linjc16/ctgov huggingface dataset:
Bioavailability Study of SPARC1210 and Reference1210 in Subjects With Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Pharmacokinetic, bioequivalence study

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: SPARC1210
* Drug: Reference1210


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject has given written, informed consent and is available for the entire study. Histologically or cytologically confirmed diagnosis of breast cancer; Locally recurrent or metastatic breast cancer for which taxane-based therapy is a rational treatment option; Age 18 years or more Exclusion Criteria: Known hypersensitivity to both the study drugs or its excipients (Cholesteryl sulfate, Caprylic acid, Polyvinylpyrrolidone, Ethanol or Polyethylene glycol); Presence of clinically evident active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy; Pre-existing clinically significant peripheral neuropathy (Grade 2 or higher according to CTCAE, Version 4.0); Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPARC1210<br>Intravenous administration of SPARC1210 | Drug: SPARC1210<br> <br> |
| Active Comparator: Reference1210<br>Intravenous administration of Reference1210 | Drug: Reference1210<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed concentration (Cmax) | Samples will be collected from all subjects at scheduled time-points: pre-dose and up to 3 days post-dose. | Pre-dose, post-dose up to 3 days |
Biomarkers in Urine Samples From Patients With Wilms Tumor

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of urine from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer. PURPOSE: This clinical trial studies biomarkers in urine from patients with Wilms tumor.

Detailed Description
-----------------
OBJECTIVES: To validate the prognostic performance of specific-candidate Wilms tumor markers by measuring their urinary concentration using enzyme-linked immunosorbent assays (ELISAs) in urine specimens collected at diagnosis from 50 patients with favorable histology Wilms tumor who relapsed and 50 patients who did not relapse. OUTLINE: Urine specimens are analyzed using enzyme-linked immunosorbent assays (ELISAs) for biomarkers.

Official Title
-----------------
Discovery and Validation of Wilms Tumor Markers Using Urine Proteomics

Conditions
-----------------
Kidney Cancer

Intervention / Treatment
-----------------
* Genetic: proteomic profiling
* Other: enzyme-linked immunosorbent assay
* Other: laboratory biomarker analysis
* Other: medical chart review


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Urine specimens collected at diagnosis will be selected from patients with stage II-III Wilms tumors, with both local and non-local sites of disease relapse Clinical patient information (urinalysis/macro, age, gender, congenital defects/syndromes, comorbidities, tumor stage, size, pathology, therapy, outcome) available PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: proteomic profiling|nan|
|Other: enzyme-linked immunosorbent assay|nan|
|Other: laboratory biomarker analysis|nan|
|Other: medical chart review|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wilms tumor biomarkers identified by ELISA |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage II Wilms tumor, stage III Wilms tumor, recurrent Wilms tumor and other childhood kidney tumors
3D Reconstructed Image Processin by Computer Proram From MRI Data

Study Overview
=================
Brief Summary
-----------------
We use the three-dimensional image software reconstruct MRI. The propose of this research purposes as follows: 1. 3D reconstructed image processing from MRI to realize the short term nervous system response after dynamic acupuncture stimulation.2. Realizing the corresponding area in the brain caused by electroacupuncture. 3. Realizing the connection between electroacupuncture stimulation and brain physics, chemistry, and physiology. The implement the two-dimentional image into three-dimensional image by Amira software, in order to find out the difference of the pre-and post- response of the nervous system. In addition, we will use describe statistics and Paired t-test statistical analysis, compare the statistical difference of blood oxygen concentration.

Detailed Description
-----------------
We use the three-dimensional image software reconstruct MRI. The propose of this research purposes as follows: 1. 3D reconstructed image processing from MRI to realize the short term nervous system response after dynamic acupuncture stimulation.2. Realizing the corresponding area in the brain caused by electroacupuncture. 3. Realizing the connection between electroacupuncture stimulation and brain physics, chemistry, and physiology. The implement the two-dimentional image into three-dimensional image by Amira software, in order to find out the difference of the pre-and post- response of the nervous system. In addition, we will use describe statistics and Paired t-test statistical analysis, compare the statistical difference of blood oxygen concentration. Anticipate of results: Using the three-dimensional software reconstruct magnetic resonance imaging to realize the immediate response of nervous system after acupoint acupuncture stimulation, and find out the meridian, nerve or physiological corresponding relationship. It will be a tremendous finding to the world if we can deliver a brain mapping concerning the localization of the response on the central nervous system after various acupoints stimulation.

Official Title
-----------------
3D Reconstructed Image Processin by Computer Proram

Conditions
-----------------
3D Reconstructed Image by Software.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The outpatient service or the in-patient, diagnoses after pediatric nerve doctor, must carry on the central nervous system MRI. Exclusion Criteria: Not symbol cooperation brain MRI condition

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 1 Year

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
-----------------
Magnetic Resonance Imaging, 3D reconstructed image
Trial of Hypofractionated Intensity Modulated Radiation Therapy With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor for Patients With Newly Diagnosed Glioblastoma Multiforme

Study Overview
=================
Brief Summary
-----------------
Phase II Trial of Hypofractionated Intensity Modulated Radiation Therapy(IMRT) With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor(GM-CSF) for Patients With Newly Diagnosed Glioblastoma Multiforme.

Conditions
-----------------
Glioblastoma Multiforme

Intervention / Treatment
-----------------
* Radiation: Hypofractionated IMRT
* Biological: Granulocyte-macrophage Colony-stimulating Factor
* Drug: Temozolomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed and pathologically confirmed glioblastoma multiforme without an enhanced lesion beside the cerebrospinal fluid space on baseline magnetic resonance imaging Karnofsky performance status more than 60 Normal liver, kidney, and bone marrow function. Exclusion Criteria: Previous allergies to granulocyte macrophage colony stimulating factor Receiving radiotherapy Receiving other investigational agents Had uncontrolled intercurrent illnesses.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMRT<br>Hypofractionated IMRT With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor | Radiation: Hypofractionated IMRT<br>* Hypofractionated IMRT<br>Biological: Granulocyte-macrophage Colony-stimulating Factor<br>* Granulocyte-macrophage Colony-stimulating Factor<br>Drug: Temozolomide<br>* Temozolomide<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS |  | From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
Effect of Pharmacist Initiated Recommendations On Prescribing For Participants In the Senior MEDS Personalized Medication Review

Study Overview
=================
Brief Summary
-----------------
What are the demographic and medication utilization characteristics of participants in the Senior MEDS personalized medication review compared to other community-dwelling elderly, what is the level of satisfaction with Senior Meds, and does the Senior Meds program lead to changes in the participants' drug regimen?

Official Title
-----------------
Participant Characteristics, Medication Utilization, and the Effects of Pharmacist Initiated Recommendations On the Prescribing For Participants In the Senior MEDS Personalized Medication Review for Adults Age 55 and Older

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 55 or older Exclusion Criteria: 54 or younger

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
Differential Clinical and Serologic Response in Psoriasis and Psoriatic Arthritis to Drug Treatment

Study Overview
=================
Brief Summary
-----------------
Psoriasis is a multifactorial cutaneous disorders which affects about 100000 patients in Taiwan. Psoriatic arthritis is also present in about 20 30 percents. Many drugs have been shown to aggravate psoriasis including drugs used in the treatment of psoriatic arthritis. On the contrary, anti-psoriatic drugs are also known to aggravate or induce psoriatic arthritis. Psoriasis and psoriatic arthritis are believed to share the same pathogenic lymphocytes, but the differential responses to drugs are intriguing. This also causes problems in the treatment of psoriasis and psoriatic arthritis. Recently different serologic markers have been found for the assessment of psoriasis and psoriatic arthritis. Recent genetic study showed a different genetic susceptibility genes. We tested the serologic responses of three new biologic drugs used in the treatment of psoriasis and psoriatic arthritis. Paired blood samples of the same patients before and after 12 weeks of treatment were used. IL6 decreased after alefacept and etanercept but was increased after efalizumab treatment without statistical significance (Paired t test: 0.3336、0.2773、0.5904)。IL-8 decreased after etanercept but increased after efalizumab and alefacept without statistical significance (Paired t test: 0.4031、0.6749、0.2998)。IL10 decreased after efalizumab and etanercept, but increased significantly after alefacept treatment (Paired t test: 0.7254、0.5123、0.0350)。None of the treatment has a significant effect on TNF-alpha. HC10 decreased after alefacept and efalizumab,but increased after etanercept treatmentwithout statistical significance (Paired t test: 0.6589、0.1576、0.1988).

Official Title
-----------------
Differential Clinical and Serologic Response in Psoriasis and Psoriatic Arthritis to Drug Treatmen

Conditions
-----------------
Psoriatic Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of psoriasis
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
-----------------
psoriatic arthritis
Prognostic Factors Affecting Survival of Gastric GIST

Study Overview
=================
Brief Summary
-----------------
Gastrointestinal stromal tumor (GIST) is the most common non-epithelial mesenchymal tumor of the gastrointestinal tract. Surgical treatment is the only curative therapy for primary localized GIST. This study aimed to identify the clinicopathological characteristics of gastric GISTs and to study the predictive factors for recurrence in Tunisian patients.

Detailed Description
-----------------
The prognosis of gastric GIST depends on various tumor factors with the most important being the mitotic index and tumor necrosis. Imatinib therapy has revolutionized the treatment of advanced GIST. They have been the subject of much controversy in terms of their histogenesis, classification, treatment and prognosis. GISTs are histologically similar to smooth muscle and nerve tumors such as leiomyomas, leiomyosarcomas or schwannomas. Currently they are well characterized with the recent discovery of the C-KIT gene mutation and the expression by tumor cells of the C-KIT protein. Moreover, the discovery of this receptor is at the origin of the introduction of a targeted therapy: an anti-tyrosine kinase molecule having revolutionized the therapeutic management of these tumors. However, the standard curative treatment of GIST remains complete surgical resection with negative margin from the tumor.

Official Title
-----------------
Clinicopathological Characteristics and Prognostic Factors of Gastrointestinal Stromal Tumors Located in the Stomach in Tunisian Patients

Conditions
-----------------
Gastric GIST

Intervention / Treatment
-----------------
* Other: total or subtotal gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient having gastric GIST - Exclusion Criteria: patient operated for other gastric tumors

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 90 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 |
| --- | --- |
| prognostic factors of gastrointestinal stromal tumors<br>for the patient diagnosed with gastic GIST , they underwent subtotal or total gastrectomy. | Other: total or subtotal gastrectomy<br>* resection of the gastric tumor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients operated for gastric GIST | the patient having adenocarcinoma or other histopathological type are excluded | 30 days |
Comparison in Difficult Airway Scenario Induced in Patients With Laryngeal Mask Airway (LMA)-Classic™, LMA™ - Flexible and LMA - Proseal™

Study Overview
=================
Brief Summary
-----------------
Supraglottic airway tools, one of the tools used in the management of the difficult airway. American Society of Anesthesiologists and the Difficult Airway Society of the United Kingdom airway management algorithms have included the LMA. In our study investigators aimed to determine which one will show the best performance with supraglottic airway means that LMA - Classic, LMA - Flexible and LMA - ProSeal in patients that difficult airway scenarios created with attaching collar.

Conditions
-----------------
Difficult Airway

Intervention / Treatment
-----------------
* Device: Laryngeal Mask Airway Classic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Without a history of difficult intubation, supine position, does not require tracheal intubation, undergo elective surgery Exclusion Criteria: High aspiration risk, who take more than 4 hours surgery Body mass index greater than of 35 kg/m² Disease related to the cervical spine The mouth opening is less than 20 mm

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LMA-Classic<br>airway management with LMA-Classic | Device: Laryngeal Mask Airway Classic<br> <br> |
| Active Comparator: LMA-Flexible<br>airway management with LMA-Flexible | Device: Laryngeal Mask Airway Classic<br> <br> |
| Active Comparator: LMA-Proseal<br>airway management with LMA-Proseal | Device: Laryngeal Mask Airway Classic<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insertion time and attempts in min. |  | through study completion, an average of 6 months | 
| oropharyngeal leak pressure in cmH20. |  | through study completion, an average of 6 months | 
| fiberoptic view grade by Brimacombe and Berry bronchoscopy score | score1-4 (easy to difficult) | through study completion, an average of 6 months |
Adherence Monitoring For Substance Abuse Clinical Trials

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the feasibility and accuracy of an automated adherence monitoring system, and to compare the variance between urine and oral fluid riboflavin levels when specimens are obtained 'as usual' and after a one-hour inter specimen interval.

Conditions
-----------------
Medication Adherence

Intervention / Treatment
-----------------
* Other: Automated Adherence Monitoring System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, aged 18 to 60 Ability to give informed consent. Be willing and able to use the study-provided phone for taking and transmitting capsule photos. Exclusion Criteria: Unwilling or unable to use a cell phone. Any medical, psychiatric, or other condition that, in the opinion of the investigator, would preclude safe, consistent, or useful participation in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Healthy Normals<br> | Other: Automated Adherence Monitoring System<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variance between urine and oral fluid riboflavin levels when specimens are obtained 'as usual' and after a one-hour inter specimen interval |  | + 1, 2, 3, 4, 6 hours post dose |
Effect of Covid-19 Affliction on Psychological and Mental Health Among College Going Students: Cross-Sectional Survey

Study Overview
=================
Brief Summary
-----------------
The study aims to study the effects of Novel corona virus (COVID-19) on the psychological and mental health of college going students. Online version of the Event Impact Scale - Revised will be used to filled by the students who got afflicted by the novel corona virus (COVID-19).

Detailed Description
-----------------
Objective : To study the impact on psychological and mental health of COVID-19 affliction among college going students Methodology: Study Design: Cross-sectional Mode of implementation: Online surveys Population : COVID positive College students Inclusion criteria: Students positive to corona tests Exclusion criteria: students negative to corona tests

Official Title
-----------------
Impact of Covid-19 Affliction on Psychological and Mental Health of the College Students: Cross-Sectional Survey

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Other: NOT APPLICABLE (NA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Students positive for COVID-19 test - Exclusion Criteria: Students negative for COVID-19 test -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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 |
| --- | --- |
| STUDENTS<br>COLLEGE STUDENTS WITH POSITIVE COVID-19 TEST | Other: NOT APPLICABLE (NA)<br>* THE INTERVENTION GROUP IS NOT APPLICABLE TO THE CURRENT STUDY DESIGN<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EVENT IMPACT SCALE - REVISED | The IES-R is a 22-item self-report measure (for DSM-IV) that assesses subjective distress caused by traumatic events. It is a revised version of the older version, the 15-item IES (Horowitz, Wilner, & Alvarez, 1979). The IES-R contains seven additional items related to the hyperarousal symptoms of PTSD, which were not included in the original IES. Items correspond directly to 14 of the 17 DSM-IV symptoms of PTSD | Within 1 month of the impact of COVID-19 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
college students, CORONA, COVID-19, Graduates