cyrilzakka/clinical-trials huggingface dataset:
A Study to Find Out How Much Mirabegron Gets Into the Body After Dosing With a Tablet Formulation

A study to evaluate how much of the active compound of mirabegron comes into the blood circulation when given as a controlled-release pill as compared to given intravenously.

All participants will receive both oral and iv formulations, separated by a washout period. Treatment arm A will receive a lower dose of mirabegron; Treatment arm B will receive a higher dose of mirabegron.

Eligibility Criteria:
Inclusion Criteria:

* Body weight between 60.0 and 100.0 kg and Body Mass Index between 18.0 and 30.0 kg/m2

Exclusion Criteria:

* Known or suspected hypersensitivity to β-adrenergic receptor agonists or constituents of the formulations used
* Clinically significant elevation of serum creatinine or liver enzymes as evidenced by creatinine \>150 ųmol/L; ASAT, ALAT or LDH\> 2x ULN; ɣ-GT \> 3x ULN and/or abnormal serum bilirubin
* Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug
* Subjects taking β blockers or β agonists (eye drops allowed)
* Any clinically significant history of upper gastrointestinal symptoms (such as nausea, vomiting, abdominal discomfort or upset, or heartburn) in the 4 weeks prior to the first admission to the Research Unit
* Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, ophthalmologic, renal, hepatic, neurological, dermatological, psychiatric or metabolic
* Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests
* QTcB interval of \> 430 (mean QTcB of two measurements \> 430msec)
* Abnormal pulse rate measurement (\<40 or \>90 bpm) at the pre-study visit after subject has been resting in supine position for 5 min.
* Abnormal blood pressure measurements taken at the pre-study visit after subject has been resting in supine position for 5 min as follows:

  * Systolic blood pressure \<95 or \>160 mmHg
  * Diastolic blood pressure \<40 or \>90 mmHg
* Positive orthostatic test at screening i.e. any symptoms of dizziness, light-headedness etc. and a fall of \> 20 mmHg in systolic blood pressure after 2 min standing and an increase in pulse rate of ≥ 20 bpm
* Regular use of any prescribed or OTC drugs except paracetamol up to 3 g/day, in the 4 weeks prior to admission to the Research Unit OR any use of such drugs in the 2 weeks prior to first admission to the Research Unit
Evaluation of NanoDoce® in Participants With Urothelial Carcinoma

This is a clinical trial studying the administration of NanoDoce as a direct injection to the bladder wall immediately after tumor resection and as an intravesical instillation. All participants will receive NanoDoce, and will be evaluated for safety and tolerability, as well as the potential effects of NanoDoce on urothelial carcinoma.

In this clinical trial, subjects with high-risk non-muscle invasive bladder cancer (NMIBC) or muscle invasive bladder cancer (MIBC), will receive NanoDoce. Subjects will be stratified into two treatment groups, Group 1 (NMIBC) and Group 2 (MIBC). All subjects will receive NanoDoce injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT), followed by an initial NanoDoce intravesical instillation.

Once the TURBT resection site is healed (approximately 1 month), Group 1 (NMIBC) subjects will proceed to a 3-month Induction period (6 weekly NanoDoce intravesical instillations, followed by 6 weeks of rest). After the Induction period, following confirmation of non-recurrence, Group 1 subjects will proceed to a 3-month Maintenance period (3 weekly NanoDoce intravesical instillations, followed by 9 weeks of rest).

After NanoDoce direct injection and the initial intravesical instillation, Group 2 subjects will proceed to institutional standard of care and will not receive Induction or Maintenance intravesical instillations.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent;
* Age ≥18 years;
* Patients with either:

  * High-risk Non-Muscle Invasive Bladder Cancer (NMIBC);
  * Muscle Invasive Bladder Cancer (MIBC);
* Urothelial carcinoma confirmed by biopsy, urine cytology, computed tomography scan (CT) or other institution-approved diagnostic methodology;
* All visible tumors removed during bladder resection (TURBT);
* Performance Status (ECOG) 0-2 at study entry;
* Life expectancy of at least 6 months;
* Adequate marrow, liver, and renal function;

  * ANC ≥ 1.5 x 10\^9/L;
  * Hemoglobin ≥ 9.5 grams/dL;
  * Platelets ≥ 75 x 10\^9/L;
  * Total bilirubin ≤ 1.5x institutional ULN;
  * AST/ ALT ≤ 2.5x institutional ULN;
  * Creatinine ≤ 1.5x institutional ULN;
* Adequate method of birth control.

Exclusion Criteria:

* Metastatic disease;
* Previous (within 12 months) or concurrent history of non-bladder malignancy, except for non-melanoma skin cancer;
* Intravesical therapy within 6 weeks prior to consent (chemotherapy or immunotherapy including BCG administered directly into the bladder);
* Resection surface area greater than 8 cm2;
* Upper tract and urethral disease within 18 months;
* Known hypersensitivity to any of the study drug components or reconstitution components;
* Pregnant or breastfeeding;
* Participation in the treatment phase of another clinical trial within 3 months prior to consent;
* Investigator's opinion of subject's probable noncompliance or inability to understand the trial and/or give adequate informed consent;
* Ongoing drug or alcohol abuse.
Shanghai Community Prediabetes Standardized Management Project

Participants with prediabetes is the key targets for diabetes prevention. So, in order to further strengthen and standardize the management of participants with prediabetes in the communities, the investigators start this project of standardized management of participants with prediabetes in communities of Shanghai. Explore the standardized management model for prediabetes participants within primary healthcare settings in Shanghai, to reduce the risk factors of diabetes, improve the blood glucose control, and the quality of life of participants with prediabetes.

Participants with prediabetes is the key targets for diabetes prevention. So, in order to further strengthen and standardize the management of participants with prediabetes in the communities, the investigators start this project of standardized management of participants with prediabetes in communities of Shanghai. Explore the standardized management model for prediabetes participants within primary healthcare settings in Shanghai, to reduce the risk factors of diabetes, improve the blood glucose control, and the quality of life of participants with prediabetes.

Through the collaboration the Shanghai Municipal Center for Disease Control \& Prevention network, this investigators will implement prediabetes screening and lifestyle intervention in around 50 community health service centers in Shanghai. Life-style interventions including exercise and diet, and diabetes prevention knowledge will be integrated into "train-the-trainers" workshops. Trainings will be provided to community health service staff and peer supporters or social workers.

Eligibility Criteria:
Inclusion Criteria:

* Chinese residents
* Adult age ≥ 18 years old, 35-75 years old preferred
* Participants receiving prediabetes management of the basic public health services package in community health centers
* BMI≥24 kg/m2 or central obesity (Waist circumference≥90 cm in males，Waist circumference≥85 cm in females) or Hypertension (SBP≥140 mmHg and/or DBP≥90 mmHg) preferred
* Signed informed consents and willing to participate

Exclusion Criteria:

* With serious chronic diseases, tumors, acute and chronic infectious diseases, limb movement disorders, and any mental illnesses
* Women during pregnancy or breastfeeding
* With excessive drinking or illicit drug use
* Unwilling to participate in the project
* Histories of severe cardiovascular events (myocardial infarction, stroke, acute coronary syndrome, or transient ischemic attack (TIA))
Preoperative Exercise Test and Postoperative Intensive Care Unit Need in Bariatric Surgery

The aim of our study is to evaluate the efficacy of "60 meters 60 seconds exercise test" (a test designed by the study group) done preoperatively as a predictor test for postoperative intensive care unit need and extubation success in patients undergoing bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

patients between 18-60 years old patients with BMI \> 40 patients undergoing Laparoscopic Sleeve Gastrectomy

Exclusion Criteria:

patients with Chronic obstructive pulmonary disease (COPD) or Asthma, patients with uncompensated heart failure Patients Who have orthopedic problems that effects the exercise test (such as gonarthrosis)
Incidence of Malignant Peripheral Nerve Sheath Tumor (MPNST) Development in Participants With Neurofibromatosis Type 1 (NF1) Receiving and Not Receiving Medical Therapies Directed at Plexiform Neurofibromas (PN)

Background:

NF1 is a genetic syndrome. Tumors appear early in life. Many people with NF1 develop PN. These tumors can become an aggressive cancer called MPNST. People with MPNST may benefit from treatment with a MEK inhibitor (MEKi). Researchers want to learn if there is an increased risk of MPNST formation from MEKi treatment in people with NF1. To do this, they will review data that has been collected in NIH NF1 studies.

Objective:

To describe the characteristics of people who have taken part in NF1 studies at NIH and to compare the risk of MPNST formation in those treated with MEKi or other PN-directed treatment.

Eligibility:

People with NF1 who were seen at NIH from Jan. 1, 1998, to Jan. 1, 2020.

Design:

Participants medical records will be reviewed. Participants who opted out of future use of their data will not be included.

Demographic data, like sex, race, and date of birth, will be collected.

Data about MEKi and non-MEKi treatments will be collected.

Clinical data, such as surgery and treatment details, will be collected.

The differences between all participants who were seen at NIH for any NF1 related study will be compared. Participants will be put into 4 groups:

History of MEKi therapy

Treatment with tumor directed therapy other than MEKi

Treatment with both MEKi and non-MEKi tumor directed therapies

No tumor directed medical therapy

Participants with NF1 who were treated for PN with either a MEKi treatment or a non-MEKi treatment will also be compared.

The study will last for 3 to 6 months.

Study Description: This is a retrospective review that includes all patients with NF1 enrolled on natural history and treatment trials at the National Cancer Institute (NCI) from 1/1/1998 to 1/1/2020, excluding patients referred for treatment of MPNST.

Objective: To describe the clinical and demographic characteristics of NF1 study participants who come for evaluation at the NCI and to compare the risk of MPNST formation in patients treated with MEK 1/2 inhibitor (MEKi) or other PN-directed treatment.

Study Population: All participants with NF1 seen at the NIH from 1/1/1998 to 1/1/2020

Description of Sites/Facilities conducting research: This is a single site study initiated by the Pediatric Oncology Branch at the National Cancer Institute

Study Duration: Data abstraction to completion of data analyses will take 3-6 months.

Eligibility Criteria:
* Inclusion Criteria:
* All participants seen at the NIH from 1/1/1998 to 1/1/2020 with a clinical or laboratory diagnosis of NF1
* Participants beyond the neonatal period (4 weeks).

Exclusion Criteria:

-All participants seen at the NIH from 1/1/1998 to 1/1/2020 with a clinical or laboratory diagnosis of NF1 who opted out of future use.
A Study of Markers of Glucocorticoid Effects in Patients With Addisons Disease (DOSCORT)

DOSCORT is a 2-dose, cross-over study primarily aiming to identify and validate novel biological markers (biomarkers) of glucocorticoid effect in the human body. Patients with Addison´s disease, primary adrenal insufficiency, with life-long glucocorticoid replacement therapy will undergo 2 treatment periods where their usual hydrocortisone treatment will be replaced with betamethasone in physiological and supra physiological doses. Blood, saliva, urine, health related Quality-of-life self-assessment forms, measurements of physical activity and sleep quality will be collected from both treatment periods.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females at ages 20-65 years
2. Previously diagnosed (e.g. more than 12 months ago) with primary adrenal insufficiency due to autoimmune adrenalitis, i.e. Addison´s disease
3. A stable daily glucocorticoid replacement dose for at least 3 months prior to study entry
4. An oral glucocorticoid replacement dose of 15-30 mg Hydrocortisone total daily dose
5. If needed, a stable fludrocortisone replacement dose for at least 3 months prior to study entry
6. Body mass index (BMI) of 20-35 kg/m2
7. Ability to comply to the protocol procedures and having signed informed consent to participate in the study

Exclusion Criteria:

1. Clinical or laboratory signs of significant cerebral, cardiovascular, respiratory, hepaticobiliary/ pancreatic disease which in the investigators judgement may interfere with the study assessment of completion of the study
2. Clinically significant renal dysfunction with a serum creatinine above 150 mmol/L
3. Pregnant or lactating women
4. Diabetes Mellitus
5. Systemic infections
6. Regular dehydroepiandrosterone (DHEA) medication for the past 4 weeks
7. Any medication with agents which in the investigators judgement might interfere with the study drugs kinetics, including therapies affecting gastro intestinal emptying or motility
8. Alcohol/drug abuse or any other condition associated with poor patient compliance, including expected non-cooperation, as judged by the investigator
9. Hypersensitivity to the active substance or any excipients used in the study drug of choice
10. Any additional underlying disease that may need regular or periodic pharmacological treatment with glucocorticoids during the trail, such as asthma, skin- or eye conditions treated with inhaled or topical glucocorticoids
11. Any additional underlying condition that needs treatment with intramuscular or intra-articular steroid injections during the trial
Optimization and Harmonization of Advanced MRI Sequences

Development of a shared multimodal MRI protocol for the definition and quantification of imaging biomarkers in AD, DLB, FDT dementias, especially white matter alterations.

Development of a shared multimodal MRI protocol for the definition and quantification of imaging biomarkers in AD, DLB, FDT dementias, especially white matter alterations.

Eligibility Criteria:
Inclusion Criteria:

for patients

* accident cases
* time of onset of NOT MORE THAN 24 months
* Clinical Dementia Rating Scale (CDR) \<=2;
* MoCA\<=17

for controls absence of complaints of cognitive disorders and/or neurological/neuropsychological visits for the evaluation of such disorders;

* CDR = 0;
* MoCA\>=27. for all Age \>= 50 and \<= 80;
* Hachinski Ischemic Scale - 7 items \< 2;
* visual and/or auditory acuity sufficient to carry out the neuropsychological assessment;
* if on neuropsychopharmacological therapy, stability for 4 weeks before the start of the study.

Exclusion Criteria:

for all

* any uncontrolled medical condition or neurological/neurodegenerative disease that, in the opinion of the recruiting physician, could contribute to the individual's cognitive impairment \[e.g., kidney disease, liver disease, brain tumor, alcohol or drug abuse, abnormal thyroid function, hydrocephalus normotensive, vascular dementia, neurocognitive disorder due to head trauma (according to the diagnostic criteria of the DSM V)\];
* transient ischemic attack or stroke during the 12 months preceding screening; history of unstable angina, myocardial infarction, heart failure (New York Heart Association Class III or IV), or clinically significant heart rhythm disturbances documented within one year of screening;
* history of malignant tumor disease, except: cancer in remission for more than 5 years since screening; prostate cancer in situ;
* history of surgically treated squamous cell carcinoma or basal cell carcinoma;
* impaired liver function or liver failure;
* history or evidence of autoimmune disease considered clinically significant by the doctor or requiring the chronic use of corticosteroids or other immunosuppressive drugs;
* clinically significant systemic illness or infection within 30 days of screening; comorbidity for primary psychiatric or neurological disorders;
* absence of an informant (partner, relative, adult child or friend) who knows the subject well enough to be able to provide reliable information on his cognitive and functional abilities.
* contraindication to carrying out the MRI exam.
Intralipid for Repeated Implantation Failure

Intralipid infusion can improve outcome in women with recurrent Intracytoplasmic sperm injection ( ICSI) failure due to elevated TH1 cytokine response.

Infertile patients undergoing Intracytoplasmic Sperm Injection (ICSI) cycle with history of repeated implantation failure, intralipid will be given to the intervention group.

The primary outcome measure is the clinical pregnancy rate, secondary outcome measures implantation rate, ongoing pregnancy rate, abortion rate.

Eligibility Criteria:
Inclusion Criteria:

* Infertile patients undergoing ICSI cycle with history of repeated implantation failure

Exclusion Criteria:

1. Disturbances of normal fat metabolism such as pathologic hyperlipemia
2. Allergic to it; or to eggs, soybean oil, or safflower oil.
3. Severe liver disease, kidney disease, lung disease, anemia, blood clotting disorder.
4. Uterine fibroid, endometrial polyp, endometriosis and hydrosalpinx.
A Study to Evaluate the Safety and Tolerability of MK0217 in Women (0217-219)

This study is to assess the safety and tolerability of MK0217 being evaluated to treat women with postmenopausal osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Women with postmenopausal osteoporosis

Exclusion Criteria:

* High risk for fractures
* Esophageal abnormalities
* Upper gastrointestinal symptoms that are not relieved with medication
* Metabolic bone disease (example - vitamin D deficiency)
* Medications that would affect the breakdown or build-up of bone
Effect of Upper Eyelid Surgeries on Corneal Characteristics

The goal of this prospective observational study is to learn about the impact of conventional eyelid correction surgery on the eye's health and function in ptosis and eyelid retraction patient. The main questions it aims to answer are: •

1. Changes in corneal topography, higher-order corneal aberrations, corneal biomechanical characteristics, and corneal epithelial thickness before and after the surgery
2. Influence of corneal refraction examinations , vision change, and tear film function after the surgery

Fifty participants will undergo conventional eyelid correction surgery by the same ophthalmologist (YH Wei) and non-invasive examinations before and after the surgery. The patient will be separate to 2 groups, including 30 with correction for ptosis and 20 with correction for eyelid retraction. The research will collect information of the operated eye and fellow eye, and the data will be compared between operated and fellow eye and with the other group.

The position of the upper eyelid affects the health and function of the eye. Ptosis can obstruct the vision, and eyelid retraction can result in the loss of proper protection of the ocular surface. Through conventional upper eyelid correction surgery, the height of the upper eyelid can be adjusted to a proper position. However, after upper eyelid surgery, the pressure of the upper eyelid on the corneal surface may change, affecting corneal topography, higher-order corneal aberrations, corneal biomechanical characteristics, and corneal epithelial thickness. These changes may affect postoperative vision and visual quality. The impact of upper eyelid surgery on corneal refraction and corneal biomechanical characteristics remains inconclusive in current studies, and the impact on corneal epithelial thickness is even less investigated. This is a prospective observational study, expecting to enroll 50 patients who have undergone upper eyelid surgery, including 30 for ptosis correction and 20 for eyelid retraction correction. Non-invasive examinations will be used to assess changes in corneal topography, higher-order corneal aberrations, corneal biomechanical characteristics, and corneal epithelial thickness before and after the surgery to understand the impact of upper eyelid surgery on the ocular surface and the possible mechanism or influencing factors of postoperative vision changes.

Eligibility Criteria:
Inclusion Criteria:

Group 1:

* marginal reflex distance 1 (MRD1) ≦ 2-2.5 mm
* levator muscle function (LMF) ≧ 8 mm

Group 2:

* with upper scleral show

Exclusion Criteria:

* pregnancy
* previous corneal surgery
* with corneal scar
* pterygium
* keratoconus
* significant ocular surface disease
* wearing rigid contact lens
Assess Efficacy of Vardenafil 10mg in Erectile Dysfunction Within Intake of 6 Hours

Assess efficacy of vardenafil within 6 hours after intake


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years and older
* Males with erectile dysfunction
* Stable heterosexual relationship

Exclusion Criteria:

* Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
* Nitrate use
Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging

The goal of this pilot clinical study is to evaluate the feasibility of collecting Spatial Frequency Domain Imaging (SFDI) data in patients with circulatory compromise due to thermal burns using the FDA-cleared Clarifi Imaging System and the next generation handheld m-Clarifi. Accurate assessment of burn depth and assessment at the point of care is an essential input for clinicians to plan proper treatment and management. SFDI has been shown to be a promising method to evaluate burn depth and extent within 24 hours in pre-clinical studies. The two feasibility goals of this study are as follows: 1) Do the values obtained with a commercial SFDI system provide utility in assessing burn depth in a clinical setting? And 2) Do Clarifi and m-Clarifi provide equivalent data when assessing subjects with burn injuries (biomarker imaging values, clinical workflow).


Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years of age or older
2. Thermal burns of any depth (superficial, deep partial thickness, or full thickness).

Exclusion Criteria:

1. Patients less than 18 years of age
2. Pregnant or breastfeeding women