cyrilzakka/clinical-trials huggingface dataset:
The Effect of Acupressure Chemotherapy-related Nausea Vomiting in Children

This study is carried out to evaluate and compare the efficiency of acupressure practice applied with pressure or sea-band and their placebo on managing the acute nausea-vomiting symptoms developing due to chemotherapy in pediatric oncology patients.

Every year children aged 0 to 19 years old are diagnosed with cancer around the world. For pediatric oncology patients, chemotherapy-related acute nausea and vomiting are among most common symptoms and has a bad influence on quality of life. When it cannot be prevented, it can cause serious medical problems. Continuous, repetitive and unavoidable vomiting affects patients' and their families' quality of life adversely, causing delay or even termination in chemotherapy treatment. It is a well-known fact that medical treatment is insufficient to control nausea and vomiting symptoms. Therefore, supportive care is needed besides medical treatment. One of the approaches mentioned is acupressure. Non-invasive stimulation of the P6 acupuncture point is a harmless and complementary approach to health. The point between flexor carpi radialis and palmaris longus, located at a three finger distance from the wrist crease, is named as "P6 Nei-Guan". This acupuncture point, placed on the pericardium channel, is generally used to harmonize stomach and relieve the vomiting. Acupressure is a way of stimulation applied on acupuncture points by finger, palm or acustimulation bands (sea-band, relief band) and can be used for children as well. Acupressure is defined as one of the complementary health approaches which nurses can apply. It is stated that this method, which is non-invasive, economical, easy to apply and reliable, has no side effect and patients can apply to themselves with a good guidance.

Chemotherapy-related nausea and vomiting are among the symptoms affecting children's quality of life and their adaptation to the treatment. There are limited amount of research intended to manage pediatric oncology patients' chemotherapy-related nausea and vomiting symptoms by using acupressure. It is thought that the research will provide significant contribution for literature, nursing practice and the quality of patient care since power of the study is high and it is the first study which efficiency of wrist-band, manuel acupressure and placebos is being compared for management of chemotherapy-related acute nausea and vomiting symptoms in pediatric oncology patients.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 5-18,
* Who have a chemotherapy protocol with a high and moderate emetogenic effect according to MASCC / ESMO Antiemetic Guidance Classification
* Not having a verbal communication disorder.

Exclusion Criteria:

* If the participants did not receive chemotherapy or were receiving it for the first time,
* Branching, redness, phlebitis, edema, open wound, fracture, infection, etc. in the wrist
* Any obstacles for the verbal assessment of the child (intubation, etc.).
Hemodialysis-based Interventions to Preserve Cognitive Function

This will be a pilot, single center, randomized, controlled trial to slow cognitive decline in adults undergoing hemodialysis (HD). The investigators will test two interventions (cognitive training and exercise training) against the standard of care.

This will be a pilot, single center, randomized, controlled trial to slow cognitive decline in adults undergoing hemodialysis (HD). The investigators primary objective is to demonstrate feasibility for the interventions (cognitive training and exercise training) in Aim 1. The investigators will formally test whether whether cognitive training (tablet-based brain games) and exercise training (stationary foot pedal) administered during HD slow cognitive decline as well as improve secondary outcomes (physical function, frailty, and health-related quality of life (HRQOL) as part of Aim 2. The investigators will compare these two interventions against the standard of care. Pre- and post-intervention assessments will be conducted at the dialysis unit by a study coordinator and by research assistants. Participants will be followed for 6 months to assess cognitive decline.

Eligibility Criteria:
Inclusion Criteria:

* Men and women with end stage renal disease and receiving hemodialysis at the DaVita Dialysis Centers located at 409 N. Caroline St., Baltimore, MD will be approached by our study coordinator to determine eligibility.

  * Must be at least 18 years or older at enrollment
  * Must be English speaking
  * Must be willing to participate in research and able to give informed consent

Exclusion Criteria:

* Chronic lung disease requiring oxygen
* Cerebrovascular disease
* Musculoskeletal conditions that limit mobility
* Lower or upper extremity amputation
* Orthopedic disorders exacerbated by physical activity
* Decreased mental capacity
* Dementia (diagnosed)
Strength Training for Elderlies and Their Effects on Muscle Fatigue and Microcirculation - Randomized Clinical Trial

The purpose of this study is to verify the effects of a strength training program on functional capacity, muscle performance and microcirculation in the elderly.

Purpose

The primary research question is:

Do muscular strength training programs can improve functional capacity, muscle performance and microcirculation in the elderly? Hypothesis: Strength training program will promote electromyographic changes during the development of peripheral muscle fatigue and microcirculatory blood flow contributing to functional autonomy.

Secondary Research Questions

1. Does the strength training program in the elderly improve the standard of electromyographic fatigue? Hypothesis: Elderly practitioners of strength exercise program showed increased neuromuscular efficiency and electromyographic fatigue index.
2. Do the strength training program in the elderly improve peripheral microcirculation? Hypothesis: A regular program of strength exercise in the elderly increases the blood flow in peripheral microcirculation changing the process of muscle fatigue. These biomechanical and physiological changes contribute to increased functional autonomy and reducing the risk of falls in the elderly.

Eligibility Criteria:
Inclusion Criteria:

* sedentary elderly
* individuals who have physical and medical conditions to perform strength training
* individuals who participate in the Open University Maturity Program

Exclusion Criteria:

* individuals who do not have physical and medical conditions to perform strength training
Clopidogrel Pharmacogenetics (PGX) Bench to Bedside

Clopidogrel (also known as Plavix) is used commonly in patients to prevent heart attacks and conditions caused by blood clots. Although clopidogrel works in many individuals, some people do not respond as well to this drug. The variation in treatment response may be linked to genetics. This study will examine the effects of clopidogrel in a population in which sequencing for certain genes has been performed in order to determine the role that genes play in the response to various clopidogrel maintenance doses.

Clopidogrel is a prodrug with high inter-individual response variability. Clopidogrel is converted to an active drug in part through an enzyme encoded by the gene named CYP2C19. Individuals with genetically-impaired CYP2C19 metabolism have lower capacity to convert the prodrug to its active form. Consequently, these individuals have lower blood levels of the activated form of clopidogrel, diminished antiplatelet responses, and higher rates of cardiovascular events and stent thrombosis. Increasing doses of clopidogrel in such patients represents a possible approach to managing the gene-drug interaction.

The purpose of this study is to evaluate whether increasing the dose of clopidogrel increases antiplatelet responses and active metabolite exposure in individuals with genetically reduced CYP2C19 metabolism relative to those with normal CYP2C19 metabolism.

The primary objective is to assess changes in clopidogrel response and exposure at three clopidogrel dose levels and with coadministration of omeprazole.

Eligibility Criteria:
Inclusion Criteria:

* Amish men or women between 20 and 70 years of age who participated in PAPI

Exclusion Criteria:

* Severe hypertension (bp \> 160/95 mm Hg)
* Co-existing malignancy
* Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) \> 2 times normal
* Creatinine \>2.0
* Hct \< 32 or Hct \> 50
* Thyroid Stimulating Hormone (TSH) \< 0.40 or \>5.50
* History of bleeding disorder or gastrointestinal bleeding
* History of unstable angina, myocardial infarction (MI), angioplasty, coronary artery bypass surgery
* History of atrial fibrillation, stroke or transient ischemic attacks or deep vein thrombosis
* Type 2 diabetes
* Thrombocytosis (platelet count \> 500,000) or thrombocytopenia (platelet count \< 150,000)
* Surgery within six months
* Clopidogrel allergy
* Pregnant women
* Currently breast feeding
* Omeprazole allergy
* Prospective participants taking medications that would affect the outcome(s) to be measured and who cannot willingly and safely, in the opinion of the treating physician and study physician, discontinue these medications for 1 week prior to protocol initiation, or who are taking vitamins and/or other supplements and who are unwilling to discontinue their use for at least 1 week prior to study
Nasal Olfactory Stimulation and Its Effect on Respiratory Drive in Preterm Infants

This trial analyzes the effect of an olfactory stimulation with vanilla or strawberry aroma compared to placebo on desaturations and bradycardia in preterm infants with apnea of prematurity. Infants on continuous positive airway pressure (CPAP) support will be included and the aroma will be applied to the inner surface of the CPAP mask using designated scent pens. The trial uses a cross-over design. Infants are randomised to begin the study with either aroma or placebo which will be applied into the breathing mask every 3 to 4 hours during 12 hours for each of the two intervention periods. Identically looking pens with either aroma or placebo are used and patients, parents, medical staff and the study team are blinded to this allocation. Infants are monitored with an oximetry sensor to measure peripheral oxygen saturation (SpO2) and pulse rate.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age at birth: 23 0/7 to 31 6/7 weeks
* Postnatal age: \>72 hours old
* Respiratory support: nCPAP
* Treatment with caffeine citrate for apnea of prematurity
* Written informed consent by one of the patient's parents

Exclusion Criteria:

* Olfactory impairment such as choanal atresia
* Intraparenchymal intracranial hemorrhage or intraventricular hemorrhage with ventricular dilation
* Culture-proven sepsis during the study period or any acute clinical deterioration requiring an intervention such as intubation or a new start of antibiotic treatment.
* Severe congenital malformation adversely affecting life expectancy
Study of Low-Dose Radiotherapy (LDRT) Concurrent Cisplatin/Carboplatin Plus Etoposide With Atezolizumab for Patients With Extensive-Stage Small Cell Lung Cancer

This is a Phase II, single arm, multicenter study designed to evaluate the safety and efficacy of low-dose radiotherapy (LDRT) concurrent cisplatin/carboplatin plus etoposide with atezolizumab in participants who have extensive-stage small cell lung cancer (ES-SCLC) and are chemotherapy-navïe for their extensive-stage disease.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed ES-SCLC
* No prior treatment for ES-SCLC
* Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation.
* ECOG performance status of 0 or 1
* Life expectancy \>= 3 months
* Adequate hematologic and end-organ function
* For participants receiving therapeutic anticoagulation: stable anticoagulant regimen
* Negative human immunodeficiency virus (HIV) test at screening
* Negative hepatitis B surface antigen (HBsAg) test at screening
* Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: Negative total hepatitis B core antibody (HBcAb), or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test. The HBV DNA test must be performed for participants who have a negative HBsAg test, a negative HBsAb test, and a positive total HBcAb test.
* Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test must be performed for participants who have a positive HCV antibody test.
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Exclusion Criteria:

* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* History of leptomeningeal disease
* Uncontrolled tumor-related pain
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
* Uncontrolled or symptomatic hypercalcemia
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
* Active tuberculosis
* Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
* History of malignancy other than small cell lung cancer (SCLC) within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death
Efficacy and Safety Study of Ingavirin® 90 mg Once Daily to Treat Influenza and Other Acute Viral Infections in Adults

The purpose of this study is to determine whether Ingavirin® 90 mg once daily is effective and safe for the treatment of influenza and other laboratory confirmed acute respiratory viral infections in the course of standard therapy in patients 18-60 years old.

Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy and Safety of Ingavirin in the Treatment of Influenza and Other Acute Viral Respiratory Infection. Study treatment was 5 days followed by 2 ± 1 days of follow up period. Thus, study participation was 7 ± 1 days (8 days max).

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically diagnosed influenza, body temperature ≥ 38 ºС or other acute respiratory viral infection, body temperature ≥ 37 ºС, with no less than 2 symptoms of catarrhal and intoxication each:

  * Intoxication symptoms: Dizziness, headache, chills, fever, sweating, fatigue, myalgia, pain while moving eyes, flushing, pale skin, sleep disturbances, decreased appetite, nausea, vomiting, epistaxis, cyanosis, meningeal signs.
  * Catarrhal symptoms: Sore throat, rhinorrhea and nasal congestion, difficulty swallowing, hoarseness, stridor, wheezing, rattling dry and wet cough, expectoration.
* Laboratory confirmation of viral origin of the disease
* Uncomplicated influenza and other acute respiratory viral infections
* Interval between onset of symptoms and enrollment to the study not more than 48 hours
* Have read, understood and signed an informed consent form

Exclusion Criteria:

* Complicated course of influenza and other acute respiratory viral infections (secondary bacterial infection)
* Pregnancy and Breastfeeding
* Severe decompensated or unstable medical or psychiatric conditions (any diseases or conditions that threaten the life of the patient or worsen the patient's prognosis)
* Cancer, HIV infection, tuberculosis, including those in history
* History of alcohol and drug abuse
Stressor-evoked Brain and Cardiovascular Responses to Acute Psychological Stress

The present study will examine the relationship between metabolically excessive cardiovascular and neural responses to acute psychological stress using a cross-sectional approach.

All participants in this study will undergo an acute psychological stress paradigm, there will be no randomization or assignment since all participants will complete the same tasks. Sample size was calculated based off of recent papers examining multivariate pattern brain responses predicting cardiovascular responses to stress.

Eligibility Criteria:
Inclusion Criteria:

18-30 years old

Exclusion Criteria:

Chronic medical or neurological condition Pregnant Current illness or infection Any condition that would prohibit engaging in physical exercise Any metal implants in body Claustrophobia
A Study to Evaluate the Effects of Vildagliptin on the Insulin Response to Glucose in Subjects With Pre-diabetes

This is an exploratory study to assess whether vildagliptin, an unapproved drug, can increase insulin secretion in subjects with pre-diabetes who have a defect in the insulin response and elevated levels of fasting glucose.


Eligibility Criteria:
Inclusion Criteria:

* BMI in the range 22-45 and with a stable weight for the last 6 months
* Blood glucose criteria must be met
* Written informed consent

Exclusion Criteria:

* Pregnancy or lactation
* Previous diagnosis of type 2 diabetes or treatment with hypoglycemic agents
* Type 1 diabetes
* Evidence of cardiovascular complications as defined by the protocol
* Evidence of diabetic complications as defined by the protocol
Anti-inflammatory Effects of Colchicine in PCI

Peri-procedural inflammation is associated with increased rates of post-procedural myocardial infarction (MI), which occur in up to 35% of PCI patients and are themselves associated with increased risk of later MI and death. Statins suppress both inflammatory markers and MI rates during and after PCI, but ≥ 40% of PCI patients go statin-untreated, due in part to side effects such as myalgia. Moreover, because their mechanism of action relies on post-translational effects, statins must be given ≥ 12 to 24 hours prior to PCI, a time frame that is not always feasible. The investigators propose a novel alternative approach to reduce inflammation during PCI employing colchicine, an anti-inflammatory medication used frequently in gout and pericarditis. Colchicine may be particularly applicable to the PCI setting due to its rapid onset of action and excellent side-effect profile at low doses, as well as its known mechanisms of action. However, data on colchicine use in patients with coronary disease is extremely limited, and no studies to date have evaluated the use of colchicine in patients undergoing PCI. The investigators aim to characterize a potential mechanism of benefit in patients undergoing PCI by evaluating the effects of colchicine on soluble and leukocyte surface markers after PCI. The investigators also aim to determine the effects of colchicine on peri-procedural myonecrosis and MI. Accordingly, the investigators propose a prospective randomized study to characterize the effect of colchicine on inflammation and peri-procedural myocnecrosis. Patients referred for possible PCI will be randomized in a double-blinded fashion to placebo or colchicine (1.2mg 1 to 2 hours before PCI, followed by 0.6mg 1 hour later). The primary endpoint will be post-procedural interleukin-6 level. Secondary endpoints will include other relevant soluble and leukocyte-associated inflammatory markers. Sample size needed is 200 patients undergoing PCI. To adjust for a floor effect, 280 patients undergoing PCI will be needed. 400 patients will likely be needed to be enrolled to reach 280 PCIs (the remaining will have undergone a diagnostic only procedure). Of note, this is a substudy of the COLCHICINE-PCI trial (NCT 02594111)


Eligibility Criteria:
Inclusion Criteria:

* Patients must be more than 18 years of age and referred for coronary angiography

Exclusion Criteria:

* Plan for diagnostic-only coronary angiography
* On colchicine chronically
* History of intolerance to colchicine
* Glomerular filtration rate \<30mL/minute or on dialysis
* Active malignancy or infection
* History of myelodysplasia
* High-dose statin load \<24 hours prior to procedure
* Use of oral steroids or non-steroidal anti-inflammatory agents other than aspirin within 72 hours or 3 times the agent's half-life (whichever is longer)
* Use of strong CYP3A4/P-glycoprotein inhibitors (specifically ritonavir, ketoconazole, clarithromycin, cyclosporine, diltiazem and verapamil)
* Unable to consent
* Participating in a competing study
High Dose Chemotherapy and Allogeneic Hematopoietic Cell Transplant for Non-Hodgkin's Lymphoma

To evaluate the role of allogeneic hematopoietic cell transplantation in the treatment of NHL.

To determine safety and toxicity of a regimen of high dose chemotherapy with allogeneic peripheral blood progenitor cell transplantation; determine the efficacy of the procedure by following clinical outcomes and quality of life measures; and evaluate graft versus host disease incidence and severity with regimen.

Eligibility Criteria:
Inclusion Criteria:Morphologically confirmed relapsed non-Hodgkin's lymphoma

Age: \>18 and \<61 years of age

Signed informed consent Exclusion Criteria:Hepatic dysfunction defined by serum transaminases \>2.5X normal values

Serum creatinine of \> 2 mg/dl or creatinine clearance \< 60 ml/min

Diseases other than non-Hodgkin's lymphoma

Prior bone marrow transplant procedure

Severe psychological or medical illness
Study of the Concentration-effect Relationship of Nivolumab in Patients With Kidney or Lung Cancer

To assess the relationship between progression free survival of patients treated with nivolumab for metastatic non small cell lung carcinoma or a metastatic renal cell carcinoma and nivolumab blood concentration.

Collection of standard data prospectively.

Nivolumab is a monoclonal antibody used for the treatment of non small cell lung carcinoma and renal cell carcinoma. Huge variability exists between patients treated by nivolumab in terms of efficacy and side effects. Like others monoclonal antibodies, a relation between concentration and effects of nivolumab may exist.

The aim of this study is to assess the relationship between blood concentration of nivolumab and progression free survival, overall survival and side effects on the one hand, and on the other to describe pharmacokinetic of nivolumab

Eligibility Criteria:
Inclusion Criteria:

* Patient with squamous or non squamous non small cell lung cancer stage IV or patient with renal cell carcinoma stage IV
* Patient receiving nivolumab or who will receive nivolumab
* Age ⩾ 18 years old
* OMS stage ≤ 2
* Evaluable disease

Exclusion Criteria:

* Active brain metastasis not treated before by surgery or radiotherapy
* Autoimmune disease
* Patient having objected to the processing of his data
Investigation Of How PD 0332334 And Metformin Are Eliminated From The Body When They Are Administered At The Same Time

1. To estimate the effects of multiple doses of PD 0332334 on the elimination of a single dose of metformin from the body
2. To estimate the effects of multiple doses of metformin on the elimination of a single dose of PD 0332334 from the body
3. To evaluate the safety and tolerability when PD 0332334 and metformin are administered at the same time.

Detailed Description:

Additional Study Purpose Details: To assess the pharmacokinetics of metformin and PD 0332334 with concurrent administration.

On February 18th 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Nonsmokers
* Male or female adults

Exclusion Criteria:

* Current or history of significant medical illness
* Smokers
* Illicit drug use