cyrilzakka/clinical-trials huggingface dataset:
Effects of an Adaptogenic Extract on Electrical Activity of the Brain in Elderly Subjects With Cognitive Impairment

A randomized, double-blind, placebo-controlled, two arm cross-over study to determine whether a specific combination of Andrographis paniculata and Withania somnifera can be regarded as a safe and effective treatment for cognitive deficits.


Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers suffering from cognitive deficits.
* Questionnaire-DemTect. "DemTect" (for pre-selection of subjects) - score values 8-12 are regarded as conclusive.
* Age between 60 and 75 years (both included).
* Subjects should be right-handed.
* Subject must be capable of giving informed consent.
* Acceptance of written consent to participate in the study after instruction in written and oral form (informed consent).

Exclusion Criteria:

* Subjects with acute or chronic diseases that are relevant to the study and asked for by the study staff are excluded.
* Acute or chronic disease with an impact on the study, which becomes obvious by case history or clinical examination.
* Clinically relevant allergic symptoms.
* Detection of alcohol at the time of initial examination (day SC) or on study day A (positive alcohol test) or by case history.
* Consumption of clinically relevant medication during last 14 days before and during the active study period based on the notification of the subject or his case history.
* Consumption of medication with primarily central action (i.e. psychotropic drugs or centrally acting antihypertensive drugs). Known intolerance / hypersensitivity (allergy) to plant derived extracts or any of the ingredients of the investigational product (anamnestic).
* Presence of a rare, genetic disease such as fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase deficiency (anamnestic).
* Consumption of unusual quantities or misuse of coffee (more than 4 cups a day), tea (more than 4 cups a day).
* Detection of alcohol at the time of initial examination as well as on day A, B, C and D (alcohol test).
* Smoking in the study center on study days A, B, C and D.
* Result of the DemTect Questionnaire score \<8 or \>12.
* Participation in another clinical trial within the last 60 days.
* Bad compliance.
* Cancellation of informed consent.
Bioimpedance as a Tool for Fluid Management in Peritoneal Dialysis (PD) Patients

Hypothesis: The investigators hypothesize that regular monitoring of BIA adds value to the management of fluid status in PD patients

Objectives of the study: The objective is to show that in patients where the additional information of body composition is available to the clinician that the ECFv is maintained within pre-agreed limits, \~ 1 liter, over the observation period of 12 months.

SCIENTIFIC BACKGROUND:

Low peritoneal ultrafiltration, and by inference low sodium removal, is associated with worse outcomes in PD. Equally, excessive fluid removal is a risk factor for dehydration and loss of residual renal function. Current guidelines have advocated a daily UF volume of 1litre; their blunt application could lead to either inappropriate early loss of residual function or modality transfer. There is a significant need for evidence on how to best manage fluid status in PD patients, both in terms of an appropriate clinical strategy and also a simple but reproducible tool to guide clinicians in how to apply this strategy.

It is likely that BIA will become the standard tool to aid clinicians in assessing fluid status. It is simple to perform, intervention studies have demonstrated its ability to identify changes in fluid status in response to changes in therapy and it is a powerful predictor of patient survival. There is, however a clear need at this stage for proof of principle studies to establish its true potential for added value in the routine management of patients.

Body composition changes spontaneously with time on PD. Short term changes in hydration (specifically extracellular fluid volume, ECFv) combined with medium term changes in muscle and fat make it difficult for the clinician to be sure if fluid status is stable. It is anticipated that regular BIA measurements will aid the clinician in managing this problem over and above monitoring of weight and fluid status. By randomizing patients into two groups who have regular BIA measurements, one of which the BIA data is available to the clinician it will be possible to see if these spontaneous changes in body composition can be accounted for.


Eligibility Criteria:
Inclusion Criteria:

* All PD patients who are clinically stable

Exclusion Criteria:

* Patients planning discontinuation of PD within 6 months.
* Patients who are unable to give consent.
* Patients who have peritonitis the last 30 days prior to study enrollment.
* Patients who are pregnant.
Barriers to Patients' Early Presentation, Diagnosis and Treatment in Childhood Hydrocephalus

Patient with childhood hydrocephalus (HC) tend to present late in Low medium income countries (LMICs). This project will study the barriers leading to patients' and health system delay in patients with childhood HC. This will be done via a quantitative and qualitative study analysis. The data will be collected prospectively.

Children less than 5 years of age with HC confirmed with either magnetic resonance or computerized tomographic images will be recruited. In addition, Hospital staff members, who have been working within the Neurosurgical unit for at least 5 years will be interviewed.

The patients' data that will be collected will include gender, age at presentation, socioeconomic class of parents (or guardians), religion, referral source, presenting complaint with its duration, physical findings, ventricular diameter. The Pre-presentation symptoms interval (PPI) will be defined as the number of days between the onset of symptoms and first presentation at any type of healthcare service centre (including primary healthcare centre, secondary health institutions); Presentation Interval (PI)- Number of days from symptoms to presenting at Neurosurgical centre; Pre-diagnostic interval (PDI) will be defined as the interval in days between symptoms and completion of pre-operative investigations. Patient interval (PI) will be defined as the number of days from the onset of symptoms and patient's first contact with the Neurosurgical center. Hospital interval (HI)- number of days from completion of investigations to surgical intervention. The collected data will be analyzed according to qualitative conventional content analysis. Nvivo software version 13 and Statistical Product and Service Solutions (SPSS) version 23 will be used for data analysis.

Eligibility Criteria:
Inclusion Criteria:

* All patients less than 5 years of age with HC confirmed with either magnetic resonance or computerized tomographic images
* Patients' parents' inclusion criteria will be parents (Guardians) of children with radiologically confirmed HC with either magnetic resonance or computerized tomographic images.
* Hospital staff members, who have been working within the Neurosurgical unit for at least 5 years.

Exclusion Criteria:

* All patents not investigated or operated at our centre
* Patients older than 5 years
Job Strain, Ambulatory Blood Pressure and Hypertension

To analyze the association between an objective measure of "job strain" and risk of stroke, and change in ambulatory blood pressure.

BACKGROUND:

Cardiovascular disease accounts for 43 percent of all deaths in the United States. Hypertension affects as many as 50 million Americans, however the causes of essential hypertension are not well known. A new CVD risk factor ("job strain") has emerged as a potential major cause of essential hypertension. By 1995, over 20 studies had found significant positive relationships between "job strain" and CVD, coronary heart disease, all-cause mortality or hypertension. "Job strain" is defined as high psychological workload demands combined with low"decision latitude". An expanded concept of "job strain" which included low workplace social support ("iso-strain") was developed and examined in the study.

Important questions remained to be answered about "job strain", CVD and hypertension. In most studies, "job strain" was only measured at one point in time, while, in fact, cumulative exposure to "job strain" was believed to be the risk factor. In addition, most studies relied on self-report measures of "job strain". Also, no studies specifically examined risk of stroke and "job strain".

DESIGN NARRATIVE:

Data from the Cornell University cohort study of Psychosocial Factors and Cardiovascular Disease and the Columbia University-Northern Manhattan Stroke Study were analyzed. The study had five specific aims, including to determine whether: blood pressure levels were associated with cumulative exposure to "job strain"; differences in blood pressure increases were associated with an objective measure of "job strain"; increased risk of stroke was associated with an objective measure of "job strain"; changes in psychological variables over time were associated with job characteristics; changes in CVD risk factors (other than hypertension) were associated with job characteristics.

Paul Landsbergis also constructed measures of cumulative exposure to "job strain" and determined their association with blood pressure, and analyzed the association between job characteristics and change in psychological variables and cardiovascular disease (CVD) risk factors.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Comparison of Low and Intermediate Dose Low-molecular-weight Heparin to Prevent Recurrent Venous Thromboembolism in Pregnancy

This is a randomized-controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the American College of Chest Physicians (ACCP), but it is not known which dose is more efficacious in preventing recurrent venous thromboembolism in pregnancy.

Patients enter the study and will be randomized as soon as a home test confirms pregnancy. LMWH will be administered until 6 weeks postpartum. Follow-up will continue until 3 months postpartum. Patients will be recruited by their treating physician, either an obstetrician or internist.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years or older, and;
* Pregnancy confirmed by urinary pregnancy test, and;
* Gestational age \< 14 weeks, and;
* Previous objectively confirmed VTE, either unprovoked, in the presence of use of oral contraceptives or estrogen/progestagen use, or related to pregnancy or the postpartum period, or minor risk factors (e.g. long distance travel, minor trauma).

Exclusion Criteria:

* Previous VTE related to a major provoking risk factor (e.g. surgery, major trauma or plaster cast immobilisation in the 3 months prior to VTE) as the sole risk factor, or;
* Indication for treatment with therapeutic dose anticoagulant therapy (e.g. treatment of acute VTE; permanent use of therapeutic anticoagulants outside of pregnancy), or;
* Inability to provide informed consent, or;
* Any contraindication listed in the local labelling of LMWH.
Exploratory Interventional Study of Prognostic Serum Biomarkers of Cancer Progression

Exploratory interventional study of prognostic serum biomarkers of cancer progression.

Study of the relationship between the blood levels of soluble PDL1 and β2-microglobulin, and the clinical course of a metastatic solid tumor treated with a first-line therapeutic of checkpoint immune inhibitor.

Primary objective To study the relationship between the blood levels of soluble PDL1 and β2-microglobulin measured at the diagnostic stage, and the clinical course of a metastatic solid tumor (non-small cell lung cancer, kidney cancer, or melanoma) treated with a 1st line therapeutic immune checkpoint inhibitor.

The secondary objectives are:

* To study the relationship between the blood levels of soluble PDL1 and β2-microglobulin measured during treatment, and the clinical course of a metastatic solid tumor treated with a first-line therapeutic immune checkpoint inhibitor.
* To study the correlation between the soluble PDL1 level and the tumor PDL1 level.
* To study the correlation between the blood levels of soluble PDL1 and β2-microglobulin.
* To study the relationship between the blood levels of soluble PDL1 and β2-microglobulin measured during the treatment, and the tolerance of treatment with immune checkpoint inhibitor in 1st line therapy.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient, male or female, with metastatic cancer of the non-small cell, renal or malignant melanoma type, eligible for treatment with a first-line immune checkpoint inhibitor (immunotherapy alone or in combination with another immunotherapy, chemotherapy or targeted therapy).
* Affiliation to a Social Security organization
* Able to give informed consent to participate in research.

Exclusion Criteria:

* Pregnant women
* Patient under guardianship, curatorship or legal protection
* Patient unable to understand the protocol (language barrier, cognitive difficulties)
* Patient with another active cancer
* Patient with creatinine clearance \<60 mL / min
* Patient participating in a therapeutic clinical trial
* Refusal of participation
Preventive Effect of Leg Wrapping Combined With Trendelenburg Position on Hypotension Induced by Propofol

Although propofol is widely used as an induction agent for a general anesthesia, it can induce a profound hypotension, which leads to the hypo-perfusion of end organs and eventually increases morbidities. Theoretically, applying Trendelenburg position (head down and leg up position) increases cardiac preloads and cardiac outputs. However, in past researches, changing to Trendelenburg position alone is not enough and does not prevent propofol induced hypotension. Previous studies proved that leg wrapping effectively prevent hypotension after neuraxial anesthesia during Cesarean section. The leg wrapping prevents hypotension by increasing vascular resistance of lower extremities. The investigators made a hypothesis that applying both Trendelenburg position and leg wrapping prevent propofol induced hypotension more effectively than either applying Trendelenburg position only or taking no preventive measures.

\*\* Study procedure

1. check baseline blood pressure ( systolic, diastolic, mean) and heart rate.
2. apply pre-defined measures to each group(arm) ( summarized in arms and interventions section )
3. induction using propofol 2mg/kg
4. After bispectral index (BIS) goes below 60 \& patient become unconsciousness, inject rocuronium 0.6mg/kg
5. intubate patient between 3 and 4 minutes after propofol injection
6. measure blood pressure ( systolic, diastolic, mean ) \& heart rate at 1,2,3,4,5 minutes after propofol injection
7. phenylephrine injection if hypotension develops

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist's physiologic status class 1, 2, and 3.
* under general anesthesia

Exclusion Criteria:

* severe cardiac/pulmonary/liver/renal disease
* BMI \> 30 kg/m2
* known or risk factor of increased intraocular pressure or intracranial pressure
* uncontrolled hypertension
* high risk for propofol allergy
* allergies to medications related to anesthesia
* mechanical difficulties with leg wrapping ( wound on legs, devices on legs )
* emergent operation
* high risk of gastric aspiration ( gastrointestinal obstruction, short nil per os(NPO) time )
* patient wearing elastic stocking for therapeutic purpose
Health Information Technology in the Nursing Home

The magnitude and intensity of medication use among our nation's 1.6 million nursing home residents matches or exceeds that of hospitalized patients. The residents of nursing homes are among the most frail patients in the population; the challenges of using medications in this setting are great, not only because of the physiologic declines and pharmacologic changes that occur with aging, but also because of the special clinical and social circumstances that often characterize nursing home care. In our previous research, we have determined that medication errors resulting in adverse drug events occur most often at the ordering and monitoring stages of pharmaceutical care. Clinical decision-support systems are clinical consultation systems that combine individual patient information with population statistics and scientific evidence to offer real-time information to health care providers. These systems have been found to improve the quality of medication prescribing in the hospital setting. In this study, we intend to determine the extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring for residents in the long-term care setting through a randomized trial. We will track the costs associated with this system and the system's impact on the productivity of providers. We will also assess the culture of U.S. nursing homes and the organization of the nursing home setting with respect to readiness to incorporate computerized provider order-entry with computer-based clinical decision support. Our project addresses specific areas that are of particular interest to AHRQ with special relevance to the delivery of high-quality care to a priority population--the frail elderly patient population residing in nursing homes. The project will assess the economic implications of health information technology in the nursing home environment that will be of interest to key stakeholders, including physicians, pharmacists, nurses, payers, policymakers, the nursing home industry, and pharmaceutical vendors to long-term care institutions.


Eligibility Criteria:
Inclusion Criteria:

* prescriber at the study facility

Exclusion Criteria:

* not a prescriber at the study facility
Randomized Placebo-Controlled Study of Aerobic Exercise and Resistance Training Plus Megestrol Acetate for HIV-Wasting

OBJECTIVES: I. Evaluate the effect of aerobic exercise and progressive resistance plus megestrol acetate on lean body mass of patients with human immunodeficiency virus-related weight loss (HIV-wasting).

II. Evaluate whether exercise acutely alters immune function. III. Evaluate whether long-term exercise improves immunocompetence. IV. Evaluate the accuracy of multifrequency bioelectrical impedance spectral analysis in measuring body composition.

V. Assess the impact of these therapies on quality of life. VI. Evaluate the effect of these therapies on the balance of energy intake and energy expenditure.

PROTOCOL OUTLINE: Patients are randomly assigned to 1 of 3 therapy groups: megestrol acetate alone, exercise plus megestrol acetate, or exercise plus placebo. Therapy continues for 12 weeks.

A single dose of oral megestrol acetate or placebo is administered each morning.

The exercise program consists of aerobic exercise and resistance training performed 3 times a week under supervision. Hard aerobic exercise is performed for 45 minutes plus a warm-up and cool-down period; the patient chooses to work on 3 of 5 pieces of exercise equipment. Exercise intensity is adjusted to a heart rate corresponding to 65% of maximal oxygen consumption.

Resistance training is done on a universal gym; exercises are designed to work all 6 major muscle groups. Each exercise is performed at 70% of maximal single repetition resistance. Resistance is increased 5% when the patient can perform 15 repetitions without failure.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Human immunodeficiency virus seropositive with acquired immune deficiency syndrome

Documented weight loss 5% to 15% below ideal weight

--Prior/Concurrent Therapy--

No concurrent appetite stimulants

At least 6 weeks since initiation of new antiretroviral therapy

--Patient Characteristics--

Performance status: Karnofsky 70%-100%

Hepatic: No ascites

Renal: No nephrosis

Other:

* No acute or untreated infection within 4 weeks prior to entry
* No hospitalization within 2 weeks prior to entry
* No gonadal insufficiency
* No edema
* No pleural effusion
* No uncontrolled diarrhea
* No physical or functional obstruction to food intake
* No physical handicap that would prevent resistance or aerobic exercise
* No cardiac abnormality that would render aerobic exercise a health risk
* No concurrent regular exercise of 3 or more hours a week
* No mental incompetence
Safety and Pharmacokinetic Interaction Study of Tadalafil and Dutasteride

This is an open-label, two-arm, one-sequence, cross-over study to evaluate the safety and pharmacokinetic interaction after oral concomitant administration of tadalafil and dutasteride in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age 20 to 29 years 2. Weight 60 kg or more, within 20% of Ideal body weight 3. No congenital or chronic diseases, no disease symptoms or findings 4. Eligible according to the laboratory results of hematology, blood chemistry and urinalysis 5. Voluntarily signed the informed consent form

Exclusion Criteria:

* 1. Clinically significant disorders of hepatobiliary system, kidney, neurology, respiratory, hemato-oncology, endocrine, dermatology, urology, ophthalmology, psychiatry, musculo-skeletal system, immunology, otorhinolaryngology, and cardiovascular system 2. Gastrointestinal diseases or surgery which may affect absorption of the investigational products 3. hypersensitivity to tadalafil or phosphodiesterase type 5 inhibitor, and dutasteride or 5-α reductase inhibitor 4. Lactose intolerance 5. SBP ≥ 140 mmHg or \< 90 mmHg or DBP ≥ 95 mmHg or \< 60 mmHg 6. Serum creatinine \> ULN 7. History or positive result of drug abuse 8. Drugs which induce or inhibit drug metabolism including barbiturates within 1 month 9. Prescribed drugs or herbal medicines within 2 weeks, or over-the counter drugs or vitamins within 1 week 10. CYP3A4 inhibitors or CYP3A4 inducers within 2 weeks 11. Food including grapefruit from Week -1 to final dose 12. Participated and administered the investigational products in other clinical trial within 2 months 13. Donated whole blood within 2 months or apheresis within 1 month, or transfusion within 1 month 14. Plans to donate blood for at least 6 months after final dose of dutasteride 15. Scheduled dental treatment and elective surgery from informed consent to post-study visit 16. Excessive alcohol consumption (\> 21 units/week, 1 unit = 10 g of pure alcohol) 17. Smoked more than 10 cigarettes a day for past 3 months 18. Not eligible due to other reasons including laboratory results