linjc16/ctgov huggingface dataset:
The Effect of Emotional Freedom Techniques (EFT) in Smokers Failing a Smoking Cessation Program

Study Overview
=================
Brief Summary
-----------------
The National Health Service (NHS) stop smoking service at the Central Lancashire NHS Trust serves a diverse population of smokers, with a very good quit rate and high standards. However, clinical experience predicts that some clients are unlikely to succeed through the NHS smoking cessation program. This special population has difficulty quitting for a variety of reasons. Some relapse over the course of the following two years and return repeatedly to the service. Others, for instance those with health problems, may be highly motivated to quit, but unable to resist their cravings. The purpose of this study is to determine if EFT makes a difference in quit rates with the most challenging population of clients.

Official Title
-----------------
The Effect of EFT (Emotional Freedom Techniques) in Smokers Failing a Smoking Cessation Program

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Behavioral: EFT (Emotional Freedom Techniques)
* Behavioral: CBT (Cognitive Behavioral Therapy)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High anxiety related to the quit attempt Cravings which sabotage the quit attempt Low confidence at their ability to quit and remain quit Exclusion Criteria: None, all NHS clients are eligible

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 99 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CBT<br>Cognitive Behavioral Therapy | Behavioral: CBT (Cognitive Behavioral Therapy)<br>* CBT is a behavioral intervention that seeks to challenge and change negative client cognitions about events and life circumstances.<br>|
| Experimental: EFT<br>Emotional Freedom Techniques, a novel but efficacious stress-reduction technique | Behavioral: EFT (Emotional Freedom Techniques)<br>* EFT is a brief but efficacious stress-reduction intervention. It combines exposure, cognitive structuring, and somatic stimulation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quit rate |  | treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological symptoms and physiological symptoms | Symptoms and smoking 3, 6 and 12 months post-intervention | Three, 6, and 12 months after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking, EFT (Emotional Freedom Techniques), CBT (cognitive behavior therapy), cravings, trauma
Evaluation of an Oral Nutritional Supplement Containing AN777

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of an experimental oral nutritional supplement containing AN777 compared to another oral nutritional supplement in a malnourished, elderly population.

Official Title
-----------------
Evaluation of an Oral Nutritional Supplement Containing AN777 in Malnourished and Frail Subjects

Conditions
-----------------
Malnutrition, Sarcopenia

Intervention / Treatment
-----------------
* Other: medical food with AN777
* Other: oral nutritional formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject (male or female) is > or equal to 65 and < or equal to 90 years of age Subject is ambulatory Subject has a Subjective Global Assessment of B or C Subject has gait speed <0.8 m/s AND/OR low hand-grip strength Subject has Class 1 or Class 2 sarcopenia Subject agrees to refrain from starting a resistance exercise program Exclusion Criteria: Subject has type 1 or type 2 diabetes Subject has inflammatory disease with elevated high sensitivity C-reactive protein Subject has renal function impairment Subject reports gastrointestinal disorder (severe chronic diarrhea, nausea, vomiting) that would preclude ingestion of the study product; an obstruction of the gastrointestinal tract, inflammatory bowel disease; short bowel syndrome or other major gastrointestinal disease Subject reports of current active malignant disease or other significant medical diagnoses. Subject reports a history of allergy to any of the ingredients in the study products Subject reports currently taking medications/dietary supplements/substances that could profoundly modulate metabolism or weight.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 90 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: medical food with AN777<br> | Other: medical food with AN777<br>* Two(220 mL)servings every day for six months<br>|
| Active Comparator: oral nutritional formula<br> | Other: oral nutritional formula<br>* Two (220 mL) servings daily for six months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee extensor strength |  | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg muscle mass |  | Six months | 
| Body Weight |  | Six months | 
| Functional measures |  | Six months |
Evaluation of Safety and Performance of the Orbix Breast Lift System

Study Overview
=================
Brief Summary
-----------------
The study is using a new breast lift system to complement a breast-lift operation. In general there will be recurrence of breast-ptosis after a correcting operation. With this device we want to minimize this recurrence and provide an internal bra.

Official Title
-----------------
Phase 1 Study to Evaluate the Safety and Performance of the Orbix Breast Lift System

Conditions
-----------------
Breast Ptosis

Intervention / Treatment
-----------------
* Device: Breast lift system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Female subject between 30-50 years of age 2. Subject is referred for mastopexy(breast lifting)due to one of the following reasons: Breast ptosis grade I or II (minimal invasive) Breast ptosis grade I to IV (open procedure) pseudoptosis following breast reduction surgery 3. subject willing to participate as evidenced by signing the written informed consent 4. Minimal invasive: breast cup size <C Exclusion Criteria: Pregnant or lactating women history of surgical procedures involving the ribs and rib cage Osteoporosis breast implants breast carcinoma auto-immune disease -

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Breast lift system|During a breast operation for ptosis a device is brought into the breast and attached to the ribs, to provide lifting of the breast|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Result after using the breast lift system,recurrence of ptosis. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast ptosis, Breast lift
Sexual Risks in Prep Users

Study Overview
=================
Brief Summary
-----------------
Primary purpose of the study: to describe sexual behavior of Prep users, whatever mode of intake, ie continuous or on-demand; it has been shown in some studies, an increase of sexual risks in Prep users, and therefore an similar increase of STIs (sexually transmitted diseases); using a self-questionnaire, we'd like to evaluate sexual behavior before, and 6 months after, starting Prep. Secondary purposes: to describe medical characteristics of Prep users (past medical condition, demographic characteristics, vaccinations, kidney function, serological results, urine and anal/pharyngeal swabs), clinical and biological Prep safety, STIs occurrence, and antibiotic prescriptions, continuous or on-demand intake, Prep indication.

Official Title
-----------------
Analysis of Sexual Risks in Prep (Pre-exposure Prophylaxis) Users Followed-up in a University Care Centre (Le Trait d'Union)

Conditions
-----------------
HIV Infection, Prep Prescription, Vaccinations, Sexually Transmitted Diseases

Intervention / Treatment
-----------------
* Behavioral: PrEP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non HIV-infected subjects men aged 18 years or older having non protected sexual relationship taking Prep (emtricitable/tenofovir disoproxil fumarate) either every day, or on-demand affiliated to social security Exclusion criteria: HIV-infected patients refusal of study participation not on Prep not fluent in French language safeguarding justice on guardianship or trusteeship

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

| Intervention/Treatment |
| --- |
|Behavioral: PrEP|Define the behavioral characteristics of the active file of patients using PrEP in Strasbourg in 2019.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of sexual behavior in Prep users | Sexual behavior will be evaluated with a questionnaire | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the medical profile of the Strasbourgeoise active file | Describe the active line of people using Prep and followed in the center | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prep, Sexual behavior, HIV, Syphilis, Chlamydia infection, Hepatitis, Gonococcus
Effect of Rollator on Walking Distance in Elderly Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of a rollator on 6 Minute Walking Test (6MWT) in elderly people.

Conditions
-----------------
Healthy Elderly

Intervention / Treatment
-----------------
* Procedure: six minute walking test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elderly people (older than 60 years) Exclusion Criteria: respiratory diseases

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With rollator<br>Six minutes walking test with rollator | Procedure: six minute walking test<br> <br> |
| Active Comparator: Without rolator<br>Six minutes walking test without rollator | Procedure: six minute walking test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| six minute walking test |  | 6 minutes |
Impedance Cardiography During Major Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators validated ICG's(impedance cardiography) usefulness during the abdominal surgery, by comparing it with FloTrac/Vigileo™ (Edwards Lifesciences,Irvine, CA, USA)

Detailed Description
-----------------
Intrathoracic structures have relatively constant resistance except the influence of changing diameter of aorta. Great vessels in thorax has the lowest resistance, and their diameter changes by the beats of the heart. As their diameter increases, their resistance decreases. ICG measures the difference between the resistances caused by heartbeats, and calculates cardiac output. But during the surgery, there are many interfering electrical currents made by electro cautery, patient positioning, and internal organ handling. Therefore, it has been thought that ICG is not a valid tool for measuring cardiac output during the surgery. The investigators validated ICG's usefulness during the surgery, by comparing it with Floctac/Vigileo.

Official Title
-----------------
Comparison of Cardiac Output Derived From Flotrac/Vigileo and Impedance Cardiography During Major Abdominal Surgery

Conditions
-----------------
Abdominal Surgery

Intervention / Treatment
-----------------
* Device: Niccomo™ (Medis, Ilmenau, Germany) impedance cardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing open gastrectomy with arterial line ASA 1 & 2 Exclusion Criteria: severe valve disease severe lung disease

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Niccomo™ (Medis, Ilmenau, Germany) impedance cardiography|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output | Cardiac output will be measured using an ICG and compared with cardiac output measured using Flotrac/vigileo |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
impedance cardiography, Flotrac/Vigileo, cardiac output
Ultrasound-Guided Stellate Ganglion Block With Botulinum

Study Overview
=================
Brief Summary
-----------------
the local stellate ganglion block with bupivacaine and corticosteroid treatment for acute peripheral facial nerve palsy in patients can induce hyperglycemia, and an alternative local therapy may be necessary and some time may ve ineffective. Our purpose in this study is to evaluate therapeutic effects of stellate ganglion block (SGB) Botulinum Toxin on referactory facial nerve palsy

Detailed Description
-----------------
:Idiopathic facial nerve palsy (Bell's palsy) is caused by damage to the facial nerve at any site of the peripheral branches after the facial nucleus.Stellate ganglion block is inteneded to increase blood flow and promotes nerve regeneration. the local stellate ganglion block with bupivacaine and corticosteroid treatment for acute peripheral facial nerve palsy in patients can induce hyperglycemia, and an alternative local therapy may be necessary and some time may ve ineffective. Our purpose in this study is to evaluate therapeutic effects of stellate ganglion block (SGB) Botulinum Toxin on referactory facial nerve palsy

Official Title
-----------------
Ultrasound-Guided Stellate Ganglion Block With Botulinum Toxin Versus Steroid in Refractory Bell's Palsy

Conditions
-----------------
Change From Baseline House-Brackmann

Intervention / Treatment
-----------------
* Drug: Botox
* Drug: triamcinolonacetonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed by clinical and neurological assessment as one-sided idiopathic facial palsy Age 18 to 60 •-ASA i-II Exclusion Criteria: Exclusion Criteria: diabetic coagulation dysfunction mental or cognitive dysfunclion allergy to injected medication

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Botulinum Toxin<br>injected 10 mL of 0.1% bupivacaine with 100 Botox units (BOTOX®, Allergan Inc., Irvine, CA, USA) | Drug: Botox<br>* injected 10 mL of 0.1% bupivacaine with 100 Botox units (BOTOX®, Allergan Inc., Irvine, CA, USA)<br>|
| Active Comparator: steroid<br>injected 10 mL of 0.25% bupivacaine with triamcinolonacetonide 4 mg/ml | Drug: triamcinolonacetonide<br>* triamcinolonacetonide stellate ganglion injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline House-Brackmann | Change from Baseline House-Brackmann | : Baseline ,change from baseline House-Brackmann at 7th day,one month,two month, three month |
Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI

Study Overview
=================
Brief Summary
-----------------
Under conditions of first-line drug treatment in antidiabetic drug naïve/drug free patients with type 2 diabetes mellitus and dyslipidemia, to show that :- the efficacy of a fixed combination (FC) of fenofibrate and metformin on glycemic control is not inferior to that of rosiglitazone and the efficacy of FC of fenofibrate and metformin on triglyceride control is superior to that of rosiglitazone.

Official Title
-----------------
A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of a Fixed Combination of Fenofibrate and Metformin vs Rosiglitazone in Patients With Type 2 Diabetes Mellitus and Dyslipidemia

Conditions
-----------------
Dyslipidemia, Glucose Metabolism Disorder

Intervention / Treatment
-----------------
* Drug: fenofibrate (F) + metformin (M) hydrochloride fixed combination
* Drug: Rosiglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with Type 2 diabetes mellitus and dyslipidemia inadequately controlled with lifestyle modifications. Exclusion Criteria: Type 1 diabetes.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: 1<br> | Drug: fenofibrate (F) + metformin (M) hydrochloride fixed combination<br>* First period: F80mg/M500mg - per os - twice a day during 2 weeks and F80mg/M850mg - per os - twice a day during 10 weeks - Second period: F54mg/M850mg - per os - three times a day during 12 weeks<br>|
| Active Comparator: 2<br> | Drug: Rosiglitazone<br>* First period: 4 mg - per os - daily during 12 weeks - Second period: 4 mg - per os - twice a day during 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c/TG |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid and glycemic parameters. |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus
The Th17/Treg Cells and IL-23/IL-17 Axis and Early Enteral Nutrition in Sepsis

Study Overview
=================
Brief Summary
-----------------
The investigators aim to evaluate the roles of Th17/Treg cells and IL-23/IL-17 axis in the mechanisms of early enteral nutrition (EEN) correcting immune imbalance of sepsis by means of improving the intestinal flora disturbance. The results of this study would lay the foundation for revealing the mechanisms of EEN improving immune imbalance of sepsis and provide a new idea to the early treatment of sepsis

Official Title
-----------------
The Roles of Th17/Treg Cells and IL-23/IL-17 Axis in the Mechanisms of Early Enteral Nutrition Improving Immune Function of Sepsis

Conditions
-----------------
Sepsis, Immune System Disorder, Enteral Feeding

Intervention / Treatment
-----------------
* Other: enteral nutrition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of sepsis Within 3 days of sepsis onset before ICU admission No artificial nutrition (enteral or parenteral nutrition) were provided before ICU admission Exclusion Criteria: Ileus Digestive tract hemorrhage Inflammatory bowel disease Abdominal hypertension (IAP >25mmHg) Cancer or chronic organ dysfunction (e.g., hepatic or renal dysfunction) Malnutrition or immunodeficiency Long-term use of hormones

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: early enteral nutrition<br> | Other: enteral nutrition<br>* early enteral nutrition group or delayed enteral nutrition group<br>|
| Active Comparator: delayed enteral nutrition<br> | Other: enteral nutrition<br>* early enteral nutrition group or delayed enteral nutrition group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-d mortality |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immune parameters | serum Th17 and Treg lymphocyte percentages | 7 days | 
| immune parameters | IL-23, IL-17, IL-6, IL-10 levels | 7 days |