cyrilzakka/clinical-trials huggingface dataset:
Diabetes Care Management Trial of Telemetric Monitoring

The study is a two-arm, parallel-comparison, single-blind, randomized controlled trial, and will be offered to Kaiser Permanente members aged 18 - 75 years old who present to the Santa Rosa Diabetes Care Management Center with Type 2 diabetes mellitus. Participants will be randomly assigned to one of two treatment arms. The telemedicine group or the group receiving usual care (the control group).

This study hopes to show the usefulness of this telemonitoring technology and more specifically, to assess whether this device improves markers of control of diabetes, glycemic control, and cardiovascular risk factors


Eligibility Criteria:
Inclusion Criteria:

* 18 - 75 years old,
* diagnosis of type 2 diabetes mellitus for at least 1 month,
* eligible for and referred to the diabetes care management program,
* HbA1c values in the range: 7.5% to 10.5%.

Exclusion Criteria:

* Weight \> 330 lbs,
* estimated glomerular filtration rate (GFR) \< 45,
* unstable coronary artery disease,
* severe peripheral vascular disease which restricted exercise,
* end-stage liver disease,
* undergoing treatment for cancer,
* pregnant or not using appropriate birth control,
* no broadband internet access in their homes.
Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant

This Phase II trial studies the side effects of denosumab and to see how well it works in treating patients with bone loss who have received a donor stem cell transplant. Patients receiving a donor stem cell transplant may experience accelerated bone loss and an increase risk of bone fractures, leading to a decrease in satisfaction and quality of life. A type of immunotherapy drug called denosumab binds to a protein called RANKL, which may help keep bone from breaking down.

PRIMARY OBJECTIVES:

I. To evaluate the efficacy and safety of denosumab therapy for the treatment of bone loss in patients who have received an allogeneic hematopoietic stem cell transplant.

OUTLINE:

Patients receive 2 doses of denosumab subcutaneously (SC) between days 70-130 and days 250-310 after allogeneic hematopoietic stem cell transplant in the absence of disease progression or unacceptable toxicity.

After completion of study treatment patients are followed up at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* The patient has undergone an Allogeneic Hematopoietic Stem Cell Transplant
* The patient has completed a base line dual x-ray absorptiometry (DXA) scan =\< 6 months prior to transplantation
* The patient has completed a post-transplant DXA scan at day 100 (+/- 30 days) or up to 6 months post transplantation
* The patient has completed and passed a dental clearance exam up to 6 months prior to transplant or 6 months after transplant
* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* The patient has a history of a hypersensitivity reaction to denosumab
* The patient has a history of osteonecrosis of the jaw
* The patient has predisposing risk factors for hypocalcemia including the following:

  * Hypoparathyroidism
  * Creatinine clearance (CrCl) \< 30 mL/min
  * Dialysis
  * Malabsorption syndrome
* The patient has history of any bone fracture =\< 30 days prior to denosumab therapy
* Pregnant or nursing female patients.
* The patient has clinically significant GVHD leading to hospitalization at the time of denosumab dose per prescriber discretion.
* The patient has clinically significant infection leading to hospitalization at the time of denosumab dose (excluding hospitalization due to complexity of treatment leading to inability to treat outpatient, ie. Foscarnet) per prescriber discretion
* The patient is unwilling or unable to follow protocol requirements
* The patient has any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug including relapsed malignancy
CareTaker Respiratory Rate Detection Study

The goal of the proposed study is to test the capability of the CareTaker monitor to extract the respiration signature from its acquired signal, and to determine a respiration rate of breaths/minute that meets or exceeds the performance levels of its predicate device.

The goal of the proposed study is to test the capability of the CareTaker monitor to extract the respiration signature from its acquired signal, and to determine a respiration rate of breaths/minute that meets or exceeds the performance levels of its predicate device.

The detection approach of RSPR (respiratory rate) that the CareTaker technology takes is based on peak detection and pulse analysis of arterial pressure pulse signals, as well as spectral analysis of the raw CareTaker sensor signal.

The study was performed under the supervision of the Chesapeake IRB and involved 21 subjects \>18 y who were monitored during spontaneous and metronome-paced breathing.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age, who are able and willing to participate and have given verbal assent

Exclusion Criteria:

* Unable to give written consent
* \<18 years of age
* No or poor finger pulse, as determined through visual inspection for ischemic hands
Biomarkers Identification of Anti-tumor Necrosis Factor (TNF) α Agent's Efficacy in Ankylosing Spondylitis Patients

To identify new candidate genes and proteins that are differentially expressed in responders' vs non-responders to anti-TNF alpha therapy at the several time points the investigators will use the transcriptomic and proteomic analyses. Demonstrate a link between gene expression and protein markers regarding prediction to anti-TNF alpha therapy efficacy.


Eligibility Criteria:
Inclusion Criteria:

* AS according to Portuguese Society of Rheumatology (SPR) guidelines (1984 modified New York Criteria, but allowing the use of MRI as imagiological criteria)
* Patient enrolment followed national guidelines for TNF antagonist use for the treatment of AS
* Adults between 18 to 75 years
* Ability to provide informed consent
* Corticosteroid therapy allowed (equivalent to ≤ 10 mg prednisone) and / or NSAID(nonsteroidal antiinflammatory drug), stable dose in 4 weeks before study initiation
* Adequate contraception (barrier or hormonal) in men and women of childbearing age (patients and their partners
* Adequate renal and hepatic function (2 times ULN)

Exclusion Criteria:

* Current pregnancy or breastfeeding
* Previous treatment with biologic DMARD's (disease-modifying antirheumatic drug)
* Intraarticular injections or infiltrations of extraaxial joints and tendons within 28 days before or at screening, or intraarticular injections of sacroiliac joints ≤ 28 days before screening
* History of rheumatic disorder other than AS
* Other forms of spondylarthritis than AS
* Any uncontrolled medical condition (e.g., uncontrolled diabetes mellitus, unstable ischemic heart disease)
* History or signs of demyelinating disease
* Malignancy (except for completely treated squamous or basal cell carcinoma)
* Moderate to severe heart failure (NYHA class III/IV) Positive serology for hepatitis B, hepatitis C, or human immunodeficiency virus
* Active or latent tuberculosis (TB) or histoplasmosis or other severe infections such as sepsis, and opportunistic infections
* Infections requiring hospitalization or intravenous treatment with antibiotics within 30 days or oral treatment with antibiotics within 14 days before enrollment
* Ankylosis of the spine (syndesmophytes presence at all levels from D12 to S1 in X-ray (XR) lateral view)
* Hypersensitivity to the active substance or to any of the excipients
The Role of Sulfur Amino Acids in Risk of Kwashiorkor

This observational cross-sectional study is investigating if young children in populations with higher prevalence of kwashiorkor malnutrition have lower dietary sulfur amino acid intake than populations with lower prevalence of kwashiorkor, controlling for multiple potential confounding factors. Intake is estimated through diet recalls during interviews with a child's caregiver, analysis of urine samples and analysis of food samples for their amino acid profiles.

Kwashiorkor is one of two categorizations of severe acute malnutrition, but its etiology remains unclear. Although kwashiorkor is found only where diets are low in quality protein, comparisons of total dietary protein of individual children with and without kwashiorkor has been inconclusive. This study aims to compare amino acid profiles of the diets, not just total protein.

Evidence has shown that children with kwashiorkor consistently have very low circulating levels of sulfur amino acids (cysteine and methionine). Typical staple foods in regions with endemic kwashiorkor are generally poor in sulfur amino acids and the signs characterizing kwashiorkor can plausibly be explained by a shortage of sulfur amino acids.

In eastern Democratic Republic of the Congo, certain populations have chronically higher prevalence of kwashiorkor than neighboring populations with similar livelihoods, religion, environment, language and ethnicity. This study will compare these two populations to understand what differences between them may explain the difference in prevalence.

Eligibility Criteria:
Inclusion Criteria:

* resident of the selected population
* in the appropriate age range

Exclusion Criteria:

* caregiver reports the child has an illness that has required treatment for at least 6 months
Cerebral Perfusion Pressure Using Precedex and Other Sedatives

The purpose of this study is to examine the effects of using dexmedetomidine (Precedex) in addition to the current standard-of-care for sedation.

Primarily, this study seeks to explore whether there is a difference in mean arterial pressure (MAP) variability, incidence of intracranial hypertension, intracranial pressure (ICP) variability, cerebral perfusion pressure (CPP) and Cerebrovascular pressure reactivity index (PRx) in two groups of subjects.

Patients must be submitted to the ICU and be endotracheally intubated and receiving mechanical ventilation with continuous IV sedation for less than 24 hours after recruitment into the study.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to Duke University Neuro Critical Care Unit (NCCU)
* Adult (18 years of age or older)
* Expected Mechanical Ventilation for \>48 hours with sedation
* Intraventricular catheter in situ

Exclusion Criteria:

* Hypersensitivity to study drugs
* Prisoners
* Moribund state or death expected within 24 hours
* Surgery planned within 24 hours of subject enrollment
* Receiving study drug, Precedex, prior to entering study
Improving Health Outcomes With Kefir

The purpose of the study is to ascertain whether traditional kefir not only enhances vascular health but also contributes to improved immune outcomes in both male and female participants at higher risk or living with Type 2 Diabetes (T2D) after 12 weeks of treatment.

Participants who sign the written consent form will undergo a screening process to determine eligibility for study entry. At the baseline visit, recruited participants will be randomized in a double-blind manner (participant and study coordinator) to consume either 350 mL of traditional fermented kefir or 350 mL of a placebo (milk) daily. During the 12 weeks of intervention, health outcomes will be measured and collected for further analysis.

Eligibility Criteria:
Inclusion Criteria:

1. females and males (24-70 years old) living in Edmonton (or Edmonton area/driving distance);
2. overweight or obesity (BMI \>25 Caucasian, \>23 Asian);
3. at higher risk of T2D (fasting blood glucose ≥ 5.6 - 6.9 mmol/L or/and HbA1C ≥ 5.5 - 6.4%); or
4. with diagnosis of T2D (fasting blood glucose ≥ 7.0 mmol/L or/and HbA1C ≥ 6.5%).

Exclusion Criteria:

1. a usual high intake (maximum intake 3 servings/week) of fermented foods excluding cheese (i.e., kefir, kombucha, kimchi, etc.) for the past 3 months;
2. gastrointestinal (GI) disorders of any kind;
3. being pregnant or breastfeeding;
4. monogenic dyslipidemias and endocrine disorders except for diabetes;
5. use of medications within the last 3 months (i.e., antibiotics or antifungals, corticosteroids, methotrexate, or immunosuppressive cytotoxic agents);
6. any health conditions deemed to interfere with primary outcomes at the investigator's discretion (e.g., kidney disease, liver disease, cancer, GI surgery, heavy alcohol consumption, etc.);
7. having a pacemaker or any electrical medical device that prevents the individual from undergoing the bioelectrical impedance analysis bioimmunoassay (BIA) test."
Exploring the Effect of Mindfulness on Quality of Life (QoL) in Spinal Cord Injury (SCI)

The purpose of this study is to determine if practicing mindfulness breathing exercises has an effect on the overall health of persons with SCI


Eligibility Criteria:
Inclusion Criteria:

* Adult males and females aged 18-70 who are living with spinal cord injury
* C5 to the T10 levels
* Self-reported American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS) A-D
* Eligible participants must be able to understand and provide consent, be in good health operationalized as free from acute treatable illness, pressure injury, and cardiovascular disease.

Exclusion Criteria:

* Participants taking medications that alter chronotropic and pressor responses will be excluded.
* Pregnant women will not be eligible to participate
Idiopathic Purpura Fulminans Associated With Anti-PS Antibodies in Children

Idiopathic purpura fulminans by anti-protein S antibody is a very rare but potentially extremely serious entity. The data in the literature are poor with only isolated report boxes and a single series of less than 10 boxes. The creation of a larger series of cases would make it possible to better understand this pathology and to offer assistance in diagnosis and management.


Eligibility Criteria:
Inclusion criteria:

* diagnostic of idiopathic purpura fulminans
* Acquired protein S deficiency

Exclusion criteria:

- Other infecious purpura diagnosis
Nicergoline Use in Dysphagia Patients

Dysphagia is a complication in patient with stroke, Parkinson's disease or dementia that can lead to aspiration pneumonia. This study aimed to investigate dysphagia improvement after treatment with nicergoline low dose and high dose, the relationship between nicergoline dose and clinical improvements, side effect of nicergoline and simulation optimal nicergoline dose in dysphagia improvement.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 20 years
* Stroke (post events at least 2 months), Parkinson's disease and dementia patients who have dysphagia symptom
* Do not take nicergoline prior recruit 2 weeks
* Continue current medications
* Consent to join

Exclusion Criteria:

* Allergy to gentamicin or components
* On anticoagulants including Heparin, Enoxaparin, Fondaparinux, Warfarin, Dabigatran, Apixaban, Rivaroxaban and Edoxaban
* On antiplatelet \> 1 drug (ex. dual antiplatelet)
* On ACE-I or Dopaminergic agent 2 months or less
* Chronic dyspepsia
* Chronic gout or hyperuricemia \> 8 mg/dL
* CrCl \< 30 ml/min
* Impair hepatic function including child puge B, C or active hepatitis
* Brainstem stroke
* Parkinson plus syndrome: PSP, MSA, DLB, etc
* Advanced cancer or other medical conditions
* Bed ridden
* Laryngopharynx surgery
* SBP\<100 or DBP 60 mmHg
* HR\<50/min
* Active bleeding
* Pregnancy or lactation
* Known of poor compliance for any treatments
U/S Guided vs. Traditional Palpation for Radial Artery Cannulation

The purpose of this study is to compare the efficacy of ultrasound- guided with the traditional palpation radial artery cannulation in critically ill children.

Arterial catheterization is often performed in critically ill patients for continuous hemodynamic monitoring and blood sampling. However, insertion of radial artery catheter with traditional palpation may be technically challenging, particularly in pediatric patients. There are few published studies on the use of ultrasound guidance for radial-artery catheter placement and mostly they were elective surgery children which received inhalation or deep sedative medication. Recently no setting published in pediatric intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients who required radial artery cannulation for hemodynamic monitoring or frequent blood samples in intensive care unit

Exclusion Criteria:

* Wound at area of cannulation
* Can not palpate or weak radial artery pulse
Randomized Trial of Home Versus Clinic-Based STD Testing

This study randomizes St. Louis men to home-based STD screening or clinic-based STD screening. Home-based screening will be completed through the mail and clinic-based screening in a local clinical setting. We hypothesize that men randomized to home-based screening will be more likely to complete screening.


Eligibility Criteria:
Inclusion Criteria:

* Men
* Ages 18-45
* Residing in St. Louis City or County
* English-speaking

Exclusion Criteria:

-
Effects of Motor Imagery Training on Performance and Heart Rate Variability in Adolescent Basketball Players

The aim of this study is to examine the investigation of the effects of motor imagery to facilitate sensorimotor re-learning training on performance and heart rate variability in adolescent basketball players.

Motor imagery is defined as the mental process of simulating a certain action without any movement. In one study, researchers showed that motor imagery training activates the sensorimotor system and that brain plasticity resulting from actual movement execution also occurs as a result of motor imagery. When the literature is examined, it has been reported in studies that muscle strength may increase as a result of imagery training. However, there are also studies reporting that imagery training is effective on performance in basketball players.

Dynamic motor imagery, on the other hand, is a type of motor imagery in which the athletes adopt a harmonious body position and embody the spatial and/or temporal invariants of the movement without fully realizing it. According to a study, dynamic imagery training has a positive effect on free throw performance in basketball players. To facilitate sensorimotor relearning, which is a new training model, motor imagery training is an approach that approaches athletes with a holistic perspective, combining both physical exercises and dynamic motor imagery training. In a study, it was reported that training is more fun than just physical exercises . When the literature is examined; no study has been found examining the effects of motor imagery training on performance and heart rate changes in order to facilitate sensorimotor relearning in adolescent basketball players.

Eligibility Criteria:
Inclusion Criteria:

1. Being between the ages of 11-19
2. Playing licensed basketball for at least 2 years
3. Being a man

Exclusion Criteria:

1. Coming to the hospital with a musculoskeletal injury in the last 3 months
2. Not being willing to participate in the study
Assessment of Vitamin B12 Bioavailability From Egg

The hypothesis of this study is that chicken eggs can be enriched in vivo with 14C-B12 and fed to healthy human subjects to determine B12 bioavailability from eggs.

The goal of this research is to enrich eggs in vivo with radioactively labeled vitamin B12 to a level that allows us to feed the enriched eggs to humans and determine how much of the vitamin B12 is digested and absorbed into the body. This will tell us if eggs are a good dietary source of vitamin B12. Importantly, sensitive technology available at the Lawrence Livermore National Laboratories allows us to measure very low amounts of radioactive vitamin B12. This allows us to do this experiment with a level of radioactive B12 that is not harmful to animals or humans. The results of the investigators first experiment indicate that the investigators can inject radioactively labeled vitamin B12 into a laying hen and detect the radioactive vitamin B12 in the eggs at a level sufficient for feeding to humans in a bioavailability study.


Eligibility Criteria:
Inclusion Criteria:

* normal healthy subjects, adequate B12 status and absorptive capacity and the availability to complete the protocol.

Exclusion Criteria:

* any chronic health disorder, anemia of any kind, renal insufficiency, and pregnancy or lactation.
Trans GERD: Efficacy and Tolerability of Esomeprazol in Patients Under Ordinary Medical Care Conditions

Under daily routine conditions and without any intervention by the sponsor regarding the selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non- medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians (i.e. general practitioners and internists) are asked to document relevant data related to esomeprazole therapy in patients with gastrointestinal disorders. Patients with acid associated gastrointestinal symptoms can be included.


Eligibility Criteria:
Inclusion Criteria:

* patients with gastrointestinal disorders and patients with acid associated gastrointestinal symptoms treated with esomeprazole.

Exclusion Criteria:

* limitiations; possible risks; warnings; contraindications mentioned in the SPC.
Anticoagulation in Cancer Related Stroke

Purpose: Cancer associated intravascular coagulopathy is the primary mechanism of cancer-related stroke, particularly in those without conventional stroke etiologies. Randomized clinical trials have investigated efficacy of vitamin K-dependent oral anticoagulant (warfarin), low-molecular-weight heparin (LMWH) and non-vitamin K-dependent oral anticoagulant (NOAC) for the prevention of systematic venous thromboembolism. However, relatively little is known about the biological changes underlying intravascular coagulopathy and mechanisms of anticoagulation therapy in patients with cancer-related stroke. The aim of this study is to evaluate to determine the biological markers for intravascular coagulopathy causing stroke and for monitoring the effects of anticoagulation therapy, in patients with active cancer and stroke.


Eligibility Criteria:
Inclusion Criteria:

* Age 20 years and older
* Acute ischemic stroke presented within 7 days of symptom onset
* Cancer related stroke: active cancer (diagnosis of cancer within 6 months of stroke onset, any treatment for cancer within the previous 6 months, or recurrent or metastatic cancer) and ischemic stroke which could not be explained by conventional stroke mechanisms including large artery atherosclerosis, cardioembolism, lacunar infarction, or other etiologies (e.g., dissection)
* Signed informed consent or appropriate signed deferral of consent where approved

Exclusion Criteria:

* Primary intracranial malignancy
* Incomplete workup for stroke etiology (either vascular or cardiologic studies)
* Any signs of infectious or immunological diseases which may influence plasma D-dimer levels
* Patients with stroke suspected to be caused by the tumor itself (i.e., tumor emboli) or cancer treatment (i.e., chemotherapy-induced stroke)