cyrilzakka/clinical-trials huggingface dataset:
Continuous Heart Rate Variability Monitoring in Doctors; Understanding Patterns of Stress and Recovery and Their Relationship With Self-reported Resilience, Burnout and Wellbeing.

Burnout is an increasing concern in the medical professions. This study aims to utilise established, validated self-report measures combined with continuous heart rate variability measurements to better understand the stress and recovery patterns experienced by doctors that may contribute to burnout.

This mixed methods study design will consist of an ecological momentary assessment phase where participants will complete commonly used and validated real-time subjective measures while concurrently wearing a heart rate variability monitor to provide an objective measure of stress. Following on from this, participants of interest will be invited to participate in semi structured interviews to further explore their experiences of stress and recovery.


Eligibility Criteria:
Inclusion Criteria:

* Working within NHS Grampian
* Access to a smartphone

Exclusion Criteria:

* Cardiac arrhythmias/endocrine disease.
* Prescription beta blockers, calcium channel blockers, ACE inhibitors, benzodiazepines, antidepressants and antianxiety medications.
* Insufficient non-working time prior to study commencement.
Community-Based Integrated Treatment for Adolescents

This study will examine the effectiveness of an integrated treatment for adolescents who are depressed and use alcohol in an intensive outpatient setting in the community.

Studies have consistently shown that alcohol use disorders (AUDs) and mental health disorders are related in adolescence. For example, in a community sample, teens who reported a history of AUD were almost four times as likely to have a history of Major Depressive Disorder (MDD) than teens with no history of AUD. The scientific community has only recently begun to examine how to treat adolescents with both AUD and MDD. Reviews have concluded that depression negatively affects treatment for substance abuse. At the same time, substance use issues are often not assessed or addressed in outpatient psychotherapy. Thus, we believe that protocols are needed to specifically address substance abusing, depressed adolescents. This study is designed to determine if an integrated (CBT-I) protocol designed to treat both substance use and depression in adolescents aged 12 to 18 years with AUD/MDD will produce better treatment outcomes compared to standard care (CBT-SC). Both the integrated CBT-I and CBT-SC conditions will be delivered by licensed mental health workers at a community mental health clinic - Gateway - that uses an Intensive Outpatient Program (IOP) model to treat adolescents with AUD and mental health disorders. Two hundred adolescents (50 per year for 4 years) will be recruited from Gateway's Dual Diagnosis IOP. If an adolescent screens in by reporting both depressed mood and substance abuse, these eligible families will complete a thorough baseline assessment and will then be assigned to either CBT-I or CBT-SC. The baseline battery will be repeated at the end of treatment, and 6 and 12 months after treatment completion to determine how families in the study do over time.

Eligibility Criteria:
Inclusion Criteria:

* English speaking adolescent and parent
* Current substance use disorder
* Co-occurring psychiatric symptomatology

Exclusion Criteria:

* IQ \< 80
* Diagnosis of psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, bulimia nervosa or anorexia nervosa
* Adolescent use of illicit "hard" substances such as cocaine, heroine, and opiates 13 or more times over the prior 90 days
Two-Part, Open-Label, Multi-Center, Phase 1/2 Study of BIW-8962 as Monotherapy in Subjects With Lung Cancer

This Phase 1/2 study is designed to assess the following: safety and tolerability of BIW-8962, Dose Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD), Recommended Phase 2 Dose (RP2D) in Phase 1 in subjects with advanced/recurrent lung cancers or mesothelioma and preliminary efficacy in Phase 2 in subjects with advanced/recurrent Small Cell Lung Cancer.


Eligibility Criteria:
Inclusion Criteria:

* Phase 1: histopathological-documented, measurable or non-measurable unresectable, advanced primary or recurrent SCLC, NSCLC or mesothelioma
* Phase 2: measurable, unresectable advanced or recurrent SCLC
* A life expectancy \> 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 at study entry
* Echocardiogram or multigated acquisition (MUGA) scan with left ventricular ejection fraction (LVEF) ≥ 50%, or ≥ institution's established lower limit of normal
* Adequate hematologic, hepatic, renal and lung function

Exclusion Criteria:

* Subject received cytotoxic anti-cancer chemotherapy, orally available signaling pathway-targeted therapy, hormonal therapy, radiotherapy, immunotherapy, or investigational agents within 3 weeks prior to the first dose
* Subject received monoclonal antibodies within 4 weeks of the first dose
* Major surgery within 4 weeks prior to the first dose
* Known symptomatic brain metastases
* Clinically significant cardiovascular disease
* Leptomeningeal disease
* Uncontrolled intercurrent illness including ongoing or active infection, uncontrolled diabetes, etc
* Known HIV disease or acquired immunodeficiency syndrome-related illness
* A psychiatric illness, disability or social situation
* Hypersensitivity reaction to monoclonal antibodies, other therapeutic proteins
* A history of primary brain/CNS malignancy
* Neurological paraneoplastic syndrome
Evaluation of the Association Between Osteoporosis and Postural Balance in Postmenopausal Women

The incidence of osteoporosis has been increasing, as have fractures resulting from falls.

The overall objective of this study is to evaluate bipodal postural balance in postmenopausal women with and without lumbar osteoporosis. The specific objective is to determine the relationship between the degree of thoracic kyphosis and dosing of 25 OH vitamin D with postural balance in postmenopausal women with lumbar osteoporosis.

One hundred and twenty-six postmenopausal women between 55-65 years of age were evaluated and separated into two groups according to the bone mineral density values of their lumbar spine: the osteoporosis group and the control group.

Functional mobility was evaluated through the Timed Up and Go Test. Postural balance was evaluated using a AccuSway® model portable force platform, in standard standing position, with eyes open and closed, for 60". Data were collected, stored, and processed by the Balance Clinic® program, configured to 100 Hz frequency, with a frequency cut-off filter at 10 Hz.

Muscle strength was evaluated via a Biodex® isokinetic dynamometer in the concentric/concentric knee extension mode at 60o/s.

Dosing of 25 OH vitamin D and thoracic spine x-rays to determine the degree of kyphosis measured by the Cobb angle were performed in the osteoporosis group.

Eligibility Criteria:
Inclusion Criteria:

* absence of impairment of the vestibular, proprioceptive, auditory or neurological system, and/or any mental disturbances or disorders;
* no use of medications that might compromise postural balance;
* absence of lesions, surgery or disease that might have caused lower-limb joint limitations over the previous six months;
* absence of lower-limb dysmetria;
* presence of clinically normal gait, without claudication.

Exclusion Criteria:

* the presence of pain or inability to complete any of the tests
* along with occurrences of blood pressure increase before the strength evaluation.
An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin®

The objective of this study is to observe the safety, tolerability, and compliance in the use of Fragmin® for prolonged thromboprophylaxis in post-surgery high-risk orthopedic patients.

All patients prescribed Fragmin® (Dalteparin Sodium) for prolonged thromboprophylaxis will be eligible for study

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient, undergoing major orthopedic surgery
* At least 18 years old

Exclusion Criteria:

* Hypersensitivity to Fragmin or other low molecular weight heparins or unfractioned heparin;
* History of heparin induced thrombocytopaenia type II
* Acute gastroduodenal ulcer, cerebral haemorrhage, or other active haemorrhage.
* Serious coagulation disorder;
* Septic endocarditis;
* Injuries to and operations in the central nervous system, eye and ear within one month before orthopaedic surgery;
* Spinal or epidural anesthesia or other procedures requiring spinal puncture and concomitant treatment with high doses of dalteparin (such as those needed to treat acute deep vein thrombosis, pulmonary embolism, and Unstable coronary artery disease);
* Patients with serum creatinine level \> 150 umol/l;
* Platelet count of less than 100 000 per cubic millimeter at the beginning of the therapy;
* High probability that patient will not return to the centre for follow-up;
* Patient on oral anticoagulation therapy in the last 7 days;
* Ongoing anticoagulant therapy with other medications or non-pharmacologic therapy during the study period;
* Weight less than 40 kg;
* Simultaneous participation in another pharmacological study or receiving any investigational drug 30 days or less before surgery;
* Pregnancy or breastfeeding;
* Clinically significant hepatic dysfunction.
SLeep and IMagery Correlates (SOMMEIL-IMAGERIE)

This study is designed to determine the neural networks underlying the sleep-related motor consolidation process following motor imagery practice. While beneficial effects of sleep are expected for sequential movement but not for adaptation motor tasks, the corresponding neuroanatomical correlates have not yet been investigated when participants acquired the motor tasks through mental practice. Data should substantially promote how designing motor imagery interventions targeting (re)learning and/or motor recovery in patients suffering from motor disorders.


Eligibility Criteria:
Inclusion Criteria:

* Healthy right-handed persons without neurologic disease
* Persons having signed informed consent for a neuroimagery study

Exclusion Criteria:

* Persons under curatorship or any administrative/judicial measure
* Participants refusing to be informed of the results of the experiment
* Pregnant women
* Participants with contraindications to the MEG examination: head size, presence of a neurostimulator, steel pivot for the root canal, metallic fragments, ear implants, metal screws in the body or mouth.
* Persons using a pacemaker, insulin pump, or working regularly with iron filings
* Claustrophobic persons
A Study on Rheumatoid Arthritis Patients Treated With Rituximab

The purpose of the study is to obtain an overall picture of rituximab treatments and treatment responses in RA patients.


Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis (RA) patients treated with rituximab in Finland

Exclusion Criteria:

* Not applicable
Evaluate the Effect of Tirazamine on Primary Liver Cancer.

This Phase I/II trial aims to evaluate the pharmacokinetics, efficacy, and safety of tirapazamine administered via hepatic artery injection followed by TACE in patients with intermediate-stage HCC. The trial will compare the outcomes of TATE with standard TACE.

The clinical trial is bifurcated into two distinct strata.

Phase One:

This stratum is designed to elucidate the pharmacokinetics of Tirapazamine, specifically its concentration in peripheral blood, in patients with hepatocellular carcinoma (HCC) subsequent to hepatic arterial infusion of Tirapazamine at dosages of 5, 10, and 20 mg/m², culminating in hepatic arterial embolization. A total of approximately 12 patients are slated for enrollment, with 3 to 6 patients allocated to each dosage tier. This constitutes a multicenter, open-label, dose-escalation study. Initiation occurs at a Tirapazamine dosage of 5 mg/m² (administered to 3 patients), followed by escalation to 10 mg/m² (administered to 3 patients), and culminating at 20 mg/m² (administered to 6 patients). All subjects undergo hepatic arterial infusion of Tirapazamine directed towards the tumor vasculature, followed by embolization utilizing a formulation comprising iodized oil, gelatin sponge, and contrast agent (the preparation and application of the embolic agent are delineated in Appendix E).

Phase Two:

Phase Two is delineated as a Phase II open-label, randomized, controlled trial that compares the therapeutic outcomes of TATE (Transarterial Tirapazamine Embolization) and TACE (Transarterial Chemoembolization) in patients with intermediate-stage primary hepatocellular carcinoma who are candidates for hepatic arterial embolization. This phase may be conducted contemporaneously with Phase One. Approximately 200 patients will be randomized in a 1:1 ratio to either the experimental arm (Group A, TATE ) or the control arm (Group B, TACE ). Inter-arm crossover is proscribed.

Eligibility Criteria:
Inclusion Criteria:

* Hepatocellular carcinoma, either histologically/cytologically confirmed or clinically diagnosed
* Age 18-80 years
* Patient is eligible to do TAE or TACE treatment.
* ECOG performance status score 0-1.
* Child-Pugh score 5 - 7 .
* No portal vein tumor thrombus, lymph node metastasis, peritoneal tumor seeding, or extrahepatic metastasis.

Exclusion Criteria:

* Prior liver transplantation
* History of liver tumor embolization or radioembolization
* Uncontrolled HBV or HCV infection
* Significant cardiovascular, pulmonary, or renal disease
* QTc prolongation or use of QTc-prolonging medications
Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

Relaxin is a naturally occurring protein prduced by the ovary or placenta in pregnancy. It has ani-fibrotic properties. Previous studies have shown that relaxin is safe at concentrations upto 60 times higher than achieved in pregnancy. Study is designed to see if skin improvement and improvement in functional ability can be achieved.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 to 70 years of age with diffuse SSc
* Disease duration 5 years since the onset of the first non-Raynaud sign or symptom
* A baseline modified Rodnan skin score (MRSS) of 20 or greater, or at least 16 if truncal involvement was present.
* Recombinant human relaxin (10 or 25 ug/kg/day), or placebo was administered for 24 weeks as a continuous subcutaneous infusion and there was a follow-up safety visit at week 28.
Brain Markers of Depression Vulnerability: the Case of Prefrontal Haemodynamic Response

Functional near infrared spectroscopy (fNIRS) offers a cheap and reliable tool to investigate prefrontal brain activation in the healthy and diseased human brain. As such, fNIRS bears great potential as a diagnostic tool for clinical practice. Research indicates that fNIRS, together with a relatively simple task to activate the prefrontal cortex, the so-called verbal fluency task (VFT), elucidates prefrontal dysfunction in major depressive disorder (MDD). This finding can potentially serve as an imaging marker for disease pathology, even when depressive symptoms are absent. Indeed, recent research also suggests prefrontal dysfunction in fully remitted MDD (rMDD). Prefrontal haemodynamic responses may therefore serve as a trait marker for MDD vulnerability.

This study aims to investigate the haemodynamic response in rMDD, healthy participants with increased MDD risk (HCr; having a 1st-degree relative with MDD), and low-risk healthy participants (HCnr; having no 1st-degree relatives with MDD) using fNIRS. The investigators hypothesize lower prefrontal reactivity in HCr compared to HCnr, and lowest prefrontal reactivity in rMDD compared to HCnr.

This study has the potential to elucidate the neuronal underpinnings of depression vulnerability in the absence of symptoms that are sometimes considered a confounding factor when it comes to studying the biological encoding of depression.

Healthy participants with a high risk of MDD (HCr), healthy participants with a low risk of MDD (HCnr) and rMDD participants will be included in this study.

Prefrontal haemodynamic response will be measured in all participants during the verbal fluency test (VFT) using 52 channels fNIRS. The VFT involves two neural conditions, one positive condition, and one negative condition.

Both the neuroimage change and the behavioral outcomes of VFT will be compared within-group and among groups. The correlation between the neuroimage change and the behavioral outcomes will be analyzed as well.

Eligibility Criteria:
Inclusion Criteria:

* Mini-mental state examination (MMSE) \> 24

Exclusion Criteria:

* Current diagnosis of psychiatric disorders, such as depression, anxiety, schizophrenia, or autism
* current or past diagnosis of neurological disorders, such as head injuries, strokes, encephalitis, epilepsy, Parkinson's, or Alzheimer's
Phase IV Comparing Rods of Yield Strengths to Correct Adolescent Idiopathic Scoliosis.

There has been a growing trend amongst surgeons to use a construct for correction of scoliosis which involves segmental instrumentation with pedicle screws. Pedicle screw proponents cite greater curve control in all planes, which results in improved spinal curve correction. Some surgeons have noted due to the increased strength of the all screw construction that the rod is now the weak part of the spinal fixation. Although no evidence has been raised in regards to hardware failure there is a perception that a loss of balance in the sagittal plane is the result of flex in the titanium rod. A novel solution to the issue of rod flexibility is raised with the expedium super steel instrumentation which allows for greater stiffness than a 5.5 mm titanium rod with the same lower profile. This study aims to compare the new super steel technology with other established instrumentations used to correct spinal stenosis.

screw purchase was to be recorded but study has been withdrawn.

Eligibility Criteria:
Inclusion Criteria:

* aged 10-20;
* presenting with a progressive lenke type 1A, N; or
* type idiopathic adolescent scoliosis measuring greater than 45 degree cobb angle

Exclusion Criteria:

* rigid scoliosis requiring a three column release or osteotomy;
* patients that can not have pedicle screw instrumentation due to technical concerns
Screening Expiratory Flow Limitation by Flow-time Curve

Expiratory flow limitation (EFL) is defined as a dynamic condition that expiratory flow cannot be further increased with higher expiratory driving pressure. Under mechanical ventilation, it can cause intrinsic positive end-expiratory pressure (PEEP) and dynamic hyperinflation, and be associated with worse clinical outcome. The detection of EFL however needs special maneuvers and offline analysis of flow-volume curves, which are infeasible in routine practice and cannot be used during real-time monitoring. The investigators propose a new and simple approach using flow derived parameters to detect EFL in real time without needing any intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years, intubated or tracheostomized
2. Receiving invasive mechanical ventilation in assist/control mode with PEEP ≥ 5 cmH2O
3. Receiving continuous intravenous sedation
4. Displaying a monotonous regular breathing pattern with no obvious asynchrony

Exclusion Criteria:

1. Severe hypoxemia in baseline clinical ventilator settings (SpO2 \< 90%)
2. Hemodynamic instability (mABP \<60 mmHg, systolic arterial pressure \>180 mmHg, heart rate \<40/min or \>150/min)
Biomarker in Tissue Samples From Patients With Ewing Sarcoma

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in tissue samples from patients with Ewing sarcoma.

OBJECTIVES:

* To determine the frequency of INI-1 protein loss in Ewing Sarcoma.

OUTLINE: Previously collected tissue samples are analyzed for INI-1 protein loss by IHC and tissue microarray.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of Ewing sarcoma
* Prepared tissue microarray with Ewing sarcoma samples available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Neuropsychological Profiles of Pediatric Obsessive Compulsive Disorder (OCD)

The neuropsychological profiles of children treated with standard CBT for OCD are evaluated.

The neuropsychological profiles of children treated with standard CBT for the treatment of OCD will be compared at pre-treatment and post-treatment. Children between the ages of 8 and 16 years who have a primary diagnosis of OCD will be participants. Treatment will last 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Children 8-16 years old who have a primary diagnosis of Obsessive Compulsive Disorder

Exclusion Criteria:

* Risk of suicidal or homicidal behavior
* Presence of another psychological disorder as the primary disorder
* Psychotic disorder, bipolar disorder, Pervasive Developmental Disorder, Thought Disorder, Uncontrolled ADHD, Eating Disorder, Substance Use Disorders, School refusal behavior characterized by missing more than 25% of days in most recent term, does not speak English, youth does not have at least one parent who speaks English
Effect of Neuromuscular Electrical Stimulation of Lower Limbs on Improving Exercise Self-Efficacy, Dyspnea During Activity and Fatigue in Patients with Chronic Obstructive Pulmonary Disease

Patients diagnosed with COPD who meet the inclusion and exclusion criteria, either inpatients or outpatients, will be informed about the study'sstudy's purpose and procedures by the principal investigator. After understanding their rights, they will provide informed consent.

The process of the experiment The study adopts a quasi-experimental design with convenience sampling. Data collection will be done through structured questionnaires. Patients who meet the inclusion criteria will be referred by physicians, and before enrollment, a verbal introduction will be given explaining the study's purpose, the questionnaire, and the intervention procedure and duration. The experimental group will participate in both pulmonary rehabilitation exercises and an additional intervention of lower limb neuromuscular electrical stimulation, 30 minutes per session, three times per week, for eight weeks. The control group will only participate in pulmonary rehabilitation exercises. Neuromuscular electrical stimulation should continue for 4 to 8 weeks. Questionnaires will be administered before the intervention and at the 2nd, 4th, 6th, and 8th weeks post-intervention, including basic information, Modified Medical Research Council Dyspnea Scale, Manchester COPD Fatigue Scale, and Self-Efficacy for Exercise Scale. Data collection will take approximately 25 minutes, and questionnaires will be personally retrieved by the researcher.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with COPD as per pulmonary function reports, with post-bronchodilator FEV1/FVC ratio \< 0.7, confirmed as mild to severe COPD by physician, without acute exacerbation, aged 18 or above, enrolled in a pulmonary rehabilitation program, able to communicate clearly in Mandarin or Taiwanese, and without history of a psychiatric disorders.

Exclusion Criteria:

* Patients unable to comply with long-term follow-up for lower limb neuromuscular electrical stimulation intervention, those with cardiac pacemakers, lower limb bone, joint, or neuromuscular diseases, obesity (BMI \>35 kg/m2), or systemic vascular diseases (e.g., lupus erythematosus).