linjc16/ctgov huggingface dataset:
Pneumological Acute Coronary Syndrom (ACS) Phenotyping Aachen

Study Overview
=================
Brief Summary
-----------------
In this open, monocentric, observational study acute coronary syndrom (ACS) patients will be characterized by pneumological examination concerning a concomitant chronic obstructive pulmonary disease (COPD). Often COPD coexists with ACS; therefore ACS patients benefit either from prevention or potential therapy of chronic hypoxia.

Detailed Description
-----------------
In this study patients with either non ST-segment-elevation myocardial infarction (NSTEMI) or ST-segment-elevation myocardial infarction (STEMI) will be included. After amnesis patients will undergo blood withdrawal, blood-gas analysis and examinations concerning pulmonary function (Bodyplethysmography). In addition to routine blood withdrawal for differential blood count, 9 ml blood sample is takenfor molecular analysis of relevant prognostic chronic obstructive pulmonary disease (COPD)-blood based biomarkers, an for establishing a library of biomaterial in form of a biobank.

Official Title
-----------------
Pneumological Phenotyping of Acute Coronary Syndrom (ACS) Patients Concerning Concomitant Chronic Obstructive Pulmonary Disease (COPD)

Conditions
-----------------
Acute Coronary Syndrom, Chronic Obstructive Pulmonary Syndrom

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written declaration of consent Patients with acute myocardial infarct which can be either non ST-segment-elevation myocardial infarct (NSTEMI) or ST-segment-elevation myocardial infarct (STEMI), in both cases exaggeration of cardiac ischaemic markers Exclusion Criteria: Patients not fulfilling the incluson criterias or: Pregnant or breastfeeding women Participation in other studies Persons in depency from the sponsor or working with the sponsor Persons without mental ability or capacity to understand and follow the instructions of the investigator

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 |
| --- | --- | --- |
| Number of patients with Acute Coronary Syndrom (ACS) and concomitant Chronic Obstructive Pulmonary Disease (COPD) |  | During 1-2 hours (at time of examination) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular analysis of relevant blood based chronic obstructive pulmonary disease (COPD) biomarkers |  | An average of 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute coronary syndrom, Chronic obstructive pulmonary disease, Myocardial infarction, Blood based biomarkers
Buprenorphine and Naloxone Combination Study - 10

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine pharmacokinetics and dose proportionality of sublingual tablets containing varying doses of buprenorphine and naloxone.

Detailed Description
-----------------
The objective of this study is to examine pharmacokinetics and dose proportionality of sublingual tablets containing varying doses of buprenorphine and naloxone.

Official Title
-----------------
PK0496 Pharmacokinetics of Buprenorphine

Conditions
-----------------
Heroin Dependence, Opioid-Related Disorders

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male/Female between the ages of 21 and 45. Within 15% of ideal body weight. No oral pathology that would interfere with the sublingual absorption of the medication. Experienced in the use of opiates but not dependent. Exclusion Criteria: LFT's exceeding than 3x's normal. History of seizure. Opiate dependent.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological measures |  |  | 
| Measurements of buprenorphine and naloxone in plasma |  |  | 
| Subjective symptoms measures |  |  |
Measurement of Early Bone Loss Around a Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Research with DXA has shown the pattern of bone remodelling around an implant. The baseline and reference value for such calculations is the first measurement after the operation. The baseline measurement is performed at different time from study to study. If there is a rapid bone loss the first weeks after an operation, this will influence the reference value and then the results. To evaluate DXA as a method we decided to set up a study with 3 DXA measurements within the first 2 weeks. Our hypothesis is that there is a rapid bone loss the first 2 weeks after operation and that timing of the first post operative measurement will influence the later results.

Detailed Description
-----------------
Dual x-ray absorptiometry (DXA) has become the most used and proven to be a precise method to investigate changes in bone mass density (BMD). Research with DXA has shown the pattern of bone remodelling around an implant. Results from implant studies are often presented as changes in BMD as a function of time. The baseline and reference value for such calculations is the first measurement after the operation. The most pronounced bone loss after implantation of hip prosthesis usually comes within 3 months. The baseline measurement is performed at different time from study to study. If there is a rapid bone loss the first weeks after an operation, this will influence the reference value and then the results. To evaluate DXA as a method we decided to set up a study with 3 DXA measurements within the first 2 weeks. We included 23 patients operated with total hip prosthesis (THP). They were measured with DXA at 1, 5 and 14 days, 3 and 12 months after the operation. Results were given in percent (+/-SD) for each Gruen zone. There were no changes in bone density between the first 3 measurements. In all zones, except zone 1, the lowest BMD was measured after 3 months. We concluded that DXA measurements done within 14 days after the operation can be used as reference measurements for later follow ups.

Official Title
-----------------
Measurement of Early Bone Loss Around a Total Hip Arthroplasty. A Prospective Trial With Dual Energy X-ray Absorptiometry.

Conditions
-----------------
Coxarthrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: degenerative hip osteoarthritis Exclusion Criteria: metastasis to bone dementia
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
-----------------
DXA, Hip, Arthroplasty
A Study to Explore the Association Between Blood Pressure, HIV and Antiretroviral Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the association between blood pressure, HIV and/or its treatment in a cross sectional observational study.

Detailed Description
-----------------
Deaths from AIDS have declined dramatically since the introduction of highly active antiretroviral therapy in HIV infected patients. However the incidence of heart disease has increased four-fold and is now one of the major causes of death in HIV infected patients. While HIV drugs are known to adversely affect serum lipids, the evidence concerning the association between raised blood pressure (a major risk for cardiovascular disease) HIV and/or its treatment is limited and conflicting. The researchers believe it of interest to study heart disease risk factors in patients with HIV infection to avoid one premature cause of death (AIDS) being replaced with another potentially preventable cause of death and disability (heart disease). In this cross sectional observational study the researchers will systematically measure blood pressure and other cardiovascular risk factors in HIV positive patients on and off antiretroviral therapy. These individuals will be matched for age, sex and ethnic group with HIV negative individuals.

Official Title
-----------------
A Study to Explore the Association Between Blood Pressure, HIV and Antiretroviral Therapy

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Procedure: Blood Pressure Measurement
* Procedure: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Attending St. Mary's sexual health outpatient department Patients willing to give written informed consent Ability to communicate in English Exclusion Criteria: Failure to give written informed consent in English
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Blood Pressure Measurement|nan|
|Procedure: Questionnaire|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
-----------------
Blood Pressure, HIV, Antiretroviral therapy
Study of T-PRED(TM) Compared to Pred Forte(R) II

Study Overview
=================
Brief Summary
-----------------
Study of T-PRED(TM) Compared to Pred Forte(R)

Detailed Description
-----------------
This study was a multi-center, randomized, double-masked, bioequivalence study. A total of 172 participants undergoing bilateral cataract surgery were assigned investigational product to each eye according to a computer-generated randomization list for each of 2 study variables: treatment with T-PRED or Pred Forte in the first eye undergoing cataract extraction and the aqueous humor sampling time point. The investigator determined which eye was clinically suited for the first operative procedure; treatment of this eye was randomized to either T-PRED or Pred Forte. The second eye received the other study treatment (RP if the first eye received T-PRED; T-PRED if the first eye received Pred Forte) at the time of the second cataract extraction.

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Drug: T-Pred
* Drug: Pred Forte


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Exclusion Criteria: No active or adverse disease

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T-Pred<br>Tobramycin prednisolone acetate combination | Drug: T-Pred<br>* sterile ophthalmic solution<br>|
| Active Comparator: Pred Forte<br>Prednisolone acetate | Drug: Pred Forte<br>* sterile ophthalmic solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Means Aqueous Humor Prednisolone Acetate Concentration |  | 35 days |
International Register of Open Abdomen

Study Overview
=================
Brief Summary
-----------------
To evaluate the different indications to Open Abdomen, the different techniques used to perform it, it's management, it's definitive closure and mortality rates linked to the different variables. Moreover to evaluate the 1 month and 1 year follow up in patients underwent to Open Abdomen.

Official Title
-----------------
International Register of Open Abdomen

Conditions
-----------------
Open Abdomen Procedure

Intervention / Treatment
-----------------
* Procedure: Open abdomen procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No age limit Indication to Open Abdomen Informed consent Exclusion Criteria: Informed consent refusal No indication to Open Abdomen
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open Abdomen patients<br>All patients underwent to open abdomen procedure | Procedure: Open abdomen procedure<br>* Patients who may need at the end of surgical procedure will be left with open abdomen dressed with different devices or dressing according to the institutional indications.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indications to open abdomen |  | Enrollment | 
| Techniques to perform open abdomen |  | Enrollment | 
| Management of open abdomen |  | Visit 2 | 
| Definitive closure techniques |  | Visit 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rates linked to different techniques of open abdomen |  | During All study period | 
| Morbidity rates linked to different techniques of open abdomen |  | During All study period |
APPEndicitis and Laparoscopic Criteria; APPEL Study

Study Overview
=================
Brief Summary
-----------------
A diagnostic laparoscopy is frequently used to confirm the diagnosis of appendicitis. However, laparoscopic criteria for determining appendicitis are not defined. If there is any doubt about the presence of an abnormal appendix, it is usually removed. However, an appendectomy of a negative appendix has a certain morbidity and for that reason it should be avoided. The purpose of this study is to establish laparoscopic criteria for the diagnosis appendicitis during diagnostic laparoscopy.

Detailed Description
-----------------
The UMCG hospital protocol of suspicion of appendicitis includes a diagnostic laparoscopy. The laparoscopic inspection of the appendix is carried out according to a specific protocol. In case of appendicitis the appendix is removed laparoscopically, a normal appendix is not removed. The primary outcome of the study is: appendicitis according to pathologic examination following appendectomy, or appendicitis according to clinical follow-up in case the appendix is not removed. The clinical diagnosis of appendicitis in the follow-up should be confirmed radiologic examination (ultrasound, CT-scan, MRI) or by a re-operation.

Official Title
-----------------
A Prospective Evaluation to Determine Laparoscopic Criteria for the Diagnosis Appendicitis During a Diagnostic Laparoscopy

Conditions
-----------------
Appendicitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Patients who will undergo a diagnostic laparoscopy for suspicion of appendicitis No age or gender limits Exclusion Criteria: Elective scheduled appendectomy Unable to give informed consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Appendicitis<br>Patients with suspected appendicitis who are to be operated upon by diagnostic laparoscopy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of appendix characterization by histology or clinically |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission |  | 3 months | 
| Re-operation |  | 3 months | 
| Intra-abdominal abcess |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Appendicitis, Laparoscopy, Appendectomy
Functional Imaging in the Acute Phase of Transient Ischemic Attacks

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to find a radiological biomarker of Transient Ischemic Attacks (TIA) thanks to functional Magnetic Resonance Imaging (fMRI) done within the 24 hour after symptoms onset.

Official Title
-----------------
Contribution of Functional Imaging to the Diagnostic and Assesment of the Acute Phase of Transient Ischemic Attacks : a Preliminary Study

Conditions
-----------------
Transient Ischemic Attack

Intervention / Treatment
-----------------
* Diagnostic Test: Functional Magnetic Resonance Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient admitted in for a transient neurologic deficit and suspicion of TIA of carotid circulation Prescription for conventionnal MRI Exclusion Criteria: Contraindication to MRI Previous neurological disease (with lesions) Severe psychiatric disease

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Confirmed TIA<br>Confirmed TIA at 3 months with standardized neurological expertise | Diagnostic Test: Functional Magnetic Resonance Imaging<br>* fMRI sequences done with motor paradigm (right and left arm), followed by resting state acquisition<br>|
| Other: Confirmed non-TIA<br>Not-confirmed TIA at 3 months with standardized neurological expertise | Diagnostic Test: Functional Magnetic Resonance Imaging<br>* fMRI sequences done with motor paradigm (right and left arm), followed by resting state acquisition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood-Oxygen-Level Dependent signal | BOLD effect differences in motor cortex from pathological side versus healthy side measured by fMRI within the 24 hours after symptom onset, during a motor paradigm | 24 hours after symptoms onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting state | Bold effect differences in resting state networks from pathological side versus healthy side measured by fMRI within the 24 hours after symptom onset, during a motor paradigm | 24 hours after symptoms onset | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transient Ischemic Attack, Stroke, functional Magnetic Resonance Imaging
Bimatoprost/Timolol Versus Travoprost/Timolol

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare 2 fixed combination medications in intraocular pressure lowering.

Detailed Description
-----------------
PURPOSE: To compare the efficacy of bimatoprost/timolol (BTFC) or travoprost/timolol (TTFC) fixed combinations on intraocular pressure (IOP) reduction in an Egyptian population. METHODS: Patients with primary open angle glaucoma (POAG) were randomized to receive either BTFC or TTFC. IOPs were measured at baseline, 2 weeks, and 1, 2, 4, and 6 months. The primary outcome measures were the mean change in IOP from baseline

Official Title
-----------------
Bimatoprost/Timolol Versus Travoprost/Timolol Fixed Combinations in an Egyptian Population: A Hospital-Based Prospective Randomized Study

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Drug: Ganfort
* Drug: Duotrav


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Glaucoma Exclusion Criteria: No other ocular diseases
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: Glaucoma fixed Combination Medications<br> | Drug: Ganfort<br>* Bimatoprost/Timolol fixed combination<br>* Other names: Bimatoprost/Timolol vs Travoprost/Timolol fixed combination;Drug: Duotrav<br>* Fixed combination of Travoprost and Timolol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of drop of intraocular pressures from baseline. |  | 1 year |