cyrilzakka/clinical-trials huggingface dataset:
Glucose Monitoring in Tissue Transfers

The purpose of this study is to determine if 1) a continuous glucose monitoring system can measure glucose levels in transferred tissue during reconstructive surgery, and 2) if glucose measurements from a continuous glucose monitoring system correlate with tissue blood perfusion.


Eligibility Criteria:
Inclusion Criteria:

* presence of a soft tissue deformity where reconstruction with a pedicled or free tissue transfer is indicated
* age 18 and over
* ability to follow-up post-operatively

Exclusion Criteria:

* age less than 18
* prisoner status
* inability to participate in a standard post-operative follow-up visit
Study of DAC Combined With HAAG Regimen in Newly Diagnosed Younger AML Patients

The purpose of this study is to evaluate the safety and efficacy of DAC combined with HAAG regimen in the induction treatment of newly diagnosed AML patients younger than 60 years.

This is a phase 3, randomized, controlled, multi-center study in newly diagnosed AML patients younger than 60. The patients will be randomized to receive either DAC combined with HAAG or IA regimen in the induction treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia.
2. Age 18-59.
3. ECOG score: 0-2.
4. Treatment related or secondary AML.
5. No history of previous chemotherapy or target therapy.
6. Provide informed consent.

Exclusion Criteria:

1. Patients are pregnant or lactating.
2. Patients have acute promylocytic leukemia or chronic myeloid leukemia in blast crisis.
3. Patients with another malignant disease.
4. Patients with uncontrolled active infection.
5. Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
6. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL.
7. Patients with creatinine clearance rate \< 50ml/min.
8. Patients with active hepatitis B or hepatitis C infection.
9. Patients with HIV infection.
10. Patients with other commodities that the investigators considered not suitable for the enrollment.
BiOSS Study (BiOSS LIM C Stent Registry in Bifurcated Lesions)

The BIOSS Lim C pharmacoactive Stent has characteristics of design that makes it very suitable for the treatment of bifurcational lesions . The objective of the study is providing deeper knowledge into the results of this stent in the treatment of bifurcational lesions.

The BIOSS Lim C pharmacoactive Stent has characteristics of design that makes it very suitable for the treatment of bifurcational lesions . The objective of the study is providing deeper knowledge into the results of this stent in the treatment of bifurcational lesions.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years.
* Clinical indication of coronary angioplasty in bifurcated lesion.
* Bifurcated lesions with both distal branches at least 2 mm in diameter.
* The lesion must be located in the main branch, with a severe stenosis by visual estimation at some point in the main branch, with or without involvement of the lateral branch.
* Express acceptance and signature of informed consent.

Exclusion Criteria:

* Express rejection of the patient to participate in the study.
* Exclusive involvement of the lateral branch (Medina lesion 001).
* Contraindication for antiplatelet treatment.
* Lesions due to restenosis.
* Lesions in saphenous grafts.
* Total chronic occlusions.
* Cardiogenic shock.
Periprosthetic Bone Remodeling Around Uncemented Components in Total Hip Arthroplasty

This is a randomized clinical trial comparing two different uncemented femoral stems and two different uncemented sockets using Dual-energy x-ray absorptiometry, Radiostereometry and clinical evaluation.

Hypothesis:

1. A short uncemented stem gives less periprosthetic bone resorption in the proximal femur than a conventional uncemented stem.
2. An uncemented acetabular component with a backside of three-dimensional Titanium porous construct gives less periprosthetic bone resorption than a backside covered with a conventional porous coating with Titanium-beads and a hydroxy-apatite layer.

Consecutive patients 40-70 years old who are being planned for Total Hip Arthroplasty (THA) will be eligible for inclusion in the study.

Periprosthetic bone remodeling, migration of the components and clinical scores will be recorded prospectively.

Eligibility Criteria:
Inclusion Criteria:

1. Age 40-70 years old
2. Primary osteoarthritis of the hip
3. Type A or B femur according to Dorr10
4. Femoral anatomy allowing implantation of both femoral stems
5. Willingness and ability to follow study-protocol -

Exclusion Criteria:

1. Inflammatory arthritis
2. Abnormal femoral anatomy after hip dysplasia, not suitable for implantation of components
3. Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months prior to surgery
4. Ongoing oestrogen treatment
5. Type C femur according to Dorr
6. Not suited for the study for other reason (surgeons preference)
Exercise Training and Metabolic Syndrome

The present study aimed to determine the effects of 16 weeks of aerobic interval training on quality of life and a set of clinical biomarkers.

Besides the traditional metabolic syndrome risk factors (dyslipidemia, raised blood pressure, central obesity and dysglycemia) subclinical disorders related to chronic inflammation and cell damage have been reported on metabolic syndrome. Therefore, regarding the systemic feature of metabolic syndrome, we investigated an new approach of aerobic interval training on several clinical biomarkers widely used. Such training used differs from current aerobic protocols in order to attenuate metabolic and musculoskeletal overload on untrained and unhealthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Having metabolic syndrome according to international diabetes foundations definition (IDF).
* Age between 35 - 60 years and untrained subjects.

Exclusion Criteria:

* Musculotendinous or osteoarticular injuries in the lower limbs and/or spine
* Chronic pulmonary diseases
* Neurological disorders
* Kidney failure
* High-risk cardiovascular diseases (Unstable angina pectoris, Uncompensated heart failure, complex ventricular arrhythmias or myocardial infarction during the last month).
Registry on NeVa VS for CerebraL VAsospasm ManagemenT in Post SAH PatiEnts

A multi-center, observational registry study intended to assess the HDE-approved NeVa VS cerebral artery dilation device in patients with symptomatic cerebral vasospasm caused by aneurysmal subarachnoid hemorrhage (aSAH)


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥22
2. Symptomatic cerebral vasospasm secondary to aneurysmal subarachnoid hemorrhage (aSAH) in the internal carotid artery (ICA), middle cerebral artery (MCA), anterior cerebral artery (ACA), posterior cerebral artery (PCA), or basilar artery (BA)
3. Vessel dilation procedure was performed with the NeVa VS
4. Subject or legal representative is able and willing to give informed consent within 3 days (72 hours) post-index procedure

Exclusion Criteria:

* None
Study About Effect of Preoperative Bowel Preparation Versus no Bowel Preparation Before Spinal Surgery

This study investigated the effect of preoperative bowel preparations for patients undergoing spinal fusion surgery.

This was a randomised clinical trial with one control group and two treatment groups.

Forty-five elective spinal fusion patients were randomised into three groups who received preoperative treatment with either enema of sorbitol and docusat natrium, Bisacodyl suppository or no bowel preparation.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing spinal fusion surgery
* Age 15 years or older
* The patients had to understand oral and written Norwegian.
* Postoperative pain management via epidural catheter should have been planned.
* Exclusion Criteria:
* Constipation
* Regularly use of enema
The Cancer of the Pancreas Screening-5 CAPS5)Study

Johns Hopkins clinical research office quality assurance group will monitor and audit this study at Johns Hopkins. The Sub Investigator at each site will be responsible for internal monitoring at their site.

The Sub Investigator at each site will be responsible for internal monitoring at their site. The site sub Investigator and study team will report any serious adverse events to Principal Investigator and annually report adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Hereditary Pancreatitis or
* Peutz-Jeghers Syndrome or
* Strong family history of pancreas cancer on one side of the family tree or
* Confirmed germline mutation carrier (BRCA2, FAMMM (CDKN2A/p16), PALB2, BRCA1, ATM, HNPCC, Lynch Syndrome (hMLH1, hMSH2, PMS2, hMSH6, EpCAM) PRSS1, PRSS2, R122H, N291l, SPINK1, CFTR
* Endoscopic evaluation of pancreas scheduled

Exclusion Criteria:

* Medical comorbidities or coagulopathy that contraindicate endoscopy
* Prior surgery that prevent optimal endoscopic ultrasound such as partial or complete gastrectomy with Bilroth or Roux-en-Y anastomosis
* Stricture or obstruction in the upper GI tract that does not allow passage of the echoendoscope
* Poor performance status
* Inability to provide informed consent
* Pregnancy.
PK of Meropenem in Patients on Plasma Exchange

Therapeutic plasma exchange (TPE) has been shown to be an important procedure for treatment of a variety of refractory immune complex disorders, such as Guillain-Barré syndrome and neuromyelitis optica. The intervention removes plasma, albumin, or some other substance. Meropenem is a broad-spectrum beta-lactam antimicrobial agent that is used for the treatment of serious nosocomial infections. Pathophysiological changes in patients on TPE can alter the pharmacokinetic (PK) patterns of coadministered antibiotics. This effect has an impact on the antimicrobial agents when paticipants are administered during the intervention. The aim of this study was to investigate the impact of TPE on meropenem PK.


Eligibility Criteria:
Inclusion Criteria:

* age≥ 18 years
* no shock
* hemoglobin ≥ 7 g/dl

Exclusion Criteria:

* pregnancy or breast-feeding female
* history of hypersensitivity to carbapenems
* renal replacement therapy
Value of Ankle Pressure Index After Maximal Exercise Tests

Estimate the response of ankle to brachial pressure index to incremental maximum exercise in subjects free from prior cardiovascular disease.

Estimate morbi-mortality of included patients over a 5 years follow up.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old and more

Exclusion Criteria:

* patient with recent cardiovascular event
Early Psychological Intervention After Rape

The aim of the study is to translate and adapt a brief treatment protocol based on prolonged exposure provided within 72 hours after a rape to a Swedish context and pilot test feasibility and delivery in ten executive patients recruited at the Emergency Clinic for Rape victims in Stockholm.

The aim of the study is to translate and adapt a brief treatment protocol based on prolonged exposure provided within 72 hours after a rape to a Swedish context and pilot test feasibility and delivery in ten executive patients recruited at the Emergency Clinic for Rape victims in Stockholm.

ENDPOINTS The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), Beck Depression Inventory (BDI) at baseline and post-treatment.

Insomnia Severity Index (ISI) , Multidimensional Scale of Perceived Social Support (MSPSS), World Health Organization Disability Assessment Schedule(WHODAS-12) at post-treatment.The clinician-administered PTSD scale for DSM-5 (CAPS-5) at follow up.

Data on feasibility aspects of the intervention will also be collected: compliance to the intervention/homework/assessments, possibilities to recruit, adverse events.

Recruitment The investigatorors will recruit ten consecutive patients attending at the Emergency Clinic for Rape victims at Stockholm South Hospital, Sweden.

Safety parameters Participants had the opportunity to report any adverse events during treatment, at posttreatment and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Attending at the Emergency Clinic for Rape victims at Stockholm South Hospital, Sweden within 72 hours after experiencing a rape)
* Remembered the event.

Exclusion Criteria:

* ongoing suicidal ideation or attempted suicide within the last two months
* ongoing self-harm behavior
* ongoing intoxication
* other serious psychiatric comorbidity (ongoing psychotic symptoms or manic episode)
* low cognitive capacity
* not fluent in Swedish
* subjected to ongoing violence or threat
Thromboelastometry Prediction Utility for Risk of Abortion

This study will use thromboelastometry in ED patients with vaginal bleeding, as well as healthy pregnant controls, to determine if abnormal results are associated with the presence of vaginal bleeding as well as later complications during pregnancy.

First, a case control study with samples collected from patients in the ED and OB clinic at Mount Sinai Hospital will be performed. Blood samples are being collected at time of study entry. Patient health history will be collected and blood samples will be tested using thromboelastometry in prospective fashion. Samples will be compared between groups.

A prospective cohort will then be established using the subjects from the case control study. The purpose of this prospective cohort will be to collect outcomes of pregnancies to determine association with the initial thromboelastometry results.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will include pregnant women seen in the ED and OB clinic.

The ED patients will include those seen for vaginal bleeding during pregnancy at less than 20 weeks gestation.

OB Clinic patients will include those seen for first prenatal visit at which blood draw is performed, as long as this is also within 20 weeks estimated gestational age.

Exclusion Criteria:

* Patients with known histories of recurrent miscarriage, previously diagnosed thrombophilia, or other coagulopathy will be excluded.
* Patients with ectopic pregnancies will also be excluded.
Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer

The purpose of this study is to evaluate the safety, performance and usability of the Xoft Axxent Electronic Brachytherapy System and Cervical Applicator as incorporated into the physician's current standard treatment practice and in replacement of high-dose-rate after-loaders using Iridium-192 or low-dose-rate Cesium treatments. Data will be collected on treatment delivery, safety, and acute toxicity.

Our hypothesis is that the treatment is safe as incorporated into the physician's current standard of practice.


Eligibility Criteria:
INCLUSION CRITERIA:

* Brachytherapy is indicated after EBRT for all cases of locally advanced disease (Stages Ib2 - IVA)
* Inoperable Stage Ia1 and Stage Ia2 may be treated with tandem-based brachytherapy alone
* Inoperable Stage Ib1 should be treated radically with brachytherapy in conjunction with EBRT. Concurrent chemotherapy may be considered at the physician's discretion and based on the presence of high risk features.
* Subjects can be treated with brachytherapy regardless of lymph node status, grade, and presence of lymphovascular invasion, tumor size, age, or histology.
* Medically fit for general or spinal anesthesia, or conscious sedation, for the insertion process
* Subjects of childbearing potential must have a negative serum pregnancy test at Screening inclusion Criteria:

EXCLUSION CRITERIA:

* Medical Contraindications to Brachytherapy (scleroderma, collagen vascular disease, active lupus )
* Prior pelvic radiotherapy with brachytherapy
* Hemoglobin level at screening \< 8
* Life expectancy \< 6 months
Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients

This trial is conducted in Europe. The aim of this trial is to assess the effect of somatropin (Norditropin®) replacement therapy on the left ventricular mass of adult patients with a growth hormone deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Childhood or adult onset growth hormone deficiency (GHD)
* GHD evidenced by two stimulation tests
* Duration of GHD at least 5 years
* Other hormone deficiencies associated with growth hormone deficiency

Exclusion Criteria:

* Pregnancy or pregnancy desired during the suggested duration of the study
* Personal history of colonic polyp or family history of colonic polyposis
* Known insulin-dependent or non-insulin-dependent diabetes
* Cardiovascular disease, left ventricular hypertrophy from other aetiology, recent auricular or ventricular arrhythmia, history of vascularisation by aortocoronary bypass significative mitral or aortic valvular disease, preexcitation syndrome, auriculoventricular conduction delay, bradycardia-tachycardia syndrome, left ventricular mass interfering treatment
* BMI (Body Mass Index) at least 30
* Growth hormone treatment during the 24 months prior to inclusion, history of treatment with extractive pituitary growth hormone, allergy or suspected allergy to somatropin therapy
* Patient who has participated in a different clinical study within the past two months
* Any condition which, in the opinion of the Investigator or the Scientific Committee, may interfere with successful implementation of the study
* Notion of breast cancer for the mother or the sister
To Study the Impact of CPAP on Gait Parameters in OSA Patients

To study the impact of CPAP therapy on gait in patients with obstructive sleep apnea syndrome.

To study the impact of CPAP therapy on gait velocity and temproral gait in patients with obstructive sleep apnea syndrome using the SMTEC system. Patients will be assessed before and 8 weeks after CPAP therapy.

Eligibility Criteria:
Inclusion Criteria:

* OSA patients newly diagnosed

Exclusion Criteria:

* acute medical illness in the past months
* neurological and psychiatric diseases
* orthopaedic, rheumatologic or any sensory conditions affecting normal walking
Coupler-Based Hearing-Aid Fitting Approach for Experienced Users

The overall aim of the study is to compare the verification accuracy and hearing-aid outcomes between the traditional, fitting approach where the patient is present during the visit and a coupler-based fitting approach where the patient is not present and mailed their hearing aids. If the coupler-based fitting protocol tested in this study as effective as the traditional fitting protocol, then patients receiving replacement hearing aids may circumvent a face-to-face visit.

This study will incorporate a verification technique that simulates the patient's actual ear during probe microphone verification measurements, called real-ear to coupler difference (RECD). Because the patient's ear is not used during the RECD measurement, but rather simulated, the patient would not need to be present during the RECD verification. This RECD hearing aid verification can occur in the clinic after which the hearing aids will be mailed to the patient. This study will compare the fitting accuracy and outcomes between the two approaches.

Eligibility Criteria:
Inclusion Criteria:

* no more than a moderate sensorineural hearing loss (defined as \< 60 dB HL pure-tone average at 500, 1000, and 2000 Hz AU)
* experienced BTE hearing-aid users who are obtaining replacement VA-issued BTE hearing aids coupled to a custom earmold that is simply an upgrade in model with the same style earmold
* ability to read and write in English as determined by reading a few sentences from the consent document aloud so that self-report measures can be completed

Exclusion Criteria:

* outer or middle ear pathology as determined by otoscopy, immittance, and/or audiometric testing (e.g., conductive or mixed losses)
* lack of phone or non-use of the phone as the participants will be required to conduct a telephone interview after they obtain their replacement hearing aids
* unwilling or unable to be mailed hearing aids
* co-morbid condition that would preclude their participation as determined by a chart review
Use of the VisuMax Femtosecond Laser Lenticule Removal Procedure for the Correction of Hyperopia

The correction of farsightedness using ReLEx SMILE for hyperopia is focus of this investigation. The objective is to evaluate the safety and effectiveness.

The VisuMax laser keratome is an ophthalmic surgical femtosecond laser intended for use in patients requiring corneal incisions. The cutting action of the VisuMax laser keratome is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused, ultra-short pulses, delivered through a disposable applanation lens while fixating the eye under a low vacuum. ReLEx SMILE combines state-of-the-art femtosecond laser technology of the VisuMax with high-precision lenticule extraction to provide minimally invasive refractive correction. It is distinguished by its flapless, minimally invasive laser correction. A refractive lenticule is created in the intact cornea, but removed via a small incision. The changed form of the cornea corrects the refraction error. ReLEx SMILE for myopia is a well-established treatment with extensive supporting published evidence for efficacy and safety. It is CE marked and available since 2011; more than 1 Million procedures have been performed worldwide. The correction of farsightedness using ReLEx SMILE for hyperopia is focus of this investigation and is therefore not yet CE marked.

Eligibility Criteria:
Inclusion Criteria:

* Normal corneal topography;
* Predicted post-operative keratometry ≤51 D;
* Contact lens wearers must stop wearing their contact lenses before baseline measurements according to local requirements of the clinic;
* Patients should be able to understand the patient information and willing to sign an informed consent;
* Patients should be willing to comply with all follow-up visits and the respective examinations;
* Patients with hyperopia or hyperopia with astigmatism (attempted correction: sphere up to +6.00D, cylinder up to 5.00D and maximum hyperopic meridian up to +7.00D);
* The corrected distance visual acuity should be 20/25 or better in each eye pre-operatively;
* A difference between cycloplegic and manifest refractions of ≤1.00 D spherical equivalent in the eye to be treated;

Exclusion Criteria:

* The patients presenting at least one of the characteristics as described for exclusion criteria in the documentation set of the VisuMax laser keratome ReLEx SMILE option.
* Mixed astigmatism
* Any impaired person (minors, pregnant or breast feeding women or persons incapable of giving consent) are definitely excluded from the study.
Fast Magnetic Resonance Imaging as Compared to Computed Tomography Scan in Pediatric Orbital Cellulitis Imaging

The aim of the study is to compare orbital and central nervous system (CNS) imaging with Computed Tomography (CT) scan to that of Fast Magnetic Resonance Imaging (Fast MRI) in children with mild, moderate or severe orbital cellulitis with medical indications for imaging.


Eligibility Criteria:
Inclusion Criteria:

* Children with orbital cellulitis with indications for imaging

Exclusion Criteria:

* All others