cyrilzakka/clinical-trials huggingface dataset:
The Effect of Aromatherapy on Cognitive Functions, Anxiety and Sleep

The aim of this study is to determine the effect of aromatherapy application on cognitive functions, anxiety and sleep quality in elderly people with diabetes.

In addition to its physiological complications, diabetes is a disease that has negative effects on cognitive functions and is accompanied by anxiety and sleep problems. These problems negatively affect diabetes management and glycemic control. Ensuring glycemic control is the most important goal of diabetes treatment. The chronic and progressive nature of diabetes, the continuous increase in the number of individuals with diabetes and the accompanying problems lead the individual to seek alternative treatment methods in addition to clinical medical treatment. When the literature is examined, it is seen that aromatherapy is used in many clinical applications. Studies have shown the positive effects of lavender and rosemary and aromatherapy on cognitive functions, anxiety and sleep problems. However, no comprehensive studies on its effects in the elderly with diabetes were found. This study was planned to determine the effect of aromatherapy application on cognitive functions, anxiety and sleep quality in elderly people with diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Who agreed to participate in the research
* Those aged 65 and over
* Diagnosed with diabetes for at least 1 year
* Having no problems with hearing, speaking, seeing and smelling in a way that hinders communication
* Those who have no problem in verbal communication
* Passing the sense of smell test
* Not taking current anxiolytic or hypnotic therapy
* Not diagnosed with a psychiatric illness and without a diagnosis of mental disability
* Do not have any respiratory system disease such as asthma, COPD and allergic skin disease
* No diagnosis of epilepsy disease
* No known allergy to essential oils to be used in the application
* Those who did not use any of the other complementary and integrative application methods at the time of the study.
* Not using sleeping pills

Exclusion Criteria:

* Failure to make interventions within the specified time
* Not attending one of the sessions
* Unwillingness to cooperate with the study
* In addition to existing diseases, respiratory system diseases such as asthma, COPD and allergic diseases
* Known allergy to essential oils and oil used in the study.
* Failed to pass the sense of smell test.
* Receiving anxiolytic or hypnotic therapy
* Those with a diagnosis of psychiatric illness
* Those with a diagnosis of epilepsy disease
* Speech, hearing and vision loss
* Those who do not agree to participate in the research
* Living alone
The Effect of Virtual Reality Glasses on Dental Anxiety Control

In this clinical study, it was aimed to evaluate whether there is a decrease in patient anxiety by applying virtual reality glasses, which are the product of new technology, during scaling and root planing treatment.

Patients who required scaling and root planing treatment and also scored 9 or above according to the Dental Anxiety Scale were included in our study. Scaling and root planing was performed in a randomly selected intraoral quadrant of the patients, in the same way, with or without the use of virtual reality glasses. In the virtual reality glasses application, a video consisting of images of nature landscapes developed for patient rehabilitation was projected onto the screen in front of the patient's eyes. The Dental Anxiety Scale was reapplied after the completion of the treatment.

In the intraoral quadrant where virtual reality glasses were used, it is expected that lower Corah Dental Anxiety Scale scores may be obtained after the treatment is completed, compared to the intraoral quadrant where the treatment is performed without glasses, thus reducing anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old
* Being systemically healthy
* Needing treatment in at least two quadrants of the mouth
* At least five teeth in each quadrant and at least one region with a terminal pocket depth ≥4 mm
* Having a score of 9 or higher on the dental anxiety scale

Exclusion Criteria:

* Having a history of seizures or a convulsive disorder
* Balance disorders such as nystagmus, vertigo
* Use of psychotropic drugs
* Getting treatment for anxiety
* Presence of dermatological lesions on the face and especially around the eyes
* The presence of a lesion in the eye that will prevent the use of virtual reality glasses
The Effects of Use of Mirror Image on Radiation Exposure During Fluoroscopically Guided Transforaminal Epidural Injection

Lumbar Transforaminal Epidural Injection is helpful for the treatment of lumbosacral radicular pain.

Tunnel view technique is the basis of X-ray assisted intervention. In this technique, it is necessary to handle the block needle in order to adjust the direction of needle to the tunnel view toward target. If a mirror is used during needle handling, overall procedure time and radiation exposure can be reduced.

1. A planned Fluoroscopically Guided Lumbar Transforaminal Epidural Injection should be performed after receiving the informed consent of the patient.
2. This study is single-blind because it is not possible to blind the practitioner performing the injection.
3. Subjects were randomly assigned to the normal method group (group A) and the mirror use group (group B) by a random random number table, and the possibilities for belonging to any group were all the same and can not be artificially controlled by researchers.
4. After the procedure, a resident who does not know of this study records the radiation exposure time displayed on the monitor and the overall procedure time

Eligibility Criteria:
Inclusion Criteria:

1. Magnetic resonance imaging (MRI) and clinical manifestations of adult men and women over 20 years of age are eligible for radiculopathy due to back nerve root compression and subject to fluoroscopically guided lumbar transforaminal epidural Injection at the suspected spinal nerveroots level.

Exclusion Criteria:

1. Blood clotting disorder
2. Infection around the site
3. Contrast agent allergy
4. Uncontrolled cardiovascular, cerebrovascular, kidney disease
5. Past history of spinal surgery (ex, spinal fusion)
6. If can not block due to Non-cooperation with subjects (ex, if you can not take the stomach)
7. Patients taking narcotic analgesics
Psychosocial Risk Factors in Stroke and Myocardial Infarction

The aim of this study is to identify groups of subjects at risk of recurrence in secondary prevention based on Psychosocial Factors.

The aim is also to propose novel levers to reduce health inequalities in this population so as to develop new prevention strategies for neuro- and cardio-vascular health This study is based on data from questionnaires (Quality of life at work, perceived stress, perceived disease severity) and on behavior indicators (factors related to lifestyle: alcohol, smoking, obesity, sedentarity).

Biomarkers of endothelial function (ADMA) will also be assayed. It's an interventional study because of blood sample


Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided oral consent to participate
* Patients over 18 years
* Patients hospitalized for type 1 MI or ischemic stroke/TIA \< 24H after symptom onset
* Age \< 65 years
* With a professional activity (INSEE definition) at the time of the neuro or cardiovascular event
* At least one of the following risk factors: current smoking, obesity (waist circumference \> 88 cm (W)/102 cm (M) or a waist/hip ratio 0.85(W)/0.9(M), sedentarity (physical activity \< 150 min / week), alcohol consumption (\> 3 standard glasses per day for men, \> 2 standard glasses/d for women)

Exclusion Criteria:

* Adult under guardianship
* Patients without national health insurance cover
* Pregnant or breast-feeding women
* Clinical state making it impossible to use questionnaires or to measure risk factors
* Stroke or TIA not related to atheroma or cardioembolism (dissection, hemopathy...)
* type \> 1 MI
Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19

This is a three-arm randomized trial comparing the efficacy of single agent hydroxychloroquine to the combination of hydroxychloroquine and azithromycin, and to a delayed hydroxychloroquine regimen, which will serve as a contemporaneous Day 1-6 supportive care control, in eliminating detectable SARS-CoV-2 on day 6 following the initiation of treatment in order to determine which regimen is more effective.

PRIMARY OBJECTIVE:

I. Determine change in viral load at day 6 compared to baseline between two regimens to treat COVID-19 and a contemporaneous control group.

SECONDARY OBJECTIVES:

I. Time to resolution of symptoms (symptom questionnaire)

II. Change in the fever curve resulting in shorter time to afebrile for 48 hours

III. Normalization of vital signs

IV. Time to discharge (if hospitalized)

V. Assessment of agent toxicity as measured by standard metrics

VI. Collection of throat swab and blood for viral load, presence of IgM or IgG antibodies

VII. If feasible on samples collected for quantitative PCR decrease in virus shedding (in oropharyngeal secretions)

VIII. Measures of cytokines in blood including IL6, IL-8, TNF, INF

IX. Routine standard of care labs obtained as part of the care of these patients such as differential white count, CRP, troponin and LFTs will be analyzed for correlative trends

Eligibility Criteria:
Inclusion Criteria:

* Patients with proven SARS-CoV-2 infection by an accepted assay with symptoms consistent with COVID-19
* Ability to measure and quantify viral load by quantitative PCR
* Age 18 to 89
* Ability to swallow oral medications
* Patients must read, understand and sign IRB approved informed consent

Exclusion Criteria:

* Pregnancy or women who are breast feeding
* Two consecutive negative assays for SARS-CoV-2 infection
* Patients that lack decision-making capacity will not be approached to participate in this study
* Inability to tolerate oral medications
* Allergy or prior adverse reaction to either azithromycin or hydroxychloroquine sulfate
* QTc interval \> 470 mSEC
* History of ongoing ventricular cardiac dysrhythmias of grade 2 as described by NCI CTCAE 5.0 criteria
* History of serious ventricular arrhythmia (VT or VF \> 3 beats in a row)
Assessing the Feasibility of the Use of Visual Aids in Patient Education in Adults With Down Syndrome (DS)

Purpose: To assess the feasibility of using videos depicting people with DS to teach other adults with DS to perform healthy behaviors.

Hypothesis: Videos of adults with DS performing healthy behaviors is a more effective way to promote healthy behaviors by adults with DS than other methods tested.

This project will study whether videos showing a person with DS washing his hands correctly can improve hand washing by other adults with DS.

The subjects will be recruited and identified and consented. Subjects will be randomized to one of 4 groups.

i. Verbal instructions on hand washing with pictures (using the Illinois department of public health tools) ii. Verbal instructions on hand washing and video of the ADSC iii. Verbal instructions on hand washing and video of an adult without DS washing his hands iv. Verbal instructions on hand washing and video of an adult with DS washing his hands.

Videos of the handwashing process will be taken pre intervention and then again post intervention.

Scoring assessments will be completed upon review of the 2 files by 2 separate study team members, the second of which will be blinded to the information they will be reviewing.

Eligibility Criteria:
Inclusion Criteria:

* People with Down syndrome receiving care at Advocate
* No known sensitivity to soap

Exclusion Criteria:

* Pregnant women, prisoners
* Known sensitivity to soap
Lowering Total Immunosuppressive Load in Renal Transplant Recipients More Than 12 Months Posttransplant

To compare the change in renal function between CsA or MMF withdrawal from before to 12 months after drug withdrawal in renal transplant recipients on triple immunosuppressive therapy

To compare the change in renal function between CsA or MMF withdrawal from before to 12 months after drug withdrawal in renal transplant recipients on triple immunosuppressive therapy.

Secondly to examine safety following withdrawal of CsA or MMF, respectively, by the following parameters:

* Biopsy verified acute rejection episodes, time to first rejection and number of steroid resistant rejection episodes within 12 months.
* Hematology (Hb, WBC, platelets) abnormalities within 12 months.
* Graft and patient survival at 12 months and 5 years. Absolute difference in renal function between withdrawal groups at 12 months. Three monthly changes in renal function from drug withdrawal to 12 months. Change in dyslipidemia frequency from drug withdrawal to 12 months. Change in hypertension frequency from drug withdrawal to 12 months. Change in glucose tolerance from drug withdrawal to 12 months. Cumulative incidence of clinical infections resulting in hospitalization within 12 months.

Sub protocols will also examine the following aspects:

Cardiovascular: Homocysteine. Lipid peroxidation. Microvascular function and vasoactive parameters Quality of life (QoL): ESRD SCL-TM, SF-36 (short version) and EQ-5D (GI-checklist extended) questionnaires will be used.

Pharmacoeconomical evaluation.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients of either gender above 18 years of age at time of randomisation. 2. More than twelve months posttransplant. 3. Treated with an immunosuppressive protocol consisting of CsA, MMF and steroid from the time of discharge from the transplant clinic (e.g. 3 months posttransplant).

  4. Kidney (only) transplant recipients with stable renal function (S-creatinine \< 300 umol/L and an average increase in S-creatinine \< 20% the last 6 months prior to inclusion) and without treated clinically and/or biopsy proven acute rejection episodes the last 6 months prior to inclusion.

  5. No previous steroid resistant acute rejections (e.g. treated with ATG/OKT3). 6. Not more than two steroid sensitive acute rejections posttransplant. 7. Signed informed consent.

Exclusion Criteria:

- 1. PRA positivity \> 20%. 2. Concomitant therapy with other investigational drugs or prohibited medication specified in the protocol.

3. Life expectancy less than one year. 4. Acute illness or acute fungal, bacterial or viral infection at screening. 5. Unable and/or unlikely to follow the study protocol.
Phase I Study of Indibulin in Patients With Solid Tumors

Dose-finding and pharmacokinetic trial of orally administered Indibulin to patients with solid tumors.


Eligibility Criteria:
Inclusion Criteria

* Male or female patient, \>= 18 years of age.
* Histologically/cytologically proven solid malignant tumor, for which standard treatment of proven efficacy are not or no longer available.
* Performance status 0-2 ECOG/WHO.
* Life expectancy \> 3 months.
* Able and willing to undergo blood sampling for pharmacokinetics.
* Written informed consent.

Exclusion Criteria

* Safety concerns:
* Any non-compensated or uncontrolled non-malignant condition, such as, symptomatic heart failure, active tuberculosis or any other chronic or active infection.
* History of allergic reaction to one of the ingredients of the trial medication.
* Clinically relevant abnormality in organ function as evidenced by any of the following pa¬ra¬meters:
* White blood cell count: \< 3.0 x 109/l ANC: \< 1.5 x 109/l
* Thrombocytes: \< 100 x 109/l
* Hemoglobin \< 6.0 mM
* Bilirubin (total): \> 1.5 times upper limit of normal range
* ASAT, ALAT: \> 2.5 times upper limit of normal range unless related to metastases in which case \> 5 times upper normal limit is allowed
* Creatinine (serum) \> 135 µmol/l (\> 1.5 mg/100ml) OR
* Creatinine clearance: \< 50 ml/min (calculated according to modified Cockcroft and Gault)
* Breast feeding, pregnancy or planned pregnancy. A reliable method of contraception must be used in men and in women of childbearing potential during the study and for 3 months after last study drug administration.
* Lack of suitability for the trial:
* Concomitant treatment with any other investigational drugs or exposure to another investigational agent within the last 4 weeks prior to study specific screening procedures (period should be extended if the patient has received any drug which is known to have de¬layed toxicity or prolonged half-life).
* Active peptic ulcer or any GI condition that could alter absorption or motility.
* Chronic use of H2-antagonists or proton pump inhibitors.
* Any other cancer treatment during the study or administered within the last 4 weeks (6 weeks for nitrosoureas, mitomycin C, high-dose carboplatin or extensive radiotherapy) before start of study treatment, except irradiation of non-target lesions for symptom relief and bi-phosphonate treatment of bone metastases.
* Clinically symptomatic brain metastases or leptomeningeal disease.
* Neurological or psychiatric disease or drug or alcohol abuse which would interfere with the patients proper completion of the protocol assignment.
* Administrative reasons:
* Anticipated non-availability for study visits/procedures.
A Study on the Efficacy of Immunotherapy, the Occurrence and Severity of Adverse Reactions in Patients with Non-small Cell Lung Cancer in High-altitude Areas

As a major disease with high incidence and mortality rate, lung cancer seriously threatens the health of our people and causes a huge burden of disease. In recent years, with the widespread use of immune checkpoint inhibitors (ICIs), great progress has been made in the treatment of lung cancer, which has brought significant survival benefits to patients. Although ICI has greatly improved the prognosis of lung cancer patients, due to the complexity of the mechanism of action of ICI and the heterogeneity within the tumor, the benefit population of treatment is relatively limited, and some patients are still at risk of primary drug resistance and tumor hyperprogression.In this study, we aimed to compare the differences in the efficacy and adverse reactions of immunotherapy in patients with advanced non-small cell lung cancer at high and low altitudes, and to find out the relevant factors from multiple omics such as imaging, pathology, and genetics, so as to solve the problem of immunotherapy resistance


Eligibility Criteria:
Inclusion Criteria:

* (1) Patients with primary non-small cell lung cancer (adenocarcinoma/squamous cell carcinoma/adenosquamous cell carcinoma/large cell lung cancer/others) with clear cellular/histopathological evidence; (2) Primary non-small cell lung cancer of any stage receiving immunotherapy for the first time; (3) Patients who have undergone at least 2 cycles of immunotherapy during the treatment period and have undergone one efficacy evaluation; (4) Patients with at least one evaluable target lesion (except for those with uncontrolled brain metastases) according to Response Evaluation Criteria for Solid T Tumors (RECIST, version 1.1); (5) Voluntary participation in research and strong willingness to cooperate; (6) has been residing in Qinghai Province since birth; (7) Have been residing in Shaanxi Province since birth; (8) Be at least 18 years old;

Exclusion Criteria:

1. Patients with unknown histopathological type were excluded;
2. Patients with unclear diagnosis and treatment information and immunotherapy-related adverse reactions;
3. Patients with bipolar/multiple primary non-small cell lung cancer with other tumors were excluded;
4. Patients who are unwilling to join the study and have poor willingness to cooperate;
5. Patients who migrated to Qinghai or Shaanxi from different altitudes and had a history of migration between the two provinces were excluded;
6. exclude patients with a history of emigration from parents;
7. Patients who have received immunotherapy for other tumors in the past;
8. Prior immunosuppressive therapy prior to exclusion
Non-invasive Objective Assessment of Hemodynamics in Preterm Neonates

Study type: Prospective Observational trial Study design: Longitudinal Population: Preterm newborns \<32 weeks gestational age Hypothesis: The inclusion of non-invasive physiological measures of cardiac output, peripheral perfusion and brain oxygenation (NIRS) for preterm neonates is feasible and reveals additional information on the hemodynamic status compared to blood pressure alone. These measurements can improve the ability to rapidly identify those infants who might benefit from intervention and are correlated with short term clinical outcomes.

Understanding neonatal hemodynamics is key to neonatal care. Despite decades of research, uncertainty continues as to how best assess impaired hemodynamics.

Hypotension defined by a low Mean Arterial Blood Pressure (MABP) remains a common issue in preterm infants, affecting up to 30% of extremely preterm infants.

It is common to focus only on MABP thus neglecting the complex and dynamic (patho)physiology that may be present in newborn infants. Providing sufficient cellular oxygenation is the primary task of the circulatory system and different factors may compromise it. In this prospective observational study the investigators will examine various forms of objective non-invasive continuous hemodynamic monitoring methods in very preterm infants

1. For feasibility of non-invasive CO measurement (first 20 patients)
2. For reproducibility and correlation of this measurement and ECHOcardiography (first 40 echocardiographic examinations)
3. For prediction of therapy response.
4. For correlation with clinical definitions of hypotension/hypoperfusion
5. For prediction of later clinical problems/complications of prematurity and impaired hemodynamic status.

Eligibility Criteria:
Inclusion Criteria:

* Neonates of 23 weeks 0 days to 31 weeks 6 days
* NIRS/non-invasive Cardiac Output - device available
* Parental Informed Consent

Exclusion Criteria:

* Congenital anomalies
* Major cardiac defects
* Hydrops
* Parents decline to consent to the study
Phase I Study of the Third Generation Adenovirus H5.001CBCFTR in Patients With Cystic Fibrosis

OBJECTIVES:

I. Assess the safety and feasibility of gene transfer with the third generation adenovirus H5.001CBCFTR in patients with cystic fibrosis.

PROTOCOL OUTLINE: H5.001CBCFTR, an adenovirus vector containing the cystic fibrosis transmembrane conductance regulator gene, is administered endobronchially.

Cohort of 2 patients receive 1 of 6 H5.001CBCFTR concentrations. There is no intrapatient dose escalation.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Cystic fibrosis diagnosed as follows: Sweat sodium or chloride greater than 60 mEq/L by pilocarpine iontophoresis or cystic fibrosis genotype Clinical manifestations Estimated 2-year survival greater than 50%, i.e.: FEV1 at least 30% of predicted PaO2 greater than 55 mm Hg on room air PaCO2 less than 50 mm Hg on room air --Prior/Concurrent Therapy-- At least 2 months since systemic glucocorticoids At least 90 days since participation in investigational therapeutic study --Patient Characteristics-- Pulmonary: No pneumothorax within 12 months No asthma or allergic bronchopulmonary aspergillosis requiring glucocorticoids within 2 months No sputum pathogens unless sensitive to at least 2 antibiotics No hemoptysis of more than 250 mL blood over 24 hours within 1 year Other: No active adenoviral infection Ad5 (or similar type) antibody seropositive No other contraindication to protocol participation, e.g.: Drug abuse Alcoholism Psychiatric instability Inadequate motivation Documented azoospermia (men) Bilateral tubal ligation or hysterectomy (women) Screening exams within 4 weeks prior to registration