linjc16/ctgov huggingface dataset:
Feasibility Study of Evaluating Breast Cancer Patients With Ductal Lavage

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this research is to analyze the cells present in the fluid obtained via ductal lavage from the nipple of a woman with a known diagnosis of breast cancer. A portion of the lavage fluid may be used in future breast cancer biomarkers. Remaining lavage fluid will be used to analyze its biochemical composition, for investigational purposes only.

Official Title
-----------------
UMCC 2-48 Feasibility Study of Evaluating Breast Cancer Patients With Ductal Lavage

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

Intervention / Treatment
-----------------
* Procedure: Ductal lavage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age biopsy-proven unilateral invasive breast cancer of any histology or ductal carcinoma in situ patient desires or requires treatment with mastectomy any patient who has undergone prior excisional biopsy of their primary breast tumor must have had margins positive for disease, or must have either mammographic or ultrasonographic evidence of probable residual disease in the breast. patients receiving induction chemotherapy remain eligible for participation in the study regardless of tumor response; those with a clinical complete response remain eligible. voluntarily signed informed consent. - Exclusion Criteria: male gender lobular carcinoma in situ as the only cancerous histology prior margin-negative excisional biopsy of primary breast tumor, with no evidence of residual disease patient being treated with breast conservation therapy inability to understand the nature of the procedure pregnancy and/or active lactation

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

| Intervention/Treatment |
| --- |
|Procedure: Ductal lavage|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Isolated Bowman Layer Graft for Reducing and Stabilizing Advanced Keratoconus

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of mid-stromal implantation of an isolated Bowman layer graft, to reduce and stabilize ectasia in eyes with advanced keratoconus

Official Title
-----------------
Mid-stromal Isolated Bowman Layer Graft Implantation to Reduce and Stabilize Advanced Keratoconus

Conditions
-----------------
Advanced Keratoconus

Intervention / Treatment
-----------------
* Procedure: Bowman layer graft implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: •Advanced keratoconus Exclusion Criteria: Further ophthalmic diseases History of ocular surgery Pregnancy, brest feeding

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Bowman layer graft implantation<br> | Procedure: Bowman layer graft implantation<br>* For patients with progressive advanced keratoconus, a mid-stromal manual dissection is made and a donor isolated Bowman layer is positioned into the stromal pocket.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal power | Reduction and stabilizing of the corneal power after Bowman layer graft implantation | 2011-2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity |  | 2011-2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Keratoconus, Bowman layer
Electroencephalography Study Investigating the Effects of Vortioxetine in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
To explore a neurophysiological marker (electroencephalography) of cognitive effect of vortioxetine

Official Title
-----------------
Interventional, Randomised, Double-blind, Placebo-controlled, Active Comparator, Four-way Crossover Electroencephalography Study Investigating the Effects of Vortioxetine (Lu AA21004) in Healthy Male Subjects

Conditions
-----------------
Healthy Men

Intervention / Treatment
-----------------
* Drug: Vortioxetine 10 mg
* Drug: Vortioxetine 20 mg
* Drug: Escitalopram 15 mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject has a normal resting EEG at screening visit The subject is able to perform tasks with an auditory stimulus The subject is not visually impaired - normal prescription glasses are accepted The subject has a normal circadian rhythm, defined as a person who usually wakes between 6:00 and 9:00 a.m. and goes to sleep between 9:00 pm and midnight. Exclusion Criteria: The subject has worked shifts, including night duty, or has travelled across >3 time zones <2 weeks prior to the first dose of IMP. Other inclusion and exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vortioxetine 10 mg<br>encapsulated tablets; 3 daily doses in each treatment period; orally | Drug: Vortioxetine 10 mg<br> <br> |
| Experimental: Vortioxetine 20 mg<br>encapsulated tablets; 3 daily doses in each treatment period; orally | Drug: Vortioxetine 20 mg<br> <br> |
| Active Comparator: Escitalopram 15 mg<br>encapsulated tablets; 3 daily doses in each treatment period; orally | Drug: Escitalopram 15 mg<br> <br> |
| Placebo Comparator: Placebo<br>capsules; 3 daily doses in each treatment period; orally | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Battery of EEG measurements | Peak amplitude and latency of P300 AUC of qEEG power spectral bands delta, theta, alpha, beta and gamma AUC of evoked gamma power spectral band Peak amplitude and latency of N200 Peak amplitude and latency of error related negativity Peak amplitudes and latencies in the evoked responses during successful versus non-successful encoding in the verbal memory task between treatments | The EEG task battery will be conducted on Days -1 and starting 6 hours post-dose on Days 1 and 3 of each treatment period. |
Tear Collection in Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
This exploratory study will collect tear samples from adult volunteers for determining and quantifying tear composition profiles. No investigational drug will be administered in this study.

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Procedure: Tear Sample Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Adult volunteers without ocular disease. Exclusion Criteria: Systemic medications that could affect eye health taken within 1 month of enrollment Eye infection or inflammation in either eye 3 months prior to screening History of herpes in either eye Diagnosis of dry eye or meibomian gland dysfunction Diagnosis of glaucoma Allergic conjunctivitis Use of rigid contact lenses within 1 year of screening Use of soft contact lenses within 1 week of enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| All Participants<br>Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study. | Procedure: Tear Sample Collection<br>* Tear sample collection as per protocol. No investigational drug is administered in this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Lipid Composition Profile | Basal (non-stimulated) tear samples were collected from one eye for lipid analysis. 13 different lipids classes were detected in individual tear samples. The concentration of each lipid class is reported in picomoles (pmole). | Day 1 |
Prognostic Impact of Programmed Death Ligand-1 Expression in Advanced Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to assess the frequency of PD-L1 expression in stage III-IV ECs and to investigate its correlation impact with progression-free survival (PFS), and clinicopathological features including microsatellite instability and quantified stromal and intraepithelial tumor-infiltrating CD8+ lymphocytes (TILs)

Official Title
-----------------
Prognostic Impact of Programmed Death Ligand-1 Expression in Advanced Endometrial Cancer

Conditions
-----------------
Endometrial Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients consecutively enrolled from January 2004 to December 2014 treated for Endometrial cancer Stage III-IV endometrial cancer with available tissue blocks, including biopsies, hysterectomy specimens and resections of metastatic foci Exclusion Criteria: A patient record captured outside the time frame from January 2004 to December 2014

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

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 |
| --- | --- | --- |
| progression-free survival |  | 84 months |
Hypercapnia During Shoulder Arthroscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of hypercapnia on hemodynamics and cerebral oxygenation during shoulder arthroscopy.

Detailed Description
-----------------
The patients are randomly allocated to receive normocapnia or hypercapnia . After the 70º sitting position, record the mean arterial pressure (MAP), heart rate, and regional oxygen saturation (rSO2).

Official Title
-----------------
The Effect of Hypercapnia on Regional Cerebral Oxygen Saturation in the Sitting Position

Conditions
-----------------
Cerebral Ischemia

Intervention / Treatment
-----------------
* Behavioral: hypercapnia
* Behavioral: normocapnia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing elective shoulder arthroscopic surgery Exclusion Criteria: a history of age > 65 years, morbidly obesity (BMI > 30 kg/m2), diffuse lung disease, uncontrolled systemic hypertension, intracranial disease, cardiovascular and cerebrovascular disease.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: normocapnia<br>Tidal volume (10 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 35mmHg | Behavioral: normocapnia<br>* Tidal volume (10 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 35mmHg<br>* Other names: ETCO2-35;|
| Active Comparator: hypercapnia<br>Tidal volume (6ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 45mmHg | Behavioral: hypercapnia<br>* Tidal volume (6 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 45mmHg<br>* Other names: ETCO2-45;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional cerebral oxygen saturation |  | Change from Regional cerebral oxygen saturation at 2,4,6,8,10,20 min after anesthetic induction and sitting position |
A Study of Drug-Induced Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify incidence of Chinese herb nephropathy in a medical center

Detailed Description
-----------------
This is a retrospective study, by computer screening, chart review and phone survey to find herbal nephropathy and determine the cause-relationship. Using ICD-9-CM code as a tool to screen the newly diagnosed ESRD in NTUH computer data base, and divided patients into those with underlying disease(s) that cause the renal failure and those without.

Official Title
-----------------
A Study of Drug-Induced Kidney Disease

Conditions
-----------------
End Stage Renal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient who was newly diagnosed as end stage renal disease who need dialysis Exclusion Criteria: started dialysis before 2000
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 |
| --- | --- | --- |
| The incidence of herbal nephropathy |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The epidemiology of primary diagnosis for end stage renal disease in Taiwan |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
herbal nephropathy, Chinese herbal nephropathy, nephrotoxicity, renal disease, adverse drug reaction, Chinese herbal medicine
Phase 1 Study of DDI Between DW330SR and DW1030 in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate drugs interactions to compare pharmacokinetics in groups of monotherapy DW330SR, monotherapy DW1030, and coadministration DW330SR and DW1030

Official Title
-----------------
A Randomized, Open Label, Single-Dose, 6-sequence, 3-period, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between DW330SR and DW1030 in Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Drug: DW330SR 45mg
* Drug: DW1030 75mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Adult males aged 20 40 years at screening visit Subjects with range of 19 kg/m2   27 kg/m2 as BMI measurements at screening visit Subjects with BP range of below: 90 mmHg ≤ Systolic BP ≤ 140 mmHg 50 mmHg ≤ Diastolic BP ≤ 90mmHg Subjects who voluntarily agreed with written consent that be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the reguirement of the study Exclusion Criteria: Subjects with clinically significant disease or history such as Liver, kidney, gastrointestinal, respiratory, musculoskeletal, endocrine, nervous psychiatric, blood tumor system and cardiovascular. (In particular, bronchial asthma, severe hepatic, renal failure, severe blood disorders, severe myasthenia gravis, cardiac dysfunction, peptic ulcer, etc.) Subjects with history of gastrointestinal disease (ex, Chrones dz, peptic ulcer, etc) affect the absorption of Investigational drugs or history of surgery (except for a simple appendectomy or hernia surgery) Subjects with hypersensitivity reaction or clinically significant disease in drugs (Aspirin, NSAID and antibiotics) including ingredient of DW330SR and DW1030 and Food

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>only DW330SR 45mg | Drug: DW330SR 45mg<br> <br> |
| Experimental: B<br>only DW1030 75mg | Drug: DW1030 75mg<br> <br> |
| Experimental: C<br>DW330SR 45mg and DW1030 75mg | Drug: DW330SR 45mg<br> <br> Drug: DW1030 75mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trans-OH as Main Metabolites of DW330SR, DW330SR, Cmax, AUClast of DW1030 |  | -28   -2day(screening), -1day, 1day, 2day |
Medical Device for Drug Allergy Diagnosis

Study Overview
=================
Brief Summary
-----------------
The COBIOPHAD project targets the development of a highly sensitive, selective, and multiplexed diagnostic device to provide a quick and inexpensive in vitro test to address the most prevalent drug hypersensitivity to betalactams antibiotics, (BLCs). During a retrospective study, BLC structures involved in drug hypersensitivity will be identified from sera of allergic patients (versus controls) and coupled on the device. A prospective study will be performed for the recruitment of samples corresponding to patients with known IgE hypersensitivity to BLCs based on results from allergy tests and clinical history. Controls will include: non-allergic individuals with known tolerance to betalactams. The samples will be used for the validation of the COBIOPHAD device in real settings.

Official Title
-----------------
Compact Biophotonic Platform for Drug Allergy Diagnosis

Conditions
-----------------
Drug Hypersensitivity

Intervention / Treatment
-----------------
* Procedure: Immediate hypersensitivity to BLC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - patients with known hypersensitivity to BLC (proven by means of in vivo tests) (cases) Exclusion Criteria: patients with contraindications to BLC allergy work-up patient refusal to enter the study vulnerable patients according to French regulation

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immediate hypersensitivity to BLC<br>immediate hypersensitivity to BLC by In vitro diagnosis | Procedure: Immediate hypersensitivity to BLC<br>* immediate hypersensitivity to BLC by In vitro diagnosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC |  | up to 1 hour | 
| Specificity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC |  | up to 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Betalactams, In vitro diagnosis
Outcomes Of Social Service Programs For Homebound Older Adults

Study Overview
=================
Brief Summary
-----------------
The objective of this prospective study is to document the impact of social service interventions (including meals, telephone reassurance, and friendly visiting)provided by the Burden Center, a model community social service agency, on overall quality of life.

Detailed Description
-----------------
Specific outcomes include mental and physical function as measured by the SF-36, and depressive symptoms as measured by the CES-D depression scale. The hypothesis is that a multicomponent social service intervention program that provides social support and reduces social isolation can prevent depression and decline in quality of life in this vulnerable population.

Official Title
-----------------
Outcomes Of Social Service Programs For Homebound Older Adults

Conditions
-----------------
Homebound, Elderly

Intervention / Treatment
-----------------
* Behavioral: Social Services


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All new clients of the Burden Center for the Aging who are homebound, out of the home less than one time per week, and cognitively intact will be eligible for enrollment. Exclusion Criteria: Clients unable to give informed consent such as those suffering from a major psychiatric disease or those who are not cognitively able to give informed consent will be excluded. Clients who refuse to participate will be excluded

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Social Services|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life Depressive symptoms |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Social service intervention, Social support, Elderly, Homebound, Quality of life