cyrilzakka/clinical-trials huggingface dataset:
Neighborhood Influence on Parenting Practices Regarding Youth Outdoor Play

Parental constraint of outdoor play may be fueling unhealthy emotional and physical development in today's children and adolescents. Time spent outdoors is a key determinant of unstructured play and overall physical activity levels, both of which are crucial to optimal development in youth. Modern barriers - such as crime, poor social ties among neighbors, and unsafe physical environments - constrain parental practices and reduce opportunities for outdoor play in children and youth. Low levels of perceived collective efficacy, a measure of perceived neighborhood cohesion and the collective capacity to solve neighborhood problems, has been proposed as a social environmental factor that constrains outdoor play by parents either attempting to avoid potentially dangerous situations or using defensive behavior by upgrading security measures. Moreover, incivilities in the neighborhood physical environment (e.g. litter, graffiti, blighted property) may influence parents' perceived collective efficacy. Consequently, a child's ability to achieve the recommended minimum of 60 minutes of daily physical activity may be limited by a complex interaction between neighborhood social and physical environmental factors and the extent to which parents respond by constraining offspring outdoor play. The central hypothesis of this research is that modifiable factors in the neighborhood social and physical environment result in parental constraint of offspring outdoor play, which reduces overall physical activity during critical years of development. This research will use qualitative methods to generate a comprehensive understanding of how and which environmental factors play a crucial role in parental constraint of outdoor play and promote low levels of within-neighborhood physical activity. This ancillary study will recruit 32 parents/guardians of participants from the parent study, Translational Investigation of Growth and Everyday Routines in Kids (TIGER Kids) Study (USDA 3092-51000-056-04A), to participate in in-depth interviews. My ultimate goal is to use knowledge gained from this ancillary study to generate community-based interventions that will target neighborhood factors to successfully reduce parental constraints on outdoor play.


Eligibility Criteria:
Inclusion Criteria:

-Child completed baseline measures (Y0) for the parent study, TIGER Kids Study (USDA 3092-51000-056-04A).

Exclusion Criteria:

* Child did not complete baseline measures (Y0) of the TIGER Kids Study.
* Did not report a home address at the baseline (Y0) TIGER Kids study visit.
* Unwilling or unable to participate in an in-depth interview.
Pain Processing In Relation To Breathing

The goal of this clinical trial is to investigate the effect of breathing on the processing of experimental pain in healthy participants. The main questions are:

1. Does breathing rate influence the spatial extent of thermally induced secondary hyperalgesia, a proxy of central sensitization?
2. Does resonance frequency breathing influence the autonomic nervous system, compared to baseline and compared to paced breathing at a natural frequency?
3. Is spinal excitability, measured using the magnitude of the nociception withdrawal reflex (NWR), affected by resonance frequency breathing, compared to paced breathing at a natural frequency?

Participants:

* will receive heat stimuli
* 's skin's sensitivity will be tested using quantitative sensory testing tools.
* will receive various instructions on the speed of their breathing
* 's heart rate, respiratory rate and sweat response will be measured
* will fill in questionnaires

Researchers will compare the spatial extent of sensitivity resulting from application of heat stimuli during paced resonance frequency breathing compared to paced breathing at a natural frequency to see if the breathing rhythm influences central sensitization processes.


Eligibility Criteria:
Inclusion Criteria:

1. over 18 and below 40 years of age
2. good general health
3. able to give informed consent

Exclusion Criteria:

1. any major medical or psychiatric condition (e.g. heart disease, diabetes, autoimmune disorders, infectious diseases, major depressive disorder), any chronic pain condition, any respiratory problems, any current acute pain at time of study
2. inability to follow study instructions, e.g. due to language problems
3. Consumption of alcohol, drugs, analgesics within the last 24 h
4. Consumption of no more than 100 mg of caffeine within the last 8 h
5. Scar tissue or generally reduced sensitivity in the designated testing site areas

Additional exclusion criteria for experiments 3 and 4

1. Shoe size \< 38
2. Restless-Legs-Syndrome
Biomarker Feedback for Smoking Cessation

The purpose of this study is to examine the impact of providing light smokers with feedback about their health, including exposure to tobacco-related chemicals.

The smoking pattern among adults in the US is undergoing a remarkable change. A substantial proportion of smokers are now light smokers (smoke ≤ 10 cigarettes per day), yet little is known about how to help light smokers quit. The prevalence of light smoking is high (\~50%) among African Americans (AAs) who compared to other groups have high cotinine levels, are less successful quitting smoking, and experience disproportionately higher smoking-related cancers. Because light smokers often think that smoking fewer cigarettes a day is safe, a potential smoking cessation strategy is therefore to provide light smokers with feedback on biomarkers of tobacco exposure and increased cancer risk. The objective of this proposal is to develop and pilot test a biomarker risk assessment intervention to enhance smoking cessation for AA light smokers. The proposal builds on our previous work that shows that light smokers have 1) difficulty quitting smoking, 2) lower perceived health risks, but high levels of biomarkers (e.g. cotinine). This study will occur in 2 phases. Phase 1 will utilize focus groups to examine prevailing knowledge, attitudes, and beliefs about biomarkers as well as preferences about how participants would like to receive biomarker feedback (BF; e.g. by mail, phone, in-person). In Phase 2, data from the focus groups will be used to develop a (BF) intervention for light smokers. The new intervention will undergo further feasibility evaluation among 60 adult light smokers. Outcomes in Phase 2 will include process measures, (e.g. perceived usefulness, acceptance, and adherence) and changes in biomarker values with smoking reduction or cessation. By the end of the proposed pilot study, we expect to have developed a replicable, feasible, and acceptable BF intervention that will be ready for efficacy testing in a large clinical trial for smoking cessation or smoking reduction. The aims of the application are to: 1) Examine the prevailing knowledge, attitudes, beliefs, and preferences about BF for smoking cessation among AA light smokers; 2) Develop a BF intervention for smoking cessation among AA light smokers; and 3) Test the feasibility of a BF intervention for smoking cessation in AA light smokers.

Eligibility Criteria:
Inclusion Criteria:

* Male or female cigarette smokers, 18-75 years
* Smoked an average of less than 10 cigarettes per day during past month
* A personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Only one subject per household may participate
* Pregnancy
Risk of Hepatitis B Virus Reactivation in Patients Undergoing Allografting

The purpose of this study is to evaluate the risk of hepatitis B reactivation in patients undergoing allografting.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing an allograft for hematological malignancies
Predictive Value of QoR15 for Complications

Surgical operations and recovery after anesthesia is a complex process. Studies examining the interventions performed in the preoperative period often focus on classical clinical outcomes such as postoperative organ dysfunction, morbidity or complications. Postoperative recovery of the patient is rarely considered the most important outcome variable in interventional studies.

In this study, the Quality of recovery 15 (QoR - 15) questionnaire that measures the recovery score, and the American college of surgeons surgical risk calculator have been used to compare the predictive values of patient's preoperative condition on postoperative recovery period and possible morbidity and mortality.

Surgical operations and recovery after anesthesia is a complex process. Studies examining the interventions performed in the preoperative period often focus on classical clinical outcomes such as postoperative organ dysfunction, morbidity or complications. Postoperative recovery of the patient is rarely considered the most important outcome variable in interventional studies. In this study, the effects of both preoperative patient condition and postoperative recovery on morbidity and mortality are investigated.

In order to evaluate the ability of QoR - 15 to predict postoperative complications patients who underwent major abdominal surgery, patients answer the Quality of Recovery 15 questionnaire both in the preoperative and postoperative periods.

In addition, the risk of postoperative complications is calculated in the preoperative period with the American college of surgeons (ACS) surgical risk calculator.

Finally, postoperative complications of all patients are recorded according to Clavien Dindo classification.

The primary goal is to understand the predictive value of the QOR15 score on postoperative complications. Secondarily, it is to compare of predictive values of QoR15 with ACS risk calculator on morbidity and mortality. Another secondary aim is to investigate the effect of preoperative conditions of patients on postoperative recovery.

Eligibility Criteria:
Inclusion Criteria:

All the patients who undergone major GIS surgery

Exclusion Criteria:

1. Patients who has an expected mortality in six months because of the primary disease
2. Patients who received parenteral nutrition before surgery
3. Patients who has a previous major abdominal surgery
4. Patients who do not accept the surgery
5. Patients with a disability who require a nursing care
PErfusioN, OxyGen ConsUmptIon and ENergetics in ADPKD (PENGUIN)

Autosomal dominant polycystic kidney disease (ADPKD) is the most common monogenic cause of end-stage kidney disease (ESKD). The disorder is characterized by development and continued growth of multiple cysts requiring renal replacement therapy in 50% of patients by age 60 years. However, ADPKD is also a complex metabolic disorder defined by insulin resistance (IR) and mitochondrial dysfunction which may be causally related to cyst expansion, kidney function decline and contribute to reduced life expectancy. Renal hypoxia, stemming from a potential metabolic mismatch between increased renal energy expenditure and impaired substrate utilization, is proposed as a novel unifying early pathway in the development and expansion of renal cysts in ADPKD. By examining the interplay between renal O2 consumption and energy utilization in young adults with and without ADPKD, the investigators hope to identify novel therapeutic targets to impede development of cyst expansion in future trials.

The investigators propose to address the specific aims in a cross-sectional study with 20 adults with ADPKD (50% female, ages 18-40 years). Comparative data will be provided from healthy adults from an ongoing study with similar study design and methods (CROCODILE Study: Control of Renal Oxygen Consumption, Mitochondrial Dysfunction, and Insulin Resistance). For this protocol, participants will complete a one day study visit at Children's Hospital Colorado. Patients will undergo a dual energy x-ray absorptiometry (DXA) to assess body composition, and a 11C-acetate positron emission tomography (PET/CT) scan to quantify renal O2 consumption. After the PET/CT, participants will undergo a hyperinsulinemic-euglycemic clamp while fasting to quantify insulin sensitivity. Glomerular Filtration Rate (GFR) and Effective Renal Plasma Flow (ERPF) will be measured by iohexol and PAH clearances during the hyperinsulinemic-euglycemic clamp.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Autosomal dominant polycystic kidney disease
* Age 18-40 years
* BMI \>= 18.5 and \<30 kg/m2
* Weight \<350 lbs

Exclusion Criteria:

* Diabetes mellitus, based on previous diagnosis
* Albuminuria (≥30mg/g) or estimated glomerular filtration rate (eGFR) \<75ml/min/1.73m2
* Pregnancy or nursing
* Anemia
* Allergy to shellfish or iodine
* Vaptan therapy (e.g. tolvaptan)
* Uncontrolled hypertension (average ≥140/90 mmHg)
Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy

The purpose of this study is to determine whether a larger dose of the aldosterone antagonist spironolactone combined with a lower dose of an ACE inhibitor is more effective in reverse left ventricular remodeling in severe congestive heart failure in patients with nonischemic cardiomyopathy.

In the investigators' recent daily clinical practice, they found that the larger dose of the aldosterone antagonist spironolactone combined with a lower dose of an ACE inhibitor and the highest tolerable dose of beta blockers could reverse left ventricular remodeling more effectively than a smaller dose of spironolactone. The ventricular remodeling could get back to normal, especially in patients with none-ischaemic cardiomyopathy. The investigators hypothesize that long term use of a larger dose of the aldosterone antagonist spironolactone could reverse left ventricular remodeling by stimulating new myocyte formation. Thus, they designed this study to verify its efficacy and safety in reversing left ventricular remodeling in severe congestive heart failure in patients with nonischemic cardiomyopathy. To avoid hyperkalemia, the investigators routinely use larger doses of diuretics in combination with a lower dose of an ACE inhibitor to offset the potassium-sparing effects of spironolactone and follow the patients closely.

Eligibility Criteria:
Inclusion Criteria:

* New York Heart Association (NYHA) Functional class Ⅲ or Ⅳ
* Left Ventricular Ejection Fraction (LVEF) \<35%
* Nonischemic cardiomyopathy
* Preserved renal function: Cr ≤2.5 mg/dL in males; Cr ≤2.0mg/dL in females

Exclusion Criteria:

* Hyperkalemia (≥5.0 mEg/L)
* Left ventricular systolic dysfunction with pericardial diseases, congenital heart diseases, pulmonary heart diseases, heart valvular diseases, acute coronary syndrome and short life expectancy.
Study of Genetic Factors Other Than CYP2C9 and VKORC1 That Influence Warfarin Dose Requirements in a South-east Asian Population

Warfarin is a commonly used anti-coagulant, but has a narrow therapeutic index and wide inter-individual and inter-ethnic variation in dose requirements. Several genetic and non-genetic factors have been identified that could influence warfarin dose requirements. However, current known predictive factors could only explain about 50-60% of warfarin dose variability. Inter-ethnic differences in genetic influences on warfarin dose requirements also exist. We hypothesize that genetic factors other than CYP2C9 and VKORC1 may influence warfarin dosing and serve to further optimize warfarin dosing.


Eligibility Criteria:
Inclusion Criteria:

* patients receiving maintenance warfarin therapy with a stable therapeutic international normalized ratio (INR) between 2 and 3 for at least 3 months,
* patients recruited from the anticoagulation clinics at the National University Hospital and Tan Tock Seng Hospital in Singapore between June 2002 and June 2004 for a previous genotyping study (C/00/510, NUH; C/00/535, TTSH, PI-Dr Goh Boon Cher).

Exclusion Criteria:

* patients below 21 years old, or
* patients with liver disease, malabsorption or chronic diarrheal diseases, or
* patients taking drugs that may potentially interact with warfarin.

Dietary advice to avoid foods that may interfere with warfarin pharmacokinetics will be given to patients during warfarin therapy.
Long-term Quality of Life Among Survivors of Sepsis in China Assessed by EQ-5D

Sepsis is a common critical illness in Intensive Care Unit (ICU). With the continuous progress of severe medicine, the mortality rate of ICU hospitalization for sepsis has decreased, but the long-term prognosis is not satisfied. Due to the high long-term mortality, poor physical and mental health and cognitive impairment, the long-term quality of life decreases greatly, putting great burden on the family and society. Therefore, it is of great significance to understand the epidemiology and risk factors of the long-term prognosis of sepsis and find out how to improve the prognosis .

Sepsis is a clinical syndrome in which the body's host response to uncontrolled infection leads to life-threatening organ dysfunction. In recent years, with the continuous improvement of the early diagnosis ability of sepsis, the deepening of the understanding of pathophysiology, and the continuous updating of treatment, the hospital mortality rate of sepsis has decreased significantly. However, studies have shown that the prevalence of sepsis is still increasing year by year, and the number of deaths due to sepsis is increasing. Sepsis is the main cause of death in ICU patients.

Although the mortality rate of patients with sepsis is significantly reduced, the increasing survival of patients with long-term outcome is not satisfied. All studies have shown that patients with sepsis have a high long-term mortality, and the long-term physiological, psychological, and cognitive function levels are reduced, which increases the economic burden and mental burden of the family and society. The increasing number of discharges has been considered a potential public health threat. In recent years, more and more researchers begin to pay attention to the long-term outcome of sepsis survivors. But compared with other acute or severe diseases, such as stroke, cancer, sepsis survivors has not been paid enough attention.

Therefore, all stages of treatment and rehabilitation of sepsis require extensive social attention. Continuous research and input are needed to explore predicting factors and effective interventions to improve the outcome and help patients and their families return to normal life,to reduce the social burden.

Eligibility Criteria:
Inclusion Criteria:

* survivors in the prior study (epidemiology survey of Chinese sepsis patients)

Exclusion Criteria:

* : patients who are unwilling to answer or lose their interviews
Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Hematologic Malignancies

The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.

Subjects will have been recently diagnosed with an untreated hematologic malignancy. Subjects will have a blood sample collected at enrollment and provide medical history prior to initiation of treatment. There will be no further follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female ≥ 18 years of age.
* Subject has an untreated hematologic malignancy.
* Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria:

* Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers).
* Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
* Any treatment for the primary malignancy. Subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment prior to blood sample collection.
* Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
* Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
* IV contrast (e.g. CT and MRI) within 1 day \[or 24 hours\] of blood collection.
* Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression

The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression

The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression - a dose-ranging study

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of TRD

Exclusion Criteria:

* Other comorbidities
Conservative Therapy Versus Epidural Steroids for Cervical Radiculopathy

The main objective of this study is to determine whether interventional treatment (i.e. epidural steroids), conservative therapy, or the combination, is superior for cervical radiculopathy. One hundred and sixty eight patients with radicular neck pain will be randomized in a 1:1:1 ratio to receive either cervical epidural steroid injections (CESI), non-interventional management with physical therapy and medications, or a combination of the two. The first follow-up visit will be at 1-month. In patients who obtain some benefit but continue to report significant pain, either a 2nd CESI can be done, the patient's medications can be adjusted, or both in the combination group. Those patients who fail to obtain any benefit will exit the study to receive another treatment or alternative care. The second follow-up visit will be at 3-months. Similar to the 1-month follow-up, the doctor may elect to change nothing in patients who are satisfied, adjust medications, schedule the patient for another CESI, or do both in the combination group. Patients who fail to obtain any benefit can exit the study to receive alternative treatment. The final follow-up visit will be at 6 months.


Eligibility Criteria:
Inclusion Criteria:

1. Cervical radicular pain based on history and physical exam (e.g. pain radiating into one or both extremities, sensory loss, muscle weakness, Spurling's test etc.)
2. NRS arm pain score \> 3
3. MRI evidence of disc pathology consistent with symptoms

Exclusion Criteria:

1. Untreated coagulopathy
2. Previous spine surgery
3. No MRI study
4. Arm pain \> 4 years duration
5. Epidural steroid injection within past 3 years
6. Radiculopathy not resulting from disc pathology (e.g. foraminal stenosis or tumor)
7. Signs or symptoms or myelopathy or spinal cord compression
8. Previous failed trials with gabapentin or pregabalin, and nortriptyline or amitriptyline
9. Allergic reactions to gabapentin or nortriptyline
10. Referrals from surgery for diagnostic injections for surgical evaluation
11. Serious medical (e.g. congestive heart failure) or psychiatric (untreated depression) condition that might preclude optimal outcome
12. Pregnancy