cyrilzakka/clinical-trials huggingface dataset:
Fitness Training After Traumatic Brain Injury

The aim of this project is to compare the efficacy of two different fitness exercise programmes on improving fitness and psychosocial functioning in a traumatic brain injured population. We hypothesize that a supervised fitness-centre based exercise programme, compared to an unsupervised home-based exercise programme will show significant improvements in cardiorespiratory fitness, depression and community integration.

The objective of this project is to compare a three-month supervised fitness centre-based exercise programme to a 3-month unsupervised home-based exercise programme on discharge from inpatient rehabilitation on improving cardiorespiratory fitness and psychosocial functioning in a traumatic brain injured population. We plan to carry out a multi-centre, assessor blinded, randomised controlled trial with a parallel group design to compare the two interventions. We hypothesise that the supervised fitness-centre based programme will provide significantly better outcomes, and that these gains will not only be evident on completion of the programme, but will be maintained on follow-up, thereby demonstrating that investment in a supervised exercise programme can provide beneficial long-term effects.

Eligibility Criteria:
Inclusion Criteria:Patients who have sustained a traumatic brain injury who have completed their inpatient rehabilitation at either of the three Sydney Metropolitan Brain Injury Units (Liverpool, Ryde or Westmead) will be included in this study if they:

* have sustained a very severe or extremely severe traumatic brain injury
* have had a hospital admission of \> 1 month
* are able to walk independently at \> 1 m/s on discharge
* are able to commit 3 hours per week to a fitness programme
* live within the area serviced by the 3 units

Exclusion Criteria:

* have a concurrent medical condition for which moderate to high intensity exercise is contraindicated
* are still in Posttraumatic Amnesia (PTA)
* have cognitive or language problems that affect their ability to understand verbal instructions
* have behaviour problems not suitable for a fitness centre environment
Physiological and Perceptual Responses During 4-Second Exercise

The purpose of this study is to investigate the acute effects of different intensities (i.e., 50, 75, and 100% of maximal anaerobic power) of 4-s sprint interval exercise on physiological responses. Secondly, it will determine the relationship between intensity and recovery duration (i.e., 15, 30, or 45-s) that will stimulate the cardiovascular and metabolic systems.

Background Short sprint interval training (sSIT) is typically performed at maximal intensity, generating power far above what is needed to reach peak oxygen consumption (VO₂peak). However, the physiological effects of submaximal sprint intensities and different recovery periods are not well understood.

Study Aim This study examined how power output and oxygen consumption (VO₂) respond to repeated 4-second sprints at 50%, 75%, and 100% of maximal power (Pmax) with rest periods of 15, 30, or 45 seconds.

Methods Eleven recreationally active participants completed nine trials, each consisting of thirty 4-second cycling sprints under different intensity and recovery conditions.

Eligibility Criteria:
Inclusion Criteria:

* Young (18-30),
* Healthy,
* Recreationally active, but untrained (not meeting ACSM's recommendations of 150 min/week of moderate-vigorous aerobic exercise)

Exclusion Criteria:

* Cardiovascular disease
* Smoking
* Subjects who were exercising regularly (\>75 min/week) were excluded.
Study of Yoga and Mindfulness for Psychological and Physical Wellness

The study rationale is to analyze the extent to which adult U.S. or non U.S. veterans or active duty military personnel who participate in the Yoga for Men (YfM) online Yoga and meditation classes report changes in symptoms of psychological trauma, depression, anxiety, stress, sleep quality, and pain. The serial measurement of symptom status over a 12-month period will provide information on the trajectory of change in symptom status, as well as insight into the extent to which this program may be an effective modality for veterans and service members who are experiencing symptoms of psychological trauma, depression, anxiety, stress, sleep quality, and pain. The purpose of this study is to evaluate whether the existing YfM online program is helpful to study qualifying veterans with symptoms of PTSD and related conditions.

Yoga is an ancient Indian science and way of life that includes the practice of specific postures, regulated breathing, and meditation. It is designed to bring balance and health to the physical, mental, emotional, and spiritual dimensions of the individual.

A recent systematic review of 17 studies published between the years 2011-2013 reported that most studies of yoga demonstrated positive changes in psychological or physiological outcomes related to stress. In addition, the practice of yoga also seems to be associated with moderate improvements in cognitive function , which in turn, may be expected to positively impact overall psychological well-being. These selected results provide a strong rationale to examine the effects of yoga for a range of health conditions, in addition to across various setting and by use of different delivery methods.

Much of the research on mindfulness has been in the area of anxiety and depression. Evidence suggests that mindfulness-based stress reduction, an intervention that teaches individuals to attend to the present moment in a nonjudgmental, accepting manner , can result in reduced symptoms of depression and anxiety .

Eligibility Criteria:
Inclusion/Exclusion Form

ID# __________ Visit: Screening Date: ____________________

Inclusion Criteria (all must be marked "Yes" to be eligible for the study).

1. Age 18 years or older and military service member active duty or retired Yes ___ No ___
2. Access to a computer and internet service Yes ___ No ___
3. Able to read English at 8th grade level or higher. Yes ___ No ___
4. One or more symptoms endorsed on Appendix B. Yes ___ No ___

Exclusion Criteria (must be marked "No" to be eligible for the study).

1. Never served in the military. Yes ___ No ___

Is Subject eligible for participation? Yes_____ No_____
Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus Nephropathy

Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus Nephropathy Resistant to Conventional Treatments

Randomized, open, controlled, multicenter, clinical trial in patients with lupus nephritis previously treated with cyclophosphamide and mycophenolate. These patient can not have received Rituximab in the previous year. The number of patients estimated to reach statistical significance is 18 in each arm, a total sample size of 32 patients is needed.

The hypothesis is that the alternative procedure (a second cycle of Rituximab)will reduce the relapse rate of lupus nephritis and the consequent deterioration of renal function. Besides it will reduce health care expenses(hospitalization, medication, hemodialysis and renal transplantation).

Eligibility Criteria:
Inclusion Criteria:

* Both men and women between 18 and 70 years.
* Patient with active lupus nephritis, previously treated with cyclophosphamide and mycophenolate (sodium or mofetil), who have not received rituximab in the previous year.
* Women in childbearing age must have a pregnancy test in serum or urine negative and should use a contraceptive method suitable since at least 14 days prior to their inclusion in the study and up to 6 months after the last dose of the medication of the test.
* Informed consent form signed.

Exclusion Criteria:

* Patients treated with rituximab in the previous years
* Active/sepsis serious infections
* Renal biopsy showing interstitial fibrosis and/or glomerular over 75%.
* Known neoplasia
* Heart failure with III/IV functional class
* Pregnancy
* Nursing
* Known anaphylaxis to the product
* History of hepatitis c
* History of tuberculosis
* Cardiovascular disease or uncontrolled hypertension
* Chronic hepatitis B
* Serious Cytopenia (granulocytes \< 500/mm3, further \< 10000/mm3)
* Immunodeficiency (CVI, immunoglobulins deficiency)
* Infection with HIV
A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary

The purpose of this study is to perform an epidemiological survey of the adult population in Hungary to calculate the seroprevalence of pertussis.

The protocol posting was amended to correct the detailed title. Since a sample of blood will be collected from all subjects (outside of routine hospital procedure), the study does not meet GSK's definition of an observational study and hence the term "observational" was deleted from the detailed title.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol.
* Written informed consent will be obtained from subjects prior to performing any study procedures.
* Males or females ≥ 18 years of age at the time of enrollment.
* Agreeing to collection of a blood sample for the study.

Exclusion Criteria:

• Confirmed or suspected immunological disorder.
Avoidable Hospitalizations/ Emergency Department Visits- Systematic Review and Meta-synthesis of Qualitative Research

The aim of the study is to synthesize qualitative evidence related to preventable hospitalizations/ emergency department visits from the perspectives of patients, their families/caregivers, health care providers, and stakeholders, in the hope to identify generalizable conclusions about why social risk factors matter to preventable hospitalizations/ emergency department visits

The present study is a qualitative systematic review and meta-synthesis study. The study primarily focused on the qualitative studies that collected and analyzed narratives from patients who experienced preventable hospitalizations. The information from their families, health care providers, and stakeholders in the qualitative studies are also included. The data collections from patients occurred during their hospital stay, emergency department stay, or after discharge to the community are included. Patients included all ages and gender, regardless of their race/ethnicity and countries.

The qualitative studies must be published in peer-reviewed journals, with language as english and no restriction on publication date or country of origin. Two authors (HC and HL) independently screened the title and reviewed abstracts, then full texts for eligibility. Thorugh synthesizing, the present study is expected to develop themes and sub-themes related to preventable hospitalizations/emergency department visits, in the hope to assist policymakers health care professionals, and stakeholders in properly addressing the underlying factors leading to preventable hospitalizations/emergency department visits .

Eligibility Criteria:
Patients were admitted to hospitals and/ or visited the emergency department due to preventable conditions, including diabetes acute complications, diabetes chronic complications, uncontrolled diabetes, low-extremity amputation due to diabetes, COPD, heart failure, hypertension, urinary tract infection, and pneumonia. Patients' families and their health care providers are also included.

exclusion criteria: patients with dementia, mental illness, or cancer
The Percent of AKI Occurred in Patient with Comorbidities Undergoing Colonoscopy

observation the percent AKI in patient with comorbidities undergoing colonoscopy

recording the data of the patient if there are any comorbidities like DM or HTN and observation of the kidney functions before and after the colonoscopy to record the percent of the AKI in patient undergoing colonoscopy

Eligibility Criteria:
Inclusion Criteria:

* Adult patient aged \>18 years old Patient with eGFR\>30ml/min

Exclusion Criteria:

* patient with eGFR \<30ml/min patient with serum electrolytes abnormalities patient with heart diseases (uncontrolled heart failure, unstable angina, myocardial infarction, coronary intervention within the previous 3 months) patients with ascites
The Efficacy and Safety of Task-state-based Temporal Interference Stimulation (TI) in the Treatment of Patients With Depression

This study intends to investigate the intervention efficacy of temporal interference stimulation (TI) on mood symptoms in depressed patients, as well as to explore the neuroimaging mechanisms of TI improvement in depressed patients using pre- and post-treatment magnetic resonance.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-50 years old, right-handed, and completed nine years of compulsory education;
2. Met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for depression;
3. HAMD-17≥18;
4. Subject was a first-time medication-naïve patient or had previously used antidepressant medication and was currently off medication for ≥2 weeks;
5. The subject/ legal guardian is willing to actively cooperate with the treatment and sign an informed consent form after fully understanding the temporal interference stimulus (TI).

Exclusion Criteria:

1. Co-morbid other psychiatric disorders, including bipolar disorder, affective psychiatric disorders, anxiety spectrum disorders, mental retardation, substance dependence (abuse), etc.;
2. Severe suicidal ideation or behavior;
3. History of a serious physical illness or a disease that may affect the central nervous system;
4. Neurologic disorders or risk of seizures such as previous cranial disorders, head trauma, abnormal electroencephalograms, magnetic resonance evidence of structural brain abnormalities, or a family history of epilepsy;
5. Contraindications to magnetic resonance scanning or time-interference stimulation (TI), such as the presence of metallic or electronic devices in the body (intracranial metallic foreign bodies, cochlear implants, pacemakers and stents, and other metallic foreign bodies);
6. Those who have received or are receiving electroconvulsive therapy (ECT ), modified electroconvulsive therapy (MECT ), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or other neurostimulation treatments;
7. Pregnant and lactating women, and women of childbearing age with positive urine pregnancy.
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion

This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD). Additionally, this study design will evaluate the safety and efficacy of using Clinolipid in a pediatric population.


Eligibility Criteria:
Inclusion Criteria:

1. Patients and/or their legal representative must be able to understand the study and voluntarily sign the ICF
2. Patients age \<18 years
3. Patients who are able to adhere to protocol requirements
4. Patients who are expected to require PN for at least 7 days
5. Premature infants (\<36 weeks of gestation) require at least 80% PN to meet nutrition requirements at study entry; full term infants and children require at least 70% PN to meet nutrition requirements at study entry

Exclusion Criteria:

1. Patients who are not expected to survive hospitalization or with a severe illness with foreseeable intercurrent events that could jeopardize the patient's participation in the study
2. Patients with a known hypersensitivity to lipid emulsion, egg or soybean proteins, or any of the active substances, excipients, or components of the container
3. Patients with a diagnosis of shock, renal failure requiring dialysis, or severe metabolic acidosis (eg, pH \<7.10, serum bicarbonate level ≤15 mEq/L , and/or an Anion Gap \>16 mEq/L)
4. Patients with hemodynamic instability as judged by the Investigator
5. Patients with uncorrected metabolic disorders (eg, diabetes) or liver disease including cholestasis
6. Patients with severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (triglyceride \>400 mg/dL)
7. Patients who are unable to tolerate the necessary laboratory monitoring
8. Patients who have a new and active infection (as assessed by the investigator) at time of initiation of study treatment
9. Patients who are enrolled in another clinical trial involving an investigational agent
10. Patients who were treated with IV lipids within 48 hours of randomization into the study
Oscillatory Activity in Basal Ganglia Circuits During Normal and Pathological Movement

The expression of hypokinetic and hyperkinetic motor symptoms is accompanied by pathological synchronous oscillations of neuronal activity in this cortico-subcortical network with a wide frequency range.

The purpose of this research is to study cortico-subcortical oscillations and their synchronization in two pathologies emblematic of hypokinetic (Parkinson's disease) and hyperkinetic (epilepsies) phenomena using a simple motor task and comparing different situations.

In order to define the link between the characteristics of the oscillations (frequency, amplitude, phase relation) within this cortico-subcortical network and movement (normal or pathological) in humans, a simple motor task of gripping/pulling a lever has been designed.

The local field potentials (LFPs) will be collected during the same motor task in :

i) patients with Parkinson's disease, using a high-resolution electroencephalogram (EEG) and the PERCEPT(TM) system (Medtronic) equipped with a "sensing" function for deep LFP recordings and in EEG-HR (for high resolution) for cortical recordings

ii) patients with focal drug-resistant epilepsy, during a pre-surgical assessment by stereo-electro-encephalography (SEEG). The SEEG allows the recording of both the cortex and the subcortical regions in a concomitant manner, and a direct correlation can be studied.

Eligibility Criteria:
Inclusion criteria :

* Male or Female
* Between 18 and 75 years of age
* With Parkinson's disease and already operated with implantation of electrodes in the Subthalamic nucleus connected to a PERCEPT (TM) device.
* Giving free, informed, written consent signed by the participant and the investigator Or
* With drug-resistant epilepsy and benefiting from a phase II pre-surgical assessment with intracerebral electrophysiological exploration by stereo-EEG
* With at least one electrode exploring the basal ganglia or the thalamus.
* Able to perform the simple motor task
* Affiliated or beneficiary of a social security scheme;
* Giving free, informed, written consent signed by the participant and the investigator

Exclusion criteria:

* Be incapable of giving consent personally
* Be subject to a legal protection measure or be placed under judicial protection;
* Being pregnant or breastfeeding
* Present a serious and/or decompensated somatic or psychiatric illness
Characterization of Hyperpolarized Pyruvate MRI Reproducibility

The purpose of the study is to test a new approach to see if the test results can be reproduced each time the Magnetic resonance imaging (MRI) is done for an individual patient. The study will explore the use of an imaging agent called hyperpolarized \[1-13C\] pyruvate (HP) with MRI scans. (MRI) is a technique that takes pictures of the body's organs using a magnetic field and radiofrequency waves that cannot be felt. In order to accomplish the goal of the study the patient will have two hyperpolarized MRI scans to assess if scans can be reproduced. The hyperpolarized MRI scans will be compared with the pathological results of the surgery to see if the hyperpolarized MRI provides additional information regarding disease metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Patients with history of histologically-confirmed malignant solid tumor (histology confirmed by MSKCC Department of Pathology.) NOTE: An exception will be made for patients with brain lesions. Patients identified by a radiologist to have a brain lesion with high suspicion for neoplasm given MRI features will be enrolled, prior to histological confirmation.
* Disease measurable or evaluable as defined by RECIST 1.1, a mass of greater than 1cm in the long axis and/or other tumor response criteria from an MSKCC IRB-approved clinical research protocol. NOTE: Study patients do not need to be participating in an MSKCC approved clinical trial prior to study recruitment.
* Negative serum or urine pregnancy test for female patients of childbearing age and potential (as defined by MSKCC Standards \& Guidelines), from assays obtained \< 2 weeks prior to study enrollment.
* This study will include only patients with sarcoma, prostate, breast, brain, metastatic or pancreatic cancer. In the future other patient groups may be included through amendment of this protocol.

Exclusion Criteria:

* Inability or refusal to have at least one peripheral intravenous line for intravenous access (as applicable to the day of \[1-13C\] pyruvate injection)
* Breast-feeding
* Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)
* Hepatic: from assays obtained within 3-4 weeks prior to study enrollment. For each patient, the upper limit of normal (ULN) value for a particular assay will be defined by the normal reference values of the laboratory that performed the assay
* Bilirubin \> 1.5 x (ULN)
* AST/ALT \>2.5 x ULN
* Albumin \< 3 g/dl
* GGT \> 2.5 x ULN if Alkaline phosphatase \> 2.5 x ULN.
* Renal: Creatinine \>1.5 x ULN or creatinine clearance \< 60 mL/min, from assays obtained within 3-4 weeks prior to study enrollment
* Acute major illness (e.g., unstable cardiovascular condition, etc.)
* Standard MRI exclusion criteria will also be applied, including pacemakers and metal clips located in the patient.
Cognition and Health in Adolescents, Mindfulness as Prevention of Stress.

The purpose of this study is to determine whether mindfulness is useful as primary prevention for psychological health in highschool students, primarily related to stress, and whether mindfulness can improve cognitive function.

There is a general suspicion that stress and stress-related psychological disorders is growing in highschool students in Sweden. Mindfulness is a well researched therapeutical method for treating stress-related disorders. This study will first collect data on stress-related psychological symptoms by several well-validated surveys. The surveys will be made twice with 8 weeks in between to examine variability. After the second survey the population of highschool students will be randomly assigned to web-based mindfulness intervention, music relaxation intervention or control group. A third survey will be conducted after eight weeks of intervention and before and after an external stressor.

Eligibility Criteria:
Inclusion Criteria:

* High school student from designated school

Exclusion Criteria:

* None Swedish-speaking