linjc16/ctgov huggingface dataset:
Magnetocardiography (MCG) in Asymptomatic Individuals - Pilot Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to perform serial magnetocardiographs (MCG)and cardiovascular risk factor assessments on individuals with no symptoms or history of heart disease. This small sized study of MCG in healthy individuals will allow for data collection for power analysis for a larger prospective trial. Volunteers are not compensated or paid.

Detailed Description
-----------------
The Magnetocardiography (MCG) has been approved by the U.S Food and Drug Administration (FDA) as a tool to measure the heart's magnetic field.However, it is not yet approved for the specific diagnosis of coronary artery disease. The MCG scan is entirely non-invasive, rapid and no risk, since it does not require stress provocation, radiation, or use of medication or contrast. In this study, the MCG will be used to compare the scans of normal, healthy volunteers to those which have been previously or are currently being collected in subjects with known heart disease.

Official Title
-----------------
Magnetocardiography (MCG) in Asymptomatic Individuals - Pilot Trial

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects without chest pain and known heart diseases. Subjects > or = 18 years of age. Exclusion Criteria: Heart disease patients Patients with chest pain Subjects with magnetic metal fragments in the head or torso Subjects unable to consent Minors < 18 years of age Subjects unable to lie flat for the examination

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Subjects without any cardiovascular risk factors: Age ≥ 45 in men; Age ≥ 55 in women. Hypertension: BP > 140/90 mmHg or on BP meds. Diabetes Mellitus: Known fasting blood sugar >126 mg/dl or on DM meds. Dyslipidemia: On lipid lowering medication or LDL ≥ 160 mg/dl in absence of other risk factors; ≥ 130 mg/dl if other non-diabetic risk factors; ≥ 100 mg/dl if diabetic. Known HDL < 40 mg/dl. Cigarette smoking (past or present). Family history of premature CAD in first degree relatives: Age < 55 in men; Age < 65 in women. | |
| 2<br>Subjects with 1 cardiovascular risk factor (listed above) | |
| 3<br>Subjects with 2 cardiovascular risk factors (listed above) | |
| 4<br>Subjects with more than 2 cardiovascular risk factors (listed above) | |

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
-----------------
MCG, Non-invasive heart scan, Cardiac Risk Factors, healthy volunteers
Study of Pregabalin Therapy for Pain Relief in Subjects With Post-Herpetic Neuralgia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure how rapidly pregabalin treatment can relieve pain in patients with post-herpetic neuralgia

Official Title
-----------------
A Double-Blind Randomized Placebo-Controlled Trial of the Time to Onset of Pain Relief in Subjects With Post Therapeutic Neuralgia (PHN) Treated With Pregabalin (150 - 600 Mg/Day Flexible Optimized Dose or 300 Mg/Day Fixed Dose) or Placebo

Conditions
-----------------
Post-Herpetic Neuralgia

Intervention / Treatment
-----------------
* Drug: pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of PHN with pain present for at least three months after the healing of a Herpes Zoster skin lesion. Subjects must have completed the Daily Pain Rating Scale in the electronic diary at least 4 times during screening and have an average daily pain rating score of greater than or equl to 4 during the 7 +/- 3 days prior to randomization (Visit 2). Exclusion Criteria: History of neurolytic or neurosurgical therapy for PHN. Presence of any severe pain associated with conditions other than PHN that may confound the assessment or self-evaluation of the pain due to PHN.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pregabalin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset meaningful pain reduction |  |  |
Identify the Clinical Significance and Potential Implications of Peritoneal Washing Cytology (PWC) in Patients With Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
Pancreatic cancer is a disease with an extremely poor prognosis. Such poor results are largely due to a high incidence of local or peritoneal recurrence even after curative R0 resection. If occult microscopic metastasis or residual cancer could be predicted correctly and identify the high risk of peritoneal recurrence, we may have chance to treat these patients by different multimodal locoregional or adjuvant therapy to improve the treatment outcome.

Detailed Description
-----------------
The purpose of this study has three specific aims: (1) to determine the relationship between peritoneal washing cytology (PWC) results and clinicopathologic parameters of pancreatic cancers, (2) to identify the predictive value of PWC and postoperative drainage cytology on the peritoneal recurrence or outcomes, (3) to dissect the molecular mechanism of peritoneal recurrence, especially on the PWC-inducing peritoneal seeding process.

Official Title
-----------------
Identify the Clinical Significance and Potential Implications of PWC in Patients With Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pancreatic cancers, other non-ductal pancreatic cancers , and benign pancreatic tumors (as negative control population) operated in Surgical Department after IRB proof and receiving patients' informed consent. Exclusion Criteria: Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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
-----------------
Peritoneal washing cytology, pancreatic cancer, peritoneal metastasis, anoikis, to determine the relationship between PWC results and clinicopathologic parameters of pancreatic cancers, to identify the predictive value of PWC and postoperative drainage cytology on the peritoneal recurrence or outcomes, to dissect the molecular mechanism of peritoneal recurrence, especially on the PWC-inducing peritoneal seeding process.
Evaluation of Long-Term Immunogenicity in Children and Adolescents Boosted With a New Pediatric TBE Vaccine After Five Years

Study Overview
=================
Brief Summary
-----------------
blood draw five years after booster-immunization with TBE vaccine to investigate immunogenicity in children

Official Title
-----------------
A Phase IV, Uncontrolled, Open-Label, Multi-Center Study in Children and Adolescents: Evaluation of Long-Term Immunogenicity in Subjects Boosted With a New Pediatric TBE Vaccine (Free of Protein-Derived Stabilizer) in Study V48P4E1, Five Years After First Booster Immunization

Conditions
-----------------
Encephalitis, Tick-Borne

Intervention / Treatment
-----------------
* Procedure: blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers of both sexes aged >1 years at the time of enrollment in V48P4 who participated in studies V48P4E1 and V48P4E2, and who/whose parents or legal guardians are willing to sign informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: blood draw|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) To investigate the kinetics of the immune response of subjects who participated in studies V48P4 (primary immunization), V48P4E1 (first booster immunization) and V48P4E2 (serological follow-up) with respect to antibody titers in terms of:· percentage |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (2) To investigate the kinetics of the immune response of subjects who participated in studies V48P4 (primary immunization), V48P4E1 (first booster immunization) and V48P4E2 (serological follow-up) in terms of:· percentage of subjects with antibody conce |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TBE, blood draw five years after booster-immunization with TBE vaccine to investigate immunogenicity in children
Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures

Study Overview
=================
Brief Summary
-----------------
This study is aimed to evaluate the efficacy, safety and tolerability of oxcarbazepine monotherapy in adults with partial seizures.

Official Title
-----------------
A 24-Week Prospective, Open-Label, Multicenter Study to Evaluate the Effect on Seizure Frequency, Safety and Tolerability of Oxcarbazepine Monotherapy in Adult Patients With Partial Seizures

Conditions
-----------------
Epilepsy, Partial Seizures

Intervention / Treatment
-----------------
* Drug: Oxcarbazepine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males and females, 18 - 70 years of age; diagnosis of epilepsy, partial seizures; ineffective or intolerable present therapy with 1 antiepileptic drug, or none of previous therapy with antiepileptic drugs Exclusion Criteria: progressive lesion of brain revealed by CT/MRI that performed no earlier than 2 years prior to screening; non-epileptic seizures; drug or alcohol dependence during a year prior to screening; Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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 |
| --- |
|Drug: Oxcarbazepine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epileptic activity at electroencephalography in rest |  |  | 
| Flash light and hyperventilation test with electroencephalography |  |  | 
| Frequency of epileptic episodes according to patient's diary |  |  | 
| Electrocardiogram analysis for rhythm and conduction |  |  | 
| Blood test for sodium, hepatic enzymes and blood cells |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life assessment at baseline, last visit |  |  | 
| Tolerability and safety of 24 week's treatment with oxcarbazepine monotherapy in adult patients with partial seizures |  |  | 
| Rate of patients with total and partial control of epilepsy |  |  | 
| Rate of patients requiring additional antiepileptic drugs |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
partial epilepsy, oxcarbazepine, adults
Validation of Study in Respiratory Physiology and it Interactions

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to validate tools of physiological signal processing and interpretation on healthy human volunteers in order to improve the understanding in respiratory physiology and its interactions with heart function, and swallowing.

Official Title
-----------------
Validation of Tools Studying Respiratory Physiology and it Interaction With Swallowing and Cardiac Physiology.

Conditions
-----------------
Life Experiences, Respiratory Function, Cardiac Function

Intervention / Treatment
-----------------
* Other: Non-invasive physiological signal recording on healthy volunteer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subject between 18 and 60 years old Exclusion Criteria: patient person protected by the law

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physiological measurments<br> | Other: Non-invasive physiological signal recording on healthy volunteer<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Heart rate is calculated on electrocardiograph | one measure within two weeks of inclusion | 
| end tidal CO2 | end tidal CO2 of each breath measured with an infrared CO2 analyzer | one measure within two weeks of inclusion | 
| Non invasive arterial pressure |  | one measure within two weeks of inclusion | 
| Non invasive stroke volume | measured with impedance cardiography | one measure within two weeks of inclusion | 
| Inspiratory and expiratory times | obtained for each breath with flow signal | one measure within two weeks of inclusion | 
| Tidal volume | obtained for each breath with flow signal | one measure within two weeks of inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Swallowing, Hyperventilation
Basal Ganglia Local Field Potentials in Gait and Speech

Study Overview
=================
Brief Summary
-----------------
Electrid activity of the basal ganglia will be recorded with an implantable deep brain stimulation device (supplied by Medtronic Inc). Study hypothesis is that these activities differ according to what the patient does, i.e. are different during gait and speech.

Official Title
-----------------
Recording of Gait and Speech Related Neurophysiological Parameters With an Implantable Bi-directional Deep Brain Stimulation System in Parkinson's Disease

Conditions
-----------------
Basal Ganglia Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: good levodopa response Exclusion Criteria: dementia

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 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 advanced Parkinson's disease<br>no intervention - observational study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of frequency spectrum of basal ganglia local field potentials during gait and speech |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence for the benefit of different stimulator settings for gait and speech |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
deep brain sitimulation, local field potentials
Preventing Age-Related Weight Gain in the Workplace With Daily Weighing

Study Overview
=================
Brief Summary
-----------------
To examine the effectiveness of daily weighing to prevent age-related weight gain.

Detailed Description
-----------------
Cornell employee's were recruited for a two-year weight gain prevention study. Height and weights were taken in our metabolic center. They were randomized into two group. The experimental group was given an internet based scale and asked to weigh themselves every morning immediately after rising. The other group was asked to return at the end of the study when they height and weight will again be measured.

Official Title
-----------------
Preventing Age-Related Weight Gain in the Workplace With Daily Weighing

Conditions
-----------------
Weight Gain

Intervention / Treatment
-----------------
* Device: Daily Weighing Group
* Device: Control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, non-diabetic Exclusion Criteria: History of eating disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Effect of self-weighing to prevent age-related weight gain
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daily Weighing Group<br>This group will be weighed and height measured in our metabolic unit at the beginning and end of the two year experimental period. In addition, the intervention in Daily Weighing Group is that they will be given an internet based scale and asked to weigh themselves immediately after rising from bed every morning for the duration of the two year experimental period. | Device: Daily Weighing Group<br>* The Experimental group will weigh themselves everyday<br>* Other names: Daily weighing;|
| Active Comparator: Control Group<br>The only intervention for the control group is that they will be weighed and height measured at the beginning and end of the experimental period in our metabolic unit. | Device: Control group<br>* This group will be weighed and measured at the beginning and end of the study and will not be weighing themselves daily<br>* Other names: Not weighing daily;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Change | body weight | 2 year |
HUD: PIP Joint Implant

Study Overview
=================
Brief Summary
-----------------
This surgery involves the use of a finger joint replacement device for treatment of patients with certain kinds of arthritis (osteo - arthritis or post traumatic arthritis) and who expect to place their hands in heavy loading situations, or patients needing revision of a failed implant placed in the PIP joint. A joint replacement surgery is an operation where the arthritic joint is removed and a metal and plastic joint is inserted to replace the natural joint. The surgery is expected to last about 2 hours. The procedure is done in the operating room and requires general anesthesia or an axillary block. (General anesthesia affects the entire body and is accompanied by a loss of consciousness. An axillary block results in anesthesia of the hand and forearm only. A tourniquet is applied to the arm to prevent bleeding during the surgery.)

Official Title
-----------------
HUD: Proximal Interphalangeal (PIP) Joint Implant Finger Prosthesis

Conditions
-----------------
Arthrosis, Osteoarthrosis

Intervention / Treatment
-----------------
* Device: SR PIP Implant System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with disability of the their finger from arthrosis Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: SR PIP Implant System|HUD for use in arthroplasty of the PIP joint|

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
-----------------
Proximal interphalangeal joint deformity, Arthroplasty