cyrilzakka/clinical-trials huggingface dataset:
Cocoa Flavanols in Renal Disease

Purpose of the study is to characterize the potential acute and long-term improvement of dietary flavanols on vascular function in patients with end-stage renal disease (ESRD).

Patients will twice daily receive either a flavanol-poor or a flavanol-rich drink. In a double blind, placebo-controlled crossover study the safety, efficacy and acute beneficial effects of flavanol ingestion will be assessed in 10 patients with ESRD. In a 30 day long-term, double blind, placebo-controlled parallel study the chronic effects of dietary flavanols on vascular function in 52 patients with ESRD will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* end stage renal disease
* \>18 years
* chronic intermittent hemodialysis

Exclusion Criteria:

* acute Infection
* acute renal failure
* heart failure (NYHA IV)
* pregnancy
* anuria
ARCHIMEDES Compassionate Use Supplement

The purpose of this Compassionate Use Supplement to the IDE Protocol is to assure and monitor the safety of six Subjects (in the United States) implanted with ARCHIMEDES until all remaining implanted pumps are explanted.

Pain management has been a long-standing challenge to the medical community, specifically the treatment of chronic pain. On October 3, 2002, FDA approved Codman's IDE Study of Codman's Implantable Constant-Flow Infusion Pump System (ARCHIMEDES). The first Subject was implanted on February 12, 2003. Since then, ten Subjects have had the ARCHIMEDES implanted, with one Subject, implanted twice. Codman notified the FDA in 2004 that it wished to discontinue enrollment into the study \& bring it to a close because of projected slow enrollment and waning physician interest.

Codman felt there was no readily acceptable alternate therapy that would not require a pump explant first. It is possible to replace the ARCHIMEDES with another pump system, which is already approved for use in the United States. However, such an action would necessitate the removal or explant of the ARCHIMEDES, thereby exposing the Subjects to additional risks inherent in such a surgical procedure, including those associated with anesthesia. Since these Subjects have been treated with the investigational device for at least 2 years without experiencing any unanticipated adverse device effects, Codman felt that the risk of explanting the pump was significantly greater than the risk of continuing treatment with the investigational device.

It should also be noted that this pump does not have a battery and that replacement is dictated by the number of times the septum is punctured (500). This translates into approximately twenty years of therapy if the septum is punctured an average of 20 times.

FDA approved Codman's Compassionate Use Protocol in 2005.

Eligibility Criteria:
Inclusion Criteria:

* U. S. Subjects implanted with constant flow pump in 2003.

Exclusion Criteria:

* N/A
Effectiveness of Electric Stimulation Therapy in Raynaud's Phenomenon

The purpose of this study is to analyze the effects of an intervention with galvanic electrical current on the number of attacks , temperature, pain, peripheral blow flow and upper limb functionality in patients with Raynaud's Phenomenon in comparison to a control group that will maintain their habitual treatment.

Raynaud's Phenomenon is a disorder that causes pain and functional limitation in people who suffer it.

Investigators considerer that the application of an electrotherapy intervention with galvanic current, thanks to its vasodilator action, will produce clinically significant improvements in the number of attacks, temperature and blood flow of patients with Raynaud's Phenomenon, which can lead to a decrease in pain associated, frequency and severity of ischemic attacks and therefore an improvement in the functionality of the upper limbs.

The experimental group will receive an electrotherapy treatment using galvanic current. To apply the treatment, we will place the patient seated, with their hands inside two containers filled with water up to the limit of their nails without touching them. Next we will connect the electrodes and apply a galvanic current for 10 minutes, there will be a minute of rest for the patient while we change the polarity of this current and we will apply it another 10 minutes. The intensity of the current depends on the threshold of the patient.

The control group will maintain their usual conservative and pharmacological treatment without receiving electrotherapy

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years of age.
* Being diagnosed with Primary or Secondary Raynaud Phenomenon according to the criteria established by LeRoy-Medsger.
* A history of at least one year of regular attacks of pallor or acral cyanosis caused by exposure to cold and/or stress.
* Having signed the informed consent document and willingness to participate in the study

Exclusion Criteria:

* Presence of skin alterations such as stings, scars, ulcers or gangrene in the examined area.
* Suffering upper limb entrapment syndrome, central nervous system polyneuropathy, Hypothyroidism, renal failure, cerebral or cardiac ischemic disease.
* History of drug or alcohol abuse.
* Pregnant or breastfeeding women.
* Use of vibratory tools.
* Participants with tumour process.
"Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction"

The purpose of this study is to determine a preventative dose of study drug, Arixtra® for patients with kidney disease. We will measure the blood levels of Arixtra® in patients with kidney disease and develop guidelines for dosing.


Eligibility Criteria:
Inclusion Criteria:

* Inpatients who are 18 years or older
* estimated creatinine clearances between 20-50 ml/min
* current hospitalization for a cancer-related abdominal, breast surgery or elective orthopedic surgery
* able to give informed consent
* need for prophylactic anticoagulant therapy for increased risk of a thrombotic episode

Exclusion Criteria: Use of the following

* clopidogrel, aspirin, or NSAID usage,(usage is prohibited while patients are participating in the study)
* body weight \< 50 kg
* anticoagulation therapy for thrombosis or other indication
* pregnant or breast-feeding
* hypersensitivity to Arixtra®
* thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of Arixtra®
* bacterial endocarditis
* brain malignancy
* increased risk of bleeding.
Clinical Evaluation of the Vital Signs Monitoring System (VSMS)

This is an observational, cohort-based, single-site, prospective study conducted in accordance with ISO 14155-1:2003 and ISO 14155-1:2011. The primary objectives are to evaluate the accuracy of the device's measurements/readings in comparison to a gold standard or standard of care patient monitor.

This is an observational, cohort-based, single-site, prospective clinical study enrolling up to 100 patients who are hospitalized in the internal ward. There is no control group.

The primary objectives of the study are:

1. Evaluate the body temperature measured by the ear unit and validate its accuracy.
2. Evaluate the accuracy of SPO2 signals and results by comparing the readings to a gold standard device with a finger sensor.
3. Evaluate the ECG and respiration signals recorded by the patch device by comparing them to the signals recorded by a patient monitor with standard leads.

   The secondary objectives of the study are:
4. Usability - evaluate the ease of use of the device by medical staff and patients (e.g., positioning, activation, replacement of patch, understanding processes and requirements).
5. Evaluate the signals quality and the patch adherence after 5 - 7 days on the chest.

The study will assess the safety and effectiveness of the Vital Signs Monitoring System (VSMS) for its intended use/proposed indications. Data will be collected while the VSMS is adhered to each patient for the entire hospitalization period, up to 7 days. There is no follow-up required.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Age above 18 years from both genders
* American Society of Anesthesiologists (ASA) physical status classification of 1-4
* Hospitalized in internal ward

Exclusion Criteria:

* Abuse of alcohol or illicit drugs
* History of mental retardation or any mental disease
* Skin irritation / Atopic dermatitis or any other skin condition in the area of patient's upper chest that might affect his/her ability to adhere the device appropriately
Use of the VasoNova VPS System During PICC Placement in an Algorithm Confirmation Study Using Fluoroscopy

Subjects meeting study requirements will be consented and have their PICC catheter placed using navigational technology and the tip placement confirmed with radiographic imaging.


Eligibility Criteria:
Inclusion Criteria:

* Adult with a PICC placement order

Exclusion Criteria:

* Pregnant or nursing
* Abnormal ECG
* Anatomic irregularities or history that would prevent proper placement
* Subject does not consent to photography, release of data and x-ray confirmation
* Subject does not understand or is not willing to sign informed consent for the VPS implant procedure and data release
A Study To Evaluate The Safety And Efficacy Of PF-04958242 In Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)

The purpose of this study is to determine whether PF-04958242 is safe and effective in the treatment of cognitive dysfunction in schizophrenia subjects

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Key Inclusion Criteria:

* Otherwise healthy male and/or female subjects between the ages of 18 and 50 years, inclusive, with Diagnostic Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia of at least 2 years duration as confirmed by the M.I.N.I 7.0 for Psychotic Disorders
* Evidence of stable schizophrenia symptomatology \>=3 months (ie, no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms of schizophrenia).
* Subjects must be in ongoing maintenance atypical antipsychotic therapy (except clozapine), on a stable treatment regimen for \>=2 months prior to Baseline/Day 1, including concomitant psychotropic treatments. Subjects should be on no more than 2 background antipsychotics.
* Subject must have an identified informant
* Subject must reside in a stable living situation for at least 12 weeks prior to Screening.

Key Exclusion Criteria:

* Subjects with a current DSM-5 diagnosis of schizoaffective disorder in the judgment of the investigator.
* Subjects with a current DSM-5 diagnosis of major depressive episode, manic and hypomanic episode, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder on the M.I.N.I 7.0 for Psychotic Disorders or in the judgment of the investigator.
* Subjects with a lifetime DSM-5 diagnosis of antisocial personality disorder, anorexia nervosa, bulimia nervosa, binge-eating disorder on the M.I.N.I 7.0 for Psychotic Disorders or in the judgment of the investigator.
* Subjects who meet the DSM-5 diagnosis of moderate or severe psychoactive substance use disorder (excluding nicotine dependence) within 12 months of screening on the M.I.N.I 7.0 for Psychotic Disorders interview and as determined by the investigator.
* Subjects with significant extrapyramidal symptoms which have not been stabilized with anticholinergics.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Tactile Massage in Type 2 Diabetes

Tactile massage is a gentle form of massage that probably exerts its effect through relaxation. In a pilot study of 11 subjects an effect on HbA1c of 0.8%-units was seen.

The study aimed at comparing the effect of tactile massage sessions for one hour given once a week for 10 weeks in comparison with relaxation through a relaxation CD performed once a week during 10 weeks. Primary outcome was HbA1c measured after completed intervention and after yet another 12 weeks. Secondary outcomes were quality of life by SF-36, other markers of metabolism (fasting glucose, insulin resistance by HOMA-model), inflammation (CRP, cytokines) and stress (cortisone, catecholamines).

Effects of different relaxation techniques on metabolic control in type 2 diabetes have been described. A pilot study indicated an effect by tactile massage, a Swedish form of gentle massage given in sessions of around one hours and including treatment of the whole body in general, on metabolic control measured as HbA1c and on plasma corticosteroids.

The present study aimed at studying the effects in a randomized controlled study, with patients provided with a relaxation cd available at pharmacies in Sweden. Power calculations found that 20-25 subjects in each group would be sufficient to show effect on HbA1c (0.8% vs 0.3%), but that 45-50 subjects would be needed to show clinical relevant effect on quality of life.

Patients aged 35-75 years with type 2 diabetes and BMI 25-30 and HbA1c 6-8%-units (Swedish standard, corresponding to 7-9%-units in DCCT standard) from primary health care centres in Stockholm County were invited to participate, and was randomly assigned to tactile massage or relaxation groups.

Exclusion criteria was heart or renal failure, treatment with insulin, problems with Swedish language. Besides, only subjects of Swedish ethnicity were included in this first study, in order to refine results and avoid confusional results.

Examination with laboratory tests, body examination and questionnaire, including SF-36 and questions on smoking, dietary and physical activity habits, was performed before intervention, after the 10 weeks examination and after yet another 12 weeks. Urine sampling on catecholamines and corticosteroids was performed, and blood tests on HbA1c, fasting glucose, insulin, CRP, cytokines (TNF-alpha, IL-6), adiponectin, leptin, ghrelin.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* 35-75 years
* BMI 25-30, HbA1c (Swedish standard)
* Oral antidiabetic treatment

Exclusion Criteria:

* Heart failure
* Renal failure
* Insufficient knowledge in Swedish
Feasibility of Music Therapy for Spontaneous Breathing Trials

In this study, the investigators will study music therapy for patients during breathing trials, a procedure performed in intensive care units. Participants will be assigned either to standard medical care or standard medical care plus music therapy. Participants have a 50/50 chance (like flipping a coin) of being in either group. In the music therapy group, a board-certified music therapist will sing softly with guitar accompaniment to provide music during the breathing trial. The music is in addition to the usual treatment provided by hospital staff. Participants in the standard medical care group will receive the usual medical care given by hospital staff members. Information will be collected from participant's charts and by observation of vital signs during the breathing trial.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18+
* Admitted to MUSC's Main Hospital medical intensive care unit (MICU) or Ashley River Tower medical-surgical intensive care unit (MSICU)
* Intubated and will undergo a spontaneous breathing trial

Exclusion Criteria:

* Patients who have had any prior SBTs
* Patients known to have a neurological injury
* Patients who are known to be deaf
* Patients whom (or whose LAR) are unable or unwilling to give informed consent.
Comparing New Prothesis PROPRIO-FOOT® Versus Usual Prothesis Tasks Tibial Amputees

Evaluate a new porosthetic device in lower limb amputees.

Randomisation between usual and new prosthesis Cross over study of walking performance and VO2 on treadmill with the two devices after 1 month adaptation to each system.

Eligibility Criteria:
Inclusion Criteria:

* Tibial amputation
* Ability top walk on treadmill
* Stable prosthesis for at least 3 months

Exclusion Criteria:

* Bilateral amputation
* Cancer
* Absence of consent
Multiple Myeloma Outcomes Based on Maintenance Therapy Post Autologous Stem Cell Transplant

The purpose of the study is to determine outcomes for Multiple Myeloma patients on maintenance single agent vs. doublet (IMiD + PI) combination chemotherapy post Autologous Stem Cell Transplant (ASCT).

This non-interventional, cohort prospective research study will assess outcomes for Multiple Myeloma patients on maintenance single agent vs. doublet (IMiD + PI) combination chemotherapy post ASCT.

Eligibility Criteria:
Inclusion Criteria:

* All MM patients (18 years or greater) receiving autologous transplantation given as first line therapy (Melphalan at least 140 mg/m2) will be screened and enrolled in the study if they qualify and willing to participate.
* Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
* Histologically confirmed diagnosis of multiple myeloma.
* Received high dose melphalan (≥ 140 mg/m2) followed by ASCT based on the institutional guidelines and within +60 and +180 after ASCT at the time of maintenance initiation.
* Disease status must be very good partial response (VGPR), complete remission (CR), or stringent complete remission (sCR) per IMWG response criteria at time of study entry.
* Measurable disease at diagnosis per IMWG criteria serum M spike ≥ 1g/dL, or Urine M protein ≥ 200 mg/24h or involved free light chain ≥ 100 mg/L with an abnormal ratio.
* Patients must have the Clonoseq ID sample showing a trackable clone in bone marrow.

Exclusion Criteria:

* Patients who have purely non-secretory multiple myeloma (i.e., the absence of a measurable protein in serum by electrophoresis and immunofixation and the absence of Bence-Jones protein in the urine defined by use of electrophoresis and immunofixation)
* Prior evidence of disease progression
* Patients who have other malignancy associated with a high risk of progression in the next 2 years.
Six Minutes Walk Test and Shuttle Walk Test in Eisenmenger Syndrome

The purpose of this study is to verify the applicability Six minutes walk test and Shuttle walk test in assessing functional capacity in patients with Eisenmenger Syndrome. Patients will undergo three functional tests, being the six-minute walk test, shuttle walk test and cardiopulmonary exercise test on a cycle ergometer, associated with evaluation of metabolic and ventilatory variables and cardiac monitoring throughout the test.

It has seen an increasing number of individuals with congenital heart diseases mainly due to the development of new diagnostic techniques, assessment and treatment, thereby contributing to longer survival. These individuals that survive to adulthood, many sometimes develop other secondary problems to the underlying pathology, one of Pulmonary Arterial Hypertension. The Syndrome Eisenmenger is the most advanced form of pulmonary hypertension secondary to congenital heart defects. It is known that patients with pulmonary hypertension secondary congenital heart disease have marked functional limitation and high risk of death. Among the various forms of assess exercise capacity, Walk Test Six Minutes (6MWT), Shuttle walking test and Cardiopulmonary Exercise Test are among the most applicable. Little has been studied about the patients with pulmonary hypertension secondary to congenital heart disease and Eisenmenger Syndrome. The characterization of this profile of patients against the effort becomes necessary and useful in determining strategies and identification of factors that may be limited to functional capacity and quality of life. Objectives: To verify the applicability Six minutes walk test and Shuttle walk test in assessing functional capacity in patients with Eisenmenger Syndrome. Methods: Cross-sectional study with patients diagnosed with Eisenmenger Syndrome, of both sexes, without changing pace or lower limbs, who have performed echocardiography in the last 6 months and clinical stability. Patients will undergo three functional tests, being the six-minute walk test, shuttle walk test and cardiopulmonary exercise test on a cycle ergometer, associated with evaluation of metabolic and ventilatory variables and cardiac monitoring throughout the test. Also will be held assess respiratory endurance and strength, peripheral muscle strength and manual pinch, Heart rate variability, inflammatory mediators and blood lactate, besides questionnaires about quality of life, quality of sleep and daytime drowsiness.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Eisenmenger syndrome
* To understand the realization of tests
* That do ambulatory monitoring of congenital heart of Federal University of São Paulo..

Exclusion Criteria:

* Donw Syndrome
* Changing pace or lower limbs
* Neuromuscular disease
* Pulmonary Obstructive disease
An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)

This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD.


Eligibility Criteria:
Inclusion Criteria:

* The participant was a man or woman ≥18 years of age.
* The participant had read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed.
* At the time of enrolment, the participant had been scheduled via written documentation to undergo an ICA for the assessment of CAD.
* The participant had undergone a clinically indicated SPECT OR the participant was willing to undergo SPECT MPI for the purposes of the clinical study.
* The participant was male or was a nonpregnant, nonlactating female who was either surgically sterile or was post-menopausal.
* The participant was able and willing to comply with all study procedures as described in the protocol.

Exclusion Criteria:

* Participants who were pregnant, may possibly be pregnant, or wish (including their partners) to became pregnant during the study period, or were lactating.
* Participants who were unable to undergo all of the imaging procedures.
* Participants who had an established diagnosis of CAD as confirmed by any of the following:

  1. Previous myocardial infarction (MI);
  2. Previous cardiac catheter angiography showing ≥50% stenosis;
  3. Previous coronary revascularisation, such as percutaneous coronary intervention (PCI), thrombolysis or coronary artery bypass graft (CABG) placement.
* Participants incapable of undergoing either exercise or pharmacological cardiac stress testing.
* Participants who had a current illness or pathology that, in the opinion of the investigator, would pose a significant safety risk for the participant during cardiac stress testing.
* Documented history of heart failure and/or cardiomyopathy and/or prior LV ejection fraction (LVEF) \<50%).
* Participants scheduled for or planning to undergo any cardiac interventional procedures between enrolment and ICA.
* Participants undergoing evaluation for heart transplantation or with history of heart transplantation.
* Participants enrolled in another clinical study within the 30 days prior to being enrolled in this study or scheduled to participate in another clinical study during the 7-day follow-up period of this study.