linjc16/ctgov huggingface dataset:
Nutrition-Focused Quality Improvement Program (QIP) Among Community Dwelling Malnourished Patients

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the malnutrition prevalence of Colombian community-dwelling adults and evaluate the feasibility of a nutrition-focused QIP implemented in a Colombian ambulatory care facility on healthcare utilization.

Official Title
-----------------
Assessing Malnutrition Prevalence and Impact of a Nutrition-Focused Quality Improvement Program (QIP) Among Community-Dwelling Malnourished Colombian Patients Receiving Care in an Ambulatory Health Clinic

Conditions
-----------------
Malnutrition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is screened as being malnourished or at risk for malnutrition Patient can consumer beverages and food orally Patients have a life expectancy of equal or greater than 90 days Patient is literate and willing to voluntarily sign and date an Informed Consent Form (ICF) after it is explained Exclusion Criteria: Patient is pregnant Patient is intubated, receiving tube feeding or parenteral nutrition Patient has severe dementia, delirium or history of significant psychiatric disorder and no dedicated caregiver who could assure their compliance with QIP study requirements and help with the completion of QIP study materials Any other disorder that may interfere with QIP product consumption or compliance with QIP protocol procedures Patient has an allergy or intolerance to any of the ONS ingredients Patients does not want to participate or sign ICF Patient is bedridden or confined in a wheelchair

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Historical Control Group<br>Retrospective chart review | |
| Prospective QIP Group<br>Participants that meet eligibility criteria will be prospectively enrolled into QIP including malnutrition screening, nutrition consultation, expedited provision of oral nutritional supplementation (ONS) and encouragement of ONS consumption. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Malnutrition | Measured by the Mini Nutritional Assessment (MNA®) a maximum 30 point scale resulting in a single Malnutrition Indicator Score where lower number indicates malnutrition | Change from Baseline to Week 10 post-QIP enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare Resource Utilization | Chart Review | 10-weeks follow-up period post enrollment from ambulatory care facility |
Infraorbital Nerve Involvement on Magnetic Resonance Imaging in European Patients With IgG4-related Ophthalmic Disease

Study Overview
=================
Brief Summary
-----------------
Systematic medical chart and imaging files review of patients presenting with non-lymphoma, non-thyroid-related orbital inflammation. The review aims at comparing the frequency of MRI infra-orbital nerve enlargement, between patients diagnosed with an IgG4-related ophthalmic disease (IgG4-ROD) and other patients.

Conditions
-----------------
Orbital Inflammation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient suffering from acute orbital inflammation Exclusion Criteria: Thyroid disease Lymphoma

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 |
| --- | --- | --- |
| Infra-orbital nerve enlargement on orbital MRI |  | Within 1 week following diagnosis |
Prevalence, Risk Factors and Complications of Oropharyngeal Dysphagia in Stroke Patients

Study Overview
=================
Brief Summary
-----------------
Oropharyngeal dysphagia (OD) is a common morbidity after stroke that disrupts swallowing physiology. The investigators aimed at evaluating the prevalence of oropharyngeal dysphagia (OD) after stroke and analysing the risk factors and associated complications.

Official Title
-----------------
Prevalence, Risk Factors and Complications of Oropharyngeal Dysphagia in Stroke Patients

Conditions
-----------------
Deglutition Disorders

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to hospital with confirmed stroke diagnosis; signed informed consent Exclusion Criteria: previous diagnosis of OD; transient ischemic attack; and being transferred from another hospital.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dysphagia<br>Patients with stroke associated dysphagia | Other: No intervention<br>* No intervention<br>|
| No dysphagia<br>Patients without stroke associated dysphagia | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | OD mortality rates has been assessed | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke
Bariatric Surgery and Pharmacokinetics of Amlodipine

Study Overview
=================
Brief Summary
-----------------
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study we investigate the pharmacokinetic effects of bariatric surgery on amlodipine.

Official Title
-----------------
Bariatric Surgery and Pharmacokinetics Amlodipine: BAR-MEDS Amlodipine

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Drug: Amlodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway Being a Norwegian citizen Exclusion Criteria: Having previously undergone resections in the GI-tract

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Amlodipine|Patients are tested for their normal prescription amlodipine medication|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amlodipine concentration in blood serum (area under curve (AUC)) |  | From baseline to 1 year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Gastrointestinal tract, Biological availability, Pharmacokinetics, Amlodipine
DatScan With Prototype Collimator

Study Overview
=================
Brief Summary
-----------------
A collimator is an accessory to a SPECT/CT scanner. It can be compared to a camera lens or filter that enhances or improves photos. The prototype collimators are able to magnify target organs about four times compared to the current collimators. In this study we are validating a new collimator design, which will allow for quantitative measurement of dopamine receptors within the brain, not previously performed using a single photon gamma camera.

Detailed Description
-----------------
Previously PET/CT has been used for this measurement but the L-DOPA is not FDA approved and thus of limited availability. DatScan (I123 ioflupane) is an FDA approved and clinically indicated biomarker, which has a high binding affinity for presynaptic dopamine transporters (DAT) in the brains of mammals, in particular the striatal region of the brain. A feature of Parkinson's disease is a marked reduction in dopaminergic neurons in the striatal region. By introducing an agent that binds to the dopamine transporters a quantitative measure and spatial distribution of the transporters can be obtained. The use of SPECT/CT (with the new validated collimators) and the FDA approved DATScan biomarker would allow for readily available diagnosis of Parkinson's disease

Official Title
-----------------
Investigating the Use of Siemens Prototype UHRSZ Collimator for Imaging DatScan SPECT/CT Imaging

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

Intervention / Treatment
-----------------
* Device: Prototype UHRSZ (UltraHigh Resolution Smart Zoom) Collimator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients referred Exclusion Criteria: anyone who wishes to not participate and cannot lay on the table for an additional 30 minutes.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Prototype UHRSZ (UltraHigh Resolution Smart Zoom) Collimator|In DATScan SPECT scans, the UHRSZ collimator will be exchanged for the standard collimator following completion of the clinically ordered scan. A scanning sequence will be repeated with the prototype collimator in place. Images from the two scanning sequences will be compared.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparing images with prototype collimator to clinical images |  | baseline |
Application of Ectoine Nasal Spray in Comparison With Cromolyn Sodium Containing Nasal Spray in Patients With Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
This is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of Ectoin Allergy Nasal Spray. In addition the effectiveness and safety shall be compared to a Cromoglycid acid containing nasal spray. The patient applies Ectoin Allergy Nasal Spray or Cromoglycid acid containing nasal spray according to the instructions for use. The observation takes place over a period of 14 days. Response to treatment is recorded at day 7 and day 14 by the physician and by the patient in a dairy at defined time intervalls.

Official Title
-----------------
Non Interventional, Open Label Trial of Ectoine Containing Nasal Spray in Comparison With Cromoglycic Acid Containing Nasal Spray in Patients With Allergic Rhinitis

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

Intervention / Treatment
-----------------
* Other: Medica device, drug-like


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female or male individuals ≥ 18 years Patients with proven Allergic Rhinitis which are treated with Ectoin Nasal Spray or -Cromoglycic acid nasal Spray during the observational period Exclusion Criteria: Contra indications according to the label

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ectoin group<br>Ectoin Allergy Nasal Spray | Other: Medica device, drug-like<br>* Ectoin (R) Allergy Nasal Spray<br>|
| Cromolyn group<br>Cromolyn sodium | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in combined nasal symptom Score | The change in the sum of the three different parameters nasal congestion, rhinorrhea and nasal errhine were investigated as combined score. | Time Frame: day 1, day 7, day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's and physician's judgment of efficacy | Patient and physician were asked to grade the efficacy of the treatment on a scale from 0 to 8. | Day 7 and 14 | 
| Eye itching score, |  | Day 1, 7, 14 | 
| Epiphora score |  | Day1, Day 7 and Day 14 | 
| Conjunctivitis score, |  | Day 1, Day 7 Day 10 | 
| Palatal itching score |  | Day 1, Day 7, Day 14 | 
| Nasal muscle hyperplasia score |  | Day 1, Day 7 and Day 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic Rhinitis, Ectoine, bitop
Physical Status of OSA Patients

Study Overview
=================
Brief Summary
-----------------
To investigate the differences in postural stability, anxiety/depression, and quality of life of the patients according to the severity of Obstructive Sleep Apnea Syndrome.

Official Title
-----------------
Examination of Postural Stability, Quality of Life, Depression in Patients With Obstructive Sleep Apnea Syndrome

Conditions
-----------------
Obstructive Sleep Apnea Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: Evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old. Getting a diagnosis of OSAS with polysomnography. Agree to participate in the study. Exclusion Criteria: Having respiratory system disease (COPD, asthma, bronchiectasis, lung cancer, etc.). Sedative, hypnotic drug intake. Use of medical supplements such as diazepam. Hypothyroidism, acromegaly. Diagnosis of a psychiatric illness. Uncontrolled arrhythmia causing symptoms or hemodynamic impairment. Pulmonary edema. Pregnancy.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No-Mild Severity OSAS<br>Mild sleep apnea: An Apnea-Hypopnea Index (AHI) of five to 14 events per hour. | Diagnostic Test: Evaluation<br>* To examine the differences in postural stability, anxiety/depression, and quality of life of the patients according to the severity of Obstructive Sleep Apnea Syndrome.<br>|
| Moderate to Severe OSAS<br>Moderate sleep apnea: An Apnea-Hypopnea Index (AHI) of 15 to 29 events per hour.Severe sleep apnea: An Apnea-Hypopnea Index (AHI) of 30 or more events per hour. | Diagnostic Test: Evaluation<br>* To examine the differences in postural stability, anxiety/depression, and quality of life of the patients according to the severity of Obstructive Sleep Apnea Syndrome.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postural stability | The 30 Seconds Sit to Stand Test is a method used to measure the lower extremity muscle strength and postural stability. | Day 1. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety and depression | The Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed to determine the risk levels of patients in terms of anxiety and depression. HADS consists of two subscales, one measuring anxiety, with seven items, and another measuring depression, with seven items, which score separately. Those with a score of 10 and above for the anxiety subscale and those with a score of 7 and above for the depression subscale are defined as high-risk patients. | Day 1. |
Clinical Value of G-EYE Colonoscopy in Daily Practice for Adenoma Detection and Time for Polyp Removal

Study Overview
=================
Brief Summary
-----------------
Colonoscopy parameters will be compared before the introduction of the G-EYE endoscope and after the introduction of the G-EYE endoscope

Detailed Description
-----------------
Colonoscopy parameters such as demographics, findings and procedural times will be compared before the introduction of the G-EYE endoscope and after the introduction of the G-EYE endoscope

Official Title
-----------------
Clinical Value of G-EYE Colonoscopy in Daily Practice for Adenoma Detection and Time for Polyp Removal

Conditions
-----------------
Adenoma, Colo-rectal Cancer

Intervention / Treatment
-----------------
* Device: Standard Colonoscopy
* Device: G-EYE Colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Indication for screening or surveillance colonoscopy based on the German guideline for colon cancer screening Exclusion Criteria: Emergency procedure Patients with known inflammatory bowel diseases Patients with hereditary cancer syndromes Patients with acute colonic inflammation (e.g. diverticulitis, ischemic colitis) Patients after radiation of the abdomen or pelvis Patients with colonic surgery (except appendectomy) Patients with incomplete colonoscopy Patients with insufficient bowel preparation
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 |
| --- | --- |
| Standard Colonoscopy<br>Colonoscopy with a standard colonoscope | Device: Standard Colonoscopy<br>* Colonoscopy with a standard colonoscope<br>|
| G-EYE® Colonoscopy<br>Colonoscopy with a G-EYE Colonoscopy | Device: G-EYE Colonoscopy<br>* Colonoscopy with a G-EYE Colonoscope<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate - measured by adenoma detection rate (% subjects having at least 1 adenoma) | G-EYE® colonoscopy adenoma detection rate compared to adenoma detection rate of standard colonoscopy | February 2021 | 
| Effectiveness of intervention - measured by polyp removal time (mm:ss) | G-EYE® colonoscopy polyp removal time compared to polyp removal time of standard colonoscopy | February 2021 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adenoma, Colorectal Cancer
Growth of Infants Fed an Elemental Medical Food

Study Overview
=================
Brief Summary
-----------------
Effects on weight will be monitored in healthy infant subjects consuming assigned infant formulas.

Official Title
-----------------
Growth of Infants Fed an Elemental Medical Food

Conditions
-----------------
Healthy Infants

Intervention / Treatment
-----------------
* Other: Control Study Formula
* Other: Experimental Study Formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton, healthy infant Gestational age of 37 to 42 weeks Birth weight of 2500 grams or greater Age between birth and 9 days of age Parents agree to not administer mineral or vitamin supplements during the study period Parents agree to feed study formula exclusively for the duration of the study Exclusion Criteria: Maternal, fetal or perinatal history which may have adverse effects on growth Multiple birth

Ages Eligible for Study
-----------------
Maximum Age: 9 Days

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Study Formula<br>protein hydrolysate formula | Other: Control Study Formula<br>* feed as lib<br>* Other names: Nutramigen;|
| Experimental: Experimental Study Formula<br>free-amino acid-based medical food | Other: Experimental Study Formula<br>* feed as lib<br>* Other names: EleCare;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | weight gain during the study period | 14 days of age to 112 days of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric Measurements | length, head circumference, and length gain | 14 days of age to 112 days of age | 
| GI Tolerance | daily stool number, stool consistency, formula intake | At visits 14 and 28 | 
| Lab Measurement | serum albumin | At 112 day visit |