linjc16/ctgov huggingface dataset:
Hepatitis C Education for Pregnant Women With Opiate Addiction - Phase 1

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to assess the health literacy level of patients enrolled in the HOPE program, identify any gaps in their knowledge of hepatitis C, analyze the variables that may influence patients' knowledge, and educate patients on Hepatitis C.

Detailed Description
-----------------
The study will compare the effectiveness of providing a pamphlet and expert education compared to providing a pamphlet only. The information gained in completing this study will help the medical community improve patient education on the disease and specifically understand how the medical community can best serve pregnant patients with opiate dependence burdened by Hepatitis C.

Official Title
-----------------
Hepatitis C Education for Pregnant Women With Opiate Addiction - Phase 1

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Other: Qualitative Interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria The study will include patients with and without Hepatitis C diagnosis. Patients will be recruited at their routine prenatal and post-partum visits. Patients who speak and understand English Exclusion Criteria: Patients under the age of the 18 years

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Qualitative Interview|Complete 6 open-ended qualitative questions on patients in the HOPE program to assess basic current understanding about Hepatitis C and topics of interest that patients in the HOPE program would like to learn more about.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discovering the gaps in patients' knowledge of Hepatitis C | Through interview, 6 open-ended qualitative questions will be asked of the patients in the HOPE program to assess basic current understanding about Hepatitis C | 2 months |
Orthostatic Hypotension and Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Rationale: Orthostatic hypotension increases with age and is associated with increased vascular and all-cause mortality. The prevalence of orthostatic hypotension is also increased in diabetic subjects. In order to prevent related adverse events and vascular mortality it is of great interest to examine the prevalence of orthostatic hypotension in elderly diabetic subjects. Objective: To examine the prevalence of orthostatic hypotension and associated adverse events in type 2 diabetic elderly subjects. Study design: Cross-sectional observational study. Study population: Elderly type 2 diabetic subjects (70 years and older).

Official Title
-----------------
The Orthostatic Hypotension in the Diabetic Elderly Patients Trial (ODET)

Conditions
-----------------
Orthostatic Hypotension, Diabetes Mellitus Type 2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetes mellitus age (70 years and older) Exclusion Criteria: Known autonomic dysfunction Neurodegenerative diseases Current malignancy Living in a nursing-home Irregular pulse

Ages Eligible for Study
-----------------
Minimum Age: 70 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 |
| --- | --- |
| Study group<br>Type 2 diabetic patients aged 70 years and older. | |
| Control group<br>Patients aged 70 years and older, with no history of type 2 diabetes mellitus. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of orthostatic hypotension |  | 1-12 months (orthostatic blood pressure is assessed only once during the running time of the study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, Score risk profile questionnaire, Heart rate, Gender, Body mass index, Medication, Smoking, History of cardiovascular disease, Family history of cardiovascular disease, Duration of diabetes mellitus, Glycosylated haemoglobin, Insulin use |  | 1-12 months (the outcome measures are assessed only once during the running time of the study) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes mellitus, Elderly, Orthostatic hypotension
Nottingham Osteoarthritis Biomarker Study 2011

Study Overview
=================
Brief Summary
-----------------
Osteoarthritis is by far the most common joint condition and the single largest cause of disability in the older population. The investigators still have a poor understanding of the nature of osteoarthritis and factors that influence its development and progression. Identification of biochemical markers that relate to cartilage loss, bony overgrowth and other features that occur with osteoarthritis will advance our understanding. Over the last 5 years analytical methods have developed to measure a range of different biomarkers. This pilot study will use these analytical methods to measure biomarker levels in joint fluid, urine and blood of 50 participants with Osteoarthritis (OA) and 50 healthy volunteers. This study will provide novel pilot data on the changes in the composition of the synovial fluid, urine and blood in patients with OA. Apart from being a key target site for OA, the knee is a suitable joint for study because of its accessibility to clinical assessment, joint aspiration and imaging.

Official Title
-----------------
Nottingham Osteoarthritis Biomarker Study 2011

Conditions
-----------------
Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All participants: Be able to provide written informed consent Aged 30 and over Knee OA patients: • Radiographic signs of OA - that is definite joint space narrowing plus osteophyte in at least one compartment of the knee Normal controls: No knee pain No clinical or radiographic changes of knee OA

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| Knee osteoarthritis<br> | |
| No knee pain/osteoarthritis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the levels of pro-inflammatory and anti-inflammatory lipids mediators between individuals with knee osteoarthritis and those with normal knees. |  | within 6 months of recruitment of last participant |
Return to Work After Potential Severe Injury

Study Overview
=================
Brief Summary
-----------------
In Norway an estimated 10 % of the population is injured annually. Of these 36.000 sustain permanent functional impairment, 1.200 receive disability pension, and approximately 2.500 die because of their injuries. Mortality is the most common variable measuring trauma outcome. However, measuring only trauma mortality may be looking merely at the tip of the iceberg. For every trauma death, there are ten-folds suffering long term functional impairment. Mortality is therefore a too crude variable to describe the impact of injuries - both for the individual trauma patient and for society as a whole. There is a need for variables describing long-term outcomes on a functional level. The aim of this study is to use the rate of return to work and education as an alternative outcome measure. The ability of returning to work after injury is a central indicator of individual functional outcome, combining both physical and mental skills in performing complex and compound tasks. Previous studies on return to work after injury are limited by a combination of short follow-up times, the use of patient reported outcomes and having mainly been focusing on only severely injured patients (ISS > 15). This a population-based study including all patients in working age (16 - 65 years) received by a trauma team in any of the eight hospitals within the region of Central Norway in the time period from June 1st,2007 to May 30th, 2010. Already collected trauma registry data will be linked with national register data on sickness and disability benefits, employment and education.

Official Title
-----------------
Return to Work After Potential Severe Injury; a Population Based Observational Study

Conditions
-----------------
Multiple Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: exposed to traumatic injuries received by trauma team attendance received by trauma team activation protocol

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Return to work |  | up to 8 years | 
| Return to education |  | up to 8 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Outcome Assessment (Health Care), Return to work, Registries, Norway
A Randomized Controlled Trial of the Effects of Reactive Neuromuscular Training on Balance

Study Overview
=================
Brief Summary
-----------------
Falls are a major concern for the geriatric population and represent a significant public health problem. Various interventions are being explored to improve balance and decrease falls in the elderly. Success has been shown in some programs; various exercise interventions place emphasis on strength, balance, or endurance exercises. Results reported in the literature are still equivocal. Controversy exists as to optimal types of exercise, and the optimum frequency, duration, and intensity of exercise. It is believed that the SpineForce device, which places a unique combination of strength and balance demands upon the user, can result in rapid increases in balance as compared to other rehabilitation programs. Gains in balance have implications for geriatric populations as well as those seeking enhanced sports performance and injury prevention. The Purpose of this study is to assess the SpineForce device as a novel intervention in the treatment of balance disorders.

Conditions
-----------------
Balance

Intervention / Treatment
-----------------
* Device: SpineForce Reactive Neuromuscular Trainer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Young, healthy adults between the ages of 20 - 30, asymptomatic with respect to any balance specific disorder, and who are currently enrolled at Logan College. Exclusion Criteria:Exclusion criteria include: A previous lower extremity injury; Previous lower extremity surgery; A visual or vestibular condition with accompanying balance difficulty; A diagnosis of Knee osteoarthritis; Currently receiving spinal manipulative therapy; Current participation in a regular exercise program; Use of any prescription medication, or herbal substance that may affect balance; Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: SpineForce Reactive Neuromuscular Trainer|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effectiveness of a Physiotherapy Treatment for Temporomandibular Hyperlaxity

Study Overview
=================
Brief Summary
-----------------
A 14-day physiotherapy treatment for temporomandibular joint hyperlaxity is established. Pre-intervention measurements and intermediate and end-of-treatment measurements are taken. Range of movement, algometry and muscle balance are assessed.

Official Title
-----------------
Effectiveness of a Physiotherapy Treatment for Temporomandibular Hyperlaxity: a Case Report.

Conditions
-----------------
Disorders, Temporomandibular Joint, Range of Motion, Articular

Intervention / Treatment
-----------------
* Other: Physiotherapy treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman with temporomandicular joint pain for six months and diagnosed with hyperlaxity in the joint. Exclusion Criteria: Men No temporomandibular joint pain or hyperlaxity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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: patient with temporomandibular joint disorders<br> | Other: Physiotherapy treatment<br>* A treatment plan is carried out which aims to improve pain, muscle balance and range of motion of the temporomandibular joint.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range motion | The range of movement in the temporomandibular joint is assessed. | 14 days | 
| VAS | Pain in the temporomandibular artiuclation measured with an algometer and VAS is assessed. | 14 days | 
| Strength | The strength of the temporomandibular joint musculature measured with an algometer is assessed. | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
range of motion, articular, disorders, temporomandibular joint
Cardiovascular Risks and Urinary Albumin Excretion(UAE) in Polycystic Ovarian Syndrome (PCO)

Study Overview
=================
Brief Summary
-----------------
PCO patients will be assessed clinically,urine & blood samples will be tested. Systolic & diastolic blood pressure, serum glucose & insulin levels, lipid profile, C-reactive protein, complete hormonal profile, and Urinary albumin excretion will be measured.

Detailed Description
-----------------
PCO patients with 2 of 3 criteria: oligo- or anovulation ; hyperandrogenism &polycystic ovaries. Exclusion criteria: pregnancy, diabetes, hypertension , adrenal & thyroid dysfunction. Blood samples after overnight fast (8hrs) at day 2 or 3 of menstrual cycle. Serum concentration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin, total testosterone & sex hormone binding globulin, serum 17-hydroxy (OH) progesterone & dehydroepiandrosterone sulfate will be measured. Oral glucose tolerance test & plasma insulin levels will be measured. Total cholesterol, triglycerides, high& low density lipoproteins. Urinary albumin will be measured& all the data will be analysed.

Official Title
-----------------
Urinary Albumin Excretion in Women With Polycyclic Ovary Syndrome and it's Relation to Cardiovascular Risk Factors

Conditions
-----------------
Urinary Albumin Excretion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PCO patients Exclusion Criteria: pregnancy diabetes hypertension adrenal dysfunction thyroid dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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 |
| --- | --- | --- |
| Number of patients with hyperinsulinemia (uIU/ml) |  | 3 months | 
| Number of patients with hyperlipidemia (mg/dl). |  | 3 months | 
| Number of patients with albuminuria(ug/ml) |  | 3 months |
Study of the Effects of Chemotherapy on Memory and Other Mental Functions in Women With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Many breast cancer patients treated with chemotherapy complain of problems with concentration and memory. This has been referred to as chemo fog. The current study is investigating this phenomenon by measuring mental function of breast cancer patients prior to and after exposure to chemotherapy, and by comparing mental function in those patients who receive chemotherapy and those who do not.

Detailed Description
-----------------
Many breast cancer patients treated with chemotherapy complain of problems with concentration and memory. This has been referred to as chemo fog. The current study will investigate this phenomenon by measuring neuropsychological functioning in early stage breast cancer patients prior to and after exposure to chemotherapy, and by comparing change in cognitive function in patients who receive chemotherapy to similar breast cancer patients receiving hormonal therapy only.

Official Title
-----------------
A Prospective, Longitudinal Investigation of the Neuropsychological and Psychosocial Effects of Cancer Therapy

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stage I or II breast cancer; woman; 50-65 years old; post-menopausal Exclusion Criteria: history of previous cancer or chemotherapy; significant neurological or psychiatric history

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chemotherapy patients<br>Breast cancer patients treated with adjuvant chemotherapy of various types. | |
| Hormonal patients<br>Breast cancer patients treated with adjuvant hormonal therapy but not chemotherapy. | |

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
-----------------
breast cancer, chemotherapy, hormonal therapy, cognitive function, chemo fog
Prospective Observational Cohort Study for the Durability of Anti-viral Therapy in Patients With Chronic Hepatitis B

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the off-treatment sustained virological and biochemical response in chronic hepatitis B patients following the guideline by the Asian Pacific Association for the Study of the Liver (APASL) in Korea.

Detailed Description
-----------------
In the recommendation by the Asian PAcific Association for the Study of the Liver(APASL), antiviral drug is recommended to stop when HBeAg seroconversion has developed for more than 6 months among HBeAg-positive patietns. For HBeAg-negative patients, the APASL consensus recommended stopping anti-viral treatment when HBV DNA remained undetectable for three separates occasion 6 months apart. Nontheless, approximately 25% to 50% of the patients still develop hepatitis relapse after stopping anti-viral therapy even if these recommendations are followed. In this study, the investigators aimed to investigated the off-treatment sustained response in chronic hepatitis B parients following the stopping anti-viral treatment guideline in Korea.

Official Title
-----------------
Phase IV Study of Durability of Anti-viral Therapy in Patients With Chronic Hepatitis B

Conditions
-----------------
Chronic Hepatitis B

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: More than 20 years old Chronic hepatitis B patients under anti-viral therapy In HBeAg-positive patient; if HBeAg seroconversion with undetectable HBV DNA is documented on two separate occasions at least 6 months In HBeAg-negative patient; if undetectable HBV DNA has been documented on three separate occasions 6 months apart Exclusion Criteria: Patients who had chronic liver disease due to hemochromatosis, autoimmune hepatitis, drug-induced hepatitis, or thalassemia Patients who suffered from other chronic medical condition

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Chronic hepatitis B<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virological response after stopping anti-viral treatment | The proportion of patients with sustained virological response after stopping anti-viral treatment | Up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic hepatitis B, Nucleos(t)ide analogue, Antiviral treatment, Korea