linjc16/ctgov huggingface dataset:
IV Dexketoprofen vs Placebo in Migranie Attack

Study Overview
=================
Brief Summary
-----------------
H0 hypothesis: IV dexketoprofen is equivalent to placebo in ceasing migraine attack in emergency department. H1 hypothesis: IV dexketoprofen is not equivalent (superior) to placebo in ceasing migraine attack in emergency department.

Detailed Description
-----------------
Migraine attack is one of the most leading causes presentations to emergency department. Patients with migraine attack seek urgent care to cease their pain. There are so many interventions defined in the medical literature that can be used in migraine attacks. However, as a IV drug, dexketoprofen; little known whether IV dexketoprofen is superior to placebo or not. In the present study we aimed to determine the effects of IV dexketoprofen in migraine attack in emergency department.

Official Title
-----------------
Study of Comparing Dexketoprofen to Placebo in Migraine Attack

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: Dexketoprofen
* Other: Normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients presented with headache who diagnosed as migraine attack according to the international headache society Exclusion Criteria: denied to give inform concent, illiterate patients, chronic renal failure, taking NSAIDs during the last six hours, pregnancy

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexketoprofen<br>50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion. | Drug: Dexketoprofen<br>* 50 mg intravenous arveles in 50 ml saline in 5 minutes<br>* Other names: Arveles;|
| Placebo Comparator: normal slaline<br>50 ml normal saline | Other: Normal Saline<br>* 50 ml normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale Change | Change from baseline in Visual Analogue Scale, 100 mm, at 45th minutes. Visual Analogue Scale is measurement tool scoring tool between 0 (no pain) and 100 mm (worst pain). Minimum clinically significant change in pain score is 13 or 16 mm. | 45 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Effects | The adverse effects is being recorded to the study form after the study drugs are administered at the 45th minutes. | 45th minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
migraine, emergency department, dexketoprofen, placebo
SIB-Norwegian Version, Validation and Reliability Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate and to test interrater reliability for the Norwgian version of Severe Impairment Battery (SIB).

Detailed Description
-----------------
The study will include 60 persons with mild to severe dementia. To test the validation of SIB, we will interview the included persons with Severe Impairment Battery (SIB) and compare the results with Clinical Dementia Rating (CDV)reported by their nurses. To test interrater reliability 30 of the included persons will be interviewed with SIB by two different raters, and the two raters results will be compared.

Official Title
-----------------
Severe Impairment Study - Norwegian Version. A Validation and Reliability Study.

Conditions
-----------------
Dementia, Diagnostic Tests, Routine

Intervention / Treatment
-----------------
* Behavioral: Diagnostic Screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dementia, mild to severe. Nursing Home resident Exclusion Criteria: No ability to write or read. Physical handicapped, unable to use hands.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Diagnostic Screening|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
-----------------
Severe Impairment Battery, Clinical Dementia Rating
Implementing Resistance Exercise to Reduce Frailty for Older Adult

Study Overview
=================
Brief Summary
-----------------
To develop an intervention specifically targeted for these clients who have the frailty syndrome. The Investigators propose to develop an exercise intervention that can reduce frailty in older adults to facilitate their ability to age-in-place. The long-term objective of this work is to develop a package of interventions that can be administered within the existing Medicaid Home and Community Based Services (HCBS) Waiver programs. The specific goal of this proposal is to develop a resistance exercise intervention to reduce frailty in older adults receiving long term care services in their home through the Illinois Community Care Program, a HCBS Waiver Program.

Official Title
-----------------
Implementing Resistance Exercise to Reduce Frailty for Older Adult Medicaid Waiver Recipients

Conditions
-----------------
Sarcopenia

Intervention / Treatment
-----------------
* Behavioral: Resistance exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria for Home Care Aides: - Employees of Help at Home, with one eligible client Inclusion criteria for clients: aged 65+ years receive HCA services two or more days per week English-speaking not currently participating in regular exercise as defined as 30 minutes three or more days per week, - - no health problems that contraindicate participation in exercise based on the EASY: Exercise Assessment and Screening for You Telephone Interview for Cognitive Status score > 26 Exclusion criteria for HCAs: - no clients who enroll in the study Exclusion criteria for clients: legally blind, no voluntary extremity movement physician does not provide clearance for participation classified as non-frail based on the SHARE-FI frailty testing Telephone Cognitive Status score < 25.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 100 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual Care Group | |
| Other: Intervention<br>Intervention Group | Behavioral: Resistance exercise<br>* resistance exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with frailty or pre-frailty as assessed by the SHARE-FI |  | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores of self-reported overall health as measured by the PROMIS-global health |  | 26 weeks | 
| Quadriceps muscle strength as assessed by the 30 second chair rise test |  | 26 weeks |
Novel Medication as a Potential Smoking Cessation Aid

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide preliminary information assessing if levomilnacipran may be effective at increasing smoking cessation rates.

Official Title
-----------------
Novel Medication as a Potential Smoking Cessation Aid

Conditions
-----------------
Tobacco Use Disorder

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be between 25 years old and 55 years old Smoke a minimum number of cigarettes per day Indicate motivation to quit smoking Exclusion Criteria: Current or history of medical or psychiatric conditions that could interfere with measures being studied or that could be affected by the study medication Use of medication that could interfere with measures to be studied or that could be expected to interact with levomilnacipran Are pregnant or breast feeding The investigators will evaluate if there are other reasons why someone may not be eligible to participate

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levomilnacipran<br>In the first three week period levomilnacipran is evaluated whereas in the second three week period placebo is evaluated | Drug: Levomilnacipran<br> <br> * Other names: Fetzima;Drug: Placebo<br> <br> |
| Experimental: Placebo<br>In the first three week period placebo is evaluated whereas in the second three week period levomilnacipran is evaluated | Drug: Levomilnacipran<br> <br> * Other names: Fetzima;Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Days of Confirmed Abstinence (Out of 5 Maximum) | Subjects will be asked to abstain for five consecutive days during the third week of each intervention period with the percentage of confirmed abstinence days being the primary outcome measure | 5 days |
Detecting Circulating Tumor Cells (CTCs) and Cell Free DNA (cfDNA) in Peripheral Blood of Breast Cancer (BC) Patients to Develop the Clinical Application for Early Detection and Diagnostics

Study Overview
=================
Brief Summary
-----------------
Utilization of circulating-tumor-cell (CTC) and cell free DNA (cfDNA) as novel and noninvasive tests for diagnosis confirmation, therapy selection, and cancer surveillance is a rapidly growing area of interest. In the wake of FDA approval of a liquid biopsy test, it is important for clinicians to acknowledge the obvious clinical utility of liquid biopsy for cancer management throughout the course of the disease.

Official Title
-----------------
Detecting Circulating Tumor Cells (CTCs) and Cell Free DNA (cfDNA) in Peripheral Blood of Breast Cancer (BC) Patients to Develop the Clinical Application for Early Detection and Diagnostics

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects need to sign the informed consent form and age is above 20. Control group need to have mammogram /ultrasound results category1-3 and confirmed by PI. Cancer group subjects with pathology report confirmed to be malignant have not yet done surgery or treatment will be enrolled to the malignant group for analysis Exclusion Criteria: Not willing to sign the informed consent form Have been undergone general anesthesia or regional anesthesia in 1 month Have been diagnosed with any type of cancer and been treated Have been suffering from autoimmune disorder such as SLE and RA Have been suffering from chronic infection such as IBD, pancreatitis, COPD or Interstitial pneumonia. Have been suffering from acute infection or other infectious diseases in 3 moths such as TB, pneumonia, urinary tract infection, or cellular infection Diagnosed with myelodysplastic syndrome or myeloproliferative diseases Other condition which may affect the CTC results, when determined by PI can be confirmed by other tests are if necessary

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Group<br>Mammography/ultrasonography confirmed no findings. | |
| Cancer Group<br>The biopsy result is breast cancer. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective of this study is to demonstrate that CTC assay counts can distinguish between healthy subjects and malignant breast cancer subjects, including early stage breast cancer subjects. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer. Circulating tumor cells. CTCs. Cell free DNA. cfDNA
Meta-analysis of Stannous Fluoride and the Effects on Dental Plaque

Study Overview
=================
Brief Summary
-----------------
The aim of this 18 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) dentifrices when used up to 3 months on dental plaque relative to a positive or negative control dentifrice.

Official Title
-----------------
A Review of Meta-Analyses on Bioavailable Stannous Fluoride Dentifrices: Effects on Dental Plaque

Conditions
-----------------
Dental Plaque

Intervention / Treatment
-----------------
* Drug: Stannous fluoride dentifrice
* Drug: Positive control dentifrice
* Drug: Negative control dentifrice


Participation Criteria
=================
Eligibility Criteria
-----------------
Subjects were excluded from this study for the following reasons; pregnancy, rampant caries, severe periodontitis, at discretionary of the Principal Investigator.

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 |
| --- | --- |
| Stannous Fluoride Dentifrice<br>Twice daily brushing | Drug: Stannous fluoride dentifrice<br>* Stannous fluoride (0.454%) dentifrice<br>|
| Positive control dentifrice<br>Twice daily brushing | Drug: Positive control dentifrice<br>* Positive control dentifrice containing (0.3%) triclosan.<br>|
| Negative control dentifrice<br>Twice daily brushing | Drug: Negative control dentifrice<br>* Negative control dentifrice containing either sodium fluoride (0.243%) or sodium monofluorophosphate (0.76%)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental Plaque Scores | Change from baseline as measured by mean plaque score reduction from baseline (via Quigley-Hein, Turesky Modification Index or Rustogi Modification of the Navy Plaque index). | Up to 12 weeks |
Prosthetic Valve Sweing Ring Injection by Antiboitics Can Affect the Rate of Postoperative Infective Endocarditis?

Study Overview
=================
Brief Summary
-----------------
Follow-up of patients undergoing cardiac valve replacements with prosthetic valve after injection of sewing ring of prosthetic valve with aminoglycoside for prevention of infective endocarditis.

Official Title
-----------------
Prosthetic Valve Sweing Ring Injection by Antiboitics Can Affect the Rate of Postoperative Infective Endocarditis?

Conditions
-----------------
Prosthetic Valve Endocarditis

Intervention / Treatment
-----------------
* Drug: Aminoglycoside


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who need cardiac valve replacement for rheumatic or degenerative causes Exclusion Criteria: Patients undergoing open heart surgery for any cause other than valve replacement patients who are younger than 20 years old. Patients undergoing valve repair.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 undergoing Cardiac valve replacement<br> | Drug: Aminoglycoside<br>* injection of sewing ring of prosthetic valve with aminoglycoside<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients diagnosed with Infective endocarditis post valve replacement | percentage of post operative clinical and echocardiographic diagnosis of infective endocarditis on prosthetic valve | 6 months post operative |
Association Between Non-alcoholic Fatty Liver Disease (NAFLD) and Coronary Artery Calcification

Study Overview
=================
Brief Summary
-----------------
Coronary artery disease are 8 times more prevalent in patients with NAFLD then the general population and are being considered the most common cause of death. Cardiac CT is a reliable non invasive method in demonstrating Coronary Plaques. However the association between coronary artery calcium score (CAC) and NAFLD remains controversial

Detailed Description
-----------------
Coronary artery disease are 8 times more prevalent in patients with NAFLD that the general population and are being considered the most common cause of death. Cardiac CT is a reliable non invasive method in demonstrating Coronary Plaques. However the association between coronary artery calcium score (CAC) and NAFLD remains controversial. AIM: the aim is to evaluate the association between CAC score ( CT) and NAFLD (CT). the working hypothesis is that Beside the traditional risk factors including age, diabetes, NAFLD is also associated with moderate to high risk of CAD.

Official Title
-----------------
Association Between NAFLD and Coronary Artery Calcification

Conditions
-----------------
Coronary Artery Calcification

Intervention / Treatment
-----------------
* Procedure: CT Cardiac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who will undergo cardiac CT for patients with low to intermediate risk for CAD Exclusion Criteria: Patients with PCI or CABG will be excluded

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: CT cardiac<br>the patient will undergo cardiac CT | Procedure: CT Cardiac<br>* the patient will undergo cardiac CT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total calcium score measurement | total calcium score will be measured | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NAFLD, Calcium score, Liver Fat, Visceral fat, excessive visceral fat, excessive liver fat accumulation, Biomarkers of insulin resistance (HOMA), inflammation (CRP) and (MDA-Paraoxonase)
Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

Study Overview
=================
Brief Summary
-----------------
The effect of haematopoietic growth factors on neutrophil recovery after allogeneic bone marrow transplantation is well recognized. Recent laboratory studies demonstrated that these cytokines may also modify T-cell and dendritic cell function, but whether the effect is strong enough to alter the risk of graft-versus-host disease (GvHD) is unclear. The aim of this randomised study is to determine the effect of granulocyte colony-stimulating factor [G-CSF] (Neupogen; filgrastim) on the risk of acute GvHD after allogeneic bone marrow transplantation.

Official Title
-----------------
Randomized Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

Conditions
-----------------
Graft vs Host Disease

Intervention / Treatment
-----------------
* Drug: filgrastim


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: > 16 years and < 46 years Geno-identical allogeneic bone marrow transplantation Myeloablative conditioning regimen Haematological malignancies and acquired aplastic anemia Written and informed consent Exclusion Criteria: ECOG performance score > 2 T-cell depletion Serum creatinine level > 133 µmol/L Abnormal liver function Positive HIV test Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: filgrastim|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
-----------------
Granulocyte colony stimulating factor
Inhaled Treprostinil for PAH: Open-label Extension

Study Overview
=================
Brief Summary
-----------------
Open-label extension of RIN-PH-302.

Official Title
-----------------
Inhaled Treprostinil in Subjects With Pulmonary Arterial Hypertension: An Open-Label, Phase III, International, Multi-Center Study

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: inhaled treprostinil


Participation Criteria
=================
Eligibility Criteria
-----------------
Participation and completion of all required visits for study RIN-PH-302.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: inhaled treprostinil<br> | Drug: inhaled treprostinil<br>* 0.6mg/mL inhalation solution, up to 12 breaths four times a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term safety of inhaled treprostinil |  | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-minute walk distance |  | up to 5 years |