linjc16/ctgov huggingface dataset:
Keratoconus Detection Using MS39 and Pentacam

Study Overview
=================
Brief Summary
-----------------
This retrospective study aims to investigate whether the MS39 and Pentacam are delivering comparable results in the diagnosis of keratoconus. In the future, these measurement devices could be interchangeable in usage.

Detailed Description
-----------------
Keratoconus is a degenerative pathology of the cornea, which tends to progress. It comes along with central and paracentral thinning of the cornea as well as with an apical protrusion of the cornea. Keratoconus leads to vision loss. This pathology is diagnosed by using CE certified OCT technology in order to map the topography of the cornea. This process constitutes a really important step in the line of management of the keratoconus. MS39 and Pentacam are used for detection. Retrospectively, data will be investigated, in order to see if these measurement devices deliver comparable results. In the future, these measurement devices could be interchangeable in usage.

Official Title
-----------------
Keratoconus Detection Using MS39 and Pentacam - a Retrospective Study

Conditions
-----------------
Keratoconus

Intervention / Treatment
-----------------
* Other: retrospective analyze


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age older than 14 years patients who show up at Keratokonus consultation hours Exclusion Criteria: age younger than 14 years age older than 100 years

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: retrospective analyze|retrospective analyze of MS39 and Pentacam images|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| topography of the cornea | measurement of the topography of the cornea with MS39 and Pentacam | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Keratoconus, Pentacam, MS39
The Effect of Morphine on Prasugrel Absorption in STEMI Patients

Study Overview
=================
Brief Summary
-----------------
Heart Attacks are a major cause of death in this country. When patients have a heart attack, they are treated with anti-clotting drugs, one of which is a drug called Prasugrel. It is important that Prasugrel starts to work as quickly as possible following a heart attack. As many patients who have a heart attack experience excruciating pain, they are often given morphine (a strong painkiller) by the Ambulance crew. We think that morphine may affect how Prasugrel is absorbed from the stomach and may delay how quickly it starts to work. We intend to study the effect of morphine on the absorption of Prasugrel.

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Drug: morphine
* Drug: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years of age and willing and able to provide informed consent Admission to hospital with a STEMI >12 months prior to recruitment Previous prasugrel and morphine use with no adverse effect Exclusion Criteria: Active respiratory disorder, resting oxygen saturation < 95% or decompensated congestive cardiac failure Current use of anti-platelet or anti-coagulant drugs apart from aspirin 75 mg daily, or receipt of any dose of clopidogrel, prasugrel or ticagrelor in the last 2 weeks Current use of opiate analgesia

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Morphine<br>the effect of morphine on prasugrel absorption will be tested | Drug: morphine<br>* 2.5mg of morphine will be given post Prasugrel administration with a further 2.5mg 5 minutes later<br>|
| Placebo Comparator: Saline<br> | Drug: saline<br>* 2.5ml of saline will be given post Prasugrel followed by a further 2.5ml as a comparator for the morphine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VerifyNow P2Y12 PRU measurement at 2 hours post dose | Assessment of platelet function | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated time to PRU less than 150; maximal LTA response to ADP 20 microM at 2 hours post dose; final LTA response to ADP 5 microM at 2 hours post dose. | further assessment of platelet function | 2 hours |
Epidemiological Study to Evaluate Adherence to Treatment in Bipolar Disorder: Adherence Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate adherence to treatment in bipolar patients, to characterize patients based on adherence degree and to describe the variables linked to poor adherence to treatment in real-life practice.

Official Title
-----------------
Epidemiological Study to Evaluate Adherence to Treatment in Bipolar Disorder: Adherence Study

Conditions
-----------------
Bipolar Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with bipolar disorder I or II DSM-IV Patients treated with at least one oral antipsychotic Subjects able to read and write Exclusion Criteria: Patients participating in clinical trials

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 |
| --- | --- |
| 1<br>Patients diagnosed with bipolar disorder I or II (DSM-IV) in ambulatory settings | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morisky-Green Scale |  | Once, at the visit moment | 
| Drug Attitude Inventory Scale (DAI-10) |  | Once, at the visit moment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impressions for Bipolar illness-modified (CGI-BP-M) |  | Once, at the visit moment | 
| Functioning Assessment Short Test (FAST) |  | Once, at the visit moment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar disorder, adherence, treatment, real life practice
Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap Elevation for Head and Neck Reconstruction

Study Overview
=================
Brief Summary
-----------------
This study is to compare the efficacy of Harmonic Scalpel with conventional diathermy technique in terms of reducing elevation time and perioperative complications of perforator flaps for head and neck reconstruction.

Official Title
-----------------
Prospective, Randomised, Single-blinded Study : Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Procedure: Diathermy
* Procedure: Harmonic Scalpel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: head and neck reconstruction with perforator flap informed consent from the patient Exclusion Criteria: coagulation problem refused to participate

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Placebo Comparator: Diathermy<br>Perforator flap elevation using conventional diathermy technique | Procedure: Diathermy<br>* flap dissection with conventional diathermy<br>|
| Active Comparator: Harmonic Scalpel<br>Perforator flap elevation using Harmonic Scalpel | Procedure: Harmonic Scalpel<br>* flap dissection using harmonic scalpel (FOCUS)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flap elevation time: from identification of skin perforator to completion of dissection to main pedicle |  | 1 hour after completion of flap elevation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative complications: bleeding, perforator injury (thermal, mechanical) |  | 1 hour after completion of flap elevation | 
| postoperative drainage amount |  | 1 week after flap inset | 
| postoperative pain measured by visual analogue scale (VAS) |  | 1 week after completion of flap elevation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, reconstruction, free flap, surgery
Comparison of Metformin and Pioglitazone Effects on Adipokines Concentrations in Newly Diagnosed Type 2 Diabetes Patients

Study Overview
=================
Brief Summary
-----------------
Oral hypoglycemic agents encompass the mainstay of treatment in the majority of patients with type 2 diabetes. Thiazolidinediones (such a pioglitazone) and Biguanides (such as metformin), are two major groups of hypoglycemic medications that while function via different pathways, are both effective in short- and long-term glycemic control . These medications diminish or at least delay long term micro- and macrovascular complications associated with prolonged insulin resistance although at different rates. The mechanisms by which this aim is achieved, nevertheless, remains largely unclear. With adipokines playing a key role in development of both insulin resistance and atherosclerosis, oral hypoglycemic agents might regulate these substances by direct and indirect routes.

Official Title
-----------------
Comparing Effects of Metformin and Pioglitazone on Regulation of Serum Adipokines in Newly Diagnosed Type 2 Diabetes Patients

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

Intervention / Treatment
-----------------
* Drug: Metformin
* Drug: Pioglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed type 2 diabetes patients based on American Diabetes Association criteria (2011) for diagnosis of diabetes Exclusion Criteria: previous intake of oral hypoglycemic agents for treatment of diabetes or other hyperglycemia associated conditions intake of glucocorticoids in the past one year major illnesses of heart, lung, kidney, and liver.

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metformin<br>patients receiving fixed dose metformin 1000 mg daily | Drug: Metformin<br>* Metformin 1000 mg fixed dose, twice daily (500 mg tablets x 2)<br>|
| Active Comparator: Pioglitazone<br>patients receiving fixed dose pioglitazone 30 mg daily | Drug: Pioglitazone<br>* Pioglitazone 30 mg fixed dose, twice daily (15 mg tablets x 2)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentrations of omentin | Serum concentrations of adipose tissue derived cytokine omentin | 12 weeks | 
| Serum concentrations of leptin | Serum concentrations of adipose tissue derived cytokine leptin | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adipokines, leptin, chemerin, omentin, metformin, type 2 diabetes mellitus
Use of Fibryga, a Fibrinogen Concentrate in Real World: Retrospective Collection of Clinical Data

Study Overview
=================
Brief Summary
-----------------
To describe the characteristics of patients treated with Fibryga®, the indications and conditions of use of Fibryga® and, for patients treated  on-demand, the short-term outcomes.

Official Title
-----------------
Use of Fibryga, a Fibrinogen Concentrate in Real World: Retrospective Collection of Clinical Data

Conditions
-----------------
Bleeding

Intervention / Treatment
-----------------
* Drug: Fibryga


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with fibrinogen deficiency (congenital or acquired) Having received an treatment with Fibryga® during the recollection period Having been informed of the potential retrospective collection of their data by a Clinical Research Associate mandated by Octapharma® when Fibryga® has been delivered and who did not refuse. 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 |
| --- | --- |
| Fibryga<br> | Drug: Fibryga<br>* Fibryga<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of treatments given for an ongoing bleeding episodes | Estimate the proportion of treatments given for an ongoing bleeding episodes (opposed to preventative treatment administered for example before surgery or to regular prophylaxis) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| On-demand Treatment Success | on-demand treatment of spontaneous or surgical bleeding episodes, success is defined as bleeding control (complete cessation of bleeding or < 20% decrease in hemoglobin). | 6 months | 
| Surgical Prophylaxis Success | Surgical prophylaxis success is defined as no bleeding or oozing and control of bleeding with fibrinogen concentrate (as anticipated or requiring increased dosing or additional infusions not originally anticipated). | 6 months |
Association of Egg and Dietary Cholesterol Consumption With Mortality and Diseases

Study Overview
=================
Brief Summary
-----------------
To assess the associations between egg and dietary cholesterol consumption with mortality and metabolic syndrome (MetS).

Detailed Description
-----------------
Substitution models, sensitivity analyses, subgroup analyses and multiple linear regression analyses will be conducted to specifically estimate the hazard ratios and 95% confidence intervals of mortality and MetS associated with egg and cholesterol consumption.

Official Title
-----------------
Association of Egg and Dietary Cholesterol Consumption With Mortality and Metabolic Syndrome

Conditions
-----------------
Mets, Death

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participants aged ≥20 y Exclusion Criteria: missing creatinine, age, cannot be linked to socio-demographic data; aged less than 20; without complete dietary data .
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | mortality | participants were followed up from 1991 to 2015 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metabolic syndrome | MetS was defined according to the updated National Cholesterol Education Program Adult Treatment Panel III (NCEP: ATP III) criteria for Asian-Americans. | The blood samples were collected in 2009 for the first time. |
Characterization of the Nutritional Status in the Patient With Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
In the subgroup of patients with sarcopenia, regardless of their body mass index, we want to verify the real impact of nutritional supplements with branched chain amino acids on the standard treatment based on nutritional intervention and physical exercise.

Official Title
-----------------
Characterization of the Nutritional Status in the Patient With Liver Cirrhosis and Impact of a Nutritional Intervention With Nutritional Supplements With BRCA vs. Standard Treatment in the Subgroup of Patients With Sarcopenia

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

Intervention / Treatment
-----------------
* Dietary Supplement: Branched chain amino acids (BRCA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhotic patients with sarcopenia in abdominal CT. Exclusion Criteria: chronic renal failure or being on hemodialysis active hepatitis B or C virus infection active alcohol abuse coinfection with human immunodeficiency virus renal or previous liver transplantation history of neoplasia requiring chemotherapy or radiotherapy hepatocellular carcinoma outside of Milan criteria TIPs unwillingness to participate in the study.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BRCA<br>They were in treatment with BRCA and standard treatment based on nutritional intervention and physical exercise. | Dietary Supplement: Branched chain amino acids (BRCA)<br>* They were with BRCA during the day apart of following the standard recommendations<br>|
| Placebo Comparator: Placebo<br>They only were on standard treatment based on nutritional intervention and physical exercise. | Dietary Supplement: Branched chain amino acids (BRCA)<br>* They were with BRCA during the day apart of following the standard recommendations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of muscle mass in patients with sarcopenia | To assess whether to add to dietary and physical activity recommendations, nutritional supplements with BRCA under usual clinical conditions can lead to a greater change of muscle mass in patients with sarcopenia | 12 weeks |
Observational Study of Cortical Spreading Depression in Human Brain Trauma

Study Overview
=================
Brief Summary
-----------------
Since the primary damage from traumatic brain injury (TBI) is irreversible, the focus of medical management of TBI is preventing secondary injury that can be life-threatening and worsen patient outcome. Insight into the pathologic mechanisms of secondary injury, which are largely unknown, is required for developing better treatments. In preliminary studies, the investigators have found that a pathologic brain activity, known as spreading depression, recurs in a large number of TBI patients in the first week after injury. Spreading depressions are short-circuits of brain function that arise spontaneously from an injury and spread repeatedly as waves into neighboring brain tissue. Animal research has shown that spreading depressions can cause secondary injury to the brain. The primary objective of this observational study is to determine whether the occurrence or severity of spreading depression is related to worse neurologic recovery from TBI. Results from the study will determine whether monitoring of spreading depression should be used as a guide or target for improved medical management of the TBI patient.

Official Title
-----------------
Spreading Depressions as Secondary Insults After Traumatic Injury to the Human Brain

Conditions
-----------------
Traumatic Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-80 years old diagnosis of TBI craniotomy performed as per required treatment of TBI craniotomy surgery < 7 days after TBI GCS<13 at time of decision for surgery expected neuromonitoring for >72 hr Exclusion Criteria: any failure to meet above criteria pregnancy GCS 3 with fixed, dilated pupils

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Incidence of spreading depressions as assessed by continuous electrocorticography for 3-7 days after surgery. Primary neurologic outcome will be measured by the Glasgow Outcome Score - Extended. |  | Six months post-TBI. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-traumatic epilepsy questionnaire. |  | 6, 12, and 24 months post-TBI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spreading cortical depression, electroencephalography, traumatic brain injury, intensive care, vascular hypotension, intracranial hypertension
Postoperative Evolution After Small Gauge Vitrectomy Without Eye Occlusion

Study Overview
=================
Brief Summary
-----------------
After an uneventfully small gauge vitrectomy we don´t think is necessary to occlude the eye for 24 hours

Conditions
-----------------
Vitrectomy

Intervention / Treatment
-----------------
* Procedure: vitrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with uneventful vitrectomy Exclusion Criteria: Complicated vitrectomy or corneal lesion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| eye occlusion<br> | Procedure: vitrectomy<br> <br> |

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
-----------------
Occlusion, vitrectomy, small gauge vitrectomy, Postoperative occlusion