linjc16/ctgov huggingface dataset:
Observational Study of Lumigan® 0.01% for Treatment of Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

Study Overview
=================
Brief Summary
-----------------
This is an observational study in patients with POAG or OHT that will collect data on the use of Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) in a routine clinical setting. Patients will be seen at baseline and at a follow-up visit approximately 8-12 weeks after baseline, as per normal clinical practice.

Conditions
-----------------
Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Bimatoprost 0.01% ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of POAG or OHT Prescribed Lumigan® 0.01% 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br>Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician. | Drug: Bimatoprost 0.01% ophthalmic solution<br>* Bimatoprost 0.01% ophthalmic solution eye drops at a dose and frequency as determined by the physician.<br>* Other names: Lumigan®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) at Baseline | IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at Baseline. | Baseline | 
| Intraocular Pressure (IOP) at Week 12 | IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left eye and the right eye at Week 12. The lower the IOP values the greater the improvement. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Assessment of Treatment Tolerability Using a 4-Point Scale | Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported. | 12 weeks | 
| Physician Assessment of Treatment Tolerability Using a 4-Point Scale | The Physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported. | 12 weeks | 
| Physician Reported Reasons for Treatment Discontinuation | The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient. | 12 weeks | 
| Number of Patients Continuing Treatment After 12 Weeks | The number of patients continuing treatment after 12 weeks was determined by the physician answering yes to the question: Is the patient continuing on Lumigan® 0.01% treatment? | 12 weeks |
Determine if Apparent Diffusion Coefficient (ADC) Values Can Differentiate Tumors From Normal Tissue

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine normal measurements (ADC values) from the head and neck of healthy volunteers using 3T MRI.

Detailed Description
-----------------
The purpose of this study is to determine normal measurements (ADC values) from the head and necks of healthy subjects using 3T MRI.

Official Title
-----------------
Retrospective - Prospective - Study to Determine if Apparent Diffusion Coefficient (ADC) Values Can Differentiate Tumors From Normal Tissues at 3T MRI

Conditions
-----------------
Neck Cancer, Brain Cancer

Intervention / Treatment
-----------------
* Procedure: 3T MRI scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects 18 years of age or older. Exclusion Criteria: Under 18 years of age Women of child bearing potential Pregnant or lactating women All potential volunteers will be pre-screened by MRI personnel to determine if there is any medical reason that you should not be included in this study.

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

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

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

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: A<br>To determine if apparent diffusion coefficient values can differentiate tumors from normal tissues using a 3T MRI scan. | Procedure: 3T MRI scan<br>* Establishing/evaluating apparent diffusion coefficient (ADC) values using a 3T MRI scan to differentiate tumors from normal tissue.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if ADC values determined at 3T are different between normal tissues and tumors arising from the extracranial head and neck. |  | 1 year |
Study of M2ES With Paclitaxel/Carboplatin (TC Regimen) in Advanced Non Small Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate safety and tolerance of M2ES with TC regimen in advanced NSCLC.

Official Title
-----------------
Single-center, Open Trail of Phase 1 of M2ES With TC Regimen in Advanced NSCLC

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: M2ES


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-70 years old; Patients with Ⅲ/Ⅳ NSCLC confirmed by histopathology or cytology who ware naive or previous chemotherapy without TC regimen; No contraindication for chemotherapy; ECOG performance scale 0-2; No history of anti-angiogenesis therapy; Patients are voluntary to participate and sigh the informed contents. Exclusion Criteria: Concurrent use of other anti-cancer agents; Allergic history to M2ES and biological agents; Pregnant or breast-feeding women; With other malignancy; With severe cardiopulmonary disease; Uncontrolled brain metastasis patients; Other conditions that are regarded for exclusion by the trialists.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: M2ES combined with chemotherapy<br> | Drug: M2ES<br>* polyethylene glycol rh recombinant endostatin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events incidence,including severe adverse events incidence |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response rate and disease controlled rate |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
M2ES, NSCLC, Phase I Trial, Advanced NSCLC, Recurrent NSCLC
Telecare in Rural Senior Centers

Study Overview
=================
Brief Summary
-----------------
The objective of this project is to assess the feasibility of telehealth stations at community centers as a mechanism to increase healthcare access for older adults living in rural communities.

Official Title
-----------------
Feasibility to Embed Telecare in Rural Community Senior Centers

Conditions
-----------------
Health Care Utilization

Intervention / Treatment
-----------------
* Other: Telecare


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 21 years or older Independently capable to complete electronic survey form Cognitive capable to verbalize consent for semi-structured interview Exclusion Criteria - Unable to complete an electronic survey form

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Pre/Post-test design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Senior Center Members<br>Participants who are using the provided telehealth stations in senior centers. | Other: Telecare<br>* The University of Kentucky (UK) will embed telehealth stations at community-based senior centers. Individuals who utilize these telehealth stations will be invited to complete a demographic survey prior to their telehealth appointment. Following their appointment, they will be invited to complete a semi-structured interview with the research team. Participants who elect to use telehealth station will be doing so as telehealth visits already scheduled with patients as Standard of Care (SOC). The telehealth station in the senior center will be used to increase ease and access to telehealth should the patient/provider choose to use such an approach (for example, in instances when the patient does not have sufficient technology, internet access, or capability to operate telehealth at home).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of embedded telehealth stations in senior centers as mechanism to increase healthcare access for older adults. | Feasibility will be measured based on acceptance of the telehealth program by community residents evident by 5 Telehealth healthcare contacts per month | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
telehealth, rural, brain, aging
Effects of Inhibition of NO-Synthesis on Renal Hemodynamics and Sodium Excretion in Patients With Essential Hypertension and Healthy Controls

Study Overview
=================
Brief Summary
-----------------
The study tests the hypothesis that systemic and renal nitric oxide synthesis is changed in essential hypertension by investigating the effects of a non selective nitric oxide inhibitor on renal hemodynamics and sodium excretion in patients with essential hypertension. The results are compared with a group of healthy subjects.

Detailed Description
-----------------
The study investigates the effects of Ng-monomethyl-L-arginine (L-NMMA) on: renal hemodynamics (renal plasma flow and glomerular filtration rate) renal sodium excretion lithium clearance and fractional lithium excretion plasma levels of vasoactive hormones blood pressure and heart rate

Official Title
-----------------
Phase 1 Study of the Effects of Systemic Nitric Oxide Inhibition With Ng-Monomethyl-L-Arginine on Renal Hemodynamics and Sodium Excretion in Patients With Essential Hypertension and Healthy Controls

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Ng-monomethyl-L-arginine (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Essential hypertension (blood pressure > 140/90) with no signs of secondary hypertension P-creatinine < 200 µmol/L Exclusion Criteria: Anamnestic or clinical signs of heart disease, renal disease, liver disease, neoplastic disease, anemia or cerebro-vascular insult Medication except antihypertensives Drug or alcohol abuse Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ng-monomethyl-L-arginine (drug)|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
-----------------
hypertension, nitric oxide, renal hemodynamics
Quality of Life After Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
This study aims to assess long term outcomes for patients who have underwent bariatric surgery. In particular, it aims to assess the quality of life of these participants.

Official Title
-----------------
Quality of Life After Bariatric Surgery

Conditions
-----------------
Bariatric Surgery Candidate, Obesity, Obesity, Morbid, Quality of Life

Intervention / Treatment
-----------------
* Procedure: Bariatric Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese, either received bariatric surgery or have been referred for bariatric surgery. Exclusion Criteria: Emergency cases, Obese patients who have not been referred for bariatric surgery.

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 |
| --- | --- |
| Pre-operative Group<br>This is the group of participants who suffer from obesity and are awaiting bariatric surgery. | |
| Post-operative Group<br>This is the group of participants who suffer from obesity and have received bariatric surgery. | Procedure: Bariatric Surgery<br>* Bariatric surgery includes sleeve gastrectomy and gastric bypass.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life before and after bariatric surgery | Difference in SF-36 between post-bariatric surgical patients and representative pre-operative patients who have not undergone bariatric surgery (quality of life). | This represents the patients current quality of life within the last 4 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Current Weight | This represents the patients current weight in kilograms. | This is the patients current weight within the last 4 weeks | 
| Lowest Weight | This represents the patients lowest weight after bariatric surgery | Retrospectively reviewed on average of 5 years | 
| Change in marker of Type 2 Diabetes Mellitus | Using HbA1C scores and use of insulin | Preoperative use compared to results within the last 4 weeks | 
| Change in marker of hypertension | Number of medications used to manage condition | Preoperative use compared with use in the last 4 weeks | 
| Change in marker of hyperlipidemia | Number of medications used to manage condition | Preoperative use compared with use in the last 4 weeks | 
| Change in marker of GORD | Number of medications used to manage condition | Preoperative use compared with use in the last 4 weeks | 
| Change in marker of OSA | Use of CPAP | Preoperative use compared with use in the last 4 weeks |
The Safe Teen Study

Study Overview
=================
Brief Summary
-----------------
The study examines (1)the incidence of preventive health services provided by family physicians to adolescent patients, and (2)barriers and facilitators of prevention discussions between family physicians and their adolescent patients.

Detailed Description
-----------------
This study used a card study design to allow volunteer physicians to record research data in the context of providing clinical care. The method was brief, simple, and convenient for busy practicing clinicians. Volunteer resident physicians and faculty carried data collection checklists in their pockets and completed one for every adolescent patient seen during a randomly selected two week period. Physicians attempted to collect data on ten consecutive encounters with teen patients aged 11-21 years. The checklist documented patient characteristics (age, gender and ethnicity), reason for visit, parent presence, and types of prevention issues discussed during the visit. Patient and visit information was collected to assess its influence on physician prevention discussions. Finally, the checklist asked open-ended questions related to barriers to and facilitators to teen prevention discussions. The study involved five clinical sites comprising approximately 140 faculty and resident family physicians. The investigators sought 10-15 volunteer physicians from each site (60-90 physicians), and asked them to complete data checklists on 10 consecutive adolescent patients (600-900 visits). After a training session, each site randomly selected data collection periods. Physicians provided usual care for adolescent patients and recorded on the checklists any prevention discussions during the visit.

Official Title
-----------------
The SAFE TEEN Study: Family Physicians' Reports of Facilitators of and Barriers to Preventive Care for Adolescents.

Conditions
-----------------
Prevention

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Family Medicine Residency physicians and faculty in six residency programs in Texas Exclusion Criteria: Physicians not in the residency programs

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Family Physicians, Adolescents, Preventive Care, Health Behavior
Multi Dimensional Precise Exploration of Immunoconsolidation Therapy for Locally Advanced NSCLC After Chemo-radiotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to carry out a prospective observational study in patients with locally advanced NSCLC receiving radical concurrent chemoradiotherapy and follow-up immune consolidation therapy. By detecting ctDNA and TILs of the patients, we explored the value of blood dynamic monitoring of ctDNA in patients with prognosis stratification and treatment effect, and explored the patients before and after concurrent chemoradiotherapy and immune consolidation therapy The characteristics of DNA, RNA, T cells and other biomarkers were correlated with the efficacy and prognosis.

Official Title
-----------------
Multi Dimensional Precise Exploration of Immunoconsolidation Therapy for Locally Advanced Non-small Cell Lung Cancer After Chemo-radiotherapy

Conditions
-----------------
NSCLC, Chemoradiotherapy, ctDNA

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non small cell lung cancer patients confirmed by pathology; They were 18-80 years old; The tumor could not be resected or could not tolerate surgery; Planed to receive chemoradiotherapy and subsequent immunoconsolidation therapy; Clinical stage III (AJCC, 8th Edition, 2017); After systematic detection of non-small cell lung cancer core indicators including EGFR, ALK, ros1, KRAS, ntrk, TMB, etc; Patient informed consent. Exclusion Criteria: After radiotherapy and chemotherapy, the disease progressed and immune maintenance therapy could not be carried out It can not cooperate with the completion of baseline mutation screening and subsequent sample detection Factors judged by other researchers not suitable for further study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Correlation between ctDNA dynamic detection and 1-year PFS rate after chemoradiotherapy | The ctDNA dynamic detection will contain NGS test including mutations(both somatic and germline), copy number variations, gene fusions along with genetic interpretation for each and every mutation identified in each test(both blood and tissue) during the whole therapeutic process | Six months after consolidation treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS |  | Six months after consolidation treatment | 
| OS |  | Six months after consolidation treatment |
Propofol Versus Dexmedetomidine for Prevention of Sevoflurane Agitation in Recipients of Living Donor Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
The use of propofol or dexmedetomedine for prevention of sevofurane emergence agitation in LDLT recipients

Conditions
-----------------
Liver Transplantation

Intervention / Treatment
-----------------
* Drug: Propofol
* Drug: dexmedetomedine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All recipients of living donor liver transplantation Exclusion Criteria: patient refusal Allergy to either propofol or dexmedetomediene CNS disease

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 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 |
| --- | --- |
| No Intervention: Control<br>No drugs will be given. the emergence agitation will be monitored and recorded | |
| Experimental: Propofol group<br>Propofol at dose of 1 mg/kg over 5 minutes will be started before extubation. the emergence agitation will be monitored and recorded | Drug: Propofol<br>* Infusion of propofol to prevent emergence agitation in liver transplanta recipients<br>|
| Experimental: dexmedetomedine group<br>dexmedetomedine at dose of .5 mic/kg over 5 minutes will be started before extubation. the emergence agitation will be monitored and recorded | Drug: dexmedetomedine<br>* Infusion of dexmedetomedine to prevent emergence agitation in liver transplanta recipients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of emergence agitation in liver trasnplant recipients |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recipients