linjc16/ctgov huggingface dataset:
Clinical Effects of Locally-delivered Gel Containing Camella Sinensis Extracts as an Adjunct in Peridontitis Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate clinical result including plaque index, gingival inflammation, bleeding score, pocket depth reduction and clinical attachment level gain after used locally-delivered gel containing Camella sinensis extracts as an adjunctive treatment in periodontal therapy

Official Title
-----------------
Clinical Effects of Locally-delivered Gel Containing Camella Sinensis Extracts

Conditions
-----------------
Periodontitis

Intervention / Treatment
-----------------
* Drug: Camella sinensis gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects have sound tooth with pocket depth = or > 5 mm. without caries, restoration, mobility and furcation involvement no systemic complicated factors no allergy to green tea or product of green tea signing in informed consent form Exclusion Criteria: smoking pregnancy or lactation antibiotic premedication or antibiotic intake in previous 3 month

Ages Eligible for Study
-----------------
Minimum Age: 34 Years
Maximum Age: 74 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gel a<br> | Drug: Camella sinensis gel<br>* clinical effect of locally-delivered gel between Camella sinensis and placebo<br>|
| Placebo Comparator: gel b<br> | Drug: Camella sinensis gel<br>* clinical effect of locally-delivered gel between Camella sinensis and placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pocket depth reduction, clinical attachment level gain, gingival index, bleeding score |  | baseline, 1, 3 and 6 month after gel had loaded | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plaque index |  | baseline, 1, 3, and 6 month after gel had loaded |
The Antigagging Effect of Granisetron (Kytril), an Antiemetic Drug, in Dental Situations

Study Overview
=================
Brief Summary
-----------------
Antigagging effect of kytril (granisetron) an antiemetic drug in dental situations Gagging in dental situations can be a problem to the patient and the operating dentist. There are not proven methods of eliminating this reflex which sometimes will not allow routine quality dental care. Pharmacological and behavioral approaches to eliminate this reflex have been tried with limited success. This suggested study will test a potent antiemetic drug used in other clinical situations such as antineoplastic treatment. Granisetron is a potential antagonist for the 5-hydroxytryptamine3-receptor - 5HT(3), The drug binds to the receptor and blocks the effect of nausea and vomiting. Kytril mechanism of action was successfully proven for various medical situations as a potential antiemetic agent. Our Center for dental sedation and anesthesia in the oral medicine department have received approval to use Granisetron as an antigagging drug in dental situations based on several pilot studies conducted in other medical centers in different clinical situations such as strabismus corrections, post hysterectomy and others. Our preliminary clinical impression is that pre-emptive IV administration of this drug to patients with increased gag reflex is beneficial. In our research we try to investigate the possibility of using kytril in dental situations. In the first stage of this research we will study the INTRAVENOUS use of this drug and its effects On normal subjects compare them to themselves with placebo. According to the results of this study we will go on to the second stage of the research and try the same drug under oral administration. The purpose of this study is to test the antigagging effect of this drug in a controlled manner in dental situations. Our working hypothesis is that administration of this drug in dental situations with success, will allow many patients to receive good dental care

Conditions
-----------------
Antiggaging Effect, Antiemetic, Granisetron, Gag Reflex, Dental Situations

Intervention / Treatment
-----------------
* Drug: GRANISETRON


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal subjects Exclusion Criteria: presence of systemic disease subjects under medication or drug or food complementary agents

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Test of Iron Malabsorption in Patients With Iron Deficiency Anemia

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to develop a simple, noninvasive test for evaluation of iron absorption as a tool to determine the cause of iron deficiency anemia. Healthy, premenopausal women with iron deficiency with or without anemia will be recruited for the study. Participants will, over the course of two months, ingest an iron solution three times; after each iron ingestion, participants will collect their stool and bring it to the study investigators for assessment of iron content.

Conditions
-----------------
Iron Deficiency Anemia

Intervention / Treatment
-----------------
* Drug: stable isotope of iron, dysprosium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ferritin <40 Exclusion Criteria: pregnant, post-partum, s/p GIT surgery, known malabsorption, coeliac disease, Helicobacter pylori

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: stable isotope of iron, dysprosium|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| initial mucosal uptake of iron |  |  | 
| intra- and inter-individual variability |  |  | 
| red cell incorporation of iron |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anemia, iron deficiency anemia, iron deficiency, absorption, iron absorption, iron uptake
Acceptability Lactoserum (Dermacyd Delicata - New Fragrance)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Femina Delicata.

Official Title
-----------------
Safety Dermatological Evaluation of the Acceptability With Gynecological Follow up for Dermacyd Femina Delicata

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: Lactoserum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Integral skin in the tested region Exclusion Criteria: Pregnancy or breastfeeding women Use of Anti-inflammatory or immune-suppression drugs Topical medication use at the tested region Active cutaneous gynaecological disease which may interfere in study results Personal history of allergic disease at the area to be treated Allergic or atopic history The above information is not intended to contain considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and local tolerability |  | 21 days | 
| Adverse events and their association with the treatment. |  | 21 days |
The Effect of Pregnancy on the PK of Isentress®: A Longitudinal Investigation in the Second and Third Trimesters

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether pregnancy affects the blood concentrations of raltegravir by comparing the second trimester and third trimester drug concentrations with post partum.

Official Title
-----------------
The Effect of Pregnancy on the Pharmacokinetics of Isentress®: A Longitudinal Investigation in the Second and Third Trimesters

Conditions
-----------------
HIV, Pregnancy

Intervention / Treatment
-----------------
* Other: Pharmacokinetics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV Infected Pregnant At least 18 years of age Planning to initiate or currently received raltegravir as part of an antiretroviral regimen with plans to continue at least 8-10 weeks post partum Exclusion Criteria: Less than 18 years of age Hemoglobin <9 g/dL or Hematocrit <27.3 at screening

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Raltegravir in Pregnancy<br>HIV positive pregnant women currently on raltegravir as part of combination antiretroviral therapy | Other: Pharmacokinetics<br>* Up to three 12 hour PK sampling sessions, one in the second trimester, one in the third trimester and one post partum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Heat Wrap Device Safety With Age and Body Fat

Study Overview
=================
Brief Summary
-----------------
This study is designed to compare the safety, as measured by skin findings and adverse events, of two different heat devices in elderly, overweight, and elderly and overweight subjects.

Detailed Description
-----------------
Safety measurements

Official Title
-----------------
An Open Label Study To Compare The Effects Of Age And Body Fat On The Safety Of Two Heat Wrap Devices In Healthy Subjects

Conditions
-----------------
Back Pain

Intervention / Treatment
-----------------
* Device: thermal therapy
* Device: marketed heatwrap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females in generally good health, and who are either 18-54 years of age with a body mass index of ≥ 30 kg/m2 or 55-84 years of age and with a body mass index ≥ 30 kg/m2 or < 30 kg/m2 Females who are not pregnant or breastfeeding Subject is medically cleared for study participation Exclusion Criteria: No sensitivity or allergy to device components in contact with skin Diabetes Any active skin disease or tattoos at the test site that would affect participation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 84 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>thermal therapy | Device: thermal therapy<br>* heat therapy device, topical, two applications, at 0-3 hours and 4-6 hours on treatment day<br>|
| Active Comparator: Treatment B<br>ThermaCare Lower Back/Hip heatwrap | Device: marketed heatwrap<br>* heatwrap, topical, one time application, 8 hour duration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with any thermal-related skin events (defined as elevated skin response, erythema ≥ 2.0 [moderate], or pain upon touch plus non-zero erythema) |  | morning after product wear through 15 days after last product application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with any adverse event |  | during and after wear for 28 days after last wear | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heat, device, safety, performance, heatwrap, elderly, overweight
Phase 1 Study of Daewon-ES(B) & Megace in Healthy Male Volunteers Under Fasting and Fed Condition

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(B) 625mg/5ml and Megace 800mg/20ml in healthy male volunteers under fasting and fed condition.

Official Title
-----------------
A Randomized, Open Label, Single Dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of DW-ES(B) and Megace® Under Fasting and Fed Conditions in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: Megace
* Drug: DW-ES(B)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males aged 20 to 40 years at screening. No significant congenital/chronic disease. No symptoms in physical examination. Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis. Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation. Exclusion Criteria: History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders. History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Megace / Fasting condition<br>800mg | Drug: Megace<br>* 800mg<br>|
| Experimental: DW-ES(B) / Fasting condition<br>625mg | Drug: DW-ES(B)<br>* 625mg<br>|
| Active Comparator: Megace / Fed condition<br>800mg | Drug: Megace<br>* 800mg<br>|
| Experimental: DW-ES(B) / Fed condition<br>625mg | Drug: DW-ES(B)<br>* 625mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (normal results for safety tests) | Adverse events Physical examination, vital signs | 30days |
Study of Fibrinogen Metabolism During Severe Trauma and Burns

Study Overview
=================
Brief Summary
-----------------
To study the fibrinogen metabolic changes in relation to coagulation disorder in patients with severe burns and trauma injuries. As a result of the burn or trauma injury breakdown of fibrinogen is accelerated.

Detailed Description
-----------------
In this protocol, we will investigate fibrinogen metabolism in burn and trauma patients, using an 8h infusion of stable isotopes labeled amino acids (1-13C-phenylalanine, 2H5-phenylalanine, and 2H3-ketoisocaporate). The increase of the labeled amino acids incorporating into fibrinogen during the infusion and the decay of labeled fibrinogen after stopping the isotopes infusion (as measured by GC-MS) will be used to calculate fibrinogen synthesis and degradation. Stable isotopes are non-radioactive.

Official Title
-----------------
Alteration in Fibrinogen Metabolism in Patients With Severe Burns and Traumatic Injuries

Conditions
-----------------
Burn Injury, Major Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20% total body surface area burn or more severe trauma with injury severity score greater than 10 between ages of 18 and 65 years Exclusion Criteria: history of blood clotting disorder history of liver disease such as cirrhosis or hepatitis pregnant or nursing allergic to iodine, shellfish or dye used in X-Rays taking long term medications for blood clotting usch as Coumadin or Plavix prisoners receiving total parenteral nutrition

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Volunteers<br>Healthy Volunteers | |
| Burn patients<br>Patients who have sustained burn injury greater than or equal to 20% of total body surface area | |
| Trauma patients<br>Patients who have undergone trauma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| During the flow phase following burn or trauma injury, fibrinogen degradation is accelerated |  | 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibrinogen degradation stimulates fibrinogen synthesis at the expense of whole body protein catabolism |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fibrinogen, burns, trauma, metabolism
Safety, Tolerability and Renal Effects of APX-115 in Subjects With Type 2 Diabetes and Nephropathy

Study Overview
=================
Brief Summary
-----------------
This is a proof of concept (PoC) trial to evaluate the safety, tolerability and renal effect of APX-115 in subjects with Type 2 diabetes and nephropathy.

Official Title
-----------------
A Randomized, Placebo-controlled, Double-blinded, Multi-centre, Phase 2 Study to Assess Safety, Tolerability and Renal Effects of APX-115 in Subjects With Type 2 Diabetes and Nephropathy

Conditions
-----------------
Diabetic Nephropathies, Diabetes Mellitus, Type 2, Nephropathy, Diabetic

Intervention / Treatment
-----------------
* Drug: APX-115
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical Diagnosis of type 2 diabetes and nephropathy First morning void (FMV) UACR between 200 and 3000 mg/g, inclusive 30 mL/min/1.73m2 ≤ eGFR ≤ 90 mL/min/1.73m2 using CKD-EPI formula at screening HbA1c ≤ 10% at screening visit Subject who has been taking unchanged dosage of ACE inhibitor or ARB medication for at least 3 months prior to screening and is not anticipated to change its dosage during the course of the study Willing to be under dietary management for diabetes Exclusion Criteria: History of type 1 diabetes mellitus or gestational diabetes Subject's renal impairment and/or albuminuria is considered to be of origin other than Diabetic Kidney Disease Subject with uncontrolled blood pressure Clinically significant abnormal laboratory findings History of any cardiovascular event within 6 months prior to screening or cardiovascular procedure planned during the clinical trial Diagnostic or interventional procedure requiring a contrast agent within 4 weeks before the screening visit or planned during the course of the study Clinically significant ECG abnormalities on a 12-lead ECG at the screening visit or before randomization Current or history of NYHA class IV heart failure

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APX-115<br>Oral administration of APX-115 400mg, daily | Drug: APX-115<br>* oral administration of APX-115 400mg capsule once daily for 12 weeks<br>|
| Placebo Comparator: Placebo<br>Oral administration of APX-115-matching placebo 400mg, daily | Drug: Placebo<br>* oral administration of APX-115-matching placebo 400mg capsule once daily for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in urine albumin to creatinine ratio (UACR) in APX-115 group compared to placebo group |  | week 12 |