linjc16/ctgov huggingface dataset:
Hyperbaric Levobupivacaine for Spinal Anaesthesia

Study Overview
=================
Brief Summary
-----------------
Spinal anaesthesia also called spinal block or sub-arachnoid block (SAB), is a form of regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space, generally through a fine needle. There is no generic hyperbaric form of levobupivacaine currently available so we aimed in this study that to find the appropriate concentration of the levobupivacaine which achieves unilateral spinal anesthesia. The potential benefits of this type of anesthesia are less motor blockade and urinary retention, decrease in hospital stay. Therefore, it seems to be suitable for outpatient anesthesia.

Conditions
-----------------
This Study Was Focused on Selective Spinal Anesthesia for Lower Extremity Surgery in Order to Achieve Early Mobilization and to Shorten Hospital Stay

Intervention / Treatment
-----------------
* Drug: levobupivacaine
* Drug: levobupivacaine
* Drug: levobupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Approval to participate in the study and spinal anesthesia American society of anesthesia (ASA) I,II physical status Scheduled for lower extremity surgery Exclusion Criteria: Refuse to participate in the study American society of anesthesia (ASA)III, IV physical status Hypersensitivity to local anesthetics Emergency surgery Chronic pain treatment Peripheral neuropathy Severe systemic disease

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: levobupivacaine I<br>group that was administered levobupivacaine plus 60mg dextrose | Drug: levobupivacaine<br>* levobupivacaine plus 60 mg dextrose<br>|
| Experimental: levobupivacaine II<br>group that was administered levobupivacaine plus 80 mg dextrose | Drug: levobupivacaine<br>* levobupivacaine plus 80 mg dextrose<br>|
| Experimental: levobupivacaine III<br>group that was administered levobupivacaine plus 100 mg dextrose | Drug: levobupivacaine<br>* levobupivacaine plus 100 mg dextrose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of motor blockade |  | until dissolve of motor blockade |
Effect of Caudal Nalbuphine on Postoperative Analgesia in Children

Study Overview
=================
Brief Summary
-----------------
Nalbuphine as an adjuvant to bupivacaine caudal anesthesia for postoperative analgesia in children undergoing Hypospadias repair. 2 groups, 30 patients each

Official Title
-----------------
Nalbuphine as an Adjuvant to Caudal Bupivacaine for Postoperative Analgesia in Children Undergoing Hypospadias Repair

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

Intervention / Treatment
-----------------
* Drug: Nalbuphine plus Bupivacaine
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children undergoing elective Hypospadias repair with American Society of Anesthesiologists (ASA) physical status I age 2-10 years Exclusion Criteria: Coagulation disorder allergy to study medications major malformations of the lower spine or meninges or any cutaneous or subcutaneous lesion at the site of injection.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 10 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nalbuphine group<br>30 children will be given Caudal Bupivacaine plus Nalbuphine. | Drug: Nalbuphine plus Bupivacaine<br>* Addition of caudal Nalbuphine to the standard Bupivacaine<br>|
| Other: Control group<br>30 children will be given Caudal Bupivacaine. | Drug: Bupivacaine<br>* Caudal Bupivacaine is the standard of care will be considered as a control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain intensity Measured by Face, Legs, Activity, Cry & consolability (FLACC) pain scale |  | During 24 h in the postoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortisol level |  | 6 hours |
Transitioning From Cyclosporine to Alefacept in Psoriasis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to devise a safe and effective method for transitioning patients from cyclosporine to alefacept.

Detailed Description
-----------------
The purpose of this study is to devise a safe and effective method for transitioning patients from cyclosporine to alefacept. Patients in the study are well controlled on cyclosporine and desire to switch to alefacept. The study is done in three phases. In Phase 1 (12 week duration) the two drugs will be overlapped, with cyclosporine slowly tapering. Both drugs will be discontinued after 12 weeks. In Phase 2 (12 weeks duration), patients are off both drugs. In Phase 3 (24 weeks long), patients are on a second course of alefacept alone for 12 weeks and then off for 12 weeks. Topical and UV light treatments are allowed throughout the study. Total length of study is one year.

Official Title
-----------------
Investigator-Initiated, Use Study of Alefacept (Amevive) in Combination With Tapering Doses of Cyclosporine in Patients With Moderate to Severe Psoriasis

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Transitioning patients from cyclosporine to alefacept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Adult psoriasis patients (18 to 80 years old), who are well controlled on cyclosporine (Static PGA score of mild, minimal or clear) and who need or desire to stop cyclosporine and start alefacept. Exclusion Criteria CD4 <400 Active infection (other than trivial URI, etc.) History of AIDS or Hepatitis B, C Inability to understand consent or comply with study requirements Pregnancy or Lactation History of heart or liver disease

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Transitioning patients from cyclosporine to alefacept|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static physicians global assessment (PGA) and quality of life as measured by DLQI |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psoriasis, cyclosporine, transition, alefacept
The Leipzig TAVI Registry

Study Overview
=================
Brief Summary
-----------------
A single-center registry including all patients treated with TAVI at the Heart Center, Leipzig, Germany

Detailed Description
-----------------
A single-center registry including all patients treated with transcatheter aortic valve implantation (TAVI) at the Heart Center, Leipzig, Germany. Patients undergo a routine clinical and echocardiographic follow-up schedule, including a long-term follow-up plan up to 10 years to assess valve durability.

Official Title
-----------------
An Observational Follow-up Assessment of Transcatheter Aortic Valve Implantation in Leipzig

Conditions
-----------------
Aortic Valve Stenosis

Intervention / Treatment
-----------------
* Device: Transcatheter Aortic Valve Implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients treated with TAVI Exclusion Criteria: None

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Transcatheter Aortic Valve Implantation|Interventional replacement of the aortic valve|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Cardiovascular and not cardiovascular death identify the current incidence of periprocedural complications. identification of risk groups description of the long-term outcome with special attention to the durability of the different prostheses | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structural valve deterioration | Transposthetic mean pressure gradient ≥ 40mmHg and/or ≥20mmHg rise from baseline OR severe intraprosthetic aortic regurgitation | Up to 10 years |
Use of FDG PET as Predictor of Residual Disease and Subsequent Relapse in Patients With NHL and HD Undergoing HDC and ASCT

Study Overview
=================
Brief Summary
-----------------
Cytogenetic Analysis of Bone Marrow Specimen Prior to High Dose Chemotherapy and Autologous Stem Cell Transplantation in Patients with Non-Hodgkin's Lymphoma or Hodgkin's Disease

Official Title
-----------------
Use of FDG PET as Predictor of Residual Disease and Subsequent Relapse in Patients With NHL and HD Undergoing HDC and ASCT

Conditions
-----------------
Lymphoma, Non-Hodgkin, Hodgkin Disease

Intervention / Treatment
-----------------
* Procedure: FDG PET


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with NHL and HD undergoing HDC and ASCT
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

| Intervention/Treatment |
| --- |
|Procedure: FDG PET|FDG PET|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognosis |  | overall | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NHL and HD
Fasciocutaneous Flaps for Leg Defects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of fasciocutaneous flaps for leg defects.

Detailed Description
-----------------
The fasciocutaneous flaps are tissue flaps which include skin, subcutaneous tissue, and the underlying fascia. Including the deep fascia with its prefascial and subfascial plexus enhances the circulation of these flaps. The investigators determined long-term outcomes of fasciocutaneous flap reconstruction in patients with lower limb defects.

Official Title
-----------------
Study of Fasciocutaneous Flaps for Treatment of Leg Defects

Conditions
-----------------
Limb Defects

Intervention / Treatment
-----------------
* Procedure: fasciocutaneous flap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with leg defects Exclusion Criteria: patients with underlying diseases
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: fascio-cutaneous flap<br>flaps which include skin, subcutaneous tissue, and the underlying fascia. | Procedure: fasciocutaneous flap<br>* flaps which include skin, subcutaneous tissue, and the underlying fascia.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| necrosis |  | at three years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| venous congestion |  | at three years after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Flap, leg defect, reconstruction, tissue
Prevalence of MTHFR Polymorphisms in Venous Disease

Study Overview
=================
Brief Summary
-----------------
The etiologies of varicose veins and the progression to more serious forms of chronic venous disease and identification of appropriate diagnostic tests to better aid patient management by identifying individuals who may benefit from more aggressive treatment and/ or prophylactic measures.

Official Title
-----------------
Prevalence of MTHFR Polymorphisms in Venous Disease With or Without Concomitant Thrombosis

Conditions
-----------------
Varicose Veins, MTHFR, Venous Disease, Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or over No venous disease (N=30); or C2-C3 venous disease (N=30); or C4-C6 venous disease (N=30) Exclusion Criteria: Pregnancy Cancer Chronic obstructive pulmonary disease (COPD) Any systemic inflammatory disease Any of the following within the previous 30 days: Trauma Any surgery Periods of prolonged inactivity

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of MTHFR mutation between patients | Determine whether the prevalence of the MTHFR mutation differs between patient with varicose veins compared to controls and with or without superficial vein thrombosis. | Baseline |
Angiotensin Converting Enzyme Inhibitors in Treatment of Covid 19

Study Overview
=================
Brief Summary
-----------------
ACEIs as treatment for COVID19

Detailed Description
-----------------
ACEIs as suggested treatment for COVID19

Official Title
-----------------
Randomized Trial of ACEIs in Treatment of COVID-19

Conditions
-----------------
COVID

Intervention / Treatment
-----------------
* Drug: ACEIs
* Drug: Conventional treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients infected with covid 19 Exclusion Criteria: allergy or contraindications to the drug
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 |
| --- | --- |
| Experimental: ACEIs<br>ACEIs with conventional treatment for COVID19 | Drug: ACEIs<br>* Captopril or enalapril<br>* Other names: Enalapril, Captopril;Drug: Conventional treatment<br>* alexoquine<br>* Other names: chloroquine;|
| Experimental: Conventional treatment of COVID19<br>Conventional treatment of COVID19 | Drug: Conventional treatment<br>* alexoquine<br>* Other names: chloroquine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with virological cure | number of patients with virological cure | 6 months |
A Study of Administration of Trastuzumab (Herceptin) by a Single-use Injection Device Versus a Handheld Syringe

Study Overview
=================
Brief Summary
-----------------
This randomized, open-label, parallel, 2-arm, multicenter study will compare the administration of Herceptin (trastuzumab) with a single-use injection device versus a handheld syringe in healthy male volunteers. The volunteers will receive a single dose of 600 mg Herceptin. The anticipated time of the study is 21 weeks.

Official Title
-----------------
A Randomized, Open-label, 2-arm, Parallel Group, Single Dose, Multi-center Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of Trastuzumab Administered Subcutaneously as the Trastuzumab/rHuPH20 Formulation Using a Handheld Syringe or Using the Proprietary Single-use Injection Device (SID)

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: trastuzumab [Herceptin]
* Drug: trastuzumab [Herceptin]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male patients, 18 to 45 years of age, inclusive No history of hypersensitivity or allergic reactions following drug administration No history of clinically significant or clinically relevant cardiac condition No history of previous anticancer treatment Body mass index (BMI) between 18-32 kg/m2, inclusive Exclusion Criteria: Positive test result for drugs of abuse Positive test result for hepatitis B, hepatitis C, or HIV 1 or 2 Systolic blood pressure greater than 140 mmHG or less than 90 mmHG, or diastolic blood pressure greater than 90 mmHG or less than 50 mmHG Clinically significant abnormal laboratory values

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: trastuzumab [Herceptin]<br>* 600 mg subcutaneously using a single-use injection device on Day 1<br>|
| Active Comparator: 2<br> | Drug: trastuzumab [Herceptin]<br>* 600 mg subcutaneously using a handheld syringe on Day 1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under plasma concentration curve of trastuzumab |  | 21 days | 
| Maximum observed plasma concentration of trastuzumab |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of trastuzumab |  | Day 21 | 
| Safety: Incidence of adverse events |  | 21 weeks |
A Study to Compare the Blood Levels of Sildenafil Following Administration of an Experimental Tablet vs. the Conventional Oral Tablet in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This study to will compare the blood levels of sildenafil following administration of an experimental tablet vs. the conventional oral tablet.

Official Title
-----------------
An Open-Label, Crossover Study In Healthy Volunteers To Evaluate The Pharmacokinetics Of Sildenafil Following Administration Of An Experimental Tablet Of Sildenafil With Or Without Water Relative To Viagra® Conventional Oral Tablet With Water.

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Sildenafil
* Drug: Sildenafil
* Drug: Sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males between the ages of 18 and 55 years. Body Mass Index of 18 to 30 kg/m2, and a total body weight >50 kg (110 lbs). Exclusion Criteria: Smoking in excess of the equivalent of 5 cigarettes per day. Treatment with an experimental drug within 30 days or sildenafil, vardenafil, tadalfil within 4 days before first study dose. Develop blood pressure lowering or experience dizziness, lightheadedness when going from the laying down position to standing position.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Oral Tablet With Water<br> | Drug: Sildenafil<br>* Single Dose of 50 mg Sildenafil Oral Tablet With Water<br>|
| Experimental: Experimental Tablet With Water<br> | Drug: Sildenafil<br>* Single Dose of 50 mg Sildenafil Experimental Tablet With Water<br>|
| Experimental: Experimental Tablet Without Water<br> | Drug: Sildenafil<br>* Single Dose of 50 mg Sildenafil Experimental Tablet Without Water<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of sildenafil |  | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of a metabolite of sildenafil |  | 1 Day | 
| Side Effects |  | 1 Day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sildenafil, Pharmacokinetics, Healthy Volunteer