linjc16/ctgov huggingface dataset:
Ultrasound Paravertebral Block in Breast Surgery.

Study Overview
=================
Brief Summary
-----------------
The purpouse of the study is to determine wether Ultrasound Guided,Ens-assisted paravertebral block with single shot is a safe and reliable anesthetic technique in breast surgery.

Detailed Description
-----------------
General anaesthesia is currently the conventional technique used for breast surgery. Thoracic Paravertebral block (PVB) has been used with multiple injection. We compared a single injection thoracic PVB with general anaesthesia (GA) in 20 consenting patients, scheduled for unilateral breast surgery.

Official Title
-----------------
Single Injection, Ultrasound Guided Paravertebral Block for Anesthesia in Breast Surgery.

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists classification I-III Written informed consent Age older than 18 years old Exclusion Criteria: allergy to local anesthetics local sepsis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TPVB group<br>In this group of patients thoracic paravertebral block is performed. | |
| GA group<br>In this group of patients general anesthesia is performed. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain | The anesthesist evaluated the post-operative pain at rest and in movement with the NRS at 3-6-12-24 hours. | Up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption of analgesic drugs | We register the consumption of analgesic drugs in both groups in the post-operative period till 24 hours. | up to 24 hours | 
| Efficacy of Paravertebral block | We evaluate efficacy and extension of the block with ice test and pin-prick test | pre-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasound-guided paravertebral block, regional anesthesia, breast surgery
ASA Levels in TEP and Lichtenstein Repair Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine and compare the possible affects of two different inguinal hernia repair technique (TEP and Lichtenstein) on serum ASA levels.

Detailed Description
-----------------
Antisperm antibody levels are thought to be indirect indicators of spermatic duct injuries. The investigators' ultimate goal is to draw a conclusion about the effect of the type of surgery on spermatic duct integrity. The investigators are going to collect serum samples from inguinal hernia patients before and after surgery. The investigators aim to assess the effect of surgery on antisperm antibody levels of patients who undergo Licthenstein and TEP repair. Preoperative antisperm antibody levels will serve as control levels for each patient group.

Official Title
-----------------
Comparison of Anti-sperm Antibody Levels in Inguinal Hernia Patients Who Undergo Totally Extra-peritoneal and Lichtenstein Repair

Conditions
-----------------
Hernia, Inguinal

Intervention / Treatment
-----------------
* Procedure: Lichtenstein Repair
* Procedure: TEP Repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: to accept the terms of the randomization and all study to have unilateral inguinal hernia and set for an inguinal hernia repair to be a father Exclusion Criteria: to have any kind of autoimmune disorders any kind of infertility history to have a history of inguinal and/or genital surgery and/or trauma

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TEP group<br>Patients who undergo totally extraperitoneal hernia repair, TEP Repair. | Procedure: TEP Repair<br>* Laparoscopic totally extraperitoneal repair for inguianal hernias<br>|
| Active Comparator: Lichtenstein group<br>Patients who undergo Lichtenstein repair. | Procedure: Lichtenstein Repair<br>* Well defined Lichtenstein Repair for inguinal hernias<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Anti-sperm antibody levels after inguinal hernia surgery | Samples will be collected before hernia surgery and three months after surgery | Three months for each patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Anti-sperm antibody levels between inguinal hernia patients who have undergone laparoscopic totally extraperitoneal repair and Lichtenstein repair techniques |  | 2 years anticipated |
Testing Mestinon and Exercise in Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial was to test the combined and independent effects of 6 months of exercise and Mestinon in people with fibromyalgia. Specifically, we wanted to determine if Mestinon helped people with fibromyalgia have an easier time exercising and if their symptoms improved by the end of the trial.

Detailed Description
-----------------
Earlier, we demonstrated that people with fibromyalgia fail to make adequate growth hormone when they exercise intensively. We also demonstrated that a single dose of Mestinon helped people make normal levels of growth hormone when they exercised in our laboratory. We wanted to know if 6 months of exercise with concurrent Mestinon therapy would make growth hormone (and related markers) normal and improve fibromyalgia symptoms.

Official Title
-----------------
Maximizing Exercise Effectiveness in Fibromyalgia

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Behavioral: Exercise
* Drug: pyridostigmine
* Drug: Placibo
* Behavioral: Attention Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have Fibromyalgia Exclusion Criteria: Subjects will be excluded if they have a history of rheumatic disease or other disorder that may compromise ability to safely complete study protocol, be pregnant, nursing, or currently involved in unresolved litigation.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Behavioral: Exercise<br> <br> Drug: pyridostigmine<br> <br> * Other names: Mestinon;|
| Experimental: 2<br> | Drug: pyridostigmine<br> <br> * Other names: Mestinon;Drug: Placibo<br> <br> |
| Experimental: 3<br> | Behavioral: Exercise<br> <br> Behavioral: Attention Control<br> <br> |
| Experimental: 4<br> | Drug: Placibo<br> <br> Behavioral: Attention Control<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of Growth Hormone Post Exercise | Serum growth hormone at peak V02/treadmill | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Fibromyalgia Symptoms |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibromyalgia, Exercise, Mestinon
Ambulatory Care Characteristics as Predictors of Mortality and Re-Admission

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to construct a prognostic model to identify risks of poor outcomes at one year following hospital discharge of patients treated in an ambulatory cate setting. The study will incorporate pre-hospitalization characteristics, hospitalization events, comorbidity burden, psychosocial measures and post-hospitalization care characteristics to predict re-hospitalization and mortality at one year.

Detailed Description
-----------------
This model will identify potentially modifiable variables in the post-hospitalization clinic setting that result in increased rates of hospital readmission and mortality. Specifically, it is hypothesized that longer time to first outpatient visit after hospitalization, multiple providers, poor follow-up with scheduled appointment and discrepancies between discharge and outpatient medication lists will be predictors of adverse outcomes. Utilizing statistical modeling methods, it will be possible to recognize at risk patients, to identify modifiable risk factors and outpatient care characteristics, and in the future, to direct patient specific interventions to improve outcomes.

Official Title
-----------------
Ambulatory Care Characteristics as Predictors of Mortality and Re-Admission

Conditions
-----------------
Ambulatory Care Patients Who Were Hospitalized in 2001 at the Cornell Campus of the New York-Presbyterian Hospital

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. All patients admitted to New York Presbyterian Hospital and followed in Cornell Internal Medicine Associated for at least one year prior to admission. Exclusion Criteria: Patients who do not wish to participate in the study. Patients who are not followed in Cornell Internal Medicine Associates.

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 |
| --- | --- | --- |
| Psychosocial measures |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pre-hospitalization characteristics, Post-hospitalization characteristics, Psychosocial measures, Predict re-hospitalization
NovaLign Intramedullary Fixation System (IFS) for the Treatment of Humeral Fractures

Study Overview
=================
Brief Summary
-----------------
This post-market clinical study is being done to evaluate the use of the NovaLign™ Intramedullary Fixation System in the treatment of humeral fractures.

Detailed Description
-----------------
This is an observational, prospective, nonrandomized open label, post-market clinical study, designed to evaluate the use a flexible intramedullary fixation device used in the treatment of fractures of the humerus. This is a multicentre trial.

Official Title
-----------------
A Study to Evaluate the Safety and Effectiveness of the NovaLign Intramedullary Fixation System for the Treatment of Humeral Diaphysis Fractures

Conditions
-----------------
Fracture

Intervention / Treatment
-----------------
* Device: NovaLign Intramedullary Fixation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Humeral Fracture Surgical intervention can be performed within 14 days of injury (injury being Day 0 for this particular criteria) Fully functioning contralateral limb (e.g., hand, arm, shoulder) Age 18 years or older and skeletally mature Exclusion Criteria: Intraarticular fractures or those involving shoulder or elbow of the index arm Pathologic fracture (e.g., tumor involvement, osteomalacia, etc.; osteoporosis is not an exclusion) Evidence of neurologic injury in the index arm, including compartment syndrome or radial nerve palsy Additional upper body injuries (e.g., upper extremity, abdominal, thoracic, neck or head injury) that may affect or inhibit the evaluation of the index or contralateral arm, shoulder, elbow, etc or would not allow the patient to follow or comply with appropriate post-operative regimens Any previous bodily injury or surgery that may interfere with function or evaluation of index or contralateral arm, shoulder, elbow, etc.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intramedullary Fixation System<br>Humeral fractures to be treated with the Intramedullary Fixation System | Device: NovaLign Intramedullary Fixation System<br>* Intramedullary fixation of broken humerus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic union and safety |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function, pain, and quality of life assessments at regular intervals |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fracture, Humerus, Intramedullary, Fixation
Global Lomitapide Pregnancy Exposure Registry

Study Overview
=================
Brief Summary
-----------------
To evaluate the outcomes of pregnancy in women treated with lomitapide.

Detailed Description
-----------------
To evaluate the outcomes of pregnancy in women treated with lomitapide at any time within 30 days prior to first day of Last Menstrual Period (LMP) or during pregnancy. The outcomes of primary interest are major congenital anomalies.

Official Title
-----------------
Global Lomitapide Pregnancy Exposure Registry

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Drug: lomitapide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant females exposed to lomitapide at any time within 30 days prior to first day of the LMP or during pregnancy. Exclusion Criteria: Patients who are unable or unwilling to provide written informed consent or assent are not eligible to participate in the PER.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lomitapide|As prescribed by Physician.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy | To evaluate the outcomes of pregnancy in women treated with lomitapide at any time within 30 days prior to first day of Last Menstrual Period (LMP) or during pregnancy. The outcomes of primary interest are major congenital anomalies. | 2 Years |
Platelet Inhibition and Bleeding in Patients Undergoing Non-Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate if there is an association between platelet inhibition and surgery-related bleeding in patients undergoing non-cardiac surgery during dual antiplatelet therapy.

Official Title
-----------------
Does Platelet Inhibition Predict Surgery Related Bleeding in Patients Undergoing Non-Cardiac Surgery During Dual Antiplatelet Therapy

Conditions
-----------------
Postoperative Bleeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intake of Clopidogrel, Prasugrel, or Ticagrelor within the last 7 days spontaneous bleeding or impeding surgery (major vascular surgery, intraperitoneal or intrathoracic surgery, ENT-surgery, orthopedic or trauma surgery, prostatic surgery) Exclusion Criteria: concomitant medication with warfarin renal insufficiency needing dialysis concomitant therapy with GPIIB/IIIA Antagonists expected duration of operation >30min
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| elective and acute non-cardiac surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increased risk of bleeding (according to TIMI definition) |  | 24hours postoperatively |
Intraoperative Optimisation of Tissue Oxygenation

Study Overview
=================
Brief Summary
-----------------
Monitoring and optimizing tissue oxygenation (StO2) in high-risk surgery and/or high-risk surgical patients may decrease the risk of postoperative complications. Tissue hypoxia occurs frequently during high-risk surgery in high-risk patients. The investigators want to see if an algorithm aimed at optimizing intraoperative tissue oxygenation reduces perioperative complications as well as length of stay in the intensive care unit (ICU LOS), 28-day mortality, and the duration of mechanical ventilation in these patients.

Official Title
-----------------
Intraoperative Monitoring and Optimisation of Tissue Oxygenation In High-Risk Surgical Patients for Reduction of Postoperative Complications: a Pilot Study

Conditions
-----------------
Higk Risk Surgery

Intervention / Treatment
-----------------
* Device: connected to the InSpectra Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: . Major elective surgery Aged over 65 years with moderate functional limitation of one or more organ systems ASA classification III or IV, i.e. severe cardiac, vascular, respiratory or metabolic illness resulting in severe functional limitation Routine use of arterial and central venous lines Planned postoperative stay on ICU or PACU Exclusion Criteria: Refusal of consent acute myocardial ischemia prior to enrolment patients receiving palliative treatment only disseminated malignancy patients unlikely to survive more than 6 hours emergency surgery transplantations neurosurgical patients patients undergoing extensive liver surgery requiring low CVP management

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard care<br>The data from the InSPectra Monitor in the Control group will be inaccessible for the Investigator since this is not a part of their daily medical practice | |
| Active Comparator: Treatment group,<br>The data given by the monitor will be available for the Investigator and used to apply the optimization protocol | Device: connected to the InSpectra Monitor<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of perioperative complications | organ dysfunction, SOFA score, troponin T, creatinin, CRP | during operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tissue oxygenation, higk risk surgery, high risk patient, postoperative complications
IFN-gamma-releasing Assay Based Approach in Patients With Suspected Tuberculous Peritonitis

Study Overview
=================
Brief Summary
-----------------
The diagnosis of tuberculous peritonitis (TBP) is still challenging, and largely dependent on invasive procedures such as laparoscopy. A recently developed RD-1 gene-based assay for diagnosing TBP shows has given promising results. The investigators thus created a 2-step algorithm using the Blood/Ascites ELISPOT assays and adenosine deaminase (ADA) in ascites for differentiation of TBP from other diagnoses (Blood ELISPOT ≥6 spots or ADA ≥ 21 U/L' as a rule-out test and 'Ascites/Blood ratio ≥3' as a rule-in test). This study is the randomized controlled trial on whether this 2-step algorithm-based approach can reduce the laparoscopic biopsy for the diagnosis of TBP in patients with suspected TBP.

Official Title
-----------------
IFN-gamma-releasing Assay Based Approach in Patients With Suspected Tuberculous Peritonitis

Conditions
-----------------
Suspected Tuberculous Peritonitis

Intervention / Treatment
-----------------
* Other: Blood and Ascites ELISPOT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with suspected tuberculous peritonitis age 16 or more formal informed consent Exclusion Criteria: not specified

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: conventional diagnostic flow arm<br>Perform the laparoscopic biopsy as a discretion of attending physician's decision | |
| Experimental: two-step algorithm-based approach<br>Perform the laparoscopic biopsy as a discretion of attending physician's decision, but if the below conditions are met, do not perform the laparoscopic biopsy. Blood ELISPOT >= 6 spots or ascites adenosine deaminase > 20 IU/L, and Ascites ELISPOT/Blood ELISPOT rato > 3 | Other: Blood and Ascites ELISPOT<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the frequency of laparoscopic biopsy |  | 1 week after the enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the frequency of correct or wrong diagnosis | the frequency of correct or wrong diagnosis | 6 months after the enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tuberculosis, peritonitis, laparoscopy