linjc16/ctgov huggingface dataset:
Characterization of a Clinical Subpopulation With Autism Spectrum Disorder

Study Overview
=================
Brief Summary
-----------------
The main objective for this research study is to gather additional information to help confirm identification of new subgroups within the autism spectrum.

Official Title
-----------------
Characterization of a Clinical Subpopulation With Autism Spectrum Disorder

Conditions
-----------------
Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants previously diagnosed with ASD (DSM-5) supported by either autism diagnostic interview revised (ADI-R) or Autism Diagnostic Observation Scale (ADOS-2) scores Available health records within the first 2 years of life Participants must have a parent or reliable caregiver who agrees to provide information about the participant Exclusion Criteria: Genetically identified ASD (syndromic form of autism, e.g. fragile X) Episode of fever (i.e. ≥100.5 °F) or clinically significant illness without fever (as judged by the Investigator), within 10 days before the study visit

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observation|Clinical signs and symptoms|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of non-behavioral phenotypical traits in sub-populations with Autism Spectrum Disorder (ASD) | A questionnaire will be administered to collect non-behavioral traits and co-occurring conditions data of the participants | Day 0 |
Treatment of Prostate Cancer With Firmagon®

Study Overview
=================
Brief Summary
-----------------
How are testosterone levels of patients with prostate cancer under treatment with Firmagon® changing. Former studies showed a quick fall of testosterone levels after start of therapy with Firmagon® and a quick recovery when therapy is stopped. The investigators want to prove this in a normal outpatient urologist setting. Furthermore data is collected to prove the adherence to the German S3-Guideline for the treatment of prostate cancer.

Official Title
-----------------
Effectiveness and Safety as Well as Adherence of the S3 Guidelines for the Treatment of Prostate Cancer in the Treatment of Patients of Patients With Firmagon®

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Degarelix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: advanced hormone-dependent prostate cancer with no other previous hormone therapy for whom - irrespectively of this NIS -the use of Firmagon® is intended Exclusion Criteria: contraindication for Degarelix

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Degarelix<br>adult male patients with advanced hormone dependent prostate cancer who receive 240 mg as a start dose and then monthly 80mg Firmagon® for one year | Drug: Degarelix<br>* subcutaneous injection<br>* Other names: Firmagon®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA-/Testosterone Level |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| S3 Guideline | Percentage of patients who have been treated in accordance with the grade A recommendations of the S3 guideline for treatment of prostate cancer | 12 months | 
| Anxiety | Anxiety score | 12 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
testosterone, S3-Adherence, Quality of Life
Study of Tetrathiomolybdate in Patients With Wilson Disease

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: Evaluate the safety and efficacy of ammonium tetrathiomolybdate alone and compared with trientine therapy as initial treatment in patients with Wilson disease presenting neurologically.

Detailed Description
-----------------
PROTOCOL OUTLINE: This a double blind, randomized study. Patients are randomized into one of two treatment arms. Arm I: Patients receive tetrathiomolybdate (TM) 3 times a day with meals and 3 times a day between meals for 8 weeks in the absence of neurologic deterioration or unacceptable toxicity. Arm II: Patients receive trientine therapy for 8 weeks in the absence of neurologic deterioration and unacceptable toxicity. Additional therapy (off study): Patients in the TM group may receive maintenance zinc, while those in the trientine group may continue on trientine or switch to zinc.

Conditions
-----------------
Wilson Disease

Intervention / Treatment
-----------------
* Drug: tetrathiomolybdate
* Drug: trientine


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Wilson disease presenting with neurologic or psychiatric symptoms No concurrent seizure activity No white matter lesions on brain magnetic resonance imaging --Prior/Concurrent Therapy-- No more than 2 weeks of prior therapy No penicillamine or trientine for longer than 2 weeks --Patient Characteristics-- Hepatic: No severe hepatic failure Other: No psychiatric or medical contraindication to protocol therapy Not pregnant

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tetrathiomolybdate|nan|
|Drug: trientine|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
-----------------
Wilson disease, inborn errors of metabolism, rare disease
Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Clinical Early Stages of Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Randomized Phase III trial of surgery alone or surgery plus preoperative Gemcitabine-Cisplatin in clinical early stages of non-small cell lung cancer

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Radiation: Surgery alone or surgery plus preoperative Gemcitabine-Cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with early stage NSCLC
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: Surgery alone<br>Surgery alone | Radiation: Surgery alone or surgery plus preoperative Gemcitabine-Cisplatin<br>* Surgery + Chemo + RT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS, MS, DFS |  | overall | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSCLC
HyperArc Registry Study

Study Overview
=================
Brief Summary
-----------------
The HyperArc registry is designed to collect data from which the efficacy of the HyperArc procedure can be assessed and compared to alternative treatments.

Detailed Description
-----------------
A significant percentage of newly diagnosed cancer patients will develop brain metastases. For many of these patients, stereotactic radiosurgery (SRS) is recommended as a primary treatment option. Concerns about complexity, patient safety, cost, and human resources can make SRS challenging. HyperArc radiotherapy addresses these challenges by introducing key technology and workflow elements to streamline multi-leaf collimator-based, non-coplanar SRS. HyperArc is designed to deliver SRS treatments from the TrueBeam linear accelerator platform. The HyperArc registry is designed to collect data from which the efficacy of the HyperArc procedure can be assessed and compared to alternative treatments.

Official Title
-----------------
HyperArc Registry Study

Conditions
-----------------
Brain Metastases, CNS Neoplasm, CNS Disorder, Intracranial

Intervention / Treatment
-----------------
* Radiation: Stereotactic radiosurgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received or scheduled to receive treatment using the HyperArc treatment method Age of legal adult according to local law Signed informed consent form, or, informed consent waived by the local ethics board/institutional review board Exclusion Criteria: None, apart from not meeting Inclusion Criteria

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

| Intervention/Treatment |
| --- |
|Radiation: Stereotactic radiosurgery|HyperArc is a radiotherapy treatment with a structured workflow to plan and deliver stereotactic radiosurgery (SRS).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Survival | follow until death, on average approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local tumor control | Response of treated tumors | follow until death, on average approximately 2 years | 
| HyperArc Patterns of Care | Dosimetry information for clinically delivered HyperArc treatments | Limited to course of treatment: up to 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stereotactic Radiosurgery
Intravenous Sodium Fluorescein Versus Oral Phenazopyridine for Ureteral Patency

Study Overview
=================
Brief Summary
-----------------
To determine the safety profile of sodium fluorescein in women undergoing cystoscopy during gynecologic surgery. To determine if either oral phenazopyridine or sodium fluorescein result in shorter cystoscopy times.

Official Title
-----------------
A Randomized Trial Comparing Intaoperative Intravenous Sodium Fluorescein to Pre-Operative Oral Phenazopyridine For Evaluation of Ureteral Patency

Conditions
-----------------
Ureteral Injury

Intervention / Treatment
-----------------
* Drug: sodium fluorescein
* Drug: phenazopyridine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients must be 18 years or older as well as willing and able to provide informed consent Patients undergoing a scheduled gynecologic procedure with cystoscopy Exclusion Criteria: - Patients are younger than 18 years Patients are unable or unwilling to provide informed consent Patients with a history of an allergic reaction to sodium fluorescein or phenazopyridine Patients with a history of renal insufficiency Patients with a history of liver disease Patients with a history of sickle cell disease Patients with a history of glucose-6-phosphate dehydrogenase deficiency Patients with a history of chronic obstructive pulmonary disease or currently being treated for asthma

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sodium Fluorescein<br>Patients will receive an intravenous dose of 0.25 mL of 10% (500 mg, 5 mL) sodium fluorescein at the time of cystoscope insertion, for a total dose of 25 mg. Cystoscopy will be performed in the standard fashion during the course of the operation. | Drug: sodium fluorescein<br> <br> |
| Active Comparator: oral phenazopyridine<br>Patients randomized to the phenazopyridine arm will be given a 200 mg pill with a sip of water in the pre-operative area 1 hour before their scheduled procedure. Cystoscopy will be performed in the standard fashion during the course of the operation. | Drug: phenazopyridine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| differences in time that elapses between starting cystoscopy and identifying both ureteral jets between treatment groups |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with intra-operative and immediate and post-operative treatment-related adverse events as assessed by CTCAE v4.0 |  | 12 months |
Does Long-Term Natalizumab (NTZ) Therapy Normalize Brain Atrophy Rates and Quality of Life (QOL) in Relapsing Remitting Multiple Sclerosis (RRMS)?

Study Overview
=================
Brief Summary
-----------------
Primary Aims: To determine how effective long term Natalizumab (NTZ) therapy is in slowing the progression of whole brain atrophy. Whole brain atrophy rates will be measured through magnetic resonance imaging (MRI) scans and compared between patients with Multiple Sclerosis (MS) who have been using NTZ for at least 2 years versus age and gender-matched healthy controls. The primary outcome will be whole brain atrophy rate measured as the percent change in brain volume (PBVC) over a two-year period. Primary hypothesis: The investigators hypothesize that long term (>2 years) NTZ therapy will slow the rate of whole brain atrophy in patients with Multiple Sclerosis (MS) (as measured by percent change in brain volume), reaching a whole brain atrophy rate similar to that of non-MS controls (a true disease activity free state).

Official Title
-----------------
Does Long-Term Natalizumab (NTZ) Therapy Normalize Brain Atrophy Rates and Quality of Life (QOL) in Relapsing Remitting Multiple Sclerosis (RRMS)? A Longitudinal Study Using Whole Brain, Neocortical and Subcortical Atrophy Rates and Patient Reported Outcomes (PROs).

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-55 inclusive years of age at the time of informed consent Diagnosis of relapsing multiple sclerosis as defined by the 2010 revised McDonald criteria Currently taking Tysabri Exclusion Criteria: Systemic steroid users comorbidities that could confound MRI outcomes

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Brain Atrophy Rate |  | Baseline, Year 1, and Year 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Cortical Thickness |  | Baseline, Year 1, and Year 2 | 
| Change in Neocortical Gray Matter Volume |  | Baseline, Year 1, and Year 2 | 
| Change in Subcortical Gray Matter Volume |  | Baseline, Year 1, and Year 2 |
Pretreatment Lymphocyte Monocyte Ratio on Outcome HCC Patients

Study Overview
=================
Brief Summary
-----------------
To assess the prognostic role of pretreatment LMR in hepatocellular carcinoma(HCC).

Detailed Description
-----------------
The exact molecular mechanisms responsible for the prognostic impact of lymphocyte monocyte ratio in Heatocellular carcinoma are unclear.It has been suggested that cross-talk between the inflammatory response and tumor progression play a critical role in the initiation and progression of Heatocellular carcinoma. In the tumor microenvironment, inflammatory infiltrates have a large influence on the biological behavior of Heatocellular carcinoma. Tumor-infiltrating lymphocytes, as representative component of the immune microenvironment ,are implicated in several stages of Heatocellular carcinoma progression, and Tumor-infiltrating lymphocytes phenotypes may be a predictor for favorable prognosis. Conversely, low lymphocyte counts might result in an insufficient immunological reaction, which lead to inferior survival in multiple cancers. Monocytes infiltrating tumor tissue are also involved in Heatocellular carcinoma development and progression. Activated monocytes in Heatocellular carcinoma micro environments can trigger and polarize T-cell responses and facilitate inflammation-induced tumor development. Tumor-associated macrophages are derived from circulating monocytes. Tumor-associated macrophages can accelerate Heatocellular carcinoma cell proliferation,tumor-associated angiogenesis, and metastasis. Several studies showed that high infiltration of Tumor-associated macrophages predicted decreased survival in various cancers.

Official Title
-----------------
The Impact of Pretreatment Lymphocyte to Monocyte Ratio on Clinical Outcome for Patient With HCC

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

Intervention / Treatment
-----------------
* Diagnostic Test: CBC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with child A Hepatocellular carcinoma. Exclusion Criteria: Patients with child C Hepatocellular carcinoma. Patients with heart failure

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: CBC|lymphocyte and monocyte count|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increased over all survival | Elevated pretreatment lymphocyte monocyte ratio may be a favorable prognostic factor for clinical outcomes in patients with hepatocellular carcinoma. | 1 year |
CGH Array in Bilateral Clubfoot

Study Overview
=================
Brief Summary
-----------------
In prenatal diagnosis of isolated bilateral clubfoot our team propose genetic analysis: a CGH-array. We want to study the rate of aberrations in these cases.

Official Title
-----------------
Evaluation of CGH Array in Prenatal Diagnosis of Bilateral Clubfoot

Conditions
-----------------
Clubfoot, Prenatal Disorder

Intervention / Treatment
-----------------
* Genetic: CGH array


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women fetus with isolated bilateral clubfoot Exclusion Criteria: no

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| clubfoot fetuses<br> | Genetic: CGH array<br>* a CGH array is systematically offer to women when the fetus show bilateral clubfoot during prenatal ultrasound screening<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of abnormal CGH-array in the population |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| type of abnormalities in CGH-array study |  | 9 months |
Multinational Study of Acinetobacter Bloodstream Infection: Clinical Outcomes and Global Epidemiology-PITT Protocol

Study Overview
=================
Brief Summary
-----------------
The objectives of this multinational study are to assess the clinical outcomes of patients with Acinetobacter bloodstream infection and to further assess the predictors of mortality in this patient population. We also aim to characterize the molecular epidemiology of this remarkable organism in an attempt to further understand its transmission dynamics on a global level and to determine whether increased pathogenicity is geographically dependent.

Detailed Description
-----------------
Medical records will be reviewed and information collected to assess the clinical outcomes of patients with Acinetobacter bloodstream infection and to further assess the predictors of mortality in this patient population.

Official Title
-----------------
Multinational Study of Acinetobacter Bloodstream Infection: Clinical Outcomes and Global Epidemiology-PITT Protocol

Conditions
-----------------
Acinetobacter Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Acinetobacter infections Exclusion Criteria: Those that do not meet entry criteria

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
isolate, Acinetobacter, infection