linjc16/ctgov huggingface dataset:
Investigating The Experiences of Patients In Immunotherapy Clinical Trials

Study Overview
=================
Brief Summary
-----------------
It has been observed before that participation in medical trials has been in favor of specific demographic groups. But research pointing out which trial attributes impact participation positively or negatively is sparse. This study invites various participants to collect more data on their immunotherapy clinical experiences. The goal is to know which factors always limit how patients participate or complete the medical study they are first interested in. The data obtained in the trial will be assessed through a variety of demographic lenses to discover patterns that might improve the experience of immunotherapy patients in the future.

Official Title
-----------------
An Observational Study Investigating The Experiences of Patients In Immunotherapy Clinical Trials

Conditions
-----------------
Immunotherapy, Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has self-identified as planning to participate in an interventional clinical trial using immunotherapy Patient has been diagnosed with a type of cancer Patient is a minimum of 18 years or older Exclusion Criteria: Patient has an ECOG score of 4 or higher Patient is not able to provide consistent digital reporting as per study requirements Patient does not complete Informed Consent Form

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Number of patients who decide to enroll in an immunotherapy clinical trial |  | 3 months | 
| Rate of patients who remain in immunotherapy clinical trial to trial completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunotherapy, Cancer, Diversity In Immunotherapy Clinical Trials
Risk Factors for the Leakage of Anticancer Drugs to Systemic Circulation by Transcatheter Arterial Chemoembolization

Study Overview
=================
Brief Summary
-----------------
Hepatocellular carcinoma (HCC) is the most common malignant tumor of the liver. Transcatheter arterial chemoembolization (TACE) is the traditional method for the palliative management of patients with HCC. Few previous studies had demonstrated that the serum level of anticancer drug from patients treated by TACE was similar to those treated by systemic chemotherapy. The defense ability of the patient treated by TACE may thus be influenced by the leakage of anticancer drug to the systemic circulation. Since more than 80% patients with HCC also have liver cirrhosis, the toxicity for those anticancer drugs with hepatic transformation will be increased caused by the cirrhotic liver. The severity of pancytopenia in cirrhosis will be exacerbated by the effect of bone marrow suppression caused by anticancer drugs. Patients are at high risk for infection and hemorrhage. Therefore, it is of clinical importance to prevent or decrease the leakage of anticancer drugs to systemic circulation in patients treated by TACE. The procedures of TACE performed by previous studies were not constant and the distributions of tumor vessels were not evaluated in detail. The possible risk factors for the leakage of anticancer drug have not been investigated. This project will collect 60 patients with HCC including 30 patients with hepatitis B and 30 patients with hepatitis C. The blood levels of anticancer drugs (epirubicin, mitomycin C and cisplatin) will be determined within one hour and at the third day after TACE.

Official Title
-----------------
Investigation the Risk Factors for the Leakage of Anticancer Drugs to Systemic Circulation in Patients With Hepatocellular Carcinoma Treated by Transcatheter Arterial Chemoembolization

Conditions
-----------------
Hepatocellular Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hepatocellular carcinoma caused by hepatitis B or C who will be treated by TACE Exclusion Criteria: Previously treated by antiviral drugs for hepatitis B or C

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| 1<br>only one arm for study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The blood levels of anticancer drugs (epirubicin, mitomycin C and cisplatin) will be determined within one hour and at the third day after TACE. |  | within one hour and at the third day after TACE | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epirubicin, mitomycin C, cisplatin, Hepatocellular carcinoma
Simultaneous Therapy With Intravitreal Dexamethasone Implant and Bevacizumab for the Treatment of Macular Edema

Study Overview
=================
Brief Summary
-----------------
Retrospective cases series is a non-randomized, open-label, single-center investigation (Retina Clinic, São Paulo, Brazil) of patients diagnosed with macular edema secondary to diabetic retinopathy (DME) and retinal vein occlusions who underwent to simultaneous treatment with intravitreal injection of bevacizumab 1.25mg and implant of dexamethasone 0.7mg.

Detailed Description
-----------------
This retrospective cases series is a non-randomized, open-label, single-center investigation (Retina Clinic, São Paulo, Brazil) approved by the Institutional Review Board of Hospital Oftalmológico de Sorocaba/SP, and adhered to the tenets of the Declaration of Helsinki. Were included patients older than 18 years, treated between April 2014 and July 2015, diagnosed with macular edema secondary to diabetic retinopathy (DME) and retinal vein occlusions who underwent to simultaneous treatment with intravitreal injection of bevacizumab 1.25mg (Avastin; Genentech, South San Francisco, CA) and intravitreal implant of dexamethasone 0.7mg (Ozurdex; Allergan, Inc, Irvine, CA).

Official Title
-----------------
Simultaneous Therapy With Intravitreal Dexamethasone Implant and Bevacizumab for the Treatment of Macular Edema

Conditions
-----------------
Macular Edema

Intervention / Treatment
-----------------
* Drug: simultaneous treatment with intravitreal injection of bevacizumab 1.25mg and intravitreal implant of dexamethasone 0.7mg.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: central macular thickness > 300 µm on optical coherence tomography (OCT) macular edema secondary to diabetic retinopathy (DME) and retinal vein occlusions Exclusion Criteria: intravitreal anti-VEGF within 6 weeks treatment with laser or intravitreal corticosteroids within 3 months of study entry.

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 |
| --- | --- |
| bevacizumab plus dexamethasone 0.7mg<br>simultaneous treatment with intravitreal injection of bevacizumab 1.25mg and intravitreal implant of dexamethasone 0.7mg | Drug: simultaneous treatment with intravitreal injection of bevacizumab 1.25mg and intravitreal implant of dexamethasone 0.7mg.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in BCVA |  | 6 months |
Effect of Ultrasound and Laser in Chronic Low Back Pain: Randomized Double-blinded Controled Trial

Study Overview
=================
Brief Summary
-----------------
The low level laser therapy has a better effect in decrease the pain than ultrasound therapeutic.

Detailed Description
-----------------
The laser will be applied with the dosimetry 3 J/cm², 2 minutes in 6 points around the back spine, during 4 weeks. Before the women will be evaluate again.

Official Title
-----------------
Effect of Laser and Ultrasound in Pain and Disability in Women With Chronic Non-specific Low Back Pain: Randomized Double-blinded Controled Trial

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Device: pulsatile ultrasound
* Device: continuous ultrasound
* Device: laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic low back pain 3,0 - 7,0 in the visual analogic scale Exclusion Criteria: no use of medications no other treatment without fractures, pregnancy, psychiatric or neurologic disorders, diabetes, amputations with diagnostic of low back pain

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laser<br>3 J/cm², 2 minutes in 6 points around the back spine | Device: pulsatile ultrasound<br>* 1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.<br>Device: continuous ultrasound<br>* 1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.<br>|
| Experimental: pulsatile ultrasound<br>1 W/cm², 2 minutes in 6 points around the back spine | Device: continuous ultrasound<br>* 1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.<br>Device: laser<br>* 1 W/cm², 2 minutes in 6 points around the back spine<br>|
| Experimental: continuous ultrasound<br>1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks. | Device: pulsatile ultrasound<br>* 1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.<br>Device: laser<br>* 1 W/cm², 2 minutes in 6 points around the back spine<br>|
| No Intervention: control<br>no treatment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Visual Analog Scale | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain quality | McGill questionaire | 4 weeks | 
| Disability | Roland Morris Questionaire | 4 Weeks |
Safety of Vitamin D Supplementation in Older Persons

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety over 6 months of two different doses of vitamin D (cholecalciferol) in men and women age 65 and older. It will also evaluate if supplementation with vitamin D improves physical performance.

Detailed Description
-----------------
120 ambulatory men and women ages 65 to 95 will be enrolled in this study. Each subject will participate in the clinical trial for 6 months. Parathyroid hormone, vitamin D, and serum and urinary calcium will be measured periodically. Physical performance will be tested at baseline and throughout the study.

Official Title
-----------------
Safety of Vitamin D Supplementation in the Elderly

Conditions
-----------------
Vitamin D Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: cholecalciferol (vitamin D)
* Dietary Supplement: cholecalciferol (vitamin D)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ambulatory Exclusion Criteria: hypercalcemia hypercalciuria > 4 mg/kg body weight/day primary, secondary, or tertiary hyperparathyroidism renal insufficiency (serum creatinine > 2 mg/dL ) history of nephrolithiasis treatment with vitamin D (ergocalciferol, cholecalciferol, calcitriol) treatment with anticonvulsants Paget's disease severe cardiac, pulmonary, hepatic, renal, or neurological disease life expectancy < 1 year participation in another trial

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 95 Years

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

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

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: 1<br>vitamin D (cholecalciferol) 400 IU daily orally - low dose | Dietary Supplement: cholecalciferol (vitamin D)<br>* 400 IU daily (low dose)<br>|
| Active Comparator: 2<br>vitamin D (cholecalciferol) 2000 IU daily orally - high dose | Dietary Supplement: cholecalciferol (vitamin D)<br>* 2000 IU daily (high dose)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Develop Hypercalcemia | calcium serum levels measured at baseline and at the end of the intervention (6-months) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Serum 25-hydroxyvitamin D Levels |  | baseline and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin D, deficiency, elderly
Varicose Vein in Patients Under the Age of 40

Study Overview
=================
Brief Summary
-----------------
Varicose veins are a result of valvular insufficiency and presented with twisted, enlarged veins. They not only cause cosmetic concerns but also lead to limb edema, skin pigmentation/lipodermatosclerosis, and even venous ulcers. This disease affects a large percentage of the population. Although there have been several researches on the risk factors for varicose veins and the outcomes of alternative therapies , there is currently limited data focusing on varicose veins in young patients. In this case-control study, we wanted to assess the risk factors for varicose veins in patients under the age of 40, as well as their long-term results of surgery.

Official Title
-----------------
Varicose Vein in Patients Under the Age of 40

Conditions
-----------------
Varicose Veins

Intervention / Treatment
-----------------
* Procedure: Great saphenous vein stripping and ambulatory phlebectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: great saphenous varicose veins (GSVV) with saphenous vein reflux >0.5s. lower extremity venography excluding iliac vein compression; treated by great saphenous vein stripping and ambulatory phlebectomy. the patient had a minimum follow-up of five years. Exclusion Criteria: secondary varicose veins (defined as varicose veins caused by deep vein thrombosis, iliac venous compression or venous injury etc.); small saphenous veins; treated by endovenous ablation/laser or sclerotherapy alone.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The younger group<br>Patients who were under the age of 40 | Procedure: Great saphenous vein stripping and ambulatory phlebectomy<br>* All patients included in the study were treated with great saphenous vein stripping and ambulatory phlebectomy.<br>|
| The older group<br>Patients who were more than 40 years old | Procedure: Great saphenous vein stripping and ambulatory phlebectomy<br>* All patients included in the study were treated with great saphenous vein stripping and ambulatory phlebectomy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative varicose veins sequelae | The sequelae of the varicose vein were assessed by Venous Clinical Severity Score (VCSS). The total score is 0 30. The higher scores mean a worse outcome. | Five years after surgery. | 
| Postoperative quality of life | Quality of life was assessed by the Aberdeen Varicose Vein Questionnaire (AVVQ). The total score is 1 100. The higher scores mean a worse outcome. | Five years after surgery. |
A Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD1446 Administered for 4 Weeks in Elderly Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of two doses of AZD1446 or placebo in subjects when given for 4 weeks.

Official Title
-----------------
A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group, Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1446 in Healthy Elderly Male and Female Volunteers During 4 Weeks of Treatment

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: AZD1446
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or non-fertile female, elderly Subjects, aged ≥65 to ≤85 Body mass index (BMI) between 18 and 30 kg/m2 Clinically normal findings on physical examination Exclusion Criteria: History of any clinically significant disease or disorder History of severe allergy/hypersensitivity reactions including severe food allergy as judged by the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD1446 Low<br>Low dose of AZD1446 | Drug: AZD1446<br>* Solution, oral, for 4 weeks<br>|
| Experimental: AZD1446 High<br>High dose of AZD1446 | Drug: AZD1446<br>* Solution, oral, for 4 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of AZD1446 dosed for 4 weeks as compared to placebo in healthy elderly male and female volunteers. Safety and tolerability outcomes include adverse events, clinical chemistry and vitals (pulse and blood pressure). |  | During the whole study period, Study days 1-68 (30 days of enrolment , study day 1-28 and follow up visit study days 35-38). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the PK of AZD1446 dosed for 4 weeks in healthy elderly male and female volunteers. PK parameters include renal clearance, AUC (0-24)ss and T1/2 eff. |  | PK sampling taken at defined timepoints during the treatment period (study days 1-28) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AZD1446, to investigate safety and tolerability in Healthy subjects during 4 weeks of administration
Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)

Study Overview
=================
Brief Summary
-----------------
Use of oral clarithromycin for treatment of chronic lung disease due to Mycobacterium avium-intracellulare and other non-tuberculous Mycobacteria

Detailed Description
-----------------
Oral clarithromycin for treatment of MAC and other nontuberculous mycobacteria in adults with clinical history

Official Title
-----------------
Open Study of Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)

Conditions
-----------------
Nontuberculous Mycobacteria, Mycobacterium Avium Complex

Intervention / Treatment
-----------------
* Drug: Clarithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet American Thoracic Society criteria for nontuberculous lung disease: two or more AFB smear positive, culture positive sputums or bronchoscopic samples and/or two or more AFB smear negative respiratory samples with moderate to heavy growth (2+-4+); abnormal CXR consistent with M. avium lung disease; absence of other potential lung pathogens (except for the coexistence of M. abscessus) Age 18 years and older Exclusion Criteria: History of macrolide allergy Must not receive the antihistamines terfenadine (Seldane) or astemizole (Hismanal) while on clarithromycin Children less than 18 years of age If a menstruating female, not pregnant and on adequate birth control

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: treatment of MAC and other NTM<br>Clarithromycin drug given twice daily. | Drug: Clarithromycin<br>* Dosage dependent on clinical factors such as age, weight and patient-specific health status<br>* Other names: Biaxin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and microbiological outcomes, such as clinical symptoms and laboratory cultures | neg culture x3( sputum conversion) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological cultures | neg culture for 1 yr on treatment | 1yr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MAC, NTM