cyrilzakka/clinical-trials huggingface dataset:
The ICU Care Knowledge Study

Family members have poor overall understanding of ICU patients' prognosis, resuscitation status and care, defined a priori as less than 75% correct responses to the yes/no ICU care questions.

Family members of all adult patients admitted to an intensive care of San Francisco General Hospital will be screened for enrollment and recruited sequentially over a period of nine months (August 1, 2005-March 31, 2006). We will determine the frequency of family members' correct responses to the survey questions about ICU care. Family member responses will be compared to the chart and real-time patient observation reality (gold standard).

Hypothesis # 2 Poor English language comprehension and low education level (defined as not having completed high school) are risk factors for poor ICU care understanding and knowledge.

During their surveys family members will be asked questions regarding their English language comprehension and education level. Association of these possible risk factors with low level of ICU care knowledge will be tested primarily using analysis of variance. Should our hypothesis #2 prove to be correct, our future goal will be to develop recommendations for interventions to increase understanding specific for these high risk groups. One of these interventions is described in Hypothesis #3 below.

Hypothesis # 3 Provision of the results of family members' knowledge assessment to health care providers will result in improved ICU care knowledge on subsequent testing.

Subjects will be randomized to two groups-one group's health care providers will be shown the results of family members' initial ICU knowledge assessment; the other group's providers will not be given these results. One to two days after providing this summary to providers, all randomized subjects will undergo a second interview assessing their ICU care knowledge. Changes in the frequency of correct responses between the two groups will be compared using mean differences in proportions with 95% confidence intervals.


Eligibility Criteria:
Inclusion Criteria:

* family member of ICU patient

Exclusion Criteria:

* incarceration, unable to participate in interview
Frequency of Interrupting Sitting and Cognitive Function

Rationale: Sedentary behavior (SB) has been associated with impaired cognitive function in elderly, and negatively impacts glucose metabolism. Interrupting sitting with physical activity (PA) bouts may exert beneficial effects on cognitive function via an improved glucose metabolism. Nevertheless, the impact of breaking up prolonged sitting with various frequencies of PA bouts remains unexplored in young sedentary adults. Moreover, we hypothesize that the pattern of the breaks modifies the effects. Thus, randomized controlled trials (RCTs) are highly needed to investigate the effects of interrupting sitting with different frequencies of PA on cognitive function and glucose metabolism. We now hypothesize that interrupting sitting with different frequencies of walking breaks differentially affects cognitive function and glucose metabolism.

Objective: The aim is to investigate the effects of breaking up sitting with different frequencies of PA bouts on cognitive function and glucose metabolism in young sedentary adults.

Study design: A randomised, controlled cross-over study will be performed, consisting of four interventions in a counterbalanced order: uninterrupted prolonged sitting, short breaks, moderate breaks, and long breaks.

Intervention: Participants will complete four conditions in a randomized, counterbalanced order: sitting (uninterrupted prolonged sitting without any interruptions), short breaks (walk 1 minute every 10 minutes), moderate breaks (walk 3 minutes every 30 minutes), and long breaks (walk 27 minutes during the intervention). Each condition lasts 4.5 hours.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18-35 years;
* BMI between 18.5-24.9 kg/m2;
* SB, i.e. sitting for an average of at least 9 hours per day;
* Physically inactive, i.e. engaging in exercise for less than 2 to 3 times per week;
* Stable body weight (weight gain or loss \< 3 kg in the past three months);
* Willingness to engage in four 6-hour laboratory visits;
* No difficult cannulation.

Exclusion Criteria:

* Not sedentary, i.e. sitting for less than an average of 9 hours per day;
* Physically active, i.e. engaging in exercise for more than 3 times a week;
* Abuse of drugs;
* Use medication to treat BP, lipid, or glucose metabolism;
* Pregnant females.
Prevalence of Metabolic Liver Diseases in Patients With Type 1 Diabetes Mellitus

Nonalcoholic fatty liver disease (NAFLD) has been extensively studied in the context of type 2 diabetes mellitus (T2D) due to its higher prevalence and its association with obesity and syndrome metabolic, a well-established risk factor for NAFLD. Although several studies have reported the accumulation of liver fat in patients with type 1 diabetes mellitus (T1D), the prevalence, etiology, and the consequences of NAFLD in patients with T1D are poorly characterized, requiring more studies in this field. In addition, liver involvement at the metabolic level in patients with T1D raises the differential diagnosis between NAFLD and glycogen hepatopathy (GH), a rare complication associated with the poorly metabolic control of diabetes and probably underdiagnosed, since the ultrasound pattern is the same than the NAFLD. The investigators have designed a cross-sectional observational study with the objective of describing the prevalence of metabolic liver diseases (NAFLD and GH) in the population of patients with T1D in the healthcare area of Hospital del Mar and Hospital de Vilafranca, as well as studying the relationship of these pathologies with the degree of metabolic control, the presence of metabolic syndrome and the presence of micro and macrovascular complications.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged ≥ 18 years.
* Diagnosed with T1D of at least 6 months of evolution.
* Patients who give their informed consent in writing.

Exclusion Criteria:

* Active alcoholism\> 30 g / day in men and\> 20 g / day in women.
* Known non-metabolic liver disease: alcoholic hepatitis, viral hepatitis from HBV infection and / or HCV, hemochromatosis, Wilson's disease, α-1 antitrypsin deficiency, autoimmune hepatitis, hepatic granulomatous (tuberculosis, mycobacteria, histoplasmosis), hepatic lymphoma, primary neoplasia liver, liver metastasis.
* Active treatment with hepatotoxic drugs: amiodarone, isoniazid, rifampicin, sulfa drugs, tetracyclines, amoxycline / clavulanate, ketoconazole, methotrexate, valproic acid, trazodone, tamoxifen, methyldopa, reverse transcriptase inhibitors, chemotherapy, immunotherapy.
* Pregnant women.
* Acute decompensation of T1D (ketoacidosis) in the 3 months prior to inclusion. The inclusion after this period.
Unilateral Pulmonary Edema After Minimal-invasive Mitral Valve Surgery

Unilateral pulmonary edema after minimal-invasive mitral valve surgery is a rare but in some cases severe complications, sometimes causing extracorporeal life support. The investigators have observed over several years 5 cases of instantaneous postoperative severe pulmonary edema. This is a retrospective analysis of over 200 minimal-invasive mitral valve surgery procedure.

Unilateral pulmonary edema after minimal-invasive mitral valve surgery is a rare but in some cases severe complications, sometimes causing extracorporeal life support. The investigators have observed over several years 5 cases of instantaneous postoperative severe pulmonary edema. After having studied the available literature on this particular topic the investigators have decided to prepare a retrospective analysis of over 200 minimal-invasive mitral valve surgery procedure focusing on radiological and clinical signs of unilateral pulmonary edema.

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years of age

Exclusion Criteria:

* urgent surgery
Different Dosage of Domestic and Imported Clopidogrel on the Platelet Inhibition Ratio in Patients Undergoing PCI

This is a single-center, randomized, single-blind, investigator-initiated, pharmacological study with a parallel design. Patients with non-ACS undergoing primary percutaneous coronary intervention will be randomized after informed consent, in a 1:1:1:1 ratio to the following treatment groups:

Group Α: Domestic Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day.

Group B: Domestic Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day.

Group B: Imported Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day.

Group D: Imported Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day.

Platelet inhibition ratio assessment by thrombelastogram will be performed，2 hours after the loading dose(Day 0)， 6 hours after thrombelastogram (Day 0), 30 day after thrombelastogram. Documentation of major adverse cardiac events (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG) and serious adverse events (bleeding, other adverse events)will be performed until Day 30.


Eligibility Criteria:
Inclusion Criteria:

1. The patient is scheduled to undergo non-urgent PCI
2. The patient is between 18 and 75 years of age (inclusive) and willing to comply with the protocol
3. The patient or legally acceptable representative is able to read and give written informed consent and has signed an informed consent form approved by the Investigator's IRB/IEC

Exclusion Criteria:

1. Estimated or measured weight \< 55 kg
2. Acute non-ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation myocardial infarction (STEMI) within 7 days prior to PCI
3. Uncontrolled hypertension at the time of initial study drug administration defined as measured systolic blood pressure \> 190 mm Hg or diastolic blood pressure \> 108 mm Hg
4. Patient has received a clopidogrel loading dose (≥300 mg) within 30 days prior to randomization; patients on maintenance clopidogrel may be enrolled
5. Administration of thrombolytic agents, fondaparinux, or oral anticoagulants (e.g., warfarin) within the 7 days prior to PCI
6. Estimated creatinine clearance (e.g. Cockcroft-Gault) \< 45 mL/min
7. Anemia with hemoglobin level \< 10 g/dL
8. Thrombocytopenia (platelet count \< 100,000/mm3)
9. ALT and/or AST \> 2.5 x the ULN or other indication of clinically significant hepatic dysfunction
10. Facial or head trauma within the last 30 days
11. Intraocular hemorrhage within the last 30 days
12. Gastrointestinal bleeding within the last 30 days
13. Active bleeding, or history of a bleeding disorder or known intracranial vascular malformation
14. Known allergy or contraindication to aspirin, heparin, clopidogrel, or to any contrast media
15. Participation in any investigational drug study within 30 days prior to enrollment.
Health Economics of the Use of Ferrous Iron Salts in Primary Care in the UK.

Iron deficiency anaemia (IDA) affects approximately 4.7 million of people in the UK, with children and pre-menopausal women being at higher risk (1). Each year more than 6.8 million prescriptions for oral iron are filled in England alone (NHS Information Centre data). However, gastrointestinal symptoms limit adherence in 10-30% of otherwise healthy patients (2-4) and in up to 50% of patients with gastrointestinal disorders (5). Simple ferrous iron salts constitute the vast majority of currently prescribed oral iron because these are cheap and well absorbed. However, they are also poorly tolerated and thus, we believe, are expensive to the NHS.

Funded by the Medical Research Council, we have developed an alternative oral iron supplement, that we name IHAT (iron hydroxide adipate tartrate), as an efficacious therapy for IDA with minimal side-effects.

In the study proposed here we aim to assess the total health cost associated with current oral iron supplements and, hence, define the clinical unmet need for alternative treatments. We will use Clinical Practice Research Datalink (CPRD) GOLD data to (i) estimate the pattern of prescribing to oral iron in primary care in the general population and (ii) develop a health economics model in pre-menopausal women. These data will provide evidence for the total health system costs associated with current oral iron treatment. Furthermore, this study will provide data from which the cost-effectiveness and total health system costs of alternative effective and treatments with minimal side-effects could be estimated.

Our research objective is to gather evidence for the unmet clinical need for safe, low-side-effect oral iron in the UK.

To achieve this objective we aim to determine:

1. Pattern of prescribing to oral iron in primary care in GP practices in England: estimate prescription rates, efficacy and intolerance of treatment with all forms of currently prescribed oral iron.
2. Health economics of the use of ferrous iron salts in primary care: estimate patterns of individual response to treatment; determine the costs of ferrous iron (sulphate, fumarate and gluconate) therapy in pre-menopausal women in primary care, and develop a cost-effectiveness model for alternative treatments with minimal side-effects.

Eligibility Criteria:
Inclusion Criteria:

* patients prescribed oral iron in primary care practices included in the UK CPRD database

Exclusion Criteria:

* N/A
The Use of Mentoring to Promote Well-being for Female SMART Members

Women are highly underrepresented in the construction skilled trades. In addition to facing the industry's well-known physical risks, women are subjected to discrimination, harassment, and skills under-utilization. As a result, tradeswomen have increased risk for injury, stress-related health effects, and high attrition rates from apprenticeship programs, thus perpetuating their minority status. Mentoring is a well-established technique for learning technical and personal navigation skills in new or challenging social environments. The investigators propose development and dissemination of a mentorship program through local unions of the International Association of Sheet Metal, Air, Rail and Transportation Workers (SMART), and evaluating its success in reducing women's injury and work stress, while improving retention.

Journey-level workers will be trained on effective mentoring techniques, and matched to approximately 100 women apprentices within participating local unions. Mentees will be followed for two years within the mentorship program, with another 100 women apprentices in locals not receiving the mentorship training similarly followed as controls. The impact of participation in mentoring programs will be measured through apprentices' experience of stress, coping mechanisms, safety climate, and retention in the apprenticeship programs. Specifically, the investigators propose to:

Aim 1: Develop a mentorship training program for journey-level sheet metal workers to assist women apprentices in navigating the challenges faced by women in trades

Aim 2: Disseminate the training and assist locals in developing effective mentorship programs

Aim 3: Evaluate the effectiveness of the mentoring programs specified in Aims 1 and 2

Aim 4: Disseminate the best practices for supporting women apprentices in the skilled trades.

Eligibility Criteria:
Inclusion Criteria:

* All mentors must be journey-level sheet metal workers that are members of the SMART (International Association of Sheet Metal, Air, Rail, and Transportation Workers) Union. All mentees and control apprentices must be apprentice-level sheet metal workers that are members of the SMART Union, and identify as woman.

Exclusion Criteria:

* No exclusions will be made on the basis of sex, race, ethnicity, age, disability or religion for mentors, mentees, and control apprentices. No exclusions will be made on the basis of gender for mentors. For mentees and control apprentices, those that do not identify as a woman will be excluded.
A Follow-up Study to Assess Long-term Immunogenicity and Safety of NicVAX/Placebo as an Aid to Smoking Cessation

The purpose of the study is to obtain two year follow up data for subjects that received six vaccinations of NicVAX in prior phase III studies. No treatment will be administered. Anti-nicotine antibody levels and safety data will be collected.

This study will follow subjects that participated in the NicVAX phase III studies for a second year. These predecessor studies, Nabi-4514 (NCT#00836199) and Nabi-4515 (NCT#01102114) evaluate the efficacy and safety of 6 vaccinations of NicVAX or placebo as an aid to smoking cessation. The two phase III studies are one year in duration, and subjects who complete these studies are eligible to enroll in Nabi-4522. As the phase III studies are ongoing, subject assignment to NicVAX or placebo will remain masked. No intervention will be administered in Nabi-4522. Subjects will be followed for immunogenicity (anti-nicotine antibody level)and for safety.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who agree and sign consent to participate in this follow-up study.
* Subjects randomized and completed month 12 of the Nabi-4514 or Nabi-4515 study.
* Subjects who have received a total of 6 injections in Nabi-4514 or Nabi-4515.

Exclusion Criteria:

* Anticipated inability to follow the study protocol through-out the study period.
* Known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder compliance or failure to sign informed consent.
* Subjects who intend to receive, or who are receiving an Investigational New Drug/Device during the study.
The Metabolite Profiling of Obese Subjects Before and After Sleeve Gastrectomy

The purpose of this prospective observational study is to generate further insight into the numerous metabolic adaptations associated with sleeve gastrectomy surgery in obese subjects by profiled serum metabolites before and after the surgery and integrated metabolite changes with clinical data.

In the present study we examine the metabolic fluctuations of the most important amino acids and fatty acids to better understand the metabolic process in weight reduction in obese subjects that underwent sleeve gastrectomy surgery.

The availability of the tandem equipment for amino acids and fatty acids determinations for the medical system gives us an opportunity to investigate the metabolic turmoil of weight reduction seen in obese subjects after sleeve gastrectomy.

We evaluated the lipid metabolism by the measurements of the fraction of carnitine fatty acids which is the most available one because only a small blood specimen from a finger puncture is needed.

In the present study we measured the blood concentrations of monocarboxylic and dicarboxylic fatty acids bounded to carnitine, free carnitine and also free amino acids 2 weeks before the surgery while subjects eat their regular high caloric diet, one week, one month and 3 month after the procedure.

Carnitne fatty acids comprise only the tip of the iceberg of all circulating fatty acids in the blood with a roughly distribution of: triglycerides, phospholipids and cholesteryl fatty acids 4 (Lipids43-65), free fatty acids 0.6, and carnitne fatty acids 0.005 mM. Some additional amount is also circulating in lipoproteins. Even carnitine monocarboxylic fatty acids comprise around 1% of the free fatty acids and around 0.1% of all fatty compounds, the fluctuations in their concentrations probably reflect the most dynamics metabolic events because fatty acid oxidation must initiate by binding fatty acid to carnitine. The concentration of dicarboxylic carnitine fatty acids is much higher and comprises about 2% for malic carnitine and about 10% for glutaric carnitine in the total amount of free acids (http://www.hmdb.ca/). Yet, as for monocarboxylic fatty acids, a remarkable mass of dicarboxylic acids is still present as free acids.

For all carnitne acyl compounds the distribution forms have a high variability on different physiological conditions.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30
* Willing to undergo sleeve gastrectomy

Exclusion Criteria:

* Inability to sign the informed consent
Intravesical Gemcitabine Instillation Followed by Transurethral Resection for the Treatment of Patients With Superficial Bladder Cancer at Low Risk.

The purpose of this study is to determine whether neoadjuvant intravesical Gemcitabine is enough active in patients with a solitary, low risk superficial bladder cancer.After diagnostic urethrocystoscopy or bladder sonography, all patients will receive intravesical gemcitabine once a week during 6 weeks. Two weeks after finishing antiblastic therapy, all patients will be submitted to a new cystoscopy, with TUR or cold biopsies of the site of the initial lesion.


Eligibility Criteria:
Inclusion Criteria:

* Primary solitary bladder tumour not exceeding 2 cm of diameter at sonography and/or at cystoscopy, judged by the investigator not muscle infiltrating and at low risk
* Urinary cytology negative for severe dysplasia (G3).
* ECOG performance status 0-1
* Absence of anti-coagulant therapy or acetyl-salicylic acid chronic therapy
* Absence of other present or past neoplasias except for healed skin basalioma

Exclusion Criteria:

* Tumours with infiltrative patterns at cystoscopy
* Transitional carcinoma of the upper urinary tract and prostatic urethra.
* Any previous or concomitant malignancy other than superficial bladder cancer with the exception of cutaneous basalioma and/or cancer of the cervix, adequately treated.
Gut Microbiota as a Therapeutic Target for CVD

Background: The Mediterranean Diet (MD) is considered an healthy diet useful in the prevention of cardiovascular disease (CVD). High quality extra virgin olive oil (HQ-EVOO, \[1\]), an essential component of this diet, exerts a protective effect against CVD. Moreover, the gut microbiota (GM) has recently been recognized as a key factor in driving metabolic activities and involved in the stimulation of host immunity \[2\]. In particular, Lactic Acid Bacteria (LAB) and their probio-active cellular substances produce beneficial effects in the gastrointestinal tract, thus representing important assets in pathological conditions such as obesity and CVD \[3,4\].

Objective: The purpose of this study is to demonstrate that 3 months of treatment (MD with 40g/die HQ-EVOO) in 36 subjects (cases: overweight/obese vs controls: normal weight) may change their GM and inflammatory panel.


Eligibility Criteria:
Inclusion Criteria:

* normal weight subjects (M and F) with Body Mass Index (BMI) between 18.5 and 24.9 Kg/m2 following MD;
* overweight/obese subjects with a BMI ≥ 25 Kg/m2, not necessarily following MD.

Exclusion Criteria:

* eating disorders;
* recent or ongoing antibiotic therapy.
Static Versus Dynamic Stretching; Short Term Effects On Physical Performance In Non-Athletes

This study will compare the short-term effects of static and dynamic stretching on the physical performance of undergraduate students who are not involved in athletic activities. It will be observed if a significant difference lies between these stretchings.

The individual participant will be assessed at baseline and then stretching will be performed after that. Group A will perform static stretching and group B will perform dynamic stretching. Immediate assessment will be done after 5 minutes, a second assessment will be done after 6 hours and a third one will be done after 24 hours to measure the short-term effects.

After that, a gap of 3 days will be given and stretching will be performed again. Now, group A will perform dynamic stretching and group B will perform static stretching. A similar assessment will be repeated after 5 minutes then 6 hours and then after 24 hours to determine the difference.

Eligibility Criteria:
Inclusion Criteria:

* Male undergraduate students aged between 18-25
* Lower Limb range; Hip SLR\>80 degree Knee flexion \>130 degree Ankle dorsiflexion \>20 degree
* Those who fall under normal BMI range

Exclusion Criteria:

* acute injuries of the lower limb.
* active participants of sports and any training programs.
* lower limb disabilities.