linjc16/ctgov huggingface dataset:
Incidence of Various Types of Systemic Reactions Related to Spinal Steroid Injection: A Prospective Study

Study Overview
=================
Brief Summary
-----------------
Many systemic reactions occur commonly after spinal steroid injections, especially in patients, and may be associated with underlying disease, such as hypertension and diabetes mellitus, as well as steroid dose and repetition of spinal steroid injection.

Detailed Description
-----------------
Evaluate the incidence and types of systemic reactions after spinal steroid injections and to investigate the association of spinal steroid injection with patient demographics, history of previous injections, type and dose of steroid, and method and site of previous and current injections.

Official Title
-----------------
Prospective Observational Study of Evaluate the Incidence and Types of Systemic Reactions After Spinal Steroid Injections

Conditions
-----------------
Incidence and Types of Systemic Reactions Occurring After Spinal Steroid Injection in a Large Population

Intervention / Treatment
-----------------
* Drug: Spinal Steroid Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indicaion of steroid injction. Exclusion Criteria: Contraindiation of steroid injction.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 94 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 |
| --- | --- |
| Steroid Injection<br>Reactions associated with spinal steroid injection | Drug: Spinal Steroid Injection<br>* Steroid Injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| episodes of systemic reactions after spinal steroid injection | Evaluation of episodes of systemic reactions after spinal steroid injection | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal injection; Steroid; Systemic reaction; Complication; Side effect; Diabetes mellitus; Hypertension; Risk factor
Mutations of the Pre-core Region of Hepatite B Virus (HBV)

Study Overview
=================
Brief Summary
-----------------
Hepatitis B virus (HBV) infection constitutes a major public health threat worldwide. A total of 92 patients with HBeAg-negative chronic hepatitis B infection were recruited at Amiens University Hospital. The diagnostic workup included a physical examination.In conclusion, the study results confirmed that the HBV DNA level is associated with liver fibrosis status and that HBV viral load is strongly correlated with BCP and PC mutations, and it demonstrated that the impaired base pairing 1858-1896 mutations at the base of the bulge in the e encapsidation signal is independently associated with high serum HBV DNA levels.

Detailed Description
-----------------
The progression of liver disease in hepatitis B virus (HBV) infection is fostered by active virus replication. Mutations in the basal core promoter (BCP) and precore (PC) regions of the HBV genome are known to have an impact on viral replication. The aim of the present study was to assess the correlation of mutation profiles in the BCP and PC regions with the viral load in HBeAgnegative chronically infected patients. The HBV genotype, BCP/PC mutations, serum HBV DNA levels, and associated serological markers were analyzed in 92 HBeAgnegative chronically infected patients.

Official Title
-----------------
Influence of Mutations in the Pre-core Region of Heptatis B Virus (HBV) and Its Promoter on Serum VHB Viral Load in Chronically Infected Patients

Conditions
-----------------
Hepatitis B Virus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients included will be chronic carriers (HBsAg + for more than 6 months) of HBV, with detectable serum viral load greater than or equal to 100 IU / mL, included in the queue followed by Drs. Dominique Capron and Eric N'Guyen-Khac. These patients will not be on anti-HBV treatment. Exclusion Criteria: Patients under 18 years old Patients with their hepatitis B Patients with HBV viral load undetectable or less than 100 IU / mL. Immunosuppressive treatments such as corticosteroids or other The co-infection with the hepatitis C and / or HIV virus Patients with cancer

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genotype of HBV for which the HBV viral load is a function of pre-core mutations | The main objective of the study is toevaluate a genotype of HBV for which the HBV viral load is a function of pre-core mutations in chronically infected patients.The HBV markers (including HBsAg, HBeAg and anti- HBe) were measured with chemiluminescent microparticle immunoassays running on an Architect system. | 2-years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mutations, infected patients
Methotrexate in Symptomatic Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
Osteoarthritis (OA) is a common disabling condition, for which no effective therapy currently exists.Synovitis is commonly demonstrated in knee OA imaging. Methotrexate (MTX) helps to decrease synovitis in many inflammatory joint diseases, particularly rheumatoid arthritis.Accordingly,the aim of the present study was to assess the efficacy of MTX in decreasing pain and inflammation.Eighty-eight patients with clinical and radiographic criteria of primary knee OA with knee pain, were included in this study.Patients meeting the eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral MTX(n=44)or placebo(n=44)for 16 weeks. The primary outcome measure was pain reduction and secondary outcome measures included improvements in physical function scores.There was a statistically significant reduction in pain and improvement in function in the MTX group compared to the placebo group at 16 weeks.

Official Title
-----------------
Randomized Controlled Trial Using Methotrexate for Knee Osteoarthritis

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

Intervention / Treatment
-----------------
* Drug: Methotrexate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary knee osteoarthritis pain not responding to the usual therapy synovitis Exclusion Criteria: any other inflammatory conditions, hepatic and renal insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 60 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methotrexate<br>25mg/week orally | Drug: Methotrexate<br>* Methotrexate 25mg/week for 16 weeks<br>|
| Active Comparator: Placebo<br>Placebo-sugar tablets identical in colour and shape to methotrexate given once a week for 16 weeks. | Drug: Placebo<br>* Placebo tablets once a week for 16 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction |  | 4 months | 
| Pain reduction |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in physical function scores |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Methotrexate, Knee Osteoarthritis, Synovitis, Pain reduction, Function scores
A Single-blind, Dose-tapering Study of KWA-0711 in Patients With Chronic Constipation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of tapered KWA-0711 dose in chronic constipation patients.

Conditions
-----------------
Chronic Constipation

Intervention / Treatment
-----------------
* Drug: KWA-0711


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who experienced fewer than three spontaneous bowel movements per week for more than 6 months prior to the enrollment. The patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation Exclusion Criteria: Patients who have secondary constipation caused by systemic disorder. Patients who have organic constipation. Patients who received intestinal resection.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KWA-0711 Dose1<br> | Drug: KWA-0711<br> <br> |
| Experimental: KWA-0711 Dose2<br> | Drug: KWA-0711<br> <br> |
| Experimental: KWA-0711 Dose3<br> | Drug: KWA-0711<br> <br> |
| Experimental: KWA-0711 Dose4<br> | Drug: KWA-0711<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of signs and symptoms associated with constipation | Frequency of Spontaneous Bowel Movements Bowel Movement Timing Stool Consistency Abdominal Assessment QOL Assessment | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Constipation, Constipation, Functional gastrointestinal disorders
Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether administrating of Amantadine (a dopamine agonist) to patients suffering from Parkinson disease during the perioperative period is safe, and to asses potential benefits of this treatment.

Official Title
-----------------
Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine

Conditions
-----------------
Parkinson Disease, Perioperative Care

Intervention / Treatment
-----------------
* Drug: Amantadine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with a diagnosis of Parkinson Disease refered for surgery at our institution. Exclusion Criteria: Cardiac and neurosurgical procedures Inability to sign informed Consent allergy to Amantadine Congestive heart failure Arrythmia (including bradycardia below 55 bpm) renal failure (creatinin above 1.5) If a patient will develop agitation or delirium lasting longer then 8 hours he will not receive the second dose of amantadine.
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: A<br> | Drug: Amantadine<br>* IV Amantadine 200mg *1/d at the beginning of surgery and 24 hours following surgery<br>* Other names: PK MERZ;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality, Surgical site infection, Pneumonia, Myocardial Infarction, Cerebral Vascular Accident (CVA). |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS score |  | 2,28 days | 
| Pain (vas score), Analgetic drugs requirement |  | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amantadine
NIRS and DO2i Correlation

Study Overview
=================
Brief Summary
-----------------
This study evaluates the association between near infrared spectroscopy (NIRS) and indexed oxygen delivery (DO2i) and their possible correlation with postoperative organ failure.

Detailed Description
-----------------
Literature evidences show that levels of DO2i under 262-272 mL/min/m2 during cardiopulmonary by-pass (CPB) are associated with an increased incidence of acute kidney injury (AKI). Furthermore, it has been demonstrated that keeping a NIRS of 75-80% compared to the basal value reduces the risk of perioperative morbidity. On the other hand, a NIRS < 50% of basal value seems to be predictive of an increase in morbidity. All of those studies had been performed during CPB and knowledge lacks in management of DO2i and NIRS before and after CPB.

Official Title
-----------------
Evaluation of NIRS and DO2i Correlation and Their Relationship With Organ Failure During Cardiac Surgery: a Prospective Monocentric Study.

Conditions
-----------------
Multiorgan Failure, Perfusion; Complications

Intervention / Treatment
-----------------
* Procedure: NIRS
* Other: DO2i


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing cardiac surgery with cardiopulmonary by-pass whose have been signed the consent informed Exclusion Criteria: Impossibilty to collect a correct continuous cardiac output measure with PiCCO (chronic atrial fibrillation or severe peripheral vasculopaty)

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: NIRS|NIRS devices patch will be applied on patients' head in order to measure the cerebral saturation of each cerebral emisphere|
|Other: DO2i|Oxygen delivery standardized to the body surface area will be calculate in order to optimize tissue perfusion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the correlation between NIRS and DO2i during cardiac surgery |  | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the correlation between NIRS, DO2i and SOFA score |  | 7 days postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NIRS, DO2
Sleep Extension and Blood Pressure

Study Overview
=================
Brief Summary
-----------------
Emerging evidence suggests that approximately 30% of the US adult population sleeps less than 7 hours per night, and those who do exhibit 20-52% enhanced risk to develop cardiovascular diseases and particularly hypertension. Since sleep curtailment is largely voluntary, sleep deficiency can be corrected and its detrimental health consequences potentially reversed. The purpose of the present proposal is to investigate the cardiovascular and metabolic effects of sleep extension in prehypertensive and stage 1 hypertensive subjects who report habitual short sleep.

Official Title
-----------------
Lowering Blood Pressure by Sleep Extension: a Randomized, Controlled Trial

Conditions
-----------------
Sleep Extension

Intervention / Treatment
-----------------
* Behavioral: sleep extension
* Behavioral: sleep maintenance


Participation Criteria
=================
Eligibility Criteria
-----------------
Age: 18 to 65 (inclusive) Gender: both males and females Body mass index (BMI): 18.5-34.9 kg/m2 Habitual sleep duration: <7 hours Presence of either: Prehypertension: office systolic BP (SBP) 120-139 mmHg and/or diastolic BP (DBP) 80- 89 mmHg; Stage 1 hypertension: office SBP 140-159 mmHg and/or DBP 90-99 mmHg Either on no prescription medications (other than oral contraceptive pills, or intrauterine devices) or on stable medical regimen for at least 1 month, if taking prescription medications for chronic conditions Not pregnant or breast feeding and not intending to become pregnant or breast feed Not a current smoker or tobacco user Ability to provide written informed consent

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sleep extension<br> | Behavioral: sleep extension<br> <br> |
| Active Comparator: sleep maintenance<br> | Behavioral: sleep maintenance<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in 24-hour mean arterial pressure |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in baroreflex sensitivity |  | 8 weeks | 
| change in endothelial function |  | 8 weeks | 
| change in insulin sensitivity |  | 8 weeks |
Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients With Graft vs. Host Disease

Study Overview
=================
Brief Summary
-----------------
This trial is in high risk patients to determine the safety, tolerance and efficacy of posaconazole (POZ) vs. fluconazole in the prophylaxis against development of invasive fungal infections (IFI).

Detailed Description
-----------------
This study is designed to determine the safety, tolerance and efficacy of POZ used as prophylaxis of IFI in high-risk subjects with Grade II-IV acute graft vs. host disease (GVHD) or extensive chronic GVHD. The primary objective is to assess the efficacy of SCH56592 vs fluconazole in preventing proven or probable IFI within the time period from randomization to 16 weeks after the start of treatment with study drug.

Conditions
-----------------
Mycoses

Intervention / Treatment
-----------------
* Drug: Posaconazole oral suspension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hematopoietic progenitor cell transplant subjects with chronic or Grade II-IV acute GVHD being treated with high dose immunosuppressive therapy. One of the following to the subject's prior immunosuppressive regimen: at least 1mg per kg per day of methylprednisolone or equivalent, Antithymocyte globulin (ATG) for the therapy of acute GVHD, Tacrolimus, mycophenolate mofetil, or other steroid-sparing immunosuppressive regimen.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Posaconazole oral suspension|nan|

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
-----------------
Allogenic Stem cell transplantation, Fungal infections
Orientation for Hearing Aid Users: Information Retention

Study Overview
=================
Brief Summary
-----------------
Aim: To verify how much of the orientation provided at diagnosis and hearing aid fitting are retained by new hearing aid users and analyze whether age, degree of hearing loss, academic and socio-economics status have an influence on this

Detailed Description
-----------------
Introduction: The understanding and retention of orientations provided by the health professional increases patient's satisfaction and compliance to treatment and reduces treatment duration and costs. Aim: To verify how much of the orientation provided at diagnosis and hearing aid fitting are retained by new hearing aid users and analyze whether age, degree of hearing loss, academic and socio-economics status have an influence on this. Methods: Participated in this study 30 adults (18 female and 12 male) with age varying from 18 to 88 years, with post lingual uni or bilateral hearing loss of various degrees and types. Orientations were offered at the time of diagnosis and hearing aid fitting. At the first follow up visit patients were interviewed regarding their hearing loss' characteristics as well as hearing aid care and use (probed recall task). It was also evaluated how participants manipulated their devices. A protocol was used to score participant's responses. Results: on average participants could retain 31,6% and 83,6% of the orientation provided regarding their hearing loss and hearing aid care and use. There was a negative correlation between age and amount of information retained. There was no influence of degree of hearing loss, academic and socio-economic statues. Conclusion: The hearing impaired patients have difficulty to recall orientation provided therefore the use of facilitation strategies to information retained is necessary.

Official Title
-----------------
Orientation for Hearing Aid Users: Information Retention

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Behavioral: Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 years old sensorineural hearing loss, hearing aid candidate Exclusion Criteria: severe dexterity or visual problems. Cognitive or memory disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 88 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 |
| --- | --- |
| Audiology counseling<br> | Behavioral: Counseling<br>* Informational Counseling provided after hearing aid fitting<br>|

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
-----------------
hearing aids, counseling