cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating The Excretion Of Moxidectin Into The Breast Milk Of Lactating, Non-Breastfeeding Women

The purpose of this study is to evaluate the extent of moxidectin transfer into the breast milk of lactating women and to provide the initial pharmacokinetic and safety profile of moxidectin in lactating women.


Eligibility Criteria:
Inclusion criteria:

Healthy lactating women aged 21 to 45 years inclusive at screening. Women should:

* Be at least 12-weeks postpartum after uncomplicated delivery with a full milk supply established.
* Be willing to discontinue breastfeeding permanently and should be in the process of weaning their infant. Care should be taken to ensure that subjects have not discontinued breastfeeding an infant in order to participate in the study.
* Not plan to breastfeed within 9 months of study drug administration.
* Be willing to fully express breast milk from both breasts during the duration of the milk collection portion of the study. Subjects must be able to express milk from each breast at each pumping session using a breast pump.
* Body mass index in the range of 18 to 35 kg/m2.

Exclusion criteria:

* Presence or history of any disorder that may prevent the successful completion of the study.
* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Endobronchial Ultrasound-Guided Transbronchial Needle-Aspiration with Suction in Obtaining Samples from Patients with Suspected Nodal Metastatic Lung Cancer

This trial studies how well endobronchial ultrasound-guided transbronchial needle-aspiration (EBUS-TBNA) with suction works in obtaining samples from patients with suspected lung cancer that has spread to the nodal. EBUS-TBNA samples obtained with additional suction may help to improve material-amounts and decrease blood contamination in the samples.

PRIMARY OBJECTIVES:

I. To evaluate if suction applied with a vacuum syringe during EBUS-TBNA sampling helps to obtain more material for molecular analyses.

OUTLINE:

Patients undergo bronchoscopy with EBUS-TBUA first without and then with applied vacuum.

Eligibility Criteria:
Inclusion Criteria:

* Computed tomography (CT)-scan finding suspicious for lung cancer with nodal metastases
* Clinically stable to undergo diagnostic workup by bronchoscopy with endobronchial ultrasound

Exclusion Criteria:

* Pregnant female
* Minors
* Prisoners
* Patients with contraindication for EBUS such as non-reversible anticoagulation
Efficacy and Safety Prediction of Milrinone or Levosimendan as Initial Inotropic Drug Therapy in Patients With Acute and Advanced Heart Failure With Renal Insufficiency

1. To evaluate the efficacy and safety of levosimendan and milrinone in the treatment of with acute heart failure with or without renal dysfunction;
2. Predictive modeling of the efficacy and safety of levosimendan and milrinone.

By comparing the safety and efficacy of milrinone with levosimendan as an initial inotropic agent for the treatment of patients with acute heart failure with or without abnormal renal function, a preliminary efficacy and safety prediction model was developed for levosimendan and milrinone based on the basic characteristics of the patients and the level of renal function.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* Patients who were clearly diagnosed with heart failure ( cardiac insufficiency ) and LVEF(Left Ventricular Ejection Fraction) \< 50 %, and were judged by the physician to need and agree to use levosimendan or milrinone to maintain hemodynamic stability

Exclusion Criteria:

* chronic heart failure and New York Heart Association ( NYHA ) class I \~ II
* Complicated with infective endocarditis, aortic dissection, severe liver dysfunction ( child-pugh C ), severe renal insufficiency ( CrCl \< 30 ml / min ), hypertrophic obstructive cardiomyopathy, ventricular assist device or surgical cardiac surgery within 30 days before the use of levosimendan
* Patients with severe ventricular arrhythmia 1 within 24 hours before levosimendan and systolic blood pressure 100 times / min within 2 hours before levosimendan
* During hospitalization, other positive inotropic drugs 2 were used when levosimendan was intravenously pumped or dripped, excluding the use of catecholamines for rescue
* received positive inotropic drug 2 treatment in the last 30 days
* Lack of serum creatinine, brain natriuretic peptide or brain natriuretic peptide precursor, serum total bilirubin, cardiac ultrasound baseline ( within 14 days before using levosimendan ) data
* pregnant and lactating women
PR in Endoscopic LAR for Rectal Cancer

The anastomotic leakage remains the major early complication after laparoscopic anterior resection(LAR) for medium \& low rectal cancer. Pelvic floor reconstruction (PR) is a key step in various standard resections for open radical rectal cancer surgery, which was considered to be helpful for decreasing the rate of leakage. However, PR in endoscopic LAR surgery is not routine practice and remains controversial. The purpose of this study is to evaluate the efficacy of PR during LAR for mid/low rectal carcinoma, especially in preventing anastomotic leakage.

Eligible patients with rectal cancer will be randomly assigned to group with pelvic floor reconstruction(PR) versus group without pelvic floor reconstruction(NPR).

We want to investigate the rate of anastomotic leakage and re-operation between the two groups, some other relevant outcomes will be concerned all the same.

Eligibility Criteria:
Inclusion Criteria:

1. patients with histologically proven rectal adenocarcinoma
2. tumor located in the middle and lower rectum and anastomosis under the peritoneal reflection
3. Tumor assessed as a depth of invasion that was confined to pT1-pT3, bN0-1M0 by ultrasound colonoscopy and/or pelvic MRI
4. Negative circumferential resection margin confirmed by MRI
5. Performance status (ECOG) 0\~1
6. Written informed consent for participation in the trial

Exclusion Criteria:

1. History of accepting lower abdominal surgery.
2. More than one colorectal tumor
3. Patients with unresectable distant metastasis or multiple metastases
4. Received neoadjuvant radiotherapy before surgery
5. Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery
6. Patients and/or family members cannot understand and accept this study
7. Non-rectal adenocarcinoma was confirmed by postoperative pathological examination
Beta Endorphins,Interleukin 1 and Interleukin 38 in Covid Patients Associated With Neuropsychological Manifestations.

Measurement of Beta endorphins,interleukin 1 and interleukin 38 in covid patients associated with neuropsychological manifestations.

The world is facing one of its worst infectious disease pandemics in history, i.e., Covid-19. Coronavirus, SARS-CoV-2 was identified as the cause of an outbreak of a severe pneumonia-like disease, currently known as Covid-19. When COVID-19 infect the upper and lower respiratory tract it can cause mild or highly acute respiratory syndrome with consequent release of pro-inflammatory cytokines, including interleukin (IL)-1β and IL-6. (Herold T., et al., 2020) Although the main risks of COVID-19 is to cause injuries to the upper and lower respiratory track and lung, other organs are also affected including CNS leading to variety of neuropsychatric symptoms including headache, depression, and memory impairment.These psychological symptoms become more obvious by quarantine which is one of the most common protections against virus infections .These psychological symptoms also aasociated with alteration of level of beta endorphins. (Long B et al.,2020).

β-Endorphin, a morphine-like peptide, was identified in brain as an endogenous opioid peptide hormone that is produced and secreted in the pituitary gland and related to pain modulation and strongly linked to chronicity and severity of depression. The specific receptor for β-endorphin is the μ-opioid receptor. (Tanaka et al., 2003) β-Endorphin stimulates chemotaxis of monocytes, their differentiation into macrophages, and production of reactive oxygen species, interleukin (IL)-1β, IL-10, interferon-γ, and tumor necrosis factor-α in monocytes/macrophages. The μ-opioid receptor is upregulated by IL-1α and IL-1β. (Gein et al.,2016) The psychological disorders caused by Covid-19 have significant effects on the immune system, resulting in mast cell activation, increased generation of cytokines like IL-1, IL-37, IL-6, and C-reactive protein. Endorphin release therapy (ERT) can be very effective to reactivate thymus gland, increase production of NK cells and CD4+ cells and inhibit CD8+cells, prevent, and reduce inflammation in Covid-19 patients, thereby reducing many complications and associated deaths. (Ahmadpoor P et al ., 2020 ) IL-38 is the newest cytokine of the IL-1 family members, produced by several immune cells including B cells and macrophages. IL-38 is a suppressor cytokine which inhibits IL-1β and other pro-inflammatory IL-family members. IL-38 is a potential therapeutic cytokine which inhibits inflammation in viral infections including that caused by coronavirus-19, providing a new relevant strategy. (Gómez-Rial J et al.,2020)

Eligibility Criteria:
Inclusion Criteria: Patients had positive throat swab. Patients had chest finding on CT

Exclusion Criteria:

Other respiratory diseases
The Role of Acupuncture-induced Exosome in Treating Post-stroke Dementia

Stroke is the main cause of disability and the second main cause of dementia. Approximately 21.5% of patients develop dementia within 4 years after stroke. The main clinical manifestation of dementia is memory and cognitive impairment. At present, acetylcholinesterase inhibitors and NMDA glutamate receptor antagonists, were used for dementia treatment, but those drugs have limited efficacy. Exosome is an extracellular vesicle from the endosomal, size range from \~40 to 160 nm (average \~100 nm). It contains many cells including DNA, RNA, fat, and metabolites, as well as cytoplasm and cell surface proteins that play a role in regulating intercellular communication. Some studies believe that exosomes in the circulation are an ideal marker to reflect the pathological progress and recovery of stroke, and play a key role in the reorganization of tissues and the progress of neurodegeneration after stroke. Our previous studies have known that acupuncture can increase the long-term potentiation of hippocampal CA1 in rats with ischemic stroke, and improve learning-memory and neurological function. Therefore, the purpose of this study is to explore the role of acupuncture-induced exosome in the treatment of post-stroke dementia.


Eligibility Criteria:
Inclusion Criteria:

1. History of stroke.
2. MMSE score between 16 and 26.

Exclusion Criteria:

1. Those with serious diseases, such as heart failure, chronic failure or cancer patients, etc.
2. Intolerance to acupuncture treatment.
3. Allergy to acupuncture needles.
4. Refusal to sign the informed consent form.
A Dose Escalation Trial of Stereotactic Body Radiotherapy (SBRT) After Induction Chemotherapy for Locally Advanced Pancreatic Cancer

The purpose of this study is to find out the maximum dose of SBRT that can be safely given after chemotherapy for treatment of pancreatic cancer that cannot be removed surgically.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytopathologically confirmed adenocarcinoma of the pancreas.
* Locally advanced, unresectable pancreatic cancer as confirmed by the multidisciplinary input from a hepatobiliary surgeon and as defined on CT as having tumor abutment of \>180° (\> 50%) of the circumference of the superior mesenteric artery (SMA) or celiac axis, unreconstructable superior mesenteric vein (SMV) or PV involvement.
* No evidence of distant metastasis either prior to or after induction chemotherapy.
* Completion of at least 3 months, but no more than 6 months of standard induction chemotherapy for LAPC, which may include FOLFIRINOX or gemcitabine and nab-paclitaxel, preferably within 2-4 weeks but no longer than 8 weeks.
* Pancreatic tumor size ≤ 5 cm.
* Age ≥18 years
* ECOG 0-1.
* Patients must have acceptable organ and marrow function as defined below:

  * Leukocytes \>3,000/uL
  * Absolute neutrophil count \>1,500/uL
  * Platelets \>50,000/uL
  * Total bilirubin Within 2 x upper limit of normal
  * AST (SGOT)/ALT (SGPT) \<2.5 x institutional upper limit of normal
  * Creatinine-Creatinine clearance Within 1.5 x upper limit of normal OR \>60 mL/min for patients with creatinine levels above institutional normal
* Ability to understand and follow the breathing instructions involved in the respiratory gating procedure or to tolerate compression sufficient to reduce fiducial motion to ≤ 5mm
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients who have had prior abdominal radiotherapy.
* Patients receiving any other investigational agents
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Contraindication to Magnetic Resonance Imaging
* Patients in which iodine contrast is contraindicated
* Pregnant and breastfeeding women are excluded. Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 4 weeks after the study are excluded. This applies to any woman who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months, or women on hormone replacement therapy with serum FSH levels greater than 35 mIU/mL. A negative urine or serum pregnancy test must be obtained within 14 days prior to the start of study therapy in all women of child-bearing potential. Male subjects must also agree to use effective contraception for the same period as above.
Sustained Release Oral Formulation for Treatment of Parkinson's Disease

Achieving sustained blood levels of carbidopa/levodopa has been a challenge in the treatment of PD and although levodopa remains the most commonly used drug, motor fluctuations remain a major disability especially in advanced Parkinson's disease. The aim of this study is to determine the efficacy of a novel oral carbidopa-levodopa formulation in achieving a sustained blood level of levodopa and carbidopa in PD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with idiopathic PD
* Experiencing motor fluctuations

Exclusion Criteria:

* Inability to consent for thmeselves
* Inability to fast
Piloting a Healthy Aging Cohort in Manitoba

The purpose of this study is to set up and pilot baseline data collection for a prospective cohort designed to explore the relationships between medical fitness facility usage, lifestyle behaviours and health outcomes as individuals age. Additionally, this pilot study will set up the overall objectives for the larger, prospective cohort study using a public engagement participatory approach with public/patient partners involved in determining which healthy aging outcomes to include.

This project will cover the set-up, development, and user-testing of the baseline visit data collection in the first 20 participants. Data will be collected on physical activity, diet, sleep, stress, cognition, frailty, health history (including diabetes, alcohol and smoking), facility and program usage at the Wellness Institute (WI), height, weight, volitional oxygen intake (VO2 max), blood pressure, heart rate, clinical chemistry, urinalysis, body composition, social determinants of health, and wellbeing.

Additionally, a public engagement participatory approach will be used to determine which healthy aging outcomes are important to study, including discussion on research priorities, research question, research design, data collection approaches, outcome measures, analysis of results, relevance of findings, and dissemination of findings. Therefore, this pilot project will include the formation of a project advisory group that will include public/patient partners. The advisory group members will discuss ideas around healthy aging and lifestyle and what outcomes are most important to them; and will provide information on the reasons for joining as well as the use of the medical fitness facility, any barriers they face and program needs. The project advisory group will be an integral part of this pilot project. The information obtained from the advisory group meetings and the pilot project will be used to develop the outcomes for the larger cohort study.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 30 years or above.
* Able to communicate in English and provide written informed consent
* Current member of the Wellness Institute
* Access to a device such as an android or iOS smartphone or tablet for use with the dietary tracking application.

Exclusion Criteria:

• Female participant who is pregnant or lactating
A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy And/or Breastfeeding.

This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy. Women exposed to efgartigimod or efgartigimod PH20 SC only during breastfeeding will also be eligible to enroll. Background rates of major congenital malformations (MCMs) will be obtained from populations within the same countries/regions as the countries/regions in which the efgartigimod or efgartigimod PH20 SC exposed pregnancies were reported.


Eligibility Criteria:
Inclusion Criteria:

* Women with exposure to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy, or women with exposure to efgartigimod or efgartigimod PH20 SC during breastfeeding. The timeframe of 25 days prior to conception is calculated based on five times the efgartigimod half-life, which is 3 to 5 days.
* Written/verbal informed consent or eConsent (depending on country regulations) (for adolescents under the age of majority, written/verbal informed assent or eConsent by the pregnant minor (where applicable) and written/verbal informed consent or eConsent by the parent/legal guardian).

Exclusion Criteria:

* None
A Single-session Intervention Adaptation of the Habit Framework for the Prevention of Eating Disorders

The purpose of this proposal is to launch the first trial of a single-session intervention (SSI) specifically for the prevention of eating disorders (EDs).

The emergence of EDs is bimodal such that there is a period of risk in early adolescence and a period of risk in late adolescence/early adulthood. EDs can lead to significant mental and physical health consequences and have one of the highest mortality rates of any mental illness. Prevention and treatment programs for EDs are fraught with barriers to access, particularly related to seeking care in-person. SSIs have been identified as a pathway to address the gap in care for EDs after showing promise for other psychiatric problems, including depression, anxiety, and suicidality .

Eligibility Criteria:
Inclusion Criteria:

* EAT-26 score ≥ 20 ( EAT-26, participants will meet the "referral criteria" which includes a score of 20 or more or meeting frequency criteria on bingeing, purging, laxative/diuretic use, and/or exercise.)
* English-language fluency, self-reported3
* Access to a phone, tablet, or computer

Exclusion Criteria:

* Failure to correctly complete one of the attention checks in the survey prior to the intervention
* Failure to correctly complete both anagram tasks in the survey prior to the intervention
* Completion of the screening survey or pre-intervention surveys in an improbably fast time
Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract

Prehypertension and mild hypertension affect an estimated 157 million U.S. adults. Cardiovascular disease (CVD) risk and associated mortality is elevated in this population. Treatment options are limited consisting of lifestyle modification, which is often ineffective, or drug therapy, which carries risk of side effects. Highly safe, efficacious, and acceptable treatment options for this population are needed. Hawthorn standardized extract (HSE) is approved for use in Europe to treat heart failure, and preliminary evidence suggests it may have a blood pressure lowering effect. However, prior trials of hawthorn have based dosage recommendations on animal studies. Therefore, the investigators propose a dose-finding study to measure the pharmacodynamic effect of three doses of standardized hawthorn extract and placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Recent ambulatory daytime systolic BP average between 120 - 155 mmHg or diastolic BP between 80-95 mmHg
2. Age 18 years and older.
3. Ability to speak English

Exclusion Criteria:

1. Any antihypertensive medication use (ACE inhibitors, ARB, beta-blockers, calcium channel blockers, diuretics, alpha agonists or antagonists, nitrates, direct vasodilators such as hydralazine, aldosterone antagonists, direct renin inhibitors, endothelin antagonists)
2. Current tobacco use.
3. Diagnosed with diabetes, known coronary artery disease, severe aortic stenosis, idiopathic hypertrophic subaortic stenosis (IHSS), or upper extremity vascular obstruction.
4. Pregnancy or breast feeding.
5. Using estrogen-containing birth control methods.
6. Unwillingness to forgo vitamins C and E, fish oil, niacin, arginine, OTC decongestants, and NSAIDs such as advil, motrin, and nuprin during the study period.
7. Unwillingness to forgo use of phosphodiesterase inhibitors (sildenafil - 36 hours, vardenafil - 36 hours, tadalafil - 96 hours) prior to study visits.
8. Unwillingness to refrain from vigorous exercise on the morning of study visits.
9. Women with childbearing potential who do not agree to practice effective birth control (condom, diaphragm, cervical cap, copper IUD, abstinence).
Bilateral Erector Spinae Plane Block for Myofascial Pain Syndrome

The investigators aimed to evaluate the effectiveness of bilateral erector spina plane block application in myofascial pain syndrome.

The investigators aimed to evaluate the effectiveness of bilateral erector spina plane block application in myofascial pain syndrome by comparing trigger point injection. Group 1 only one time erector spinae plane block and group 2 once a week total three times trigger point injection. Before the application, one week after application and one month after first application the investigators aimed to compare pressure pain threshold with algometer, visual analog scale score, short form-36 score, neck disability index score, beck depression scale score for the two groups. Each group has 30 participants, total 60 participants included this study. The investigators planned to show that bilateral erector spinae plane block can be used as an effective and safe method in the treatment of myofascial pain syndrome, since it is easier to apply than other invasive procedures used in the treatment and has a very low complication profile.

Eligibility Criteria:
Inclusion Criteria:

* Get a myofascial pain syndrome diagnosis
* No invasive procedure for myofascial pain syndrome in the last 1 month
* Signing the informed consent form

Exclusion Criteria:

* Cervical disc herniation
* Neck/shoulder, thoracal trauma or operation history
* Malignancy
* Kyphoscoliosis
* Inflammatory diseases (Rheumatoid arthritis, ankylosing spondylitis...)
* Congenital vertebral anomalies
* Neck pain with neurological deficit
* Pregnancy
* Mental, psychogenic disorder
* Hematological diseases that cause bleeding and coagulation disorders
* Use of antiplatelet, anticoagulant and drugs that cause bleeding tendency
* Severe systemic infection such as sepsis and local infection at the intervention site
* Having an allergy to any of the drugs to be used