cyrilzakka/clinical-trials huggingface dataset:
Phase 1 to Investigate Safety, Tolerability, PK/PK of J2H-1702 in Healthy Males

1. Research Purpose: To evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic properties of J2H-1702 (a candidate for treatment of non-alcoholic steatohepatitis) in healthy men.
2. Design: A dose block-randomized, double-blind, placebo controlled, single- and multiple dosing, dose-escalation phase 1 clinical trial

Subjects in all dose groups will be randomized to the study group (J2H-1702 group) and the control group (Placebo group) in a 8:2 ratio. Adverse event (AE) collection, physical examination, vital signs, ECG, clinical laboratory tests, etc. will be performed to assess the safety and tolerability, and blood and urine sampling will be performed to assess the PK/PD characteristics. In addition, blood sampling for mass cytometry (multiple administration study) and baseline fibroscan will be performed for the exploratory evaluation.

Eligibility Criteria:
Inclusion Criteria:

1. A healthy male adult within the range of 19 to 45 years old
2. BMI=18.0\~27.0kg/m2 (Body mass index, BMI)
3. A subject confirmed to be clinically healthy based on the medical history, physical examination, vitals signs, ECG, and appropriate clinical laboratory tests
4. A subject who his spouse or partner agrees to use dual contraceptive methods and not to donate sperms
5. A subject who has voluntarily agree to participate in the study

Exclusion Criteria:

1. A subject who had or has the disease corresponding to clinically significant liver, etc.
2. A subject with a history of gastrointestinal diseases or surgery
3. A subject who has a history of clinically significant hypersensitivity to drugs containing 11β-HSD1 inhibitor
4. A subject who has genetic problems such as galactose intolerance, Lap galactose intolerance, Lap lactase deficiencies, or glucose ∙galactose malabsorptivity, etc.
5. One who has drug abuse and one who is positive response in urine drug screening tests
6. A subject with abnormal vital signs at the screening visit
7. A subject who has participated in another clinical trial or bioequivalence test
8. A subject who donated whole blood or the ingredient, or received blood transfusion
9. A subject who took drug metabolizing enzyme-inducing and inhibitory drugs
10. A subject who consumes grapefruit/caffeine-containing food
11. A subject who took any prescription drug or herbal medicine or took any Over The Counter Drug (OTC)
12. High caffeine intaker, high alcohol intaker or excessive smoker
13. A subject who cannot eat meals provided by the Clinical Trial institution.
14. A subject who participated in this trial and were administered the investigational product.
15. A subject who is positive for serum test
16. A subject who the investigator deems inappropriate for this clinical trial.
The Impact of Improved Vagal Function on Periaqueductal Gray Connectivity

This study is being to see if participating in breathing exercise training and practicing this training will help with Postural tachycardia syndrome (POTS). The information may help doctors to learn more about how the different parts of people's brains communicate.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-50 years
* Diagnosis of POTS, orthostatic intolerance (with or without syncope), syncope, or near-syncope
* Can speak and read in English
* Upcoming new patient VCU Comprehensive Autonomics Center clinic visit scheduled at least 1 week in the future

Exclusion Criteria:

* Inflammatory arthritis, connective tissue or auto-immune disorder
* Any chronic neurological disorder besides POTS, orthostatic intolerance (with or without syncope), syncope, or near-syncope
* Patients who have already had a new patient clinic visit where they were exposed to breathing exercise education
* Evidence of unstable medical disorder, such as kidney (rising creatinine, or end-stage renal failure) or liver impairment (rising AST or ALT, or end-stage with coagulopathy), poorly controlled significant cardiovascular (CHF), respiratory, endocrine (diabetes - A1c \> 9 - or untreated thyroid dysfunction) or uncontrolled psychiatric illness (such as untreated depression, psychosis, etc.)
* Neuropathy, central nervous system disorder (e.g., Cerebral palsy, developmental delay, seizure disorder, MS, stroke, etc.)
* Treatment with a drug or medical device within the previous 30 days that has not received regulatory approval
* Use of hormones (except insulin, thyroid replacement or oral contraceptives, which will be carefully documented)
* Current substance or alcohol abuse
* Any major surgical intervention with general anesthesia in the last 60 days and minor procedure, such as tooth extraction, endoscopy, etc., with local or conscious sedation within 7 days
* Any on-going or pending medical, health or disability related litigation, or current pursuit of disability
* Any condition that in the judgment of the investigator would interfere with the patient's ability to provide informed consent, comply with study instructions, place the patient at increased risk, or which would clearly confound the interpretation of the study results (specific reason will be documented)
* Chronic use of narcotics for pain
* Claustrophobia or any metal hardware that may interfere with MRI
* Investigators and study staff
Feasibility of Evaluating Gene Alteration Analysis Using Samples Obtained by EBUS-TBNA in Patients With Lung Cancer

Lung cancer is the leading cause of death in the world. Overall 5-year survival rate is fewer than 10% and the effectiveness of conventional chemotherapy is limited. The new knowledge shows the correlation between genetic alteration and effective of chemotherapy. Therefore non-surgical modalities to obtain tumor specimens for genetic alteration analysis are particularly critical in lung cancer, since many patients have advanced disease at the time of first presentation, and are therefore not eligible for radical surgery. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) samples obtained during diagnosis of lung cancer can be used for molecular analysis that will predict response to treatment and prognosis. In this study, we will detect specific target molecules related to the effectiveness of treatment (surgery, chemotherapy, radiotherapy) and prognosis in patients with lung cancer using EBUS-TBNA samples and its combined with xenograft technology.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Patients with confirmed or suspected lung cancer who require EBUS-TBNA as part of their staging investigations of the mediastinum will be considered for the trial.
* Patients with undiagnosed enlarged lymph nodes in the mediastinum suspicious for lung cancer in which a tissue diagnosis is required.

Exclusion Criteria:

* Patients who are deemed on clinical grounds not to be medically fit for a bronchoscopy.
* Patients where there is a high clinical suspicion of lymphoma.
Powered Assist to Improve Ambulation in Severe Lung Disease

Chronic respiratory disease (CRD) is among the most prevalent and growing diseases worldwide with disabling consequences. Many with a compromised respiratory system cannot support the metabolic energy demands of walking causing them to walk slowly and stop often. Those with CRD could receive substantial benefit from a powered wearable exoskeleton device that assumes part of the energy of walking. Assisting the legs will lower the metabolic energy demands, and therefore the ventilation required for exercise, thereby allowing them to walk faster and further. Proposed is a series of single-case experiments comparing walking endurance with and without a powered exoskeleton assist. The aim of this study is to determine the efficacy of an exoskeleton on walking endurance in ventilatory limited patients with CRD. An exoskeleton could be a novel immediate and long term strategy to augment walking as part of the spectrum of pulmonary rehabilitation and community reintegration.


Eligibility Criteria:
Inclusion Criteria:

* stable chronic respiratory disease
* modified medical research council dyspnoea score (mMRC) ≥ 2

Exclusion Criteria:

* evidence of cardiac rhythm or circulatory compromise
* myocardial infarct within the previous three months
* moderate-severe aortic stenosis
* uncontrolled hypertension
* sustained cardiac arrhythmias
* untreated neoplasia
* lung surgery within the previous three months
* any other predominant co-morbidities or treatments that might influence walk testing
* body size outside of exoskeleton fit specifications
* skin sores or skin breakdown in the area where the device is worn
* a high risk of fracture
A Study of LY900014 in a Medtronic Pump

The purpose of this study is to compare the study drug LY900014 to insulin lispro (Humalog) when both are delivered by the Medtronic MiniMed 670G System in adults with type 1 diabetes (T1D). The study will consist of two treatment periods of 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have been diagnosed with type 1 diabetes and have been using insulin continuously for at least 12 months
* Participants must be using an insulin pump with "rapid-acting insulin" for at least 6 months and the same "rapid acting insulin" for at least the past 30 days
* Participants must have hemoglobin A1c (HbA1c) values ≥6.0% and ≤8.0%
* Participants must have been using the MiniMed 670G insulin pump for at least the past 90 days
* Participants must use their Guardian (3) sensor at least an average of 75% of the time and remain in Auto Mode an average of 70% of the time

Exclusion Criteria:

* Participants must not have had more than 1 emergency treatment for very low blood glucose or any hospitalizations for poor glucose control (very high blood sugar or diabetic ketoacidosis) in the last 6 months
* Participants must not have significant abnormal accumulation of fat, loss of fat tissue, or scars just under the skin in areas of infusion or have a history of an infection at an infusion site within 90 days prior to screening
* Participants must not have a total daily insulin dose \>100 units
* Participants must not be receiving any oral or injectable medication intended for the treatment of diabetes other than rapid-acting analog insulin via CSII in the 30 days prior to screening
* Participants must not have major problems with their heart, kidneys, liver, or have a blood disorder
Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using Shapematch Cutting Guides:Sub-Study A

This is a prospective, non-randomized, study of the clinical outcomes of participants that receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using ShapeMatch® Cutting Guides.

This is a prospective, non-randomized, study of the clinical outcomes of participants that receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using ShapeMatch® Cutting Guides. Sub-study A aims to quantify the reproducibility of intra-operatively positioning the cutting guides onto the affected femoral and tibial joint surfaces.

Eligibility Criteria:
Inclusion Criteria:

* The patient is a male or non-pregnant female between the ages of 50-90.
* The patient requires a primary total knee replacement and is indicated for computer-assisted surgery.
* The patient has a primary diagnosis of osteoarthritis (OA).
* The patient has intact collateral ligaments.
* The patient is able to undergo MRI scanning of the affected limb.
* The patient has signed the study specific, HREC-approved, Informed Consent document.
* The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.

Exclusion Criteria:

* The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint.
* The patient has had a high tibial osteotomy or femoral osteotomy.
* The patient is morbidly obese (BMI ≥ 40).
* The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
* The patient has a varus/valgus malalignment ≥ 15° (relative to mechanical axis).
* The patient has a fixed flexion deformity ≥ 15°.
* The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
* The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
* The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
* The patient has a cognitive impairment, an intellectual disability or a mental illness.
* The patient is pregnant.
* The patient has metal hardware present in the region of the hip, knee or ankle (as this is known to create geometrical distortion in the region of the implant).
* The patient has any known contraindications for undergoing assessment by MRI (e.g. ferrous implants, metallic clips, magnetically activated implanted devices such as cardiac pacemakers, etc).
Investigation of the Relationship Between Pelvic Floor Awareness and Urinary Incontinence

There is no study in the literature examining the knowledge level and urinary symptoms of active athletes about the pelvic floor. The aim of this study is to determine the relationship between PTC awareness and incontinence in young athletes who engage in long-term and high-intensity activities that increase the risk of SUI.


Eligibility Criteria:
Inclusion Criteria:

18-25 years old Young athletes

Exclusion Criteria:

Having a neurological disorders
The Status Quo of Diagnosis and Treatment of Pediatric Outpatients With Respiratory Diseases

A cross-sectional study is expected to conducted by inquiring about the history, diagnosis results and medication details of respiratory diseases of the outpatient pediatric patients with respiratory diseases in the pediatric departments at specialist children's hospital at the second class and above, general hospitals and maternal and child healthcare hospitals. About 10,000 electronic questionnaires are expected to be collected in total, with about 100 participating hospitals and 100 electronic questionnaires from each participating hospital.Diagnosis and treatment information of pediatric patients are expected to be collected in the third week in April, July and October 2021 and in January 2022.

Respiratory diseases are easy-to-transmit among and are common in children, especially acute respiratory infections in children which contribute to more than 60% of pediatric outpatient cases. In pediatric internal medicine outpatient cases, trachitis/bronchitis, acute upper respiratory tract infection, pneumonia, acute tonsillitis and asthma are the most common diseases torturing pediatric patients.

Children are prone to recurrent respiratory infections which may impose heavy burdens on their families. Ten million children under 5 years old are killed by recurrent respiratory infections every year. In China, daily outpatient visits of children with recurrent upper respiratory tract infections account for 10%-20% of the total daily outpatient visits for respiratory diseases. The outpatient medication for pediatric patients is found of non-compliance issues. According to the data in 2014, more than 33.8% of pediatric patients of all ages were given off-label medication, and more than 30% were given off-label medication in treatment.

The trial will be completed in 1 years with 10,000 participants taken from hospitals in partnership with clinical research collaboration of National Clinical Research Center for Respiratory Diseases, China, and analyze the status quo of diagnosis results and medication details of respiratory diseases of the outpatient pediatric patients with respiratory diseases in China.

Eligibility Criteria:
Inclusion Criteria:

* All children participating in this clinical study must meet all of the following criteria.

  1. age: 0-14 years old, male and female;
  2. accord with diagnostic criteria of respiratory diseases
  3. Agreed to informed consent

Exclusion Criteria:

* All children with any of the following conditions must be excluded from this study:

  1. children who visit hospital duo to discharge of hospital
  2. Children who visit hospital beyond 2 times in 7 days.
Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment

Up to 10 subjects will be enrolled. All subjects will receive an increased density UltherapyTM treatment at dual depth. Treatments will be provided to the lower 2/3 of the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.

This is a prospective, single-site, non-randomized clinical trial efficacy of an additional Ultherapy™ treatment for subjects who were minimal or non-responders at Day 90 in a previous Ulthera clinical trial. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 30 to 65 years.
* Subject in good health.
* BMI \< 30.
* Skin laxity in the submental area as demonstrated by a grade II or III on the Knize scale for classification of cosmetic deformity of the cervicomental angle
* Previous participation in ULT-107, and adequate compliance with all treatment and follow-up visits. Groups (surgery or surgery naïve) will be designated based on group assigned in ULT-107).
* Have not had any concomitant surgical or skin tightening procedures since their Ultherapy™ treatment with ULT-107.

Exclusion Criteria:

* Pregnant, lactating, or are planning to become pregnant, and/or not using a reliable form of birth control.
* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Excessive subcutaneous fat on the cheeks.
* Excessive skin laxity on the lower face and neck
* Significant scarring in areas to be treated.
* Open wounds or lesions in the area to be treated.
* Severe or cystic acne on the area to be treated
Endocrine Regulation of Lipolysis in Obesity and Diabetes

Adipose tissue (AT) dysfunction is a commonly observed feature of metabolic dysfunction in obesity and diabetes. An important characteristic when examining AT function is the capacity to break down stored lipids (i.e. lipolysis) and its regulation. In the present study, the aim was to investigate whether atrial natriuretic peptide-mediated lipolysis is altered in different adipose tissue depots (subcutaneous and visceral adipose tissue) of obese subjects with or without type 2 diabetes, compared to age-matched lean men. Eventually, the knowledge gained from this research will contribute to a better understanding of the present adipose tissue dysfunction and to the optimization of exercise programs for people with obesity and diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Lean group: BMI \< 25 kg/m², insulin sensitive (HOMA-Insuline Resistance (IR) \< 2.3), age 40-65
* Obese groups: BMI \> 30 kg/m², presence or absence of type 2 diabetes based on use of glucose lowering medication or HbA1c \> 6.5%, age 40-65

Exclusion Criteria:

* presence of a history of heart, lung or kidney disease and/or presence of endocrine anomalies. Use of beta-blockade medication.
Measurement of Spinal Kinematics During Various Movements

Participants will perform movements while receiving different visual cues. Spinal kinematics will be measured during these movements and compared between asymptomatic and CLBP participants. Participants will come for a unique session.


Eligibility Criteria:
Inclusion Criteria:

- sufficient French level to understand the instructions for the tests, the information sheet, the consent form.

For CLBP patients:

- diagnosis of non-specific low back pain (pain from lower ribs to gluteal folds) for more than 3 months.

For asymptomatic participants:

* no history of LBP requiring medical attention during the last two years
* no other concomitant pain or condition that could compromise the evaluation of lumbar kinematics.

Exclusion Criteria:

* pregnancy
* skin allergy to tape
* body mass index (BMI) above 32

For patients with CLBP only:

* specific low back pain (such as the presence of infection, rheumatological or neurological diseases, spinal fractures, tumours)
* any known important spinal deformities
* previous back surgery that limits spinal mobility
* high level of pain at the time of experiment that prevents repeated movements (severity and irritability)
* other concomitant pain or condition that could compromise the evaluation of spinal kinematics.
Hypertension in Young Adults Trial

This is a pilot randomized controlled trial which will test the effect of 3 different anti-hypertensive agents and 3 different strategies of engaging young adults in home blood pressure monitoring on blood pressure control, with secondary outcomes focused on quality of life and adverse events.


Eligibility Criteria:
Inclusion Criteria:

* 18-40 years of age
* Diagnosis of hypertension or receiving anti-hypertensive therapy OR Has clinical BP readings \>130/80 mmHg that would meet the definition of hypertension and have home BP readings \>=125/80 mmHg

Exclusion Criteria:

* are or are planning to become pregnant, due to inability to take multiple classes of anti- hypertensive agents
* are marginally housed, due to concerns regarding routine follow-up
* are actively participating in a different interventional trial that may affect blood pressure
* are unwilling to consent to participate
* institutionalized individuals or prisoners
* are actively abusing illicit drugs or alcohol
* have a history of poor or doubtful compliance (e.g., frequently missed appointments)
* have cognitive impairment prohibiting participation in the study
* History of allergy to any of the randomized medications
* Serum potassium \>5.5 meq/L at the screening visit
* BP \> 160/100 mmHg in clinic (stage II hypertension), regardless of whether patient is on therapy
* eGFR \< 30 mL/min/1.73 m2
Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke

This study will allow determination of the pharmacokinetic and pharmacodynamics of SB424323 in a relevant population. The data from this study will be used along with other data to aid in choosing the most appropriate dose for the later phase study.

A randomized, double blind, double dummy, parallel group, placebo controlled study to evaluate the pharmacodynamic and pharmacokinetic response and safety and tolerability of SB424323 (250 mg, 375 mg and 500 mg) administered twice daily for 16 weeks, on top of aspirin (325 mg, qd) in men and women with non valvular atrial fibrillation at a low or intermediate risk for stroke

Eligibility Criteria:
Inclusion Criteria:

* Patients with non valvular atrial fibrillation and any of the following:
* \</= 60 years old with no heart disease.
* 60 years old with heart disease but no risk factors.
* \>/=60 years old and \</=75 years old with no risk factors and no heart disease.
* Must be able to take aspirin.

Exclusion Criteria:

* Previous heart attack or stroke.
* History of high blood pressure, diabetes or a prior blood clot.
* Liver or kidney disease.
* Need for anti-thrombotic or anti-platelet drugs.
* Need for cardiovascular medicines.