cyrilzakka/clinical-trials huggingface dataset:
HEPA, PM2.5, and Cardiometabolic Health

The goal of this randomized, double-blind, crossover trial is to test the hypothesis that a longer-term indoor HEPA filtration intervention can improve cardiometabolic profiles by reducing indoor PM2.5 exposures in at-risk individuals.

This randomized, double-blind, crossover trial will recruit 52 non-diabetic adults and will investigate potential benefits of HEPA air purifiers on improving cardiometabolic profiles. Participants will be contacted and recruited to the study based on inclusion and exclusion criteria. After consenting, participants will be block randomized to HEPA and control groups for 6-month interventions by sex. After 6-month wash-out period, participants will be switched to the other arm of the intervention. During the trial, project specialists will complete a series of home visits before and after each intervention session to set up air purifiers and indoor and outdoor air pollution monitors, as well as conduct interview to collect questionnaire data, measure body weight and blood pressure, and collect biospecimen. In aim 1, the researcher will assess the effect of a 6-month residential HEPA intervention on changes of type 2 diabetes-related metabolic outcomes in 52 adults. In aim 2, the researchers will examine the association between reduction in indoor PM2.5 exposure brought by the intervention and changes in metabolic outcomes adjusting for ambient PM2.5 exposure. In aim 3, the researchers will explore major pathophysiologic changes pertinent to the cardio-metabolic profile of type 2 diabetes relevance in response to the intervention and changes in PM2.5 exposure.

Eligibility Criteria:
Inclusion Criteria:

* Age between 65 and 84 years old;
* Nonsmoker for at least 1 year;
* History of BMI ≥ 25 kg/m2 in the past based on EMR information;
* Either an English or Spanish speaker;
* Live in the Los Angeles County.

Exclusion Criteria:

* History of diabetes (both type 1 and type 2) or degenerative disease of the nervous system (Alzheimer's disease or dementia);
* Currently have active cancer treatment;
* The residential house has already had HEPA filters;
* Participants will move out of the current house in the next 2 years;
* Participants will spend more than one month living outside the primary home;
* Have any health conditions that prohibit collecting health and covariate data and biospecimen;
* The residential houses are not feasible for setting up air purifiers and air pollutants monitors;
* Have high blood glucose from finger stick test (\> 200 mg/dL).
Reversibility of Diastolic Disfunction in Septic Shock

Objectives: To study the prognostic value of the evolution of diastolic function according to fluid balance in patients admitted to the ICU with a diagnosis of septic shock, in terms of mortality (ICU and hospital) and mortality at 90 days.

2.4. Secondary objectives: A) Incidence and reversibility of myocardial dysfunction (left ventricular systolic and diastolic) in septic shock.

B) Incidence and reversibility of diastolic dysfunction according to the echocardiographic criterion used.

C) Incidence and reversibility of right ventricular systolic dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the ICU with diagnosis of septic shock, and stay longer than 48h

Exclusion Criteria:

* No echocardiographic window
* Fatal prognosis with do not resuscitate orders at admission
* Previous history of Ischemic cardiomyopathy
* Valvular prosthesis
* Advanced degree of valvular disorder
* Advanced degree of pericardial effusion
Recurrent Carotid Stenosis

To determine whether recurrent stenosis following carotid endarterectomy could be reduced by pre- and post-operative oral administration of platelet-inhibiting drugs.

BACKGROUND:

Following endarterectomy, platelets adhere and aggregate on the endarterectomized surface and release platelet-derived growth factor which induces smooth muscle cell migration and proliferation which may result in restenosis. Many patients had been treated with aspirin and dipyridamole, but not in a controlled trial. The Recurrent Carotid Stenosis Study established whether antiplatelet therapy was beneficial in the prevention of recurrent carotid artery stenosis.

DESIGN NARRATIVE:

Randomized, double-blind. Eighty-three patients (90 endarterectomies) were randomly assigned to receive 325 mg of oral aspirin plus 75 mg of dipyridamole, beginning 12 hours pre-operatively, followed by a second dose administered within eight hours after the operation, and given three times daily thereafter for one year. Eighty patients (85 endarterectomies) received placebo. After the adequacy of the surgical procedure was confirmed by intraoperative angiography, restenosis at the endarterectomy sites was evaluated using serial duplex ultrasound before hospital discharge and at three-month intervals postoperatively for one year.

Eligibility Criteria:
Men and women who had recently undergone carotid endarterectomy.
Resting State Electroencephalogram for Psychotic Disorders

Electroencephalography (EEG) has been proposed as a neurophysiological biomarker to delineate psychotic disorders. Meanwhile, the increased appetite, which might related to self-control process, has been an increasing concern for the management of psychotic disorders. In this cross-section study, investigators collect the resting state EEG data, self-control related scale, eating behaviour questionnaire and psychotic syndrome related assessement and try to find the connection between those measurers, in order to provide novel understanding on the mechanism of psychotic diseases.


Eligibility Criteria:
Inclusion Criteria:

Diagnosed with schizophrenia or bipolar disorder or MDD in accordance with DMS-5 Informed Consent

Exclusion Criteria:

Diagnosed with other mental disease in accordance with DSM-5 Comorbid with other severe physiological disease Drug or alcohol abuse Pregnant or lactating
Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)

This is a phase 1b, open-Label study of sorafenib with BIIB022 in subjects with advanced hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Histologically-confirmed advanced HCC with at least 1 target lesion measurable by modified RECIST.
* Child-Pugh score A5 or A6.
* ECOG Performance Status of ≤2.

Exclusion Criteria:

* Known central nervous system or brain metastases.
* Prior anti-IGF-1R therapy.
* Prior systemic therapy for advanced HCC. Prior local therapies are only permitted if subjects have documented disease progression according to modified RECIST.
* Concurrent anticancer therapy.
* History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure.
* Acute hepatitis
* Fibrolamellar HCC

Other protocol-defined inclusion/exclusion criteria may apply
Yoga and Pilates Based Respiratory Training Effect for Individuals with Urinary Incontinence

The aim of the study is to examine and compare the effects of yoga-based and pilates-based respiratory training on incontinence severity, pelvic floor muscle function and quality of life in the rehabilitation of individuals with urinary incontinence.

In the literature, it has been stated that the pelvic floor alone does not play a singular role in maintaining continence, but rather forms a functional unit with the diaphragm, abdominal, and spinal muscles. Since the inability of any of these structures to perform their function properly negatively affects the function of the others, normalization and optimal functioning of the pelvic floor-thoracic diaphragm relationship are crucial in individuals with urinary incontinence. This study aims to investigate the effectiveness of yoga and Pilates approaches, considering breath as a fundamental building block, through respiration-based training programs in women with urinary incontinence.

The participants who volunteered to take part in the study will be randomly divided into two groups, namely the Yoga-based Respiration Group (Group 1) and the Pilates-based Respiration Group (Group 2), using a computer-assisted randomization program. After the groups are assigned, the initial three sessions for both groups will be conducted face-to-face under the guidance of a physiotherapist to ensure the correct execution of the exercises. The exercise program for both groups will consist of approximately 20-minute sessions, with two sessions per day, five days a week, for a total of six weeks. On the days when face-to-face sessions are held, one session will be conducted in-person, while the other session will be performed at home. During the 3rd and 5th weeks, the exercises will be progressively intensified for both groups to ensure progression, and patients will be called for face-to-face sessions. At the end of the six weeks, patients will undergo face-to-face evaluations once again.

Eligibility Criteria:
Inclusion Criteria:

* Having the diagnosis of stress or mixed urinary incontinence.
* Being volunteer to participate in the study.
* Having planned routine treatment program and being compliant with treatment
* Having no obstacles for the planned assessments.
* People who capable of written, verbal and visual communication

Exclusion Criteria:

* Having received treatment for urinary incontinence in the last 3 months.
* Using medication for vaginal or urinary tract infections.
* Pregnancy.
* Being within the first 3 years postpartum.
* Presence of concurrent pulmonary, neurological, rheumatological, or musculoskeletal disorders affecting spinal alignment.
* History of surgery that may impede the exercise planned within the scope of the study.
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up

The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive days as field treatment


Eligibility Criteria:
Inclusion Criteria:

* Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on the full balding scalp (the balding part of the scalp should be greater than 25 cm2 (4 in2) and up to approximately 250 cm2 (40 In2)
* Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking area of 50 cm2 (8 In2). The tracking area must be within the treatment area

Exclusion Criteria:

* Location of the treatment area (balding scalp) within 5 cm of an incompletely healed wound or within 5 cm of a suspected BCC or SCC
* Treatment with ingenol mebutate gel in the treatment area within the last 12 months
* Lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions)
* History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g. eczema, unstable psoriasis, xeroderma pigmentosum)
Effect of Exercise in OI

The main limitation patients with orthostatic intolerance (OI, or postural tachycardia syndrome, POTS) have to exercise is related to their increase in heart rate when standing. Main pharmacological treatment today is aimed at reducing heart rate with the use of betablockers (propanolol), this theoretically could also improve their exercise capacity; if their heart rate do not increase as much with the medication, they could exercise more. In addition, it has been suggested that in healthy volunteers subjected to head down tilt for 2 weeks (situation that produces a "simulated" transient POTS-like state) a single bout of intense exercise can improve orthostatic tolerance the day after exercising. The mechanisms involved in such response are not that clear but could be an increase in plasma volume already diminished in POTS patients. It seems likely that the same could be true for POTS patients.

The purpose of the present study are to pharmacologically improve the amount of exercise POTS patients can perform by reducing their baseline heart rate (specific aim 1) and to evaluate next day heart responses to an acute bout of intense exercise.

Therefore, the specific aims of this study are:

1. To test the hypothesis that lowering heart rate response with propanolol will result in an increase in exercise capacity.
2. To test the hypothesis that a single bout of exercise will result in an improvement in orthostatic tolerance the day after exercising.

* Subjects will be studied twice, once after receiving placebo and in a second occasion after receiving propanolol.
* An exercise capacity test with estimation of maximal oxygen consumption (VO2 max) will be done within 1 hour of receiving a pill containing placebo and that will be in appearance identical to the one for propanolol. This test will be conducted on a stationary bicycle and the effort will be gradually increased while expired air is measured during exhaustive physical work. The test will last approximately 30 minutes and be conducted in Vanderbilt's Clinical Trial Center.
* The day before and the day after the exercise test subjects will be asked to collect urine for 12 hours each time and to keep a record of how much liquid they ingest.
* Posture study tests (measurements of heart rate and blood pressure taken while lying down and at intervals for up to 30 minutes while standing) will be done the day before and the day after the exercise test.

Eligibility Criteria:
Inclusion Criteria:

* Meet diagnostic criteria of POTS (Raj, et al., 2005)
* Age between 18-65 years
* Male and female are eligible (although the majority of patients POTS are female).
* Able and willing to provide informed consent

Exclusion Criteria:

* Presence of medical conditions that can explain postural tachycardia (e.g., dehydration, medications)
* Pregnancy
* Other factors which in the investigator's opinion would prevent the subject from completing the protocol.
* Patients who are bedridden or chair-ridden.
Study on Neurofeedback and Relaxation

This longitudinal study deals with the characterization of the electrophysiological and behavioral effects of alpha-based neurofeedback training on the brain networks involved in the relaxation process of healthy people.

Despite a growing number of studies dedicated to neurofeedback, the underlying cerebral mechanisms (plasticity phenomena underlying neurofeedback training or learning) are very poorly known. In most of the work on stress and anxiety reduction, the neural parameters on which neurofeedback is performed are low frequency waves like alpha waves. But the effects that an alpha-based neurofeedback has on these waves and more generally on the oscillatory behaviour of the networks involved after the neurofeedback sessions, are very little studied.

Thus, the NEURORELAX study aims to clarify the effects on neurofeedback training at the (electro)physiological level (changes in brain responses in terms of frequency of oscillations, power and location of the cerebral sources of these activities) and/or behavioural level (relaxation and reduced susceptibility to anxiety). It will use the Melomind neurofeedback device as built by myBrain Technologies company, which will make it additionally possible to assess feasibility of neurofeedback training with this reduced mobile device comprising of 2 dry electrodes. For these purposes, the investigators will propose a series of auditory neurofeedback training sessions to the participants, accompanied by electrophysiological (EEG) and clinical measures. The level of relaxation of the subjects will be characterized by self-reported questionnaires and by electrophysiological signal measurement.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary adult subjects, aged 18 to 60
* No known neurological history
* Having an anxiety level higher than 35 on the STAI-YA scale
* Insured under the French social security system
* Signature of the informed consent
* Absence of visual, hearing, sensory or motor deficits incompatible with participation in the study

Exclusion Criteria:

* recreational use of psychotropic drugs
* ongoing anxiolytic / benzodiazepine treatment
* current depressive episode and/or generalized anxiety troubles
* person under guardianship, curatorship or safeguarding of justice or any other measure
* administrative or judicial deprivation of rights or liberty
* pregnant or breastfeeding
* unable to give consent
* person subject to a period of exclusion from further research
Smoking Relapse-Prevention Intervention for Cancer Patients

The purpose of this study is to test different ways to help cancer patients maintain their smoking abstinence. Participants may receive educational materials as part of the study.

This study involves participation at four distinct time points over a one-year period.

* Baseline assessment
* 2-month follow-up telephone call
* 6-month follow-up telephone call
* 12-month follow-up telephone call

Eligibility Criteria:
Inclusion Criteria:

* Have smoked at least 10 cigarettes per day for at least one year prior to cancer diagnosis
* Able to read and write English
* Able to give informed consent
* Have quit smoking after receiving their cancer diagnosis
* Have not quit greater than 3 months prior

Exclusion Criteria:

* Individuals who have been abstinent for greater than 3 months are not included because they are less likely to relapse. A quit will be defined as self-reported no smoking for 24 hours. Individuals with metastatic disease will be excluded because participation in the study might be burdensome.
Comparison Study of Drugs for Symptom Control and Complication Prevention of Atrial Fibrillation (AF) (Code-AF Trial)

This study is prospective Cohort study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is all patients with atrial fibrillation who visit hospital. The purpose is to analyze complication, composite outcome (all cause mortality, hospitalization, the incidence of stroke, heart failure and cardiovascular event (MACE)) according to the 1) the use of anti-arrhythmic drugs (AADs), 2) use of medication for rate control (beta blocker, calcium channel blocker and digoxin) and 3) use of anticoagulation agents (warfarin, coumadin, an NOAC)


Eligibility Criteria:
Inclusion Criteria:

* patients with atrial fibrillation
* patients with age more than 19
* patients who agree with study inclusion

Exclusion Criteria:

* patients who do not agree with study inclusion
* patients with age less than 19
* Pregnancy, Breastfeeding
Safety and Immunological Effect of Pembrolizumab in Resectable or Borderline Resectable Pancreatic Cancer

The purpose of this clinical trial is to study an experimental drug called pembrolizumab or MK-3475 for use in combination with chemotherapy and radiation therapy for patients with resectable (surgical removal) or borderline resectable pancreatic cancer. In general, pancreatic cancer that cannot be removed by surgery is sometimes treated with chemotherapy and radiation therapy, called neoadjuvant treatment, to shrink the tumor so that surgery might be possible. However, this is not always effective at shrinking the tumor enough to allow it to be removed with surgery. Recent discoveries suggest that the investigators own immune system might have a role in controlling the growth of tumors. Drugs such as pembrolizumab can stimulate the immune system against cancer. The purpose of this study is to investigate whether pembrolizumab can be used safely during neoadjuvant treatment and can improve the body's immune response against pancreatic cancer.

Pembrolizumab has been approved for treatment of patients with melanoma but has not been proven to be safe or helpful in patients with pancreatic cancer and is not approved by the U.S. Food and Drug Administration (FDA) for this purpose.


Eligibility Criteria:
Inclusion Criteria:

1. Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.
2. Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
3. Adequate organ function
4. In subjects requiring biliary decompression, metal stent or drainage using percutaneous transhepatic cholangiogram (PTC) are allowed

Exclusion Criteria:

1. Immunodeficiency or taking steroid or any other form of immunosuppressive therapy
2. Has a plastic biliary stent for decompression
3. Metastatic disease
4. Prior treatment for pancreatic cancer (other than 4-8 cycles of Folfirinox) or prior treatment with radiation for other diagnoses to the expected pancreatic cancer treatment area
5. Active autoimmune disease
6. Pregnancy or Nursing
7. Known history of Human Immunodeficiency Virus (HIV) or Hepatitis B or C
8. Prior monoclonal antibody within 4 weeks prior to study Day 1
9. Known additional malignancy that is progressing or requires active treatment
10. Evidence of interstitial lung disease or active, non-infectious pneumonitis
11. Active infection requiring systemic therapy
12. Prior therapy with an anti-Program Death (PD-1) antibody, anti-PD-L1, anti-PD-L2, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody
Infusion of a Local Anaesthetic in the Surgical After Modified Radical Mastectomy With Expander

Background: The use of local anesthetics as a supplement to conventional techniques in breast surgery is widely reported in the literature. Currently there is controversy regarding the efficacy of surgery for breast infusion of local anesthetic after surgery. The aim of this study demonstrate the efficacy of administering a local anesthetic into the surgical bed of women operated radical mastectomy for breast cancer for the control of postoperative pain.

Material and methods: double-blind randomized clinical trial. The investigators recruited patients who underwent modified radical mastectomy that met inclusion and exclusion criteria. The intervention group were infused with L-bupivacaine 0.50% 2 ml/h for 48 hours, and saline control group at 2 ml/h during surgery and anesthetic technique 48 hours. Local anesthetic and rescue medication was identical in both groups.

Statistical analysis: The baseline patient characteristics of the patients were analyzed by Chi square or Student t always meet criteria of normality, otherwise it will use the Mann-Whitney. To determine the effectiveness of treatment as well as pain scale adverse events will be held on chi-square test.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with operable breast cancer, which will be submitted to modified radical mastectomy
* Sign informed consent.

Exclusion Criteria:

1. Mastectomy without lymphadenectomy
2. Over 80 years
3. Cognitive impairment and patients with serious psychiatric disorders before diagnosis of the cancer process
4. Severe liver or kidney disease
5. Patients allergic or intolerant to any of the drugs used in the study protocol.
6. Regular users of analgesics or narcotics