linjc16/ctgov huggingface dataset:
Gender, Pain, and Placebo Analgesia

Study Overview
=================
Brief Summary
-----------------
The response to standard pain stimuli in males and females is investigated, together with the effect of informing participants about the effect of a painkiller. Physiological response to pain is recorded.

Detailed Description
-----------------
The social context in which pain is reported has been found to modulate pain. Specifically, male participants reporting pain to female observers report significantly lower pain levels compared to male participants reporting to male observers. Female participants seem less affected by social context. This is a methodological problem in the study of pain and has consequences in the development of new drugs, and for pain research in general. The present study has two aims: To investigate whether social context affects also the placebo response to pain, i.e. the reduced pain often observed after administration of a an inert substance the participants believes to be a painkiller. It is hypothesized that placebo analgesia will be larger in males reporting pain to females. Secondly, heart rate variability and skin conductance, measures of parasympathetic and sympathetic activity, will be recorded, to investigate if social context affects not only pain report, but also pain response.

Official Title
-----------------
Effect of Participant Gender, Experimenter Gender, and Drug-Related Information on Placebo Analgesia

Conditions
-----------------
Experimental Pain

Intervention / Treatment
-----------------
* Behavioral: Information (behavior)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-40 years, healthy Exclusion Criteria: pregnant, earlier serious disease or injury,

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Information (behavior)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain report, heart rate variability, skin conductance |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective arousal |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Experimental pain, Placebo analgesia, Heart rate variability, Skin conductance
Corneal Endothelium Morphology and Central Thickness in Type II Diabetes Mellitus and Normal Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare corneal endothelium morphology and central thickness in type II Diabetes Mellitus and normal subjects with special reference to glycemic status.

Detailed Description
-----------------
Diabetes might influence the health of the corneal endothelium. Older studies have presented different results and the glycemic status of the patients have not been reported. In this study we examine the corneal endothelium morphology and central thickness in type II Diabetes Mellitus and normal subjects with modern specular microscopy. Each patient and control is examined once (entry to study).

Official Title
-----------------
Corneal Endothelium Morphology and Central Thickness in Type II Diabetes Mellitus and Normal Subjects

Conditions
-----------------
Corneal Dystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type II diabetes (diagnose confirmed by general practitioner) Controls with no diabetes (confirmed by blood testing). Exclusion Criteria: Glaucoma Uveitis (current or previous) Corneal scaring Previous eye surgery
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 |
| --- | --- |
| Diabetes Type II<br>Patients with type 2 Diabetes Mellitus | |
| Control<br>Patients with no diabetes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal endothelium cell number | The study is a cross-sectional study. We compare a cohort of patients with DM to a cohort with no DM. We examine each patient and control once. We call time of appointment or examination for at entry to study. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal endothelium morphology | The size and hexagonality of the cells are analysed automaticly by computer recognizion. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Corneal endothelium, diabetes mellitus, corneal thickness
VIVO European Observational Registry

Study Overview
=================
Brief Summary
-----------------
A multi-center, observational registry conducted in Europe and the UK to prospectively review VIVO in a clinical setting in 125 patients.

Official Title
-----------------
VIVO in a Practical Clinical Experience

Conditions
-----------------
Ventricular Arrythmia, Ventricular Tachycardia, Premature Ventricular Contraction

Intervention / Treatment
-----------------
* Device: VIVO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must at least 18 years of age Patients who have signed an IRB/EC approved patient informed consent and applicable patient privacy protection authorization per local law Patients who have previously had contrast cardiac imaging or will have cardiac imaging ordered per standard of care Patients will be selected without regard to gender. Exclusion Criteria: • Patients that are unable to receive contrast cardiac imaging (MR or CT)

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 |
| --- | --- |
| VIVO<br>Patients in which VIVO is used. | Device: VIVO<br>* VIVO is a per-procedural planning tool designed to non-invasively identify the origin of a ventricular arrhythmia.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness | The primary effectiveness objective is to assess the types of procedures where VIVO is used to plan and/or guide the ablation procedure or to determine a diagnosis of arrhythmia. Primary Effectiveness endpoint: Summarize the types of procedures where VIVO was utilized in the procedure. | 1 day | 
| Safety | Primary safety objective is to assess any adverse events related to the device and procedure. Primary Safety endpoint: Summarize the number of adverse events related to VIVO or procedure. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness | Secondary effectiveness objective is to evaluate the success of the ablation procedure (if performed) at follow- up visits (3, 6 and 12 months). Secondary effectiveness endpoint: Summarize the success of the ablation procedure at each follow up visit. | 12 months |
Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography Imaging(PARADIGM)

Study Overview
=================
Brief Summary
-----------------
To describe the natural history of the coronary atherosclerotic plaque development and progression over time by CCTA with demographic and laboratory data for refinement of risk stratification of patients referred for CCTA.

Detailed Description
-----------------
All PARADIGM study patients underwent initial and follow-up CCTA based on order from their primary physician. Demographic data, targeted medical history, cardiovascular risk factors, and laboratory data was prospectively collected in electronic case report forms (eCRFs) at the time of the initial CCTA and at the time of follow-up CCTA.

Official Title
-----------------
Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography Imaging(PARADIGM)

Conditions
-----------------
Coronary Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients underwent two or more clinically indicated CCTA with 64-detector rows or greater for CAD evaluation patients underwent at least 2 year interval between the baseline and follow-up CCTA Exclusion Criteria: poor image quality of CCTA

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 |
| --- | --- | --- |
| Change in plaque volume and composition detected by follow up CCTA |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac mortality (yes or no) |  | 2 years | 
| Myocardial infarction (yes or no) |  | 2 years | 
| Unstable angina requiring hospitalization (yes or no) |  | 2 years | 
| Revascularization (yes or no) |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Heart Disease, Coronary Computed Tomography Angiography (CCTA), Coronary Atherosclerotic Plaque, coronary atherosclerosis
Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With Two iStents

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess efficacy and safety of two iStents for the reduction of intraocular pressure associated with primary open-angle glaucoma.

Detailed Description
-----------------
This study evaluates the safety and efficacy of two iStents implanted in primary open-angle glaucoma subjects.

Official Title
-----------------
A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With Two Trabecular Micro-bypass Stents

Conditions
-----------------
Subjects With Primary Open-angle Glaucoma (POAG)

Intervention / Treatment
-----------------
* Device: iStents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with primary open-angle glaucoma (POAG) Subjects on two topical hypotensive medications Exclusion Criteria: Traumatic, uveitic, neovascular, or angle closure glaucoma Fellow eye already enrolled

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Two iStent devices and medication<br>Implantation of two iStents through small temporal clear corneal incision | Device: iStents<br>* Implantation of two iStents through a small temporal clear corneal incision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean diurnal IOP reduction of greater than or equal to 20% at Month 12 vs baseline |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean diurnal IOP < 18 mmHg at month 12 |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open angle, Glaucoma, Surgery, Glaucoma Open-Angle, Ocular Hypertension, Eye Diseases
Hepatic Steatosis and Pituitary Gland Failure, Evaluation by Nuclear Magnetic Resonance (NMR) Imaging

Study Overview
=================
Brief Summary
-----------------
The investigator put forward the hypothesis that liver fat mass in patients with pituitary gland failure is greater than that in a control population. Failure of the anterior pituitary and more particularly impaired production of growth hormone (GH) could be the principal mechanism responsible for increased liver fat mass in these patients.

Official Title
-----------------
Hepatic Steatosis and Pituitary Gland Failure, Evaluation by NMR Imaging

Conditions
-----------------
Hepatic Steatosis, Pituitary Gland Failure

Intervention / Treatment
-----------------
* Other: NMR
* Biological: Blood samples
* Other: fibroscan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have provided consent Patients over 18 years Patients with pituitary disease (Pituitary adenoma, anterior pituitary failure, craniopharyngioma, empty sella syndrome, hypophysitis, infiltration of the stalk) requiring Magnetic Resonance Imaging (MRI) of the pituitary. Exclusion Criteria: Persons without national health insurance Pacemaker (Contra-Indication for MRI) Alcohol consumption greater than 4 glasses a day Any treatment able to increase liver fat content (glitazones, systemic corticoids, immunosuppressants) are forbidden Presence of metallic implants (Contra-Indication for MRI) Claustrophobia Adult under guardianship Pregnant or breast-feeding women Patients with a liver disease other than non-alcoholic steatosis

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pituitary gland failure<br> | Other: NMR<br> <br> Biological: Blood samples<br> <br> Other: fibroscan<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of liver fat mass by Magnetic Resonance Imaging (MRI) |  | Measured at Day 0 |
Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine what corticosteroid receptor (and the dose of) is responsible for cortisol inducing hypoglycemia associated autonomic dysfunction in Type 1 DM. Specifically, we aim to determine whether stimulating the type 1 corticosteroid receptor (via fludrocortisone), the type 2 corticosteroid receptor (via dexamethasone), or both causes hypoglycemia associated autonomic dysfunction in Type 1 DM.

Official Title
-----------------
Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 1

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Drug: Fludrocortisone
* Drug: Dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 16 (8 males, 8 females) Type 1 diabetic patients aged 18-45 yr. HbA1c > 7.0% Had diabetes for 2-15 years No clinical evidence of diabetic tissue complications 16 (8 males, 8 females) Healthy volunteers aged 18-45 yrs. Body mass index < 27kg · m-2 Exclusion Criteria: Prior or current history of poor health Abnormal results following blood and physical examination Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Day 1 hyperinsulinemic euglycemic clamps with either 0.2 mg fludrocortisone, 0.75 mg Dexamethasone, or both given orally before each morning and afternoon clamp. Day 2 hyperinsulinemic hypoglycemic glucose clamp. | Drug: Fludrocortisone<br>* Oral Fludrocortisone 0.2 mg x 2 prior to each experimental period on Day 1<br>|
| Experimental: 2<br>Fludrocortisone will be administered in doses of 0.05mg, 0.1mg and 0.2 mg form at the start of each clamp period on day 1. Dexamethasone will be administered orally in the doses of 0.18 mg, 0.375mg and 0.75mg doses. The combination of the 0.05mg fludrocortisone and 0.18mg dexamethasone and 0.1mg of fludrocortisone and 0.375 mg doses will be administered at the start of each day 1 clamp period. Day 2 90 minutes of moderate exercise. | Drug: Dexamethasone<br>* Oral Dexamethasone 0.75 mg x 2 administered prior to each experimental period on Day 1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| catecholamines |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypoglycemia, exercise, corticosteroids
General Surgery Residency Training in Low Income Countries

Study Overview
=================
Brief Summary
-----------------
The general surgery residency program was initiated in 2013 between Istanbul Medeniyet University and Benadir University. A formal training program was established that covered 3-year theoretical and practical training that would form the structure of academic, clinical and technical criteria by evaluating all the requirements of the surgical residency training. A resident logbook was prepared to track exam results, practices, knowledge and skill status that the residents achieved in the training process. Candidates who graduated from medical school and were successful in the multiple-choice exam consisting of basic and clinical sciences were accepted to the program each year in different numbers according to the capacity. From the initiation, 16 surgeons -9 in 2016, 3 in 2017 and 4 in 2018- graduated from the program. This study was designed after the last resident group graduated and worked as an attending surgeon at least for a year.

Detailed Description
-----------------
The data were collected from graduates who were working as surgeons in Somalia to reveal the features and numbers of elective, emergency, trauma, and non-general surgical interventions performed in a month. A questionnaire consisting of pathology, type and numbers of interventions performed in one month by graduate surgeons (GS), including general surgery and other specialties, was prepared.

Official Title
-----------------
Surgical Residency Training Program in Somalia: Outcomes of 7 Years

Conditions
-----------------
Global Surgery

Intervention / Treatment
-----------------
* Other: Outcome


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: surgeons who completed program surgerons who currently working as an attending physician in Somalia Exclusion Criteria: surgeons who has not completed program surgeons who did not completed the questionare
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Outcome|The number of surgeries|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of surgical interventions in one month | quantitative | 1 month |
Evaluation of the Efficacy of Oxygen Therapy and Clinical Feasibility of High Flow Nasal Cannula During Moderate and Deep Sedation in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
The investigators evaluate the efficacy and safety of routine administration of oxygen during moderate or deep sedation in pediatric patients. In addition, in terms of efficacy and safety, oxygen administration via nasal prong and high flow nasal cannula will be compared.

Official Title
-----------------
Evaluation of the Efficacy of Oxygen Therapy and Clinical Feasibility of High Flow Nasal Cannula During Moderate and Deep Sedation in Pediatric Patients

Conditions
-----------------
Pediatric Sedation

Intervention / Treatment
-----------------
* Device: high flow nasal cannula
* Device: nasal prong


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children under the age of 18 who undergo moderate-deep sedation Exclusion Criteria: Respiratory failure patients Increased intracranial pressure Recent massive nasal bleeding History of airway surgery Complete nasal obstruction Pulmonary hypertension Skull base fracture

Ages Eligible for Study
-----------------
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Nasal prong is applied, but sedation is performed without oxygen administration. | |
| Experimental: Low flow group<br>Oxygen administration by nasal cannula | Device: nasal prong<br>* Oxygen is administered via nasal prong<br>|
| Experimental: High flow group<br>Oxygen is administered at a rate of 2L/kg/min using an Optiflow device | Device: high flow nasal cannula<br>* The heated air is administered at a rate of 2L/kg/min using an Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand). Inhalation oxygen concentration starts with 50%.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Desaturation (≤95%) | Occurrence of desaturation (pulse oximeter ≤95%) | through study completion, average 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Desaturation (≤90%) | Occurrence of desaturation (pulse oximeter ≤90%) | through study completion, average 30 minutes | 
| CO2 value | percutaneous CO2 (maximum, minimum, mean values) | through study completion, average 30 minutes | 
| Minimum saturation during sedation |  | through study completion, average 30 minutes | 
| Complications | Any complications during sedation | through study completion, average 30 minutes |