linjc16/ctgov huggingface dataset:
Progression of Cognitive and Physical Symptoms in Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at multiple sclerosis patients process of awareness, learning, and judging status over a 3 year time period.

Detailed Description
-----------------
Patients with multiple sclerosis (MS) frequently experience cognitive and emotional difficulties. Theses neuropsychiatric symptoms are known to be associated with reduced quality of life. However, little is known about the evolution of MS patients' neuropsychiatric difficulties and how these neuropsychiatric changes may be related to other MS symptoms. The purpose of the present study is to examine MS patients' cognitive and emotional status over time as part of standard neuropsychological evaluations in a private practice setting. MS patients presenting for neuropsychological evaluation at the MidAmerica Neuroscience Institute will be provided with the option of participating in thorough evaluation of their cognitive and affective MS symptoms. They will then be followed clinically and receive re-evaluation over a period of 3 years on a yearly basis. It is hoped that this study will help us obtain a better understanding of the factors associated with worsening cognition in MS. A greater understanding of the factors associated with cognitive and affective decline in MS help could lead to the early identification and treatment of at-risk patients.

Official Title
-----------------
Progression of Cognitive, Affective, and Physical Symptoms in Multiple Sclerosis.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male/female subjects at least 18 years of age with a diagnosis of Clinically Definite Multiple Sclerosis (CDMS) or Clinically Isolated Syndrome (CIS)as confirmed by a neurologist. Subjects must be able to give written informed consent and comply with the study protocol. Subjects must also be able to read, write and understand English. Are capable of performing the requirements of the neuropsychological test battery. Exclusion Criteria: As judged by the investigator, any clinically significant, unstable or major concomitant disorder or medications. In the opinion of the Investigator should not 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?
-----------------
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
-----------------
Cognition, Affective MS symptoms
Complications and Adverse Effects in Continuous Peripheral Regional Anesthesia

Study Overview
=================
Brief Summary
-----------------
The investigators prospectively document infectious, neurological, and other complications or adverse events occurring during peripheral regional anesthesia via a catheter using computer-based data recording.

Detailed Description
-----------------
Perineural blocks with catheter placement are more and more frequently used. Few data dealing with infectious complications of perineural catheters exist. We assess incidence and localization of infectious complications of perineural catheters by means of computerized data acquisition. We prospectively evaluate perineural catheters placed at different sites for regional anesthesia and postoperative analgesia. The catheters were placed under standardized sterile conditions by using the nerve stimulator technique. Local inflammation is defined as the presence of at least two of the three signs: redness, pain on pressure or swelling. Infection is defined as the presence of at least two of the following criteria: pus at the catheter insertion site, fever, increased CRP and/or leukocytes requiring antibiotic therapy.

Official Title
-----------------
Complications and Adverse Effects in Continuous Peripheral Regional Anesthesia Results of Investigations on 3,491 Catheters

Conditions
-----------------
Infection, Inflammation, Adverse Effects

Intervention / Treatment
-----------------
* Procedure: perineural block (anesthesia)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients receiving perineural blocks via catheter Exclusion criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: perineural block (anesthesia)|continuous peripheral regional anesthesia ropivacaine 0.33% for 3 to 5 days|

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
-----------------
complications, adverse events, regional anesthesia, adverse effects
Docetaxel Plus Capecitabine in Newly Diagnosed Localized or Locally Advanced Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Purpose: The purpose of this clinical trial is to look at the chemotherapy combination of docetaxel and capecitabine in the treatment of newly diagnosed or locally advanced prostate cancer, and to determine if this treatment is an acceptable, effective and a safe treatment option. In addition, this clinical trial will evaluate how this treatment affects chemicals (enzymes), and other cancer related genetic changes in the tumor. Optional: This clinical trial will conduct extra imaging studies for research purposes including combined endorectal prostate magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRSI) and diffusion weighted imaging (DWI) to evaluate prostate cancer and response to study treatment.

Official Title
-----------------
Evaluation of Primary Chemotherapy With Docetaxel Plus Capecitabine in Selected Patients With Newly Diagnosed Localized or Locally Advanced Prostate Cancer

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

Intervention / Treatment
-----------------
* Drug: Capecitabine
* Drug: Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients must have newly diagnosed prostate cancer with at least one of the following criteria: Clinical Stage > T2 PSA > 15 ng/ml Biopsy Gleason's sum > 8 All patients must have a minimum PSA value of > 5 ng/ml. Patients may not have evidence of distant systemic metastasis. Patients may not undergo concurrent hormonal, biologic, or chemotherapy. Patients may not have prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil. Patients with a history of severe reaction to docetaxel or other drugs formulated with polysorbate 80 will not be eligible. Patients may not have an underlying cardiac 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel and Capecitabine<br> | Drug: Capecitabine<br> <br> Drug: Docetaxel<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients who respond to treatment | To evaluate the response rate associated with capecitabine and docetaxel combination chemotherapy in selected patients with localized or locally advanced prostate cancer. Response is defined as a reduction in the PSA (Prostate Specific Antigen) by at least 50%. | 6 months |
Comparison of Two Pen Systems in Patients With Diabetes Treated With Insulin

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to compare two insulin delivery pens in the everyday life setting of patients with diabetes treated with insulin.

Official Title
-----------------
An Open-label, Multi-centre, Multi-national, Comparative, Randomised, Cross-over Trial Evaluating Preference as Well as Performance, Acceptance, Handling and Safety of NovoPen™ 4 (MS236) Versus NovoPen 3® in Insulin Treated Diabetic Patients

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Delivery Systems

Intervention / Treatment
-----------------
* Device: NovoPen™ 4
* Device: NovoPen® 3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 or type 2 diabetes mellitus for at least 12 months Adults at least 18 years Children/adolescents between 9-18 years HbA1c lesser than or equal to 11.0% Exclusion Criteria: Known or suspected alcohol or drug abuse Patients who are not able to read the user manual (may wear glasses if needed) Hypoglycaemic unawareness as judged by the investigator Visual and/or dexterity impairments as judged by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 9 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: NovoPen™ 4|nan|
|Device: NovoPen® 3|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of overall pen preference |  | after 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  |  | 
| Adverse device effects |  |  | 
| Adverse events |  |  |
Xarelto for VTE Prophylaxis After Hip or Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The main goal is to provide additional information to the risk-benefit assessment of the drug.

Official Title
-----------------
Xarelto in the Prophylaxis of Post Surgical Venous Thromboembolism After Elective Major Orthopedic Surgery of Hip or Knee

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Drug: Rivaroxaban (Xarelto, BAY59-7939)
* Drug: Standard care treatment for VTE prophylaxis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female and male patients who will undergo elective hip or knee arthroplasty. Exclusion Criteria: Exclusion criteria must be read in conjunction with the local product information.

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 |
| --- | --- |
| Group 1<br> | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* Female and male patients, who are at least 18 years of age and will undergo elective hip or knee arthroplasty, after the decision for VTE prophylaxis with Rivaroxaban has been made<br>|
| Group 2<br> | Drug: Standard care treatment for VTE prophylaxis<br>* Female and male patients, who are at least 18 years of age and will undergo elective hip or knee arthroplasty, after the decision for a pharmacologic VTE prophylaxis treatment other than rivaroxaban has been made<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data collection on: Bleeding events reported as serious or non-serious adverse events; Symptomatic thromboembolic events (DVT, PE) reported as adverse events; Uncommon adverse events (incidence rate between 0.1 % and 1 %); All cause mortality |  | During observation period of three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prophylaxis of Venous Thromboembolism
Orbital Fractures Measurement: Intraoperative Versus Computed Tomography (CT) Scan

Study Overview
=================
Brief Summary
-----------------
Purpose to compare the orbital fracture size measured by orbital CT scan and compare it to the actual orbital fracture size intraoperatively in patients who needed surgical intervention to correct the fracture. Hypothesis: there is difference between the CT measure fracture size and the actual intraoperative size.

Conditions
-----------------
Orbital Fractures

Intervention / Treatment
-----------------
* Procedure: operative fracture size vs CT fracture size
* Procedure: orbital fracture intraoperative measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: With orbital fracture (trauma) proved by CT scan and need operative repair. Agree to participate. Exclusion Criteria: Patients that refuse to be included in the study. Under the age of 18 years. CT not performed or not available. Not qualified to sign the consent form.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: orbital fractures size<br>patients who undergo surgical repair of orbital fracture with measuring the fracture size intraoperatively and had available orbital Ct scan preoperatively. | Procedure: operative fracture size vs CT fracture size<br>* comparing actual intraoperative fracture size to the CT fracture size<br>Procedure: orbital fracture intraoperative measurement<br>* comparing intraoperative fracture size to the CT orbital fracture size<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients with orbital fractures that require surgical repair will have their fractures size measured intraoperatively by a ruler and/or a caliper in millimeters and compare it to the size measured by the CT scan. | Patients with orbital fractures that need to be operated. Their intraoperative fracture size will be measured by the orbital surgeon by a ruler or/and a caliper in millimeters. Size on CT scan is determined by counting the number of slides that show the fracture (for anteropsterior fracture we measure the number of coronal sections that show the fracture multiply X1-each section is 1millimeter thickness, and so on for mediolateral fractures we measure saggital sections number and for superoinferior fractures the axial sections that show the fracture. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Orbit, Fracture, measurement, CT, intraoperative
Inherited Susceptible Genes Among Epithelial Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
Purpose: To investigate the prevalence of the germline mutations in the BRCA 1/2 and mismatch repair genes in patients with epithelial ovarian cancer (EOC) and their relatives, and related somatic mutations in tumor tissues in the northern part of china. Patients and methods: A multicenter prospective study will be hold in the northern part of china form 2017. About 1000 female patients with epithelial ovarian cancer and their ralatives will be tested for germline mutations in the BRCA 1/2 and mismatch repair genes and related somatic mutations in tumor tissues, regardless of the family history. Study type: Observational Official title: Prevalence study of germline mutations in susceptibility ovarian cancer genes in patients with epithelial ovarian cancer and somatic mutations in their tumor tissures in the northern part of china. Enrollment: 1000

Official Title
-----------------
Cohort Study on Characters and Distribution of Inherited Susceptible Genes Among Epithelial Ovarian Cancer Patients and Their Relatives in the North of China

Conditions
-----------------
Ovarian Neoplasm Epithelial, Hereditary Breast and Ovarian Cancer Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: epithelial ovarian cancer and their relatves living in the north of Huaihe River in China being Han Chinese Exclusion Criteria: non-epithelial ovarian cancer without specific pathological diagnosis non-Han Chinese
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 |
| --- | --- | --- |
| herited gene mutations susceptible to epithelial ovarian cancer in patients and their relatives |  | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High-Throughput Nucleotide Sequencing, epithelial ovarian cancer, Hereditary Breast and Ovarian Cancer Syndrome, next-generation sequencing
Serum Concentrations of Pregnancy-associated Proteins for Assessment of Gestational Age Before Abortion

Study Overview
=================
Brief Summary
-----------------
This will be a case-series multicenter study enrolling 800 pregnant people. Serum will be collected from people seeking abortion and assayed at a qualified laboratory.

Detailed Description
-----------------
Knowledge of gestational age (GA) is essential for guiding abortion care. In 2016, Gynuity Health Projects (GHP) launched a portfolio of research that aims to explore the possibility of developing a blood or urine test for this purpose.The goal of the present study is to validate initial study findings (protocol 8000) in a larger population of people seeking abortion. Staff will obtain a serum specimen from each participant before any cervical manipulation is performed and before any abortifacient drug is administered. The site will send the specimens to a central facility for storage until assay. Serum assays for PAPP-A and possibly other proteins will be performed at a selected laboratory by qualified experts.

Official Title
-----------------
Serum Concentrations of Pregnancy-associated Proteins for Assessment of Gestational Age Before Abortion

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant and seeking medical or surgical abortion Has had or will have an ultrasound on the day of study enrollment or earlier during the current pregnancy Able to provide blood and urine specimens before any trans-cervical procedure or mifepristone ingestion Not previously enrolled in this study Exclusion Criteria: Does not meet Inclusion Criteria
Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|no intervention, just specimen collection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative Predictive Value 70 days | Negative Predictive Value of Prespecified Protein Concentration in Serum for Predicting a GA of ≤70 days is >95% | 1 day | 
| Negative Predictive Value 105 days | Negative Predictive Value of Prespecified Protein Concentration in Serum for Predicting a GA of ≤105 days is >95% | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
placental protein, gestational age, abortion
Tailored Therapy for Clarithromycin-Resistant H. Pylori

Study Overview
=================
Brief Summary
-----------------
Clarithromycin-resistant H. pylori is the main cause of H. pylori eradication failure. Tailored therapy on the basis of detection of a clarithromycin resistance mutation by PCR has been studied recently, however, there have been few studies comparing treatment regimen in patient with clarithromycin-resistant H. pylori. We used sequencing-based clarithromycin resistance mutation and aimed to compare PAM (proton pump inhibitor, amoxicilline, metronidazole) regimen and PBMT (proton pump inhibitor, bismuth, metronidazole, tetracyclin) regimen in patient with clarithromycin-resistant H. pylori.

Official Title
-----------------
Efficacy Comparison of Metronidazole-based Triple and Bismuth-based Quadruple Therapy for Clarithromycin Resistant-Helicobacter Pylori Infection: Randomized Controlled Trial

Conditions
-----------------
Helicobacter Pylori Infection

Intervention / Treatment
-----------------
* Drug: PAM
* Drug: PBMT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: peptic ulcer disease H. pylori gastritis low grade MALT lymphoma Exclusion Criteria: history of gastric cancer surgery severe comorbidity (ESRD, LC) hypersensitivity to drug pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PAM<br>treatment with PPI, metonidazole, amoxicillin | Drug: PAM<br>* treatment with PPI, metonidazole, amoxicillin<br>|
| Active Comparator: PBMT<br>treatment with PPI, metonidazole, bismuth, tetracyclin | Drug: PBMT<br>* treatment with PPI, metonidazole, bismuth, tetracyclin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| H. pylori eradication rate | H. pylori eradication rate | 14 days |