cyrilzakka/clinical-trials huggingface dataset:
Can Protein Intake be Increased by Offering Protein-enriched Foods and Drinks?

The objective of this study is to investigate whether a protein-enriched daily menu is acceptable and effective in increasing protein intake in elderly in a residential care home up to an intake of 1,2 gram/ kg body weight per day.

The investigators hypothesise that when elderly eat 2 slices of bread, 1 portion of juice and 1 portion of soup each day, the protein intake can be increased by at least 20 grams/day. On average this can lead to an intake of 1,2 gram/ kg body weight per day.

Rationale: Due to inactivity, elderly are prone to lose muscle mass. With an increased protein intake, muscle mass might be maintained. The current recommendation for protein intake for elderly is the same as for younger adults, but researchers and geriatricians appeal for a higher recommended protein intake to maintain health and function. One way to reach a higher intake is by providing protein-enriched foods. Because of concerns that these foods are more satiating, careful monitoring of protein intake after introducing these foods is warranted.

Objective: To investigate whether a protein-enriched daily menu is acceptable and effective in increasing protein intake in elderly in a residential care home up to an intake of 1,2 gram/ kg body weight per day.

Study design: Dietary intake will be monitored before and after introducing a protein-enriched daily menu. The menu will be provided for 10 days to all residents of the care home. For residents who give consent, intake will be recorded by trained research assistants and nurses on 2 consecutive days before the pilot and on days 9 and 10 of the pilot. After the pilot residents will return to their regular menus.

Study population: The study population consists of elderly men and women (aged 65 or older) living in a care home in Wageningen, the Netherlands.

Intervention: A protein-enriched daily menu for 10 days.

Main study parameters/endpoints: Protein intake and resident satisfaction with the menu.

Eligibility Criteria:
Inclusion Criteria:

* Aged 65 or older
* living in care home Nudehof
* able to give consent
* without dietary protein restrictions

Exclusion Criteria:

* cognitive impaired
* having dementia
* having dysphagia
* receiving only tube feeding
* known kidney disease
* having food allergies that exclude them from having the protein-enriched products
* following a low protein diet or a diet low in sodium
* receiving palliative care
Comparison of the Hemodynamic Effect of Three Positions During Induction of Anesthesia

The most common methods for prevention of post-induction hypotension are preoperative fluid loading and vasopressors. Leg elevation induces an intrinsic transfusion of 150 mL blood from the lower limbs to the central fluid compartment. Leg elevation was previously reported by our group to decrease the incidence of maternal hypotension after spinal anesthesia for caesarean delivery. Passive leg raising was also reported to provide a stable hemodynamic profile during induction of anesthesia for cardiac surgery. Head-down position was previously reported as a useful measure for management of hypovolemia in various patient groups. No studies to the best of our knowledge had evaluated the compare both positions (leg elevation position and head-down position) during induction of anesthesia in non-cardiac surgery

Upon arrival to the operating room, routine monitors (ECG, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and routine pre-medications (ranitidine 50 mg and midazolam 3-5 mg) will be administrated.

Before induction of anesthesia, patients will be randomly allocated into:supine group, head-down group or leg elevation group Baseline mean arterial blood pressure will be obtained as average of 3 reading before induction of anesthesia at supine position.

Induction of anesthesia will be achieved using fentanyl (2 mcg/Kg), propofol (2 mg/Kg), and atracurium (0.5 mg/Kg). Endotracheal tube will be inserted after 3 minutes of mask ventilation. Anesthesia will be maintained by isoflurane (1-1.5%) and atracurium 10 mg increments every 20 minutes. Ringer lactate solution will be infused at a rate of 2 mL/Kg/hour.

Any episode of hypotension (defined as mean arterial pressure \< 80% of the baseline reading) will be managed by 5 mcg norepinephrine. If the hypotensive episode persisted for 2 minutes, another bolus of norepinephrine will be administered.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (18-60 years), american society of anesthesiologist physical status I-II, scheduled for elective non-cardiac surgery under general anesthesia

Exclusion Criteria:

* Patients with cardiac morbidities (impaired contractility with ejection fraction \< 50%, heart block, arrhythmias, tight valvular lesions), patients on antihypertensive medications, and patients with uncontrolled hypertension will be excluded from the study. Patient with decompensated respiratory disease (poor functional capacity, generalized wheezes, peripheral O2 saturation \< 90% on room air), patients at increased risk of aspiration (Inadequate fasting time, chronic renal failure, diabetes mellitus, BMI≥40 kg/m2, Gastroesophageal reflux disease, Gastrointestinal obstruction, Previous upper gastrointestinal surgery and/or undergoing Upper gastrointestinal surgery), pregnant patients and patients with increased intracranial tension will be also excluded from the study
the Observance of Emergency Exit Treatments During the Stay of Care at the Exit of Reims Emergencies

The investigators would like to include patients consulting in a Accident and Emergency Department (AED) during the permanence of care the week of March 11 to 17, 2018. The data collection would concern socio-demographic data, their consultation to the AED, the follow-up given to the consultation and would take place by telephone contact of patients within 48 hours of the consultation.

why patients come to the emergency room, what are they waiting for? what are their main motivations? what do they do in emergencies, do they follow the treatments and recommendations?

Study of the observance of emergency exit treatments during the permanence of care. This is a descriptive study with a prospective data collection that does not alter the management of the patient. The study is epidemiological, cross-sectional, prospective inclusion.

The investigators would like to include patients consulting in a AED during the permanence of care the week of March 11 to 17, 2018. The data collection would concern socio-demographic data, their consultation to the AED, the follow-up given to the consultation and would take place by telephone contact of patients within 48 hours of the consultation.

The objective is to study the follow-up given by the consultation to the emergencies, in terms of compliance, follow-up of the recommendations, the objective sought by the patient coming to the emergency department.

Understand the motivation of the consultation and why the treatment was not followed where appropriate.

Is there a sociodemographic explanation or is it the health network that results in the saturation of emergency services? Does the system still meet the expectations of people using it?

Eligibility Criteria:
Inclusion Criteria:

* adults
* consultation during the early stages of care
* leaving after consultation
* agrees to participate in the study

Exclusion Criteria:

* minor patients
* permanently off care
* hospitalized patients
* refusal to participate in the study
Randomized Study of Polyethylene-Glycol-Conjugated Interleukin 2 in Patients With Common Variable Immunodeficiency

OBJECTIVES: I. Determine whether polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) can reduce the number of infections in patients with common variable immunodeficiency.

II. Determine whether this therapy can improve lung functions in these patients with pulmonary impairment.

PROTOCOL OUTLINE: This is a randomized, open-label study. Patients are randomized to receive polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) or placebo.

Patients receive PEG-IL-2 or placebo by subcutaneous injection weekly for 18 months. Patients maintain a daily diary for 24 months.

Patients are followed every 4 months for 2 years.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Documented common variable immunodeficiency defined as a reduction of serum IgG by at least 2 standard deviations

In vitro lymphocyte proliferative response to PEG-IL-2 of at least 10 times more than unstimulated cultures

--Prior/Concurrent Therapy--

No biologic response modifier therapy (i.e., interferon, cyclosporin A) except prednisone (maximum 10 mg/day)

Concurrent treatment with same dosage intravenous gamma-globulin for at least 6 months is required

--Patient Characteristics--

Life expectancy: At least 24 months

Other: Not pregnant or nursing HIV negative
Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder

This is an open trial that seeks to determine the safety and tolerability of using inositol for children and adolescents with bipolar disorder and comorbid anxiety disorders with an exploration of efficacy and dose-response.

Anxiety disorders are common comorbidities among children and adolescents with bipolar disorder. Treatment with standard pharmacologic agents may worsen mood problems or lead to drug dependency. Inositol has shown benefits for bipolar depression in adults. This is an open multi-case control study. The investigators will enroll 20 children and adolescents ages 8-17 treated at the Child and Adolescent Bipolar Services (CABS) at Western Psychiatric Institute and Clinic. Participants' involvement will be 14 weeks, including the initial titration of the supplement, maintenance, and taper. Primary outcomes will include standard measures of mood and anxiety. Also, physiologic measures including body mass index and bedside glucose will be followed.

Eligibility Criteria:
Inclusion Criteria:

1. Evidence in the medical record confirming the DSM-V diagnosis of bipolar disorder. If this documentation is not in the record, then the appropriate sections of K-SADS will be administered to confirm the diagnosis.
2. Evidence in the medical record confirming the DSM-V diagnosis of anxiety disorder including; separation anxiety disorder, generalized anxiety disorder, and/or social phobia. If this documentation is not present or is more than 2 years old, then the appropriate section of the K-SADS will be administered to confirm diagnosis.
3. At least moderate severity of anxiety symptoms as determined by score of ≥ 13 on the Pediatric Anxiety Rating Scale (PARS).
4. On a stable dose of psychotropic medications for at least one month, with no major changes projected.

Exclusion Criteria:

1. Presence of prominent diarrhea.
2. Diagnosis of diabetes mellitus.
3. Presence of active suicidal ideation and behavior or psychosis. B-SSRS ideation score greater than 1. B-SSRS behavior score greater than 0.
4. Weight less than 20 kg.
5. Known pregnancy.
EGFR-TKI With Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism

BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in patients who had NSCLC with EGFR mutations. In the study, the investigators want to use EGFR-TKI with chemotherapy as first line treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.

BIM deletion polymorphism was a poor clinical response marker to EGFR-TKIs in NSCLC patients who had EGFR mutations. In the study, the investigators want to use EGFR-TKI with chemotherapy as 1 st treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.

Eligibility Criteria:
Inclusion Criteria:

Signed informed consent Age \>=18 years Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC) A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology) Must have measurable or non-measurable disease Must be able to comply with study and follow-up procedures

Exclusion Criteria:

Small cell, carcinoid, or mixed small cell lung cancer Malignancies within 3 years except for adequately treated carcinoma in situ of -the cervix or basal or squamous cell skin cancer Symptomatic or untreated brain metastases Prior systemic chemotherapy for NSCLC Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible) History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption Pregnancy or lactation
Activity Scheduling for Older Adults With Dementia

This study is to evaluate the results from an intervention designed to encourage older adults with dementia for their engagement in activities through their active participation of activity scheduling (AS).

The study compares two interventions by using a 12-week longitudinal randomized controlled trial. For the first 2 weeks, all participants receive the same health care education program. Then for the following 10 weeks, participants will be randomized to either one of the two following groups with different conditions. For the control group, participants receive ten session of dementia care education. For the experimental activity scheduling group, participants receive ten session of dementia care education, plus weekly activity scheduling (AS) practice that focus on pleasant event scheduling and improving communication.

Eligibility Criteria:
Inclusion Criteria:

* patients had to have an age of at least 65 years,
* a diagnosis for dementia in medical history and had to meet international classification of disease-10 criteria for dementia,
* diagnosed by a psychiatrist.
* patients had to have cognitive impairment, as determined by the Montreal Cognitive Assessment

Exclusion Criteria:

* any major neurological illness other than AD,
* any psychiatric disorder or a known history of substance abuse.
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Adults on Chronic Hemodialysis

The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV-1) infected adults with end-stage renal disease (ESRD) on chronic hemodialysis (HD).


Eligibility Criteria:
Key Inclusion Criteria:

* Currently on a stable antiretroviral regimen for ≥ 6 consecutive months
* Plasma HIV-1 ribonucleic acid (RNA) concentrations \< 50 copies/mL for ≥ 6 months preceding the screening visit and have HIV-1 RNA \< 50 copies/mL at screening
* No documented history of HIV-1 resistance to elvitegravir (EVG), emtricitabine (FTC), lamivudine (3TC) or tenofovir (TFV) and no history of switching off EVG, FTC, 3TC or TFV due to concern for resistance
* Cluster determinant 4 (CD4+) T cell count ≥ 200 cells/μL
* ESRD with estimated glomerular filtration rate (eGFR) \< 15 mL/min by Cockcroft-Gault formula for creatinine clearance
* On chronic HD for ≥ 6 months prior to screening
* Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm\^3; platelets ≥ 50,000/mm\^3; hemoglobin ≥ 8.5 g/dL)

Key Exclusion Criteria:

* Hepatitis B co-infection
* Any clinical history, condition, or test result that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements
* Administration of other investigational agents (unless approved by Gilead Sciences). Participation in any other clinical trial, including observational trials, without prior approval from the sponsor is prohibited while participating in this trial.
* History or presence of allergy or intolerance to the study drugs or their components
* A new acquired immunodeficiency syndrome (AIDS)-defining condition (excluding CD4+ T cell count and percentage criteria) diagnosed within the 30 days prior to screening, with the exception of oropharyngeal candidiasis
* Received solid organ or bone marrow transplant

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Correlation Between Five Asthma Control Questionnaires

This observational study aims to assess the correlation between many questionnaires designed to assess the level of control of asthma. The five questionnaires will be submitted, at the same time and in a random order, to asthma patients. Some other parameters will be recorded (e.g. lung function, epidemiological data). The hypothesis is that the results of the questionnaires will be the same. If not, we will try to understand why.

The investigators will include 100 patients, stratified with relation to their level of asthma severity (25 patients for each level of severity - described by the GINA guidelines).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma confirmed by a pulmonologist
* Patient have had a lung function testing on the same day than the questionnaires are fulfilled.
* Age equal or upper than 18 years
* Agreement to participate to this study

Exclusion Criteria:

* Age under 18 years
* Refusal to participate to this study
Mindful Melody: Feasibility of Implementing Music Listening on an Inpatient Psychiatric Unit and Its Relation to the Use of As Needed Medications for Acute Agitation

In this quality improvement project, our objectives were to assess the feasibility and effectiveness of using music as an adjunct to or replacement of pharmacological interventions for patient agitation on an inpatient psychiatric unit. We hypothesized that music availability would help to reduce agitation and reduce the amount of as-needed medications used for cases of patient agitation.

The number of as-needed medications for agitation was quantified during a three month period during which patients had the option of listening to music in cases of agitation. This was compared to the number of medications needed for agitation during another 3 month period during which music was not available. The medications used were quantified using pharmacy records. Patients and nurses were surveyed to determine how effective and feasible they thought the music intervention was. The study was conducted at the SUNY Upstate University Hospital inpatient psychiatric unit, which is a 24-bed unit. 172 patients were included in the project.

Before starting to offer music, a basic training meeting was held with nursing staff to understand the purpose of the project. Patients participating had the option of selecting a preferred musical genre and they listened to music using wireless headphones. The playlists used were genre playlists automatically generated by Spotify music application. If patients did not like the song that was generated, they had an option to skip the song using their bluetooth headphone controls. Headphones were collected after 30 minutes of listening unless they were return prior to completion of the listening session.

Eligibility Criteria:
Inclusion Criteria:

* Any patient 18 years or older admitted to the inpatient psychiatric unit

Exclusion Criteria:

* Patients who did not want to listen to music or be included in the project were excluded
Group Versus Traditional Prenatal Care for Diabetes

The investigators primary objective is to conduct a randomized trial to determine the effect of diabetes group prenatal care on glycemic control and postpartum weight retention in women with type 2 diabetes and gestational diabetes.

Long term, the investigator aims to test the central hypothesis that group prenatal care, compared to traditional prenatal care, will improve, 1.) glycemic control and, 2.) postpartum weight retention in women with type 2 and gestational diabetes. The objective of this proposal is to conduct a randomized trial in two phases to determine the effect of Diabetes Group Care (GC) on glycemic control in pregnant women with T2DM and GDM (Antepartum Phase) and the impact on postpartum weight retention (Postpartum Phase).

Eligibility Criteria:
Inclusion Criteria:

1. English speaking
2. Type 2 diabetes OR gestational diabetes diagnosed by 2-step method(1) OR likely pre-existing Type 2 diabetes with one of the following during pregnancy and \</= 34 weeks:

   1. 1 hour glucose challenge test \>/= 185mg/dL OR
   2. A1c \>/= 6.5% OR
   3. Fasting plasma glucose \> 126mg/dL (2)
3. Ability to attend group prenatal visit at specified days and times
4. Willingness to be randomized at 22 weeks 0 days-34 weeks 0 days OR initial visit between 24 weeks 0 days-34 weeks 0 days
5. Ability to give informed consent

Exclusion Criteria:

1. Prior participation in diabetes group care
2. Type 1 Diabetes
3. Multiple gestation
4. Major fetal anomaly
5. Serious medical co-morbidity necessitating more care than can be safely provided in group setting, as deemed by medical provider.
6. Serious psychiatric illness including schizophrenia necessitating more care than can safely be provided in group setting, as deemed by medical provider.