linjc16/ctgov huggingface dataset:
Study Evaluating MAC-321 in Non-small Cell Lung Cancer Refractory to Platinum-based Therapy

Study Overview
=================
Brief Summary
-----------------
This non-randomized, open-label clinical trial is designed to determine safety and clinical activity of a new chemotherapeutic agent, MAC-321, when given intravenously to patients with non-small cell lung cancer. Clinical activity will be evaluated by determining the percentage of patients with an objective tumor response after treatment with MAC-321. Patients must have been previously treated with a platinum-containing chemotherapy regimen. A total of 96 patients will be enrolled in this trial. Eligible patients will receive MAC-321 intravenously every 3 weeks for up to a total of 6 courses of treatment. All patients will receive MAC-321 at the same dose. MAC-321 is an experimental drug, and is not offered outside of this research trial.

Official Title
-----------------
A Phase 2, Open-label Study of MAC-321 Administered Intravenously as a Single Agent for the Treatment of Non-small Cell Lung Cancer Refractory to Platinum-based Therapy

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

Intervention / Treatment
-----------------
* Drug: MAC-321


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recurrence of non-small cell lung cancer after at least 1 prior chemotherapy regimen containing a platinum agent Recovery from all acute side effects of prior therapies (with the exception of hair loss) Adequate bone marrow, liver, and kidney function Exclusion Criteria: More than 2 prior chemotherapy regimens for treatment of advanced or metastatic non-small cell lung cancer. (Treatment given in conjunction with surgery will not be included in the maximum of 2 prior regimens) Radiation therapy, chemotherapy or any other anticancer therapy within 28 days of beginning study Symptomatic brain metastases

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: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MAC-321|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
-----------------
Non-Small-Cell Lung Carcinoma, Lung Cancer, Cancer of Lung
Comparison of Two Fragmentation Modalities in Femtosecond Laser-assisted Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
Femtosecond laser-assisted cataract surgery consists in nuclear lens fragmentation, followed by ultrasound phacoemulsification of nuclear lens, which is then removed. It can be assumed that fragmenting the nuclear lens in more pieces could facilitate the post-laser ultrasound phacoemulsification to extract the lens, with a lesser amount of ultrasonic energy. The decrease of ultrasonic energy delivered during cataract surgery is beneficial to the patient because it optimizes the vitality of corneal endothelial cells, which ensure corneal transparency.

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: nuclear lens fragmentation in 8 pieces
* Device: nuclear lens fragmentation in 16 pieces


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient aged ≥ 18 years old first Femtosecond Laser-assisted Cataract Surgery scheduled cataract density ≥ 3 according to the lens opacities classification system (LOCS) Exclusion Criteria: corneal guttata, uncontrolled glaucoma shallow depth of anterior chamber patient's refusal to participate in the study pregnant or breast feeding patient patient under legal protection no health coverage

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 16 pieces fragmentation<br> | Device: nuclear lens fragmentation in 16 pieces<br> <br> |
| Active Comparator: 8 pieces fragmentation<br> | Device: nuclear lens fragmentation in 8 pieces<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| energy delivered for lens nucleus aspiration during phacoemulsification | ultrasound power delivered (measured in Hertz) | approximatively 15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
femtosecond laser-assisted cataract surgery, nuclear lens fragmentation
Maintenance of Recommended Sodium Intake

Study Overview
=================
Brief Summary
-----------------
The overall objective of this study is to assist the general public in achieving and maintaining the currently recommended sodium intake of 1500 mg/day through a reduced sodium intervention that emphasizes spices and herbs. The investigators hypothesize that after four weeks of eating a controlled diet, individuals will acclimate and adhere to a reduced sodium intake of 1500 mg/day and their taste preferences will change. The investigators also hypothesize that individuals in a low sodium behavioral intervention will maintain greater adherence to a dietary sodium intake of ≤ 1500 mg/day than individuals in a self-directed control group.

Official Title
-----------------
Maintenance of Recommended Sodium Intake

Conditions
-----------------
Maintenance of Recommended Sodium Intake

Intervention / Treatment
-----------------
* Behavioral: Behavior and lifestyle counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults to whom the U.S. Dietary Guideline of < 1500 mg/day of sodium applies Exclusion Criteria: Individuals with chronic kidney disease, Chronic poor health state, Pregnancy, Inability to complete feeding study, Investigator discretion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 105 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Self directed control<br> | |
| Active Comparator: Behavior and lifestyle counseling<br> | Behavioral: Behavior and lifestyle counseling<br>* 20 week intervention period where one group gets behavior and lifestyle counseling and the other group gets no active intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in urinary sodium excretion |  | Weeks 4, 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in preferences for level of sodium in food products |  | Weeks 4, 24 | 
| Percentage of people below 2300 mg/day sodium intake |  | Weeks 4, 24 | 
| Percentage of people below 1500 mg/day sodium intake |  | weeks 4, 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sodium, Diet, Urinary sodium excretion, Feeding study, Diet maintenance
A Neuroimaging and Epigenetic Investigation of Antidepressants in Depression

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is: to find out the structural or functional effects of selective serotonin reuptake inhibitors (SSRI) in major depressive disorder (MDD); find special abnormalities in depression secondary to other disease, e.g., autoimmune disease like systemic lupus erythematosus (SLE). find the relationship between the efficacy of antidepressant and the change of neuroimaging in MDD to find possible predispose to MDD to explore the DNA methylation status in depression;

Detailed Description
-----------------
to explore the pathology of depression to identify the difference between MDD and depression secondary to other disease ,especially autoimmune disease to explore the effect of gene-environment interaction on the epigenetic regulation of the depression

Official Title
-----------------
A Neuroimaging and Epigenetic Investigation of Antidepressants in Depression

Conditions
-----------------
Depression, Depression Secondary to Other Disease

Intervention / Treatment
-----------------
* Drug: Escitalopram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV Major Depression or Dysthymia Age 18-65 Physically healthy Drug-free Exclusion Criteria: Body metal (e.g., wire stitches, screws in bones, stainless steel hips) History of Psychosis or Epilepsy Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol) Bipolar I Need for wash-out from effective treatment in order to participate Pregnant High suicide risk Currently taking (within 2 weeks; 4 weeks for Fluoxetine) antidepressants

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A,1<br>A: Escitalopram, 20 mg/day,8weeks | Drug: Escitalopram<br>* A,1: Escitalopram, oral, 20 mg/day, 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of fMRI after medication |  | baseline, 4 weeks, 8 weeks |
Controlled Propofol Administration

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the administration of the standard anesthetic agent (propofol) using this automatic system with the manual administration of propofol by the anesthesiologist.

Official Title
-----------------
Comparison of Closed-oop of Propofol Versus Manual Control Using Bispectral Index (BIS)

Conditions
-----------------
HYPNOSIS

Intervention / Treatment
-----------------
* Drug: propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged 18 to 90 years surgery lasting more than 30 min Exclusion Criteria: inability to provide informed consent allergies to study drug

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: control propofol administration<br> | Drug: propofol<br>* propofol administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of control administration of propofol with manual administration. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence from anesthesia |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypnosis with propofol
Safety and Effectiveness of Zemplar Injection in Decreasing iPTH Levels in Pediatric ESRD Subjects on Hemodialysis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if Zemplar, a vitamin D medication, safely and effectively decreases parathyroid hormone in children ages 2-20 with End Stage Renal Disease.

Official Title
-----------------
Safety and Effectiveness of Zemplar Injection in Decreasing iPTH Levels in Pediatric ESRD Subjects on Hemodialysis

Conditions
-----------------
Secondary Hyperparathyroidism, End Stage Renal Disease

Intervention / Treatment
-----------------
* Drug: paricalcitol injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Subjects ages 2-20 with ESRD on hemodialysis with Secondary hyperparathyroidism

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 20 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: paricalcitol injection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving at least a 30% decrease from baseline iPTH sustained for at least two consecutive iPTH measurements. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects in each group who achieve two consecutive iPTH values below 300 pg/mL. |  |  |
Studio NaVA - National Study on Quality of Life in Adolescents Affected by Allergic Rhinitis With or Without Asthma

Study Overview
=================
Brief Summary
-----------------
Studio Nava is a National Study aiming to assess allergic rhinitis and asthma outcomes on Quality of Life and Quality of Sleep in adolescent patients by means of Web Survey. Studio Nava also proposes the innovative use of a web platform (http://nava.ibim.cnr.it/) that contains all standardized tools (medical-healthcare web form, ACT, Asthma control test; PSQI, Pittsburgh Sleep Quality Index; T5SS, Total Symptom Score; modified SIDRIA for adolescents; Rhinasthma; VAS scale), that will be available for the doctors after the registration to the web platform. Downloaded questionnaires will be delivered to case-patient, asking him/her to fill them during the waiting time of the visit.

Official Title
-----------------
Studio NaVA - Studio Nazionale Sulla Qualità Della Vita in Adolescenti Con Rinite Allergica Con e Senza Asma

Conditions
-----------------
Allergic Rhinitis, Asthma

Intervention / Treatment
-----------------
* Other: Data Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical cases n°: 600 adolescents affected by allergic rhinitis with/without asthma, from 14 to 17 years age. Controls n°: 600 subject (5 for each participant Pediatrician) of the same age range, without respiratory pathology. Exclusion Criteria: Subjects that have not allergic rhinitis with/without asthma diagnosis or are <14 years old or >17 years old

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 17 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 |
| --- | --- |
| Allergic rhinitis with/without asthma, from 14 to 17 years age<br>600 adolescents with allergic rhinitis with/without asthma, from 14 to 17 years age, recruited from Pediatricians of the Italian territory. | Other: Data Collection<br> <br> |
| Without respiratory pathology<br>600 subject (5 for each participant Pediatrician) of the same age range, without respiratory pathology (patient family) | Other: Data Collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the allergic rhinitis impact on quality of life |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of AR and asthma on quality of sleep |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescents, Respiratory Pathology
Anesthetic and Dilating Gel for Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
To prepare the eye for cataract surgery, drugs must be given to the eye to allow for surgery to take place. Traditionally, dilating drops and drops containing NSAIDs (to control inflammation) are given to the patient well in advance of surgery at repeated time intervals. As well, a gel containing lidocaine is applied to the eye just prior to surgery to anesthetize (reduce pain and feeling) in the area of the eye. Although effective, the procedure is time-consuming and costly for nursing staff. Recently, a few hospitals have reported success in mixing the pupil-dilating and NSAID drops with the lidocaine gel, creating an anesthetic dilating gel. Although success has been reported, there have been no studies to clearly demonstrate that the anesthetic dilating gel is as effective at dilating the pupil and reducing sensitivity of the cornea during surgery than the traditional methods of drops and gel. It is possible that the dilating gel is less effective due to slower diffusion of drugs into the eye. The study will compare the effectiveness of the anesthetic dilating gel with the standard pre-operative pharmacologic regimen for cataract surgery. Stability (maintaining effectiveness over time) and contamination of the study gel will also be assessed. If the dilating gel is shown to be as effective in regards to pupil dilation and corneal anesthesia, while maintaining stability and sterility over time, hospitals can be encouraged to use such a anesthetic dilating gel routinely during pre-operative procedures before cataract surgery.

Official Title
-----------------
Comparison of an Anesthetic and Dilating Gel Cocktail Versus the Standard Pre-operative Pharmacologic Regimen for Cataract Surgery on Corneal Anesthesia and Pupil Dilation.

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Drug: Anesthetic Dilating Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled for first cataract surgery (i.e., first eye) Exclusion Criteria: previous ocular surgery, pseudoexfoliation syndrome, diabetes, herpetic eye disease, posterior synechiae, previous uveitis
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Anesthetic Dilating Gel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pupil dilation |  |  | 
| Corneal anesthesia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gel stability |  |  | 
| Gel sterility |  |  | 
| Patient comfort |  |  |
Family Exergaming: A Research Study Testing a Videogame Intervention to Increase Physical Activity for Families

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if an interactive game (Dance Dance Revolution/DDR) can promote healthy physical activity for the health of all family members

Official Title
-----------------
Family Exergaming: A Research Study Testing a Videogame Intervention to Increase Physical Activity for Families

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Exergame (DDR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 9-17 Overweight status (BMI of 85% and above) Willing to come to two (2 hour) visits to MMCRI for measurements and complete surveys Family participation Exclusion Criteria: Serious heart condition Photo-sensitive seizures Previous extensive history using DDR

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 17 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: Lifestyle Counseling<br> | Behavioral: Exergame (DDR)<br>* Use of an active videogame vs. pedometers given to entire families to promote physical activity.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of physical activity |  | 14 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Exergames, Videogames, Prevention, Family, Dance Dance Revolution, Pedometer