linjc16/ctgov huggingface dataset:
NETTUNIT - Italy-Tunisia Cross-border Environmental network_2

Study Overview
=================
Brief Summary
-----------------
The study involves the development and validation of a questionnaire for risk perception to be administered to residents of areas declared to be at high risk of environmental crisis in the areas of Caltanissetta (Italy) and Tunis (Tunisia). The questionnaire will be administered twice, at baseline and after 1 month.

Official Title
-----------------
NETTUNIT - Italy-Tunisia Cross-border Environmental network_2

Conditions
-----------------
Risk Perception

Intervention / Treatment
-----------------
* Other: Risk perception questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals aged 20-90 years of both sex, living in the areas of Caltanissetta (Italy) and Tunis (Tunisia). Exclusion Criteria: Individuals with learning difficulties.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- |
| Residents of areas at high risk of environmental crisis<br>1000 adult males and females living in areas declared at high risk of environmental crisis in the areas of Caltanissetta (Italy) and Tunis (Tunisia). | Other: Risk perception questionnaire<br>* A questionnaire for risk perception will be developed and administered<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Construct validity of the questionnaire score at baseline administration | The ability of the questionnaire score at baseline to differentiate between sub-samples that are known or expected to differ | Baseline administration | 
| Construct validity of the questionnaire score 1 month after the baseline administration | The ability of the questionnaire score 1 month after the baseline administration to differentiate between sub-samples that are known or expected to differ | 1 month after the baseline administration | 
| Repeatability of the questionnaire score between the first (baseline) and second (1 month) administration | The extent to which the answer distribution will be similar between the two administrations | Baseline administration and 1 month after the baseline administration |
Liver Transplantation and Metastatic Colo-rectal Cancer.

Study Overview
=================
Brief Summary
-----------------
Survival of colo-rectal cancer patients after liver transplantation.

Detailed Description
-----------------
Survival, time to progression, other malignancy, side-effects, quality of life.

Official Title
-----------------
Liver Transplantation and Metastatic Colo-rectal Cancer.

Conditions
-----------------
Colo-rectal Cancer

Intervention / Treatment
-----------------
* Procedure: Liver transplantation and colo-rectal cancer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Colo-rectal cancer - Exclusion Criteria: -

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: Liver transplantation<br> | Procedure: Liver transplantation and colo-rectal cancer<br>* Liver transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression side-effects |  | 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver transplantation
Regional Anesthesia in THR - Comparing the Analgesic Efficacy of Fascia Iliaca Block and Erector Spinae Plane Block

Study Overview
=================
Brief Summary
-----------------
THR (Total Hip Replacement) can be very painful and regional anesthesia is very effective in reducing postoperative pain. Fascia Iliaca Block (FIB) and Erector Spinae Plane Block (ESPB) are indirect approaches to the lumbar plexus that resulted to be very promising for THR. However, no studies investigated the analgesic superiority of either FIB or ESPB. In our study the investigators compare FIB and ESPB in terms of pain relief expressed as morphine consumption in the first 24 hours after primary THR.

Official Title
-----------------
Regional Anesthesia in THR - Comparing Analgesic Efficacy of Fascia Iliaca Block and Erector Spinae Plane Block

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

Intervention / Treatment
-----------------
* Procedure: FIB
* Procedure: ESPB
* Procedure: spinal anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary THR informed consent Exclusion Criteria: allergies to study drugs spinal anesthesia contraindicated kidney failure epilepsy, psychiatric disease, neurologic deficits revision surgery neuropathies in the lumbar area no informed consent pregnancy alcohol/opioid abuse emergency surgery/intensive care

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: randomized trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FIB<br>ultrasound guided Fascia Iliaca Block | Procedure: FIB<br>* FIB with ultrasound: Ropivacaine 0.5% 40 ml<br>Procedure: spinal anesthesia<br>* bupivacaine 0,5% 2.2 ml<br>|
| Experimental: ESPB<br>ultrasound guided Erector Spinae Plane Block | Procedure: ESPB<br>* ESPB (L4) with ultrasound: Ropivacaine 0.5% 40 ml<br>Procedure: spinal anesthesia<br>* bupivacaine 0,5% 2.2 ml<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine | milligrams of morphine consumed in the first postoperative day | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perceived postoperative pain: Numeric Rating Scale (NRS) | 11 point scale from 0 = no pain to 10 = worst imaginable pain | 24 hs | 
| perceived postoperative pain: Numeric Rating Scale (NRS) | 11 point scale from 0 = no pain to 10 = worst imaginable pain | 48 hours | 
| side effects | occurrence of nausea/vomiting, ileum, pruritus and urinary retention in the first 48 hours | 48 hours |
Pharmacokinetics of Propofol in Morbidly Obese Patients

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are To determine PK of propofol in bariatric patients To identify the physiological variables that induce propofol PK changes in bariatric patients, when compared to a normal-weight population. To define context-sensitive half-time profiles for propofol in bariatric patients.

Official Title
-----------------
Pharmacokinetics (PK) of Propofol in Bariatric (Morbidly Obese) Patients

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients admitted to the Aker University Hospital, scheduled for general or bariatric surgery, Both genders. Female subjects of childbearing potential must be using adequate contraception (i.e. using oral or IM contraception or an IUCD) and must have a negative pregnancy test (urine beta-HCG). Aged 18 - 60 years, both inclusive Body mass index (BMI) ≥ 20 kg/m2 Written informed consent Exclusion Criteria: Patients that are considered not to tolerate a standard dose of propofol administered as a bolus. Known hypersensitivity to propofol or its ingredients (soy, lecithin, glycerol, oil acid) Known hypersensitivity to any of the anesthetic agents to be used Pregnant women Lactating women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacokinetics<br>Propofol pharmacokinetics | Drug: Propofol<br>* Intravenous infusion over 30 min of Propofol 3-4 mg/kg body weight<br>* Other names: Diprivan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Propofol plasma concentrations | Arterial blood samples will be collected 0, 1, 2, 4, 8, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 480, 600, 720, and 1440 min after start of propofol bolus infusion. 2 samples will be collected at 0 and 1440 minutes, respectively. The remaining 6 blood samples will be collected according to a block sampling regimen, selected randomly within a time block containing 4 consecutive time points from the time point list noted above. In total 8 samples are drawn from each patient. | 0-24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Anesthetics, intravenous, Propofol, Pharmacokinetics
Complications of Ethanol-amine Oleate Intralesional Sclerotherapy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to clarify complications of Ethanolamine Oleate intralesional injections of maxillofacial venous formations in pediatric patients

Detailed Description
-----------------
Maxillofacial Venous malformations cause many functional and esthetic complications in children, intralesional sclerotherapy is the best choice of treatment; and Ethanol-amine Oleate has been the most commonly used sclerosing agent. The aim of this study is to clarify complications of Ethanolamine Oleate intralesional injections of maxillofacial venous formations

Official Title
-----------------
Complications of Ethanol-amine Oleate Intralesional Sclerotherapy Injections of Maxillofacial Venous Malformations in Pediatric Patients

Conditions
-----------------
Venous Malformation

Intervention / Treatment
-----------------
* Drug: Ethanol-amine Oleate Sclerotherapy Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: maxillofacial venous malformation - Exclusion Criteria: Patients with lung, liver, or kidney diseases Patients with Klippel-Trenaunay syndrome Patients mental or physical disabilities

Ages Eligible for Study
-----------------
Maximum Age: 12 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ethanol-amine Oleate Sclerotherapy Injection|Intralesional Sclerotherapy Injection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response | Complete Response - Marked Improvement - Moderate Improvement - No Response | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Maxillofacial, Pediatric, Venous Malformations, Ethanol-amine Oleate
Impact of Resected Gastric Volume on Postoperative Weight Loss After Laparoscopic Sleeve Gastrectomy for Morbid Obesity

Study Overview
=================
Brief Summary
-----------------
Impact of resected gastric volume on postoperative weight loss after laparoscopic sleeve gastrectomy for morbid obesity. Observational study with a mathematical method to approximate the calculation of the resected gastric volume after a sleeve gastrectomy and see the outcome on weight loss.

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Procedure: Gastric volume resected in sleeve gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI over 60 kg/m2 in high-risk patients, BMI between 50 and 60 kg/m2 in nondiabetic patients, BMI between 40 and 50 kg/m2 in patients refusing a complex procedure like Roux-en-Y gastric bypass, patients with severe gastric inflammatory disease and H. pylori infection, patients with previous abdominal surgery involving the intestines, and young patients refusing gastric banding Exclusion Criteria: severe and documented gastroesophageal reflux disease previous gastric surgery.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Gastric volume resected in sleeve gastrectomy|Misure of resected gastric volume and outcome|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resected gastric volume in laparoscopic sleeve gastrectomy | Impact of resected gastric volume on postoperative weight loss after laparoscopic sleeve gastrectomy for morbid obesity | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleeve gastrectomy, Morbid obesity, Resected gastric volume
Comparison of Vibration Arthrometry Between Patella Resurfacing and Patella Non-resurfacing in Total Knee Replacement Patients

Study Overview
=================
Brief Summary
-----------------
Patellar crepitus is a complication of total knee arthroplasty (TKA).The development of patellar crepitus after TKA are related to many factors such as femoral component design, surgical errors, and postoperative patellar baja. However, it is unclear whether patella resurfacing or patella non-resurfacing are associate with patellar crepitus. The primary objective of this study are to compare the prevalence of patellar crepitus and the mean value of vibroacoustic signal between patellar-resurfacing and patellar non-resurfacing in TKA. The secondary objective is to study the association between patellar crepitus and vibroacoustic signal.

Official Title
-----------------
Prospective Randomized Controlled Trial: Comparison of Vibration Arthrometry Between Patella Resurfacing and Patella Non-resurfacing in Total Knee Replacement Patients

Conditions
-----------------
Patellar Crepitus, Vibroacoustic Signal

Intervention / Treatment
-----------------
* Procedure: patellar resurfacing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary osteoarthritis of knee Exclusion Criteria: rheumatoid arthritis morbid obesity severe patellofemoral joint destruction patella maltracking patellofemoral incongruent inflammatory arthritis refuse to participation
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patellar resurfacing<br>patellar resurfacing TKA | Procedure: patellar resurfacing<br>* patellar component insert with cement<br>|
| No Intervention: patellar non-resurfacing<br>patellar non-resurfacing TKA | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of patellar crepitus | patellar crepitus investigate by physical examination | pre-op, 3, 6 month | 
| change of mean of vibroacoustic signal |  | pre-op, 3, 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patellar crepitus related to mean of vibroacoustic signal | study the association between patellar crepitus and vibroacoustic signal, patellar crepitus investigate by physical examination and mean of vibroacoustic signal assessed by an acceleration sensor | pre-op, 3, 6 month |
Electrogram and Hemodynamic Characteristics of Adaptive LBBAP in Patients With Heart Failure or Bradycardia

Study Overview
=================
Brief Summary
-----------------
This is a multi-site, non-randomized, data collection study. The purpose of this study is to investigate the cardiac electrical and mechanical function during LBBAP with different AV intervals.

Detailed Description
-----------------
Left bundle branch pacing (LBBP), achieved via trans-septal approach with the pacing tip at the left side of the ventricular septum, has recently initiated and been well practiced in China. LBBP is characterized with relatively ease of implantation (usually <5 minutes fluoroscopic use time), narrow paced QRS duration (similar to physiological pacing), low and stable pacing threshold (usually around 0.5V @0.5ms, good for device longevity and long-term stability without need of back-up pacing lead), high R wave amplitude for pacing management, and LBBB (left bundle branch block) correction by a low pacing output. LBBAP (left bundle branch area pacing) can generate a relatively narrow QRSd and fast left ventricular activation. As AV interval is an important pacing parameter relevant to cardiac function. This study is to investigate the cardiac electrical and mechanical function during LBBAP with different AV intervals.

Official Title
-----------------
Electrogram and Hemodynamic Characteristics of Adaptive LBBAP in Patients With Heart Failure or Bradycardia

Conditions
-----------------
Cardiac Pacing, Pacing Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged from 18 to 80 years old Patients who are willing to provide Informed Consent Patients who received LBBAP for at least 3 months Patients' implanted device can provide intracardiac electrograms Bradycardia patients with AVB or heart failure patients with LBBB Exclusion Criteria: Patients who are pregnant or have a plan for pregnancy during the study Patients with persistent AF Patients who have medical conditions that would limit study participation Patients who were already enrolled in other clinical trial which would impact his/her participation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECG QRS duration | The primary endpoint is QRS duration during LBBP | At least 3 months post implant |
Cortical Organization in Allogeneic Transplants or Heterotopic Hand Replants

Study Overview
=================
Brief Summary
-----------------
The investigators hope to gain insights into the functional organization of the human cerebral cortex in response to upper limb amputation and surgical interventions including hand replantation and hand transplantation.

Official Title
-----------------
Cortical Organization in Allogeneic Transplants or Heterotopic Hand Replants

Conditions
-----------------
Hand Transplant, Hand Replant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: between 18-70 yrs old undergone successful allogeneic transplantation of one or both hands OR undergone successful reattachment of one or both hands OR will have experienced surgical repair of one or more severed nerves (ulnar, medial, radial, digital in the upper limb must speak English Exclusion Criteria: younger than 18 years or older than 70 years not undergone a replant or transplant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Hand Transplant Patients<br>These will be subjects who have undergone a hand transplant. | |
| Hand Replant Patients<br>These will be patients who have undergone a hand replant procedure. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound Biomicroscopy | We will scan the cross section of the medial nerve at the pisiform bone level to determine the level of CTS with Ultrasound Biomicroscopy machine. This device is not approved for clinical decisions, only used for research purposes. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip Strength |  | Up to 12 months | 
| Pinch Strength |  | Up to 12 months | 
| DASH Questionnaire | Subjects will complete the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. | Up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hand transplant, hand replant