cyrilzakka/clinical-trials huggingface dataset:
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants

This is a Phase 1, open-label, nonrandomized, single-dose study in healthy male participants to investigate the absorption, metabolism and excretion of DNL343.


Eligibility Criteria:
Inclusion Criteria:

* Males, aged between 18 to 65 years, inclusive
* Body mass index between 18.0 and 32.0 kg/m2
* In good health
* When engaging in sex with a woman of child bearing potential, both the male participant and his female partner must use highly effective contraception
* History of a minimum of 1 bowel movement per day

Exclusion Criteria:

* History or clinical manifestation of any clinically significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
* Have a history of malignancy, except fully resected basal cell carcinoma
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
* Have previously completed or withdrawn from this study or any other study investigating DNL343 and have previously received DNL343
Using Social Media to Decrease Healthcare Utilization for Pediatric Asthma

The purpose of this study is to evaluate if social media enhanced education (SME) will reduce total number of treatment days defined as summation of days of subsequent hospital admission, emergency room visits, and clinic visits, reduce missed school days, reduce total costs from a health system perspective, have increased effect with increased social media engagement, have increased effect in participants with both caregiver and patient (combined) with social media accounts, compared to participants where only the patient or only the caregiver uses social media (single),have increased patient satisfaction in the asthma education received and to obtain the experience and data needed to refine SME to be able to expand this platform for other chronic medical conditions with high healthcare utilization including pediatric diabetes, epilepsy, and sickle cell disease in children with asthma.


Eligibility Criteria:
Inclusion Criteria:

* hospitalized to Children's Memorial Hermann admitted for asthma exacerbation
* patient and/or primary caregiver must have internet access on cellular phones or at home and use a social media account (Facebook, Twitter, Instagram, and/or Snapchat)

Exclusion Criteria:

* other chronic conditions besides asthma that may necessitate frequent health care utilization. i.e. children with complex chronic conditions, sickle cell, seizures, diabetes.
Study of Prevalence of Colorectal Adenoma in 30- to 49-year-old Subjects With a Family History of Colorectal Cancer

Current guidelines for initiating screening colonoscopies in patients younger than 50 years of age who have a first relative history of colorectal cancer are controversial. The aim of this study was to prospectively define the prevalence of colorectal adenoma 30- to 49-years-old asymptomatic subjects with a first relative history of colorectal cancer and to compare the data with controls.

Design: Single-center prospective study

Colorectal cancer screening is recommended for average-risk persons beginning at age 50. A family history of colorectal cancer is recognized as a risk factor for colorectal adenoma. However, the strength of this association is uncertain. Current guidelines for initiating screening colonoscopies in patients younger than 50 years of age who have a first relative history of colorectal cancer have proved controversial. The conflicting recommendations are partly attributable to the lack of data about the prevalence of CRC and adenomas among 30- to 49-year-old individuals with a first relative history of colorectal cancer. This prospective study will quantify the prevalence of adenomas (any size) and advanced adenomas among 30- to 49-year-old individuals undergoing their first screening colonoscopy because of a first relative history of colorectal cancer and compare the data with controls(asymptomatic subjects without a first relative history of colorectal cancer).

Eligibility Criteria:
Inclusion Criteria:

* 30- to 49-year-old asymptomatic subjects
* First relative history of colorectal cancer

Exclusion Criteria:

* previous colonoscopy for any reason
* personal history of colorectal adenomas or CRC
* history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or inflammatory bowel disease
* documented history of occult GI bleeding, lower gastrointestinal tract bleeding not attributable to hemorrhoid, or
* iron deficiency anemia
* unexplained weight loss of \>10% of the body weight in the 6 months before colonoscopy
* incomplete examination of entire colon
Vagus Nerve-guided Robotic-assisted Splenectomy and Azygoportal Disconnection

This study aimed to evaluate whether vagus nerve-guided robotic-assisted splenectomy and azygoportal disconnection is effective and safe, and to determine whether a reduction in the incidence of postoperative complications of the digestive system improves postoperative quality of life compared with conventional robotic-assisted splenectomy and azygoportal disconnection.

After successful screening the cases of cirrhosis of liver irrespective of the etiology who have non tumor portal vein thrombosis will be enrolled. The baseline parameter will be recorded and the patient will be randomized into either interventional (vagus nerve-guided robotic-assisted splenectomy and azygoportal disconnection) or control (conventional robotic-assisted splenectomy and azygoportal disconnection) group. From postoperative day 3, all patients will receive 2.5 mg oral Apixaban tablets (Bristol-Myers Squibb, Cruiserath, USA) twice daily for 6 months, low-molecular-weight heparin (CS Bio, Hebei, China) subcutaneously (4.100 IU/day) for 5 days, and 25 mg of oral dipyridamole (Henan Furen, Henan, China) thrice daily for 3 months. At months 3 after operation, electron gastroscopy examination for delayed gastric emptying will be done for all patients. Postoperative complications of the digestive system (including diarrhea, epigastric fullness, bloating, nausea, and vomiting), liver and renal function, and body weight will be recorded at the seventh day and months 3 after operation. Then 3 months monitoring will be done in the both groups as per the primary or secondary outcome.

Eligibility Criteria:
Inclusion Criteria:

1. A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
2. Splenomegaly with secondary hypersplenism
3. Bleeding portal hypertension
4. No evidence of portal vein system thrombosis by ultrasound evaluation and angio-CT
5. Informed consent to participate in the study

Exclusion Criteria:

1. Delayed gastric emptying
2. Diarrhea
3. Hepatocellular carcinoma or any other malignancy,
4. Hypercoagulable state other than the liver disease related
5. DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
6. Child - Pugh C
7. Recent peptic ulcer disease
8. History of Hemorrhagic stroke
9. Pregnancy.
10. Uncontrolled Hypertension
11. Human immunodeficiency virus (HIV) infection
Suvorexant to Reduce Symptoms of Nicotine Use

The purpose of this study is to assess the impact of suvorexant on established measures of smoking relapse risk (craving,withdrawal, stress reactivity, latency to self-administration) and to validate the somnolent effect of suvorexant on sleep metrics in a sample of individuals with tobacco use disorder


Eligibility Criteria:
Inclusion Criteria:

* non-treatment seeking cigarette smokers that report smoking atleast 10 cigarettes per day

Exclusion Criteria:

* greater than mild substance use disorder on drugs other than nicotine
* a Diagnostic and Statistical Manual of Mental Disorders(DSM)-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
* significant current suicidal or homicidal ideation - medical conditions contraindicating administration of suvorexant (e.g., severe pulmonary disease, severe cardiovascular disease or clinically abnormal EEG, severe liver or kidney disease, seizure disorder, or sleep disorder - particularly narcolepsy)
* taking medications known to have significant drug interactions with the study medication(s) (e.g., Monoamine oxidase inhibitors(MAO) inhibitors, anticonvulsants, haloperidol, phenothiazines, anesthetics, and all sedatives)
* currently or recently (last 3 months) treated for substance use \[other than nicotine\] or another psychiatric condition
* conditions of probation or parole requiring reports of drug use to officers of the court
* impending incarceration
* pregnant or nursing for female patients
* inability to read, write, or speak English \[required for lab tasks and psychometric scales\]
* unwillingness to sign a written informed consent form
* subjects with alcohol use disorders or report recent problem drinking (5/4 drinks for males/females in \< 2.5 hours or \> 10 alcoholic drinks per week)
* any illness,condition, or use of medications which in the opinion of the PI and/or admitting physician would preclude safe and/or successful completion of the study.
Breath Test for Biomarkers in Humans Receiving Total Body Irradiation

The effect of radiation on normal tissue varies widely between individuals. Consequently, a test to measure tissue response to radiation could be clinically useful by permitting more accurate titration of dosage in patients undergoing radiotherapy. Also, in view of emerging concerns about possible nuclear terrorism a test for exposure to radiation might also be useful in evaluating victims of a "dirty bomb" explosion. A number of different techniques have been previously reported in epidemiological studies for the estimation of prior radiation exposure. This study explores one approach to estimating radiation exposure by measurement of increased oxidative stress which can be detected by a breath test.

In this study subjects undergoing significant exposure to therapeutic radiation will provide breath samples for analysis in a central laboratory. The hypothesis of the study is that the analysis of these samples will lead to the identification of a set of markers of radiation exposure.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Subject is willing and able to cooperate with study and give signed informed consent to participate
3. Subject has been diagnosed with a condition that requires treatment with a TBI protocol of daily irradiation for one to five days
4. Actively smoking subjects, as well as never smokers and former smokers are eligible for the study so long as a complete smoking consumption history can be recorded
5. Subject will be available for follow-up breath tests following each session of TBI. Subjects receiving only one day of TBI will be available for a follow-up 24-36 hours following TBI
6. Subject is an in-patient at the hospital

Exclusion Criteria:

1. Subject has had chemotherapy within preceding 21 days
Hyperthermia Combined With Immune Checkpoint Inhibitor Therapy for Advanced Gastrointestinal Tumours

Gastrointestinal tumours (GITs) are the most common and fatal cancers worldwide; 96% of GITs show the microsatellite-stable (MSS)/proficient mismatch repair (pMMR) phenotype, and these tumours have a poor response to immune checkpoint inhibitor (ICI) therapy. Hyperthermia combined with ICI treatment (HIT) has been reported to show a synergistic sensitisation effect in numerous basic studies. This study aimed to validate the effectiveness, safety, and feasibility of water-filtered infrared A radiation (WIRA) whole-body hyperthermia combined with PD-1 inhibitor therapy and evaluate the real-world clinical application prospects of HIT. This open-label single-arm phase 2 clinical trial aimed to enrol advanced GIT patients with the MSS/pMMR phenotype in the East Asian population who had received third-line or higher treatment. The patients were treated with whole-body hyperthermia on days 1 and 8 of each HIT cycle along with administration of tislelizumab 200 mg on day 2 (24 h after the hyperthermia at day 1). The primary outcome was the disease control rate (DCR), while the secondary outcomes were progression-free survival (PFS), overall survival (OS), safety, and improvement in quality of life.

The specific treatment process is shown in the trial flow diagram. The patients underwent WIRA whole-body hyperthermia on days 1 and 8 of each HIT cycle. On day 2 (24 h after hyperthermia on day 1), 200 mg of tislelizumab prepared with 100 mL of normal saline was intravenously administered for less than 30 min. After six HIT cycles, tislelizumab was administered intravenously every 21 days until drop-out. For quality control of hyperthermia, the core temperature was set to 38·5-39·5 °C and measured using a rectal temperature-sensing probe. Hyperthermia was considered to have been achieved when this temperature range was recached and maintained for 60 min. Each hyperthermia session lasted for 2 h, including a 30-min heating stage, a 60-min insulation stage, and a 30-min cooling stage. Clinical data were collected every two HIT treatment cycles and evaluated using the RECIST version 1.1 standard.

Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced GIT who have previously received third-line or above treatment.
* Patients are aged 18-75.
* Patients with at least one measurable tumor lesion.
* Patients' all physiological indexes meet the HIT requirements.

Exclusion Criteria:

* Patients have participated in other clinical trials within 4 weeks before enrollment.
* Patients contraindicate to whole-body hyperthermia.
* Patients contraindicate to immunotherapy.
* Patients cannot fully cooperate with HIT and follow-up.
* Pregnant or lactating women.
* Other circumstances may affect the results.
Effectiveness of Telepractice by Smartphone App Technology in Preventing Voice Problems

Voice disorders in teachers have a significant impact on communication, quality of life, and economic costs to the healthcare system. We need to advance the prevention of voice disorders in teachers by testing an online telepractice model with synchronous (in real-time) and asynchronous (stored and accessed later) methods. The current study will investigate the effectiveness of the theoretically-driven Global Voice Prevention Model (GVPM) delivered by two methods; 1) online telepractice (synchronous and asynchronous) and 2) traditional, in-person for vocally healthy physical education and vocal music student teachers. Effectiveness of the model will be assessed by voice-related measures captured daily on a smartphone app during student teaching, matching the asynchronous aspects of the telepractice model and representing the effects of vocal loading from teaching.


Eligibility Criteria:
Inclusion Criteria:

* senior at West Chester University as of fall 2016 and fall 2017,
* student teaching during spring 2017 or 2018,
* healthy voice user,
* owns a smartphone

Exclusion Criteria:

-
Weighted Blankets and Chronic Pain

The purpose of the study is to test whether the use of weighted blankets can change the experience of chronic pain and to examine if social, psychological, or health factors influence the perception of the blanket. Multiple blanket weights will be tested.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Fluent in English
3. Diagnosis of chronic pain (self-report; those already indicating this diagnosis on researchmatch.org)
4. Willing to sleep with a weighted blanket and fitness watch for 1 week
5. Able to safely lift up to 15lb
6. Willing and able to use their personal smartphone for fitness tracker app and EMA app to submit ratings using personal data plan

Exclusion Criteria:

1. Pregnancy
2. Major medical conditions such as kidney, liver, cardiovascular (hypertension, preexisting cardiac arrhythmia), autonomic, pulmonary, or neurological problems (e.g., seizure disorder)
3. Current or previous use of a weighted blanket
4. Claustrophobia
Associations Between Periodontitis and Autoimmune Antibodies in Rheumatoid Arthritis Disease

The aim of this case control study is to explore the possible association between periodontal destruction and serum anti-CCP antibodies in RA patients and healthy subjects.

In patients with RA, the anti-CCP antibody titer seems positively correlated to their periodontal destruction and disease activity in comparison with healthy subjects.

Eligibility Criteria:
Effect of High volumeHemodiafiltration on Lung Oxygenation

High volume hemodiafiltration (HVHDF) has been used in septic patients to get hemodynamic improvement and possibly survival benefit.

Sepsis, defined as life-threatening organ dysfunction caused by dysregulated immune response to infection. Hemofiltration has been suggested as beneficial in restoring immune homeostasis. High volume hemodiafiltration (HVHDF) is a hybrid method of intermittent renal replacement therapy (RRT), where high filtration volumes are applied. In several studies; higher filtration volumes have been shown to achieve hemodynamic improvement and possibly survival benefit in patients with septic shock.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years
2. Severe sepsis defined by Quick SOFA score by presentation of 2 or more of the following criteria:

   * Mental clouding: decreased glasco coma scale GCS \< 15
   * Hypotension: Systolic blood pressure \< 100 mmgH
   * Tachypnea: respiratory rate \> 22 breath/ minute Then serum lactate is analysed to confirm sepsis hypoperfusion if ≥ 2mmol/L
3. Organs dysfunction (including one of them respiratory failure).

Organ dysfunctions are defined as following:

Respiratory dysfunction (criteria for ARDS):

* PaO2/FiO2 \<200
* Bilateral infiltrates in chest X-ray
* Resistant hypoxemia
* Tachypnoea (RR \> 40 breath/minute)
* The need for invasive mechanical ventilation
* Excluded cardiac causes of pulmonary edema

CNS failure:

* Decreased GCS ≥ 4 decreased points

CVS dysfunction:

* Sustained hypotension even on very high inotropes doses (Noradrenaline \>1µm/min)+ adrenaline\>1.5µm/min associated
* with high CVP pressure \> 12 mmHg and not responding to fluid challenge test to exclude hypovolemia.
* Cardiomegaly detected by either echocardiography assessment, or chest X-ray
* Resistant frequent ventricular ectopics not explained by organic causes.

Liver dysfunction:

* Elevated total and direct bilirubin than double normal or basal levels
* Elevated prothrombin time \> 17 seconds or INR \> 1.5
* Elevated liver enzymes \> triple normal level

Renal dysfunction:

* Decreased urine output \< 0.5 ml/kg.
* Elevated creatinine level \> 164 µmol/L (1.5mg/dL).
* Decreased creatinine clearance \<50ml/minute if available.

Bone marrow depression:

* Decreased platelets \< 90 X 103/µL
* Decreased leukocytes \<4 X 103/µL
* Decreased RBCs count \< 4 X 106/µL

Exclusion Criteria:

1. Patient relatives' refusal
2. Pregnancy
3. Recent active internal hemorrhage
4. Not mechanically ventilated.
5. Hypersensitivity to the dialyser fluid
Predictive Value of Risk Scores in Acute Coronary Syndrome

role of different risk scores in acute coronary syndrome to predict left ventricular remodeling

patients with acute coronary syndrome (STEMI, NSTEMI, UA) will be included and different risk scores will be calculated for each patient.

after that in-hospital and short-term outcome beside left ventricular systolic and diastolic functions (at admission and 3m later) will be assessed to be correlated with different risk scores to determine which score system was able to predict left ventricular remodeling and what was the cut off value, sensitivity, and specificity of the score

Eligibility Criteria:
Inclusion Criteria:

* patients with acute coronary syndrome

Exclusion Criteria:

* previous acute coronary syndrome previous PCI or CABG chronic renal disease decompensated liver disease patient refusal to participate patients dropped during follow up
Vascular Effects of Dietary Salt in Humans With Salt-Resistant Blood Pressure

The purpose of this study is to determine the effects of dietary salt restriction on central hemodynamics and vascular function in men and women with salt resistant blood pressure.

Cardiovascular disease remains a major Public Health problem and is the leading cause of death in the US. Dietary sodium restriction is considered an important lifestyle modification for individuals with hypertension; however, there is controversy about the effects of dietary salt given that many individuals do not have "salt sensitive" blood pressure. Deleterious effects of salt on the vasculature may explain the finding that chronic DSR reduces the cardiovascular event rate by 25%despite only minor reductions in BP. It is not known whether dietary sodium restriction improves central pulsatile hemodynamics, known to be related to the development of left ventricular hypertrophy and heart failure risk, and whether the hypothesized improvements in central hemodynamics are similar in men \& women. The purpose of this study is to determine the effects of dietary sodium restriction through dietary counseling on central hemodynamics and vascular function in men and women with salt resistant blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Habitual dietary sodium intake \> 3400mg per day

Exclusion Criteria:

* Abnormal resting ECG
* Current abnormal blood panel (assessed by comprehensive metabolic panel, lipid panel and complete blood count).
* Hypertension (currently taking anti-hypertensive medications or resting blood pressure \>140/90 mmHg)
* Medical history of cardiovascular disease, malignant cancer, diabetes or kidney disease
* Obesity (Body Mass Index \> 30)
* Current pregnancy
* Unable to provide consent
A Non-interventional Ambispective Real-world Cohort of rEfractory and reLapsed (R/R) FLT3 Mutated Acute MyEloid Leukemia (AML) Patients Treated With Gilteritinib in FrANCE

Gilteritinib is available in early access in France through Temporary Authorisation of Use (or ATU program) since March 2019. The ATU program reflects a real-life treatment situation and the related clinical data would help to better understand the benefit/risk profile of gilteritinib and to better document gilteritinib efficacy and safety in patients who received midostaurine in First Line (1L) setting.

The main objective is to describe gilteritinib effectiveness in FLT3 (Fms Related Tyrosine Kinase 3) -mutated AML patients in Refractory/Relapsed(R/R) situation treated in the context of early access program to gilteritinib in France through Temporary Authorisation of Use, the so-called ATU program, and the post ATU period from marketing authorisation to launch when reimbursement and price are published.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years at AML diagnosis
* Patients that started gilteritinib during ATU and post-ATU period from 19th March 2019 to 30th March2021
* Patients diagnosed with refractory or relapsed AML as defined by the World Health Organization (WHO) Classification
* Patients with FLT3 genetic testing performed at diagnosis and/or at R/R (if available)
* Gilteritinib with or without other drug (chemotherapy, hypomethylating agent, hydroxyurea, etc.)

Exclusion Criteria:

* Newly diagnosed AML patients
* Participant opposed to the collection and analysis of their medical data
* Prescription of gilteritinib out of the scope of its marketing authorisation approval such as post HSCT maintenance in patients in first complete remission after intensive chemotherapy
* persons placed in curatorship,guardianship or guardianship orders