cyrilzakka/clinical-trials huggingface dataset:
Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V

The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.

The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.

Eligibility Criteria:
Inclusion Criteria:

Unequivocally positive ANA test result and/or a positive anti dsDNA at screening Active biopsy-proven lupus nephritis within 3 months of screening demonstrating Class III or IV lupus nephritis with or without co-existing features of Class V lupus nephritis.

Documentation of active renal disease at the time of screening necessitating the commencement of therapy with corticosteroids in combination with MMF/MPS.

eGFR ≥ 30 ml/min/1.73 m2 Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infections Vaccination against Haemophilus influenzae infection Supportive care including stable dose regimen of anti-malarials (e.g. hydroxychloroquine) unless contraindicated, ACEi or ARB at either locally approved maximal daily dose or the maximally tolerated dose (per investigators' judgement) at screening, as per the local clinical practice. Doses should remain stable throughout the study.

First presentation or flare of lupus nephritis.

Exclusion Criteria:

Induction treatment with cyclophosphamide within 3 months of planned treatment for this study; treatment with calcineurin inhibitors within the previous 3 months prior to randomization.

Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to screening.

Renal biopsy presenting with interstitial fibrosis/tubular atrophy (IF/TA) or glomerulosclerosis of more than 50%, or which in the opinion of the investigator is such that it precludes likely response to immunosuppressive therapy.

Participants being treated with systemic corticosteroids (\>5 mg/day prednisone or equivalent) for indications other than SLE or LN e.g. acute asthma, inflammatory bowel disease.

Participants being treated with systemic corticosteroids for SLE or LN will be excluded if they have taken more than an average of 15 mg/day prednisone (or equivalent) in the previous 4 weeks and more than an average of 30 mg/day in the previous 1 week Receipt of more than a total dose of 1000 mg equivalent i.v. pulse methylprednisolone (cumulative dose) within 2 weeks prior to enrollment (and at enrollment)

Other protocol-defined inclusion/exclusion criteria may apply
Artesunate Plus Sulfadoxine-Pyrimethamine Versus Chloroquine for Vivax Malaria

The purpose of this study was to determine whether the proposed first line treatment for falciparum malaria in this region (sulfadoxine-pyrimethamine + artesunate) would be no worse a treatment for vivax malaria that the standard vivax treatment of chloroquine. In areas where vivax and falciparum malaria co-exist misdiagnosis of vivax malaria as falciparum is not unlikely; it is important to know whether adequate treatment will be received in these cases.

In areas co-endemic for falciparum and vivax malaria incorrect differential diagnosis is always a risk. Where the recommended treatment for the two diseases is the same this presents no problem for effective treatment or clinical cure of either species. Chloroquine remains an effective treatment of choice for vivax malaria in most settings, but with the spread of chloroquine-resistant falciparum malaria across Asia, many countries now use artemisinin-based combination therapy for this species of malaria. Differential diagnostic practices, have not improved in parallel. In Afghanistan the adoption of sulfadoxine-pyrimethamine plus artesunate (SP+AS) as first-line falciparum treatment raises the prospect of a significant proportion of vivax malaria being misdiagnosed and treated with the combination. SP is considered to have limited efficacy against vivax malaria and the efficacy of SP+AS against vivax has not been established in areas that have made the switch. A randomized, non-inferiority trial comparing SP+AS (1 day SP, 3 days AS) to chloroquine monotherapy was undertaken on 190 vivax patients in Eastern Afghanistan. A margin of equivalence of 14%, with 90% power and 95% CI (two-sided α = 0.05) was used. Standard WHO procedures for in vivo evaluation of antimalarial drugs were followed. 180 individuals completed the trial to day 42. The primary outcome was proportion of patients free from failure at day 28. Using a per protocol analysis both regimens resulted in ≥96% treatment success at 28 days, but significantly more cases failed in the CQ arm (46%) than in the SP+AS arm (24%) by day 42. Based on predetermined statistical criteria SP+AS was shown to be non-inferior to the standard chloroquine treatment. In areas where vivax infections might be misdiagnosed as falciparum infections and treated with SP+AS, patient management would be as good or better than with the standard CQ treatment.

Eligibility Criteria:
Inclusion Criteria:

* microscopy confirmed P. vivax mono-infection
* age \>2 years
* weight \>5kg
* \>1 asexual parasite per 10 fields

Exclusion Criteria:

* pregnant
* evidence of concomitant infection or serious disease
* recent use of antimalarial drugs
* severe malaria
* known allergy to study drugs
Pilot Study of Fenofibrate for PSC

The purpose of this study is to determine whether fenofibrate is safe and effective in the treatment primary sclerosing cholangitis (PSC).


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients of 18 to 75 years old
* Confirmed diagnosis of PSC including typical findings of stricturing and dilatations of the intra and/or extrahepatic biliary ducts in radiographic exam, (endoscopic retrograde cholangiopancreatography -ERCP, percutaneous cholangiogram - PTC or magnetic resonance cholangiopancreatography- MRCP)
* Serum alkaline phosphatase levels elevated to at least 1.5 times the upper limit of normal.

Exclusion Criteria:

* Hypersensitivity to fenofibrate
* Prisoners and institutionalized subjects
* Pregnant or nursing women
* Anticipated need for liver transplantation in one year
* Recipients of liver transplantation
* Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
* Co-existing liver diseases including auto-immune and viral hepatitis
* Acute or chronic renal failure, defined as glomerular filtration rate (GFR)\< 60 ml/min, GFR calculated using the Modification of Diet in Renal Disease (MDRF) GFR calculator
* Known cholecystitis
* Current use of statins
* Current use of coumadin anticoagulant therapy
* Previous history of, or known high risk for, venous thromboembolism,
Recording for Potential AF Drivers and Patient Specific Atrial Anatomy & Atrial Electrogram Maps

The 64 pole basket catheter used for the mapping procedure will be defined "atypical" sites which sustain atrial fibrillation. The ablation through the driver will lead to more rapid ablation of the atrial fibrillation.

Atrial fibrillation (AF) is a common abnormal and rapid heart rhythm characterized by erratic electrical activity of the upper chambers of the heart. This cardiac arrhythmia may lead to stroke, heart failure, low blood pressure, chest pain, and increased mortality rate. Treatment may include medication to stop the rhythm abnormality, blood thinners, and/or ablation. Ablation involves application of heat or freezing to the area sustaining the rhythm abnormality. This requires tubes (catheters)to be placed in the heart. Human atrial fibrillation may be sustained by localized drivers (rapid and/or organized sites of atrial electrical activation). By mapping/recording the patient's specific atrial anatomy and atrial electrical activity with the 64-pole basket catheter, we may add to the knowledge base of these driver locations. We may also add to the knowledge about where best to ablate to terminate the arrhythmia. Typical anatomic

Eligibility Criteria:
Inclusion Criteria:

* Patients at VCU Medical Center who are 21 years or older undergoing EPS for ablation of persistent AF (non-rheumatic) whose AF episodes last equal to or greater than 7 days but terminate with DC cardioversion or anti-arrhythmic drugs and do not recur within 24 hours.
* Per current standard of care, AF patients must have failed equal to or greater than 1 anti-arrhythmic drug to qualify for ablation.

Exclusion Criteria:

* Active coronary ischemic in the past year
* Rheumatic valve disease, that leads to distinct AF and increases thromboembolic risk
* Prior ablation or cardiac surgery, that alters atrial electophysiology
* Left atrial clot or dense contrast on TEE, which would increase thromboembolic risk
* Out of range serum electrolytes, including K outside 4.0-5.0 mmol/1
* Left atrial diameter greater than 60 mm, to exclude extreme structural remodeling and failure to maintain sinus rhythm
* Thrombotic disease, venous filters, transient ischemic attack or cerebrovascular accident, to minimize additional risk
* Pregnancy
* Inability or unwillingness to provide informed consent
* Unable to converse in English
* Use of anti-arrhythmic drug less than 5 X half-life Prior ablation or cardiac surgery, that alters atrial electophysiology
Iloprost for Prevention of Contrast-Mediated Nephropathy in High-Risk Patients Undergoing Coronary Angiography and/or Intervention

The prevention of contrast-mediated nephropathy (CMN), which accounts for considerable morbidity and mortality, remains a vexing problem. Contrast induced renal vasoconstriction is believed to play a pivotal role in the CMN mechanism. The aim of this study is to examine the efficacy of the prostacyclin analogue iloprost (dose 1ng/kg/min) in preventing CMN in high-risk patients undergoing a coronary procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing clinically driven, non-emergent coronary angiography or intervention in our institution were eligible for inclusion if their serum creatinine concentration was ≥1.4 mg/dl (124 μmol/l) and/or their creatinine clearance was \<60 ml/min on their most recent sample drawn within 1 month of the planned procedure

Exclusion Criteria:

* Circulatory shock for any reason, systolic blood pressure \<95 mm Hg
* Known acute renal failure
* End-stage renal disease requiring dialysis
* Intravascular administration of a contrast medium within the previous 10 days
* Anticipated re-administration of contrast medium within the following 6 days
* Inability to administer intravenous hydration at least 4 h before the procedure or study medication at least 30 min before the procedure
* Primary intervention for acute infarction with ST elevation
* A procedure performed within 2 h of acute hospital admission
Effects of Transcutaneous Vagus Nerve Stimulation (taVNS) in Individuals With Primary Dysmenorrhea

This study aims to investigate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on pain, functional and emotional symptoms, and physical performance in individuals with primary dysmenorrhea (PD).

In this study, which will be conducted over two menstrual cycles, 34 patients with PD will be randomised into two groups: taVNS and sham treatment. From the onset of pain during the menstrual cycle, taVNS or sham treatment will be applied for five days. Pain assessment will be conducted using the Numerical Rating Scale (NRS), pressure pain threshold with an algometer, menstrual symptoms using the Menstrual Symptom Scale (MSS) and the Functional and Emotional Measure of Dysmenorrhea (FEMD), anxiety using the Hamilton Anxiety Scale (HAM-A), and physical performance using the 6-Minute Walk Test (6MWT) during the first and second menstruation.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with PD according to the No. 345 Primary Dysmenorrhea Consensus Guidelines,
* An NRS score of at least three during menstruation before treatment,
* Being a woman between the ages of 18-40,
* A regular menstrual cycle of 28±7 days,
* Being nulliparous,
* No history of brain surgery, tumour or intracranial metal implantation,
* No chronic genitourinary infection or alcohol or drug use.

Exclusion Criteria:

* History of dizziness or epileptic disease,
* Pregnancy,
* Women with intrauterine devices,
* Metal implants in the head area,
* Women with skin lesions in the area where the electrodes will be placed,
* Use of analgesic drugs during treatment,
* Women with neurological or heart disease,
* Women are diagnosed with gynaecological conditions (endometriosis, adenomyosis, uterine fibroids, etc., which may be associated with secondary dysmenorrhea).
The Effectiveness of Self-thoracic Spine Mobilization on Improving Sleep Quality in Patients Who Have Shoulder Pain

This project aims to study the impacts of self-thoracic spine and rib mobilization on sleep quality in patients who present to UTSW physicians with shoulder pain. The investigators plan to randomize participants into treatment and control groups, but the investigators will provide education on sleep hygiene for each group. The treatment group will also receive instruction to mobilize their thoracic spine and ribs each night before going to sleep.

Subjects with a chief complaint of musculoskeletal pain will be recruited from clinics in the Departments of Internal Medicine, Family Medicine, and Orthopedic Surgery. Subjects will be randomized into either the intervention or control group. The intervention group will receive education on sleep hygiene and instruction to use a foam roller to mobilize the thoracic spine and ribs just before the subject goes to sleep. The control group will receive education on sleep hygiene. Valid and reliable measures will be used to assess sleep quality (Pittsburgh Sleep Quality Index), pain (Numeric Pain Rating Scale), and function (SF-36 and ASES), as well as a sleep diary. Measures will be taken at baseline as well as two weeks after the subject's enrollment in the study.

Eligibility Criteria:
Inclusion Criteria:

* Shoulder pain with associated sleeping disturbance
* Between the ages of 18-89
* Present to the clinics in the Departments of Internal Medicine, Family Medicine, and Orthopedic Surgery at UTSW

Exclusion Criteria:

* non-English speakers
* chronic pain or rheumatic disorders
* unstable psychopathology, cognitive impairment (including dementia)
* current or recent history (within 6 months) of substance abuse disorders
* recent history of surgery or fracture to the cervical spine, thoracic spine, ribs, or shoulders (within 6 months)
* metabolic bone disease (including osteoporosis)
* fusion or ankyloses
* osteomyelitis, pregnancy, vertebral basilar insufficiency, neoplastic disease, malignancy in the area of treatment
* actively treated for sleep disorders (including insomnia)
* uncontrolled congestive heart failure, COPD, hypertension, or other serious medical illness
Does Motor Imagery Training Enhance Control of Movement in Older Adults?

The goal of this clinical trial is learn about motor imagery training (i.e. imagining a task) with healthy older adults. The main question this clinical trial aims to answer is:

• Will imagining a task improve control of force during an elbow flexion muscle contraction in healthy older adults?

Participants will:

* Complete questionaries about general activity levels and ability to imagine tasks
* Perform either motor imagery training or watch a documentary
* Perform maximal and submaximal elbow flexion contractions

Researchers will compare the motor imagery training with the control group to see if control of force is improved in the motor imagery training group.

Motor imagery training could be beneficial in rehabilitative settings when participants are not physically capable of preforming a motor task or in injury prevention scenarios such as when multiple repetitions of a motor task should not be performed. If the effects of motor imagery training are favourable then they could have meaningful influence on the performance of steady movements in older adults who experience declines in force steadiness with age. Therefore, the first aim of this study will be to determine if one session of motor imagery training will influence corticospinal excitability in older adults and improve force steadiness during isometric elbow flexion contractions with the observed benefit being greater in females. The second aim of this study will be to determine if there is an associated change in oscillations in common synaptic input to motor neurons with a change in force steadiness.

Eligibility Criteria:
Inclusion Criteria:

Healthy older adults aged 65 to 90 years old

Exclusion Criteria:

1. have had an injury or orthopaedic surgery to the arm or shoulder in the prior 6 months
2. are involved in high levels of upper-body strength training
3. have history of training in fine motor tasks (i.e., musicians)
4. have a history of MIT
5. have systemic diseases and/or nerve damage affecting neuromuscular function
6. have severe cognitive impairment
7. are unable to read or speak English fluently
8. are left hand dominant
Comparison of SVF-gel Filling and CO2 Fractional Laser on Atrophic Acne Scar Treatment

Background Adipose extracellular matrix/stromal vascular fraction gel（SVF-gel）, which contains adipose-derived stem cells, endothelial cells, smooth muscle cells, pericytes, and other cell components.

Objective To determine the efficacy and safety of SVF-gel for treating acne scars and to compare the results with CO2 fractional laser.

Methods Seventeen patients with moderate to severe acne scars were treated with SVF-gel filling and CO2 fractional laser through a 24-week, randomized split-face study. One randomly assigned half side of each patient's received one SVF-gel filling treatment and the other side by two CO2 fractional laser treatment once one months. Clinical improvement was assessed by two blinded investigators with Echelle d'Evaluation Clinique des Cicatrices d'acne (ECCA) scale, VISIA and Antaro-3D detection.

This study was designed as a 24-week, prospective, randomized split-face protocol that compared clinical courses between two facial sides either receiving SVF-gel injection or CO2 fractional laser for acne scars. At the initial presentation, the evaluation of the severity of acne scar by Echelle d'Evaluation Clinique des Cicatrices d'acne (ECCA) scale (Table1), VISIA and Antera 3D analysis for all enrolled patients. Then, each facial side of every patient was randomly assigned into either SVF-gel injection or CO2 fractional laser treatment side. A random allocation sequence was created using computer-based random number generators to assign the treatment modality of each side. Randomization codes were secured in a safe until all data analyses were finished. Each patient was received SVF-gel injection for just one time on one half face, CO2 fractional laser treatment for two consecutive sessions at 8-week intervals on the other half face, with a follow-up visit at 16 weeks after the final CO2 fractional laser treatment. Evaluations of each treatment sessions were performed after 1 week, 2 months of every treatment. Two dermatologists evaluating the severities of acne scars were blinded to the assignment. At patients' each evaluation visit, photographic assessments by dermatologists, VISIA and Antera 3D analysis and patients' subjective assessments were conducted.

Eligibility Criteria:
Inclusion Criteria:

* Acne scar patients with severity of moderate to severe by ECCA scale evaluation.
* All the subjects were not allowed to use any systemic, topical, or light-based acne scar treatment during the course of this study.

Exclusion Criteria:

* pregnancy, mental illness.
* Intake of oral isotretinoin within 3 months
* Application of the other chemical peeling and light-based treatments within 8 weeks
Comparative Study of Ceftazidime-Avibactam Versus Standard of Care as Therapy in Febrile Neutropenic Adults With Cancer

This study will evaluate the effect, safety, and tolerability of ceftazidime-avibactam (CAZ-AVI) plus vancomycin or linezolid compared to standard of care plus vancomycin or linezolid as empiric therapy in febrile neutropenic adults with cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients with neutropenic fever who have existing malignancy or have undergone hematopoietic stem cell transplantation
* Requires hospitalization for intravenous (IV) empiric antibiotic therapy

Exclusion Criteria:

* Fungal or viral infection requiring additional therapy
* Known acute viral hepatitis
* Known to be human immunodeficiency virus (HIV) positive
* Expected requirement for hemodialysis while on study therapy
* Received \>24 hours of systemic antibacterial therapy within 72 hours of initiation of inpatient IV study drug
* Past or current history of epilepsy or seizure disorder
* Evidence of immediately life-threatening disease, progressively fatal disease, or life expectancy of 3 months or less.
Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Patient Deterioration in Patients Admitted With COVID-19 Infection

For patients admitted with COVID-19 infection, it is often difficult to predict if or when their clinical condition will deteriorate. However subtle changes in vital signs are usually present 8 to 24 hours before a life-threatening event such as respiratory failure leading to ICU admission, or unanticipated cardiac arrest. Such adverse trends in clinical observations can be missed, misinterpreted or not appreciated as urgent. New continuous and wearable 24/7 clinical vital parameter monitoring systems offer a unique possibility to identify clinical deterioration before patients condition progress beyond the point-of-no-return, where adverse events are inevitable. The primary aim of this study is to test the effect of continuous wireless vital signs monitoring with generation of real-time alerts through a purpose-built GUI, compared to standard EWS monitoring on the cumulative duration of any severely deviating vital signs


Eligibility Criteria:
Inclusion criteria

* Adult patients (≥18 years).
* Inclusion possible within 72 hours of admission, OR within 48 hours of discharge from an ICU to a medical ward
* At least one expected overnight stay.
* Patient admitted with confirmed COVID-19 infection

Exclusion criteria

* Patient expected not to cooperate with study procedures.
* Allergy to plaster or silicone.
* Patients admitted for palliative care only (i.e. no active treatment).
* Patients previously enrolled in the studies WARD-COPD (H-18026653) or WARD-Surgery (H-17033535).
* Inability to give informed consent.