linjc16/ctgov huggingface dataset:
Study of Talabostat + Docetaxel Versus Docetaxel in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy

Study Overview
=================
Brief Summary
-----------------
This Phase 3 study will compare the efficacy of talabostat plus docetaxel to docetaxel plus placebo in patients with Stage IIIB/IV NSCLC who have failed a platinum-based chemotherapy regimen.

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

Intervention / Treatment
-----------------
* Drug: talabostat mesylate
* Drug: docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Men or women age 18 years or older Histologically or cytologically confirmed NSCLC Recurrent, locally advanced or metastatic, inoperable NSCLC (Stage IIIB/IV) Patients with Stage IIIB NSCLC must have a cytologically documented pleural effusion Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC Measurable disease on computerized tomography (CT) scan ECOG Performance Status of 0 or 1 Expected survival ≥12 weeks Provide written informed consent EXCLUSION CRITERIA: More than 2 prior chemotherapy regimens Clinically significant laboratory abnormalities, specifically: Total bilirubin ≥ institutional upper limit of normal (ULN) Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN Serum creatinine ≥2.0mg/dL Absolute neutrophil count <1500/μL or platelets <100,000/μL Untreated or symptomatic brain metastases Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix A history of severe hypersensitivity to drugs formulated with polysorbate 80 Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol Patients who are within 28 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for NSCLC. Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must agree to use a barrier method of contraception.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: talabostat mesylate|nan|
|Drug: docetaxel|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
-----------------
Stage IIIb/IV non-small cell lung cancer, NSCLC, Lung Cancer
An Observational Study of Distress, Immune Function, and Pain in HIV.

Study Overview
=================
Brief Summary
-----------------
This case-control study focuses on pain in HIV, which is common despite antiretroviral therapy and compromises quality of life, mental health and daily functioning. Specifically, it will investigate the relationships between psychosocial distress, inflammation and pain in HIV.

Detailed Description
-----------------
We plan to recruit 100 people and follow them for 6 months, taking repeated measures. Participants who report persistent pain at enrolment will be assessed at 0 (baseline), 2, 4, and 6 months. Participants who report no pain at enrolment will be assessed at 0 (baseline) and 6 months. All participants will also be invited to participate in weekly remote assessment of selected self-reported outcomes.

Official Title
-----------------
An Observational Study of Shared Variation and Reciprocal Influences: Distress, Immune Function and Pain in HIV.

Conditions
-----------------
HIV, Chronic Pain, Distress, Emotional, Immune System and Related Disorders, Central Sensitisation

Intervention / Treatment
-----------------
* Other: Pain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-positive with viral suppression report either persistent pain or no pain at enrolment Exclusion Criteria: pregnancy acute psychiatric condition requiring urgent care cognitive impairment preventing full participation

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pain-free<br>Report persistent pain at enrolment | |
| Persistent pain<br>Report no pain at enrolment | Other: Pain<br>* As above<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hopkins Symptom Checklist 25-item questionnaire | Psychosocial distress | Baseline | 
| Provoked inflammatory response | Multiplex assay | Baseline | 
| Brief Pain Inventory | Pain intensity | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary hyperalgesia (surface area) | Induced in a subgroup | Baseline assessment only | 
| Brief Pain Inventory | Pain locations | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic pain, HIV, Innate Immune Response, Mental health, Hyperalgesia, secondary
Rotation Stability of Toric Intraocularlens (IOL) Compared Sitting Against Lying After Cataract Operation

Study Overview
=================
Brief Summary
-----------------
To assess the rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation.

Detailed Description
-----------------
To assess the rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation.

Official Title
-----------------
Rotation Stability of Toric Intraocularlens (IOL) Compared Sitting Against Lying After Cataract Operation

Conditions
-----------------
Astigmatism

Intervention / Treatment
-----------------
* Other: catarct surgery with toric intra ocular lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cataract Age 21 and older Regular corneal astigmatism ≥ 1.5 D written informed consent prior to surgery Exclusion Criteria: Relevant other ophthalmic diseases such as: pseudoexfoliation, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. Marfan syndrome) High myopia (> 29 mm AL) Irregular corneal astigmatism on corneal topography In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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 |
| --- | --- |
| Other: lying<br>after cataract lying for 1 hour | Other: catarct surgery with toric intra ocular lenses<br>* rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation<br>|
| Other: sitting, walkin<br>after cataract sitting or walking for 1 hour | Other: catarct surgery with toric intra ocular lenses<br>* rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of toric IOL rotation between both groups (mean ≠ SD) | Aim is to see if the lying down after the operation lowers the risk of toric IOL rotation compared to sitting down | 1 Year |
Potential Benefits of Radiotherapy in Prone Position for Breast Cancer Patients: a Planning Study

Study Overview
=================
Brief Summary
-----------------
This study has the purpose to investigate the benefit of treating breast cancer patients in prone position. This treatment is compared to the standard technique in our center (supine position with or without respiratory gating). The investigators want to compare the doses on the organs at risk (heart and lungs) in the different techniques.

Official Title
-----------------
A Comparison of Three Radiotherapy Techniques for Breast Cancer: a Planning Study

Conditions
-----------------
Breast Neoplasms, Radiation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication for radiotherapy of the breast and /or lymph nodes Exclusion Criteria: none ( planning study)
Sexes Eligible for Study
-----------------
Female

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
-----------------
respiratory gating, prone radiotherapy, breast cancer
Autism Spectrum Disorders (ASD) Characterization Study

Study Overview
=================
Brief Summary
-----------------
The overarching aim of the study is to characterize children and adults with ASDs, and compare them with age-matched controls in relation to their functioning in family, academic, employment, and social spheres. Subjects will be comprehensively assessed in multiple non-overlapping domains of functioning, using psychiatric, cognitive, and psychosocial instruments.

Official Title
-----------------
A Characterization Study of Individuals With Autism Spectrum Disorders

Conditions
-----------------
Autism Spectrum Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 6-60 years old For subjects who have ASD: Meet DSM-IV PDD criteria based on clinical assessment including PDD module of structured interview For subjects who have ASD: One parent/guardian available for interviews about each subject. If a parent or guardian is not available, a reliable adult reporter identified by the subject available for an interview Full-scale IQ of above 80 Exclusion Criteria: Major sensorimotor handicaps (e.g. deafness, blindness) Any severely unstable psychiatric conditions including the following: psychosis, suicidality, bipolar disorder, substance use disorders (alcohol or drugs) that would require in-patient hospitalization. Inadequate command of the English language.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 60 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 |
| --- | --- |
| ASD<br>Children and adults with Autism Spectrum Disorders. | |
| Non-ASD<br>Healthy volunteers who have never been diagnosed with an Autism Spectrum Disorder in their lifetime. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall level of functioning of children and adults with autism spectrum disorders (ASD) compared to individuals without ASD. |  | single time point | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autism Spectrum Disorder, ASD, Autism, Asperger's Syndrome, PDD-NOS, Pervasive Developmental Disorders- Not Otherwise Specified, Adults, Children
A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy

Study Overview
=================
Brief Summary
-----------------
This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the study.

Official Title
-----------------
A Phase III, Randomized, Open-label, Multicenter Study of the Safety and Efficacy of Efavirenz Versus Tenofovir When Administered in Combination With the Abacavir/Lamivudine Fixed-dose Combination Tablet as a Once-daily Regimen in Antiretroviral-naive HIV-1 Infected Subjects.

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Drug: efavirenz
* Drug: tenofovir
* Drug: abacavir/lamivudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Participants must be able to provide informed consent. Have documented HIV-1 infection. Have not received more than 14 days of prior treatment with antiretroviral drugs. Meet laboratory test criteria. Women of childbearing potential must abstain from sexual intercourse or use acceptable contraception. Must be able to take study medications as directed and complete all study visits and evaluations during the 48 week study. Exclusion criteria: Enrolled in other HIV treatment studies. Pregnant or breastfeeding.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: efavirenz|nan|
|Drug: tenofovir|nan|
|Drug: abacavir/lamivudine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load response at 48 weeks |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability Viral load response at 24 weeks Change in T-cell count Resistance Pharmacokinetics |  | 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-1 Efavirenz Tenofovir
Clinical Study to Evaluate the Short Time Efficacy of AP Green Tea Extract Affer High Fat, High Carbohydrate Diet

Study Overview
=================
Brief Summary
-----------------
The objective of this clinical trial is to evaluate the short term effects of single dose AP green tea extracts in subjects with BMI (< 30 kg/m2) and fasting glucose level of > 100 mg/dL after high-fat/high-carbohydrate meal.

Official Title
-----------------
A Randomized, Cross-Over Clinical Study to Evaluate the Acute Efficacy of AP Green Tea Extract After a Meal Composed of High-Fat/High-Carbohydrate

Conditions
-----------------
Blood Glucose, High

Intervention / Treatment
-----------------
* Dietary Supplement: AP green tea extract


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects aged 19 years or over BMI < 30 kg/m2 Fasting glucose level > 100 mg/dL (who is not under medication) Subjects who voluntarily decide to participate in this clinical study and sign the informed consent form on their own or through their representatives Exclusion Criteria: At the screening visit, subjects who were diagnosed with obesity, diabetes, dyslipidemia and undergoing medication Subjects who were diagnosed with ventricular associated disease, unstable and uncontrolled chronic medical disease, hyper/hypothyroidism, or active malignant tumor and undergoing medication within 4 weeks prior to the first administration of the investigational product Subjects who have renal failure, acute or chronic hepatitis or known liver cirrhosis In addition to the above, subjects who are determined to be ineligible to participate in the clinical study according to the investigator's medical opinion

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AP green tea extract<br> | Dietary Supplement: AP green tea extract<br>* single intake of AP green tea extract<br>|
| No Intervention: No intervention control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Blood glucose level | Change of Blood glucose level before and after high-carbohydrate/high-fat meal | 0 - 300 minute | 
| Change of Insulin level | Change of Insulin level before and after high-carbohydrate/high-fat meal | 0 - 300 minute | 
| Change of Triglyceride level | Change of Triglyceride level before and after high-carbohydrate/high-fat meal | 0 - 300 minute |
New Findings About Somatosensory Evoked Potentials (SEP) During Surgery for Cerebral Aneurysms

Study Overview
=================
Brief Summary
-----------------
During surgery, electrophysiological signals will be acquired with the instrument (ISIS IOM, NeuroExplore, Software Version 4.4, Inomed) already in use at the Neurosurgery Service of the Neurocentro of the Hospital Civic Italian Switzerland in Lugano. Simultaneously to Somatosensorial Evoked Potential (SEP) will also be recorded the Electroencephalography (EEG) activity with the same detection of locations. For the purposes of the study the signals transmitted to the neurosurgeon through the hardware and the corresponding assessments done by the neurophysiologist responsible for intraoperative monitoring will be recorded. It will also be kept track of procedures performed during surgery.

Official Title
-----------------
I Potenziali Somato-sensoriali Nella Chirurgia Degli Aneurismi Cerebrali

Conditions
-----------------
Cerebral Aneurysm

Intervention / Treatment
-----------------
* Diagnostic Test: electrophysiological signal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old Patient bearer of a not broken cerebral aneurysm, which has been defined per size and morphology susceptible to surgery Aneurysms located on cerebral arteries of the anterior circulation (carotid, middle cerebral arteries, anterior cerebral, anterior communicating, pericallose); Cases of multiple aneurysms are also eligible Informed consent for participation in the study Exclusion Criteria: Patient with an aneurysm of the posterior circulation (vertebrobasilar system) The aneurysm was a source of bleeding (subarachnoid hemorrhage, intracerebral, intraventricular). Patient with a pace-maker (for the risk that the electric currents used in the study could compromise the operation of the pace-maker)

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 |
| --- |
|Diagnostic Test: electrophysiological signal|trasmit the electrophysiological signals to the neurosurgeon through the hardware|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hardware performance | Collection of information on the hardware performance for reading and interpretation of the SEP and EEG signal and sending an alarm in visual form (light signal) in the eyepiece of the operating microscope during cerebral aneurysm interventions | at the moment of the surgery | 
| Identification of sensitive electrophysiological index sensible to cerebral ischemic suffering | study of the morphology and the analysis of the high frequency of the SEP signal | up to 3 months |
Central Hypothyroidism, a Novel Laboratory Measurement

Study Overview
=================
Brief Summary
-----------------
Medical management of central hypothyroidism is controversial due to lack of reference for evaluation of pituitary negative feedback. Therefore, titration of medical treatment is based on T4 levels, measured with variable laboratory methods. Patients who have central hypothyroidism usually have concomitant deficiencies in other pituitary hormones for which they need replacement therapy such as steroids, testosterone and growth hormone. This combined hormone deficiency makes clinical and laboratory evaluation challenging among these patients. Symptomatically, central hypothyroidism is relatively mild and lack non-specific and it might be overlooked due to other hormonal deficiencies. Replacement therapy for central hypothyroidism is titrated by arbitrary target free T4 levels of above 50th percentile of normal. The goal of our study is to compare the standard results from well known measure methods to a new method for measuring Ft4 using Liquid chromatography - tandem mass spectrometry.

Official Title
-----------------
Central Hypothyroidism,a New Laboratory Approach for Hormone Measurement

Conditions
-----------------
Central Hypothyroidism

Intervention / Treatment
-----------------
* Drug: Eltroxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical evidence of central hypothyroidism: status post pituitary surgery and/or radiotherapy plus laboratory documentation of central hypothyroidism, with or without concurrent hormonal deficiencies in other axes, such as ACTH, LH, FSH Exclusion Criteria: Primary hypothyroidism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: Eltroxin|Eltroxin dosage titration according to free T4 measurement every 3 months|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| free T4 levels |  | a year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of hypothyroidism |  | a year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
central hypothyroidism, hypopituitarism, eltroxin