linjc16/ctgov huggingface dataset:
A Phase I/II Dose-escalating Study of the Safety, Tolerability and Efficacy of KIO-301 Administered Intravitreally to Patients With Retinitis Pigmentosa and Choroideremia (ABACUS)

Study Overview
=================
Brief Summary
-----------------
A phase I/II dose-escalating study of the safety, tolerability and efficacy of KIO-301 administered intravitreally to patients with retinitis pigmentosa and choroideremia (ABACUS). Open label.

Official Title
-----------------
A Phase I/II Dose-escalating Study of the Safety, Tolerability and Efficacy of KIO-301 Administered Intravitreally to Patients With Retinitis Pigmentosa and Choroideremia (ABACUS)

Conditions
-----------------
Retinitis Pigmentosa, Choroideremia

Intervention / Treatment
-----------------
* Drug: KIO-301


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a clinical diagnosis of retinitis pigmentosa (Cohorts 1 - 3) or choroideremia (Cohort 3 only). Have a visual acuity of: no light perception for Cohort 3 or no light perception or bare light perception for Cohort 1 confirmed with a LogMar >2.9 using the Berkeley Rudimentary Vision Test (BRVT), or count fingers or hand motion for Cohort 2 as confirmed by a LogMar ≤ 2.9 and > 1.6 using the BRVT. Have similar visual acuity in both eyes as defined as a LogMar difference between eyes of < 0.05 using the BRVT. Exclusion Criteria: Have evidence of material/substantial optic nerve disease. Have a history of retinal detachments. Have clinically significant ocular disease (e.g., corneal oedema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study or clinically significant opacities of the media. Have high intraocular pressure (IOP) >22 mm Hg. Have had a previous intraocular surgery (excluding phakocataract surgery). Have aphakia.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with Retinitis Pigmentosa and Choroideremia<br> | Drug: KIO-301<br>* KIO-301 intravitreal injection at ascending doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by overall changes in retinal thickness and appearance, clinical chemistry and hematology, and other eye assessments. |  | 84 days |
The Effect of 0.5% Roxithromycin Lotion for Androgenetic Alopecia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is exploiting the new drugs for androgenetic alopecia because there are still no effective and safe topical drug for androgenetic alopecia. Roxithomycin is one of the macrolide antibiotics that has immunomodulatory effects. We firstly found that roxithromycin increases the rate of murine and human hair follicle elongation in vitro. Therefore, we apply this drug on this disease therapy.

Detailed Description
-----------------
The topical therapy for androgenetic alopecia is still not enough to improve cosmetically. Thereforem we try to find new effective and safe topical therapy for this disease. Roxithromycin has not only antibacterial action but also immunomodulatory and anti-inflamatory potency. For example, roxitromycin inhibits T cell responces to mitogens and production of cytokines, IL-2 and IL-5. We firstly found that roxitromycin increased human and murine hair elongation in vitro to inhibit apoptosis of hair bulb. Then, we wish to apply roxithromycin on the therapy for androgenetic alopecia.

Official Title
-----------------
The Study for New Effect of Roxithromycin on Androgenetic Alopecia.

Conditions
-----------------
Alopecia

Intervention / Treatment
-----------------
* Drug: roxithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Androgenetic alopecia Exclusion Criteria: Cicatricial alopecia Allergy to roxitromycin Children (19years old or younger) Pregnant female

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: roxithromycin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological study taken from lesional scalp skin. |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
androgenetic alopecia, roxitromycin, apoptosis
Non-selective Beta Blockers Versus EVL for Primary Prophylaxis of Esophageal Variceal Bleeding in Patients With Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis.

Study Overview
=================
Brief Summary
-----------------
Every patient with HCC (Hepato-Cellular Carcinoma) with main portal vein thrombosis will be screened for presence of large esophageal varices and will be randomized between non-selective beta blocker versus primary endoscopic variceal ligation. They will be followed to assess the rate of reduction of index bleed rate as well as survival difference between the groups.

Official Title
-----------------
A Prospective Randomized Controlled Trial Comparing Non-selective Beta Blockers Versus EVL for Primary Prophylaxis of Esophageal Variceal Bleeding in Patients With Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis

Conditions
-----------------
Hepatocellular Carcinoma With Portal Vein Thrombosis

Intervention / Treatment
-----------------
* Procedure: Endoscopic Variceal Ligation
* Drug: Carvedilol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of cirrhosis with Hepatocellular carcinoma and portal vein thrombosis Presence of large oesophageal varices or small with high risk Exclusion Criteria: Any contra-indication to beta-blockers Any Endoscopic Variceal Ligation or Sclerotherapy within last 3 months High risk gastric varices Any past history of Transhepatic Intrajugular Portosystemic Shunt or surgery for portal hypertension Significant cardio or pulmonary co-morbidity Any extrahepatic malignancy Patients with past history of variceal bleed Patients with non-tumor portal vein thrombosis Refusal to participate in the study

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic Variceal Ligation<br>Endoscopic Variceal Ligation every 3 weeks till eradication | Procedure: Endoscopic Variceal Ligation<br>* Endoscopic Variceal Ligation every 3 weeks till eradication.<br>|
| Active Comparator: Carvedilol<br>Carvedilol 3.125mg BD increased after 1 week to reach 6.25mg BD | Drug: Carvedilol<br>* Carvedilol 3.125mg BD increased after 1 week to reach 6.25mg BD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Variceal Bleeding |  | 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 1.5 years | 
| Procedure related complications. |  | 1.5 years | 
| Reappearance of Esophageal varices in presence of Portal Vein Thrombosis |  | 1.5 years |
Functional and Morphologic MRI in the Detection of Prostate Cancer in Patients With Prior Negative Biopsy

Study Overview
=================
Brief Summary
-----------------
Prostate specific antigen (PSA) and digital rectal exam (DRE) are used to screen for prostate cancer. Patients with abnormal DRE or elevated PSA undergo transrectal ultrasound guided biopsy (TRUS-Bx). There are some men who have a normal TRUS-Bx despite persistent elevated PSA and may harbor occult prostate cancer. The purpose of this study is to determine if MRI using an endorectal coil, and advanced MRI methods called H1 MR Spectroscopy (MRS) and Dynamic MR Perfusion Imaging (dMRI) can help identify and localize prostate cancer in these patients and direct repeat TRUS-Bx to the most suspicious location in the prostate gland. 100 men, currently under observation with elevated PSA but negative TRUS-Bx will be enrolled in the study.

Detailed Description
-----------------
Prostate specific antigen (PSA) and digital rectal exam (DRE) are used to screen for prostate cancer. Patients with abnormal DRE or elevated PSA undergo transrectal ultrasound guided biopsy (TRUS-Bx). There are some men who have a normal TRUS-Bx despite persistent elevated PSA and may harbor occult prostate cancer. The purpose of this study is to determine if MRI using an endorectal coil, and advanced MRI methods called H1 MR Spectroscopy (MRS) and Dynamic MR Perfusion Imaging (dMRI) can help identify and localize prostate cancer in these patients and direct repeat TRUS-Bx to the most suspicious location in the prostate gland. 100 men, currently under observation with elevated PSA but negative TRUS-Bx will be enrolled in the study.

Official Title
-----------------
The Utility of Functional and Morphologic MRI in the Detection of Prostate Cancer for Patients With Elevated PSA and Prior Negative Biopsy

Conditions
-----------------
Elevated PSA, Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prior ultrasound biopsy of prostate showing no cancer or only single microfocus of cancer Exclusion Criteria: contraindication to contrast enhanced endorectal coil MRI

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: MRI|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Right Hepatectomy in Patients Beyond 70 Years Old

Study Overview
=================
Brief Summary
-----------------
As a consequence of the increase in life expectancy, hepato-biliary surgeons have to deal with an emerging aged population, which has a potential higher risk for complication and worse long-term outcome. The investigators will be analyzing the liver function and outcome after right or extended right hepatectomy in patients over 70 years old.

Official Title
-----------------
Right and Extended Right Hepatectomy in Patients Beyond 70 Years of Age - Liver Function and Outcome

Conditions
-----------------
Complications, Liver Failure, Acute

Intervention / Treatment
-----------------
* Procedure: Right hepatectomy
* Procedure: Extended right hepatectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years Elective right hepatectomy Elective extended right hepatectomy Exclusion Criteria: Age < 18 years Pregnancy Other type of hepatectomy Emergency hepatectomy

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elderly<br>Patients more or equal to 70 years old | Procedure: Right hepatectomy<br>* Right liver resection<br>* Other names: Liver surgery;Procedure: Extended right hepatectomy<br>* Right hepatectomy involving 5 or more segments<br>* Other names: Liver surgery;|
| Young<br>Patients less than 70 years old | Procedure: Right hepatectomy<br>* Right liver resection<br>* Other names: Liver surgery;Procedure: Extended right hepatectomy<br>* Right hepatectomy involving 5 or more segments<br>* Other names: Liver surgery;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | Any type of complication defined according to the Clavien-Dindo Classification of surgical complications. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Patient death occuring 90 days post-operatively | 90 days | 
| Liver failure | Defined according to the Belghiti 50-50 criteria for liver failure. | 90 days | 
| Hospital stay | Total hospital stay (including re-admission hospital stay) in days | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Complications, Mortality, Liver, Failure
Measurement of Patient Reported Outcomes in Renal Transplant Patients With And Without Gastrointestinal (GI) Symptoms

Study Overview
=================
Brief Summary
-----------------
This study will access the GI complaints on patients reported outcomes and to determine the improvement in quality of life in patients.

Official Title
-----------------
Open, Multi-centre, Non-interventional, Observational Study to Characterize the Impact That GI Complaints Have on Patient-reported Outcomes in Patients Who Have Had a Renal Transplant. Patients Will be Evaluated at Visit 1 and Then Again After 4 (+2) Weeks (Visit 2)

Conditions
-----------------
Kidney Transplantation, GI Symptoms Severity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient received kidney transplant at least 1 month prior to study with MMF as a part of the treatment for at least 2 weeks. Eligible to convert to myfortic because of GI complaints or not currently experiencing GI complaints and stable on current immunosuppressive regimen. At least 18 years of age; Willing to provide written informed consent; and Able to meet all study requirements including completing paper questionnaires and completing two study visits. Exclusion Criteria: GI symptoms assumed or known not be caused by MPA therapy and have recent acute rejection at least 1 week prior to the study. Breast-feeding or pregnant woman. Patients with psychiatric illness. Underlying acute medical intervention or hospitalization Receiving investigational drug within 30days prior to 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| With Gastro-Intestinal (GI) symptoms<br> | |
| Without GI symptoms<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if GI symptoms severity and health related quality of life of patients has improved after being converted from MMF to EC-MPS due to GI complaints. |  | 4-6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify and evaluate quality of life and impact on symptom severity based on patients perception. |  | 4-6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney transplantation, mycophenolate sodium, EC-MPS, Health Related Quality of Life, GI symptoms, Immunosuppressants, HRQL, PGWB, GIQLI
Ventilation and Pulmonary Aeration, Electrical Impedance Tomography, Interscalene Brachial Plexus Block

Study Overview
=================
Brief Summary
-----------------
Patients with indication of shoulder surgery will be submitted to ultrasound-guided interscalene brachial plexus block with 4ml or 15ml of bupivacaine- epinephrine 0,5%- 1:200,000 at level of C5-6 roots and will be evaluated their ventilation and pulmonary aeration by electrical impedance tomography

Official Title
-----------------
Evaluation of Variation of Ventilation and Pulmonary Aeration Using Electrical Impedance Tomography in Patients With Interscalene Brachial Plexus Block for Shoulder Surgery

Conditions
-----------------
Brachial Plexus Block, Pulmonary Ventilation

Intervention / Treatment
-----------------
* Drug: Bupivacaine 4 mL
* Drug: Bupivacaine 15 mL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: shoulder surgery indication of interscalene brachial plexus block American Society of Anesthesiology Physical Status Classification I or II Exclusion criteria: refuse to participate previous lung or diaphragma surgeries

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine 4ml<br>The interscalene brachial plexus block is performed with 4ml at level of C5-6 roots | Drug: Bupivacaine 4 mL<br>* The interscalene brachial plexus block is performed with 4ml of bupivacaine-epinephrine 0,5%- 1:200,000<br>|
| Active Comparator: Bupivacaine 15ml<br>The interscalene brachial plexus block is performed with 15ml at level of C5-6 | Drug: Bupivacaine 15 mL<br>* The interscalene brachial plexus block is performed with 15ml of bupivacaine-epinephrine 0,5%- 1:200,000<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of pulmonary function | Evaluation of variation of pulmonary aeration and ventilation after interscalene brachial plexus block with 4ml or 15 ml of bupivacaine- epinephrine 0,5%1:200,0000. The pulmonary function will be evaluated by electrical impedance tomography. | 4 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | Opioid consumption (Tramal - mg) will be recorded during the first 24 hours. | 24 hours | 
| Post-Operative pain | The post operative pain will be evaluated using Visual Analog Score for pain during the first 24 hours. | 24 hours |
Surgical Stress Measured by Microdialysis

Study Overview
=================
Brief Summary
-----------------
Paraspinal muscle damage is inevitable during conventional posterior lumbar fusion surgery. Minimal invasive surgery is postulated to result in less muscle damage and better outcome. The aim of this study is to monitor metabolic changes of the paraspinal muscle and to evaluate paraspinal muscle damage during surgery using microdialysis (MD).

Detailed Description
-----------------
Posterior approach is a common and important surgical procedure for various lumbar diseases. Owing to the anatomy, the damage of paraspinal muscle is inevitable during conventional posterior lumbar fusion surgery. Degeneration and malfunction of the paraspinal muscle might associate with pain and inferior postoperative clinical outcome.

Official Title
-----------------
Microdialysis of Paraspinal Muscle in Healthy Volunteers and Patients Underwent Posterior Lumbar Fusion Surgery

Conditions
-----------------
Trauma

Intervention / Treatment
-----------------
* Procedure: Posterolateral lumbar fusion surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: patients who undergo conventional instrumented posterolateral lumbar fusion. Exclusion criteria: previous fusion chronic metabolic disease tumor or metastasis postoperative surgical complications and complications during surgery

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy group<br>Eight healthy volunteers (five males and three females) with a body mass index of 23.8 and without chronic metabolic disease or low back pain. They are all non-smokers and non-medicated. | Procedure: Posterolateral lumbar fusion surgery<br>* Two MD catheters with 1% lidocaine 1-2 ml are placed in the paraspinal muscle.<br>* Other names: Lumbar diseases;|
| Experimental: Surgery group<br>Two MD catheters is placed in the paraspinal muscle at the level of midpoint of incision bilaterally. A reference catheter is placed in the deltoid muscle. | Procedure: Posterolateral lumbar fusion surgery<br>* Two MD catheters with 1% lidocaine 1-2 ml are placed in the paraspinal muscle.<br>* Other names: Lumbar diseases;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The glycerol concentration | To study whether the glucerol concentration can be used to evaluate surgery related paraspinal muscle damage | Two hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glucose, Lactate pyruvate ratio, Glycerol, Paraspinal muscle, Microdialysis
Post-marketing Surveillance of Administration of Botulinum Toxin Type B(NerBloc)-Investigation of the Clinical Condition in Patients With Change From Botulinum Toxin Type A

Study Overview
=================
Brief Summary
-----------------
Investigation of the clinical condition in patients with cervical dystonia by Toronto Western Spasmodic Torticollis Scale (TWSTRS)

Conditions
-----------------
Cervical Dystonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with cervical dystonia who was treated by botulinum toxin type A in the past. Patients who was enrolled in NB01S and was evaluated by TWSTRS at the first injection of NerBloc.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| E2014<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole improvement level | Toronto Western Spasmodic Torticollis Scale (TWSTRS) | Up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Torticollis, rimabotulinumtoxinB