cyrilzakka/clinical-trials huggingface dataset:
Biomarkers Related to Thrombosis in Patients With Newly Diagnosed Multiple Myeloma Receiving Chemotherapy

RATIONALE: Studying samples of blood in the laboratory from patients receiving chemotherapy may help doctors learn more about the effects of chemotherapy on cells. It may also help doctors understand how patients respond to treatment.

PURPOSE: This research study is studying biomarkers related to thrombosis in patients with newly diagnosed multiple myeloma receiving chemotherapy.

OBJECTIVES:

Primary

* To measure levels of circulating tissue factor (TF) in patients with newly diagnosed multiple myeloma at several time points before, during, and after the administration of chemotherapy and/or antiangiogenic agents.

Secondary

* To measure the correlation of TF with two markers of coagulation activation (i.e., D-dimer, thrombin-antithrombin \[TAT\] complexes) and two markers of endothelial activation (i.e., soluble E-selectin, soluble thrombomodulin) in these patients.
* To measure and compare (descriptively) our microparticle-associated TF procoagulant activity assay with two other assays using samples from these patients.

OUTLINE: Patients undergo blood sample collection at baseline and then periodically during treatment. Circulating tissue factor (TF) activity levels and coagulation and endothelial activation (by ELISA) are measured. Medical charts are reviewed for sociodemographic and medical information.

After completion of study, patients are followed up for 3 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Newly diagnosed; relapsed, or refractory multiple myeloma

PATIENT CHARACTERISTICS:

* Central venous access devices allowed
* Recruited by the Division of Hematology/Oncology and the Lineberger Comprehensive Cancer Center at the University of North Carolina
* No history of venous thromboembolism
* No hospitalization for \> 2 days within the past month
* Not pregnant
* No patient who refuses or is deemed unsuitable for chemotherapy

PRIOR CONCURRENT THERAPY:

* No surgery within the past month

  * Bone marrow biopsies, central venous line placement and diagnostic biopsies by surgery or fine-needle aspiration allowed
* \* No concurrent anticoagulation therapy

  * Concurrent antiplatelet agents, such as aspirin and/or clopidogrel, allowed
BGEM Use as Blood Glucose Prediction Model in T2DM Population of Indonesia

Using signals from consumer-grade PPG sensors on wrist wearables, smart rings or hearables, BGEM® AI model computes the relevant digital biomarkers correlated with the change of blood glucose level to predict a blood glucose result for monitoring and evaluating diabetic risks Ukrida in collaboration with Actxa \& Lif aims to enhance the current model's prediction accuracy to predict the blood glucose levels of individuals almost as accurately as a glucometer. To achieve this, Actxa aims to collect data from around 500 individuals with diabetes in this exercise and 400 healthy or undiagnosed (prediabetes/diabetes) individuals.

Background Powered by our AI-driven algorithm, the Actxa's Blood Glucose Evaluation and Monitoring (BGEM®) is a cloud-based technology that enables wearables with photoplethysmography (PPG) sensors to monitor and evaluate diabetic risk of individuals regularly in a non-invasive way.

Using signals from consumer-grade PPG sensors on wrist wearables, smart rings or hearables, BGEM® AI model computes the relevant digital biomarkers correlated with the change of blood glucose level to predict a blood glucose result for monitoring and evaluating diabetic risks. Our previous study has shown the potential of using PPG sensors to detect elevated blood glucose levels among a non-diabetic population1.

Objective Ukrida in collaboration with Actxa \& Lif to enhance the current model's prediction accuracy to predict the blood glucose levels of individuals almost as accurately as a glucometer. To achieve this, Actxa aims to collect data from around 500 individuals with diabetes in this exercise and 400 healthy or undiagnosed (prediabetes/diabetes) individuals, as part of Actxa's collaboration with UKRIDA Hospital.

With the data collected, our algorithm holds the potential to significantly improve the management of blood glucose levels for people with and without diabetes, ultimately enhancing their overall quality of life.

Eligibility Criteria:
Inclusion Criteria:

* age between 18-59 yo
* diabetic or non diabetic
* healthy enough to undergoes normal daily activity

Exclusion Criteria:

* o Wears a pacemaker

  * Is currently pregnant
  * Has an infection
  * Has a fever
Safety, Efficacy, and Feasibility of High-dose Cholecalciferol in Pediatric Patients With Cystic Fibrosis

Children with Cystic Fibrosis, ages greater than and equal to 36 months of age and less than or equal to 18 years of age, with a 25OHD level less than 30 ng/dL will be asked to participate in this study. Upon consent, they will be given oral cholecalciferol supplementation of 250,000 IU during their next CF clinic visit. The safety will be assessed by measuring a serum calcium level within 1 week of supplementation. Efficacy will be assessed using repeated 25OHD levels throughout the course of 12 months. Feasibility will be assessed with the previous two measures as well as a brief questionnaire administered via telephone within 1 week of supplementation.

Children and adults with Cystic Fibrosis (CF) are at risk of developing a vitamin D deficiency or insufficiency, defined as a 2,25-hydroxyvitamin D (25OHD) serum blood level \<30 ng/dL. Greater than 85% of people with CF have pancreatic insufficiency, which contributes to poor absorption of fat soluble vitamins in addition to dietary fat. A 25OHD level greater than 30 ng/dL has been described as providing potential improvements to markers of inflammation in adults with CF and is known to improve bone mineral density and prevent bone fractures in all populations, including CF. This study will assess the safety of a one-time high dose of cholecalciferol or vitamin D3 along with the efficacy and feasibility.

Children between the ages of 3 years and 18 years (inclusive), with a 25OHD level \<30 ng/dL will be provided with a vitamin D3 supplement of 250,000 international units (IU) observed in our CF clinic. We hypothesize that this one-time, oral, high dose of vitamin D3 will safely and effectively raise the 25OHD level to above 30 ng/dL.

Safety will be monitored with serum calcium levels 1 week following the dosage, since 25OHD has a half-life of 2-3 weeks and this serum calcium level measurement time-point would be in or near the middle of this range. Feasibility will be measured using a 5-question phone survey 1 week following the dosage (see appendix A - attached). Efficacy will be measured by the 25OHD level itself; if 25OHD levels are found to be between 30-100 ng/dL over the course of the study, the dose will have demonstrated effective in achieving the study's goal.

The purpose of this study is to show that 25OHD levels can be safely corrected with a one-time dose of vitamin D3 that can be safely and feasibly provided in the outpatient setting to children with CF.

Eligibility Criteria:
Inclusion Criteria:

* Children with Cystic Fibrosis \>36 months of age
* Serum/blood 25OHD level \< 30 ng/dL
* Ability to provide valid informed consent to be a part of the study

Exclusion Criteria:

* Any history of kidney disease, kidney stones or on dialysis
* Any history of hypercalcemia
* Any history of hypercalciuria
* Pregnancy at time of enrollment
* Any history of parathyroid disorders
* Inability to swallow pills by mouth
Long-term Sacral Nerve Stimulation for Irritable Bowel Syndrome.

A recent randomised, controlled, crossover study has shown that sacral nerve stimulation (SNS) significantly reduces symptoms and improves quality of life of highly selected patients with irritable bowel syndrome (IBS). Relief of IBS symptoms during SNS is associated with consistent changes in rectal sensitivity and biomechanical wall properties.

The aim of the present study is to evaluate long-term efficacy of sacral nerve stimulation on symptoms and quality of life in patients with IBS in a randomised, placebo-controlled, crossover study.

Twenty two patients with IBS-D or IBS-M according to the ROME III criteria, will be enrolled by invitation in the study.

Having meet inclusion criteria, the patients are first set subsensory for 4 weeks and then randomised to receive either OFF-subsensory or subsensory-OFF stimulation in a 4+4-week period.

During the PNE test the effect of the stimulation is evaluated by specific IBS symptom and quality of life questionnaires (GSRS-IBS and IBS-IS) and bowel habit diaries.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are psychologically stable and suitable for intervention and able to provide informed consent
* Patients who are diagnosed with IBS according to the Rome III criteria and characterised with IBS-D or IBS-M.
* Patients who have been treated with sacral nerve stimulation for a minimum of 3 years.

Exclusion Criteria:

* Other bowel diseases including inflammatory bowel disease
* Pregnant or breast feeding
* Patients who are considered unable to follow the planned programme of the study, including mentally illness or physiological instability
* Patients who are on medication with known influence on gastrointestinal motility including those for thyroid disease, diabetes mellitus, celiac disease and neurological diseases.
Clinical Reminder Changes to Increase Smoking Cessation Treatment in Outpatient Psychiatry

This study will use a scientifically robust, mixed-methods, two-arm cluster-randomized study design. Investigators will implement a tobacco use clinical reminder for outpatient psychiatrists practicing at the VA New York Harbor Healthcare System (N = 20). Half of the psychiatrists will receive a reminder that encourages the psychiatrist to offer cessation medications and referral to cessation counseling to patients interested in quitting (Opt-In Reminder). The other half will receive a clinical reminder that includes a standing nicotine replacement therapy (NRT) order and a referral to cessation counseling that will automatically generate unless the provider actively opts-out (Opt-Out Reminder). Prior to implementation of the reminders, psychiatrists in both arms will receive a one-hour training on tobacco treatment and individual education outreach to demonstrate the clinical reminder and answer questions (academic detailing).


Eligibility Criteria:
Inclusion Criteria:

* Psychiatrists
* Works in outpatient psychiatry at Manhattan or Brooklyn VA campus and has no plans to leave in the next 6 months
* Patient Post-Visit Survey Population
* Had a visit with a psychiatrist included in the study Current smoker

Exclusion Criteria:

* Outpatient Psychiatrists:
* None
* Patient Post-Visit Survey Population:
* Non-English speaking
The Effect of Black Currant on Postprandial Glucose Metabolism

The study examines the effect of black currant on glucose and insulin concentrations after a meal. In addition, the cytokine and free fatty acids levels are of interest.

The study examines the effect of black currant on glucose and insulin concentrations after a meal.

Healthy (n= 30) volunteers are recruited to participate in four consecutive visits in the research laboratory, when four meals are served in randomised order. Meals are: black currant puree, black currant and quinoa based snack, quinoa base and liquid containing glucose, fructose and sucrose. The meals contain the same amount of carbohydrates.

In addition to glucose and insulin concentration, cytokine and free fatty acid concentrations are measured after each meal.

Eligibility Criteria:
Inclusion Criteria:

* age: 25-65 years
* BMI: 20-28 kg/m2
* Perceived health status: Good

Exclusion Criteria:

* fasting glucose: \> 7.0 mmol/l
* LDL-cholesterol: \> 3.0 mmol/l
* total cholesterol: \> 6.5 mmol/l
* blood pressure : \> 160/100 mmHg
* weight change of \> 5% during previous 6 months or active weightreduction
* no serious chronic diseases
* one exception of the exclusion criteria maybe accepted after the MD consideration
Hemodynamic Measurements at Different Inclinations of the Head

The purpose of this study is to determine whether hemodynamic measures vary in angles bedside before and after volume challenge.

* Check if values of central venous pressure (CVP), pulse pressure variation (Δpp), heart rate (HR), mean arterial pressure ((PAM) vary in different angles headboards
* Compare values of CVP, Δpp, HR and MAP as predictors of blood volume after supply of 500 ml of 0.9% saline solution.

Eligibility Criteria:
Inclusion Criteria:

* Being in circulatory shock and have at least one of the following criteria to identify loss of tissue perfusion: systolic blood pressure \<90 mmHg or need for vasoactive drugs, urine output below 0.5 ml / kg / h.
* Being under sedation, assessed by the scale of Richmond agitation and sedation (RASS) -5, mechanically ventilated in volume control mode with tidal volume between 8 to 12 ml/kg, PEEP to 8 cm H2O.
* Tue signing the informed consent by legal guardian.

Exclusion Criteria:

* Presence cardiac arrhythmias.
* Presence of abdominal or thoracic trauma.
* Contraindication for passive elevation of the members.
* Hypoxia significant PaO2/FiO2 \< or equal 100.
Cardiac Cath Lab Staff Radiation Exposure

The objective of this randomized safety and observational study is to demonstrate CorPath GRX chronic total occlusion PCI is safe, and that Cardiac Catheterization Laboratory staff have no additional exposure to radiation when compared to conventional manual chronic total occlusion PCI procedures without added procedure time.

This is prospective, dual-arm, randomized, multi-center, observational study comparing patient outcomes and staff radiation exposure in chronic total occlusion PCI procedures through 48 hours post procedure or hospital discharge, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

* CTO lesion, successfully crossed with conventional manual techniques;
* The Investigator deems the procedure appropriate for robotic-assisted CTO PCI with the CorPath GRX System;
* Individual monitoring of radiation dose, using the pocket dosimeter, was initiated at start of procedure;
* The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

* Failure/inability/unwillingness to provide informed consent, or
* Cardiogenic Shock; or
* Perforation which requires treatment (e.g. covered stent, coil and other embolization techniques, or pericardiocentesis).
The Diagnostic Experience of Male Rett Syndrome

The Diagnostic Experience of Male Rett Syndrome collects information on the lived experiences of parents or caregivers to boys with Rett Syndrome. Key information examined includes the process of getting a male Rett syndrome diagnosis, your son's systems of care, and your priorities for his health needs.

Enrolled participants will complete an online survey with questions about having a son with Rett Syndrome. The Diagnostic Experience of Male Rett Syndrome study is available to parents or caregivers to boys (alive or passed) with Rett Syndrome. Compensation is not provided.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking parents (over the age of 18) of male children (all ages, alive or deceased) with confirmed genetic diagnosis of male RTT

Exclusion Criteria:

* parents of male MECP2 duplication syndrome
Enabling Genomic Testing in Cancer of Unknown Primary

Cancer of Unknown Primary (CUP) is where cancer cells are found in the body but the place the cancer began is not known. It is the 6th leading cause of cancer death in the UK and the prognosis is poor with a median survival of 6-9 months. There is a higher than average incidence of CUP in the North West (NW) of England (population of 7.4 million). Precision medicine has transformed treatment strategies in known tumour types, however in CUP there remains an urgent need to better understand CUP molecular characteristics to establish potential roles for novel therapeutic strategies. Treatment options remain limited due to difficulties in determining the primary site of the tumour and the lack of access to validated biomarkers. Access to good-quality tissue for molecular profiling remains a huge challenge in CUP. The emergence of liquid biopsies (sequence DNA in a blood test) as a source of biomarkers is also gaining rapid ground and this study aims to explore the potential utility of liquid biopsies in CUP.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 16 years or over
2. Written informed consent according to ICH/GCP and national regulations
3. ECOG Performance status 0-2
4. Confirmed diagnosis of CUP as per the ESMO guidelines. Patients must have;

   1. The local pathology reports confirming compatibility with CUP diagnosis and the associated slides used for the diagnosis
   2. Discussion at a local CUP MDT confirming diagnosis
5. Availability of archival tumour histological report
6. Willingness to provide blood samples on up to two occasions during the study

Exclusion Criteria:

1. Patient with an immunohistochemistry profile that provides a definitive clinical indication of a primary cancer with a specific treatment
2. Known HIV, Hepatitis B, C positive, due to the difficulties in handling high-risk specimens
3. Patients who are unable to provide fully informed written consent
4. Presence of any medical, psychological, familial or sociological condition that, in the investigator's opinion, will hamper compliance with the study protocol and follow-up schedule
5. Bleeding diathesis (patients' on anticoagulation are permitted to enter the trial if anticoagulation can be safely managed to enable blood sampling)
6. Conditions in which blood sampling may increase risk of complications for the patients and/or investigator
Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder

The purpose of this clinical study is to investigate the safety, tolerability, and feasibility of Deep Brain Stimulation (DBS) of the nucleus accumbens (NAc) and ventral internal capsule (VC) for participants with treatment refractory opioid use disorder (OUD) who have cognitive, behavioral, and functional disability.

The overarching goal of this study is to evaluate the safety, tolerability, feasibility and impact on outcomes of NAc/VC DBS for treatment refractory OUD. In treatment refractory OUD, innovative approaches and more invasive interventions including DBS are warranted to improve outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age 22-50 years at time of enrollment.
* Fulfills current DSM-5 diagnostic criteria for severe OUD with at least a 5-year history.
* Participants may have comorbid SUD diagnoses at a mild, moderate or severe level, however, OUD must be the primary disorder for which the individual is seeking treatment and the other use disorders must occur in the context of relapse.
* At least one lifetime overdose survival.
* Demonstrated greater than five years of refractory symptoms of OUD.

Exclusion Criteria:

* Diagnosis of acute myocardial infarction or cardiac arrest 1 within the previous 6 months.
* Past or present diagnosis of schizophrenia, psychotic disorder, bipolar disorder, or untreated depression other than one determined to be substance induced.
* Unable to undergo MR-imaging
Voglibose Tablets 0.2 / OD Tablets 0.2 Special Drug Use Surveillance "Long-term Use in Patients With Impaired Glucose Tolerance"

The purpose of this study is to determine the safety and efficacy of long-term use of Voglibose (Basen) to prevent progression to type 2 diabetes mellitus in participants with impaired glucose tolerance in the routine clinical setting.

This is a special drug use surveillance on long-term use of Voglibose (Basen) designed to determine the safety and efficacy of long-term use of Voglibose (Basen) to prevent progression to type 2 diabetes mellitus in participants with impaired glucose tolerance in the routine clinical setting.

Particioants will be patients with impaired glucose tolerance. The planned sample size is 1,000.

The usual adult dosage is 0.2 mg of voglibose administered orally three times daily immediately before each meal.

Eligibility Criteria:
Inclusion Criteria:

* Participants must meet all of the following criteria (\[1\] to \[3\]) to be included in this study:

  1. Determined as having IGT (defined as fasting blood glucose \< 126 mg/dL and 2-hour post 75-g oral glucose tolerance test \[OGTT\] blood glucose of 140-199 mg/dL) without improvement despite treatment with diet therapy and exercise therapy for 3-6 months
  2. Meets any of the following conditions:

     (i) Concurrently has hypertension\*1 (ii) Concurrently has dyslipidemia\*2 (iii) Is obese (BMI ≥25 kg/m\^2) (iv) Has a family history of diabetes mellitus in relatives to the second degree as defined by Japanese law\*3
  3. Regularly visits the study site and can be observed for 72 weeks

     * 1: Hypertension: Patients with systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, or patients on oral antihypertensive medication.
     * 2: Dyslipidaemia: Participants with any of the following conditions or participants on oral antidyslipidemic medication
* Hyper LDL cholesterolemia (fasting LDL-cholesterol ≥140 mg/dL)
* Hypo HDL cholesterolemia (fasting HDL-cholesterol \< 40 mg/dL)
* Hypertriglyceridemia (fasting triglyceride ≥150 mg/dL) \*3: Relatives to the second degree of consanguinity refer to blood relatives who are the subject's "father or mother, grandfather or grandmother, brothers or sisters, children, or grandchildren." Note that these do not include spouse's relatives.

Exclusion Criteria:

* Participants meeting either of the following criteria (\[1\] or \[2\]) will be excluded:

  1. Previously diagnosed with diabetes mellitus
  2. Has any contraindications to Basen as specified below:

     (i) Severe ketosis, diabetic coma or precoma (ii) Severe infection, perioperative state, or serious trauma (iii) History of hypersensitivity to any ingredients of Basen
Effect of Salovum™ and SPC-Flakes™ on Abemaciclib-induced Gastrointestinal Toxicity in Early Breast Cancer

The present study aims to investigate a proactive strategy including Salovum™ and SPC-flakes to prevent the occurrence of abemaciclib-induced diarrhea in patients with early breast cancer.

In patients with high-risk luminal breast cancer, the addition of CDK 4/6-inhibitor abemaciclib to adjuvant endocrine therapy for two years has been associated with improved disease-free survival and is now recommended from national and international guidelines as the preferred treatment strategy for this patient group. However, patients treated with abemaciclib have higher risk of diarrhea which primarily occurs during the first three months from treatment initiation and seems to impact patients' quality of life. As a result, early and proactive strategies to reduce the occurrence of diarrhea from the initiation of abemaciclib should be investigated to ensure that patients in whom adjuvant abemaciclib is recommended can complete their treatment as planned.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Histologically confirmed diagnosis of luminal breast cancer.
* No clinical evidence of metastatic disease.
* Planned to start abemaciclib in adjuvant setting (according to current national guidelines).
* Signed informed consent.

Exclusion Criteria:

* Contraindications to the investigational product, e g known or suspected hypersensitivity to the investigational products or expected inability to their use in accordance with the protocol.
* Lack of suitability for participation in the study, e g expected difficulties to follow the protocol procedures, as judged by the investigator.
* Prior exposure to abemaciclib.
* Prior exposure to Salovum or SPC-flakes.
* Past or present history of inflammatory bowel disease.