linjc16/ctgov huggingface dataset:
SHOX2_PTGER4 DNA Methlyation in Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Data on SHOX2 and PTGER4 DNA Methylation suggest possible use as a biomarker for early lung cancer diagnosis. In this study a control group consisting of COPD patients with a CT-scan of the chest no older than 6 weeks and a control group of patients with a nodule and ruled out diagnosis of lung cancer will be included. SHOX2 and PTGER4 will be analyzed via PCR.

Detailed Description
-----------------
Data on SHOX2 and PTGER4 DNA Methylation suggest possible use as a biomarker for early lung cancer diagnosis. In this study a control group consisting of COPD patients with a CT-scan of the chest no older than 6 weeks and a control group of patients with a nodule and ruled out diagnosis of lung cancer will be included. A total of 150 patients will be enrolled in this study. SHOX2 and PTGER4 will be analyzed via PCR of blood plasma samples.

Official Title
-----------------
Establishing a Non-invasive Diagnostic Biomarker Test for Early Diagnosis of Lung Cancer

Conditions
-----------------
Lungcancer

Intervention / Treatment
-----------------
* Genetic: lung cancer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspicious finding for lung cancer on CT-scan Exclusion Criteria: history significant for former malignant diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| lung cancer<br>stage IA-IIIA lung cancer | Genetic: lung cancer<br>* PCR for SHOX2 and PTGER4<br>|
| benign nodules<br>ruled out lung cancer via Operation or CT-scan follow-up | Genetic: lung cancer<br>* PCR for SHOX2 and PTGER4<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA Methylation at early stages of lung cancer |  | 1 year |
Retrospective Analysis of the Safety and Effectiveness of Using the Silicone Block in Penile Surgery

Study Overview
=================
Brief Summary
-----------------
This is a retrospective evaluation of all subjects who successfully received implantation of the Silicone Block for correction of soft tissue deformities of the penis. In addition, subjects will be sent a questionnaire to complete that will evaluate the subject's ongoing satisfaction with the implant and any adverse events that may not have been reported to the physician.

Official Title
-----------------
Retrospective Analysis of the Safety and Effectiveness of Using the Silicone Block in Penile Surgery

Conditions
-----------------
Penile Implant

Intervention / Treatment
-----------------
* Procedure: Silicone Block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Successful penile implantation with the Silicone Block. Successful implantation is defined as the successful completion of the implantation procedure. Exclusion Criteria: Medical records for the subject are not available for review or tabulation Subject did not comply with pre-operative or post-operative instructions.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>This was the group that received the penis implant, consented for participation and completed the follow-up questionnaire. | Procedure: Silicone Block<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events | Number of adverse events that occurred from implantation through the time of the study. | Up to 4 years, with an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Esteem Score | Evaluation of a self-esteem score done pre-surgery and post-surgery | 7 days pre-surgery to 90 days post-surgery | 
| Self-confidence score | Evaluation of a self-confidence score done pre-surgery and post-surgery | 7 days pre-surgery to 90 days post-surgery | 
| Flaccid penile girth | Measurement of flaccid penile girth done pre-surgery and post-surgery | 7 days pre-surgery to 90 days post-surgery | 
| Quality of Life Questionnaire | Measurement of issues with penis size from pre-surgery to post-surgery | 7 days pre-surgery to 90 days post-surgery |
Evaluation of the Effect of Sitagliptin on Gut Microbiota in Patients With Newly Diagnosed Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The present study will recruit 9 newly diagnosed type 2 diabetic patient to receive sitagliptin 100mg daily for 12 weeks. The aim of this study was to investigate the composition of gut microbiota before and after the therapy of sitagliptin.

Detailed Description
-----------------
The present study will included 9 newly diagnosed type 2 diabetic patient to receive sitagliptin 100mg daily for 12 weeks. These patients will receive 75g oral glucose tolerance test and fasting plasma glucose levels, lipids levels, fasting insulin levels and 2 hour post-load plasma glucose levels will be measured. Stool samples will be collected before the initiation of the use of sitagliptin. After 12 weeks, all patients will have fasting plasma glucose levels, lipids levels, fasting insulin levels tested. Stool samples will be collected again.

Official Title
-----------------
Evaluation of the Effect of Sitagliptin on Gut Microbiota in Patients With Newly Diagnosed Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Sitagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly-diagnosed type 2 diabetic patients aged between 40-70 years Exclusion Criteria: Any chronic disease (other than diabetes) Alcohol consumption/smoking Pregnancy/breastfeeding The use of antibiotics, pro-prebiotics within 3 months History of intestinal surgery

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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: sitagliptin<br>All the patients will receive sitagliptin 100mg daily. | Drug: Sitagliptin<br>* All the patients will receive sitagliptin 100mg daily<br>* Other names: Sitagliptin phosphate (Januvia; Merck);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of the composition of gut microbiota before and after the use of sitagliptin |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of HbA1c levels |  | 12 weeks | 
| Changes of fasting plasma glucose levels, lipids levels and insulin sensitivity |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, gut microbiota, sitagliptin
Efficacy of Botulinum Toxin for the Treatment of Dystonia Associated With Parkinson's Disease and Atypical Parkinsonism

Study Overview
=================
Brief Summary
-----------------
Dystonia is a disabling symptom affecting both patients with idiopathic Parkinson's disease (PD) and atypical parkinsonism (AP). Botulinum toxinum (BoNT), by blocking muscle contraction, is a possible treatment for focal dystonia. The benefit of BoNT treatment has been proven in some focal dystonia associated with PD or AP. The investigators aim to give an overview of the efficacy of BoNT in a variety of focal dystonia in a large cohort of parkinsonian patients.

Official Title
-----------------
Efficacy of Botulinum Toxin for the Treatment of Dystonia Associated With Parkinson's Disease and Atypical Parkinsonism: a Monocentric Cohort Study With Patient Reported Outcome

Conditions
-----------------
Parkinson Disease, Atypical Parkinsonism, Dystonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed Parkinson's disease or Atypical Parkinsonism Age > 18 years Reported dystonia At least 1 injection with Botulinum toxin realized Exclusion Criteria: Refusal to participate in the study

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 |
| --- | --- |
| Patients with dystonia secondary to atypical Parkinsonism or Parkinson's disease<br>Patients with dystonia secondary to idiopathic Parkinson's disease or atypical parkinsonism and treated with BoNT | |
| Patients with atypical Parkinsonism or Parkinson's disease and no dystonia<br>Patients with idiopathic Parkinson's disease or atypical parkinsonism and without reported dystonia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the patient reported efficacy of botulinum toxin treatment between PD and AP patients | Evaluation by the patient of the efficacy of the former injection on an improvement scale ranging from 0 to 100% (minimum value : 0, maximum value : 100, higher scores mean a better outcome) systematically made in routine care during follow up appointment | Up to twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the patient reported duration of improvement after treatment by botulinum toxin between PD and AP patients | Evaluation by the patient of the duration of the period during which symptoms were improved (in weeks) systematically made in routine care during follow up appointment | Up to twelve months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Botulinum toxinum, Dystonia, Parkinson Disease, Atypical Parkinsonism
KETOR: Effects of Peri Operative Administration of Ketamine on Long Term Post Thoracotomy Pain

Study Overview
=================
Brief Summary
-----------------
We assessed the effects of the N Methyl aspartate receptor antagonist Ketamine on long-term post thoracotomy pain. We hypothesized that ketamine could prevent supersensitization of the central nervous system involved in this chronic neuropathic pain.

Detailed Description
-----------------
In this clinical, randomized prospective study, peri operative administration of ketamine was compared to placebo on long term post thoracotomy pain after a 2 months follow up period.

Official Title
-----------------
Effects of Peri Operative Administration of Ketamine on Long Term Post Thoracotomy Pain

Conditions
-----------------
Ketamine, Chronic Post Thoracotomy Pain, Thoracotomy, Pain, Neuralgia

Intervention / Treatment
-----------------
* Drug: Ketamine (or placebo : isotonic saline solution)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients eligible for thoracotomy or pneumectomy Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 80 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: Ketamine (or placebo : isotonic saline solution)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term (2 months) post thoracotomy pain was assessed using a french equivalent of the Mc Gill Pain score and pain area measurements in both groups |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analogic pain scores at rest and after coughing |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ketamine, Chronic post thoracotomy pain, NMDA, Post operative
SARC021C: A Continuation Study of TH-CR-406/SARC021

Study Overview
=================
Brief Summary
-----------------
SARC021C is a nonrandomized, open-label, multicenter, continuation study designed to provide access to TH-302 for patients currently receiving and benefiting from single agent TH-302 therapy as part of the Phase III TH-CR-406/SARC021 study.

Detailed Description
-----------------
The goal of this study is to provide continuation therapy with TH-302 to patients with soft tissue sarcomas who obtained response or stabilization of disease with prior treatment on TH-CR-406/SARC021 protocol. After written informed consent has been obtained and eligibility has been established, patients will receive the study drug as part of the continuation study. Patients will receive treatment on study as long as they have clinical benefit and do not experience unacceptable toxicity.

Official Title
-----------------
A Continuation Study of TH-CR-406/SARC021 for the Remaining Subjects Enrolled in TH-CR-406/SARC021 in the US

Conditions
-----------------
Soft Tissue Sarcoma

Intervention / Treatment
-----------------
* Drug: Th-302


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee. Previously enrolled on the TH-CR-406/SARC021 protocol and benefiting from treatment. Study investigator deems continued participation is appropriate based on overall health of the patient. Exclusion Criteria: Any of the criteria for study discontinuation are met. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study. Unwillingness or inability to comply with the study protocol for any reason.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Th-302|300 mg/m2 IV on Days 1 and 8 of a 21-day cycle.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical AML Registry and Biomaterial Database of the Study Alliance Leukemia (SAL)

Study Overview
=================
Brief Summary
-----------------
This is a registry study in adult patients with newly diagnosed or refractory/relapsed acute myeloid leukemia. Investigator's sites: 46 sites in Germany. Primary objectives: Identification of epidemiological data on AML: age, prognostic factors and subgroup distributions. Incidence and age distribution are compared with the data of population-related tumor registry. Evaluation of the most important patient-relevant clinical endpoints (outcomes): relapse-free survival (RFS) / time to relapse (TTR), calculation of cumulative incidence of relapse (CIR) and overall survival (OS) Documentation of treatment strategy

Detailed Description
-----------------
see brief summary

Official Title
-----------------
Clinical AML Registry and Biomaterial Database of the Study Alliance Leukemia (SAL)

Conditions
-----------------
Acute Myeloid Leukemia (AML)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AML according to the WHO (World Health Organization) diagnostic criteria, including acute promyelocytic leukemia Age ≥ 18 years. There is no upper age limit. Signed written informed consent Exclusion Criteria: there are no exclusion criteria

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 |
| --- | --- | --- |
| Epidemiological parameters | Epidemiological parameters | 10 years | 
| Relapse free survival (RFS) | Relapse free survival | 10 years | 
| Time to relapse (TTR), | Time to relapse (TTR), | 10 years | 
| Overall Survival (OS) | Overall Survival (OS) | 10 years | 
| cumulative incidence of relapse (CIR) | cumulative incidence of relapse (CIR) | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Remission (CR) | Complete Remission | yearly follow up 10 years | 
| Treatment related mortality (TRM) | Treatment related mortality | yearly follow up 10 years | 
| Therapy-associated morbidity | grade IV toxicities | yearly follow up 10 years | 
| Recording and evaluating the quality of therapy and diagnosis | Recording and evaluating the quality of therapy and diagnosis | 10 years | 
| Validation of published prognostic factors at the registry cohort and the search for new possible prognostic factors | Validation of published prognostic factors at the registry cohort and the search for new possible prognostic factors | 10 years | 
| Recording and describing new forms of therapy and new supportive measures | Recording and describing new forms of therapy and new supportive measures | 10 years |
Urine Adiponectin Concentration in Prediction of Contrast Induced Nephropathy

Study Overview
=================
Brief Summary
-----------------
The present study is to determine the ability of urinary total adiponectin and its isoforms excretion in the prediction of contrast induced nephropathy (CIN) in the patients undergoing PCI.

Detailed Description
-----------------
Contrast induced nephropathy (CIN) is a severe complication after percutaneous coronary intervention (PCI). CIN is responsible for approximately genic renal insufficiency and is the third cause of hospital-acquired renal failure and the injury of endothelial of renal tubule is responsible for the CIN. However markers reliably identifying CIN in the patients undergoing PCI are rare. Adiponectin is a 30-kDa adipocyte-derived vasoactive peptide closely linked to components of the metabolic syndrome. Recent study demonstrates that the quantification of urinary adiponectin excretion appears to be an independent indicator of vascular damage potentially identifying an increased risk for vascular events. Therefore, the investigators presume that the adiponectin excretion may predict the incidence of the CIN. The present study is to determine the ability of urinary total adiponectin and its isoforms excretion in the prediction of CIN in the patients undergoing PCI.

Official Title
-----------------
Urine Total Adiponectin and Its Isoforms Concentration in Prediction of Percutaneous Coronary Interventions Contrast Induced Nephropathy

Conditions
-----------------
Myocardial Ischemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients > 18 of age who are undergoing elective PCI and are able to give informed consent are eligible for study. Exclusion Criteria: The end-stage renal failure The patients who are relieving dialysis

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients underging PCI<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase in SCr 0.5 mg/dL(44.2 mol/L) from baseline | samples will be collected at 24, 48 and 72 hours after PCI | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a 25% increase in SCr from baseline | samples will be collected at 24, 48 and 72 hours after PCI. | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contrast Induced Nephropathy, percutaneous coronary interventions
Changes of Cerebral Glucose Metabolism After 12 Weeks of Paroxetine Treatment in Panic Disorder

Study Overview
=================
Brief Summary
-----------------
Panic disorder is one of the most prevalent and disabling psychiatric disorders. Brain regions such as amygdala, hippocampus, periaqueductal gray (PAG), locus coeruleus, parahippocampal gyrus, frontal cortex, and thalamus has been reported to be related with the pathophysiology and treatment outcome in panic disorder. Paroxetine has been used as primary agent for treatment of panic disorder but there is little information on how paroxetine affects the brain function in patients with panic disorder. The specific aim of this study is to examine the differences in brain activity between responders and nonresponders and to determine the predictor of paroxetine treatment in patients with panic disorder in terms of brain activity.

Official Title
-----------------
Phase 4 Study of Panic Disorder That Expresses to Change of Cerebral Glucose Metabolism After 12 Week of Paroxetine Treatment

Conditions
-----------------
Panic Disorder

Intervention / Treatment
-----------------
* Drug: Paxil CR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: panic disorder 20-60 years Exclusion Criteria: history of major psychosis (schizophrenia or bipolar disorder), social phobia, obsessive-compulsive disorder, and generalized anxiety disorder, and posttraumatic stress disorder, alcohol abuse and dependence, current regular use of benzodiazepines less than 17 on the HAM-D

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: paroxetine cr<br>single arm | Drug: Paxil CR<br>* 12 week treatment of Paxil(20-40mg)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 18FDG PET, PDSS & HAM-A |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
panic disorder, paroxetine, PET