linjc16/ctgov huggingface dataset:
Comparison of Effectiveness of Pre-cooling With Ethyl Chloride Versus Honey

Study Overview
=================
Brief Summary
-----------------
Comparing Pre-cooling with Ethyl Chloride versus Honey in Alleviating Intra-oral injection pain in Adult patients

Official Title
-----------------
Comparison of Effectiveness of Pre-cooling With Ethyl Chloride Versus Honey in Alleviating Intra-oral Injection Pain in Adult Patients

Conditions
-----------------
Irreversible Pulpitis

Intervention / Treatment
-----------------
* Drug: Ethyl chloride
* Other: Honey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No medical history Patients suffering from Symptomatic Irreversible Pulpitis requiring buccal infiltration Exclusion Criteria: Patients having any medical conditions considered to affect patient safety or the quality of the study if they had any known hypersensitivity to local anaesthetics of amide type or any of the other contents in the substance used

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ethyl chloride<br> | Drug: Ethyl chloride<br>* Ethyl chloride is an agent that is widely used in dental practice as the standard modality for pulp vitality tests .<br>|
| Experimental: Honey<br> | Other: Honey<br>* Honey is a natural dietary product<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To alleviate dental injection pain | Post administration of oral local anesthetic infiltration pain will be measured by using Visual Analogue Scale(VAS) which is an 10-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured | immediately after completion of administration of oral local anesthetic infiltration within 60 seconds |
Study To Investigate Effect Of A New Drug (PF-00446687) In Post-Menopausal Women Who Suffer From Sexual Dysfunction.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on acute sexual arousal and sexual interest in post menopausal females, as well as examining the safety and toleration of the drug.

Official Title
-----------------
Phase 2A Multi-Centre, Double Blind, Placebo Controlled 3-Way Cross-Over Study To Investigate The Effect Of Single Doses Of PF-00446687 On Sexual Arousal And Sexual Desire In Women Suffering From Female Sexual Dysfunction (FSD).

Conditions
-----------------
Female Sexual Dysfunction

Intervention / Treatment
-----------------
* Drug: PF-00446687
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who have evidence of Female Sexual Arousal Disorder. Women who experience personal distress due to Female Sexual Dysfunction. Post menopausal women aged between 45 and 65 years. Exclusion Criteria: Women whose sexual dysfunction is limited to certain types of stimulation, situation or specific partners. Women who experience pain with sexual intercourse or who have a sexual aversion disorder. Women suffering from female sexual dysfunction where the cause is treatable, for example inadequately controlled diabetes or thyroid dysfunction.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study period 1, 2 or 3<br> | Drug: PF-00446687<br>* Single 200mg dose<br>|
| Placebo Comparator: Placebo Study period 1, 2 or 3<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess effect of single doses of PF-00446687 on acute sexual arousal and sexual interest, using questionnaires, in post menopausal women suffering from Female Sexual Dysfunction. A diary will be completed for 7 days following the 3 dosing days. |  | From day of dosing until 7 days post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess effect of single doses on medium term (1 week) sexual arousal and interest. |  | Until 7 days post-dose | 
| Assess variability of response and repeatability of design between 2 similar doses. |  | Comparison of response to be assessed until 7 days post dose | 
| If possible assess the effect of PF-00446687 on vaginal blood flow on day 1 of each study period. |  | Day of dosing | 
| Assess PK , safety and toleration on day 1 of each study period. |  | Day of dosing |
Evaluation of the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the rate of fracture healing and fracture union, repaired with the LISS device, will be as good as or better than the usual fracture fixation systems.

Official Title
-----------------
Prospective Randomized Clinical Study to Evaluate the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures

Conditions
-----------------
Femoral Fractures

Intervention / Treatment
-----------------
* Device: Plates to treat fractures of the distal femur
* Device: LISS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has read and agree to the consent Patient is 16 years or older (bones have finished growing) The injury happened in the last 14 days Exclusion Criteria: The patient taking part in another study The patient has an infection at the operative site The patient has a health condition that affects bone healing or interferes with their ability to complete the study requirements (questionnaires, examinations), for example Paget's disease or osteomalacia The patient is taking medication that affects bone healing (such as systemic steroids) The patient has malignant (tumor) disease The patient is unable to attend follow-up clinic visits

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Active Comparator: LISS<br>Treatment of distal femur fracture with less invasive stabilization system | Device: LISS<br>* treatment of distal femur fractures with less invasive stabilization systems<br>|
| Active Comparator: Standard Treatment<br>Treatment of distal femoral fractures using locking condylar plates or dynamic condylar screws | Device: Plates to treat fractures of the distal femur<br>* use of dynamic condylar screws or locking condylar plates in the treatment of distal femur fractures<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delayed union or nonunion of the distal femur | Determined via radiographic analysis | 12 months post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clinical healing | assessed by weight-bearing ability and pain | 12 months | 
| Function as assessed by patient | Assessed using LEM, SMFA, and SF-36 questionnaires | 6 months, 12 months | 
| Frequency of adverse events |  | 12 months | 
| Range of motion |  | Post-op, 6 weeks, 3 months, 6 months, 12 months | 
| Gait analysis |  | 12 months |
Shared Decision Making in Patients With Thyroid Nodules

Study Overview
=================
Brief Summary
-----------------
The objective of this project is to evaluate a treatment decision aid for patients with low risk thyroid cancer.

Official Title
-----------------
Shared Decision Making in Patients With Thyroid Nodules

Conditions
-----------------
Thyroid Nodule, Thyroid Cancer

Intervention / Treatment
-----------------
* Other: Thyroid Decision Aid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Clinical diagnosis of low risk thyroid cancer Exclusion Criteria: -Does not have the cognitive capacity to provide consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implementation Arm<br> | Other: Thyroid Decision Aid<br>* The Thyroid Decision Aid is a tool designed to help clinicians and patients discuss treatment options for thyroid nodules.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of treatment choices between patients receiving usual care versus decision aid | Distribution of treatment choices between patients receiving usual care versus decision aid | Up to six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shared Decision Making, Decision Aid
Researching AXIUM Coiling Experience and Recanalization (RACER)

Study Overview
=================
Brief Summary
-----------------
The data collected in this study will be used to support International Regulatory submissions. The study objective is to evaluate the continued safety and efficacy of the AXIUM Progressive Coil System. This Device has been used clinically at approximately 150 Institutions under FDA 510(k) clearance since April 24, 2007. The device received CE authorization on June 30, 2007. Through December 2007, more than 1000 patients have been treated with the AXIUM Coils.

Official Title
-----------------
ev3 Researching AXIUM Coiling Experience and Recanalization (RACER)

Conditions
-----------------
Aneurysms, Vascular Diseases, Cerebrovascular Disorders, Intracranial Arterial Diseases

Intervention / Treatment
-----------------
* Device: The AXIUM Progressive Coil System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient or patient's legally authorized representative has signed and dated an Informed Consent Form Must be at least 18 years of age Aneurysm location, angio-architecture, morphology, or medical condition, is considered by the neurosurgical / interventional team to be at very high risk for management by traditional operative techniques, or aneurysm is considered to be inoperable Patient is willing to conduct follow-up visits Exclusion Criteria: Aneurysm was previously treated Patient has a cerebral aneurysm with a location, angioarchitecture or morphology that presents an unacceptable risk of morbidity due to the Study procedures Patient is participating in another clinical research Study Patient has a medical, social or psychological condition, which precludes the patient from receiving Study required treatment, evaluation, procedures and follow-up Female patient is pregnant or breast-feeding

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 |
| --- | --- |
| AXIUM Coils<br> | Device: The AXIUM Progressive Coil System<br>* Embolization of aneurysm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Occlusion |  | Defined in protocol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity/Mortality |  | Defined in protocol | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ev3 Neurovascular, aneurysms, cerebrovascular, endovascular, neurovascular therapies, RACER, AXIUM, The AXIUM Progressive Coil System, ev3, MTI, Micro Therapeutics, FX detachable coil system, K060747, brain diseases
Influence of Protein Source on Satiety and Metabolism

Study Overview
=================
Brief Summary
-----------------
Dietary protein is the more satiating nutrient, however it is not clear whether satiety may be influenced by the nature of the protein. This study was designed to assess potential differences between protein sources on satiety and their relationship with digestive and metabolic kinetics.

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

Intervention / Treatment
-----------------
* Dietary Supplement: Casein-enriched diet
* Dietary Supplement: Milk soluble protein-enriched diet
* Dietary Supplement: Casein and milk soluble proteins-enriched diet
* Dietary Supplement: Soy proteins-enriched diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 25 and 30 Exclusion Criteria: allergy to milk proteins

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Casein<br> | Dietary Supplement: Casein-enriched diet<br>* Subjects consume for 9 days a supplement of 30g/d of casein<br>|
| Experimental: MSP<br> | Dietary Supplement: Milk soluble protein-enriched diet<br>* Subjects consume for 9 days a supplement of 30g/d of milk soluble protein<br>|
| Experimental: Casein/MSP<br> | Dietary Supplement: Casein and milk soluble proteins-enriched diet<br>* Subjects consume for 9 days a supplement of 30g/d of a mix of casein and milk soluble protein<br>|
| Experimental: Soy protein<br> | Dietary Supplement: Soy proteins-enriched diet<br>* Subjects consume for 9 days a supplement of 30g/d of soy protein<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satiety |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hormonal profiles, digestive fluxes of nutrients, postprandial dietary N metabolism |  | 9 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy subjects
Safety, Pharmacokinetic, and Pharmacodynamic Study of NKTT120 in Adult Patients With Stable Sickle Cell Disease (SCD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety, pharmacokinetics, and pharmacodynamics of NKTT120 in adult patients with stable sickle cell disease.

Official Title
-----------------
A Single Ascending Dose Phase 1 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biologic Activity of Intravenous NKTT120 in Adults With Stable Sickle Cell Disease

Conditions
-----------------
Sickle Cell Disease

Intervention / Treatment
-----------------
* Drug: NKTT120


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 50 years Subject has a confirmed diagnosis of HbSS or HbSβ0thal Subject has stable SCD defined as not having acute VOC, ACS, or other major SCD associated event during the month prior to enrollment Exclusion Criteria: Subject had an SCD-related VOC or ACS that required hospitalization or treatment in acute care outpatient setting in the month prior to enrollment Subject requires a program of prescheduled regularly administered packed red blood cell (pRBC) transfusions or Subject received a pRBC transfusion in the month prior to enrollment Subject has evidence of latent or active tuberculosis Subject has a major concurrent illness or medical condition Subject is pregnant or nursing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: NKTT120<br> | Drug: NKTT120<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as assessed by (1) adverse events (2) laboratory values (3) vital signs and (4) physical exam. |  | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics assessed by plasma drug concentration levels |  | 0; 15, 30, 60 minutes; 3,6, hours; 1,2,3,7,14,30,60,90 days | 
| Pharmacodynamics as measured by assessments of peripheral blood lymphocyte subsets |  | 0, 0.25, 1, 2, 7, 14, 30, 60, 90, 120 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sickle cell disease
Socio-Educational Intervention for Rural Suicide Attempters

Study Overview
=================
Brief Summary
-----------------
Compared to a treatment-as-usual group, providing brief mental health education to suicide attempters from rural parts of China at the time of their treatment in the emergency departments of general hospitals or local clinics and 6 home-visits (FOR those subjects WITH PHONES refuse home visits, THE INTERVIEWS WILL BE CONDUCTED OVER THE PHONE) over the twelve months after the attempt demonstrate continuing concern about the attempters ('befriending'), strengthen their social support networks and improve their problem-solving skills will significantly reduce their hopelessness, the severity of depressive symptoms, and level of suicidal ideation.

Official Title
-----------------
A Randomized Control Trial of a Socio-Educational Intervention for Rural Suicide Attempters in Tianjin Municipality and Shandong Province of China

Conditions
-----------------
Suicide, Attempted

Intervention / Treatment
-----------------
* Other: socio-educational intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suicide attempters must be 18 years or older no-zero intent to die Exclusion Criteria: with communication difficulties living outside of the research sites

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>brief education and 6 follow-up visits | Other: socio-educational intervention<br>* brief mental health education and 6 follow-up visits<br>* Other names: psychosocial intervention on suicide prevention;|
| No Intervention: 2<br>treatment-as-usual | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the severity of depressive symptoms |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency and intensity of suicidal ideation |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
attempted suicide, socio-educational intervention, follow up study