cyrilzakka/clinical-trials huggingface dataset:
Short-term Health Benefits of Using Fresh Air Filtration System in Classroom

A randomized crossover trial will be conducted in 90 primary school children in 3 classrooms in Shanghai, China. The effects of fresh air ventilation/filtration system, fresh air ventilation system with no filtration and natual ventilation will be compared on the effects of reducing indoor PM2.5 and chilhood health. Biological samples of children are going to be collected to investigate the associations between indoor air pollution and biomarkes of certain health effects.

A randomized crossover trial among 90 primary students in 3 classrooms in Shanghai, China will be performed. Three arms are going to be 1) fresh air filtration system, 2) fresh air system with no filtration and 3) natural ventilation. Each arm is going to be in use for five continuous weekdays followed by one week of wash-out. After one-week of wash out, a cross over change between 3 arms is going to be taked. Then the 2nd week of intervention is performed followed by the 2nd wash-out week. The same cross-over change between 3 arms is going to be repeated again until each classroom will be applied by all three arms of ventilation. A total of 5 weeks is required for the project. Children's biological samples including saliva, urine and skin samples will be collected as well as exhaled NO. A questionnaire on children's perception on air quality will be assessed as well.

Eligibility Criteria:
Inclusion Criteria:

* All invited primary school children in Grade 5 in an artibrarily selected school

Exclusion Criteria:

* Current airway symptoms (cough, airway infection, asthma et al.)
* Acute infectious diseases
Computerized Stage-Matched Intervention for Juvenile Offenders

Juvenile crime imposes enormous costs on victims, on society, and on juvenile offenders themselves. However, research assessing the efficacy of interventions for young offenders show, on average, only small effects on recidivism, substance abuse, and other behavioral outcomes. A major problem with existing interventions is that they tend to neglect individual differences in motivation and readiness to make positive changes. In earlier research, we used an empirically validated model of behavior change, the Transtheoretical Model (TTM, the "stage" model), and expert system technology to develop the Rise Above Your Situation program (RAYS), a prototype of a multimedia computerized tailored intervention designed as an adjunct to traditional juvenile justice programs. The intervention delivers assessments and individualized feedback matched to readiness to stay out of trouble with the law and quit alcohol and drugs. At the end each session the program also generates a helpgiver report that summarizes the youth's feedback and presents concrete, easy-to-implement strategies helpgivers can use to reinforce stage-matched concepts. In the current research, the goals are to complete development of the computerized tailored intervention; develop training and other support materials for helpgivers; and assess the efficacy of the intervention package in a randomized clinical trial involving 700 medium- to high-risk court-involved juveniles aged 13-17 recruited by 54 probation officers randomly assigned to treatment or standard care. Primary outcomes will be criminal recidivism and substance abuse abstinence at 6 and 12 months follow-up.

Fifty-four probation officers employed by the Iowa's Juvenile Court Services agreed to participate in the study and to be randomly assigned to treatment or standard care. A Multiattribute Utility Measurement Approach (Graham, Flay, Johnson, Hansen, \& Collins, 1984) was used to ensure that probation officers assigned to the two conditions were approximately equivalent on level of education, years of experience working with juvenile offenders, number of hours of training on the TTM, and confidence using the TTM in their work.

Probation officers were responsible for recruiting moderate- and high-risk youth on probation, and delivering baseline assessment sessions and intervention sessions. However, local project site coordinators were available to provide assistance, as needed.

Computerized follow-up assessments and urine drug testing at 6 and 12 months follow-up are being administered by "trackers" at a time and place that is convenient for the youth. Study protocols include best practices (Scott, 2004) for maximizing retention at follow-up in research involving high-risk populations.

Eligibility Criteria:
Inclusion Criteria:

Juvenile offenders:

* Score in the moderate- to high-risk range on the short-form Iowa Delinquency Assessment
* Age 13 to 17 at the time of recruitment
* Able to understand and read English

Probation officers:

* Employed by Iowa Juvenile Court Services
* Work with moderate- to high-risk youth
The Effect of Pneumoperitoneum and Trendelenburg Position on Intracranial Pressure: Ultrasonographic Measurement of Optic Nerve Sheath Diameter

The steep Trendelenburg position and pneumoperitoneum during laparoscopic surgery have the potential to cause an increase of intracranial pressure (ICP). Previous studies have proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP. Therefore, this study is aim to confirm the increased ICP by ultrasonographic measurement of ONSD during laparoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (20-90 years of age) scheduled for undergoing robot-assisted laparoscopic prostatectomy undergoing general anesthesia

Exclusion Criteria:

* Patients with previous history of neurologic disease, carotid disease, transient ischemic attack, ocular disease and ocular surgery
Effect of Hepatectomy on the Prognosis of Patients With Nasopharyngeal Carcinoma Liver Metastases

The goal of this clinical trial is to learn about hepatectomy on the prognosis of patients with nasopharyngeal carcinoma liver metastases (NCLM). The main questions it aims to answer are:

To explore the effect of hepatectomy on the overall survival, recurrence-free survival and other prognostic indicators of patients with NCLM.

To explore the impact of hepatectomy on the safety of patients with NCLM.

Researchers will compare the prognosis of the patients in the hepatectomy group and the patients with NCLM who were prospectively enrolled in the same institution and received only systemic treatment at the same time by propensity score matching.


Eligibility Criteria:
Inclusion Criteria:

* Nasopharyngeal carcinoma liver metastases (NCLM) are diagnosed by pathological confirmation of liver biopsy or imaging findings combined with clinical history.
* ECOG score ≤ 2 points.
* 1. Patients with no recurrence of the primary tumor and oligometastasis in the liver. 2. Patients with multiple metastases (bone) without primary tumor recurrence and liver metastases have stable disease (SD) or partial remission (PR) or complete remission (CR) after systemic treatment except for liver lesions. 3. Patients with primary tumor recurrence and liver metastasis (may be combined with bone metastasis) have SD or PR or CR after systemic treatment except for liver lesions.
* Able to perform radical resection of liver lesions.
* Good liver function (Child-Pugh grade A liver function, estimated remaining liver volume ≥ 30%).
* Blood test, coagulation function, liver and kidney function, electrocardiogram, chest X-ray and other preoperative examinations show no clear contraindications for surgery.
* Expected survival ≥ 6 months.
* Those who voluntarily participate in this study and signe the informed consent form.

Exclusion Criteria:

* Younger than 18 or older than 70 years old.
* ECOG score \> 2 points.
* Combined with distant metastasis other than liver and bone.
* Disease progression (PD) after systemic treatment of the primary tumor and bone metastases.
* The liver lesion cannot be resected by R0.
* Insufficient liver reserve function (preoperative liver function Child-Pugh B or C grade and cannot be reduced to A grade in a short time, or estimated remaining liver volume \<30%).
* Combined with surgical contraindications in the preoperative examination, such as cardiac clinical symptoms or diseases that are not well controlled, abnormal coagulation function with bleeding tendency, or receiving thrombolytic therapy, etc..
* Liver metastases have received local treatment for liver metastases such as interventional and radiofrequency.
* Pregnant or lactating women.
* History of malignant tumors in other parts, severe mental illness, etc..
* Patients or family members cannot understand the conditions and objectives of this study.
Investigation of Metabolic Risk in Korean Adults

A cohort study with Korean adults to investigate biomarkers in prediction of cardiometabolic and other diseases

This is a prospective cohort study with Korean adults to investigate biomarkers in prediction of cardiometabolic and other diseases

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults without chronic diseases
* Diabetic patients who are well controlled with oral antidiabetic agents
* Hypertensive patients who are well controlled with oral antihypertensive agents
* Dyslipidemic patients who are well controlled with oral lipid-lowering agents

Exclusion Criteria:

* Malignancy
* Chronic wasting disease
* Long-term steroid use
A Comparison of DFD01 Spray Versus Vehicle Spray in Subjects With Moderate Psoriasis

The objectives of this study are to compare the efficacy and safety of DFD01 Spray to Vehicle Spray for topical treatment of moderate plaque psoriasis


Eligibility Criteria:
Inclusion Criteria:

Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.

Subjects with psoriasis involving 10 to 20% BSA, not including the face, scalp, groin, axillae and other intertriginous areas.

Subjects must have an IGA grade of 3 (moderate) at the Baseline Visit

Exclusion Criteria:

Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).

Presence of pigmentation, extensive scarring, or pigmented lesions or sunburn which could interfere with the rating of efficacy parameters.

History of psoriasis unresponsive to topical treatments. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.

Use within 180 days prior to Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, or alefacept).

Have received treatment for any type of cancer within 5 years of the Baseline Visit except skin cancer and cervical cancer (in situ) are allowed within 1 year of the Baseline Visit.

Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) or 3) oral retinoids (e.g., acitretin, isotretinoin).

Use within 30 days prior to the Baseline Visit of: 1) systemic steroids, 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy. Inhaled, intraocular, and intranasal steroids are allowed.

Use within 14 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene), 2) topical retinoids (e.g., tazarotene, tretinoin) or 3) topical corticosteroids.

Require use of beta blockers, lithium, ACE inhibitors, and/or NSAIDs (indomethacin, ibuprofen, aspirin, naproxen) with a medical history that these medications affect the subject's psoriasis, except if the subject has been using the medication routinely during the 180 days prior to the Baseline Visit, these medications are allowed.
Interest of a TEteleconsultation of a Psychological Support Nurse on Psychological Distress in Patients with a Primary Malignancy of the Central Nervous System

The goal of this clinal trial is to compare the effectiveness of nurse-led teleconsultation with usual care (intervention group) on psychological distress in patients with primary malignant tumors of the central nervous system between diagnosis and first anti-cancer treatment, versus usual care alone (control group).

Participants will be randomized into two groups :

* group A) intervention: usual care + nurse teleconsultation for psychological support
* group B) control: usual care alone

Enrolment = Day0 (D0)

Participants will :

* groups A and B: D0: complete 4 questionnaires (Quality of Life, Screening for Distress, Screening for Anxiety and Depression, Social Support Questionnaire)
* Group A : D0+2/4 das : nursing teleconsultation for psychological support
* Groups A and B: D0+10days : telephone call to complete the same 4 questionnaires as at inclusion
* Group A : D0+15days: semi-directive interview, at home, for voluntary patients.

The expected benefits are as follows:

For the patient :

* Reduction in pre-treatment psychological distress
* Reduced pre-treatment anxiety and depression
* Better understanding of disease and treatments
* Better adherence to the care proposed in the treatment pathway
* Reduced stress during first hospital treatment

For healthcare professionals :

* Early detection of psychological distress
* Early detection of unmet needs and appropriate individualized responses
* Establishment of a climate of trust between patient and caregiver
* Improved professional practices

For the healthcare system :

* Lower healthcare costs (fewer anxiolytic treatments, etc.)
* Therapy to be integrated into the treatment pathway of patients with central nervous system cancer
* Reduced socio-territorial inequalities in healthcare provision

Eligibility Criteria:
Inclusion Criteria:

* aged 18 and over
* being treated for a primary malignant tumor of the central nervous system (positive biopsy)
* with a Mini-Mental State score greater than 24
* not receiving first-line treatment (chemotherapy, targeted radiotherapy, surgery)
* with a distress score above 3 on the Psychological Distress Thermometer
* have access to computer equipment equipped with a microphone and webcam (smartphone, computer)
* able to read, write and speak French
* have given free and informed consent
* being affiliated to a social security scheme

Exclusion Criteria:

* with a history of psychiatric illness
* with recurrent cancer of the cerebral nervous system
* having begun first-line treatment (drug therapy, curative surgery, radiotherapy or palliative care)
* under guardianship, curatorship or deprived of liberty
Donepezil Treatment for Sleep Apnea Patients

The purpose of this study is to determine the effects of the anticholinesterase drug donepezil on sleep apnea patients. Sleep structure and respiratory parameters will be analyzed by polysomnography.

Cholinergic activity also influences the upper airway opening via central and peripheral mechanisms. Decreased thalamic pontine cholinergic projections may affect respiratory drive leading to both central and obstructive apnea at least in certain degenerative conditions.In contrast to the prolific literature on physical and surgical treatments for sleep apnea there is a dearth of effective pharmacological approaches.Most drugs previously tested for this purpose acted upon monoaminergic and adenosinergic systems and showed unsuccessful or ambiguous results.A previous study showed that donepezil treatment improved apnea-hypopnea index and oxygen saturation in patients with Alzheimer's disease. Treatment also increased REM sleep duration and reduced ADAS-cog scores.Based on these facts we hypothesize that donepezil treatment may be beneficial for sleep apnea patients.

Intervention: Patients will be administered donepezil or placebo. The study has a randomized, double-blind placebo-controlled design. Complete polysomnography will be performed at baseline, after 28 days of drug or placebo treatment, after 15 days drug or placebo washout and after 28 days of CPAP treatment.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of obstructive sleep apnea according to American Academy of Sleep Medicine criteria

Exclusion Criteria:

* body mass index \> 40
* use of psychoactive drugs
* presence of neurological, cardiological and pulmonary diseases
Natural History of Atherosclerosis

20 patients will be recruited. The aim of the study is to determine the natural progression of atherosclerotic disease.


Eligibility Criteria:
Inclusion Criteria:

* stable carotid artery disease not requiring revascularization
* asymptomatic carotid artery stenosis \< 80% or symptomatic patients with stenosis \< 60 %
* prophylactic therapy with aspirin (\> 100mg/day, statin, blood pressure therapy if indicated (goal \< 130/80 mmHg))
* informed consent

Exclusion Criteria:

* non atherosclerotic occlusive disease (Bürgers disease)
* uncontrolled BP (DBP \> 110 mmHg and/or SBP \> 200 mmHg)
* hemorrhagic disease or platelet count \< 100'000 mm\^3
* Known active liver disease (elevations of GPT GOT or increased ammonia)
* impaired renal function (crea \> 180 mmol/l)
* pregnancy
* severe claustrophobic reactions
* short - term life - threatening pathology
* physically unable to participate in the study
* compliance not guaranteed
Exchange Transfusion Versus Plasma From Convalescent Patients With Methylene Blue in Patients With COVID-19

The aim of this project is to introduce way for treatment of patients with severe COVID-19 disease with respiratory complications.

Study Tools AND/ OR procedure

The patients were subjected to the following:

Clinical parameters:

Complete history taking and thorough clinical examination

1. Laboratory parameters:
2. CBC with differential counts.
3. Reticulocytic count.
4. Blood film for shistocytes.
5. Serum ferritin and transferrin saturation.
6. D dimer.
7. Liver function tests, kidney function tests, electrolytes.
8. ESR.
9. CRP.
10. LDH.
11. Viral markers (HCV Ab, HBsV AG, HIV Ab).
12. ADAM'S 13 assays.
13. Serum soluble CD 25.

Other investigations:

1. Chest X ray.
2. Pelviabdominal US.
3. CT chest.
4. ECG.
5. Echocardiography

The patients will be divided into three groups, each group formed of 5 patients with severe COVID-19 or on mechanical ventilator receiving standard of care All the groups matched regarding age, sex and the severity of the disease.

Group I:

Will receive exchange transfusion by venesection of 500cc blood with good replacement of one unit packed washed RBCs daily for 3 days according to daily clinical and investigational follow up

Group II Will receive IV methylene blue 1 mg/kg IV over 30 minutes with 200 CC plasma from convalescent matching single patient by plasma extractor machine for 3 days according to daily clinical and investigational follow up.

Group III Will receive exchange transfusion by venesection of 500cc blood with good replacement of one unit packed washed RBCs and IV methylene blue 1 mg/kg IV over 30 minutes with 200 CC plasma from convalescent matching single patient by plasma extractor machine for 3 days according to daily clinical and investigational follow up.

N.B.: Convalescent plasma and regular blood will be taken from ministry of health after administrative approval All groups will receive

1. Low dose anticoagulant (LMWH 1 mg/kg/day).
2. Steroid (methyl prednisone 1 mg/ kg IV daily and according to patients' condition and presence of complications like hemophagocytosis).
3. All allergic precautions if needed like antihistaminics , epinephrine and steroid.

Close monitoring for:

1. Allergic reactions.
2. ECG changes daily.
3. Volume overload.
4. Complications of other comorbidities like DM or HTN.
5. Liver function and kidney function and organ dysfunction daily.

Terms of discontinuation:

Deterioration of clinical condition or organ functions.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients are 18 years old or above.
2. Inpatients diagnosed as severe COVID - 19 disease according to WHO criteria.
3. CT chest with extensive lung disease (ground-glass and consolidative pulmonary opacities).
4. O2 saturation less than 93% resting.
5. Respiratory rate equal or more than 30 per minute.

Exclusion Criteria:

1. Patients with pregnancy and lactation.
2. Renal failure and heart failure.
3. Contraindication for plasma or blood transfusion.
Integrative Therapy for Holistic, Natural Cognition and Lifestyle Rehabilitation

An observational study to determine outcomes of older adults who are under naturopathic medical care for cognitive complaints at a specific clinic in Southern California.

This prospective observational study will examine patient outcomes associated with individualized, whole-system integrative medical care, provided by a naturopathic physician at a specific clinic in the state of California. Participants will be older adult patients of the clinic who present with objectively measurable cognitive dysfunction, and who elect to voluntarily participate in the study.

Participants' cognitive function will be assessed using validated objective (NIH Toolbox) and subjective (NIH Neuro-Quality of Life questionnaires) instruments. The primary outcomes are change from baseline to six months post-baseline in these two instruments.

Additionally, physical activity and sleep data will be tracked using wearable telemetry, and neurophysiological parameters will be measured with electroencephalography. Detailed treatment descriptions and adverse events will be tracked.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling adults ≥60 years of age.
* Montreal Cognitive Assessment (MoCA) score of 12-23.
* Able to independently make decisions.
* Able to safely travel to North County Natural Medicine for 4 study visits and approximately 4 clinical visits, for a duration of 6 months.
* Able to wear an Oura Ring, download data every 6 days, and keep the ring regularly charged for the duration of participants' involvement in the study.
* A high school diploma or equivalent.
* Ability to communicate via email.
* Ability to independently fill out a computer-administered questionnaire.
* Ability to withhold from seeing another integrative or alternative medicine provider for the 6 months of participation in the study.

Exclusion Criteria:

* Inability to read and write in English.
* MoCA score \>23.
* A visual impairment that would prevent reading a computer screen.
* Partial or full deafness.
* A previous diagnosis of dementia (e.g. Alzheimer's Disease or any other kind of dementia).
* Congenital cognitive impairment or disability.
* Alcohol or substance abuse.
* Serious somatic disease, neurodegenerative disease, acute onset of cognitive decline, or rapid neurological impairment.
* Inability to bring an affiliate to the Informed Consent Consultation.