cyrilzakka/clinical-trials huggingface dataset:
Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis

This is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of anifrolumab versus placebo as added to SOC (consisting of MMF and glucocorticoids) in adults with active proliferative Class III or Class IV LN (both with or without concomitant Class V). The total study duration may be up to approximately 116 weeks, including the Screening and Follow-up. Approximately 360 participants will be randomized in a 1:1 ratio to receive anifrolumab or matching placebo throughout during the Treatment Period.

Eligibility Criteria:
Inclusion Criteria:

1. Active proliferative LN Class III or IV either with or without the presence of Class V according to the 2003 ISN/RPS classification
2. Renal biopsy obtained within 6 months prior to signing the ICF or during Screening Period.
3. Urine protein to creatinine ratio \> 1 mg/mg (113.17 mg/mmol)
4. eGFR ≥ 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula).
5. Fulfills updated 2019 EULAR/ACR SLE classification criteria.
6. No signs of symptoms of active TB prior to or during screening or no treatment for latent TB

Exclusion Criteria:

1. A diagnosis of pure Class V LN based on the renal biopsy obtained within 6 months prior to signing the ICF or during Screening.
2. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV confirmed by the central lab at Screening - an HIV test must be performed during Screening, and the result should be available prior to Week 0 (Day 1).
3. Evidence of hepatitis C or active hepatitis B.
4. Any history of cancer except sucessfully cured skin squamos or basal skin carcinoma and cervical cancer in situ.
5. Receipt of the following for the current LN flare (ie, since the qualifying renal biopsy): IV cyclophosphamide \> 2 pulses of high-dose (≥ 0.5 g/m2) or \> 4 doses of low dose (500 mg every 2 weeks) or Average MMF \> 2.5 g/day (or \> 1800 mg/day of enteric coated mycophenolate sodium) for more than 8 weeks or Tacrolimus \> 4 mg/day for more than 8 weeks; Cyclosporine for more than 8 weeks or during last 8 weeks prior to signing the ICF; Voclosporin for more than 8 weeks or during last 8 weeks prior to signing the ICF; Belimumab for more than 12 weeks or during last 12 weeks prior the ICF.
6. Previous receipt of \>◦2 investigation treatments (other than anifrolumab) for LN or SLE since time of diagnosis and through the ICF.
7. Known intolerance to ≤ 1.0 g/day of MMF.
8. Any history of severe COVID-19 infection.
Peripheral Nerve Stimulation in Diabetic Patients

The prevalence of diabetes mellitus (DM) in industrialized countries is estimated to be about 7.3% and its incidence has been growing in recent years. The prevalence of diabetic neuropathy in the diabetic patient population is up to 50%. When limb surgery is necessary, it is reasonable to assume that diabetic patients will benefit from a peripheral regional anesthesia because of the severe comorbidities associated with DM. On the other hand, the use of regional anesthesia (RA) has generally not been recommended in patients with preexisting neuropathies mainly because of medical liability issues, as worsening neuropathy could be attributed to nerve damage caused by the regional anesthetic. The current state of the art of peripheral regional anesthesia for the identification of correct placement of an injection needle suitably close to the target nerve is to elicit a motor response by current injection through the needle. Constant reduction of the current as the nerve is approached ensures close proximity so that an effective nerve block is obtained when the local anesthetic is delivered through the needle, and absence of a motor response at 0.3 mA is generally accepted as a safety marker to avoid harmful intraneural injection. An important deficit in our understanding is whether diabetic neuropathy influences the stimulation parameters for peripheral nerve stimulation (PNS), possibly decreasing safety.

The currently proposed research is guided by the hypothesis that nerves in patients with DM are more resistant to stimulation and the current thresholds for PNS have to be set much higher to prevent injections from occurring within the epineurium. The investigators will examine the effect of DM on nerve excitability in a blinded, prospective, observational case control trial. Accordingly, the investigators have defined following aims:

Specific Aim 1: To characterize the required stimulation current in patients with and without diabetes mellitus.

Specific Aim 2: Follow-up to examine if the rate of adverse neurologic events is higher in diabetic patients.

Specific Aim 3: Guided by the results, formulate recommendations for the performance of regional anesthesia in patients with a history of DM.

These experiments will provide better understanding of the needle-current-nerve relationship during peripheral nerve stimulation. Findings from this study will have a major impact on patient safety, especially in the subgroup with preexisting neuropathy, undergoing regional anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes
* age more than 18 years
* American Society of Anesthesiology status 1 to 4
* signed informed consent

Exclusion Criteria:

* Pregnancy
* Allergies to local anesthetics
* Unwillingness or incapability to sign informed consent
* Any preexisting neurological deficit of the lower limb that cannot be attributed to diabetic neuropathy
* Ongoing dual anti-platelet therapy
Efficacy and Safety of SHR0302 in Patients With Relapsed/Refractory Peripheral T/NK Cell Lymphoma

This is a non-randomized, open-label, Phase 1b clinical study to evaluate the safety, tolerability and anti-tumor efficacy of SHR0302 as monotherapy in patients with relapsed/refractory peripheral T/NK cell lymphoma. Around 7-18 patients will be subsequently enrolled into 3 different dose ascending cohorts. Additional 12-18 patients may be enrolled to further explore a selected dose defined by dose escalation cohorts.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18;
2. Pathologically confirmed T or NK cell lymphoma at the enrolling institution;
3. Measurable disease;
4. Relapse or refractory disease after at least 1 systemic therapy;
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 ；
6. With a life expectancy of ≥12 weeks;
7. Adequate bone marrow reserve and organ system functions;
8. Women of Childbearing Potential (WOBCP) must undergo a serum pregnancy test within seven days before the first medication and the results are negative. WOBCP or men and their WOBCP partners should agree to take effective contraceptive measures from the signing of ICF until 180 days after the last dose of the study drug is used;
9. Willing to provide written informed consent.

Exclusion Criteria:

1. Patient has undergone an allogeneic stem cell transplant. Or patient had autologous stem cell transplant within 6 months;
2. Any unsolved toxicity \> Common Terminology Criteria for Adverse Events (CTCAE) grade 1 from previous anti-cancer therapy (except alopecia);
3. Central nervous system (CNS) or leptomeningeal lymphoma;
4. received any antitumor therapy within 28 days prior to the first drug use, or the first dose was given within five half-lives of the previous antitumor drug, whichever is shorter;
5. Major surgical procedures were performed within 28 days before the first dose of study treatment, or surgery was planned during the study period;
6. Diagnosed with any other malignancies ≤5 years prior to the first dose, early tumors cured after radical treatment were evaluated by PI and considered for exclusion or not;
7. History of psychotropic substance abuse or drug use;
8. Previous history of allergy to the investigational drug or its excipients;
9. Severe cardiovascular disease;
10. Significant impairment of lung function;
11. Active infections;
12. Pregnant or lactation;
13. Known GI disease or GI procedure that could interfere with the oral absorption of oral medications, including not well controlled refractory nausea, vomiting, chronic gastrointestinal disorders, or capsule swallowing difficulties, or prior surgical resection of intestinal segments;
14. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
Camostat With Bicalutamide for COVID-19

This will be a randomized, open-label study to determine if camostat+ bicalutamide decreases the proportion of people with COVID-19 who require hospitalization, compared to historical controls. Patients with symptomatic COVID-19, diagnosed as outpatients, will be randomized 1:1, stratified by gender, to treatment with standard of care alone (Arm 1) or with camostat and bicalutamide (Arm 2).


Eligibility Criteria:
Inclusion Criteria:

* \>= 60 years of age
* COVID-19 infection, confirmed by polymerase chain reaction (PCR) test \<=5 days from enrollment done in the ambulatory setting
* Able to provide informed consent
* Symptom related to COVID-19. This includes: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea or other symptom recognized by the Centers for Disease Control to be a symptom of COVID-19.

Exclusion Criteria:

* Patients who undergo asymptomatic screening test that is positive and remain asymptomatic during the eligible time window
* Patients who have had one or more positive more than 5 days prior to enrollment but within 60 days of enrollment (ex. if a patient has a positive test 10 days prior to enrollment and then a second positive test the day referred for enrollment, that patient would be excluded. If a patient had a positive test 5 months ago, and then another positive test the day he/she was referred for enrollment, that patient would be eligible)
* Unable to take oral medication
* Male patients with female partners of reproductive potential who are unable to maintain effective contraception during the recommended time period (during treatment and for 130 days after the final dose)
* Symptoms requiring hospitalization or immediate referral to hospital
* Taking bicalutamide, any systemic hormonal therapy, or camostat within one month of study entry
* Known hypersensitivity to bicalutamide, or camostat, or its components.
* On coumadin anticoagulation (because of drug-drug interaction with bicalutamide)
* Self-reported past medical history of chronic liver disease or cirrhosis
* Self-reported myocardial infarction within 6 months or past medical history of congestive heart failure with known ejection fraction \< 40%
* Taking any other investigational treatment for COVID-19 or COVID-19 prophylaxis (COVID-19 vaccines and treatments allowed under FDA Emergency Use Authorization are allowed.)

Women and people from all ethnic and race groups are eligible for this study.
Impact of Cholesterol Level on Long-term Coronary Bypass Graft Patency

This single-centre cross-sectional study aims to ascertain the impact of dyslipidemia on long-term graft patency after coronary artery bypass grafting (CABG).

All consecutive patients who underwent CABG from 1st January 2007 to 31st December 2008 at the Prince of Wales Hospital were eligible for entry.

Graft patency will be determined by computed tomography coronary angiogram. The severity of stenosis will be classified by the Fitzgibbon classification system.

The levels of individual lipid profile subcomponents, namely LDL-C, high-density lipoprotein cholesterol (HDL-C), total cholesterol and triglycerides (TG) will be obtained. A plot of lipid profile subcomponent measurements against time will be compiled and the area under the curve is calculated to estimate gross exposure after CABG. Average lipid exposure is calculated by dividing the gross exposure by the number of days lapsed between the first and last lipid profile measurements.

The association between average cholesterol target attainment and graft patency will then be determined.

Eligibility Criteria:
Inclusion Criteria:

- All consecutive patients on record who underwent coronary artery bypass graft surgery in 2007 and 2008

Exclusion Criteria:

* Death
* Single vessel LIMA-LAD anastomosis only
* Concomitant valve and aortic procedures
* Concomitant repair of post-infarct ventricular septal rupture
* Defaulted follow-up
* Informed consent cannot be obtained
* Intermediate to high risk for contrast nephropathy, defined as estimated glomerular filtration rate less than 45 ml/min/1.73m2 or serum creatinine level \<1.5 mg/dL (based on American College of Radiology criteria for diagnostic computed tomography risk)
* Pregnancy
Hepatitis C Patient Management and Family Health Education

INTRODUCTION: Hepatitis C virus (HCV) is recognized as the leading cause of chronic liver disease worldwide. However, the screening rate and treatment rate of HCV-infected patients in China is low, which increases the burden of patients and the infection risk of their family members. WeChat, an instant messaging software, is used in a very high proportion in China. Health promotion based on WeChat public platform is a very convenient and effective way of health education. Therefore, this study plans to apply WeChat to conduct health intervention for HCV-infected patients. The objective is to explore the effect of We-media-based health promotion method on the detection rate and treatment rate of HCV-infected and their family members.

METHOD: Recruitment will be conduct in 10 hospitals in Jilin, Beijing, Henan and Anhui provinces. The subjects should be patients new diagnosed with hepatitis C at the hospital and aged 18 to 69. After signing the consent form, eligible participants were selected through the inclusion and exclusion criteria. 1000 participants will be recruited for the trial. After completing an baseline reseach by a online questionnaire, patients will be randomly assigned to receive a targeted short article on HCV weekly or a general health article with no mention of HCV. The intervention will last three months and a follow-up will be conduct at three month after the last intervention.

OUTCOMES: The primary outcome is antiviral therapy. The secondary outcomes are cognition and attitude towards hepatitis C, factors influencing antiviral therapy, time to first treatment and the compliance of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Permanent residents in the province
* Ages 18-69 (inclusive)
* Both blood anti-HCV test and HCV-RNA test is positive
* Familiar with the use of mobile phones and WeChat
* Informed consent and voluntary participation in the study

Exclusion Criteria:

* Temporary staff who come to the city to work, travel or visit relatives, or those who will be living in other cities for a long time
* Suffering from other serious diseases
* Patients with mental disorder or memory disorder
* Pregnant women or those who have a plan to prepare for pregnancy within one year
* Refuse to participate in the investigation
Kegel Exercise-focused Interventions in Elderly Women

Purpose: This study was conducted to investigate the effects of Kegel exercises-focused intervention undergone by elderly women diagnosed with urinary incontinence on their incontinence, quality of life and perceived impact level.

Design: The study has a single-blind randomized controlled experimental research design.

Methods: The study was carried out between December 2017 and March 2019 with 60 elderly women registered at the Home Health Unit of a Metropolitan Municipality in Turkey. The women were assigned to the intervention (n=30) and control (n=30) groups. The participants in the intervention group were paid home visits to provide them with individual training and counseling on Kegel exercises. Whether the participants did the exercises was followed up by weekly phone calls. The frequency of urinary incontinence, the amount of urine leaking and the quality of life of the participants and their complaints about incontinence were assessed with the International Consultation on Incontinence Questionnaire Short Form and questions on the assessment of the perceived impact at the onset of the study (0th week), and at home visits paid at the 6th and 12th weeks after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 65,
* Being women,
* Diagnosed with UI,
* Being literate,
* Being able to communicate in Turkish,
* Standardized Mini Mental Test result was \> 24,
* Agree to participate in research.

Exclusion Criteria:

* Who had received training on incontinence and Kegel exercises in the last 1 year,
* Had symptoms of urinary tract infection were identified,
* Being treated for UI,
* Having health problems affecting the muscle and nervous system,
* Being not able to perform daily life activities,
* Having pelvic organ prolapse,
Efficacy of Vojta on Balance and Quality of Life in Subject With CNLBP

. To investigate the effect of Vojta method on static balance ,dynamic balance, quality of life in patients with chronic non - specific low back pain

This randomized controlled trial is to investigate the effect of Vojta method on balance and quality of life in patients with chronic non-specific low back pain.

Forty patients (male and female) complaining of chronic non -specific low back pain was recruited to share in this study

. The recruited patients were randomly recruited into two groups; group A (control group) and group B (study group).

Group A: received conventional treatment of back pain which included; TENS 20 min and hot packs 10 min .The total treatment session is 30 min three session per week for four weeks Group B: received conventional treatment of back pain in addition to Vojta method. The total treatment session is 40 min.

Patient in both groups performed 10 sessions, 3 session per week

Eligibility Criteria:
Inclusion Criteria:

1. Patients with chronic non -specific low back pain for more than 3 months.
2. Their age ranged between 18-35 years old
3. Both sexes were recruited in this study.
4. Their BMI ranged between 18-25 kg/m2

Exclusion Criteria:

1- Patients with previous spinal surgery 2. Patients who have radiological diagnosis of spondylolysis or spondylolisthesis.

3. Patient with neurological disease . 4. Chest problems 5. Systematic disease
Role of the Pronator Quadratus in Distal Radius Fractures

The skin, the bones, and most muscles received branches from the source arteries of at least two angiosomes, thus revealing one of the important anastomotic pathways by which the circulation is reconstituted in those cases where a source artery is interrupted by disease or trauma.

There are numerous metaphyseal-epiphyseal branches arise within the pronator quadratus and the anterior interosseous artery and course towards the distal radius. These branches may be fundamental to the healing of the distal radius fractures and make nonunion a rare complication. The aim of this study is the evaluation of the role of the pronator quadratus muscle and its repair in volar approach in distal radius fractures treated with plate fixation.

Nonunion is an extremely rare complication in distal radius fractures and is most likely to occur in patients with conditions such as diabetes, peripheral vascular disease, or alcoholism. Diagnosis of nonunion is based on the absence of radiographic signs of union at 6 months. Treatment should be individualized but options are reconstructive procedures or wrist arthrodesis. In volar plating and often by the fracture injury itself, the complete pronator quadratus is stripped off the volar radius. Thus, the intraosseous collateral circulation must be sufficient for clinical healing. Any operative approach to the distal radius fracture should not compromise both volar radial and the dorsoulnar arteries.

While the branches to the pronator quadratus must be sacrificed in a palmar approach, the distal perforator can and should be spared. This is true even in the flexor carpi radialis extended approach. In distal radius fractures, when the normal outward flow of blood through the cortex is blocked, the periosteal arterioles have more ability than medullary arterioles to function and proliferate.

Eligibility Criteria:
Inclusion Criteria:

* Distal radius fractures with intra-articular fragment, comminuted or displaced fracture
* Adults between 18- 90 years old

Exclusion Criteria:

* Children
* Non displaced distal radius fractures treated with immobilization.
* Adults older than 90 years old
The Effect of Kangaroo Father Care Transport on Preterm Infants

This study was planned to investigate the effect of paternal kangaroo care and transport on physiologic parameters, anxiety and paternal attachment in preterm infants.

This study was conducted to determine the effects of paternal kangaroo care and transport of preterm infants on the physiologic parameters of the infant and the anxiety and attachment levels of the fathers.

Eligibility Criteria:
Inclusion Criteria:Neonatal related;

* Born by caesarean section,
* Born at 34-36+6 weeks gestation,
* Apgar score of 7 and above at 1 and 5 minutes,
* Stable and healthy,
* Infants with a body weight of 1500 g and above were included. It's about the father;
* Who volunteered to participate in the study,
* No mental and psychological problems,
* No communication problems (speech, hearing and severe visual impairment),
* Fathers who did not carry contact-transmitted diseases (Covid-19, herpes simplex, scabies, etc.) were included.

Exclusion Criteria:- Congenital anomalies,

* Abdominal defects such as ompholocele, diaphragmatic hernia, gastroschisis,
* Receiving invasive and noninvasive respiratory support,
* With chest tube and umbilical catheter,
* Foreign babies and their fathers were ostracized.
Hypercapnia During Shoulder Arthroscopy

The purpose of this study is to evaluate the effects of hypercapnia on hemodynamics and cerebral oxygenation during shoulder arthroscopy.

The patients are randomly allocated to receive normocapnia or hypercapnia . After the 70º sitting position, record the mean arterial pressure (MAP), heart rate, and regional oxygen saturation (rSO2).

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective shoulder arthroscopic surgery

Exclusion Criteria:

* a history of age \> 65 years, morbidly obesity (BMI \> 30 kg/m2), diffuse lung disease, uncontrolled systemic hypertension, intracranial disease, cardiovascular and cerebrovascular disease.
Mindfulness Training in Adolescents With Type 1 Diabetes

Creation of an adaptation of a mindfulness-based stress reduction mobile health application specifically designed for adolescents living with Type 1 diabetes. Aim to determine whether daily mindfulness improves anxiety symptoms in adolescents with Type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Type 1 diabetes for 6 months or longer
* Anxiety score of 5 or higher on the Generalized Anxiety Disorder 7-item scale
* Must be able to read and speak English

Exclusion Criteria:

* Clinical diagnosis of a chronic medical condition requiring intensive daily management