Primary Hyperparathyroidism in the Elderly - a Prospective Study

Conditions
-----------------
Multigland Disease in Primary Hyperparathyroidism

Intervention / Treatment
-----------------
* Procedure: unilateral neck exploration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with primary hyperparathyroidism. patients with an indication for surgery. Suspected adenoma on preop images. minimum age of 65. Exclusion Criteria: patients younger than 65. cases where imaging didn't locate any adenoma. patients who did not consent to participate in the study.

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Experimental: unilateral neck exploration<br>unilateral neck exploration of elderly with primary hyperparathyroidism | Procedure: unilateral neck exploration<br>* All elderly patients with primary hyperparathyroidism suspected to have a single gland disease will have a unilateral neck exploration following the index gland identification.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of multigland disease in hyperparathyroidism in the elderly. |  | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Hyperparathyroidism, multigland disease, neck exploration, elderly
Myocardial Hemodynamic Effects of Levosimendan

Study Overview
=================
Brief Summary
-----------------
This study will test the hypothesis that mechanical efficiency as measured by pressure-volume loop assessment should improve during short-term treatment with intravenous levosimendan. Levosimendan (SimdaxTM, Abbott Laboratories, Abbott Park, IL) is a calcium sensitizer which has been shown to have beneficial hemodynamic effects in patients with decompensated congestive heart failure (CHF). Levosimendan is a new calcium sensitizer that binds to troponin C. This agent is approved in Europe for treatment of heart failure patients. In the United States, this agent is currently under phase III investigation for intravenous treatment of patients with acutely decompensated HF who have dyspnea at rest or with minimal activity. Levosimendan has been studied in these patients with acute HF and is considered experimental in the United States for this population.

Official Title
-----------------
Myocardial Hemodynamic Effects of Levosimendan

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

Intervention / Treatment
-----------------
* Drug: levosimendan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients will have either a sinus or paced atrial rhythm with atrioventricular synchrony on electrocardiography All patients will have a history of heart failure diagnosed clinically with history of prior symptoms or signs of heart failure with at least one of the following symptoms within the past month: dyspnea on exertion, orthopnea, paroxysmal nocturnal dyspnea, pedal edema In asymptomatic patients, patients may be enrolled if they have at least one of the following clinical signs of heart failure: left ventricular third and/or fourth heart sound, jugular venous pressure >7 mmHg, sustained left ventricular impulse, or pulmonary congestion on auscultation all patients will have echocardiographic evidence of left ventricular dysfunction Exclusion Criteria: Under age 18

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: 1<br>All randomized patients receive drug. | Drug: levosimendan<br>* 10-minute infusion<br>* Other names: Simdax;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter. | Left ventricular end-diastolic pressure (LVEDP) recorded from CD Leycom ConductNT software analysis. | From baseline to 30-minutes after levosimendan started. |
Nanopore Sequencing in Ophthalmology

Study Overview
=================
Brief Summary
-----------------
In this pilot study, the feasibility of the Oxford Nanopore MinION to identify pathogens from vitrectomy samples in eyes with endophthalmitis shall be assessed. The MinION is a low cost commercially available device for DNA/ RNA analysis that, in studies, has been used for pathogen determination in various infectious diseases as well as for the genetic characterization of hematologic tumors.

Detailed Description
-----------------
Vitreous samples and anterior chamber taps from eyes with endophthalmitis are taken during routine vitrectomy. The gathered samples are divided in half to undergo routine culture for microbial growth and nanopore sequencing with the MinION Mk1b, a commercially available device for DNA/RNA sequencing. Base reads from Nanopore sequencing are then compared with available libraries for pathogen identification. The Nanopore sequencing results for pathogens are compared versus the results of the microbiological culture of the same eye as the gold standard. Clinical features and visual function before and after vitrectomy are gathered from patient charts. Treatment is not altered due to results of the Nanopore sequencing.

Official Title
-----------------
Nanopore Sequencing in Ophthalmology - a Paradigm Shift in Pathogen Determination?

Conditions
-----------------
Endophthalmitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eyes of patients with endophthalmitis Exclusion Criteria: No informed consent possible Participation in other studies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathogen detection | Pathogens detected by Nanopore sequencing versus microbiologic culture | In vitro analysis after vitrectomy for endophthalmitis. Start of analysis: Within the next working day after sample acquisition. Time for Nanopore sequencing: Approximately up to 10 hours. Time for culture: 24 hours up to 14 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to pathogen detection | Time in days from gathering of the sample until arrival of results | Time measured from start of analysis until arrival of results. Time for Nanopore sequencing: Approximately up to 10 hours. Time for culture: 24 hours up to 14 days. | 
| Visual acuity | Visual acuity measured with Snellen charts | Gathered from patient charts two months after vitrectomy. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endophthalmitis, Nanopore sequencing, Next Generation Sequencing
Proof of Concept Study of Cognitive Improvement in Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that AZD3480 improves cognition in patients with stable schizophrenia who are being treated with an atypical antipsychotic and who are active cigarette smokers, to assess the safety and tolerability of AZD3480 and to define the optimal dose(s) to be used in future trials.

Official Title
-----------------
A Multi-Center Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase IIb Proof of Concept Study With 3 Oral Groups of AZD3480 During 12 Weeks Treatment of Cognitive Deficits in Patients With Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: AZD3480


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of schizophrenia Outpatient at the time of screening and randomization Stable housing defined as having a place to live in the community (ie, not in a hospital or nursing home) Active cigarette smoking (10 or more cigarettes per day Exclusion Criteria: Any significant psychiatric or neurological disease other than schizophrenia, or current diagnosis of major depressive disorder Known or suspected drug or alcohol abuse within the 6 months or urine toxicology test positive for illegal or non-prescribed substances Impaired vision and/or hearing making cognitive testing difficult

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: AZD3480<br>* oral capsule<br>|
| Experimental: 2<br>AZD3480 oral | Drug: AZD3480<br>* oral capsule<br>|
| Experimental: 3<br>AZD3480 oral dose | Drug: AZD3480<br>* oral capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Domain scores for Attention/Vigilance, Working Memory, Verbal Learning, Speed of Processing and Verbal Fluency as measured on the IntegNeuro computerized test battery of cognitive function |  | Change from baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UCSD Performance Based Skills Assessment (UPSA2) and on the Social Functioning Scale (SFS) |  | Change from baseline to Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Cognitive Deficits
A Study of the Impact of an Early Biopsy in Patients Treated With CellCept (Mycophenolate Mofetil) After Kidney Transplantation

Study Overview
=================
Brief Summary
-----------------
This 2 arm study will evaluate the impact on fibrosis at week 52 of an early biopsy, in patients who have received a kidney transplant from an expanded criteria donor. Patients will be randomized to one of two groups; the first group will have a biopsy at day 10, and the second group will receive standard management. All patients will be given CellCept as standard of care. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.

Official Title
-----------------
A Randomised, Multicenter, Open-label Study Evaluating the Impact on the Fibrosis at Week 52 of an Early Biopsy at (D10) Versus Standard Management in Patients Who Have Undergone de Novo Renal Transplantation and Received a Marginal Organ Transplant

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: mycophenolate mofetil [CellCept]
* Drug: mycophenolate mofetil [CellCept]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >=18 years of age; in receipt of an initial cadaveric kidney transplant; in receipt of graft with biopsy; in receipt of a 'marginal' kidney transplant. Exclusion Criteria: in receipt of a second kidney transplant; in receipt of a multi-organ transplant or a double kidney transplant; malignant tumor, or a history of cancer in past 5 years, other than successfully treated basal cell or spinocellular cancer or cancer in situ of cervix; replicating hepatitis B and/or C, or HIV positive serology.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: mycophenolate mofetil [CellCept]<br>* As prescribed; + early biopsy<br>|
| No Intervention: 2<br> | Drug: mycophenolate mofetil [CellCept]<br>* As prescribed; + standard treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with >=25% increase in fibrosis score |  | Day 0 to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function (creatinine clearance) |  | From randomization to Week 52 | 
| Incidence and time of occurrence of clinical acute rejection |  | From randomization to Week 52 | 
| Adverse events, laboratory parameters, cancers and lymphoproliferative syndromes |  | Throughout study |
A Study to Compare PK, PD and Safety of CKD-381 and D026 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy subjects

Official Title
-----------------
A Randomized, Open-label, Multiple-dose, and Crossover Study to Compare Pharmacokinetics, Pharmacodynamics and Safety of CKD-381 and D026 in Healthy Subjects

Conditions
-----------------
GERD

Intervention / Treatment
-----------------
* Drug: CKD-381
* Drug: D026


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 19 aged and 50 aged in healthy male adult Body weight more than 55kg Body Mass Index more than 18.5 and under 25 Exclusion Criteria: Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease. Have a gastrointestinal disease history that can effect drug absorption or surgery. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Investigational product, additives or benzimidazole family.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TR group<br>Period 1: Test drug(CKD-381) Period 2: Reference drug(D026) | Drug: D026<br>* 1 tablet administered before the breakfast during 7 days<br>|
| Experimental: RT group<br>Period 1: Reference drug(D026) Period 2: Test drug(CKD-381) | Drug: CKD-381<br>* 1 tablet administered before the breakfast during 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state) | Evaluation PK for Esomeprazole after multiple dose | 0 24h | 
| Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose | Evaluation PD for ambulatory 24hr pH monitor | Baseline versus Multiple dose during 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CKD-381, D026
Unloading Respiratory Muscles During NIV: Comparison of a Spontaneous and Auto-adjusting Controlled Mode

Study Overview
=================
Brief Summary
-----------------
Measurement of Work of breathing (WOB), as well as pressure time product (PTP) of transdiaphragmatic pressures to evaluate the degree of muscle activity and muscle unloading during non-invasive ventilation. The study makes comparison of a new developed auto adjusting controlled mode and a regular spontaneous mode.

Detailed Description
-----------------
Non-invasive ventilation (NIV) reduces carbon dioxide in hypercapnic respiratory failure by unloading the respiratory muscles. Spontaneous modes of NIV are usually being used in these situations. Spontaneous modes have the disadvantage, that the patient has to trigger the ventilator. The work to activate the trigger (WT) is estimated to be as high as up to 50% of the total work of breathing dependent on the underlying disease. Elimination of WT would increase the degree of respiratory muscle unloading. A new pressure controlled mode incorporated into the ventilogic mechanical ventilator (Weinmann, Germany) is capable of self adjusting respiratory parameters in a preset range according to the patient requirements. After a short period where the patients spontaneous respiratory parameters are being analyzed, the ventilator slowly implements a pressure controlled mode that matches the patients requirements. This study intends to investigate if this new mode achieves a higher degree of respiratory muscle unloading compared to a spontaneous mode.

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

Intervention / Treatment
-----------------
* Device: non-invasive ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy voluntary individuals PFT within normal limits Exclusion Criteria: Disease of the upper GI-tract Any form of lung disease or disease of the upper airways Any form of muscular disease, especially neuromuscular disease pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: non-invasive ventilation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work of breathing, pressure time product |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comfort |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
work of breathing, pressure time product, muscle pressures
Phase III Study to Assess the Efficacy and Safety of SK3530 in Patients With Erectile Dysfunction and Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of SK3530 in men with ED and hypertension who were taking antihypertensive medication.

Detailed Description
-----------------
SK3530 is a potent and selective phosphdiesterase type 5(PDE 5) inhibitor developed for the treatment of erectile dysfunction(ED). Since ED is common in men with hypertension, it is important to determine the efficacy and safety of SK3530 in men with ED taking antihypertensive medication.

Official Title
-----------------
A Double Blind, Randomized, Placebo-controlled, Parallel Group, Multi-center, Phase III Study to Assess the Efficacy and Safety of SK3530 in Patients With Erectile Dysfunction Taking Antihypertensive Medication

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: SK3530


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertension patient taking stable hypertensive medication for at least 4 weeks Score below 25 from IIEF EF domain during 4 weeks of treatment run-in period Failure rate above 50% from sexual attempt above 4 during 4 weeks of treatment run-in period Exclusion Criteria: Lab abnormality Uncontrolled diabetic mellitus High or low blood pressure, orthostatic hypotension Hyper- or hypo-thyroidism

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1<br> | Drug: Placebo<br>* Placebo as a substitute of SK3530 100mg<br>|
| Experimental: Group 2<br> | Drug: SK3530<br>* SK3530 100 mg<br>* Other names: Mvix;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile Function domain score (sum of Question 1,2,3,4,5 and 15) of the International Index of Erectile Function (IIEF) Questionnaire |  | 0, 4, 8, 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the score from : 1) IIEF Q3 & Q4, 2) other domains of IIEF, 3) Sexual Encounter Profile(SEP)Q2 and Q3, 4) Life Satisfaction Checklist, 5) Global Efficacy Assessment Question(GEAQ) |  | 0, 4, 8, 12 W | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erectile dysfunction, Hypertension, SK3530