linjc16/ctgov huggingface dataset:
Biochemical Recurrence Rate of Radical Prostatectomy Combined With Neoadjuvant and Adjuvant Chemotherapy in High Risk Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Effect of Radical Prostatectomy Combined with Neoadjuvant and Adjuvant Chemotherapy in Patients with High Risk Prostate Cancer. The purpose of this study is to evaluate whether neoajuvant and adjuvant docetaxel and prednisone are effective in the treatment of high risk localized prostate cancer.

Detailed Description
-----------------
The purpose of this study is to evaluate whether neoajuvant and adjuvant docetaxel and prednisone are effective in the treatment of high risk localized prostate cancer.

Official Title
-----------------
Biochemical Recurrence Rate of Radical Prostatectomy Combined With Neoadjuvant and Adjuvant in Patients With High Risk Locallized Prostate Cancer

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

Intervention / Treatment
-----------------
* Drug: DOCETAXEL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prostate Cancer PSA > 20 OR Clinical Stage > T2C OR GS > 7
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: contol<br>control group | Drug: DOCETAXEL<br>* 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: 3 times pre-op and 3 times after surgery<br>* Other names: taxotere;|
| Other: chemotherapy<br>neoadjuvant chemotherapy | Drug: DOCETAXEL<br>* 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: 3 times pre-op and 3 times after surgery<br>* Other names: taxotere;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biochemical recurrence rate of Radical Prostatectomy Combined with Neoadjuvant and Adjuvant Chemotherapy in Patients with High Risk Prostate Cancer |  | 2 Years After RRP |
This Study Uses Ultrasound to Determine Whether Atorvastatin or Pravastatin Effects the Progression of Coronary Plaque.

Study Overview
=================
Brief Summary
-----------------
This study was designed to assess the effects on coronary artery plaque using aggressive lipid-lowering therapy versus moderate lipid-lowering therapy. A substudy will examine the effect of these treatments on brachial artery vasoactivity.

Official Title
-----------------
A Prospective, Randomized, Double-Blind, Multi-Center Study Comparing the Effects of Atorvastatin Versus Pravastatin on the Progression and Quantification of Coronary Atherosclerotic Lesions as Measured by Intravascular Ultrasound (REVERSAL)

Conditions
-----------------
Coronary Arteriosclerosis

Intervention / Treatment
-----------------
* Drug: Atorvastatin
* Drug: Pravastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Angiographic evidence of coronary artery disease as defined by a lesion that has at least 20% reduction in luman diameter by visual (angiographic) estimation in any native coronary artery. LDL cholesterol equal to 125mg/dl - 210mg/dl. Exclusion Criteria: Patients who are anticipated to undergo coronary bypass surgery or cardiac transplantation during the course of the study. Known major hematologic, neoplastic, metabolic, gastrointestinal or endocrine dysfunction.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atorvastatin|nan|
|Drug: Pravastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy parameter is the percent change in total plaque volume for all slices of anatomically comparable segments of the target coronary artery from baseline to month 18. |  |  | 
| The primary efficacy parameter for brachial artery vasoactivity is the nominal change (month 3 - baseline) in the percent arterial diameter change. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The nominal change (month 18 - baseline) in total plaque volume as measured by the sum of plaque areas for all slices of anatomically comparable segments of the target coronary artery. |  |  | 
| Changes in brachial artery vasoactivity will be correlated with changes in total cholesterol, LDL-C, triglyceride and apolipoprotein B levels following 3 months of treatment. |  |  |
Preemptive Local Anesthesia in Vaginal Surgery

Study Overview
=================
Brief Summary
-----------------
Preemptive analgesia is an intervention which provides an anesthetic prior to initiating a painful stimulus. This trial is examining the effects of a local anesthetic given at the point of innervation prior to performing a vaginal hysterectomy with suspension sutures.

Official Title
-----------------
Preemptive Local Anesthesia in Vaginal Surgery, A Prospective, Randomised Trial

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: bupivacaine and epinephrine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing vaginal hysterectomy with McCall's culdoplasty

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PLA<br>Active preemptive local analgesia. | Drug: bupivacaine and epinephrine<br>* 20 ml of 0.5% bupivacaine with 1:200,000 epinephrine paracervical injection.<br>|
| Placebo Comparator: Placebo<br>Placebo for preemptive local analgesia. | Drug: Placebo<br>* 20 ml normal saline injection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) Pain Score | Visual Analogue Scale (VAS) pain score on a scale from 0 (None) to 10 (Worst) points. | 30 minutes post-op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preemptive analgesia, paracervical block, vaginal hysterectomy
Investigation of the Relationship Between New Coronary Virus Disease (COVID-19) and Anxiety and Depressive Symptoms in Pregnant Women

Study Overview
=================
Brief Summary
-----------------
In our study; Anxiety and depression levels, socio-demographic characteristics of the pregnant women who were admitted to our hospital between 25.04.2020-25.07.2020 and treated with the diagnosis of covid 19, and the change in anxiety and depression levelsWİTH Beck Depression and Anxiety Score after the disease regressed are planned. (Beck depression scale contains 10 questions and a total of 1 to 100 points is obtained. High score indicates that depression and anxiety are high.) 0-16 points = mild depressive symptoms 17-29 points = moderate depressive symptoms 30-63 points = severe depressive symptoms

Detailed Description
-----------------
The sociodemographic data form prepared by the researchers will be filled out by interviewing the patients who are willing to participate in the study. In addition, Beck Depression Scale, Beck Anxiety Scale, State and Trait Anxiety Scale will be given by the participants themselves. When the patients come to their first control after discharge, the scales specified will be repeated.

Official Title
-----------------
''(COVID-19) and Anxiety and Depressive Symptoms in Pregnant Women

Conditions
-----------------
COVID, Anxiety, Depression, Postpartum

Intervention / Treatment
-----------------
* Behavioral: covid-19 positive pregnant women


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: covid -19 pcr positive pregnant women no psychiatric diagnosis no use of psychiatric medicine Exclusion Criteria: Non-pregnant patients, A psychiatric diagnosis use of psychiatric medicine

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: covid-19 positive pregnant women|It is planned to receive pregnant women who are admitted to the clinic or outpatient clinic and who are offered inpatient follow-up and treatment with the diagnosis of COVID-19. Pregnant women who do not have covid-19 disease as a control group and who do not have a comorbid disease at similar gestational week will be included in the study. As a control group, covid-19 pcr negative patients will be admitted to our clinic in the same period.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of depression and anxiety score changes of covid-19 positive pregnants | Evaluation of depression and anxiety score changes of covid-19 positive pregnants Pregnant women are questioned how this period was affected, as the pandemic period loaded with extra stress and caused depression and anxiety. | 4 months |
Role of Magnetic Resonance Imaging (MRI) Perfusion to Detect Disease in Prostate Carcinoma

Study Overview
=================
Brief Summary
-----------------
This is a pilot study of 50 patients to establish whether there is a potential role for MRI perfusion in the detection of locally recurrent or persistent prostate carcinoma after previous treatment with radiotherapy. All subjects will be patients who have had localised prostate cancer treated with radiotherapy and have already agreed to undergo a biopsy of the prostate to look at local control within the prostate as part of their management. The objective of the study is to establish whether there is a relationship between recurrent or persistent disease within the prostate and increased perfusion on MRI at these sites.

Official Title
-----------------
The Role of MRI Perfusion to Detect Locally Recurrent or Persistent Disease in Prostate Carcinoma Treated With Radiation Therapy - A Pilot Study

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Device: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously have had radical radiotherapy for localised prostate cancer Due to undergo routine post-treatment prostatic biopsies Suitable for MRI scan Adequate renal function No previous reaction to gadolinium Able to give informed consent No recent prostate biopsy within 6 weeks of enrolment Performance status (Eastern Cooperative Oncology Group [ECOG]) 0 or 1 Exclusion Criteria: Not suitable for MRI scan Previous reaction to gadolinium Impaired renal function Inability to give informed consent

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

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

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

| Intervention/Treatment |
| --- |
|Device: MRI|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether there may be a role for MRI perfusion in the detection of recurrent or persistent prostatic cancer after previous radiotherapy |  |  |
Mechanisms of Disease Severity in Multiple Sclerosis: an Integrative Multimodal Study

Study Overview
=================
Brief Summary
-----------------
This study will identify a combination of disease severity markers (genetic, immunology, epigenetic, imaging) associated with disease severity and progression in a cohort of patients with multiple sclerosis.

Detailed Description
-----------------
The heterogeneity of multiple sclerosis evolution relies on several pathophysiological mechanisms including neuroinflammation, neurodegeneration and remyelination and repair mechanisms. The study will identify markers of disease severity in a longitudinal cohort of patients with multiple sclerosis who are siblings (both siblings having multiple sclerosis) including: biological markers (genetic, immunological and epigenetic markers, advanced MRI markers). An integrative model to predict disease progression will be proposed based on multimodal markers.

Official Title
-----------------
Mechanisms of Disease Severity in Multiple Sclerosis: an Integrative Multimodal Study

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: Composite severity score calculation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically isolated syndrome or Multiple sclerosis (2010 Mc Donald criteria) Sibling having Clinically isolated syndrome or Multiple sclerosis (2010 Mc Donald criteria) willing to participate to the study Affiliated to the French social security or equivalent Exclusion Criteria: Cyclophosphamide, mitoxantrone or methylprednisolone infusion within one month before inclusion Multiple sclerosis relapse within one month before inclusion Concomittant severe or uncontrolled disease

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 |
| --- | --- |
| Multiple Sclerosis siblings<br>Group of siblings having multiple sclerosis, n=120 Composite severity score calculation for all subjects | Other: Composite severity score calculation<br>* Neurological examination, cognitive testing, and MRI exam<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Expanded disability status scale | Change in the neurological assessment of disability related to multiple sclerosis | Baseline and 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in neuropsychological scores | Change in the battery of neuropsychological tests adapted for multiple sclerosis | Baseline and 18 months | 
| Change in T2 lesion volume | Change in volume of T2 lesion in the white matter | Baseline and 18 months | 
| Grey matter volume change | Change in cerebral grey matter volume | Baseline and 18 months |
A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Metastatic Bone Disease.

Study Overview
=================
Brief Summary
-----------------
This single arm study will assess the efficacy of loading doses of intravenous Bondronat in reducing pain in patients with breast cancer and metastatic bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Official Title
-----------------
An Open Label Study to Assess the Effect of Intravenous Loading Doses of Bondronat on Metastatic Bone Pain in Patients With Breast Cancer and Skeletal Metastases.

Conditions
-----------------
Pain, Bone Neoplasm, Neoplasm Metastasis

Intervention / Treatment
-----------------
* Drug: ibandronate [Bondronat]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >=18 years of age; breast cancer; bone metastases; mean worst pain score >=4 during 3 day baseline period; stable dose of analgesics over a 3 day baseline period; adequate renal function. Exclusion Criteria: bisphosphonate treatment within 3 weeks of study enrollment; a change in antineoplastic treatment within 6 weeks of study enrollment; bone radiation within 2 weeks of study enrollment; active infection.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: 1<br> | Drug: ibandronate [Bondronat]<br>* 6mg iv on days 1-3<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain response (20% decrease in mean pain score compared to baseline, and <=50% increase in mean analgesic consumption |  | Days 5 - 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean worst pain score over first 7 days |  | Day 7 | 
| Analgesic consumption |  | Day 7 | 
| Karnofsky index |  | Day 7 | 
| AEs, laboratory parameters |  | Throughout study |
SMAD2, SMAD3 AND TGF-β GENE EXPRESSION IN URGE URINARY INCONTINENCE

Study Overview
=================
Brief Summary
-----------------
Urge urinary incontinence (UUI) is a common health problem. Changes in collagen metabolism in pelvic support organs, such as uterosacral ligaments (USLs), might be responsible for the complex pathophysiology of UUI. The TGF-β pathway is involved in collagen synthesis and degradation. The Transforming Growth Family- β (TGF-β) superfamily has essential intracellular signaling components, such as newly identified SMAD family members. We evaluated the changes in the levels of TGF-β and SMAD gene and protein expression in the USL of patients with concomitant pelvic organ prolapse (POP) and UUI.

Detailed Description
-----------------
This study included 10 patients who had been diagnosed with POP and UUI in the study group and 14 asymptomatic women without complaints of POP and UUI in the control group. Biopsy samples were collected from bilateral USL tissues during vaginal or abdominal hysterectomy. Total RNA was extracted from USL tissue and analyzed by qPCR. The protein expression levels were also analyzed with ELISA.

Official Title
-----------------
ARE SMAD2, SMAD3 AND TGF-β GENE EXPRESSION VALUABLE IN THE MANAGEMENT OF THE URGE URINARY INCONTINENCE?

Conditions
-----------------
SMAD2, SMAD3, TGF-β, Pelvic Organ Prolapse, Urge Urinary Incontinence

Intervention / Treatment
-----------------
* Genetic: SMAD2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who had been diagnosed with POP and UUI asymptomatic women without complaints of POP and UUI Exclusion Criteria: Women who have SUI, a history of gynecologic malignancy, endometriosis, connective tissue disorders, asthma, previous pelvic inflammatory disease, pelvic radiation anamnesis, smoking, previous surgery for POP or UI, those on steroid therapy and hormone replacement therapy

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>wıth URGE INCONTINANCE | Genetic: SMAD2<br>* a family of structurally related cytokines<br>* Other names: TGF-β1;|
| Control group<br>not urge incontinance | Genetic: SMAD2<br>* a family of structurally related cytokines<br>* Other names: TGF-β1;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SMAD2 | tissue expression and protein level | intraoperative | 
| SMAD3 | tissue expression and protein level | intraoperative | 
| TGF-ß1 mRNA Expression Levels | tissue expression and protein level | intraoperative |
Value of PCT When Diagnosing Candidemia

Study Overview
=================
Brief Summary
-----------------
This study is a retrospective analysis to identify and compare the shift in inflammatory biomarkers in ICU patients immediately before and after the first identification of candidemia.

Detailed Description
-----------------
As above.

Official Title
-----------------
Value of PCT When Diagnosing Candidemia

Conditions
-----------------
The Value of Procalcitonin in Patients With Suspected Candidemia

Intervention / Treatment
-----------------
* Diagnostic Test: Serum procalcitonin concentration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (all has to be fullfilled): ICU patients with blood cultures showing growth of Candida species clinical records including daily data on WBC, CRP, Procalcitonin and body temperature Exclusion Criteria: Age lower than 18 years blood cultures with growth of Candida species before ICU admission incomplete records of daily WBC, CRP, Procalcitonin or body temperature

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Serum procalcitonin concentration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute procalcitonin concentration |  | 9 days | 
| Shift (trend) procalcitonin concentration |  | 9 days |