cyrilzakka/clinical-trials huggingface dataset:
A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy

The primary objectives of this study are: In Part 1 to evaluate the efficacy of zanubrutinib as measured by proteinuria reduction, and in Part 2 to evaluate the efficacy of zanubrutinib compared with tacrolimus as measured by complete remission rate, in participants with primary membranous nephropathy (PMN) who are on optimal supportive care.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-confirmed PMN within 5 years before the initial screening (ie, the day the informed consent is signed)
* UPCR (based on 24-hour urine collection) \> 3.5 at initial screening and at confirmation assessment
* Treatment with a maximally tolerated or allowed dose of an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB) for ≥ 24 weeks before randomization (12 weeks before initiation of study drug for Part 1) and with adequate blood pressure control (blood pressure \< 130/80 mmHg, measured on ≥ 2 occasions \[not on the same day\] within 4 weeks before the assignment of study treatment)
* Anti-PLA2R antibody \> 50 RU/mL at confirmation assessment (Part 1 only)

Exclusion Criteria:

* Participants with a secondary cause of membranous nephropathy
* Type 1 or 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥ 7% at screening
* Severe renal disease as determined by rapid decline in eGFR (defined as \> 15 mL/min/1.73m\^2 within 24 weeks prior to randomization, not otherwise explained)
* A known history of a primary immunodeficiency or an underlying condition such as human immunodeficiency virus (HIV) infection or splenectomy that predisposes the participant to infections
* Patients at risk for tuberculosis at screening
* Known infection with serologic status reflecting active or chronic hepatitis B virus infection, or presence of hepatitis C virus antibody
* Severe hepatic insufficiency (Child-Pugh C)
* Clinically significant cardio-cerebrovascular diseases

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Coping and Adjusting to Living With Multiple Sclerosis

The purpose of this project is to test a brief, telephone-based psychological intervention, CBT-UT, to improve the ability to tolerate uncertainty-and thereby to reduce distress-in people with a recent diagnosis of Multiple Sclerosis (MS). There are three treatment arms for this study. Participants will receive either (1) CBT for Uncertainty Tolerance, (2) Traditional CBT, or (3) treatment as usual.

Despite substantial improvements in diagnosis and treatment, Multiple Sclerosis (MS) remains an unpredictable disease. Although some physicians can make some predictions about expected progression, the variable course of exacerbations makes it almost impossible to predict how MS will develop or affect function over time. As a result, people with MS must learn to live in a state of chronic uncertainty and the ability to tolerate and cope with this kind of uncertainty is central to quality of life with MS. Individuals who require certainty about the future and are not able to tolerate ambiguity are said to be high in a personality trait known as intolerance of uncertainty (IU). There is a significant gap in MS clinical intervention that necessitates attention. An intervention that specifically targets IU, is developed for people recently diagnosed with MS, and can be provided remotely via telehealth can make a significant impact for this population. Study aims include: (1) to determine the efficacy of CBT-UT relative to traditional cognitive behavioral therapy (tCBT) or treatment as usual (TAU) in people diagnosed with MS in the past 3 years; and (2) To increase our understanding of the mechanisms underlying the intervention effects.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years of age
* MS diagnosis using revised McDonald Criteria
* Able to read, speak, and understand English
* At least mild psychological distress evidenced by (1) a score of 20 or higher on the Kessler Psychological Distress Scale OR (2) a score greater than or equal to 5 on the Perceived Stress Scale.

Exclusion Criteria:

* Severe cognitive impairment defined as one or more error on the Six-Item Screener
* Psychiatric condition or symptoms that would interfere with participation, specifically (1) current, active suicidal ideation with current intent to harm oneself, (2) current psychosis, or (3) current mania.
Detection of hEad Pulse for Ischemic StrOke Verification Study

Prehospital providers encounter patients with suspected stroke frequently. Prehospital providers need tools to help triage large vessel stroke patients to comprehensive stroke centers. This device will identify large vessel stroke to ultimately improve triage decisions and optimize outcomes.

Patients suspected of stroke by a prehospital provider will have a headset placed to record their headpulse during the encounter. These measurements will be used to assess the accuracy of the device at predicting the presence of large vessel occlusion (LVO) stroke. The MindRhythm, Inc., Harmony® 5000 device is intended to be used in the pre-hospital setting by medical professionals to diagnose large vessel occlusion stroke in adults suspected of having a stroke.

Eligibility Criteria:
Inclusion Criteria:

• suspected stroke in the prehospital setting

Exclusion Criteria:

* scalp laceration
* Patient refusal
* Prisoner, other vulnerable population
* Prehospital provider feels that the recording may interfere with care
Resuscitative TEE Collaborative Registry

The general objective of this study is to evaluate the clinical impact and safety of focused, point-of-care transesophageal echocardiography (TEE) used during the evaluation of critically-ill patients in the emergency and intensive care settings. The target population for this study are critically-ill patients over the age of 18 who as part of their routine clinical care are receiving a focused TEE.

The primary objective of this study is to determine the clinical impact and safety of TEE performed during the evaluation of critically-ill patients in the emergency department and intensive care settings.

The secondary objective(s) of this study are to characterize the use of this imaging modality in the subsets of critically-ill patients in shock and cardiac arrest; including but not limited to; description of the frequency of studies, clinical indications, clinician characteristics, echocardiography findings, timing of studies, procedure-related complications and patient outcomes.

Vision

The Resuscitative TEE Collaborative Registry aims to accelerate the development of outcome-oriented research and knowledge translation on the use of TEE in emergency and critical care settings.

Mission

The registry aims to catalyze clinical research involving the use of TEE in critically-ill patients through the following strategic initiatives:

* Facilitate collaboration between different clinical teams and organizations across the entire spectrum of users of TEE in acute care setting, including emergency departments and intensive care units.
* Standardize data collection and reporting that enables multi-institutional data sharing.
* Provide an efficient research infrastructure that facilitates data capture, management and analysis, enabling teams around the world to conduct research studies in this field.
* Make shared data open and accessible to clinicians and researchers.

Eligibility Criteria:
Inclusion Criteria:

* Adult critically-ill patients who as part of their routine clinical care receive focused TEE in the emergency department of intensive care setting.

Exclusion Criteria:

* Children (age under 18 years)
* Vulnerable populations
Effects of Tablets of Silybum Marianum, Pueraria Lobate and Salvia Miltiorrhiza on Fatty Liver

Objectives: To examine the effects of tablets of silybum marianum, Pueraria lobate and salvia miltiorrhiza on the progression of fatty liver in patients with fatty liver.

Design: a double-blinded randomized placebo-controlled clinical trial.

Setting: community residents, Guangzhou city, South China.

Participants: a total 118 men and women (18-65 years), with BMI range of 24-30 kg/m2, and with fatty liver screened by ultrasound or MR at baseline.

Arms and Interventions: 118 participants were randomly allocated into two arms using a block randomization method. Experimental Arm: tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza, 3 tablets (1g each) twice a day for 6 months; Placebo Arm: placebo tablets, 3 tablets (1g each) twice a day for 6 months.

Outcome Measures: determined at baseline and at 6 months post treatment

1. Primary Outcome Measures: 1) proton density fat fraction of liver assessed by MR; 2) serum liver fibrosis biomarkers: type procollagen III N terminal peptide, hyaluronic acid, laminin, collagen type IV, and glycocholic acid; 3) NAFLD fibrosis score.
2. Secondary Outcome Measures: 1) serum liver function biomarkers: AST, ALT, GGT, ALP, total protein, and bile acids; 2) fasting blood lipids: total triglycerides, total cholesterol, HDL cholesterol and LDL cholesterol; 3) fasting serum glucose and insulin; 4) serum inflammatory factors (hsCRP and IL-6); 5) oxidative stress: SOD and MDA; and 6) body measurements and body fat mass.

Data Analyses: Mean changes in the above outcome measures from baseline to 6 months will be compared between the two arms.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65 years
* BMI: 24-30 kg/m2
* Fatty liver, assessed by ultrasound or MR
* Had normal diet and normal daily life.

Exclusion Criteria:

* Hospital confirmed diseases of heart, liver (viral hepatitis, drug-induced liver injury, cirrhosis), kidney, brain, hematopoietic system，diabetes, immune system, and cancer；
* Taking medicine or supplements known to affect fatty liver, body fat;
* Body weight had changed more than 10% within the past 3 months;
* Physical or mental disabled to participate the trial;
* Compliance of tablet consumption is/was less than 80% in run-in period;
* Pregnant or lactating women, or intended pregnancy during the trial period;
* Be allergic to the proposed supplements；
* Attended or plan to attend other trial(s);
* Be unwell to sign the informed consent form, or have other conditions that be not suitable to attend the trial considered by the investigators.
Evaluation of Executive Functions in Children With Cochleovestibular Deficit

Vestibular system activity supports many functions ranging from gaze stabilization and postural control to high-level cortical functions involving spatial cognition, body perception, verticality perception, orientation, navigation, and spatial memory. Few studies have assessed the impact of a vestibular deficit on executive functions taking into account the simultaneous existence of sensorineural deafness in a child population. The BRIEF questionnaire (Behavioral Rating Inventory of Executive Function) allows a parental assessment of executive functions and is validated from the age of 5. Children were recruited from a pediatric population followed in the Ear Nose and Throat (ENT) department for audio-vestibular assessment and BRIEF questionnaire was completed by the accompanying parent.

Vestibular system activity supports many functions ranging from gaze stabilization and postural control to high-level cortical functions involving spatial cognition, body perception, verticality perception, orientation, navigation, and spatial memory. Few studies have assessed the impact of a vestibular deficit on executive functions taking into account the simultaneous existence of sensorineural deafness in a child population. The BRIEF questionnaire (Behavioral Rating Inventory of Executive Function) allows a parental assessment of executive functions and is validated from the age of 5. Children were recruited from a pediatric population followed in the Ear Nose and Throat (ENT) department for audio-vestibular assessment and BRIEF questionnaire was completed by the accompanying parent.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged ≥ 5 years \< 18 years with vestibulopathy confirmed during an ENT consultation
* Affiliated to the social security system
* Holders of parental authority and Patients informed and not opposed to participating in the research
* Mastery of the French language by patients and their parents

Exclusion Criteria:

* Refusal to participate
* Existence of another neurodevelopmental pathology or specific cognitive disorder
Fascial Manipulation® Associated With Standard Care Versus Standard Post-surgical Care for Total Hip Arthroplasty

Post-surgical physiotherapy programs following to total hip arthroplasty (THA) show important differences between types and numbers of treatment sessions. Objectives are to investigate effectiveness of Fascial Manipulation when associated to a standard protocol of care.

Background. Post-surgical physiotherapy programs following to total hip arthroplasty (THA) show important differences between types and numbers of treatment sessions. Objectives are to investigate effectiveness of Fascial Manipulation when associated to a standard protocol of care.

Methods. Fifty-one subjects operated with THA were randomized into two groups, both followed a standard protocol of care where two sessions were replaced with Fascial Manipulation in the study group. Functional outcomes measures collected before and after treatment and at the end of the rehabilitation program included Harris Hip Score, Time Up and Go test, articular range of motion and verbal numerical scale.

Eligibility Criteria:
Inclusion Criteria:

* first THA surgery,
* posterior-lateral access,
* onset of pain of maximum 2 years

Exclusion Criteria:

* patients with previous hip or knee prosthesis,
* congenital hip dysplasia,
* revision THA,
* elective THA secondary to trauma,
* real leg-length discrepancy (≥1.5cm),
* cognitive impairment,
* concomitant rheumatic pathology in acute phase,
* serious comorbidities including cardiac,
* respiratory and/or neuromuscular pathologies.
Effect of Nutritional Indices on the Prognosis of HCC Patients

Primary liver cancer has recently ranked among the leading causes of cancer death, with hepatocellular carcinoma (HCC) accounting for 75%-85% of these cases. In recent years, immune checkpoint inhibitors (ICIs) combined with tyrosine kinase inhibitors (TKIs) have achieved good results in the treatment of advanced HCC patients. So far, there is a lack of studies exploring the relationship between nutritional index and the prognosis of HCC patients treated with ICIs combined with TKIs, and there are few studies on the prognostic value of nutritional index in HCC patients treated with transarterial chemoembolization (TACE). This retrospective study aims to analyze the prognostic value of prognostic nutritional index(PNI)，body mass index (BMI), psoas muscle index（PMI）and geriatric nutritional risk index (GNRI) in HCC patients who received ICIs combined with TKIs or TACE, and to provide reference for the selection of nutritional intervention programs for HCC patients.

Patients who confirmed HCC in the Second Affiliated Hospital of Chongqing Medical University were enrolled in the retrospective study. The subjects were divided into two cohorts, both of which met the inclusion and exclusion criteria.The data needed to be collected included age, gender, height and weight at initial treatment and regular follow-up. Blood routine, liver function, kidney function, coagulation function, electrolytes, PIVKA-II, AFP, HBV-DNA, CT, MRI information, China liver cancer staging (CNLC), complications, treatment plan, etc. Follow-up time after initiation of treatment and time of death or significant disease progression. The survival was estimated by the Kaplan-Meier method and curves were compared by the log-rank test.Logistic regression was used to univariate and multivariate analyze the effect of variables on the outcome. Variables with P\<0.05 on a univariate analysis were subjected to a multivariate analysis.

Eligibility Criteria:
Inclusion Criteria:

Cohort 1:HCC patients received ICIs combined with TKIs regularly and periodically.

Cohort 2:HCC patients who underwent TACE as initial treatment.

Exclusion Criteria:

1. Patients with systemic malignant tumors other than HCC.
2. Patients with severe hypertension, diabetes, coronary heart disease, systemic infection and other serious diseases.
3. patients with immunodeficiency or autoimmune diseases.
4. Patients with severe malnutrition.
5. Not adhering to regular and periodic treatment.
6. Patients without regular follow-up or with missing data to be collected.
Digital Intelligent Assistant for Nursing Application

This is an observational study that intends to compare falls or fall-risk related alarms derived from a three-dimensional sensor system with the clinical reality definded by attending nurses.

Three dimensional sensor technology (3DS) is available for fall detection and fall prevention (e.g. unwanted getting up in persons with risks for frequent falls) in several institutions in Europe and Switzerland. 3DS are capable to analyze completely anonymized data and alert nurses towards a dangerous (fall) or potentially dangerous (getting out of bed) event during day- and nighttime. Multi-sensor technology has been applied to assess activities of daily living in persons cognitive problems living at home. To our knowledge, 3DS technology has not been examined as part of a structured clinical protocol. In addition, the combination of two digital technologies (3DS and a server based software) as an integrative platform could help to develop algorithms to analyze complex human activities such as using a toilet. Automated analyses of such complex activities have the potential to support nursing staff in the future.

Eligibility Criteria:
Inclusion criteria Informed consent given by person or caregiver Patients admitted

* with or without cognitive decline for any reason
* with acute and/or chronic conditions
* after any kind of surgery

Exclusion Criteria:

1. For Falls assessment by 3D sensors:

   • Based on the multifactorial risk for falls there are no exclusion criteria for falls assessment
2. For the development of toileting algorithm:

   * severe urine or fecal incontinence
   * permanent indwelling urinary catheter
   * permanent urinary or bowel stoma
Coenzyme Q10 and Vitamin A, C, E in Relation to the Oxidative Stress, Antioxidant Enzyme Activity and Inflammation in Subjects With Metabolic Syndrome

Metabolic syndrome (MS) is a significant risk factor of cardiovascular disease. However, the relationships between coenzyme Q10, antioxidant vitamins (Vitamin A, C, E) and the prevention of the risk of MS are still inconsistent. The purposes of this study are going to investigate the relation of coenzyme Q10, antioxidant vitamins concentration with the blood lipid levels, the markers of lipid peroxidation (TBARS), antioxidant enzymes activities (catalase, glutathione peroxidase and superoxide dismutase), and the inflammatory markers (hs-CRP,IL-6 and adiponectin). The investigators will recruit MS patients (case group, n = 100) and age-gender matched healthy subjects from previous study(n = 105) as a control group . The inclusion criteria of MS are according to the Bureau of Health Promotion, Department of Health in Taiwan (2007).Hopefully, the results of this study could provide the information to what has been know in MS subjects. The investigators expect coenzyme Q10 or antioxidant vitamins could be a preventive supplement to reduce the risk of MS.


Eligibility Criteria:
Inclusion Criteria:

* Metabolic syndrome
* Healthy individuals with normal blood biochemical values.

Exclusion Criteria:

* Age \< 18y
* Antioxidant vitamins supplements use
* Pregnant women
Xenon Inhalation During Orthopaedic Surgery in Elderly Subjects.

The primary objective was to explore the feasibility of inhaled xenon for sedation in terms of its effect on postoperative cognitive function in elderly, in comparison with the postoperative cognitive function found after IV propofol sedation in the same population.The secondary objectives were designed to assess the feasibility of xenon sedation in terms of its effects on different neuropsycho-logical test variables, vital signs, sedation levels and safety in elderly orthopaedic subjects.

Primary endpoint: - The primary efficacy parameter was a combined score based on the seven variables derived from four validated neuropsychological tests of cognitive function; Visual Verbal Learning test, Concept Shifting test, Stroop Color Word Interference test and Letter Digit Coding test. The parameter was used for comparing changes in test results between the screening and first postoperative follow-up testing for the treatment groups.Secondary endpoints:- Cognitive performance changes from baseline to the first post-operative follow-up judged separately for each of the seven variables from the changes in the test results.- Cognitive performance changes from baseline to the second postoperative follow-up judged separately and globally for each of the seven variables from the changes in test results.- Adequacy of ventilation (respiratory rate and pulse oximetry)- Adequacy of xenon sedation by monitoring depth of unconsciousness, signs of airway irritation, need for additional sedatives, time to recovery from anaesthesia. - Technical performance of xenon delivery device

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects ≥ 60 years of age.
* American Soc. of Anaesthesiologists Physical Status Classification (ASA) I-III status \[27\]
* Referred for elective orthopaedic knee surgery with an anticipated duration of \> 45 min
* Expected to remain in hospital for at least 3 days
* Expected to be able to comply with the study protocol throughout the study period
* Mini Mental State Examination (MMSE) score \> 23
* Informed consent given

Exclusion Criteria:

* Disease of the CNS (infectious, metabolic, tumours, dementia, epilepsy, major psychiatric disease, confusion/ delirium according to Diagnostic \& Statistical Manual of Mental Disorders (DSM) IV criteria)
* Contradiction for spinal anaesthesia
* Contradiction for laryngeal mask
* Regular use of tranquillisers, or antidepressants, if prescribed by psychiatrist for psychosis or depression
* Undergone neuropsychological testing within the last year
* Unable to follow study procedures, illiteracy, or poor comprehension of the language used in the psychometric tests
* Severe visual or auditory disorder
* Alcoholism or drug abuse

CNS disease BMI \> 35 Inab
Gut Microbiota in Obesity and Diabetes

An altered gut microbiota composition has recently been linked to obesity and diabetes. The principal aim of this study was to investigate and compare the gut microbiota composition of obese, diabetic and control individuals. Then, associations between analyzed gut microbial concentrations and clinical-biochemical blood parameters were assessed.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with obesity or newly diagnosed type 2 diabetes
* 18 years to 65 years of age

Exclusion Criteria:

* Any chronic disease (other than obesity and diabetes)
* Alcohol consumption/smoking
* Pregnancy/breastfeeding
* The use of antibiotics, pro-prebiotics within 3 months
* \<18 years or \>65 years
* History of intestinal surgery