cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence Study of Budesonide Rectal Aerosol Foam and Uceris® Rectal Aerosol Foam

To evaluate the bioequivalence between the Test Product Budesonide rectal aerosol foam and Reference Product Uceris® rectal aerosol foam after a single-dose in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

1. Healthy, non-smoking, male and female subjects, 18 years of age or over.
2. No clinically significant findings in vital signs measurements or 12-lead electrocardiogram (ECG) or abnormal laboratory values.
3. Have no significant diseases.
4. Willing to use an acceptable, effective method of contraception.
5. Informed on the nature of the study and have agreed to and are able to read, review and sign all consent documents.
6. Have no clinically significant findings from a physical examination.

Exclusion Criteria:

1. Known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
2. Known history or presence of hypersensitivity or idiosyncratic reaction to budesonide, any other components of the drug products, or any other drug substances with similar activity or sodium phosphate
3. History or presence or of diabetes mellitus, glaucoma or cataracts, hypertension, or osteoporosis
4. History of drug or alcohol addiction requiring treatment.
5. History of malabsorption within the last year.
6. Presence of hepatic or renal dysfunction.
7. Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
8. Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
Prostate Cancer Genetic Risk Evaluation and Screening Study

This study aims to define the natural history of men at high genetic risk for prostate cancer on the basis of specific germline genetic mutations, family history, or Black/African ancestry and evaluate the utility of prostate MRI as a screening tool. The hypothesis is that this targeted population of men are at elevated risk of developing prostate cancer compared to the general population, and enhanced screening with MRI will enable early detection and diagnosis of potentially aggressive prostate cancer, characterization of the penetrance of specific mutations, and potentially identify new genetic risk mutations.

Prostate cancer is the most common malignancy and the second leading cause of cancer-related deaths in American men. Prostate cancer has substantial inherited predisposition and men harboring specific genetic variants or a positive family history have been associated with an increased risk of developing prostate cancer. Men with specific genetic variants, such as pathogenic BRCA2 mutations, are at particularly greater risk of developing aggressive forms of prostate cancer and thus warrant undergoing careful screening for prostate cancer. However, the penetrance of many mutations in prostate cancer risk genes is unknown, and some men have no identifiable mutations in known risk genes despite a strong family history of prostate cancer. Prospectively collected clinical data along with biospecimens from unaffected individuals at high genetic risk for developing prostate cancer will advance the understanding of how specific mutations contribute to the development of prostate cancer and how these prostate cancers might be best detected. The purpose of this study is to prospectively screen men at high risk genetic risk for prostate cancer by prostate exam, PSA, and prostate MRI to characterize the penetrance and cancer-related outcomes of specific mutations, identify potentially novel genetic risk mutations and/or markers for early detection.

Eligibility Criteria:
Inclusion Criteria:

* Men 35-74 years old
* No known diagnosis of prostate cancer
* Life expectancy \>10 years
* Meet cohort A, B, or C criteria
* Cohort A: Documented pathogenic or likely pathogenic germline genetic mutation in a prostate cancer risk gene from a CLIA-certified laboratory (ATM, ATR, BRCA1, BRCA2, BRIP1, CHEK2, EPCAM, FANCA, GEN1, HOXB13, MLH1, MSH2, MSH6, NBN, PALB2, PMS2, RAD51C, RAD51D, TP53)
* Cohort B: A strong family history suggestive of high genetic risk for prostate cancer with negative clinical genetic testing
* Cohort C: Individuals who self-identify as Black American or Black Caribbean with both parents and all four grandparents of Black/African ancestry

Exclusion Criteria:

* Prior diagnosis or treatment of prostate cancer
* Inability to undergo prostate MRI
* Inability to receive MRI contrast agent
DETERMINE: Detemir vs NPH

The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.

Insulin detemir has been used and is FDA approved for type 1 diabetes in pregnancy women and its safety has been well established. At this point, the only long or intermediate acting medication that is approved for type 2 diabetes or gestational diabetes is insulin NPH. The most serious side effect of insulin detemir is hypoglycemia but the rates of hypoglycemia are lower when comparted to NPH both during pregnancy and outside of pregnancy. Diabetes mellitus (DM) is the most common diagnosis in pregnancy and its incidence is continuing to increase. Recent epidemiologic reports place the risk of pre-gestational diabetes at 1-2% and gestational diabetes (GDM) at 12.5%. Risk factors for type 2 diabetes (T2DM) and GDM include obesity, hypertension, family history of diabetes, polycystic ovarian syndrome, or excessive weight gain in pregnancy. Suboptimal control of DM in pregnancy confers significant morbidity on both the mother and fetus, including increased risk of preeclampsia, preterm delivery, perineal lacerations, cesarean delivery, neonatal hypoglycemia, and NICU admissions.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria will include pregnant women with pre-existing T2DM and GDM who requiring insulin to manage their blood sugars in pregnancy.

Exclusion Criteria:

1. Multiple Gestation
2. Type 1 Diabetes mellatus
3. Age \< 18
4. Known or suspected hypersensitivity to NPH or insulin detemir
5. Known fetal major malformations
6. Chronic renal or hepatic insufficiency
7. Known to be HIV, Hepatitis B, or Hepatitis C positive
8. Indication for planned premature delivery (placenta accrete, or prior classical cesarean delivery)
9. Insulin dependent before conception
IL-2 for Multi Drug Resistant Nephrotic Syndrome

The aim of the study is to design an open-label phase 1-2 trial to assess safety and clinical and immunologic effects of repeated administration of recombinant low dose IL2 (Proleukin) in 5 patients with idiopathic nephrotic syndrome unresponsive to drugs (steroids, calcineurin inhibitors, Rituximab), following the therapeutical scheme indicated for crioglobulinemic nephropathy:

cycle1: IL2 1x106 /m2 s.c for 5 consecutive days cycle2: IL2 1.5 x106 / m2 s.c for 5 consecutive days, starting from 3 weeks after the first cycle.

cycle3: IL2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 6 weeks after the first cycle.

Cycle 4: IL2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 9 weeks after the first cycle.

Current therapy with steroids and calcineurin inhibitors (Prograf) will be maintained during the first cycle and progressively reduced during the subsequent cycles.

The first cycle will be performed during hospitalization in the investigators Unit; subsequent cycles will be performed at nephrology outpatients. All laboratory values normally utilized in the follow up of patients affected by idiopathic nephrotic syndrome will be evaluated during the first week of treatment and at the end of the protocol, together with specific cellular values (Tregs, B cells, NK).


Eligibility Criteria:
Inclusion Criteria:

* Drug resistance: persistence of proteinuria in nephrotic range after a cycle of steroids of at least 3 months and an association with cyclosporine/tacrolimus for at least other 6 months
* Parents'/guardian's written informed consent, and child's assent given before any study-related procedure not part of the subject's normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his or her future medical care.
* Age between 2 and 18 years
* Histological pattern of minimal change disease, mesangial proliferation with IgM deposits or focal segmental glomerulosclerosis

Exclusion Criteria:

* Positivity to autoimmunity tests (ANA, dsDNA, ANCA).
* Reduction of C3 levels.
* Hystological pattern characterized by elements suggestive for congenital disease: diffuse mesangial sclerosis without IgM deposits, cystic-like tubular dilatation, mitochondrial abnormalities evident on electron microscopy, IF suggestive for congenital collagen 4 disease.
* Histological pattern not suitable with INS in the pediatric age (membranous glomerulonephritis, lupus nephritis, diffuse and/or localized vasculitis, amyloidosis)
* Homozygous or heterozygous mutations of to the 3 genes (NPHS1, NPHS2, WT1) whose mutations are known to be responsible of almost 80% of familiar cases
Effectiveness of Facet Joint Infiltration in Low Back Pain

The purpose of this study is to evaluate the effectiveness of facet joint infiltration with corticosteroids in the treatment of low back pain due to facet joint osteoarthritis.

Sixty subjects with diagnostic of facet joint syndrome will be enrolled in the study.

They were randomized into experimental and control groups. The experimental group will be submitted to intra-articular infiltration of six facet joints. The control group will be submitted to intramuscular injection of six lumbar paravertebral points. After the randomization, all subjects will be assessed by an investigator blinded to the groups. The assessment will be taken just before the interventions (T0) and them 7 , 30 , 90 and 180 days after the interventions. The following assessment instruments will be used: pain visual analogical scale (VAS) (0-10cm), pain visual analogical scale during extension of the spine (VAS E) (0-10cm), Likert scale for improving (0-5), percentage scale of subjective improving perception(0-100%), Rolland-Morris questionnaire (0-24), short health survey questionnaire (SF36), accountability of medications taken for back pain: analgesics and non-steroidal antiinflammatories (NSAIDs).

Eligibility Criteria:
Inclusion Criteria:

* low back pain up to 3 months
* pain on back extension
* radiologic findings of facet joint osteoarthritis

Exclusion Criteria:

* other causes of back pain
* fibromyalgia
* diabetes, arterial hypertension or glaucoma not well controlled
* patients with contrast allergy
A Study to Determine the Role of Physician Gestalt in Predicting COVID-19 in Patients

THIS IS A PROSPECTIVE OBSERVATIONAL STUDY TO DETERMINE THE ROLE OF PHYSICIAN GESTALT IN CLINICAL PREDICTION OF COVID 19.

Among patients attending the Emergency Department, prompt identification of possible cases of COVID 19 is important to avoid the spread. An immediate clinical diagnosis is important for point of care decision making on choice of treatment facility as well as for triaging, testing and to quarantine patients admitted to the hospital from emergency room. Hence this study attempts to find out the role of physician gestalt in early diagnosis and differentiation of COVID 19.

Eligibility Criteria:
Inclusion Criteria:

* All patients presenting to ED, who undergo COVID 19 specific testing.

Exclusion Criteria:

* Patients with active COVID 19 disease diagnosed outside All brought dead cases. All patients not consenting to take part in the study.
The Degree of Accuracy of Patient-specific PEEK Implant to Restore Chin Deficiency

computer guided patient-specific PEEK implant will be used to augment patients with chin deficiency or chin asymmetry.

augmentation genioplasty will be done to patients with chin deficiency or asymmetry. using cone beam CT for each patient and special soft ware "MIMICS 15" , patient-specific implant design can be done. PEEK will be milled as CAD-CAM technique to finally get patient specific PEEK implant. with patient is under General anesthesia, the implant will inserted and fixed with titanium screws. closure in two layers will be done.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female patients.
* Patients with retruded chin or with chin asymmetry.
* Patients with good oral hygiene.

Exclusion Criteria:

* Patients that need skeletal procedure in the mandible, other than genioplasty, at the same time of surgery or was done within time period less than 6 months.
* Patients with medical condition that may compromise the healing process.
* Patients with medical condition that is contraindicated for general anaesthesia.
* Presence of pathological lesion related to chin area.
Labor and Delivery Implant Insertion: A Randomized Controlled Trial

A barrier to initiating progestin contraceptives in the early postpartum period is the concern of interference with breastfeeding, specifically lactogenesis. In this trial, the investigators aim to describe the effects of immediate insertion of the contraceptive implant on breastfeeding. The investigators seek to examine the time to lactogenesis with immediate post-delivery insertion in delivery room versus insertion of a contraceptive implant in the postpartum ward prior to medical discharge. For this study, 82 consenting women will be randomized to immediate implant insertion (0-2 hours following delivery) in the delivery room or insertion of the implant following delivery in postpartum room and prior to medical discharge (24-48 hours following delivery).

Participants complete a questionnaire that asks questions about breastfeeding continuation, supplementation, duration, and exclusivity. This questionnaire also includes questions about contraceptive continuation, patient satisfaction with implant, pregnancy, and postpartum care visits.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who are patients of the Stanford University Obstetrics service
* Pregnant women who delivery a healthy infant, regardless of gestational age.
* Intend to breastfeed
* Desire the contraceptive implant as their method of contraception
* Agree to be randomized to delivery room vs. postpartum ward insertion

Exclusion Criteria:

* Not English or Spanish speaking
* Allergy or Contraindication to contraceptive implant.
GALLANT 8 Tesaglitazar Add-on to Metformin

This is a 24-week randomized double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 mg and 1 mg) given as add-on therapy to metformin in patients with type 2 diabetes, not adequately controlled on optimized metformin treatment and on diet/lifestyle advice during the titration and run-in period. The study comprises a 2-week enrollment period, 6 week placebo metformin titration period, 2-week single-blind run-in period, followed by a 24-week double blind treatment period and a 3-week follow-up period


Eligibility Criteria:
Inclusion Criteria:

* Provision of a written informed consent
* Men or women who are \>=18 years of age
* Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
* Diagnosed with type 2 diabetes
* Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents

Exclusion Criteria:

* Type 1 diabetes
* New York Heart Association heart failure Class III or IV
* Treatment with chronic insulin
* History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
* History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
* Creatinine levels above twice the normal range
* Creatine kinase above 3 times the upper limit of normal
* Received any investigational product in other clinical studies within 12 weeks
* Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
The Efficacy and Safety Study of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines

This study will be conducted in Phase Ⅲ clinical trials. In Phase Ⅲ, subjects with moderate to severe glabellar lines are enrolled and those who are judged to be eligible for this study will be injected with the "PROTOXIN" at a total of 20U(4U/0.1mL each) in five sites of the glabellar lines. The investigational product is administered once, maintaining double-blind for a total of 16 weeks of observation. Thereafter, efficacy and safety are assessed by comparing with BOTOX® after regular visits conducted at 4,8,12 and 16 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 19 to 65 years old
* Subjects attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
* Those who understand and comply with clinical trial procedures and visit schedules
* Subjects who voluntarily decides to participate and signs the consent form after hearing the explanation of this clinical trial.

Exclusion Criteria

* Those with or accompanied by the following diseases at the time of screening

  1. Subjects with Neuromuscular Junction Disorder that may affect neuromuscular action
  2. Subjects with previous history of weakness or paralysis in the forehead area
  3. Subjects with infection, skin disorders, or scars at the glabellar region
* Subjects with wrinkles that physically prevent wrinkles from spreading, such as when wrinkles are not spread out by hand
* Subjects who is administering a drug with muscle relaxation within four weeks of screening.
* Subjects who have taken Aspirin and NSAIDs within 7 days prior to administration of the investigational drug
* Subjects with surgical history who may affect wrinkles around the forehead or glabellar region
* Subjects who have planned facial cosmetic procedure during the clinical trial
* Subjects who have been administered similar drugs within 12 weeks (Botulinum toxin type A) or within 16 weeks (Botulinum toxin type B) before screening
* Subjects who are expected to administer botulinum toxin preparations other than Investigational product during the clinical trial period
* Subjects with allergy or hypersensitivity to the botulinum toxin or their components
* A history of drug or alcohol abuse
* Anxiety disorders or other significant mental disorders based on the judgment of an investigator
* Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception
* Pregnant or lactating women
* Subjects with severe comorbidities or acute diseases that does not suitable for participation in clinical trials
* Those who participated in other clinical trials/clinical medical device trials within 30 days prior to screening and who received Investigational product/medical devices/procedures, or those who had less than 5 times the half-life of the Investigational product
* Subjects who are not eligible for this study based on the judgment of an investigator
Diagnosis of Pancreatic Cysts: Endoscopic Ultrasound With Fine Needle Aspiration (EUS/FNA), Direct Visualization, and Confocal Laser-induced Endomicroscopy-A Pilot Study

The purpose of this study is to assess the yield of combination modalities in the diagnosis of pancreatic cysts using EUS/FNA, Fiber optics (direct visualization probe), and prototype needle based confocal laser-induced endomicroscopy miniprobe (nCLE).

Data will be analyzed descriptively to include patient characteristics, procedural variables, and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for an EUS-FNA procedure of a pancreatic cyst,
* Aged above 18 years
* Granted written informed consent for the study can be included in the study.

Exclusion Criteria:

* Contraindication for undergoing EUS/FNA procedure (such as unwilling or medically unstable patients, patients with severe coagulopathy, patients with poor visualization on EUS for various reasons, etc)
* Pregnant or breastfeeding
* Allergy to fluorescein
* Renal insufficiency
A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants

The purpose of this study is to assess the relative biological availability and the effect of food on the drug levels of Danicamtiv in health adults.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2 inclusive
* Participants with resting heart rate ≥ 55 bpm
* Seasonal allergies that do not require medication at the time of the study are acceptable

Exclusion Criteria:

* Any acute or chronic medical illness
* Head injury, intracranial tumor, or aneurysm within 2 years prior to screening
* History of chronic gastrointestinal disorders or gastrointestinal (GI) surgery (including cholecystectomy) that could impact on drug and food absorption and/or drug excretion
Subcutaneous Contouring Using High Intensity Focused Ultrasound

The device delivers High Intensity Focused Ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to body sculpting, such as a reduction in waist circumference.


Eligibility Criteria:
Inclusion Criteria:

All of the following inclusion criteria must be met at the time of screening before the subject is enrolled into the study:

1. Male or female subjects, 18 to 65 years of age
2. Body Mass Index ≤30
3. Thickness of subcutaneous adipose tissue in the anticipated treatment area of ≥ 2.5 cm
4. Subjects must agree to not alter their normal and regular diet or exercise routines during the course of the study.
5. Subjects must be of African descent AND have Fitzpatrick skin types IV, V, or VI.

Exclusion Criteria:

A subject is ineligible to participate in this study if they meet any of the following exclusion criteria at screening:

1. Female subject who is pregnant (i.e., has a positive urine pregnancy test), is suspected to be pregnant, or is lactating or becomes pregnant during the course of the study. (NOTE: Females of childbearing potential must have a negative urine pregnancy test prior to enrollment in the study.)
2. Subjects diagnosed with coagulation disorders or are receiving anticoagulant therapy or medications or dietary supplements which impede coagulation or platelet aggregation.
3. Subject has diabetes or cardiovascular disease.
4. Subject has had any aesthetic procedure to the region to be treated.
5. Subject has systemic skin disease or skin disease in the areas to be treated.
6. Subject has any abnormality of the skin or soft tissues of the abdominal wall in the areas to be treated.
7. Subject has had previous open or laparoscopic surgery in the anticipated treatment area.
8. Subjects is on prescription or over the counter weight reduction medication or programs, or had weight reduction procedures (e.g.: gastric bypass, Lap-Band, etc.)
9. Subject has skin or superficial tissue that does not lie flat on its own when the subject is in the supine position.
10. Subjects undergoing chronic steroid or immunosuppressive therapy.
11. Subjects who have cardiac pacemakers or any implantable electrical device, e.g. pacemaker, defibrillator, or neurostimulators.
12. Subjects who have metal implants of any type in the area to be treated.
13. History of cancer.
14. Subjects who have sensory loss or dysesthesia in the area to be treated.
15. Subject currently uses illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day).
16. Subjects who cannot adhere to the study visit schedule (e.g., subjects not likely to stay in the study for a maximum of 27 weeks - screening through exit visit).
17. Subjects who are unable, or lack the capacity, to self consent.