linjc16/ctgov huggingface dataset:
A Study of Two Anti-HIV Drug Combinations in HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and effectiveness of giving HIV-infected patients delavirdine (DLV) plus zidovudine (ZDV) plus 2 doses of indinavir (IDV) or ZDV plus IDV plus lamivudine (3TC). This study also examines how the body processes DLV when it is given in combination with other drugs.

Detailed Description
-----------------
In this multicenter, open-label study, 45 HIV-1-positive patients receive either combination drug therapy with delavirdine (DLV), zidovudine (ZDV), and indinavir (IDV) or combination drug therapy with ZDV, lamivudine (3TC), and IDV. NOTE: Patients are treated for 24 weeks and may opt to continue on study for 24 additional weeks, if HIV-1 RNA is less than 5,000 copies/ml or at the investigator's discretion.

Official Title
-----------------
An Open-Label Randomized Study of Delavirdine Mesylate (Rescriptor) in Combination With Zidovudine (Retrovir) and Two Doses of Indinavir (Crixivan) Versus Zidovudine, Lamivudine (Epivir), and Indinavir in HIV-1-Infected Individuals

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Indinavir sulfate
* Drug: Delavirdine mesylate
* Drug: Lamivudine
* Drug: Zidovudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV-1 positive. CD4 count above 50. HIV-1 RNA greater than 20,000. Prior Medication: Allowed: Less than 1 month prior treatment with zidovudine. Exclusion Criteria Prior Medication: Excluded: Prior 3TC, protease inhibitors, or non-nucleoside reverse transcriptase inhibitors. Prior ZDV of greater than 1 month total duration. Prior Treatment: Excluded: Lamivudine. Protease inhibitors. Non-nucleoside reverse transcriptase inhibitors.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Indinavir sulfate|nan|
|Drug: Delavirdine mesylate|nan|
|Drug: Lamivudine|nan|
|Drug: Zidovudine|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-1, Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, Lamivudine, Indinavir, RNA, Viral, Delavirdine, Reverse Transcriptase Inhibitors
Individual Patient Expanded Access for AB-PA01, an Investigational Anti-Pseudomonas Aeruginosa Bacteriophage Therapeutic

Study Overview
=================
Brief Summary
-----------------
The purpose of the expanded access program is to allow physicians to provide treatment with investigational drug, AB-PA01, for patients with serious or immediately life-threatening Pseudomonas aeruginosa infections, for which no alternative treatment(s) are currently available, and who meet the criteria for treatment under FDA's Expanded Access regulations and criteria set forth by AmpliPhi Biosciences Corporation. To be considered for expanded access, the request should be submitted to AmpliPhi by a qualified and licensed physician with expertise and facilities appropriate for the administration of the investigational medicine. Treating physicians should contact AmpliPhi by emailing expandedaccess@ampliphibio.com with Expanded Access Request in the subject line, and include in the email the treating physicians name, organization/hospital/institution, physical address, email address, telephone number, and a brief description of the indication/condition. Any approval of expanded access to investigational medicine must always comply with the applicable laws and regulations.

Official Title
-----------------
Expanded Access Program for AB-PA01, an Investigational Anti-Pseudomonas Aeruginosa Bacteriophage Therapeutic, for the Treatment of Individual Patients With Serious or Immediately Life-threatening Infections Caused by Pseudomonas Aeruginosa

Intervention / Treatment
-----------------
* Biological: AB-PA01


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: AB-PA01|AB-PA01 is an investigational bacteriophage therapeutic for treatment of Pseudomonas aeruginosa infections|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Sequential Therapy (FK506 + Monoclonal Anti-IL2R Antibodies + MMF) Versus FK506 With Steroids in Liver TX

Study Overview
=================
Brief Summary
-----------------
Study to evaluate the benefits and any risks of the delayed administration of tacrolimus in a combined regimen of mycophenolate mofetil and monoclonal anti-IL2R antibodies (daclizumab), in comparison with a standard steroid + tacrolimus double drug regimen

Official Title
-----------------
An Open, Randomized, Multicentre Clinical Study to Compare the Safety and Efficacy of a Combination of Sequential Therapy of Tacrolimus (FK506) With Monoclonal Anti-IL2R Antibodies and Mycophenolate Mofetil Versus Tacrolimus (FK506) With Steroids in Liver Allograft Transplantation

Conditions
-----------------
Liver Transplantation

Intervention / Treatment
-----------------
* Drug: tacrolimus
* Drug: Anti-IL2R AB
* Drug: Mycophenolate mofetil
* Drug: prednisone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is undergoing orthotopic liver allograft transplantation. This includes partial organ transplantation. Age of donor between 5 and 65 years Exclusion Criteria: Patient has previously received or is receiving an organ transplant (including liver re-transplantation) Recipient of an auxiliary graft or in which a bio-artificial liver has been used Patient is receiving a living related liver transplantation Patient is requiring steroids as well as chemotherapy prior to transplantation Patient having any previous history of neoplastic disease of any type (including leukaemia). However, patients with primary liver carcinoma can be included if they meet the following criteria: > 3 nodes No node larger than 5 cm No metastases No vascular invasion

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Tacrolimus + Anti-IL2R AB + Mycophenolate mofetil | Drug: tacrolimus<br>* oral<br>* Other names: Prograf;Drug: Anti-IL2R AB<br>* i.v.<br>* Other names: daclizumab;Drug: Mycophenolate mofetil<br>* oral<br>|
| Active Comparator: 2<br>Tacrolimus + Steroid | Drug: tacrolimus<br>* oral<br>* Other names: Prograf;Drug: prednisone<br>* oral<br>* Other names: steroid;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of first acute rejection |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall frequences of acute rejection episodes |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver allograft transplantation, sequential therapy, tacrolimus
FungiScope - A Global Emerging Fungal Infection Registry

Study Overview
=================
Brief Summary
-----------------
The objective of this registry is to broaden the knowledge on epidemiology, diagnostic procedures and clinical course of emerging invasive fungal infections.

Detailed Description
-----------------
The specific objectives are: To determine the fungal species causing invasive fungal infection in different parts of the world. To determine the clinical pattern of disease and document procedures performed for confirmation of the diagnosis. To describe the therapeutic regimens used and their efficacy. To share clinical isolates among the contributors of Fungiscope. To develop molecular biology tools for identification of strains in histopathologically proven invasive fungal infection.

Official Title
-----------------
FungiScope - A Global Emerging Fungal Infection Registry

Conditions
-----------------
Invasive Fungal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cultural, histopathological, antigen or DNA evidence of invasive fungal infection Exclusion Criteria: Infection due to Candida spp., Cryptococcus neoformans, Pneumocystis jiroveci Endemic fungal infection such as coccidioidomycosis or histoplasmosis Colonisation or other non-invasive infection
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Emerging fungal infections<br>Web-based registry of invasive infections by emerging fungi | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment efficacy of emerging fungal infections | failure, stable disease, partial response or complete response | At 90 days from diagnosis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
invasive fungal infection, Web-based registry
A Phase 3 Clinical Study of KHK4827

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate safety and efficacy of long-term exposure of KHK4827 in subjects with moderate to severe plaque psoriasis who have completed the preceding Study 4827-002.

Official Title
-----------------
An Extension Study in Subjects With Plaque Psoriasis

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

Intervention / Treatment
-----------------
* Drug: KHK4827


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has voluntarily signed the written informed consent form to participate in this study Subject has completed the week 12 evaluation of Study 4827-002 Exclusion Criteria: Subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration) Subject has been judged to be ineligible for participation in the study by the investigators/subinvestigators

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KHK4827 140mg SC<br> | Drug: KHK4827<br> <br> |
| Experimental: KHK4827 210mg SC<br> | Drug: KHK4827<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and types of adverse events and adverse reactions |  | 52 weeks | 
| Laboratory values and vital signs |  | 52 weeks | 
| Development of anti-KHK4827 antibody |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) |  | 52 weeks | 
| A 50% improvement in PASI (PASI 50), PASI 75, PASI 90 and PASI 100 response |  | 52 weeks | 
| Static physician's global assessment (sPGA) of clear or almost clear (0 or 1) |  | 52 weeks | 
| sPGA of clear (0) |  | 52 weeks | 
| Body surface area involvement (BSA) of lesion |  | 52 weeks | 
| American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis) |  | 52 weeks | 
| Profiles of pharmacokinetics | Concentration of KHK4827 in serum | 52 weeks |
COPD and Inflammatory Mediators

Study Overview
=================
Brief Summary
-----------------
Chronic obstructive pulmonary disease (COPD) is widely spread all over the world. It is predicted to be the third leading cause of death by 2020.

Detailed Description
-----------------
COPD is a common, preventable treatable disease that is characterized by an airflow limitation which is not fully reversible.Not only the long-term exposition to noxious particles and gases contributes to the development of COPD, but also many others factors such as genetics and cigarette smoking. Cigarettes are harmful and contribute to different extra pulmonary disorders. Although COPD affects lungs some extrapulmonary manifestations are prescribed such as muscle dysfunction, abnormal respiratory muscles and systemic inflammation. Indeed, the systemic inflammation[6, 8] is considered as a key process in the pathogenesis of COPD. It involves different cells and molecules; high levels of circulating of white blood cells, increased plasma c-reactive proteins (CRP), interleukin 6 (Il6) have been reported in.those patients.Likewise, systemic inflammation could worsen the comorbidities (cardiovascular, osteoporosis..) and may lead to the exercise limitation.

Official Title
-----------------
Comparison of Exercise Training

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Other: exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD diagnosed by pulmonary function testing Clinically stable Abscence of other obstructive diseases Signed written consent Exclusion Criteria: Neuromuscular diseases -Severe psychiatric, neurologic or musculoskeletal conditions cardiovascular diseases. Contre-indications to physical therapy Acute exacerbations a month before the intervention

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PR<br> | Other: exercise training<br>* The patients are allocated to PR+ET group or PR Each group receive an exercise training<br>|
| Experimental: PR+ET<br> | Other: exercise training<br>* The patients are allocated to PR+ET group or PR Each group receive an exercise training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Interleukins concentrations | ELISA assay | Before the training, 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6Minutes Walk test | patients performed the test | Before the training, 2 months |
Role of NGAL in Vitiligo

Study Overview
=================
Brief Summary
-----------------
Role of serum Neutrophil Gelatinase-associated Lipocalin in early detection of cardiovascular risk in patients with Vitiligo

Official Title
-----------------
Role of Serum NGAL Inearly Detection of CVR in Patients With Vitiligo

Conditions
-----------------
Vitiligo

Intervention / Treatment
-----------------
* Diagnostic Test: NGAL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with vitiligo above 20y Exclusion Criteria: patients with systemic disease Pregnants female Lactating females Patients less than 20 y Patients with active lesions

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cases<br>group of vitiligo patients | Diagnostic Test: NGAL<br>* Serum NGAL in blood for early detection of CVR<br>|
| Active Comparator: control group<br>healthy group | Diagnostic Test: NGAL<br>* Serum NGAL in blood for early detection of CVR<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum Neutrophil Gelatinase-associated Lipocalin in patients with Vitilig | Role of serum Neutrophil Gelatinase-associated Lipocalin in early detection of cardiovascular risk in patients with Vitiligo | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NGAL & CVR
DOAC in Unusual Site Venous Thrombosis

Study Overview
=================
Brief Summary
-----------------
Unusual site venous thromboembolism (VTE) refers to thrombosis occurring in venous districts outside the veins of the lower extremities and the pulmonary arteries, and includes splanchnic vein thrombosis (SVT), cerebral vein thrombosis (CVT), retinal vein thrombosis, ovarian vein thrombosis, and renal vein thrombosis. The use of the novel direct oral anticoagulants (DOAC), thrombin or factor Xa-inhibitors (such as dabigatran, apixaban, edoxaban, rivaroxaban), in patients with unusual VTE in clinical practice is increasing. Through an international multicentre prospective registry, the investigators aim to evaluate the rationale for the use of the DOAC for the treatment of unusual site VTE and to assess the safety and effectiveness of this approach in real life clinical practice.

Official Title
-----------------
International Registry on the Use of the Direct Oral Anticoagulants for the Treatment of Unusual Site Venous Thromboembolism

Conditions
-----------------
Splanchnic Vein Thrombosis, Cerebral Vein Thrombosis, Ovarian Vein Thrombosis, Renal Vein Thrombosis, Retinal Vein Thrombosis

Intervention / Treatment
-----------------
* Drug: Direct Oral Anticoagulants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Objective diagnosis of venous thrombosis not involving the upper limbs, lower limbs and pulmonary arteries Treatment with one of the DOAC (e.g. apixaban, dabigatran, edoxaban, rivaroxaban) Exclusion Criteria: • Enrolment in interventional studies evaluating the DOAC for the treatment of unusual site VTE

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

| Intervention/Treatment |
| --- |
|Drug: Direct Oral Anticoagulants|Consecutive adult patients with objectively diagnosed unusual site venous thrombosis and treated with one of the DOAC (e.g. apixaban, dabigatran, edoxaban, rivaroxaban) will be eligible for this observational prospective registry|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rationale for the use of the direct oral anticoagulants | Possible reasons for choosing one of the direct oral anticoagulant (multiple choice question) | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of major bleeding events |  | 12 months | 
| Rate of vascular events |  | 12 months |
Role of Overjet and Trauma in Libyan Children

Study Overview
=================
Brief Summary
-----------------
Traumatic dental injuries are one of the commonly encountered dental emergencies. Missing anterior tooth in children due to any injury can be a source of considerable physical and psychological discomfort for the child. These consequences also have significant impact on parents, who are generally concerned with esthetic and economic aspects of this problem. It varies from small crack in the enamel to complete loss of the tooth. Injury to children teeth can be both painful and traumatic to the children

Detailed Description
-----------------
Traumatic injuries to anterior teeth have reported by several investigators. In Asia and Africa, the prevalence of TDI to anterior teeth among adolescents ranges from 4% to 35% and 15% to 21%, respectively and in America and Europe, the prevalence varied from 15% to 23% and 23% to 35%, respectively . 50% of school children have sustained traumatic injuries prior to graduation . A contributing factors make children susceptible to injuries have been widely investigated. These factors included Class-II, div.1 malocclusion, increased overjet . 71% to 92% of all injuries sustained in a lifetime occur before the age of 19 years, which occur at home, followed by school and public places.The aim of this study is to assess the mean overjet value in Libyan children and to examine the relationship between increased overjet and trauma to permanent incisor teeth

Official Title
-----------------
Trauma to Permanent Incisors and Overjet in Libyan Children

Conditions
-----------------
Trauma, Overjet

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Libyan children. The permanent incisors are present & sufficiently erupted. Exclusion Criteria: Non Libyan children. The permanent incisors are absent, or un-sufficiently erupted.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 16 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 |
| --- | --- | --- |
| Number of school children with overjet | Presence of overjet among school children, is evaluated by observational method,measured by 1-1mm-3mm;2-3mm-5mm;3-5mm< | From baseline to 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental trauma among school children | Presence of trauma ,by observational method; Grading done by 0- No trauma;1-trauma related to incisal region;2-trauma related to mid half;3-trauma pertaining to cervical region | From baseline to 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overjet, libya, schoolchildren, trauma