cyrilzakka/clinical-trials huggingface dataset:
Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine

The primary purpose of this study is to compare the effect on 24-hour blood glucose patterns, HbA1c, and weight management when adding insulin glargine, or exenatide, or a combination of insulin glargine and exenatide to metformin.

The primary objective of this study was to characterize the diurnal glucose patterns produced by insulin glargine alone, exenatide (GLP-1 agonist) alone and the combination of insulin glargine and exenatide in subjects taking stable dose of metformin and to evaluate their efficacy in terms of improvement in glucose exposure, variability, stability, incidence of hypoglycemia and weight management.

An ancillary study was approved as part of this study. The purpose of the ancillary study was to use CGM to characterize the glycemic response to a fixed breakfast meal consumed by study participants receiving different medications.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects ≥18 and ≤75 years of age
* Clinical diagnosis of type 2 diabetes
* Diabetes duration ≥ 1 year
* HbA1c ≥7.0%
* Currently treated with metformin (HbA1c ≤9%) or metformin/sulfonylurea (SU) (HbA1c ≤8%)or SU alone (HbA1c ≤8%)

Exclusion Criteria:

* Previously treated with insulin or incretin-based therapy
* Treated with a thiazolidinedione within past 6 weeks
* Taken oral or injected prednisone or cortisone medications in the previous 30 days
* Any pancreatic disease or at high risk of pancreatitis (history of alcohol abuse, active gallbladder disease)
* Serum creatinine \>1.4mg/dL (women) or \>1.5 mg/dL (men)
* eGFR (Estimated Glomerular Filtration Rate) \<30 ml/min (using MDRD/ Modification of Diet in Renal Disease equation)
* ALT(Alanine Transaminase) \> 2x Upper Limit of Normal (ULN)
* Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise he subject's safety or successful participation in the study
* Currently pregnant or planning pregnancy during the study period
* Unable to follow the study protocol
* Unable to speak, read and write in English
* Uncontrolled hyperglycemia with HbA1c \> 9% on metformin or \>8% on SU or metformin/SU combination or ketonuria requiring immediate insulin therapy
* At the investigator's discretion for other medical or psychological reasons
Bivalirudin/Prasugrel Versus Abciximab/Clopidogrel in Patients Presenting With STEMI

In the setting of ST elevation myocardial infarction newer therapies has been recently studied and, following encouraging results, introduced into the clinical practice. Prasugrel showed to be a valid alternative to overcome limitation of clopidogrel therefore providing a better ischemic protection. On the other hand, bivalirudin is at least as beneficial as heparin/abciximab as anticoagulant agent but associated with fewer hemorrhagic events. The primary hypothesis of the study is that the combination of prasugrel plus bivalirudin can be associated with a better risk/benefit profile.

Background:

In the setting of STEMI, adjunctive pharmacological therapy plays a key role in the acute management. Along with the clear benefit of mechanical reperfusion strategies, several drugs showed to be beneficial. On top of clopidogrel, heparins and IIB/IIIa glycoprotein, other drugs have been recently introduced showing encouraging results. These "new" drugs, namely prasugrel and bivalirudin, have only been compared separately.

Primary hypothesis: the combination of prasugrel/bivalirudin is superior to the combination of clopidogrel and heparin/abciximab in terms of net adverse clinical events, i.e. ischemic events plus hemorrhagic events

Setting:

- patients presenting with ST-elevation myocardial infarction undergoing primary PCI

Mechanical reperfusion:

-primary percutaneous coronary intervention

Pharmacological Interventions:

- Two arms: Clopidogrel plus heparin/abciximab vs Prasugrel plus Bivalirudin

Follow up:

- 1 year

Measurements:

* efficacy end points in terms of reduction of ischemic events
* safety end points in terms of reduction of bleeding events

Eligibility Criteria:
Inclusion Criteria:

* ST elevation myocardial infarction
* No contraindication to primary PCI

Exclusion Criteria:

* Known intolerance/allergy to one of the study drugs or their components
* Clinical indication to treatment with oral anticoagulant, including use of warfarin or dabigatran or other oral anticoagulant agents
Motor rECovery witH eArly imagiNg In STroke

This study will contribute to the field of stroke rehabilitation research by expanding the investigator's understanding of the neural mechanisms responsible for the development and expression of abnormal flexion synergy, a primary movement impairment due to stroke. The study will longitudinally evaluate motor tract morphology and motor impairment/function in an attempt to develop early neuroimaging-based predictors of the development of flexion synergy and its impact on reaching and hand recovery (6 month). The study will utilize quantitative motor testing (kinematics and kinetics) to measure motor impairment and reaching and hand function. Both neuroimaging and quantitative motor testing will be conducted within 96 hours-, 2 weeks-, 3 months-, and 6 months-post stroke. The knowledge gained by this study will provide crucial structural and functional neuroimaging evidence that demonstrates the timeline of progressive ipsi- and contralesional motor pathway (including bulbospinal pathways) changes and the associated development of flexion synergy that grossly impacts reaching and hand function in individuals with moderate to severe stroke.


Eligibility Criteria:
Inclusion Criteria:

1. Stroke within the middle cerebral artery distribution based on brain MRI done within 48 hours of admission
2. 18 to 85 years old
3. Isolated motor deficits (hemiparesis) without significant aphasia, visual disturbances, or neglect based on the following scores on the NIH Stroke Scale: 1a (level of consciousness) = 0- Alert; keenly responsive. 1b (LOC questions) = 0- Asked month and age; Answers both correctly. 1c (LOC commands) = 0- Asked to open/close eyes, grasp/release hand; Performs both correctly. 2 (Best Gaze) = 0- Horizontal eye movements; Normal. 5 (Motor Arm) = 1, 2, 3, or 4- Arm placed at 90 (sitting) or 45 (supine), Drift, Some effort, No effort against gravity, or No movement. 7 (Limb Ataxia) = 0- Finger-nose-finger or heel-shin test; Absent. 8 (Sensory) = 0 or 1- Pin prick; Normal or Mild-to-moderate sensory loss. 9 (Best Language) = 0 or 1- Describe picture; No or Mild-to-moderate Aphasia. 11 (Extinction and Inattention) = 0 or 1- No abnormality or Inattention to one modality.

Exclusion Criteria:

1. Premorbid disability or sensorimotor impairment
2. Comorbidity medically contraindicating the administration of subsequent MRI scanning and motor assessments
3. Pain or hypersensitivity limiting motor assessment
4. Limb edema limiting motor assessment
University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol

The objective of this protocol is to use established standard criteria and methods for the collection of hMSC (human mesenchymal stromal cells) from healthy bone marrow donors. The hMSC collected from the donors will use to develop well-defined and reproducible cell banks. Standard manufacturing procedures and quality control testing methods will be used to characterize and evaluate the final cell product. After the cell banks are created, these cell products will be used in future translational or clinical research.

Cell banks will be manufactured and cellular products used for future translational or clinical research.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 35 years
* Willingness to provide written informed consent

Exclusion Criteria:

* Presence of risk factors for or clinical evidence of Human immunodeficiency virus (type 1 and 2), Hepatitis B, Hepatitis C, Human T-lymphotrophic virus (type I and II), Human transmissible spongiform encephalopathy (including Creutzfeldt-Jakob disease) treponema pallidum,
* Presence of communicable disease risk associated with xenotransplantation.
* Test positive for Human immunodeficiency virus (type 1 and 2), Hepatitis B, Hepatitis C, Human T-lymphotrophic virus (type I and II), cytomegalovirus (CVM), West Nile Virus, treponema pallidum.
* Use of investigational drug within 30 days or 5 half lives which ever is longer. Use of investigational implanted device.
* History of malignancy.
* Pregnancy
* In the opinion of the hematologist or the investigator, a condition that compromises the ability of the donor to safely provide BM donation.
The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy

This study is designed to compare the safety and efficacy of a commercially available mesh kit used for surgical repair of anterior vaginal wall prolapse with traditional suture repair surgery.

This is a multicenter, double blinded, randomized controlled trial, comparing Elevate® System with Interpro® Lite™, Anterior and Apical Prolapse Repair System (American Medical Systems) and Anterior Colporrhaphy (anterior suture repair) in women with symptomatic pelvic organ prolapse, who have opted to have surgical repair.

The goals of the study are to compare both efficacy and safety of the two procedures and to compare the surgical impact of mesh and suture repairs on vaginal function.

The principal investigator is from Mayo Clinic in Rochester, Minnesota. Mayo Clinic will serve as the data gathering and coordination site for this multicenter trial.

Eligibility Criteria:
Inclusion Criteria:

* Women with symptomatic pelvic organ prolapse who opt for a vaginal repair
* Require both apical and anterior compartment repairs
* Willing to return for follow-up visit
* Understand and have signed informed consent to undergo randomization
* Need both an apical and anterior repair
* All trial participants who have a uterus will require a hysterectomy

Exclusion Criteria:

* Known or suspected vulvodynia
* Known or suspected interstitial cystitis
* History of chronic pelvic pain
* Current pregnancy
* Desire to maintain fertility
* History of reconstructive pelvic surgery with synthetic mesh
* History of radical pelvic surgery
* History of pelvic radiation therapy
* Currently undergoing treatment for a malignancy
* Medically poor candidates for surgery
Safety and Efficacy Study of the NG Shield, a Device Intended to Reduce Pain and Discomfort Level Related to Nasogasstric Tube Usage

The purpose of the study i to demonstrate the safety and efficacy of a device that intends to reduce pain/discomfort related to nasogfastric tube usage by reducing the friction between the tube and internal orifice (nose and pharynx)using micro vibrations


Eligibility Criteria:
Inclusion Criteria:

1. Subject is in good health and able to undergoes the NG tube insertion procedure, according to the PI decision
2. Subject is able to understand and answer the pain and discomfort questionnaires
3. Subject has been fasting for at least 12h prior to the insertion phase
4. Subject underwent a physical examination by the PI
5. Subject able, agrees and signs the Inform Consent Form (ICF)

Exclusion Criteria:

1. Subject has any history of dysphagia or esophageal disease
2. Subject used anti pain medications during the last week prior to the study date
3. Subject used Antibiotics during the last week prior to the study date
4. Subject with Asthma
5. Subject with chronic or acute nasal or throat disorder
6. Subject who suffered from upper respiratory infection at least 7 days prior to the insertion procedure
7. Any pain from other source prior to the initiation of the study procedure according to the PI judgment and decision
8. Subject has any condition, which precludes compliance with study and/or device instruction for use
9. Subject is currently participating in another clinical study
Predictive Model of Axillary Nodal Status After Neoadjuvant Chemotherapy in Breast Cancer Patients

The management of patients diagnosed with breast cancer (BC) with axillary nodal involvement is still a controversial topic. These patients' treatment usually involves the administration of a neoadjuvant chemotherapy (NAC) in order to improve survival rates and increase local disease control. Depending on the tumor subtype, an axillary pathologic complete response (pCR) is achieved in 40-70% of initially axillary node-positive patients (cN+). Concerning patients with an axillary pCR, thus a clinically negative node status (cN0), axillary lymphadenectomy (ALND) might be replaced by less invasive surgical approaches and sentinel lymph node biopsy (SLNB) is considered, in these cases, an effective alternative treatment.

However, the relatively high false negative rates, reported in several validation trials, points out the complexity concerning these patients' treatment. Moreover, histological findings' predictive and prognostic value, after SLNB, of micrometastases and isolated tumor cells (ITCs) is still unclear.

Currently, dual-tracer-guided lymph node biopsy and the surgical removal of ≥ 3 sentinel lymph nodes are known as effective strategies aimed to reduce the false negative rates.

There are several ongoing clinical trials to understand and define the best approach for these patients.

Nowadays, there's great interest in potential prognostic role of systemic inflammation's biochemical markers such as neutrophil-to-lymphocyte ratio (NLR). Systemic inflammation's markers may be nodal pCR's predictors after NAC in node-positive breast cancer patients.

The aim of the study is to develop and validate a pre-operative model, able to predict pCR after NAC to select the patients suitable for a surgery de-escalation strategy.

This is a retrospective, observational, multicentric and no profit study. The study involves patients with diagnosis of cN+ breast cancer who underwent neoadjuvant treatment and then treated with lymph node biopsy or axillary lymphadenectomy, referring to the participating centers.

For each patient the following clinical-anamnestic information will be collected: age, pre-NAC blood cell count, tumor dimension, clinical staging (cT, cN), histological information (tumor subtype, grading, receptors' status, Ki-67 value), neoadjuvant treatment regimen, clinical and radiological local response after NAC, clinical and radiological nodal response after NAC, type of surgery, number of examined lymph nodes, number of positive lymph nodes, pathological staging after surgery (ypT, ypN).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of breast cancer confirmed by histological examination
* Patients who underwent neoadjuvant chemotherapy
* Axillary lymph nodes involvement at diagnosis (cN≥1), identified by clinical examination and/or imaging techniques and/or axillary lymph node cytology aspirate positive for breast cancer cells.

Exclusion Criteria:

* Patients with M+ at diagnosis
* Contraindications for neoadjuvant chemotherapy
Post Mastectomy Shoulder Problems and Kinesio Taping

Applications of new treatment modality which is Kinesio tape in post mastectomy shoulder problems.

Post-mastectomy complications are often noted and complaints by breast cancer survivors. It often involves the development of chronic arm pain with accompanying limitation of shoulder motion. Aim of the study was to investigate the effect of the kinesio tape (KT) on the shoulder pain and range of motion (ROM).

Method: 74 female patients underwent modified radical mastectomy were involved in this study. They were randomly divided into two groups, experimental who received KT for shoulder joint in addition to conventional physiotherapy program while, the control group received the physiotherapy program only. Outcome measures were visual analogues scale, shoulder ROM and shoulder Pain and Disability Index.

Eligibility Criteria:
Inclusion Criteria:

* Underwent modified radical mastectomy for at least 2 weeks and taking chemotherapy and radiation therapy for stage 1 or II breast cancer.
* Presence of shoulder pain with associated limitation of motion of the shoulder.
* Good compliance and willingness to participate in kinesio taping sessions with a written consent

Exclusion Criteria:

* Still diagnosed with active breast CA at the time of the study.
* Presence of skin hypersensitivity to kinesio tape material.
* Presence of treatment contraindications including the presence of a pacemaker, heart disease, pregnancy, infectious disease, epilepsy thrombophlebitis, arterial hypertension or metastatic cancer .
* Presence of mental disturbances of the sensorium or language problems which can make communication and cooperation problematic.
Skin Tone Preferences and Their Influence on Skin Care Behaviors

The purpose of this study is to classify participants by actual skin tone and skin tone preference and identify whether an association exists between these skin tone preferences and knowledge of skin care recommendations, attitudes towards healthy skin care, or skin care behaviors.

This study seeks to examine if there is a difference between ideal and actual skin tone among minority populations. In addition, we hope to assess whether various demographic factors as well as disparity between ideal and actual skin tone effect skin protective behaviors (i.e. sun screen use, dermatologist appointments, skin self-exams) or skin destructive behaviors (i.e. outdoor tanning, tanning salon use, use of skin lightening products) in minority populations.

Eligibility Criteria:
Inclusion Criteria:

* Subjects age 18 years old or older
* Self-identified members of a minority (African, Asian, Hispanic/Latino, American Indian, Alaskan native, etc.) population
* Subjects who are capable of completing an online, English survey

Exclusion Criteria:

* Subjects age 17 years old or younger
* Subjects not self-identified members of a minority (African, Asian, Hispanic/Latino, American Indian, Alaskan native, etc.) population
* Subjects who are incapable of completing an online, English survey
Diagnostic and Prognostic Value of p16INK4a Expression in Low Grade Squamous Intraepithelial Lesions of the Cervix.

P16INK4a has recently been described as a surrogate marker for HR-HPV associated squamous and glandular intraepithelial lesions of the cervix. The immunohistochemical staining pattern of p16INK4a in high grade intraepithelial neoplasia of the cervix (CIN 2 and 3) is diffuse, whereas in CIN 1 different staining patterns (diffuse, sporadic, focal or negative) can be seen. The aim of our study is to find out whether the p16INK4a staining pattern of CIN 1 is able to predict the outcome of the lesion. The retrospective part of the study includes cervical biopsies of 200 patients with CIN 1 and clinical follow-up for at least 5 years. p16INK4a staining and HPV detection by IHC will be correlated to clinical outcome.The prospective part of the study includes 300 patients with CIN 1 and LSIL on cytology. HPV detection by HCII and p16INK4a immunohistochemistry on liquid based cytology samples as well as p16INK4a staining and HPV detection by ISH on colposcopy guided biopsies will be correlated to clinical follow-up and colposcopy findings. Slides are analysed by 2 pathologists without knowledge of clinical data.


Eligibility Criteria:
Responsible women \> 18 years with histologically proven CIN 1
Innervation of Vascularized Iliac Transplant Avoids Resorption in Jaw Bone Reconstruction

The purpose of this study is to determine the efficacy of simultaneous innervation to prevent graft bone resorption in maxillofacial reconstruction. It may provide basis for future clinical trials and new strategies for improving the functional reconstruction of large jaw bone defects.

The use of autograft is still the main method for reconstructing large defects of jaw bones. However, the spontaneous resorption of the graft bone is still severe, and hinders the success of dental implant(s) and chewing function even after microsurgical vascularization. But till now, there is no effective prevention method for this major problem. Based on previous studies, the investigators pioneered a simultaneous innervated vascularized iliac bone graft method, through neurorrhaphy between the nerves innervating iliac bone and recipient site. A clinical retrospective study showed that this new method significantly decreases postoperative osteoporosis, and ensures the success of dental implants (Refer to our published article Wang L\*, Wei J, Yang X, Yang Z, Sun M, Cheng X, Xu L, Lei D, Zhang C\*. Preventing early-stage graft bone resorption by simultaneous innervation: innervated iliac bone flap for mandibular reconstruction. PlastIc Reconstructive Surgery, 2017, 139(5):1152e-1161e, Cover Featured Article).

The investigators intend to randomly divide the vascularized iliac bone graft cases into traditional group without innervation and simultaneous innervation group (through neurorrhaphy between the nerves innervating iliac bone flap and recipient site). The efficacy of simultaneously innervated maxillofacial reconstruction for preventing graft bone resorption will be assessed using bone mineral density test of grafted bone, as a blinded method. The innervation and sensation of the internal oblique abdominis muscle island will be tested using neuroelectrophysiological examination. The recipient nerve having the best effect on preventing bone resorption, will be determined using hierarchical comparison method.

Eligibility Criteria:
Inclusion Criteria:

1. Patients between the age of 17 to 65 years (to avoid possible postmenopause osteoporosis), irrespective of gender.
2. Post resection segmental defect of mandible between 5-9 cm long.
3. Acceptable systemic conditions like nonmenopausal-related osteoporosis, Diabetes mellitus, in controlled normal range.
4. Patients agreeing to sign the informed consent form.

Exclusion Criteria:

1. Advanced malignant tumors.
2. Poor general condition, who can not tolerate vascularized bone flap reconstruction.
3. History of drugs affecting bone metabolism, like bisphosphonates, calcium agents or others.
The Impact of Mitotane Therapy on Serum Free Proteins in Patients With Adrenocortical Carcinoma

This work will evaluate the effects of mitotane treatment on serum protein concentrations in patients treated for ACC with mitotane therapy and compare them to patients with an adrenal neoplasm and pregnant cohort. All of the individuals were treated at King's Hospital between April 2019 and June 2020. Proteins which will be evaluated during this study, include CBG and TBG.

Background: Adrenocortical Carcinoma (ACC) is a rare malignancy of the adrenal cortex. The annual incidence of ACC is thought to be between 0.5-2.0 cases per million. Adjunctive therapy with mitotane may be offered post- surgically to minimise risk of recurrence.

Aims: Evaluate the effects of mitotane treatment on serum protein concentrations in patients treated for ACC with mitotane therapy and compare to patients with an adrenal neoplasm and a pregnant cohort. Patients were treated at King's Hospital between April 2019 and June 2020.

Methods: Cortisol, TFT's ACTH, CBG, TBG and gonadotrophins will be measured during the same venepuncture using serum samples. SPSS v27 and GraphPad Prism v9.3.1 will be used for analysis and illustrations. Thirty-five patients will be included, within ACC with mitotane, adrenal neoplasm or pregnant groups. Data will be tested for normality, described as Mean± SD, compared using paired sample t-test with 5% p-value for significance and 95% confidence interval (CI).

Eligibility Criteria:
Inclusion Criteria: An individual being investigated for a malignant neoplasm treated with mitotane or matched number of patients with adrenal neoplasm not treated with mitotane under the Endocrinology team or a matched cohort of pregnant women.

Patients included in the analysis were seen in the period between April of 2019 and June 2020 at King's College Hospital NHS Foundation Trust.

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Exclusion Criteria:

* Patients not investigated for a malignant neoplasm/ adrenal neoplasm under the Endocrinology team or were a matched cohort of pregnant women at King's College Hospital NHS Foundation Trust during the period Someone under the age of 18