cyrilzakka/clinical-trials huggingface dataset:
Phase III Clinical Study of SHR-2004 Injection in Preventing Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty

The purpose of the study is to evaluate the efficacy and safety of SHR-2004 in preventing venous thromboembolism after elective unilateral total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

1. Understand the research procedures and methods, volunteer to participate in this trial, and sign the informed consent form in writing;
2. Planned elective schedule total knee arthroplasty (TKA) patients;
3. Men or women who are ≥ 18 years old and \< 80 years old on the day of signing the informed consent form.

Exclusion Criteria:

1. Unable to receive CT angiography of both lower limbs;
2. Malignant tumor within one year of the screening;
3. Myocardial infarction, transient ischemic attack or ischemic stroke occurred within 6 months of the screening;
4. Any medical history that may increase the risk of bleeding or any conditions that the investigator considers to increase the risk of bleeding;
5. History of drug abuse;
6. Pregnant or lactating women.
Misago® RX Self-expanding Peripheral Stent for Common And/or External Iliac Artery

This is a multi-center, single arm, non-randomized, prospective clinical study using the Misago® RX Self-expanding Peripheral Stent for treatment of de novo, restenotic, and/or occlusive lesion(s) of the common and/or external iliac artery.


Eligibility Criteria:
Inclusion Criteria:

1. Is ≥ 18 years old and of legal consent.
2. Is willing to comply with all follow-up evaluations at the specified times.
3. Subject or subject's legal representative has been informed of and understands the nature of the study and provides signed informed consent to participate in the study.
4. Has a Rutherford Clinical Category Score of 2, 3 or 4.
5. Radiographic evidence of ≥ 50% stenosis or restenosis (from PTA or adjunct therapy, not including stents or stent grafts), or occlusion of target lesion(s) in the common iliac artery and/or external iliac artery.

Exclusion Criteria:

1. Has had previous stent or stent-graft implantation in the target lesion(s).
2. Has a contraindication or known untreatable allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs or any other drug used during the study according to the protocol.
3. Has known hypersensitivity to contrast material that cannot be adequately pretreated.
4. Has known hypersensitivity to nickel-titanium (nitinol).
Holistic Wellbeing in COPD: Communication About Sexuality (COSY)

The aim of this study is to assess the effectiveness of a communication intervention about sexuality on quality of life and other outcomes like physical activity, exercise capacity and health status in people with chronic obstructive pulmonary disease (COPD).

Human sexuality is a universal part of living and associated with quality of life and mental and physical health benefits. Improved sexual relationships and sexual activity might also be an intrinsic motivator to stay physically active. However, problems with sexuality and loss of sexual drive are common in older and chronically ill people like persons with chronic obstructive pulmonary disease (COPD). In persons with COPD sexuality is rarely addressed during medical consultations and the topic is not sufficiently researched despite the fact that a thorough assessment of quality of life is incomplete without considering sexuality.

Based on this background, the investigators developed an instrument that supports healthcare professionals to start and shape communication about sexuality: COSY. The COSY intervention consists of four tools (communication leaflet for health care professionals, application guidance, pictorial representation of the spectrum of intimacy for health care professionals, patient information booklet) and aims to sensitize persons with COPD with the topic sexuality.

The aim of this study is to assess the effectiveness of the COSY communication intervention on quality of life and other outcomes like physical activity, exercise capacity and health status in people with COPD.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥60 years
* Diagnosis of COPD, defined as forced expiratory volume in 1s/forced vital capacity (FEV1/FVC)\<70% predicted, FEV1\<80 % predicted after bronchodilation corresponding to a Global initiative on Obstructive Lung Disease (GOLD) stage II-IV
* Knowledge of German language to understand study material and assessments and being able to give informed consent as documented by signature

Exclusion Criteria:

* Unstable COPD at the time of recruitment, unstable cardiovascular comorbidities, severe depression, or predicted life expectancy of less than one year, as judged by the referring clinician or the intervention physician
Prediction of Recovery in Patients With Neck Pain

This prognostic prediction model will be a reference for the health care professionals in clinical decision making and subsequent outcomes in dealing with patients having sub-acute and chronic neck pain, as well as, it will be a guide regarding therapeutic management and patients' education. Although various studies have evaluated the prognostic factors for individual neck pain conditions or treatment, to author Knowledge, no such prognostic model is available yet that predict the recovery in patients of sub-acute and chronic neck pain when managed conservatively. Therefore, this study is aimed to create a prediction model suggesting the recovery time for neck pain.

Neck pain is a highly prevalent condition that leads to considerable pain, disability, and economic cost. It not only constitutes a major personal burden but also affects families, the health system and the economic structure of countries. Neck pain is described as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage" in the neck region, which starts at the superior nuchal line and continues down to the level of the scapular spine. Acute, sub-acute and chronic neck pain is defined as neck pain with full-time sick-listing for 0 - 21 days (3 weeks), 22 - 84 days (4-12 weeks) and more than 12 weeks, respectively. A number of studies have explored prognostic factors for neck pain. Most frequently reported prognostic factors are age, gender, pain severity, a history of neck pain, concomitant low back pain, duration of pain, occupation, previous trauma, and degenerative changes on X-ray. Physiotherapy interventions for chronic neck pain showing the strongest support for an effect on pain are strength and endurance training. Two of the most widely used treatment strategies for the management of neck pain is exercise therapy (ET) and manual therapy (MT). ET is defined as a regimen or plan of physical activities designed and prescribed for any therapeutic goals, which includes strength exercises, stabilization exercises and endurance exercises. MT may is defined as "the use of hands to apply a force with therapeutic intent. various studies have evaluated the prognostic factors for individual neck pain conditions or treatment. but the author Knowledge, no such prognostic model is available yet that predict the recovery in patients of sub-acute and chronic neck pain when managed conservatively.

Eligibility Criteria:
Inclusion Criteria:

* Subacute and chronic neck pain.
* Patients with neck pain with a score of 4-10 on the numeric pain rating scale.

Exclusion Criteria:

* Acute neck pain.
* Neck pain due to fracture, tumour, infection or metabolic bone disease.
* History of cervical spine injury or surgery.
* Patients presented with disc herniation.
* Cervical instability
Effects of Transcutaneous Spinal Direct Current Stimulation in Incomplete Spinal Cord Injury

The purpose of the study is to investigate the effects of a novel therapeutic approach with transcutaneous spinal direct current stimulation (tsDCS) to promote functional recovery and spasticity in chronic spinal cord injury (SCI).

The purpose of the study is to investigate the effects of a novel therapeutic approach to promote functional recovery and spasticity in chronic SCI. The tsDCS effect on neuro-physiological measures such as H reflex and somatosensory evoked potential (SSEP) wiil be evaluated in subjects with SCI. This incremental, design will allow the establishment of strong electrophysiological data prior to rapid clinical translation of the findings about this promising, early-stage technique.

The central hypothesis is twofold: 1) active tsDCS will lead to a change in Hmax/M max ratio than sham tsDCS, in a polarity dependent manner; and 2) active tsDCS will lead to a change in SSEP amplitude and latency, in a polarity dependent manner.

Eligibility Criteria:
Inclusion Criteria:

* Providing written informed consent prior to any study related procedures
* 18-65 years of age
* Motor incomplete SCI classified as B, C or D by the American Spinal Injury Association Impairment Scale (AIS)
* Traumatic lesion at or above T8-T9 neurological level
* Body mass index ≤ 30 (in order to facilitate reliable location of body landmarks guiding stimulation);
* Chronic SCI (time since injury\>6 months)

Exclusion Criteria:

* Unstable cardiopulmonary conditions
* History of seizure, head injury with loss of consciousness, severe alcohol or drug abuse, and/or psychiatric illness
* Any joint contracture or severe spasticity, as measured by a Modified Ashworth Score 4
* Subject who cannot provide self-transportation to the study location
* Cardiac or neural pacemakers
* Pregnancy
* lower motor neuron injury (eg: peripheral neuropathy, cauda equina syndrome)
* Uncontrolled diabetes with HbA1C\>7
* History of severe autonomic dysreflexia
* No planned alteration in therapy or medication for muscle tone during the course of the study(No botulinum toxin injections in last 3 months, No phenol injections in last 6 months, intrathecal baclofen pump dose stable for past 3 months, etc)
* Conditions for e.g., severe arthritis, extreme shoulder pain that would interfere with valid administration of the measures or with interpreting motor testing;
* No contraindications to tsDCS
* ferromagnetic material in the brain or in the spine (except for titanium used in segmental)
Effect of Mental Imagery Training on Brain Plasticity and Motor Function in Individuals With Parkinson's Disease

Effect of Mental Imagery Training on Brain Plasticity and Motor Function in Individuals with Parkinson's Disease: A functional MRI investigation.

This project will examine the effect of functional MRI-based neurofeedback on brain plasticity and motor performance in patients with Parkinson's Disease (PD).

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of idiopathic PD defined according to the UK Brain Bank diagnostic criteria and on a stable dopaminergic medication regimen will be included.

Exclusion Criteria:

* Age \< 40 years
* Non-English speaking
* Pregnancy
* Breastfeeding
* Excessive alcohol consumption (\> 7 drinks per week for women, \> 14 drinks per week for men) or substance use
* History of a neurological disorder such as a brain tumor, stroke, central nervous system infection, multiple sclerosis, movement disorder (other than PD), or seizures
* History of schizophrenia, bipolar disorder, attention deficit disorder, or obsessive compulsive disorder
* History of head injury with loss of consciousness
* Metallic surgical implants or traumatically implanted metallic foreign bodies
* Inability to lie flat for about an hour
* Discomfort being in small, enclosed spaces
* Dementia (Montreal Cognitive Assessment score \< 21)
* Depression (Beck Depression Inventory-II score \> 19)
* Hoehn \& Yahr stage \> 3 (i.e., able to stand and walk, but not fully independent)
* Focal neurological findings on exam that suggest cerebral pathology other than that associated with parkinsonism
* Motor symptoms that could potentially introduce too much motion artifact in the imaging data (e.g., MDS-UPDRS resting tremor score \> 1 in limbs, head/chin tremor, or dyskinesia by history or exam).
Impact of Spinal Curves on Asymmetric Posture in Idiopathic Scoliosis

Asymmetric postures are often observed in patients with adolescent idiopathic scoliosis (AIS) and are partially associated with instability in sitting and standing positions, as well as with imbalances in gait kinematic parameters in cases of moderate or severe scoliosis.

Based on the currently available data, no correlation has been identified between habitual postures in daily life and the presence of scoliosis. However, the asymmetry of preferred postures in relation to the morphological characteristics of the curves, and how this might contribute to the progression of the clinical condition due to prolonged uneven load distribution, has not yet been analyzed.

Understanding any preferential direction in postures habitually adopted by patients with idiopathic scoliosis could provide valuable insights for the conservative management of the condition.

The aim of this study is to analyze the influence of the morphological characteristics of scoliotic curves (type and laterality) in patients with juvenile and adolescent idiopathic scoliosis on the choice of preferentially maintained asymmetric postures in daily life, using a descriptive questionnaire completed by family members and caregivers, compared to a group of non-scoliotic subjects.

Evaluate the effect of curve magnitude, age, sex, and Risser grade on the choice of usual asymmetric postures.

Estimate the impact of prolonged maintenance of habitual asymmetric postures on the clinical progression in patients with juvenile and adolescent idiopathic scoliosis


Eligibility Criteria:
Scoliosis group:

Inclusion Criteria:

* Diagnosis of juvenile or adolescent idiopathic scoliosis;
* Age between 6 and 18 years;
* Full spine X-ray in a standing position with anteroposterior projection performed within the year prior to completing the questionnaire.

Exclusion Criteria:

* Diagnosis of secondary scoliosis
* Patients with neuromotor control disorders

Control group:

Inclusion criteria:

* Age between 6 and 18 years;
* No diagnosis of sciolisis
* Full spine X-ray in a standing position with anteroposterior projection performed within the year prior to completing the questionnaire.

Exclusion Criteria:

- Patients with neuromotor control disorders
Reduced Manipulation of the Aorta and Neurobehavioral Outcome Trial

The purpose of this trial is to determine whether aortic manipulation in patients undergoing coronary bypass graft surgery leads to increased incidence of microemboli and subsequent impairment of neurobehavioral function.

Patients who have coronary artery bypass graft (CABG) surgery must have their aorta (the large blood vessel that is attached to the heart) clamped with an instrument. There are two basic ways of manipulating the aorta during surgery. One way is to place a single clamp across the aorta. The other way is to place more than one clamp on the aorta in several places. Both methods are used, but it is not known if one way is better than the other.

The purpose of this study is to compare the two methods of clamping to see if one way is better than the other, and to determine whether patients who undergo reduced manipulation of the aorta have fewer microemboli delivered to the brain during CABG surgery and have a lower incidence of neurobehavioral problems following surgery. Microemboli are tiny fat particles that enter the bloodstream during surgery, circulate to the brain, and block tiny blood vessels, causing brain deficits.

Participants in this trial will be randomly classified into one of two groups: the experimental group will undergo cross clamping of the aorta with a single clamp and be given retrograde cardioplegia for heart protection, and the control group will undergo cross clamping of the aorta with multiple clamps and be given antegrade cardioplegia for heart protection. Neurobehavioral assessments will be accomplished with a comprehensive battery of neurological and neuropsychological tests.

Eligibility Criteria:
* Participants must be English-speaking patients,
* 50 years of age or older, and
* undergoing elective CABG surgery.
* Participants of both genders and all races are eligible.
BLI-800-302: BLI-800 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

This is a randomized, parallel, multi-center, single-blind study, comparing BLI-800 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

-Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication, including:

Evaluation of BE results GI bleeding Anemia of unknown etiology Neoplastic disease surveillance Endosonography Inflammatory bowel disease Unknown diarrhea or constipation etiology Polypectomy Laser therapy Routine Screening

* At least 18 years of age
* Otherwise in good health, as determined by physical exam and medical history
* If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, abstinent, or vasectomized spouse)
* Negative urine pregnancy test at screening, if applicable
* In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

* Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or megacolon.
* Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
* Subjects who are undergoing colonoscopy for foreign body removal and decompression.
* Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
* Subjects with a history of renal or hepatic insufficiency or congestive heart failure.
* Subjects who had previous gastrointestinal surgeries
* Subjects who are pregnant or lactating, or intending to become pregnant during the study.
* Subjects of childbearing potential who refuse a pregnancy test.
* Subjects who are allergic to any preparation components
* Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
* Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days.
Association Between ΜFR and CABG Outcomes

The goal of this observational study is to evaluate the association between Murray law-based quantitative flow reserve and outcomes after coronary artery bypass graft surgery.

The goal of this observational study is to evaluate the association between Murray law-based quantitative flow reserve and outcomes after coronary artery bypass graft surgery. By constructing registry database during 10-year periods, several types of study objectives including 'graft patency' and 'long-term clinical outcomes' will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. patients who underwent isolated off-pump CABG for 3-vessel disease,
2. patients who underwent preoperative coronary angiography that fits for μFR analysis,

Exclusion Criteria:

1. Patients who underwent on-pump CABG
2. Patients in whom quality of preoperative coronary angiography did not fit for μFR analysis
A Clinical Study of MIL62 in Primary Membranous Nephropathy

This study will evaluate the efficacy, safety, pharmacokinetics(PK) ,pharmacodynamics and anti-drug antibodies（ADA） of MIL62 compared with cyclosporine in participants with primary membranous nephropathy (pMN).


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80;
2. Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening;
3. 24 hours urinary protein \> 3.5g at initial screening and confirmation assessment;
4. Epidermal growth factor receptor (EGFR ) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥40 mL/min/1.73 m\^2;
5. If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required;
6. Sufficient organ function;
7. Able and willing to provide written informed consent and to comply with the study protocol.

Exclusion Criteria:

1. Participants with a secondary cause of MN;
2. Cyclosporine resistance;
3. Received treatment drugs for membranous nephropathy;
4. Concomitant with other serious diseases；
5. Received live vaccination, major surgery (other than diagnostic), and participated in other clinical trials within 28 days prior to receiving the first study drug;
6. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA );
7. Subjects with CD4+ T lymphocyte count \< 300 cells/μL;
8. Those who have a clear history of tuberculosis or have received anti-tuberculosis treatment;
9. Subjects with known history of severe allergic reactions to humanized monoclonal antibodies，MIL62，or Cyclosporine；
10. Breastfeeding or pregnant women;
11. Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method
12. Other conditions unsuitable for participation in this study determined by the Investigator.
The Value of MultiSpectral 3 Tesla MRI in Active Surveillance of Prostate Cancer

MultiSpectral 3 Tesla MRI (MS3TMRI) can increase the yield of Trans Rectal Ultrasound Biopsy (TRUSBx) to improve identification of patients on active surveillance requiring treatment.

This is a prospective single arm study. 120 patients at risk for significant occult prostate cancer on an active surveillance program will undergo MS3TMRI followed by a standard TRUSBx and additional biopsies guided by the MS3TMRI results. The positive predictive value (PPV) of MS3TMRI-TRUSBx for cancer requiring consideration of therapy will be compared to the PPV of TRUSBx alone. MS3TMRI consists of T2, diffusion-weighted imaging (DWI), dynamic contrast enhanced MRI (DCEMRI), proton MR spectroscopy (MRS) interpreted by a radiologist and by CAD methods validated on whole mount prostate specimens.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in active surveillance at Sunnybrook Health Sciences Centre, requiring biopsy as part of surveillance protocol.
* Clinically eligible for radical prostatectomy and willing to undergo surgery
* Clinically eligible for and willing to undergo ultrasound biopsy within 8 weeks of MRI

Exclusion Criteria:

* Claustrophobia
* Contraindication to MRI
* Contraindication to receiving low molecular weight MRI contrast agent
* Prior hormone therapy except 5-alpha reductase inhibitors such as Avodart. FloMax etc
* Clinically suspected or known compromised renal function or calculated estimated Glomerular Filtration Rate (eGFR) \<30ml/min