cyrilzakka/clinical-trials huggingface dataset:
Evaluation Inhaled Corticosteroids on Exhaled Nitric Oxide Gas Exchange

To evaluate the role of inhaled corticosteroids to suppress nitric oxide gas exchange in stable patients with moderate-to-severe COPD who are current non-smokers and not on oral corticosteroids.

Stable, non-smoking COPD patients not on oral corticosteroids will be randomized in single blinded study to evaluate nitric oxide gas exchange at baseline, and subsequent effects of fluticasone 100mcg/salmeterol 50mcg bid, and fluticasone 250mcg/salmeterol 50mcg bid. Primary end points will include measurements of nitric oxide at varying expiratory flow rates to calculate bronchial, and small airway/alveolar nitric oxide. Secondary end points will evaluate lung function. Exhaled nitric oxide production presumably reflects endogenous inflammation. Normal healthy, non-smoking controls will be used for comparison, with exhaled nitric oxide measured before and after 3 weeks of low dose inhlaed corticosteroids.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of copd
* Current non-smoker
* Not on oral corticosteroids
* Must be able to use Advair discus or salmeterol discus

Exclusion Criteria:

* Pregnancy
* Current smoker
* On corticosteroids
* Clinically unstable
Intervention to Improve the Adherence in Community Pharmacies

The ANM is the first initiative that puts advanced pharmaceutical care into practice in Andalusia (Spain). The aim of this is study is to evaluate the effectiveness of the intervention Assistance to New Medicines (ANM) in the improvement of adherence to treatment in community pharmacies.

Design: parallel cluster pragmatic randomized controlled trial. The study includes patients users of a community pharmacies, who meet the following inclusion criteria: patient who starts treatment of any of the following pathologies: Chronic Obstructive Pulmonary Disease (COPD), Arterial Hypertension or Diabetes Mellitus in Andalusia (Spain).

In order to avoid possible contamination between patients assigned to the control and intervention group, randomization will be carried out at the pharmacy level; preventing the pharmacist from applying part of the intervention to the control group.

Interventions: patients randomized: (i) current practice; or (ii) ANM intervention thru a pharmacist delivered support for a newly prescribed medicine.

Eligibility Criteria:
Inclusion Criteria: patient who starts treatment of any of the following diseases:

* Chronic Obstructive Pulmonary Disease (COPD).
* Arterial Hypertension
* Diabetes Mellitus.
* Anticoagulants

Exclusion Criteria:

* those users who do not know how to read and write in Spanish,
* Suffer from a physical or mental disorder that makes it impossible to perform the
Safety and Efficacy of Valiant Mona LSA Stent Graft System

The Valiant Mona LSA thoracic stent graft system is for the endovascular repair of aneurysms of the descending thoracic aorta (DTA) in patients who require coverage of the left subclavian artery (LSA).The study is intended to assess safety and performance of the device acutely and at 30 days.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age.
* The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form
* Subject must be considered a candidate for revascularization of the LSA.
* Subject has a DTA which will require coverage of the LSA
* Subject's anatomy must meet the anatomical criteria to receive that implanted device

Exclusion Criteria:

* Subject has had previous endovascular repair of the ascending and/or descending thoracic aorta.
* Subject is in acute renal failure or has renal insufficiency with a serum creatinine ≥ 2.0 mg/dL
* Subject is a pregnant female.
* Enrollment in another clinical study
* Subject has had a cerebral vascular accident (CVA)or myocardial infarction (MI) within 3 months.
* Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
* Subject has a known allergy or intolerance to the device components.
* Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury

Induction of hypothermia to \< 35˚C by \< 2.5 hours after severe traumatic brain injury, reaching 33˚C by 4 hours after injury and maintained for 48 hours in patients aged 16-45 will result in an increased number of patients with good outcomes at six months after injury compared to patients randomized to normothermia.

NABIS:HIIR was a randomized clinical trial conducted in patients with severe brain injury, age 16-45. Patients were randomized to standard treatment at normothermia or to standard treatment with moderate hypothermia (32.5-34C for 48 hours). An intent to treat analysis was used with the primary outcome measure as the Glasgow Outcome Scale at six months after injury. GOS is dichotomized into good outcome (Good Recovery/Moderate Disability) and poor outcome (Severe Disability, Vegetative, Dead).

Eligibility Criteria:
Inclusion Criteria:

1. Non-penetrating brain injury with post-resuscitation Glasgow Coma Score (GCS) \< 8 (motor 1-5)
2. Estimated or known age \> 16 and \< 45 years old
3. Time of Injury within 2.5hrs of arrival at hospital

Exclusion Criteria:

1. GCS = 7 or 8 with a normal head Cat Scan (CT) scan or showing only mild Subarachnoid hemorrhage (SAH)or skull fracture or GCS \> 9 post- randomization
2. GCS = 3 AND bilaterally non-reactive pupils
3. Abbreviated Injury Score (AIS) \> 4 for any body area except head
4. Positive abdominal ultrasound or CT scan
5. Persistent hypotension (systolic blood pressure \< 110mmHGg)
6. Persistent hypoxia (O2 Saturation \< 94%)
7. Positive pregnancy test
8. Injured greater than 2.5 hours from hospital arrival
9. Pre-existing medical conditions, if known
The Feasibility And Efficacy Of A Telerehabilitation Program For People With Knee Osteoarthiritis In Sri Lanka

it will be 8 week zoom program of exercises for knee osteo arthritis. participant will be selected according to elegibilty criteria. pre and post measurements will be obtained. then feasibility and efficacy will be assesed.

This research is to check the feasibility and efficacy of a telerehabilitation program for people with knee osteoarthritis in Sri Lanka. 14 people with knee OA will be recruited according to the inclusion and exclusion criteria. Study group will be selected with advertisement on facebook.

People who are interested will be included. Exercise booklet and instruction materials will be given to patients and initial measurement of Pain using VAS scale, 30 CST (30 second chair stand test)- Lower extremity muscle strength and dynamic balance, WOMAC (Western Ontario and McMaster Universities Arthritis Index)- pain, stiffness and physical activity will be obtained. Study group will go for 8 weeks of zoom program of exercises. Classes will be taken by the physiotherapist 3 days per week with standardized program called PEAK.knee log book will be maintained by therapist. Post 8 week same measurements on baseline will be reassessed and additional to that, Feasibility and acceptability for tele rehabilitation and Patient adherence and Safety will be assessed with attrition rate, satisfaction rate , participation to the program and measuring adverse effect respectively. Statistical Package for Social Science (SPSS) version for Windows will be used for data analysis. Pair t test will be used to compare the baseline and post 8 week results.

Eligibility Criteria:
Inclusion Criteria:

Meet National Institute for Health and Care Excellence clinical criteria for OA

* Age ≥45 years.
* Activity-related knee joint pain.
* Morning knee stiffness ≤ 30 min.
* Report history of knee pain ≥ 3mths.
* Report knee pain on most days of the past month.
* Report an average pain score of at least 4 on an 11-point numeric rating scale during walking over the previous week.
* Report difficulty walking and climbing stairs.
* Have access to a device with internet connection: if they can use without assistance if possible

Exclusion Criteria:

* On waiting list for/planning knee/hip surgery in next 12 months.
* Previous arthroplasty on affected knee.
* Recent knee surgery (past 6 months).
* Consulting/ed physiotherapy or doing strengthening exercise for knee (past 6 months).
* Self-reported inflammatory arthritis (eg rheumatoid arthritis).
* Any neurological condition affecting lower limbs; and/or any unstable/uncontrolled cardiovascular condition.
* Clearance to participate from a general practitioner will be required for anyone who reported a fall (past 12 months) or is house-bound due to immobility
First-line Chemotherapy for Recurrent Cervical Cancer

The response rate of traditional first-line chemotherapy for recurrent or persistent advanced cervical cancer was low. This single arm, open, phase II trial would recruit 37 eligible patients. A combination of cisplatin, paclitaxel and apatinib would be given for first 23 patients. If at least 13 patients achieved complete or partial remission, the same regimen would be given for rest patients. The primary end is overall response rate (ORR). The second ends include progression-free survival, overall survival, disease control rate, remission duration, and adverse events. A molecular testing, mainly consisting of genomic analysis, will be carried in the oncologic tissues.


Eligibility Criteria:
Inclusion Criteria:

* Female of 18-75 years old
* Eastern Cooperative Oncology Group score 0-1
* Pathological confirmed of uterine cervical adenocarcinoma, squamous carcinoma, or adenosquamous carcinoma, with stage IA1 (with lymph-vascular space invasion) to IVB, which had accepted radical treatment for the purpose of cure
* An interval of 3 months or more since the fulfilling of last treatment
* At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1
* Anticipative survival period of 3 months or more
* Lab testing within reference ranges
* With appropriate contraception
* Provided consents of participating the trial

Exclusion Criteria:

* With a history of exposure to other antiangiogenic agents
* With other malignancies within past 3 years
* With vital complications
* With uncontrolled hypertension despite of medical treatment
* With severe cardiac disease, coagulation disorders, bleeding disorders, vascular diseases, deep venous thrombosis
* With brain metastasis
* With addiction to psychiatric medications or with mental disorders
* With severe open trauma, fracture or major surgery with past 4 weeks
* With disorders which would hamper the absorption of oral drugs, or with intestinal perforation or ileus with past 6 months
* Urine protein ≥++, or 24 hr urine protein ≥1.0 g
* With potential allergy or intolerance to study regimens
* Not eligible for the study judged by researchers
Study of Health Personnel and the Assistance to Patients With Tuberculosis in Hospital Environment

The purpose of this study is to evaluate in hospital environment the knowledge of the health care professionals about fundamental concepts on tuberculosis and the accomplishment to respiratory isolation practices for patients with pulmonary tuberculosis hospitalized in a public hospital in Fortaleza, Ceará, Brazil.

A cross-sectional study of health care professionals using a study instrument with questions to evaluate the knowledge of basic concepts about tuberculosis. A retrospective study reviewing medical records of patients with suspected tuberculosis hospitalized in the units of Adult and Pediatric Clinics and in the Critical Care Unit in a general hospital in Fortaleza-CE.

Eligibility Criteria:
Inclusion Criteria:

* Health care professionals working in a public hospital (HGWA) in the units of Adult and Pediatric Clinics and in the Critical Care Unit in a general hospital in Fortaleza-CE

Exclusion Criteria:

* Health care professionals working in HGWA but in units other than Adult and Pediatric Clinics and in the Critical Care Unit
Bio-significance of LPC16:0 in Fibromyalgia

Fibromyalgia (FM) is a very common but mysterious pain disorder characterized by chronic widespread muscular pain. Fatigue, anxiety and depression are common comorbidities. The syndrome is commonly associated with several symptoms, including fatigue, sleeping disturbance, cognitive impairment, and comorbid pain syndrome, especially irritable bowel symptoms and temporomandibular disease. Anxiety and depression are common psychiatric co-morbidies. Daily stress is believed to trigger or aggravate pain conditions. These symptoms can markedly affect patients' quality of life, and even lead to disability. So far, the etiology and pathogenesis are largely unknown, and diagnostic biomarkers and curative treatment remain to be developed. Recent technological advances enable scientists to explore mechanisms by genetic, transcriptomic, proteomic, and metabolomic researches. However, no definitive result has been concluded for clinical practice so far.

In this study, the investigators use tailored questionnaires to evaluate fibromyalgia and associated symptoms, including numeric rating scale for soreness, widespread soreness index, Fibromyalgia impact questionnaire, Hospital Anxiety and Depression Scale, and perceived stress scale. The investigators also use metabolomics and lipidomic approach to probe the potential pathophysiology of fibromyalgia. In our prior translation research (PMID: 32907805), the investigators found that excessive LPC16:0 resulting from lipid oxidization inflicts psychological stress-induced chronic non-inflammatory pain via activating ASIC3. In this content, our prior translational research identified a potential nociceptive ligand that causes fibromyalgia symptoms, which is likely to function as biomarkers for diagnosis or disease monitor. In the current clinical investigation, the investigators aim to reversely translate the novel findings in animal studies and validate the bio-significance of LPC16:0 for fibromyalgia with clinical approaches.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of fibromyalgia

Exclusion Criteria:

1. Systemic rheumatological or immune disorders (e.g., systemic lupus erythematosus, inflammatory myositis),
2. Systemic use of corticosteroids,
3. Pregnancy,
4. Chronic diseases under poor control
5. Malignancies.
Early Discharge and Outpatients Care in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Previously Treated With Intensive Chemotherapy

This phase II trial studies how well early discharge and outpatient care works in patients with myelodysplastic syndrome or acute myeloid leukemia previously treated with intensive chemotherapy. Gathering information about patients with myelodysplastic syndrome or acute myeloid leukemia who are discharged after finishing chemotherapy, or who stay in the hospital until blood counts return to normal, may help doctors learn more about the safety of allowing patients to leave the hospital early, the patient's quality of life, use of medical services, and the cost of these services associated with such a policy.

PRIMARY OBJECTIVES:

I. Estimate the early death rate in patients discharged after completion of intensive induction or salvage chemotherapy.

SECONDARY OBJECTIVES:

I. Compare the costs incurred by patients discharged early after induction or salvage chemotherapy with similar patients who are discharged only after their blood counts recover.

II. Compare resource utilization (transfusions, etc.) in patients discharged early after induction or salvage chemotherapy with similar patients who are discharged only after blood count recovery.

III. Compare the quality of life in patients discharged early after induction or salvage chemotherapy with similar patients who are discharged only after their blood counts recover.

OUTLINE:

Patients are discharged within 72 hours after completion of chemotherapy and undergo standard outpatient care by a registered nurse (RN), physician assistant (PA), or resident/fellow at a local facility or the study center approximately 3 times per week, as clinically indicated for up to 45 days.

After completion of study, patients are followed up for 1 month.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) other than acute promyelocytic leukemia (APL) with t(15;17)(q22;q12), (promyelocytic leukemia \[PML\]/retinoic acid receptor \[RAR\]), or variants according to the 2008 World Health Organization (WHO) classification
* Currently undergoing AML-like intensive induction or re-induction chemotherapy, or is planned to start such therapy within 1 week
* Provide signed written informed consent
* Patients can be repeatedly enrolled in this protocol (e.g. for induction and 1st or subsequent salvage therapy)

Exclusion Criteria:

* Drug hypersensitivities or allergies disabling use of prophylactic antimicrobials
Improvement of the Glottic View by Video Laryngoscope

This study aims to compare the exposure of glottis by the use of video and direct laryngoscopy.

It is well known that a video laryngoscope can provide better glottic view than a direct laryngoscope. However, to date, a direct laryngoscope has been the standard equipment for tracheal intubation. Recently, it seems that use of the video laryngoscope has increased. However, the advantage of the video laryngoscope over a direct laryngoscope has not been measured quantitatively. In this study, the glottic view by the use of video laryngoscope will be compared with that of the direct laryngoscope simultaneously, by using C-MAC S-imager installed with a disposable Macintosh blade. Intubating anesthesiologists will use it as if it is a direct laryngoscope. Simultaneously, the glottic views visualized on the monitor of the video laryngoscope will be recorded and evaluated later. For quantitative comparison, the glottic view will be scored with the Percentage of glottic opening scale, for both direct laryngoscopy and video laryngoscopy. Also, the glottic view will be compared by Cormack-Lehane grade.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are over 18 years old, and are planning surgeries that require general anesthesia and tracheal intubation.

Exclusion Criteria:

* Patients who are not agreed to participate in the trial
* Patients who have a poor dental condition which requires other than direct laryngoscopy
* Patients who require rapid sequence induction technique
* Patients with cervical spine instability
Effects of Life Review Intervention on Meaning in Life Among Older Adults With Disabilities

The goal of this interventional study is to learn if life review works to improve the sense of meaning in life in older adults with disabilities who live at home. The main questions it aims to answer are:

Does life review enhance the sense of meaning in life of participants? Does life reviews enhance the life satisfaction of participants. Does life reviews enhance the quality of life of participants?

Researchers will compare the life review program to routine community health services to see if the life review intervention program is effective in enhancing the sense of meaning in life of older adults with disabilities who live at home.

Participants will:

Take face-to-face life review interview or routine community health service every week for 6 weeks.

Take the the questionnaire survey before and after the six-week life review intervention.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥60 years old
* Conform to the diagnosis of disability
* Those who scored \<38 points on the Chinese version of the Meaning of Life Scale (C-MLQ)
* Conscious, able to comprehend the questionnaire, and have the ability to communicate verbally
* Voluntarily participate in the study and sign the informed consent form

Exclusion Criteria:

* With cognitive impairment
* Unable to complete the questionnaire due to their physical condition
* Participated in other psychosocial interventions during the same period
Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia

This is an open label, eight week, clinical trial of a proprietary high CBD/low THC sublingual solution for the treatment of clinically significant anxiety and agitation in individuals with mild cognitive impairment (MCI) or mild to moderate Alzheimer's Disease (AD).


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of probable Alzheimer's Dementia via criteria from McKhann et al., or MCI
2. MMSE score of 15-30 (inclusive)
3. Clinically significant degree of anxiety, as defined by a Clinical Impression total column score of ≥4 on the Anxiety domain of the NPI-C
4. A health care proxy available to sign consent on behalf of the participant (if applicable)
5. A caregiver who spends at least 10 hours per week with the subject who is able to attend all study visits
6. Participants and their study partner must be fluent in English
7. Must be 55-90 years old (inclusive)

Exclusion Criteria:

1. Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease, which might confound assessment of safety outcomes.
2. Seizure disorder
3. Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, as determined by the MINI
4. Current episode of major depression, as determined by the MINI
5. Active substance abuse or dependence within the past 6 months, as determined by the MINI
6. Delirium (as measured by the CAM)
7. Current inpatient hospitalization
8. Current regular use of cannabinoid products (\>1 use per month)
9. Positive urine screen for THC at the screening or baseline visit
10. Allergy to coconut
11. Participants taking strong inhibitors or inducers of CYP3A4 (e.g. fluconazole, fluoxetine, fluvoxamine, ticlopidine, St. John's Wort, etc.), CYP2C19 (ketoconazole, erythromycin, etc.), or anti-epileptic drugs
EUpertstrain 4 Study of Bordetella Pertussis Isolates

This study focus on the genetic changes of B. pertussis clinical isolates. For this panels of B. pertussis isolates has been collected during four periods in different European countries.

B. pertussis is considered as a monomorphic pathogen. However, genetic changes have been observed in several antigens (pertussis toxin, pertactin, filamentous haemagglutinin and fimbriae) included in the current acellular pertussis vaccines between vaccine strains and circulating isolates.

To study genetic changes in the B. pertussis populations in Europe, four distinct panels have been collected: EUpert I in 1999-2001 including 102 isolates, EUpert II in 2004-2005 including 154 isolates, EUpert III in 2007-2009 including 140 isolates and EUpert IV in 2012-2015 including 265 isolates. Selection criteria have remained unchanged for all four collections, which enables the opportunity to study changes in B. pertussis populations during the last 15 years.

Eligibility Criteria:
Inclusion Criteria:

* B. pertussis clinical isolates should be collected from subjects from different regions and be epidemiologically unrelated.
* An equal number of isolates from vaccinated and unvaccinated subjects should be collected. Optimally, the isolates are preferred to be selected from individuals less than 5 years of age.
* For countries with large numbers of isolates in their collections, isolates should be randomly selected according to criteria above.

Exclusion Criteria:

* There is no strict exclusion criteria for this study