linjc16/ctgov huggingface dataset:
Nutritional Prognostic Factors in ALS

Study Overview
=================
Brief Summary
-----------------
Background. Several nutritional factors have been evaluated as prognostic factors for survival in ALS patients at earlier stages of the disease [body mass index (BMI), body composition expressed as fat free mass (FFM), fat mass (FM), phase angle (PhA), low-density lipoprotein/high-density lipoprotein (LDL/HDL) ratio, cholesterol levels], while only two studies have evaluated some of these parameters after PEG placement. Aim. BMI and cholesterol levels were evaluated as prognostic factors for survival after percutaneous endoscopic gastrostomy (PEG) placement Moreover, the relationship between body composition and BMI in a subgroup of ALS patients was evaluated.

Detailed Description
-----------------
Methods. Nutritional and neurological parameters were assessed at the time of PEG placement (T0) in 47 consecutive patients. Body composition and PhA were measured in only 22 patients within 2 months from T0. Survival was calculated as the time from the PEG placement to tracheostomy or death.

Official Title
-----------------
Nutritional Prognostic Factors in Patients With Amyotrophic Lateral Sclerosis and Percutaneous Endoscopic Gastrostomy

Conditions
-----------------
Nutritional Deficiency, Neuro-Degenerative Disease, Gastrostomy

Intervention / Treatment
-----------------
* Other: Nutritional assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ALS patients who underwent PEG tube placement from 2006 to 2015 and were referred to the artificial nutrition team of the Gastroenterology Unit Exclusion Criteria: ALS patients without PEG
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Nutritional assessment|BMI and cholesterol levels evaluation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nutritional assessment | Weight and height (combined to report BMI in kg/m^2) | at the time of PEG placement (one day) | 
| biochemical nutritional assessment | cholesterol levels | only at the time of PEG placement (one day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body composition assessment | Evaluation of fat mass and fat free mass | within 2 months from the PEG implantation (one day) |
Frequency Analysis of Carotid Artery Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if carotid artery stenosis can be detected using an electronic stethoscope. This study will use a commercially available electronic stethoscope to record carotid sounds in patients with suspected carotid artery stenosis. The presence of absence of abnormal vessels will be confirmed by diagnostic ultrasound as part of normal patient care at this institution.

Official Title
-----------------
A Single-centered Investigation Into the Frequency Domain Patterns in the Carotid Vessel in Patients With Suspected Stenosis

Conditions
-----------------
Carotid Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 40-80 Indicated for diagnostic ultrasound related to carotid artery stenosis Exclusion Criteria: Pregnant women Prior carotid intervention

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diagnosis, carotid, artery, disease, auscultation, sound
A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the administration of the study drug is effective in increasing the chance of survival in patients with severe sepsis. Patients entered into this study will be randomly assigned to one of two treatment groups. Patients in each treatment group will be given either the study drug or placebo as a continuous infusion directly into the bloodstream through a catheter placed in one of the patient's veins. The study drug is an investigational drug that is still in development. It has been studied in approximately 30 healthy subjects, approximately 30 patients with either kidney failure or arthritis, and approximately 600 patients with severe sepsis. Patient participation in this study will last for about one month.

Official Title
-----------------
A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Drug: sPLA2 Inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must show evidence of acute infection meet specified time windows be 18 years of age or older Exclusion Criteria: Patients must not have low white blood cell count have undergone certain organ transplants be HIV positive be pregnant or breast feeding have severe underlying medical problems

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sPLA2 Inhibitor|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
-----------------
Sepsis, sPLA2 Inhibitor
Pilot Study: Hypovitaminosis D, Hyperparathyroidism and Hypomagnesemia in Patients With Congestive Heart Failure

Study Overview
=================
Brief Summary
-----------------
People with heart failure may have low magnesium and low vitamin D levels. They may also have abnormally high levels of parathyroid hormones. Magnesium and vitamin D are important chemicals that are not routinely measured in blood tests. We are studying how many people with heart failure have low levels of magnesium and vitamin D. We are also studying how many people with heart failure have overactive parathyroid glands and if that is related to their vitamin D levels.

Detailed Description
-----------------
This is a single-encounter crossectional prevalence study in which demographic information, health opinion surveys and labwork are all obtained at one visit. There are no follow up visits, however, if abnormal lab results are discovered, participants will be notified via US mail.

Official Title
-----------------
Pilot Study: Hypovitaminosis D, Hyperparathyroidism and Hypomagnesemia in Patients With Congestive Heart Failure

Conditions
-----------------
Congestive Heart Failure, Hypovitaminosis D, Hyperparathyroidism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: congestive heart failure Exclusion Criteria: pregnant hospitalized within one month taking calcium, vitamin D or magnesium supplements proteinuria > 1g/24h creatinine clearance <35 (MDRD)

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 |
| --- | --- | --- |
| Prevalence of hypovitaminosis D, Hyperparathyroidism, Hypomagnesemia in our cohort of CHF patients |  | One year |
Anastrozole Administration in Elderly Hypogonadal Men

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the effects of sustained aromatase inhibitor therapy to reduce estrogen levels in elderly men with mild hypogonadism (a decreased level of sex hormones).

Detailed Description
-----------------
It has long been accepted that aging in men is associated with a slow, steady decline in gonadal androgen (male sex hormone) production. Several studies have explored androgen replacement, but the safety and efficacy of testosterone administration remains controversial. Aromatase inhibitors may provide a particularly useful way to restore normal androgen production in aging men. This study will recruit 150 male volunteers, 60 years of age or older, to be randomized to receive either anastrozole or a placebo for 24 months. Six visits are planned over the 96-week treatment period.

Official Title
-----------------
Anastrozole Administration in Elderly Hypogonadal Men

Conditions
-----------------
Hypogonadism

Intervention / Treatment
-----------------
* Drug: anastrozole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men ages 60 and older Serum testosterone between 150-300 ng/dL Symptoms suggestive of androgen deficiency

Ages Eligible for Study
-----------------
Minimum Age: 60 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anastrozole<br>anastrozole | Drug: anastrozole<br>* 1 mg QD<br>* Other names: arimidex;|
| Placebo Comparator: placebo<br>placebo | Drug: anastrozole<br>* 1 mg QD<br>* Other names: arimidex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lean Body Mass |  | Baseline and 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aging
A Study of the Safety and Efficacy of Tofimilast in Adult Asthmatics

Study Overview
=================
Brief Summary
-----------------
This is an initial proof of concept, phase to study to assess the safety and efficacy tofimilast for the chronic maintenance treatment of adults with persistent asthma

Official Title
-----------------
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Six-Week Study Of The Efficacy And Safety Of Tofimilast Dry Powder For Inhalation In Adults With Persistent Asthma

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

Intervention / Treatment
-----------------
* Drug: Tofimilast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild to moderate persistent asthma (NAEPP/GINA Step 2-3) Reversibility to albuterol at least 12% and 200 mL Exclusion Criteria: Any significant co-morbid disease, particularly cardiovascular Use of any maintenance therapy except short acting bronchodilators Smoking history > or = 10 years

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: Tofimilast|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in FEV1 compared to placebo |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in other lung function parameters, disease control and quality of life compared to placebo |  |  |
To Demonstrate the Relative Bioequivalency of Comparing Single 100 mg Doses Of Cord's 50 mg Desipramine HCL Tablets To Merrell Dow's 50 mg Norpramin Tablets

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioequivalency of comparing single 100 mg doses Of Cord's 50 mg Desipramine Hcl tablets to Merrell Dow's 50 mg Norpramin tablets.

Official Title
-----------------
A Two-Way Crossover Bioequivalency Study Comparing Single 100 mg Doses Of Cord's 50 mg Desipramine HCL Tablets To Merrell Dow's 50 mg Norpramin Tablets

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: Desipramine HCl 50 mg Tablets Cord Laboratories
* Drug: Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, Inc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Desipramine HCl 50 mg Tablets Cord Laboratories | Drug: Desipramine HCl 50 mg Tablets Cord Laboratories<br> <br> |
| Active Comparator: 2<br>Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, Inc | Drug: Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, Inc<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antidepressant
Facilitated Referral for Children Screening Positive for Mental Illness

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out how prevalent unidentified Mental Health issues are in the pediatric population that visits the Emergency Department in an urban city.

Detailed Description
-----------------
The purpose of this research study is to find out how many children in the Emergency Room have emotional issues and how many of them go unnoticed. In particular the study looks at how well a questionnaire for children and teenagers, the DISC Predictive Scales, Version IV (DPS-IV) works and what is the best way to ask the questions. In addition, for children aged 9-17 this study will look at families' readiness to seek care when a problem is indicated.

Official Title
-----------------
Facilitated Referral for Children Screening Positive for Mental Illness in the Pediatric Emergency Department and Readiness to Seek Care

Conditions
-----------------
Mental Disorders, Mentally Ill Persons, Emergency Medicine

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child Must be With Biological Mother Child Presenting to Emergency Department with an Urgent But Stable condition Child must be between the ages of 6 years and 18 years Child must have no prior history of Behavioral Health concerns or diagnoses Exclusion Criteria: Child has prior Behavioral Health history, diagnosis, or concerns Child not between ages of 6 years and 18 years of ages Child presenting without Biological Mother present Child acuity level outside of Urgent But Stable for presenting complaints

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 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 |
| --- | --- |
| positive screen, negative screen<br>Positive screens are those who received positive feedback regarding their answers to a mental illness screening assessment. Negative screens received feedback stating that they did not screen positive for any mental illness. | |

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
-----------------
Mental Disorders, Mentally Ill Persons, Emergency Medicine, Emergency Department, Screening
Clinical Epidemiology and Characteristics Of Covid-19 Cases Occurred In A Lymphoma Setting In The First Epidemic Phase (LymphoCov1)

Study Overview
=================
Brief Summary
-----------------
The main objective of this retrospective clinical epidemiology study is to describe the characteristics of Covid-19 cases requiring hospitalization in adult patients with lymphomas during the initial phase of the epidemic (from 01/03/20 to 30/04/20). The specific objectives are to estimate the frequency of severe forms of Covid-19 and those requiring intensive care hospitalisation, as well as the mortality related to the epidemic among the active file of patients followed for lymphoma at each study site, to investigate whether certain chemotherapy and/or immunotherapy treatments seem to be associated with severe forms or prolonged evolutions of Covid-19, to describe possible atypical clinical forms among the population of patients treated for lymphoma. Translated with www.DeepL.com/Translator (free version)

Detailed Description
-----------------
I Methods : Multicentric retrospective observational epidemiological study based on the collection of data from patient records. Selection of voluntary hospital sites in regions with excess mortality during the epidemic phase. Systematic identification of Covid-19 cases from coding data (PMSI) from the medical information departments which will be compared with the numbers of patients followed for lymphoma in the haematology departments of each site during the 6 months preceding the epidemic, identified through the PMSI. Establishment of an ad hoc CRF for cases only with collection of clinical data concerning lymphoma and Covid-19 and routine biological data: Cytopenia (and in particular depth of lymphopenia), hypogammaglobulinemia, inflammatory markers. Estimated total number of sites: 10-15 and number of cases to be collected: 50-60. Translated with www.DeepL.com/Translator (free version)

Official Title
-----------------
Épidémiologie Clinique et caractéristiques Des Cas de Covid-19 Survenus Dans un Contexte de Lymphome Lors de la première Phase épidémique

Conditions
-----------------
COVID, Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at least 18 years of age with lymphoma and a diagnosis of Covid-19 requiring hospitalization. In order not to bias the data by excluding patients with adverse outcomes, we will also collect data from deceased patients. Exclusion Criteria: Patients who refused to participate -

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 |
| --- | --- | --- |
| mortality |  | 2 months | 
| transfer to ICU |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
covid, lymphoma, epidemiology
SNIF (Sniff Nasal Inspiratory Force) Reference Values Of Mediterranean Population

Study Overview
=================
Brief Summary
-----------------
SNIF test has been described as a method to explore the diaphragmatic function. But there are no defined the reference values of this test in healthy population. The investigators' hypothesis is that there is a variation on SNIF values in Mediterranean population depending on gender, age and anthropometric variables such as height and weight. The investigators will analyze 1000 SNIF test of healthy people. The investigators will divide in 5 groups of age (20-30, 30-40, 40-50, 50-60, 60-70) and in each group the investigators will study 100 men and 100 women. All the subjects will perform a forced spirometry, maximal inspiratory pressure (MIP) and SNIF. If spirometry and MIP are correct the investigators will consider that person has a correct diaphragmatic function and strength. Then the investigators will measure the SNIF test. With all of these SNIF values the investigators will try to achieve the reference values of this test in the different groups of age in Mediterranean population. And the investigators will compare SNIF with MIP. Cross multicentric study. Hospitals involved: Hospital de Bellvitge, Hospital del Mar, Hospital Parc Taulí, Hospital de la Santa Creu i Sant Pau (coordinator center) and Hospital de la Vall d'Hebrón.

Official Title
-----------------
SNIF (Sniff Nasal Inspiratory Force) REFERENCE VALUES OF MEDITERRANEAN POPULATION.

Conditions
-----------------
Healthy People Programs

Intervention / Treatment
-----------------
* Other: SNIF test (Sniff Nasal Inspiratory Force)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy people with spirometry and MIP values in the reference range Age between 20 and 70 years old Caucasian race Exclusion Criteria: Rhinitis Nasal obstruction Frequent episodes of epistaxis Ongoing cold

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| Healthy population<br> | Other: SNIF test (Sniff Nasal Inspiratory Force)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SNIF test | Main objectives: To define the SNIF reference values in a healthy Mediterranean population. Analyze the influence of different variables such as gender, age, height and weight on this measure. | Basal |