linjc16/ctgov huggingface dataset:
Piezosurgery in the Treatment of Class II Furcation Involvement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of piezosurgery in the treatment of class II furcation involvement using biomaterials and new surgical techniques

Official Title
-----------------
Piezosurgery in the Treatment of Class II Furcation Involvement

Conditions
-----------------
Furcation Defects

Intervention / Treatment
-----------------
* Procedure: Piezosurgery with biomaterial mp3 + bracket
* Procedure: Piezosurgery with biomaterial mp3
* Procedure: Piezosurgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: previous subgingival instrumentation with adequate plaque control (FMPS < 20%) and bleeding on probing (FMBS < 20%). one or more mandibular molar with buccal class-II furcation involvement Exclusion Criteria: diabetes mellitus pregnancy and lactation period subjects smoking > 10 cigarettes/day were excluded subjects in chronically treatment with calcium antagonist, immunosuppressive drugs and Antiepileptic Drugs

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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OFD with piezosurgery<br>Open flap debridement with Piezosurgery | Procedure: Piezosurgery<br> <br> |
| Experimental: OFD with piezosurgery+biomaterial<br>Open flap debridement with Piezosurgery with biomaterial mp3 | Procedure: Piezosurgery with biomaterial mp3<br> <br> |
| Experimental: OFD with piezosurgery+mp3+bracket<br>Open flap debridement with Piezosurgery with biomaterial mp3 + bracket | Procedure: Piezosurgery with biomaterial mp3 + bracket<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Horizontal probing depth (PH) | horizontal probing depth | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque index (PI) | plaque index | 180 days | 
| Bleeding on probing (BoP) | bleeding on probing | 180 days | 
| Pocket probing depth (PPD) | pocket probing depth | 180 days | 
| Furcation closure (FC) | furcation closure | 180 days | 
| Clinical attachment level (CAL) | clinical attachment level | 180 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
class II furcation involvement, piezoelectric surgery, regeneration, biomaterial
Safety and Efficacy of Insulin Detemir in Combination With OADs in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia. The aim of this trial is to evaluate the blood glucose achieved with insulin detemir as add-on to current oral antidiabetic drug (OAD) treatment in subjects with type 2 diabetes.

Official Title
-----------------
Evaluation of Insulin Detemir in Combination With OADs in Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes for at least 12 months since diagnosis Insulin naive subjects OAD treatment for at least 4 months with max. two OAD treatments Body mass index below 30.0 kg/m2 HbA1c between 7.0-11.0% Exclusion Criteria: OAD treatment with three or more OADs Secondary diabetes Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator Uncontrolled hypertension Known or suspected allergy to trial product or related products

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: insulin detemir|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 20 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma glucose (FPG) |  |  | 
| Within-subject variation |  |  | 
| Change in body weight |  |  | 
| Incidence of adverse events |  |  |
Evaluation of Videolaryngoscopes in Difficult Airway (SWIVITII)

Study Overview
=================
Brief Summary
-----------------
In this second phase of the multicenter study the investigators are going to evaluate the use of three different videolaryngoscopes in patients undergoing elective surgery requiring general anesthesia with intubation. The investigators are hypothesizing that these three videolaryngoscopes will succeed for intubation at first attempt in at least 90% of all cases using a difficult airway simulation with extrication collars. As the gold standard, a standard Macintosh blade is being used for comparison. The study consists of 4 arms. Each arm includes 120 patients, sums up to a total of 480 patients.

Official Title
-----------------
Phase 2 Study of Evaluation of Videolaryngoscopes in Difficult Airway (SWIVITII)

Conditions
-----------------
Difficult Intubation

Intervention / Treatment
-----------------
* Device: Airtraq, blade without channel for tracheal tube intubation
* Device: KingVision , blade without channel for tracheal tube intubation
* Device: A.P. Advance, blade without channel for tracheal tube intubation
* Device: Macintosh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective surgery with general anesthesia requiring intubation >18 years old ASA I-III Exclusion Criteria: known or presumed difficult airway risk of pulmonary aspiration refusing to participate

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Airtraq, blade without channel for tracheal tube<br>intubation | Device: Airtraq, blade without channel for tracheal tube intubation<br>* Intubation<br>* Other names: Macintosh;|
| Experimental: KingVision , blade without channel for tracheal tube<br>intubation | Device: KingVision , blade without channel for tracheal tube intubation<br> <br> |
| Experimental: A.P. Advance, blade without channel for tracheal tube<br>intubation | Device: A.P. Advance, blade without channel for tracheal tube intubation<br> <br> |
| Experimental: Macintosh<br>intubation | Device: Macintosh<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first attempt intubation success rate |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects | sore throat, bleeding, dental injuries | 1h and 1day after intubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intubation; Difficult
Bone Density of Newborn Infants to Mothers Treated With Selective Serotonin Reuptake Inhibitor (SSRI)

Study Overview
=================
Brief Summary
-----------------
SSRI treatment in adults was found to decrease bone density. The use of SSRI among pregnant women with depression or anxiety is extendent and raising. The effect of bone density of the infants was not yet evaluated.

Conditions
-----------------
Bone Density

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term newborn infants to mothers treated with SSRI and healthy controls Exclusion Criteria: Preterms, major congenital malformations.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 7 Days

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone density |  | 1 month | 
| bone density |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone density, SSRI, newborn infants
Effect of Cannabis (Marijuana) on Stomach Emptying Before Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to study the effect of cannabis (marijuana) on gastric (stomach) emptying before surgery. The study will include people who use cannabis (study group) and people who do not use cannabis (control group).

Detailed Description
-----------------
About 108 people will take part in this study (54 in the study group and 54 in the control group). Subjects will have an ultrasound of the abdomen before their scheduled surgery. The ultrasound will determine how much fluid remains in the abdomen. Researchers will also review subjects' medical records and will include: age, body mass index, history of cannabis use including how often and how consumed, reason for surgery, and length of time without eating before surgery.

Official Title
-----------------
Cannabis Consumption Effect on Gastric Volumes

Conditions
-----------------
Gastric Emptying, Cannabis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects 18 years and older Planned surgery at one of two hospitals within the healthcare system Willing to state if they use or do not use cannabis Able to read and consent on their own behalf Exclusion Criteria: Cognitively impaired Unable to read Children under the age of 18 Pregnant women - Pregnancy status will be obtained from the routine pregnancy test performed prior to surgery History of gastroparesis Gastric surgeries Advanced liver or renal dysfunction Critically ill Emergent/urgent cases

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>People who self-report that they do not use cannabis. | |
| Cannabis<br>People who self-report that they use cannabis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric content volume | Gastric content volume as assessed by ultrasound prior to surgery | pre-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of cannabis use | number of times per week patient uses cannabis | 3 months prior to surgery | 
| Cannabis use (chronic yes or no) | Yes or No for chronic cannabis use | 1 year prior to surgery | 
| Route of cannabis consumption | Categories of how cannabis is consumed (smoke, vape, other) | 3 months prior to surgery | 
| Time since last food; Nil per os (NPO) time | Length of time patient had no food prior to surgery | 24 hours prior to surgery |
Incidence of SCLN Metastasis in Patients Referred for EBUS-TBNA

Study Overview
=================
Brief Summary
-----------------
Evaluation of the anatomic extent of a primary lung cancer and presence of metastasis are essential for selection of an appropriate management strategy. Endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) is a reliable and established technique to evaluate involvement of mediastinal lymph nodes (LN); however, it is an invasive procedure and may not be tolerated in patients with severe underlying lung disease. One exception is the superficially located supraclavicular lymph nodes (SCLN), which can easily be biopsied with percutaneous US-guided-fine needle aspiration (US-FNA). Traditionally, this nodal group is evaluated by palpation; however, literature suggests that palpation itself fails to capture 66% of proven disease by cytology, which challenges the acceptance that non-palpable nodes are indicative of absent disease. Since all palpable SCLN are biopsied to rule out metastasis, we may potentially up-stage more patients using ultrasound evaluation for non-palpable nodes; and offer more appropriate management. Currently, the incidence for non-palpable SCLN metastasis has not been defined in this patient population presenting for EBUS-TBNA. The primary objective is to determine the incidence of supraclavicular lymph node metastasis by ultrasound evaluation in patients referred for EBUS-TBNA.

Official Title
-----------------
Incidence of Supraclavicular Lymph Node Metastasis in Patients Referred for EBUS-TBNA for Presumed Primary Lung Cancer by Interventional Pulmonologists.

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Supraclavicular lymph node ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients age 20yrs or greater referred for EBUS-TBNA with suspicion for primary lung cancer Exclusion Criteria: Refusal to sign consent Signs of skin infection along the neck Adults who lack the capacity to sign consent.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| 1<br>All patients age 20yrs or greater referred for EBUS-TBNA with suspicion for primary lung cancer | Diagnostic Test: Supraclavicular lymph node ultrasound<br>* Patients will have supraclavicular lymph node assessed prior to EBUS-TBNA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of supraclavicular metastasis | Incidence of supraclavicular metastasis | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interventional Pulmonary, EBUS-TBNA, Lung cancer staging
Functional MRI and MRA in Migraine With Aura

Study Overview
=================
Brief Summary
-----------------
Patients who report that exposure to bright light or strenuous physical activity will induce migraine aura will be provoked using one or both of these methods. Followingly the patients will be examined by functional MRI. Íf the patients develop migraine headache, MR angiography will be performed as well. The primary study hypothesis is that the functional MRI signal will show features similar to those of the electrophysiological phenomenon of cortical spreading depression.

Official Title
-----------------
Functional MRI and MRA in Migraine With Aura

Conditions
-----------------
Migraine With Aura

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with migraine with aura as defined by The International Classification of Headache Disorders 2 Age between 18 and 80 years both inclusive Reports that bright light or strenuous physical activity may trigger migraine aura Exclusion Criteria: Contraindications towards exposure to photostimulation or strenuous exercise Body weight above 130 kg Pregnant or lactating females Contraindications towards MRI scanning History or clinical signs of: cardiovascular disease, psychiatric disease, substance abuse or any symptom or disease considered relevant by the examining physician.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Nurigra Chewable Tablet in Healthy Adult Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate pharmacokinetics of sildenafil citrate in healthy male volunteers.

Official Title
-----------------
Nurigra Chewable Tablet in Healthy Adult Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: Nurigra Chewable tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy and male subjects aged 20 to 45 years A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently) A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints. Exclusion Criteria: A subject with sign or symptoms or previously diagnosed disease of liver

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurigra Chewable tablet<br> | Drug: Nurigra Chewable tablet<br>* 1 tablet of 100mg, once a day<br>|
| Active Comparator: Viagra<br> | Drug: Nurigra Chewable tablet<br>* 1 tablet of 100mg, once a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to Assess Pharmacokinetics | AUC and Cmax in plasma | 24h after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to Assess Safety | Adverse events, Physical exam, Vital sign, Laboratory, 12-lead-ECG | 24h after administration |
Electrical Stimulation for the Relief of Freezing of Gait (FOG) in Parkinson's Patients

Study Overview
=================
Brief Summary
-----------------
Potential for electrical stimulation to ameliorate Freezing of Gait (FOG)

Detailed Description
-----------------
The purpose of this study is to investigate the potential for an electrical stimulation intervention to ameliorate Freezing of Gait (FOG) and related gait disturbances in Parkinson's patients.

Official Title
-----------------
Electrical Stimulation for the Relief of Freezing of Gait (FOG)

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Device: neuromuscular stimulation device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of idiopathic Parkinson's Disease (PD) (UK, PD Brain Bank Criteria) A Hoehn and Yahr stage of 2 - 4 Exhibiting Freezing of Gait or another gait abnormality in the ON state. An ability to mobilise independently with or without a walker or walking cane for the purpose of research when in the 'ON' state Exclusion Criteria: A serious cognitive impairment (MMSE<24) Pregnant or currently involved in another clinical trial. Pacemakers On opioid or neuropathic pain medication

Ages Eligible for Study
-----------------
Minimum Age: 40 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
Intervention Model: Single Group Assignment
Interventional Model Description: Sensory electrical stimulation for the amelioration of FoG through the continuous delivery of stimulation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Freezing of Gait amelioration<br>Effect of neuromuscular stimulation device will be assessed on Freezing of Gait amelioration | Device: neuromuscular stimulation device<br>* Effect of neuromuscular stimulation device at specific muscle sites will be examined for freezing of gait amelioration.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Time in FoG PTF | We hypothesise that the delivery of continuous sensory electrical stimulation will reduce the percentage of time in FoG. | At time of intervention (seconds) | 
| Number of FoG episodes occurring | We hypothesise that the delivery of continuous sensory electrical stimulation will reduce the Number of FoG episodes Occurring (NFO). | At time of intervention (seconds) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Freezing of Gait, Gait, Comfort, Pain tolerance, Pain, Sensory threshold, Motor threshold, Pain threshold