linjc16/ctgov huggingface dataset:
No More Falls Injury Prevention Study

Study Overview
=================
Brief Summary
-----------------
A randomized controlled multi-component fall prevention study for older adults. The study integrates fall prevention into an existing community-based public health program for older adults.

Detailed Description
-----------------
A randomized controlled multi-component fall prevention study for older adults. The study integrates fall prevention into an existing community-based public health program for older adults. The study will evaluate the effectiveness of a fall prevention intervention among 552 seniors attending Preventive Health Care for the Aging (PHCA) clinics in two counties: urban San Diego county and rural Humboldt county. The intervention includes four elements: education about fall risk factors, referrals to community exercise programs to increase strength and balance, medication review, and home modification to reduce home hazards. The goal of the intervention is to reduce incidence of falls requiring hospitalization by 10%. Results of the study, which are expected to be completed by October 2004, will help guide future efforts to develop multifaceted fall prevention programs.

Official Title
-----------------
California No More Falls! Senior Injury Prevention Program

Conditions
-----------------
Falls

Intervention / Treatment
-----------------
* Behavioral: counselling, exercise, referrals (behavior)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PHCA clients age 65+ - Exclusion Criteria: Age <65 -

Ages Eligible for Study
-----------------
Minimum 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: counselling, exercise, referrals (behavior)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of falls reported after 12 months. |  |  |
Study Evaluation Tazocin Intervention

Study Overview
=================
Brief Summary
-----------------
This is an antibiotic intervention study to determine the value of using piperacillin/tazobactam in reducing the cases of ESBL producing E. coli or K. pneumoniae colonization and infection.

Official Title
-----------------
Association of Antibiotic Utilization Measures and Control of Extended-Spectrum β-Lactamases (ESBLs) Producing Bacteria

Conditions
-----------------
Bacterial Infections

Intervention / Treatment
-----------------
* Drug: Tazocin (pipercillin/tazobactam)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted or transferred to ICU/Pulmonary units Patients of either sex, 18 years of age or older Exclusion Criteria: - Patients who stay in units less than 48 hours will not be enrolled.

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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>baseline, collecting rectal swab samples | |
| Active Comparator: 2<br>use pipercill/tazobact to replace 3rd generation cephalosporin and collect rectal swab | Drug: Tazocin (pipercillin/tazobactam)<br>* over 50% third generation cephalosporin should be replaced by Pip/Taz<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. The acquisition rate of ESBL producing E. coli or K. Pneumoniae at the end of phase I (pre-intervention) and phase II (last 3 months of intervention phase) |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The infection rate due to ESBL producing E. coli or K. pnumoniae at the end of phase I (pre-intervention) and phase II (last 3 months of intervention phase) |  | 9 months |
Effects of Biphasic Insulin Aspart 70/30 vs. Exenatide in Type 2 Diabetes Patients Not Reaching Blood Glucose Targets on Metformin and a Sulfonylurea.

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). The study will compare A1C reduction achieved in patients receiving biphasic insulin aspart 70/30 once or twice daily to patients receiving exenatide twice daily. Patients enrolled in the study will be insulin naive patients who have not achieved glycemic control with metformin and sulfonylurea.

Official Title
-----------------
Effects of NovoLog® Mix 70/30 (Biphasic Insulin Aspart 70/30) BID and QD vs. Byetta™ Exenatide) BID on Glycemic Control: A Multicenter, 24-Week, Open-Label, Parallel Group Study in Patients With Type 2 Diabetes Mellitus Not Achieving Glycemic Targets With Metformin and a Sulfonylurea

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart
* Drug: exenatide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes HbA1C: At least 8% Patients that were never treated with insulin before Current therapy with metformin and a sulfonylurea. Exclusion Criteria: History of recurrent, severe hypoglycemia Hepatic insufficiency: ALT, AST or alkaline phosphatase > 2.5 times upper limits of laboratory's normal Renal insufficiency: serum creatinine > 1.3 mg/dL (males) or > 1.2 mg/dL (females) Severe gastrointestinal disease, including gastroparesis

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: biphasic insulin aspart|nan|
|Drug: exenatide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superiority as assessed by HbA1c reduction |  | at 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables |  |  | 
| Patient satisfaction |  |  |
Etanercept Survival in Elderly Population

Study Overview
=================
Brief Summary
-----------------
Evaluate the 3-year survival of etanercept in patients over 60 years with psoriasis in moderate / severe plaque and the reasons that led to the abandonment. Besides factors that might have had a positive or negative influence on adherence to treatment and analysis of efficacy (PASI 75) and safety will be identified. All variables were collected through retrospective review of medical records of patients dermatology unit are made.

Official Title
-----------------
Etanercept Survival in Elderly Population

Conditions
-----------------
Psoriasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with moderate / severe psoriasis (with / without psoriatic arthritis,PAs) defined by: PASI(Psoriasis Area and Severity Index)> 10 and / or BSA(Body Surface Area)> 10% and / or DLQI(Dermatology Life Quality Index)> 10 PASI> 10 and / or BSA(Body Surface Area)> 10% and / or DLQI(Dermatology Life Quality Index)> 10 Over 60 years of age at the start of treatment Receiving etanercept at any time Available history in the Dermatology Exclusion Criteria: Patients with insufficient clinical data in the medical record

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- | --- |
| primary ineffectiveness in patients with etanercept treatment | Number of participants not achieve PASI 50 response at 12 weeks | 24 weeks | 
| Secondary ineffectiveness in patients with etanercept treatment | Number of participants with Poor adherence to treatment with etanercept, | 24 weeks (duration of treatment with etanercept) | 
| Ineffectiveness of treatment in localized lesions in patients with etanercept treatment | Despite having achieved a good response PASI no improvement in critical injuries | 24 weeks(duration of treatment with etanercept) | 
| primary ineffectiveness in patients with etanercept treatment | Number of participants not achieve PASI 75 response at 24 weeks | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events during treatment with etanercept |  | 24 weeks | 
| Number of participants with disease remission |  | 24 weeks | 
| number of participants with Poor adherence to treatment with etanercept |  | 24 weeks | 
| number of participants with Conditions requiring hospitalization and / or surgery |  | 24 weeks |
Carpal Tunnel Syndrome: Case Reports and Analysis - Ultrasound Imaging and Pathomechanics of Median Nerve Compression

Study Overview
=================
Brief Summary
-----------------
Carpal tunnel syndrome is caused by compression of the median nerve at the wrist. The hypothesis is that ultrasound imaging can be used to visualize nerve compression in carpal tunnel patients during hand activity, and normal subjects will not demonstrate any nerve compression.

Detailed Description
-----------------
Two patients with carpal tunnel syndrome underwent nerve testing to document that they had median nerve abnormality at the wrist. They subsequently had ultrasound imaging of the wrist at rest and during a stress test using hand activity. Two control subjects had nerve testing to prove that they had no nerve abnormality at the carpal tunnel. The carpal tunnel syndrome patients demonstrated nerve compression on the ultrasound images during the stress tests and the normal subjects showed no nerve compression.

Official Title
-----------------
Carpal Tunnel Syndrome: Case Reports and Analysis - Ultrasound Imaging and Pathomechanics of Median Nerve Compression

Conditions
-----------------
Carpal Tunnel Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have symptoms consistent with carpal tunnel syndrome and electrodiagnostic testing that demonstrates abnormal median nerve function at the wrist, consistent with carpal tunnel syndrome. Normal subjects must have no upper limb symptoms to support carpal tunnel syndrome and normal nerve testing. Exclusion Criteria: Patients excluded if nerve testing was not consistent with carpal tunnel syndrome. Normals excluded if nerve testing demonstrated any median nerve abnormality.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Carpal Tunnel patients<br>These patients have documented carpal tunnel syndrome | |
| Normal Subjects<br>These individuals have no carpal tunnel syndrome | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median nerve compressive narrowing on ultrasound imaging in carpal tunnel syndrome patients |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No median nerve compressive narrowing in normal subjects |  | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carpal tunnel syndrome, median nerve, ultrasound, electrodiagnosis, Normal subjects
Evaluation of Arginine in Periodontal and Cardiovascular Disease

Study Overview
=================
Brief Summary
-----------------
Asymmetric dimethylarginine (ADMA) plays a key role in endothelial function and may be a link for the known interaction of periodontitis and coronary heart disease (CHD). The investigators compared the impact of gingival health, periodontitis (CP), CHD or of both diseases (CP+CHD) on saliva and serum ADMA levels.

Detailed Description
-----------------
The aim of this study was to evaluate a possible association between both saliva and serum ADMA levels in patients with CP and with CHD and if the serum ADMA levels are mediated by serum CRP.

Official Title
-----------------
Analysis of Serum and Salivary ADMA-Arginine Levels in Patients With Periodontal and Cardiovascular Diseases

Conditions
-----------------
Metabolic Disorder, Arginine; Hyperaminoaciduria

Intervention / Treatment
-----------------
* Other: Evaluation of arginine serum level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of at least 16 teeth CP with a minimum of 40% of sites with a clinical attachment level (CAL) ≥2mm and probing depth (PD) ≥4mm; Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs Presence of ≥40% sites with bleeding on probing (BOP) Exclusion Criteria: Intake of contraceptives Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study Status of pregnancy or lactation Previous history of excessive drinking Allergy to local anaesthetic Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 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 |
| --- | --- |
| Control<br>Healthy patients | Other: Evaluation of arginine serum level<br>* correlation of serum arginine level with periodontal and cardiovascular disease<br>|
| Periodontitis<br>Patients with periodontal disease | Other: Evaluation of arginine serum level<br>* correlation of serum arginine level with periodontal and cardiovascular disease<br>|
| Cardiovascular<br>Patients with cardiovascular disease | Other: Evaluation of arginine serum level<br>* correlation of serum arginine level with periodontal and cardiovascular disease<br>|
| Periodontitis+Cardiovascular<br>Patients with both periodontal and cardiovascular disease | Other: Evaluation of arginine serum level<br>* correlation of serum arginine level with periodontal and cardiovascular disease<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Attachment level |  | 1 year |
Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability of RAD001 (Certican) administered to pediatric renal transplant recipients, and to provide additional safety data.

Official Title
-----------------
Multicenter Trial of the Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Certican


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients no more than 16 years of age. Patients receiving a primary cadaveric or non-HLA identical living donor (related or unrelated) renal transplant. The graft must be functional within 48 hours post transplantation. Exclusion Criteria: Cold ischemia time greater than 40 hours. Patients who are recipients of multiple solid organ transplants, including dual and en bloc kidneys, or who have previously received transplanted organs. Patients with panel reactive T cell antibodies of 50 % or higher at the last assessment before transplantation.

Ages Eligible for Study
-----------------
Minimum Age: 1 Week
Maximum Age: 16 Years

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

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

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: Certican|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability at 6 and 12 Months as measured by adverse events, laboratory abnormalities and infections. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy at 6 and 12 Months as measured by rejection, graft loss, death and loss to follow up. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
de novo, renal, pediatric, transplant recipients, De novo renal pediatric transplant
A Treatment IND for 566C80 Therapy of Pneumocystis Carinii Pneumonia

Study Overview
=================
Brief Summary
-----------------
To facilitate provision of atovaquone (566C80) to patients who have mild to moderate Pneumocystis carinii pneumonia (PCP) and are intolerant and/or unresponsive to trimethoprim / sulfamethoxazole (TMP / SMX ); to monitor serious adverse events attributable to 566C80.

Official Title
-----------------
A Treatment IND for 566C80 Therapy of Pneumocystis Carinii Pneumonia

Conditions
-----------------
Pneumonia, Pneumocystis Carinii, HIV Infections

Intervention / Treatment
-----------------
* Drug: Atovaquone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have the following: Clinical diagnosis of acute mild to moderate Pneumocystis carinii pneumonia. Dose-limiting intolerance to TMP / SMX or inadequate response to TMP / SMX. Willingness and ability to give informed consent. The clinical condition of the patient and appropriate physiologic criteria should be used in evaluating patients for therapy with 566C80. Patients who are rapidly progressing in disease severity or have severe disease as evidenced by sustained tachypnea (e.g., sustained respiratory rate > 30 breaths/minute), rapid deterioration in (A-a)DO2 and chest radiograph may not be appropriate candidates for oral therapy, including 566C80. Therapy with parenteral pentamidine should be undertaken in these cases. Treatment with IV trimetrexate or primaquine / clindamycin should be considered for these patients unless the patient is known to have dose-limiting intolerance to these agents. Patients with severe PCP who are intolerant and/or unresponsive to therapy with TMP / SMX and parenteral pentamidine may enroll in the 566C80 open-label compassionate plea protocol. Exclusion Criteria Patients with the following prior conditions are excluded: History of serious or dose-limiting adverse experience during previous 566C80 therapy, thought to be attributable to the drug.

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

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atovaquone|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
-----------------
Trimethoprim-Sulfamethoxazole Combination, Pneumonia, Pneumocystis carinii, Antifungal Agents, Acquired Immunodeficiency Syndrome, atovaquone
Influence of an Anti-gravity Treadmill on Functional Outcome in Non-operatively Treated Pelvic Fractures - a Pilot Study

Study Overview
=================
Brief Summary
-----------------
Non-operative treatment of pelvic fractures is possible. Immobilisation implies different adjustment processes. Patients with pelvic ring fractures and partial weight bearing have to obtain theses. The aim of this pilot study was to prove the additional effect of the anti-gravity treadmill in patients with non-operatively treated pelvic fractures.

Detailed Description
-----------------
We prospectively included patients with non-operatively treated pelvic fractures as the intervention group (IG) and healthy volunteers of different age, sex and body mass index (BMI) as the reference group (RG). Patients of the IG participated in a training session every three days with an anti-gravity treadmill (Picture 1, alterG®, www.alterg.com) for a total of 40 days in addition to physiotherapy, lymph drainage massage and manual therapy. Patients were evaluated on three successive dates: Baseline (S1), after mobilization without crutches with full weight-bearing (20 days, S2) and after 40 days (S3)

Official Title
-----------------
Influence of an Anti-gravity Treadmill on Functional Outcome in Non-operatively Treated Pelvic Fractures - a Pilot Study

Conditions
-----------------
Weight-bearing, Rehabilitation

Intervention / Treatment
-----------------
* Device: anti-gravity treadmill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with non-operatively treated pelvic fractures Exclusion Criteria: pregnancy, neuromuscular disorders, preexisting muscle atrophy
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
Interventional Model Description: anti-gravity treadmill for a total of 40 days in addition to physiotherapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: pelvic fracture<br>patients with pelvic fracture will additionally be treated with anti-gravity treadmill | Device: anti-gravity treadmill<br>* anti-gravity treadmill for a total of 40 days in addition to physiotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| standardized gait analysis | standardized gait analysis was done with fluorescent markers and two cameras | Day 1 - 40 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numeric rating scale | numeric rating scale (NRS) to evaluate pain | Day 1 - 40 days | 
| dynamic gait index | rated gait index validated | Day 1 - 40 days |