linjc16/ctgov huggingface dataset:
Pharmaceutical Care of Ambulatory Elderly Diabetes Patients

Study Overview
=================
Brief Summary
-----------------
This trial will try to perform pharmaceutical care on ambulatory elderly diabetes patients. To provide appropriate diabetes education administration, identify and resolve drug-related problems, assess the appropriateness of their medications, establish the mechanism of medication consultations. Each patient will be assessed by the MMSE(Mini-Mental State Examination) and GDS(Geriatric Depression Scale). The effectiveness of pharmacist's intervention will be assessed by lab data and some questionnaires.

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Pharmaceutical care
* Other: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 65 years or older A1c greater than or equal to 9.0 Exclusion Criteria: Not expected to live for the duration of the study Unwillingness to participate and attend pharmacist visits Unwillingness to participate the questionnaires(MMSE, GDS)

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 90 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: Pharmaceutical care<br>The Pharmacist provided Pharmaceutical care on the ambulatory elderly Diabetes patients, provided recommendation to the physician and reffered the patients to other diabetes-care-team members, including the CDEs and dietitians. | Other: Pharmaceutical care<br>* The Pharmacist provided Pharmaceutical care on the ambulatory elderly Diabetes patients, provided recommendation to the physician and reffered the patients to other diabetes-care-team members, including the CDEs and dietitians.<br>|
| Active Comparator: Usual care<br>Patients received usual care directed by their physician. | Other: Usual care<br>* Control patients received usual care directed by their physician.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hgb A1c change | baseline, second measurement during 3 to 6 month after baseline, and the last measurement during 9 to 12 month after baseline | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-Mental State Examination(MMSE) Score change | baseline and the second test was performed after 3 month. | 1 year | 
| Taiwan Geriatric Depression Scale(GDS) Score change | baseline and the second test was performed after 3 month. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmaceutical care, Diabetes Mellitus
Epidural Nalbuphine for Postcesarean Epidural Morphine Induced Pruritus

Study Overview
=================
Brief Summary
-----------------
Can epidural nalbuphine reduce incidence or severity of epidural morphine induced pruritus in patient undergoing cesarean section?

Detailed Description
-----------------
182 parturients,ASA 1-2 undergoing cesarean section under epidural block were enrolled in the study. After obtaining informed consent,all received epidural anesthesia using 2% lidocaine with epinephrine 1:200000 via epidural cathetes at L2-3 or L3-4 in a volume suffient to achieve a T4 sensory level bilaterally. After the umbilical cord was clamped,patients were assigned randomly to three groups.The placebo group,N-5 group,and N-10 group received 4 ml epidural solution containing morphine 4 mg plus either saline, nalbuphine 5 mg, and nalbuphine 10 mg respectively.At the post anesthetic care unit, intravenous pethidine PCA were administered for inadequate pain control. Outcome measures : Incidence and severity of postoperative pruritus Quality of pain control Side effects of epidural morphine and nalbuphine such as respiratory depression,sedation

Official Title
-----------------
Study of Epidural Nalbuphine for Prevention of Epidural Morphine Induced Pruritus

Conditions
-----------------
Cesarean Section

Intervention / Treatment
-----------------
* Drug: nalbuphine
* Drug: nalbuphine
* Other: NSS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: full term parturient undergoing elective cesarean section ASA 1-2 Exclusion Criteria: drug or alcohol abuses contraindication for regional anesthesia received opioids within 12 hours

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>1= placebo | Other: NSS<br>* NSS<br>* Other names: nornal saline;|
| Active Comparator: 2<br>2=nalbuphine 5 mg | Drug: nalbuphine<br>* nalbuphine 5 mg epidural<br>* Other names: nubain;|
| Active Comparator: 3<br>3=nalbuphine 10 mg | Drug: nalbuphine<br>* nalbuphine 10 mg epidural<br>* Other names: nubaine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence and severity of pruritus |  | 24 hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue pain score |  | 24 hr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pruritus, epidural morphine
Retinal Vascular Reactivity in Subjects With Newly Diagnosed Glaucoma Before and After Selective Laser Trabeculoplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess retinal blood flow and vascular reactivity in patients with newly diagnosed primary open angle glaucoma pre- and post-primary Selective Laser Trabeculoplasty(SLT). Canon Laser Blood Flowmeter will be used for the assessment of retinal blood flow.

Detailed Description
-----------------
We previously found that vascular reactivity improved after short term treatment with dorzolamide drops. It is not clear whether this improvement was a direct effect of the medication or secondary effect of the decrease in IOP. We would like to see the change of vascular reactivity before and after SLT, which will decrease the intraocular pressure without pharmacologic effect.

Official Title
-----------------
Retinal Vascular Reactivity in Response to Isoxic Hypercapnia in Subjects With Newly Diagnosed Glaucoma

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Procedure: Selective Laser Trabeculoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 40-75 years (Male or Female) Best corrected visual acuity of at least 20/40 No previous treatment for glaucoma Ametropia less than ±6.0 DS and ±2.5 DC) Non-smoker No cardiovascular/respiratory disorders Exclusion Criteria: Past history of diabetes and cerebrovascular accident Vascular occlusive disease affecting the ocular circulation such as: diabetic retinopathy, retinal vein occlusion and retinal artery occlusion Previous intraocular surgery Ocular media opacities limiting the use of the imaging tests

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| untreated glaucoma patients<br>We will evaluate the blood flow before and after Selective Laser Trabeculoplasty in patients with primary open angel glaucoma. | Procedure: Selective Laser Trabeculoplasty<br>* Patient will have selective laser trabeculoplasty as the first treatment for glaucoma. This treatment will be dictated clinically, since we do not assign the interventions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood flow | The Canon Laser Blood Flowmetry will be used to assess the retinal blood flow. | before and two-week after SLT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocuclar pressure | Intraocular pressure (IOP) will be measured by Goldmann applanation tonometry. | before and two-week after SLT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood flow, glaucoma, SLT
Development and Pathological Changes of High Myopia Among Children and Adolescents in China

Study Overview
=================
Brief Summary
-----------------
The study aims to observe the relationship between the changes of ocular structure parameters and pathological changes among children and adolescents with high myopia. Environmental factors and family history will also be collected to explore their impacts on high myopia progression.

Detailed Description
-----------------
This study aims to observe children and adolescents with high myopia for 3 years, and to collect data of ocular pathological changes, family history and environmental factors so as to understand the natural course and internal laws of the development of high myopia.

Official Title
-----------------
A Longitudinal Study on the Development and Pathological Changes Among Children and Adolescents With High Myopia in China

Conditions
-----------------
High Myopia

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 9 to 18 years old school students in Guangzhou, with either eye had myopia equal or greater than 6.0D Or 6 to 8 years old school students in Guangzhou, with either eye had myopia equal or greater than 3.0D Written informed consent for study participation Be willing to cooperate with the relevant ophthalmological examination and complete the questionnaire. Exclusion Criteria: None school students in Guangzhou Other contraindications A history of allergy to tropicamide or topical anesthetics Missing ability to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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 |
| --- | --- |
| entire cohort (observational)<br>none (observational study) | Other: Observational<br>* none (observational study)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To observe the relationship between the changes of ocular structure parameters and pathological changes among children with high myopia. | examine the ocular pathological changes | examine every 12 months, follow up 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore the impact of environmental factors and genetic factors on the progression among children and adolescents with high myopia | axial length, refractive error changes, environmental factors, family history, exercise time, eye care habits, form of exercise | examine every 12 months, follow up 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high myopia, ocular biometric parameters, adolescent, children
Randomized Trial of Web-Delivered Acceptance Therapy for Smoking Cessation (WebQuit)

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to determine whether the ACT website provides higher quit rates than a current standard smoking cessation website.

Official Title
-----------------
Randomized Trial of Web-Delivered Acceptance Therapy for Smoking Cessation

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Behavioral: ACT
* Behavioral: CBT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 or older smokes at least five cigarettes daily for at least past 12 months wants to quit in next 30 days willing to be randomly assigned to either group resides in US has at least weekly access to a high speed Internet connection and email willing and able to read in English not participating in other smoking cessation interventions (including our other intervention studies has never used the Smokefree.gov website willing to complete all three follow-up surveys provide email, phone, and mailing address provide contact information for two collaterals (e.g., relatives). does not have family, friends, or other household members participating Exclusion Criteria: The exclusion criteria are the opposite of the inclusion criteria above.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: ACT<br>Acceptance & Commitment Therapy | Behavioral: ACT<br> <br> * Other names: Acceptance & Commitment Therapy;|
| Active Comparator: CBT<br>Cognitive Behavioral Therapy | Behavioral: CBT<br> <br> * Other names: Cognitive Behavioral Therapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day point prevalence abstinence | No smoking in the past 30 days, as reported 12 month post treatment. | 12 month post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day, 24-hour, and 30-day point prevalence quit rates | 12 months: 24-hour and 7-day point prevalence quit rates. 3 and 6 months: 24-hour, 7-day, and 30-day point prevalence quit rates. Across 3, 6, and 12 month timepoints, the repeated 30-day point prevalence abstinence. | 3 months, 6 months, and 12 months post treatment |
A Double Blind, Placebo Controlled Trial of Quetiapine in Anorexia Nervosa, a Dual Site Study

Study Overview
=================
Brief Summary
-----------------
Research studies raise the possibility that medications such as quetiapine may improve mood or reduce obsessions in people with anorexia nervosa and may even help to normalize appetite. The medication quetiapine also known as seroquel works by activating certain systems in the brain, such as ones known as dopamine and serotonin chemical systems in the brain.

Official Title
-----------------
A Double Blind, Placebo Controlled Trial of Quetiapine in Anorexia Nervosa, a Dual Site Study

Conditions
-----------------
Anorexia Nervosa

Intervention / Treatment
-----------------
* Drug: quetiapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be aged 18-65 Must be at least 15% below ideal body weight Exclusion Criteria: Allergy to quetiapine Diagnosis of schizophrenia

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: quetiapine|quetiapine dosage will be titrated to subject tolerance beginning at 50 mg every 24 hours upwards to 400 mg every 24 hours.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine efficacy of seroquel in anorexia nervosa |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anorexia, nervosa, eating, disorder, study, research, clinical, trial, psychiatry, psychiatric
A Study to Evaluate the Effectiveness and Safety of an Implant in the Treatment of Osteoarthritis of the Great Toe

Study Overview
=================
Brief Summary
-----------------
This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the great toe.

Official Title
-----------------
A Study to Evaluate the Effectiveness and Safety of an Implant in the Treatment of Osteoarthritis of the Great Toe

Conditions
-----------------
Osteoarthritis of First Metatarsalphalangeal Joint

Intervention / Treatment
-----------------
* Device: Arthrodesis
* Device: Cartiva


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years of age Osteoarthritis of the first metatarsophalangeal joint and is a candidate for arthrodesis Presence of good bone stock Capable of completing self-administered questionnaires Exclusion Criteria: < 18 years of age Osteoarthritis of the first metatarsophalangeal joint, though is not a candidate for arthrodesis Active bacterial infection of the foot Additional ipsilateral limb (hip, knee, ankle, or foot) pathology that requires active treatment (surgery or brace)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arthrodesis<br>Fusion | Device: Arthrodesis<br>* arthrodesis using screws and/or a plate<br>|
| Experimental: Cartiva<br>Synthetic Cartilage Implant | Device: Cartiva<br>* Cartiva Synthetic Cartilage Implant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS, FAAM, Safety | The individual components of the primary outcome measures will be Visual Analog Scale (VAS) Pain, Foot and Ankle Ability Measure (FAAM) Sports sub-scale score and absence of key safety issues. | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
First MTP Joint, Hallux Rigidus, Hallux Limitus, Cartilage Replacement, Osteoarthritis, First MTP Joint Osteoarthritis, Big Toe Pain
Validation of Software for Assessment of Atrial Fibrillation From PPG Data Acquired by a Wearable Smartwatch

Study Overview
=================
Brief Summary
-----------------
Validate the Fitbit PPG RhythmDetect Software System algorithm for providing notifications by identifying rhythms suggestive of atrial fibrillation or atrial flutter events.

Official Title
-----------------
Fitbit Atrial Fibrillation From PPG Data Validation Study

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Diagnostic Test: Single lead ambulatory ECG patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 22 years of age or older Capable of giving informed consent U.S. resident No prior history of atrial fibrillation or atrial flutter Fitbit account, with one of the following devices paired: Ionic, Versa, Versa Lite, Versa 2, Versa 3, Charge 3, Charge 4, Inspire HR, Inspire 2, or Sense updated to the latest available firmware. Exclusion Criteria: Diagnosis or history of Atrial Fibrillation at time of consent Diagnosis or history of Atrial Flutter at time of consent Current use of anticoagulation medication Cardiac pacemaker or implantable cardioverter-defibrillator

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Detection Notification<br>Pulse rate data will be collected from a commercial device worn on the wrist. ECG will be collected from a single lead ambulatory ECG patch worn on the chest. The data from both the commercial wrist-worn device and the ECG patch are not analyzed real-time. | Diagnostic Test: Single lead ambulatory ECG patch<br>* Single lead ambulatory ECG patch worn on the chest<br>|
| No Intervention: Non Detection Notification<br>Pulse rate data will be collected from a commercial device worn on the wrist. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Simultaneous measurement of AF ≥ 30 seconds with detection | Simultaneous measurement of AF ≥ 30 seconds on ECG patch monitor during any of the pulse tachograms that generate the first Irregular Heart Rhythm Detection during ECG monitoring. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Simultaneous measurement of AF ≥ 30 seconds with pulse tachograms | Simultaneous measurement of AF ≥ 30 seconds on the ECG patch monitor during each of the pulse tachograms that contributed to the first Irregular Heart Rhythm Detection, among those detections confirmed by ECG. | 7 days |