cyrilzakka/clinical-trials huggingface dataset:
Aging and Family Outcomes in Supportive Care of Advanced Cancer Patients

The diagnosis of advanced, incurable cancer at different stages of the adult life span holds a variety of meanings for family members who often must play critical roles in patient care and decision-making. Family caregivers are greatly affected by the diagnosis and treatment of late-stage cancer in a loved one and may find it difficult to meet the demands of taking care of their loved one through end-of-life care and taking care of their own well-being. This grant provides funding to examine processes and outcomes of the intervention for family caregivers of advanced cancer patients.

We are testing a coping and communication support (CCS) intervention for advanced stage cancer patients and their family caregivers over the period when goals of care may shift, i.e. beginning shortly after diagnosis. This randomized clinical trial is being conducted in two urban tertiary cancer clinics that reach patients and families in low income and diverse underserved populations: the Louis Stokes Cleveland VAMC and MetroHealth Medical Center. Recruitment and randomization are based on patient's diagnosis and age. The patient had to have been diagnosed with a stage IV cancer within a year of enrollment and they must fall into one of two age groups: middle-aged (ages 40-60); or older (61 and older). Patients are stratified by age group and then randomized to usual care or CCS intervention. Family care-givers are randomized along with the patient. Trained clinical nurse specialists with advanced training in mental health serve as CCS practitioners. They are available to patients and family caregivers on a 24/7 basis to assist with coping and communication challenges as they may arise. The primary goal of this project is to examine main effects of the intervention and patient age group interaction effects of the CCS intervention on perspectives and well-being of family caregivers during advanced cancer care and in bereavement.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed within 1 year with advanced cancer (stage IV), aged 40 years or older.
* Patients must be cognitively intact at time of enrollment.
* Patient need not have family care-giver to be enrolled, but if there is one, FCG is enrolled with the patient. FCG need not be 40 years of age.

Exclusion Criteria:

- Less than stage IV cancer, stage IV cancer diagnosed over 1 year previously or younger than 40 years of age.
Empagliflozin in Heart Failure: Diuretic and Cardio-Renal Effects

The investigators propose a small pilot proof of concept study to not only prove the existence of, but also probe the mechanisms underlying cardio-renal effects of empagliflozin in patients with heart failure. The investigators propose a 50 patient randomized, double-blind, placebo-controlled crossover study with patients with stable HF, type II diabetes and an eGFR \>45ml/min/1.73 m2 who are chronically receiving loop diuretics.

Study Objectives

1. Study the acute/short term effect and cardio-renal mechanisms of sodium-glucose cotransporter 2 (SGLT2) inhibition in patients with heart failure.
2. Determine the effect of chronic combined SLLGT2 and loop diuretic exposure in patients with heart failure.

Primary Outcomes

1. Aim 1 (Acute): Determine if acute SGLT2 inhibition will improve the natriuretic effect of a loop diuretic compared to placebo.
2. Aim 2 (Chronic): Determine the effect of 14 days of SGLT2 inhibition on blood volume.

Eligibility Criteria:
Inclusion Criteria:

* Stable HF as defined by:
* No hospitalization for \>60 days
* Stable HF medications for \>=2 weeks, and stable diuretics for 4 weeks
* Opinion of HF cardiologist that the patient is at their optimal volume status
* Chronic daily oral loop diuretic dose \>=20mg furosemide equivalents
* Diagnosis of type II diabetes
* Patient monitors blood glucose regularly at home
* eGFR \>=45 mL/min/1.73 m2
* \>=18 years old

Exclusion Criteria:

* Active titration of chronic HF medications expected during the study period
* Use of a non-loop diuretic, aside from an aldosterone antagonist (\<=25mg spironolactone or \<=50mg eplerenone)
* Critical stenotic valvular disease, complex congenital heart disease, or prior heart transplant
* History of diabetic ketoacidosis, "brittle" diabetes, and/or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent intervention (ER visit or EMS response, glucagon administration or forced oral carbs) in the last 6 months
* History of bladder dysfunction, incontinence, pyelonephritis, urosepsis, or frequent urinary tract infections
* Anemia (defined as hemoglobin \<8g/dL)
* Pregnancy or breastfeeding
* History of serious hypersensitivity
* Participation in another trial with an investigational drug within the 30 days prior to informed consent
* Use of another SGLT-2 inhibitor
* Appears unlikely, or unable to participate in the required study procedures, as assessed by the study PI or research RN (ex: clinically-significant psychiatric, addictive, or neurological disease)
* Inability to give written informed consent or follow study protocol
The Efficiency of Different Exercise Methods in Adolescent Idiopathic Scoliosis

The vertebral column is a structure that transfers the weight of the head and torso to the lower extremity, provides trunk movements and protects the spinal cord.A three dimensional deformity involving lateral flexion of the vertebrae in the frontal plane at 10 ° and above, including axial rotation and physiologic flexion (hypokyphosis) components in the sagittal plane, is defined as scoliosis. Adolescent idiopathic scoliosis (AIS) is a type of idiopathic scoliosis that occurs in the period from the onset of puberty (up to 10 years) until the closure of growth plates.

Scoliosis is caused by postural, balance and neuromotor disorders as a primary cause of impaired sensory integrity, proprioceptive feedback deficits, secondary lung problems, organ disorders and pain. In addition, the quality of life in these individuals is also seen to decrease.

There are no studies in the literature examining the effects of Schroth exercise training on trunk muscle strength, respiratory muscle strength, trunk muscle stiffness, balance and quality of life in children with adolescent idiopathic scoliosis.

The aim of our study is to examine whether Schroth exercise training has an effect on trunk muscle strength, trunk muscle stiffness, respiratory muscle strength, balance, quality of life and perception of cosmetic deformity in children with adolescent idiopathic scoliosis. It is thought that this study will fill the gap in the literature with the original information it will bring to the literature and will shed light on future studies.


Eligibility Criteria:
Inclusion Criteria:

* Patients with AIS scoliosis
* Individuals agreeing to participate in the study
* Patients between the ages of 10-20
* Patients with AIS whose Cobb angle measured on X-ray is between 15-40 degrees

Exclusion Criteria:

* Documented diagnosis any of cardiopulmonary, neurological, orthopedic or mental disorders which may affect the assessments results.
* Patients previously undertaken any of spinal surgeries.
* Patients involved in exercise training 3 or more days a week
Neuromodulation in Patients With Hamstring Shortening

The flexibility of the hamstrings is a very important component both for general health and when exercising. The lack of hamstring flexibility has been related to the increase in the likelihood of suffering a large number of musculoskeletal pathologies, due to the possibility of causing important muscle imbalances, which include lumbar spine pathologies, such as disc hernias or spondyloarthrosis. In addition, the decrease in the flexibility of the hamstring musculature is also related to the increased likelihood of suffering muscle strains, patellar tendon tendinopathies, femoropatellar syndrome and decreased lumbopelvic rhythm.

Clinically, an invasive technique has appeared, known as Ultrasound-guided Percutaneous Neuromodulation (PNM). This minimally invasive intervention consists in the application of a percutaneous electrical stimulation (PES) through an acupuncture needle-like electrode that is placed in close proximity to the nerve or motor point of the muscle with ultrasound guidance. At the clinical level, the PES is always used with the therapeutic aim of relieving chronic pain and neuropathic pain. Similarly, in sports, PES is used with the aim of improving muscular activity. Therefore, according to the characteristics and the therapeutic benefits of this technique, further research is needed to discover multiple clinical indications.

The aim of this study was to examine the effects on flexibility and strength of an ultrasound-guided percutaneous neuromodulation intervention in patients with shortening of the hamstring muscles.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years
* to practice some sports activity 2 or more times a week
* get less than 70º in PKE (Passive Knee Extension) with hip 90º

Exclusion Criteria:

* any previous surgery or acute trauma in the back or lower extremity.
* pain at the time of performing the assessment tests
* belonephobia
* anticoagulant consumption
* pregnancy
* hemorrhagic disorders
* immunosuppression
* inability to understand or carry out evaluations
Bone-To-Implant Contact At 4- And 6-Week Healing Stages in Implants With Different Surfaces.

Objective: Implant surface topography is a key element in achieving osseointegration. Nanostructured surfaces have shown promising results in accelerating and improving bone healing around dental implants. The main objective of the present clinical study is to compare, at 4 and 6w, bone-to-implant contact in implants having either machined surface (MAC), SLA medium roughness surface or a Nanostructured Calcium-Incorporated surface (XPEED®). Thirty five mini-implants with 3 different surface treatments (XPEED® (n=16) - SLA (n=13) - Machined (n=6)), were placed in the posterior maxilla of 11 patients then retrieved at either 4 or 6w in a randomized split-mouth study design.


Eligibility Criteria:
Inclusion Criteria:

* • Height of the residual bone crest in the programmed implant site ≥ 9 mm and thickness ≥ 7mm.

  * Availability, in each sector, of sufficient mesio-distal space allowing placement of 2 standard-sized implants and at least 2 mini-implants (3.5x8.5mm) for retrieval.
  * Healed bone crest (≥ 3 months elapsed after extraction or tooth loss).
  * Age \> 18 years.
  * Ability to examine and fully understand the study protocol.

Exclusion Criteria:

* • Myocardial infarction within the past 6 months.

  * Poorly controlled diabetes (HBA1c \> 7.5%).
  * Coagulation disorders.
  * Radiotherapy to the head/neck area within the past two years.
  * Present or past treatment with intravenous bisphosphonates.
  * Immunocompromised patients.
  * Psychological or psychiatric problems.
  * Alcohol or drug abuse.
  * Poor oral hygiene and motivation (full mouth plaque score \> 30% and/or full mouth bleeding score \> 20%).
  * Uncontrolled periodontal disease.
Trial of Vitamin D Supplementation in Asthma

The study null hypothesis is that vitamin D supplementation will not influence time to upper respiratory tract infection or time to severe asthma exacerbation in adult and adolescent patients with asthma.


Eligibility Criteria:
Principal Inclusion Criteria:

* Medical record diagnosis of asthma
* Age ≥ 16 years and ≤ 80 years on day of first dose of IMP
* If a woman of child-bearing potential, is sexually abstinent or has negative pregnancy test within 7 days of recruitment and agrees to use reliable form of contraception until she has completed the study
* Able to give written informed consent to participate in the study

Principal Exclusion Criteria:

* Diagnosis of COPD
* Known sarcoidosis, hyperparathyroidism, nephrolithiasis, active tuberculosis, vitamin D intolerance, liver failure, renal failure, terminal illness, lymphoma or other malignancy not in remission for ≥ 3 years
* Any other condition that, in an investigator's judgement, might compromise patient safety or compliance, interfere with evaluation or preclude completion of the study
* Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone
* Taking dietary supplement containing vitamin D up to 2 months before first dose of IMP
* Treatment with any investigational medical product or device up to 4 months before first dose of IMP
* Breastfeeding, pregnant or planning a pregnancy
* Baseline corrected serum calcium \> 2.65 mmol/L
* Baseline serum creatinine \> 125 micromol/L
* Smoking history \>15 pack-years
Effects of Lansoprazole on Sitagliptin Glucose-lowering Ability in Healthy Males: a Randomised Crossover Study

Oral hypoglycemic medications sometimes do not control type 2 diabetes well. Proton pump inhibitors (PPIs) as adjunctive therapy might improve diabetes control and could enhance the hypoglycemic activity of DPP4, but there is little clinical data on efficacy of this therapeutic strategy. The investigators sought to examine the effect of PPI lansoprazole, DPP-4 inhibitor sitagliptin, and their combination therapy on insulin and glucose regulation in healthy subjects in oral glucose tolerance (OGTT).

Oral hypoglycemic medications sometimes do not control type 2 diabetes well. Proton pump inhibitors (PPIs) as adjunctive therapy might improve diabetes control and could enhance the hypoglycemic activity of DPP4, but there is little clinical data on efficacy of this therapeutic strategy. We sought to examine the effect of PPI (lansoprazole), DPP4 (sitagliptin), and their combination therapy on insulin and glucose regulation in healthy subjects in oral glucose tolerance (OGTT).

Eligibility Criteria:
Inclusion Criteria:

* General good health condition
* Male subject, between 18 and 50 years

Exclusion Criteria

* Overweight (Body Mass Index ≥30)
* Metabolic disorders
* History of gastrointestinal disorders
* Regular (daily) intake of medication
* Smoking more than 10 cigarettes/day
* History of drug abuse
* Exhaustive (\> 3 units/day) alcohol consumption
* Exhaustive (\> 5 units/day) caffeine consumption (coffee, tea, cola, or other caffeine based drinks)
* Recent (in the last 14 days) donation of blood
* Recent (in the last 2 days) donation of blood plasma
* Participation in another trial within 4 weeks before the start of the study
Effect of Transversus Thoracic Muscle Plane Block (TTMP) on Analgesia

In this prospective and controlled study, the investigators investigated the effect of transversus thoracic muscle plane block (TTMP) on analgesia in patients who undergo coronary artery bypass graft (CABG) surgery with median sternotomy. For this purpose, the investigators aimed to compare the hemodynamic responses to surgical incision and sternotomy and, pain intensity, total analgesic consumption, additional analgesic requirements of the patients in the first 24 hours after extubation under postoperative patient-controlled analgesia (PCA) adminisration.

Forty-six patients aged 18-70 years, ASA class I-III, who undergo CABG surgery were included in our study. The patients were randomized into the TTKPB group and the control group. Heart rate (HR) and mean arterial pressure (MAP) were recorded before peroperative induction, before skin incision, after skin incision, before sternotomy and after sternotomy. PCA with tramadol was applied after extubation and "Numeric rating scale" NRS scores, total tramadol consumption, number of requests and additional analgesic requirements were recorded at 0, 1, 2, 4, 8, 12 and 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiologists) classification I-III
* Coronary artery bypass graft operation with median sternotomy under elective conditions

Exclusion Criteria:

* Refusing to participate in the study
* Under 18 and over 70
* ASA class IV and above
* EF (Ejection Fraction) \< 40%
* Emergency surgery or reoperation
* Intraaortic balloon pump placement
* Known allergy to local anesthetics
* Coagulation disorder
* Infection at the block site
* History of sternotomy
* Those with chronic pain complaints and long-term use of analgesics
* Patients who could not be extubated within 12 hours after the operation
Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain

This is a phase 3, multicenter, randomized, double-blind, multiple-dose, parallel-group, placebo-controlled study to evaluate the safety and efficacy of up to 3 dosing regimens of Buprenorphine Sublingual (under the tongue) Spray and/or matching placebo in participants with moderate to severe postoperative pain after bunionectomy. The study will comprise 4 periods: the Screening Period, the Surgical Period, the Treatment Period, and the Follow-up Period.

Participants will be admitted to the study site on the morning of the scheduled surgery, will remain at the study site until postoperative Day 3 (a total of 3 nights at the study site), and will return for the Follow-up Visit 5 to 9 days after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Meets protocol-specified criteria for qualification and contraception
* Is able to speak and understand the language in which the study is being conducted, is able to understand the procedures and study requirements and has voluntarily signed and dated an informed consent form approved by the Institutional Review Board before the conduct of any study procedure
* Is willing and able to comply with study requirements (including diet, alcohol, and smoking restrictions), complete the pain evaluations, remain at the study site for three days, and return for follow up between 7 and 9 days after surgery.

Exclusion Criteria:

* History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
* Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  1. the safety or well-being of the participant or study staff
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  3. the analysis of results
Inpatient and Outpatient Balloon Catheter Cervical Ripening

A randomised controlled trial comparing cervical ripening using foley catheter as in- or outpatient setting.

The study evaluated the efficacy and safety of outpatient versus inpatient Foley catheter cervical ripening and patients' satisfaction. Sixty low-risk women were randomized to outpatient and inpatient management of intracervical Foley catheter digital insertion. The outpatient group was provided with verbal and written 24-hours contact information and instructions. Both groups were reassessed the next morning unless labor had begun or the catheter had dropped off.

Eligibility Criteria:
Inclusion Criteria:

* singleton
* gestational age beyond 37 weeks
* cephalic presentation
* intact membranes
* Bishop score less than 6
* lives within 10km from National University Malaysia Medical Centre or able to reach within 30 minutes
* readily available transport

Exclusion Criteria:

* intrauterine death
* intrauterine fetal growth restriction
* estimated fetal weight more than 4000gram
* fetal anomalies
* abnormal pre-induction cardiotocograph
* non-vertex presentation
* unstable lie
* sepsis
* hypertension
* allergy to latex
* previous uterine scar
* history of antepartum haemorrhage
* parity of 6 and more
* placenta praevia
* suspected cephalopelvic disproportion
Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan

The purpose of this study is to determine the efficacy of Lenalidomide/Dexamethasone + Elotuzumab in the subjects with newly diagnosed, previously untreated Multiple Myeloma (MM) in Japan.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Newly diagnosed with symptomatic Multiple Myeloma (MM)
* Have not received any prior systemic anti-myeloma therapy
* Have measurable disease
* Are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204-116 for a subject \< 65 years old. There must be a comorbidity that prevents SCT for a subject \< 65 years old

Exclusion Criteria:

* Non-secretory myeloma
* Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
* Monoclonal Gammopathy of Undetermined Significance (MGUS)
* Active plasma cell leukemia
* Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
The Effects of Jing Si Herbal Tea on Physical and Psychological Symptoms in Peripheral Blood Hematopoietic Stem Cell Donors

This study aim to explore the impact of Jing Si Herbal Tea on pain and emotional stress in peripheral blood stem cell donors.


Eligibility Criteria:
Inclusion Criteria:

* health Men or women aged 20 to 55 years old
* willing to take Jing Si Herbal Drink

Exclusion Criteria:

* no willing to take Jing Si Herbal Drink;
* Previously already take Jing Si Herbal Drink daily
Once Weekly Subcutaneous Ports for the Administration of Anticoagulants

The purpose of this study is to ascertain whether subcutaneous ports are an effective and reliable way to administer the low molecular weight heparin (LMWH) enoxaparin to patients for the prevention or treatment of venous thromboembolism.

Subcutaneous ports have recently been used to administer Low Molecular Weight Heparin (LMWH) to patients for the prevention or treatment of venous thromboembolism; however, no studies have been performed to evaluate the ports' reliability in delivering this type of drug. Hence, it is not known whether absorption of the drug is constant over the seven-day lifespan of the port. Although the use of subcutaneous ports is not currently the standard of care, health care providers are more frequently using this as an alternative method to direct injection of LMWH, particularly in pediatric patients.

The main advantage of subcutaneous ports is the decreased number of needle sticks when using the ports to administer the medication. However, it is possible that, due to potential repeated bleeding into the subcutaneous space at the port site or other factors, drug absorption may decrease over the seven day lifespan of the port, resulting in a decrease of plasma drug level. Subtherapeutic LMWH levels and, hence, ineffective anticoagulation may result. This study's aim is to determine if the current use of subcutaneous ports is a safe, effective and reliable way of administering LMWH for the purpose of anticoagulation.

Eligibility Criteria:
Inclusion Criteria:

* Subjects receiving once or twice daily dosing of therapeutic doses of subcutaneous Enoxaparin.
* Subject has been on the same dose of Enoxaparin for at least one week.
* Anticipated length of Enoxaparin treatment at least 4 weeks.
* Age ≥ 18 years.
* Subject demonstration of proper subcutaneous catheter care during one education session with the investigator.

Exclusion Criteria:

* Chronic renal insufficiency with glomerular filtration rate \< 30 mL/min.
* Pregnancy
* Venous thromboembolism within the last 4 weeks.