linjc16/ctgov huggingface dataset:
Normal Reference Ranges for Urinary Metabolites and Supersaturation Indices in Pediatric Populations

Study Overview
=================
Brief Summary
-----------------
The reported normal values used in diagnosing and treating pediatric kidney stone formers are based on adult values or historic data from small studies. Urinary supersaturation indices which are now described in the adult stone literature as more sensitive predictors of stone composition, and precise predictors of response to therapy, are not established in children. The goals of this prospective study are to redefine normal values for pediatric urinary metabolites and supersaturation indices based on samples from a large number of healthy children and to identify if a difference in urinary supersaturations in children is protective.

Official Title
-----------------
Determining Normal Reference Ranges for Urinary Metabolites and Supersaturation Indices in the Pediatric Population

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female children between the ages of 3 and 18, inclusive, of all races who are toilet trained and who can submit a 24-hour urine sample Exclusion Criteria: Active urinary tract infection Known urologic anatomic abnormality Personal or first-degree relative family history of urolithiasis or metabolic abnormality known to lead to urinary stone development Renal insufficiency Inability to collect a 24-hour urine specimen Intake of medications known to alter the risk of stone development such as steroids or diuretics or vitamins or calcium supplementation exceeding recommended daily allowances Adherence to restrictive diet for medical reasons Inflammatory or absorptive bowel disease

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum 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 |
| --- | --- |
| pediatric<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Define normal reference ranges for urinary metabolites in the pediatric population |  | Assessed one time with normal urine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine supersaturation indices in normal urine of the pediatric population |  | Assessed one time in normal urine | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urine, pediatric, Normal urine from healthy pediatric population
Kinase Genotyping of Gastro Intestinal Stomach Tumors (GISTs) From Patients Enrolled in Pfizer A6181112 Phase IIIb Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the genetic makeup of gastro intestinal stomach tumors (GISTs) from patients enrolled in the A6181112 phase IIIb trial. Tumor samples will be screened for mutations and this information will be used to determine whether the progression-free survival of patients being treated with the cancer medication sunitinib is related to the underlying genotype of their GIST.

Detailed Description
-----------------
In this companion study, we will analyze the genomic DNA from the GIST tumor specimens of patients enrolled in the in the A6181112 phase IIIb trial at participating U.S. and ex-U.S. medical centers. Specifically, GIST samples will be screened for mutations in KIT gene exons 9, 11, 13 and 17, and PDGFRA gene exons 12, 14 and 18, to determine the primary kinase genotype. Subset analyses will be performed and compared with the overall PFS rates observed in patients with primary and secondary imatinib resistance. Based on data from a previous phase I/II trial, our hypothesis is that patients with either primary or secondary imatinib resistance having a KIT exon 9-mutant or WT GIST will have a longer PFS when treated with sunitinib than patients with exon 11-mutant GIST. We further hypothesize that this difference will be observed among patients treated with high-dose imatinib.

Official Title
-----------------
Kinase Genotyping of Gastrointestinal Stromal Tumors (GIST) From Patients Enrolled in the A6181112 Phase IIIb Trial at Participating U.S. and Ex-U.S. Medical Centers

Conditions
-----------------
Gastrointestinal Neoplasm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients enrolled in Pfizer A6181112 Exclusion Criteria: Patients who do not consent for analysis of their tumor in this companion study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | |
| 2<br> | |

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
-----------------
Gastrointestinal stromal tumor, GIST, Sunitinib, Imatinib
A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a background of standard medication for ACS (including aspirin, antihypertensives and statins). The anticipated time on study treatment is 2+ years, and the target sample size is 15,600 individuals.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Study Assessing the Effect of RO4607381 on Cardiovascular Mortality and Morbidity in Clinically Stable Patients With a Recent Acute Coronary Syndrome

Conditions
-----------------
Coronary Heart Disease

Intervention / Treatment
-----------------
* Drug: Dalcetrapib (RO4607381)
* Drug: Evidence-based medical care for Acute Coronary Syndrome
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >=45 years of age; recently hospitalized for ACS; clinically stable; receiving evidence-based medical and dietary management of dyslipidemia. Exclusion Criteria: uncontrolled diabetes; clinically unstable; severe anemia; uncontrolled hypertension; concomitant treatment with any other drug raising HDL-C (eg niacin, fibrates).

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Dalcetrapib (RO4607381)<br> | Drug: Dalcetrapib (RO4607381)<br>* 600mg po daily<br>Drug: Evidence-based medical care for Acute Coronary Syndrome<br>* As prescribed<br>|
| Placebo Comparator: Placebo<br> | Drug: Evidence-based medical care for Acute Coronary Syndrome<br>* As prescribed<br>Drug: Placebo<br>* po daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Cardiovascular Mortality and Morbidity | Number of cardiovascular events per patient per year | From date of randomization to first event up to 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Endpoint:All Cause Mortality |  | Throughout Study, up to 53 Months | 
| Change From Baseline for HDL Cholesterol |  | At 53 Months | 
| Adverse Events, Lab Parameters, Vital Signs, ECG |  | Throughout Study, up to 53 Months |
Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect blood and urine samples that may help identify and validate biomarkers for the early detection and risk assessment of acute kidney injury (AKI).

Official Title
-----------------
Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury

Conditions
-----------------
Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females 21 years of age or older; Subjects enrolled (first sample collection) from ED or Floor admitted to the ICU within 24 hours of enrollment; Subjects enrolled from ICU admitted to the ICU within the 24 hours prior to enrollment; Expected to remain in the ICU for at least 48 hours after enrollment; Use of indwelling urinary catheter as standard care expected for at least 48 hours after enrollment; At least one of the following acute conditions within 24 hours prior to enrollment: (Respiratory SOFA score of ≥ 2 (PaO2/FiO2 <300)and/or Cardiovascular SOFA score of ≥ 1 (MAP < 70 mm Hg and/or any vasopressor required). Patient (or authorized representative) able and willing to provide written informed consent for study participation. Exclusion Criteria: Special populations including women with known pregnancy, prisoners or institutionalized individuals;Previous renal transplantation;Known acutely worsening renal function prior to enrollment (e.g., any category of RIFLE criteria. Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment; Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic);Patient meets any of the following:Active bleeding with an anticipated need for > 4 units PRBC;Hemoglobin < 7 g/dL;Any other condition that in the physician's opinion would contraindicate drawing serial blood samples for clinical study purposes.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| Evaluation of Novel Biomarkers From Acutely ill Patients at Risk for AKI. | Primary outcome measure: Identification and Validation of Biomarkers from Acutely ill patients at risk for AKI. (N=744) Secondary outcomes including follow-up (N=890). | 10/2010 to 2/2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney Renal
Effectiveness Study of a Swedish Youth Mentoring Program

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the effectiveness of a one-to-one, adult-to-youth primary preventive mentoring program in Sweden. Outcome domains and criteria for inclusion and exclusion of study participants are elaborated in collaboration with the providing NGO, and the program is given as customary.

Official Title
-----------------
A Randomized Effectiveness Trial of a One-to-one, Adult-to-youth Mentoring Program in Sweden

Conditions
-----------------
Substance Use

Intervention / Treatment
-----------------
* Behavioral: Youth Mentoring program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a self-reported need of the youth for additional adult contacts Exclusion Criteria: current or past regular use of illicit drugs repeated delinquent behaviour or single acts of violence against persons ongoing contacts with psychiatric care or social services

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 14 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mentoring program<br>Mentor and mentee meet at least every second week, for 2-4 h on every occasion, during 1 year (i.e., for a minimum of two school semesters). Meetings take place outside school and work hours, and the pairs choose activities of their own preferences. No monetary incentives exist, and the mentors are laymen volunteers. The program objective is to establish a safe and supportive relationship, by which the youth is assumed to benefit in social, emotional, and academic development, and as a consequence, be less prone to use alcohol and drugs. | Behavioral: Youth Mentoring program<br> <br> |
| No Intervention: Control group<br>No intervention provided, only brief phone calls to control for attention bias | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported substance use | Self-reported substance use among youth | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Youth delinquency | Self-reported delinquency among youth | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Youth mentoring, Effectiveness, Sweden, low-risk youth
Sentinel Node and Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the relevance of sentinel node in endometrial cancer. Sentinel node is thought to reflect the status of lymph node. Only 10 to 20% of women with endometrial cancer exhibit lymph node metastasis hence systematic lymphadenectomy is questionable. In breast cancer, melanoma and vulvar cancer, sentinel node has emerged as an alternative to complete lymphadenectomy.

Detailed Description
-----------------
To investigate the relevance of sentinel node in endometrial cancer. Sentinel node is though to reflect the status of lymph node. Only 10 to 20% of women with endometrial cancer exhibit lymph node metastasis hence systematic lymphadenectomy is questionable. In breast cancer, melanoma and vulvar cancer, sentinel node has emerged as an alternative to complete lymphadenectomy. The objective of our trial is to validate the concept of sentinel node in endometrial cancer.

Official Title
-----------------
Validation of the Sentinel Node in Endometrial Cancer

Conditions
-----------------
Endometrial Neoplasms

Intervention / Treatment
-----------------
* Procedure: Detection of sentinel node


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient over 18 years old with a surgery planned for endometrial cancer endometrial cancer proved by biopsy early stage of endometrial cancer (FIGO stage 1-2) without contraindication to surgery inform consent signed affiliated to general health system Exclusion Criteria: endometrial cancer FIGO stages 3-4 previous history of surgery modifying lymphatic drainage (conization myomectomy) pregnant women or breast feeding

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients with endometrial cancer | Procedure: Detection of sentinel node<br>* Coelioscopy or laparotomy (based on the tumor size) after a colorimetric tracer injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection and false negative rates of sentinel node |  | During the surgery (hysterectomy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity and recurrence rates |  | During 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sentinel node procedure, radiocolloid, patent blue
HMP (Home Macular Perimeter) -Usability Trial

Study Overview
=================
Brief Summary
-----------------
The study is divided in two stages. The purpose of the first stage is to evaluate the percentage of subjects that can unpack the device, install it, learn the task and calibrate it according to their personal capabilities. The purpose of the second stage is to assess the ability of the subjects to perform reliable tests .

Detailed Description
-----------------
Stage I: Receive a packed HMP device. Unpack the device and install it, using a set-up guide Use an interactive tutorial to learn the task Calibrate the sensitivity of the test This stage will be completed within 1 to 5 visits, depending on personal progress rate. Subjects who have successfully completed stage I will be recruited to stage II. Those subjects will: • Perform 3 tests , each test in a different day

Official Title
-----------------
Phase III Study of the Usability of the HMP Device

Conditions
-----------------
Age Related Macular Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >50 years Familiar with computer usage Capable and willing to sign a consent form and participate in the study Ability to speak, read and understand instructions in English Exclusion Criteria: Subject already participating in another study.

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- | --- |
| Proportion of subjects who successfully set up the device |  | 1 month | 
| Proportion of subjects who successfully pass the training program (successful calibration module) |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with reliable tests results |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PHP, HMP, HPHP, AMD, CNV
Drug Use Investigation for Arepanrix® (H1N1)

Study Overview
=================
Brief Summary
-----------------
This post-marketing surveillance study is designed to collect safety information such as post-vaccination adverse events and adverse reactions from recipients of Arepanrix® (H1N1) Intramuscular Injection. The following items will be investigated as priority investigation items. <Priority investigation items> Allergic reactions Anaphylaxis

Official Title
-----------------
Drug Use Investigation for Arepanrix® (H1N1)

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: Arepanrix®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who receive Arepanrix® intramuscular injection for the first time Exclusion Criteria: Not applicable
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 |
| --- | --- |
| Subjects who receive Arepanrix®<br>Subjects who receive Arepanrix® as per routine practice | Biological: Arepanrix®<br>* Injected according to the prescribing information in the locally approved label by the authorities.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of recipients who have adverse reactions after injection |  | 29 days | 
| The number of recipients who have post-vaccination adverse events after injection |  | 29 days | 
| The number of recipients who have allergic reactions after injection |  | 29 days | 
| The number of recipients who have anaphylaxis after injection |  | 29 days |
Evaluation of Preclinical Toxicity andTherapeutic Efficacy of Kandhaga Rasayanam in Padarthamarai

Study Overview
=================
Brief Summary
-----------------
this study is intended to find out the therapeutic efficacy of the siddha drug Kandhaga Rasayanam in Padarthamarai ( Ring worm infection )

Official Title
-----------------
Evaluation of Preclinical Toxicity of a Siddha Formulation Kandhaga Rasayanam ( KR ) and Its Therapeutic Efficacy in Padarthamarai ( Dermatophytoses ) by an Open Clinical Trial

Conditions
-----------------
Tinea Infections Such as Tinea Corporis, Tinea Cruris, Tinea Pedis, Tinea Mannum, Tinea Barbae, Tinea Capitis Are Studied

Intervention / Treatment
-----------------
* Drug: kandhaga rasayanam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients clinically diagnosed with tinea infection. direct microscopy skin scraping test positive. Exclusion Criteria: pregnant or nursing women. use of other topical or oral antifungals, immunosuppressive drugs, anthelmintic drugs either currently or during 2 weeks preceeding initiation of drug trial. allergy or hyperensitivity to any component of the drug. clinical case of eczema, lichen planus, pityriasis versicolor, drug induced eruptions, urticaria, intertrigo, tinea ungium. diabetic patients.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Kandhaga Rasayanam- single arm<br>Kandhaga Rasayanam- 2grams twice a day for 45 days | Drug: kandhaga rasayanam<br>* KANDHAGA RASAYANAM is a siddha herbo mineral drug with sulphur as a sole mineral ingredient. It is chosen from the classic Siddha text Siddha Vaidhya Thirattu.<br>* Other names: Siddha herbo mineral drug KR.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin scrapping test |  | 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| itching, quality of life |  | 45 days | 

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