cyrilzakka/clinical-trials huggingface dataset:
Comparison Between the Assessment of Anxious and Depressive Symptomology

In palliative care, anxiety and depression in advanced cancer are under evaluated, under diagnosed and therefore under treated. 5 to 30% of patients present anxious and depressive disorders.

Physical symptoms are easy to assess. But in palliative care it is important to take care of moral suffering.

However, evaluation and management of patient's anxiety and depressive symptoms are difficult for physicians and caregivers.

The investigators would like to specifically compare the patient's evaluation of anxious and depressive symptomatology in palliative care with the evaluation by the physician, the nurse and the caregiver.

Then the investigators will try to collect the caregivers's difficulties in the management of anxious and depressive symptoms.


Eligibility Criteria:
Inclusion Criteria:

Patients :

* Adult patients (18 years and over)
* Advanced cancer stage
* Patients hospitalized less than 72 hours in Lyon Sud palliative care unit
* Sufficient general conditions to complete survey
* Absence of cognitive disorders
* Agreement to participate at the study

Medical Staff:

- Working full time or part time in the USP or the PMSC of CHLS

Exclusion Criteria:

Patients :

* Minor patients
* Patients hospitalized more than 72 hours in Lyon Sud palliative care unit
* Presence of cognitive disorders
* Alteration of general conditions
* Refusal to participate at the study
Laboratory Profile of Hepatitis B and C in Users of a Reference Service

Chronic hepatitis by the B virus (HBV) and/or by the C virus (HCV) is a major public-health problem since it presents a long phase of clinical latency which makes its early diagnosis difficult and results in the development of a large number of cases to complications such as cirrhosis, hepatic insufficiency and hepatocarcinoma. In Brazil, it is estimated that the number of HBV is two million, of which 72 thousand have been reported. As regards HCV, the ratio is one of three million estimated cases to 52 thousand reports. Learning about the serological profile of the users of a viral hepatitis reference service is fundamental for the planning of diagnostic and caregiving actions; therefore, it is the objective of this study.

Chronic hepatitis by virus B (HVB) and/or by virus C (HVC) is a major public-health problem since it presents a long phase of clinical latency which makes its early diagnosis difficult and results in the development of a large number of cases to complications such as cirrhosis, hepatic insufficiency and hepatocarcinoma. In Brazil, it is estimated that the number of HVB patients is two million, but only 72 thousand have been reported. As regards HVC, the ratio is three million estimated cases to 52 thousand reports. Learning about the serological profile of the users of a viral hepatitis reference service is essential for the planning of diagnostic and therapeutic actions; therefore, it is the objective of this study.

Five hundred and thirty-one HVB and HVC serological profiles of the patients referred to SAE/HD within a period of 18 months (January 2006 to June 2007) were studied by means of retrospective analysis. The patients were classified as: a) HBV: carrier, cure, isolated anti-HBc and vaccinated; b) HVC: reagent anti-HVC; c) HBV/HVC co-infection: AgHBs and reagent anti-HVC; and d) Susceptible: non-reagent serology.

As regards HBV, the following were found from the total number of patients: carriers, 12.6%; cure, 18.9%; isolated anti-HBc, 9.0% and vaccinated, 6.2%. The patients with reagent anti-HVC comprised 31.3% of the total number of individuals. HBV/HCV co-infection was 0.6%. Susceptible individuals comprised 20.5%.

It was concluded that approximately 45% of the referred patients carried chronic infection by B and/or C virus, a condition which requires additional investigation and, in many instances, specific treatment. Strategies for early diagnosis are essential in order to prevent the intrinsic complications of such condition.

Eligibility Criteria:
Inclusion Criteria:

* Patients with laboratory tests positive for hepatitis B and/or C

Exclusion Criteria:

* No laboratory tests available
The Effect of Kinesiophobia on Physical Activity, Balance and Falling in Parkinson's Disease Patients

The kinesiophobia; defined as irrational fear of movement, which may occur after painful injury and reduce physical activity. It develops the idea that movement in individuals will cause re-injury and cause additional pain to existing pain. Studies have shown that this situation leads to a decrease in physical fitness, avoidance of activity, decrease in quality of life and even depression in the long term. It is known that functional problems such as balance problems and decrease in physical activity level occur in patients with Parkinson's disease. However, in the literature, there is no study investigating the presence of kinesiophobia in patients with Parkinson's disease. Therefore, the aims of our study were to 1) determine the presence / absence of kinesiophobia in patients with Parkinson's disease 2) determine the relationship between kinesiophobia and falling, balance, physical activity level in the presence of kinesiophobia.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with Parkinson's disease according to the criteria of United Kingdom Brain Bank and diagnosed as Parkinson's disease by neurologist
* According to Hoehn-Yahr scale 1-3
* Mini-Mental Test score 24 and above

Exclusion Criteria:

* Another disease that will prevent walking
* Visual impairment and vestibular dysfunction
* Cognitive impairment
Effectiveness of Tuberosity Micro Connective Tissue Graft for Treatment of Multiple Adjacent Gingival Recession Defects

The objective of this project is to compare post-operative pain associated with palatal and tuberosity donor sites for micro-CTG, and to evaluate the outcomes in both the donor and recipient sites.

A variety of surgical methods have been reported to reestablish root coverage, including tunneling techniques and coronally and laterally advanced flaps. As thin gingival tissue is one of the predisposing factors for GRD, the adjuvant use of subepithelial connective tissue grafts (CTGs) is often considered. CTGs are thought to contribute to phenotype modification and stability of treatment outcomes and studies have indicated favorable esthetic results and high degrees of root coverage. CTGs are preferably harvested either from the lateral superficial part of the palate or from the tuberosity, due to the high amount of lamina propria and minimal submucosal tissue (adipose and glandular tissue).

When multiple adjacent teeth exhibit GRDs, the preferred surgical approach should offer the greatest possible root coverage, while limiting drawbacks (i.e., patient morbidity, esthetic problems). Thus, one of the challenges related to coverage of multiple GRDs is the scarcity of donor tissue. Modification of the harvested CTG into multiple "micro-CTG" has been proposed for the treatment of multiple adjacent GRDs (MAGRD) in order to reduce the amount of CTG to be harvested. Soft-tissue grafts from the tuberosity are increasingly gaining popularity not only because they are easier to harvest, are denser in connective tissue fibers but also because harvesting from the tuberosity presents minimal risk of intra- or post-operative complications, resulting in reduced patient morbidity. However CTG from maxillary tuberosity have been reported to induce a hyperplastic response in some patients.

The objective of this study will be to compare palatal versus tuberosity micro-CTG on postoperative pain, oral health-related quality of life (OHRQoL), degree of root coverage and esthetic outcomes.

The investigators hypothesise that no statistically significant differences will be observed in terms of %root coverage and patient satisfaction at 12 months (non-inferiority). Subjects in the test group (micro-CTG) will report significantly lower morbidity at 1 and 2 weeks post-surgery when compared to controls (superiority).

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years,
* systemically healthy,
* presenting adjacent RT1/RT2 recessions, on both sides of the anterior maxilla, with an apico-coronal extension (i.e. recession depth) \> 2mm combined with thick phenotype and deep root concavity.

Exclusion Criteria:

* pregnancy or lactation,
* heavy tobacco smoking (\>15 cigarettes/day),
* uncontrolled medical conditions and intake of medication that can affect gingival conditions.
* uncorrected trauma from toothbrushing,
* severe tooth malposition,
* history of root coverage procedures.
Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 a Subfraction of LDL in Patients With Metabolic Syndrome.

The purpose of this study is:

* To identify the common factor for L5 prevalence in patients with Metabolic Syndrome.
* To determine whether Ezetimibe, Simvastatin, and Vytorin can correct the L5- promoting factor and reduce L5 in Metabolic Syndrome patients.

Epidemiological evidence indicates that metabolic syndrome (MS) is a strong predisposing condition for atherosclerosis. Elevation of plasma low-density lipoprotein (LDL) cholesterol(LDL-C) concentration is the most important risk factor for atherosclerosis; however, LDL-C elevation is not a criterion for metabolic syndrome, raising the question of LDL's role in the syndrome's association with atherosclerosis. L5, a highly electronegative and mildly oxidized LDL subfraction that we recently isolated from hypercholesterolemic human plasma, may provide a key to answering this question. In cultured vascular endothelial cells (EC), L5 inhibits proliferation and induces apoptosis and monocyte-EC adhesion. In our preliminary studies, L5 could also be detected in patients with MS without elevated LDL-C. Because other LDL subfractions were harmless to EC, the presence of MS-L5 prompted us to hypothesize that the atherogenic role of LDL is not solely determined by plasma LDL-C concentration, but more importantly, by its composition. The proposed study is designed to test this hypothesis. The first question we will address is what lipid factor determines the prevalence of L5 in MS.

Subsequently, we will examine whether treatment with selected medicines can effectively reduce L5 in MS patients by correcting the factor favorable for L5 formation.

We are in the process of identifying the active components of L5 to fully characterize the atherogenic role of L5 in MS,. In the current proposal, we focus our interest on the efficacy of Ezetimibe, Simvastatin, and Vytorin in reducing L5 from the plasma of MS patients.

Eligibility Criteria:
Inclusion Criteria:

* Participants who meet 3 or more of the 5 criteria specified in the ATPIII guidelines will be recruited.
* The 5 criteria are:

  1. abdominal obesity (men\>40 inches, women \>35 inches);
  2. TG\> 150mg/dL;
  3. low HDL-C (men \< 40mg/dL, women \< 50 mg/dL);
  4. high blood pressure (\>or=130/\>or=85 mmHg);
  5. fasting glucose \> or = 110mg/dL.
* People with different ethnic backgrounds will be included.

Exclusion Criteria:

* symptomatic coronary artery disease
* peripheral vascular disease
* cerebral ischemia (stroke)
* smoking
* hypothyroidism
* kidney diseases
* consumption of antioxidation supplements/drugs or use of lipid-lowering drugs in the last 3 months
* women who are pregnant, nursing, or planning to become pregnant
Impact of Maternal Stress on Infant Stunting

This study takes place in rural Mam-Mayan communities of Guatemala characterized by high rates of childhood stunting. It aims to characterize women's exposure to nutrition, infection and psychosocial stressors vs. resilience factors, to evaluate the cumulative impact of maternal-level factors (nutritional, infectious, psychosocial), social factors (autonomy, social support, domestic violence), and household factors (socioeconomic status, food security) on early infant growth, and to evaluate whether maternal cortisol may be a mediator in the vertical transmission of stress.

Grounded in participatory action research and a socio-ecological framework, this mixed-methods, observational study enrolled a longitudinal cohort of 155 women, seen during pregnancy (6-9 mo), early (0-6 wks) and later (4-6 mo) postpartum, and two cross-sectional cohorts (60 early, 56 later postpartum).

Maternal and infant anthropometry was recorded, maternal fecal, urine and saliva samples were collected, and questionnaires were used to explore household factors (socioeconomic status, food security), social factors (autonomy, paternal/social support, domestic violence), and maternal-level factors (nutrition, infection, emotional distress).

Analyses focused on (1) characterizing women's exposure to nutrition, infection and psychosocial stressors vs. resilience factors, (2) describing the maternal diurnal salivary cortisol rhythm in pregnancy and postpartum and explore its association with psychosocial variables, (3) assessing the cumulative impact of maternal-level factors (nutritional, infectious, psychosocial), social factors (autonomy, social support, domestic violence), and household factors (socioeconomic status, food security) on early infant growth, and (4) evaluating whether maternal cortisol may be a mediator in the vertical transmission of stress.

In addition, Photovoice activities involved giving a camera to 23 women from study communities, who documented sources of stress vs. resilience for local women, and shared photo-elicited narratives through six group sessions.

Eligibility Criteria:
Inclusion Criteria:

* Woman from study communities
* Either pregnant or 0-6 wk postpartum or 4-6 mo postpartum
* Consenting to participate

Exclusion Criteria:

* Twin pregnancy
* Not consenting to participate
Sleep Intervention to Improve Glycemic Control in Women With Gestational Diabetes

This is a pilot randomized controlled trial involving a sleep education intervention in women with gestational diabetes to study whether sleep education during pregnancy leads to improvement in glycemic control in women with gestational diabetes and improvement in sleep duration.

Patients will be identified from the Maternal-Fetal Medicine office and the Perinatal Assessment Clinic at Magee-Womens Hospital, University of Pittsburgh Medical Center. Patients with gestational diabetes will be recruited following general education regarding gestational diabetes in pregnancy which is universally done for all patients at the time of their diagnosis of gestational diabetes. Eligible subjects will be randomized to two groups (usual care vs. sleep education program).

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant female
2. Ages 18-50
3. Gestational age between 16 0/7 weeks and 31 6/7 weeks
4. New diagnosis of GDM, not on treatment (i.e., insulin, glyburide, or metformin) at the time of enrollment

Exclusion Criteria:

1. Children less than 18 years of age
2. Non-English speaking
3. Multiple gestations (twins, triplets, etc)
FOREVR Peds VR Pilot

To determine the feasibility and acceptability of using immersive virtual reality technologies to impact clinical outcomes (e.g., pain and anxiety) and medication utilization (e.g., narcotics) in pediatric patients with acute and chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* Ages 7to 21 years
* Able to read, understand, and speak English
* Patients in the immediate postoperative period with significant pain being followed by the Acute Pain Service (acute postoperative pain cohort); patients presenting in Same Day Surgery for peripheral IV placement or patients in the CBDI clinic presenting for peripheral IV placement or Port accessing (vascular access cohort); or patients admitted to CCHMC on the Medical Pain Service (chronic pain cohort), or sickle cell patients not on the MPS list.
* Patients who have undergone bone marrow transplantation or receiving chemotherapy experiencing pain from mucositis

Exclusion Criteria:

* Outside the age range (\< 7 or \> 21 years)
* History of developmental delays, uncontrolled psychiatric conditions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting)
* History of vertigo, dizziness, and/or seizure disorder
* Conditions that would preclude the application of the VR glasses, such as surgeries of the head and neck
Factorial Trial of Antimicrobial Therapy and/or Catheter Change for Catheter Urinary Tract Infections.

Urinary tract infection (UTI) is a common infection in patients in the intensive care unit (ICU) that increases length of stay but not mortality. It is not known whether antibiotic treatment will alter outcomes. Our previous studies have documented wide practice variations exist amongst doctors, including prescribing antibiotics to asymptomatic patients. Therefore, the merits of various ways to manage the infection require further studies to minimize the potential for over-prescribing of antibiotics, a practice that can increase the development of resistant bacteria.

The objective of this pilot study is to determine the feasibility of conducting a larger definitive study that will determine the effect of catheter change and/or systemic antibiotics as compared to no interventions on outcomes and resource utilization in ICU patients with UTI. Patients will be randomized to receive no treatment, antibiotics alone, urine catheter change alone, and both catheter change and antibiotics. Their clinical outcomes will be assessed.

Results from the pilot trial will provide information about whether it is feasible to conduct the larger definitive trial. Results of the definitive study will provide guidance to clinicians on how to manage a frequent clinical problem and optimize antibiotic usage.


Eligibility Criteria:
Inclusion Criteria:

1. Adult ICU patient (≥ 18 years old)
2. Admitted to the ICU for ≥ 96 hours
3. Indwelling urinary catheter in place for ≥ 48hours that was inserted during this hospital admission
4. Urine culture positive (≥ 105 CFU/mL) for 1 or 2 organism (s) (e.g. bacteria or fungus)
5. Have received antimicrobial therapy that would cover the isolated organism(s) in the index urine culture for \< 24 hours (i.e. therapy that does NOT cover the isolated organism(s) in the index urine culture of any duration or antimicrobial that covers the index urine organism for \< 24 hours are permitted)

Exclusion Criteria:

1. Suspected or confirmed pyelonephritis, renal abscess, or concurrent bacteremia with the same organism(s) as those isolated in the index urine culture
2. Anuria (\< 50 mL/day)
3. Imminent death within 48 hours or decision to withdraw supportive care by clinical team
4. Neutropenia (\< 500/mm3)
5. Patient has an alternative infection and requires an antimicrobial that has a spectrum of activity which include all the organism(s) isolated from the index urine culture
6. Mixed fungal/bacterial CAUTI (i.e. index urine culture contains both bacteria and fungus)
Clinical Trial Assessing the Efficacy of Capsaicin Patch (Qutenza®) in Cancer Patients With Neuropathic Pain

In the oncology area, neuropathic pains are relatively frequent and can be induced by surgery, radiotherapy, or chemotherapy. In usual practice, some units are using qutenza in order to reduce neuropathic pain even though using of this patch for a population of cancer patients has never been demonstrated so far in a prospective study. The present prospective study proposes to evaluate the qutenza efficacy in peripheric neuropathic pain in cancer patients.

Drugs for neuropathic pains are generally represented by antidepressants, anti-epileptics, opioids, lidocaine patch. However, these drugs can frequently be insufficient, and/or can lead to side effects. Qutenza (8% capsaicin patch) presents an interesting alternative.

Qutenza efficacy has been shown in five principal studies conducted on 1988 adults affected by moderate or severe neuropathic pains. All patients presented Postherpetic neuralgia, or HIV associated therapy, or painful diabetic peripheric neuropathies. These studies led to qutenza approbation in Europe and in States in 2009.

In oncology, neuropathic pains are relatively frequent and can be induced by the three big actors of the anti-cancerous therapeutic arsenal (surgery, radiotherapy, chemotherapy). In usual practice, some units are usually using qutenza, but the use of this patch for this kind of patients has not been shown in a prospective study. Advantages of this treatment are numerous, and results presented in other therapeutic area are encouraging its use in oncology.

The present prospective study proposes to evaluate the qutenza efficacy in peripheric neuropathic pain in cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient with at least 18 years old;
* Patient presenting neuropathic pain secondary to an anti-cancerous treatment;
* Patient presenting a DN4 (Neuropathic Pain in Four Questions) score superior or equal to 4 out of 10
* Patient presenting a skin without lesion at the painful area
* Informed consent form signed;
* Patient affiliated to a social security scheme.

Exclusion Criteria:

* Hypersensitivity known to capsaicin;
* Instable or uncontrolled hypertension;
* Painful area localised next to eyes;
* Pregnant or breastfeeding woman;
* Protected people.
Mechanisms of Anabolic Resistance in Older Humans

The purpose of this research is to understand how chronic inflammation affects muscle function and responses to exercise in older adults.

Inflamed adipose tissue may contribute to blunted exercise response in skeletal muscle of older adults. The objective of this project is to evaluate a hypothesis that inflamed adipose secretes factors that activate inflammatory cascades in skeletal muscle, which may interfere with exercise-responsive molecular pathways and contribute to dysfunctional muscle phenotypes with aging. This project determine how adipose tissue influences skeletal muscle function and anabolic response to exercise in older adults. Young and older adults will complete studies to assess molecular response to acute exercise from protein synthesis rates, mRNA of exercise-responsive genes, and activation of signaling proteins in skeletal muscle. Adipose tissue will be assessed using a combination of non-invasive imaging and biopsy-based molecular phenotyping. The project will determine if acute exercise response is attenuated in older adults with inflamed adipose tissue phenotype.

Eligibility Criteria:
Exclusion Criteria:

1. Diabetes or fasting plasma glucose 126 mg/dL
2. Body mass index (BMI) 30 kg/m2
3. Anemia (female subjects hemoglobin of \&lt;11 g/dl and male subjects hemoglobin \&lt;12 g/dl)
4. Active coronary artery disease or history of unstable macrovascular disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment)
5. Renal failure (serum creatinine \&gt; 1.5mg/dl)
6. Chronic active liver disease (AST\&gt;144IU/L or ALT\&gt;165IU/L)
7. Oral warfarin group medications or history of blood clotting disorders.
8. Smoking
9. Pregnancy or breastfeeding
10. Alcohol consumption greater than 2 glasses/day or other substance abuse
11. Untreated or uncontrolled hypothyroidism
12. Debilitating chronic disease (at the discretion of the investigators)