cyrilzakka/clinical-trials huggingface dataset:
Features to Predict Success With Nonoperative Treatment of Patients With Rotator Cuff Tears

The goal of this study is to find which patients will improve with the nonsurgical treatment of physical therapy for the treatment of rotator cuff tears.

Rotator cuff tears are found in up to 40% of people over the age of 50 with the prevalence increasing with age. While most people remain asymptomatic, it is unknown why some develop symptoms. In symptomatic patients, surgical repair of a torn rotator cuff fails in 30-50% of patients, yet the majority of patients have a significant reduction pain despite failure of the repair. Nonoperative treatment has reported successful outcomes in 25-82% of patients yet it is not known which patient-related features predict success with nonoperative treatment. The general aim of this research effort is to identify patient features (historical information, physical examination findings, and MRI-based pathology) that would predict success (defined by reduction in visual analog pain scale, and patient satisfaction) with the nonoperative treatment of rotator cuff tears. The proposed study design is a prospective cohort study of patients with rotator cuff tears who will follow a standard physical therapy program derived from an evidence based medicine (EBM) systematic review of Level 1 and Level 2 studies.

Study the effect of historical information on predicting success (as determined by pain relief and patient satisfaction) of nonoperative treatment using the EBM based physical therapy program in treating patients with rotator cuff tears.

Study the effect of physical examination findings on predicting success of a nonoperative treatment using the EBM-based physical therapy program in treating patients with rotator cuff tears.

Study the effect of the severity of the rotator cuff pathology (using standardized magnetic resonance imaging protocols) on predicting success of nonoperative treatment for patients with rotator cuff tears using the EBM-based physical therapy program.

Eligibility Criteria:
Inclusion Criteria:

• Patients (18-100 years of age) with MRI findings of a full-thickness rotator cuff tear

Note: Criteria to obtain a shoulder MRI to evaluate for rotator cuff tear \[Appendix D\]:

1. Significant weakness (≥ 2 points per guidelines above.)
2. ADL pain or night pain \>/= 7 on VAS
3. Significant impingement (per guidelines above) + with significant symptoms for ≥ 3 months.

Exclusion Criteria:

* Acute rotator cuff tears (generally due to a high velocity injury and symptoms of less than one month)
* Associated dislocations
* Associated fractures
* Systemic Rheumatologic disease, i.e. Rheumatoid Arthritis and Systemic Lupus Erythematosis
* Patients being treated for bilateral rotator cuff tears simultaneously
* Patients unable to complete the forms
* Pain from neck or scapula
* Previous shoulder surgery
* Glenohumeral arthritis (meets ≥ 1 of below criteria)

  * osteophytes \>2mm on humeral head or glenoid
  * Joint space narrowing with sclerosis or cyst formation seen on true AP or axillary radiographs;
  * humeral head contacting acromion
* Adhesive capsulitis
PET-guided External Beam Radiotherapy in Differentiated Thyroid Cancer

Description of the role of a post-operative external beam radiotherapy in patients with differentiated thyroid cancer.

The role of post-operative external beam radiotherapy (EBRT) in differentiated thyroid cancer is still discussed considering the low clinical aggressiveness and the availability of ablative 131Iodine therapy. However, there is a subgroup of tumors which lose the ability to capture Iodine over time. This study wants to describe the role of a post-operative external beam radiotherapy in patients with differentiated thyroid cancer.

Eligibility Criteria:
Inclusion Criteria:

* detectable thyroglobulin (Tg),
* negative post-metabolic radiotherapy whole body scintigraphy,
* no surgical indications.

Exclusion Criteria:

* prior radiotherapy in the head and neck area
* pregnancy
CDH - Optimisation of Neonatal Ventilation

To determine the appropriate volume (size) of ventilator breath during volume-targetted ventilation for infants born with congenital diaphragmatic hernia.


Eligibility Criteria:
Inclusion Criteria:

* Congenital diaphragmatic hernia - post-operative Mechanically ventilated Born at \>34/40

Exclusion Criteria:

* neuromuscular blockade contraindications to NG/OG tube insertion
A Long-Term Safety Study of Asoprisnil in the Treatment of Uterine Fibroids.

This study was designed to determine the long-term safety of asoprisnil 10 mg in women with one or more uterine fibroids after an initial 12 weeks in study M99-144.

No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the long-term safety of asoprisnil 10 mg daily for 6 months, after an initial 12 weeks in study M99-144, in women with one or more uterine fibroids, confirmed by ultrasound in study M99-144. The safety endpoints for this study will be based on ultrasound and endometrial biopsy results, adverse events, and any changes from baseline laboratory values and vital signs.

Eligibility Criteria:
Inclusion Criteria:

* Completed dosing and Day 84 procedures at sites in study M99-144
* No interruption of dosing
* Otherwise continued good health

Exclusion Criteria:

* Any abnormal lab result the study-doctor considers significant
* History of severe reaction to or current use of hormone therapy
* History of alcohol or drug abuse
Effect of Resistance Training Variable Manipulation in Postmenopausal Breast Cancer Survivors.

This study intends to evaluate the impact of resistance training variable manipulation (intensity and volume) on body composition, fatigability and functional capacity in postmenopausal breast cancer survivors.

The treatment for breast cancer (chemotherapy, radiotherapy and hormone therapy) provokes collateral effects,such as muscle mass and strength losses, increase of fat mass, fatigue and disability and reduced quality of life in postmenopausal breast cancer survivors. The resistance training is assumed as a non-pharmacologic interventions in postmenopausal breast cancer survivors. However, it is unclear whether the manipulation of training variables (intensity and volume) maximize the effects of resistance training on body composition, fatigability and functional capacity in postmenopausal breast cancer survivors.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal breast cancer survivors;
* No supervised or unsupervised exercise at least for six months prior to the study.

Exclusion Criteria:

* Alcoholics;
* No controlled blood pressure and glucose;
* Presence of myopathies, arthropathies, and neuropathies;
* Presence of muscle, thromboembolic and gastrointestinal disorders, infection diseases.
Study for Atrial Fibrillation Reduction (SAFARI)

Atrial fibrillation (AF), which is the name for rapid beats in the upper chambers of the heart, is the world's most common kind of irregular heart beat. People with AF experience symptoms such as heart palpitations (a racing or pounding feeling in the chest), shortness of breath, dizziness, fatigue or weakness. Although AF can occur in otherwise healthy people for no apparent reason, it is sometimes associated with high blood pressure, heart disease or lung problems. The purpose of the SAFARI trial is to study the effectiveness of pacing algorithms in the upper chamber of the heart for patients who have both AF and bradycardia (slow heart beat).


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a slow heartbeat who are in need of dual chamber pacing (pacing in both the atrium and ventricle).
* Subjects who have experienced at least two episodes of rapid heart beats three months prior to enrollment.

Exclusion Criteria:

* Subjects who have a history of permanent (chronic) or persistent (non self-terminating) atrial fibrillation.
* Subjects with atrial fibrillation due to reversible cause, (e.g. thyroid disease, pericarditis, post-surgery, alcohol abuse).
* Subjects with a history of one or more cardioversions (changing an abnormal heart rhythm into a normal one by either using medication or by the application of an electric shock) six months prior to enrollment.
A Study of the Effect of Efavirenz on the Plasma Levels of Nemtabrutinib (MK-1026-014)

The goal of the study is to learn what happens to levels of nemtabrutinib (MK-1026) in a healthy person's body over time. Researchers will compare what happens to nemtabrutinib in the body when it is given with or without another medicine called efavirenz.


Eligibility Criteria:
Inclusion Criteria

The key inclusion criteria include but are not limited to the following:

* Is in good health based on medical history, physical examination, vital sign (VS) measurements, electrocardiograms (ECGs) and laboratory safety tests performed before allocation
* Has a body mass index (BMI) \> 18 kg/m2 and ≤ 32 kg/m\^2

Exclusion Criteria

The key exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Has a history of cancer (malignancy)
Obstructive Sleep Apnea Airway Evaluation

Current practice guidelines recommend obstructive sleep apnea (OSA) patients to stay in the post anesthetic care unit (PACU) until the risk of respiratory depression has subsided. Inevitably, a greater demand on hospital resource utilization in these patients will increase health care cost. Polysomnography (PSG) and screening questionnaires can identify OSA but they are limited by accessibility and false positive results, respectively. Inaccurate OSA identification misguides postoperative surveillance plan. In contrast with MRI and CT scans, ultrasound is more accessible and more likely a practical tool for OSA screening. However, before clinical application, airway ultrasound (US) exam must undergo vigorous testing to check its utility, accuracy, inter-observer reliability and its ability to identify OSA and its severity.

The investigators plan to recruit surgical patients at risk of OSA, exposed to sedatives,and/or general anesthesia. Surface ultrasound measurements will be conducted in a separate setting, and be correlated with the sleep study results, and a set of ultrasound parameters will be validated in this setting. Relevant clinical outcomes will be captured as well.

Eligibility Criteria:
Inclusion criteria

* age≥18
* ASA physical status I - IV;
* Suspected to have OSA for clinical reasons such as high risk on screening questionnaire i.e., a STOP-Bang score \>3, and referred to have a sleep study for OSA diagnosis by the clinical team at any point of care during the perioperative period (such as the clinic using the screening tool, during or after surgery in the ward experiencing recurrent upper airway obstructive events, need for CPAP in the postoperative period and / or suspected to have obstructive airway events). Or;
* Patients who were recently diagnosed to have OSA and underwent a laboratory sleep study within the last year.
* Patients who were recently diagnosed to have OSA but are non-compliant with treatment. Compliance defined as: median nightly CPAP or APAP use \> 70% of the nights, and for longer than 4 hours of nightly use during the last 3 months),43 or using oral appliance use (use \> 70% of nights, and for longer than 4 hours of nightly use in the last 3 months.

Exclusion criteria

* failure to understand and provide consent
* past history of oral, head and neck surgery (e.g., OSA corrective surgery)
* active head \& neck disease (e.g., cancer, infection and radiotherapy);
* inability to perform breathing tests per instruction
* Patients currently on treatment for OSA (as this may interfere with the upper airway dimensions and the US assessment may not be accurate)
Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B

This study is being conducted to compare the effectiveness and safety of telbivudine (LdT) and lamivudine in Chinese adults.


Eligibility Criteria:
Inclusion Criteria:

* Documented clinical history compatible with chronic hepatitis B infection

Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Patient is pregnant or breastfeeding
* Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV
* Patient has previously received lamivudine or any investigational anti-HBV nucleoside or nucleotide analog

Other protocol-defined exclusion criteria may apply
Low Cost QTc Meter for Long QT Syndrome Screening in Primary Care

The purpose of this study is to further develop and evaluate a diagnostic procedure suitable for use in an inexpensive diagnostic instrument suitable for screening for Long QT Syndrome (LQTS) in the primary care environment.

The study will involve acquiring ECG data in a cohort of up to 1,000 newborns and infants (500 controls (non-LQTS) and 500 LQTS newborns and infants) that are being seen in the Gonda SL ECG Lab (or Baldwin Building)and enrolled during their appointment for a clinically indicated 12-lead ECG. A second arm of Phase II of this study will include approaching 50 healthy subjects at the Baldwin Building to seek interest in participation which will consist of (1) 30 second device recording to help further calibrate and test the device for optimal enhancement. These 50 subjects will not be required to have a clinical or research 12-lead ECG as the investigators will be simply testing the efficiency and accuracy of the device. LQTS will be studied in order to assess the ability of the LQTS screener to accurately detect a patient with established QT prolongation in the context of distinct and varied T wave morphologies The advanced prototype will be placed in the same manner as the device used in Phase I of the study by being lightly placed on the child as pictured below. Similarly, the investigators will use ultrasound gel to obtain a better reading, if applicable. Once completed, a photograph of the torso of the child will be taken from the same views as before (one aerial view and one side view) with neither the head nor the face in the picture. Coded ECG-tracings will be transmitted to the app and shared with Blue Ox Health Corporation and Minnesota Health Solutions as done previously in phase I. Additionally, coded tracings and data from the 12-lead ECG will be shared with Blue Ox Health Corporation and Minnesota Health Solutions to aid in comparison to device tracings and optimization of the algorithm. The 12-lead ECG will be obtained from the subject's medical record and coded before being shared with collaborators. Study coordinators will also review the patient's medical record to determine whether the participants have been diagnosed with a genetic disease.

Eligibility Criteria:
Inclusion Criteria:

* Infants (Day 0 - 5 years).
* Long QT Syndrome(LQTS).
* Newborns without LQTS (Controls).
* Parental willingness to provide informed consent and follow the study protocol.

Exclusion Criteria:

* Children \> 5 years old.
* Those with genetically elusive LQTS.
* Infants with congenital heart disease.
* Infants born \< 32 weeks EGA.
* Patients with a cardiac device implant (pacemaker/ICD).
Long-Term PEA Safety Study

The goal of this clinical trial is to learn about the long term safety of PEA supplementation in healthy adults. This clinical trial will be in both males and females who are 18 years or older and are healthy volunteers.

The main aim of the study is to assess the safety of long-term use of PEA by assessing the difference between the two groups for serious adverse events, non-serious adverse events, vital signs and biochemistry following 12 months of PEA supplementation.

Participants will:

* Have their suitability for the study checked against the full inclusion/exclusion criteria during the screening process.
* Eligible participants will then attend a baseline visit where assessments will be performed and the participant will be randomly assigned to receive the study product or a placebo. Participants will then consume their assigned study product every day for 12 months. Participants will not know what product they have been assigned during the study.
* Following the baseline visit, there will be 4 in clinic visits over 12 months. On months where participants do not attend the clinic there will be a check in phone call.
* During clinic visits there will be safety assessments performed, blood sampling and questionnaires.

This is an interventional, phase II, randomised, double-blind, placebo-controlled, parallel dose safety study in healthy adults to assess long term population exposure to Palmitoylethanolamide (Levagen™).

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years and older)
* Generally healthy
* Able to provide informed consent
* BMI 18.5 - 35.0 kg/m2
* Agree to not participate in another clinical trial during enrolment period

Exclusion Criteria:

* Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
* Serious illness e.g., mood disorders (such as depression or bipolar disorder), anxiety, neurological disorders (such as MS), kidney disease, liver disease or heart conditions
* Unstable illness (e.g., diabetes and thyroid gland dysfunction)
* History of renal function impairment
* Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy \[(excluding low dose aspirin (under 300 mg/day)\]
* Regular consumption (\>4 times a week) of PEA over the past 2 weeks
* Substance Abuse (illicit and/or prescription) Drug (prescription or illegal substances) abuse
* Chronic past (within 12-months) and/or current alcohol use (\>14 alcoholic drinks week)
* Pregnant or lactating women
* Allergic, sensitive, or intolerant to any of the ingredients in active or placebo formula
* Has a clinically significant abnormal finding on the medical assessment, medical history, vital signs or clinical laboratory results at screening.
* Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month.
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.
A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients

This study evaluates two different immunosuppression drug regimens in patients with a recent kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and Prednisone and then randomized to discontinue either Tacrolimus or Prednisone.


Eligibility Criteria:
Inclusion Criteria:

* End-stage renal disease, with patients scheduled to receive a kidney transplant.
* Women who are of childbearing potential who are not pregnant and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of study drugs. Any woman becoming pregnant during the treatment period must discontinue the use of study drugs;
* Signed informed consent.

Exclusion Criteria:

* Evidence of active systemic or localized major infection at the time of initial study drug administration;
* Multiple organ transplants;
* Any pathology or medical condition that can interfere with this protocol study proposal.

Other exclusion applies.
2-week dc of MTX and Influenza Vaccination in RA

To investigate whether a transient discontinuation of methotrexate MTX for 2 weeks improves the vaccination response to a seasonal influenza.

Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease that affects the joints as the main target of the inflammation. Patients with RA require chronic treatment with disease modifying antirheumatic drugs (DMARDs) including methotrexate (MTX), which constitutes the mainstay of treatment. Underlying immune dysfunction and the additional immune suppression associated with treatment render patients with RA more susceptible to infection. Thus, vaccination of the preventive diseases is crucial and recommended in all patients unless contraindicated.

However, low dose of glucocorticoids, conventional DMARDs and biological DMARDs including tumor necrosis factor inhibitors have been reported to substantially decrease vaccine response (4); MTX has been reported to be associated with a decreased response to seasonal influenza vaccination by up to 15%.

To optimize a vaccine response, vaccination should be administrated before the treatment with immunesuppressive medications is initiated. However, most patients with RA are already on stable dose of MTX at the time of when vaccinations. To improve the vaccine response, a short term discontinuation of MTX could be considered. In a prior study, we discovered that a temporary discontinuation of MTX for 4 weeks during peri-vaccination period tended to be associated with an improved response to vaccination with trivalent influenza vaccination (Figure 1). It remains to be defined whether MTX discontinuation for shorter period increases the vaccination efficacy while minimizing the RA flare rate.

Eligibility Criteria:
Inclusion Criteria:

* Males or females ≥ 19 years and \< 65 years of age at time of consent
* Have a diagnosis of RA per ACR criteria
* Must understand and voluntarily sign an informed consent form including writing consent for data protection
* Stable doses of methotrexate over the preceding 6 weeks

Exclusion Criteria:

* Pregnant or lactating females
* Previous anaphylactic response to vaccine components or to egg.
* Acute infection with T \>38°C at the time of vaccination
* History of Guillain-Barre syndrome or demyelinating syndromes
* Previous vaccination with any live vaccine 4 weeks before or any inactivated vaccine 2 weeks before the study
* Blood transfusion within 6 months
* Active rheumatoid arthritis necessitating a recent change in the drug regimen
* Any other rheumatic disease such as systemic lupus erythematosus, mixed connective tissue disease, dermatomyositis/polymyositis, and vasculitis except for secondary Sjogren's disease
* Any condition including laboratory abnormality which places the subject at unacceptable risk
* Subjects who decline to participate
Evaluation of Limb Function and Perception in Rehabilitation After Traumatic Wrist Fracture Surgery

The goal of this observational study is to assess the functional and perceptual alterations of the affected limb during rehabilitation in adult orthopedic patients who underwent surgical treatment for distal radius fractures. The main questions it aims to answer are:

What is the correlation between functional and perceptual alterations of the affected limb at the beginning and end of rehabilitation? How do these alterations influence rehabilitation duration and effectiveness?

Participants will:

Complete the patient questionnaires ((QuickDASH and ALPQ). Undergo handgrip strength tests and digital dynamometer tests to assess forearm muscle strength.

Have their range of motion evaluated by a physiotherapist during outpatient visits.

No additional diagnostic or instrumental examinations are required beyond routine clinical practice. The study will recruit 100 adult patients, last 24 months, and provide insights into the role of body perception in rehabilitation after wrist fractures.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years old)
* Patients who have undergone surgical treatment with a volar approach for a traumatic distal radius fracture at IRCCS Ospedale Galeazzi - Sant'Ambrogio.
* Willingness and ability to provide written informed consent.

Exclusion Criteria:

* Pre-existing neurological, psychiatric, or cognitive disorders that could affect motor function or body perception.
* Previous fractures of the same limb.
* Pregnancy or breastfeeding (self-reported).