linjc16/ctgov huggingface dataset:
Felodipine Event Reduction Study

Study Overview
=================
Brief Summary
-----------------
FEVER is an investigator-designed, prospective, multicentre,double-bind, randomized, placebo-controlled,parallel-group trial. The primary objective is to compare the long-term effects on the incidence of fatal and non-fatal stroke (and secondarily of other cardiovascular events) of administering a small dose of the calcium antagonist felodipine (5 mg once a day) or of a placebo, in hypertensive patients whose blood pressure had preliminarily been reduced by administering a low-dose diuretic (hydrochlorothiazide,12.5 mg once a day) to be continued in association with felodipine or placebo, throughout the trial.

Official Title
-----------------
Felodipine Event Reduction Study

Conditions
-----------------
Hypertension

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SBP of 210 mmHg or less and DBP less than 115 mmHg if under antihypertensive treatment; SBP 160-210 mmHg or DBP 95-115 mmHg if untreated. Presence of at least one or two risk factors or cardiovascular diseases Informed consent obtained Exclusion Criteria: stroke or myocardial infarction during the previous 6 months; secondary hypertension; unstable angina; cardiomyopathy or significant valvular disease; serum creatinine greater than 178 mmol/l (2.0 mg/dl); gout; uncontrolled diabetes(fasting plasma glucose > 10 mmol/l, 180 mg/dl despite therapy); serious pulmonary or hepatic disease; known contraindications to study drugs; unwillingness to cooperate

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 79 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 |
| --- | --- |
| Active Comparator: felodipine group, active, pill<br>felodipine and HCTZ treatment group | Drug: Felodipine<br> <br> |
| Placebo Comparator: placebo, no treatment, pill<br>placebo and HCTZ group | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of fatal and non-fatal stroke |  | During the study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause death |  | during the study period | 
| cardiac event |  | during the study period | 
| All cardiovascular events |  | during the study period | 
| new onset diabetes |  | during the study period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, felodipine, moderate to high risk patients
Fatty Liver Disease in Nordic Countries

Study Overview
=================
Brief Summary
-----------------
A prospective cohort study, which aims to systematically evaluate biomarkers and potential targets in NAFLD and NASH.

Official Title
-----------------
Fatty Liver Disease in Nordic Countries (FLINC): a Prospective Cohort Study

Conditions
-----------------
Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Proteomics
* Diagnostic Test: Transcriptomics
* Genetic: Genomics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-alcoholic fatty liver disease and Healthy volunteers Exclusion Criteria: Other liver diseases than non-alcoholic fatty liver disease Lack of informed consent

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Proteomics|Mass-spectometry proteomics|
|Diagnostic Test: Transcriptomics|Next generation sequencing|
|Genetic: Genomics|Targeted genetics|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibrosis | Number of participants with fibrosis proression | 5 years |
ERP N1 as a Treatment Predictor of Generalized Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
Amplitude changes of the N1 and the N1/P2 ERP component in response to different tone intensities have been suggested as a correlative of central serotonergic activity. A strong loudness dependence amplitude increase (strong intensity dependence) reflects low serotonergic neurotransmission and vice versa. Many researchers assumed that the brain serotonergic activity could influence treatment response of highly selective serotonin reuptake inhibitors in depression and anxiety disorders. There are a couple of studies reporting associations of N1 amplitude intensity dependence with response to Citalopram (positive correlation) and Reboxetine (negative correlation) treatment in major depressive disorder patients. But so far there have been no reports about associations between ERP N1 and antidepressant response in GAD patients. So, it would be very interesting to explore the correlations between ERP N1 amplitude change and the Escitalopram treatment responsiveness in GAD patients.

Official Title
-----------------
The Amplitude Change of the Auditory Evoked N1 Component as a Predictor of Response to Escitalopram Treatment in Patients With Generalized Anxiety Disorder

Conditions
-----------------
Generalized Anxiety Disorder

Intervention / Treatment
-----------------
* Drug: escitalopram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV TR for GAD Hamilton Rating Scale for Anxiety (HAMA) >18 18 to 75 years old Exclusion Criteria: Severe medical illness Other psychiatric illness HAMD > 18 High suicidal risk pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GAD<br>35 patients with Generalized Anxiety disorder | Drug: escitalopram<br>* Start with escitalopram 10mg According to patient's symptoms, stay on 10mg or increase up to 20mg Concomitant therapy : up to Xanax 0.5mg, or Ativan 1mg, not allowed above these dosages Length of washout period will be at least 2 weeks for any psychotropic drugs<br>* Other names: lexapro;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event related potential (ERP) N100 |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - HAMA - HAMD - CGI - Beck Anxiety Inventory(self rating) |  | baseline, 2, 4, 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Generalized anxiety disorder, N100, Central serotonergic activity
suPAR in the Early Diagnosis of Acute Kidney Injury(AKI) After On-Pump Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Acute Kidney Injury(AKI) is of the serious complications in patients with undergoing on-pump cardiac surgery. End stage kidney failure requiring dialysis therapy after cardiac surgery is associated with more than 60% mortality rate. Involvement of AKI after on-pump cardiac surgery increases the mortality rate 19 times. suPAR is one of the novel biomarker which has potential prognostic value for renal dysfunction in patients with undergoing on-pump cardiac surgery. Early diagnosis and prompt intervention to prevent AKI has great importance for management of postoperative cardiac patients.

Official Title
-----------------
Soluble Urokinase Plasminogen Activator Receptor (suPAR) in the Early Diagnosis of Acute Kidney Injury After On-Pump Cardiac Surgery

Conditions
-----------------
Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Approved informed concent Age higher than 18 years old Exclusion Criteria: Chronic kidney disease Renal transplantation Cancer history Previous cardiac surgery Sepsis Liver failure Thyroid dysfunction Having long term steroid therapy Having renal replacement therapy Exposure to nephrotoxic drug and radiocontrast substance before 5 days of surgery Diagnosis of Acute Kidney Injury Intraaortic balloon or Extracorporeal Membrane Oxygenation insertion after surgery

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 |
| --- | --- | --- |
| Acute Kidney Injury | Patients will be classified as AKI patients and non-AKI patients according to KDIGO classification. AKI patients will be subdivided into 3 subgroup according to KDIGO criteria. | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
suPAR, Acute Kidney Injury, On-Pump Cardiac Surgery, Biomarker
Treatment of Patients With Human Immunodeficiency Virus (HIV)-Related Chronic Diarrhea With Saccharomyces Boulardii or Placebo: A Double Blind Trial

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy of Saccharomyces boulardii (a nonpathogenic yeast) in producing a significant reduction in diarrheal symptoms in HIV-infected patients with chronic diarrhea.

Official Title
-----------------
Treatment of Patients With Human Immunodeficiency Virus (HIV)-Related Chronic Diarrhea With Saccharomyces Boulardii or Placebo: A Double Blind Trial

Conditions
-----------------
Diarrhea, HIV Infections

Intervention / Treatment
-----------------
* Drug: Saccharomyces boulardii


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Antiviral medication for HIV infection. Patients must have: Documented HIV infection. Chronic diarrhea (for at least 1 month) that is either a manifestation or complication of documented HIV infection. Had a stool culture (Salmonella, Shigella, Campylobacter, and Clostridium difficile) and stool analysis for ova and parasite (O/P X 3) within the past 2 months. Failed antimicrobial treatment for diarrhea OR received no prior antimicrobials for stool pathogens because stool cultures were negative. Patients who are on antiviral medications for HIV infection must have received such medication for at least 2 weeks and must remain on stable dose for weeks 1 and 2 of study. Prior Medication: Allowed: Prior antiviral medication for HIV infection (if on such medication, must have received it for at least 2 weeks). Standard antimicrobial therapy for a documented positive gastrointestinal pathogen. Exclusion Criteria Concurrent Medication: Excluded: Gastrointestinal medications that cause diarrhea (e.g., magnesium-containing antacids, lactulose). Maintenance antifungal medication for life-threatening fungal infections (other than fluconazole <= 100 mg/day).

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Saccharomyces boulardii|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
-----------------
Saccharomyces, Diarrhea, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness and tolerability of an investigational drug for the treatment of manic episodes of bipolar disorder. The investigational drug will be given as additional treatment with either lithium or valproate, which are already FDA (Food and Drug Administration)-approved treatments for mania.

Official Title
-----------------
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder

Conditions
-----------------
Bipolar Disorder

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of bipolar disorder (type I) with manic or mixed episodes (including patients with/without psychotic features or with/without a history of rapid cycling) In need of psychiatric treatment Cooperation and willingness to complete all aspects of the study Exclusion Criteria: Current diagnosis other than bipolar I disorder History of schizophrenia or schizoaffective disorder Drug dependence within 1 month prior to study start or testing positive in a urine drug test Suicide attempt within 1 month prior to study start or at immediate risk of harm to self or others Any form of psychotherapy within 1 month prior to study start

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: licarbazepine<br> | Drug: Licarbazepine<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major improvement in anxiety and depression from baseline to endpoint (week 6) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bipolar disorder, manic episode, treatment, licarbazepine
Double GnRH Antagonist Daily Dose in Hyperresponding IVF/ICSI Cycles May Prevent the OHSS

Study Overview
=================
Brief Summary
-----------------
The possibility to prevent the early ovarian hyperstimulation syndrome (OHSS) by doubling the daily dose of GnRH-antagonist in women stimulated with the antagonist protocol who are at risk for OHSS was evaluated. Thirty-eight women of a study group who underwent ovarian stimulation using the GnRH-antagonist protocol and might have had their cycle cancelled because of OHSS were compared to 76 women of a control group. All cases of the study group were IVF women presenting a rapid rise of E2 ≥ 3500 pg/ml on the 7th day of stimulation or later while the follicles (> 12mm) were > 15 in total and the biggest one was ≤ 16mm in diameter. By decreasing the rFSH dose to 100IU a day and adding an additional dose of GnRH-antagonist (0.25 twice a day), estradiol levels were lowered or reached a plateau before hCG was given. A marked decrease or plateau of estradiol levels was observed the day of oocyte retrieval while the pregnancy rate was not adversely affected when compared with an optimum ovarian response cycles. None of the women were cancelled or developed OHSS. In overresponding IVF cycles, doubling the usual GnRH-antagonist daily-dose during the ovarian stimulation, the estradiol rise could be blocked while a minimal follicular stimulation may continue without the risk of OHSS or adversely affect pregnancy rate.

Conditions
-----------------
Ovarian Hyperstimulation Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women stimulated with the antagonist protocol who are at risk of ovarian hyperstimulation syndrome Exclusion Criteria: Has chosen other preventive protocols (coasting and/or cryopreservation)were excluded

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 35 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
GnRH antagonists, OHSS, ovarian stimulation
Accelerometry at the Neck: Comparison With m. Adductor Pollicis Stimulation

Study Overview
=================
Brief Summary
-----------------
Accelerometric Assessment of neuromuscular block during anaesthesia is routinely performed at the M. adductor pollicis. However, many operations require positioning of the patients with arms attached to the body. In these situations, the anaesthesiologist has no access to the m.adductor pollicis. In this study, a new position of accelerometry at the neck is evaluated: Stimulation of the n. accessorius with accelerometry of the m. trapezius.

Conditions
-----------------
Feasibility of Measurement of a Neuromuscular Block at the m. Trapezius

Intervention / Treatment
-----------------
* Device: accelerometry m. trapezius and m. adductor pollicis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing general anaesthesia with endotracheal intubation weight 50-90 kg Exclusion Criteria: Pregnancy allergy to one of the drugs used risk of pulmonary aspiration expected difficulties with endotracheal intubation intake of drugs known to influence neuromuscular block infection (CRP > 0,5 mg/dl, leukocyte count > 12000/µl)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group trapezius<br>Assessment of intubation conditions after onset of the neuromuscular block at the m. trapezius | Device: accelerometry m. trapezius and m. adductor pollicis<br> <br> |
| Other: group adductor pollicis<br>assessment of intubation conditions after onset of the neuromuscular block at the m. adductor pollicis | Device: accelerometry m. trapezius and m. adductor pollicis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery to a train of four ratio of 0.9 | Comparison between time to recovery [s] to a train of four ratio of 0.9 between both groups | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| onset of neuromuscular block | Comparison of onset time [s] between both groups. Onset time is defined as decrease of T1 to < 5% of initial twitch height. | 10 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
accelerometry, neuromuscular block, m. trapezius
Observational Study of NovoPen Echo® on Safety and Treatment Satisfaction in Children and Adolescents With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia, Europe and North America. The aim of this observational study is to evaluate the safety of NovoPen Echo® by collecting safety information (incidence of technical complaints related to adverse reactions). Study duration: 12-18 weeks.

Official Title
-----------------
A Multicentre, Observational Study of NovoPen Echo® on Safety and Treatment Satisfaction of Insulin Therapy in Children and Adolescents With Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Delivery Systems

Intervention / Treatment
-----------------
* Device: NovoPen Echo®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children/adolescents with type 1 diabetes mellitus After the participating physician's decision has been made to initiate treatment with NovoPen Echo®, any patient who meets all the inclusion criteria and does not meet any of the exclusion criteria, is eligible to participate Use of insulin pen or syringes for at least 12 months Exclusion Criteria: Insulin pump or Insuflon® users Any disease or condition in children/adolescents which might interfere with the study at the individual physician's discretion

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum 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 |
| --- | --- |
| A<br> | Device: NovoPen Echo®<br>* Prescribed insulin treatment delivered by NovoPen Echo®<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of technical complaints related to adverse reactions |  | after 12-18 weeks (end of study) |