linjc16/ctgov huggingface dataset:
Phase I/II Study of Itraconazole for Blastomycosis, Histoplasmosis, and Sporotrichosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate the tolerance of patients with blastomycosis, histoplasmosis, and sporotrichosis to different doses of itraconazole (R51,211). II. Determine levels of itraconazole in serum and other body fluids. III. Assess the course of illness during itraconazole therapy. IV. Determine the dosage of itraconazole that is safe and well tolerated by 80%-90% of patients and estimate the potential of this dosage for use in future comparative trials.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a study to estimate the optimal dose of oral itraconazole. Patients are treated at 1 of 3 doses of itraconazole; the starting dose for each patient is determined at entry. Therapy is administered daily for 3-6 months. Patients with progressive disease may be treated at the next higher dose; there may be only 1 such increase. Concurrent systemic and topical antifungals are prohibited. Patients are followed at 1, 3, 6, and 12 months.

Conditions
-----------------
Histoplasmosis, Sporotrichosis, Blastomycosis

Intervention / Treatment
-----------------
* Drug: itraconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Culture-proven fungal disease, i.e.: Chronic cavitary histoplasmosis Extrapulmonary histoplasmosis, e.g., mucosal disease Blastomycosis Sporotrichosis Positive culture after last dose of any prior therapy Requires antifungal therapy with amphotericin B or ketoconazole No fungal meningitis No central nervous system disease No immediately life-threatening disease --Prior/Concurrent Therapy-- At least 1 month since therapy for same disease No more than 2 mg/kg prior amphotericin B (total dose) No more than 2 mg/kg prior ketoconazole (total dose) No concurrent immunosuppressives, including: Corticosteroids Azathioprine Cytotoxic agents --Patient Characteristics-- Hepatic: AST no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Bilirubin no greater than 3 mg/dL Other: No acquired immunodeficiency syndrome No pregnant or nursing women Effective contraception required of fertile women

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: itraconazole|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
-----------------
blastomycosis, fungal infection, histoplasmosis, immunologic disorders and infectious disorders, rare disease, sporotrichosis
Improving Depression Care for Elders: Coordinating Center

Study Overview
=================
Brief Summary
-----------------
Purpose: To determine the effectiveness of the Improving Mood-Promoting Access to Collaborative Treatment(IMPACT) collaborative care management program for late-life depression.

Detailed Description
-----------------
This study tested an organized method of delivering care for late life depression in primary care. Specifically, the investigators evaluated the effectiveness of this intervention as compared to 'care as usual'. The investigators studied the effect of the intervention on clinical outcomes such as depressive symptoms, functional status, health related quality of life. They also determined the cost-effectiveness of the intervention compared to care as usual.

Official Title
-----------------
This Was a Five-year Seven-site Trial to Study the Cost-effectiveness of a Population Based Disease Management Program for Late Life Depression in Primary Care.

Conditions
-----------------
Major Depression, Dysthymic Disorder, Both Major Depression and Dysthymic Disorder

Intervention / Treatment
-----------------
* Other: IMPACT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major depression or dysthymia as diagnosed by a structured diagnostic interview. Patient plans to receive primary care at the study clinic for the next year. Exclusion Criteria: Age under 60. Current symptoms or history of psychosis or mania as determined by structured diagnostic interview. Cognitive impairment as defined by a score less than 23 on a Mini Mental Status Examination. Terminal illness - defined as having a life expectancy of less than 6 months. Active alcohol abuse as determined by a screening interview. High suicide risk as determined by current plan for suicide or a history of more than 3 prior suicide attempts in the past 10 years.

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

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

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 |
| --- | --- |
| Experimental: IMPACT<br> | Other: IMPACT<br>* IMPACT is a collaborative care management program for late-life depression<br>* Other names: Improving Mood-Promoting Access to Collaborative Treatment;|
| No Intervention: Care as Usual<br>Patients received all depression care available to them as part of care as usual in the participating primary care clinics. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of depression symptoms | Severity measured by the 21-item Hopkins Symptom Checklist. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functioning | measured by the Sheehan Health-Related Functioning Index |  |
Oral Status and Prevalence of Dental Trauma in Children Treated With Ritalin Due to Attention-Deficit Hyperactivity Disorder (ADHD)

Study Overview
=================
Brief Summary
-----------------
To evaluate the dental status of children using ritalin and suffering from ADHA in comparison to healthy children.

Detailed Description
-----------------
In this trial oral and dental status of 30 children (ages 5-12) who suffer from ADHD and treated with ritalin will be evaluated. Parameters that will be checked are the following: DMFT - decay, missing, filling teeth for dental status, GI - gingival index, PI - plaque index for periodontal status. OJ - over jet and OB - over bite for inter-maxillary relations and susceptibility for dental trauma. In addition these parameters will be collected for 30 age and sex match healthy children.

Official Title
-----------------
Oral Status and Prevalence of Dental Trauma in Children Treated With Ritalin Due to Attention-Deficit Hyperactivity Disorder (ADHD)

Conditions
-----------------
Attention Deficit Disorder With Hyperactivity, Dental Caries, Dental Occlusion, Traumatic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children ages 5-12 years healthy children children taking ritalin who suffer from ADHD Exclusion Criteria: all others

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ritalin, ADHA, dental status, periodontal status, Attention-Deficit Hyperactivity Disorder, Dental trauma
Phase I Compare OS in Post-CyberKnife Radiosurgery Tx in 1-3 VS 4 or More Brain Metastases

Study Overview
=================
Brief Summary
-----------------
The investigators will learn from this study if the CyberKnife radiosurgery (CK RS) treatment of patients with 1-3 versus 4 or more brain metastases results in the same overall survivals. The importance of this new knowledge will be to determine the treatment efficacy of CK RS with 1-3 versus 4 or more brain metastases. The outcome of this trial would give data to support either the continuation or modification of the CK RS treatment of patients with brain metastases.

Detailed Description
-----------------
This is registry-based cohort study of patients with brain metastases treated at Stanford University Medical Center (SUMC) with CyberKnife radiosurgery (CK RS). It has two components: (1) a retrospective follow-up of patients treated since 2006, and (2) the accrual of a new cohort of patients treated over a 5-year period from January 15, 2013 to December 31, 2017 and followed for at least one year thereafter. The primary aim of this study is to estimate the effect of the number of brain tumor metastases on survival after adjusting for known risk factors for mortality.

Official Title
-----------------
A Comparison of Overall Survival Post-CyberKnife Radiosurgery Treatment of Patients With 1-3 Versus 4 or More Brain Metastases

Conditions
-----------------
Brain and Nervous System

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the presence of a tumor metastasis or tumor metastases to the brain as manifested by the neurological examination and visibility of the metastatic lesion(s) on MRI and CT scans a Karnofsky performance status (KPS) score of greater than or equal to 60. Exclusion Criteria: The exclusion criteria are the converse of the above, i.e. patients without a brain tumor metastasis or brain tumor metastases or a KPS of less than 60.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 95 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 |
| --- | --- |
| retrospective cohort<br>retrospective follow-up of patients treated since 2006 | |
| prospective cohort<br>patients treated over a 5-year period from January 15, 2013 to December 31, 2017 and followed for at least one year thereafter | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | until death or the end of follow-up, whichever comes first. |
Impact of Prevention Awareness Group (PAG) on Treatment Attendance and Drug Abstinence Among Substance User

Study Overview
=================
Brief Summary
-----------------
Substance Use Disorder has been showing a rising trend all over the world including India. The project tested whether a Integrated community wide effort of Prevention and Awareness Groups (PAG) to manage substance use would have a greater effect on treatment attendance and drug abstinence than a de-addiction program alone.

Official Title
-----------------
Impact of Prevention Awareness Group (PAG) on Treatment Attendance and Drug Abstinence Among Substance User: Results of the Randomized Controlled Trial

Conditions
-----------------
Substance Use Disorder, Drug Dependence,, Alcohol Dependence

Intervention / Treatment
-----------------
* Other: Prevention Awareness Groups (PAG)
* Other: Standard Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suburban, rural Population Drug and/or alcohol dependency (DSM-IV substance use disorders criteria) Exclusion Criteria: Did not consent to participate Planning to move or relocate Severe mental disorder

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard Usual Care<br>Community program which follows with referral services | Other: Standard Care<br> <br> |
| Experimental: Prevention Awareness Groups (PAG)<br>Prevention Awareness Groups (PAG) is a community based integrated substance abuse prevention program targeting vulnerable populations. It comprises of community programs, physician led counseling followed by treatment follow up in community based clinic. | Other: Prevention Awareness Groups (PAG)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment attendance |  | Change from baseline to six month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug abstinence |  | Change from baseline to six month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Substance Use Disorder,, Community based intervention, Prevention and Awareness Groups (PAG),
Validation of a Screening Test for Sarcopenia in Older People

Study Overview
=================
Brief Summary
-----------------
Identify the threshold which the handgrip strenght can be used as a screening test of sarcopenia. Handgrip strenght can be used in daily clinical practice to screen patients having sarcopenia to improve treatment and quality of life.

Detailed Description
-----------------
A cross-sectional multicentre study will be performed in hospital and retirement houses on patients ages 75 years old or more.

Official Title
-----------------
Validation of a Screening Test of Sarcopenia in the Elderly People at Hospital and in Retirement Houses

Conditions
-----------------
Sarcopenia

Intervention / Treatment
-----------------
* Device: Handgrip test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 75 years old Exclusion Criteria: Palliative care, Protection of vulnerable adults

Ages Eligible for Study
-----------------
Minimum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Older people<br>A cross-sectional multicentre study will be performed in hospital and retirement houses on patients ages 75 years old or more. | Device: Handgrip test<br>* Handgrip strenght can be used in daily clinical practice to screen patients having sarcopenia to improve treatment and quality of life.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Handgrip test could be used as a screening test of sarcopenia |  | at day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sarcopenia, Elderly people, Hospitalization
Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how safe and how well POL-103A works in preventing the relapse of melanoma after patients who have undergone surgery.

Official Title
-----------------
A Multicenter, Double-blind, Placebo-controlled, Adaptive Phase 3 Trial of POL-103A Polyvalent Melanoma Vaccine in Post-resection Melanoma Patients With a High Risk of Recurrence

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

Intervention / Treatment
-----------------
* Biological: POL-103A
* Biological: POL-103A without API


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed Stage IIb, IIc, III melanoma Surgical resection within 90 days of first dosing Persons with positive sentinel nodes must have a complete lymphadenectomy ECOG performance status 0 or 1 Exclusion Criteria: Any prior melanoma treatment other than surgery or regional irradiation Use of biologic response modifiers within 60 days of first dosing Subjects with history of other malignancy within past 5 years (with exceptions)

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: POL-103A without API<br> | Biological: POL-103A without API<br>* Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs<br>|
| Experimental: POL-103A<br> | Biological: POL-103A<br>* POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence Free Survival (RFS) | This is an event driven trial. Recurrence-free survival time (RFS) is computed from the earliest of the date of recurrence or death or, if without recurrence or death, the date last assessed for recurrence without diagnosis of recurrence (censored). The date of recurrence is specified as the first date a recurrence is suspected, which is later confirmed by biopsy. | 436 events or approximately 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | Survival time is computed based on the date of death if the subject is known dead or the date last known to be alive (censored). Zero time is the date of randomization. | 432 events or approximately 10 years |
SCREENING OF CELIAC DISEASE IN SCHOLAR CHILDREN IN ITALY

Study Overview
=================
Brief Summary
-----------------
The main aim of the study is to currently define the prevalence of celiac disease (CD) in children aged 5-10 years in 2 Italian cities (Ancona and Verona). The screening protocol is based on a 1st line genetic test (searche of HLA DQ2/DQ8 genotypes) followed by a serological diagnosis (IgA TTG and IgG DGP).

Detailed Description
-----------------
All scholar children aged 5-10 years living in the cities of Ancona and Verona will be invited to partecipate. Children enrolled will be investigated as follows: HLA DQ2/DQ8 genotyping (by a rapid test) In children genetically predisposed to CD serological investigations will be performed (both IgA TTG and IgG DGP antibodies) The overall population will be evaluated for the prevalence and severity of dental caries (by using the DMFT/dmft index)

Conditions
-----------------
Celiac Disease, Dental Caries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 5-10 - Exclusion Criteria: celiac disease, on a gluten free diet -

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 10 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 |
| --- | --- | --- |
| prevalence of celiac serology in children aged 5-10 |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of dental caries in children genetically predisposed to CD in comparison with children not predisposed |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
caries, celiac disease, children, HLA DQ2, HLA DQ8, screening
Sport Injuries During Physical Activity Lessons in Secondary School in South of Reunion Island

Study Overview
=================
Brief Summary
-----------------
TsColEPS aims at identifying individual determinants of sport injuries during physical activity lessons in secondary school at reunion Island.

Detailed Description
-----------------
Sport injuries during physical activities lessons are the first etiology of traumatism in secondary school. Epidemiological studies on individual determinants of sport injuries are very scarce and most focused on contextual or mixed determinants. TsColEPS is a multicenter case control study with one control paired to one case. A convenience sample of 500 pupils in each group was planned on the base of a range of expected odds ratios.

Official Title
-----------------
Etude Des Traumatismes Sportifs Lors Des Cours d'éducation Physique et Sportive Chez Les collégiens Dans le Sud de l'Ile de La Reunion

Conditions
-----------------
Athletic Injuries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: in secondary public school classroom in south of Reunion Island no age limited Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Injured/Case<br>Secondary school pupil injured during a physical activity lesson between 2012-2014 in south of Reunion Island | |
| Control<br>Same age and gender than case in the same classroom and during the same physical activity lesson | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual determinants of sport injuries during physical activity lessons in secondary school measured by a series of questionnaires at school (nurse interview), at home (family interview) and at the doctor's office for diagnosis | Questionnaires are compiled in the CRC for datamanagement and analysis. Determinants are computed in frequency and proportion or mean +/- SD and analysed in a multilevel model | 2 years with 1 year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
School, Sport, Injuries