linjc16/ctgov huggingface dataset:
Loco/Regional Anaesthesia Evaluation in Laparoscopic Hernioplasty

Study Overview
=================
Brief Summary
-----------------
Laparoscopic hernioplasty is associated with lesser postoperative pain and quick return to work. TAP block is the gold standard technique in this type of hernioplasty. Our aim is to compare TAP block with a novel local infiltration technique that uses direct laparoscopical vision.

Detailed Description
-----------------
Laparoscopic hernioplasty is associated with lesser postoperative pain and quick return to work. TAP block is the gold standard technique in this type of hernioplasty. Our aim is to compare TAP block with a novel local infiltration technique that uses direct laparoscopical vision. Patients will be randomized into two arms of intervention that will be compared by a blind analysis. Primary outcomes will be postoperative pain evaluated systematically until 30 days postoperative, and analgesic consumption.

Official Title
-----------------
Loco/Regional Anaesthesia Evaluation in Laparoscopic Hernioplasty

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: Novel local infiltration technique
* Procedure: TAP block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or more. Programmed inguinal laparoscopic hernioplasty Exclusion Criteria: Allergic to medication prescribed Story of mesh rejection

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
Interventional Model Description: Two randomized cohorts of treatment.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAP block<br>TAP block technique. | Procedure: TAP block<br>* TAP block technique<br>|
| Experimental: Novel local infiltration technique<br>Local analgesic infiltration in the mesh fixation site | Procedure: Novel local infiltration technique<br>* Local analgesic infiltration in the mesh fixation site<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Postoperative main measured by an visual analogue scale | 30 days postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesics consumption | Time to analgesic consumption | 30 days postoperative | 
| type of analgesic consumption | type of analgesic consumption | 30 days | 
| pain at the moment of need of analgesics take | pain measured at the analgesic consumption | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative pain, Laparoscopic inguinal hernioplasty, TAP block
Clinical Course and Treatment of COVID-19 Inpatients in Hospital

Study Overview
=================
Brief Summary
-----------------
The study is an epidemiological observational study. It serves to collect data from patients with positive COVID-19 test results who are hospitalized. All data describing the course of the inpatient stay are recorded (Length of stay, course of therapy, medication, X-ray and CT results,ventilation mode and duration, laboratory). Furthermore, anthropometric data and information on COVID-19 symptoms is recorded.

Detailed Description
-----------------
The aim of this study is to describe the course of disease and the treatment of patients suffering from COVID-19 who are hospitalized and treated as inpatients: Are there common features (previous illnesses, medication, age, BMI, etc.), which may influence the course of disease? Are there therapeutic procedures that have a positive or negative impact on the course of the disease or the length of stay in the intensive care unit/ the duration of ventilation (early/late intubation, CPAP, NIV, ECMO)?

Official Title
-----------------
Clinical Course and Treatment of COVID-19 Inpatients in Hospital

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: positive COVID-19 test result Age > 18 years Exclusion Criteria: Age < 18 years negative COVID-19 test result lack of agreement Any medical, psychological or other condition, that restricts the ability of the person to be informed and to give the consent for voluntary participation in this trial

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

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 |
| --- | --- | --- |
| convalescence/death | has patient died or has patient recovered | through study completion, an average of 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay in the intensive care unit | length of stay in the intensive care unit | through study completion, an average of 2 months | 
| length of stay in hospital | length of stay in hospital | through study completion, an average of 2 months |
Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the analgesic efficacy and safety of N1539 in subjects undergoing abdominal laparoscopic surgery.

Official Title
-----------------
A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Analgesic Efficacy, Safety and Tolerability of Intravenous N1539 in Subjects After Abdominal Laparoscopic Surgery

Conditions
-----------------
Laparoscopic Surgery

Intervention / Treatment
-----------------
* Drug: N1539
* Drug: N1539
* Drug: N1539
* Drug: Ketorolac Tromethamine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planning to undergo elective abdominal laparoscopic surgery involving a single site/organ and does not have intraperitoneal metastases suspected or identified Exclusion Criteria: Use of ketorolac is contraindicated Use of general anesthesia is contraindicated Has a medical condition that could adversely impact subject participation Has diabetes mellitus and glycosylated hemoglobin (HbA1c) >9.5 or history of prolonged uncontrolled diabetes Body mass index (BMI) less than 18 or greater than 35 Has a history of intolerance or allergic reactions to non-steroidal anti-inflammatory drugs (NSAIDs), Cox-2 inhibitors, aspirin or other salicylates Known or suspected sleep apnea History of Hepatitis B or C Has a psychiatric disorder that impairs capability of subject to report pain Known to have chronic obstructive pulmonary disease (COPD) with carbon dioxide retention or chronic hypoxemia

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N1539 15 mg<br> | Drug: N1539<br>* IV<br>|
| Experimental: N1539 30 mg<br> | Drug: N1539<br>* IV<br>|
| Active Comparator: Ketorolac<br>IV | Drug: Ketorolac Tromethamine<br>* IV<br>|
| Placebo Comparator: Placebo<br>IV | Drug: Placebo<br>* IV<br>|
| Experimental: N1539 7.5mg<br> | Drug: N1539<br>* IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sum of the time-weighted pain intensity differences (SPID) as recorded on the Visual Analog Scale (VAS) from baseline (time 0) to 24 hours following the first dose of study medication (SPID 24) |  | 0 to 24 hours |
Clinical Status Monitoring in Implantable Cardiac Defibrillator (ICD) Patients by Physiological Diagnosis (PhD) Function

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the performance of advanced features, that have been implemented in the PARADYM ICD Platform offering single chamber (VR - model 8250), dual Chamber (DR - 8550) and Cardiac Resynchronization System with defibrillation capabilities (PARADYM CRT System, model 8750) in a general ICD population.

Detailed Description
-----------------
The study will particularly focus on a new sensor-based diagnostic feature, called PhD-Clinical Status (PhD). A dedicated PhD screen shows the trends of patients' ventilation levels at rest (MVR) and under effort (MVE), and the corresponding level of activity, day-by-day, over a period of 6 months.

Official Title
-----------------
Clinical Status Monitoring in ICD Patients by Physiological Diagnosis (PhD) Function

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: ICD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient eligible for implantation of an ICD or a CRT-D device according to current available guidelines. Documented chronic HF (NYHA Class II to IV) at the time of enrollment Scheduled for implant of a PARADYM ICD / CRT-D or implanted within the previous month Signed and dated informed consent Exclusion Criteria: Any contraindication for ICD therapy Abdominal implantation site Acute myocarditis Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month Planned heart transplant Mechanical tricuspid valve Unable to perform the 6 minute Walking Test at time of enrollment Already included in another clinical study Life expectancy less than 13 months Inability to understand the purpose of the study or refusal to cooperate Inability or refusal to provide informed consent Under guardianship Age of less than 18 years Pregnancy (Women of childbearing potential should have a negative pregnancy test prior to enrollment)

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ICD|Paradym CRT model 8750 - Paradym DR model 8550 - Paradym VR model 8250|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective is to demonstrate that agreement correlation is superior to 67% |  | 13 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PhD, EGM, CRT-D, The study will particularly focus on a new-based diagnostic feature, called PhD-Clinical Status (PhD)
Comparing the Efficacy of Visible Light-Ultraviolet A1 Light Versus Narrowband-Ultraviolet B on Generalized Vitiligo

Study Overview
=================
Brief Summary
-----------------
As part of this study, you may have a procedure called phototherapy which involves either VL-UVA or NB-UVB irradiation. NB-UVB phototherapy is not experimental in vitiligo, but use of VL-UVA1 phototherapy in vitiligo is. The purpose of this pilot study is to determine whether VL-UVA1 or NB-UVB phototherapy more efficiently induces repigmentation in patients with generalized vitiligo.

Official Title
-----------------
Comparing the Efficacy of VL-UVA1 Versus NB-UVB on Inducing Repigmentation in Subjects With Generalized Vitiligo

Conditions
-----------------
Generalized Vitiligo

Intervention / Treatment
-----------------
* Procedure: Visible Light-Ultraviolet A Light or Narrowband-Ultraviolet B phototherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects ≥ 18 years of age with a diagnosis of generalized vitiligo Subjects on a stable topical/oral regimen for the past 3 months and continuing on a stable regimen Subjects able to understand the requirements of the study Subjects able and willing to sign informed consent Exclusion Criteria: Subjects on photosensitizing medications Subjects receiving any concurrent phototherapy Subjects who plan to use tanning parlors or expose themselves to excess sunlight Subjects with known photosensitivity disorder Subjects with apparent phototoxicity Subjects with unstable vitiligo Subjects currently using bleaching agents Subjects who are pregnant, lactating, or planning on becoming pregnant Subjects who in the opinion of the investigator/sub-investigator, are not appropriate candidates for this 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
Intervention Model: Single Group Assignment
Interventional Model Description: The subject serves as their own control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: VL-UVA1 vs NB-UVB<br>Participants will be treated with both VL-UVA and NB-UVB on different areas | Procedure: Visible Light-Ultraviolet A Light or Narrowband-Ultraviolet B phototherapy<br>* Patients will have different kinds of light shined on different areas<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depigmentation of vitiligo lesion | Change in pigment will be assessed by colorimetry which measures change in pigment | 13 measurements over 26 visits | 
| Change in melanin content of vitiligo lesion | Change in pigment will be assessed by diffuse reflectance spectroscopy which will measure the melanin content and dyschromia | 13 measurements over 26 visits |
Sucrose Analgesia in Infants Undergoing Casting for Club Foot

Study Overview
=================
Brief Summary
-----------------
Babies with congenital clubfeet are treated by the Ponseti casting method. The procedure may cause discomfort to the patient. This study will examine the use of 5 CC Sucrose solution as a comforting agent for the babies.

Detailed Description
-----------------
Babies who were born with congenital clubfeet are currently being treated by the conventional Ponseti method. This procedure is done in an outpatient clinic setup. The procedure is painless but may cause some discomfort to the patient. This study will examine the use of 5 CC Sucrose solution as a comforting agent for the babies. The control group will consist of patients who will get 5cc saline pre cast application, while the study group will be given 5cc of Sucrose solution. Patients and physicians are blinded to the treatment they get. Outcome measures will include pulse rate and oxygenation as an accepted measure of discomfort.

Official Title
-----------------
Effectiveness of Sucrose Analgesia in Infants Undergoing Casting for Club Foot

Conditions
-----------------
Clubfoot

Intervention / Treatment
-----------------
* Dietary Supplement: sucrose solution
* Dietary Supplement: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All otherwise healthy babies who need casting for congenital clubfeet Exclusion Criteria: All non idiopathic conditions for clubfoot, all individuals who have any kind of known systemic illness, all babies born to diabetic mothers.

Ages Eligible for Study
-----------------
Minimum Age: 4 Weeks
Maximum Age: 12 Months

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sucrose<br>5cc sucrose solution | Dietary Supplement: sucrose solution<br>* 5cc 5% sucrose solution P/O<br>|
| Placebo Comparator: Saline<br>5cc saline p/o | Dietary Supplement: Saline<br>* 5cc saline p/o<br>* Other names: 5cc Saline solution;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse rate, Blood oxygenation |  | During casting | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clubfoot, casting, ponseti, discomfort
Early Continuous Renal Replacement Therapies (CRRT) in Patients With Severe Sepsis or Septic Shock With Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
Severe sepsis or septic shock with acute kidney injury shows high mortality in intensive care unit. A few studies have shown CRRT relating the clinical improvement seems to be related to the early initiation of therapy. But there is no consensus for proper time of CRRT may improve the prognosis. The study is a prospective randomized one center trial comparing two treatments in patients suffering from septic shock complicated with acute renal failure admitted to ICU, treated either early by CRRT (35 ml/kg/h) or by conventional RRT.

Official Title
-----------------
A Randomized Controlled Multi-Center Trial of the Early Application of CRRT in Patients With Severe Sepsis or Septic Shock

Conditions
-----------------
Severe Sepsis, Septic Shock, Acute Kidney Injury

Intervention / Treatment
-----------------
* Procedure: crrt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Septic shock (Bone criteria) for less than 14D RIFLE criteria : Injury or Failure or nearly anuria more than 2hr Age over 18 years Written informed consent by next of kin. Exclusion Criteria: Cirrhosis child class C CRF or ESRD Too high APACHE II & SOFA score at admission Age over 80 years Life expectancy less than 3 months (metastatic cancer - hepatoma, lung ca.)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: early crrt, late crrt<br> | Procedure: crrt<br>* early CRRT (35 ml/kg/h)& acute kidney injury or failure or nearly anuria more than 2hr or late conventional dialysis indication<br>* Other names: renal replacement therapy, timing;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death from all causes at 28 days after randomisation |  | 28 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death within the in the intensive care unit. Death within 90 days of randomisation. Death prior to hospital discharge. Length of ICU stay. The need for and duration of other organ support |  | 90 day |
Drug Related Problems Among Patients With Femoral Neck Fractures in an Orthopedic Ward

Study Overview
=================
Brief Summary
-----------------
the purpose of the study is to: Identify and characterize drug related problems in patients after a femur neck fracture that are hospitalized in the orthopedic department at Meir medical center. Evaluate the contribution of a clinical pharmacist in identifying,characterizing and preventing drug related problems in patients after a femur neck fracture that are hospitalized in the orthopedic department at Meir medical center.

Official Title
-----------------
Identification and Characterization of Drug Related Problems Among Patients With Femoral Neck Fractures in an Orthopedic Ward

Conditions
-----------------
Femoral Neck Fractures

Intervention / Treatment
-----------------
* Other: inspection of medical records


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients over 64 patients after a femoral neck fracture patients hospitalized in the orthopedic ward at Meir medical center patients who speak Hebrew, Russian or English Exclusion Criteria: patients under 64 patients without a femoral neck fracture patients who don't speak Hebrew, Russian or English

Ages Eligible for Study
-----------------
Minimum Age: 64 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 after femur neck fracture<br> | Other: inspection of medical records<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the overall number of drug related problems in patients with a femur neck fracture in the orthopedic department |  | participants will be followed for the duration of hospital stay, an expected average of 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clinical pharmacist, drug related problems, femoral neck fractures, orthopedic patients
Low-Dose CBCT Protocol for Pre-Surgical Evaluation of the Mandibular Third Molar, a Feasible Choice?

Study Overview
=================
Brief Summary
-----------------
Low-Dose CBCT Protocol for Pre-Surgical Evaluation of the Mandibular Third Molar. CBCT investigations with standard and low dose protocol for evalutation of the mandibular third molar.

Detailed Description
-----------------
Two CBCT scans were acquired of each examination site: one scan using the standard clinical protocol (90kV, 5mA, 9.4s) and one, the low-dose protocol (90kV, 2mA, 9.4s). All exposures were made with a Veraviewepocs 3D F40 (J Morita Corp.; Kyoto, Japan) using a field of view (FOV) of 4.0 x 4.0 cm and a rotation mode of 180°, voxel size of 0.125 mm.

Official Title
-----------------
Low-Dose CBCT Protocol for Pre-Surgical Evaluation of the Mandibular Third Molar, a Feasible Choice?

Conditions
-----------------
Cone Beam Couputed Tomography, Dose Reduction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a need for a CBCT investigation of the mandibula third molar Exclusion Criteria: been involved in radiographic examinations for science beforer.

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

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 |
| --- | --- | --- |
| evaluation of radiographic images | landmarks | 1 day |