linjc16/ctgov huggingface dataset:
Comparative Effects of Gun Massager and Transverse Friction Massage in Patients With Plantar Fasciitis

Study Overview
=================
Brief Summary
-----------------
to compare the effects of massage gun and transverse friction massage on management of pain and disability in patients with plantar fasciitis.

Official Title
-----------------
Comparative Effects of Gun Massager and Transverse Friction Massage on Pain and Disability in Patients With Plantar Fasciitis

Conditions
-----------------
Plantar Fascitis

Intervention / Treatment
-----------------
* Other: gun massager
* Other: transverse friction massage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients complaining of morning heel pain with taking first step. Patients with limited range of motion and diagnosed with plantar fasciitis. Patients who are willing to participate. Exclusion Criteria: Patient with heel fracture and surgeries will be excluded. Patient with sign of local and generalized infection or sepsis. Patient with foot deformities will be excluded

Ages Eligible for Study
-----------------
Minimum Age: 30 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: massage gun<br>15 to 20 minutes along with hot pack. | Other: gun massager<br>* 15 to 20 minutes along with hot pack.<br>|
| Experimental: transverse friction massage<br>15 to 20 minutes along with hot pack. | Other: transverse friction massage<br>* 15 to 20 minutes along with hot pack.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric pain scale | used as pain measurement tool to measure intensity of pain with 0 to 10 points. 0 Indicates no pain while 10 indicates severe pain | 4th week | 
| Foot and ankle disability index | Foot and ankle disability index is an area of explicit self-report of capacity with 2 components to evaluate disability identified with explicit conditions. The index was first portrayed in 1999 by Martin they survey impairments of everyday living | 4th week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
plantar fasciitis, foot and ankle disability index, numeric pain scale, deep friction massage, gun massager
AED 3 Post-Approval Study

Study Overview
=================
Brief Summary
-----------------
Demonstrate appropriate CPR sensor placement on pediatric and adult patients and demonstrate delivery of appropriate energy level of shocks to pediatric and adult patients.

Official Title
-----------------
Post-Approval Study for AED 3 With Uni-padz

Conditions
-----------------
Cardiac Arrest, Out-Of-Hospital

Intervention / Treatment
-----------------
* Device: AED 3 with Uni-padz


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected out-of-hospital cardiac arrest Use of ZOLL AED 3 public-access defibrillator (running software v.1.03.602 or newer (US) or v. 6.03.006 or newer(OUS)) with Uni-padz III Unconsciousness Absence of breathing Absence of pulse and other signs of circulation Exclusion Criteria: Pre-existing Do Not Attempt Resuscitation (DNAR) orders No evidence of cardiac arrest
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 |
| --- | --- |
| Other: AED 3 with Uni-padz<br> | Device: AED 3 with Uni-padz<br>* Use of AED 3 with Uni-padz by lay rescuer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPR sensor placement | Rate of appropriate placement of the CPR electrodes and compression sensor | Procedure (At time of device placement) | 
| Selection of adult or pediatric mode | Rate of appropriate selection of child mode by pressing Child Mode button or adult mode by not pressing Child Mode button determined by energy level of first shock | Procedure (At time of device placement) |
Root Resorption Accompanied Clear Aligners and Fixed Orthodontic Appliance

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare apical root resorption accompanied orthodontic treatment using clear aligners vs fixed appliances.

Detailed Description
-----------------
by using pretreatment and posttreatment CBCT, root resorption will be measured using a 3D imaging software.

Official Title
-----------------
Apical Root Resorption Accompanied Orthodontic Treatment Using Clear Aligners Versus Fixed Appliances: A CBCT Comparative Study

Conditions
-----------------
Root Resorption

Intervention / Treatment
-----------------
* Other: Leveling and alignment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy systemic condition/no systemic illness, as reported by patients. No use any form of anti - inflammatory drugs the at beginning of study. Good oral hygiene. Cooperative and motivated. In the permanent dentition with all teeth present ( except third molars). Minimum to moderate anterior crowding. No previous orthodontic treatment. Exclusion Criteria: Previous upper removable orthodontic treatment. Patients who required surgery to correct skeletal discrepancies. Patients with hyperdontia, hypodontia, or syndromic diseases (e.g. cleft lip and palate). Uncooperative patients. Patients with poor oral hygiene.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: leveling and alignment using fixed orthodontic appliance<br>leveling and alignment using fixed orthodontic appliance | Other: Leveling and alignment<br>* Root resorption comparison through the use of CBCT<br>|
| Experimental: leveling and alignment using clear aligner<br>leveling and alignment using clear aligner | Other: Leveling and alignment<br>* Root resorption comparison through the use of CBCT<br>|
| Experimental: leveling and alignment using clear aligner with low level laser therapy<br>leveling and alignment using clear aligner with low level laser therapy | Other: Leveling and alignment<br>* Root resorption comparison through the use of CBCT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Root resorption | Using pretreatment and posttreatment CBCT, volumetric root resorption will be measured by using 3D imaging software | 8 months |
Using Novel Behavioral Approaches to Improve Long-Term Weight Loss Outcomes

Study Overview
=================
Brief Summary
-----------------
This project is a randomized controlled trial to compare the efficacy of two interventions- one based on Acceptance and Commitment Therapy (ACT) and one based on Self-Regulation (SR)- and a control group (called weight loss only (WLO)) on 24-month weight loss outcomes. All participants will first participate in an initial 4-month standard behavioral weight loss program. Participants will be randomized into 1 of 3 groups and receive a 3-part workshop; the ACT workshop will teach ACT skills including acceptance and mindfulness techniques designed to promote behavior change and health behavior persistence consistent with one's core values. The SR program will focus on self-regulation, regular weighing, and modeling behavior on successful maintainers. The WLO group will receive a control workshop focused on cooking demonstrations and general nutrition topics.The primary outcome is weight loss at 24 months. The secondary outcome is change in psychological flexibility, a critical component of ACT interventions and a potential innovative mediating mechanism. Primary Hypothesis: At 24 months, the ACT group will show significantly greater weight loss as compared to the SR and WLO groups.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: ACT
* Behavioral: SR
* Behavioral: WLO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 27.5-40 Age 30-65 Exclusion Criteria: currently participating in a weight loss program pregnant or planning to become pregnant medical condition that would preclude physical activity terminal illness plans to relocate history of substance abuse or psychological problems that are judged by the investigators to be likely to interfere with study participation

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACT<br>Behavioral weight loss plus techniques from Acceptance and Commitment Therapy | Behavioral: ACT<br>* Treatment is based on Acceptance and Commitment Therapy<br>|
| Active Comparator: SR<br>Behavioral weight loss plus self-regulation techniques | Behavioral: SR<br>* Treatment is based on Self-Regulation theory.<br>|
| Active Comparator: WLO<br>Behavioral weight loss plus cooking tips and demonstrations | Behavioral: WLO<br>* Treatment is based on cooking tips and demonstrations.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | 24 months |
Comparative Study on Acute Pain Evaluation Between Spanish and French Hospital Emergency Unit

Study Overview
=================
Brief Summary
-----------------
Today, pain is a difficult affordable subject in Spain. There are however 187 units of pain care with a consultations rate in emergency center of more than 60%.For example OXYCODONE(opioid analgesic)is widely used while it's under used in Spain. In the same way MEOPA(Kalinox) is a new approach of pain care daily used as well in France (for example in dislocated shoulder pain, or ulceration care...etc) There are lots of studies relative to chronic pain but not too much about acute pain in Spain.That's why we want to focus our study on evaluation of acute pain treatment and efficacy in french and spanish hospital

Official Title
-----------------
Comparative Study on Acute Pain Evaluation Between Spanish and French Hospital Emergency Unit

Conditions
-----------------
Pain, EMERGENCY MEDICINE

Intervention / Treatment
-----------------
* Other: Observational Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient admitted in emergency center for acute pain. Patient who accept to participate. Exclusion Criteria: Refusal of patient to participate
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational Study|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain VAS (visual analogic scale) |  | 1 hour |
Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia

Study Overview
=================
Brief Summary
-----------------
To determine the efficacy and safety of Botulax® in treatment of cervical dystonia

Official Title
-----------------
A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Phase I Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia

Conditions
-----------------
Cervical Dystonia

Intervention / Treatment
-----------------
* Drug: Botulinum toxin type A injection
* Drug: Botulinum Toxin Type A Injection [Botox]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female of aged over 19 years Subjects diagnosed with primary cervical dystonia Exclusion Criteria: Subjects who have administered botulinum toxin within 16 weeks at the time of baseline Pregnant or nursing Females or males who do not agree on proper contraceptive measure

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulax®<br> | Drug: Botulinum toxin type A injection<br>* Experimental<br>* Other names: Botulax®;|
| Active Comparator: Botox®<br> | Drug: Botulinum Toxin Type A Injection [Botox]<br>* Active Comparator<br>* Other names: Botox®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of adverse event | To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after investigational product injection. | 12 weeks (during the clinical trial) | 
| Change From Baseline in the Total Score of the TWSTRS score. | The average of the change from baseline in TWSTRS-total score at Weeks 4, 8 and 12 will be determined. full name of TWSTRS is Toronto Western Spasmodic Torticollis Rating Scale. The validated assessment scale TWSTRS is consists of 3 sub-scales. severity (0 35 points) pain (0 20 points) disability( 0 30 points) Total score ranges from 0 to 85 points. | Baseline to Week 4 , Week 8, Week 12 |
The Effect of Thoracal Paravertebral Block on Seroma Reduction in Breast Surgery

Study Overview
=================
Brief Summary
-----------------
Thoracal paravertebral block (TPVB) is a commonly prefferred regional anesthesia technique to provide postoperative analgesia. In addition, the successful use of TPVB is reported for some seroma related pain cases. Postoperative analgesia in breast surgery is a difficult and overworked issue due to etensive surgery and complex innervation of the breast and in addition to this complex mechanisms, seroma accumulation has a negative effect for patients postoperatively. With this study, the investigators aimed to study the effect of TPVB on seroma reduction for breast cancer surgery.

Official Title
-----------------
The Effect of Thoracal Paravertebral Block on Seroma Reduction in Breast Surgery, a Randomised Controlled Trial

Conditions
-----------------
Seroma, Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Thoracal paravertebral block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-70 years of agge ASA I-II Undergoing elective breast cancer surgery Exclusion Criteria: obesity (body mass index >35 kg/m2) infection of the skin at the site of needle puncture area patients with known allergies to any of the study drugs coagulopathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>No intervention will be applied to control group | |
| Experimental: TPVB group<br>Thoracal paravertebral block will be performed with 20cc of 0,25% bupivacaine preoperatively. | Procedure: Thoracal paravertebral block<br>* Thoracal paravertebral block will be performed before the surgery to the TPVB group.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroma quantitiy | Seroma quantitiy of all patients will be recorded after 24 hour postoperatively. | 24 hour postoperatively. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thoracal Paravertebral Block, Breast Surgery, Seroma Reduction
A Clinical Study to Compare the Safety and Efficacy of an Aliskiren-based Regimen With a Lisinopril Based Regimen in Patients With Severe Hypertension

Study Overview
=================
Brief Summary
-----------------
To compare the safety and efficacy of an aliskiren-based regimen to a lisinopril-based regimen in the treatment of severe hypertension

Official Title
-----------------
An Eight-week, Randomized, Double-blind, Multi-center, Active-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of an Aliskiren-based Regimen Compared to a Lisinopril-based Regimen in Patients With Uncomplicated Severe Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: aliskiren


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients with essential severe hypertension Exclusion Criteria History or evidence of a secondary form of hypertension History of hypertensive encephalopathy or cerebrovascular accident. Diabetic patients requiring insulin Other protocol-defined inclusion/exclusion criteria also apply

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate safety through adverse events and laboratory abnormalities after 8 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diastolic blood pressure after 8 weeks |  |  | 
| Change from baseline in systolic blood pressure after 8 weeks |  |  | 
| Change from baseline in standing systolic blood and diastolic pressure after 8 weeks |  |  | 
| Diastolic blood pressure is less than 90 mmHg or reduction of 10 mmHg or greater from baseline after 8 weeks |  |  |
Recurrence of Acute Alcoholic Pancreatitis

Study Overview
=================
Brief Summary
-----------------
Previously our retrospective study showed that almost half of the patients with acute alcoholic pancreatitis had a recurrent attack in the long-term, mild pancreatitis and young age being risk factors for recurrence. The aim of this prospective follow-up study was aimed to find out the risk factors in detail.

Detailed Description
-----------------
Patients admitted to Tampere University Hospital for first acute alcoholic pancreatitis were included. The diagnostic criteria for acute pancreatitis were epigastric pain, serum amylase > 3 x upper normal range, elevated serum CRP and signs of acute pancreatitis in imaging. Other etiologies were excluded. Alcohol consumption and dependency were detected. Serum and fecal markers of the endocrine and exocrine function and secretin stimulated MRCP were studied. The patients were followed median 38 (25 - 61) months for the recurrences and had a follow up visit at two years to investigate trends in the alcohol consumption.

Official Title
-----------------
Recurrence of Acute Alcoholic Pancreatitis

Conditions
-----------------
Recurrent Acute Pancreatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who survived their first acute alcoholic pancreatitis. The diagnostic criteria for acute pancreatitis were epigastric pain, serum amylase > 3 x upper normal range, elevated serum CRP and signs of acute pancreatitis in imaging. Other etiologies were excluded. High alcohol consumption was detected

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