cyrilzakka/clinical-trials huggingface dataset:
Conjoint Tendon Resection During Reverse Total Shoulder Arthroplasty

Reverse total shoulder arthroplasty (RTSA) can reliably restore active forward elevation, abduction, and external rotation, which are often lost in patients with massive rotator cuff tears. However, functional internal rotation (i.e., functional movements of the hand behind the body) is often unsatisfactorily restored and/or lost after RTSA. This study aims to compare the standard surgical approach for RTSA to RTSA with conjoint tendon resection with the targeted metric being postoperative functional internal rotation.

This study will be a prospective, randomized-controlled clinical trial comparing standard of care RTSA to RTSA with conjoint tendon resection in 64 patients undergoing RTSA by a single surgeon. Participants and assessors will not be blinded to intervention. The primary outcome is postoperative functional internal rotation. Secondary outcome measures include VAS, ASES, SANE, PROMIS, and VR-12 scores, as well as forward elevation and external rotation at the side, and complications at any time point. Our null hypothesis is that patients who undergo conjoint tendon resection during RTSA will have significantly increased functional internal rotation and clinically significant improved above-mentioned scores compared to non-resected tendon patients.

Eligibility Criteria:
Inclusion criteria

- All patients undergoing primary reverse total shoulder arthroplasty (RTSA)

Exclusion criteria

* Revision RTSA
* RTSA for acute proximal humerus fracture or fracture sequela
CEUS vs. AMRI for HCC Detection in Patients With Indeterminate Liver Nodules

The study will be conducted at the following locations:

1. UT Southwestern Medical Center
2. Parkland Health and Hospital System
3. University of Michigan

Investigators will prospectively compare the performance of dynamic contrast enhanced abbreviated MRI (AMRI) and contrast-enhanced ultrasound for early-stage HCC detection in patients with indeterminate liver nodules.

Investigators will prospectively perform both abbreviated MRI and contrast-enhanced ultrasound in enrolled patients every 3-6 months. Contrast-enhanced ultrasound and abbreviated MRI will preferably be done the same day, although will be permitted to be completed within 30 days of each other. Abbreviated MRI and contrast-enhanced ultrasound will be performed every 3-6 months until HCC development, regression to LR-1 or LR-2 (i.e., definitely or likely benign, respectively), or end of follow-up at 24 months post-enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Child A or B cirrhosis from any etiology with at least one ILN on 4-phase CT, contrast- enhanced MRI, or contrast enhanced US but without HCC at baseline.
* Adults 18 years old and above

Exclusion Criteria:

* Patients post liver transplantation
* Patients with concurrent or prior HCC (LR-5 or biopsy proven)
* other liver cancer including cholangiocarcinoma
* Patients with any active extra-hepatic malignancy
* Patients with significant comorbidity and limited life expectancy, e.g., stage D congestive heart failure, in whom surveillance is not warranted are also excluded given unlikely clinical benefit
* Patients with contraindication to contrast-enhanced MRI or CEUS, including implanted medical devices that are considered MR unsafe and severe claustrophobia
Mucolytic Solution Before Upper Endoscopy

Study was designed to evaluate efficacy of mucolytic solution ingested before upper endoscopy on visibility of gastric mucosa.

Residual gastric content containing mucus, bubbles, bile and food particles may limit visibility of gastric mucosa and therefore diagnostic yield of upper endoscopy, especially in cases of early neoplastic lesions. Data on benefit of peroral mucolytic solution administered before upper endoscopy are limited.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* signed informed consent
* diagnostic gastroscopy

Exclusion Criteria:

* age \< 18 years
* interventional gastroscopy
* known disease of the upper GI tract and/or history of surgery of GI tract
* gastroscopy indicated of bleeding, dysphagia or ileus
* liver cirrhosis
* general anesthesia
Study to Evaluate Divigel for the Treatment of Postmenoupausal Symptoms

The purpose of this study is to compare the safety and efficacy of USL-221 to placebo for postmenopausal patients.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* Have moderate to severe hot flashes
* Normal Pap Smear

Exclusion Criteria:

* Abnormal mammogram
* Abnormal clinical breast exam
* BMI \>35
Efficacy and Safety of New Generation Drug Eluting Stents Associated With an Ultra Short Duration of Dual Antiplatelet Therapy. Design of the Short Duration of Dual antiplatElet Therapy With SyNergy II Stent in Patients Older Than 75 Years Undergoing Percutaneous Coronary Revascularization.

The main objective of the SENIOR study is to establish the efficacy and safety of the everolimus eluting stent with a biodegradable abluminal polymer (SYNERGY II) associated with a short dual antiplatelet therapy (DAPT) in patients ≥75 years old, suffering from stable angina, silent ischemia (1 month DAPT) or acute coronary syndromes (6 months DAPT) related to significant coronary artery disease and requiring percutaneous coronary intervention. The primary end point is to demonstrate that SYNERGY II in patients ≥75 years old is associated with a lower rate of the composite rate of major cardiovascular and cerebrovascular events (all-cause death, myocardial infarction, stroke, ischemia-driven target lesion revascularization) and a similar risk of stent thrombosis than bare metal stent at one year.


Eligibility Criteria:
Inclusion Criteria:

* 1- Patient is ≥ 75 years old
* 2- One or more significant coronary artery stenosis is/are present (defined as ≥70% by visual assessment or ≥50% with Fractional Flow Reserve \<0.80) or a left main coronary stenosis ≥50% by visual assessment) suitable for PCI with one of the following present:
* a -Silent ischemia,
* stress-induced myocardial ischemia ≥ 10% of myocardium in a asymptomatic patient or
* stress-induced myocardial ischemia \< 10% of myocardium AND FFR (Fractional Flow Reserve) ≤0.80 or
* b - Stable angina, in a patient with objective ischemia despite optimal medical therapy or
* c - acute coronary syndrome including: unstable angina, non ST- and ST elevation myocardial infarction.
* 3- All patients must also sign informed consent as per local law and comply with all study process during follow up for at least one year.

Exclusion Criteria:

* 1- The subject is not eligible for randomization if ANY of the following is present:
* 2- Indication for myocardial revascularization by coronary artery bypass grafting,
* 3- Subjects unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one month (stable angina or silent ischemia) or at least six month (acute coronary syndrome),
* 4- Subjects requiring additional surgery (cardiac or non-cardiac) within one month,
* 5- Non cardiac co-morbidities with life expectancy less than 1 year,
* 6- Prior hemorrhagic stroke,
* 7- Known allergy to aspirin or P2Y12 inhibitors,
* 8- At least one contra indication to ALL the authorized P2Y12 inhibitors at the requested dose (in case of contra indication to only one of two of the P2Y12 inhibitors, the investigators are allowed to use the P2Y12 inhibitors for which no allergy is known).
* 9- Silent ischemia \<10% of the myocardium with FFR ≥0.80.
* 10- Participation in another clinical trial
VR-Based Physical Therapy Pilot Study

The purpose of this study is to evaluate the feasibility and acceptability of using the virtual reality-based physical therapy platform in patients with extremity fracture.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Diagnosed with an operative fracture of the femur and/or tibia
* referred to physical therapy as standard of care

Exclusion Criteria:

* Injury Severity Score(ISS) \> 18
* bilateral lower extremity injuries that preclude crutch ambulation
* associated spine fractures
* Glasgow Coma scale (GCS) \< 15 at time of discharge
* major peripheral nerve injury
Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's Disease

Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study measures the efficacy, safety, and tolerability of ABBV-951 versus oral Levodopa (LD)/Carbidopa (CD) \[LD/CD\] in advanced PD participants to achieve reduction in motor fluctuations.

ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given subcutaneously (under the skin) for the treatment of Parkinson's Disease. Adult participants with advanced PD will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 80 sites across the world.

In one arm, participants will receive ABBV-951 solution as a continuous infusion under the skin plus oral placebo capsules for LD/CD. In the second arm, participants will receive placebo solution for ABBV-951 as a continuous infusion under the skin plus oral capsules containing LD/CD tablets. The treatment duration is 12 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa-responsive.
* Participant must be taking a minimum of 400 milligrams/day (mg/day) of Levodopa (LD) equivalents and be judged by the investigator to have motor symptoms inadequately controlled by current therapy, have a recognizable/identifiable "Off" and "On" states (motor fluctuations), and have an average "Off" time of at least 2.5 hours/day over 3 consecutive PD Diary days with a minimum of 2 hours each day.
* Participant or caregiver, if applicable, demonstrates the understanding and correct use of the delivery system, including the insertion of the cannula into the participant's abdomen, as assessed by the investigator or designee during the Screening period.

Exclusion Criteria:

* Clinically significant, unstable medical conditions or any other reason that the investigator determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive study drug.
* History of allergic reaction or significant sensitivity to LD or constituents of the study drug (and its excipients) and/or other products in the same class.
* Participant has not received deep brain stimulation, CD/LD enteral suspension, or any other PD medication as continuous daily infusion, whether commercially available or investigational. Previous exposure to ABBV-951 is not allowed.
Evaluation of a Novel Technique for Intrauterine Contraceptive Devices Insertion

The intrauterine devices are a safe, reliable, long-acting and reversible contraceptive method. It is also sound safe and cheap contraceptive methods available and is nearly maintenance free for up to 10 years.

The fear and the pain associated with intrauterine devices insertion consider barriers to using this contraception method, this is because that the mucosal lining of female genital tract is highly sensitive to touch and pain. However; most of small procedures done in this sensitive area are performed without analgesia.

The pain during intrauterine devices insertion is due to application of the tenaculum , traction of the cervical canal, passing the uterine sound, insertion of the intrauterine devices through the cervix, and irritation of the endometrial lining by the intrauterine devices .

Previous studies have reported different lines to decrease pain during intrauterine device insertion starting by simple methods such as pre-insertion ibuprofen use, intracervical or intrauterine lidocaine and misoprostol up to paracervical blocks.

Previous studies, in literature, have found that the most painful steps during intrauterine devices insertion were uterine sounding then intrauterine device insertion itself, followed by tenaculum placement. One recent study addressed pain effect using an atraumatic vulsellum and a single-tooth tenaculum on pain perception during intrauterine devices and found no difference in reported pain.


Eligibility Criteria:
Inclusion Criteria:

* Women requesting intrauterine contraceptive device as a contraction

Exclusion Criteria:

* Uterine abnormalities
* Endometrial lesions,
* Adenomyosis
* Fibroids
* Intrauterine adhesions.
* Chronic pelvic pain
* Spasmodic dysmenorrhea
* History of cervical surgery
Pharmacokinetic Profile and Dermatomal Coverage of the Erector Spinae Plane Block

The goals of this study are as follows:

1. to confirm the safe dosing of ropivacaine for the erector spinae plane block
2. develop a pharmacokinetic profile of the erector spinae plane block, which will help demonstrate how quickly and how closely toxic levels are reached when a routine dose of ropivacaine is given for this nerve block
3. assess numbness created by the erector spinae block when routine doses are administered


Eligibility Criteria:
Inclusion Criteria:

1. Participant's age is greater than 18 years
2. Participant is undergoing a primary coronary artery bypass grafting surgery or heart valve replacement that requires a midline sternotomy incision
3. Participant's surgery is being performed by Dr. Vig Kasirajan

Exclusion Criteria:

1. Diagnosis of cirrhosis, hepatitis, primary sclerosing cholangitis
2. Abnormal liver function tests demonstrated by lab results
3. Allergy to lidocaine, ropivacaine, or midazolam
4. Morbid obesity, defined as body mass index greater than 40
5. Existing skin neuropathy on the chest or back
6. Body weight less than 50 kg
7. Participant is not able to provide verbal feedback, such as when the participant develops altered mental status or requires prolonged mechanical ventilation and sedation
8. Participant remains intubated on post-operative day 1
9. Pregnant women
Cognitive-motor Intervention Using Virtual Reality for Middle-aged Individuals at High Dementia Risk

The primary objective of this program is to apply a virtual reality (VR) cognitive-motor intervention (compared to active and passive control groups) to delay or slow cognitive decline of middle-aged adults who have a family history of Alzheimer's disease (AD) and thus are at particularly high risk of developing the disease.


Eligibility Criteria:
Inclusion Criteria:

* The participants of the study must have at least one parent with Alzheimer's disease.
* Fluency in Hebrew, in order to understand the instructions of the cognitive tests.
* Availability of an informant for the participant.

Exclusion Criteria:

* Severe neurological or psychological conditions that may affect cognitive performance.
* Substantial orthopedic limitations which prevent the use of treadmill.
* Unstable medical condition such as an active cancer.
* Incapability of adherence to the training program.
* The participant is undergoing a treatment that may interfere with the study program.
Effects of Acute SCI on Colonic Motility & Tone

This study will compare individuals with acute SCI to control patients in order to: 1. Determine if there are changes in colonic tone and sensation after SCI by comparing the fasting responses to the postprandial responses; 2. Determine if there are changes in colonic phasic motility after SCI by comparing the fasting responses to the postprandial responses; 3. Determine if colonic motor and sensory function after SCI change over time by repeating these studies six month later in SCI and control patients.


Eligibility Criteria:
Acute SCI with impaired colonic tone
Comparison of Insulin Detemir or Insulin Glargine as Add on to Oral Antidiabetic Drugs in Type 2 Diabetes

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to test if Insulin Detemir as add-on to current Oral Antidiabetic Drug treatment is at least as effective as Insulin Glargine as add-on to current Oral Antidiabetic Drug treatment in reducing HbA1c in patients with Type 2 Diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes for more than 12 months, and no previous insulin treatment
* Oral Antidiabetic Drug treatment for at least 4 months
* Body Mass Index (BMI) less than 40 kg/m2
* HbA1c 7.5-10.0%

Exclusion Criteria:

* Current or previous treatment with thiazolidinediones within the last 6 months
* Oral Antidiabetic Drug treatment with combination of three or more Oral Antidiabetic Drugs within the last 6 months
* Proliferative retinopathy or maculopathy
* Known hypoglycaemia unawareness
Prospective Evaluation of Cognitive Outcomes After Anesthesia on Patients in the Beach Chair Position

The purpose of this study was to use Near Infrared Spectroscopy (NIRS) monitoring on participants undergoing shoulder surgery in the beach chair position (BCP) to determine cerebral desaturation events (CDE) and to further determine cognitive changes pre and post surgery using the Mini Mental State Exam.

In this prospective, randomized, controlled study, investigators used a standardized anesthesia protocol to maintain the Mean Arterial Pressure (MAP) during surgeries done in the Beach Chair Position (BCP). Investigators hypothesized that, if the MAP was maintained, Near Infrared Spectroscopy (NIRS) monitoring would not change intra-operative anesthesia management and would not affect the post-operative cognitive outcomes of participants undergoing surgery in the beach chair position. Investigators secondarily wanted to document the actual incidence of cerebral desaturation events (CDEs) recorded by NIRS occurring in participants placed in the BCP if the MAP was strictly maintained.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* elective shoulder surgery in the beach chair position

Exclusion Criteria:

* less than 18 years of age
* preoperative score of 23 or less on the pre-operative Mini Mental State Exam
* traumatic brain injury
* transient ischemic attack
* cerebrovascular incident
* any apparent clinical neurologic dysfunction
* carotid artery stenosis
* known vascular malformation in head
* inability to have blood pressure measured in the opposite extremity
* malignant hyperthermia
Microbiology Studies of Acute Head and Neck Infections

Acute head and neck infections cause significant pain and discomfort for patients and impact on their quality of life. Effective antibiotic and surgical treatments have been developed for these infections but they are still able to develop into life-threatening diseases such as meningitis and sepsis. The direct cause of acute head and neck infections is often unknown but it has been suggested that they are due to a disturbance of the normal bacterial growing in the mouth or are from dental origin.

The most common microorganisms identified from these infections in published studies are a group of bacteria known as viridans group streptococci (VGS). There are over 30 individual species of bacteria in the viridans group and VGS are difficult to identify to the level of a single species because of their variability. There is a lack of species identification within the hospital setting and this project aims to gain a deeper understanding of the microorganisms causing acute head and neck infections, focusing on identification of individual species of VGS bacteria.

The investigators will analyse bacterial DNA to determine which species have been identified and will also look at patient data and clinical outcomes (eg. length of hospital stay) to determine if the species causing the infection has any effect on patients.


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18
* Suffering with acute head and neck infection of Streptococci.
* Samples must come from Northampton General Hospital.
* Consent to participate in research with at least 24 hours of consideration.

Exclusion Criteria:

* Age \<18 years.
* Samples from other National Health Service (NHS) hospitals.
* Infections from other areas of the body.
* Infection identified as caused by non-streptococcal bacteria.
* Chosen not to participate in research.
Comparison the Value of Several Biomarkers of Sepsis

The purpose of this study is to describe the value of serum sTREM (soluble triggering receptor expressed on myeloid cells)-1, sCD163, procalcitonin (PCT), C-reactive protein (CRP) concentrations, white blood cell (WBC) count and SOFA score during sepsis and their clinical informative value in predicting outcome.

The investigators enrolled 130 subjects admitted to an ICU: 30 cases with systemic inflammatory response syndrome (SIRS), 36 cases with sepsis, 35 cases with and 29 with septic shock. Results for sTREM (soluble triggering receptor expressed on myeloid cells)-1, sCD163, procalcitonin (PCT), C-reactive protein (CRP) concentrations, white blood cell (WBC) count and SOFA score were recorded on days 1, 3, 5, 7, 10, and 14.

Eligibility Criteria:
Inclusion Criteria:

* Male and female aged 18 years old and over;
* Clinically suspected infection;
* Fulfilled at least two criteria of systemic inflammatory response syndrome (a) core temperature higher than 38 °C or lower than 36 °C (b)respiratory rate above 20/min, or PCO2 below 32 mmHg (c) pulse rate above 90/min, and (d) white blood cell count greater than 12,000/μl or lower than \< 4,000/μl or less than 10% of bands.

Exclusion Criteria:

* Those who fulfilled one below:
* neutropenia (≤ 500 neutrophils/mm3)
* HIV infection, and
* patients or their relatives refused
Immunosuppression After Repeat Keratoplasty

Purpose: To compare the efficacy of topical 0.03% tacrolimus with systemic mycophenolate mofetil (MMF) in preventing corneal allograft rejection after repeat keratoplasty.

Design: Prospective, randomized clinical trial Introduction: Repeat keratoplasty continues to be an important indication for corneal transplantation in many centers, and it accounts for up to 41% (varying from 6% to 41%) of all keraptoplasty cases performed.

Methods: This study will enroll all patients who are candidate for repeat keratoplasty after a failed penetrating keratoplasty. Group 1 will receive MMF orally 1 g twice daily for the first 6 months and then 1 g daily for the next 6 months, and group 2 will receive topical 0.03 % tacrolimus 3 times a day for 12 months. All patients are treated with topical and oral corticosteroids postoperatively. The participants are observed closely for signs of graft rejection, and the rates of rejection-free graft survival are calculated and compared between the two groups at postoperative month 12


Eligibility Criteria:
Inclusion Criteria:

* all patients who are scheduled for repeat corneal transplantation following failed primary penetrating keratoplasty (PK )

Exclusion Criteria:

* uncontrolled increase in intraocular pressure
* active herpetic keratitis and corneal ulcer
* limbal stem cell deficiency
* a history of limbal stem cell transplantation
* age less than 18 years
* pregnancy, a history of malignant disorders
* abnormal liver or kidney function
* the presence of poorly controlled systemic hypertension
* diabetes mellitus
* systemic infections
* active peptic ulcer disease
* any gastrointestinal disorders led to patient exclusion