linjc16/ctgov huggingface dataset:
Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine

Study Overview
=================
Brief Summary
-----------------
Inpatient Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Mania: This study recruits adult subjects who are diagnosed with Bipolar I Disorder and presently experiencing an episode of mania. Patients must be willing to spend initial 7 days in the hospital to observe response to medication. Patients must be refractory (intolerant or non-responsive) to treatment with lithium and valproate or carbamazepine. Patients receive study-related care at no cost. This study is sponsored by Eli Lilly and Company.

Official Title
-----------------
Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Disorder Mania

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Olanzapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject satisfied Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a primary diagnosis of Bipolar Disorder, most recently manic The patient is willing to be hospitalized on an inpatient psychiatric unit for a minimum of seven (7) days. Subject has been treated with lithium in the past. Subject has been treated with divalproex or carbamazepine in the past. Subject has been treated with Haldol or haloperidol in the past. Exclusion Criteria: Subjects lacks the capacity to provide informed consent Subject is a serious suicide risk or has medically unstable conditions as judged by the investigators Subject has been dependent on a drug (other than nicotine or caffeine) in the last three (3) months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olanzapine<br>Subjects were be started on a standardized minimum first-day dose of 15 mg olanzapine. After the first day of therapy, the daily dose was either increased or decreased, as clinically indicated, by 5 mg, within an allowed range of 5 to 40 mg | Drug: Olanzapine<br> <br> * Other names: Zyprexa;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Young Mania Rating Scale (YMRS) |  | Change from Baseline to End of Study |
The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery

Study Overview
=================
Brief Summary
-----------------
Obtaining adequate hemostasis is crucial during endoscopic sinus surgery. Submucosal injection of local anaesthetic containing adrenaline has frequently been used to improve surgical milieu. However, injection of adrenaline has potential side effects including tachycardia, hypertension as well as inducing arrhythmia. The aim of this randomized clinical trial is to assess the hemodynamic and hemostatic effects of two different concentrations of adrenaline in local anaesthetic used during endoscopic sinus surgery.

Official Title
-----------------
The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery: Randomized Clinical Trial

Conditions
-----------------
Chronic Sinusitis

Intervention / Treatment
-----------------
* Drug: 1% lidocaine with 1:100,000 adrenaline
* Drug: 1% lidocaine with 1:200,000 adrenaline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recurrent acute sinusitis, chronic sinusitis, or nasal polyposis Exclusion Criteria: bleeding disorders, under age of 18, history of cardiac disease or on antihypertensive medications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1% lidocaine with 1:100000 adrenaline<br>high dose adrenaline | Drug: 1% lidocaine with 1:100,000 adrenaline<br>* high dose<br>|
| Active Comparator: 1% lidocaine with 1:200,000 adrenaline<br>low dose | Drug: 1% lidocaine with 1:200,000 adrenaline<br>* 1% lidocaine with 1:200,000 adrenaline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Intraoperative bleeding |  | during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic fluctuation |  | during surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoscopic sinus surgery
UTERUS CLOSURE TECHNIQUES and Uterine Niche Formation

Study Overview
=================
Brief Summary
-----------------
We aimed to compare 3 different uterotomy suture techniques with each other and evaluate them in terms of niche formation.1- one layer 2- double layer 3- purse string (TURAN technique)

Detailed Description
-----------------
It is thought that the formation of the uterine niche may be mostly due to the surgical technique.We aimed to compare 3 different uterotomy suture techniques with each other and evaluate them in terms of niche formation.1- one layer 2- double layer 3- purse string (TURAN technique).

Official Title
-----------------
COMPARISON OF SINGLE, DOUBLE LAYER AND PURSE STRING TECHNIQUE (TURAN TECHNIQUE) STUR TYPES IN TERMS OF THE FORMATION OF UTERINE NICH FOR CLOSING THE UTERUS DURING CESERIAN SECTION

Conditions
-----------------
Uterus; Scar

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have a cesarean section necessity be over 18 years old being younger than 40 Exclusion Criteria: emergency cesarean section Being under 37 weeks pregnant multiple pregnancies having had uterine surgery uterine malformations

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| single layer uterotomy<br>53 women with a single-layer uterotomy while closing the uterus during Ceserian | |
| double layer uterotomy<br>53 women with a double layer uterotomy while closing the uterus during Ceserian | |
| purse string uterotomy<br>53 women with a purse string uterotomy tecnique had used while closing the uterus during Ceserian | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the formation of a uterine niche | The formation of a niche will be considered a failure, while the absence of a niche will be considered a technical success. | 6 weeks |
BAY1830839: First in Man, Single Dose Escalation, Safety & Tolerability and Pharmacokinetics

Study Overview
=================
Brief Summary
-----------------
The primary objectives of this study are to investigate the safety and tolerability of increasing single oral doses of BAY 1830839 versus placebo under fasted conditions the pharmacokinetics after single ascending oral doses of BAY 1830839 under fasted conditions

Official Title
-----------------
Randomized, Placebo-controlled, Double-blind Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Increasing Single Oral Doses of BAY1830839 in Healthy Male Subjects

Conditions
-----------------
Arthritis, Rheumatoid

Intervention / Treatment
-----------------
* Drug: BAY1830839
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) : ≥18.5 and ≤30 kg/m*2 Exclusion Criteria: Relevant diseases within the last 4 weeks prior to the first study drug administration Febrile illness within 4 weeks before the first study drug administration Known hypersensitivity to the study drugs or components of the preparations Clinically relevant findings in the physical examination

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Dose escalation with safety assessment following each dose step.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY1830839<br>Single Dose escalations | Drug: BAY1830839<br>* Dose escalation in healthy male subjects<br>|
| Placebo Comparator: Placebo<br>Matching Placebo | Drug: Placebo<br>* Matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of BAY1830839 in plasma | AUC: area under the plasma concentration vs time curve from zero to infinity after single dose. | Day 1, 2, 3, 4, 6 ,7, 9, and 12 | 
| Cmax of BAY1830839 in plasma | maximum observed drug concentration in plasma after single dose administration | Day 1, 2, 3, 4, 6 ,7, 9, and 12 | 
| Frequency of treatment-emergent adverse events |  | From first application of study intervention up to 30 days after end of treatment | 
| Severity of treatment-emergent adverse events |  | From first application of study intervention up to 30 days after end of treatment |
The Effect of Infant Feeding on Stool Characteristics

Study Overview
=================
Brief Summary
-----------------
Infants will be fed infant formula and stool characteristics assessed.

Official Title
-----------------
The Effect of Infant Feeding on Stool Characteristics

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

Intervention / Treatment
-----------------
* Procedure: fecal bacteria analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, term infants 21-30 days of age Exclusion Criteria: Infants with feeding difficulties Use of antibiotics or steroids

Ages Eligible for Study
-----------------
Minimum Age: 21 Days
Maximum Age: 30 Days

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>cow-milk based infant formula | Procedure: fecal bacteria analysis<br>* ad lib feeding<br>|
| Experimental: 2<br>cow milk based infant formula with prebiotics | Procedure: fecal bacteria analysis<br>* ad lib feeding<br>|
| Other: 3<br>human milk reference group | Procedure: fecal bacteria analysis<br>* ad lib feeding<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fecal bacteria analysis |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intake, tolerance, stool characteristics, anthropometrics |  | 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy infants
18791 - Sun Protection Factor Assay

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor (SPF) efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay UVA Protection Factor Assay (UVAPF) Minimal Persistent Pigment-Darkening Dose (MPPD)

Conditions
-----------------
Sunscreening Agent

Intervention / Treatment
-----------------
* Drug: Coppertone (BAY987517)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female Aged between 18-70 years old. Good health as determined from the HRL SHF Signed and dated Informed Consent Form Signed and dated HIPAA Form An unbmbiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been dianoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma. diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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: BAY987517<br>Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: Coppertone (BAY987517)<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment DArkening Dose (MPPD) |  | Up to 15 minutes |
Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of the Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)

Study Overview
=================
Brief Summary
-----------------
Expanded access tothe GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is safe and effective in the treatment of thoracoabdominal and pararenal aneurysms.

Detailed Description
-----------------
Gore will permit the use of the TAMBE Device in a manner consistent with the approved CIP provided that its use is needed to treat a serious, but non-life-threatening condition. In the requesting physician's opinion, there must be no acceptable alternative treatment option. Patients are to be consented with an Emergency / Compassionate Use ICF template provided by Gore upon request for this type of device use. Sites will be required to fill out a packet justifying the rationale of use as well as their plan to conduct follow-up surveillance on the non-study subject. Upon performance of the case, the site will immediately notify Gore and provide supporting documentation to facilitate timely, compliant regulatory reporting.

Official Title
-----------------
Evaluation of the GORE® EXCLUDER® Thoracoabdominal BranchTreatment of the Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)

Conditions
-----------------
Thoracoabdominal Aneurysm

Intervention / Treatment
-----------------
* Device: GORE Excluder Thoracoabdominal Branch Endoprosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
• Aortic aneurysm involving the visceral vessels requiring treatment defined as at least one of the following: Fusiform aneurysm diameter ≥ 5 cm Saccular aneurysm (no diameter requirement) Rapid aneurysm growth (≥ 5 mm in one year) An Informed Consent Form signed by Subject or legal representative Appropriate aortic anatomy to receive the TAMBE Device d

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: GORE Excluder Thoracoabdominal Branch Endoprosthesis|TEVAR|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Cutivate Lotion HPA Axis Pediatric Study

Study Overview
=================
Brief Summary
-----------------
A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate, 0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic dermatitis.

Official Title
-----------------
A Multi-Center, Open-Label Study to Evaluate the Effect of ALTANA Inc's Cutivate (Fluticasone Propionate) Lotion 0.05% on the Hypothalmic Pituitary Adrenal (HPA) Axis in the Treatment of Atopic Dermatitis in a Pediatric Population

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: Fluticasone propionate 0.05% lotion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects are 3-12 months of age Subjects diagnosed with Atopic Dermatitis (AD) and have ≥35% of Body Surface Area Subjects meet protocol specific AD signs and symptom severity score Exclusion Criteria: Subjects with conditions effecting the HPA Axis Subjects with clinically significant systemic disease Subjects who require treatment with systemic or topical retinoids during the study Subjects who have been treated with various chronic therapies identified in the protocol Subjects who have received other investigational drug treatment within 30 days prior to study entry

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 12 Months

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>Receive between 22 and 29 days of Cutivate lotion treatment | Drug: Fluticasone propionate 0.05% lotion<br>* Daily applications<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Treatment Serum Cortisol Values Will be Compared. | The primary safety parameter was the response to the CST at the end of treatment/final visit. Blood samples were collected prior to injection of cosyntropin and post-injection. Post-CST stimulation cortisol level ≤ 18micrograms/dL was considered as evidence of adrenal suppression. | Up to 29 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Record Skin Atrophy, Pigmentation Change, Hematological and Chemistry Assessments, and Changes in Atopic Dermatitis Severity | The frequency distributions of the presence/absence of adverse events associated with signs of atrophy and pigmentation changes were summarized with frequency counts. Hematology and Chemistry Assessments were summarized in shift tables. Signs and symptoms of AD were summarized at each visit. | Over 5-6 visits following the baseline visit through the end of treatment between Day 22-29 |
Accuracy of Linear Measurements of Ultra-low Dose Cone Beam Computed Tomography and Digital Panoramic Radiography

Study Overview
=================
Brief Summary
-----------------
measurements performed directly on dry mandibles will be compared with measurements obtained from CBCT( ultra-low dose) scans and Digital panoramic radiography.

Detailed Description
-----------------
Mandibular anaesthetic landmarks will be identified on each dry mandible and will be marked using gutta percha. The ten human dry mandibles will be submitted for: Digital Panoramic Radiography. Panoramic radiographs will be obtained using the SOREDEX CRANEX™ 3Dx unit. The exposure parameters will be 8Ma, 63kVp and 16.4 sec exposure time. Cone Beam Computed Tomography (CBCT). SOREDEX CRANEX™ 3Dx unit will be used in this study. Images will be acquired at a single rotation. SOREDEX® MiniDose parameters will be used. The exposure parameters will be 3.2 Ma, 90kVp and 2.3 sec exposure time to take the advantage of 3D data in dose sensitive cases like children, or reduce the radiation dose for the patient. The real linear measurements will be measured in millimeter on dry mandibles using digital caliper and will be compared with measurements obtained from both techniques. Images will be evaluated by two experienced radiologists of ten years of experience. Each one will evaluate the images separately twice with a period of two weeks in-between the two reading sessions. The researcher will measure out the real linear measurements on the dry mandibles using digital caliper.

Official Title
-----------------
Accuracy of Linear Measurements of Ultra-low Dose Cone Beam Computed Tomography and Digital Panoramic Radiography Performed on Mandibular Anaesthetic Landmarks Versus Real Mandibular Measurements

Conditions
-----------------
Cone Beam Computed Tomography

Intervention / Treatment
-----------------
* Other: CBCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 10 to 70 years no gender nor race predilection Either dentulous or edentulous are acceptable. Exclusion Criteria: fractures pathology

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 70 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: column<br>ultra-low dose CBCT versus digital panoramic radsiography | Other: CBCT<br>* ultra-low dose CBCT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of diagnostic accuracy of linear measurements | measurements made on dry mandibles will be compared with measurements obtained from CBCT scans & digital panoramic radiography | within 2 years |