cyrilzakka/clinical-trials huggingface dataset:
Confocal Endomicroscopy for Barrett's Esophagus

The purpose of this study is to determine if confocal laser endomicroscopy (CLE) can improve detection of Barrett's esophagus, dysplasia, and early esophageal cancer.

Barrett's esophagus is a leading cause of esophageal adenocarcinoma. Detection of dysplasia and early cancers in Barrett's esophagus can be challenging, time-consuming and expensive. Small lesions may be difficult to detect with standard endoscopy protocols. Confocal laser endomicroscopy (CLE) is a new type of endoscopy where a small confocal microscope is built into the tip of a standard endoscope. For this study, we are comparing confocal laser endomicroscopy (CLE) with targeted biopsies with standard endoscopy (EGD)and biopsy for Barrett's esophagus to determine if CLE is more effective for detecting dysplasia and cancer.

Participants with Barrett's esophagus in this study undergo 1) CLE with targeted mucosal biopsies (biopsy only taken if CLE shows abnormal tissue) and 2) standard EGD with biopsies. The order of procedures is randomized (some patients have CLE first while others have standard EGD first).

Eligibility Criteria:
Inclusion Criteria:

* Barrett's esophagus or suspected Barrett's-associated neoplasia
* Age \> 18
* Able to give informed consent

Exclusion Criteria:

* Known advanced malignant disease
* Allergy to the fluorescent contrast agent fluorescein sodium
* Coagulopathy or bleeding disorder
Early Intermittent Intensive Insulin Therapy as an Effective Treatment of Type 2 Diabetes (RESET-IT Pilot Study)

Type 2 diabetes mellitus is a chronic metabolic disorder characterized by progressive deterioration in the function of the pancreatic beta-cells, which are the cells that produce and secrete insulin (the hormone primarily responsible for the handling of glucose in the body). The investigators propose a pilot randomized controlled trial to determine whether intermittent intensive insulin therapy is an effective therapeutic strategy that can preserve pancreatic beta-cell function and maintain glycemic control early in the course of type 2 diabetes.

In this study, eligible patients with type 2 diabetes will be randomized to either intermittent insulin therapy or continuous metformin therapy, after both arms have first undergone a short course of intensive insulin therapy. The hypothesis under study is whether intermittent insulin therapy can better preserve beta-cell function.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women between the ages of 30 and 80 years inclusive
2. T2DM diagnosed by a physician \</= 5 years prior to enrolment
3. Negative for anti-glutamic acid decarboxylase (anti-GAD) antibodies
4. On either no anti-diabetic medication or on metformin monotherapy, with no change in dose/regimen within 4 weeks prior to enrolment
5. A1c at screening between 5.5% and 9.0% inclusive if on metformin, or between 6.0% and 9.5% inclusive if on no oral anti-diabetic medication
6. BMI \>/= 23 kg/m2
7. Negative pregnancy test at recruitment for all women with childbearing potential

Exclusion Criteria:

1. Current anti-diabetic treatment with insulin, sulfonylurea, thiazolidinedione, alpha-glucosidase inhibitor, GLP-1 agonist or dipeptidyl peptidase-4 inhibitor
2. Type 1 diabetes or secondary forms of diabetes
3. History of hypoglycemia unawareness or severe hypoglycemia requiring assistance
4. Any major illness with a life expectancy of \<5 years
5. Hypersensitivity to insulin, metformin or the formulations of these products
6. Renal dysfunction as evidenced by estimated glomerular filtration rate (eGFR) \<50 ml/min
7. Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, previous liver transplant) or transaminases \>2.5 X upper limit of normal
8. History of congestive heart failure
9. Excessive alcohol consumption, defined as \>14 alcoholic drinks per week for males and \>9 alcoholic drinks per week for females
10. Unwillingness to administer insulin therapy or perform capillary blood glucose monitoring at least 4 times per day while receiving IIT
11. Pregnancy or unwillingness to use reliable contraception. Women should not be planning pregnancy for the duration of the study or the first 3 months after the study. Reliable contraception includes birth control pill, intra-uterine device, abstinence, tubal ligation, partner vasectomy, or condoms with spermicide.
12. Non-adherence to the induction phase or any factor likely to limit adherence to the study protocol, in the opinion of the investigator
Effect of Power's Program of Gluteus Maximus on LBP

Low back pain (LBP) is highly prevalent that causes significant pain and disability. Core muscles are important for LBP. One of them is gluteus maximus, but effect of power's program for this muscle and its role in LBP is lacking in literature, so this study aims to study the effect of power's program of gluteus maximus on LBP.

Chronic mechanical low back pain (CMLBP) is a common musculoskeletal dysfunction affecting 53% of Egyptian population and 1.4 to 20.0% worldwide.

which is a major social and economic burden. Patients with CMLBP experience time loss of work and recently became a workforce burden. Giving the fact that back pain is widely prevalent across Egyptian population and by addressing the functional deficits in those patients, Proper physical therapy intervention can help reducing such burden and improve over all work performance. The 'Powers Program' is a recent concept and it had been proven to be effective in improving lower extremity function and biomechanics. Up to the knowledge of the primary investigator, GMax strengthening using this program has not been conducted in patients with CMLBP. Studying this approach may benefit physical therapists by providing an evidence-based approach in treating patients with CMLBP through exercise therapy and improve functional performance of these patients therefore they can return to normal activities faster. Moreover, this study may benefit researchers interested in Gluteus maximus (GMax) muscle strength. We believe that this study may open up more rooms for future research to address such an important issue.

Eligibility Criteria:
Inclusion criteria

* Both sex.
* Age 21-45 years.
* Chronic mechanical liw back pain for more than 3 years.
* Body mass index 18.4-29.9 kg/m\^2.

Exclusion criteria

* Back pain due to specific pathology.
* postoperative
* Trauma to lower quadrant with past 6 months.
* Radicular pain. Lumbar instability.
Dexmeditomedine Versus No Sedation in Management of Agitation in COPD Patients Receiving Noninvasive Ventilation

The aim is to compare sedation using dexmedetomidine to sedation -free approach in management of agitated COPD patients receiving NIV

The aim is to compare sedation using dexmedetomidine to sedation -free approach in management of agitated COPD patients receiving NIV

Eligibility Criteria:
Inclusion critera

* age\>18
* Agitation
* NIV intolerance Exclusion criteria
* cardiac dysfunction
* Hepatic dysfunction
* Haemodynamic instability
PK and Safety Evaluation of Daptomycin in Children Ages 2-6 With Proven or Suspected Gram-positive Infections

This is a research study designed to look at the pharmacokinetics (distribution, breakdown, and removal) and tolerability of a single dose of daptomycin in patients aged 2 to 6 years who have infections that are caused by a specific group of bacteria (called Gram-positive bacteria).


Eligibility Criteria:
Inclusion Criteria:

* Written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care;
* Male or female between the ages of 2 and 6 years old, inclusive;
* Able to comply with the protocol for the duration of the study;
* Clinically stable with no evidence of hemodynamic instability (defined as a requirement for pharmacological intervention to manage blood pressure) in the 72 hour window prior to enrollment, and no history or evidence of renal or hepatic compromise;
* Suspected or diagnosed Gram-positive infection for which the subject is receiving standard antibiotic therapy;
* A calculated creatinine clearance rate (CLcr) ≥ 80 ml/min/1.73m2 as determined by the Schwartz equation at baseline;
* Creatine phosphokinase (CPK) levels less than 2X ULN (upper limit of normal) at baseline.
* Presence of two patent intravenous lines (or comparable means of venous access) prior to dosing on Study Day 1.

Exclusion Criteria:

* Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry;
* Known allergy/ hypersensitivity to daptomycin;
* History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematologic, autoimmune disease or primary immune deficiency;
* Pneumonia as sole Gram-positive infection being treated with standard antibiotics;
* Subjects with clinically significant abnormal laboratory test results \[including electrocardiograms (ECGs)\], as determined by Investigator;
* Administration of rifampin within 7 days of study drug administration;
* Body mass index (BMI) that is outside of the 5th to 95th percentile;
* Subjects in whom collection of the required blood volume would put them at risk of hemodynamic disturbance (at the discretion of Investigator);
* History of or current clinically significant (at the discretion of the Investigator) muscular disease, nervous system or seizure disorder;
* Administration of intramuscular injection between baseline and study drug administration or expected intramuscular injection within 24 hours following dosing;
* Expected surgical procedure(s) within 24 hours prior to and following dosing;
* Unexplained muscular weakness, history of peripheral neuropathy, Guillian-Barre or spinal cord injury;
* History of or current rhabdomyolysis.
Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy

This study describes a single center, randomized, single-blinded clinical trial to assess the clinical benefits of the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands during total thyroidectomy. It compares risk-benefits and outcomes in patients undergoing total thyroidectomy where NIRAF detection with PTeye for parathyroid identification is either used or not used.

Inadvertent damage or excision of a healthy parathyroid gland (PG) following a total thyroidectomy (TTx) could result in transient hypocalcemia (\< 6 months) in 5 - 35% of cases or permanent hypocalcemia (\> 6 months) in 7% of the patients (1, 2). In both of these circumstances, patients would require calcium and active vitamin D supplementation in addition to a potentially prolonged hospital stay and/or unplanned hospital readmission adding to unnecessary burden and healthcare costs. These complications could be minimized with label-free intraoperative PG identification using near infrared autofluorescence (NIRAF) detection with a fiber-probe based approach as utilized in 'PTeye', which is medical device that was recently FDA-cleared. However, the true impact of this particular NIRAF-based approach on patient outcomes is yet to be determined

The aim of this prospective single blinded randomized study is to compare 2 groups of patients: TTx patients operated using NIRAF detection technology with PTeye as adjunct tool (NIRAF+) vs. patients operated without the adjunct technology (NIRAF-). The main objective of this study is to assess the benefit of intraoperative use of NIRAF detection technology via PTeye during TTx procedures with regard to postoperative hypocalcemia, PG identification, PG auto-transplantation and inadvertent resection rates compared to standard of care.

Eligibility Criteria:
Inclusion Criteria:

(i) All patients eligible for total thyroidectomy (TTx), with or without lymph node dissection. (includes patients undergoing a TTx who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid).

(ii) All patients undergoing completion thyroidectomy.

Exclusion Criteria:

(i) Patients with concurrent parathyroid disease.

(ii) Patients with incidental enlarged parathyroid discovered during TTx.

(iii) Patients undergoing thyroid lobectomy/partial thyroidectomy.
Deep Sequencing of the Breast Cancer Transcriptome

This project is a pilot study designed to investigate transcriptional regulation in breast cancer. Although the main focus of the present study will be triple negative breast cancer where all of the clinically relevant receptors - estrogen receptor (ER), progesterone receptor (PR) and herceptin (HER2) - are absent, all breast tissue biospecimens, including normal and mammary dysplasia, stored in the UAMS Tissue bank, procured from outside collaborators or purchased from commercial vendors will eventually be investigated. We will use high throughput molecular profiling techniques such as microarrays and next generation sequencing to correlate gene expression and gene expression regulation with clinical parameters such as tumor size, time to relapse and overall survival.


Eligibility Criteria:
Inclusion Criteria:

* There is no inclusion criteria. This study is a retrospective tissue bank study analyzing tissue collected from a previous clinical trial. No subjects will be enrolled.

Exclusion Criteria:

* There is no exclusion criteria. This study is a retrospective tissue bank study analyzing tissue collected from a previous clinical trial. No subjects will be enrolled.
Role of Femoral Nerve Block on Prevention of Postoperative Deep Venous Thromboembolism

To investigate whether preemptive analgesic of femoral nerve block could prevent deep venous thromboembolism due to inhibiting the excessive release of neutrophil elastase and inflammatory cytokines.

Femoral nerve block is an effective analgesic mode in patients after total knee arthroplasty. In recent studies, there has been shown that a large amount of neutrophil elastase release from neutrophils could induce the development of deep venous thromboembolism and femoral nerve block may reduce the incidence of the development of deep venous thromboembolism. In addition, inflammatory cytokines including interleukin-1(IL-1), IL-6, IL-8 and tumor necrosis factor(TNF) were associated with deep venous thromboembolism. Thus, the investigators hypothesised that preemptive analgesic of femoral nerve block could prevent deep venous thromboembolism due to inhibiting the excessive release of neutrophil elastase and inflammatory cytokines.

Eligibility Criteria:
Inclusion Criteria:

* adult patients scheduled for total knee arthroplasty under general anesthesia

Exclusion Criteria:

* ASA physical status Ⅳ-Ⅴ,
* psychiatric illness,
* chronic opioid consumption,
* patient refusal,
* coagulopathy,
* peripheral neurological injury,
* local anesthesia drug allergy,
* preoperative existing deep venous thromboembolism.
Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer

The study will include 50 patients newly diagnosed with low-risk thyroid cancer ranging from 18-80 years of age. After scheduling their surgeon visit, the investigators will enroll patients and measure their intended treatment choice, baseline awareness of the three treatment options, expected outcomes, self-efficacy, and activation. The participants will then be randomized 1:1 and deliver the CQUPLE intervention to the intervention group. The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit. The study team will repeat all measures prior to the surgical consult and after the surgical consult. The study team will record the patients' actual treatment choice after the consult.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80 years
* Low risk papillary thyroid cancer or highly suspicious for cancer

  * Low risk papillary thyroid cancer

    * cT1-2: Tumor size 4 cm or smaller and limited to the thyroid on ultrasound
    * cN0: No evidence of lymph node metastasis on ultrasound
    * cM0: No evidence of distant metastasis on imaging
  * Highly suspicious for cancer

    * Cytology meeting Bethesda V or Bethesday III or IV with molecular testing indicating a 70% risk of greater of thyroid cancer
    * Nodule size 4 cm and smaller
    * Limited to the thyroid on ultrasound
    * No evidence of suspicious lymph nodes
    * No evidence of thyroid cancer outside of the neck
* Referred for surgical consultation.

Exclusion Criteria:

* History of previous thyroid cancer or thyroid surgery and parathyroid surgery
* Non-English speaking
* Deaf

Subject Selection (for Surgeons)

Surgeon Inclusion Criteria

* Performs at least one thyroid surgery annually on adults
* Credentialed at Michigan Medicine

Surgeon Exclusion Criteria

* None
Primer Aligner Study

To demonstrate that a primer aligner product can achieve similar results to the currently marketed product.

The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have fully erupted dentition
* Age range ≥18 years old (Adult subject)
* Subjects who are indicated for either: 5, 7, 10, or 12 aligner sets

Exclusion Criteria:

* Subject who has unerupted, erupting, partially erupted dentition (except for 2nd and 3rd molars)
* Subject who has mixed dentition
* Subject with periodontal disease
* Subject with active caries
* Subject with Temporomandibular Joint Disorders symptoms
* Subject has undergone pre-treatment with any orthodontic appliance 3 months prior to the start of treatment
* Subject has undergone any accelerated orthodontic treatment prior to or during treatment as part of this study
* Subject has known allergy to latex or plastic
* Subjects who are pregnant or will become pregnant during treatment
Evaluation of the Immunogenicity and Safety of Concomitant Administration of Novel Oral Polio Type 2 Vaccine and Bivalent Oral Polio Vaccine

The study will assess and compare the immune response and safety following the co-administration of Novel Oral Polio Type 2 (nOPV2) and bivalent Oral Polio Vaccine (bOPV) in comparison with nOPV2 or bOPV in infants aged 2 months who have never received vaccination against poliomyelitis.


Eligibility Criteria:
Inclusion Criteria:

1. Infants aged 8 weeks (-1, + 2 weeks) with birth weight \>2,500 gm.
2. Healthy infants without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of corticosteroids or immunotherapies that preclude the subject to be in the study as established by the medical history and physical examination.
3. Written informed consent obtained from 1 or 2 parent(s) or legal guardian(s) as per country regulations.

Exclusion Criteria:

1. Infants who have received previous vaccination according to the National Immunization Program (NIP) (i.e. vaccination against poliomyelitis and/or receipt of diphtheria-tetanus-whole cell pertussis-hepatitis B-Haemophilus influenzae type b \[DTPw-HB-Hib vaccine\]).
2. Infants with anyone under 10 years of age in their household (living in the same house or apartment unit) who does not have complete "age appropriate" vaccination status with respect to poliovirus vaccines at the time of study vaccine administration according to the Dominican Republic NIP.
3. Infants having a member of their household (living in the same house or apartment unit) who is under 6 months of age at the moment of study vaccine administration.
4. Infants having a member of their household (living in the same house or apartment unit) who has received oral polio vaccine (OPV) in the previous 3 months before study vaccine administration.
5. Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the subject's household.
6. Family history of congenital or hereditary immunodeficiency.
7. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
8. Known allergy to any component of the study vaccines or to any antibiotics, that share molecular composition with the nOPV2 vaccines.
9. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
10. Acute severe febrile illness at day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all inclusion criteria are met.).
11. Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.
Effects of an Intermittent Reduced Calorie Diet on Crohn's Disease

The purpose of this study is to see how an Intermittent Calorie Reduced Diet (IRCD) that mimics fasting (also known as a fasting mimicking diet, FMD) effects inflammation in patients with mild to moderate Crohn's disease (CD). The diet may allow users to receive the benefits of fasting while also being able to enjoy food (the ingredients of which are GRAS (generally recognized as safe) by the Food and Drug Administration (FDA). Research on dietary interventions and CD are very limited. Diets that mimick fasting have been studied with support of the National Institute of Health and published in leading journals. This research investigates whether markers of inflammation decrease and/or quality of life increases after five-day periods of the IRCD, and may provide rationale for its use to treat CD.

As above

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate Crohn's disease (CDAI score 151-450)
* Between the ages of 18-70 (inclusive)

Exclusion Criteria:

* Women who are pregnant, nursing or expect to be pregnant
* Individuals allergic to nuts
* Individuals with a body mass index (BMI) lower than 18
* Individuals diagnosed with a serious medical condition (unless approved in writing by a physician)
* Individuals who have been severely weakened by a disease or medical procedure
* Individuals who are taking medication which may not be safely consumed with a calorie restricted diet
* Individuals with diabetes who are taking anti-diabetic drugs associated with risk of hypoglycemia
* Individuals with more than mild-moderate cardiovascular disease or life-threatening cancer (as determined by patient's physician) unless approved by a physician
* Individuals with history of severe cardiac disease (particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF \< 40%)
* Individuals with a history of syncope
* Individuals with dietary needs incompatible with the IRCD meal plan
* Individuals with liver or kidney disorders that may be affected by very low glucose and protein content of the diet
* Patients on a calorie restricted diet will also be excluded
* Patients with relevant prior gastrointestinal surgery and consequences such as short bowel syndrome, ostomy of small or large intestine,total colectomy, proctocolectomy, ileoanal pouch will be excluded (not excluded are patients with resection of terminal ileum, resection of short strictures of the small intestine, hemicolectomy).