linjc16/ctgov huggingface dataset:
Silver Diamine Fluoride Gel: Case Series

Study Overview
=================
Brief Summary
-----------------
A clinical case series to determine the clinical response of dental caries lesions in primary teeth where 38% silver diamine fluoride gel is applied and cover with 2.5% sodium fluoride varnish. Additionally, to assess parent satisfaction with treatment with 38% silver diamine fluoride.

Detailed Description
-----------------
A clinical case series of 235 children ages 3 and 4 with severe early childhood caries where the lesions are treated with 38% silver diamine fluoride and covered with 2.5% sodium fluoride varnish at baseline and 6 months. The primary objective is to determine the response of dental caries lesions (caries arrest) into the dentin in primary teeth at one year of follow-up. The secondary objective is to assess parent satisfaction with treatment with 38% silver diamine fluoride and 2.5% sodium fluoride varnish.

Official Title
-----------------
Evaluation of the Response of Caries Lesions in Dentin After Application of Silver Diamine Fluoride Gel: A Case Series

Conditions
-----------------
Dental Caries in Children

Intervention / Treatment
-----------------
* Device: Silver Diamine Fluoride/Sodium Fluoride Varnish


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least one active caries lesion Good general health by parent report Exclusion Criteria: Unable to cooperate with exam or procedure

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 4 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SDF/FV<br>Topical Application of 38% silver diamine fluoride and 2.5% sodium fluoride varnish at baseline and 6 months | Device: Silver Diamine Fluoride/Sodium Fluoride Varnish<br>* Application of dental caries arresting topical medication<br>* Other names: Fluorimax 2.5% Sodium Fluoride Varnish;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion Activity | Caries Lesion Arrest | 5 months | 
| Lesion Activity | Caries Lesion Arrest | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries Increment | Caries Increment (d2-4mfs) | 5 months | 
| Caries Increment | Caries Increment (d2-4mfs) | 12 months | 
| New Caries Lesions | Rate of New Caries Lesions ((d2-4mfs) | 5 months | 
| New Caries Lesions | Rate of New Caries Lesions ((d2-4mfs) | 12 months | 
| Satisfaction with Color Changes in Teeth | Bothered by Color Changes in the teeth (1-10 scale) | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Silver Diamine Fluoride, Sodium Fluoride Varnish, Dental Caries, Primary Dentition, Peru
Perineal Body Length and Perineal Lacerations

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the relationship between perineal body length and perineal laceration risk in primigravid patients. Primigravid women with singleton pregnancies in the first stage of labor at the 35th week of gestation were included in the study. The peineal body length of the patients was measured by the same physician.

Detailed Description
-----------------
After 35 weeks of gestation, nulliparous women with single gestation were included in the study and genital hiatus and perineal body measurements were taken. The presence and degree of perineal laceration after birth were determined. Correlation of genital hiatus and perineal body measurements with perineal laceration risk were evaluated. After birth, vaginal laceration, oxytocin use, fetal birth weight, the presence of episiotomy were recorded.

Official Title
-----------------
Perineal Body Length and Perineal Lacerations During Delivery in Primigravid Patients

Conditions
-----------------
Perineal Laceration Involving Skin, Delivery; Trauma

Intervention / Treatment
-----------------
* Other: Primigravid women with singleton pregnancy at 35th week over


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Primigravid women with singleton pregnancy at over 35th week Exclusion Criteria: the story of operative vaginal birth; caesarean section; breech presentation; those with a history of anorectal surgery or trauma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Primigravid women with singleton pregnancy at 35th week over|Primigravid women with singleton pregnancy at 35th week over; only observational study will be done in this group and the data will be recorded.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perineal body length | The length of the perineal body will be measured in centimeters. | during delivery | 
| perineal laceration | Laceration measurement 1.-2.-3.-4. degree. The measurement of laceration will be graded. st degree laceration is the tears formed in the vaginal epithelium and perineum skin. nd degree laceration includes perineal muscles. 3. Degree lacerations extend to the anal sphinkter complex. In the 4th degree laceration, the anal epithelium / rectal mucosa was also torn. | during delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| genital hiatus length | The length of the genital hiatus will be measured in centimeters. | during delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
perineal laceration, obstetric trauma
Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide 100 mg /25 mg Tablet Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of losartan potassium/hydrochlorothiazide 100/25 mg tablet under fed conditions.

Official Title
-----------------
A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide Tablets 100 mg/25 mg Under Fed Conditions

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: losartan potassium hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to losartan potassium hydrochlorothiazide or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: losartan potassium hydrochlorothiazide|100 mg / 25 mg tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence determined by statistical comparison Cmax |  | 25 days |
Novel Therapies for Essential Tremor

Study Overview
=================
Brief Summary
-----------------
This clinical research program is designed to evaluate medications as new treatments for essential tremor. Essential tremor is a common condition with few available therapies.

Detailed Description
-----------------
Each medication will be evaluated for effectiveness against tremor in a randomized, placebo-controlled, cross-over, double blind clinical research trial. Tremor will be assessed with accepted rating scales and accelerometry

Official Title
-----------------
Novel Therapies for Essential Tremor

Conditions
-----------------
Essential Tremor

Intervention / Treatment
-----------------
* Drug: treatments for essential tremor


Participation Criteria
=================
Eligibility Criteria
-----------------
Diagnosis of essential tremor. Tremor rating scale score 3 or one or both upper extremities Unsatisfactory response to primidone or to propanolol Not taking tremor-inducing drug Able to comply with visits

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: treatments for essential tremor|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A 10-Week Study for Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of an investigational anti-anxiety medication relative to placebo in patients with generalized anxiety disorder (GAD).

Official Title
-----------------
A 10-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dosage Study to Evaluate the Efficacy and Safety of Gabitril(up to 16 mg/Day) in the Treatment of Adults With Generalized Anxiety Disorder

Conditions
-----------------
Generalized Anxiety Disorder

Intervention / Treatment
-----------------
* Drug: Gabitril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Subjects 18 to 64 years of age (inclusive) will be eligible to participate if they satisfy the DSM-IV-TR criteria for GAD, as well as meeting the required screening and baseline visit scores for a series of psychiatric evaluations (i.e., HAM-A, HADS, MADRS and CGI-S). Exclusion Criteria: Have been previously unresponsive to two or more adequate courses of pharmacological treatment for GAD Have been diagnosed with any other psychiatric Axis I disorder (except GAD) as a principal diagnosis within the past six months Have been diagnosed with any eating disorder within the past six months Have any history of OCD, psychotic disorder, bipolar disorder or antisocial personality disorder Have any history of alcohol or substance abuse within 3 months of screening Have any history of seizures, including febrile seizures Have any history of head trauma associated with loss of consciousness within the past 15 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gabitril|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of symptomatology associated with Generalized Anxiety Disorder as assessed by the change from baseline to endpoint in the total score of the HAM-A scale. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of proportion of responders and patients in remission according to HAM-A scores and CGI ratings by visit, assessment of the safety and tolerability in patients with GAD |  |  |
Biological Markers for the Diagnosis of Central Nervous System Infective Diseases

Study Overview
=================
Brief Summary
-----------------
Bacterial meningitis is a potentially life-threatening disease that is associated with substantial neurological morbidity and mortality. Accurate diagnosis is essential to improve outcome and prevent antibiotic overuse. Here we try to explore new biological markers for the diagnosis of the central nervous system infection disease.

Detailed Description
-----------------
To investigate the diagnosis value of procalcitonin,interleukin-6, agiotensininⅡin the cerebrospinal fluid in the central nervous system infection disease.

Official Title
-----------------
Diagnosis Value of Procalcitonin, Interleukin-6, AgiotensininⅡin the Cerebrospinal Fluid of Patients With Central Nervous System Infective Diseases

Conditions
-----------------
Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 13 years or older; At least two of the following clinical characteristics:headache, fever, neck stiffness, mental symptoms or consciousness impairment or seizures Patients' family signed informed consent. Exclusion Criteria: Contraindications to lumbar puncture Patients with active malignancy

Ages Eligible for Study
-----------------
Minimum Age: 13 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 |
| --- | --- | --- |
| Levels of procalcitonin, interleukin-6, agiotensininⅡ in the serum and cerebrospinal fluid | meet the clinical diagnostic criteria for the central nervous system infection disease, the blood and cerebrospinal fluid samples after onset. | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
procalcitonin, interleukin-6, agiotensininⅡ
Incidence of Anesthesia-related Adverse Events and Obstetric Complications After Cesarean Delivery

Study Overview
=================
Brief Summary
-----------------
Recruit the parturients who underwent cesarean delivery at Far Eastern MemorialHospital during 2012-2016. After reviewing medical record related to the pregnancy, demographic data, prenatal exam, laboratory data, indication for cesarean section, perioperative events, etc. will be recorded. Analysis will be focused on incidence, temporal trend, and risk factors of anesthesia-related adverse events and obstetric complications.

Official Title
-----------------
Incidence of Anesthesia-related Adverse Events and Obstetric Complications After Cesarean Delivery: a Retrospective Study

Conditions
-----------------
Anesthesia; Adverse Effect, in Labor and Delivery

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all parturients underwent cesarean section at Far Eastern Memorial Hospital during 2012-2016 Exclusion Criteria: missing data can't be collect during medical chart review

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cesarean<br> | Other: Observation<br>* Observation only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of anesthesia-related adverse events |  | Within 42 days after delivery |
The Effects of add-on Anti-diabetic Drugs in Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
Recently, there are some new classes of anti-diabetic drugs availible in Taiwan. In this study, we will observe the change in inflammation and energy homeostasis in type 2 diabetic outpatient, who receiving a new anti-diabetic drugs.

Detailed Description
-----------------
Recently, there are some new classes of anti-diabetic drugs availible in Taiwan. However, the effects of these anti-diabetic drugs should be further evaluated. Specially, the effects on inflammation and energy homeostasis are still not well assessed. In this study, we will observe the change in inflammation and energy homeostasis in type 2 diabetic outpatient, who receiving a new anti-diabetic drugs.

Official Title
-----------------
The Effects of add-on Anti-diabetic Drugs on Inflammation and Energy Homeostasis in Type 2 Diabetic Patients

Conditions
-----------------
Hyperglycemia

Intervention / Treatment
-----------------
* Drug: anti-diabetic drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic outpatient Exclusion Criteria: Refusal of anti-diabetic drugs Preganacy

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: anti-diabetic drug|Add-on anti-diabetic drug in type 2 diabetic patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain-Derived Neurotrophic Factor (BDNF) | energy homeostasis | 3 months | 
| Body-composition | energy homeostasis | 3 months | 
| Fasting glucose |  | 3 months | 
| Hypoglycemia |  | 3 months | 
| Vascular Cell Adhesion Molecule 1 (VCAM-1) | inflammation | 3 months | 
| Ankle-Brachial Index (ABI) | peripheral artery disease | 12 months | 
| Orexin-A |  | 3 months |
Dupilumab Compassionate Use Study

Study Overview
=================
Brief Summary
-----------------
This is a single patient expanded access, compassionate and non-emergency use study that provides patients with severe asthma, who do not qualify for ongoing clinical trials with dupilumab, access to this investigational treatment.

Detailed Description
-----------------
This study is being undertaken to determine whether dupilumab has efficacy in extremely severe asthma, and to allow a very severe asthma patient, who has been tried on nearly every immunosuppressive drug, early access to a potentially effective therapy. The patient will continue in the study indefinitely. Safety will be evaluated and serious adverse events will be reported.

Official Title
-----------------
Dupilumab Compassionate Use Study

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Dupilumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sever systemic corticosteroid dependent asthma for more than 5 years Exclusion Criteria: Disease other than asthma Circulation eosinophils more than 1500/ul Current smoker or more than 10 pack years This is a single-patient study. The University of Pittsburgh site is not enrolling new patients.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dupilumab|The patient will receive a 600 mg subcutaneous dupilumab loading dose on Day 1, and then 300 mg subcutaneous dupilumab every 2 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluation of the Motus GI CleanUp System During Screening Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Motus GI is developing a single-use device that attaches to a standard colonoscope, thereby integrating colon cleansing, screening and treatment into one procedure. The device creates turbulence within the colon using water jets. The colon's fecal fluids are evacuated by the system.

Official Title
-----------------
Evaluation of the Motus GI CleanUp System During Screening

Conditions
-----------------
CRC

Intervention / Treatment
-----------------
* Device: Motus GI Clean-Up Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects in the age range of 50-69 years Subjects who are considered for routine screening colonoscopy Subjects with BMI within the range of 18.5-30 Subject is willing to sign informed consent form Exclusion Criteria: History of GI diseases or history of Colorectal cancer (personal or family) Previous major abdominal surgeries Medical status ASA grater or equal to 3 Acute GI symptoms, such as bleeding, unexplained weight loss, inflammatory bowel disease (IBD). Patients taking anticoagulants (e.g., Coumadin, Heparin, Clopidrogrel) Life-threatening condition Subjects who are unable or unwilling to cooperate with study procedures Severe Diverticula

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 69 Years

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

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colonoscopy<br> | Device: Motus GI Clean-Up Device<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean of All Subjects Colon Segments BBPS>=2 | Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon). Summing all colon segments BBPS score of all participants dividing in the number of segments is expected to be >=2. | Following the colonoscopic procedure- Up to 24 hours. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonoscopy Cleaning