cyrilzakka/clinical-trials huggingface dataset:
Feasibility of Cough Monitoring in Children

Cystic fibrosis (CF) is a disease characterized by chronic airway infection and impaired mucociliary clearance, which predisposes those affected to recurrent pulmonary exacerbations (PEx) and progressive decline in lung function. Treatment with elexacaftor/tezacaftor/ivacaftor (ETI) results in decreases in patient-reported cough and PEx. Despite this, increased cough remains the most common symptom associated with acute PEx and worsening lung disease. Cough frequency was historically difficult to measure due to reliance on human input. Recent advances in audio capture and signal processing have made automated cough detection possible. As a result there's been a surge in development of portable cough monitors, as cough is increasingly recognized as a measurable parameter of respiratory disease. The majority of cough monitors have been designed for use in adults, and little is known about the practicality of collecting cough data in the pediatric population. In this study investigators aim to assess the feasibility of using an in-home device to capture nighttime cough frequency in children with and without CF. Investigators plan to compare nighttime cough frequency between children with and without CF and, among children with CF, and determine the association between cough frequency and baseline lung function. Additionally, investigators aim to evaluate the changes in nighttime cough frequency in relationship to respiratory symptom scores surrounding clinician diagnosed pulmonary exacerbations. This study will provide important preliminary data needed for a larger study assessing the utility of home cough monitoring for clinical care and for use of cough as a clinical outcome measure in research studies.


Eligibility Criteria:
Inclusion Criteria for Children with Cystic Fibrosis

* Diagnosis of CF based on 2 known CFTR mutations and/or sweat chloride \> 60 mmol/L
* Ages 1-18 years of age
* Clinically stable at the time of consent

Exclusion Criteria

* Use of nocturnal positive pressure or supplemental oxygen
* Shared bedroom with sibling
* Use of oral or IV antibiotics within the past 2 weeks except for chronic azithromycin use
* Shared custody (i.e., the participant is splitting time between time households)

Inclusion Criteria for Healthy Controls

* Ages 1-18

Exclusion Criteria:

* Shared bedroom with sibling
* Underlying chronic respiratory or cardiac conditions including chronic cough, CF, asthma, obstructive sleep apnea, or congenital heart disease or other condition felt by the investigator to cause chronic nighttime symptoms
* Shared custody (i.e., the participant is splitting time between time households)
The Effect of Oxycodone Hydrochloride on CRBD After TURBT Under General Anesthesia

The purpose of this study is to investigate the effect of Oxycodone Hydrochloride on catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor after general anesthesia.

Catheter-related bladder discomfort(CRBD) is a frequent complication after indwelling catheter under general anesthesia. The incidence of CRBD in patients undergoing Transurethral resection is as high as 66.7-91.2%.CRBD may lead some poor prognosis including postoperative restlessness, bleeding, and circulatory instability.therefore，how to reduce the incidence of CRBD is one of the urgent problems to be solved in clinic.

Oxycodone Hydrochloride is a strong opioid receptor agonist used in clinic at present. It has certain advantages in the regulation of visceral pain and can produce analgesic effect without causing restlessness, gastrointestinal motility inhibition and respiratory inhibition through stimulating the μ and κ opioid receptor simultaneously. However, the effect of Oxycodone Hydrochloride on catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor after general anesthesia is still unknown. The purpose of this study is to explore whether Oxycodone Hydrochloride via intravenous injection could reduce the incidence of CRBD in patients undergoing transurethral resection of bladder tumor after general anesthesia and could not increase other complications during the recovery period of general anesthesiathe.

Eligibility Criteria:
Inclusion Criteria:

* More than 18 years old;
* ASA I - III;
* Plan to perform transurethral resection of bladder tumor under general anesthesia; (
* Agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

* Refuse to participate in this study;
* Emergency surgery;
* Catheter was indwelling before operation;
* Taking opioids for a long time before operation;
* Previous history of schizophrenia, epilepsy, Parkinson's disease or myasthenia gravis;
* Unable to communicate due to coma, severe dementia or language disorder before operation;
* Critical condition (ASA grade ≥ IV before operation); Severe renal function damage (requiring renal replacement therapy); Severe liver function damage (child Pugh grade C); Acute stage of chronic obstructive pulmonary disease, severe asthma, severe pulmonary heart disease;
* History of opioid allergy.
Comparison of Aortic Root Dimension Changes During Cardiac Cycle Between the Patients With and Without Aortic Valve Calcification Using ECG-gated 64-slice and Dual-source 256-slice Computed Tomography Scanners: Results of a Multicenter Study

This study seeks to compare aortic dimension changes during cardiac cycle in patients with and without aortic valve calcification and to evaluate its correlation with aortic valve calcium score in former group.

The study population comprised 104 patients referred to three cardiac imaging centers for coronary multislice computed tomography, including 52 patients with aortic valve calcification as the study group and 52 subjects without evidence of calcification in their aortic valve, who served as a control group. Data were reconstructed at each 10% of RR-interval during the cardiac cycle and reconstructed images at 30-35% and 70-75% of R-R intervals were obtained, representing systole and diastole, respectively. For diastolic phase, in most cases images at 70% were acquired. Thereafter, acquired images were transferred to a single remote workstation for post-processing and subsequent off-line analysis.

Eligibility Criteria:
Inclusion Criteria:

- Patients referring for multislice coronary computed tomography for any reason

Exclusion Criteria:

* Arrhythmia
* Hypertrophic cardiomyopathy
* Aneurysm formation of ascending aorta
* Marfan's disease
* Ehlers-Danlos syndrome
* History of coronary artery bypass surgery
* History of coronary stenting
* Aortic valve surgery
* Thoracic aorta surgery
* Aortic valve stenosis
FDG PET/CT in Monitoring Very Early Therapy Response in Patients With Glioblastoma

This pilot clinical trial studies fluordeoxyglucose (fludeoxyglucose) F-18 (FDG) positron emission tomography (PET)/computed tomography (CT) in monitoring very early therapy response in patients with glioblastoma. Diagnostic procedures, such as FDG PET/CT, may help measure a patient's response to earlier treatment. Chemotherapy can induce very rapid changes to the tumor's glucose consumption which can be measured with imaging. FDG PET/CT shortly after the start of therapy may help identify very early therapy response in patients with glioblastoma.

PRIMARY OBJECTIVES:

I. To assess very early response to therapy in glioblastoma patients using 18F-FDG PET/CT.

II. Evaluate very early changes in FDG uptake within 48 hours of start of therapy and correlate them with objective response parameters such as Response Assessment in Neuro-Oncology (RANO) and survival.

OUTLINE:

Patients undergo standard FDG PET/CT scan 6-8 weeks before start of chemotherapy and one additional FDG PET/CT scan within 48 hours of the start of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven high grade glioma
* Intention to start therapy

Exclusion Criteria:

* Severe psychiatric illness
* Inability to give written consent
* Breast feeding / pregnancy
Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs

The primary objective of this clinical study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth (evaluated per weight gain), in comparison with infant formula without human milk oligosaccharides, when the formula is fed as the sole source of nutrition.

The main goal of the study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth of term infants (evaluated per weight gain, body length and head circumference), in comparison with infant formula without human milk oligosaccharides, when the formula is fed exclusivly in the first four month of life. Additionally, a comparison of the two formula fed groups against a reference group with breastfed infants as well as the WHO growth standard reference tables will be performed. An assessment of safety and tolerability will be performed as well.

As a secondary out come of the study, we will examine the effect of the formula on the infant microbiome, as well as the HMO status of the mother's milk towards the microbial composition of the infant microbiome.

Eligibility Criteria:
Inclusion Criteria:

* Singleton birth
* Full-term infant (37 - 42 weeks of gestational age)
* APGAR score of 9 or 10
* Birth weight 2500 - 4500 g

Exclusion Criteria:

* clinically significant condition/ disorder
* Adverse maternal of fetal medical history that may influence growth/development of the subject or tolerance of the infant formula
* readmission to hospital (except for hyperbilirubinemia)
* allergy to cow's milk
* participation in another study
Prospecitve Observational Study on a Risk Adaptive Scheme for SBRT for Thoracic Nodes Metastases

Oligometastatic patients with inoperable thoracic nodes metastases from any primary, except for hematologic malignancies, will undergo a risk adaptive scheme of stereotactic body radiation therapy (SBRT).

The observational study is designed to evaluate safety and efficacy of a risk adaptive scheme of stereotactic body radiation therapy (SRT) in oligometastatic patients with thoracic nodes metastases, medically inoperable, using VMAT RapidArc approach. The potential advantage of this technique is the ability to deliver a more selective irradiation to tumour's target while reducing doses to normal tissue, optimizing the therapeutic window.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>18 years with ECOG 0-2
* Karnofsky index \> 70% (ECOG \>2)
* Any primary, except for hematologic malignancies
* DFI (Disease-free interval) from diagnosis \> 6 months
* Unresectable lesions or inoperable patients or patients who refused surgery
* Less than 3 metastatic thoracic nodes
* No extrathoracic disease or other metastatic sites stable or responding after chemotherapy, with less than 5 metastatic sites
* No life threatening conditions
* Chemotherapy completed at least 1 week before treatment
* Chemotherapy started at least 1 week after treatment allowed
* Systemic therapies other than chemotherapy allowed (i.e hormonal therapies and/or immunotherapy)
* Written informed consent

Exclusion Criteria:

* Previous RT in the same region
* Pregnant women
* Patients with inability to consent
Study of Wellness Behaviors as a Function of Oxytocin vs Placebo

The specific aim of this study is to test whether oxytocin (OT) boosts the positive emotion yield of a new wellness behavior (Lovingkindness meditation or Mindfulness meditation) and thereby increases nonconscious motives that shape daily behavioral decisions to repeat it, which in turn foster positive emotions that further augment nonconscious motives in an upward spiral dynamic.

The proposed research targets three hypotheses: (1) Oxytocin manipulation magnifies (i.e., moderates) the positive emotion yield of Lovingkindness meditation; (2) The positive emotion yield of meditation, which varies by experimental condition, increases the nonconscious incentive salience of Wellness Behavior-related cues; and (3) Behavioral decisions predict positive emotions, sparking the relationships among OT manipulation, positive emotion yield, and nonconscious incentive salience of Wellness Behavior-related cues.


Eligibility Criteria:
Inclusion Criteria:

* between the ages of 35 and 64 years old.
* Fluent in written and spoken English
* Willingness or interest in learning to meditate
* Computer literate with access to internet (weekly)

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Individuals on antihypertensive medication
* Individuals who have or have had a regular meditation practice
* Individuals who can read Chinese logographs
Expanded Access RBS2418 Treatment

This is an expanded access treatment protocol designed to provide access of RBS2418 to a single patient with pancreatic cancer.

Given lack of any therapeutic options such as standard of care chemotherapy for this single patient owing to lack of tolerability and opportunity to enroll in any clinical trial due to extent of disease, patient desires to try compassionate use protocol with RBS2418, an oral immunotherapeutic agent that is currently in clinical trials and is well tolerated by patients. Furthermore, patient's tumor has been shown to express ENPP1, the protein targeted by RBS2418

Eligibility Criteria:
Inclusion Criteria:

* The patient is willing and able to provide informed consent. Only the patient for whom this clinical study/experimental treatment was designed will be given the investigational drug under the treatment of the PI. No other patient is authorized to participate in or to receive treatment under this treatment protocol.

Exclusion Criteria:

* Not applicable
The NEXERCISE-trial: Reshaping Exercise Programs for Patients With Non-specific Neck Pain

The Nexercise-trial is a blended treatment program for patients with chronic non-specific neck pain. We will investigate whether a blended treatment approach, combining specific neck exercises and general aerobic exercises, has better outcome (on medical impact for the patient and socio-economic impact) than a specific neck exercise program alone or a general aerobic exercise program alone.

Chronic non-specific neck pain is a common musculoskeletal complaint in which several biopsychosocial factors can be involved. This condition is associated with a high socio-economic burden. The standard of care treatment for chronic neck pain in clinical practice is a combination of advice, passive manual treatment techniques and neck exercises. The implementation of exercise for the treatment of chronic neck pain is indeed recommended in several clinical guidelines. Nevertheless, exercise programs show positive though limited effects, which can be explained by its biomechanical and physiological effects on muscles and joints, but a current lack of taking into account important biopsychosocial and neurophysiological factors. For instance, specific local exercises can lead to acute pain flare-ups, hampering patient satisfaction and the adherence to exercise programs. While it is shown that general aerobic exercise leads to decreased generalized pain sensitivity, also in the affected body parts, both immediately and on the longer term, although on the longer term the effects on local pain sensitivity are better for specific local exercises.

It can be hypothesized that a blended treatment program in which local specific neck exercises are combined with general aerobic exercise in counteractive amount will avoid pain flare-ups and maladaptive exercise perceptions, positively influencing treatment adherence and generating the most optimal clinical outcome due to the local and general effects.

Therefore the aim of this project is to investigate the effect of a blended treatment program (I) to a specific exercise program alone (C1) and to a general aerobic exercise program alone (C2) on pain intensity and cost effectiveness (primary outcome measures), and also on Global Perceived Effect, other pain-related outcomes, quality of life and functionality, lifestyle factors, and health-economic measures (secondary outcome measures) (O) in chronic non-specific neck pain patients (P).

Eligibility Criteria:
Inclusion Criteria:

* Neck pain \> 3 months
* Mean pain intensity \> 3/10 during the preceding month
* Native Dutch speaker
* Being able to walk normally

Exclusion Criteria:

* People with specific causes of neck pain (such as cervical disc herniation with nerve root impingement, severe osteoarthritis, fractures)
* Major depression or psychiatric illness
* Life threatening, metabolic, cardiovascular, neurologic, systemic diseases, diagnosed sleeping disorder
* Pregnancy or given birth in the preceding year
* History of head, neck or shoulder surgery
* Fibromyalgia and chronic fatigue syndrome
* Body mass index \> 30 kg/m2
Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia

The purpose of this study is to evaluate clinically, histologically and radiographically the healing of extraction sockets covered with a resorbable collagen membrane (OSSIX-Plus) 12 weeks following exodontia.

Reduction in alveolar ridge height and width may prohibit optimal implant placement, and often compromises the esthetic and functional result. Alveolar ridge preservation has been evaluated in many studies. A variety of bone grafting materials and barrier membranes have been studied for their ability to enhance bone formation in damaged alveolar ridges, and to evaluate their bone healing and bone-forming capacity in extraction sockets. However, the newly developed resorbable collagen membrane OSSIX-Plus has not been evaluated for this purpose. This study is designed to test the ability of OSSIX-Plus (OraPharma Inc., Warminster, Pennsylvania) in promoting optimal bone healing following exodontia. We hypothesize that use of OSSIX-Plus will result in preservation of the height, width and density of the residual alveolar ridge following tooth extraction.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy subjects with 1 maxillary premolar tooth requiring extraction
* Residual extraction sockets must have \< 80% bone loss in all dimensions (3 or 4-walled bony defects)
* Nonsmokers (individuals who quit smoking at least 6 months prior to the study will be allowed to participate)
* Subjects willing and able to comply with all study-related procedures including maintenance of good oral hygiene and compliance with re-evaluation appointments
* Subjects who read, understand and are willing to sign an informed consent statement

Exclusion Criteria:

* Inadequate zone of keratinized gingiva (KG) or alveolar mucosa to obtain primary wound closure of the surgical site
* Presence of acute infections at the time of tooth extraction
* Clinically significant or unstable (as defined by the investigators) systemic diseases affecting bone or soft tissue growth or other renal, hepatic, cardiac, endocrine, hematological, autoimmune or acute infectious diseases that makes interpretation of the data more difficult
* History of head \& neck radiation therapy
* Subjects taking steroids, tetracycline or tetracycline analogs, bone therapeutic levels of fluorides, biphosphonatesm, medications affecting bone turnover, antibiotics for \> 7 days or any investigational drug
* Patients who are or become pregnant during the length of the study
* Sites in which one or both adjacent teeth are missing
Conventionally Fractionated Adaptive Radiation Therapy of Bladder Cancer an Individualized Approach

This is a single-arm, prospective, Phase II, multi-center clinical trial designed to demonstrate that adaptive radiotherapy for muscle invasive bladder cancer will translate into a decreased rate of acute gastrointestinal toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation therapy (IMRT).


Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven bladder cancer
2. Urothelial carcinoma
3. Age ≥ 18 years
4. Stage T1b-T4AN0M0
5. TUR-B and PET-CT or CT of thorax/abdomen/pelvis within 8 weeks prior to inclusion
6. Suitable for radiotherapy
7. ECOG/WHO performance status 0-2
8. Written informed consent
9. For Cohort B, participant's must have normal organ and marrow function as defined below:

   * leukocytes ≥2,500/mcL
   * absolute neutrophil count ≥1,500/mcL
   * platelets ≥100,000/mcL
   * hemoglobin ≥9 g/dL
   * total bilirubin ≤ 1,5 ULN
   * AST(SGOT)/ALT(SGPT) ≤3 × ULN
   * alkaline phosphatase ≤2.5 × ULN
   * creatinine clearance \<25 ml/min We recommend avoiding cisplatin for participants with creatinine clearance \<50 ml/min.
   * INR and aPTT £1.5 ULN

Exclusion Criteria:

1. Prior pelvic radiation therapy
2. Inability to comply with the protocol
3. Presence of a hip prothesis
4. Grade 2 or greater baseline diarrhea
5. Uncontrolled inflammatory bowel disease (ulcerative colitis or Crohn's disease)
Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients With Gout

This study will compare two different approaches to manage medications that lower uric acid levels. This study will be conducted at five VA medical centers across the United States and will take 4-5 years to complete. Individual participation will last up to two years.

This project will quantify and compare the effects of a pharmacist-led telehealth-delivered intervention versus usual care on arthritis flare burden and serum urate goal achievement in 310 U.S. Veterans with gout enrolled from five VA medical centers. The project will quantify the effects of the intervention on patient-reported outcomes (improvements in health-related quality of life, pain interference, and participant global assessment).

Eligibility Criteria:
Inclusion Criteria:

* US Veterans over the age of 18 years with physician-diagnosed
* Documented hyperuricemia (SU \>6.8 mg/dL)
* Satisfy ACR/EULAR gout classification criteria
* Report 1 or more flares in the prior 6 months
* Receipt of a new ULT prescription (allopurinol or febuxostat) initiated by a primary care provider or longer term ULT but otherwise satisfy the flare/SU criteria

Exclusion Criteria:

* Any patient intolerant or unable to take ULTs (allopurinol or febuxostat)
* Patients with a rheumatology encounter within the prior 3 months
Hemofiltration for Contrast-Induced Nephropathy

Contrast-induced acute renal failure can be prevented with hemofiltration which is performed during cardiac catheterization


Eligibility Criteria:
Inclusion Criteria:

* Patients with serum creatinine\>2.0mg/dl and/or GFR\<50ml/min

Exclusion Criteria:

* Emergent cardiac catheterization
* Patients on chronic dialysis
* Patients with HYHA\>III heart failure