linjc16/ctgov huggingface dataset:
Phase II Clinical Trial of Uncaria Tomentosa (Cat´s Claw) in Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
Cat's claw (Uncaria tomentosa) is a native amazonic plant that exhibits anti-inflammatory and antitumor properties. Patients and methods: This prospective phase II study will assess the effects of a 100-mg dose of a dry extract of U. tomentosa three times per day on individuals with advanced solid tumors, with no further therapeutic options and with at least 2 months life expectancy. In addition, several biochemical and inflammatory parameters will be analyzed.

Official Title
-----------------
Phase II Clinical Trial of Uncaria Tomentosa (Cat´s Claw) in Patients With Advanced Solid Tumors

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: uncaria tomentosa (cat´s claw)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: individuals with advanced solid tumors, with no further therapeutic options and with at least 2 moths life expectancy individuals 18 years of age and older creatinine levels up to twice the upper limit of normal (ULN) alanine (ALT) and aspartate (ASP) transaminase levels up to twice the ULN and direct bilirubin (DB) levels up to 1.5 times the ULN in cases with pre-existing liver disease, the ALT, ASP and DB levels could be up to 2.5 times the ULN Exclusion Criteria: pregnant and breastfeeding women individuals using chemotherapy or other tumor-targeting antineoplastic treatments, except for antalgic radiotherapy severe kidney or liver failure known hypersensitiveness to the components of the medication used past history of emotional disorders that could interfere with the data collection.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cat's claw<br>100 mg dose of a dry extract of U. tomentosa three times per day | Drug: uncaria tomentosa (cat´s claw)<br> <br> * Other names: 100 mg dose of a dry extract of U. tomentosa three times per day;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of benefits on quality of life after treatment during two months | Assess the efficacy and safety of a dry extract of U. tomentosa on individuals who had solid tumors with no further therapeutic options | two months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cat´s claw, uncaria tomentosa, quality of life, no further therapeutic options
Appendicitis Choice of Treatment Study

Study Overview
=================
Brief Summary
-----------------
A longitudinal observational/survey study evaluating patient centered decision making in the choice of treatment for acute appendicitis. Survey evaluates patients experience with decision making and the types of decision support they receive.

Official Title
-----------------
Appendicitis Choice of Treatment Study

Conditions
-----------------
Acute Appendicitis

Intervention / Treatment
-----------------
* Other: Patients with acute appendicitis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English Speaking Diagnosed with acute appendicitis Considered by the treating clinical team to be eligible for treatment with surgery or with non operative treatment (antibiotics) Access to an internet connected device capable of taking the survey Exclusion Criteria: Patients who do not make their own medical decisions Patients who are not felt to be candidates for a decision between operative and nonoperative treatment by the treating clinical team Under 18 years of age

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with acute appendicitis<br> | Other: Patients with acute appendicitis<br>* No intervention, single survey<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional conflict | Validated evaluation of decision making | Time of survey (2 days-2 weeks after treatment for acute appendicitis) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preparation for decision making | Validated measure for patient subject preparedness to make a treatment decision | Time of survey (2 days-2 weeks after treatment for acute appendicitis) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Decision Making, Decisional Conflict
V260 Registration Study (V260-013)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
Immunogenicity and Safety of V260 in Healthy Infants in Korea

Official Title
-----------------
Immunogenicity and Safety of V260 in Healthy Infants in Korea

Conditions
-----------------
Rotavirus

Intervention / Treatment
-----------------
* Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
* Biological: Comparator: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At first study vaccination, age 6 weeks through exactly 12 weeks Exclusion Criteria: History of congenital abdominal disorders, intussusception, or abdominal surgery History of known prior rotavirus disease Ongoing chronic diarrhea or failure to thrive Clinical evidence of active gastrointestinal illness

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 12 Weeks

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>RotaTeq | Biological: Rotavirus Vaccine, Live, Oral, Pentavalent<br>* 3 doses of rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2<br>|
| Placebo Comparator: 2<br>Placebo | Biological: Comparator: Placebo<br>* 3 doses of placebo to rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Anti-Rotavirus IgA Response | Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in Serum IgA 14 days Postdose 3 | Baseline and 14 days Postdose 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A | Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in SNA response to G1, G2, G3, G4 and P1A 14 days Postdose 3 | Baseline and 14 days Postdose 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastrointestinal Rotavirus
Phase II Study of Glucocerebrosidase in Patients With Gaucher Disease

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate the efficacy and toxicity of glucocerebrosidase enzyme therapy in patients with Gaucher disease.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients are treated with intravenous glucocerebrosidase every 2 weeks. The dose is based on clinical severity of disease and response to therapy.

Conditions
-----------------
Gaucher's Disease

Intervention / Treatment
-----------------
* Drug: glucocerebrosidase


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Gaucher disease with glucocerebrosidase deficiency confirmed by enzymatic or molecular assay At least 3 organ systems affected, based on the following criteria: Anemia Thrombocytopenia Organomegaly Bone deterioration on radiograph Pulmonary compromise Symptoms compromise daily activities or risk longevity No neurologic disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: glucocerebrosidase|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
-----------------
inborn errors of metabolism, Gaucher's disease, rare disease, sphingolipidoses
Speech Intelligibility of Patients With P D Compared to First Degree Relatives of P D Patients

Study Overview
=================
Brief Summary
-----------------
This study will examine speech intelligibility of early parkinson's disease (PD) patients, early PD patients and first degree relatives. The investigators hypothesis that advanced PD patients will present decreased speech intelligibility more than early PD patients. Speech intelligibility of first degree relatives will be normal.

Detailed Description
-----------------
in order to achieve the study's goals objective and subjective research tools will be used. Objective tools include measuring phonation time, diadokokinetic movements of the oral structures and acoustic analysis . Subjective tools include self reported questionnaires.

Official Title
-----------------
Speech Intelligibility of Patients With Parkinsons Disease at Different Stages of the Disease Compared to First Degree Relatives of Parkinson's Disease Patients

Conditions
-----------------
Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:A Advanced PD patients Early PD patients First degree relatives Exclusion Criteria: Patients with decreased cognitive abilities Patients who participate in speech therapy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| early & advanced PD 1st degree relatives<br>no intervention is performed in the study | |
| recording speech and voice<br>no intervention(s) will be administered | |
| speech intelligibility<br>no intervention(s) will be administered | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum phonation time | maximum phonation time will be measured after taking few measurements of sentence reading.It is an observational study that aim to collect data during DAY 1 only! day 1 for outcome measure time frames There are not pre/post measurements | DAY 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diadokokinetik (DDK): production time of 10x PATAKA, 7x /P/ and 7x /t/ | production time of 10x PATAKA, 7x /P/ and 7x /t/ will be measured during the examination. It is an observational study that aim to collect data during DAY 1 only! DAY 1 for outcome measure time frames There are not pre/post measurements | DAY 1 |
Research to Improve Smoke Alarm Functioning and Maintenance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to evaluate whether (1) targeted smoke alarm education, (2) general fire safety education with a smoke alarm component, (3) basic fire safety education, or (4) an unrelated intervention is most effective way to improve smoke alarm maintenance and function.

Official Title
-----------------
Research to Improve Smoke Alarm Functioning and Maintenance

Conditions
-----------------
Wounds and Injuries, Burns

Intervention / Treatment
-----------------
* Behavioral: Fire safety education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: live within four target neighborhoods in Prince George's County, MD that are at high risk for residential fire and injury. Exclusion Criteria: primary decision maker of home is less than 18 years old speak a language other than english or spanish nobody at home after six return visits to the home

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Fire safety education|Education on smoke alarm maintenance based on behavioral theories|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoke alarm functionality post-intervention. |  | 18 months |
Treatment of Disseminated High Grade Lymphoma

Study Overview
=================
Brief Summary
-----------------
Interest of the use of pegylated liposomal doxorubicin (caélyx)

Detailed Description
-----------------
R CHOP is a good standard in the treatment of diffuse high grade lymphoma. Howeverin elderly patients it is often toxic, specially with haematologic and cardiac toxicities.

Official Title
-----------------
Phase III Study of Treatment of Disseminated and Agressive Lymphoma R CHOP Versus R CLOP( With Liposomal Doxorubicin)

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Drug: Doxorubicin
* Drug: Doxorubicin pegylated


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: high grade lymphoma disseminated > 60 years old and < 75 informed consent signed cardiac state compatible with antracyclin ECOG </= 2 Exclusion Criteria: patients > 75 years old Cardiac insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 75 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 |
| --- | --- |
| Active Comparator: Doxorubicine<br>CHOP 8 courses every 21 days | Drug: Doxorubicin<br> <br> |
| Experimental: Doxorubicine pegylated<br>CLOP 8 courses every 21 days | Drug: Doxorubicin pegylated<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hematologic toxicity |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  | 6 months | 
| EFS and OS |  | 6 months | 
| Cardiac toxicity |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diffuse larg cells lymphoma, chemotherapy, toxicity, diffuse high grade lymphoma
Alpha-galactosidase Enzyme and Irritable Bowel Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether alpha-galactosidase enzyme is affective in alleviating the symptoms of irritable bowel syndrome (IBS).

Official Title
-----------------
Alpha-galactosidase Enzyme and Irritable Bowel Syndrome

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Alpha-galactosidase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of IBS according to Rome III criteria, additionally abdominal distension or flatulence the most disturbing symptom Age 18-65 years Colonoscopy conducted within the previous 5 years, finding macroscopically and histologically normal Exclusion Criteria: Organic GI disease. Treated (min. 1 year) coeliac disease patients, and subjects with known and treated lactose intolerance are allowed to participate Malignancy Significant gastrointestinal surgery Clinically significant aberrancies in the screening-phase laboratory analyses Changes in regular medication during the previous 4 weeks Pregnancy or breast feeding Other disease or state that based on the investigator's evaluation complicates the conduction of the intervention, i.e. alcoholism, dementia Hereditary galactosemia

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alpha-galactosidase<br> | Dietary Supplement: Alpha-galactosidase<br>* 3 months intervention, daily 3 x 3 capsules alpha-galactosidase enzyme (400 GalU/capsule) or 3 x 3 capsules placebo<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Alpha-galactosidase<br>* 3 months intervention, daily 3 x 3 capsules alpha-galactosidase enzyme (400 GalU/capsule) or 3 x 3 capsules placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBS symptom severity | The IBS symptom severity score (IBS-SSS) questionnaire is used | baseline | 
| IBS symptom severity | The IBS symptom severity score (IBS-SSS) questionnaire is used | 1 month | 
| IBS symptom severity | The IBS symptom severity score (IBS-SSS) questionnaire is used | 2 months | 
| IBS symptom severity | The IBS symptom severity score (IBS-SSS) questionnaire is used | 3 months | 
| IBS symptom severity | The IBS symptom severity score (IBS-SSS) questionnaire is used | follow-up (4 months) |
Modified Polyurethane Film Dressing For Skin Graft Donor Sites

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the combination of modified polyurethane film and secondary absorbent dressing for skin graft donor sites avoids the regular uncontrolled leakage, but holds up the advantages of film dressings for this kind of wound.

Official Title
-----------------
Modified Polyurethane Film Dressing For Skin Graft Donor Sites

Conditions
-----------------
Wound Healing

Intervention / Treatment
-----------------
* Device: Polyurethane Film


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults over age 18 who require skin grafting Exclusion Criteria: Individuals under the age of 18.

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 |
| --- | --- |
| A,1<br> | Device: Polyurethane Film<br>* The modified polyurethane film is combined with a secondary absorbent dressing and remained intact until the 10th postoperative day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| uncontrolled leakage |  | 1-10th day postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain |  | 1-10th day postoperative | 
| infection |  | 1-10th day postoperative | 
| epithelization status |  | 10th day postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healing time, pain, infection
Multifocal Electrophysiologic Findings After Intravitreal Bevacizumab(Avastin)Treatment

Study Overview
=================
Brief Summary
-----------------
Purpose: Determine the short-term safety of intravitreal bevacizumab by multifocal electroretinography (mf-ERG). Methods: 120 eyes with choroidal neovascularization, proliferative diabetic retinopathy and retinal vein occlusion received intravitreal bevacizumab (2.5mg/0.1cc). All patients underwent best corrected visual acuity, fluorescein angiography, optical coherent tomography and mf-ERG before and 1 month after treatment.

Conditions
-----------------
Diabetic Proliferative Retinopathy, Vascular Vein Oclussion, Choroidal Neovascularization

Intervention / Treatment
-----------------
* Drug: Intravitreal Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proliferative diabetic retinopathy, vascular vein oclussion, choroidal neovascularization Multifocal electroretinogram before intravitreal bevacizumab and at 1,3, and 6 months after treatment Completely studies Exclusion Criteria: Complications Tractional Detachment Endophthalmitis
Sexes Eligible for Study
-----------------
All

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intravitreal Bevacizumab|nan|

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

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