linjc16/ctgov huggingface dataset:
Pharmacokinetics of Irbesartan/Amlodipine FDC and Co-administration of Irbesartan and Amlodipine in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare pharmacokinetics and safety of Irbesartan and Amlodipine Fixed Dose Combination and coadministration of mono compounds in healthy adult volunteers

Official Title
-----------------
A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of Irbesartan/Amlodipine Fixed Dose Combination in Comparison With Co-administration of Mono Compounds in Healthy Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Irbesartan/Amlodipine FDC
* Drug: Irbesartan
* Drug: Amlodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are 19 years or older on screening Signed informed consent Healthy Volunteer Other inclusion applies Exclusion Criteria: Clinically relevant/significant findings as evaluated by the investigator Other exclusion applied

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Irbesartan/Amlodipine Fixed dose combination<br>participants will receive one tablet of Irbesartan/Amlodipine FDC in a crossover design | Drug: Irbesartan/Amlodipine FDC<br>* Irbesartan/Amlodipine FDC<br>|
| Experimental: Co-administration of Irbesartan and Amlodipine<br>participants will receive one table each of Irbesartan and Amlodipine in a crossover design | Drug: Irbesartan<br>* Co-administration of Irbesartan and Amlodipine<br>Drug: Amlodipine<br>* Co-administration of Irbesartan and Amlodipine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt of Irbesartan and Amlodipne |  | 72 hours | 
| Cmax of Irbesartan and Amlodipne |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of Irbesartan and Amlodipine |  | 72 hours | 
| AUCt/AUCinf of Irbesartan and Amlodipine |  | 72 hours | 
| tmax of Irbesartan and Amlodipine |  | 72 hours | 
| half-life of Irbesartan and Amlodipine |  | 72 hours | 
| CL/F of Irbesartan and Amlodipine |  | 72 hours | 
| Vz/F of Irbesartan and Amlodipine |  | 72 hours |
Safety and Efficacy Study of APD125 in Patient With Insomnia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of APD125 in patients with sleep maintenance insomnia.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study to Evaluate the Effects of APD125 in Patients With Chronic Primary Insomnia

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Drug: APD125


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary insomnia as defined in DSM-IV-TR, with predominant complaint of impaired sleep maintenance and confirmed by PSG PSQI >/= to 5 Qualifying screening PSG parameters Generally good health Exclusion Criteria: History of any sleep disorder, other than primary insomnia (e.g., restless leg syndrome, narcolepsy, sleep apnea, and disorders of REM/NREM sleep) Any clinically significant medical condition, laboratory finding, or ECG finding Pregnant and/or lactating females History of substance abuse within 2 years or positive urine drug screen Positive Hepatitis B/C results or HIV markers Apnea-Hypopnea Index (AHI) or a Periodic Limb Movement Arousal Index (PLMAI) > 10 as determined by screening PSG History of treatment with an investigational drug within the last month Recent travel involving crossing more than 3 time zones or plans to travel to another time zone (> 3 time zones) during the study

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: APD125|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conventional PSG parameters |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported subjective sleep parameters |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep maintenance, Insomnia, Sleep Consolidation, Sleep, Insomnia, primarily sleep maintenance
Two Different Preparations of Sevoflurane in Induction

Study Overview
=================
Brief Summary
-----------------
In our study we aim to study the effects of two preparations of Sevoflurane in vital capacity rapid inhalation induction.

Official Title
-----------------
A Randomized Clinical Trial on the Efficiency, Hemodynamic Effects and Patient Comfort of Two Different Preparations of Sevoflurane After Vital Capacity Rapid Inhalation Induction

Conditions
-----------------
Coughing on Induction, Vapors; Inhalation

Intervention / Treatment
-----------------
* Drug: Sevoflurane
* Drug: Sevoflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing abdominal surgery Exclusion Criteria: Patients with any cardiovascular or respiratory disease, usage of any kind of sedative drug, expected airway difficulty and obese patients (BMI>35) will be excluded from the study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sevoflurane A<br>Generic sevoflurane | Drug: Sevoflurane<br> <br> * Other names: Sevorane, Abbott Laboratories;|
| Active Comparator: Sevoflurane B<br>Orginal sevoflurane | Drug: Sevoflurane<br> <br> * Other names: Sojourn, Adeka IS A.S;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of different preparations of sevoflurane on Induction on hypnosis time | Induction for anesthesia will be achieved with sevoflurane A and Sevoflurane B in total of 100 randomized (American Society of Anesthesiology status I-II) patients undergoing abdominal surgery. During the induction patients will be asked to breath as deep as possible and then hold their breaths to the point where they cannot anymore and flexing their right arm. Occurrence of hypnosis will be confirmed with both the loss of eyelash-reflex and failing of flexed-holding arm. Time and number of breaths needed for the loss of consciousness will be noted. Existence of hiccup, cough, increase in secretions, and refusal of the mask by the patient will be reported if any. All patients will be extubated and released to the ward after they are questioned about any discomfort or issue they want to report to anesthesiologist | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of different sevoflurane preparations on hemodynamics | After the induction and occurrence of hypnosis, Systemic arterial pressure (SAP) values will be noted. Tracheal intubation will be performed and post-intubation SAP values will be noted. The SAP values will noted in the 5th minute of the induction. | 1 hour |
Bernese Next of Kin Survey Following Organ Donation Request

Study Overview
=================
Brief Summary
-----------------
6 to 18 months after organ donation request a next of kin survey using a standardized questionnaire was conducted.

Official Title
-----------------
Next of Kin Survey Following Organ Donation Request - a Single Center Experience

Conditions
-----------------
Next of Kin, Post Traumatic Stress Disorder, Organ Donation

Intervention / Treatment
-----------------
* Behavioral: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Next of kin involved in request for organ donation
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 |
| --- | --- |
| request for organ donation approved<br> | Behavioral: questionnaire<br>* a standardized questionnaire was sent to all participants<br>|
| request for organ donation rejected<br> | Behavioral: questionnaire<br>* a standardized questionnaire was sent to all participants<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| factors influencing approval/rejection of an organ donation |  | 6 to 18 months pre questionnaire | 
| factors with influence on mourning porcess |  | 6 to 18 months past request |
Methylation Level of SHOX2 in Endobronchial Ultrasound With Real-time Guided Transbronchial Needle Aspiration for Lung Cancer Staging

Study Overview
=================
Brief Summary
-----------------
A DNA hypermethylation of the gene locus SHOX2 can be frequently found in lung cancer tissue. The purpose of this study is to determine whether the assessment of the hypermethylation level of SHOX2 in specimens obtained by endosonographic guided bronchoscopy makes a contribution to lung cancer staging.

Conditions
-----------------
Lung Cancer With Mediastinal Lymph Node Involvement

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of lung cancer enlarged mediastinal or hilar lymph nodes (>10 mm) Exclusion Criteria: clinical condition which excludes general anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung cancer with lymph node involvement<br> | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Performance of SHOX2 | Diagnostic performance of SHOX2 methylation Level as biomarker for lung cancer compared to histologic evaluation of EBUS-TBNA specimen alone. | one Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung cancer, EBUS-TBNA, Epigenetics, shox2 protein, human
A Non-interventional Study (NIS) Registry for the Epidemiological and Scientific Evaluation of Epidermal Growth Factor Receptor (EGFR) Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) (Stage IIIB/IV Non-small Cell Lung Cancer).

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to collect epidemiological data on EGFR mutation status [M+(mutation positive), M-(mutation negative)] in a population of predominantly Caucasian ethnicity, and to correlate EGFR mutation status with clinico-pathological characteristics (e.g. smoking status, sex, histology, etc). In particular, the study will aim to determine the frequency of EGFR M+ lung cancers in patients with clinico-pathological characteristics that are not commonly associated with EGFR mutation positivity (i.e., smokers, men, and non-adenocarcinoma).

Official Title
-----------------
An NIS Registry for the Epidemiological and Scientific Evaluation of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic NSCLC (Stage IIIB/IV Non-small Cell Lung Cancer)-REASON STUDY.

Conditions
-----------------
Non Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent. Female or male aged 18 years or above. Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV). Patients receiving 1st-line treatment for IIIB/IV NSCLC. Patients with known EGFR mutation status (i.e. patients must be either EGFR M+, EGFR M- or EGFR Mx). Tumour not amenable to curative surgery or radiotherapy. Exclusion Criteria: 1. Mixed histology of small cell and non-small cell lung cancer.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with Non Small Cell Lung Cancer, visiting hospital oncology clinics | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity |  | Up to 2,5 years | 
| Clinico-pathological characteristics according to mutation status |  | Up to 2,5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacoeconomic data (resource use) associated with the diagnosis and treatment of EGFR M+ patients |  | Up to 3,5 years | 
| Real-life data on 1st-line treatment decisions in EGFR M+ and M-/Mx(mutation status not evaluable) patients |  | Up to 2,5 years | 
| Clinical outcome data under real life clinical practice in all EGFR M+ patients up to disease progression (PFS, OS, DCR) |  | Up to 3,5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non Small Cell Lung Cancer, EGFR mutations
Expression of Erythroid Differentiation Regulator 1 (Erdr1) in Vitiligo

Study Overview
=================
Brief Summary
-----------------
Expression of Erythroid differentiation regulator 1 (Erdr1) cytokine in vitiligo

Official Title
-----------------
Expression of Erythroid Differentiation Regulator 1 (Erdr1) Cytokine in the Vitiliginous Skin Lesions: a Case Control Study

Conditions
-----------------
Erythroid Differentiation Regulator 1 (Erdr1) Cytokine

Intervention / Treatment
-----------------
* Other: skin biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with generalized non-segmental vitiligo. Both sexes. Age >18 years old. New cases or cases not receiving any medication for at least 3 months ago. Exclusion Criteria: Segmental or Universal vitiligo Autoimmune diseases

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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitiligo patients<br>lesional skin biopsy to measure ERDR1 level | Other: skin biopsy<br>* Skin biopsy for measuring tissue levels of the Erythroid differentiation regulator 1 (Erdr1) cytokine will be taken from the lesional skin of patients of vitiligo and from normal skin of healthy controls.<br>|
| Experimental: controls<br>normal skin biopsy to measure ERDR1 level | Other: skin biopsy<br>* Skin biopsy for measuring tissue levels of the Erythroid differentiation regulator 1 (Erdr1) cytokine will be taken from the lesional skin of patients of vitiligo and from normal skin of healthy controls.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of tissue levels of erythroid differentiation regulator 1 (Erdr1) cytokine in patients of vitiligo | Expression of tissue levels of erythroid differentiation regulator 1 (Erdr1) cytokine in patients of vitiligo and comparing its level in normal subjects | 6 months |
LigaSure Hemorrhoidectomy Versus Stapled Hemorrhoidopexy

Study Overview
=================
Brief Summary
-----------------
This study was designed to compare the outcome of LigaSure hemorrhoidectomy and stapled hemorrhoidopexy for prolapsed hemorrhoids.

Detailed Description
-----------------
The study was designed as a single-blind, prospective, randomized controlled trial and was approved by the Ethics Committee of Ahmadi Hospital, Kuwait. Patients were randomly assigned to undergo either hemorrhoidectomy with the LigaSure device or stapled hemorrhoidopexy. Patients were blinded as to the type of procedure perform. Candidates for the study were consecutive patients with symptomatic grade III or IV hemorrhoids admitted to the Ahmadi Hospital (secondary care hospital), Kuwait, from January 2006 through July 2007.

Official Title
-----------------
LigaSure Hemorrhoidectomy vs Stapled Hemorrhoidopexy: a Prospective Randomized Clinical Trial

Conditions
-----------------
Prolapsed Hemorrhoids

Intervention / Treatment
-----------------
* Procedure: Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (above 18 years) With prolapsed hemorrhoids (grades III or IV) Exclusion Criteria: Complicated hemorrhoid Coexisting perianal disease Previous perianal surgery Unfit for general anesthesia Pregnancy History of bleeding tendency

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LigaSure<br>LigaSure is a vascular sealing device that can seal the hemorrhoidal plexus during hemorrhoidectomy (surgery) | Procedure: Surgery<br>* Hemorrhoidectomy using the LigaSure sealing device or hemorrhoidopexy using the stapler<br>|
| Stapler<br>Circular stapler that removes excess loose tissue above the anus and interrupts the blood supply during hemorrhoidal surgery | Procedure: Surgery<br>* Hemorrhoidectomy using the LigaSure sealing device or hemorrhoidopexy using the stapler<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of postoperative pain | Postoperative pain was assessed using the visual analogue scale (VAS) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of postoperative complications | Postoperative complications and their management were compared between both groups during the followup visits for 12 months | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemorrhoids, prolapsed, hemorrhoidectomy, Hemorrhoidopexy, LigaSure, Stapled
Photoplethysmography for Diagnose Incipient Hypovolemia

Study Overview
=================
Brief Summary
-----------------
Hypovolemia caused by acute bleeding increased morbi-mortality in emergency and operatin rooms. Precise real-time diagnosis of incipient acute hypovolemia is lacking at the bedside. We hypothesize that the infrared-red signals of pulse oximetry are sensitive to acute changes in patient's volemia. We aimed to test this hypothesis in a cohort of healthy blood donors as a model of simulated acute hypovolemia.

Detailed Description
-----------------
This is a prospective and observational study designed to determine if the changes observed in finger photoplethysmographic waveform can detect incipient hypovolemia. The investigators will studied 60 blood donor volunteers as a model of slight hypovolemia (8-10% of the volemia). Vital signs and photoplethysmography will be recorded in the thumb of the tested hand during a standard blood donation protocol. Recorded data will be analyzed and compared before and after blood donation .

Official Title
-----------------
Photopletysmography Detects Early Acute Blood Loss in Compensated Blood Donor Volunteers

Conditions
-----------------
Hypovolemia

Intervention / Treatment
-----------------
* Diagnostic Test: Finger photoplethysmography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written Inform Consent weight > 50 kg, hemoglobin >12.5 gr/dl Exclusion Criteria: pregnancy, ≤ 12 months from delivery or abortion, symptoms of allergy, fever >37 °C, infectious diseases, addictions, volunteers that received previous blood transfusions

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Finger photoplethysmography|Finger photoplethysmography in tested hand, noninvasive blood pressure and heart rate during blood donation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of the continuous component (DC) of the photoplethysmography signal. | The DC components of photoplethysmography is measured in arbitrary units (a.u). | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of non-invasive arterial blood pressure (NIBP) | NIBP is recorded in mmHg. This information is analyzed before and after blood donation. | 15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Photoplethysmography, Vital signs, Hemodynamics