linjc16/ctgov huggingface dataset:
A Preliminary Drug Drug Interaction Study With TA-8995

Study Overview
=================
Brief Summary
-----------------
A study in healthy males to look at how multiple doses of TA-8995 affect blood levels and rate of removal of other drugs, using single doses of digoxin and midazolam as examples, to see if there are any potential drug interactions that might affect patients in future studies. The study will examine whether co-administration of TA-8995 affects the pharmacokinetics of digoxin and midazolam measured by area under the curve (AUC).

Official Title
-----------------
A Phase I, Open Label Study to Assess the Effects of TA-8995 on the Pharmacokinetics of Midazolam and Digoxin in Healthy Male Subjects

Conditions
-----------------
Pharmacokinetic Interactions

Intervention / Treatment
-----------------
* Drug: TA-8995
* Drug: Midazolam
* Drug: Digoxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Healthy male subjects Exclusion Criteria Receiving any other drug therapy Clinically significant medical history Abnormal laboratory results or ECGs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digoxin with/without TA-8995<br>Digoxin with/without TA-8995 | Drug: TA-8995<br> <br> Drug: Digoxin<br> <br> |
| Experimental: Midazolam with/without TA-8995<br>Midazolam with/without TA-8995 | Drug: TA-8995<br> <br> Drug: Midazolam<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of TA-8995, midazolam and digoxin |  | Over 16 days |
PFNA vs Dual Mobility in Treatment of Unstable Trochanteric Fractures

Study Overview
=================
Brief Summary
-----------------
Proximal femoral nail [PFNA] versus dual mobility arthroplasty in treatment of unstable trochanteric fractures

Detailed Description
-----------------
compare clinial outcome between two different procdures either using pfna or arthroplasty in the treatment of unstable trochaneric fractures

Official Title
-----------------
The Usage Of Proximal Femoral Nail Versus Dual Mobility Arthroplasty In Treatment Of Unstable Trochanteric Fractures

Conditions
-----------------
Trochanteric Fractures

Intervention / Treatment
-----------------
* Device: Proximal Femoral Nail
* Combination Product: Dual Mobility Arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with trochanteric unstable fractures. age 60 or above recent fracture time within 2 weeks time period trochanteric starting point in pfna patients medical condition is stable Exclusion Criteria: stable trochanteric fractures delayed or neglected fractures unstable patients medical conditions pirformis fossa starting point in pfna

Ages Eligible for Study
-----------------
Minimum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: proximal femoral nail<br>20 patient with trochanteric fractures , unstable type will use proximal femoral nail | Device: Proximal Femoral Nail<br>* open reduction<br>* Other names: PFNA;|
| Active Comparator: Dual Mobility Arthroplasty<br>20 patient with trochanteric fractures , unstable type will use dual mobility arthroplasty | Combination Product: Dual Mobility Arthroplasty<br>* Hip Arthroplasty Surgery<br>* Other names: THA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip score | compare between hip score in first group of pfna versus hip score in second group of THA | Through study completion, an average of 1 year | 
| Operation time | compartive operative time between first group of pfna versus second group of THA | During surgery |
Tolerance of Healthy Term Infants Fed Infant Formulas #4

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental powdered formulas compared with a commercially available powdered formula.

Official Title
-----------------
Tolerance of Healthy Term Infants Fed Infant Formulas

Conditions
-----------------
Healthy Term Infants

Intervention / Treatment
-----------------
* Other: Hydrolysate based infant formula
* Other: Investigational Infant Formula A
* Other: Investigational Infant Formula B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton full term birth in good health Birth weight was > 2490 g. Between 0 and 8 days of age. Infants using medications (including OTC such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled unless both the parent and the physician agree to discontinue these agents prior to enrollment. Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study, unless instructed otherwise by their healthcare professional. Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study. Exclusion Criteria: • An adverse maternal, fetal or infant medical history and treatment with antibiotics

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 8 Days

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational infant formula A<br>Investigational Protein Hydrolysate formula | Other: Investigational Infant Formula A<br>* Investigational infant formula ad lib<br>|
| Active Comparator: Hydrolysate based Infant Formula<br> | Other: Hydrolysate based infant formula<br>* Infant formula ad lib<br>|
| Experimental: Investigational Infant Formula B<br>Investigational Protein Hydrolysate Formula | Other: Investigational Infant Formula B<br>* Investigational infant formula ad lib<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI tolerance via stool consistency |  | 28 days |
Improvement of Communicational Skills Between Health Workers and Oncological Patients During Medical Consultative Conversations

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to identify the specific patterns of communication between doctors and oncological patients during medical consultations and develop recommendations to improve its effectiveness.

Official Title
-----------------
Ways to Improve the Efficiency of Communication Between Health Workers and Oncological Patients During Medical Consultative Conversations: an Observational Clinical Study

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Behavioral: Audio recording of the counseling conversation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed prostate cancer; PSA up to 10 ng / ml; Gleason (3 + 3) = 6 (ISUP 1); the stage of the tumor T2a (low- risk according to the D'Amico scale); Exclusion Criteria: Failure of the recording device; Unsatisfactory audio quality.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with low-risk prostate cancer<br>Histologically confirmed low-risk prostate cancer (PSA up to 10 ng / ml; Gleason (3 + 3) = 6 (ISUP 1); tumor stage T2a (low- risk according to the D'Amico scale)) | Behavioral: Audio recording of the counseling conversation<br>* The patient will have an audio-recorded counseling conversation. Audio recording will be carried out using a portable recorder ZOOM H2n. The audio recordings of the counseling conversations will be performed by the health workers selected to participate in the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification the communication techniques used by the doctor in the counseling conversation; |  | 1 year |
Navigated OCT Imaging With the P200TxE

Study Overview
=================
Brief Summary
-----------------
The P200TxE will be used to obtain peripheral OCT (optical coherence tomography) images.

Official Title
-----------------
Navigated Peripheral OCT Imaging With the P200TxE

Conditions
-----------------
Retinal Disease

Intervention / Treatment
-----------------
* Device: Device: P200TxE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed; Subjects who can follow the instructions by the clinical staff at the clinical site, Subjects who agree to participate in the study; Subjects presenting with some form of peripheral retina pathology or retina pathology with peripheral manifestations. Exclusion Criteria: Subjects unable to tolerate ophthalmic imaging; Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Optical Coherence Tomographer<br> | Device: Device: P200TxE<br>* The P200TxE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative Assessment of OCT Clinical Utility | Clinical utility of the OCT scans will be assessed from the clinician questionnaire using a four point scale. | 1 year | 
| Qualitative Assessment of OCT Scan Quality | Image quality of the OCT scans will be assessed from the clinician questionnaire using a four point scale. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment from Adverse Events | Analysis of safety will be assessed through adverse events reported by the site and documented on each subject's case report form. | 1 year |
Improving Sensitivity of Urine Cytology for Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
Can a commercially available vibrating chair increase the number of urothelial cells in a urine sample of healthy participants non-invasively? The investigators plan is participants will alternate 15 minutes of drinking eight fluid ounces of water and 15 minutes of sitting in the vibrating chair for one hour. The control group will alternate 15 minutes of drinking eight fluid ounces of water and 15 minutes of sitting in a non-vibrating chair for one hour. Then, urine samples will be collected and examined for urothelial cell concentration for both groups.

Official Title
-----------------
Non-Invasive Vibrational Device to Improve Sensitivity of Urine Cytology for Bladder Cancer

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Device: La-Z-Boy Massage Chair Vibration Effect on Bladder Cancer Cell Concentration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only adult male subjects who will not have surgery within a period of 2 weeks. Over the age of 18 Have had a confirmed diagnosis of stage 0-4 transitional cell carcinoma within the last 30 days Exclusion Criteria: Cognitive impairment resulting in the inability to give informed consent Lack of spoken and written English resulting in the inability to give informed consent Presence of infectious disease Insulin dependent diabetes mellitus Endogenous osteosynthetical material implants Knee or hip prosthesis Pacemaker Epilepsy Musculo-skeletal disorders Weight in excess of 250 pounds Poor circulation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibration<br>Whole body vibration applied to a group of 20 bladder cancer patients. | Device: La-Z-Boy Massage Chair Vibration Effect on Bladder Cancer Cell Concentration<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Cancer Cells | Number of Cancer Cells in a 50 ml Urine | up to 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cytology, Whole body massage vibration
The Psychosocial Effect of Thoughts of Personal Mortality on Cardiac Risk Assessment by Medical Students

Study Overview
=================
Brief Summary
-----------------
This study was designed to examine if provoking thoughts of mortality among medical students can influence cardiac risk assessments depending on the religion of the target patient.

Detailed Description
-----------------
This study was designed to examine whether and how provoking thoughts of mortality among medical students can influence cardiac risk assessments depending on the religion of the target patient.

Official Title
-----------------
The Effects of Religion and Motivation on Medical Decision Making: A Terror Management Approach

Conditions
-----------------
Prejudice

Intervention / Treatment
-----------------
* Procedure: mortality salience


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: medical students Exclusion Criteria: non-medical students
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: mortality salience|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responses on a scale of 0-100 to each of three cardiac risk questions |  | immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bias
Effectivity of Bispectral Index Monitoring in Cases of Endoscopic Retrograde Cholangiopancreatography

Study Overview
=================
Brief Summary
-----------------
The bispectral index (BIS) monitoring is an EEG-based method that uses electroencephalogram analysis and a complex algorithm to generate a numerical scoring 0-100 (0 flat line EEG, 100, wide awake) BIS monitoring allows noninvasive, objective measurement of level of consciousness of a sedated patient. A limited number of studies have used measurements of BIS monitoring to assist endoscopic sedation.There are studies using BIS monitoring to make sedation easy for ERCP procedures. However, the studies evaluating use of BIS for gastrointestinal endoscopy show inconsistent results. The objective of this study is to evaluate effects of sedation on the dosage of propofol by monitoring with BIS values, hemodynamics, recovery parameters, respiratory functions and endoscopist satisfaction based on the hypothesis that the investigators would reduce the risk for respiratory depression using minimal doses of propofol in order to achieve the desired level of sedation with BIS monitoring.

Official Title
-----------------
Evaluation of Effectivity of Bispectral Index Monitoring in Cases of Endoscopic Retrograde Cholangiopancreatography Received Sedoanalgesia

Conditions
-----------------
Sedoanalgesia

Intervention / Treatment
-----------------
* Device: The bispectral index (BIS) monitoring
* Behavioral: Ramsay Sedation Scale (RSS) Score monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-75 years old ASA 1-2 Exclusion Criteria: Emergency Operation Those who had symptoms of neurological disease (TİA, syncope, dementia, etc.) Patients that are allergic to drugs considered to use

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| grup 1<br>Ramsay Sedation Scale (RSS) Score monitoring | Behavioral: Ramsay Sedation Scale (RSS) Score monitoring<br> <br> |
| Grup 2<br>The bispectral index (BIS) monitoring | Device: The bispectral index (BIS) monitoring<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dosage of propofol | initial dose 1 mg.kg-1 of propofol, maintenance dose: infusion of 4 mg/kg/h . In case of insufficient sedation, additional dose of 0.1 mg/kg propofol (IV) by monitoring with BIS values 65-75 during procedure | 1-3 hours | 
| The heart rate (HR)(n/dk) | During procedure | 1-3 hours | 
| mean systolic-diastolic blood pressure(mmHg) | during procedure | 1-3 hours | 
| peripheral oxygen saturation (%) | During procedure | 1-3 hours |
Travoprost 0.004% Versus Pilocarpine 1% in Patients With Chronic Angle Closure Glaucoma (CACG)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that the Intraocular Pressure (IOP) lowering efficacy of Travoprost Ophthalmic Solution 0.004% is superior to that of Pilocarpine 1% in patients with chronic angle-closure glaucoma (CACG).

Official Title
-----------------
A Twelve-Week, Double Masked, Parallel Group, Primary-Therapy Pilot Study of the Safety and Efficacy of Travoprost 0.004% Compared to Pilocarpine 1% in Patients With Chronic Angle-Closure Glaucoma

Conditions
-----------------
Angle-closure Glaucoma

Intervention / Treatment
-----------------
* Drug: Travoprost 0.004% (Travatan)
* Drug: Pilocarpine 1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Chronic Angle Closure Glaucoma (CACG) 21-35 millimeters mercury mean intraocular pressure on Eligibility visit day at 9 AM Peripheral iridotomy performed ≥ 1 Month prior to the Screening visit Anterior chamber angle in which the trabecular meshwork is not visible for ≥180 degrees in gonioscopy without indentation Peripheral anterior synechiae (PAS) Exclusion Criteria: Traumatic damage of the anterior chamber angle History of ocular inflammation or surgery (except for iridotomy) ≤ 3 months Patients who cannot be safely discontinued from use of all ocular hypotensive medication(s) for 12 days to 14 weeks Visual Acuity ≥ 1.0 Contact lenses wearer

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Travoprost 0.004% (Travatan)<br>One drop in each eye, once daily at 9 AM | Drug: Travoprost 0.004% (Travatan)<br>* One drop in each eye, once daily at 9 AM<br>|
| Active Comparator: Pilocarpine 1%<br>One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks | Drug: Pilocarpine 1%<br>* One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Intraocular Pressure (IOP) |  | 4PM at Week 12 Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Peripheral Anterior Synechiae (PAS) |  | Week 12 Visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IOP lowering efficacy, CACG