linjc16/ctgov huggingface dataset:
Adhesive Strips in Dermatologic Surgery: Is Cosmetic Appearance Improved?

Study Overview
=================
Brief Summary
-----------------
To determine whether the addition of adhesive stripping to a wound closed with dermal sutures improves outcome of wound closure. We hypothesize that the combination of adhesive strips to a wound closed with dermal sutures does not add significant cosmetic improvement of the resultant scar.

Official Title
-----------------
Adhesive Strips in Dermatologic Surgery: Is Cosmetic Appearance Improved?

Conditions
-----------------
Subjects Undergoing Surgical Procedure of the Skin

Intervention / Treatment
-----------------
* Procedure: Suture with Adhesive Stripping
* Procedure: Suture without Adhesive Stripping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Able to give informed consent themselves Willing to return for follow up visit Exclusion Criteria: Mentally handicapped Unable to understand written and oral English Unwilling to return for follow up Wounds less than 3 cm in length Adults unable to consent Individuals who are not yet adults (infants, children, teenagers 17 and under) Pregnant women Prisoners

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: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Suture with Adhesive Stripping<br>Buried dissolving subcuticular sutures are sued for both sides of the wound to approximate wound edges and then steri-strips for the adhesive stripped half of the scar is applied. | Procedure: Suture with Adhesive Stripping<br> <br> Procedure: Suture without Adhesive Stripping<br> <br> |
| Active Comparator: Suture without Adhesive Stripping<br>Buried dissolving subcuticular sutures are sued for both sides of the wound to approximate wound edges and then no closure material for the half of the scar is applied. | Procedure: Suture with Adhesive Stripping<br> <br> Procedure: Suture without Adhesive Stripping<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Split-Scar Comparison | Split-scar comparison of half of the wound closed with buried subcuticular sutures and overlying adhesive strips and half the wound closed with buried subcuticular sutures alone. | 3 months |
Italian Observational Study Assessing the Impact of Gout on Patients Disability and Quality of Life

Study Overview
=================
Brief Summary
-----------------
The study aims to identify which characteristics are associated with disability and poor quality of life in patients suffering from gout. This is a multicentre prospective observational study carried out in a cohort of Italian patients with gout. Subjects are randomly selected from a list of patients referred to each participant rheumatology clinic in the previous 2 years. Clinical evaluations are performed at baseline, at 6 and 12 months; data are retrieved about sociodemographic variables, life-styles, history of gout, comorbidities and patterns of treatment. At each visit patients complete questionnaires assessing disability and health-related quality of life. Preplanned analyses will be performed to investigate predictors of disability and poor quality of life in these patients.

Official Title
-----------------
Multicentre Prospective Observational Study for Identification of Determinants of Disability and Quality of Life in Patients With Gout.

Conditions
-----------------
Gout

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of gout Must be able to understand questionnaires Exclusion Criteria: Diagnosis not validated by rheumatologist Not able to sign informed consent

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 |
| --- | --- | --- |
| Functional disability | Health Assessment Questionnaire Disability Index (HAQ-DI) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life | Short Form-36 Physical Summary Scale (SF-36 PCS) | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gout, gouty arthritis
Altered PSA Test Due to Possible Suspected Heterophilic Antibodies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate if clinically non explainable high or low Prostate-specific antigen (PSA) levels are associated with heterophilic antibodies in the serum of participants. The investigators will examine if heterophilic antibodies are the reasons of altered PSA levels.

Official Title
-----------------
Altered PSA Test Due to Possible Suspected Heterophilic Antibodies

Conditions
-----------------
PSA

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, with a a clinically high or low unexplainable PSA measurement Age between 40 and 90 years Written informed consent Exclusion Criteria: Female No PSA measurement available or planned Age over 90 or under 40 years

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| Presence of heterophilic antibodies in the serum of participants | Heterophilic antibodies will be measured in the Blood serum of participants by sandwich Elisa assay | 1.5 years | 
| Altered PSA levels due to the Presence of Heterophilic antibodies | If heterophilic antibodies were present in the serum of the participant, another PSA test will be ran after absorbance of heterophilic antibodies to investigate whether PSA levels are changed without the presence of heterophilic antibodies | 1.5 years |
National Registry of Cardiovascular Surgery in Argentine

Study Overview
=================
Brief Summary
-----------------
The National Registry of Cardiovascular Surgery in Argentina is a registry of patients undergoing cardiovascular surgery that involves the entire country with the ultimate aim of determining the results of said surgery throughout the country.

Detailed Description
-----------------
It is an observational registry with selective inclusion of patients who undergo certain cardiovascular surgeries, where the pre-surgical status will be analyzed, the determinants during surgery and the postoperative evolution of said patients will be evaluated

Official Title
-----------------
National Registry of Cardiovascular Surgery in Argentine

Conditions
-----------------
Cardiovascular Diseases, Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Iinclusion Criteria: Over 18 years Myocardial revascularization surgery Valvular surgeries Ascending Aortic Surgery Type A Aortic Dissection Surgery Combined surgery Exclusion Criteria: Cardiovascular surgery for congenital pathologies Peripheral vascular surgery Cardiovascular surgery secondary to trauma Thoracic and abdominal aorta pathology Other surgeries

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Registry of Cardiovascular Surgery | Evaluate results of cardiovascular surgery | one year |
Changes in Cerebral Oxygenation and Cognitive Functions

Study Overview
=================
Brief Summary
-----------------
The present study aimed to assess the influence of nitroglycerin and esmolol-induced hypotension on cerebral oxygen saturation by using near-infrared spectroscopy and postoperative cognitive function in patients undergoing nasal surgery.

Official Title
-----------------
Changes in Cerebral Oxygenation and Cognitive Functions During Controlled Hypotension

Conditions
-----------------
Cognitive Dysfunction, Hypotension; Controlled

Intervention / Treatment
-----------------
* Drug: Esmolol
* Drug: Nitroglycerin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent patients with ASA physical status of I-II aged 18-65 years Exclusion Criteria: Age under 18 or above 65 ASA > II coagulation disorders history of cardiovascular and cerebrovascular disease poor Blood Pressure control anemia, pregnancy, addiction to opioids body mass index (BMI) > 35 intraoperative systolic BP < 65 mmHg surgical duration less than 30 minutes or more than 160 minutes need for an intraoperative sympathomimetic drug and the use of other hypotensive drugs preoperative Mini-Mental State Examination (MMSE) score of 23 or less.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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 |
| --- | --- |
| esmolol (Group E)<br> | Drug: Esmolol<br> <br> |
| nitroglycerin (Group N)<br> | Drug: Nitroglycerin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effects of controlled hypotension on cerebral oxygen saturation | influence of nitroglycerin and esmolol-induced hypotension on cerebral oxygen saturation by measuring regional cerebral oxygen saturation using Near-Infrared Spectroscopy | until end of the surgical procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effects of controlled hypotension on cognitive function | influence of nitroglycerin and esmolol-induced hypotension on postoperative cognitive function using mini mental test score | 24 hour before surgery and 24 hour after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebral oxygenation, cognitive function, esmolol, nitroglycerine
Protocol to Obtain Blood for Discovery of Novel Biomarkers and Potential Therapeutic Targets in Chronic Lymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect a blood sample from patients with Chronic Lymphocytic Leukemia (CLL) and from volunteers without CLL.

Detailed Description
-----------------
The blood sample will be used in the laboratory to perform focused studies on Chronic Lymphocytic Leukemia (CLL).

Official Title
-----------------
Protocol to Obtain Blood for Discovery of Novel Biomarkers and Potential Therapeutic Targets in Chronic Lymphocytic Leukemia

Conditions
-----------------
Chronic Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing routine blood draws as part of their ongoing follow-up care for CLL at the Norris Cotton Cancer Center of DHMC. Normal donors who have no history of active or prior hematologic malignancy. Exclusion Criteria: Patients who have received cytotoxic drug, oral or intravenous steroid or targeted antibody therapy for their CLL, other hematologic malignancy or other disease process within the past 2 months are excluded. Use of intravenous immunoglobulin (IVIg) is not a reason for exclusion. Normal donors who have a history of steroid use, immunosuppression therapy or autoimmune disease are excluded.

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 |
| --- | --- |
| Patients with CLL<br>Patients undergoing routine blood draws as part of their ongoing follow-up care for CLL at the Norris Cotton Cancer Center of DHMC. | Other: No Intervention<br>* No Intervention<br>|
| Normal Volunteers<br>Normal volunteers who have no history of active or prior hematologic malignancy. | Other: No Intervention<br>* No Intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify the genes that are differentially expressed at the polysomal RNA and protein levels in human patient CLL cells (compared to normal donor lymphocytes) using high-throughput microarray approaches. |  | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether the novel candidate genes from Specific Aim 1 have potential roles in CLL. (Note: Specific Aim 2 does not involve human subjects research). |  | 2 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Lymphocytic Leukemia, CLL, Normal Volunteers
Examination of the Effects of Liraglutide on the Mode of Action of Insulin Detemir

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States. The aim of this clinical trial is to investigate whether chronic liraglutide administration affects the mode of action (pharmacokinetics) of insulin detemir

Official Title
-----------------
Insulin Detemir Co-administered With Liraglutide: An Open Label Trial to Assess Insulin Detemir and Liraglutide Pharmacokinetics and Pharmacodynamics Following Liraglutide Therapy in Subjects With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: liraglutide
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with type 2 diabetes BMI less than 45.0 kg/m2 Insulin naive Currently treated with Oral Anti-Diabetic drugs (OADs) and metformin with a HbA1c between 7.0 and 9.5% or currently treated with metformin only with a HbA1c between 7.0 and 10.0% Exclusion Criteria: Any clinically significant disease other than type 2 diabetes Currently using daily insulin Thiazolidinione use or other injectable diabetes medications within the last 3 months

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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: liraglutide<br>* Subjects will self-inject liraglutide subcutaneously daily during the trial and three euglycemic clamps will be performed: one without liraglutide (insulin detemir alone), the second with only liraglutide treatment and the third with liraglutide and insulin detemir administration<br>Drug: insulin detemir<br>* Subjects will self-inject liraglutide subcutaneously daily during the trial and three euglycemic clamps will be performed: one without liraglutide (insulin detemir alone), the second with only liraglutide treatment and the third with liraglutide and insulin detemir administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin detemir pharmacokinetics with and without liraglutide administration |  | at approx. 12 weeks (including screening, washout and evaluation period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of liraglutide with and without insulin detemir |  | at approx. 12 weeks (including screening, washout and evaluation period) |
The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements

Study Overview
=================
Brief Summary
-----------------
Perioperative goal directed fluid therapy may reduce complication rate after surgery. Minimal invasive cardiac output monitoring is a key method to guide fluid therapy. More operations are being performed by keyhole surgery (laparoscopy). For laparoscopy, the abdomen is filled with carbon dioxide. Increased pressure in the abdomen may influence minimal cardiac output monitoring, therefore minimal cardiac output monitoring is not recommended during laparoscopy. This study aims to validate minimal cardiac output monitoring during laparoscopy and therefore facilitate for goal directed fluid therapy.

Official Title
-----------------
The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements

Conditions
-----------------
Pneumoperitoneum

Intervention / Treatment
-----------------
* Procedure: Pneumoperitoneum and SVV/PPV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients >18 years scheduled for robot-assisted prostatectomy able to give informed consent Exclusion Criteria: Patient with atrial fibrillation or other non-regular rhythm. Severe aorta/mitral stenosis Not able to give informed consent

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pneumoperitoneum and SVV/PPV<br> | Procedure: Pneumoperitoneum and SVV/PPV<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of stroke volume variation and pulse pressure variation during pneumoperitoneum | Change in PPV/SVV(LiDCO), PPV(Philips) and SVV/CO(TEE) in percent before and after pneumoperitoneum. | peroperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in measurements from different methods of minimal cardiac output monitoring. |  | peroperative | 
| Effect of fluid bolus under pneumoperitoneum (responder vs. non-responder) |  | peroperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Difference of, measurements, before and after
Long-term Safety Study of Treatment With the Thrombopoietin Agonists Eltrombopag and Romiplostim in Patients With Immune Thrombocytopenia (ITP)

Study Overview
=================
Brief Summary
-----------------
Thrombopoietin Receptor Agonists (TPO-ra) are novel treatment modalities for patients with refractory Primary Immune Thrombocytopenia (ITP), but only few data are available for long-term effects of these drugs. In this observational study, effects and adverse effects including evaluation of bone marrow biopsies done at fixed intervals will be recorded from ITP patients treated with TPO-ra. For some patients, blood samples will be collected for research use.

Official Title
-----------------
Long-term Safety Study of Treatment With the Thrombopoietin Agonists Eltrombopag and Romiplostim in Patients With Primary Immune Thrombocytopenia (ITP)

Conditions
-----------------
Idiopathic Thrombocytopenic Purpura

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with ITP platelet counts < 25 x10*9/L or < 50 x10*9/L with bleeding symptoms meets criteria for treatment with TPO-ra Females must use contraceptives when applicable for at least three months before inclusion Exclusion Criteria: Pregnancy or nursing Former thromboembolic events excluding one incidence of deep venous thrombosis as complication to surgery or pregnancy or one incidence of cerebral embolism as complication to atrial fibrillation Liver insufficiency (for eltrombopag only) TPO-ra contraindications (e.g. allergy) TPO-ra treatments less than 6 months prior to inclusion

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 |
| --- | --- |
| ITP patients<br>Patients with refractory ITP eligible for treatment with TPO-ra | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with sustained response at 6 months follow-up | Response is defined as platelet count > 30.000 mio/L and no bleeding | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yearly response rates | Number of patients with response to treatment at 1, 2, 3, 4, and 5-year follow-up | 5 years | 
| Frequency of relapse |  | 5 years | 
| Rate of splenectomy |  | 5 years | 
| Development of reticulin fibrosis in bone marrow biopsies |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ITP, romiplostim, eltrombopag, bone marrow fibrosis, long-term safety