cyrilzakka/clinical-trials huggingface dataset:
Correlation Analysis Between Rotator Cuff Tear and the Superior Migration of Humeral Head

To evaluate the association between rotator cuff tear and the proximal migration of humeral head

In this research, 60 patients with unilateral rotator cuff tear in Peking University People's Hospital in 2018 are planned to be recruited .They will receive Magnetic Resonance Imaging(MRI) and X-ray of the painful shoulder before enrollment in this study, the duration between the two examinations was no longer than 1 week, also there is no past history of surgery in the selected shoulders. There is no other exclusion criteria. Upward Migration Index(UMI) is the ratio between the distance of humeral head center to the lower surface of acromion, and the radius of humeral head circle. It can help to minimize the effect of anatomy difference and imaging magnification, compared with the traditional acromiohumeral distance(AHD). Then we use the Spearman correlation analysis to evaluate the relationship between UMI and fatty degeneration, rotator cuff tear size and the thickness of ruptured supraspinatus tendon from X-ray and MRI.

Eligibility Criteria:
Inclusion Criteria:

* Patient receive Magnetic Resonance Imaging half year before enrollment, showing supraspinatus tear
* Patient receive X-ray half year before enrollment
* the duration between the two examinations was no longer than 1 week
* no past history of surgery in the selected shoulders

Exclusion criteria:

* patients who cannot receive MRI.
Vigorous Cool Room Treadmill Training

People with multiple sclerosis (MS) are often offered walking aids and compensatory strategies rather than restorative rehabilitation. We have developed a cool room treadmill training method that uses body-weight support that people with MS fatigue and heat sensitivity can tolerate. Our previous research shows that people with advanced MS use three times more energy for essential tasks such as walking. This project will test whether 10 weeks of body-weight supported treadmill training in a room cooled to 16°C improves walking, fitness and fatigue in people with advanced MS.


Eligibility Criteria:
Inclusion Criteria:

* clinically definite MS
* relapse-free in the previous 3 months
* requiring ambulatory assistive devices (EDSS 6.0-7.0)
* negative PAR-Q screen for risk factors
* greater than 6-weeks post Botulinum Toxin injection (if received) in the lower extremity

Exclusion Criteria:

* pregnancy or intention of becoming pregnant
* finished a drug/device study in the last 30 days
* over 75 years of age
* unable to control bowel and bladder on physical exertion
* currently attending physical rehabilitation
* having no difficulty walking in the community (self-selected walking speed \>120 cm/s)
BCG-induced Epigenetic Modifications in the NEXT Generation

Non-specific protective effects resulting from the BCG vaccine appear to be paternally inheritable. Since the BCG vaccine is known to induce trained immunity, epigenetics might explain the fathers' contribution to the immune profile of their offspring. Epigenetic inheritance in mice has recently been demonstrated, but is not established in humans yet. By studying the DNA methylation profile of sperm cells after BCG vaccination, we aim to gain insight into the possibility of epigenetic inheritance in human males.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Male
* Age 18-25 years (at the moment of trial start)

Exclusion Criteria:

* Any systemic disease or conditin, or the use of systemic medication (with the exception of non-threatening alelrgies, e.g. hay fever)
* Smoking or drug use
* Prior BCG vaccination
* Other vaccination four weeks prior to trial start or four weeks after the first study visit (no vaccine in the same arm as the BCG vaccine for three months)
* Acute illness two weeks prior to trial start
* Known allergy or history of anaphylaxis/other serious adverse reaction to any vaccine
* Participation in another drug trial
* Legally incapacitated or unwilling to provide informed consent
Whole Body Magnetic Resonance Angiography in Ischemic Patients at 1.5 and 3T

To investigate the diagnostic performance of whole body magnetic resonance angiography (WB-MRA) using two different magnetic resonance scanners at a field strength of 1.5 and 3T. The hypothesis is that use of the 3T system gives superior signals from the investigated arteries, when compared with 1.5T.

Atherosclerosis of the lower leg arteries is a common disease. Patients with this condition has symptoms of ischemia, for instance intermittent claudication (pain during exercise). Diagnosis of atherosclerosis in the legs is normally done with an interventional x-ray-based angiography (DSA- digital subtraction angiography). This is uncomfortable for the patient, and associated with risks of complications (bleeding, vascular damage, embolism).A novel approach to diagnosing atherosclerosis is the use of magnetic resonance angiography. A variant of this is the whole body magnetic resonance angiography(WB-MRA), that produce a picture of the arteries in almost the whole body (excluding the coronary arteries). WB-MRA has a number of advantages compared to DSA. It does not use ionizing radiation, is not invasive, uses a contrast medium with fewer side affects and finally gives a covers a great deal of the arteries in the body.

This study will compare WB-MRA with DSA in patients with symptoms of peripheral atherosclerosis in the lower legs.

All the patients will undergo arterial first pass whole-body MRA in the 3T-system. This will be followed by a WB-MRA steady state examination which can be performed because we use the intravascular contrast medium Vasovist, that has a prolonged intravascular life. The steady state examination will be performed in both the 3T and the 1.5T MR-system. Half the patients will have the steady state examination performed first in the 3T and then the 1.5T-system. The other half will go to the 1.5T-system first and then return to the 3T-system.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic lower extremity ischemia (claudication, ischemic wounds) Referred to digital subtraction angiography (DSA)

Exclusion Criteria:

* Renal insufficiency (GFR \< 30 ml/min)
* Contra-indications for MRI-examination (claustrophobia, metal-implants, pacemaker)
* Dementia
* Pregnancy/lactation
* Allergy to gadolinium based MRI contrast agents
* Acute disease
Comparison Between Continuous Versus Interval Exercise Training in Asthmatic Patients

The treatment of asthma is based in clinical control. However, previous studies have been shown that patients that participate of the programs of regular or aerobic continuous exercise training (CT) presented improvements in the physical conditioning, and quality life, as well as decreased the levels of anxiety and depression, reduced the oxide nitric exhaled and leukocyte migration at the airways and reduced the airway hyperresponsiveness. The regular exercise also is important part in the rehabilitation of other lung disease as well as chronic obstructive pulmonary disease (COPD). Additionally, others studies have been shown the effects of high intensity interval training (IT) in the pulmonary rehabilitation of COPD patients, that after performed IT presented reduction of dyspnea, and increase the physical capacity. In this sense, the impact of IT in the asthmatic patients at the present moment is poorly studied, and necessity of the more investigation to prove the efficiency of this training model for asthma patients.

.

The present study will compare the impact of IT and CT in patients with moderate or severe asthma, and investigate what is the most efficient and increases the physical capacity, and quality of life and reduces the inflammatory mediators.

Sixty asthmatic adults will be randomly assigned into two groups: CT (Continuous training) or IT (Interval training). CT will have treatment 2x week, 40 min./session, 60-75% of maximum heart rate intensity and IT also 2x week, 40 min./session, 80-140% of the maximum load intensity, both performed in ergometer cycle by 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Asthma moderate and severe
* Asthma will diagnosed (Global Initiative for Asthma - GINA)
* Body Mass Index (BMI) \< 35kg/m2
* Medical Treatment for at least 6 months
* Clinically stable (i.e., no exacerbation or medication changes for at least 30 days)

Exclusion Criteria:

* Cardiovascular, musculoskeletal or other different chronic lung diseases
* Active cancer
* Pregnant
* Smokers
Study of Pexidartinib in Asian Subjects With Advanced Solid Tumors

This is a Phase I, non-randomized, open-label, multiple dose study of pexidartinib in Asian subjects with advanced solid tumors. The study will be conducted in a dose escalation to assess the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD), and preliminary antitumor activity of pexidartinib.


Eligibility Criteria:
Inclusion Criteria:

* Age should be ≥ 20 years
* Subjects must have a pathologically documented solid tumor that has relapsed from, or is refractory to standard treatment, or for which no standard treatment is available
* All associated toxicity from previous cancer therapy must have been resolved (to ≤ Grade 1) prior to administration of pexidartinib
* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
* Adequate hematologic, hepatic, and renal function tests
* Adequate treatment washout period before registration defined as:

  1. Major surgery: ≥ 4 weeks (2 weeks for less invasive surgery, such as colostomy)
  2. Radiation therapy (eg, whole brain radiotherapy): ≥ 4 weeks (if palliative stereotactic radiation therapy, ≥ 2 weeks)
  3. Chemotherapy or immunotherapy (including targeted therapy with antibody or small molecule, retinoid therapy, and hormonal therapy): 4 weeks or 5 half-lives of the agent, whichever is shorter (if the regimen has contained nitrosoureas or mitomycin C, ≥ 6 weeks)
  4. Other investigational drug therapy: ≥ 4 weeks

Exclusion Criteria:

* Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would have precluded adequate absorption
* Previous use of pexidartinib or any biologic treatment targeting colony stimulating factor-1 (CSF-1) or the receptor for colony-stimulating factor-1 (CSF1R); previous use of oral tyrosine kinase inhibitors, eg, imatinib or nilotinib, is allowed
* Clinically active primary central nervous system tumors or brain metastasis, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms
* Active or chronic infection with hepatitis C or known positive hepatitis B surface. antigen, or known active or chronic infection with human immunodeficiency virus
* A screening Fridericia-corrected time between the start of the Q wave and the end of the T wave in the heart's electrical cycle (QTcF) ≥ 450 ms (in men) or ≥ 470 ms (in women).
* A medical history or complications of clinically significant lung disease (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis)
* A history of symptomatic congestive heart failure (CHF) \[New York Heart Association (NYHA) Classes II to IV\] or serious cardiac arrhythmia requiring treatment
* A history of myocardial infarction or unstable angina within 6 months before enrollment
* An uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals
Virtual Reality to Promote Relaxation Prior to Simulation

The purpose of this study is to assess the feasibility of a pre-simulation virtual reality (VR) platform designed to promote relaxation for cancer patients planned for radiation therapy (RT).

The purpose of this prospective feasibility study is to assess the implementation of a VR-based intervention in patients who are pending initiation of RT. The investigators hypothesize that this intervention will be safe and feasible. If 75% of enrolled patients complete the VR intervention (defined as at least 8 min before permanent discontinuation), then feasibility will be met. Ten minutes' length is likely to be tolerated by most patients and likely to provide benefit. The maximum length of the VR video is 11 minutes. Patients will still be evaluable after 8 minutes of the video as this provides ample time to practice mindfulness based breathing exercises.

As this is a feasibility study, investigators and participants will not be blinded to study procedures. Potential study participants will be adult patients who are undergoing simulation for radiation treatment planning at the Perelman Center for Advanced Medicine at Penn Medicine. This is a single site study. No interim analyses or sub-studies are planned. Based on the expected accrual of 25 patients, futility and early termination will be triggered if 6 participants fail to meet the conditions described above.

Eligibility Criteria:
Inclusion Criteria:

1. Able to understand, read or speak English sufficient for signing of informed consent and completion of study assessments
2. Patients scheduled for simulation for radiation treatment planning at Perelman Center for Advanced Medicine (PCAM)
3. Adults, at least 18 years of age
4. Performance Status (ECOG) 0-2

Exclusion Criteria:

1. Prior radiotherapy
2. History of motion sickness, car sickness, vertigo, migraines, or light sensitivity within the last 6 months
3. History of epilepsy and seizures
4. Current nausea, vomiting, dizziness, lightheadedness, monocular vision or hearing loss that is not treated
Enhancing Upper Limb Prostheses With Radio Frequency Identification

The purpose of this study is to determine if Radio Frequency Identification (RFID) can lead to greater prosthesis function and control. Subjects are asked to perform specific tasks and actions using the traditional control method, as well as RFID control.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or greater.
2. Below elbow amputation, unilateral or bilateral.
3. Chronic stable amputation: \> 6 months from amputation.
4. Stable prosthesis prescription: \> 3 months since last major prosthesis modification.
5. Cognitively intact, as determined by Mini-Mental Status Examination score \> 24.
6. Able to provide informed consent and available to participate in study activities.
7. No severe residual limb motor/sensory impairment or pain likely to interfere with treatment.
8. Expected to be medically and psychiatrically stable for study duration.

Exclusion Criteria:

1. Patients with diseases which weaken and/or adversely affect the control of skeletal muscle.
2. Patients with poor skin integrity.
Mass Balance Study of AT-527 in Healthy Adult Male Subjects (R07496998)

Mass balance study of AT-527 in Healthy Male Subjects.

This is an open-label, single-dose study assessing the absorption, metabolism, excretion, and mass balance of \[14C\]-AT-527 in healthy adult male subjects.

Eligibility Criteria:
Inclusion Criteria:

* Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2
* No clinically significant diseases captured in the medical history or clinically significant findings at screening physical examination.
* A non-vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days after dosing. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to dosing. A male who has been vasectomized less than 4 months prior to dosing must follow the same restrictions as a non-vasectomized male).
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Other clinically significant medical conditions or laboratory abnormalities
Dexamethasone for ESPB in Total Hip Arthroplasty

Effect of adding Dexamethasone to Erector Spinae Plane Block in Patients undergoing Total Hip Arthroplasty

Hip arthroplasty is one of the most common orthopaedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prostheses. Regional anaesthesia methods may be performed to reduce the inflammatory response, opioid consumption, and opioid-related side effects.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for total hip arthroplasty
* patients aged \>65 and \<100 years
* patients able to provide informed consent
* patients able to reliably report symptoms to the research team

Exclusion Criteria:

* inability to provide first-party consent due to cognitive impairment or a language barrier
A Volunteer Study to Collect Imaging Data for the Development of the Medaphor Anatomy Guide.

The aim of this study is to determine if machine learning can be used to automatically highlight key anatomy on the ultrasound image to help anaesthetists perform ultrasound-guided regional anaesthesia.

The study will involve adult volunteers who are willing to be scanned by a trained sonographer to collect ultrasound video data for the following categories:

* Adductor canal
* Popliteal fossa
* Fascia Iliaca
* Rectus sheath
* Axillary region Each volunteer will be scanned to collect data for every category in the list. Where applicable, both sides of the body will be scanned.

The videos will be segmented by hand to identify the relevant anatomical regions for each category.

The primary objective for this study is to provide the range of data required to develop robust models in conjunction with additional data from patients undergoing a Peripheral Nerve Block procedure that are able to produce the desired segmentation on the unseen validation images. The models will be scored using the standard "Mean intersection over Union" pixel-level metric for semantic segmentation.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, at least 18 years of age;
2. Willing to undergo ultrasound scanning and provide ultrasound video data for the following categories:

   * Adductor canal
   * Popliteal fossa
   * Fascia Iliaca
   * Rectus sheath
   * Axillary region
3. Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

1. Aged \<18 years of age;
2. Unwilling or unable to provide informed consent.
Comparison of CorWatch With Right Heart Catheter Measurements in Heart Failure

This is an observational study to evaluate the agreement between the InCardia diagnostic technology CorWatch for the assessment of venous pressure in human subjects. This includes evaluation of InCardia technology in heart failure (HF) patients undergoing invasive right heart catheterization in a cardiac catheterization laboratory (cath lab) and in a cardiac intensive care unit (ICU).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with NYHA class II-IV heart failure irrespective of ejection fraction
* Patient is able to give consent

Exclusion Criteria:

* Severe tricuspid regurgitation
* Mechanical ventilation
* Patient is pregnant
* Inability to access either of the patient's upper arms.
Provide Initial Evidence of Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy to Support the Pivotal CT-P10 Therapeutic Equivalence Trial

This study is designed to provide initial evidence of safety, pharmacokinetics, pharmacodynamics, and efficacy to support the pivotal CT-P10 therapeutic equivalence trial.


Eligibility Criteria:
Inclusion Criteria:

1. Patient has histologically proven DLBCL, which may represent de novo DLBCL or DLBCL arising from transformed follicular lymphoma or chronic lymphocytic leukemia.
2. Patient has relapsed or refractory CD20-positive disease following previous first-line systemic chemotherapy. Patients who have failed to achieve complete remission with previous chemotherapy are defined as refractory, and those who relapsed after an initial complete remission are classified as having relapsed. A biopsy must be performed to confirm diagnosis of relapsed disease. Tumor tissue within 6 months of Day 1 of Cycle 1 of study treatment will be used for the central review.
3. Patient has at least 1 measurable tumor mass (greater than 1.5 cm in the longest dimension, or 1.1 to 1.5 cm in the longest dimension, and greater than 1.0 cm in the shortest axis) that has not previously been irradiated or has grown since previous irradiation

Exclusion Criteria:

1. Patient has allergies or hypersensitivity to murine, chimeric, human, or humanized proteins.
2. Patient has had prior allogeneic or ASCT.
3. Patient has received any other anticancer therapy within 28 days before Day 1 of Cycle 1 of study treatment and more than 1 prior line of chemotherapy, with the exception of having received the last dose of rituximab within 6 months before Day 1 of Cycle 1 of study treatment if they have undergone prior treatment with rituximab.
Prevalence of Atelectasis in Critical Trauma Patients

The purpose of this study is to identify the prevalence rate and risk factors for pulmonary complications in patients with critical trauma who intubated and mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* An inclusion criterion is the traumatic patients (e.g. head injury, blunt chest, blunt abdomen, and fracture of spine; with or without operative, pure or multitrauma) with intubation and mechanical ventilation who admit at this time period will recruit to the study.

Exclusion Criteria:

* a patients who admit less than 1 day will be excluded such as sudden death or moving to other ward because of improving conditions, etc.
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for PCOS

This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells delivered intravenously for the treatment of Polycystic Ovary Syndrome.

Stem cell treatment has shown efficacy for PCOS in both human and animal studies. Complete resolution was seen of polycystic ovary syndrome (PCOS) in a young woman after a single intravenous injection of umbilical cord derived mesenchymal stem cells (UCDSC). It is hypothesized that intravenous infusion of UCDSC can reduce or eliminate PCOS. Patients will receive roughly 2 million umbilical cord derived mesenchymal stem cells per kg of body weight. Hormone levels and ultrasound will be checked 3,6 and 12 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

• Ultrasound documented poly cystic ovary syndrome

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety
* Continued drug abuse
* Previous organ transplant
* Hypersensitivity to sulfur
* Inability to supply proper informed consent