linjc16/ctgov huggingface dataset:
Outpatient Prescription Errors: Detection, Analysis, and Impact on Safety

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to better understand outpatient prescribing errors through clinic and pharmacy-based error reporting systems.

Detailed Description
-----------------
Medication errors cause substantial morbidity and mortality in the United States. However, relatively little is known about medication errors in the outpatient setting. The broad goal of this proposal is to improve outpatient safety. Specifically, this research plan promotes the understanding of the causes of outpatient prescription errors. The specific aims of this project are: To develop and evaluate a novel reporting system in physicians' offices for detecting prescription errors To develop and evaluate a novel improvement system in community pharmacies to increase prescription error reporting by pharmacists To analyze reports of outpatient prescription errors and understand their root causes To achieve these specific aims, statewide research will be conducted utilizing qualitative and quantitative methods including root cause analysis, failure mode and effects analysis, and surveys. This research plan will promote patient safety by furthering the understanding of the causes of outpatient prescription errors in all outpatient populations, including rural, women, children, elderly, low income, and the chronically ill.

Official Title
-----------------
Outpatient Prescription Errors: Detection, Analysis, and Impact on Safety

Conditions
-----------------
Medication Errors

Intervention / Treatment
-----------------
* Behavioral: reporting system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Employed in a physician's office or community pharmacy Exclusion Criteria: Not employed in a physician's office or community pharmacy

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 |
| --- | --- |
| Primary Care Practices<br>One hundred and three prescribers, managers, nurses and office staff at seven primary care practices in Vermont | Behavioral: reporting system<br>* Nurses and office staff were asked to report all communications with community pharmacists regarding prescription problems<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
-----------------
Medical Errors, Medication Errors, Prescriptions, Drug, Pharmacies, Ambulatory Care Facilities
Blunt Needles do Not Reduce Needlestick Injuries to Doctors During Suturing After Child-Birth

Study Overview
=================
Brief Summary
-----------------
The hypothesis for this study is that use of blunt tipped needles used during the repair of an episiotomy (tear in the vagina after childbirth) will result in fewer needlestick injuries to the surgeon.

Official Title
-----------------
The Use of Blunt Needles Does Not Reduce Needlestick Injury During Obstetrical Laceration Repair

Conditions
-----------------
Needlestick Injuries

Intervention / Treatment
-----------------
* Device: Blunt needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obstetric laceration requiring suturing Exclusion Criteria: < 18 years old

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Sharp needles | Device: Blunt needle<br>* Blunt tipped suture needle<br>|
| Experimental: 2<br>Blunt tipped needles | Device: Blunt needle<br>* Blunt tipped suture needle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Holes in surgeons gloves |  | After surgical repair | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeon satisfaction with the needle assignment |  | After the surgical repair | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blunt needles, obstetric lacerations, Needlestick injuries, Needlestick injuries to physicians
Women's Use of Alternative Medicine: A Multiethnic Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine socio-cultural factors of women's use of complementary and alternative medicine (CAM). The effects of socioeconomic status, social networks and acculturation on CAM use will be assessed among white, African-, Mexican-, and Chinese-American women.

Conditions
-----------------
Uterine Fibroids, Osteoporosis, Urinary Tract Infection, High Blood Pressure, Heart Disease, Arthritis, Depression, Headaches

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Experienced one or more of the following health conditions within the last year: pregnancy related symptoms menopausal related symptoms headaches back pain osteoporosis cancer high blood pressure high cholesterol heart disease joint pain/arthritis insomnia uterine fibroids urinary tract infection vaginal tract infection medically diagnosed depression menstrual symptoms

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?
-----------------
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
-----------------
Race, Ethnicity, Complementary and Alternative Medicine, Women's health, Social determinants of Health
Simple Suppers Scale-up (S3)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine effectiveness of a family meals intervention, Simple Suppers, aimed at eliciting positive changes in child dietary intake and weight status.

Official Title
-----------------
Simple Suppers Scale-up (S3): an Expanded Pilot Study to Determine the Effectiveness of a Family Meals Intervention Aimed at Eliciting Positive Changes in Child Diet and Weight Status

Conditions
-----------------
Childhood Obesity

Intervention / Treatment
-----------------
* Behavioral: Simple Suppers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caregivers: Primary food preparer in the home; responsible for at least one child 4-10 years of age; speak English as the primary language in the home; lived in the U.S. for at least one year. Exclusion Criteria: Family member: Following a restrictive or therapeutic diet.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 10 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Waitlist control<br> | |
| Experimental: 10-week family meals program<br> | Behavioral: Simple Suppers<br>* Theory-based 10-week family meals program<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child standardized body mass index (BMI) |  | Change from baseline child BMI at 10 weeks |
Effectiveness of Photo-biomodulation in the Treatment of Chemotherapy Induced Mucositis

Study Overview
=================
Brief Summary
-----------------
The aim of the current study was to study the effect of diode laser in the treatment of chemotherapy induced mucositis in young patients suffering from leukemia

Official Title
-----------------
EFFECTIVNESS OF PHOTO BIO-MODULATION IN THE TREATMENT OF CHEMOTHERAPY INDUCED ORAL MUCOSITIS IN CHILDREN WITH ACUTE LEUKEMIA Randomized Controlled Clinical Trial

Conditions
-----------------
Mucositis

Intervention / Treatment
-----------------
* Device: Simpler diode laser
* Drug: Conventional symptomatic treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children diagnosed with mucositis and receiving chemotherapy Exclusion Criteria: diabetes trismus

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser irradiation (Test group)<br>laser irradiation over lesion | Device: Simpler diode laser<br>* Non-contacting irradiation for 30 seconds on three intraoral sites repeated four times<br>|
| Active Comparator: Conventional treatment (Control group<br> | Drug: Conventional symptomatic treatment<br>* Conventional treatment using oracure, BBC spray, miconaz three times daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported pain level | Participants were asked to report the degree of pain. This was assessed using the visual analogue scale (VAS) which ranges from zero (lowest score) to 10 (highest score). Higher scores indicate higher pain level. | up to 2 weeks | 
| Oral mucositis lesion size | This was assessed using the World Health Organization oral mucositis lesion score Grade 0: no oral mucositis. Grade1: Presence of soreness and erythema. Grade 2: Presence of painful erythema and ulcerations that do not affect the patient solid food intake. Grade3: Confluent ulceration that affect the solid food intake and require liquid diet. Grade 4: The patient requires parenteral nutrition. | up to 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mucositis - leukemia - chemotherapy
A Novel Combination Oral Agent to Treat Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a novel, combination product for the treatment of acne vulgaris in females

Official Title
-----------------
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL ORAL ACNE TREATMENT FOR THE TREATMENT OF ACNE VULGARIS

Conditions
-----------------
ACNE VULGARIS

Intervention / Treatment
-----------------
* Drug: Doxycycline and S-equol
* Drug: Doxycycline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy females 13 years of age or older Non-pregnant, non-lactating females Signed written informed consent form Must be able to understand and be willing to follow all study instructions Have a clinical diagnosis of acne vulgaris Exclusion Criteria: Female subjects who are pregnant or nursing Any concomitant dermatologic condition that may affect outcome measures Concurrent use of any other medication to treat acne vulgaris Have a history or clinical evidence of any other active acute or chronic medical disease or condition considered by the principal investigator as unsuitable for the study Are currently using any other investigational agent or device Have participated in any other clinical study within 90 days prior to enrollment Employees or family members of sponsor or research site

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 60 Years

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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral antibiotic plus soy extract<br> | Drug: Doxycycline and S-equol<br>* Oral doxycycline and s-equol twice a day<br>|
| Active Comparator: Oral antibiotic<br> | Drug: Doxycycline<br>* ORAL DOXYCYCLINE TWICE A DAY<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean number of Inflammatory Lesions on the face at the beginning and end of treatment | The number of inflammatory lesions will be counted by a trained investigator at the beginning and end of treatment. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean number of Comedones will be evaluated at the beginning and end of treatment | A trained investigator will count the number of comedones at the beginning and end of treatment. | 12 weeks |
A Trial for Evaluation of Clinical Efficacy and Safety of Healing Stone Navel Belt in Patients With Primary Dysmenorrhea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Healing stone navel belt is safe and effective in the treatment of Primary Dysmenorrhea.

Official Title
-----------------
Clinical Efficacy and Safety of Healing Stone Navel Belt in Patients With Primary Dysmenorrhea

Conditions
-----------------
Primary Dysmenorrhea

Intervention / Treatment
-----------------
* Device: Healingstone navel belt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age : female adults aged 15 45 years Subjects should diagnosed as primary dysmenorrhea, should have a primary dysmenorrhea at least a 1-day during menstrual. Subjects should have 21 42 days menstrual cycle. menstrual pain : primary dysmenorrhea at least a 1-day during menstruation is over 5 VAS(Visual Analogue Scale) without drug. Subjects must have no Serious internal medicine. Subjects must provide signed informed consent prior to participation in any study-related procedures Exclusion Criteria: Subject that oral contraceptive taken within 3 months Pregnancy or lactation. Subject have contraceptive that secrete hormone. Secondary dysmenorrhea pelvis inflammatory disease patient Other diseases or characteristics judged by the investigator to be incompatible with the assessments needed in this study or with reliable instillation of the study.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 Years

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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: a<br>healingstone | Device: Healingstone navel belt<br>* 6 8hours/day for 3months<br>* Other names: Serial Number : HS-402;|
| No Intervention: b<br>stone powder | Device: Healingstone navel belt<br>* 6 8hours/day for 3months<br>* Other names: Serial Number : HS-402;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10cm VAS of pain(Dysmenorrhea) |  | 5months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life (SF-36) |  | 7months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healingstone
Study to Determine the Efficacy and Safety of Docetaxel and Doxorubicin With INGN 201 in Locally Advanced Breast Cancer

Study Overview
=================
Brief Summary
-----------------
A maximum of 60 subjects will be enrolled in the trial. It is a non-randomized, open label, single center study. All subjects undergo INGN 201 injection and IV chemotherapy: doxorubicin and docetaxel. This is done on the first 2 days of a 3-week cycle. After completion of 4 to 6 cycles, the subject either proceeds to surgery if the tumors respond to therapy, or goes off study if there is no tumor response.

Conditions
-----------------
Locally Advanced Breast Cancer (LABC)

Intervention / Treatment
-----------------
* Genetic: INGN 201


Participation Criteria
=================
Eligibility Criteria
-----------------
Documented late stage breast cancer: stage III A-B (excluding inflammatory breast carcinoma) or localized stage IV breast cancer Male or female 18 years or older Adequate bone marrow, liver, and kidney function

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: INGN 201|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Fourier Transformed Infrared Spectroscopy in Macular Surgery

Study Overview
=================
Brief Summary
-----------------
Epiretinal membranes (ERM) are disorders leading to vision loss and metamorphopsia. Vitrectomy with membrane peeling has developed to be the gold-standard in treatment of ERM. ERM can be well visualized with spectral domain optical coherence tomography (SD-OCT). The aim of the study is to examine ERM and internal limiting membranes (ILM) exzised during routine macular surgery with fourier transformed infrared spectroscopy (FTIR) and compare results to optic coherence tomography (OCT) findings.

Detailed Description
-----------------
Purpose of the present study is to analyse components of ERM and ILM, giving hints for the origin of cells producing ERM. In contrast to electron microscopy, FTIR spectroscopy does not need any chemical fixation of the membranes and therefore structure of components of ERM and ILM are not changed by fixation. In total, 20 eyes with idiopathic ERM, 10 eyes with lamellar macular hole, 10 eyes with full thickness macular hole and 10 eyes with diabetic ERM will be examined. To our knowledge there are no previous reports about FTIR spectroscopy of ERM and ILM, therefore the study will be performed as an exploratory pilot study.

Official Title
-----------------
Fourier Transformed Infrared Spectroscopy in Macular Surgery

Conditions
-----------------
Epiretinal Membrane, Macular Hole

Intervention / Treatment
-----------------
* Device: FTIR spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic ERM, lamellar macular holes, full thickness macular holes, diabetic ERM and the indication for surgery (visual symptoms) Age 21 and older written informed consent for surgery and participation in the study prior to surgery Exclusion Criteria: - Macular edema due to other reasons than ERM Hereditary macular disorders In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

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: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: all excised membranes will be examined with FTIR spectroscopy, there will be no control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FTIR arm<br>all excised membranes are examined with FTIR spectroscopy | Device: FTIR spectroscopy<br>* FTIR spectroscopy examines collagen fibers in the excised membranes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| collagen | occurrence of different types of collagen fibres in the excised membranes | 3 months |