linjc16/ctgov huggingface dataset:
Organized Program To Initiate Lifesaving Treatment In Hospitalized Patients With Heart Failure (OPTIMIZE-HF)

Study Overview
=================
Brief Summary
-----------------
This program is designed to improve medical care and education of hospitalized patients with heart failure and accelerate the initiation of evidence-based heart failure guideline recommended therapies by administering them before hospital discharge. A registry component focusing on admission to discharge and 60- to 90-day follow-up is designed to evaluate the demographic, pathophysiologic, clinical, treatment, and outcome characteristics of patients hospitalized with heart failure.

Official Title
-----------------
Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients With Heart Failure (OPTIMIZE-HF): An Internet-based Registry and Process of Care Improvement Program for Heart Failure Patients

Conditions
-----------------
Heart Failure, Congestive

Intervention / Treatment
-----------------
* Drug: Beta-blockers including Carvedilol
* Drug: ACE inhibitors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Hospitalized for episode of worsening heart failure as primary cause of admission or significant heart failure symptoms that develop during the hospitalization when the initial reason for admission was not heart failure. Systolic dysfunction (LVEF < 40%) or heart failure symptoms in the setting of preserved systolic function (diastolic dysfunction). Exclusion criteria: This study has no exclusion criteria.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Beta-blockers including Carvedilol|nan|
|Drug: ACE inhibitors|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the number and percentage of eligible patients who are discharged on optimal therapy. Evaluate all HF indicators recommended by JCAHO and CMS. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality Recurrent hospitalization Number of patients receiving beta-blockers therapy within 60 to 90 days of initiation and mean beta-blocker dose 60-90 days following discharge. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
registry, OPTIMIZE, Heart failure, OPTIMIZE-HF
Does Placenta Pathology Predict Outcome of Neonates With Hypoxic Ischemic Encephalopathy?

Study Overview
=================
Brief Summary
-----------------
The histology of the placenta of newborn infants with perinatal asphyxia and hypoxic-ischaemic encephalopathy is analysed. There will be an evaluation if placenta could be a biomarker for neurodevelopmental outcome at 18-24 months of age.

Official Title
-----------------
Does Placenta Pathology Predict Outcome of Neonates With Hypoxic Ischemic Encephalopathy?

Conditions
-----------------
Asphyxia Neonatorum

Intervention / Treatment
-----------------
* Other: hypothermia therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:all newborn infants with APGAR <5 at 10minutes, pH<7.0, lactate >12mmol/L, base excess >16, resuscitation >10min after birth, gestational age >35 weeks and an encephalopathy - Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 4 Days

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: hypothermia therapy|newborn infants with hypoxic-ischaemic encephalopathy are cooled for 72 hours with a target temperature of 33-34°C (whole body cooling).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurodevelopmental outcome at 18-24 month of Age | The investigators will analyse if there is a correlation of placenta histology and neurodevelopmental outcome | 7 years |
A Trial Of Azithromycin SR For The Treatment Of Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis

Study Overview
=================
Brief Summary
-----------------
To evaluate the clinical efficacy and safety in patients with Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis receiving a dose of 2 g of azithromycin in the SR formulation.

Official Title
-----------------
A Multicenter, Non-Randomized, Open Label Trial Of Azithromycin Sustained Release (SR) For The Treatment Of Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis In Japan Adults

Conditions
-----------------
Upper Respiratory Tract Infection

Intervention / Treatment
-----------------
* Drug: Azithromycin SR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were diagnosed Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis Exclusion Criteria: Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Azithromycin SR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is Investigator's Clinical efficacy at Day 8. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endpoints of efficacy are as follows: Investigator's clinical efficacy (at Day 4, Day 15 and 29) Bacteriological efficacy (at Day 4, 8, 15 and 29) Safety Endpoints: Adverse events and safety Laboratory data |  |  |
Gustatory Evoked-related Potentials in Humans

Study Overview
=================
Brief Summary
-----------------
Taste perception plays an important role in maintaining nutritional balance. Gustatory evoked potentials (GEP) can be detected in response to an intermittent stimulation of the gustatory receptors by a primary flavour. GEP are non invaisve, painless and safe. The aims were to establish a reliable recording of GEP in Humans and to determine physiological variations of the gustatory evoked cerebral activity, by recording gustatory evoked potentials in different physiological situations (different intensities of taste solutions, after feeding or fasting, with different taste...). Healthy volunteers were included in this study. GEP were recorded in 9 cortical sites by EEG sensors (10/20 system), in front of the primary and the secondary gustatory cerebral areas, referenced against ear lobes.

Official Title
-----------------
Etude du contrôle hédonique de la Prise Alimentaire Par l'Analyse Des Potentiels évoqués Gustatifs

Conditions
-----------------
Gustatory Evoked Potentials

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more than 18 years old non smoker Exclusion Criteria: diabetes mellitus treatment interfering with taste history or current neurological problem

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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 |
| --- | --- | --- |
| latencies of the gustatory evoked potentials |  | during a 20 minutes taste stimulus | 
| amplitudes of the gustatory evoked potentials |  | during a 20 minutes taste stimulus |
A Registered Cohort Study on Color Discrimination Deficit Associated With Neurodegenerative Disorders.

Study Overview
=================
Brief Summary
-----------------
Color discrimination deficit is a common manifestation of Alzheimer's disease (AD). However, the pathophysiology of this dysfunction remains poorly understood. The aim of the present study was to evaluate color discrimination using the Farnsworth-Munsell 100 hue test in patients with AD and mild cognitive impairment (MCI), compared with age-matched control subjects. As a secondary aim, we evaluated whether the outcomes of these visual tests were associated with cognitive.

Official Title
-----------------
A Registered Observational Cohort Study on Color Discrimination Deficit Associated With Neurodegenerative Disorders.

Conditions
-----------------
Neurodegenerative Disorders

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients underwent extensive clinical examination including thorough neurological and somatic examination by a specialized neurologist or geriatrician and extensive neuropsychological examination by a trained psychologist. AD was diagnosed according to the NINCDS-ADRDA criteria. Exclusion Criteria: We excluded individuals with noncompensated somatic illnesses, a history of a psychiatric disorder, color blindness, ophthalmological pathology, severe cranial trauma, focal neurological signs or magnetic resonance imaging examinations suggestive of cerebrovascular disturbances.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Color discrimination deficit<br> | Other: Data collection<br>* Neuropsychological assessment, FM-1OO, brain MRI, electroencephalogram and biomarker datas will be collected<br>|
| Without Color discrimination deficit<br> | Other: Data collection<br>* Neuropsychological assessment, FM-1OO, brain MRI, electroencephalogram and biomarker datas will be collected<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MoCA scores | The Montreal Cognitive Assessment (MoCA) | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACE-III scores | Addenbrooke's Cognitive Examination (ACE) score | Baseline |
Diabetes Peripheral Neuropathy and Small-fibre Nerve Damage: A Comparative Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether patients with diabetes-related peripheral neuropathic pain also have non-recognized damage to the intestine caused by autonomic neuropathy. The model will shed light on aspects of peripheral nerve injuries on both somatic and as well as visceral sensory nerves. Classical autonomic parameters from electrocardiography (ECG) and Holter (24-h ECG and blood pressure) are compared with peripheral nerve injuries. The damage of autonomic nerves often recognized late in the course when patients develop gastroparesis, however an earlier recognition of this nerve damage may help clarifying the fundamental pathomechanisms and thereby optimize treatment for this patient group in the future.

Official Title
-----------------
Is Diabetic Peripheral Neuropathy Accompanied by Internal Nerve Damage? A Comparative, Clinical Experimental Study of Peripheral and Visceral Nerve Damage in Diabetic Patients and Healthy Controls

Conditions
-----------------
Diabetes Mellitus, Peripheral Neuropathy, Small Fibre Neuropathy, Autonomic Neuropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients between 18 and 75 years with diagnosed diabetes mellitus, according to WHO criteria (World Health Organization). Proven peripheral neuropathy. Oral and written consent, with documentation that all relevant information about the program is given to the patient. The patient must be willing and able to, to meet the planned visit and meet the planned curriculum, including the participation in the experimental investigations. Exclusion Criteria: Pregnancy or breastfeeding Medical or surgical disease for the study doctor's assessment makes the patient unsuitable for participation in the study Previous or ongoing major depression Patients who can or will not comply with the recommended instructions given by the study doctor Use of analgesic opioid medication less than 24 hours before screening Competitive conditions that can cause peripheral neuropathy (eg, herpes zooster) Clinically significant disease less than 2 weeks from the planned entry in the study People involved in the planning or execution of the study

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with diabetic peripheral neuropathy<br> | |
| Healthy matched controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose |  | one year |
A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18- 40 Years of Age

Study Overview
=================
Brief Summary
-----------------
The goals of the proposed study are to evaluate the safety, tolerability and immunogenicity of a GBS vaccine. Previous studies suggest that immune responses against GBS can protect humans from infection.

Official Title
-----------------
A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18- 40 Years of Age

Conditions
-----------------
Invasive Group B Streptococcus (GBS) Disease

Intervention / Treatment
-----------------
* Biological: GBS glycoconjugate vaccine
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy females 18 through 40 years of age; have provided written informed consent after the nature of the study has been explained; are available for all visits scheduled for the study (i.e. are not planning to leave the area before the end of the study period); are in good health as determined by: medical history ,physical assessment Exclusion Criteria: unwilling or unable to give written informed consent to participate in the study; pregnant (serum pregnancy test) unwilling to use acceptable birth control from screening and until at least 3 months after the final immunization nursing (breastfeeding) mothers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Subjects will receive either 5, 10 or 20 mcg of the vaccine | Biological: GBS glycoconjugate vaccine<br>* Study subjects will receive either GBS conjugate vaccine or placebo. Total study size is 65. Study subjects will be followed for a total of 12 months after their last vaccination.<br>|
| Placebo Comparator: 2<br>Subjects will receive placebo control | Biological: Placebo<br>* Subjects will receive one dose of placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of an intramuscular GBS conjugate vaccine |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the magnitude and durability of GBS-specific antibody responses over 12 months. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GBS
Acute Effect of Topical Menthol on Neck Pain

Study Overview
=================
Brief Summary
-----------------
Topical menthol gels are classified 'topical analgesics' and are used to relieve aching and tenderness of muscles and joints. However, double-blind randomized controlled trials are lacking. Here the investigators examine - in a double-blind randomized controlled cross-over trial - the acute effect of topical menthol (Biofreeze) and placebo (gel with a menthol scent) on neck pain.

Official Title
-----------------
Danish: Integreret Motion på Arbejdspladsen (IRMA) English: Implementation of Exercise at the Workplace

Conditions
-----------------
Musculoskeletal Disorders

Intervention / Treatment
-----------------
* Other: Biofreeze
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more than 30 days with neck pain during the last year frequent pain or discomfort, defined as at least 3 days per week pain intensity at least 4 on a scale of 0-10 working at least 30 hours per week Exclusion Criteria: blood pressure above 160/100 mmHg pregnancy life-threatening disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 67 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: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Topical gel containing a menthol scent, but no active menthol | Other: Placebo<br>* The gel will be applied at 2.5 ml per 500 cm2 to the upper trapezius and neck muscles by a gloved technician<br>|
| Experimental: Biofreeze<br>Biofreeze topical gel containing 3.5% menthol | Other: Biofreeze<br>* The gel will be applied at 2.5 ml per 500 cm2 to the upper trapezius and neck muscles by a gloved technician<br>* Other names: Topical analgesic;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck pain intensity (scale 0-10) | the participant rates pain intensity on a scale from 0-10 immediately before, and 0, 10, 20, 40 and 60 minutes after application of the gel. The primary efficacy endpoint is at 20 min | before and 20 min after application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure pain threshold (PPT) | pressure pain threshold of the upper trapezius muscle is measured by a handheld algometer immediately before, and 0, 10, 20, 40 and 60 minutes after application of the gel. | before and 20 min after application | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neck pain, menthol
Induction Chemotherapy Prior to Radio-immunotherapy in Head and Neck Cancer Stage III/IV - a Methodical Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of the trial is to determine the feasibility of an induction chemotherapy with radio-immunotherapy in patients with head and neck cancer stage III/IV

Detailed Description
-----------------
3 Cycles of: Docetaxel 75 mg/m2 on d1, Cisplatin 75 mg/m2 on d1, 5-FU 750 mg/m2 on days 1-5 as continuous i.v. infusion, Duration of 1 cycle: 21 days; Followed by Cetuximab 400 mg/m2, Start of radiotherapy: 1 week after the first application of Cetuximab, During radiotherapy (35 x 2 Gy): Cetuximab 250 mg/m2 weekly, Up to 8 applications of Cetuximab.

Official Title
-----------------
Induction by Docetaxel/Cisplatin/5-Fluorouracil (TCF) Prior to Radiotherapy With Concomintant Cetuximab in Locally Advanced Inoperable Head and Neck Tumours - a Methodical Trial

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Procedure: radio-immunotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed, locally advanced head and neck cancer stage III/IV performance status: ECOG 0-1 Exclusion Criteria: distant metastases prior radiotherapy of the head and neck region myocardial infarct in the last six months florid peptic ulcer neuropathy grade III/IV

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: radio-immunotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| locoregional tumour control |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate toxicity progression free survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
head and neck cancer, stage III/IV, no prior radiotherapy of head and neck region
Expanded Access Use of Tucatinib for HER2+ Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Physicians interested in requesting a single patient IND should contact Seattle Genetics' Medical Information (medinfo@seagen.com).

Intervention / Treatment
-----------------
* Drug: Tucatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tucatinib|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
-----------------
Neoplasms, tucatinib, Breast Cancer, ARRY-380, ONT-380, HER2 Positive Breast Carcinoma, HER2 Positive Locally Advanced Breast Cancer, HER-2 Positive Breast Cancer, HER-2 Positive Locally Advanced Breast Cancer, Recurrent Breast Carcinoma, Stage IV Breast Cancer, Metastatic Breast Cancer, Breast Carcinoma, Metastatic Malignant Neoplasm in the Brain, Brain Metastases in Breast Cancer, Breast Neoplasms, Neoplasms by Site, Breast Diseases