linjc16/ctgov huggingface dataset:
A Long Term, Safety Study of Apricitabine in HIV-infected Subjects

Study Overview
=================
Brief Summary
-----------------
The study will examine how safe and effective apricitabine is when given long term (as ongoing treatment) to HIV patients who have already completed the AVX-201 trial

Detailed Description
-----------------
An ongoing study (AVX-201) is examining the safety and efficacy of apricitabine compared to 3TC in HIV patients who are failing therapy containing 3TC and have the presence of the M184V mutation in reverse transcriptase. This extension study (AVX-201E) is available to patients who complete the AVX-201 protocol. Patients will continue to receive apricitabine open label for a further 96 weeks (making a total of 144 weeks from starting AVX-201) in addition to an optimised background. Safety markers and efficacy markers will be followed.

Official Title
-----------------
An Open Label Long Term Safety Extension Study of Apricitabine in Treatment-experienced HIV-1 Infected Subjects

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Drug: apricitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed AVX-201 protocol, Plasma HIV RNA <5000 copies/ml, CD4 cells >50 Exclusion Criteria: Pregnant or breastfeeding females, withdrawal from AVX-201

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ATC 800mg BID<br>800mg ATC BID | Drug: apricitabine<br>* 800mg apricitabine twice daily orally for 96 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to virological failure (DHSS definition) |  | week 144 | 
| incidence of AEs and laboratory abnormalities |  | Week 144 | 
| time to withdrawal due to AEs |  | Week 144 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline HIV RNA |  | weeks 72, 96, 120, and 144 | 
| Proportion of subjects with plasma HIV RNA <400 and <50 copies/ml |  | at weeks 72, 96, 120, and 144 | 
| Change from baseline and change in ratio of CD4+ and CD8+ counts |  | at weeks 72, 96, 120, and 144 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, apricitabine, drug resistance, reverse transcriptase, lamivudine
Acupuncture to Treat Cancer-Related Fatigue in Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This study will evaluate if acupuncture is helpful in treating cancer-related fatigue in breast cancer patients undergoing radiation therapy.

Detailed Description
-----------------
Each participant will have a baseline visit before her radiation therapy begins to complete questionnaires. Participants will receive either true acupuncture or sham acupuncture twice per week for the six weeks of radiation therapy. She will have a short questionnaire at three weeks into her radiation, and she will complete questionnaires again at the end of her radiation and four weeks later.

Official Title
-----------------
Acupuncture for Cancer-Related Fatigue in Breast Cancer Patients

Conditions
-----------------
Fatigue

Intervention / Treatment
-----------------
* Procedure: acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Localized breast cancer Average to above average fatigue Planning radiation therapy Exclusion Criteria: History of acupuncture treatment Allergy to stainless steel Pacemaker Anticoagulant therapy Known bleeding disorder Metastatic breast cancer Seizure disorder

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>True acupuncture using true needles | Procedure: acupuncture<br> <br> |
| Sham Comparator: 2<br>sham acupuncture using sham needles | Procedure: acupuncture<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer-related fatigue |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer-related fatigue distress |  | 10 weeks | 
| Quality of life |  | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer-related fatigue, acupuncture, breast cancer
The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators are going to investigate the efficacy of choline alfoscerate on improvement of cognitive function assessed by MMSE compared to plaebo.

Detailed Description
-----------------
The investigators will enroll patients with type 2 diabetes whose age is equal to higher than 60, and randomly assigned study drug or placebo at 1:1 ratio. The treatment duration is 6 months and extension study will be continued to 12 months.

Official Title
-----------------
The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Choline alfoscerate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes baseline MMSE score 25-28 Exclusion Criteria: type 1 diabetes diabetes ketoacidosis or hyperosmolar hyperglycemic crisis HbA1c over than 9.0% MMSE less than 25 abnormal TSH levels vitamin B12 deficiency severe infection, perioperative state, trauma hypopituitarism or adrenal insufficiency any conditions that lead to hospitalization chronic alcoholics within 1 year any drugs that can influence to cognitive function within 3 months

Ages Eligible for Study
-----------------
Minimum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Choline alfoscerate<br>choline alfoscerate 400mg (2 caps - 1 cap bid) | Drug: Choline alfoscerate<br>* Treatment duration is 6 months and can be extended to 12 months with participant's agreement.<br>* Other names: Choline;|
| Placebo Comparator: Control<br>Placebo (2 caps - 1 cap bid) | Drug: Placebo<br>* Treatment duration is 6 months and can be extended to 12 months with participant's agreement.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function | Change of MMSE Score | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose metabolism | Changes in HbA1c | 6 months | 
| Glucose metabolism | Changes in fasting glucose concentration | 6 months |
An Investigation Of The Effects Of Food On The Absorption Of A Varenicline Controlled Release Formulation

Study Overview
=================
Brief Summary
-----------------
To estimate the absorption of a single oral dose of a controlled release varenicline tablet under fed and fasted conditions. To evaluate the pharmacokinetics, safety, and tolerability of a single dose of a varenicline controlled release tablet under fed and fasted conditions.

Official Title
-----------------
Phase 1, Open-Label, Randomized, Single-Dose, Two-Way Crossover Study To Evaluate The Effect Of Food On The Oral Bioavailability Of A Varenicline Controlled Release Formulation In Healthy Adult Smokers

Conditions
-----------------
Pharmacokinetics, Bioavailability, Smoking Cessation

Intervention / Treatment
-----------------
* Drug: Varenicline Tartrate Controlled Release
* Drug: Varenicline Tartrate Controlled Release


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female adult smokers 18 to 55 years of age Exclusion Criteria: Sensitivity to varenicline Illegal drug use Pregnant or nursing females

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Varenicline Controlled Release, Fasted<br> | Drug: Varenicline Tartrate Controlled Release<br>* A single, 2.4 mg dose of a varenicline controlled release tablet administered orally under fasted conditions<br>|
| Experimental: Varenicline Controlled Release, Fed<br> | Drug: Varenicline Tartrate Controlled Release<br>* A single, 2.4 mg dose of a varenicline controlled release tablet administered orally under fed conditions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Varenicline area under the curve (AUC) from time of study medication administration to last quantifiable plasma concentration (AUClast) and AUC from time of study medication administration to infinity (AUCinf). |  | 5 days | 
| Maximum plasma concentration of varenicline |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measures including adverse events |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
food, varenicline, pharmacokinetics, bioavailability
Quantitative Ultrasonography (US) Evaluation on Femoral Condyle Cartilage

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the feasibility of using quantitative ultrasonography (US) evaluation to determine the severity of osteoarthritic femoral condyle cartilage erosion.

Official Title
-----------------
Quantitative Evaluation by Ultrasonography for Severity of Knee Osteoarthritis

Conditions
-----------------
Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with knee OA who were going to receive total knee arthroplasty Exclusion Criteria: Patients with inflammatory arthritis (e.g. rheumatic arthritis) and infectious disease (e.g. hepatitis B)

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ultrasonography, knee, early degeneration, cartilage
Venous Disease Thromboembolic and Amyotrophic Lateral Sclerosis

Study Overview
=================
Brief Summary
-----------------
Venous thrombo-embolic (VTE) rates could be high in patients with amyotrophic lateral sclerosis (ALS). Indeed, the rate of VTE in this specific population could be 7-fold higher in this population. Predictiv factors of VTE in patients with ALS are mobility reduction and neurological paralysis. However, to our knowledge, medical littérature is poor concerning VTE and ALS association. Our first aim is to define annual rate of VTE in ALS population.Then we aim to identify predictiv factors of VTE in this specific population. The studied population is Brest universitary hospital cohort of ALS patient included between 2000 and 2019.

Official Title
-----------------
Venous Disease Thromboembolic and Amyotrophic Lateral Sclerosis

Conditions
-----------------
Lateral Amyotrophic Sclerosis, Venous Thrombo-embolic Desease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with amyotrophic lateral sclerosis defined by revised El Escorial score criteria followed in competence centre of Brest Universitary Hospital during 2000 to 2019 Exclusion Criteria: no consent other neuro-degenerativ diseases
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 |
| --- | --- | --- |
| Number of venous thrombo-embolic eventsrate per year in amyotrophic lateral sclerosis patients followed between 2000 and 2019 in Brest universitary hospital | pulmonary embolism and deep venous thrombosis | 19 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of predictiv factors of venous thrombo-embolism events in amyotrophic lateral sclerosis population followed in Brest universitary hospital between 2000 and 2019 | immobilization, impairment of respiratory function,, mecanical ventilation, denutrition, artificial nutrition | 19 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lateral amyotrophic sclerosis, venous thrombo-embolic desase, pulmonary embolism, deep venous thrombosis
Pediatric Radial Arterial Cannulation

Study Overview
=================
Brief Summary
-----------------
This prospective randomized study was designed to compare ultrasound guided technique with Doppler assisted technique for radial arterial cannulation in infant and small children.

Detailed Description
-----------------
In infants, percutaneous cannulation of radial artery requires considerable expertise. People have been using Doppler guided radial artery cannulation technique to improve success rate for more than 20 years. Recently, Ultrasound sonography has been utilized for central line placement in pediatrics. The purpose of this study is whether ultrasound guided radial artery cannulation technique improves the success rate compared to traditional doppler guided technique.

Official Title
-----------------
Ultrasound-image Versus Doppler-guided Radial Artery Cannulation in Infants and Small Children

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Procedure: Ultrasound
* Procedure: Doppler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria Pediatric patient undergoing scheduled major surgery which require continuous arterial pressure monitoring Term neonates and children < 4 years old weighing >/= 3 kg and < 12 kg Exclusion Criteria: Exclusion criteria Patients with a skin wound or infection around puncture site Abnormal circulation in the hand (known vascular compromise, mottling, cool skin temp relative to other hand, poor capillary refill) Recent radial arterial puncture (less than 1 month) Any emergency surgery or profound hemodynamic instability requiring urgent arterial cannulation.

Ages Eligible for Study
-----------------
Maximum Age: 48 Months

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound<br>Arterial line placed with Ultrasound guidance. | Procedure: Ultrasound<br>* Ultrasound used to place arterial line<br>|
| Active Comparator: Doppler<br>Arterial line placed with doppler guidance | Procedure: Doppler<br>* Doppler used to place arterial line<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary object is to compare the first attempt success rate between each group. |  | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| As a secondary object, a comparison will be made between groups for overall Success rate within a 10 minute time period. |  | 10 minutes |
T-cell Based Immunotherapy for of Melanoma

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the toxicity and clinical response of therapy with tumor infiltrating lymphocytes as treatment for advanced melanoma. Patient will receive a single treatment consisting of conditioning chemotherapy for seven days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with daily low-dose interleukine-2. Patients will be evaluated for toxicity, tumor response, and immune response. After the first 6 patients the treatment with IL-2 has been changed to include higher doses of IL-2 (see intervention)

Official Title
-----------------
T-cell Based Immunotherapy for Treatment of Patients With Disseminated Melanoma.

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Biological: cyclophosphamide, fludarabine, T-cells, Interleukin-2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histological proven skin derived progressive metastatic or locally advanced malignant melanoma. Further inclusion criteria: Performance Status 0 to 1, surgical available metastasis, at least one measurable lesion, acceptable CBC and blood chemistry results. Acceptable organ functions. Exclusion Criteria: Patients with a history of any other malignancies less than five years ago. Brain metastases. Other significant illness including severe allergy, asthma, DM, angina pectoris, congestive heart failure, chronic infections, or active autoimmune disease. Treatment with immune suppressive drugs, experimental drugs, or antineoplastic drugs.

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: cyclophosphamide, fludarabine, T-cells, Interleukin-2|Two days of cyclophosphamide (60 mg/kg i.v.) and five days of fludarabine (25 mg/m2 i.v.). Infusion of Tumor Infiltrating Lymphocytes (10e9-10e10 cells). Followed by daily sc injections of 2 MIE Interleukin-2 for two weeks. After the first 6 patients the dose of IL-2 has been changed to an i.v. decrescendo regimen using 18 MIU/m2 infused over 6, 12 and 24 hours and then 4.5 MIU/m2 infused over 24 hours for three days.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity |  | week 0 to 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immune response |  | week 0 to 20 | 
| tumor response |  | week 8 and every 3rd week until progression |
Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Relapser Genotype 2 Hepatitis C Infected Patients

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and Ribavirin (RBV) in patients with genotype 2 hepatitis C, who relapsed after previous treatment.

Official Title
-----------------
A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin in Subjects With Genotype 2 Hepatitis C, Who Relapsed After Previous Treatment

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: MP-424 (generic name:Telaprevir)
* Drug: Ribavirin
* Drug: Peginterferon alfa-2b


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Genotype 2, chronic hepatitis C Relapsers (patient who relapsed after previous treatment) Able and willing to follow contraception requirements Exclusion Criteria: Cirrhosis of the liver or hepatic failure Hepatitis B surface antigen-positive or HIV antibodies-positive History of, or concurrent hepatocellular carcinoma History of, or concurrent depression, schizophrenia,; or suicide attempt in the past Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MP-424<br> | Drug: MP-424 (generic name:Telaprevir)<br>* 750mg q8h for 12 weeks<br>Drug: Ribavirin<br>* 400 - 1000 mg/day based on body weight for 24 weeks<br>Drug: Peginterferon alfa-2b<br>* 1.5mcg/kg/week for 24 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response) |  | After 24 weeks of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Genotype 2