cyrilzakka/clinical-trials huggingface dataset:
RIvaroxaban for Valvular Heart diseasE and atRial Fibrillation Trial -RIVER Trial

RIvaroxaban for Valvular heart diseasE and atRial fibrillation trial (RIVER trial).

A Phase 2, Randomized, Open label, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Rivaroxaban compared with vitamin K antagonism in Patients with Atrial Fibrillation with Bioprosthetic Mitral valves - RIVER. Main analysis for the primary endpoint are based on the Restricted Mean Survival Time (RMST) method.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged \>18 years at time of inclusion
2. Patients with Persistent or paroxysmal Atrial Fibrillation or flutter with bioprosthetic mitral valves.

   * The patient must be able to give informed consent

Exclusion Criteria:

1. Cardiovascular-related conditions as known presence of cardiac thrombus or tumor

   * Active endocarditis
   * Uncontrolled hypertension
2. Hemorrhage risk-related criteria

   * Active internal bleeding
   * History of, or condition associated with, increased bleeding risk
3. Concomitant conditions and therapies

   * History of previous thromboembolism with high risk of bleeding:

     * Severe, disabling stroke (modified Rankin score of 4-5, inclusive) within 3 months
     * Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization
     * Acute MI within the last 14 days prior to randomization
   * Treatment with: Chronic aspirin therapy \> 100 mg daily or dual antiplatelet therapy; Intravenous antiplatelets; Fibrinolytics; Anticipated need for long-term treatment with a nonsteroidal antiinflammatory drug; Systemic treatment with a strong inhibitor of cytochrome P450 3A4, such as ketoconazole or protease inhibitors; Treatment with a strong inducer of cytochrome P450 3A4, such as rifampicin, phenytoin, phenobarbital, or carbamazepine.
   * Anemia
   * Pregnancy or breastfeeding or women of reproductive age not using effective contraceptive methods
   * Calculated creatinine clearance bellow 30 mL/min
   * Known significant liver disease or alanine aminotransferase N3× the upper limit of normal
   * Previous participation in this study.
Asynchrony During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome

Asynchrony during mechanical ventilation has been poorly described in patients suffering from acute respiratory distress syndrome. The purpose of this study is to describe the frequency of asynchronies (ineffective efforts and double triggering) in these group and evaluate potential risk factors and prognosis implications.

Major patient-ventilator asynchronies have been described during assisted mechanical ventilation in different settings. Few studies have evaluated double cycling in ARDS patient. No clear predictors of this finding beside low tidal volume have been found, and clinical outcome implications have not been addressed. This study has 3 main objectives: evaluate the frequency of double cycling and ineffective efforts, seek for potential predictors and clinical outcomes related to asynchronies. Subjects with less than 72 hours of mechanical ventilation due to ARDS will be recruited. Thirty minutes of mechanical ventilation will be recorded and automatically analyzed with a custom-made program to detect asynchronies. A blood sample will be drawn to measure inflammatory and lung tissue damage biomarkers. Clinical and outcome data will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Acute Respiratory Distress Syndrome according to Berlin definition
* Intubation and mechanical ventilation within 72 hours of inclusion

Exclusion Criteria:

* Known severe neuromuscular disease
* Continuous neuromuscular blocking agents infusion
PNF Strengthening and De-lorme and Watkins Exercises on Upper Extremity Function and Strength in Stroke Patients

The aim of this study is to evaluate the effects of proprioceptive neuromuscular facilitation strengthening exercises and de-Lorme and Watkins exercises program in stroke patients with upper limb weakness in chronic stroke patients. The randomized central trial will recruit patients according to consecutive sampling into two intervention groups. One group will receive proprioceptive neuromuscular facilitation strengthening exercises and other group will receive de-Lorme and Watkins exercises program.

A study in which the participants (n=26) were recruited in the study suffering from stroke and meeting the inclusion criteria. Two groups formed such that patients in group A will be treated with conventional therapy and PNF and group B will be treated with PNF and NMES in along with conventional therapy. The protocol will cover 6 weeks of treatment. Regular assessment at 0,3rd and 6th week will be carried out. In the rehabilitation period, we will evaluate upper extremity function, activities of daily living(ADLs), mental status examination at regular interval during the rehabilitation.In previous studies there is less literature regarding the combine effects of proprioceptive neuromuscular facilitation techniques and de-Lorme and Watkins exercise program on upper limb function and strength in chronic stroke patients with upper limb weakness. Therefore there is dire need to explore which training technique is most effective in improving upper limb function and strength in chronic stroke patients therefore this study aims in comparative effects of proprioceptive neuromuscular facilitation strengthening exercises and de-Lorme and Watkins exercise program on upper limb function and strength in chronic stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* Chronic stroke patients.
* Medically stable patients having a single stroke.
* History of stroke 6 to 24 months.
* A score greater than 24-30 in mini-mental test.
* Patients having consciousness with GC;10

Exclusion Criteria:

* Recurrent stroke
* Patients with gullian berrie syndrome, multiple sclerosis lesion osteoarthritis of shoulder.
* Manual muscle testing below grade II.
The Effects of Sirolimus in Patients With Dilated Cardiomyopathy Infected With Kaposi Sarcoma-associated Virus

Evaluating the efficacy of sirolimus (compared to standard therapy alone) in the treatment of dilated cardiomyopathy infected with Kaposi Sarcoma-associated virus -- a multicenter randomized controlled study.

Dilated cardiomyopathy (DCM), defined as left ventricular or biventricular dilation and systolic dysfunction in the absence of either pressure or volume overload or coronary artery disease sufficient to explain the dysfunction, is associated with poor cardiovascular outcome and poor prognosis. Inflammation, activated by viral persistence, was considered as a key trigger factor of cardiac remodeling and thereby the development of DCM. As a risk factor for DCM, Kaposi's sarcoma-associated herpes virus (KSHV) inhibits the type I IFN signaling pathway and thereby aggravates known cardiotropic viruses-induced cardiac dysfunction and inflammatory infiltration. Activated mTOR signaling pathway is a typical feature of KSHV-infected cells, which is the most effective therapeutic target of diseases caused by KSHV infection. Sirolimus, a mTOR inhibitor, is a drug that can effectively treat the KSHV-infected diseases and suppresses the replication of KSHV.Therefore, multicenter large randomized controlled trials are needed to verify the efficacy of sirolimus on patients with DCM infected with KSHV.

This study aimed to evaluate the effiects of sirolimus on the clinical outcomes of patients with DCM infected with KSHV and provide theoretical evidence for the clinical application of sirolimus in these patients.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years of age;
* Diagnosed as dilated cardiomyopathy. Specifically, (i) left ventricular ejection fraction \<45% (\>2 SD) and/or fractional shortening \<25% (\>2 SD), as ascertained by echocardiography, radionuclide scanning, or cardiac magnetic resonance imaging; (ii) left ventricular end-diastolic diameter \>117% of the predicted value corrected for age and body surface area (Henry's formula), which corresponds to 2 SD of the predicted normal limit +5%; and (iii) In the absence of severe coronary artery disease or valvular disease.
* KSHV DNA seropositivity;
* Patients are voluntary and signed informed consent.

Exclusion Criteria:

* Allergic to rapamycin or its derivatives；
* The proportion of neutrophils less than 0.5\*10\^9/L or platelet less than 2.5\*10\^10/L;
* Pregnant women or plan to;
* Participate in any drug clinical trials within 3 months;
* Serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients);
* Previous history of cancer or tumor, or pathological examination confirmed precancerous lesions;
* Patients were not optimally managed.
Parental Affect in Dental Procedures

Background: To evaluate the effect of the anxiety of a parent accompanying a child on the child's anxiety during treatment.

Methods: Parents of 160 patients (4-8 years old) were divided into two groups anxious and non-anxious. Each groups had separated two randomized subgroups that with/without parents accompanied their children. At the first visit, participating children were examined while the behavior of the child during the examination was evaluated by a single pediatric dentist according to their heart rates measured by a portable pulse oximeter and the data were recorded (objective data).Forty-two children with a score of 1 and 4 on the Frankel Scale were excluded. After the parents were divided into two groups, anxious and non-anxious, the groups were equally divided randomly and the parents accompanied their children during the treatment.

Patients were recalled after one week for the treatment visit. Both groups were evaluated using the basic behavior technique. Compomer fillings were performed on children with infiltration anesthesia. The children's heart rates were measured by a portable pulse oximeter during treatment. Finally, the children were asked to express how they felt about the treatment by pointing out one of the faces on the Wong-Baker Faces Scale (subjective data). The children also rated the experience on the Frankel scale administered by the same operator.


Eligibility Criteria:
Inclusion Criteria:

* mentally and physically healthy children with caries requiring anesthesia and no previous dental experience were selected for the study

Exclusion Criteria:

* children with a score of 1 and 4 on the Frankel Scale were excluded.
Functional Recovery Following Orthopedic Wrist Surgery Under Peripheral Nerve Block Versus General Anesthesia

This study aims at determining if there is an association between locoregional anesthesia and postoperative functional recovery for orthopedic surgery to repair a distal radial fracture, as compared to general anesthesia.

All patients undergoing orthopedic wrist surgery under locoregional or general anesthesia at the CIUSSS de l'Estrie-CHUS who meet the selection criteria will be approach to participate in this prospective single-center observational study. Using the visual analog scale and anesthesia scale, the pain and the satisfaction of the patient will be evaluated respectively 2 weeks postoperatively. At the second visit, 6 to 8 weeks postoperatively, the participant will complete the QuickDASH questionnaire to evaluate his functional recovery and the participant's pain will be reassessed with the visual analogue scale. Finally, 12 weeks postoperatively, the wrist-joint range of motion and grip-strength test results will be recorded. The participant will also be asked to complete the QuickDASH and PRWE (Patient-Rated Wrist Evaluation) questionnaires to reevaluate his functional recovery.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and more
* American Society of Anesthesiologists (ASA) score I, II, or III
* Single distal radial fracture with or without ulna involvement
* Orthopedic surgery by open reduction of the wrist for a distal radial fracture with or without ulnar involvement

Exclusion Criteria:

* Active pregnancy
* Surgery with combined anesthesia (locoregional and general)
* Locoregional anesthesia with catheter insertion for postoperative analgesia
* Individuals with chronic pain as defined by preexisting neuropathy of the operated arm, preexisting radiculopathy of the operated limb, complex regional pain syndrome, or fibromyalgia
* Polytrauma
* Inability to consent
Vitamin K to Slow Progression of Dyslipidemia and Diabetes Risk (Vita-K 'n' Kids Study II)

Animal studies have found that vitamin K-dependent proteins matrix Gla protein and osteocalcin beneficially influence lipid and glucose metabolism, respectively. However, this concept has not been tested in humans at risk for dyslipidemia and diabetes risk. Vitamin K supplementation presents an opportunity to test the hypothesized link between the vitamin K-dependent proteins and markers of lipid and glucose metabolism. The investigators will conduct an 8-week vitamin K intervention (to manipulate carboxylation of matrix Gla protein and osteocalcin) and determine its effects on markers of dyslipidemia and diabetes risk. Sixty obese children will be randomly allocated to either the control group receiving placebo or the low-dose (45 mcg/d) or high-dose group (90 mcg/d) receiving vitamin K (menaquinone-7).


Eligibility Criteria:
Inclusion Criteria:

* Age 8 to 17 years
* Body mass index equal to or greater than 85th percentile for age and sex
* Subject and parent/guardian understands the study protocol and agrees to comply with it
* Informed Consent Form signed by the parent/guardian and assent signed by the subject

Exclusion Criteria:

* Subjects using vitamin supplements containing vitamin k
* Subjects with (a history of) metabolic or gastrointestinal diseases including hepatic disorders
* Subjects presenting chronic degenerative and/or inflammatory diseases
* Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics)
* Subjects receiving corticosteroid treatment
* Subjects using oral anticoagulants
* Subjects with a history of soy allergy
* Subjects who have participated in a clinical study more recently than one month before the current study
Acupoint Electric Stimulation Combined With Tropisetron in Preventing and Treating Nausea and Vomiting After TACE

Observation on acupoint electric stimulation combined with tropisetron in preventing and treating nausea and vomiting and improving the patient's appetite after TACE for primary or metastatic liver cancer patients.

* Classification of nausea and vomiting, as measured by NCI CTC-AE version 3
* The improvement of appetite, as measure by the classification of Appetite in accordance with NCI CTC-AE version 3.
* Quality of life: use M. D. Anderson symptom scale (the m. d. Anderson Symptom Inventory,MDASI)

Eligibility Criteria:
Inclusion Criteria:

* ECOG physical status 0,1,2
* would accept the transcatheter hepatic arterial chemoembolization of primary or metastatic liver cancer patients;
* Adult male and female 3, age 18 years old;
* the chem-scheme of arterial infusion chemotherapy based on oxaliplatin dosage of 200mg;
* signed the informed consent and understand the study design;
* Organ function examination in patients must meet the following laboratory indexes: Neutrophil\>500/Ul, hemoglobin \> 8 gm/dL, platelet \>100000/uL,Creatinine \< 2 mg/dL bilirubin \< 1.5 mg/dL, , alanine aminotransferase \< 3 times the normal value, albumin \>30g/L
* understand and complete quality of life scale ;
* women of childbearing age urine pregnancy test was negative.

Exclusion Criteria:

* The combined use of other venous chemotherapy within 5 days after TACE;
* skin infection on or near the points;
* skin hyperalgesia, unable to withstand electrical stimulation;
* other confounding factors may cause nausea and vomiting (such as intestinal obstruction, anorexia, etc.);
* heart, cerebrovascular accident history or the history of spinal cord injury;
* intestinal obstruction lead to nausea and vomiting
* installing pacemaker;
* cognitive dysfunction, unable to finish Scale;
* currently using acupuncture therapy.
A Novel Therapeutic Treatment of Pyoderma Gangrenosum

Pyoderma gangrenosum is a chronic debilitating ulcerative neutrophilic condition usually affecting the skin. The pathogenesis of pyoderma gangrenosum is poorly understood. Pyoderma gangrenosum has been estimated to have an incidence rate of 3-10 per million populations per year. Mortality estimates range up to 30%. The non-healing wounds present a significant social and economic burden on affected patients. We hypothesize that EpiFix (dehydrated human amnion/chorion membrane) will be beneficial in treating patients with pyoderma gangrenosum.

Potentially eligible patients will be pre-screened in clinic. The pre-screening process will include a medical history, including review of co-morbid medical problems and home medications, and a physical exam of the wounds.

The first stage of the study will involve a surgery in which the pyoderma gangrenosum wounds are going to be treated with the EpiFix. About a week later, the patient will then undergo another surgery where skin grafts will be placed on the wounds that were treated in the first surgery. In each surgery, samples of the wound will be taken, and genetic information from these samples will be studied to identify the genes that are active before and after treating the wound with EpiFix.

Routine post-surgery clinic visits will then be used to monitor the healing of the wounds and make sure that no extra medical treatment is needed. Study staff will evaluate wounds twice a week for the first two weeks, then once a week until 6 weeks. Following this, you will then be followed every 4 weeks up to 22 weeks. These visits to the clinic will include taking wound measurements, taking digital photos, asking about level of pain and evaluating development of infection. Patient consent will be obtained to take any photos.

In part because of its efficacy, the number of clinical indications for dehydrated human amnion/chorion membrane (dHACM) has expanded, and a number of case reports now suggest pyoderma gangrenosum can be successfully treated with dHACM. However, the mechanisms underlying dHACM's beneficial effects is entirely unstudied. The overall goal of the proposed study is to characterize the transcriptome of a pyoderma gangrenosum wound before and after successful treatment with dHACM. We will identify certain genes or genetic pathways that are specifically targeted by treatment of a wound with dehydrated human amnion/chorion membrane (EpiFix). With this data, we hope to better understand the method by which EpiFix can specifically heal a wound. Ultimately, all this data will be used to identify specific findings that aid in the diagnosis and treatment of pyoderma gangrenosum. A previous IRB-approved study by Dr. Frank Lau at LSU and colleagues (unpublished data) investigated the use of EpiFix to treat wounds in 3 patients with pyoderma gangrenosum with success and minimal complications.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with pyoderma gangrenosum
* patients over 18 years of age

Exclusion Criteria:

* members of vulnerable populations (pregnant women and prisoners)
* patients less than 18 years of age
Australian Hepatitis and Risk Survey in Prisons

The Australian Hepatitis and risk survey in prisons (AusHep) is a national prison-based blood-borne virus (BBV) surveillance study. This biobehavioural survey involves point-of-care testing for hepatitis C (HCV) antibodies and RNA (if antibody positive), hepatitis B surface antigens, hepatitis B surface antibodies, and HIV surface antibodies, and an interview-style survey on prior testing and treatment history and engagement in risk behaviours. The study will recruit approximately 2400 prisoner participants from 25 representative prisons across Australia, annually.


Eligibility Criteria:
Inclusion Criteria:

* Any remandee or sentenced prisoner who has provided informed consent is eligible to participate in the study.

Exclusion Criteria:

* Individuals who are unable or unwilling to provide consent or abide by the requirements of the study, as assessed by the trained nurses. Some individuals may be considered unable to provide consent or abide by the requirements of the study if they are:

  * Too mentally unwell to provide consent
  * Profoundly intellectually impaired
  * Unable to speak English and comprehend the survey.

Those excluded from participating in the study will be referred to the local prison clinic service for standard of care.
Outcome of Idiopathic Pulmonary Fibrosis With Pregnancy

case-control study was conducted between December 2018 to April 2020. To document outcome of IPF with pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pulmonary diseases during pregnancy

Exclusion Criteria:

* Patients with pulmonary diseases other than IPF and bronchial asthma were excluded.
Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)

SC291-102 is a Phase 1 study to evaluate SC291 safety and tolerability, preliminary clinical response, cellular kinetics and exploratory assessments for subjects with severe autoimmune diseases.

Systemic lupus erythematosus (SLE) is an autoimmune disease with multisystemic organ involvement that is often fatal. SLE is subcategorized as extrarenal lupus (ERL) or lupus nephritis (LN). B cell depletion therapies have played an important role in the treatment of multiple B cell-driven autoimmune diseases.

Subjects included in this trial will be subjects with diagnoses of systemic lupus erythematosus (SLE) including lupus nephritis (LN) and extrarenal systemic lupus erythematosus (ERL), or anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) (including Granulomatous Polyangitis and Microscopic Polyangiitis) who have refractory disease, have relapsed and have not shown appropriate clinical responses following prior systemic treatments.

This study is being conducted to evaluate the safety and efficacy of an investigational cell therapy, SC291, that can be given to patients with LN, ERL or AAV, in separate parallel cohorts, who have active disease.

A single dose of SC291 will be evaluated in patients who are pretreated with a standard regimen including cyclophosphamide (CY) and fludarabine (FLU).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 and ≤75
2. For LN cohort:

   * Diagnosis of SLE based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR)
   * Biopsy-proven LN class III or IV, according to 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria
   * Refractory disease to ≥ 2 prior treatment regimens
3. For ERL cohort:

   * Diagnosis of SLE based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for adult SLE
   * Severe or relapsing disease not responding to at least 2 prior recent disease-modifying therapies
4. For AAV Cohort, diagnosed with Granulomatous Polyangiitis (GPA) or Microscopic Polyangiitis (MPA) based on the 2022 ACR/EULAR classification criteria

Exclusion Criteria:

1. Prior CD19-directed cell therapy including CAR T treatment or other genetically modified cell therapy (e.g., Natural Killer (NK) cell)
2. For LN and ERL Cohorts, central nervous system (CNS) lupus manifestations or history or presence of CNS disorder
3. For LN and ERL Cohorts, diagnosis of anti-phospholipid antibody syndrome
4. For AAV Cohort only, Diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA) as defined by the 2022 ACR/EULAR classification criteria for EGPA -