linjc16/ctgov huggingface dataset:
Botulinum-assisted Orbital Fat Augmentation With PRP (Platelet-rich-plasma)

Study Overview
=================
Brief Summary
-----------------
immobilization of yoked extra-ocular muscles in the anophthalmic orbit, in conjunction with platelet-rich-plasma, will improve integration of viable adipocytes injected into orbital fat

Detailed Description
-----------------
Immobilization of tissue (graft, graft bed) is a prerequisite for tissue integration. Since yoked extra-ocular muscles continue to be stimulated by movements of the seeing eye after fat injection into the anophthalmic orbit, the use of botulinum toxin(s) can be used to prevent movement of the orbital tissue bed(s) and improve anchoring of injected fat. Platelet rich plasma may also improve fat cell anchoring by the action of fibrin on the adhesion process. This innovation builds on the results of IRB protocols 10.27 and 12.01 as registered with Clinical Trials.gov

Official Title
-----------------
Botulinum-assisted Orbital Fat Augmentation With PRP (Platelet-rich-plasma)

Conditions
-----------------
Orbital Atrophy

Intervention / Treatment
-----------------
* Procedure: fat, PRP, botulinum toxin
* Drug: botulinum toxin
* Device: PRP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anophthalmic enophthalmos in subjects within a 50 mile radius of New York City, grade 0-1 anesthesia risk, ages 21-75 Exclusion Criteria: radiated orbits

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

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

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

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: fat, PRP, botulinum toxin<br>Fat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin | Procedure: fat, PRP, botulinum toxin<br>* fat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin<br>* Other names: fat atrophy, absence of original eye, phthisis bulbi;Drug: botulinum toxin<br>* botulinum toxin used to immobilize extra-ocular muscles prior to fat injection.<br>* Other names: botulinum toxins;Device: PRP<br>* autologous PRP is prepared with a dedicated centrifuge at the time of fat harvesting<br>* Other names: platelet rich plasma;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Orbital volume | Augmentation of orbital volume accessed with clinical photographs and non-contrast MRI | one year |
Bioequivalence Study of Capsule and Tablet Formulations of TA-8995

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the pharmacokinetics of capsule and tablet formulations of TA-8995 in healthy male subjects aged 18 to 55 years.

Official Title
-----------------
A Phase I, Randomised, Open-label Cross-over Bioequivalence Study of Capsule and Tablet Formulations of TA-8995 in Healthy Male Subjects

Conditions
-----------------
Dyslipidaemia

Intervention / Treatment
-----------------
* Drug: TA-8995
* Drug: TA-8995


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males aged 18-55 Body Mass Index (BMI) between 18.0 and 32.0 kg/m2, inclusive Exclusion Criteria: Subject has a known hypersensitivity to any of the inactive ingredients of the study treatments. Subject has any other condition which, in the Investigator's opinion will interfere with the study. Subjects who are still participating in another clinical study (eg, attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) within 3 months or 5 half-lives (whichever is longer) prior to the first dose in this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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: Treatment Period 1<br>Either 5mg TA-8995 Capsule or Tablet | Drug: TA-8995<br>* Capsule<br>Drug: TA-8995<br>* Tablet<br>|
| Experimental: Treatment Period 2<br>Either 5mg TA-8995 Capsule or Tablet | Drug: TA-8995<br>* Capsule<br>Drug: TA-8995<br>* Tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) of TA-8995 capsule and tablet formulations |  | 72 hours | 
| Peak Plasma Concentration (Cmax) of TA-8995 capsule and tablet formulations |  | 72 hours |
The Effect of Pain Neuroscience Education on Patients With Arthroscopic Rotator Cuff Repair

Study Overview
=================
Brief Summary
-----------------
During the rehabilitation process after rotator cuff repair surgery, patients suffer from increased pain and discomfort due to dysfunction. Pain neuroscience education, a more modern educational method, has been reported to be effective in controlling pain by reducing the fear of movement based on an understanding of neurophysiology.

Official Title
-----------------
The Effect of Pain Neuroscience Education on Patients With Arthroscopic Rotator Cuff Repair

Conditions
-----------------
Rotator Cuff Injuries, Kinesiophobia, Pain, Postoperative

Intervention / Treatment
-----------------
* Other: Pain neuroscience education
* Behavioral: Rotator cuff repair rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults over 18 years old In case of 4 weeks after receiving arthroscopic rotator cuff repair If you wish to participate in research Exclusion Criteria: 65 years old or older Those who are limited in conducting education remotely If the tear area is large and augmentation is performed If there is a previous surgical history at the surgical site Osteoarthritis in the shoulder joint If you cannot understand the guidelines for evaluation or intervention Mental health and cognitive problems

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pain neuroscience education plus rotator cuff repair rehabilitation<br> | Other: Pain neuroscience education<br>* Neurophysiological education of pain allows patients to explore a wider contribution to pain through the knowledge that pain is often an unreliable indicator of the extent or extent of tissue damage. This aims at reconceptualization from biomedical or structural models to actual biological psychosocial pain models.<br>Behavioral: Rotator cuff repair rehabilitation<br>* Postoperative rehabilitation programs include thermal therapy, electrical therapy, manual therapy, and therapeutic exercise.<br>|
| Active Comparator: rotator cuff repair rehabilitation<br> | Behavioral: Rotator cuff repair rehabilitation<br>* Postoperative rehabilitation programs include thermal therapy, electrical therapy, manual therapy, and therapeutic exercise.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | A numeric pain rating scale (NPRS) consisting of 11 points in total from 0 points (no pain) to 10 points (the most severe pain imaginable) is used. The lower the score, the less the pain. | Change in pain intensity from baseline to weeks 2, 4, and 6 |
Stated-Preferences in Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The primary objectives of this study are to apply best-practice stated-preference methods to quantify patient preferences for benefit-risk tradeoffs associated with arthroplasty treatment options for end-stage osteoarthritis of the knee. Duke will develop and administer stated-preference surveys to adult patients (Ages 40-80) with knee pain to collect preference data, estimate the relative importance of treatment features and outcomes, and estimate maximum acceptable risks for given benefits and minimum acceptable benefits for given harms. This study proposal describes plans for the patient stated-preference survey.

Official Title
-----------------
Examining Stated-Preferences in Knee Arthroplasty: Unicompartmental Knee Arthroplasty (UKA) or Total Knee Arthroplasty (TKA)

Conditions
-----------------
Arthritis, Knee Osteoarthritis, Arthropathy of Knee

Intervention / Treatment
-----------------
* Other: Stated-Preferences Evaluation Instrument


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 40-80 Knee Pain Exclusion Criteria: Inability to read, understand and give effective English consent

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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 |
| --- | --- |
| Stated-Preferences Evaluation Group<br>A stated-preferences evaluation instrument will be provided to participants with knee pain in the Stated-Preferences Evaluation Group. The instrument will measure patient preferences for total knee replacement versus unicompartmental knee replacement. | Other: Stated-Preferences Evaluation Instrument<br>* A discrete choice experiment (Stated-Preferences Evaluation Instrument) will be electronically configured using best practice stated-preference methods to quantify preferences for total knee replacement versus unicompartmental knee replacement surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Preference Measurements | Patient-stated preferences regarding treatment for knee pain based on questionnaires | 20 minutes |
The Efficacy of SinoFresh Nasal and Sinus Care Nasal Spray in Eliminating MRSA From the Nasal Cavity

Study Overview
=================
Brief Summary
-----------------
This is a study to assess the ability of SinoFresh Nasal & Sinus Care, an FDA approved over-the-counter nasal spray, to eliminate the bacteria in your nose.

Official Title
-----------------
The Efficacy of SinoFresh Nasal and Sinus Care Nasal Spray in Eliminating MRSA From the Nasal Cavity

Conditions
-----------------
MRSA Infection

Intervention / Treatment
-----------------
* Drug: Sinofresh
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older The volunteer is able to adhere to the study requirements and study visits. Agrees to abstain from use of other nasal sprays for length of study. Diagnosis of an MRSA carrier by PCR testing Exclusion Criteria: History of chronic nose bleeds. History of intranasal steroids in the last 2 months Nasal obstruction severe enough to prohibit effective delivery of a nasal spray Epistaxis Significant excoriation in the opinion of the Investigator. Known hypersensitivity to any ingredients

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br>Identical-appearing placebo | Drug: Placebo<br>* two sprays in each nostril three times daily for one week<br>|
| Active Comparator: 1<br>two sprays in each nostril three times daily for one week | Drug: Sinofresh<br>* two sprays in each nostril three times daily for one week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This is a study to assess the ability of SinoFresh Nasal & Sinus Care, an FDA approved over-the-counter nasal spray, to eliminate the bacteria in your nose. |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRSA, sinofresh, nasal spray
Study for the Detection of Duodenal Papilla Using Capsule Endoscopy and Comparison of Images With EUS/ERCP Procedure.

Study Overview
=================
Brief Summary
-----------------
This observational Non-Significant Risk (NSR) Study will be used to assess the ability of CapsoCam® Plus (SV-3) capsule endoscope to detect the duodenal papilla and visualize pathology or abnormalities in the periampullary area and will prospectively compare the capsule endoscopy and EUS/ERCP pictorial images acquired in procedures conducted in a minimum of 20 and a maximum of 200 research patients.

Official Title
-----------------
Prospective Observational Study for the Detection of Duodenal Papilla Using Capsule Endoscopy and Comparison of Images With EUS/ERCP Procedure in Pancreaticobiliary and Periampullary Pathology

Conditions
-----------------
Patients Indicated for Periampullary or Pancreaticobiliary Examination

Intervention / Treatment
-----------------
* Device: CapsoCam® Plus (SV-3) capsule endoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females at least 18 years of age. Provided written HIPAA Informed Consent in the IRB approved language. Patients indicated for periampullary or pancreaticobiliary examination, with prior cross-sectional imaging (CT/MRI/US/other) performed within past 6 months. Exclusion Criteria: Patients with existing biliary stent will be excluded EUS/ERCP exclusion criteria: per medical practice, including: Patient refusal to undergo procedure, unstable cardiopulmonary, neurologic, or cardiovascular status; existing bowel perforation Structural abnormalities of esophagus, stomach, small intestine at the discretion of physician. Capsule Endoscopy (CE) exclusion criteria: CE exclusion criteria: difficulty swallowing, pregnancy, known motility issues (gastroparesis), known strictures, gastrointestinal obstructions, fistula or significantly distorted anatomy. Medical history of receipt of surgery, oncologic therapy, or radiation therapy who, in the opinion of the investigator, are at greater risk of capsule endoscope retention. Any other contra-indicated condition as noted on the CapsoCam® Plus (SV-3) Instructions for Use, package insert.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CapsoCam® Plus (SV-3) capsule endoscope<br>Endoscope Capsule | Device: CapsoCam® Plus (SV-3) capsule endoscope<br>* Endoscope Capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ability to detect and visualize the duodenal papilla | Rate of duodenal papilla detection | during capsule endoscopy procedure |
Self-managed Integrative Yoga Therapy for Older Adults Living With Chronic Pain

Study Overview
=================
Brief Summary
-----------------
Chronic pain self-management skills can help patients improve daily functioning and quality of life. The goal of this study is to evaluate chronic pain self-managed Integrative Yoga Therapy intervention delivered in a sample of 25 older adults recruited from community site in Leicester.

Official Title
-----------------
Impact of Self-managed Integrative Yoga Therapy for Older Adults Living With Chronic Pain

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Other: Integrative Yoga Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing to provide informed consent Age >= 60 years Ambulatory Community-living Self-reported chronic musculoskeletal pain > 3 months having pain made it difficult to do usual activities Ability to attend sessions one in a week for 6-weeks Exclusion Criteria: Serious illness or hospitalisation in last 3-month Planned surgery in next six months Significant cognitive impairment Other severe physical or psychiatric disorder

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrative Yoga Therapy<br>Participants engaging in a 6-week chronic pain self-management program. Intervention: Integrative Yoga Therapy | Other: Integrative Yoga Therapy<br>* Participants having an hour in-person weekly session with qualified yoga therapist for 6-weeks. At each session, the personalised yoga practices including straightening and relaxing posture of yoga, yoga breathing, Combinations of sound and imagery yoga practices were given and asked to continue practice at home during the week.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain severity and interference: Brief Pain Inventory (BPI) questionnaire | Pain severity and interference were evaluated by using the Brief Pain Inventory (BPI) questionnaire. | From baseline to 6-week post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Global Impression of Change | Participant Global Impression of Change included 2 item the change from baseline | From baseline to 6-week post intervention | 
| Participant satisfaction: Likert-scale questions | Likert-scale questions score between 1-5 for participant satisfaction with the program (Strongly Agree=1 to Strongly Disagree=5) | From baseline to 6-week post intervention |
Effect of Decreased Pump Prime Volume on Blood Transfusions and Postoperative Complications of Patients Undergoing High Risk Cardiac Surgical Procedures

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the impact of reduced pump prime on blood transfusions and postoperative complications in patients at high risk of severe hemodilution during CPB. HYPOTHESIS The use of a new CPB circuit with a smaller internal volume, together with retrograde autologous priming of the lines (RAP) will allow a smaller prime volume and therefore less significant hemodilution on pump. EXPERIMENTAL DESIGN Overview Patients will be randomized on the morning of surgery to one of the two study groups in a 1:1 allocation scheme: Low pump prime Standard pump prime Outcomes The primary outcome is the number of units of blood products transfused within the first 24 hours post CPB.

Official Title
-----------------
Effect of Decreased Pump Prime Volume on Blood Transfusions and Postoperative Complications of Patients Undergoing High Risk Cardiac Surgical Procedures: A Pilot Study

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Other: Low Prime


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 y of age Non-emergent complex cardiac surgery (any procedure other than primary isolated CABG) Any of the following: Hb < 120 g/L (Females) or < 130 g/L (Males)BSA < 1.6 m2Creatinine Clearance < 60 mL/min (Cockcroft Gault Equation) Exclusion Criteria: aPTT >50 s, INR>1.5 Plt < 100,000 x 106 Preoperative Hemodialysis Tight aortic stenosis (Aortic Valve Area < 1 cm2) Tight lesion of the left main coronary artery (> 60%) Use of Aprotinin requested by the Surgical Team

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Low Prime|The CPB circuit will be primed with mannitol (50 g of 20% solution) and crystalloid solution (Ringer's lactate) for a total volume of approximately 1200 ml.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of units of blood products transfused within the first 24 hours post CPB. |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac surgery, Pump prime, Blood transfusions