cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part III

The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO thermoregulation care alone. Part III is for preterm/low birth weight infants with or without a plastic torso wrap during the first hour after birth to assist with temperature regulation during placement in an incubator.

Incubators in the developing world often lack humidifiers. The resting dry heat increases evaporative heat loss, the most prominent form of heat loss in premature infants due to their increased body surface area and immature stratum corneum. By potentially increasing humidity around the infants and decreasing evaporative heat losses, plastic bags may improve incubator warming. This study will compare the incidence of hypothermia in infants placed in an incubator for at least one hour randomized to receive standard incubator protocol (control group) or standard incubator protocol plus a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken before placement into the incubator and one hour later when the bag will be removed. Blood pressure, blood sugar, seizures, weight gain, hyperthermia, death, observation for respiratory distress syndrome, bronchopulmonary dysplasia, pneumothorax, sepsis, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, intestinal perforation, pulmonary hemorrhage, incubator temperature, and humidity, and length of time in an incubator will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 90% and a hypothesized 20% absolute risk reduction (22% relative risk reduction), a sample size of 118 will be used to have a power of 80% and a confidence interval of 95%.

Eligibility Criteria:
Inclusion Criteria:

* Infant admitted to the NICU
* Current weight between 1,000 and 2,500g
* Being placed in an incubator

Exclusion Criteria:

* Abdominal wall defect or myelomeningocele
* Major congenital anomalies
* Blistering skin disorder
The Pharmacology/Aging Clinic

The treatment of HIV and the tests performed for HIV care have changed over the last 20 years. However, improvement of management of HIV-infected subjects is still warranted, especially as the HIV-infected population is aging. Therefore, this study will involve the collection and analysis of clinical information obtained from subjects who are over 50 years of age. For example, patients' risk of heart disease will be measured and monitored by looking at blood tests and clinical data (such as blood pressure). This will allow researchers to understand if the current way of assessing the risk of future heart disease is the best one available for HIV-infected individuals. No genetic research will be done.

Patients will be asked to read the information contained in this leaflet. No extra visits will occur; all samples will be collected at their routine visits to the pharmacology clinic. All blood samples and results will be managed by the routine clinical laboratory at Chelsea and Westminster Hospital, with the exception of the assessment of the hsCRP. The latter is a marker of inflammation that is measured to be able to add more information when cardiovascular risk is assessed. The blood sample for this test is sent to a laboratory in London called The Doctors Laboratory (TDL). All shipped samples are anonymous and patient names will not be disclosed outside the Hospital.

The clinical visits will be scheduled approximately once within one year. However, extra visits may be clinically necessary if a clinical condition requires proper follow-up. Furthermore, clinical details will be marked to show patients have agreed to their use for this research study.

Eligibility Criteria:
Inclusion Criteria:

1. The ability to understand and sign a written informed consent form
2. HIV-infected patients attending the Pharmacology/Aging Clinic (HIV/GUM Directorate, Chelsea and Westminster Hospital NHS Foundation Trust)

Exclusion Criteria:

None
Tobacco Exposure and Influencing Factors of Smoking Cessation Among Chronic Kidney Disease Patients

The purpose of this study is to describe the tobacco exposure and characteristics of patients with Chronic Kidney Disease (CKD) who quit smoking, to identify patients' tobacco-related knowledge, attitude, and practice (KAP) and explore the influencing factors of smoking cessation.

Participants will be invited to recall their smoking status and tobacco-related KAP. Smokers need to identify their smoking cessation behavior.

First part: participants need to finish the questionnaire, which includes the demographic information sheet, characteristics of smoking sheet, and tobacco-related KAP. Including (a) patients' knowledge of health risks of tobacco and tobacco-related diseases (the delphi method was used to construct this knowledge questionnaire); and (b) perceptions of tobacco harm.

Second part: smokers need to finish the questionnaire, which includes history of smoking cessation sheet, attitudes towards tobacco control smoking cessation, nicotine dependence sheet, tobacco withdrawal symptoms sheet, intention to quit smoking sheet, ability to quit smoking sheet, alcohol use disorders and physical activity.

Eligibility Criteria:
Inclusion Criteria:

1. Participants aged 18 years or older;
2. Participants with a confirmed diagnosis of Chronic Kidney Disease;
3. Participants were able to speak and read Chinese.;

Exclusion Criteria:

1. Participants who with psychiatric illness, disorders of consciousness, communication impairments, were unable to communicate effectively;
2. Participants who have acute and life-threatening exacerbations which require urgent treatment;
3. Patients who currently involved in other smoking cessation programs.
Comparison of Soy-milk and Cow Milk Consumption on Inflammatory Factors, Cardiovascular Factors ,Renal Factors, Fibrinolytic Indice and Oxidative Stress Among Type-2 Diabetic Patients With Nephropathy Stage 1 and 2

Soymilk components such as isoflavones, essential fatty acids, phytoesterols, good fats, inositols might have beneficial effects on controlling complication among diabetic nephropathy patients(DN).Most studies in this regard have been examined the effect of soy consumption on cardiorenal risk factors among patients with DN and there are few data about relationship of soy milk consumption and health effect in patients with DN . Therefore, we evaluated the effects of soy milk compared to cow's milk on blood pressure, inflammation, oxidative stress and fibrinolytic markers and cardiorenal risk factors among these patients. This was a cross-over randomized clinical trial which was conducted in Isfahan among diabetic nephropathy patients. Patients were randomly assigned to consume a diet containing cow's milk or a diet in which only one glass of soy milk was substituted; each one for 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* adults with (\>18y old) diagnosis of type 2 diabetics nephropathy (diabetics subjects that had proteinuria more than 300 mg/day and had GFR more than 90 mL/min )

Exclusion Criteria:

* exclusion criteria included diabetic nephropathy patients that they were pregnant or lactation women
* changing dosage of oral hypoglycemic agents
* insulin therapy
* lipid-lowering medications
* use of hormone replacement therapy
* alcohol and cigarette consumption;allergy or intolerance to soybeans or milk
* presence of breast malignant and avoid of advisory diet
A Phase II Study of Postoperative S-1-Based Chemoradiotherapy in Gastric Cancer

The aim of this phase II trial was to evaluate the feasibility, efficacy and tolerability of intensity-modulated radiotherapy combined with S-1 based chemotherapy in patients with pathologically positive lymph node after completely resected gastric cancer. Furthermore, the investigators sought to compare the dosimetric differences between the volumetric-modulated arc therapy (VMAT), Tomotherapy and intensity-modulated radiotherapy (IMRT) techniques in treatment planning for gastric cancer as adjuvant radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven positive lymph node gastric adenocarcinoma in patients undergoing R0 resection
* Any prior chemotherapy is allowed in this protocol
* No distant metastasis in liver,lung,,bone,central nervous system(CNS),no peritoneal transplantation
* No prior abdominal or pelvic radiotherapy
* Karnofsky performance status(KPS)≥ 70, predictive life span no less than 6 months
* Patients must have normal organ and marrow function as defined below:

  * Leukocytes greater than or equal to 3,000 G/L
  * Platelets: greater than or equal to 100,000/mm3
  * Hemoglobin:greater than or equal to 10g/L
  * Total bilirubin: within normal institutional limits
  * AST/ALT: less than or equal to 1.5 times the upper limit
  * Creatinine within normal upper limits
* Informed consent

Exclusion Criteria:

* Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
* With any distant metastasis in liver,lung,,bone,CNS,or peritoneal transplantation
* History of allergic reactions attributed to similar chemical or biologic complex to S-1
* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
* History of prior radiation to the abdomen
* Pregnant or lactating females
A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss

This study compares two types of diet interventions: a low carbohydrate ketogenic diet (Atkins) and a low-fat diet combined with a medication (Orlistat).

Overweight and obesity are increasingly prevalent in the veteran population as well as the general public. For patients with obesity-associated illnesses, there are few effective treatment options available after failed attempts at diet and exercise, even though weight loss has been shown to alleviate these conditions. The purpose of this study is to compare the tolerability, safety, and efficacy of a low-carbohydrate ketogenic diet (Atkins) with a combination of a low-fat diet and Orlistat. The outcomes examined over a 48 week duration will include body weight, risk factors for heart disease (e.g., lipid profiles), and blood sugar. This is a randomized, parallel-intervention trial. Subjects (n=150) will be recruited from the Durham VAMC Ambulatory Care Clinics. All patients receive one of the two intensive weight loss interventions.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have a VA medical center primary care provider;
* Failed first line diet and exercise recommendations;
* In stable health by screening physical and lab tests;
* Agrees to make regular visits per study protocol;
* Has access to telephone;
* Body mass index (BMI) \> or = 27 with obesity-related illness OR BMI \> or = 30 with no risk factors;
* No contraindications to Orlistat;
* Not pregnant or breast-feeding;
* No serious mental health illness such as dementia or schizophrenia;
* No use of a weight loss therapy in the month prior to screening.

Exclusion Criteria:

* No VAMC primary care provider
* Unable to attend regular study visits
* No access to telephone
* BMI \< 27
* Contraindications to Orlistat
* Pregnancy, breast feeding or planning to become pregnant
* Unstable mental health illness
* Use of a weight loss therapy in the month prior to screening
AZD9668 Relative Bioavailability

The study is designed to investigate the pharmacokinetic behaviour of the free base formulation of AZD9668. The study will compared the relative bioavailability of the free base formulation at two different dose levels compared to the tosylate salt formulation.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study-specific procedures
* female subjects may be of non-child bearing potential (i.e. post menopausal or surgically sterile).
* Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 calculated from height and weight at the screening visit; minimum weight 50 kg.
* Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol, cotinine and negative test results for Hepatitis B surface antigen, antibodies to Hepatitis C virus and antibodies to HIV-1/2 at the screening visit
* Be a none smoker or ex-smoker who has stopped smoking for \>6 months prior to visit 2 (pre-entry)

Exclusion Criteria:

* Any clinically significant disease or disorder (eg infections/viral disease, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment), which in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the absorption, distribution, metabolism and excretion of drugs.
* Any clinically relevant abnormal findings in physical examination, vital signs, clinical chemistry, haematology, urinalysis, which, in the opinion of the investigator, may put the subject at risk because of his/her participation in the study
* History of cardiac arrhythmia
Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice:

The purpose of this study is to determine whether the implementation of pre-emptive pharmacogenomic (PGx) testing of a panel of clinically relevant PGx markers, to guide the dose and drug selection for 39 commonly prescribed drugs, will result in an overall reduction in the number of clinically relevant drug-genotype associated ADRs which are causally related to the initial drug of inclusion (referred to as 'index drug').


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

1. Subject must be ≥ 18 years old
2. Subject must receive a 1st prescription (meaning no known prescription for this drug in the preceding 12 months) for a drug included in Table 1, which is prescribed to them in routine primary care.
3. Subject is able and willing to take part and willing to be followed up on for 48 weeks
4. Subject is able to donate saliva
5. Subject has signed informed consent
6. Subject meets requirement for computer access implying computer literacy as measured by active use of the patient portal or their email

Exclusion Criteria:

1. For the investigational arm only: Previous (direct-to-consumer, or clinical) pharmacogenomic testing that includes any of the genes included in the Focused Pharmacogenomics Panel
2. Pregnant or lactating (to be verbally confirmed with the patient)
3. Life expectancy estimated to be less than three months as determined by patient receiving hospice care
4. Duration of index drug total treatment length is planned to be less than seven consecutive days.
5. Current inpatients
6. Unable to consent to the study
7. Unwilling to take part
8. Subject has no permanent address
9. Subject has no current primary care provider
10. Subject is, in the opinion of the study coordinator after discussion with participating clinician/pharmacist/investigator, not suitable to participate in the study
11. Patient has a diagnosis of stage 4 or 5 chronic kidney disease (CKD) or is receiving dialysis
12. Patients with advanced liver failure (stage Child-Pugh C) or a diagnosis of liver cirrhosis
13. History of a liver transplant or an allogeneic hematopoietic stem cell transplant
14. DNA sample collected that requires retesting in the event that DNA collected was not sufficient for testing as determined by the laboratory
Sympathetic Activity and Renal Denervation

Primary hypothesis:

Catheter-based renal denervation reduces central sympathetic activation in patients with refractory hypertension.

Secondary hypotheses:

1. The magnitude of the individual depressor response after catheter-based renal denervation depends on the extent of sympathoinhibition.
2. Both, the reduction in arterial pressure and in central sympathetic activation are sustained over time up to 24±3 months after catheter-based renal denervation.
3. Catheter-based renal denervation resets the sympathetic baroreflex to lower blood pressure values.


Eligibility Criteria:
Inclusion Criteria:

* Refractory hypertension (as defined by the WHO: poorly controlled hypertension (\>140/90 mmHg) despite adequate doses of at least three antihypertensive drugs including a diuretic)
* Men or women aged \>18 years
* Intact peroneal nerve
* Written informed consent

Exclusion Criteria:

* Diseases, dysfunctions, or medications (such as NET inhibitors) that exclude a participation in the study according to the investigator.
* Legal incompetence or circumstances that interfere with the patient´s ability to fully understand scope, relevance, and/or consequences of participation in this study.
* People in custody
* hypersensitivity to clonidine, phenylephrine, or nitroprusside-sodium
* sick sinus syndrome, second or third degree AV block, bradycardia \< 50 bpm (contraindication for clonidine)
* endogenous depression (contraindication for clonidine)
Clinical Pharmacist-led Inpatient Anticoagulation Stewardship Program

This study aims at evaluating the implementation of clinical-pharmacist-led anticoagulation stewardship program in Egyptian tertiary hospital to promote a culture of safety around anticoagulants.

One of the high-alert medication categories that may cause significant patient harm if not used correctly is anticoagulants. It is not clear if medication errors are more common with this category in specific compared to other medication categories, but the ramifications of a medication error with the use of anticoagulation agents is without a doubt detrimental to the patient's health and more serious than most of other drug categories.

This prospective study evaluates the impact of implementing an anticoagulation stewardship program, led by clinical pharmacists, on anticoagulation therapy outcomes during patient hospitalization by the percent of medication errors reduction, percent of adverse drug events reduction, and percent of evidence-based guidelines compliance improvement.

Eligibility Criteria:
Inclusion Criteria:

All hospitalized patients on therapeutic anticoagulant medication during their hospitalization period.

Exclusion Criteria:

1. Patients whose age is less than 18 years old.
2. Patients who were admitted for less than 24 hours for patient on parenteral anticoagulants and less than 48 hours for patient on warfarin.
3. Patients already admitted for bleeding or thrombosis.
4. Malignancy patients.
Efficacy of IPL Treatment of Dry Eye and Ocular Rosacea

Dry eye disease (DED) is a common condition that causes ocular discomfort and reduces visual acuity. The two categories of DED are evaporative dry eye and aqueous deficient dry eye. Both conditions can involve pathology of the meibomian glands, lacrimal glands, lids, tear film and surface cells. Meibomian gland dysfunction (MGD) is the leading cause of evaporative dry eye and contributes to aqueous deficient dry eye. The goal of MGD therapy is to provide long term improvement of symptoms for patients by improving the quality of meibum, increasing meibum flow, improving tear film stability and decreasing inflammation.

Commonly used therapies include preservative free drops, omega-3 fatty acid supplementation, topical cyclosporine, serum tears, topical azithromycin, oral doxycycline, moisture chambers, intraductal probing, lib margin exfoliation, automated thermal pulsation, warm compresses, among other. Despite this variety of symptoms, patients often do not experience complete or long term relief of symptoms.

Forced meibomian gland expression (MGX) has been shown to be an effective method of rehabilitating meibomian glands and improving dry eye symptoms. The eyelid margins are forcefully compressed to express gland contents. Research has shown improvement in patient symptoms with the use of MGX.

Intense pulsed light (IPL) have been used in dermatology to treat various conditions. Patients with DED who have tried other therapies and found no relief, often resort to IPL as a last resort. Research has shown IPL alone may be effective in improving patient symptoms. In addition, such studies have failed to show significant adverse events with the use of IPL.

Here, we propose a prospective, randomized, case controlled clinical pilot study to examine the efficacy for both subjective and objective measures. 20 patients with DED will be recruited and will be randomly assigned to one of two groups: MGX alone or MGX with IPL. Objective measures will include tear cytokine levels, impression cytology, meibography, tear osmolarity and others. Subjective measures will include quality of life screening tools.

We hypothesize that the use of MGX with IPL will lead to greater improvement in subjective dry eye symptoms and objective measures. Given the lack of adverse effects reported in the literature, we do not anticipate adverse effects in our study.

Rochester staff Drs. Faustch and Bourne are providing clinical research advice but have no contact with subjects or biospecimens.


Eligibility Criteria:
Dry eye of moderate severity with ocular rosacea diagnosed by ophthalmologist. No contraindications of severe ocular surface disease or inability to be safely treated with IPL.

Dry eye symptoms must be alleviated with topical anesthetic. No GVHD, Stevens Johnson, active allergic conjunctivitis or other conjunctivitis, alkali burn history.

Subjects must have at least 50% meibomian glands viable on meibography and no new treatments for dry eye in the past 6 months.

Contact lenses and refractive surgery is okay.
Safety and Pharmacokinetics Evaluation Study According to the Dose of Camostat Mesylate in Healthy Volunteers

Safety and pharmacokinetics evaluation study according to the dose of camostat mesylate in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged ≥ 19 and ≤ 55 years at screening
* Subjects with body weight of ≥ 55.0 kg and ≤ 90.0 kg, and a body mass index (BMI) of ≥ 18.0 and ≤ 29.9
* Subjects who have no congenital or chronic disease and have no pathological symptoms or findings as a result of an internal examination

Exclusion Criteria:

* Subjects with current or prior history of a clinically significant hepatic, renal, nervous, respiratory, gastrointestinal, endocrine, hematologic and oncologic, urogenital, cardiovascular, musculoskeletal or psychiatric disorder
* Subjects with symptoms of acute disease within 28 days prior to the scheduled first administration date of IP
* Subjects with a history of gastrointestinal diseases (e.g., Crohn's disease, ulcers, etc.) or gastrointestinal resection (except simple appendectomy or hernia surgery) that may affect the absorption of drugs.