cyrilzakka/clinical-trials huggingface dataset:
Assessment of Cardiac Autonomic Behavior in Patients With Mood Disorders

The purpose of this study is to characterize the behavior of cardiac patients with Mood Disorders and its clinical course, interpreting the results from a theoretical framework of Chaos Theory and Complexity Theory and Systems as well.

Mood disorders are strongly associated with changes in cardiovascular function and alterations in Hear Rate Variability (HRV). Fluctuation in heart rate occurs over a wide frequency and demonstrates a broad, irregular variability that suggests that the mechanisms involved in cardiovascular regulation interact in a nonlinear manner. Over the past decade, there has been an increasing emphasis on applying nonlinear methods of analysis to characterize cardiac function, but the studies on the pathophysiology of mood disorders in general still remain under a linear and reductionist perspective. The scarcity of both Brazilian and international studies on the autonomic behavior in mood disorders in general and not only in Major Depressive Disorder, as well as the use of a non-linear reading of the results of this study makes an additional tool of analysis.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Bipolar Disorder (BD) or Major Depressive Disorder(MDD)

Exclusion Criteria:

* Another with criteria for Axis I or II disorders aside from the primary diagnosis of BD or MDD.
* Past history of stroke, heart attack, or cardiac disease.
* Drug abuse or dependence in the past six months.
* Diabetes.
* In use of Tricyclic Antidepressants
Concordance Between 2 Means of Temperature Measure in Neutropenic Patients Hospitalized in Intensive Hematology Care Units

Connected medicine "2.0" is a major challenge that will lead in the near future to profound changes in medical practices. Our study is part of this technological transformation, which is already taking the form of multiple devices available to practitioners: connected pill dispensers, integrated monitoring and surveillance systems (telemedicine), connected sensors, etc.

However, a symptom as crucial and simple as body temperature has not been measured by real-time enteric capsule in a context of neutropenia. We therefore wish to study the concordance between the peripheral (tympanic) temperature and that measured by a capsule ingested in a cohort of patients hospitalized in the USIH. If the measurements are clinically reliable and truly allow anticipation of antimicrobial treatments, a medico-economic evaluation will be proposed between the two options in the context of USIH before its possible generalization.


Eligibility Criteria:
Inclusion Criteria:

* Major patient admitted to USIH for an aplasia episode of at least 7 days secondary to:
* autograft conditioned by melphalan (MLP) or BEAM (BICNU, Etoposide, Aracytine, Melphalan) chemotherapy
* Aracytin chemotherapy High dose (HD) or intermediate dose (DI)
* Signed informed consent;
* Affiliated or beneficiary of a social protection scheme.

Exclusion Criteria:

* Diarrhea (\> 3 stools /day) at the time of inclusion
* Occlusive syndrome at the time of inclusion or patient at risk of developing occlusive syndrome
* Persons with or likely to have intestinal disorders that may lead to obstruction of the digestive tract, including diverticulitis
* People with digestive tract motility disorders
* Persons equipped with a pacemaker or an electro-medical implant
* Weight \< 40 kg or BMI \> 30
* Patient for whom an MRI examination may be indicated during the trial period
* Patient with proven swallowing disorders
* Refusal to participate in the study
* Induction of acute leukaemia or allograft
* Person under guardianship or curatorship, or deprived of liberty by a judicial or administrative decision
* Pregnant, parturient or breastfeeding women;
* Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographical problem, etc.)
* Patient who has already been included in the TEMPET trial during treatment
Effect of Amlodipine Versus Bisoprolol on Hypertensive Patients With End-stage Renal Disease on Maintenance Hemodialysis.

Hypertension is highly prevalent in hemodialysis (HD) patients and leads to increased morbidity and mortality due to cardiovascular disease(CVD). Left ventricular hypertrophy (LVH) is both a manifestation of hypertension caused end-organ damage and an independent risk factor for CVD. Evidence shows that Beta-blockers, especially of low dialyzability decrease risk of CVD and mortality. Calcium channel blockers (CCBs) were also shown to effectively control BP in the volume expanded state and reduce cardiovascular disease risk. Asymmetric dimethyl arginine (ADMA) is a uremic toxin that decreases NO synthesis and is correlated to LVH, carotid intimal thickness (CIT), CVD, and mortality. Amlodipine is shown in one study to significantly reduce ADMA level in HD patients. The purpose of this study is to determine the effect of calcium channel blocker Amlodipine compared to Beta-blocker Bisoprolol on regression of LVH, reduction of ADMA plasma level and on BP control among hypertensive patients on HD.


Eligibility Criteria:
Inclusion Criteria:

* On maintenance hemodialysis 3 times weekly for at least 3 months.
* Hypertensive as determined by predialytic BP \> 140/ 90, post-dialytic \> 130/80, home-measured BP \>140/90, Office based BP \>140/90 and/or on antihypertensive medication.

Exclusion Criteria:

* History of malignancy.
* History of significant valvular heart disease.
* Chronic congestive heart failure.
* History of coronary artery disease.
* Ongoing atrial fibrillation.
* Known drug abuse.
* Known contraindication to Bisoprolol or Amlodipine.
* History of MI
* History of Stroke
Urine Exosomes to Identify Biomarkers for LN

Urine exosomes will be extracted from patients with lupus nephritis, healthy controls, and patients with systemic lupus erythematosus without lupus nephritis. Transcriptome and/or metabonomics sequencing of exosomes will be performed to screen for molecules in the urine exosomes of patients with lupus nephritis that are significantly different from those of the other groups.

Lupus nephritis is one of the most common complications of SLE, and its severity is closely related to the prognosis of SLE. The gold standard for diagnosing lupus nephritis depends on the pathological results of a kidney biopsy, which is invasive and may cause some damage to the patient. Exosomes exist in almost all types of body fluids such as serum, urine and cerebrospinal fluid, and contain a variety of genetic materials and proteins secreted by cells, such as miRNA, lnRNA, cirRNA and metabolites, etc., which are potential substances that can be used as biomarkers of diseases discovered in recent years. Urine exosomes are easy to obtain and have no impact on patients' health, making them suitable for study as disease biomarkers for lupus nephritis.

In this study, urine exosomes will be extracted from patients with lupus nephritis, healthy controls, and patients with systemic lupus erythematosus without lupus nephritis. Transcriptome and/or metabonomics sequencing of exosomes will be performed to screen for molecules in the urine exosomes of patients with lupus nephritis that are significantly different from those of the other groups.

Eligibility Criteria:
Inclusion Criteria:

* No history of chronic or serious diseases such as cardiovascular disease, liver disease, kidney disease, respiratory disease, blood disease, lymphatic disease, endocrine disease, immune disease, mental disease, neuromuscular disease, gastrointestinal system disease, etc.
* General health condition is good;
* Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemical examination, coagulation function examination), electrocardiogram, and the results show normal or abnormal without clinical significance

Exclusion Criteria:

* Other rheumatic immune disease;
* Abnormal liver and kidney function;
* Acute and chronic infectious diseases.
Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia

The primary objective of this study is to evaluate the utility of \[18F\]-DOPA PET to provide improved presurgical planning and distinguish between focal and diffuse forms of HI. The investigators will perform descriptive analysis, relying on visual analysis to diagnose and localize a focal lesion. Our findings will be compared to surgical histopathology to determine sensitivity and specificity or this technique. The investigators will also track patient surgical outcomes, specifically whether the patient is surgically "cured" or still requires medical management to control residual hypoglycemia.

Hyperinsulinemic hypoglycemia is caused by low glucose due to excessive insulin secretion and remains difficult to treat because of the requirement for extensive amounts of glucose and the lack of effective long-term medical therapy. Correct diagnosis, localization, and limited excision of the focal lesion will result in a complete cure of the patient. In contrast, medically unresponsive diffuse disease requires a near total pancreatectomy, greatly increasing the risk of future diabetes mellitus. Fortunately, \[18F\]-DOPA PET has been shown to be a useful noninvasive imaging method for distinguishing between focal and diffuse forms of hyperinsulinemic hypoglycemia. In this study, the investigators seek to validate the effectiveness of using PET/MR and PET/CT with F-DOPA to accurately and reliably detect and localize disease.

Eligibility Criteria:
Inclusion Criteria:

* All Patients clinically diagnosed with Hyperinsulinemia of any age
* Patients in need of PET scan
* Patients that require sedation
* Patients that do not require sedation

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

* Patients without Hyperinsulinemia
* Patients who are or may be pregnant
* Serious intercurrent medical illness other than hypoglycemia that precludes having the scan either because of patient instability or concerns about potential toxicity.
* Patient's requiring emergency surgical intervention that would be inappropriately delayed by \[18F\]-DOPA PET imaging.
Safety and Efficacy of Single Administration of Oshadi Oral Insulin in Type I Diabetes Patients

The study will be a non-randomized, open label, single dose, single blind, placebo control, single center, single arm study in Type I diabetes patients. The study will include single dose administration for the evaluation of single dose acute toxicity, pharmacokinetics and activity.


Eligibility Criteria:
Inclusion Criteria:

* Stable type I diabetes mellitus.
* Male/female 18 years old and up.
* Glucose level is treated only by s.c basal/bolus insulin injection (not by insulin pump) at least 48 hours prior to study initiation.
* Patients must understand and be willing to give written informed consent prior to any study procedures or evaluations and be willing to adhere to all study schedules and requirements.
* Patients must be sterile or infertile or use an approved method of contraception from the time that the first dose of study medication is taken until three months following study completion or discontinuation.

Exclusion Criteria:

* Any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results.
* Patients with positive HIV serology or positive HBsAg at screening.
* History or evidence of any active liver disease.
* C-peptide \> 3 mg/ml (fasting).
* Hba1c\<10.
* eGFR\>60.
* Female patients who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
* Inability to give written informed consent.
* History of alcohol or drug abuse within 6 months of screening.
* Patients who have a positive urine drug screen for substances of abuse (benzodiazepine, THC, opiates, amphetamines, cocaine) at the screening.
* Mental disorders.
* Patients with poor venous access.
* Significant swallowing disorders.
* Digestive disorders.
* Small bowel surgery.
* Mall absorption disorders.
Assessing the Impact of Tixel Treatment of Periorbital Wrinkles on Dry Eye Symptoms and Signs

Pilot study where effect of standard Tixel treatment as used for periorbital wrinkles would be assessed on Dry Eye Disease symptoms and signs

Safety Assessment will be asses via AE/SAE reporting and Impact Assessment of the effect of treatment on dry eye symptoms and signs through multiple test indicate Dry Eye

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Mild to Moderate Periorbital wrinkles
* OSDI score of at least 23
* Noninvasive Tear film break up time (NIKBUT) ≤ 10 seconds
* No other eye or skin or immune problems
* Willing and able to provide written informed consent.
* Willing to participate in all study activities and instructions.

Exclusion Criteria:

* Pregnancy and/or breastfeeding
* Lesions in the periorbital area
* Acute severe blepharitis
* Acute conjunctivitis
* Other concomitant anterior eye disease
* Has undergone outdoors/sunbed tanning during the last 4 weeks
* Is unwilling to follow the Tixel aftercare instructions after each of the three Tixel treatments.
* Active Herpes Simplex or tendency for Herpes Simplex in the periorbital area (meaning the subject has had the condition previously).
* Current skin cancer, malignant sites and/or advanced premalignant lesions or moles in the treatment area.
* An impaired immune system condition or use of immunosuppressive medication.
* Collagen disorders, keloid formation and/or abnormal wound healing.
* Previous invasive/ablative procedures in the areas to be treated within 3 months prior to initial treatment or plans for such treatment during the course of the Tixel2 device treatment, or before complete healing of such treatments has occurred.
* Any patient who takes or has taken any medications (including via topical application), herbal treatment (oral or topic), food supplements or vitamins, which may cause fragile skin or impaired skin healing during the last 3 months.
* Any patient who has used oral Isotretinoin (Accutane® or Roaccutan®) within 3 months prior to treatment or less.
* Any patient who has a history of bleeding coagulopathies or use of anticoagulants.
* Any patient who has tattoos or permanent makeup in the treated area.
* Any patient who has burned skin, blistered skin, irritated skin, or sensitive skin in any of the areas to be treated.
* Any patient who underwent thread lifting of the area to be treated in the last 3 months.
Study to Assess Efficacy and Safety of Zoledronic Acid and the Value of Markers of Bone Resorption in the Prediction of Bone Metastases and Cancer Treatment-induced Bone Loss (CTIBL) in Patients With Prostate Cancer on Hormone Therapy

The objective of the study is to investigate whether blood markers can be used to predict the development of bone metastases and to assess the efficacy and safety of zoledronic acid in cancer treatment induced bone loss.


Eligibility Criteria:
Inclusion Criteria:

* All stages of prostate cancer without bone metastases
* No evidence of severe osteoporosis
* ECOG performance status 0, 1 or 2

Exclusion Criteria:

* Surgery / fracture at the lumbosacral spine, bilateral hip implants
* Evidence of metabolic bone diseases,
* Treatment with bisphosphonates or calcitonin within the previous year or chronic systemic corticosteroid treatment
* Abnormal kidney or liver function
* Other cancers within the last 5 years

Other protocol-defined exclusion criteria may apply.
Vibrotactile Coordinated Reset for the Treatment of Advanced Parkinson's Disease

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on advanced stage Parkinson's symptoms. VCR will be administered with a device called the Stanford CR Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as levodopa and or deep brain stimulation. Patients will be followed for two years.

This study involves gentle vibrations delivered to the finger-tips which have been shown in pilot studies to be effective in reducing motor symptoms associated with Parkinson's Disease.

Eligibility Criteria:
Inclusion Criteria:

1. Age at the time of enrollment: 18 years of age or older
2. Idiopathic Parkinson's Symptoms between hoehn and yahr stages 2 to 4
3. Fluent in English
4. If patient is on medication that affects brain function or alters EEG activity, the patient must feel comfortable going off this medication prior to EEG recording
5. Appropriate social support if required during an off state.
6. Comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes.
7. Feels comfortable going off PD related medication during in person study visits.
8. Lives in the United States

Exclusion Criteria:

1. Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies
2. Any current drug or alcohol abuse.
3. Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
4. Pregnancy, breast-feeding or wanting to become pregnant
5. Physical limitations unrelated to PD that would affect motor ratings
6. Craniotomy
7. Brain surgery
8. Patient is unable to communicate properly with staff (i.e., severe speech problems)
9. Excessive drooling
10. A type of hair style that would impede the use of an EEG cap
11. Sensory abnormalities of the fingertips
12. Patient is taking a medication that may cause significant withdrawal effects
Percutaneous Dilatational Tracheostomy and Thyroid Isthmus Penetration

A prospective randomized interventional study will be conducted in the Military University Hospital Prague at the department of Anesthesiology and Intensive care. The incidence of thyroid isthmus penetration will be evaluated during percutaneous dilatational tracheostomy in two groups (ultrasound-guided puncture vs. standard approach using only anatomical landmarks).

A prospective randomized interventional study will be conducted in the Military University Hospital Prague at the department of Anesthesiology and Intensive care. Patients indicated by the attending physician to percutaneous dilatational tracheostomy (PDTS) due to long-term need for mechanical ventilation will be randomly divided into two groups. The standard procedure group will undergo PDTS by the attending physician in the standard manner based on clinical examination and anatomical landmarks using bronchoscopic navigation. In the second group, the attending physician will additionally use ultrasound navigation during the procedure. After insertion of the guidewire, before dilation is performed, patients in both groups will be examined by ultrasound by an independent physician - the study investigator - who will verify the position of the guidewire and its relationship to the surrounding structures. In case of malposition of the guidewire (unacceptable lateral or craniocaudal), the penetration site will be adjusted and the PDTS completed.

Eligibility Criteria:
Inclusion Criteria:

* 18 Years and older
* long-term need for mechanical ventilation

Exclusion Criteria:

* not willing to participate
An Observational Study to Evaluate the Efficacy and Safety of Avelumab + Axitinib Combination in Participants With aRCC (AVION)

The main purpose of this study is to expand knowledge on the effectiveness of Avelumab intravenous infusion in combination with Axitinib as the first-line therapy in participants with advanced renal-cell carcinoma (aRCC) in addition to the safety and tolerability under routine conditions of daily clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Participants with the Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
* Participants with a histologically confirmed diagnosis of RCC with any histological origin
* Participants with a locally advanced/metastatic disease (that is \[ie\], newly diagnosed Stage 4 RCC per American Joint Committee on Cancer) or has recurrent disease
* Participants has received 1 or 2 cycles of Avelumab plus Axitinib treatment as a first-line therapy according to the approved Summary of Product Characteristics (SmPC)
* Participants willing to sign the written informed consent form (ICF) to participate in this study

Exclusion Criteria:

* Participants with contraindications for Avelumab or Axitinib according to the approved SmPC
* Participants who have participated in any interventional clinical study of a drug or device within 28 days prior to the start of Avelumab plus Axitinib
Effect of Socket Wall Height With Vacuum Suspension for Above Knee Amputees

Individuals with transfemoral (TF) amputation (above the knee amputation) may benefit from a socket that uses vacuum assisted suspension (VAS) to hold the socket onto the amputated limb. VAS may improve stability, weight bearing, comfort, proprioception, limb health, and function. To date, there is no evidence to support whether VAS alters balance, kinematics, and kinetics when walking for TF amputees as compared to conventional socket suspension technology. Further, there is question regarding what the optimal height of the socket should be to maintain stability and function. So long as stability is not sacrificed, it may be advantageous to lower the height of the socket to allow full hip motion and improve sitting comfort. The purpose of this investigation is to assess if the socket height alters the motion of the leg and changes the way one walks when using VAS compared to conventional socket suspension technology. In this study, TF amputees will be fitted with a VAS socket that will be attached to their current prosthesis using similar alignment. Individuals will be assessed while walking on a level floor and during stair negotiation while wearing the prosthesis with the VAS socket at various socket heights as well as their current socket. Additionally, balance and socket standing and sitting comfort will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between the ages of 21 and 75 with a transfemoral amputation.
* Limited household ambulators (K1) to those considered unlimited community ambulators (K4).
* People who are comfortably fitted with a prosthesis for at least 6 months.

Exclusion Criteria:

* People with severe cardiac or pulmonary disease that limits ability to walk.
* People with too much discomfort and/or pain.
* People with active wounds on their residual limb or other foot.