linjc16/ctgov huggingface dataset:
Serum Interleukin 6 in Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to estimate level of IL 6 in COPD patients and its relation to COPD severity and acute exacerbation.

Detailed Description
-----------------
A detailed clinical history was be carried out for every patient. In the clinical history, duration of COPD with a history of exacerbation and treatment will be elicited. History of the presence of risk factors such as smoking, exposure to fumes (biomass), and the presence of any other chronic disease were be inquired. Thereafter, the detailed physical examination also had been carried out. Pulmonary function test was performed by master screen NO : 781040 (care fusion) Measurements were obtained for FVC,FEV1,Ratio between them, PEF,FEF25%,FEF50% ,and FEF75% (The readings for FEV1 and Ratio were the ones included in the statistical analysis as indices for obstructive pattern of respiration). Labs including Complete blood count, urea, and serum creatinine ,ESR was done for all patients Exercise capacity by six minutes' walk test. Dyspnea score by MMRC score. Health state assessment by CAT score 3- 8- Determination of IL 6 serum levels. by sandwich enzyme-linked immunosorbent assay (ELISA). The detection range (0.2 ng/L- 8ng/L)

Official Title
-----------------
Serum Interleukin 6 in Chronic Obstructive Pulmonary Disease Patients and Its Relation to Severity and Acute Exacerbation

Conditions
-----------------
Chronic Obstr Lung Disease

Intervention / Treatment
-----------------
* Diagnostic Test: interleukin 6


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients aged >40 years and <80 years, of both gender Diagnosed to have COPD according to GOLD 2019 by spirometry Given the consent for participation in the study Exclusion Criteria: 1- Any patient with systemic inflammation as Bronchial asthma, rheumatoid arthritis.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: COPD patient<br>COPD patients diagnosed based on spirometry, PFT and history | Diagnostic Test: interleukin 6<br>* assessment of serum IL-6 by ELISA<br>|
| No Intervention: Control<br>Healthy volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure level of IL-6 | using ELISA | 9 monthes |
Diagnostic Study of Biomarkers in BAL of ICU Patients With Lung Infiltrates

Study Overview
=================
Brief Summary
-----------------
The aim of this project is therefore to explore on the clinical significance of analyzing surrogate markers combined with conventional diagnostics in the ICU setting. BAL, blood and biopsy samples will be subjected to a combined analysis of GM, BDG, Aspergillus specific PCR assays in addition to conventional diagnostics (Microscopy, Culture,Histology) for ICU pts with pulmonary infiltrates. As GM and BDG are not species-specific, three established and repeatedly published species specific PCR-based assays (nested PCR, real time PCR assay, multifungal DNA Array)developed by our group will be investigated in combination with the serological tests in a multicenter prospective clinical diagnostic trial.

Official Title
-----------------
Open, Prospective, Multicenter Trial to Evaluate the Clinical Significance of Combined Serological (Galactomannan ELISA, Beta D Glucan Assay) and Molecular (Nested Aspergillus PCR Assay, Real-time qPCR Assay, Multifungal DNA Microarray) Diagnostic Assays to Detect and Characterize Fungal Pathogens in Bronchoalveolar Lavage (BAL)and Blood Samples of Intensive Care Unit Patients With Pulmonary Infiltrates

Conditions
-----------------
INvasive Aspergillosis, Mechanical Ventilation, Lung Infiltrates, Diagnostics, Biomarker

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: underlying conditions (see above) being on mechanical ventilation lung infiltrates Exclusion Criteria: immunocompetent patients (not fulfilling the criteria above)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Immunosuppressed ICU Patients with lung infiltrates<br>Immunosuppressed ICU Patients with lung infiltrates | |
| Control Group<br>BAL and blood aliquots of 20 immunocompetent pts (suffering from lung diseases) will be collected and tested identically as a control population. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of combined biomarker testing in BAL fluid in relation to diagnostic certainty | Evaluation of diagnostic accuracy of the combined biomarker approach | 6 weeks |
Alternate-Day Buprenorphine. Phase V - 6

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate buprenorphine blockade challenge.

Official Title
-----------------
Alternate-Day Buprenorphine. Phase V

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 49 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Buprenorphine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Opioid withdrawal |  |  | 
| Subjective dose estimate |  |  | 
| Drug effect characteristics: ARCI |  |  | 
| Physiological changes in: pupil diameter |  |  | 
| Physiological changes in: blood pressure |  |  | 
| Physiological changes in: heart rate |  |  | 
| Physiological changes in: respiration |  |  | 
| Physiological changes in: bup plasma levels |  |  |
Monitoring of Neoadjuvant Therapy in Locally-Advanced Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether four new alternative imaging methods can be used to follow the response of breast cancer to the treatment patients are being given. These methods produce an image of the inside of the breast so that doctors can better decide whether breast cancer is responding to therapy. An important part of the study is to examine the same person with all methods in order to directly compare results. The four methods are: MRI Elasticity Imaging (abbreviated MRE), Electrical Impedance Spectroscopy (abbreviated EIS), Microwave Imaging and Spectroscopy (abbreviated MIS), Near Infrared Spectroscopy (abbreviated NIR). In addition to the experimental imaging methods, patients may also undergo a contrast-enhanced MRI, and/or additional mammography, which will help researchers compare the experimental methods. These additional examinations are accepted diagnostic procedures; they are not experimental. Some participants will have one or both of these additional examinations if clinically indicated.

Official Title
-----------------
Monitoring of Neoadjuvant Therapy in Locally-Advanced Breast Cancer

Conditions
-----------------
Locally Advanced Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Locally advanced breast cancer, with or without metastatic disease Patient to receive systemic therapy Breast size and epithelial integrity adequate to allow alternate imaging exams. Patient able to provide written informed consent. No serious associated psychiatric illness Age ≥ 18 years old Exclusion Criteria: Cardiac pacemaker Any implanted electronic device Severe claustrophobia Allergy to the MRI contrast agent gadolinium

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

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

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 |
| --- | --- | --- |
| Objective Response | Correlate changes in each imaging modality with objective response to therapy, as defined by conventional criteria (clinical exam and conventional imaging). | at baseline, at conclusion of treatment (up to 6 months) |
An Expanded Access Study to Assess Brensocatib for Participants With Non-Cystic Fibrosis Bronchiectasis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to allow early access to brensocatib for participants with non-cystic fibrosis bronchiectasis (NCFBE) who have successfully completed the INS1007301 ASPEN Clinical trial.

Detailed Description
-----------------
Participants will receive brensocatib 10 mg, oral tablets, once daily.

Official Title
-----------------
Brensocatib in Patients With Non-Cystic Fibrosis Bronchiectasis

Conditions
-----------------
Non-Cystic Fibrosis Bronchiectasis

Intervention / Treatment
-----------------
* Drug: Brensocatib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant had agreed to provide their informed consent to participate per local requirements. Participant had successfully completed Clinical Trial INS 1007-301 ASPEN, including the End of study Visit 12 prior to receiving treatment. Requests for Post-Trial access for brensocatib had come from ASPEN investigator. Had received brensocatib treatment. Exclusion Criteria: Participant had experienced a serious adverse event deemed to be related to brensocatib during the study and required permanent participant is continuation. The participant is immunocompromised or chronically treated with any investigational or commercialized immunomodulatory agent that is directed to any component of the adaptive or innate immune systems. Note: The use of any immunomodulatory agents (including but not limited to: bortezomib, ixazomib, thalidomide, cyclophosphamide, mycophenolate, Janus kinase inhibitors, IFN-γ, and azathioprine) is prohibited during the program. The participant had undergone continuous use of high dose non-steroidal anti-inflammatory drugs. The participant had undergone chronic use of systemic steroids for any chronic condition, except steroids with topical anti-inflammatory activities (ie, oral budesonide). Participant had planned to receive live attenuated vaccines during the program (treatment must be postponed until 4 weeks after the last dose of drug). Participant had planned to use investigational drugs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Brensocatib|Brensocatib tablets|

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
-----------------
Cathepsin G, CKD-EPI, NCFBE
Effects of Dextromethorphan on Opioid Tolerance in Methadone Patients - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if addition of dextromethorphan to a stable dose of methadone in opioid dependent subjects will significantly affect physical and psychological aspects of opioid tolerance.

Official Title
-----------------
Effects of Dextromethorphan on Opioid Tolerance in Methadone Patients

Conditions
-----------------
Opioid-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: Dextromethorphan


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dextromethorphan|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
-----------------
opiate dependence
Hospital In-Patient Insulin Study

Study Overview
=================
Brief Summary
-----------------
Hyperglycaemia has been shown to increase morbidity and mortality in patients with critical illness, myocardial infarction and stroke. This study aims to look at patients with hyperglycaemia and reduce their blood sugar levels using differing combinations of subcutaneous and intravenous insulin.

Detailed Description
-----------------
This is a randomised trial involving patients with type II diabetes who are brought into the hospital with a problem other than a diabetic emergency. Patients will be included, who have a blood sugar > than 17mmols. They will be randomised to one of two groups and either given intravenous or subcutaneous insulin. Outcome measures are length of stay, glucose control and comparison of the two regimens. Cost implications will also be analysed.

Official Title
-----------------
A Randomised Study Comparing Continuous Intravenous Insulin Infusion With Subcutaneous Insulin Analogues in Hospitalised Patients With Type II Diabetes and Hyperglycaemia

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type II diabetes Blood glucose > 17mmols Exclusion Criteria: Type I diabetes Hyperosmolar non-ketotic coma (HONK) Diabetic ketoacidosis (DKA) Myocardial infarction (MI) Vomiting

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Detemir|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose control |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus
Comparison of Vasopressin and Other Pressors in Septic Shock

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the classical tactics in the treatment of septic shock (dopamine, noradrenalin and dobutamine) to the use of vasopressin as first choice pressor. Vasopressin seems to be an interesting alternative in the treatment of septic shock. To this date, available studies have showed that it could correct hyperkinetic syndrome and vasoplegia in septic shocks without noticeable side effect. It as been demonstrated that vasopressin improves renal function, as no effect on digestive organs and as no metabolic effect.

Official Title
-----------------
Comparative Prospective Study of Vasopressin and Catecholamine in Septic Shock

Conditions
-----------------
Shock, Septic

Intervention / Treatment
-----------------
* Drug: vasopressin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Legally major patient presenting a septic shock. The time window between beginning of symptoms and onset of treatment is established at 12 hours. The patient must be intubated and mechanically ventilated. Patient presenting a mean arterial blood pressure of less than 60 mm Hg after adequate fluid resuscitation (at least 1 L of colloid or crystalloid) and 10 ug/Kg/min of dopamine. Patient presenting a cardiac index of at least 3 L/min/m2 Exclusion Criteria: Shock other than septic cardiac hypokinesia a pre-existing organic renal failure that needs hemodyalisis oesophagal or gastric phatology that would lead to a naso-gastric tube contraindication

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: vasopressin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficiency of vasopressine to the standard and usual treatment of septic shock on the reverse of the hemodynamic criterion of septic shock |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare these two categories of treatment on: |  |  | 
| tonometric parameters |  |  | 
| renal function |  |  | 
| in term of tolerance: metabolic effects (increase in lactate and glycaemia), cardiac effects (tachycardia being defined as a heart rate increase of 15%), increase of cardiac enzymes (troponine, CK, CK-MB), and cutanuous vasoconstriction. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Septic shock, catecholamine, vasopressin, tonometria, lactate
Heart Failure Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to compile a large clinical database on the medical management of patients hospitalized with acute heart failure, using information collected from acute care hospitals across the United States.

Detailed Description
-----------------
ADHERE is a phase IV, multicenter, observational, open-label registry of the management of patients treated in the hospital for acute heart failure (HF) in the United States. The target population consists of patients admitted to an acute care hospital who are treated actively for acute heart failure, where acute HF is defined as new-onset HF with decompensation; or chronic HF with decompensation. Patient eligibility is based upon the presence of an acute HF diagnosis and is not tied to the use of any specific therapeutic agent or regimen. Collect data on the episode of hospital care beginning with the point of initial care in the hospital and/or emergency department and ending with the patient's discharge, transfer out of the hospital, or in-hospital death. N/A

Official Title
-----------------
ADHERE Core II - Acute Decompensated HEart Failure REgistry

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received or is eligible to receive a principal hospital discharge diagnosis of HF or decompensated HF is present as determined clinically by the patient care team Exclusion Criteria: Heart Failure is present as a co-morbid condition, but is not a principal focus of diagnosis or treatment during this hospitalization episode

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, Congestive, Registry, Acute Decompensated Heart Failure, Dyspnea