cyrilzakka/clinical-trials huggingface dataset:
Air Pollution, Inflammation, and New Onset Asthma

To examine air pollution, inflammation and new onset asthma in a large cohort of children in southern California.

BACKGROUND:

Ambient air pollution is well accepted as a cause of asthma exacerbations, but its role in the etiology of new onset asthma is less clear. Evidence for an etiologic role of ambient air pollutants is emerging from epidemiologic studies; however, the ecologic patterns of increasing asthma prevalence concurrent with decreasing levels of some pollutants have raised questions about the validity of these associations. A better understanding of the biological processes that mediate the effects of ambient air pollution on asthma occurrence is likely to contribute to answering these questions. Chronic oxidative/nitrosative stress and airway inflammation are probably critical processes in asthma etiology and these inter-related processes may mediate the increased asthma risk from air pollution.

This study builds on the existing Asthma Incidence Risk (AIR) study which is an ongoing cohort study consisting of 6000 children with new onset asthma. The children live in 12 communities in Southern California. The communities were chosen to give a range of the key ambient air pollutants of ozone, small particulates, NOx, acid vapors and tailpipe emissions.

DESIGN NARRATIVE:

The study will use exhaled nitric oxide (eNO) to investigate the role of inflammation and oxidative/nitrosative stress in the pathobiology of new onset asthma, with a focus on ambient air pollution and genetic susceptibility. The investigators choose ambient pollutants based on potential contribution to oxidative/nitrosative stress (O3; particulates (PM10 and PM2.5 and their chemical constituents, particle counts, NOx (NO and NO2), acid vapors; and fresh tailpipe emissions). The primary hypotheses to be assessed in the program of research are: 1) children with high ambient air pollution exposures have chronic airway inflammation as indicated by elevated eNO. 2) susceptibility to airway inflammation and oxidative/nitrosative stress from ambient air pollution varies by NOS1, NOS2. NOS3. GSTM1. GSTP1. NQO1, and HO-1 haplotypes and functional variants, and 3) children with chronic airway inflammation as indicated by elevated eNO are at increased risk for new onset asthma. To test these hypotheses, the study builds on the population resource of the Asthma Incidence Risk (AIR) study, an ongoing prospective cohort study of the determinants of new onset asthma in 6000 children in 13 southern California communities, and an extensive program of ambient air pollution exposure characterization in these communities. The investigators will measure eNO using off-line techniques and genotype 3000 children from the AIR cohort. A number of resources will enhance the study, including the Children's Environmental Health Center, the Molecular Biology Core of Southern California Environmental Health Sciences Center, and expertise from the Southern California Particle Center and Supersite.

Eligibility Criteria:
No eligibility criteria
Effectiveness of Nurse-based Care Coordination on Readmissions Among Primary Care Patients: a Stepped Wedge Cluster Randomized Trial

This trial will evaluate the effectiveness of nurse-based care coordination and nurse-based remote patient monitoring on hospital readmissions among primary care patients.


Eligibility Criteria:
Inclusion Criteria:

* Discharged from the hospital in the past 7 days
* LACE+ score of 59 or greater and at least two chronic conditions
* Index hospitalization with discharge directly to community dwelling home (home, assisted living)
* English speaking
* Normal cognitive function - mild dementia or mild cognitive impairment is allowed if a caregiver is able to work with the care coordinator and patient during program enrollment
* Mayo Clinic or Mayo Clinic Health System provider managing the patient's care (e.g. primary care); patient is assigned to the panel of a Mayo Clinic Medical Doctor/Nurse Practitioner/Physician Assistant
* Access to and ability to communicate via telephone (either patient or caregiver)

Exclusion Criteria:

* Psychiatric hospital admission
* Patients with a serious and persistent mental health disorder or severe treatment interfering behavior that require a higher level of service than is available at the patient's clinic
* Untreated active substance or alcohol abuse
* Dementia or moderate to severe cognitive impairment
* Discharged to one of the following: rehabilitation unit, skilled nursing facility, assisted living memory unit, group home
* Pregnancy
* Active treatment for cancer
* Receiving dialysis or transplant services
* Life expectancy \< 6 months or enrolled in hospice or palliative care programs
* Patient is unwilling to sign a Release of Information (ROI); ROI allows those providing care, internal and external, to be actively involved in the patient's care coordination
* Patients with active tuberculosis (TB)
* Violent patient flag noted in Epic (for adult medical care coordination)
* Patient declines home visit (for adult medical care coordination)
* Patient is already enrolled in remote patient monitoring or the care transitions program
Circulating and Imaging Biomarkers to Improve Lung Cancer Management and Early Detection

Validation of biomolecular markers in the circulation and radiomic features are the focus of this project.The aim is to assess the role of molecular and cellular biomarkers (exosomes antigens, Circulating tumor cells - CTCs, panel of mutations in circulating free DNA) and radiomic signature, as complementary to assist early detection of lung cancer by LDCT.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 55 years old and exposure to smoking more than 30 packs-year; which corresponds to 6-year risk of lung cancer, calculated according to the plco score (≥ 2%).
* Smoker or former smoker Former smokers must have ceased smoking within the 15 years prior to enrollment in the study.
* Absence of symptoms of lung cancer such as worsening of cough, hoarseness, hemoptysis and weight loss.

Exclusion Criteria:

* Previous diagnosis of lung cancer.
* Positive extrapulmonary cancer history in the last 5 years (excluding in situ tumors or skin epidermoid tumor).
* Performing a chest CT scan in the last 18 months.
* Severe lung or extrapulmonary diseases that may preclude or invalidate appropriate therapy in case of diagnosis of malignant pulmonary neoplasia.
Treatment of Postpartum Haemorrhage (PPH) Using Misoprostol in Home Births

A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan.

A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan. The purpose of the study is to assess the overall clinical and programmatic effectiveness of Traditional Birth Attendants (TBAs) administering 800 mcg sublingual misoprostol to treat Postpartum Haemorrhage (PPH) at the community level.

The study will recruit pregnant women who deliver at home. All women enrolled in the study will receive misoprostol for prevention (600 mcg oral dose). Women diagnosed with PPH will be randomized to receive either a) standard care + 800 mcg sublingual misoprostol (four 200 mcg tablets) or b) standard care + four placebo tablets resembling misoprostol. In this setting, standard care is uterine massage and/or compression and referral to the nearest health facility or attendance by the Lady Health Visitor/ Community Health Nurse.

Eligibility Criteria:
Inclusion Criteria:

* Women who deliver at home with a study TBA present.
* Women must be willing and able to provide informed consent
* Women must agree to participate in a follow up interview
* Women must agree to have pre and post-partum haemoglobin taken

Exclusion Criteria:

* If the woman does not meet any of the above outlined inclusion criteria
Evaluation of the Timing of the Nebulization Related to the Physiotherapy Session

The purpose of this study is to determine the optimal time for the nebulization depending on the respiratory physiotherapy session in cystic fibrosis patients.


Eligibility Criteria:
Inclusion Criteria:

* Stable cystic fibrosis patients older than 16 y.o.
* Pseudomonas aeruginosa colonization
* Hypersecretion

Exclusion Criteria:

* Kidney failure
* No pregnancy
Entospletinib Monotherapy and in Combination With Chemotherapy in Adults With Acute Myeloid Leukemia (AML)

This study will evaluate the efficacy, safety, and tolerability of entospletinib when administered as monotherapy or in combination with chemotherapy in adults with acute myeloid leukemia (AML).


Eligibility Criteria:
Key Inclusion Criteria:

* Adults with AML in need of treatment
* Group A : Individuals ≥ 18 years of age with previously untreated AML by World Health Organization (WHO) criteria who are able and should receive up to 2 cycles of induction chemotherapy with 7+3 as determined by the treating physician
* Group B: Individuals \> 70 years of age with previously untreated AML by WHO criteria; or individuals ≤ 70 years of age with previously untreated AML who refuse or are unable to receive chemotherapy with 7+3 as determined by the treating physician
* Group C: Individuals ≥ 18 years of age with relapsed/refractory AML by WHO criteria; or with relapsed/refractory AML with mixed-lineage leukemia (MLL); or with previously untreated AML by WHO criteria and who would have met disease eligibility criteria for Group A or B but refuse or are unable to receive chemotherapy and hypomethylating agent as determined by the treating physician

Key Exclusion Criteria:

* Known active central nervous system or leptomeningeal lymphoma
* Subjects with acute promyelocytic leukemia (M3)
* Treatment with proton pump inhibitors (PPIs) within 7 days prior to enrollment.

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Pregnancy in GUCH Patients

This study aims to investigate the impact of congenital heart diseases on maternal and foetal-neonatal health, the effect of pregnancy on maternal cardiac health, and the outcome of newborns/children born from Grown-Up Congenital Heart (GUCH) mothers with follow-up at one year, extendable to two.

The main question it aims to answer is:

-Does maternal congenital heart disease affects outcomes of newborn?

After being informed about the study and potential risks all patients giving written informed consent will undergo:

* Cardiological and obstetric evaluation in the first trimester of pregnancy;
* Cardiological and obstetric revaluation in the second trimester of pregnancy;
* Cardiological and obstetric revaluation in the third trimester of pregnancy;
* Cardiac and general neonatal evaluation at birth;
* 2-year follow-up: maternal and neonatal cardiology evaluation, childhood neurodevelopment evaluation

Eligibility Criteria:
Inclusion Criteria:

* Congenital heart disease in natural history or undergoing corrective and/or palliative cardiothoracic surgery.
* Chronological age \> 18 years.
* Single pregnancy progressing normally at a gestational age of 14 weeks + 0.
* Correct pregnancy dating based on CRL as per ISUOG guidelines. (26)
* Normal results of non-invasive screening tests for foetal aneuploidies.
* Normal first-trimester ultrasound examination.
* Informed consent of the woman.

Exclusion Criteria:

* Maternal chromosomal abnormalities.
* Maternal syndromic conditions.
* Spontaneous abortion.
* Vanishing Twin.
* High risk for chromosomal abnormalities on screening tests performed in the 1st Trimester (Combined Test/NIPT) or Major foetal structural anomalies identified during first-trimester ultrasound evaluation.
Effect of Brain Training Through Visual Mirror Feedback, Action Observation Training and Motor Imagery on Orofacial Sensorimotor Variables in Asymptomatic Subjects: A Single-blind Randomized Controlled Trial.

The main objective of the present study was to evaluate the effects of action observation (AO), visual mirror feedback (VMF), motor imagery (MI) combined with an orofacial exercise program in asymptomatic subjects.


Eligibility Criteria:
Inclusion Criteria:

1. healthy individuals with no pain
2. aged between 18 and 65 years
3. subjects with correct masticatory function and labial and lingual mobility

Exclusion Criteria:

1. individuals who presented systemic, cardiorespiratory, central nervous system or rheumatic diseases, or those who presented any musculoskeletal or craniocervical pathology
2. underage individuals
3. individuals with orofacial pain or temporomandibular disorders at the time of the study; (d) subjects' complaint of toothache or tenderness to percussion.
Effects of Joint Integrity Exercises Verses Mirror Therapy in Hemineglect Stroke Survivors

The aim of this study is to compare the effects of joint integrity exercises and mirror therapy to evaluate that which intervention is more effective to improve proprioception and motor function of upper limb in hemineglect stroke survivors. This will be randomized clinical triall study. Data will be collected from Lahore General Hospital by using non-probability convenient sampling technique. Patients will be divided into two groups, (Group A and Group B). Group A will include patients that will be treated with joint integrity exercises of upper limb by applying tactile stimulation, kinaesthetic stimulation and stereognosis. and Group B will include those patients which will be treated with mirror therapy of upper limb. Session will be 3 days per week. Data will be collected pre (baseline=0 week) and post intervention (after 6 weeks) from two groups using Nottingham sensory assessment, Fugl Mayer Assessment and Motor assessment scale. SPSS for windows software, version 25 will be used to analyze the data.


Eligibility Criteria:
Inclusion Criteria:

* Hemi neglect stroke patients after performing line bisection test
* Patients having Mini mental State Examination score above 24
* Patients having Catherine Bergego scale score above 27
* Patients having minimum MIQ-3 score 6 or above
* Sub-acute phase (2 Months) following stroke

Exclusion Criteria:

* Patients with neurological conditions other than stroke including Parkinson's, Alzheimer and Multiple sclerosis
Prospective Observational Epidemiologic Study of Maraviroc's Safety

The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.

All patients meeting the study eligibility criteria at participating sites will be invited to participate.

Eligibility Criteria:
Inclusion Criteria:

* Treatment experienced, HIV-1 infected patients
* 18 years or older
* Receive an approved assay for determination of HIV-1 tropism

Exclusion Criteria:

* Pregnant or lactating
* Using CCR5 inhibitor other than maraviroc
Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal intensiVE Care Patients -2

The study is a non-blinded trial with one single intervention in sick newborn infants. The Neosense umbilical catheter will be used instead of the routinely used umbilical catheter on infants where the treating physician has ordered use of an umbilical catheter. The catheter will be connected to the Neosense monitor/measuring unit.

Blood samples for blood gas analysis are collected from the patients according to the clinical routine (every 4th to 6th hour). Oxygen tension data from the Neosense measuring system, from the time points when a blood gas sample was collected, will be recorded. This data will be compared to the oxygen tension value from the blood gas sample collected at the same time point. The blood gas samples will be analysed according to clinical and laboratory routine.

The infants will remain in the study as long as the Neosense measuring system is used


Eligibility Criteria:
Inclusion Criteria:

Sick newborn infants where the clinical routine indicates use of an umbilical catheter. At least one of the criteria below should be fulfilled:

* The infant needs invasive measurement of blood pressure.
* The infant needs repetitive sampling of blood.
* The infant needs prolonged infusion(s) \> 2 days.
* The infant needs infusion of vessel irritating and potentially vessel harming solutions.
* The infant is born extremely preterm (before 28+0 weeks gestational age).
* A newborn infant with severe respiratory disorder, requiring oxygen treatment (more than 40% Fraction of inspired oxygen (FiO2)).
* The infant is undergoing therapeutic hypothermia following asphyxia ("oxygen deficiency at birth").
* The infant has a severe infection/sepsis.

Also:

• Signed informed consent form by both parents (or guardians), (if the infant has only one parent (or guardian) one informed consent is required).

Exclusion Criteria:

* Gastroschisis
* Omphalocele
* Peritonitis
* Necrotizing enterocolitis
* Omphalitis
* The infant has a severe infection/sepsis
* Expected MRI investigation within the 7 first days after birth
* The infants birth weight is below 750 g
* The infant is born before week 25+0
* Local vascular compromise in lower limbs or buttocks area, or portal venous hypertension
The Weight of Victory: Exploring Short- and Long-term Health Outcomes in Former Male & Female Elite Athletes from Weight-sensitive Sports

The health of former elite athletes has been identified as a critical research gap where there is limited knowledge about both short- and long-term consequences after ending their careers. The transition phase from an active elite career to everyday life has been shown to be particularly problematic, yet this issue has been little studied among former Norwegian elite athletes. Furthermore, questions remain regarding the health of athletes from weight-sensitive sports, such as weight-class, aesthetic, and certain endurance sports. These athletes face specific challenges related to maintaining a certain physique and frequent changes in body weight during their active careers. This group has been shown to be vulnerable to a range of problematic health outcomes related to low energy availability, and little is known about the long-term effects of a career involving this.

Therefore, the overall purpose of the project is to map the mental and physical health of former elite athletes. At the same time, there will be a particular focus on the differences between weight-sensitive and less weight-sensitive sports, different types of sports, gender, as well as previous dieting and eating behaviors.

The project will be a quantitative cross-sectional study that includes former elite athletes from both weight-sensitive and less weight-sensitive sports, as well as a sample from the general population for comparison. Information will be collected via an electronic questionnaire that surveys a range of physical and mental health variables among the participants. In addition, behavioral variables related to impulse control, eating and dieting patterns, and weight regulation will be assessed.

Furthermore, the project is expected to contribute new knowledge by identifying health challenges and the explanatory variables for these challenges among former elite athletes. Thus, the project can inform the development of targeted preventive measures, interventions, and policy changes that can improve health and quality of life both during and after athletes' careers and be of significant importance for future athletes.

Eligibility Criteria:
Inclusion Criteria:

* Represented the national team at senior and/or junior level, (Non-organized sports) competed at national and/or international level. , \>1 year since retirement , \>18 years old,and a proficient level of Norwegian reading and writing skills

Exclusion Criteria:

-
Interest of Flow Cytometry for the Diagnosis, the Follow up and Specific Immunotherapy (SIT) Arrest of Hymenoptera Venom Allergy

The aim of this study is to show that flow cytometry can be an accurate tool to help physicians regarding the diagnosis, the SIT decision and the SIT arrest of hymenoptera venom allergy.

75 patients having a story of reaction to hymenoptera venom will be selected for this trial.

Blood samples will be analyzed at: inclusion visit, Week 1 visit, Week 3 visit, Week 10 and Week 21 visit.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (18 - 70 years)
* Patient being informed and accepting to participate in the study with signature of informed consent
* Patients having a clinical systematic and local, loco-regional story of reaction to the piqures of hymenopterans.
* Patients treated by SIT for at least 5 years
* Patients benefiting from a national insurance health

Exclusion Criteria:

* Children
* Pregnant woman or who breast-feed
* Patient under antihistaminic or corticoid for less than 8 days before the blood drawing
* Protected Patient
* Patient not having given his agreement after it was informed
Sprix for Postoperative Pain Control Following Gynecologic Surgery

The ongoing opioid epidemic has altered both how physicians prescribe narcotics and patients' perceptions of those prescriptions. Along with increased scrutiny regarding the quantity of opioids that be may prescribed after acute injury, for chronic conditions and following surgery the healthcare industry as a whole continues to search for alternative medications that provide adequate pain relief and have a reduced tendency for abuse/dependence/addition. To that end this study has the following aims:

1. To evaluate the amount of opioids consumed following minimally invasive, female pelvic surgery when patients' postoperative pain is managed via:

   1. Acetaminophen plus Ibuprofen plus breakthrough pain opioids (Standard protocol)
   2. Acetaminophen plus Intranasal Ketorolac Tromethamine plus opioids for breakthrough pain (Sprix protocol)
2. Patient satisfaction with the aforementioned methods
3. Evaluate and compare pain scores via validated questionnaire

Hypothesis:

Primary:

1. Patients prescribed intranasal Ketorolac (Sprix protocol) will consume significantly less Morphine Milliequivalents (mEqs) of narcotics compared to the standard protocol following minimally invasive female pelvic surgery.

Secondary:

1. Patients in the Sprix protocol will have lower Visual Analog Scale (VAS) measures of pain which will be measured on a 0-10 scale where 0 denotes no pain and 10 denotes maximum experience of pain
2. Patients in the Sprix protocol will have lower numeric pain score and on POD#4
3. Patients in the Sprix protocol will have higher Quality of Recovery 40 (QoR-40 )scores on POD#1
4. Patients in the Sprix protocol will have higher QoR-40 scores on POD#4
5. Patients will not have any significant difference in overall surgical satisfaction on POD#1 and POD#4 using a numerical satisfaction score
6. Patients in the Sprix protocol will be more likely to consume no narcotics at all once discharged to home


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years of age
2. Weight ≥ 110lbs
3. English Speaking and Reading
4. All consecutive, consenting female patients undergoing Pelvic Organ Prolapse (POP) surgery - vaginal prolapse surgery, laparoscopic vaginal prolapse surgery or robotic assisted vaginal prolapse surgery - with or without Bilateral or Unilateral Salpingoopherectomy, with or without concomitant hysterectomy, with or without urinary anti-incontinence surgery

Exclusion Criteria:

1. Patients taking opioids chronically at the time of surgery
2. History of Coronary Artery Bypass Graft (CABG)
3. History of peptic ulcer disease or bleeding in the stomach or intestines
4. History of asthma attack, hives, or other allergic reaction with aspirin or any other Non-Steroidal Anti-inflammatory Drug (NSAID)
5. Uncontrolled hypertension at the time of consent and/or surgery
6. History of renal impairment as defined by blood creatinine of 1.1 or greater at any time