linjc16/ctgov huggingface dataset:
Salivary TAS, TOS, LL-37 and Dental Status in Passive Smoking Children

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to determine the effect of passive smoking on the levels of salivary TAS, TOS, LL-37 and dental status in children.In the study the parents of children were asked to fill out a complete survey about smoking habits. After filling out the questionnaire, according to the survey results, a total of 180 children were included to the study as follows; 90 children exposed to passive smoking, and 90 children in the control group (unexposed controls). Also demographic data were recorded (age, gender, parental education levels, child's tooth-brushing habit and child's daily dietary sugar exposure, family income). Dental examination of children were performed and caries prevalance of the patients were recorded. Unstimulated saliva samples were collected from children. Saliva 'cotinine levels' which are expected to increase in passive smoking group; 'antimicrobial peptide LL-37' and oxidative stress markers 'total antioxidant status' (TAS), and' total oxidant status' (TOS) were evaluated by using Enzyme-linked immunosorbent assay (ELISA). The obtained data parameters of the two groups were evaluated and comparison was performed.

Conditions
-----------------
Passive Smoking, Oxidative Stress, Dental Caries, Children

Intervention / Treatment
-----------------
* Diagnostic Test: taking saliva samples to determine TAS, TOS and LL-37


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Systemically healthy children Exclusion Criteria: The presence of orthodontic / intraoral appliance Any disease or condition known to affect defense system Uncooperative children

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 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 |
| --- | --- |
| study group (passive smoking children)<br> | Diagnostic Test: taking saliva samples to determine TAS, TOS and LL-37<br> <br> |
| control group<br> | Diagnostic Test: taking saliva samples to determine TAS, TOS and LL-37<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| salivary oxidative stress values: TAS level | Unstimulated saliva samples were collected from children. | 1 day (once after the dental examination) | 
| salivary oxidative stress values: TOS level | Unstimulated saliva samples were collected from children. | 1 day (once after the dental examination) | 
| salivary LL-37 level | Unstimulated saliva samples were collected from children. | 1 day (once after the dental examination) | 
| salivary cotinine levels | Unstimulated saliva samples were collected from children for describing passive smoking children. | 1 day (once after the dental examination) |
Validation of Bladder Health Instrument for Evaluation in Women

Study Overview
=================
Brief Summary
-----------------
The Prevention of Lower Urinary Symptoms (PLUS) Research Consortium is working to optimize prevention of lower urinary tract symptoms (LUTS) in women and adolescent females across their life spans. The ability to measure bladder health and key risk and protective factors is crucial to the PLUS mission. To describe and measure the spectrum of bladder health in diverse populations, researchers need a valid and reliable instrument. To date, the Consortium's work on design of a bladder health instrument has been a culmination of expert opinion, information from focus groups, and incorporation of previously validated items and language where appropriate, along with cognitive interviews of participants from the general public. The next step in the consortium's work is to prospectively collect data to test and validate bladder health instrument (BHI) items for inclusion in a final bladder health scale (BHS) that can assess the full range of bladder health of women. This will be through a combination of general population recruitment for completing mailed surveys, clinical population recruitment for completing surveys and an in-person evaluation, and postpartum women.

Official Title
-----------------
Validation of Bladder Health Instrument for Evaluation in Women

Conditions
-----------------
Lower Urinary Tract Symptoms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Community dwelling Age ≥18 years old Female sex assigned at birth Fluent in written and spoken English Able to read and provide informed consent Exclusion Criteria: Institutional living arrangement, e.g., skilled nursing, long term care or rehabilitation center Physical or mental condition that would prohibit self-administration of questionnaire either electronically or using paper and pencil (e.g., dementia/cognitive impairment/blindness/severe arthritis).

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bladder Health Instrument | Multi-item measurement is used to assess the range of bladder health dimensions as defined by the model of bladder health adopted by the PLUS consortium. It is anticipated that the self-administeredBHI instrument (PAPI or CASI) will consist of approximately 85 items: 53-67 are items all respondents will be asked to answer, and 48 are asked only of women who self-identify as experiencing a specific LUTS. The items cover the range of bladder health dimensions specified by our model. | Will be assessed throughout the duration of study, an average of one year. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bladder Health, LUTS, PLUS, VIEW
Identification of Serum Markers For Tumor Hypoxia in Non-Small Cell Lung Cancers

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to identify a surrogate serum marker for tumor hypoxia in patients with lung cancers.

Official Title
-----------------
Identification of Serum Markers For Tumor Hypoxia in Non-Small Cell Lung Cancers

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- Newly diagnosed patients with lung cancer who are undergoing surgical resection of their tumors Exclusion Criteria:- Patients without non-small cell lung cancer

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pre-post Spinal Popliteal Block

Study Overview
=================
Brief Summary
-----------------
This is a retrospective chart review to determine the non-inferiority of performing lower extremity peripheral nerve block placement under spinal anesthesia compared to its pre-spinal counterpart.

Detailed Description
-----------------
This is a retrospective chart review to determine the non-inferiority of performing lower extremity peripheral nerve block placement under spinal anesthesia compared to its pre-spinal counterpart. Primary outcome: - The investiigators will be looking into persistent abnormal neuropathic symptoms lasting more than 7 days following a sciatic popliteal nerve block.

Official Title
-----------------
Comparison of Success and Injury (Neuropraxia) Rate When Performing the Sciatic Nerve Block in the Popliteal Fossa Pre vs. Post Spinal Anesthesia for Foot and Anke Procedures: Retrospective Review

Conditions
-----------------
Foot Surgery, Ankle Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ambulatory foot surgery ambulatory ankle surgery use of spinal Anesthesia use of pre-spinal anesthesia nerve block techniques use of sciatic nerve block Exclusion Criteria: all other surgeries
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 |
| --- | --- | --- |
| Persistent Abnormal Neuropathic Symptoms | Definition of abnormal neuropathic symptoms including numbness, tingling, burning, or pain sensation. | lasting more than 7 days following a sciatic popliteal nerve block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS pain scores in recovery | A score on a scale from 0 to 10 on how bad the pain is. 0 means no pain, 10 means worst pain. A lower score means a better outcome. | PACU recovery stay (up to 48 hours) | 
| Amount of supplemental analgesic and antiemetic provided in the PACU | This includes: IV dilaudid push, oral oxycodone, tramadol, hydrocodone, dilaudid, acetaminophen, ketorolac, ondansetron, dexamethasone. | PACU recovery stay (up to 48 hours) | 
| Anesthesia induction time | time from entering the OR to time of anesthesia induction end as defined by the completion of both the spinal and sciatic nerve blockade | From the time which patients enter the OR to time of anesthesia induction end (up to 24 hours) | 
| Number of hypoxemia events during induction time |  | during induction time (up to 24 hours) | 
| Amount of sedation given | fentanyl, ketamine, midazolam, propofol | during induction time (up to 24 hours) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lower extremity peripheral nerve block, spinal anesthesia
Menorrhagia Study in Women With Treatment-resistant Menorrhagia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to explore effects of the investigational product for the treatment of treatment-resistant menorrhagia without organic cause.

Detailed Description
-----------------
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official Title
-----------------
A Multi-center, Double-blind, Placebo-controlled, Randomized, Parallel Group Study to Evaluate the Effects of Different Doses of SH T 00127B in Women With Treatment-resistant Menorrhagia Aged 30 to 55 Years After Daily Oral Administration of Multiple Doses for 35 up to 50 Days

Conditions
-----------------
Menorrhagia

Intervention / Treatment
-----------------
* Drug: Asoprisnil (BAY86-5294)
* Drug: Asoprisnil (BAY86-5294)
* Drug: Asoprisnil (BAY86-5294)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with treatment-resistant menorrhagia scheduled for hysterectomy. Exclusion Criteria: Organic causes of menorrhagia Current hormone treatment

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 55 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Asoprisnil (BAY86-5294)<br>* 5mg/day<br>|
| Experimental: Arm 2<br> | Drug: Asoprisnil (BAY86-5294)<br>* 10mg/day<br>|
| Experimental: Arm 3<br> | Drug: Asoprisnil (BAY86-5294)<br>* 25mg/day<br>|
| Placebo Comparator: Arm 4<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual relative change in uterine bleeding scores by PBAC |  | Pretreatment cycle treatment phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endometrial thickness |  | End of treatment | 
| Adverse events collection |  | Whole treatment period | 
| Bleeding pattern |  | Treatment period | 
| Endometrial histology incl. immunohistochemical evaluations |  | End of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment-resistant menorrhagia
Fluid Management After Surgery in the Post-Anesthetic Care Unit (PACU)

Study Overview
=================
Brief Summary
-----------------
The objective of the present study is to describe the current practice of postoperative fluid management in the Post Anesthesia Care Unit (PACU) of the Shaare Zedek Medical Center, Jerusalem, Israel.

Detailed Description
-----------------
The aim of this study is to follow and present the current practice of fluid administration in the PACUof Shaare Zedek Medical Center for an extended period of time as a first step towards establishing guidelines for postoperative fluid management.

Official Title
-----------------
The Practice of Fluid Management in the Post-anesthetic Care Unit (PACU) of Shaare Zedek Medical Center in Patients Undergoing Elective Surgery: an Observational Study

Conditions
-----------------
Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 yrs elective surgery ASA I-III Exclusion Criteria: massive intraoperative blood loss non elective surgery pregnant women stay in the PACU < 15 minutes

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| elective post surgery patients<br> | |

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
-----------------
Surgery, elective, Fluids, Post Anesthesia Care Unit, PACU, Fluid management
Role of Ablative Radiotherapy in the Management of Metastatic Disease: A Patient Data Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide a registry of participants in order to assess the acute adverse event rates following ablative radiotherapy for metastatic disease.

Official Title
-----------------
Role of Ablative Radiotherapy in the Management of Metastatic Disease: A Patient Data Registry

Conditions
-----------------
Oligometastasis, Metastatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years of age Radiographic evidence of metastatic disease (may include oligoprogression, oligorecurrence or oligometastasis) at the time of study enrollment Planned to receive, currently receiving, or have completed hypofractionated image guided radiotherapy (ablative radiotherapy) to an extracranial site(s) Patient must sign study-specific informed consent Exclusion Criteria: • None

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of acute adverse events following radiotherapy |  | 90 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ablative radiotherapy
Patient Reported Outcome Post Radiation Therapy or Chemoradiotherapy Patient Care in Patients With Oropharyngeal Cancer

Study Overview
=================
Brief Summary
-----------------
This study examines patient reported outcomes post radiation therapy or chemoradiotherapy patient care in patients with oropharyngeal cancer. This study may help researchers learn about the symptoms that patients with oropharyngeal cancer have after completing radiation therapy.

Detailed Description
-----------------
PRIMARY OBJECTIVE: I. To provide evidence of clinically relevant symptoms for integrating into a user-friendly, automated pathway for real-time tracking and management of symptoms during post radiation therapy (RT)/chemoradiation (CRT) for oropharyngeal cancer (OPC). OUTLINE: Patients complete questionnaire over 10-20 minutes at baseline, 2 times every week during weeks 1-8 of radiation therapy, and at the end of the study.

Official Title
-----------------
A Pilot Study to Define PROs for Establishing a Pathway for Post Radiation or Concurrent Chemo Radiation (RT/CRT) Patient Care for Oropharyngeal Cancer

Conditions
-----------------
Oropharyngeal Carcinoma

Intervention / Treatment
-----------------
* Other: Electronic Health Record Review
* Other: Questionnaire Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were seen for new patient evaluation at clinics and HNC centers at MD Anderson Cancer Center Adult patients with OPC (> 18 years old) who have been enrolled under PA14-0947

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (questionnaire)<br>Patients complete questionnaire over 10-20 minutes at baseline, 2 times every week during weeks 1-8 of radiation therapy, and at the end of the study. | Other: Electronic Health Record Review<br>* Review of medical records<br>Other: Questionnaire Administration<br>* Complete questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores of symptoms on the MD Anderson Symptom Inventory - Head and Neck (MDASI-HN) relevant to toxicities | All symptom PRO items on MDASI-HN (MD Anderson Symptom Inventory - Head and Neck (MDASI) would be rated by patients on 0 -10 of severity scale, with 0 being no symptom, and 10 being symptom as bas as imagine. | From the end of radiation therapy (RT)/chemoradiotherapy (CRT) treatment to 2 months post-treatment |
Neuromuscular Characteristics of Individuals With Down Syndrome (DS)

Study Overview
=================
Brief Summary
-----------------
Evaluation of muscle strength and central activation of muscle in individuals with Down Syndrome

Official Title
-----------------
Neuromuscular Characteristics of Individuals With Down Syndrome

Conditions
-----------------
Down Syndrome

Intervention / Treatment
-----------------
* Other: muscle strength


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-45 years old good health with no contraindications to exercise documented DS (not for control subjects) Exclusion Criteria: contraindications to exercise, severe or profound MR documented atherosclerotic heart disease documented atlantoaxial instability uncorrected congenital heart disease implanted prosthetic device implanted pacemaker

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| DS<br>Individual with Down Syndrome | Other: muscle strength<br>* muscle strength<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength Central activation ratio |  | One time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Evaluation of muscle strength and central activation
Analyzing Clinical Trial Experiences of Prostate Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Participation in clinical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the participation or completion of these specific demographic groups. This study will admit a wide range of data on the clinical trial experience of Prostate Cancer patients to determine which factors prevail in limiting a patient's ability to join or finish a trial. It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might shed insights for the sake of future Prostate Cancer patients.

Official Title
-----------------
Analyzing Clinical Trial Experiences of Prostate Cancer Patients To Determine How Trial Attributes Affect Completion Rates For Specific Demographic Groups

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has been diagnosed with Prostate Cancer as identified by imaging Patient has self-identified as planning to enroll in an interventional clinical trial for Prostate Cancer Patient is at least 18 years of age Exclusion Criteria: Patient does not understand, sign, and return consent form Inability to perform regular electronic reporting Patient has a ECOG score of 4

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

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

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 |
| --- | --- | --- |
| Rate of patients who decide to enroll in a Prostate Cancer Clinical Trial |  | 3 months | 
| Number of patients who remain in Prostate Cancer clinical trial until completion of clinical trial |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer, Prostate, Prostate Clinical Trials