linjc16/ctgov huggingface dataset:
Study to Assess the Absorption, Metabolism, Excretion and Pharmacokinetics of [14C]-AKB-9778

Study Overview
=================
Brief Summary
-----------------
Open-label, single-dose, Phase 1 study to assess the absorption, metabolism, excretion and pharmacokinetics of [14C]-AKB-9778 in healthy male volunteers

Official Title
-----------------
An Open-Label, Single-Dose, Phase 1 Study to Assess the Absorption, Metabolism, Excretion, and Pharmacokinetics of [14C]-AKB-9778 in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: AKB-9778 subcutaneous injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 18 - 33 kg/m2 Exclusion Criteria: Significant cardiovascular, pulmonary, or renal disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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: AKB-9778<br>Single dose of [14C]-radiolabeled subcutaneous (SC) injection of AKB-9778 in the morning of Day 1 | Drug: AKB-9778 subcutaneous injection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of radioactive dose recovered in urine and feces |  | 7 days | 
| Concentration of total radioactivity in blood and plasma |  | 7 days | 
| Cmax of AKB-9778 and any major metabolites identified |  | 7 days | 
| Tmax of AKB-9778 and any major metabolites identified |  | 7 days | 
| AUC of AKB-9778 and any major metabolites identified |  | 7 days | 
| t1/2 of AKB-9778 and any major metabolites identified |  | 7 days | 
| Elimination rate of AKB-9778 and any major metabolites identified |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events and change in vital signs and laboratory values |  | 7 days |
Specific Preoperative Dynamic Contrast-enhanced MRI Semi-quantitative Markers Can Correlate With Vascularity in Specific Areas of the Glioblastoma Tissue and Predict Recurrence

Study Overview
=================
Brief Summary
-----------------
Radiological Markers of vascularity as wash-in rate, washout rate, and capillary time to peak in different single tumour regions were extracted for all glioblastoma patients before being surgically resected from preoperative DCE-MRI. Tissue samples were obtained from different intratumoral regions and peritumoral oedema and evaluated for the vascular endothelial growth factor (VEGF)

Official Title
-----------------
Specific Preoperative Dynamic Contrast-enhanced MRI Semi-quantitative Markers Can Correlate With Vascularity in Specific Areas of the Glioblastoma Tissue and Predict Recurrence

Conditions
-----------------
Glioblastoma

Intervention / Treatment
-----------------
* Other: Dynamic contrast-enhanced MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with newly diagnosed glioblastoma with a maximum diameter from 3-5 cm as a single lesion identified by MRI. The lesions should be surgically resected at the time of the presentation. Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Dynamic contrast-enhanced MRI|Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) is the acquisition of sequential images during the passage of a contrast agent within a tissue of interest.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of tumor |  | 2018-2021 |
To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets under Fasting Conditions.

Official Title
-----------------
To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets Under Fasting Conditions.

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

Intervention / Treatment
-----------------
* Drug: Bupropion HCl 100 mg Tablets (Invamed Inc.)
* Drug: Wellbutrin 100 mg Tablets (Glaxo Wellcome)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Bupropion HCl 100 mg Tablets (Invamed Inc.) | Drug: Bupropion HCl 100 mg Tablets (Invamed Inc.)<br> <br> |
| Active Comparator: 2<br>Wellbutrin 100 mg Tablets (Glaxo Wellcome) | Drug: Wellbutrin 100 mg Tablets (Glaxo Wellcome)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 29 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antidepressant
Role of the Cystic Fluid Interleukins and Tumor Necrosis Factor (TNF) Levels in Characterizing Pancreatic Cysts Detected by Endoscopic Ultrasound (EUS)

Study Overview
=================
Brief Summary
-----------------
This study aims to find a correlation between cytokines levels and malignancy potential of different cystic types.

Official Title
-----------------
The Role of the Cystic Fluid Interleukins 1,8, & 10 and Tumor Necrosis Factor (TNF) Levels in Characterizing Pancreatic Cysts Detected by Endoscopic Ultrasound (EUS)

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Procedure: EUS with fine-needle aspiration of pancreatic cyst
* Diagnostic Test: Laboratory Blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pancreatic cyst Exclusion Criteria: None

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One arm containing patients with pancreatic lesion and one control group arm of healthy volunteers
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients with pancreatic cysts<br>Fine-needle aspiration (FNA) by Endoscopic Ultrasound (EUS) will collect liquid from patients' pancreatic cysts to measure their Interleukin and TNF levels | Procedure: EUS with fine-needle aspiration of pancreatic cyst<br>* EUS with fine-needle aspiration<br>|
| Active Comparator: Healthy volunteers<br>Laboratory blood test to measure Interleukin and TNF levels | Procedure: EUS with fine-needle aspiration of pancreatic cyst<br>* EUS with fine-needle aspiration<br>Diagnostic Test: Laboratory Blood test<br>* Laboratory Blood Test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of malignant potential of pancreatic cyst by measuring Interleukin levels | Interleukin 1,8,10 will be measured quantitatively by an enzyme-linked immunosorbent assay. The same interleukins levels will be measured in serum of same patients and control group. Results will enable classification of cysts to either high or low risk malignancy potential. | Two years | 
| Prediction of malignant potential of pancreatic cyst by measuring TNF levels | TNF levels will be measured quantitatively by an enzyme-linked immunosorbent assay. The same TNF levels will be measured in serum of same patients and control group. Results will enable classification of cysts to either high or low risk malignancy potential. | Two years |
Effect of Roselle-based Drink on Blood Pressure and Skin

Study Overview
=================
Brief Summary
-----------------
This randomized, placebo-controlled, double-blind, and cross-over study was designed to check whether the roselle-based drink (2 bottles every day) can alter blood pressure and skin condition in elderly healthy subjects.

Detailed Description
-----------------
The subjects were assigned into two groups (control group and test group), each group subject was requested to drink 2 bottles every day (100 mL/bottle, one in the morning and another in the evening), the rate of drinking is 75.42%. There are 39 subjects (25 females and 14 males) completely involved in the thirteen-month trial (cross-over). Blood samples were collected at the initial, 3rd, 6th, 7th, 10th, 13th months of the trial. Skin examinations were performed at the initial, 6th, 7th, 13th months.

Official Title
-----------------
Effect of Roselle-based Drink on Blood Pressure, Antioxidative Activity and Skin Condition

Conditions
-----------------
Other Skin and Subcutaneous Infections

Intervention / Treatment
-----------------
* Dietary Supplement: Drink


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults Subjects should not be under any medication Subject must be able to drink Exclusion Criteria: Subjects with chronic renal, liver or cardiac disorders, Diabetes, hyperlipidemia. Also pregnant women, chain smokers, high alcohol consumers should not be included.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 81 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo/Control<br>Placebo drink-- Orally (200 ml/day) | Dietary Supplement: Drink<br>* Roselle and placebo drink for 6 months<br>* Other names: Roselle Drink (SF-R product of Han Bu);|
| Experimental: Roselle Based drink (Test)<br>Roselle-Based Drink--- Orally (200 ml/day) | Dietary Supplement: Drink<br>* Roselle and placebo drink for 6 months<br>* Other names: Roselle Drink (SF-R product of Han Bu);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure by sphygmomanometer (mmHg) | Both systolic and diastolic blood pressure were changed after Roselle drink | 6 months |
Postamputation Pain: Peripheral Mechanisms

Study Overview
=================
Brief Summary
-----------------
Stump and phantom pain after amputation are common, but the responsible mechanisms are still not clarified. It has been suggested that phantom limb pain can be reduced by regional anaesthesia and in several recent studies, pain was reduced following intrathecal and intraforaminal blocks. In this study, the investigators want to investigate if spontaneous and evoked pain in amputees will be relieved by regional nerve blocks involving the damaged nerves.

Official Title
-----------------
Postamputation Pain: Peripheral Mechanisms

Conditions
-----------------
Neuropathic Pain, Amputation, Traumatic, Nerve Block, Phantom Limb Pain, Stump Pain

Intervention / Treatment
-----------------
* Device: Lidocaine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Amputees with chronic amputation pain (stump or phantom pain) 3 or above on NRS (numerical ratio scale). Exclusion Criteria: Severe somatic or psychiatric diseases Other peripheral neuropathy Lack of ability to cooperate to the clinical examination Allergy to Lidocaine or similar analgetics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine block<br> | Device: Lidocaine<br>* Intervention is a nerve block with Lidocaine 2% with Adrenaline.<br>|
| Placebo Comparator: Isotonic saline block<br> | Drug: Placebo<br>* Intervention is a placebo nerve block with isotonic saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in spontaneous pain on a Numeric Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain) | The patient will be asked about spontaneous pain, including stump and phantom pain on a Numerical Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst pain). | From 0 minutes until 120 minutes after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in evoked pain on a Numerical Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain). | The patient will be asked about evoked pain on a Numerical Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst pain). Evoked pain is triggered by a SOMEDIC brush, thermo rolls (20 degrees Celcius and 40 degrees Celcius) and pinprick with a von Frey filament (60 g). | From 0 minutes until 120 minutes after injection |
Pain and Fear of Venous Blood Collection in Children

Study Overview
=================
Brief Summary
-----------------
Nurses are in the position of primary health care provider in relieving children's pain and fears of bloodletting in the wards where they work. As a result of this study, it is aimed to encourage nurses to apply non-pharmacological interventions during painful medical procedures, to facilitate the provision of necessary and different means of distraction to blood collection services, and to contribute to the development of in-house health policies and the preparation of appropriate clinical guides and to add an innovative perspective.

Official Title
-----------------
The Effect of Chocolate Smell and Stress Ball on Pain and Fear in Venous Blood Collection in Children

Conditions
-----------------
Pain, Fear

Intervention / Treatment
-----------------
* Other: Chocolate Scent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6-12 age group, children who need blood drawn for any reason have no disease that can cause chronic pain, no olfactory disorder no mental or neurological problems able to communicate speaks Turkish Exclusion Criteria: those who did not give consent to the research by both the child and the parent

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chocolate Scent<br> | Other: Chocolate Scent<br>* Chocolate Scent:Children in this group will be given chocolate scent sniffing as a non-pharmacological distraction method. Stress Ball:Stress ball squeezing will be used as a non-pharmacological distraction method for children in this group.<br>* Other names: Stress Ball;|
| Experimental: Stress Ball<br> | Other: Chocolate Scent<br>* Chocolate Scent:Children in this group will be given chocolate scent sniffing as a non-pharmacological distraction method. Stress Ball:Stress ball squeezing will be used as a non-pharmacological distraction method for children in this group.<br>* Other names: Stress Ball;|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wong-Baker Faces Pain Rating Scale |  | 12 week | 
| Child Fear Scale |  | 12 week |
The Comparison of the Clinical Efficacy Between I-gel and LMA-Supreme, the Two Most Recently Developed Supraglottic Airway Devices, in Infants

Study Overview
=================
Brief Summary
-----------------
Although the safety and efficacy of the I gel in children has been shown in several large observational studies, There is no study about comparison of the clinical efficacy between I-gel and LMA-Supreme , in particular sizes 1 and 1½. The pediatric i-gel and LMA Supreme are new supraglottic airway device for children. It is made of a soft, gel-like elastomer with a noninflatable cuff. Studies about I-gel and LMA Supreme in adults have been promising, showing an easy insertion, high airway leak pressures, and low complication rates with few postoperative complaints. The aim of this study is to compare clinical performance of the pediatric i-gel and LMA Supreme in infants.

Conditions
-----------------
Elective Surgery of Short Duration (Less Than 2 hr) Undergoing General Anesthesia Using Supraglottic Airway

Intervention / Treatment
-----------------
* Device: I gel
* Device: LMA Supreme


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Infants (0-1 year of age) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway Exclusion Criteria: 1. Patients with an abnormal airway, reactive airway disease, gastroesophageal reflux disease, chronic respiratory disease, or a history of an upper respiratory tract infection in the preceding 6-week period

Ages Eligible for Study
-----------------
Maximum Age: 1 Year

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1) I gel group<br>using supraglottic airway I gel | Device: I gel<br> <br> |
| Active Comparator: 2) LMA Supreme group<br>using supraglottic airway LMA Supreme | Device: LMA Supreme<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| airway leak pressure | Airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 30 cmH2O (fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached. | within 5 min of insertion of each device | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LMA Supreme, i-gel, supraglottic airway
STernectOmy Repair Efficiency of a Ceramic Implant

Study Overview
=================
Brief Summary
-----------------
For the replacement of the sternum, there is no consensus regarding the most appropriate and most effective physiologically material. The use of ceramic implant offers significant operational time saving and biocompatibility coupled with the strength of the material allow us to realize a more natural operation, limiting the risk of infection and rejection. Main objective: to evaluate the efficiency of the replacement of the sternum by a ceramic implant on the respiratory capacity at 3 months post surgery.

Official Title
-----------------
STernectOmy Repair Efficiency of a Ceramic Implant

Conditions
-----------------
Bones, Tumors

Intervention / Treatment
-----------------
* Device: Ceramic Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient major Having a replacement indicating the sternum (or a part of the sternum) With an expected life of over one year, estimated by the principal investigator Written consent of the patient Exclusion Criteria: People under safeguard justice, Patient under guardianship, Patient pregnant or breastfeeding, Topic attending another search including a period of exclusion still going to run-in Contraindication to general anesthesia Of alumina allergy antecedent Recent infectious disease unsupported BMI> 40

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sternum by a ceramic implant<br>The replacement of the sternum by a ceramic implant | Device: Ceramic Implant<br>* The replacement of the sternum by a ceramic implant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vital capacity | Slow Vital Capacity (liters), forced vital capacity (liters) | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sternectomie, Ceramic Implant, Bones Tumors