linjc16/ctgov huggingface dataset:
A Drug Interaction Study of Montelukast and Levocetirizine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the drug-drug interaction between montelukast sodium and levocetirizine dihydrochloride in healthy male volunteers.

Official Title
-----------------
Open Label, Randomized, 6-sequence Crossover Study to Evaluate the Drug-drug Interaction Between Montelukast Sodium and Levocetirizine Dihydrochloride in Health Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: Levocetirizine
* Drug: montelukast sodium
* Drug: Montelukast & levocetirizine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male Age between 20 and 55 Signed informed consent Exclusion Criteria: Has a history of hypersensitivity to IP ingredients Hypotension or hypertension Has a history of acute infection within 14days of screening

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

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: Montelukast and levocetirizine<br> | Drug: Montelukast & levocetirizine<br>* Montelukast sodium 10mg & levocetirizine dihydrochloride 5mg PO. Single dose.<br>|
| Active Comparator: Montelukast<br> | Drug: montelukast sodium<br>* Montelukast sodium 10mg. PO. Single dose.<br>|
| Active Comparator: Levocetirizine<br> | Drug: Levocetirizine<br>* Levocetirizine dihydrochloride 5mg. PO. Single dose.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast |  | 0-36hrs | 
| Cmax |  | 0-36hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax |  | 0-36hrs | 
| T1/2 |  | 0-36hrs | 
| AUCinf |  | 0-36hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
montelukast, levocetirizine, interaction
Comminuted Proximal Humeral Fractures. A Randomised Study of Surgical Versus Conservative Treatment

Study Overview
=================
Brief Summary
-----------------
Do a standardized surgical treatment of unstable displaced proximal humerus fracture in patients aged over 60 compared to a standardized conservative treatment gain a better functional outcome after one year? Do surgical treatment gain more QALY than conservative treatment after one year?

Official Title
-----------------
Health and Cost Consequenses of Surgical Versus Conservative Treatment for a Comminuted Humerus Fracture. Do Interlocking Plate Surgery Benefit Displaced Proximal Humerus Fractures? A Randomized Clinical Trial

Conditions
-----------------
Proximal Humeral Fracture, Osteosynthesis or Conservative Treatment

Intervention / Treatment
-----------------
* Procedure: Surgical treatment with LCP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: proximal humerus fracture of AO group B2 or C2 (displaced fracture of extra-articular or articular, bifocal type) admitted in hospital Exclusion Criteria: aged less than 60 year patients of non-Scandinavian ethnicity previous history of injury or illness of the injured or contralateral shoulder injury of other part of the humerus or the contralateral upper extremity, alcohol- or drug abuse dementia or neurological diseases severe cardiovascular disease that would contraindicate surgery

Ages Eligible for Study
-----------------
Minimum Age: 60 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conservative /Physiotherapy<br>Active training protocol with instructed physiotherapy and self excercises | |
| Active Comparator: Surgery with LCP T plate<br>Surgical treatment with interlocking plate | Procedure: Surgical treatment with LCP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional shoulder score according to Constant (Original described Differences between the injured and uninjured shoulder as well as Adjusted according to age and gender). |  | 12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QALY (HRQoL score according to Harri Sintonen 15D and Costs) |  | 12 and 24 months | 
| ASES score (modified self assessment) C) Radiographic score |  | 12 and 24 months | 
| Radiographic score |  | 12 and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Proximal Humerus Fracture in elderly
Clinical Comparative Trial of a Modified Polyurethane Dressing and Aquacel

Study Overview
=================
Brief Summary
-----------------
The almost single disadvantage of conventional polyurethane film dressings, an uncontrolled leakage, is probably as often described as its numerous advantages for split-thickness skin graft (STSG) donor sites. This shortcoming can be overcome by perforating the polyurethane dressing (MPD), which permits a controlled leakage into a secondary absorbent dressing. The study was conducted to compare the MPD-system and Aquacel® (ConvaTec), a hydrofiber wound dressing, which also seems to fulfill all criteria of an ideal donor site dressing.

Conditions
-----------------
Reepithelialization of Skin Graft Donor Sites

Intervention / Treatment
-----------------
* Device: modified polyurethane film dressing (OpSite, Smith&Nephew, London, UK)
* Device: Aquacel® (ConvaTec, Skillman, NJ, USA), sodium carboxy-methylcellulose hydrocolloid polymer dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: skin graft donor site anterolateral thigh men and women > 18 years Exclusion Criteria: informed consent missing repeated skin graft take or prior injury at the observed site Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study History of hypersensitivity to the investigational products

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MPV<br> | Device: modified polyurethane film dressing (OpSite, Smith&Nephew, London, UK)<br> <br> |
| Active Comparator: Aquacel<br> | Device: Aquacel® (ConvaTec, Skillman, NJ, USA), sodium carboxy-methylcellulose hydrocolloid polymer dressing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reepithelialization rate |  | 10th day postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain, scar formation, complications (e.g. infection), costs |  | pain until and during dressing removal, scar formation 60 days following surgery |
PHOX2B Mutation-Confirmed Congenital Central Hypoventilation Syndrome in A Chinese Family: Presentations From Newborn to Adulthood

Study Overview
=================
Brief Summary
-----------------
Detect the PHOX2B Mutation-confirmed congenital central hypoventilation syndrome

Detailed Description
-----------------
Background: Congenital central hypoventilation syndrome (CCHS) is characterized by compromised chemo-reflexes that results in hypoventilation during sleep. Recently, a heterozygous PHOX2B gene mutation was identified in CCHS. This report was made to increase physicians' awareness of this rare disease. Methods: A Chinese family of CCHS with presentations from newborn to adulthood and genetic analysis confirming the PHOX2B mutation was analyzed. After identifying central hypoventilation in an adult male (index case), clinical evaluation was performed on the complete family, which consisted of the parents, five siblings, and five offsprings. In addition, pulmonary function test, overnight polysomnography, arterial blood gas, and hypercapnia ventilatory response, and genetic screening for PHOX2B gene mutations were performed on living family members.

Official Title
-----------------
PHOX2B Mutation-Confirmed Congenital Central Hypoventilation Syndrome in A Chinese Family: Presentations From Newborn to Adulthood

Conditions
-----------------
Central Alveolar Hypoventilation Syndrome

Intervention / Treatment
-----------------
* Device: CPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Members of familiar congenital central hypoventilation syndrome Exclusion Criteria: Refuse to participate study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observation<br>a family of congenital central hypoventilation syndrome | Device: CPAP<br>* CPAP treatment for patients with congenital central hypoventilation syndrome<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory failure |  | cross sectional observation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep apnea, PHOX2B, hypoventilation, polysomnography
Retrospective Encore Reverse Shoulder Prosthesis Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the survivorship and efficacy of the Encore Reverse Shoulder Prosthesis in a group of no more than 50 subjects for whom data collection has already begun.

Official Title
-----------------
Post Market Study on the Efficacy of the Encore Reverse Shoulder Prosthesis in a Small Group of Subjects

Conditions
-----------------
Rotator Cuff Deficiency, Glenohumeral Arthritis

Intervention / Treatment
-----------------
* Device: Encore Reverse Shoulder Prosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The RSP is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for Cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only. Exclusion Criteria: Infection or sepsis Insufficient bone quality which may affect the stability of the implant, as determined by the physician Muscular, neurological, or vascular deficiencies, which compromise the affected extremity Alcoholism or other addictions Materials (metals, etc) sensitivity Loss of ligamentous structures High levels of physical activity Non-functional deltoid muscle

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 |
| --- | --- |
| Encore RSP<br>Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study. | Device: Encore Reverse Shoulder Prosthesis<br>* rotator cuff deficiency and glenohumeral arthritis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship of the Encore Reverse Shoulder Prosthesis | Number of subjects who completed all study visits through the 1 year visit. | 1 year |
Thrombosomes for Expanded Access Use

Study Overview
=================
Brief Summary
-----------------
Expanded use of Thrombosomes where a clinical trial with Thrombosomes is not an option, Cellphire may elect to provide the Sponsor/Investigator (S/I) expanded access to its investigational product, Thrombosomes.

Official Title
-----------------
Thrombosomes for Expanded Access Use

Conditions
-----------------
Bleeding

Intervention / Treatment
-----------------
* Biological: Thrombosomes®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has presented with WHO Grade 2 or higher bleeding which requires treatment with platelet therapy and there is limited availability of platelets or no other approved clinical alternative. Evidence from the facility blood bank/Medical Director that there are no approved platelet products available for transfusion, or the patient is refractory to platelet transfusion. Exclusion Criteria: Clinical circumstances of a history of thrombosis, thromboembolism, or vascular occlusion/ischemia in the prior six months such as defined by a past history of current diagnosis of one or more of the following: arterial or venous thromboembolic disease including acute coronary syndrome peripheral vascular disease arterial or venous thrombosis (except when a prior history of central line thrombosis has resolved) myocardial infarction (MI) stent placement valve replacement and/or repair sinusoidal obstruction syndrome (veno-occlusive disease)

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Thrombosomes®|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
SNAP VS BIS(OAA/S) Scale During a Sedation Regimen With and Without Ketamine

Study Overview
=================
Brief Summary
-----------------
The study question: Does the SNAP-Index (SI) correlates better with the OASS than the BIS Monitor during sedation with ketamine? The study hypothesis: Since the SNAP II monitor seems to be more responsive during emergence of anesthesia, it will have a better correlation with the OASS than the BIS monitor with the use of ketamine.

Official Title
-----------------
A Comparison Between the Correlation of the Bispectral Index Versus Snap Index With the Observer's Assessment of Alertness and Sedation (OAA/S) Scale During a Sedation Regimen With and Without Ketamine

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Ketamine group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age : 18-64 years ASA : I-III Procedure : Breast or gynecological surgery Anesthesia :Monitored anesthesia care Exclusion Criteria: Pregnancy Breast Feeding Body Mass Index >35kg/m2 Drug or Alcohol abuse Use anticonvulsants History of CVA Drop-out criteria: Patient or surgeon request Conversion to general anesthesia Inability to obtain data from both monitors

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

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketamine Group<br>ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min. | Drug: Ketamine group<br>* ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.<br>|
| No Intervention: No ketamine<br>No ketamine added to anesthesia regimen | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TcCO2 Above 50 | % Time Tosca Monitor (TcCO2) above 50. A TcCo2 above 50 is indicative of hypoventilation. | Intraoperative, an average of about 1 and 1/2 hours. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bispectral Index, Ketamine
Postoperative Analgesic Effects of Dexmedetomidine for Transversus Abdominis Plane Block

Study Overview
=================
Brief Summary
-----------------
the aim of this study is evaluate postoperative analgesic effects of dexmedetomidine added to bupivacaine on TAP block in patients undergoing lower abdominal surgery.

Detailed Description
-----------------
TAP block is being used a method of multimodal balanced analgesia reduces postoperative pain, opioid requirement after surgery and adverse effect of opioid such as sedation, nausea vomiting and ileus. Dexmedetomidine ,an alfa-2 adrenoreceptor agonist, is being used and adjuvant capable of prolonging duration of sensory and motor block on nerve blocks.

Official Title
-----------------
Postoperative Analgesic Effects of Dexmedetomidine Added to Bupivacaine for Transversus Abdominis Plane Block for Lower Abdominal Surgery

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Drug: Dexmedetomidine
* Drug: serum physiologic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1-2 18-65 aged patient undergoing lower abdominal surgery Exclusion Criteria: chronic opioid consumption bupivacaine and dexmedetomidine allergies coagulopathy infection at the needle insertion side chronic liver and kidney disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bupivacaine<br>0,5% 20 ml bupivacaine added 0.9% 1 ml serum physiologic on TAP block | Drug: Bupivacaine<br>* 21 ml 0.5 %bupivacaine is applied interfasially<br>* Other names: marcaine;|
| Active Comparator: dexmedetomidine<br>100 mcg dexmedetomidine added to 0,5% 20 ml bupivacaine on TAP block | Drug: Dexmedetomidine<br>* 1 ml dexmedetomidin + 20 ml 0.5 % bupivacaine are applied interfasially<br>* Other names: precedex;|
| Sham Comparator: serum phsyologic<br>0,9% 21 ml serum physiologic | Drug: serum physiologic<br>* 21 ml serum physiologic is applied interfasially<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opioid consumption | patient controlled analgesia | postoperative 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scale |  | postoperative 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TAP block, bupivacaine, dexmedetomidine, postoperative analgesia
Assessment of Electromagnetic Interference Between E-transportation and Cardiac Implantable Electronic Devices

Study Overview
=================
Brief Summary
-----------------
E-Transportation is increasing all over the world. It is not known if the used engines interfere with cardiac implantable electronic devices. The study evaluates such potential interferences in vivo.

Detailed Description
-----------------
E-Transportation is increasing all over the world. It is not known if the used engines interfere with cardiac implantable electronic devices. The study evaluates different types of electric motors with regard to electromagnetic interference with implanted pacemakers or cardioverter-defibrillators.

Official Title
-----------------
Assessment of Electromagnetic Interference Between E-transportation and Cardiac Implantable Electronic Devices

Conditions
-----------------
Electromagnetic Interference

Intervention / Treatment
-----------------
* Device: Electromagnetic field


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: implanted cardiac implantable electronic device with regular function Exclusion Criteria: implanted cardiac implantable electronic device with irregular function

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electromagnetic field<br>Exposure to the elctromagnetic field of an electric motor | Device: Electromagnetic field<br>* Exposure to the electromagnetic fields of electric motors<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of electromagnetic interference | Occurrence of electromgantic interference during an exposure time of approximately 5 minutes | acute setting |