cyrilzakka/clinical-trials huggingface dataset:
Dexcom G6 for Total Pancreatectomy With Islet Autotransplantation (TPIAT) Patients

A single-center prospective trial on the effects of standard of care radiation exposure on the Dexcom G6 continuous glucose monitoring (CGM) device.

To determine if standard of care radiation exposure longitudinally effects the accuracy and precision of the G6 transmitter in the post TPIAT in-patient population.

Reduce burden for patients to remove and waste a functional and expensive Dexcom G6 CGM for radiologic procedures.

Eligibility Criteria:
Inclusion Criteria:

* Planned TPIAT at CCHMC
* Staying in-patient at CCHMC post TPIAT
* Planned to receive a Dexcom G6 CGM

Exclusion Criteria:

• Hemo- or peritoneal dialysis
Clinical Evaluation of Stability of Implants Placed in Partially Edentulous Maxilla With Poor Bone Quality Via New Reverse Drilling Technique Versus Osteotome Technique.

The study will compare between osteotome technique and New Reverse Drilling Technique in the placement of dental implant in posterior maxilla , primary outcome will be Implant stability that will be measured by Periotest device . follow up for 6 month.

secondary outcomes will be crestal bone loss , pain and swelling.


Eligibility Criteria:
Inclusion criteria:

1. Partially edentulous patients in the maxillary posterior region.
2. Systemically healthy patient.
3. Presence of proper inter-arch space for placement of the implant prosthetic part.
4. Sufficient bone height and width for implant placement (bone height ≥10mm and bone width ≥6mm).
5. Non-smoker.
6. Patients who are ≥ 20 years old.
7. Good oral hygiene.
8. Acceptance of a one year follow-up period.
9. Informed consent is provided by the patient.

Exclusion criteria:

1. Patients with systemic conditions that may interfere with implant stability,
2. Patients with local pathological defects related to the area of interest.
3. Unmotivated, uncooperative patients with poor oral hygiene.
4. Patients with habits that may jeopardize the implant longevity and affect the results of the study such as alcoholism or parafunctional habits.
5. Inadequate inter-arch space for implant prosthetic part
Efficiency of a Small-peptide Enteral Feeding Formula Compared to a Whole-protein Formula

An early and efficient enteral nutritional support could improve the clinical outcomes of brain injured critically ill patients. Gastrointestinal feeding intolerance defined as an increased gastric residual volume frequently occurs in these patients.

Previous experimental studies have suggested that a small-peptide enteral feeding formula could promote the gastric emptying compared to a whole-protein formula. An improved gastrointestinal tolerance of enteral nutrition should allow a rapid increase in the daily caloric intake and enhance nutritional support of brain injured critically ill patients.

This open-labelled prospective randomized trial aims to compare 2 groups of patients: the Study Group and the Control Group. The randomization process will concern the allocation of the type of enteral feeding formula administered for nutritional support: Peptamen® AF in the Study Group, and Sondalis® HP in the Control Group. 2 centers are involved in this study.

Each patient admitted in the critical care unit will be assessed for eligibility. After written informed consent is obtained from relatives, patient without any exclusion criteria will be included in the study.

The allocation of the type of enteral nutritional feeding formula will be randomized after inclusion.

Enteral nutrition according to the randomization group will start within the 48 hours of admission and up to 10 days, if requested. Beyond the 10th day, all patients will receive standard enteral nutrition formula.

After inclusion, data regarding efficacy and tolerance will be assessed daily up to day 10.

Mortality and outcome will be assessed at day 28 and at day 60.

Eligibility Criteria:
Inclusion Criteria:

* Admission in our surgical critical care unit.
* Traumatic brain injury.
* Non-traumatic brain injury: stroke, intracranial and/or subarachnoid hemorrhage, subdural and/or extradural hematoma.
* Expected duration of mechanical ventilation \> 48 hours.

Exclusion Criteria:

* Abdominal surgery in the previous 30 days.
* Pregnancy.
* Breast-feeding.
* Hemodynamic instability defined as infusion of norepinephrine \> 3 mg/h, or epinephrine \> 1 mg/h, or as increasing needs in vasopressive or inotropic drugs.
Urology Database to Evaluate Clinical Information and Improve Patient Care.

The purpose of initiating the Urology Database is to evaluate the outcomes of urology procedures and medical management to enhance the care and treatment of urology patients.

The current study population will include all patients having had a radical prostatectomy for the treatment of prostate cancer, surgical prolapse repair as well as patients having had InterStim sacral nerve stimulator implantation. The database will house data extracted from the medical records. Patient demographics, and preoperative, intra-operative, postoperative, and follow-up clinical data will be collected.

Eligibility Criteria:
Inclusion Criteria:

All patients undergoing radical prostatectomy, pelvic organ prolapse repair and neurostimulator (Interstim) implantation at William Beaumont Hospital beginning January 1, 1998, as well as other urology patients as research questions are identified. Only patients who have accepted William Beaumont Hospital's Privacy Notices will be included in the database.

Exclusion Criteria:

Patients not acknowledging acceptance of William Beaumont Hospital's Privacy Notices.
Cosmetic Outcome of Electrocautery, Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions

This study will compare the cosmetic scar result from the use of scalpel, electrocautery, and pulsed electron avalanche knife (PEAK) PlasmaBlade (PPB) for the initial skin incision for total mastectomy procedures without immediate breast reconstruction.

It is hypothesized that there will be no significant difference in mastectomy scar cosmesis.

The purpose and objectives of this study are:

1. To evaluate and compare the cosmetic scar result from the use of scalpel, standard electrocautery, or PEAK PlasmaBlade for initial incision for total mastectomy procedures without immediate breast reconstruction.
2. To inform future equipment choices for breast surgery including potential elimination of scalpels and their attendant risks.

Scalpel, electrocautery, and PEAK PlasmaBlade (PPB) have all been shown to be safe techniques for surgical incision, but no study has proven the superiority for cosmesis for PPB incision when compared to conventional electrocautery or scalpel.

The investigators propose a double blind prospective randomized controlled study of consecutive patients scheduled for total mastectomy +/- axilla staging without immediate breast reconstruction to evaluate the cosmetic scar result from the use of scalpel, standard electrocautery or PEAK PlasmaBlade.

Scar cosmesis will be evaluated postoperatively at two-to-four weeks, six months, and twelve months by two independent observers blinded to the equipment used, and patient reported outcomes will be reported using the validated SCAR-Q questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Patients having a total mastectomy with or without axilla surgical staging

Exclusion Criteria:

* Patients having immediate breast reconstruction
* Patients with a diagnosis of inflammatory breast cancer
* History of keloid scar formation
* History of connective tissue disorder (scleroderma or rheumatoid arthritis with skin involvement)
* Patients with prior incision at the planned mastectomy site.
* Patients with known suture hypersensitivity
* Patients with evidence of current infection
Study of Efficacy of Induction Chemotherapy With Gemcitabine and Carboplatin for Operable Non-small-cell Lung Cancer Before Surgery

To study the activity of chemotherapy with Gemzar-carboplatin in the preoperative setting for operable stages of non-small-cell lung cancer and to identify novel molecular markers correlated with chemosensitivity and prognosis


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven, newly diagnosed primary bronchogenic non-small cell lung cancer
* Measurable or evaluable tumour on chest X-ray or CT scan.
* No multiple ipsilateral or contralateral parenchymal tumours
* Stage I(exceptT1N0),II,IIIa disease as shown by PET-CT
General Anesthesia and Paravertebral Blocks vs. General Anesthesia Only: Influence Inflammation Factors and Clinical Outcomes in Modified Radical Mastectomy

Regional anesthesia and analgesia may maintain immune function, reduce surgical stress, and also reduce volatile anesthetics and opioids requirements. Local anesthetic drugs used in regional anesthesia and analgesia work to have anti-proliferative and cytotoxic effects on cancer cells. Pro-inflammatory cytokines such as IL-1, IL-6, and TNF-alpha increase in levels in peripheral nerves, spinal cord, brain (brain stem, locus sereleus, thalamus, hippocampus, and prefrontal cortex) after peripheral nerves are injured. The anti-inflammatory cytokine IL-10 is decreased in levels after peripheral nerve injury. The balance between pro-inflammatory and anti-inflammatory cytokines affects the severity of pain.


Eligibility Criteria:
Inclusion Criteria:

* Patient with breast cancer (stadium Ia, Ib, IIa, IIb, IIIa, IIIb) undergoing MRM surgery
* Balinese race
* ASA physical status I, II, III

Exclusion Criteria:

* History of allergy to drugs used in anesthesia
* History psychiatric disorder
* History of perioperative transfusion
* History of autoimmune disease
* History of taking beta blockers or anti-platelet aggregation medications
* Previous breast surgery
* Spine deformity
* Coagulopathy
* Local infections in paravertebral block site
* Decreased renal function
* Neurological deficits
* Peptic ulcer
Diabetes Research on Patient Stratification

The overarching goal of the IMI DIRECT (Innovative Medicines Initiative Diabetes Research on Patient Stratification) Consortium is the identification of biomarkers that aid therapeutic targeting in prediabetes (Study 1) or early onset type 2 diabetes (Study 2).

There are two multicentre prospective cohort studies within the glycaemic deterioration work package of IMI DIRECT (WP2). These two cohorts are designed to address the area of glycaemic deterioration by amassing data and biomaterials that will be used to discover novel biomarkers for glycaemic deterioration in people at high risk of developing type 2 diabetes (Study 1) and in those who have recently been diagnosed with the disease (Study 2).

Eligibility Criteria:
Study 1

Inclusion criteria

* No treatment with insulin-sensitising, glucose-lowering or other antidiabetic drugs
* Fasting capillary blood glucose \<10 mmol/l at baseline
* White European (self-report of parental ethnicity)
* Age ≥35 and \<75 years

Exclusion criteria

* Diagnosed diabetes of any type, HbA1c ≥6.5% (48 mmol/mol) or fasting plasma glucose ≥7.0 mmol/l or 2 h plasma glucose \>11.0 mmol/l previously
* For women, pregnancy, lactation or plans to conceive within the study period
* Use of a pacemaker
* Any other significant medical reason for exclusion as determined by the investigator

Study 2

Inclusion Criteria:

* Patients diagnosed with type 2 diabetes not less than 6 months and not more than 24 months before baseline examination
* Management by lifestyle with or without metformin therapy
* All HbA1c \<7.6% (\<60 mmol/mol) within previous 3 months
* White European
* Age ≥35 and \<75
* Estimated GFR \>50 ml/min'

Exclusion Criteria:

* Type 1 diabetes

  * A previous HbA1c \>9.0% (\>75 mmol/mol)
  * Prior treatment with insulin or an oral hypoglycaemic agent other than metformin
  * BMI \<20 or \>50 kg/m2
  * Pregnancy, lactation or plans to conceive within the study period
  * Any other significant medical reason for exclusion as determined by the investigator
Evaluation of Circulating Neutrophils in Antisynthetase Syndrome

Antisynthetase syndrome (ASyS) is a rare and heteregeneous overlapping connective tissue disease, characterized by myositis, interstitial lung disease (ILD), joint involvement, Raynaud's phenomenon and cutaneous manifestations ("mechanic's hands"). Over 50% of patients develop ILD, which is the leading cause of death.

The role of neutrophils - innate immune cells involved in inflammatory processes and induced in particular by cytokines of the Th17 pathway - during AS is unknown. Direct pathogenic role of neutrophils has been described during idiopathic inflammatory myopathies, with an increase of netosis correlated with disease activity and muscle damage. During ASyS, a higher number of alveolar neutrophils has been observed in patients with rapidly progressive ILD.

There are few data on the specific evaluation of circulating neutrophils in ASyS. Investigators suppose that circulating neutrophils level could represent a simple and accessible severity biomarker in patients with ASyS.

The main objective is to evaluate the diagnostic performance of the circulating neutrophils level (\> 7000/mm3) at diagnosis on ASyS severity.

The secondary objectives are:

* to define a threshold for circulating neutrophils levels at diagnosis allowing to predict ASyS severity and to assess the diagnostic performance of this threshold.
* to study the correlation between the level of circulating neutrophils and ASyS severity at diagnosis of the disease.
* to compare the circulating neutrophils level at ASyS diagnosis and after 1 year of treatment.
* to compare patients characteristics according to ASyS severity at diagnosis.
* to compare BAL fluid neutrophils level according to ILD severity at ASyS diagnosis in patients with ILD.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ASyS diagnosis according to Connors criteria

Exclusion Criteria:

* Active infection at ASyS diagnosis
* Evolutive cancer at ASyS diagnosis
* Corticosteroid therapy initiation before circulating neutrophils evaluation
Effects of Prismatic Spectacle Lenses on Symptoms of Dizziness, Headache and Anxiety as Caused by Vertical Heterophoria

The purpose of this study is to demonstrate whether, in patients diagnosed with Vertical Heterophoria, the symptoms of dizziness, headache and / or anxiety are reduced or eliminated when a kind of correction called vertical prism is added to the patient's normal eye glass prescription.

The experiment will involve giving the patient two pairs of glasses (one pair containing the baseline prescription with vertical prism (Standard Treatment Glasses) and the other pair containing the baseline prescription but without vertical prism (Placebo Glasses)) to demonstrate which pair of glasses is most effective in reducing the symptoms of dizziness, headache and / or anxiety in these patients.


Eligibility Criteria:
Inclusion Criteria:

* First time appointment for a patient at designated optometry office for treatment of symptoms associated with Vertical Heterophoria
* Must have symptoms of dizziness or headache or both:

  * Dizziness defined as one or more of these: lightheadedness,dizziness, vertigo, feeling off-balance, lack of coordination / "clumsy", unsteadiness while walking or drifting / veering to one side while walking, motion sickness
  * Headache defined as one or more of these: pain anywhere in the head,posterior neck / upper trapezius (upper back), face, and in and / or around the eyes
* Duration of symptoms greater than 4 months
* Evaluated for these symptoms previously by at least 1 other doctor (General Practice, Family Practice, Internal Medicine, Neurology, ENT, Emergency Medicine, Pediatrics, PM\&R, Ophthalmology).
* Age \>14
* The patient (or their representative) must be able and willing to fill out extra paperwork
* All Patients to be seen by same Optometrist for all visits
* Must be willing to wear glasses.
* The patient (or their representative) must be able to sign informed consent
* Must have a driver for Follow Up visits where Control and Treatment Glasses are dispensed, and when Washout period is initiated
* Must have a driver for Follow Up visits where Control and Treatment Glasses are dispensed, and when Washout period is initiated
* Must have previous negative Neuroimaging (HCT or MRI) that was ordered to assess for headache and / or dizziness

Exclusion Criteria:

* Previous diagnosis of strabismus, vertical heterotropia, CN 3, 4 or 6 palsy, "lazy eye"
* Previous eye injury or eye operation (including RK and Lasik)
* Diagnosis of glaucoma
* Diagnosis of cataracts
* Diagnosis of proptosis
* Previous C-spine surgery / fusion
* Previous Rx contains prismatic correction
* \>18 PD of exophoria
* \> 4 PD of vertical heterophoria on Initial Exam
Efficacy of MySkin Patch for the Healing of Burn Wounds: a Randomised Controlled Trial

Evaluation of clinical efficacy of my skin (hydrogel and polyurethane film) plus best practice clinical care in subjects with burn injuries with particular regard to: 1) Wound healing (complete reepithelialization), 2) the patient's pain. In the context of the study will be collected secondary outcomes related to type of lesion and its clinical evolution through the analysis of the items in the scale of the PSST.


Eligibility Criteria:
Inclusion Criteria:

* Presence of at least one injury burn covered by a dressing of 10x8 cm (80 cm2)
* Injury treated with medication in use at the center
* Patients assisted at the emergency care, or at the outpatient
* Extension of the lesion less than 80 cm2 (including dressings in cm10x8cm)
* Patient age greater than or equal to 18 years
* Patients who have given consent to enrollment in the trial and the processing of personal data
* Patient / lesion that has already been recruited in the study or who have previously passed a period of 10 days (washout) of "no treatment" according to the research protocol

Exclusion Criteria:

* A end-stage of disease
* Suspected or known allergic diathesis to the product of medication
* Subjects that do not give consent to data processing
* Dry lesion with necrosis or eschar
* Presence of both local and systemic infection or inflammation
* Injuries that to the decision of the provider of care, needs a targeted local treatment other than as provided for in the Protocol
* Patient / lesion that has already been previously recruited into the study, before a period of 10 days (washout) of suspension from the same research protocol
* Patients who use alternative medicine treatments such as aloe
Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of MNS075 (Intranasal Morphine)

The purpose of this study is to characterize the repeat dosing plasma profile, extent of accumulation and repeat dose pharmacokinetics of morphine, morphine-3-glucuronide, and morphine-6-glucuronide during administration of MNS075 in two different, clinically-relevant dosing schedules.

This study is an open label, randomized, two-treatment, two-period, two-sequence, single-center, crossover study comparing the pharmacokinetics, safety and tolerability of MNS075 (intranasal morphine) at doses of 7.5 mg self-administered q1h for 7 hours (8 doses) and 15 mg self-administered q3h for 9 hours (4 doses).

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers 18 years of age or older

Exclusion Criteria:

* History of alcohol, drug addiction, or substance abuse.
* Known to or suspected to be currently abusing alcohol or drugs.
* Allergy or hypersensitivity to shellfish or opioids.
* History of seizures.
* Clinically significant structural or functional abnormalities of the nose and upper airway, obstruction of the nasal passages, or mucosal lesions of the nostrils.
* Smoked or used tobacco or nicotine products in the past six months or expects to during the study.
* Positive for hepatitis B or hepatitis C or HIV antibodies.
Diagnostic and Prognostic Value of PTEN Expression in Functional and Pathological Endometrial Biopsies

endometrial hyperplasia may progress to endometrial adenocarcinoma. the exact possibility of such progression is not determined. there a need to detect biological markers that can help in detecting high risk cases of patients with endometrial hyperplasia that may progress to endometrial adenocarcinoma. PTEN is a tumor suppressor gene that inhibit cell migration, proliferation and may induce apoptosis in damaged cells. variable expression of PTEN in functional, hyperplastic and neoplastic endometrial tissues may be of great help in detecting cases of hyperplasia that may progress to endometrial adenocarcinoma.

Adenocarcinoma of the endometrium is the most prevalent invasive tumor of female genital tract. Endometrial carcinoma is divided to 2 different types as regards to genitical and phenotypical features, type I endometrial carcinoma represents more than three quarters of all cases. Type I is inevitably preceded by hyperplastic changes in the endometrium. However, the malignant potential of endometrial hyperplasia to carcinoma is markedly variable and subjected to interobserver variations. Determine of novel biological markers for detection of precancerous endometrial hyperplasia that may proceed to endometrial adenocarcinoma is a must. PTEN is a tumor suppressor gene. it inhibits cell mitosis and migration. PTEN induce the damaged cells to pass in apoptosis. Low levels of PTEN expression noted in many human malignancies as melanoma, mammary and ovarian carcinomas.

The aim of this study is to evaluate the expression of PTEN (by immunohistochemistry) in different endometrial biological conditions as endometrial hyperplasia and primary endometrial adenocarcinoma specimens, and correlate that expression to PTEN expression in physiological endometrial specimens.

Eligibility Criteria:
Inclusion Criteria:

* all cases of endometrial biopsies and hystrectomy specimens diagnosed as endometrial hyperplasia and/or primary endometrial adenocarcinoma.
* all cases of normal endometrium obtained from hystrectomy specimens due to other pathological conditions as prolapsed uteri, uterine leiomyoma and adenomyosis.

Exclusion Criteria:

* autolysed samples, very tiny specimens cervical tissues and specimens with histological picture of endometritis.