linjc16/ctgov huggingface dataset:
Comorbidities and Healthcare Utilisation: Indicators for Improving COPD Diagnosis

Study Overview
=================
Brief Summary
-----------------
To characterise and understand the current UK COPD population including demographics, active comorbidities and missed opportunities for COPD diagnosis in the years previous to diagnosis

Detailed Description
-----------------
Using real-world primary care clinical databases, ascertain whether 1) trends in respiratory resource utilisation prior to COPD diagnosis (including lower respiratory tract infections [LRTIs], consultations and hospitalisations) could be used as 'flags' to aid earlier diagnosis, and 2) characterize comorbid conditions present at the time of COPD diagnosis, and evaluate the relationship to COPD disease severity and age at diagnosis.

Official Title
-----------------
Improving Diagnosis of COPD Through Characterisation of Comorbidities Present at, and Healthcare Utilisation Prior to, Diagnosis of COPD in UK. A Retrospective Primary Care Database.

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 40 years or older Electronically coded diagnosis of COPD made between 1990 and 2009 A minimum of three years continuous practice data including two years prior to and one year post diagnosis to ensure patients recieved COPD therapy post diagnosis Recieved two or more prescriptions for COPD therapies in the 12 months post diagnosis year 1. Exclusion Criteria: Aged less than 40 years No diagnosis of COPD between 1990 and 2009 Less than three years continuous practice data including two years prior to and one year post diagnosis Less than two prescriptions for COPD therapies in the 12 months post diagnosis year 1.

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Chronic Obstructive Pulmonary Disease<br>All patients with a coded diagnosis of COPD entered into their electronic clinical record between 1990 and 2009. | |

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, Primary Care, Comorbidities, Healthcare utilisation
Antimicrobial Resistance Rate In Escherichia Coli And Klebsiella Pneumonia : A Retrospective Study

Study Overview
=================
Brief Summary
-----------------
Antibiotics are medicines used to avoid and treat bacterial infections. Antibiotic resistance is increasing to dangerous level globally.

Detailed Description
-----------------
Antibiotics resistance is a global health problem.

Official Title
-----------------
Antimicrobial Resistance Rate In Escherichia Coli And Klebsiella Pneumonia : A Retrospective Study

Conditions
-----------------
Antibiotic Reaction

Intervention / Treatment
-----------------
* Diagnostic Test: urine culture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with UTI patients with dysuria patients with loin pain Exclusion Criteria: patients with surgery patients with cancer

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 88 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: urine culture|urine culture and antibiotic susceptibility test|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urine culture results | type of bacterial strain was isolated | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antibiotics, urine, resistance
Perioperative Management of Patients With Cardiac Implantable Electronic Devices

Study Overview
=================
Brief Summary
-----------------
Data on the perioperative management of patients cardiac implantable electronic devices (CIEDs) is limited and published guidelines rely mainly on the experience of the cardiologists and anesthesiologists who manage these patients. Depending on the device type and patient's dependency, these guidelines recommend the intraoperative magnet use, reprogramming of devices or no action. Magnet placement on a CIED (very simple and applicable method) has become the standard approach in many centers, while CIED reprograming by trained personnel is required in most centers. Therefore, our objective is to compare in a prospective randomized clinical trial the safety of intraoperative magnet use vs. CIEDS reprogramming vs. no intervention (in the appropriate subjects)

Official Title
-----------------
Perioperative MAnaGement of patieNts With Cardiac Implantable Electronic Devices: Randomized Controlled Pilot Trial (MAGNET Trial)

Conditions
-----------------
CARDIAC PACEMAKERS DEFIBRILLATOR ELECTROMAGNETIC

Intervention / Treatment
-----------------
* Device: MAGNET APPLICATION
* Device: REPROGRAMING
* Device: NO ACTION


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects with cardiac implanted electronic device (CIED) who are candidates of non-cardio-thoracic surgery or endoscopy and anticipated use of electrocautery Exclusion Criteria: Recent CIED implantation (less than 6 weeks) Subjects with ICD who are pacemaker dependent Cardio - thoracic surgery Surgery over the CIED site Surgery site that preclude use of magnet in efficient way Subjects with Implanted unipolar leads

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MAGNET<br>magnet application over cardiac device | Device: MAGNET APPLICATION<br> <br> |
| Active Comparator: REPROGRAMING<br>reprograming of cardiac device by trained technician/electrophysiologist | Device: REPROGRAMING<br> <br> |
| Active Comparator: NO ACTION<br>no action is performed if patient meets inclusion criteria | Device: NO ACTION<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any inappropriate sensing of EMI caused by electrocautery. |  | DURING SURGERY/PROCEDURE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any significant change in CIEDS parameters |  | WITHIN 1 DAY OF SURGERY/PROCEDURE |
PsoVac: Educational Needs re Vaccines for Biologic Patients With Psoriasis

Study Overview
=================
Brief Summary
-----------------
To determine if there is a need for further education on vaccines with psoriasis patients who are on a biologic. In regards to the COVID-19, it is important that psoriasis patients - whether on a biologic or not - understand whether they can have certain vaccines. That will depend on the type of vaccine that becomes available.

Official Title
-----------------
PsoVac: A Psoriatic Patient-based Survey on the Understanding of the Use of Vaccines While on Biologics During the Covid-19 Pandemic

Conditions
-----------------
Psoriasis, Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: psoriasis patient Exclusion Criteria: no exclusions
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Psoriasis patients treated with non-biologic | |
| Non-Control<br>Psoriasis patients treated with biologic | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients not understanding the interaction of vaccines and their biologic, assessed with voluntary survey. | Assessment is based upon survey responses. By answering multiple questions we will determine if more education is needed based on the answers. | Data will be collected over a span of 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Education, Vaccine, Biologic
Combination Chemotherapy for the Treatment of Indian Kala-Azar

Study Overview
=================
Brief Summary
-----------------
The investigators are using a sequential design to combine miltefosine and AmBisome in different doses.

Detailed Description
-----------------
In this sequential design four arm study one arm is a reference arm but the three arms will consist an of initial dose of liposomal amphotericin B on first day followed by miltefosine. Both the drugs will be used in different doses. Reference arm will consist only a single dose of amBisome at 5 mg/kg. After the end of treatment, the post treatment assessment will be done on day 16 (initial cure) and six months (final cure). Safety parameters will be evaluated on day 0, 8 and 16. An arm with an efficacy of less than 75% will be closed. There will be periodical assessment of study results after completion of 5 patients in each arm.

Official Title
-----------------
Combination Chemotherapy for the Treatment of Indian Visceral Leishmaniasis: Miltefosine Plus Liposomal Amphotericin B - Dose and Duration Ranging Study

Conditions
-----------------
Visceral Leishmaniasis

Intervention / Treatment
-----------------
* Drug: Combination therapy with AmBisome and miltefosine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of active VL with consistent signs and symptoms (e.g., fever, splenomegaly). Confirmed diagnosis by bone-marrow or splenic aspirate smear showing characteristic amastigotes. Male or female. Ages 12 to 65 years. Both newly diagnosed cases and patients who have received previous treatment (in the latter case a 2-week wash-out will be required before starting the study treatment). WBC > 1,000/mm3. Hemoglobin ≥ 4 g/dL Exclusion Criteria: Pregnancy or breast-feeding. HIV positive serology. ASAT, ALAT, AP ≥ 3 times upper limit of normal range. Bilirubin ≥ 2 times upper limit of normal range. Prothrombin time ≥ 5 seconds above control. Serum creatinine or BUN ≥ 1.5 times upper limit of normal range. Any medical condition or situation that compromises compliance with study procedures. HIV

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 65 Years

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

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: Combination therapy with AmBisome and miltefosine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of clinical kala-azar at six month follow up |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Visceral leishmaniasis, miltefosine, AmBisome, Combination
IMP3 and PCNA Expression in Laryngeal Squamous Cell Carcinoma in Sohag Governorate

Study Overview
=================
Brief Summary
-----------------
Laryngeal cancer is responsible for 2-5% of all new cancer cases worldwide. Squamous cell carcinoma of the larynx (LSCC) is the most common malignant tumor of the larynx, accounting for 85-90% of all laryngeal malignancies. Despite significant therapeutic developments in recent decades, increases in patients' 5-year survival rates are still minimal , which is likely due to late-stage diagnosis and other complex factors. Therefore, to improve the outcome, timely diagnosis, selection of the most appropriate therapy, and an adequate follow-up approach is needed. The insulin-like growth factor II m-RNA-binding protein 3 (IMP3) is a new biomarker that may be implicated in the carcinogenesis of various malignancies, including head and neck squamous cell carcinoma. IMP3 normally expressed in embryonic tissue but decreases after birth and is no longer detectable in adult tissue With the exception of a few tissues. As a result, IMP3 is expressed only in tumors and not in neighboring normal tissues. Proliferating Cell Nuclear Antigen (PCNA) is a nuclear protein that acts as a cell proliferation marker. In most forms of solid malignancies, such as colorectal cancer and breast cancer, PCNA is closely linked to prognosis and survival. In this study, hoping to improve diagnosis of LSCC and assess prognosis better by using both IMP3 and PCNA biomarkers. As IMP3 may have a role in cell growth and proliferation and PCNA is a marker of cell proliferation; studying the association between both markers in laryngeal carcinoma is recommended.

Official Title
-----------------
Immunohistochemical IMP3 and PCNA Expression as Diagnostic and Prognostic Markers in Laryngeal Squamous Cell Carcinoma in Sohag Governorate

Conditions
-----------------
Laryngeal Squamous Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laryngeal resection (total or partial laryngectomy) and biopsies. Complete clinical data. Exclusion Criteria: Patients with recurrence of the primary tumor. Patients with a history of preoperative chemotherapy and/or radiotherapy.
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 |
| --- | --- | --- |
| Diagnosis and prognosis of Laryngeal Squamous Cell Carcinoma | Immunohistochemical Expression of IMP3 and PCNA in Laryngeal Squamous Cell Carcinoma | One or two days after staining sections with the markers |
A Study to Characterize Epidemiology, Clinical and Genetic Features of Kallmann Syndrome in Finland

Study Overview
=================
Brief Summary
-----------------
Objective is to characterize epidemiology, clinical and genetic features of Kallmann syndrome in Finland.

Detailed Description
-----------------
Kallmann syndrome is comprised of idiopathic hypogonadotropic hypogonadism and anosmia (inability to smell). Associated phenotypes may include cryptorchidism, microphallus, bone deformations, mirror movements, hearing loss and infertility. Objective is to characterize epidemiology, clinical and genetic features of Kallmann syndrome in Finland.

Official Title
-----------------
Kallmann Syndrome in Finland

Conditions
-----------------
Kallmann Syndrome

Intervention / Treatment
-----------------
* Drug: Short withdrawal of testosterone, gonadotropins or estrogenic compounds (see below)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kallmann syndrome Age 15 yrs or more Exclusion Criteria: Severe mental retardation

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Short withdrawal of testosterone, gonadotropins or estrogenic compounds (see below)|clinical examination, biochemical profile, and genetic characterization. Possibility to stop hormone therapy with drugs containing testosterone (Atmos®, Testim®, Testogel®, Nebido®, Panteston®, Sustanon®), FSH (Gonal-F®, Puregon®), hCG (Pregnyl®), estrogenic compounds (such as Estrofem®, Divigel®, Estrena®, Climara®, Estradot®, Evorel®, Femseven®: Merimono®, Progynova®, Ovestin®, Zumenon®, Estrogel®, Femoston®, Femoston combi®, Divina®, Divitren®, Indivina®, Estalis sekvens®, Evorel sequi®, Novofem®, Trisekvens®, Activelle®, Estalis®, Evorel conti®, Kliogest®, Mericomb®, Mericomb Mite®, Merigest®: Angeliq®) for 3 mo to assess reversibility of GnRH-deficiency will be offered.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical features including quality of life, reversibility and genetic features of Kallmann syndrome in Finland |  | 0, 3 mo and during subsequent F/U | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| epidemiology |  | by 2012 (anticipated) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kallmann Syndrome, hypogonadotropic hypogonadism
Analysis of Expression of Specific Markers in Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
Hepatocellular carcinoma is an aggressive disease with limited therapeutic options. Therefore, new approaches to treat this type of cancer are needed with immunotherapy potentially being one of these. As a first step in the development of novel therapies, expression analysis of specific markers, including tumor antigens will be carried out. This will be done retrospectively using available hepatocellular carcinoma tissue samples.

Official Title
-----------------
Analysis of the Incidence of Expression of a Specific Set of Genes and of Tumor Antigens in Cancer Tissue From Patients With Hepatocellular Carcinoma

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Other: Retrospective analysis of already archived samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient had pathologically proven hepatocellular carcinoma All the data required are available from patient's records A sufficient amount of RNA is available for all three tissue samples Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>No intervention | Other: Retrospective analysis of already archived samples<br>* RNA extracted from tissue samples already archived<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study will also analyze whether this gene-expression signature is present in matched cirrhotic tissue and the interface tissue with the tumor. |  | At the time of analysis. | 
| Proportion of hepatocellular carcinoma cancer patients whose tumor tissue -expresses any one or more of specific target antigens -overexpresses c-MET -expresses a pre-defied gene-expression signature |  | At the time of analysis. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
markers, expression analysis
Tenelia Elderly CGMS Study(TEDDY)

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy and safety of Teneligliptin in Patients aged 65 and Older with inadequately controlled type 2 diabetes.

Detailed Description
-----------------
To assess the efficacy and safety of Teneligliptin in Patients aged 65 and Older with inadequately controlled type 2 diabetes.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase IV Study to Evaluate the Efficacy and Safety of Tenelia® in Patients Aged 65 and Older With Inadequately Controlled Type 2 Diabetes

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are 65 years or older on screening Patients with type 2 diabetes mellitus Patients with 7.0% ≤ HbA1c ≤ 9.0% at the screening visit Patients with FPG < 270mg/dL on screening visit Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Experimental: Teneligliptin<br> | Drug: Teneligliptin<br>* 20mg/qd<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 1T/qd<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Change of HbA1c | after 12wks on baseline |