linjc16/ctgov huggingface dataset:
Pre Emptive Analgesics for Pain Relief in Impacted Lower Third Molar Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the efficacy of pre-emptive paracetamol in reducing intra operative pressure and post operative pain after surgical removal of impacted mandibular third molar using visual analogue scale

Official Title
-----------------
Pre-emptive Analgesics for Additional Pain Relief in Impacted Third Molar Surgery by depositing4% Articaine With 1:200000 Epinephrine Using Vazirani-Akinosi Closed Mouth Technique- A Randomized Clinical Trial

Conditions
-----------------
Impacted Third Molar Tooth

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 21 years and above Healthy patients (ASA I) Patients who are not allergic to the drugs and local anesthetic agents used Exclusion Criteria: Patients who are on concurrent treatment with NSAIDs or corticosteroids Patients with pericoronitis or periapical infection

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paracetamol<br>Paracetamol | Drug: paracetamol<br>* tablet paracetamol 500 mg<br>* Other names: Paracetamol 500 mg;|
| Placebo Comparator: Placebo<br>placebo | Drug: Placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative pain | A 10 mm Visual Analogue Scale with higher score depicting severe pain | during luxation of tooth | 
| postoperative pain | A 10 mm Visual analogue scale with higher score depicting severe pain | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to rescue medication | minutes | upto 360 minutes | 
| number of patients taking rescue medications | Total number of patients taking rescue medications | Upto 360 minutes |
Does Mirabegron Have a Positive Impact on Sexual Function in Females With Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
80 female patients evaluated for sexual function after receiving Mirabegron 50 mg once daily for 6 months for treatment of overactive bladder symptoms

Detailed Description
-----------------
80 female patients evaluated for sexual function after receiving Mirabegron 50 mg once daily for 6 months for treatment of overactive bladder symptoms

Official Title
-----------------
Does Mirabegron Have a Positive Impact on Sexual Function in Females With Overactive Bladder ?

Conditions
-----------------
Females With Overactive Bladder Symptoms, Urgency & Urge Incontinence

Intervention / Treatment
-----------------
* Drug: Follow up of female sexual function


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any female with overactive bladder symptoms, urgency and urgency incontinence Exclusion Criteria: neurologic abnormalities Weak bladder contractility Diabetics
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Follow up of female sexual function|Mirabegron 50mg once daily for treatment of overactive bladder symptoms|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual function evaluation after 6 months | Sexual function evaluation using female sexual function index FSFI | 6 months |
Discarded Materials Study

Study Overview
=================
Brief Summary
-----------------
Use of discarded embryos to advance laboratory expertise and technology in the area of human embryo development and assisted reproductive technologies

Detailed Description
-----------------
1- Testing methods or freezing before implementing techniques. 2- Develop cell surgery and micromanipulation techniques. 3- Develop methods to optimize the determinations of genes and chromosomes 4- Quality-assess laboratory equipment. 5- Test proficiency of laboratory staff. 6- Analyze what effects the early development of embryos. 7- Develop new methods and media to allow for higher survival rates of embryos. 8- Develop non-invasive tests for predicting embryo quality to predict IVF success.

Official Title
-----------------
Laboratory Evaluation of De-identified, Developmentally Arrested Embryos of Embryos Diagnosed as Having an Abnormal Number of Chromosomes for Optimization of Techniques for Assisted Reproduction

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: none Exclusion Criteria: none

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methods for freezing -embryos | To test, standardize and implement better methods for the freezing embryos prior to these techniques being used in the clinical setting | duration of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development non-invasive tests | To develop non-invasive tests for predicting embryo quality as well as IVF success | duration of the study | 
| Factors that control embryo development | To analyze embryos to learn more about what controls their early development and function. | duration of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVF
Long-Term Treatment Effect of DiaPep277 in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The study is an open-label extension study, offering patients who participated and completed previous study 901 to continue treatment with DiaPep277 and clinical follow-up, for 2 additional years. The expectation is first to demonstrate that extended treatment with DiaPep277 is safe and second to evaluate the long-term effectiveness of treatment. Only patients who completed the previous 2-year study and still have beta-cell function above a threshold level will be eligible for this extension study.

Official Title
-----------------
Open Label Study to Evaluate Long Term Treatment Effect of DiaPep277® in Patients Who Have Completed Studies 461* (Phase II) or 901** (Pase III)

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Drug: DiaPep277


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A patient that participated in previous 461/PO and 901 studies and received all doses of study medication, per protocol. Evidence of clinically significant residual beta-cell function demonstrated by MMTT stimulated C-peptide concentrations ≥ 0.20 nmol/L. Exclusion Criteria: The patient is pregnant or intends to become pregnant or is unwilling to use effective contraceptive method throughout the study. The subject has clinical evidence of any diabetes-related complication, or severe allergy or immune deficiency.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 48 Years

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: 1<br> | Drug: DiaPep277<br>* 1.0mg dose, injected subcutaneously at baseline and every 3 months thereafter (at 0, 3, 6, 9, 12, 15, 18, 21 months)for a total of 8 administrations.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preservation of endogenous insulin secretion/beta-cell function, as measured by mixed-meal tolerance test stimulated C-peptide secretion. |  | every 6 months up to 24 months from T0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improved metabolic control and the insulin dose required to maintain it. |  | every 3 months up to 24 months from T0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 1 diabetes, beta cells, immunomodulation, immunointervention
A Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of LC28-0126.

Study Overview
=================
Brief Summary
-----------------
To assess the safety, tolerability and pharmacokinetic characteristics of LC-28-0126 multiple iv injection in healthy male subjects.

Official Title
-----------------
A Dose Blocked-randomized, Double-blind, Placebo-controlled, Multiple Dosing and Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of LC28-0126 in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: LC28-0126
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects between the ages of 19 and 45 years at screening. Subjects with BMI between 18.0(inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive) Exclusion Criteria: Participation in a clinical research study within the previous 3 months Regular alcohol consumption >21 units per week.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LC28-0126<br>LC28-0126(IV) | Drug: LC28-0126<br>* LC28-0126<br>|
| Placebo Comparator: Placebo<br>Placebo of LC28-0126 | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 18 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | up to 6 days post-dose | 
| AUC |  | up to 6 days post-dose |
Optical Coherence Tomography of Airway and Pleural Disorders

Study Overview
=================
Brief Summary
-----------------
The researcher can use Optical coherence tomography a near-infrared diode to emit light that can produce images of the specimen under investigation and provide information about tissue abnormalities without causing damage.

Detailed Description
-----------------
The researcher can use Optical coherence tomography endoscopic imaging to improve diagnosis and treatment of airway and pleural malignancy. In the events of burn injury and smoke inhalation injury, the Optical coherence tomography can determine the change of the airway tissues and severity of airway injury. During endoscopic procedure the lesions will be biopsied and prepared by standard histologic methods. The Optical coherence tomography endoscopic imaging can measured histologic of the tissue samples and compared to standard histologic examination. The Optical coherence tomography endoscopic imaging can measured the epithelial thickness and compared to visual inspection of the mucosa on bronchoscopy.

Official Title
-----------------
Optical Coherence Tomography of Airway and Pleural Disorders

Conditions
-----------------
Disorder of Pleura and Pleural Cavity

Intervention / Treatment
-----------------
* Device: Optical Coherence Tomography imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult 18 or older, male or female. Plans for bronchoscopic with possible biopsy procedures. Exclusion Criteria: Age less than 18 years of age Not plan for bronchoscopic with possible biopsy procedures. Pregnant or breastfeeding.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Airway and Pleural Disorders<br>Optical Coherence Tomography imaging | Device: Optical Coherence Tomography imaging<br>* Optical Coherence Tomography imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| histopathology |  | up to 4 weeks |
24 Month Extension to Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients(Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients

Study Overview
=================
Brief Summary
-----------------
This study will provide continued treatment and assess the long term safety, efficacy and tolerability of oral AEB071 plus tacrolimus vs. mycophenolic acid plus tacrolimus after kidney transplantation.

Official Title
-----------------
A 24 Month Extension to a 12-month Open Label, Randomized, Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients

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

Intervention / Treatment
-----------------
* Drug: AEB071
* Drug: mycophenolic plus tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Participation in core study CAEB071A2203 The patient has been maintained on AEB071/mycophenolic acid or tacrolimus/mycophenolic acid, consistent with their original randomization, at their core study Month 12 visit. Women capable of becoming pregnant are required to practice a medically approved method of birth control as long as they are on study medication and for a period of 3 months following discontinuation of study drug(s). Exclusion criteria: Pregnancy. Other protocol-defined inclusion/exclusion criteria may apply

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>mycophenolic and tacrolimus | Drug: mycophenolic plus tacrolimus<br>* 720mg b.i.d. 2yrs<br>|
| Experimental: 2<br>mycophenolic and tacrolimus | Drug: AEB071<br>* 200mg oral b.i.d.<br>* Other names: mycophenolic plus tacrolimus;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term safety assessed by and renal safety defined by measuring renal function using Modification of Diet in Renal Disease (MDRD) formula for Glomerular Filtration Rate (GFR) beyond 12 months. |  | three Yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy assessed by: the incidence over 36 months of the composite endpoint of biopsy proven rejection ≥ 1A, graft loss, death, or loss to follow-up in the two study arms. |  | Three yrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kidney transplantation, rejection, AEB071, tacrolimus, mycophenolic acid, immunosuppression
GAPcare Fall Prevention Pilot Survey

Study Overview
=================
Brief Summary
-----------------
GAPcare (Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention) is an early stage investigation that surveys older adults who present to the Emergency Department for any illness to determine the feasibility of an Emergency Department (ED)-based multidisciplinary intervention for preventing recurrent falls in older adults. In this observational study, older adults will be approached during routine clinical care in the ED and asked about prior falls, prior experiences having falls treated in the inpatient and outpatient setting, and the investigators will solicit feedback on potential improvement to care in the ED setting for falls.

Official Title
-----------------
GAPcare: The Geriatric Acute and Post-acute Care Coordination Program - Pilot Survey

Conditions
-----------------
Fall

Intervention / Treatment
-----------------
* Other: Exposure: Fall


Participation Criteria
=================
Eligibility Criteria
-----------------
Study inclusion criteria for GAPcare Adult 65 years-old or older Able to communicate in English No cognitive impairment (≥4 on SIS) Exclusion criteria • Unable to give informed consent due to intoxication or altered mental status

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Exposure: Fall|Participants will be asked about prior falls|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of enrollment | The investigators will assess the number of patients who were screened and enrolled at the study site | at study enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of preventative services offered after a prior fall | Participant will be asked what services they were provided after prior falls. | at study enrollment | 
| Satisfaction with prior Emergency Department evaluations after a fall using a likert scale | Participant will be asked about their satisfaction with prior fall assessments in the ED. | at study enrollment | 
| Feedback on prior fall evaluations | Participants will give free-text feedback on their perception of the quality of prior outpatient and inpatient fall care | at study enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
geriatric
A Brief Intervention for Patients on Opioids for Acute Pain

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate benefits of a brief intervention for patients who are prescribed opioids for acute pain.

Official Title
-----------------
A Brief Intervention for Patients on Opioids for Acute Pain

Conditions
-----------------
Acute Pain

Intervention / Treatment
-----------------
* Behavioral: Mindfulness
* Other: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are admitted to Henry Ford Hospital Patients who have been evaluated by the Psychosomatic Medicine Service Patients who are prescribed at least one opioid for an acute pain condition Exclusion Criteria: Patients taking an opioid for a chronic pain condition within the previous year History of an opioid use disorder.

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 |
| --- | --- |
| Experimental: Intervention<br>Participants will learn a brief, mindfulness skill | Behavioral: Mindfulness<br>* Patients will learn how to use diaphragmatic breathing with mindfulness<br>|
| Placebo Comparator: Education<br>Participants will receive education about the effects of emotions on pain | Other: Education<br>* Patients will be provided with education regarding the Gate Control Theory of Pain.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain severity | Pain severity rated on a 0-10 scale | Change from pre- to post-intervention. The intervention is approximately 10 minutes so the measurements are taken about 10 minutes apart. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress level | Stress level rated on a 0-10 scale | Change from pre- to post-intervention. The intervention is approximately 10 minutes so the measurements are taken about 10 minutes apart |