linjc16/ctgov huggingface dataset:
Defining the Radiotherapy Dose and Volume Parameters Affecting Postoperative Complications in Esophageal Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify features of the cumulative dose-volume histogram (DVH) for patients treated with trimodality therapy in oesophageal cancer and correlate these with postoperative complications.

Detailed Description
-----------------
Intention to treat analysis in patients initially assigned to be treated with the trimodality protocol: neoadjuvant chemoradiotherapy followed by surgery. The investigators will retrospectively evaluate several parameters of the treatment planning of patients treated with a preoperative regimen (CROSS regimen 41,4 Gy in 23 fractions or 50, 4 Gy in 28 fractions ): PTV volume1 MLD, V30, V20, V15, V10, VS5 (Volume lung less dan 5 Gy)2 (lung toxicity) MHD, V20, V30, V403 (heart toxicity) Mean stomach dose, V50 stomach Mitochondrial DNA if available per patient Pre-existing cardiac,pulmonary comorbidity, smoking behavior, BMI, type of surgery and chemotherapy (especially taxanes) will be scored and take into account in a multivariate analysis. The investigators will collect these data and correlate the data with the presence of postoperative complications, time of onset of complications and duration of hospitalization. These latter data are already scored in a prospective manner at the Atrium Medical Center in Heerlen.

Official Title
-----------------
Correlation of Radiotherapy-related Features With Postoperative Complications in Patients With Esophageal Cancer Treated With Trimodality Therapy

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Other: Trimodality protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Oesophageal cancer patients initially treated with a preoperative dose of radiation in combination with chemotherapy and subsequently undergone surgical resection Exclusion Criteria: Patients who were treated with definitive chemoradiation or palliative radiotherapy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Trimodality protocol|neoadjuvant chemoradiotherapy followed by surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Cardiac complications (arrhythmia etc ) Respiratory complications (pneumonia, pleural effusion etc) Anastomotic leakage Postoperative 30-day mortality Total postoperative mortality Treatment-related mortality Hospitalization and stay at intensive care unit duration | within 30 and 90 Days after operation |
Sympathetic Neural Outflow During Xenon Anesthesia in Humans

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the hypothesis that sympathetic neural outflow to muscles as well as a sympathetic baroreflexes are not altered during xenon anesthesia in Healthy Volunteers.

Detailed Description
-----------------
Objectives for this study : Main Objective : Influence of Xenon anesthesia on Sympathetic Nervous Activity Secondary Objectives : Security under LENOXe™ (xénon 100 % v/v) anesthesia

Official Title
-----------------
Sympathetic Neural Outflow During Xenon Anesthesia in Humans

Conditions
-----------------
Sympathetic Nervous System

Intervention / Treatment
-----------------
* Drug: xenon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers > 18 years and < 65 years of age ASA physical status I Legal competence for whom the consent form has been signed Exclusion Criteria: Healthy volunteers < 18 years and > 65 years of age Pregnancy, lactation period or missing secure anticonvulsive therapy Missing legal competence Participation in other clinical trials Contraindications as mentioned on §4.3 of the SPCs of LENOXe™ (xénon 100 % v/v) Any medication especially of Sildenafil (Viagra®) or other potency remedy Existing relationship of dependency to the sponsor or the investigator

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LENOXe™ (xénon 100 % v/v)<br>Influence of LENOXe™ (xénon 100 % v/v) anesthesia on Sympathetic Nervous Activity and Security under LENOXe™ (xénon 100 % v/v) anesthesia | Drug: xenon<br>* Inhalational gas; dose allowed max.70 Vol.% in 30 % oxygen; the duration of the treatment will be to 30 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Sympathetic Activity (MSA)and Baroreflex reagibility under Xenon Anesthesia in comparison to awake |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial blood pressure, Heart frequency, Arterial O2 and CO2 Saturation,Skin conductance,Concentration of plasma catecholamines, Angiotensin & Renin under Xenon Anesthesia in comparison to awake |  | In continuous during 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Xenon Anesthesia, LENOXe™ (xénon 100 % v/v) anesthesia, Muscle Sympathetic Activity, Baroreflex reagibility
Quality of Life Among Hungarian Women With Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the prevalence of urinary incontinence among Hungarian women. In addition to that, we aim evaluate the health related quality of life among Hungarian women with urinary incontinence and to culturally adapt the following questionnaires for the Hungarian population: Incontinence Impact Questionnaire - Short Form (IIQ-7) and King's Health Questionnaire (KHQ).

Official Title
-----------------
Health-related Quality of Life Among Hungarian Women With Urinary Incontinence

Conditions
-----------------
Urinary Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman Age 18 and above Providing consent to participate Ability to read and write Hungarian Exclusion Criteria: Respondents who are unable to complete the online survey due to illiteracy Man

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 |
| --- | --- | --- |
| International Consultation of Incontinence Questionnaire - Short Form | The International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF) will be used to gather information about the symptoms of urinary incontinence. It contains six questions. The total score can range from 0 to 21, with higher scores suggesting more severe symptoms. | Baseline | 
| King's Health Questionnaire | The King's Health Questionnaire (KHQ) will be used to measure the impact of urinary incontinence on the subject's health related quality of life. It assesses quality of life in nine different domains of life. Each domain is scored separately ranging from 0 (best) to 100 (worst). | Baseline | 
| Incontinence Impact Questionnaire short form | The Incontinence Impact Questionnaire short form (IIQ-7) will be also used to measure the impact of urinary incontinence on the subject's health related quality of life. It is comprised of seven questions. The total score ranges from 0 to 21, with higher scores indicating more severe symptoms and worse quality of life. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-Form-36 | The Short-Form-36 (SF-36) will be used to measure the generic health-related quality of life of participants. It consists of 35 individual questions and it is divided into eight domains of health. The total score ranges from 0 (worst health state) to 100 (best health state). | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of life
Comparison of Midline With Lateral Skin Incision in Simultaneous Bilateral TKA

Study Overview
=================
Brief Summary
-----------------
This is a RCT which compare skin numbness, kneeling ability and functional outcome between midline incision and lateral incision in patients undergoing simultaneous bilateral TKA

Official Title
-----------------
Comparison of Skin Numbness and Kneeling Ability Between Midline Skin Incision Medial to Tibial Tubercle With Lateral to Tibial Tubercle Skin Incision in Simultaneous Bilateral Total Knee Arthroplasty

Conditions
-----------------
Skin Numbness and Kneeling Ability

Intervention / Treatment
-----------------
* Procedure: Skin incision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient undergoing simultaneous bilateral TKA Normal skin sensation on both knees Informed consent Good cognitive function Exclusion Criteria: Previous surgical wound around the knee Peripheral vascular disease

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Midline incision<br>Skin incision at the midline, 1 cm medial to tibial tubercle | Procedure: Skin incision<br>* Skin incision on medial or lateral to tibial tubercle<br>|
| Experimental: Lateral incision<br>Skin incision at 1 cm lateral to tibial tubercle | Procedure: Skin incision<br>* Skin incision on medial or lateral to tibial tubercle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin numbness | area of skin numbness | 6 weeks, 3, 6 , 9, 12 months after surgery | 
| Kneeling ability | Ability to kneel at 90 and 110 degrees on hard, firm and soft surface | 6 weeks, 3, 6 , 9, 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome | Modified WOMAC, Joint forgotten score | 6 weeks, 3, 6 , 9, 12 months after surgery | 
| Knee range of motion | flexion and extension angle of knee by goniometer | 6 weeks, 3, 6 , 9, 12 months after surgery | 
| Incision length | Skin incision length at 90 degrees knee flexion | 3 months | 
| Complication | chronic eczema at surgical wound | 6 weeks, 3, 6 , 9, 12 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin incision, numbness, kneeling, total knee arthroplasty
Do Self-Rated Performance Status Scores Correlate With Health-Care-Provider-Scores?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if patients are able to self-rate their physical abilities and how these ratings compare to the ratings of their health-care provider.

Detailed Description
-----------------
The Karnofsky Performance Scale (KPS) is a highly validated and essential measuring tool across the cancer population. The scale relates to purely physical ability and covers 11 stages, ranging from normal health to death, with each stage scored as a percentage. The score is determined by the health-care provider and is based on observation and narrative patient descriptions. The purpose of this study is to compare the scores rated by the health-care provider to the scores that patients assign to themselves.

Official Title
-----------------
Do Self-Rated Karnofsky Performance Status (KPS) Scores Correlate With Health-Care-Provider-Rated Scores?

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: Karnofsky Performance Status Score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of brain or spinal tumor. Receiving medical care under the supervision of the Principal Investigator. Written informed consent. Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Karnofsky Performance Status Score<br> | Other: Karnofsky Performance Status Score<br>* Karnofsky Performance Status scores will be independently completed by both the patient and their health-care provider at each routine clinic visit.<br>* Other names: Performance Status Scale;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the correlation between self-rated and health-care-provider-rated Karnofsky Performance Status scores. |  | 2 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
QOL, Quality of Life, KPS, Karnofsky Performance Status, Cancer
A Study of Cabergoline for the Treatment of Cocaine Dependence - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess cabergoline for the Treatment of Cocaine Dependence

Detailed Description
-----------------
To assess the efficacy and safety of cabergoline in reducing cocaine use in subjects with cocaine dependence. This is a DB, placebo-controlled, parallel group design study where subjects will receive either .5mg cabergoline or placebo for 12 weeks with a 4 week follow-up.

Official Title
-----------------
Phase 2, Double-Blind, Placebo Controlled Trial of Cabergoline for the Treatment of Cocaine Dependence

Conditions
-----------------
Cocaine-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: Cabergoline
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have a DSM-4 criteria for cocaine dependence; be seeking treatment for cocaine dependence; have the ability to understand and provide written informed consent; females of child-bearing potential using proper method of birth control. Exclusion Criteria: Additional criteria available during screening at the site.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cabergoline<br>Subjects received one tablet of 0.5 mg of cabergoline tablet per week for 12 weeks. | Drug: Cabergoline<br> <br> * Other names: Dostinex;|
| Placebo Comparator: Placebo<br>Subjects received one tablet of 0.5 mg of cabergoline matched placebo tablet per week for 12 weeks. | Drug: Placebo<br>* sugar pill manufactured to mimic cabergoline 05mg tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of cabergoline in reducing cocaine use in subjects with cocaine dependence | Success in the reduction of cocaine use was determined by comparing cocaine non-use days (self-report confirmed or disproved by urine BE level at each study visit) expressed as the weekly mean proportion of non-use days to the total number of non-missing study days that week. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in cocaine use | Measured by the weekly mean proportion of non-use days according to the subject's self report without regard to BE levels | 12 weeks |
A Study and 12 Month Extension to Evaluate Two Investigational Drugs in Postmenopausal Women With Osteoporosis (MK-0217-907)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study and 12 month extension is to evaluate the effects of two investigational drugs on osteoporosis in postmenopausal women.

Official Title
-----------------
A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Evaluate and Compare the Effects of Alendronate and Risedronate on Bone Mineral Density in Postmenopausal Women With Osteoporosis; A 12 Month Extension to: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Evaluate and Compare the Effects of Alendronate and Risedronate on Bone Mineral Density in Postmenopausal Women With Osteoporosis

Conditions
-----------------
Osteoporosis, Postmenopausal

Intervention / Treatment
-----------------
* Drug: MK0217, alendronate sodium/Duration of Intervention: 12 mo
* Drug: Comparator: risedronate / Duration of Intervention: 12 mo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women with osteoporosis Exclusion Criteria: Any known allergy to the study drug

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0217, alendronate sodium/Duration of Intervention: 12 mo|nan|
|Drug: Comparator: risedronate / Duration of Intervention: 12 mo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean percent change from baseline in hip trochanter bone mineral density (BMD) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean percent change from baseline in PA lumbar spine, total hip, and femoral neck BMD |  |  |
Removal of mtDNA in Plasma by Continous Venovenous Hemofiltration in Sepsis

Study Overview
=================
Brief Summary
-----------------
The plasma level of mtDNA in sepsis is affected by continous venovenous hemofiltation（CVVH）

Detailed Description
-----------------
Continous renal replacement therapy （CRRT）has become routine for patients with chronic renal failure ，AKI，fliud overload as well as oliguria in ICU .In clinical patients ，continous venovenous hemofoiltration （CVVH）is actually the method of chioce for CRRT in critically ill and hemodynamic instable patients .CVVH has significant beneficial effects on removing inflammatory cytokines ，improving oxygen index，increasing cardiac index and regulating immune dysfuntion .

Official Title
-----------------
Removal of mtDNA in Plasma by Continous Venovenous Hemofiltration in Sepsis

Conditions
-----------------
Intensive Care Unit

Intervention / Treatment
-----------------
* Procedure: continous venovenous hemofiltraion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult septic patients undergoing CRRT Exclusion Criteria: Missing vists transplatation cancer aquired immunodeficiency syndrome

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Septic patients require CVVH<br>continuous venovenous hemofiltration. Continuous renal replacement therapy（CRRT）has become routine for patients with chronic renal failure ，AKI，fliud overload as well as oliguria in ICU .Continuous venovenous hemofiltration（CVVH）is the method of chioce for CRRT in critical ill .CVVH has significant beneficial effects on removing inflammatory cytokines ，improving oxygen index ，decreasing vasopressor requirements，increasing cardiac index and regulating immune dysfunction . | Procedure: continous venovenous hemofiltraion<br>* CVVH<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of mtDNA concentration in plasma | The specimens in the prefilter and postfilter blood as well as in the ultrafiltrate were obtained at the beginning of CRRT (T0) and 6 h (T6h), 12 h (T12h) after the setup of CVVH. | befor,6hours, 12hours, after CVVH treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mitochondrial DNA, Sepsis, Continous venovenous hemofiltation, Intensive Care Unit